clinicaltrials.gov search results 11/12/2021

ClinicalTrials.gov Search Results 12/17/2021

NCT Number Title Other Names Status Conditions Interventions Characteristics Population Sponsor/Collaborators

FunderType

Dates Locations

1 NCT05161130 Predicting Outcomes AfterLumbar Fusion for DegenerativeDisease

Study Documents:

•Statistical Analysis Plan

Title Acronym:

FUSE-ML

Other Ids:

FUSE-ML

Completed •Low Back Pain

•Disk HerniatedLumbar

•Spinal StenosisLumbar

•Procedure: LumbarSpinal Fusion

Study Type:

Observational

Phase:

Study Design:

•Observational Model:Cohort

•Time Perspective:Retrospective

Outcome Measures:

•Visual Analogue Scale forBack Pain

•Visual Analogue Scale forLeg Pain

•Oswestry Disability Index

Enrollment:

1115

Age:

18 Years and older (Adult, OlderAdult)

Sex:

All

•Bergman Clinics

•MICN Lab,UniversityHospital Zurich

•Other Study Start:

January 1, 2021

Primary Completion:

November 1, 2021

Study Completion:

November 1, 2021

First Posted:

December 16, 2021

Results First Posted:

No Results Posted

Last Update Posted:

December 16, 2021

•Medical University of Innsbruck,Innsbruck, Austria

•La Pitié Salpetrière Hospital,Paris, France

•Department of Neurosurgery,Bergman Clinics, Naarden,Netherlands

•Bergman Clinics, Naarden,Netherlands

2 NCT05161117 Virtual Reality Fall Education forCaregivers

Study Documents:

Title Acronym:

Other Ids:

21-247

Recruiting •Accidental Fall

•Nurse's Role

•Behavioral: Virtualreality simulationapp for caregivereducation

•Behavioral: onlinefall preventioneducation module

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: Randomized

•Intervention Model: ParallelAssignment

•Masking: None (OpenLabel)

•Primary Purpose: Other

Outcome Measures:

•Change from baselinerating of self-reporteduse of environmental fallprevention interventions at1 month and 3 months postintervention

•Change from baselinerating of perceivedeffectiveness ofenvironmental fallprevention interventions at1 month and 3 months postintervention

Enrollment:

288

Age:

Child, Adult, OlderAdult

Sex:

All

•The ClevelandClinic


March 31, 2021

Primary Completion:

March 31, 2022

Study Completion:

March 31, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Cleveland Clinic AkronGeneral, Akron, Ohio, UnitedStates

•Cleveland Clinic Avon Hospital,Avon, Ohio, United States

•Cleveland Clinic EuclidHospital, Euclid, Ohio, UnitedStates

•Cleveland Clinic HillcrestHospital, Mayfield Heights,Ohio, United States

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https://ClinicalTrials.gov/show/NCT05161130



https://ClinicalTrials.gov/ProvidedDocs/30/NCT05161130/SAP_000.pdf




FunderType

Dates Locations

3 NCT05161104 A Multicenter Cross-sectionalStudy of Cardiac UltrasoundPhenotypes in Patients WithSepsis

Study Documents:

Title Acronym:

Other Ids:

K2021-10-001

Enrolling byinvitation

•Cardiac UltrasoundPhenotypes

•Septic MyocardialSuppression

•HyperdynamicState LeftVentricularFunction in SepsisPatients

•Outcome

Study Type:

Observational

Phase:

Study Design:

•Observational Model:Case-Crossover

•Time Perspective: Cross-Sectional

Outcome Measures:

• in-hospital mortality

•28-day mortality

• length of stay in the ICU

•number of days ofmechanical ventilation

Enrollment:

200

Age:


Sex:

All

•Fujian ProvincialHospital


November 23, 2021

Primary Completion:

November 23, 2024

Study Completion:

November 23, 2025

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Fujian Provincial Hospital,Fuzhou, Fujian, China

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FunderType

Dates Locations

4 NCT05161091 Efficacy of Orosol® in theTreatment of Chemo- andRadiation-induced Mucositis.

Study Documents:

Title Acronym:

OROSOL

Other Ids:

•RBHP 2021DEVOIZE(OROSOL)

•2021-A00488-33

Not yetrecruiting

•Oral Mucositis •Device: Topicalapplication ofOrosol®

•Device: Topicalapplicationof Placebocomparator

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Quadruple(Participant, Care Provider,Investigator, OutcomesAssessor)

•Primary Purpose:Treatment

Outcome Measures:

•Demonstrate theeffectiveness of thecurative treatment withOrosol® on mucositisscore (WHO)

•Demonstrate theeffectiveness of thecurative treatment withOrosol® on mucositisscore (NCI-CTCAE v3.0)

•Demonstrate theeffectiveness of thecurative treatment withOrosol® on oral feeding(NCI-CTCAE v4.0)

•Assessment of generalstate of health of the mouthwith Oral AssessmentGuide (OAG) scale "itemvoice"

•Assessment of generalstate of health of the mouthwith Oral AssessmentGuide (OAG) scale "itemswallowing"

•Assessment of generalstate of health of the mouthwith Oral AssessmentGuide (OAG) scale "itemtongue aspect"

•Assessment of generalstate of health of the mouthwith Oral AssessmentGuide (OAG) scale "itemsalivation"

•Assessment of generalstate of health of the mouthwith Oral AssessmentGuide (OAG) scale "itemmucous membrane andgums"

•Assessment of generalstate of health of the mouthwith Oral AssessmentGuide (OAG) scale "teeth"

•Assessment of generalstate of health of the mouthwith Oral AssessmentGuide (OAG) scale "lips"

•Burning sensation

•Pain intensity

Enrollment:

54

Age:


Sex:

All

•UniversityHospital,Clermont-Ferrand


December 2021

Primary Completion:

January 2024

Study Completion:

January 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Centre Jean-Perrin, Clermont-Ferrand, France

•CHU clermont-ferrand,Clermont-Ferrand, France

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FunderType

Dates Locations

5 NCT05161078 Carpediem Outcomes in InfantsThrough Collaboration

Study Documents:

Title Acronym:

ICONIC

Other Ids:

CIN001 - ICONIC

Not yetrecruiting

•Acute Kidney Injury

•Chronic KidneyDiseases

•Renal Dialysis

•Device:CARPEDIEM

Study Type:

Observational

Phase:

Study Design:


•Time Perspective: Other

Outcome Measures:

•Number of CARPEDIEMfilters to meet prescribedtreatment length

•Rate of patient survival

•Rate of renal recovery

Enrollment:

1000

Age:


Sex:

All

•Children'sHospitalMedical Center,Cincinnati


January 1, 2022

Primary Completion:

December 31, 2025

Study Completion:

December 31, 2029

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Cincinnati Children's HospitalMedical Center, Cincinnati,Ohio, United States

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FunderType

Dates Locations

6 NCT05161065 Comparison of QT IntervalReadings Between SmartwatchCombined With CardiologsArtificial Intelligence and 12-leadECG

Study Documents:

Title Acronym:

Other Ids:

WatchQT

Not yetrecruiting

•Atrial Fibrillation •Device: Cardiologs Study Type:

Observational

Phase:

Study Design:

•Observational Model:Case-Only

•Time Perspective:Prospective

Outcome Measures:

•Concordance betweenQTc intervals (in ms)measured by smartwatchcombined with CardiologsAI and that measured bymanually read 12-leadECG

•Description of thesensitivity and specificity ofthe smartwatch combinedwith Cardiologs AI

•Concordance betweenQTcB and QTcF intervalsmeasured by the differentmethods

•Description of the QTcinterval measurements inNSR

•Quantitative analysisto determine theinterobserver variability

•Description of theQT interval definedas uncertain by thesmartwatch combined withCardiologs AI

•Descriptive analysis of QTinterval measurementsin AF measured bysmartwatch combinedwith Cardiologs AI andmanually read 12-leadECG

•Analysis of QT intervalmeasured in subsets ofsubjects with and withoutwide QRS

Enrollment:

50

Age:


Sex:

All

•CardiologsTechnologies

•Industry Study Start:

December 2021

Primary Completion:

December 2021

Study Completion:

March 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Massachusetts GeneralHospital, Boston,Massachusetts, United States

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FunderType

Dates Locations

7 NCT05161052 Assessment of CornealStiffness in Keratoconus AfterCrosslinking by Corvis ST andOCT.

Study Documents:

Title Acronym:

Other Ids:

MD-80-2021

Not yetrecruiting

•Keratoconus •Device: CorvisST (dynamicScheimpflugtechnology)

Study Type:

Interventional

Phase:

Not Applicable

Study Design:


•Intervention Model: SingleGroup Assignment


•Primary Purpose:Diagnostic

Outcome Measures:

Measuring changes incorneal stiffness parametersin keratoconus afterCXL by Corvis ST whichmeasures corneal stiffnessparameters.

Enrollment:

55

Age:

18 Years to 40Years (Adult)

Sex:

All

•Cairo University •Other Study Start:

January 1, 2022

Primary Completion:

January 1, 2023

Study Completion:

February 1, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

8 NCT05161039 Serranator Recoil Study

Study Documents:

Title Acronym:

Other Ids:

CSP-0485

Recruiting •Peripheral ArterialDisease

•Critical LimbIschemia

•Device: Serranator

•Device: POBA

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: Non-Randomized

•Intervention Model:Sequential Assignment



Outcome Measures:

Presence of post treatmentrecoil

Enrollment:

20

Age:


Sex:

All

•Cagent VascularLLC


November 15, 2021

Primary Completion:

February 2022

Study Completion:

February 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Stanford University, Palo Alto,California, United States

•Klinik für Angiologie, KlinikumHochsauerland GmbH,Arnsberg, Germany

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FunderType

Dates Locations

9 NCT05161026 Impact of Allo-HSCT on BoneRemodeling: Evolution of BoneMineral Density and ArchitectureMeasured by Bone Densitometry

Study Documents:

Title Acronym:

REMODALLO

Other Ids:

19-047

Not yetrecruiting

•Myeloid Leukemia,Acute

•Other: Boneosteodensitometry

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•bone mineral densityevaluation

•Bone architecturalabnormalities and fracturerisk

•bone remodeling markers

•Pain evaluation

Enrollment:

120

Age:

18 Years to 75Years (Adult,Older Adult)

Sex:

All

•UniversityHospital, Caen


December 10, 2021

Primary Completion:

December 1, 2026

Study Completion:

December 1, 2027

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Chu Amiens, Amiens, France

•CHU CAEN, Caen, France

•Chu Lille, Lille, France

•Chu Rouen, Rouen, France

10 NCT05161013 A Proof-of-Concept StudyEvaluating LINFU™

Study Documents:

Title Acronym:

Other Ids:

Adenocyte 102

Recruiting •PancreasAdenocarcinoma

•Dysplasia

•Diagnostic Test:LINFU™

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: N/A



•Primary Purpose: DeviceFeasibility

Outcome Measures:

Does LINFU™ yield anadequate number ofcells that can be used tohelp diagnose pancreaticprecancers and cancers?

Enrollment:

10

Age:


Sex:

All

•Adenocyte, LLC •Industry Study Start:

December 5, 2021

Primary Completion:

March 1, 2022

Study Completion:

March 30, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Gastroenterology Associatesof Sarasota, Sarasota, Florida,United States

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FunderType

Dates Locations

11 NCT05161000 Oral Nutritional Supplementationin Children at Risk ofUndernutrition

Study Documents:

Title Acronym:

Other Ids:

AL48

Not yetrecruiting

•Undernutrition •Other: OralNutritionalSupplement

•Other: Dietarycounseling

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Single(Outcomes Assessor)


Outcome Measures:

•Weight-for-age z-score(WAZ)

•AnthropometricMeasurement Calculations

•Mid-upper-armcircumference (MUAC)

•Weight

•Height

•Dietary Diversity

•Appetite

Enrollment:

200

Age:

36 Months to 107Months (Child)

Sex:

All

•Abbott Nutrition •Industry Study Start:

December 2021

Primary Completion:

March 2023

Study Completion:

March 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•HealthStar ResearchGlenwood, Glenwood,Arkansas, United States

•HealthStar Research, LLC,Hot Springs, Arkansas, UnitedStates

•Kissimmee Clinical Research,Kissimmee, Florida, UnitedStates

•Dade Research Center, LLC,Miami, Florida, United States

•D&H National ResearchCenters, Miami, Florida, UnitedStates

•Suncoast Research, Assoc.,LLC, Miami, Florida, UnitedStates

•Southern Clinical Research,Zachary, Louisiana, UnitedStates

•Alivation Research (PrimaryCare), Lincoln, Nebraska,United States

•Tribe Clinical Research LLC.,Greenville, South Carolina,United States

•Invesclinic US LLC, Edinburg,Texas, United States

•Gulf Bank Medical Center,Houston, Texas, United States

•Chrysalis Clinical Research,Saint George, Utah, UnitedStates

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FunderType

Dates Locations

12 NCT05160987 Effect of Remimazolam WithProtocolized Sedation onCritical Ill, Mechanical VentilatedPatients Compared WithMidazolam

Study Documents:

Title Acronym:

Other Ids:

2021-KY-089-02

Not yetrecruiting

•Sedation andAnalgesia

•Drug:Remimazolam

•Drug: Midazolam

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Single(Participant)


Outcome Measures:

•Duration of mechanicalventilation

•Duration of endotrachealintubation

•Completion rate ofsedation goal

•Remediation is defined asrequiring combination withother sedations

•Length of stay in ICU andtotal length of stay

•Anterograde amnesia

•28 day mortality

•total cost of sedative drugsin ICU

•hospitalization expenses inICU

Enrollment:

440

Age:


Sex:

All

•ZhujiangHospital

• IntegratedtraditionalChinese andWesternMedicineHospital ofSouthernMedicalUniversity

•First AffiliatedHospital ofShantouUniversityMedical College

•The AffiliatedHospital ofGuangdongMedical College

•Yunfu People'sHospital

•ShanweiPeople'sHospital

•Huizhou ThirdPeople'sHospital

•ShenzhenUniversityGeneral Hospital

•Bao'an DistrictCentral Hospitalof Shenzhen

•The SecondPeople'sHospital ofFoshan

•and 5 more


January 1, 2022

Primary Completion:

December 31, 2024

Study Completion:

December 31, 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Department of CriticalCare Medicine of ZhujiangHospital,Southern MedicalUniversity, Guangzhou,Guangdong, China

- of 74 -







FunderType

Dates Locations

13 NCT05160974 QTERN (SAXAGLIPTIN/DAPAGLIFLOZIN FDC)Regulatory Post-MarketingSurveillance

Study Documents:

Title Acronym:

Other Ids:

D1683R00008

Not yetrecruiting

•Type 2 DiabetesMellitus

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•• Incidence (%) of AEs inpatients who are treatedwith Qtern

•• Nature of AE in patientswho are treated with Qtern

•• Nature of unexpectedadverse drug reactions inpatients who are treatedwith Qtern

•• Severity of AE in patientswho are treated with Qtern

•• Incidence of unexpectedadverse drug reactions inpatients who are treatedwith Qtern

•• Severity of unexpectedadverse drug reactions inpatients who are treatedwith Qtern

•• Incidence (%) of SAEs inpatients who are treatedwith Qtern

•• Change in HbA1c duringthe observation period

•• Change in FPG duringthe observation period

•• Change of PPG-2hrduring the observationperiod

•and 7 more

Enrollment:

600

Age:


Sex:

All

•AstraZeneca •Industry Study Start:

December 15, 2021

Primary Completion:

September 30, 2022

Study Completion:

September 30, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

- of 74 -






FunderType

Dates Locations

14 NCT05160961 US-Guided SAPB Versus ESPBon Acute and Chronic Pain AfterVATS

Study Documents:

Title Acronym:

Other Ids:

E.Kurul-E1-21-2142

Recruiting •Postoperative Pain

•Video-AssistedThoracoscopicSurgery

•Serratus AnteriorPlane Block

•Erector SpinaePlane Block

•Acute Pain

•Chronic Pain

•Procedure:Serratus anteriorplane block

•Procedure: Erectorspinae plane block

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Double (CareProvider, OutcomesAssessor)


Outcome Measures:

•Pain scores

•Chronic pain

Enrollment:

60

Age:


Sex:

All

•Atatürk ChestDiseases andChest SurgeryTraining andResearchHospital


December 3, 2021

Primary Completion:

September 15, 2022

Study Completion:

October 15, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Ankara Atatürk Chest Diseaseand Chest Surgery Trainingand Research Hospital,Kecioren, Ankara, Turkey

15 NCT05160948 Change in Knowledge AfterReceiving Personal Air PollutionResults

Study Documents:

Title Acronym:

Other Ids:

•2021-0707

•5R21ES030092-02


•EnvironmentalExposure

•Other: InformationalReport

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Report-Back Pre/PostSurvey

Enrollment:

118

Age:

15 Years to 99Years (Child,Adult, Older Adult)

Sex:

All


•National Instituteof EnvironmentalHealth Sciences(NIEHS)

•Other

•NIH

Study Start:

November 10, 2021

Primary Completion:

November 10, 2022

Study Completion:

November 10, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021


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FunderType

Dates Locations

16 NCT05160935 Effect of the Education Givento the Patients Who Will BeApplied Coronary Angiography

Study Documents:

Title Acronym:

Other Ids:

2021-1

Not yetrecruiting

•CoronaryAngiography

•Anxiety

•Vital Signs

•Education

•Nursing

•Nursing Care

•Behavioral:Education

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: N/A



•Primary Purpose: HealthServices Research

Outcome Measures:

•To accept the hypothesisthat "the education givento the patients whowill undergo coronaryangiography has an effecton reducing the anxietylevels of the patients".

•To accept the hypothesisthat "the education givento the patients whowill undergo coronaryangiography has apositive effect on theblood pressure (mm-Hg)level, one of the vital signsvalues of the patients".

•To accept the hypothesisthat "the education givento the patients whowill undergo coronaryangiography has a positiveeffect on the heart rate(beats/min) level, whichis one of the vital signsvalues of the patients".

•To accept the hypothesisthat "the education givento the patients whowill undergo coronaryangiography has a positiveeffect on the vital signs ofthe patients, the respiratoryrate (respiratory rate/min)".

•To accept the hypothesisthat "the education givento the patients whowill undergo coronaryangiography has a positiveeffect on the vital signsvalues of the patients andthe body temperature (°C)level".

•To accept the hypothesisthat "the education givento the patients whowill undergo coronaryangiography has a positiveeffect on the oxygensaturation (SpO2) level,one of the vital signsvalues of the patients".

Enrollment:

79

Age:


Sex:

All

•EskisehirOsmangaziUniversity


January 1, 2022

Primary Completion:

April 30, 2022

Study Completion:

June 30, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

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FunderType

Dates Locations

17 NCT05160922 Crizotinib Continuation ClinicalStudy

Study Documents:

Title Acronym:

Other Ids:

A8081075

Not yetrecruiting

•NSCLC

•ALCL

•IMT

•Drug: crizotinib Study Type:

Interventional

Phase:

Phase 4

Study Design:

•Allocation: N/A




Outcome Measures:

•Number of participants withadverse events leading topermanent discontinuationof study intervention

•Number of serious adverseevents reported for allparticipants

Enrollment:

80

Age:

1 Year to 99 Years (Child, Adult,Older Adult)

Sex:

All

•Pfizer •Industry Study Start:

December 31, 2021

Primary Completion:

December 30, 2026

Study Completion:

December 30, 2026

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

18 NCT05160909 Evaluation of SurgicalPositioning in ArthroscopicShoulder Stabilization

Study Documents:

Title Acronym:

Other Ids:

MBis21E.593


•ShoulderDislocation

•Procedure: BeachChair Position

•Procedure: LateralDecubitus Position

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Shoulder instability

•Postoperative patientsatisfaction

Enrollment:

556

Age:


Sex:

All

•RothmanInstituteOrthopaedics


December 6, 2021

Primary Completion:

December 6, 2023

Study Completion:

December 6, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Rothman Orthopaedic Institute,Philadelphia, Pennsylvania,United States

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FunderType

Dates Locations

19 NCT05160896 SALIRI Based Regimen as First-line Treatment for AdvancedMetastatic Colorectal Cancer

Study Documents:

Title Acronym:

Other Ids:

SALIRI-2021

Recruiting •AdvancedMetastaticColorectal Cancer

•Drug: Raltitrexed

•Drug: Irinotecan

•Drug: Bevacizumab

•Drug: Cetuximab

Study Type:

Interventional

Phase:

Phase 2

Study Design:

•Allocation: N/A




Outcome Measures:

•ORR

•PFS

•OS

•DCR

•WHO-QOL

•AEs

Enrollment:

90

Age:


Sex:

All

•Second AffiliatedHospital, Schoolof Medicine,ZhejiangUniversity


November 12, 2021

Primary Completion:

June 30, 2023

Study Completion:

June 30, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•the Second Affiliated Hospitalof Medical College of ZhejiangUniversity, Hangzhou,Zhejiang, China

20 NCT05160883 Neuroimaging Changes inHereditary Ataxia

Study Documents:

Title Acronym:

Other Ids:

Wulab-MRI in HA

Recruiting •Hereditary Ataxia Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

neuroimaging information

Enrollment:

500

Age:


Sex:

All



June 30, 2021

Primary Completion:

December 25, 2025

Study Completion:

December 25, 2025

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Second AffiliatedHospital,Zhejiang UniversitySchool of Medicine, Hangzhou,Zhejiang, China

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FunderType

Dates Locations

21 NCT05160870 Genotype-phenotype Correlationand Pathogenic Mechanism inHereditary Ataxia

Study Documents:

Title Acronym:

Other Ids:

Wulab-sNfL in HA

Recruiting •Hereditary Ataxia Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Serum neurofilament lightchain

Enrollment:

500

Age:


Sex:

All



June 30, 2021

Primary Completion:

December 25, 2022

Study Completion:

December 25, 2025

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Second Affiliated Hospital,Zhejiang University School ofMedicine, Hangzhou, Zhejiang,China

22 NCT05160857 Clinical Study on theEfficacy and Safety ofHetropapa EthanolamineTablets in the Treatment ofThrombocytopenia Causedby Concurrent Radiotherapyand Chemotherapy in CervicalCancer

Study Documents:

Title Acronym:

Other Ids:

SecondShanxiMU

Not yetrecruiting

•TumorChemotherapy-relatedThrombocytopenia

•Drug: HerombopagOlamine

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

Platelet index

Enrollment:

30

Age:


Sex:

All

•SecondHospital ofShanxi MedicalUniversity


December 31, 2021

Primary Completion:

December 31, 2022

Study Completion:

December 31, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•The second hospital of ShanxiMedical University, Taiyuan,Shanxi, China

23 NCT05160844 SIRT1 Gene Polymorphism WithPremature Myocardial Infarctionin Young Egyptian Patients

Study Documents:

Title Acronym:

SIRT1

Other Ids:

Soh-Med-21-11-33

Recruiting •PrematureMyocardialInfarction in YoungEgyptian Patients

Study Type:

Observational

Phase:

Study Design:

•Observational Model:Case-Control


Outcome Measures:

•Endothelial nitric oxidesynthase level

•SIRT1 Genotyping

Enrollment:

100

Age:


Sex:

All

•Sohag University •Other Study Start:

September 1, 2021

Primary Completion:

January 30, 2022

Study Completion:

February 28, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Sohag uniersity hosoital,Sohag, Egypt

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FunderType

Dates Locations

24 NCT05160831 Human Umbilical CordMesenchymal Stem Cells in theTreatment of Knee Osteoarthritis

Study Documents:

Title Acronym:

Other Ids:

SCforKneeOA

Not yetrecruiting

•Knee Osteoarthritis •Biological: Humanumbilical cordmesenchymal stemcells

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•VAS score

•Kellgren-Lawrence score

Enrollment:

50

Age:


Sex:

All

•SouthwestHospital, China


January 20, 2022

Primary Completion:

January 20, 2023

Study Completion:

January 20, 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

25 NCT05160818 Hypofractionated Versus SingleFraction Stereotactic AdjuvantRadiotherapy to the ResectionCavity of Brain Metastases

Study Documents:

Title Acronym:

SATURNUS

Other Ids:

RadOnc MRI TUM- 2

Recruiting •Brain Metastases

•Resection Cavity

•Radiation:Hypofractionatedstereotacticradiotherapy(HFSRT) versussingle fractionstereotacticradiotherapyradiosurgery (SRS)

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Local control

•LC

•LRC

•OS

•Salvage-free survival

•Intracranial salvagetherapy

•Pseudoprogression

•Irradiation-related toxicity

•QoL

•Time to loss ofindependence

Enrollment:

126

Age:


Sex:

All

•TechnischeUniversitätMünchen


February 1, 2021

Primary Completion:

August 1, 2025

Study Completion:

August 1, 2025

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Dept. Radiation Oncology,Munich, Bavaria, Germany

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FunderType

Dates Locations

26 NCT05160805 A Phase 1b Study of ONL1204Ophthalmic Solution in PatientsWith Progressing Open AngleGlaucoma

Study Documents:

Title Acronym:

Other Ids:

ONL1204-OAG-001

Not yetrecruiting

•Open AngleGlaucoma

•Drug: ONL1204Ophthalmic solution(Dose A)

•Drug: ONL1204Ophthalmic solution(Dose B)

•Procedure: Shamprocedure

Study Type:

Interventional

Phase:

Phase 1

Study Design:



•Masking: Single(Participant)


Outcome Measures:

Safety and Tolerability ofONL1204 as assessed byAE reporting and clinicalevaluations

Enrollment:

25

Age:


Sex:

All

•ONLTherapeutics


February 2022

Primary Completion:

June 2023

Study Completion:

September 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Albury Eye Clinic Wodonga,Albury, New South Wales,Australia

•Centre for Eye ResearchAustralia (CERA), Melbourne,Victoria, Australia

27 NCT05160792 Comfort of GraduCheck UnderCompression Bandaging

Study Documents:

Title Acronym:

Other Ids:

VS-SH-2021-02

Not yetrecruiting

•CompressionBandage

•Device: Pressuremonitoring systemunder compressionbandages on indexleg

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: N/A



•Primary Purpose: DeviceFeasibility

Outcome Measures:

Comfort

Enrollment:

12

Age:


Sex:

All

•The WhiteleyClinic

•Veinsense Ltd


January 2022

Primary Completion:

March 2022

Study Completion:

March 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

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FunderType

Dates Locations

28 NCT05160779 Impact of GeneticPolymorphisms of VasoactivePeptides on the Prognosis ofPatients With COVID19

Study Documents:

Title Acronym:

Other Ids:

20211214

Not yetrecruiting

•Sars-CoV-2Infection

•Other: Analysisof geneticpolymorphisms ofvasoactive peptidesin COVID-19

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

Correlation betweenpolymorphisms andCOVID-19 progression

Enrollment:

151

Age:


Sex:

All

•LeonardoParoche deMatos

•Prof. Dr. JoséAntônio SilvaJúnior

•Msc. Allan LuisBarboza Atum


January 2022

Primary Completion:

January 2022

Study Completion:

February 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•University Ninth of July, SãoPaulo, Sao Paulo, Brazil

•Guarulhos City Hall, Guarulhos,São Paulo, Brazil

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FunderType

Dates Locations

29 NCT05160766 Assessing Immune Response ofDifferent COVID-19 Vaccines inOlder Adults

Study Documents:

Title Acronym:

EU-COVAT-1

Other Ids:

•EU-COVAT-1_AGED

•2021-004526-29

•uni-koeln-4602

Recruiting •VaccinationReaction

•COVID-19

•Vaccination;Infection

•Biological:Comirnaty(BTN162b2)

•Biological:Spikevax(mRNA-1273)

Study Type:

Interventional

Phase:

Phase 2

Study Design:




•Primary Purpose:Prevention

Outcome Measures:

•Immunogenicity responseto different mRNA-based vaccines as 3rdvaccination dose

•Comparison of the humoralimmune response againstwild-type SARS-CoV-2between heterologousand homologous 3rdvaccination dose

•Comparison of the humoralimmune response againstwild-type SARS-CoV-2between cohorts

•Immune response againstSARS-CoV-2 variantsof concern of differentbooster strategies

•CD4+ and CD8+ T cellresponse in heterologousand homologous boosterstrategies

•Long-term humoralimmune response ofdifferent booster strategies

Enrollment:

600

Age:

75 Years and older (Older Adult)

Sex:

All

•Oliver Cornely,MD

•EuropeanCommission

•VACCELERATE

•University ofCologne


November 8, 2021

Primary Completion:

April 2022

Study Completion:

May 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•University Hospital Cologne,Cologne, Germany

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FunderType

Dates Locations

30 NCT05160753 Laparoscopic Gastric FunctionPreserving Surgery CombinedWith Resection of the AnteriorLymphatic Drainage Area

Study Documents:

Title Acronym:

Other Ids:

LGFPS

Not yetrecruiting

•Patients With EarlyDistal GastricCancer

•Procedure:Laparoscopicgastric functionpreserving surgerycombined withresection of theanterior lymphaticdrainage area

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Double(Participant, Care Provider)


Outcome Measures:

Disease-free survival (DFS)at three years

Enrollment:

580

Age:


Sex:

All

•AffiliatedHospital ofNantongUniversity

•TongzhouDistrict Hospital

•Haimen People'sHospital

•Dongtai People'sHospital

•Qidong CityPeople'sHospital

•Rudong CountyHospital ofTraditionalChineseMedicine


January 2022

Primary Completion:

June 2024

Study Completion:

December 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

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FunderType

Dates Locations

31 NCT05160740 Indocyanine Green MolecularFluorescence ImagingTechnique Using in Diagnosisand Treatment of Primary LiverCancer

Study Documents:

Title Acronym:

ICGMFITinPLC

Other Ids:

2021-KY-090-01

Recruiting •Liver Cancer •Drug: Indocyaninegreen for injection

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•3-year disease freesurvival rate

•Positive margin rate

•Negative margin rate

•Length of the shortestcutting edge

•Operation time

•Intraoperative blood loss

•Intraoperative bloodtransfusion volume

•The number of smalllesions of HCC

•Residual tumor at themargin of liver cross-section

•Intraoperative biliary fistuladetection rate

•and 10 more

Enrollment:

348

Age:


Sex:

All

•ZhujiangHospital


September 23, 2021

Primary Completion:

December 31, 2022

Study Completion:

December 31, 2025

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Zhujiang Hospital of SouthernMedical University, Guangzhou,Guangdong, China

32 NCT05160727 Radiotherapy Combined WithTislelizumab and Irinotecan inMSS/pMMR Recurrence andMetastatic Colorectal Cancer

Study Documents:

Title Acronym:

Other Ids:

CARTOnG-2104

Recruiting •Mismatch Repair-proficient

•Colorectal CancerMetastatic

•MicrosatelliteStable

•Drug: Tislelizumab

•Drug: Irinotecan

•Radiation:radiotherapy

Study Type:

Interventional

Phase:

Phase 2

Study Design:

•Allocation: N/A




Outcome Measures:

Objective response rate

Enrollment:

44

Age:


Sex:

All

•Zhejiang CancerHospital


October 1, 2021

Primary Completion:

October 2024

Study Completion:

October 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Zhejiang Cancer Hospital,Hangzhou, Zhejiang, China

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FunderType

Dates Locations

33 NCT05160714 Individualized Response-adaptive Radiation DosePrescription in HNC Based onMRI

Study Documents:

Title Acronym:

MRL-02

Other Ids:

081/2021B01

Not yetrecruiting

•Head and NeckCancer

•Radiation: Real-time ADC-guidedresponse adaptiveBoost in HNC

Study Type:

Interventional

Phase:

Phase 1

Study Design:

•Allocation: N/A




Outcome Measures:

•Dose limiting toxicity (DLT)

•Regional tumor control

•Disease free survival

Enrollment:

24

Age:


Sex:

All

•UniversityHospitalTuebingen


January 1, 2022

Primary Completion:

March 30, 2023

Study Completion:

March 30, 2025

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

34 NCT05160701 Bringing Health Home

Study Documents:

Title Acronym:

BHH

Other Ids:

HP-00098021

Not yetrecruiting

•Mental Disorders,Severe

•Other: Medherent Study Type:

Interventional

Phase:

Not Applicable

Study Design:


•Intervention Model:Crossover Assignment



Outcome Measures:

•Health Service Utilization

•Consumer SatisfactionSTAR-P

•Diabetes control asreported hemoglobin A1clevels

•Reported Low-densitylipoprotein (LDL)/High-density lipoprotein (HDL)

•High blood pressure.

•Change in Health ServiceCosts

Enrollment:

300

Age:


Sex:

All

•University ofMaryland,Baltimore


January 2022

Primary Completion:

September 2024

Study Completion:

December 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

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FunderType

Dates Locations

35 NCT05160688 Changes in Cognition andPsychiatric Disorder SymptomsDuring Cannabis AbstinenceUsing a Novel Discordant TwinDesign

Study Documents:

Title Acronym:

Other Ids:

21-4899

Not yetrecruiting

•Cannabis •Behavioral:Contingencymanagement

Study Type:

Interventional

Phase:

Not Applicable

Study Design:




•Primary Purpose: BasicScience

Outcome Measures:

•Change in attentionperformance

•Change in episodicmemory

•Change in workingmemory

•Change in receptivevocabulary

•Change in readingdecoding

•Change in immediatememory/verbal learning

•Change in patterncomparison processingspeed

•Change in oral symbol digittest processing speed

•Change in attention andexecutive function

•Change in anxietysymptoms

•Change in depressivesymptoms

•Change in attention deficit/hyperactivity disordersymptoms

Enrollment:

100

Age:


Sex:

All

•Universityof Colorado,Denver

•Universityof Colorado,Boulder


July 2022

Primary Completion:

August 2026

Study Completion:

August 2026

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

- of 74 -







FunderType

Dates Locations

36 NCT05160675 Nutrition, Microbiome and BoneHealth During Early Life Relatedto Health

Study Documents:

Title Acronym:

Bamboo

Other Ids:

20.27.NRC

Recruiting •Healthy Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•gut microbiome

•dietary factors

•bone development

•bone health

•dietary intakes and healthoutcomes

•Gut microbiome

•Urinary markers of bonemetabolism

•breast milk composition

Enrollment:

2760

Age:

up to 6 Months (Child)

Sex:

All

•Nestlé

•Tianjin Womenand Children'sHealth Center

•BGI-research

•Industry

•Other

Study Start:

September 3, 2021

Primary Completion:

September 30, 2025

Study Completion:

December 31, 2025

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Tianjin Women and ChildrenHealth Center#, Tianjin, China

37 NCT05160662 The Important Project of ObesePregnant Women

Study Documents:

Title Acronym:

Other Ids:

102030

Recruiting •Overweight andObesity

•Procedure: Newguidlines

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

reduced unnecessaryinterventions

Enrollment:

600

Age:


Sex:

Female

•KarolinskaInstitutet


August 1, 2021

Primary Completion:

July 30, 2023

Study Completion:

August 1, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Eva Wiberg-Itzel, Stockholm,Sweden

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FunderType

Dates Locations

38 NCT05160649 Effect of Covid 19 Infection onFetomaternal Outcome

Study Documents:

Title Acronym:

Other Ids:

S 280

Recruiting •COVID-19Pneumonia

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•first, second and thirdtrimester feto-maternalcomplications.

•fetal outcome

•time of infection and fetalcomplication

Enrollment:

50

Age:


Sex:

Female

•FayoumUniversity


October 10, 2021

Primary Completion:

February 2022

Study Completion:

March 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Fayoum university, Fayoum,Egypt

39 NCT05160636 Patient Reported Health-RelatedQuality of Life Associated WithCOVID-19.

Study Documents:

Title Acronym:

Other Ids:

C4591034

Not yetrecruiting

•COVID19 •Other: ARIsymptom andPositive RT-PCRfor COVID-19

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Utility Index

•Utility decrements

•EQ-5D VAS Score

•WPAI scores

•Proportion of subjects withlong-COVID symptoms

•Proportion of subjects withemergency room (ER) visit

•Proportion of subjectswith hospital inpatientadmission

Enrollment:

600

Age:


Sex:

All

•Pfizer •Industry Study Start:

December 31, 2021

Primary Completion:

August 31, 2022

Study Completion:

September 30, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

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FunderType

Dates Locations

40 NCT05160623 Treatment of Blepharitis WithPovidone-Iodine 1%

Study Documents:

Title Acronym:

Other Ids:

18004714

Recruiting •Anterior Blepharitis •Drug: Povidone-Iodine 1 % TopicalSolution

•Drug: Eyelidcleansing wipes

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Triple (CareProvider, Investigator,Outcomes Assessor)


Outcome Measures:

•Blepharitis signs on slit-lamp examination

•OSDI score

•Subjective eye complaints

•TBUT

•National Eye Institute/Industry (NEI) gradingscale

•Schirmer's test

Enrollment:

100

Age:


Sex:

All

•Shaare ZedekMedical Center


August 16, 2021

Primary Completion:

December 2022

Study Completion:

December 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Ophthalmology clinic, ShaareZedek Medical Center,Jerusalem, Israel

- of 74 -




FunderType

Dates Locations

41 NCT05160610 Improving ThrombolysisImplementation Based onElectronic Monitoring in AcuteIschemic Stroke (ITEM)

Study Documents:

Title Acronym:

Other Ids:

ITEM

Not yetrecruiting

•Thrombolysis Rate •Behavioral:Multilevelintervention

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Thrombolysis rate within4.5 hours

•Thrombolysis rate within 3hours

•Excellent neurologicaloutcomes

•Favorable neurologicaloutcomes

•modified Rankin Scalescore

•All-cause death rate

•Hemorrhagictransformation

•Symptomatic intracranialhemorrhage

•Door-to-image time

Enrollment:

2720

Age:


Sex:

All



January 1, 2022

Primary Completion:

December 31, 2022

Study Completion:

June 30, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

42 NCT05160597 Image-Guided (68Ga-PSMA-11PET/CT) Prostate Biopsy for theDiagnosis of Prostate Cancerin Men With Prior Negative/Inconclusive Biopsy

Study Documents:

Title Acronym:

Other Ids:

•21-001122

•NCI-2021-12975

Not yetrecruiting

•Prostate Carcinoma •Procedure: Biopsyof Prostate

•Other: Gallium Ga68 Gozetotide

•Procedure:TransrectalUltrasonographyGuided Biopsy

Study Type:

Interventional

Phase:

Early Phase 1

Study Design:

•Allocation: N/A




Outcome Measures:

Detection rate of clinicallysignificant prostate cancer

Enrollment:

30

Age:


Sex:

Male

•JonssonComprehensiveCancer Center


January 31, 2022

Primary Completion:

July 31, 2024

Study Completion:

July 31, 2025

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•UCLA / JonssonComprehensive Cancer Center,Los Angeles, California, UnitedStates

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FunderType

Dates Locations

43 NCT05160584 A Study of Real-Life CurrentStandards of Care inParticipants With Relapsed and/or Refractory Multiple Myeloma

Study Documents:

Title Acronym:

MoMMent

Other Ids:

•CR109118

•64407564MMY4001

Recruiting •Relapsed/Refractory MultipleMyeloma

•Other: Nointervention

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Overall Response Rate(ORR)

•Very Good PartialResponse (VGPR) Rate

•Complete Response (CR)Rate

•Stringent CompleteResponse (sCR) Rate

•Minimal Residual Disease(MRD) Negative Rate

•Clinical Benefit Rate (CBR)

•Duration of Response(DOR)

•Time to Response (TTR)

•Time to Best Response

•Time to Next Treatment(TTNT)

•and 8 more

Enrollment:

100

Age:


Sex:

All

•JanssenPharmaceuticaN.V., Belgium


December 15, 2021

Primary Completion:

November 30, 2024

Study Completion:

November 30, 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•UZ Leuven, Leuven, Belgium

•Ucl de Mont-Godinne, Yvoir,Belgium

•CHRU de Lille - Hôpital ClaudeHuriez, Lille, France

•CHU de Montpellier, HopitalSaint-Eloi, Montpellier Cedex 5,France

•CHU de Nantes hôtel-Dieu,Nantes Cedex 1, France

•Hôpital Saint Louis, ParisCedex 10, France

•Centre hospitalier Lyon-Sud,Pierre-Bénite, France

•CHU Poitiers - Hôpital laMilétrie, Poitiers Cedex, France

•Pôle IUC Oncopole CHU,Toulouse cedex 9, France

•Universitätsklinik Hamburg-Eppendorf - OrthopädischeUniversitätsklinik und Poliklinik,Hamburg, Germany

•and 36 more

44 NCT05160571 A Retrospective MulticenterReview to Evaluate thePerformance of the IonEndoluminal System inSampling Pulmonary Lesions

Study Documents:

Title Acronym:

Other Ids:

ISI-ION-R01

Recruiting •Lung Cancer

•Pulmonary Nodule

•Device: IonEndoluminalSystem

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Diagnostic yield

•Sensitivity for malignancy

•Pneumothorax

•Bleeding

•Adverse events

•Conversions

Enrollment:

400

Age:


Sex:

All

• Intuitive Surgical •Industry Study Start:

November 1, 2021

Primary Completion:

March 31, 2022

Study Completion:

March 31, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Winchester Medical Center,Winchester, Virginia, UnitedStates

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FunderType

Dates Locations

45 NCT05160558 A Pharmacokinetics and SafetyStudy of BIIB132 in Adults WithSpinocerebellar Ataxia 3

Study Documents:

Title Acronym:

Other Ids:

•260SA101

•2021-002223-37

Not yetrecruiting

•SpinocerebellarAtaxia Type 3

•Drug: BIIB132

•Drug: BIIB132-Matching Placebo

Study Type:

Interventional

Phase:

Phase 1

Study Design:





Outcome Measures:

•Number of Participantswith Adverse Events (AEs)

•Number of Participantswith Serious AdverseEvents (SAEs)

•Area Under theConcentration-Time Curve(AUC) of BIIB132

•Area Under theConcentration VersusTime Curve, from Timeof Dosing (Time = 0) toInfinity (AUCinf) of BIIB132

•Area Under theConcentration VersusTime Curve, from Time ofDosing (Time = 0) to Timeof the Last MeasurableEffect (AUClast) of BIIB132

•Maximum ObservedConcentration (Cmax) ofBIIB132

•Time to Reach MaximumObserved Concentration(Tmax) of BIIB132

•Elimination Half-Life (t½) ofBIIB132

Enrollment:

48

Age:


Sex:

All

•Biogen •Industry Study Start:

December 28, 2021

Primary Completion:

January 12, 2026

Study Completion:

January 12, 2026

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

- of 74 -





FunderType

Dates Locations

46 NCT05160545 A Study of GNC-035, a Tetra-specific Antibody, in ParticipantsWith Locally Advanced orMetastatic Breast Cancer

Study Documents:

Title Acronym:

Other Ids:

GNC-035-103(V1.0)

Recruiting •Breast Cancer •Drug: GNC-035 Study Type:

Interventional

Phase:

Phase 1

Study Design:

•Allocation: N/A




Outcome Measures:

•DLT

•MTD or MAD

•TEAE

•The recommended dosefor future clinical study

•AESI

•Cmax

•Tmax

•T1/2

•Incidence and titer of ADA

•ORR

•and 3 more

Enrollment:

29

Age:


Sex:

All

•Sichuan BailiPharmaceuticalCo., Ltd.


November 30, 2021

Primary Completion:

November 30, 2023

Study Completion:

November 30, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Sun Yat-sen Memorial Hospital,Guangzhou, Guangdong, China

47 NCT05160532 Intraarticular DextroseProlotherapy for SymptomaticKnee Osteoarthritis

Study Documents:

Title Acronym:

Other Ids:

21-008778

Not yetrecruiting

•Knee Osteoarthritis •Drug: Placebo

•Drug: Dextroseprolotherapy (DPT)

Study Type:

Interventional

Phase:

Phase 2

Study Design:



•Masking: Double(Participant, Investigator)


Outcome Measures:

•Change in Western Ontarioand McMaster UniversitiesOsteoarthritis Index(WOMAC)

•Change in pain

Enrollment:

160

Age:


Sex:

All

•Mayo Clinic •Other Study Start:

January 2022

Primary Completion:

January 2023

Study Completion:

January 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Mayo Clinic in Arizona,Scottsdale, Arizona, UnitedStates

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FunderType

Dates Locations

48 NCT05160519 Class IV Laser Therapy onEjection Fraction, CardioBiomarkers and FunctionalOutcomes

Study Documents:

Title Acronym:

Other Ids:

•MMDU/IEC/2157

•U1111-1270-8393

Not yetrecruiting

•Acute CoronarySyndrome

•Radiation: Class IVLaser

•Radiation: ShamClass IV Laser

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Double(Participant, OutcomesAssessor)


Outcome Measures:

•Left Ventricular EjectionFraction

•Cardiac Biomarkers

•Functional outcomes

Enrollment:

86

Age:


Sex:

All

•Asir JohnSamuel

•MaharishiMarkendeswarUniversity(Deemed to beUniversity)


January 10, 2022

Primary Completion:

March 30, 2023

Study Completion:

September 30, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

- of 74 -






FunderType

Dates Locations

49 NCT05160506 Corticosteroids to TreatPancreatitis

Study Documents:

Title Acronym:

CRISP

Other Ids:

2021P-000803

Not yetrecruiting

•Pancreatitis

•Pancreatitis, Acute

•Corticosteroid

•Hydrocortisone

•Drug:Hydrocortisone

•Drug: Placebo

Study Type:

Interventional

Phase:

Phase 2

Study Design:





Outcome Measures:

•Severity of Illness Measure

•Respiratory FailureMeasure

•Alive and Ventilator FreeDays

•Long-term Functional/Quality of Life Measure

•In-hospital mortality

•28-day mortality

•90-day mortality

•Alive and Hospital freedays

•Severity of Illness MeasureStratified By PredictedSurvival (PhysicianOpinion)

•Severity of Illness MeasureStratified By BedsideIndex of Severity in AcutePancreatitis (BISAP) score

Enrollment:

86

Age:


Sex:

All

•Beth IsraelDeaconessMedical Center


April 2022

Primary Completion:

January 2027

Study Completion:

April 2027

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

- of 74 -




FunderType

Dates Locations

50 NCT05160493 The Effect of EsketamineCombined With Pregabalin onChronic Postsurgical Pain inPatients After Craniotomy.

Study Documents:

Title Acronym:

Other Ids:

20211206

Not yetrecruiting

•ChronicPostsurgical Pain

•Drug: S-ketamineand pregabalin

•Drug: Normalsaline and placebocapsule

Study Type:

Interventional

Phase:

•Phase 2

•Phase 3

Study Design:





Outcome Measures:

Proportion of craniotomypatients with NRS scoregreater than one 3 monthsafter surgery

Enrollment:

246

Age:


Sex:

All

•Beijing TiantanHospital


December 15, 2021

Primary Completion:

December 31, 2023

Study Completion:

March 31, 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

51 NCT05160480 A Pilot Study of Total-bodyPET Using FDA-approvedRadiotracers Beyond 18F-FDG

Study Documents:

Title Acronym:

Other Ids:

EXPLLN21-01


•Prostate Cancer

•Breast Cancer

•NeuroendocrineTumors

•Diagnostic Test:Total-body PETimaging

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

measure radiotracer avidity

Enrollment:

9

Age:


Sex:

All

•University ofCalifornia, Davis

•LantheusMedical Imaging

•Other

•Industry

Study Start:

January 1, 2022

Primary Completion:

January 1, 2023

Study Completion:

January 1, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•UC Davis EXPLORERMolecular Imaging Center,Sacramento, California, UnitedStates

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FunderType

Dates Locations

52 NCT05160467 Bio Electrical ImpedanceAnalysis to Monitor FluidStatus During DeresuscitationStrategy in Continuous RenalReplacement Therapy

Study Documents:

Title Acronym:

UF BIA

Other Ids:

532

Recruiting •Fluid Overload •Diagnostic Test:Segmentalmulti-frequencybio electricalimpedance analysis

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Correlation coefficientbetween changes inextracellular water volumeestimated by BIA andcumulative fluid balancebetween day 0 and day 5(mL).

Enrollment:

23

Age:


Sex:

All

•Hospices Civilsde Lyon


March 15, 2021

Primary Completion:

November 15, 2021

Study Completion:

January 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Hôpital cardiologique LouisPradel Groupe Hospitalier Est,Bron, France

53 NCT05160454 NIRS to EvaluateHaemodynamic Reserve inPaediatric Moyamoya

Study Documents:

Title Acronym:

NIRS moyamoya

Other Ids:

16NC24

Suspended •Moyamoya •Device: nearinfraredspectroscopy

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Number of NIRS studiesthat can be completed inmoyamoya patients

•Patient questionnaireto evaluate children'sexperience of NIRS inmoyamoya

Enrollment:

20

Age:

6 Years to 18Years (Child,Adult)

Sex:

All

•Great OrmondStreet Hospitalfor Children NHSFoundation Trust


February 14, 2018

Primary Completion:

June 30, 2022

Study Completion:

June 30, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Great Ormond Street Hospitalfor Children NHS FoundationTrust, London, United Kingdom

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FunderType

Dates Locations

54 NCT05160441 Comparing Platelet RichPlasma and Corticosteroid forMilitary & Civilian Patients WithGlenohumeral Osteoarthritis

Study Documents:

Title Acronym:

PRP

Other Ids:

WRNMMC-2021-0345

Not yetrecruiting

•Osteoarthritis of theShoulder

•Corticosteroid

•PRP

•Pain

•Biological: PlateletRich PlasmaInjection

•Biological:CorticosteroidInjection

•Biological: DelayedPlatelet RichPlasma InjectionAfter CorticosteroidInjection Failure

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Change in the SingleAssessment NumericEvaluation (SANE) frombefore injection to afterinjection

•Change in the AmericanShoulder and ElbowSurgeons StandardizedShoulder Form (ASES)from before injection toafter injection

•Change in the VisualAnalogue Scale (VAS)from before injection toafter injection

•Change in the VeteransRAND 12-Item HealthSurvey (VR-12) frombefore injection to afterinjection

•Change in the WesternOntario OsteoarthritisShoulder Index (WOOS)from before injection toafter injection

•Change in range ofmotion (ROM) from beforeinjection to after injection

Enrollment:

600

Age:


Sex:

All

•Walter ReedNational MilitaryMedical Center

•United StatesNaval MedicalCenter, SanDiego

•Brooke ArmyMedical Center

•UniformedServicesUniversity of theHealth Sciences

•U.S.Fed

Study Start:

January 2022

Primary Completion:

January 2026

Study Completion:

January 2026

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

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FunderType

Dates Locations

55 NCT05160428 Posy Covid-19 VaccinationDevelopment or Flare of ARD

Study Documents:

Title Acronym:

PoCov-ARD

Other Ids:

Post CovidVaccination ARD

Not yetrecruiting

•COVID-19

•Vaccination;Infection

•RheumaticDiseases

•Biological:COVID-19vaccination

Study Type:

Observational

Phase:

Study Design:

•Observational Model:Other


Outcome Measures:

•-Prevalence of new ARDafter covid-19 vaccinations

•prevalence of flare of ARDafter covid-19 vaccinations

•Prevalence of non-specificMSK symptoms afterCovid-19 vaccine.

•Correlation of the MSKto the 1st and 2nd Covidvaccine dose

•comparison betweendifferent type of covid-19vaccine in inducing ARD orflare up.

•disease activity statusin the patients whodeveloped the ARDsymptoms before and afterthe vaccine.

•Any correlation betweenthe appearance of MSKsymptoms and thepatient's medications

Enrollment:

500

Age:


Sex:

All

•Cairo University •Other Study Start:

December 20, 2021

Primary Completion:

February 1, 2022

Study Completion:

March 1, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

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FunderType

Dates Locations

56 NCT05160415 A Study of EDG-5506 in AdultMales With Becker MuscularDystrophy

Study Documents:

Title Acronym:

ARCH

Other Ids:

EDG-5506-002

Not yetrecruiting

•Becker MuscularDystrophy

•Drug: EDG-5506 Study Type:

Interventional

Phase:

Phase 1

Study Design:

•Allocation: N/A




Outcome Measures:

•Incidence of AEs in thosetreated with EDG-5506

•Frequency of AEs in thosetreated with EDG-5506

•Severity of AEs in thosetreated with EDG-5506

•Incidence of treatment-emergent abnormal clinicalchemistry test results

•Incidence of treatment-emergent abnormalhematology test results

•Incidence of treatment-emergent abnormalcoagulation test results

•Incidence of treatment-emergent abnormalurinalysis test results

•Number of participantswith changes in clinicalchemistry

•Number of participants withchanges in hematology

•Number of participants withchanges in coagulation

•and 9 more

Enrollment:

8

Age:


Sex:

Male

•EdgewiseTherapeutics,Inc.

•Medpace, Inc.


December 2021

Primary Completion:

June 2022

Study Completion:

June 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Rare Disease Research,Atlanta, Georgia, United States

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FunderType

Dates Locations

57 NCT05160402 Evaluation of IGM-6268 inHealthy Volunteers

Study Documents:

Title Acronym:

Other Ids:

IGM-6268-001

Recruiting •Healthy Volunteers •Drug: IGM-6268

•Drug: Placebo

Study Type:

Interventional

Phase:

Phase 1

Study Design:





Outcome Measures:

•Safety & tolerability ofIGM-6268 by assessingthe number, severity, andtype of adverse events perCTCAE 5.0

•IGM-6268 in serum

•Incidence of anti-IGM-6268antibodies in serum

Enrollment:

48

Age:


Sex:

All

• IGMBiosciences, Inc.


December 7, 2021

Primary Completion:

March 30, 2022

Study Completion:

April 30, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Aventiv Research, Columbus,Ohio, United States

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FunderType

Dates Locations

58 NCT05160389 A Study to Assess the Effectof Food on the Absorption andBioavailability of PBI-200

Study Documents:

Title Acronym:

Other Ids:

PBI-200-103

Recruiting •Food Effect inHealthy Volunteers

•Drug: PBI-200 Study Type:

Interventional

Phase:

Phase 1

Study Design:





Outcome Measures:

•Time to MaximumConcentration [T(max)] ofPBI-200

•Area Under theConcentration-Time Curve(AUC) of PBI-200 fromtime zero to the timeof the last measurableconcentration [AUC(0-t)]

•AUC of PBI-200 from timezero to infinity [AUC(0-inf)]

•Time of the maximumobserved drugconcentration [T(max)]

•Terminal elimination half-life [T(1/2)]

Enrollment:

18

Age:


Sex:

All

•PyramidBiosciences


November 17, 2021

Primary Completion:

December 2021

Study Completion:

December 2021

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Bio-Kinetic ClinicalApplications, Springfield,Missouri, United States

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FunderType

Dates Locations

59 NCT05160376 Efficacy of Guided andUnguided Online Self-helpPsychological Intervention: APilot Randomized ControlledTrial

Study Documents:

Title Acronym:

Other Ids:

PSY018

Not yetrecruiting

•Online Self-helpTransdiagnosticPsychologicalIntervention

•Anxiety

•Depression

•Other: Self-helpCBT

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Change in DepressiveSymptoms - The PatientHealth Questionnaire-9(PHQ-9)

•Change in AnxietySymptoms - The GeneralAnxiety Disorder-7(GAD-7)

•Change in Quality-adjustedLife Years - The ShortForm Six-Dimension(SF-6D)

•Change in InsomniaSeverity Index (ISI)

•Change in the PerceivedStress Scale (PSS)

•Change in emotionalregulation strategies- Emotion RegulationQuestionnaire (ERQ)

•Change in frequency ofapplying CBT-based skills- Frequency of Actions andThoughts Scale (FATS)

•Change in Positive Beliefsabout Rumination Scale -Adapted Version (PBRS-A)

Enrollment:

96

Age:


Sex:

All

•ChineseUniversity ofHong Kong


December 6, 2021

Primary Completion:

March 31, 2022

Study Completion:

July 31, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•The Chinese University of HongKong, Sha Tin, Hong Kong

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FunderType

Dates Locations

60 NCT05160363 A Healthy Volunteer SafetyStudy of PyronaridineTetraphosphate Taken inCombination With PiperaquineTetraphosphate

Study Documents:

Title Acronym:

Other Ids:

MMV_SMC_21_01

Not yetrecruiting

•Healthy •Drug: PyronaridineTetraphosphate

•Drug: Piperaquinetetraphosphate

•Drug: Placebo

Study Type:

Interventional

Phase:

Phase 1

Study Design:



•Masking: Triple(Participant, Investigator,Outcomes Assessor)


Outcome Measures:

Assessment of safety andtolerability through thecollection of treatment-emergent adverse events,vital signs, laboratory safetyassessments and ECGrecordings.

Enrollment:

40

Age:


Sex:

All

•Medicines forMalaria Venture

•RichmondPharmacologyLimited

•PharmaKineticLtd

•Other

•Industry

Study Start:

January 2022

Primary Completion:

April 2022

Study Completion:

April 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Richmond Pharmacology Ltd,London, United Kingdom

61 NCT05160350 Probiotic in Treatment of AdultPatients With Drug-resistantEpilepsy

Study Documents:

Title Acronym:

Other Ids:

6938

Completed •Epilepsy

•Treatment

•Drug: Probiotic Study Type:

Interventional

Phase:

Phase 4

Study Design:



•Masking: Triple(Participant, Care Provider,Outcomes Assessor)


Outcome Measures:

Reduction in seizurefrequency

Enrollment:

42

Age:


Sex:

All

•MazandaranUniversityof MedicalSciences


April 21, 2021

Primary Completion:

October 23, 2021

Study Completion:

October 30, 2021

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Bu Ali Sina Hospital, Sari,Mazandaran, Iran, IslamicRepublic of

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FunderType

Dates Locations

62 NCT05160337 Validation of the Stability ofDiagnostic Biomarkers onHealthy Volunteers

Study Documents:

Title Acronym:

Other Ids:

2021-A00405-36

Not yetrecruiting

•Healthy •Diagnostic Test:Biomarker basedIVD tests

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

• lncRNA Biomarkerexpression beforebreakfast intake

•lncRNA Biomarkerexpression after breakfastintake

•sncRNA Biomarkerexpression beforebreakfast intake

•sncRNA Biomarkerexpression after breakfastintake

•mRNAs Biomarkerexpression beforebreakfast intake

•mRNAs Biomarkerexpression after breakfastintake

•Soluble proteins Biomarkerexpression beforebreakfast intake

•Soluble proteins Biomarkerexpression after breakfastintake

Enrollment:

48

Age:


Sex:

All

•Firalis SA •Industry Study Start:

January 2022

Primary Completion:

April 2023

Study Completion:

April 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Firalis Clinical InvestigationCenter, Huningue, France

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FunderType

Dates Locations

63 NCT05160324 T1-T2 Breast Cancer:Comparison Between Removaland Preservation of AxillaryLymph Nodes. (SINODAR ONE)

Study Documents:

Title Acronym:

SINODAR ONE

Other Ids:

1317

Active, notrecruiting

•Breast Cancer •Procedure:Removal of axillarylymph nodes.

•Procedure:Preservation ofaxillary lymphnodes

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Overall Survival (OS)

•Regional Disease FreeSurvival (RDFS)

•Disease-free distancesurvival (DDFS)

Enrollment:

889

Age:


Sex:

Female

•FondazioneHumanitas per laRicerca


April 14, 2015

Primary Completion:

April 30, 2025

Study Completion:

April 30, 2025

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

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FunderType

Dates Locations

64 NCT05160311 Percutaneous Revascularizationin Infarction With LatePresentation and Absenceof Viability: Effects on LeftVentricular Remodeling andContractility

Study Documents:

Title Acronym:

Other Ids:

5106

Recruiting •STEMI - STElevationMyocardialInfarction

•MyocardialDysfunction

•PercutaneousCoronaryIntervention

•Drug: OptimizedMedical Treatment(OMT)

•Device: DrugEluting Stent(DES) CoronaryAngioplasty

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Evaluate reversemyocardial remodelingafter late recanalization inpatients without viability

•Assess change in CardiacEjection Fraction (EF)

•Evaluate changes insegmental myocardialcontratility

•Assessment of Quality oflife

•Incidence of Acute MI

•Incidence of Unplannedrevascularization

•Incidence ofCardiovascular Death

•Incidence of NewCardiovascular relatedHospitalization

•Incidence of Stroke

Enrollment:

70

Age:


Sex:

All

• Instituto DantePazzanese deCardiologia


August 1, 2021

Primary Completion:

December 1, 2023

Study Completion:

July 1, 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Instituto Dante Pazzanese deCardiologia, Sao Paulo, Brazil

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FunderType

Dates Locations

65 NCT05160298 Analgesic Effect of BilateralErector Spinae Plane Block WithRopivacaine After Sternotomyfor Cardiac Surgery

Study Documents:

Title Acronym:

ESB-Sterno

Other Ids:

ESB-Sterno(RBHP2021ELJEZI)

Recruiting •Cadiac Surgery

•Median Sternotomy

•RegionalAnesthesia

•Postoperative Pain

•Drug: Ropivacaine0,2% InjectableSolution

•Other: Controlgroup

Study Type:

Interventional

Phase:

Phase 2

Study Design:



•Masking: Triple(Participant, Care Provider,Outcomes Assessor)


Outcome Measures:

•Change of pain scoreduring cough

•Change of pain scoreduring patient tourn inthe bed (lateralization) fornursing

•Change of pain scoreduring central venouspressure measuring

•Change of sternal painscore at rest

•Change of dorsal painevaluation at rest

•Opioid consumption

•Satisfaction assessed bythe Likert scale

•Spirometry measure offorced vital capacity (FVC)

•Spirometry measure offorced expiratory volume inone second (FEV1)

•Spirometry measure ofFEV1/FVC

•and 8 more

Enrollment:

84

Age:


Sex:

All

•UniversityHospital,Clermont-Ferrand


October 20, 2021

Primary Completion:

November 2, 2023

Study Completion:

November 30, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•CHU, Clermont-Ferrand,France

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FunderType

Dates Locations

66 NCT05160285 Neoadjuvant Nivolumabfor Upper Tract UrothelialCarcinoma

Study Documents:

Title Acronym:

Other Ids:

•KCGMHCTC-2019005

•CPRPG8J0011

Recruiting •Upper UrinaryTract UrothelialCarcinoma

•Drug: Nivolumab100 MG in 10 MLInjection

Study Type:

Interventional

Phase:

Phase 2

Study Design:

•Allocation: N/A




Outcome Measures:

•pathologic completeresponse rate (pCR)

•Treatment related adverseeffect

•Surgical complication

•Objective response rate

•Disease free survival

•Overall survival

Enrollment:

29

Age:


Sex:

All

•YULISU

•OnoPharmaceuticalCo. Ltd

•Chang GungMemorialHospital

•Other

•Industry

Study Start:

December 25, 2020

Primary Completion:

December 15, 2023

Study Completion:

December 30, 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Kaohsiung Chang GungMemorial Hospital, Kaohsiung,Taiwan

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FunderType

Dates Locations

67 NCT05160272 Effects of GABAA ReceptorModulation by AP-325 on InsulinSecretion in Patients With Type2 Diabetes

Study Documents:

Title Acronym:

Other Ids:

GAP-325

Not yetrecruiting

•Type2 Diabetes •Drug: AP-325

•Drug: Placebomatching AP-325

Study Type:

Interventional

Phase:

Phase 2

Study Design:





Outcome Measures:

•Circulating C-peptide byiAUC of C-peptide duringan IVGTT

•Basal insulin level

•C-peptide level

•Glucose level

• iAUC of circulating insulin(overall)

• iAUC of C-peptide level(overall)

• iAUC of glucose level(overall)

• iAUC of circulating insulin(AIR) (first 10 min)

• iAUC of C-peptide (first 10min)

• iAUC of glucose (first 10min)

•and 8 more

Enrollment:

38

Age:


Sex:

All

•The DeutscheDiabetesForschungsgesellschafte.V.

•komIT - Centerof Competencefor InnovativeDiabetesTherapy

•GermanDiabetes Center


December 2021

Primary Completion:

June 2022

Study Completion:

September 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•German Diabetes Center,Duesseldorf, NRW, Germany

68 NCT05160259 Radial Visualization of theForamen Arcuale Atlantis

Study Documents:

Title Acronym:

Other Ids:

Project#5


•Patients WithKimmerle'sAnomaly

•Radiation: Radialvisualization of theforamen arcualeatlantis

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Radial visualization of theforamen arcuale atlantis

Enrollment:

60

Age:


Sex:

All

•SamarkandState MedicalInstitute


February 1, 2020

Primary Completion:

December 31, 2026

Study Completion:

December 31, 2026

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Samarkand State MedicalInstitute, Samarkand,Uzbekistan

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FunderType

Dates Locations

69 NCT05160246 The Instant Effect of KinesiologyTaping in Patients With KneeOA

Study Documents:

Title Acronym:

Other Ids:

Kinesiotape inKnee OA

Recruiting •Knee Osteoarthritis •Other: kinesiologytape

•Other: sham tape

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•muscle activation

•timed up and go test

•sit-to-stand test

•proprioception

•WOMAC (Western Ontarioand McMaster UniversitiesOsteoarthritis Index)

Enrollment:

40

Age:


Sex:

All

•K#r#kkaleUniversity


September 6, 2021

Primary Completion:

June 1, 2022

Study Completion:

June 1, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•K#r#kkale University,K#r#kkale, Turkey

70 NCT05160233 Digital Treatments for Opioidsand Other Substance UseDisorders in Primary Care: ARandomized Controlled Trial

Study Documents:

Title Acronym:

DIGITS

Other Ids:

•1794767

•R01DA047954

Recruiting •Drug Use Disorders

•Illicit Drug Use

•Alcohol-RelatedDisorders

•Opioid UseDisorder

•Behavioral:Standardimplementation

•Behavioral: HealthCoaching

•Behavioral:Practice Facilitation

Study Type:

Interventional

Phase:

Not Applicable

Study Design:


•Intervention Model:Factorial Assignment



Outcome Measures:

•Reach of the digitaltherapeutic to patients inthe primary care clinic

•Fidelity of patients' use ofthe digital therapeutic toclinical recommendations

•Engagement

•Economic costs

Enrollment:

13000

Age:


Sex:

All

•KaiserPermanente

•National Instituteon Drug Abuse(NIDA)

•Other

•NIH

Study Start:

December 9, 2021

Primary Completion:

March 9, 2023

Study Completion:

July 9, 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Kaiser PermanenteWashington, Seattle,Washington, United States

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FunderType

Dates Locations

71 NCT05160220 Naturalistic Study of MicrodosingWith Psilocybin

Study Documents:

Title Acronym:

NATMICRO

Other Ids:

001

Completed •Cognitive Change

•Creativity

•Mood Change

•Sleep

•Drug: Psilocybin

•Drug: Placebo

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Resting state oscillationsmeasured with EEG

•Attention

•Inhibitory control

•Conscious access

•Visual perception

•Physical activity

•Divergent thinking

•Cognitive flexibility

•Convergent thinking

•Effect positive/negativeaffect and well-being

•and 3 more

Enrollment:

34

Age:


Sex:

All

•National Councilof Scientificand TechnicalResearch,Argentina


January 20, 2021

Primary Completion:

June 30, 2021

Study Completion:

October 1, 2021

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Instituto de Fisica de BuenosAires (IFIBA), Buenos Aires,Argentina

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FunderType

Dates Locations

72 NCT05160207 Intubation-induced Decrease inHeart Rate as an Indicator forIntraoperative Bradycardia

Study Documents:

Title Acronym:

Other Ids:

2021-10378-BO-ff

Recruiting •Tracheal Intubation

•AirwayManagement

•Heart Rate

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Intraoperative decrease ofthe heart rate

•Intraoperative asystolia

•Application of atropinesulfate

•Application of positiveinotropic drugs

•Cardiac arrhythmias

•Hypotension

•Application ofcatecholamines orvasoactive drugs

•Adverse cardiocirulatoryevents

•PACU stay

Enrollment:

50

Age:


Sex:

All

•UniversitätsklinikumHamburg-Eppendorf


November 4, 2021

Primary Completion:

February 4, 2022

Study Completion:

March 4, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•University Medical CenterHamburg-Eppendorf, Hamburg,Germany

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FunderType

Dates Locations

73 NCT05160194 Gaining Real-Life Skills Over theWeb

Study Documents:

Title Acronym:

GROW

Other Ids:

90IFDV0003


•Traumatic BrainInjury

•Behavioral:Positive ParentingIntervention

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Center for EpidemiologicStudies Depression ScaleChange

•Parenting Stress IndexChange

•Patient-ReportedOutcomes MeasurementInformation SystemChange

•Family Burden of InjuryInterview Change

•MacArthur-BatesCommunicativeDevelopment InventoriesChange

•Caregiver-ChildObservation Change

•GROW Satisfaction Survey

•Background & FamilyInformation Form

Enrollment:

20

Age:

up to 4 Years (Child)

Sex:

All


•National Instituteon Disability,IndependentLiving, andRehabilitationResearch

•Other

•U.S.Fed

Study Start:

September 30, 2017

Primary Completion:

December 30, 2021

Study Completion:

December 30, 2021

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021


- of 74 -




FunderType

Dates Locations

74 NCT05160181 Impact of Yogotherapeutics onChronic Pains' Patients

Study Documents:

Title Acronym:

YOGADO

Other Ids:

CHRD1119

Recruiting •Chronic Pain •Other: Yogatherapy Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Evolution of the patient'spain

•Evolution of the patient'spain over time

•Improvement of patient'ssleep

•Evolution of the patient'squality of life

•Evolution of the patient'stherapeutic

Enrollment:

50

Age:


Sex:

All

•CentreHospitalier RenéDubos


September 13, 2021

Primary Completion:

February 2022

Study Completion:

February 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Departement of Chronic PainConsultation, Hospital RenéDubos,, Pontoise, France

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FunderType

Dates Locations

75 NCT05160168 A Study of THE-630 in PatientsWith Advanced GastrointestinalStromal Tumors (GIST)

Study Documents:

Title Acronym:

Other Ids:

THE630-21-101

Not yetrecruiting

•GastrointestinalStromal Tumors(GIST)

•Neoplasms,Connective Tissue

•Neoplasms,Connective andSoft Tissue

•Neoplasms byHistologic Type

•Neoplasms

•GastrointestinalNeoplasms

•Digestive SystemNeoplasm

•Digestive SystemDisease

•GastrointestinalDiseases

•Drug: THE-630 Study Type:

Interventional

Phase:

•Phase 1

•Phase 2

Study Design:





Outcome Measures:

•Dose Escalation (Phase1): Number of participantswith dose-limiting toxicities(DLT) following oraladministration of THE-630

•Dose Escalation (Phase1): Determination of RP2Dof orally administeredTHE-630

•Dose Escalation (Phase1): Determination of MTDof orally administeredTHE-630

•Dose Escalation (Phase1): Safety Analysis -Number of participantswith treatment-emergentadverse events asassessed by CTCAE v5.0

•Expansion (Phase 2):Expansion Cohorts 1, 2, 3and 4: confirmed ObjectiveResponse Rate (ORR)

•Dose Escalation (Phase1): Confirmed ObjectiveResponse Rate (ORR)

•Expansion (Phase 2):Safety Analysis - Numberof participants withtreatment-emergentadverse events asassessed by CTCAE v5.0

•Cmax; Maximum ObservedConcentration of THE-630and its Metabolite

•Tmax; Time of FirstOccurrence of MaximumPlasma Concentration(Cmax) of THE-630 and itsMetabolite

•AUC 0-24; Area Underthe Concentration-timeCurve from Time Zero to24 hours for THE-630 andits Metabolite

•and 9 more

Enrollment:

160

Age:


Sex:

All

•TheseusPharmaceuticals


December 2021

Primary Completion:

June 2025

Study Completion:

June 2026

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

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FunderType

Dates Locations

76 NCT05160155 Comparison of the AnalgesicEfficacy of Serratus AnteriorPlane Block and IntercostalBlock

Study Documents:

Title Acronym:

Other Ids:

E.Kurul-E1-21-2143

Recruiting •Rib Fractures

•Serratus AnteriorPlane Block

•Erector SpinaePlane Block

•Acute Pain

•Procedure:Serratus AnteriorPlane Block vsIntercostal Block

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Pain scores

•Need for additionalanalgesia

Enrollment:

60

Age:


Sex:

All

•Atatürk ChestDiseases andChest SurgeryTraining andResearchHospital


December 3, 2021

Primary Completion:

June 3, 2022

Study Completion:

July 3, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Ankara Atatürk Chest Diseaseand Chest Surgery Trainingand Research Hospital,Kecioren, Ankara, Turkey

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FunderType

Dates Locations

77 NCT05160142 Diabetes Inspired CulinaryEducation

Study Documents:

Title Acronym:

DICE

Other Ids:

STUDY20190718

Completed •Type I Diabetes •Behavioral: DICE Study Type:

Interventional

Phase:

Early Phase 1

Study Design:

•Allocation: N/A



•Primary Purpose:Supportive Care

Outcome Measures:

•% Change in HemoglobinA1c

•Change in daily servings offruit

•Change in daily servings ofvegetables

•Change in daily servings ofwhole grains

•Change in daily servingsof sugar-sweetenedbeverages

•Change in daily totalcaloric intake

•Change in primarycaregiver body mass index(kg/m2)

•Change in child body massindex z-score

•Change in child bloodpressure z-score

•Change in child foodpreparation attitude, self-efficacy and frequency ofinvolvement

•and 4 more

Enrollment:

22

Age:

6 Years and older (Child, Adult, OlderAdult)

Sex:

All

•Case WesternReserveUniversity


September 5, 2019

Primary Completion:

November 21, 2019

Study Completion:

November 21, 2019

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Dave's Grocery Store andTeaching Kitchen, Cleveland,Ohio, United States

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FunderType

Dates Locations

78 NCT05160129 Connectomic Deep BrainStimulation for ObsessiveCompulsive Disorder

Study Documents:

Title Acronym:

Other Ids:

•STUDY-21-00125

•1R01MH123542-01

Recruiting •ObsessiveCompulsiveDisorder (OCD)

•Device: Selectivefocal stimulation ofALIC-pathways

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Change in Yale BrownObsessive CompulsiveScale (Y-BOCS)

•Investment Task

•Reversal Task

•Stop Signal Task

•Tractography pathwayactivation models(Diffusion-weighted-imaging)

•Deep brain stimulationevoked potentials (EEG)

•Change in BeckDepression Inventory (BDI)

•Change in Beck AnxietyInventory (BAI)

•Change in BarrattImpulsiveness Scale(BIS-11)

•Change in Young ManiaRating Scale (YMRS)

•Change in Columbia-Suicide Severity RatingScale (C-SSRS)

Enrollment:

20

Age:


Sex:

All

• Icahn Schoolof Medicine atMount Sinai

•National Instituteof Mental Health(NIMH)

•Other

•NIH

Study Start:

August 13, 2021

Primary Completion:

March 2026

Study Completion:

March 2026

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Mount Sinai West, New York,New York, United States

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FunderType

Dates Locations

79 NCT05160116 Influence of Timing of SwitchOperation in Transposition ofGreat Arteries

Study Documents:

Title Acronym:

Other Ids:

CHUB-PED-Timing_Switch

Not yetrecruiting

•Transposition ofGreat Vessels

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Mortality

•Incidence (percent) ofsevere postoperativemorbidity

Enrollment:

250

Age:

up to 1 Year (Child)

Sex:

All

•BrugmannUniversityHospital


January 15, 2022

Primary Completion:

February 28, 2022

Study Completion:

March 31, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Hôpital Universitaire desEnfants Reine Fabiola,Brussels, Belgium

80 NCT05160103 16-Week Randomized Split-Face Efficacy Study of CosmeticFormulations in PhotoagedPigmented Skin Subjects

Study Documents:

Title Acronym:

Other Ids:

001-2021

Not yetrecruiting

•Aging Problems

•Pigmentation

•Other: CosmeticFormulations

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Skin Tone Unevenness

•Skin Firming

•Skin Moisture

•Skin Oiliness

Enrollment:

84

Age:


Sex:

Female

•Avon Products,Inc.

•University ofCape Town,Groote SchuurHospital

• Industry

•Other

Study Start:

January 2022

Primary Completion:

April 2022

Study Completion:

May 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

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FunderType

Dates Locations

81 NCT05160090 SINGLE DOSE CROSSOVERCOMPARATIVEBIOAVAILABILITY STUDY OFBUPROPION HCl MR TABLET300 MG

Study Documents:

Title Acronym:

Other Ids:

AMC-P7-739

Completed •Bioequivalence •Drug: BupropionHCl MR tablets300mg

Study Type:

Interventional

Phase:

Phase 1

Study Design:





Outcome Measures:

•Cmax

•AUC0-T

•AUC0-#

Enrollment:

34

Age:


Sex:

All

•AlembicPharmaceuticalsLtd.


January 18, 2020

Primary Completion:

February 5, 2020

Study Completion:

February 5, 2020

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Algorithme Pharma, MountRoyal, Quebec, Canada

•Algorithme Pharma Inc., Mount-Royal, Quebec, Canada

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FunderType

Dates Locations

82 NCT05160077 Optoacoustic Characterizationof Postprandial Intestinal BloodFlow

Study Documents:

•Study Protocol and StatisticalAnalysis Plan

Title Acronym:

NEPOMUC

Other Ids:

346_21 B

Recruiting •Digestive SystemDisease

•Inflammatory BowelDiseases

•Diagnostic Test:Multispectraloptoacoustictomography(MSOT)

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Change of the quantitativede-/oxygenatedhemoglobin signal (inarbitrary units)

•Change of the qualitativeand quantitative ICG signal(in arbitrary units)

•Change of the quantitativesingle wavelengths signal(in arbitrary units)

•Change of theoptoacoustic spectrum (inarbitrary units, normalized)

•Change of Blood flow inthe big splanchnic arteries.

•Change of ResistanceIndex in the big splanchnicarteries.

•Change of PulsatilityIndex in the big splanchnicarteries.

•Change of peak systolicvelocity in the bigsplanchnic arteries.

•Change of end diastolicvelocity in the bigsplanchnic arteries.

Enrollment:

10

Age:


Sex:

All

•Universityof Erlangen-NürnbergMedical School


November 18, 2021

Primary Completion:

January 2022

Study Completion:

January 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•University Hospital Erlangen,Erlangen, Bavaria, Germany

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https://ClinicalTrials.gov/ProvidedDocs/77/NCT05160077/Prot_SAP_000.pdf

https://ClinicalTrials.gov/ProvidedDocs/77/NCT05160077/Prot_SAP_000.pdf


FunderType

Dates Locations

83 NCT05160064 Long-term Registry of PatientsTreated With LoncastuximabTesirine

Study Documents:

Title Acronym:

Other Ids:

ADCT-402-N01

Not yetrecruiting

•B-Cell Lymphomas Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Progression-free Survival(PFS)

•Overall Survival (OS)

•Duration of Response(DoR)

•Overall Response Rate(ORR)

•Time to Partial Response(PR)

•Time to CompleteResponse (CR)

•Time to DiseaseProgression

•Number of Patients withAdverse Events

•Number of Hospitalizations

•Duration ofHospitalizations

•and 8 more

Enrollment:

500

Age:


Sex:

All

•ADCTherapeuticsS.A.


December 15, 2021

Primary Completion:

December 2024

Study Completion:

January 2025

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

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FunderType

Dates Locations

84 NCT05160051 68Ga-FAPI-46 PET for Imagingof FAP Expressing Cancer

Study Documents:

Title Acronym:

Other Ids:

FAPI-PET Trial

Recruiting •Tumor, Solid •Diagnostic Test:68Ga-FAPI-46 PETScan

Study Type:

Interventional

Phase:

Phase 2

Study Design:

•Allocation: N/A




Outcome Measures:

•Positive predictivevalue (PPV) on a per-region- and per-patient-basis (table 3) of 68Ga-FAPI46 PET for detectionof histopathology-FAP-positive tumorlesions, confirmed byhistopathology/biopsy(reached for # 75%).

•Correlation between68Ga-FAPI-46 PETuptake intensity andhistopathologic FAPexpression

•Sensitivity and specificityof FAPI-PET on a per-patient and per-region-basis for detectionof histopathology-FAP-positive tumorlesions confirmed byhistopathology/biopsy

•Detection rate of FAPI-PETversus previous standardimaging on a per-patientand per-region-basis fordetection of tumor location,also stratified by tumormaker serum level

•Sensitivity and specificityof FAPI-PET vs. previousstandard imaging on a per-patient and per-region-basis for detection oftumor lesions confirmedby combined histo/biopsy/FU imaging/clinical FUreference standard

•Inter-reader reproducibility:determination of FAPI-PET scan interpretationreliability by threeindependent evaluators

•Safety (AEs, SAEs,SUSARs)

•Change in staging/prognostic groups persurvey of referringphysician who wasprovided with FAPI-PETscan information.

Enrollment:

155

Age:


Sex:

All

•UniversityHospital, Essen


December 1, 2021

Primary Completion:

December 31, 2022

Study Completion:

June 30, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Department of Nuclearmedicine, University hospitalEssen, Essen, NRW, Germany

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FunderType

Dates Locations

85 NCT05160038 Embodied Virtual Reality forChronic Pain

Study Documents:

Title Acronym:

Other Ids:

EmbVRpain

Recruiting •Complex RegionalPain Syndromes

•Complex RegionalPain SyndromeType I of the UpperLimb

•Complex RegionalPain Syndrome I(CRPS I)

•Complex RegionalPain Syndrome I ofUpper Limb

•Complex RegionalPain SyndromeType II

•Complex RegionalPain Syndrome II ofUpper Limb

•Peripheral NerveInjury Upper Limb

•Osteoarthritis Hand

•OsteoarthritisFinger

•Device: Embodiedvirtual reality

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Pain assessment baseline

•Pain assessment post -block 1 (session 1 - 4)





•Body perceptiondisturbances - post VRsession 1




•and 5 more

Enrollment:

80

Age:


Sex:

All

•University ofZurich

•BalgristUniversityHospital


May 31, 2021

Primary Completion:

January 31, 2022

Study Completion:

January 31, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•University of Zurich, Zurich, ZH,Switzerland

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FunderType

Dates Locations

86 NCT05160025 Immersive Virtual RealityBicycling for Persons WithParkinson's Disease

Study Documents:

Title Acronym:

Other Ids:

•Pro2021001412

•1F30AG072807-01

•1R15AG063348-01

Not yetrecruiting

•Parkinson Disease •Other: Virtual realitybicycling

Study Type:

Interventional

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Neuromuscular Intensity(Bicycling cadence,revolutions per minute) -Feedback

•Neuromuscular Intensity(Bicycling cadence,revolutions per minute) -Self-Competition

•Neuromuscular Intensity(Bicycling cadence,revolutions per minute) -Other-Competition

•Motivation (IntrinsicMotivation Inventory) -Feedback

•Motivation (IntrinsicMotivation Inventory) -Self-Competition

•Motivation (IntrinsicMotivation Inventory) -Other-Competition

•Cardiovascular Intensity(Heart rate, beats perminute) - Feedback

•Cardiovascular Intensity(Heart rate, beats perminute) - Self-Competition

•Cardiovascular Intensity(Heart rate, beatsper minute) - Other-Competition

•Visual Attention (infraredeye-tracking datarepresenting gazepositions in a 3Dcoordinate plane to beused in calculating dwelltime in regions of interestin the virtual simulation) -Feedback

•and 15 more

Enrollment:

35

Age:


Sex:

All

•Rutgers, TheState Universityof New Jersey

•National Instituteon Aging (NIA)

•Other

•NIH

Study Start:

January 2022

Primary Completion:

September 2022

Study Completion:

September 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Rutgers School of HealthProfessions, Newark, NewJersey, United States

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FunderType

Dates Locations

87 NCT05160012 Peer Comparison Feedbackto Providers to ImproveHypertension Control

Study Documents:

Title Acronym:

Other Ids:

849584

Not yetrecruiting

•Hypertension •Behavioral: PeerComparisonMessage

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Double(Investigator, OutcomesAssessor)


Outcome Measures:

•Change in newhypertensive medicationprescriptions or anincreased dose ofhypertensive medication

•Change in hypertensioncontrol percentage

Enrollment:

75

Age:


Sex:

All

•University ofPennsylvania


January 2022

Primary Completion:

June 2022

Study Completion:

July 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

88 NCT05159999 The Home Blood Pressure (BP)Trial

Study Documents:

Title Acronym:

Home-BP

Other Ids:

•STUDY00012367

•R01DK123104

Not yetrecruiting

•End Stage RenalDisease on Dialysis

•Other: Dry weighttarget adjustment

•Drug: Anti-hypertensivemedications

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Intradialytic hypotension(IDH), defined as systolicblood pressure<90 mmHgduring dialysis

•Fatigue by SONG-HDScore

•Cramping

•Rates of hospitalizationsfor cardiovascular eventsand volume overload

•Correlation between pre-dialysis and home SBP

Enrollment:

200

Age:


Sex:

All

•University ofWashington

•University ofCalifornia, SanFrancisco

•National Instituteof Diabetes andDigestive andKidney Diseases(NIDDK)

•Other

•NIH

Study Start:

December 2021

Primary Completion:

May 2026

Study Completion:

May 2026

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•University of California SanFrancisco, San Francisco,California, United States

•University of Washington,Seattle, Washington, UnitedStates

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FunderType

Dates Locations

89 NCT05159986 Diadynamic and Exercises inKnee Osteoarthritis

Study Documents:

Title Acronym:

Other Ids:

CT01306435

Completed •Osteoarthritis, Knee •Procedure: Groupthat receivedaplication ofDiadynamiccurrents associatedto Exercise duringeight weeks withthree sessions aweek

•Other: Group thatreceived exerciseduring eight weekswith three sessionsa week

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Single(Investigator)


Outcome Measures:

•Change in pain intensity

•Change in Disability

•Change in Medicationintake (Paracetamol) forknee pain relief

•Change in Mobility andbalance

•Change in Range ofmotion

•Change in Muscularstrength

•Change in Physical activity

Enrollment:

60

Age:


Sex:

All

•University of SaoPaulo GeneralHospital


January 1, 2021

Primary Completion:

April 1, 2021

Study Completion:

August 1, 2021

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Raquel Aparecida Casarotto,São Paulo, Brazil

90 NCT05159973 Patients With Non-ST-segmentElevation Acute CoronarySyndrome

Study Documents:

Title Acronym:

SCA

Other Ids:

8410

Recruiting •MyocardialInfarction

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

Study of serious rhythmiccomplications in patientswith non-ST-segmentelevation acute coronarysyndrome

Enrollment:

500

Age:


Sex:

All

•UniversityHospital,Strasbourg,France


October 1, 2021

Primary Completion:

October 2022

Study Completion:

October 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Service des Urgences Médico-Chirurgicales Adultes -Hôpitaux Universitaires deStrasbourg, Strasbourg, France

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FunderType

Dates Locations

91 NCT05159960 Optimal Treatment Protocol forSelective Laser Trabeculoplasty- Repeat Trial

Study Documents:

Title Acronym:

OSLT-R

Other Ids:

•OSLT-R

•277612

Not yetrecruiting

•Glaucoma, Open-Angle

•PseudoexfoliationGlaucoma

•OcularHypertension

•Procedure: SLT Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Relative IOP reduction foreach SLT iteration

•Survival (for each SLTiteration)

•Survival (repeat SLTallowed)

•Achievement of 20%reduction in IOP

•Absolute IOP reduction foreach SLT iteration

•Pain perioperatively: on ascale

•Pain postoperatively: on ascale

•Light sensitivitypostoperatively: on a scale

•Impairment of visionpostoperatively: on a scale

•Redness postoperatively:on a scale

•Adverse events

Enrollment:

400

Age:


Sex:

All

•Vastra GotalandRegion

•GöteborgUniversity


January 10, 2022

Primary Completion:

June 30, 2025

Study Completion:

June 30, 2025

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Department of Ophthalmology,Skaraborg Hospital, Skövde,Vastra Gotaland, Sweden

•Department of Ophthalmology,NU Hospital Group, Uddevalla,Vastra Gotaland, Sweden

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FunderType

Dates Locations

92 NCT05159947 SPT-07A Injection in PatientsWith Acute Ischemic Stroke(AIS): A Phase III Clinical Trial

Study Documents:

Title Acronym:

SPAIR-2

Other Ids:

SPT-07A

Not yetrecruiting

•Stroke, Acute •Drug: SPT-07Ainjection

•Other: placebo

Study Type:

Interventional

Phase:

Phase 3

Study Design:





Outcome Measures:

•Good outcome at 90 days

•proportion of subjects witha modified Rankin Scale(mRS) # 2 at day 90(±7)

•National Institute of Healthstroke scale (NIHSS) atday 8(+1)

•Barthel Index (BI) at day90(±7)

•modified Rankin Scale(mRS) at day 8(+1), 30(±3)and day 90(±7)

•National Institute of Healthstroke scale (NIHSS) atday 8(+1), 30(±3) and day90(±7)

•Barthel Index (BI) at day8(+1), 30(±3) and day90(±7)

Enrollment:

1112

Age:


Sex:

All

•Wuhan UnionHospital, China

•Suzhou HuyunNew DrugResearch andDevelopmentCo., Ltd

•ShanghaiCanmingPharmaceuticalTechnology Co.,Ltd

•Beijing HaijingePharmaceuticalTechnology Co.,Ltd

•The FirstAffiliatedHospital ofBaotou MedicalCollege, InnerMongoliaUniversity ofScience andTechnology

•Xiang YangNO.1 People'sHospital

•XiangyangCentral Hospital

•Wuhan NO. 4hospital

•The AffiliatedHospital ofXuzhou MedicalUniversity

•Xuzhou CentralHospital

•and 48 more


December 2021

Primary Completion:

January 2022

Study Completion:

January 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Wuhan Union Hospital, Wuhan,Hubei, China

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FunderType

Dates Locations

93 NCT05159934 Nicotine Differences in Smokers

Study Documents:

Title Acronym:

Other Ids:

MS063

Not yetrecruiting

•NicotineDependence

•Drug: 0.05, 0.025,and 0.0125 mgnicotine/pulse ofnicotine

•Drug: Saline

Study Type:

Interventional

Phase:

Phase 1

Study Design:





Outcome Measures:

Drug Effect Questionnaire

Enrollment:

20

Age:


Sex:

All

•Yale University •Other Study Start:

January 5, 2022

Primary Completion:

January 2, 2023

Study Completion:

March 1, 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

94 NCT05159921 Can the SurgInfoBot Improvethe Consent Process forEndoscopy? A RandomisedControlled Trial

Study Documents:

Title Acronym:

Other Ids:

REC: 2021-11

Recruiting •Gastro-IntestinalDisorder

•Other: Accessto an automatedconversationalagent (SurgInfoBot)

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Single (CareProvider)


Outcome Measures:

•Patient Satisfaction

•Knowledge

•Knowledge (subjective)

•Peri-procedural anxiety

•SurgInfoBot Usability

Enrollment:

70

Age:


Sex:

All

•TallaghtUniversityHospital

•Royal Collegeof Surgeons,Ireland


November 29, 2021

Primary Completion:

November 2022

Study Completion:

July 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Tallaght University Hospital,Dublin, Ireland

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FunderType

Dates Locations

95 NCT05159908 A Study to Investigate HowEffective, Safe and Tolerable theDrug NBI-921352 is When UsedWith Anti-seizure Medicationsin Adults With Focal OnsetSeizures

Study Documents:

Title Acronym:

Other Ids:

•NBI-921352-FOS2021

•2021-001433-39

Recruiting •Focal OnsetSeizure

•Focal OnsetEpilepsy

•Drug: NBI-921352

•Drug: Placebo

Study Type:

Interventional

Phase:

Phase 2

Study Design:



•Masking: Triple(Participant, Care Provider,Investigator)


Outcome Measures:

•Number of Participantswith Serious Treatment-emergent Adverse Events(TEAEs), TEAEs Leadingto Discontinuation of StudyTreatment, and FatalTEAEs

•Average plasmaconcentration ofNBI-921352

•Percent Change fromBaseline in Monthly FocalOnset Seizure FrequencyDuring the TreatmentPeriod

•Percent Change fromBaseline in Monthly FocalOnset Seizure FrequencyDuring the Maintenanceperiod

•Clinical Global Impressionof Change (CGIC) Scoresat Week 11

•Percentage of Participantswith a # 50% reduction inmonthly (28 days) focalonset seizure frequencyduring the treatment period

Enrollment:

100

Age:


Sex:

All

•NeurocrineBiosciences


January 2022

Primary Completion:

February 2023

Study Completion:

May 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Neurocrine Clinical Site, Praha6, Czechia

•Neurocrine Clinical Site, Praha8, Czechia

•Neurocrine Clinical Site,Rychnov Nad Kn#žnou,Czechia

•Neurocrine Clinical Site,Madrid, Spain

•Neurocrine Clinical Site,Valencia, Spain

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FunderType

Dates Locations

96 NCT05159895 Pharmacokinetic and MassBalance Study of Oral-Administrated [14C]-DZD9008 inHealthy Male Subjects

Study Documents:

Title Acronym:

Other Ids:

DZ2021E0003

Recruiting •Healthy Volunteers •Drug: [14C]-DZD9008

Study Type:

Interventional

Phase:

Phase 1

Study Design:

•Allocation: N/A




Outcome Measures:

•Percentage of TotalRadioactivity (Cum%Dose) Recovered inUrine Relative to theAdministered RadioactiveDose

•Percentage of TotalRadioactivity (Cum%Dose) Recovered inFeces Relative to theAdministered RadioactiveDose

•Amount of TotalRadioactivity Excreted inUrine (Ae [UR])

•Amount of TotalRadioactivity Excreted inFeces (Ae [Fe])

•Percentage ofAdministered RadioactiveDose (%Dose) Excreted inUrine for [14C]-DZD9008

•Percentage ofAdministered RadioactiveDose (%Dose) Excreted inFeces for [14C]-DZD9008

Enrollment:

8

Age:


Sex:

Male

•DizalPharmaceuticals


September 24, 2021

Primary Completion:

March 2022

Study Completion:

October 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Labcorp Clinical ResearchUnit, Madison site, Madison,Wisconsin, United States

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FunderType

Dates Locations

97 NCT05159882 Safety and Efficacy of THR-1442Compared to Dapagliflozin asAdd-on Therapy to Metformin inT2DM

Study Documents:

Title Acronym:

Other Ids:

THR-1442-C-606

Recruiting •T2DM •Drug: THR-1442and Dapagliflozinplacebo

•Drug: Dapagliflozin10mg andTHR1442 placebo

Study Type:

Interventional

Phase:

Phase 3

Study Design:



•Masking: Triple(Participant, Care Provider,Investigator)


Outcome Measures:

•Change From Baseline inHbA1c at Week 24

•Change From Baseline inFPG at Week 24

•Change in Body WeightFrom Baseline to Week 24

•Changes in blood pressurefrom baseline to week 24

Enrollment:

390

Age:


Sex:

All

•NewsoaraBiopharma Co.,Ltd.


April 15, 2021

Primary Completion:

September 30, 2022

Study Completion:

September 30, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•The Fourth Hospital of HarbinMedical University, Harbin,Heilongjiang, China

•The First People's Hospitalof Changzhou, Changzhou,Jiangsu, China

•The Second Affiliated Hospitalof Nanjing Medical University,Nanjing, Jiangsu, China

•Shandong Province QianfoshanHospital, Jinan, Shandong,China

•Affiliated Huzhou HospitalZhejiang University School ofMedical, Huzhou, Zhejiang,China

•China-Japan FriendshipHospital, Beijing, China

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FunderType

Dates Locations

98 NCT05159869 User-Led Meaningful Activityand Early-Stage Dementia

Study Documents:

Title Acronym:

Other Ids:

•IRB00191838

•1K23AG05880901

Not yetrecruiting

•Dementia •Behavioral: User-Led MeaningfulActivity Plan

Study Type:

Interventional

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Change in Premorbidcognitive function asassessed by the WechslerTest of Adult Reading

•Change in global cognitivefunction as assessed bythe Wechsler MemoryScale-III

•Change in the cognitivedomain of attention asassessed by the WechslerAdult Intelligence Scale

•Change in the cognitivedomain of processingspeed as assessed by theTrail-Making Test Part A

•Change in the cognitivedomain of executivefunction as assessed bythe Trail-Making Test PartB

•Change in the cognitivedomain of executivefunction as assessed bythe Stroop Color-WordTest

•Change in the cognitivedomain of executivefunction as assessed bythe Clock Drawing Test

•Change in the cognitivedomain of memory andlearning as assessedby the California VerbalLearning Test

•Change in the cognitivedomain of immediatememory and learningas assessed by theRepeatable Batteryfor the Assessment ofNeuropsychological Statuslist learning subtest

•Change in the cognitivedomains of memory andlearning as assessed bythe Repeatable Batteryfor the Assessment ofNeuropsychological StatusStory Memory subtest

•and 18 more

Enrollment:

70

Age:


Sex:

All

•Johns HopkinsUniversity

•National Instituteon Aging (NIA)

•Other

•NIH

Study Start:

December 15, 2021

Primary Completion:

April 2023

Study Completion:

April 2023

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

•Johns Hopkins School ofNursing, Baltimore, Maryland,United States

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FunderType

Dates Locations

99 NCT05159856 Early Detection of Long-termDiabetic Complications inChildren and Adolescents WithType 1 Diabetes

Study Documents:

Title Acronym:

Other Ids:

H-20038547

Not yetrecruiting

•DiabetesComplications

•type1diabetes

•Children, Only

•DiabeticNeuropathies

•Arterial Stiffness

Study Type:

Observational

Phase:

Study Design:



Outcome Measures:

•Arterial stiffness in childrenand adolescent with type1 diabetes (T1D) > 12months and its associationto glycemic control (currentand past).

•Peripheral neuropathyassed by DPN-check inchildren and adolescentwith type 1 diabetes (T1D)> 12 months

•Autonom neuropathyassed by Sudoscan inchildren and adolescentwith type 1 diabetes (T1D)> 12 months

•Prevalence ofcardivascular autonomicneuropathy assed byVagusDevice in childrenand adolescent with type1 diabetes (T1D) > 12months

•The association betweenearly markers of diabeticcomplications andglycemic control

Enrollment:

400

Age:


Sex:

All

•Steno DiabetesCenterCopenhagen


January 10, 2022

Primary Completion:

February 2024

Study Completion:

August 2024

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

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FunderType

Dates Locations

100 NCT05159843 Effects of Nursing Diabetes Self-management Education

Study Documents:

Title Acronym:

Other Ids:

Tesis-ETD-2021

Not yetrecruiting

•Diabetes Mellitus,Type 1

•Health Behavior

•Behavioral:Therapeuticeducation

Study Type:

Interventional

Phase:

Not Applicable

Study Design:



•Masking: Double(Participant, Care Provider)


Outcome Measures:

•Knowledge in diabetesmanagement

•Glycemic control

•Healthy diet and physicalexercise

•Mood of patient

Enrollment:

176

Age:


Sex:

All

•HospitalesUniversitariosVirgen del Rocío


January 10, 2022

Primary Completion:

May 31, 2022

Study Completion:

September 1, 2022

First Posted:

December 16, 2021


No Results Posted

Last Update Posted:

December 16, 2021

398,416 additional studies not shown

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services

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