louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05712005: Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding of Cognivue Study
Official title: Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding of Cognivue Study (FOCUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Change
Keywords: cognition
brain neurology
neuropsychology
brain health
digital cognitive testing
digital biomarkers
computerized cognititve testing
Lead sponsor: Cognivue, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Velocity Clinical Research
First posted: 2023-02-03
Enrollment: 1437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll up to 2,000 subjects at up to 20 study sites throughout the United States. Subjects will be divided into 6 age groups (i.e., 18-29; 30-39; 40-49; 50-59; 60-69; 70 and above). Subjects will complete one visit lasting up to two hours.

Brief summary: An open-label, multi-site, validity and reliability study to obtain data on the Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests to assess scoring and normative ranges and compare against other cognitive tests within a diverse population.


Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Fluent in English
* Full vision in at least one eye
* Full use of at least one functional hand
* In overall good health, not experiencing any acute symptoms
* Agrees to cognitive examinations administered by research team

Exclusion Criteria:

* Age under 18
* Not fluent in English
* Blind in both eyes (any level of diagnosed blindness)
* Lacking a functional hand
* Those entering or in hospice
* Inability to agree to cognitive examinations administered by research team

Primary outcomes:
measure: Confirmation of scoring and normative ranges.
timeFrame: 4 months
Secondary outcomes:
measure: Stratify study population by age
timeFrame: 4 months
measure: Stratify study population by sex
timeFrame: 4 months
measure: Stratify study population by education
timeFrame: 4 months
measure: Stratify study population by ethnicity
timeFrame: 4 months
measure: Training effect
timeFrame: 4 months
measure: Compare test sensitivity
timeFrame: 4 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Velocity Clinical Research
state: North Carolina
Study officials:
affiliation: University of Miami
name: James Galvin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03759405: IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure
Official title: Myocardial Cell Vein Transplantation for Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Chronic Heart Failure
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Dongzhimen Hospital, Beijing
First posted: 2018-11-30
Enrollment: 3
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Based on the safety evaluation of primates, the best cell transplantation scheme was integrated. One patient with CHF caused by coronary heart disease, one patient with CHF caused by dilatation and one patient with CHF caused by Keshan disease were selected and treated with autologous iPS differentiated cardiomyocyte intravenous transplantation. The safety evaluation of human body was completed and combined with subjective and objective indexes respectively. Structural and functional indicators were used to evaluate the therapeutic effect of cell transplantation. The results of animal experiments confirmed the safety and effectiveness of intravenous myocardial cell transplantation, and clarified its possible mechanism.


Eligibility criteria: Inclusion Criteria:

* It accords with the diagnostic standard of chronic heart failure.
* The etiological diagnosis accords with the corresponding diagnostic standard.
* The age is 30\~80 years old.
* Cardiac function classification is III- grade IV.
* Signed informed consent.

Exclusion Criteria:

* Those who did not meet the diagnostic criteria and were included in the standard.
* Patients with severe dyspnea (such as COPD with pulmonary encephalopathy, upper gastrointestinal bleeding, etc.) accompanied by obvious hypoxemia and hemodynamic instability.
* Patients with severe primary diseases, such as liver and kidney diseases, hematological diseases, autoimmune diseases, malignant tumors, progressive diseases or diseases with poor prognosis, such as severe infection, severe water and electrolyte disorders, acid-base imbalance.
* Various infectious diseases.
* Participants in other clinical trials in the past two months.

Primary outcomes:
measure: Quality of life assessment
timeFrame: 6 months
measure: Curative effect evaluation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing University of Chinese Medicine
state: Beijing
Study officials:
References:
Clinical trial NCT01269905: Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation
Mechanical Heart Valve Replacement
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2011-01-04
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients received heart valve replacement and were retrospectively allocated in three groups

Brief summary: The optimal valve substitute for patients between 60-70 years is controversial. We compared anticoagulation-related adverse events (ARAE) in patients receiving mechanical heart valve replacement (MHVR) on INR self-management vs. stentless bioprosthesis, to assess whether the risk of structural valve deterioration (SVD) is still out-weighted by the benefit of not requiring permanent anticoagulation.


Eligibility criteria: Inclusion Criteria:

* heart valve replacement

Exclusion Criteria:

* CABG
* Afib

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04189705: A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
Official title: A Multi-center, Randomized, Double-blind, Active-controlled, Non-inferiority, Phase 3 Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Gastritis
Chronic Gastritis
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-06
Enrollment: 392
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-blind, active-controlled, non-inferiority, phase 3 study to evaluate the efficacy and safety of MCT-SR in patients with gastritis.

Detailed description: To contribute greater treatment compliance and patient convenience, the rebamipide SR formulation has been developed.

Eligibility criteria: Inclusion Criteria:

* Adult males and females aged ≥19 and \<75 years
* Patients diagnosed with acute or chronic gastritis by gastroscopy with at least 1 erosion confirmed by gastroscopy within 7 days prior to the first dose of the Investigational Product(IP)

Exclusion Criteria:

* Patients ineligible for gastroscopy
* Patients who took other drugs for treating gastritis within 2 weeks prior to the first dose of the IP.
* Patients who have to continue taking drugs that may induce gastritis
* Other clinically significant medical or psychiatric findings that the investigator considers inappropriate for the study

Primary outcomes:
measure: Endoscopic Improvement Rate
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: JaeGyu Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03304197: Hydration and Exercise Performance in Cycling
Official title: How Does Altering the Composition of Ingested Fluids Affect Hydration Status Whilst Cycling?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects manipulating ingested fluids can have on hydration status and cycling performance. There will be 4 different conditions.

Detailed description: Being dehydrated can decrease endurance exercise performance. The investigators wish to test which of three drinks is most effective at re-hydrating cyclists and if this affects performance. Subjects will undertake 4 tests: once dehydrated, once hydrated with water, once hydrated with a sports-specific drink, and once with an altered sports drink. Blood samples will be taken and expired gasses will be sampled at various time points throughout the tests for later analysis. A small amount of labelled water will be consumed with each drink, a technique which will allow us to quantify the absorption of each of the drinks.

Eligibility criteria: Inclusion Criteria:

* Highly trained cyclists (vo2max \>55 ml/kg/min, PPO (peak power output) \> 4 w/kg)
* Training at least 4 times a week
* Females must be taking an oral contraceptive, or using the contraceptive implant

Exclusion Criteria:

* Recent history of musculoskeletal injury
* Diagnosed cardiovascular disease
* Regular use of nutritional supplements that may interfere with the protocol

Primary outcomes:
measure: Absorption of fluid through the gut
timeFrame: To begin 10 minutes after the completion of the 90 minute steady-state cycle
Secondary outcomes:
measure: Work done (kJ) during 15 minute cycling time-trial
timeFrame: Throughout the 90 minute steady-state cycle & the 15 minute time trial.
Other outcomes:
measure: Substrate utilisation
timeFrame: Throughout the 90 minute steady-state cycle
measure: Plasma metabolites
timeFrame: Throughout the 90 minute steady-state cycle and time-trial
measure: Heart rate
timeFrame: Throughout the 90 minute steady-state cycle and time-trial
measure: RPE (rating of perceived exertion)
timeFrame: Throughout the 90 minute steady-state cycle and time-trial
measure: Core body temperature
timeFrame: Throughout the 90 minute steady-state cycle and time-trial
Locations:
city: Exeter
country: United Kingdom
facility: School of Sports and Health Sciences
state: Devon
Study officials:
affiliation: The University of Exeter
name: Andrew D Davenport, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04561297: Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts
Official title: Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: tissue dielectric constant
breast cancer
tumor
biopsy
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: Surgical Specialists of Miami
First posted: 2020-09-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients scheduled for biopsy of the breast
Primary purpose: DIAGNOSTIC

Brief summary: Patients with pending breast biopsies will have the tumor site's tissue dielectric constant (TDC) measured prior to the biopsy. Similar TDC measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast.

Detailed description: Patients with pending breast biopsies will have the tumor site's tissue dielectric constant (TDC) measured prior to the biopsy. Similar TDC measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast. Values obtained at the biopsy site will be compared against the outcome of the biopsy analysis: benign vs. malignant. In addition the measurements obtained at the standardized site for all breasts will be used to establish a set of reference values to characterize breast TDC values. In addition, inter-breast differentials will be used to characterize these ranges for future studies and clinical assessments.

Eligibility criteria: Inclusion Criteria:

* You must be scheduled for a breast biopsy of a breast mass or abnormality with the collaborating centers

Exclusion Criteria:

* You have any open wounds over the breasts
* You have had breast cancer
* You have or have had breast implants or have undergone any breast surgery or breast biopsy
* You have any implantable wires, this includes a Pacemaker, Implantable Cardioverter ° Defibrillators (ICDs), and/or Left Ventricular Assist Device (LVAD)
* You are pregnant

Primary outcomes:
measure: TDC Tumor Differential
timeFrame: one hour
measure: TDC Inter-Breast Differentials
timeFrame: one hour
measure: TDC reference values for breasts
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Surgical Specialists of Miami
state: Florida
Study officials:
References:
Clinical trial NCT01146197: Input of the Use of Indometacin in Gitelman Syndrome as Compared to Potassium Sparing Diuretics
Official title: Evaluation of Safety and Efficacity of Indometacin and Two Potassium Sparing Diuretics in Adult Patients Affected by Gitelman Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gitelman Syndrome
Keywords: Hypokalemia
Hypomagnesemia
Salt loosing nephropathy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-06-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to cardiac and muscles symptoms.

Detailed description: Patients with received in random order 75mg/day indometacin (Chronoindocid®), 10-20 mg/day amiloride and 50-150 mg /day eplerenone (Inspra ®). The three 6 weeks-periods of treatment will be followed by six weeks washout period. 3-6 weeks before the first period of treatment, a supplementation with potassium and magnesium will be orally given, and maintained at the same dose throughout the study and stoped 6 weeks after the end of the third period of treatment.

Eligibility criteria: Inclusion Criteria:

* patients 18-60 yrs old, both sex, with genetically proven Gitelman's syndrome, under birth pill control for woman.

Exclusion Criteria:

* counter-indication to treatment under study
* Other diuretic or NAIS treatments than amiloride, spironolactone, or indometacin

Primary outcomes:
measure: To evaluate the efficacy of indomethacin on hypokalemia versus potassium and magnesium supplementation alone
timeFrame: 2 months
Secondary outcomes:
measure: To evaluate the effectiveness of indomethacin on disorders possibly induced by chronic hypokalemia and /or hypomagnesemia (EKG, lipid disorders related to insulin resistance, glucose/ insulin ratio)
timeFrame: 2 months
measure: To evaluate the effectiveness of eplerenone and amiloride on hypokalemia.
timeFrame: 2 months
measure: To evaluate and compare indomethacin, eplerenone or amiloride in terms of efficiency on biological and hormonal disorders
timeFrame: 2 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Européen Georges Pompidou
Study officials:
affiliation: APHP
name: Blanchard Anne, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
Clinical trial NCT01979497: Adhesive Strips in Dermatologic Surgery: Is Cosmetic Appearance Improved?
Official title: Adhesive Strips in Dermatologic Surgery: Is Cosmetic Appearance Improved?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects Undergoing Surgical Procedure of the Skin
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine whether the addition of adhesive stripping to a wound closed with dermal sutures improves outcome of wound closure. We hypothesize that the combination of adhesive strips to a wound closed with dermal sutures does not add significant cosmetic improvement of the resultant scar.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Able to give informed consent themselves
* Willing to return for follow up visit

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Unwilling to return for follow up
* Wounds less than 3 cm in length
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers 17 and under)
* Pregnant women
* Prisoners

Primary outcomes:
measure: Split-Scar Comparison
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis, Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Custis T, Armstrong AW, King TH, Sharon VR, Eisen DB. Effect of Adhesive Strips and Dermal Sutures vs Dermal Sutures Only on Wound Closure: A Randomized Clinical Trial. JAMA Dermatol. 2015 Aug;151(8):862-7. doi: 10.1001/jamadermatol.2015.0174.
Clinical trial NCT00771797: Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical Assessment
Official title: Clinical Study to Assess the Clinical Efficacy of Flavanol-rich Cocoa on Vascular Function in Diabetic Patients With PAOD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Peripheral Artery Disease
Keywords: PAOD
diabetis
vascular function
in diabetics with PAOD
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Heinrich-Heine University, Duesseldorf
First posted: 2008-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the clinical efficacy and to simultaneously explore the underlying molecular mechanisms of the beneficial effects of flavanol-rich cocoa on vascular function diabetic patients with peripheral artery occlusive diseases (PAOD) of the lower extremities will be investigated.

Detailed description: 50 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 200 m will be enrolled. In a randomized controlled parallel group study the before established novel 5-level approach of vascular diagnostics will be realised. In order to test the hypothesis, whether cocoa rich in flavanols improves vascular function of diabetic PAOD subjects will regularly intake flavanol rich cocoa (group 1: 975 mg/d, n=50 versus group 2: 90 mg/d, n=50) over a period of two months. Clinical endpoints are the Ankle-Brachial-Index, measured by Doppler ultrasound and the pain-free walking distance determined by a treadmill ergometer. All parameters of vascular diagnostic (see 5-level approach above) will be determined before and two month after cocoa ingestion.

Eligibility criteria: Inclusion Criteria:

1. Diabetes mellitus type 2 defined by the criteria of the American Diabetes Association

   * Fasted plasma glucose greater than 126 mg/dL
   * Plasma glucose levels greater than 200 mg/dL 2 hours after OGT
   * Casual plasma glucose greater than 200 mg/dL combined with diabetic symptoms.
2. Endothelial dysfunction defined by FMD \<4%
3. No changes of medication for 2 months
4. Significant PAOD (level IIb, III)

Exclusion Criteria:

1. Ejection fraction \<30%
2. Malignoms
3. Terminal renal failure with hemodialysis
4. Relevant cardiac arrhythmias
5. Acute inflammation defined as CRP \>0,5 mg/dl
6. PAOD (level IV)

Primary outcomes:
measure: Vascular function
timeFrame: before treatment and after 30 and 60 days
Secondary outcomes:
measure: pain free walking distance
timeFrame: before treatment and 30 and 60 days afterwards
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-University, Düsseldorf
Study officials:
affiliation: Clinic for Cardiology, University Düsseldorf
name: Tienush Rassaf, MD
role: PRINCIPAL_INVESTIGATOR
References: