louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00634335: Echocardiographic Characteristics of High Endurance Israeli Athletes
Official title: Echocardiographic Characteristics of High Endurance Israeli Athletes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Athlete's Heart
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: professional bicyclists in Israel

Brief summary: The purpose of this study is to characterize the cardiac adaptive changes of professional Israeli bicyclists by using echocardiography.

Detailed description: Adaptive cardiac changes, such as enlargement of left ventricle mass and enlargement of left ventricular wall was observed in athletes. The physiological limit of remodeling changes in accordance to sex, type of activity, intensity of activity, genetics and race.

Although many studies were conducted on this subject, it is still impossible to predict if an athlete from a certain sport will develop cardiac changes and their what will those changes characteristics will be.

Sudden cardiac death is the leading cause of death among young athletes, this is because of high physical activity in the presence of a hidden heart disease, therefore there is much debate about the needed screening tests for athletes.

In Israel, there is only one study in this subject that showed no significant cardiac changes in Olympic athletes of various types of sports. the study didn't focused on high endurance sport athletes such as professional bicyclists although cardiac endurance is a main factor in cardiac changes.

Eligibility criteria: Inclusion Criteria:

* Known athletes of the bicyclists organization of Israel or any other known organization for 2 year at least.
* Participated in at least one contest recognized by the bicyclists organization of Israel.
* Had been in training for the last 3 months at least, which included minimum of 8 hours a week in average

Exclusion Criteria:

* Do not suffer any known cardiac disease
* Had declared that they are not using drugs which are forbidden by the Olympic committee

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Soroka medical center, Israel
name: Sergio Kobal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00308035: Foot Posture in People With Paralysis on One Side After Stroke
Official title: Foot Posture in People With Hemiplegia After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2006-03-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with hemiplegia from chronic stroke and limited ankle mobility

Brief summary: People who have had a stroke often have difficulty walking and problems with their balance. The purpose of this project is to examine problems with foot postures in people who have weakness on one side of their body

Detailed description: The specific aims of this study are to:

1. Describe foot posture in individuals with hemiplegia following stroke using a quantitative navicular drop test.
2. Determine differences in people with normal, hypotonic, and hypertonic foot posture with regard to ankle range of motion, ankle strength, gait, and balance.

This is an observational design study to describe relationships between the variables. Measurements will include both descriptive and quantitative measures.

Thirty subjects with stroke will participate in one session of testing which will include: clinical assessment of foot posture using a descriptive classification system, quantitative measurement of navicular drop during standing, measurements of ankle range of motion, ankle strength, gait (lower extremity biomechanics and forceplate analysis), and static and dynamic balance. A chi-square test will be used to determine goodness of fit between classification with the descriptive system and the quantitative measurement. Independent one-way ANOVAs will be used to determine the mean differences in the foot posture groups for each of the dependent variables.

Eligibility criteria: Inclusion Criteria:

* subjects must have a diagnosis of a single stroke with resultant hemiplegia and be able to stand up from a seated position and walk 30 feet without assistance.

Exclusion Criteria:

* Subjects will be excluded if they present with significant foot or ankle pathology, other medical problem that would affect gait or balance, or language / cognitive deficits that would impair ability to give informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Patricia Kluding, PT PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05034458: Diet in Pediatric Crohn´s Disease Treated With Biologics
Official title: Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cded in remission patients with high calprotectin

Detailed description: Due to the success of diet in achieving remission in mild-moderate forms of the disease, and an increasing number of patients with loss of response to available drugs despite increasing dose and pathophysiology of the disease, the aim of the present study is to evaluate whether there is response with the addition of diet therapy in patients with moderate/severe forms of CD receiving biologic therapy (infliximab or adalimumab) and presenting active disease.

Eligibility criteria: Inclusion Criteria:

* Patients under 18 years of age
* With a diagnosis of CD
* Who have completed remission induction with biologic therapy
* Who are on maintenance biologic therapy
* Present calprotectin values higher than the limit values established by the laboratory (higher than 250 ug/g).

Exclusion Criteria:

* Children who are unable to receive enteral dietary intake
* Comorbidities affecting nutritional status and/or bone metabolism, growth or pubertal development
* Children already on special diets

Primary outcomes:
measure: Number of Participants with calprotectin less than 250 at week 12
timeFrame: week 12
measure: Level of calprotectin
timeFrame: week 12
Secondary outcomes:
measure: Adherence
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano
name: Marina Orsi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04301258: ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry
Official title: ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cartilage Injury
Cartilage Damage
Keywords: Cartilage
Cartilage Injury
Cartilage Repair
Cartilage Damage
Cartilage Lesion
Cartilage Defect
Lead sponsor: AlloSource
Sponsor class: INDUSTRY
First posted: 2020-03-10
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, who diagnosed by their treating physician, have a cartilage defect in the knee, ankle, foot or hip that requires surgical intervention utilizing ProChondrix CR.

Brief summary: The primary objective of this registry is to obtain long-term outcomes on ProChondrix CR in cartilage repair procedures of the knee, ankle, foot and hip.

Detailed description: This multi-center, observational registry will be used to evaluate the effectiveness of ProChondrix CR in patients who undergo treatment for an articular cartilage defect in the knee, ankle, foot or hip.

This registry will be performed at up to 30 clinical sites across the United States.

Patient follow-up will occur following an articular cartilage repair procedure in which the patient receives ProChondrix CR. During this follow-up period, each patient will be evaluated at least four (4) times at: 3, 6, 12 and 24 months after surgical intervention and will continue annually for as long as patients are willing to fill out questionnaires and outcomes assessments up to 10 years post operatively.

Eligibility criteria: Inclusion Criteria:

* Diagnosed by physician to have a cartilage defect in the knee, ankle, foot or hip that requires surgical intervention;
* Will be having, or has had, a cartilage repair procedure using ProChondrix CR;
* Has the ability to understand the requirements of the registry, to provide written informed consent and to comply with the registry protocol;

Exclusion Criteria:

• Is a ward of the state, prisoner, or transient.

Primary outcomes:
measure: Long-Term Outcomes of ProChondrix CR
timeFrame: 10 Years Post-Operative
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of Southern Alabama
state: Alabama
city: Wheat Ridge
country: United States
facility: Rocky Mountain Foot and Ankle Center
state: Colorado
city: Washington
country: United States
facility: CAO Research Foundation
state: District of Columbia
city: Lexington
country: United States
facility: University of Kentucky Research Foundation
state: Kentucky
city: Cincinnati
country: United States
facility: Beacon Orthopaedics & Sports Medicine
state: Ohio
Study officials:
References:
Clinical trial NCT01009658: MSG and Gastrointestinal Motility
Official title: Effect of Monosodium Glutamate on Upper Gastrointestinal Tract Motility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: Gastrointestinal motility
Gastroesophageal reflux
Gastric emptying
Sodium glutamate
Lower esophageal sphincter
Lead sponsor: Gunma University
Sponsor class: OTHER
First posted: 2009-11-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to clarify the physiological function of sodium glutamate by measuring its effect on upper GI motility ( gastric emptying).

Detailed description: Amino acids such as monosodium glutamate are known to stimulate both endocrine and exocrine secretion. In addition, there is a report that oral intake of glutamate evokes the activation of vagal afferent nerves in the rat. Thus, such amino acids are thought to be influential in the process of digestion and absorption.

. To investigate the effect of monosodium glutamate on gastrointestinal motility, we planned a single-blind randomized study. The participants will take either monosodium glutamate or sodium chloride before the first examination of upper GI motility and the other agent before the second examination. The order of intake will be randomized by the envelope method.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Must not have digestive symptoms
* Must not eat within six hours of study participation

Exclusion Criteria:

* Regular medications for the gastrointestinal tract
* Previous Helicobacter pylori infection
* Previous abdominal surgery

Primary outcomes:
measure: Gastric emptying
timeFrame: 0-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Maebashi
country: Japan
facility: Gunma university hospital
state: Gunma
Study officials:
References:
Clinical trial NCT01101958: A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR)
Official title: A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR) in Subjects With Heterogeneous Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emphysema
Lead sponsor: Pulmonx Corporation
Sponsor class: INDUSTRY
First posted: 2010-04-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Use of the Chartis® Assessment System prior to EBV Treatment

Detailed description: This is a multi-center study which will enroll up to 120 patients. Subjects will undergo a Chartis Assessment prior to EBV treatment. The Chartis assessment will determine the presence or absence of collateral ventilation, a potential determining factor in the success of EBV therapy. This study is not randomized; all subjects are eligible to receive EBV Treatment, regardless of Chartis Assessment outcome. Follow-up data will only be collected on those patients that meet the Chartis inclusion criteria.

Eligibility criteria: Inclusion Criteria:

* Heterogeneous emphysema
* Able to obtain a Chartis value during Assessment

Exclusion Criteria:

* Any co-existing major medical problems that would not make it possible for the subject to tolerate a bronchoscopic procedure.

Primary outcomes:
measure: Lung Volume Change
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Groningen
country: Netherlands
facility: UMC Groningen
Study officials:
References:
citation: Herth FJ, Eberhardt R, Gompelmann D, Ficker JH, Wagner M, Ek L, Schmidt B, Slebos DJ. Radiological and clinical outcomes of using Chartis to plan endobronchial valve treatment. Eur Respir J. 2013 Feb;41(2):302-8. doi: 10.1183/09031936.00015312. Epub 2012 May 3.
Clinical trial NCT05031858: Effect of Vojta Therapy on Covid-19 Respiratory Disease
Official title: Effect of Vojta Therapy in Respiratory Disease Caused by SARS-CoV-2. Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Keywords: Vojta therapy
Respiratory physiotherapy
Lead sponsor: NUMEN Foundation
Sponsor class: OTHER
Collaborators: name: Hospital de Emergencias Enfermera Isabel Zendal de Madrid
First posted: 2021-09-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vojta therapy is a physiotherapy intervention with scientific evidence in respiratory pathologies in children and proven in adults. In this pilot study with an RCT design, its effect in adult patients with respiratory pathology caused by the SARS-CoV-2 virus will be studied. The non-invasive and non-painful technique consists of applying tolerable pressure to specific areas of the patient's body. The objective is to activate, in a reflex way, the ventilatory physiology. It is compared with the conventional respiratory physiotherapy approach.


Eligibility criteria: Inclusion Criteria:

* respiratory disease by covid-19

Exclusion Criteria:

* patient older than 75 years

Primary outcomes:
measure: SpO2
timeFrame: 3 weeks
measure: Breathing frequency
timeFrame: 3 weeks
measure: Stay time
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03843658: Identifying Novel Biomarkers in Early Rheumatology Patients
Official title: Identifying Novel Biomarkers in Early Rheumatology Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatologic Disorder
Lead sponsor: Arthritis Northwest PLLC
Sponsor class: INDUSTRY
Collaborators: name: Inova Diagnostics Inc
name: Bristol-Myers Squibb
name: University of Nebraska
First posted: 2019-02-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newly referred adults to Arthritis Northwest PLLC will be offered the opportunity to enroll in the study.

Brief summary: Patients new to a rheumatology practice will be asked if they want to consent to their blood sample, medical records, and hand/foot x-rays (with sharp scores) for the analysis and correlation with the diagnosis they will receive from the rheumatologist.

Detailed description: At the end of their first visit new rheumatology patients will be asked for their interest in joining the Inova biomarker study. If yes, the patient will be consented, blood will be drawn for the Inova biomarkers, and x-rays will be sent for sharp scoring. Patients may decline and will not be part of the Inova study. Patients who decline will continue to receive standard of care treatment henceforth.

Patients in the Inova trial will receive a diagnosis from their doctor and are placed into separate cohorts based upon their diagnosis. The Inova biomarker results of each cohort will be cross-correlated with diagnoses, pre-screening tool results. Baseline disease activity and sharp scores will also be correlation variables.

Eligibility criteria: Inclusion Criteria:

* Newly referred Arthritis Northwest PLLC
* Age 18 or older

Exclusion Criteria:

* None.

Primary outcomes:
measure: The correlation between novel biomarkers and the primary rheumatology diagnosis
timeFrame: 18 month enrollment period. No follow-up period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00801658: Efficacy of SLT in Patients With Insufficient IOP Control Under Maximum Tolerated Drug Therapy (Eye Drops)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: glaucoma
SLT
Laser treatment
IOP
glaucoma treated with eye drops but IOP not controlled
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Ellex Medical Pty, 82 Gilbert Str., Adelaide, SA 5000
First posted: 2008-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Examination and follow-up of efficacy and safety of SLT in patients with unsufficient IOP control despite maximum tolerated topical therapy. In addition, it will be examined whether medical treatment can be reduced after the SLT procedure and whether filtering surgery - as the only remaining option - may be postponed.

Detailed description: SLT (Selective Laser Trabeculoplasty) uses the Nd:YAG-Lasers (wavelength 532nm, Q-switched, frequency-doubled). Thanks to the low laser energy used and the short duration of treatment, only pigmented cells of the trabecular meshwork are targeted and selectively treated. Neighboring, non-pigmented cells and tissue are spared collateral and thermic damage, the architecture of the trabecular meshwork remains intact. The SLT procedure uses less than 1% of the energy of the ALT procedure with an extremely low pulsation duration.

Several studies confirm the effective IOD reduction of SLT and rate the procedure as an relatively safe and effective therapy for glaucoma. Also repeated use of the SLT procedure is considered as meaningful. Meanwhile the SLT procedure is used as primary and supplementary treatment of glaucoma and study confirmed that the SLT procedure was just as effective as administration of Latanoprost in reducing IOD in newly-diagnosed glaucoma.

Eligibility criteria: Inclusion criteria: Patients with

* primary open angle glaucoma (including normal tension glaucoma)
* pseudoexfoliation glaucoma
* pigment dispersion glaucoma

Exclusion criteria: previous intraocular surgery closed angle glaucoma pediatric glaucoma inflammatory or uveitic glaucoma unclear view of the trabecular meshwork

Primary outcomes:
measure: IOP lowering effect of SLT in a special patient group
timeFrame: 1 day, 1 , 3, 6 , 12 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT04050358: Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance
Official title: The Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance in Healthy 18 - 35 Year Olds
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Elysium Health
Sponsor class: INDUSTRY
Collaborators: name: University of Exeter
First posted: 2019-08-08
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a single-center, randomized, placebo-controlled pilot study to evaluate the effects of high intensity interval training (HIIT) and daily administration of BasisTM for 3 weeks, in 18-35 year old males.

The study will consist of a screening visit, baseline visit, followed by treatment and HIIT phase (3 weeks) and a post-supplementation, follow-up visit (this will occur 48 h (or more) after the final HIIT session). Following the screening phase, subjects who meet entry criteria will be randomly assigned to 1 of 2 treatment groups: recommended dose of BasisTM (250 mg Nicotinamide Riboside and 50 mg Pterostilbene) per day or matching-placebo in a 1:1 ratio.


Eligibility criteria: Inclusion Criteria:

* 18 to 35 year old males
* Body mass index between 18.5-30 kg.m-2
* Ability to give informed consent
* Recreationally active (defined in the present study as exercising once a week or more).

Exclusion Criteria:

* Those regularly conducting HIIT or highly trained in endurance events (e.g. triathlete)
* Currently taking supplements known to affect metabolism (e.g. ibuprofen, stimulants, vitamins, NR)
* Taking prescribed medication
* Consuming a vegan diet
* Consuming a high fat, low carbohydrate diet
* Habitual consumption of protein and/or dairy supplements (e.g. whey protein)
* Smokers

Primary outcomes:
measure: Mitochondrial function
timeFrame: 3 weeks
Secondary outcomes:
measure: Exercise Capacity
timeFrame: 3 weeks
measure: Muscle strength
timeFrame: 3 weeks
measure: Muscle power
timeFrame: 3 weeks
measure: Mitochondrial proteins
timeFrame: 3 weeks
measure: Body Mass
timeFrame: 3 weeks
measure: Percent Body Fat
timeFrame: 3 weeks
measure: Recovery via POMS
timeFrame: 3 weeks
measure: Recovery via RESTQ
timeFrame: 3 weeks
measure: Physical activity levels using FitBit
timeFrame: 3 weeks
measure: Height
timeFrame: 3 weeks
measure: Blood pressure
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
Study officials:
affiliation: University of Exeter
name: Timothy Etheridge, PhD
role: PRINCIPAL_INVESTIGATOR
References: