louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01319071: Genetic Polymorphism and Israeli Top-level Athletes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Top-level Athletes
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Wingate Institute
First posted: 2011-03-21
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Athletes training at the Wingate Institute

Brief summary: It is still unknown whether different genetic elements play a role in athletes' ability to create their area of specificity.In a study conducted in our laboratory few years ago, we genotyped 22 genes in 2 athletic groups (endurance and sprinters) and in age and gender matched nonathletic controls. Few of these genes were found to be associated with athletic performance and area of specificity. Since then a few more genes have been found that are related to athletic performance, and our aim in the current study is to expand our research to these new genes which include 3 genetic cascades: genes associated with body fluid balance and homeostasis, genes associated with muscle strength, and genes associated with bioenergy.


Eligibility criteria: Inclusion Criteria:

* Top-level athletes
* Other athletes

Exclusion Criteria:

* All others

Primary outcomes:
measure: Identification of genes related to top-level athletes
timeFrame: Four months
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Wingate Institute
Study officials:
References:
Clinical trial NCT03019471: Non Invasive Cancer Test (NICT): a Proof of Principle Study.
Official title: Non Invasive Cancer Test (NICT): a Proof of Principle Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplasmata
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Patients with newly diagnosed local or metastatic breast cancer, colorectal cancer, non-small cell lung cancer and anaplastic glioblastoma, before start of radiation therapy, chemoradiation or chemotherapy.
2. Patients age \> 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent

Brief summary: The investigators aim to collect tumor DNA out of blood of cancer patients. If this is successful this could lead to the development of a cancer test in blood in the future, which is less invasive than current diagnostic methods.


Eligibility criteria: Inclusion Criteria:

1. Patients with newly diagnosed local or metastatic breast cancer, colorectal cancer, non-small cell lung cancer and anaplastic glioblastoma, before start of radiation therapy, chemoradiation or chemotherapy.
2. Patients age \> 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent

Exclusion Criteria:

1. Patients with a history of malignant disease other than the disease under study, with an exception for adequately treated squamous cell carcinoma of the skin, basal cell carcinoma of the skin and in situ cervix carcinoma.
2. Pregnancy

Primary outcomes:
measure: ctDNA
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Clinical Geneticist in MUMC+
name: Christine C. De Die-Smulders, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00436371: Amisulpride in Schizophrenic Acute Phase Patients
Official title: The Use of Amisulpride in Schizophrenic Acute Phase Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To collect the safety and response of using Amisulpride in acute schizophrenic patients


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed as Diagnostic and Statistical Manual of Mental Disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode

Exclusion Criteria:

* Patients previously treated with amisulpride
* Patients have comorbidity which may interfere with the treatment or follow-up
* Patients currently taking depot antipsychotics (at least 30 days washout period is needed)
* Patients currently/ or recently (\< 3 months) withdrawn from drug or alcohol abuse
* Pregnant or lactation

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Adverse events
timeFrame: all across the study
Secondary outcomes:
measure: Clinical Global Impressions
timeFrame: All accross the study
measure: Patient compliance
timeFrame: all across the study
measure: Percentage of patient completing treatment
timeFrame: all across the study
measure: Changes in body weight
timeFrame: At baseline and day 84
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Elaine Tang
role: STUDY_DIRECTOR
References:
Clinical trial NCT02819271: A First-in-Human Study of the Safety of Single Continuous Intravenous (IV) Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers
Official title: A First-in-Human Study of the Safety of Single Continuous Intravenous Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Cardioxyl Pharmaceuticals, Inc
First posted: 2016-06-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* No evidence of any acute or chronic health disorder
* Not have taken any prescription medication within 15 days of study entry
* Not have taken any over-the-counter medication or herbal/vitamin supplement within 3 days of study entry
* Not have not have any dietary restrictions
* Have a body mass index (BMI) of ≥18 to ≤34
* Weigh at least 50kg (110 pounds)

Exclusion Criteria:

* Be a current or recent (within 6 months of the Screening Visit) smoker or user of any nicotine-containing product
* Have a history of symptomatic hypotension, orthostatic hypotension or syncope
* Have a history of headaches or other symptoms attributable to caffeine withdrawal
* Have a history of any bleeding diathesis
* Have a positive serology screen for HIV antibody, hepatitis B surface antigen or hepatitis C antibody at screening

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 31 days
measure: Tolerability measured by percentage of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 31 days
Secondary outcomes:
measure: Steady-state plasma concentration (Css)
timeFrame: Up to 4 days
measure: Area under the plasma concentration (AUC) vs. time curve
timeFrame: Up to 4 days
measure: Terminal elimination half-life (1/2)
timeFrame: Up to 4 days
measure: Total body clearance (CL)
timeFrame: Up to 4 days
measure: Steady-state volume of distributions (Vss)
timeFrame: Up to 4 days
measure: Time to Css
timeFrame: Up to 4 days
Other outcomes:
Locations:
Study officials:
affiliation: Cardioxyl Pharmaceuticals
name: Cardioxyl Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06632171: CBT-based and Motivational Interviewing Supported Psychoeducation in Obese Individuals
Official title: The Effect of Cognitive Behavioral Therapy-Based and Motivational Interviewing-Supported Psychoeducation on Emotional Eating and Psychological Resilience in Individuals With Obesity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Obesity, Cognitive Behavioral, Motivational Interviewing
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effects of cognitive-behavioral and motivational interview-supported psychoeducation on emotional eating and psychological resilience in obese individuals. The study will be conducted with a randomized controlled experimental design. The sample of the study will consist of 102 obese individuals in total, 51 in the experimental group and 51 in the control group, who meet the inclusion criteria. A cognitive-behavioral and motivational interview-supported psychoeducation program will be applied to the experimental group. All patients will be evaluated at three time points: pre-test (baseline), post-test (8 weeks), and follow-up test (3 months after the post-test). No intervention will be applied to the control group. The Emotional Eating Scale and Psychological Resilience Scale will be used as data collection tools in the study. As a result of the study, the hypothesis that the cognitive-behavioral and motivational interview-supported psychoeducation program is effective in reducing the emotional eating levels of obese individuals and increasing their psychological resilience levels will be tested. The findings of the study will contribute to the importance and effectiveness of psychological approaches in the treatment of obesity.


Eligibility criteria: Inclusion Criteria:

* Obese individuals (body mass index 30 kg/m2 or more)
* Between the ages of 18-65
* Not having any psychiatric disorder or not using psychiatric medication
* Volunteering to participate in psychoeducation
* Being in a physical and mental condition that will allow them to adapt to treatment
* Signing the informed consent form

Exclusion Criteria:

* Having communication problems
* Having a medical condition (e.g. Cushing syndrome, hypothyroidism) or taking medication that causes obesity
* Having a psychiatric diagnosis (e.g. depression, anxiety disorder, eating disorder) or taking psychotropic medication
* Being pregnant or breastfeeding
* Participating in another diet or exercise program

Primary outcomes:
measure: Emotional eating scale
timeFrame: 2 months
measure: Psychological resilience scale
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02422771: Effect of the FIFA 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes
Official title: Effect of the Fédération Internationale de Football Association (FIFA) 11+ Injury Prevention Program on Performance & Movement Control in Young Female Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury of Anterior Cruciate Ligament
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 47
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In response to high injury rates in soccer, the Fédération Internationale de Football Association (FIFA) developed an injury prevention program called the "11+". It is designed to replace a standard warm-up and takes about 20 minutes to complete. The program has proven remarkably effective in decreasing the rate of injury in soccer players. However, uptake of the 11+ has been less than desired. Adoption of the program may be increased if additional benefits can be demonstrated and the program is introduced at a younger age. The goals of this study are to (1)establish that young athletes can tolerate the program, and (2)measure the effects of the 11+ program on the physical performance of 10-12 year old girls. Three teams will be randomly assigned to the intervention group and carry out the 11+ program for the duration of the indoor soccer season. Another 3 teams will continue with their usual warm-up. Pre- and post-intervention, balance, agility, core strength and movement control will be assessed in all athletes. The investigators hypothesize that the athletes will tolerate the program well and that the intervention group will improve on the performance tests significantly more than the control group.


Eligibility criteria: Inclusion Criteria:

* Bonivital club level soccer athlete

Exclusion Criteria:

* any condition or injury present at pre-testing that may place the athlete at risk (e.g. sprained ankle)

Primary outcomes:
measure: Change in single leg squat score at 6 months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Landing Error Scoring System (LESS) score at 6 months
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Joanne L Parsons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04697771: Effect of Telerehabilitation on Handwriting Performance in Children With ADHD: RCT
Official title: The Effect of Telerahabilitation on Fine Motor Skills and Writing Performance in Children With Attention Deficit and Hyperactivity Disorder: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Handwriting
Telerehabilitation
Fine Motor Skills
Keywords: ADHD
Handwriting
Occupational Therapy
Telerehabilitation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly divided into two groups. The same intervention will be applied to the second group after the first group has received intervention for 8 weeks.
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled study examining the effect of telerehabilitation on fine motor performance and handwriting difficulties experienced by children with attention deficit hyperactivity disorder.

Detailed description: It is planned that 40 children between the ages of 6-8 diagnosed with attention deficit and hyperactivity disorder and their families will participate voluntarily. An informed consent form, BOT-2 and Minnesota Handwriting Test will be sent to volunteer participants via e-mail. An evaluation session on Zoom application will be held for each participant with the participation of the occupational therapist, child and family. After the evaluation, the participants will be randomized and allocated to study and control groups.

Fine motor skills training will be given to the study group 3 sessions a week. The training will be given on the Zoom application and the duration is 8 weeks. At the end of 8 weeks, the evaluation will be done again with BOT-2 and Minnesota Handwriting Test.

The control group will be evaluated with BOT-2 and Minnesota Handwriting Test for the second time after waiting 8 weeks and will receive fine motor skills training.

Eligibility criteria: Inclusion Criteria:

* To be in the age range of 6-8,
* Diagnosed with Attention Deficit Hyperactivity Disorder-Predominantly Inattentive subtype according to DSM-5 and ADHD Rating Scale-5,
* Continuing individual education,
* After being informed about the study have agreed to participate in the study.

Exclusion Criteria:

* Children with an additional physical and neurological problem to accompany

Primary outcomes:
measure: Minnesota Handwriting Test
timeFrame: 5 minute
Secondary outcomes:
measure: Bruininks-Oseretsky Motor Proficiency Test- 2 Short Form (BOT-2)
timeFrame: 15 minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Ankara - Altındağ
Study officials:
affiliation: Hacettepe University
name: Gonca Bumin, Prof
role: STUDY_DIRECTOR
affiliation: Ankara City Hospital Bilkent
name: Hakan Öğütlü, Msc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01536171: Peak Impact Forces and Metabolic Cost During Mid-Forefoot Striking in Shod Versus Barefoot Runners
Official title: Peak Impact Forces and Metabolic Cost During Mid-Forefoot Striking in Shod Versus Barefoot Runners: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: runners
mid-foot strike
fore foot strike
metabolic costs
trained runners (men,women) with a FM strike
shod running
barefoot running
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: trained runners (men and women) who run with a FM strike (self-reported and verified in the laboratory).

Brief summary: This experimental study will compare impact forces and metabolic cost in runners (N=20; ages 18-45 years, who already use a forefoot strike running gait) in two treadmill running test sessions (shod vs barefoot running)

Detailed description: Specific Aim 1: To identify if differences in metabolic cost exist between barefoot versus cushioned shod FM strikers during an acute bout of running exercise. Hypothesis: The metabolic cost will be higher in the cushioned shod runners with forefoot and midfoot strike compared to the barefoot runners.

Specific Aim 2: To identify if differences in peak impact forces exist between barefoot versus cushioned shod runners in forefoot-midfoot (FM) strikers.

Hypothesis: Peak impact forces will be higher in the barefoot runners with a forefoot and midfoot striking running style compared to the cushioned shod runners with a forefoot and midfoot striking running style.

Eligibility criteria: Inclusion Criteria:

* trained runners with a running foot striking style of either initial forefoot or midfoot strike.
* run on average at least 20 miles/week
* be able to run for at least 20 minutes at one session
* free of any orthopedic limitation

Exclusion Criteria:

* history of lower extremity injury within the last 6 months prior to testing
* rear-foot strike running style
* does not run in a cushioned shoe on any occasion
* runs on average \< 20 miles/week
* unable to run for 20 minutes or greater
* presence of any open wound or deformity on the feet which would prevent participant from running barefoot
* neurologic injury that would preclude normal running activity.

Primary outcomes:
measure: Metabolic Rate During Barefoot and Shod Running
timeFrame: Study consists of two visits, approximately 2 hours for each visit
Secondary outcomes:
measure: Peak Impact Forces During Barefoot and Shod Running
timeFrame: Study consists of two visits, approximately 2 hours for each visit
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF&Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Heather K Vincent, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00575471: Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes
Official title: A Randomized, Double-Blind, Placebo-Controlled 12-Week Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: rivoglitazone HCl
thiazolidinedione
peroxisome proliferator-activated receptor gamma (PPARgamma)
diabetes mellitus, type 2
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2007-12-18
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus
* HbA1c \>6.5% and \<10%
* FPG \>126 mg/dL (7mmol/L) and \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* history of type 1 diabetes
* history of ketoacidosis
* current insulin therapy
* C-peptide \<0.5ng/mL
* impaired hepatic function
* CHF or history of CHF (NYHA stage I - IV)
* uncontrolled hypertension

Primary outcomes:
measure: Change in HbA1c from baseline for rivoglitazone compared to placebo
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to placebo
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fukuoka
country: Japan
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
References: