cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study in Patients With Major Depressive Disorder

The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The safety and how well the body can handle the drug will also be investigated. The study will be conducted in Russia in hospitalised patients with severe depression. GSK163090 will be compared with placebo, which looks like the study drug but does not contain any active substance. Subjects will be given either the study drug or the matching placebo.

This is a randomised, multi-centre, double-blind, placebo-controlled, repeat dose, parallel group study in male and female patients with severe depression requiring hospitalization. Efficacy, safety and tolerability will be assessed in three treatment arms. The study will consist of a screening period, a treatment phase (up to 6 weeks) and a post-treatment follow-up visit. The study duration from screening to follow up will be approximately 9 weeks. Subjects who pass screening will be randomized on Day 1 to one of three treatment arms (low dose arm, high dose arm or placebo). Each treatment arm will contain approximately 50 subjects. The subject's depressive symptoms will be assessed using the HAMD17- CR.

Eligibility Criteria:
Inclusion Criteria:

* Currently have severe depression (Major Depressive Disorder - without psychotic features)
* meet criteria (DSM IV-TR ) for current major depressive episode for at least 4 weeks but for no greater than 24 months
* depression questionnaire (HAMD17) total score greater than or equal to 24
* subject must read and able to give written informed consent
* male or female 18 to 64 years
* use appropriate birth control method
* BMI 18.8 - 35.0 kg/m2 (inclusive)

Exclusion Criteria:

* Primary diagnosis of other psychiatric disorders
* thoughts of killing ones self or someone else
* taking psychiatric medicine or therapy within the six months
* Has previously failed an adequate course of medication for MDD from two different classes of antidepressants.
* Unstable medical disorder or a disorder that would interfere with the action of the drug
* Abuse of alcohol or drugs
* Past history of serotonin syndrome or a history of clinical significant intolerance of SSRIs (class of drugs used for depression).
* History of migraine headaches that respond to treatment with triptan medication.
* History of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
* Currently taking part in another clinical study or has done so within six months
* Pregnant, planning to become pregnant shortly or breastfeeding
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy
Evaluation of Four Reconstructions After Total Gastrectomy

There are four capital reconstructions after total gastrectomy which is widely used in China. Life quality is the only standard to evaluate postoperative results of different reconstructions. In order to determine the best reconstruction after total gastrectomy, we designed this study to compare life qualities of four reconstructions.


Eligibility Criteria:
Inclusion Criteria:

* Patients should be younger than 80 years old with adequate renal, pulmonary, and heart functions.

Exclusion Criteria:

* death or other reason which cause information discontinue
Study of ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Coronary Artery Disease

The purpose of this research is to determine the relationship between proteins and enzymes in the blood and how they work with platelets to form blood clots in patients with coronary artery disease. The investigators hypothesize that the relationship between these factors could potentially be useful in identifying patients at higher risk for heart attacks.


Eligibility Criteria:
Inclusion Criteria:

* Admission to hospital with suspected index event of Non-ST-Elevation Myocardial Infarction (NSTEMI), Unstable Angina (UA) or Stable Angina (SA)
* Planned percutaneous coronary intervention during admission

Exclusion Criteria:

* Recent history (\< 6 months) of an acute coronary syndrome (other than current admission) or stroke
* Recent history (\< 6 months) of major surgery, trauma or thromboembolic event
* Percutaneous coronary or peripheral intervention or any stent placement performed within the past 6 months
* Current evidence of infection
Exercise Efficacy on Autism Spectrum Disorder

The goal of this clinical trial is to learn if regular exercise intervention may improve the health status of the participants diagnosed with autism spectrum disorder, ages between 5-13 years old. The main question it aims to answer is:

* if combined regular exercise program improves motor skills, repetitive movements, aerobic capacity and quality of life of participants?
* Researchers will compare the exercising and non-exercising participants to see if regular exercise improves the health related parameters.

Participants will do exercise for 12 weeks regularly.

Before and after the exercise program;

* the parents of the participants will fill out the ABC problem behaviour control scale
* the participants will perform 6 minute walk test, sit-reach flexibility test, grip strength test. Body fat analysis will be performed by using Bioimpedance Analysis Method.
* participants will also perform MoBAK-1 test which measures motor competencies

Exercise program include; 10 minutesTreadmill Walk, Playdough or ball squeeze, Towel wring,Throwing to target, catching the tennis ball, bouncing a ball inside borders without losing control, dribbling a ball inside borders without losing control, tandem walk, Single leg stance balance on balance pad or pillow, rolling forward, Jumping exercises, Side stepping, etc.

The implementation of exercise programs, the follow-up process, and data recording methods will be documented and applied by the research team.

Data will be analyzed in the SPSS 28 statistical package program. The data distribution will be checked by Kolmogorov Smirnov and the homogeneity of variances by the Levene test. For variables with normal distribution, One-Way ANOVA will be used for multiple comparisons, and an Independent t-test will be used for pairwise comparisons. Wilcoxon test will be used for pairwise comparisons in dependent variables that do not fit a normal distribution, and the Mann- Whitney U test will be used in independent variables. The relationship between continuous variables will be tested using the correlation coefficient, and the relationship between categorical variables will be tested using the chi-square test. Descriptive statistics will be given as mean ± standard deviation. Results will be considered statistically significant for p\<0.05.

Eligibility Criteria:
Inclusion Criteria: children with autism spectrum disorder

-

Exclusion Criteria:

* children who are unable to adapt exercise programs
tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis

This study is testing whether the addition of a noninvasive form of brain stimulation called transcranial direct current stimulation (tDCS) when combined with meditation helps decrease the abdominal pain in patients with chronic pancreatitis. The device involved in this study, transcranial direct current stimulation (tDCS) is investigational. This means that the study device is still being tested in research studies and is not approved by the Food and Drug Administration \[FDA\].

This is a double-blind, pilot study with the goal of testing the effects of tDCS coupled with meditation in the management of visceral pain in patients with chronic pancreatitis. We will enroll a total of 14 subjects with chronic pancreatitis. After enrollment, subjects will be randomized to active stimulation plus mediation (7 subjects) or sham stimulation plus meditation (7 subjects). Subjects will undergo 5 days of active tDCS stimulation plus meditation or sham tDCS plus meditation. Sessions will last approximately 30 min - 1 hour. EEG activity will be measured in the first, last and follow-up visits. After each stimulation session, we will assess for adverse effects using the tDCS adverse effects questionnaire. We will also have the subject fill out a pain/medication diary during the 5 days of treatment. All study procedures will be completed at BIDMC.

Eligibility Criteria:
Inclusion Criteria:

1. Provide informed consent to participate in the study
2. 18 years old
3. If taking pain medications, stable doses are required for at least 1 month prior to initiation of the study

Exclusion Criteria:

1. History of alcohol or substance abuse within the last 6 months as self-reported
2. Suffering from severe depression (with a score of \>30 in the Beck Depression Inventory)
3. Diagnosis of any neurological diseases (such as epilepsy)
4. Episodes of seizures within the last 6 months
5. Unexplained loss of consciousness
6. Use of carbamazepine or neuropsychotropic drugs
7. Have had no neurosurgery as self reported
8. Contraindications to tDCS

   1. Metal in the head
   2. Implanted brain medical devices
9. Pregnant at time of enrollment
10. Previous experience with meditation
Growing Future Physician Leaders: A Randomized Trial of an Educational Intervention in Postgraduate Trainees

Study objective: The objective of this trial was to determine the effectiveness of a Leadership Development Program (LDP) aimed at 1) establishing basic management knowledge and 2) promoting reflection of leadership skills.

Study design: Randomized, controlled, single-blind trial. Study participants: Senior postgraduate medical and surgical trainees at an urban university health care centre.

Methods: Eligible participants were randomized to either the LDP(intervention group) or to regular postgraduate training (control group). For ethical reasons, all participants assigned to the control group were offered the LDP at the end of the trial. The 1º outcome measure used was a knowledge-based written exam. The sample size was estimated on finding a 20% difference in mean test scores between groups. Participants' reflective capacity and higher order leadership role skills were tested through a personal learning project (PLP, 2º outcome measure).

Study objective: The objective of this trial was to determine the effectiveness of a Leadership Development Program (LDP) aimed at 1) establishing basic management knowledge and 2) promoting reflection of leadership skills.

Study design: Randomized, controlled, single-blind trial. Study participants: Senior postgraduate medical and surgical trainees at an urban university health care centre.

Methods: Eligible participants were randomized to either the LDP(intervention group) or to regular postgraduate training (control group). For ethical reasons, all participants assigned to the control group were offered the LDP at the end of the trial. The 1º outcome measure used was a knowledge-based written exam. The sample size was estimated on finding a 20% difference in mean test scores between groups. Participants' reflective capacity and higher order leadership role skills were tested through a personal learning project (PLP, 2º outcome measure).

Eligibility Criteria:
Inclusion Criteria: Postgraduate trainees in PGY 3 or higher -

Exclusion Criteria: Program director does not allow participation

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A Teleintervention in Developmental Coordination Disorder

The principal study goals are to determine if a randomized control trial would be feasible, particularly with regards to i) recruitment and retention of parents of children having a diagnosis or a suspicion of diagnosis of DCD, and ii) parents' utilization of the teleintervention. The study will also examine quantitatively and qualitatively families' acceptability of- and satisfaction with the teleintervention.

Developmental coordination disorder (DCD) is a neurodevelopmental disorder characterised by difficulties in planning and execution of motor coordination activities like dressing, sports and writing. Increasing parents' capacity to manage their children's needs is part of the recommended DCD best practices, as soon as children are suspected to have DCD or early following diagnosis. Parents' capacity could be increased through simple, community-based interventions using a consultative approach. Using the Internet could be an interesting avenue to develop public community-based services and build parents' capacity to manage their child with DCD. The feasibility of recruiting and using the Internet to build parents' capacity is however unknown, since no such study have been conducted.

This randomized feasibility trail will experiment a teleintervention, characterized by a virtual interaction between a health professional and a user by Internet, for children with DCD. The principal study goals are to determine if a randomized control trial would be feasible, particularly with regards to i) recruitment and retention of parents of children having a diagnosis or a suspicion of diagnosis of DCD, and ii) parents' utilization of the teleintervention. The study will also examine quantitatively and qualitatively families' acceptability of- and satisfaction with the teleintervention. As part of the evaluation of acceptability, the impact of the teleintervention on parental competencies will be explored. At the end of the 3-months randomized feasibility trial, the influence of the number of participants on the utilization of the teleintervention will be explored by providing access to the teleintervention to all participants (control and intervention).

Eligibility Criteria:
Inclusion Criteria:

* A DCD medical diagnostic (or DCD medical hypothesis)
* Must be at or under the 16e percentile for the global score at the Movement Assessment Battery for Children-2 (MABC-2) or be at or under the 5e for one of the 3 subscale of the MABC-2.

Exclusion Criteria:

* Do not have other neurodevelopmental diagnoses, with the exception of Attention Deficit Hyperactivity Disorder (ADHD)
* Do not receive rehabilitation services for DCD in the public health care system
Inpatient Versus Outpatient Rehabilitation After TKA

The purpose of this study is to compare the effectiveness of inpatient and outpatient rehabilitation following total knee arthroplasty. No studies exist that have evaluated these two rehabilitation programmes in a specific orthopaedic patient population with a focus on motor performance. We hypothesized that patients participating in outpatient care tend to be physically more active than patients in the rehabilitation clinic, leading to the assumption that outpatient rehabilitation has superior functional outcomes compared to the inpatient standard-of-care therapy.


Eligibility Criteria:
Inclusion Criteria:

* patients with knee osteoarthritis and scheduled for primary TKA
* age: 50-80

Exclusion Criteria:

* BMI \> 40
* musculoskeletal and neurological disorders that limit physical function
* any planned further joint surgery within 6 months
* substantial pain or functional limitation which make the patients unable to perform study procedures
Psychosocial Treatment for Attention Deficit Hyperactivity Disorder in Adults

This study will determine the effectiveness of group cognitive-behavioral therapy as compared to a problem-solving social support group in treating problems of time management, organization, and planning in adults with attention deficit hyperactivity disorder (ADHD).

ADHD is a chronic neurobiological condition that affects people of all ages, genders, and races. Symptoms of ADHD may include, but are not limited to, the following: poor attention span; physical restlessness or hyperactivity; excessive impulsivity; chronic procrastination; frequently losing things; poor organization, planning, and time management skills; and excessive forgetfulness. Not every person with ADHD exhibits all of these symptoms, and the severity of the disorder can range from mild to severe. While there is no cure for ADHD, the condition can be managed with an accurate diagnosis and proper treatment. Left untreated, individuals with ADHD may experience significant impairment in social, emotional, occupational, and academic functioning. Stimulant and non-stimulant medications are usually effective in alleviating symptoms of ADHD in adults. However, some research suggests that medications may not effectively treat self-management functioning problems and that as many as one-third of adults with ADHD have inadequate responses to medication treatment. Additional research on the benefits of psychosocial treatments for ADHD in adults is needed. This study will determine the effectiveness of group cognitive-behavioral therapy as compared to a problem-solving social support group in treating problems of time management, organization, and planning in adults with ADHD.

Individuals interested in participating in this study will first undergo an assessment of their eligibility for inclusion in the study. The assessment will last approximately 6 hours, but can be broken up into as many as 4 separate visits. Eligible participants will be randomly assigned to either receive group cognitive-behavioral therapy or join a problem-solving social support group. Both groups will meet once a week for 12 weeks. Each session will last roughly 2 hours and will focus on building time management, organizational, and planning skills. Time management, planning, and organizational skill levels will be assessed at the treatment mid-point, immediately following the intervention, and at 3 and 6 months following the treatment. Self-esteem and symptoms of depression and anxiety will also be measured at these visits.

Eligibility Criteria:
Inclusion Criteria:

* Suspected of having or have been diagnosed with ADHD
* May potentially benefit from the ADHD group treatment

Exclusion Criteria:

* Any overt cognitive disability (e.g., Alzheimer's disease, mental retardation)
* Deemed not to potentially benefit from the proposed ADHD group treatment
CB1 Receptors in Human Brown Adipose Tissue

This study investigates cannabinoid CB1 receptors in human brown adipose tissue (BAT) and other tissues using positron emission tomography (PET) imaging. Subjects will be scanned in room temperature conditions and during controlled cold exposure, and the density of CB1 receptors in BAT and other tissues will be quantified. The investigators hypothesize, that cannabinoid signaling is increased in cold conditions, when BAT is metabolically active.

Understanding the mechanisms of BAT activation and the role of endocannabinoids in humans is important and beneficial in fighting against the epidemic of obesity and diabetes.

Endocannabinoids have an important role in regulating energy balance and metabolism. Cannabinoid 1 receptors (CB1) are found in several tissues such as brown adipose tissue (BAT). Endocannabinoids and CB1 receptors participate in the control of lipid and glucose metabolism, and blockage of CB1 receptors has been found to improve metabolic factors linked to obesity and cardiovascular disease, making CB1 antagonists potential drugs against obesity and diabetes.

In this study the investigators use a PET radiotracer \[18F\]FMPEP-d2, which binds to CB1 receptors in vivo, to quantify the CB1 receptor density in BAT, white adipose tissue, muscle and the brain. This study is done once in warm conditions and once during controlled cold exposure. To verify whether the subject has metabolically active BAT, an additional PET scan with the radiotracer \[18F\]FDG is performed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Group 1: BMI 20-26 kg/m2, Group2: BMI 27-40 kg/m2

Exclusion Criteria:

* BMI \< 20 kg/m2or BMI \> 40 kg/m2
* Any chronic disease that could affect the study outcome, including medicated type 2 diabetes
* Mental disorder or poor compliance
* Eating disorder or excessive use of alcohol, tobacco smoking or drug use
* Past dose of radiation
* Presence of any ferromagnetic objects that would make MR imaging contraindicated
* Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
Use of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn

Frenotomy of tongue-tie is commonly performed to resolve breastfeeding difficulties, eg maternal nipple pain and infant's latching difficulties. The procedure carries minor discomfort for the infants. It is not known whether the use of topical benzocaine, a very bitter tasting material' applied to the tongue-tie would decrease the length of cry. We will measure the duration of crying in infants treated with topical benzocaine to the duration in those not treated with the mediation.


Eligibility Criteria:
Inclusion Criteria:

* Full term Newborn infant
* Tongue-tie upon physical examination
* Maternal complains of nipple pain or difficult latch

Exclusion Criteria:

* Abnormal oral or nasopharyngeal anatomy
* Any known congenital malformations
* Prematurity
Impact of Fruit and Vegetables in PKU

In the UK, some fruits and vegetables are permitted without measurement in the diets of people with phenylketonuria (PKU). It is proven that fruits and vegetables containing phenylalanine (Phe) up to 75mg/100g (e.g. carrots, sweet potato, tomatoes) do not affect blood Phe control but it is unknown to what extent fruits and vegetables containing Phe from 76-100mg/100g (e.g. cauliflower, broccoli, beansprouts and asparagus) increase blood Phe levels. In addition, there is very little information about how differently animal and vegetable protein affect blood Phe levels. It is believed that plant protein may have less bioavailability and therefore have less impact on blood Phe control. The investigators aim is to perform a randomized controlled study over 21 weeks in children (5-12y) with PKU. Children will be studied during five different time periods, examining the effect on blood Phe control when increasing Phe intake from vegetables/fruits containing Phe from 76-100 mg/100g vs. animal sources. At the end of the study, fruits and vegetables containing 76- 100mg Phe/100g will continue to be given as "exchange-free" for 6 months. This is a practical, cost effective study and should bring benefit to all people with PKU following a very restrictive diet both within the UK and throughout the world.


Eligibility Criteria:
Inclusion Criteria:

* PKU patients diagnosed by NBS and BH4 deficiencies;
* Early and continuously treated;
* Adherent to their prescribed PKU diet consisting of a protein-restricted diet and Phe-free amino acid based protein substitute;
* In good general health as evidenced by medical history;
* Able to provide written informed consent/assent (parent/child);
* Able to comply with the study protocol and take study product according to the opinion of the PI;
* Patients with good metabolic control (age 5-12y, 120-360μmol/L) with 3 out of 4 levels within range prior to consent (if 2 of 4 above target range but one close to the upper limit, PI to decide if patient can enter the study).

Exclusion Criteria:

* Concomitant diseases / disorders such as renal or gut disease / disorders and diabetes;
* Dislikes fruits and vegetables containing 76-100 mg of Phe/100g e.g.brocolli or cauliflower;
* Treated with BH4 (sapropterin);
* Presence of intercurrent infection;
* Patients with poor metabolic control (age 5-12y, \>360μmol/L).