cyrilzakka/clinical-trials huggingface dataset:
Obesity and Psychotherapy as an Alternative to Treatment

Adherence to obesity treatment programs has been a limiting factor to good results in loosing weight. This study aimed to verify if obese subjects submitted to a physical exercise program and group psychotherapy would have a greater adherence, than obese people exercising only.

The sample was forty people, both genders, mean age: 42,2 ± 10,7 years old. Physical exercise consisted of walking and stretching three times a week, during 50 minutes, with intensity verified by the Borg Scale, during three months. One of the days were supervised by the authors while two were freely chosen by the participant, without supervision. The verified variables were: total body mass, height, body mass index, physical activity level, caloric expenditure, waist circumference and fat percentile. Half of the sample participated of group psychotherapy once weekly.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>= 30 kg/m2

Exclusion Criteria:

* Age less than 25 or more than 62
A Study to Measure Needle Bending and Changes in Prostate Shape During a Prostate Seed Implant

Prostate brachytherapy is an effective treatment option for men with localized prostate cancer, with excellent cure rates and a favorable toxicity profile. With the current needle insertion technique, seed placement inaccuracy is primarily caused by needle deflection and soft tissue deformation, which both occur during the brachytherapy operation. This study will accrue 20 patients undergoing prostate brachytherapy implants and acquire a series of ultrasound images, video clips and one CT scan.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer
* Treated with prostate brachytherapy at the Cross Cancer Institute
* Low and intermediate risk prostate cancer
* ambulatory patients
* stable medical condition
* Over 18 years of age
* Capable of giving informed consent

Exclusion Criteria:

* Any hormonal therapy
Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements

The primary objective of this clinical study is to collect clinical data to support FDA 510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The secondary objective is to evaluate any adverse events found during the clinical study.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age of either sex and any race or ethnicity;
* Willing and able to provide written informed consent prior to any study procedures being performed;
* Willing and able to follow all instructions and attend all study visits;
* Best Spectacle Corrected Visual Acuity (BSCVA) of 0.3 logMAR (20/40 Snellen equivalent) or better in both eyes as measured using an ETDRS chart.

Exclusion Criteria:

* Only one functional eye;
* Poor or eccentric fixation;
* Corneal scarring or have had corneal surgery, including corneal laser surgery;
* Microphthalmos;
* Buphthalmos;
* Contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
* Dry eyes, meaning having been diagnoses by a physician with dry eyes and currently using a prescribed medication;
* Lid squeezer - blepharospasm;
* Nystagmus;
* Keratoconus;
* Any other corneal or conjunctival pathology or infection;
* Condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
Executive Training and Brain in Adolescent

The purpose of this study is to investigate the cognitive and brain effects of inhibitory control (IC) training at adolescence.

Brain imaging now allows to study non-invasively cognitive learning processes. An area of strong scientific interest is the development of executive control, an essential cognitive domain for academic and professional success and for mental and physical health. These functions are essentially located within the prefrontal cortex, characterising by a late maturation until the end of adolescence and, while under genetic control, can likely be improved with targeted interventions. The objective of this project is simple and innovative: testing in adolescents with the most appropriate brain imaging technologies available today (the Magnetic Resonance Imaging, MRI), the effect of an executive training focused on the inhibitory control (IC). This project aims at precisely testing the effect at the cognitive and brain levels of IC training in adolescence. To do this, the investigators will recruit two groups of 30 teenagers aged 16 to 17 years old, each assigned to one of two learning situations: IC vs Active Control (AC). Each participant will participate in 25 training sessions of 15 minutes per day, 5 days a week for a month. Brain structural and functional differences in the brain and between the pre-test and post-test related to intense IC training will be correlated with cognitive progress.

Eligibility Criteria:
Inclusion Criteria:

* 16-17 years old
* girl or boy ;
* French mother tongue;
* Handedness: Right;
* Schooled in a level corresponding to its age (2nd or 1st)
* Informed consent signed by the (s) holder (s) of parental authority, in agreement with the teenager
* Normal medical, neurological, neuroradiological examinations.
* Health insurance

Exclusion Criteria:

* classical exclusion criteria for MRI
* Has chronic use of alcohol or drugs;
* Abuse or substance dependence (excluding nicotine) or a toxic over 5 years or has led to comas (overdoses)
* Cognitive disorders of sudden onset that may reflect a stroke; history of head trauma with loss of consciousness for more than 1 hour, or encephalitis;
* A chronic neurological disorder, psychiatric, endocrine, hepatic and infectious disorder;
* Major disease history (diabetes, chronic lung disease, heart disorder, metabolic, hematologic, endocrine or immunological severe cancer);
* A medication that may interfere with brain imaging measures (psychotropic drugs, hypnotics, anxiolytics, antipsychotics, anti-Parkinson, benzodiazepines, anti-inflammatory drugs, antiepileptics, antihistamines, analgesics and muscle relaxants central);
* dyschromatopsia
* Impossibility to submit itself to the study for geographical or psychiatric reasons;
* Pregnant and lactating women;
* Has pervasive developmental disorders and / or acquisitions identified by parents or legal guardian and (or) the teachers;
* Cerebral palsy;
* Fine motor disorder
* Unaccompanied by parent (s) (s) or at least a person with parental authority during the visit to the research platform;
* Tattoo on the head, neck or shoulders
Insulin Action During Pregnancy in Woman at High Risk for Gestational Diabetes

The project objective is to validate a new indirect estimate of insulin status in both pregnant African-American women and Caucasian women in southern Louisiana who are at risk for gestational diabetes mellitus. There are racial differences in carbohydrate metabolism that are potentially linked to complications during pregnancy and to increased risks of obesity and diabetes in later life. The investigators will explore the use of indexes of insulin status to identify the metabolic risk profile of pregnant women which may vary by race. Understanding whether there are differences which vary by race may influence clinical screening and treatment of pregnant women.

The major goal of our proposed study is to validate a new approach to estimating insulin sensitivity and ß-cell function in African-American women compared to non-Hispanic white women in southern Louisiana who are at a high risk for gestational diabetes mellitus (GDM). We will determine whether the whole body insulin sensitivity index (WBISI) and insulinogenic index (IGI) \[derived from an oral glucose tolerance test (OGTT)\] can be used during 24-28 weeks of pregnancy to accurately estimate the degree of insulin resistance relative to ß-cell function in women with GDM in those with impaired glucose tolerance (IGT) as well as those who are glucose tolerant. Fasting values will also be assessed using the homeostasis model assessment (HOMA-IR and HOMA-%B) to evaluate insulin resistance and ß-cell function. We will explore the potential use of these measures to define the metabolic risk profile of these pregnant women and compare them with obstetric outcomes. We will determine if there are differences in risk that vary by race. Second, given the high likelihood that women who manifest GDM will develop type 2 diabetes mellitus (DM), identification of these patients by ethnic group or other independent determinants will permit intervention after delivery that might delay or prevent the onset of type 2 DM.

Eligibility Criteria:
Inclusion Criteria:

* 18-42 years of age
* at 20-30 weeks of gestation
* Caucasian or African-American and non-users of medications known to influence carbohydrate metabolism.

Exclusion Criteria:

* \<18 years or \>42 years of age
* non-Caucasian or non-African-American ethnicity
* use of drugs that could interfere with glucose or insulin metabolism; or health problems such as diabetes mellitus or liver, heart, lung and kidney diseases
VAC NPWT KCI Dressing Study

In this study, the investigators propose using negative pressure wound therapy (NPWT) to aid in wound healing along the lines of closure for lower extremity amputation and complex abdominal wounds. This study is designed to be a prospective, randomized clinical trial to evaluate the effectiveness of NPWT versus accepted standard surgical dressings on these wounds. Study participants will be randomized to one of the two treatment groups (NPWT vs. standard dressing) prior to surgery, and will be followed in the post operative period to monitor the effects on their surgical closures. The experimental group will consist of participants receiving NPWT and will have a Vacuum Assisted Closure (V.A.C., KCI inc.) device placed intra-op along the line of closure. The control group will receive a standard surgical dry sterile dressing. The surgical closures will be assessed after three days of treatment as well as the first outpatient post-op visit and any subsequent visits through the following 6 months. By doing so, the investigators hope to demonstrate the utility of NPWT on difficult, at risk surgical closures. Additionally, the investigators hope to show a difference in clinical outcome of incisions treated by NPWT over our current standard technique.

All patients in the principal and co-investigators practice who are scheduled to undergo lower extremity amputation or complex abdominal closure will be eligible for enrollment in this prospective randomized study. There are no exclusion criteria. Informed consent will be obtained pre-operatively. Data collection will include basic demographic data, disease history, past medical and social history as well key data relating to wound healing (infection, wound dehiscence or breakdown) and hospital course (length of stay, operative complications). The investigators will use simple statistical methods (ANOVA and chi-squared analysis) to compare surgical wound healing between the two populations. The only deviation from current standard of care in these populations includes utilizing a V.A.C. system on the closure line of the experimental group versus the standard dry sterile dressing.

No further description is desired

Eligibility Criteria:
Inclusion Criteria:

* patients presenting to wound center undergoing wound treatment with expected closure of wounds including: Midfoot amputations, below knee amputations, knee disarticulations, above knee amputations, and trunk wounds
* wounds must be closed primarily without the use of grafts

Exclusion Criteria:

* any patient \<18 years old
* any patient whose wound is unable to be closed primarily
Metabolomics and Microbiomics in Cardiovascular Diseases

"MEtabolomics and MicrObiomics in caRdIovAscular diseases Mannheim (MEMORIAM) " is a single-center, prospective and observational study investigating to identify disease-specific metabolic, respectively microbiomic, patterns of patients with high-risk cardiovascular diseases. High-risk cardiovascular diseases comprise patients suffering from acute heart failure (AHF), ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), sepsis, septic shock, ischemic and non-ischemic cardiomyopathy.

Scientific evidence about the metabolomic and microbiomic changes in high-risk cardiovascular patients is still lacking.

The acute, critical or progressive disease status predestinies to relevant changes in cardiovascular metobolism. High-risk patients in the present trial comprise those with acute heart failure, myocardial infarction (STEMI and NSTEMI), sepsis, septic shock, ischemic and non-ischemic cardiomyopathy with severely reduced left ventricular ejection fraction (LVEF \<35%).

Therfore this study investigates to identify disease-specific patterns of metabolic and microbiomic changes. These patterns may help to understand pathophysiology at the metabolic stages and find out those patients being at highest risk of adverse future outcome.

Eligibility Criteria:
Inclusion Criteria:

* above mentioned diseases, diagnosis according to respective guideline
* written informed consent

Exclusion Criteria:

* under 18 years
* cancer
* rheumatic diseases
* infections (except septic group)
* higher grade heart valve diseases
Mindful Parenting and Parent Training Program Study

The Mindful Parenting and Parent Training Study will be investigating the combination of Bögels and Restifo's (2014) Mindful Parenting Program and Chorpita and Weisz's (2009) Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH) Program, specifically the BPT module. The Mindful Parenting Program is an adaptation for parents of the Mindfulness-Based Cognitive Therapy, and the Mindfulness-Based Stress Reduction program; the program will consist of 7-weekly 2.5-hour parent group sessions. Following the completion of the Mindful Parenting group sessions, half of the participants will be randomly selected to receive individually-implemented MATCH BPT sessions, which will consist of 8-12 weekly (depending on how long it takes for individual parents and their assigned trainer to get through the material), 1.5-hour sessions. The other half of families will have the opportunity to also receive the MATCH BPT program following the completion of data collection.

Both evaluation and treatment services will be offered at no cost to study participants. Parents, children, and teachers will also be offered monetary incentive to thank them for their time and effort completing study related assessments throughout the course of the study to determine if the combination of the Mindful Parenting Program with BPT improves functioning in children with disruptive behavioral problems, as well as the parent-child relationship and the parent's acquisition and enactment of the skills they learn in BPT.


Eligibility Criteria:
Inclusion Criteria:

1. the child participant must be between the ages of 6 and 11 years old at baseline/time of pretreatment data collection;
2. he/she must have an elevated score (i.e. a t-score of 60 or greater) on one or more of the Externalizing Problems clinical scales (i.e. Hyperactivity, Aggression, and Conduct Problems) or on the Attention Problems clinical scale of the Behavior Assessment System for Children 3rd Edition - Parent Report (BASC-3; Reynolds \& Kamphaus,

2015), as assessed during the intake assessment for the study; 3) both the parent and child participants must be fluent English speakers, and; 4) the parent participant(s) must be available to attend weekly treatment sessions and assessments for up to 26 weeks at New York University - Kimball Hall.

Exclusion Criteria:

1. There is evidence of significant developmental delay or psychosis that impacts the child's ability to fully engage in the intervention;
2. The youth or parent presents with emergency psychiatric needs that require services beyond that which can be managed within this intervention format (e.g. hospitalization, specialized placement outside the home);
3. if the parent and/or child are not fluent English speakers;
4. if the family is currently enrolled in any type of behavioral parent or parent management training program; and
5. if the child has an estimated Full Scale IQ below 80, based on completing two subtests of the Wechsler Abbreviated Scale of Intelligence, Second Edition during the intake assessment for the study.
A Study to Compare the Blood Level of Bimekizumab Injected Subcutaneously Either by a Prefilled Syringe or by an Auto-injector in Adult Healthy Volunteer Participants

The purpose of the study is to evaluate the pharmakokinetics (PK), safety, tolerability, and immunogenicity of bimekizumab (BKZ) when administered subcutaneously (sc) via 3 different BKZ delivery devices in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant is male or female aged \>=18 years and \<=55 years at Screening Visit
* Participant must be in good health (physically and mentally) as determined by the Investigator based on medical history (any chronic and acute illness), physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory screening tests during the Screening Period
* Participant has a body mass index (BMI) of 18-32 kg/m2 and a minimum body weight of 50 kg for male participants and 45 kg for female participants, and a maximum body weight of 100 kg for all participants
* Participant is willing to abstain from alcohol-, tobacco-, and caffeine-containing products for 48 h prior to admission into the clinic and during the entire in-clinic stay

Exclusion Criteria:

* Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections
* Participant has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening Visit
* Participant has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
* Female participant who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method
* Participants receiving any live (includes attenuated) vaccination within the 8 weeks prior to Screening visit (eg, inactivated influenza and pneumococcal vaccines are allowed but nasal influenza vaccination is not permitted). Live vaccines are not allowed during the study or for 20 weeks after the last dose of the IMP
* Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study
* Participant has active neoplastic disease or history of neoplastic disease within 5 years of Screening Visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects

Writer's cramp is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. Patients with Writer's cramp also have difficulty in fine control of grip force.

The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by each fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active ('stationary') fingers. Different tasks have been developed to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed.

The aim of this study is to assess if developed tasks allow to precisely characterize writer's cramp condition in terms of abilities aforementioned.

To do so, performance of 20 writer's cramp patients in the developed task will be compared with performance of 20 control participants (matched in age, sex and writing hand) in the same tasks.


Eligibility Criteria:
Inclusion criteria for patients with writer's cramp

* Patient with writer's cramp and writing speed \<140 letters / min
* Writer's cramp focal dystonia specific to the task of writing
* Patient treated or not with botulinum toxin injection
* Person having attended school in French

Non inclusion criteria for patients with writer's cramp

* Patients whose writer's cramp has no impact on the handwriting and has kept a writing speed\> 140 letters per minute.
* Tremor of writing
* Neurological condition other than writer's cramp (eg Parkinson's syndrome)
* Pain, trauma or pathology of the upper limb of the writing member other than the writer's cramp who required medical or surgical treatment in the last 6 months preceding the initial check-up

Inclusion criteria for control subjects

•\> 18 years old

* Without writer's cramp
* Person having attended school in French

Non inclusion criteria for control subjects

* Tremor of writing
* Neurological condition other than writer's cramp (eg Parkinson's syndrome)
* Pain, trauma or pathology of the upper limb of the writing member other than the writer's cramp who required medical or surgical treatment in the last 6 months preceding the initial check-up

Matching criteria between cases and control patients

* Age (± 5 years)
* Gender
* Hand writing
Left Atrial Mechanical Function Improvement After Atrial Fibrillation Catheter Ablation

The objective of the study was to estimate the efficacy of telmisartan and amlodipine combination on the restoration of left atrial mechanical function after atrial fibrillation catheter ablation.

64 candidates to atrial fibrillation ablation were included in the study. Patients were randomly assigned to telmisartan/amlodipine combination in dose 80/5 mg (group I, n=34) or placebo (group II, n=30) taking daily for up to one week. Echocardiography was performed before the procedure, immediately after it, and after a week of therapy. The six-minute walk test and SF-36 questionnaire results were evaluated a day before the procedure and after a week of the therapy. The left ventricular end-diastolic pressure was invasively measured after transseptal puncture and before left atrial sheath removal.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic (III-IV class by European Heart Rhythm Association scale) paroxysmal atrial fibrillation;
* Ineffective therapy by at least one of the class I or III antiarrhythmic drugs;
* Left atrial diameter 5 cm or less;
* Estimated catheter radiofrequency pulmonary vein antrum isolation;
* Signed informed consent.

Exclusion Criteria:

* Intolerance/allergy or contraindications to telmisartan, amlodipine, warfarin or enoxaparin;
* Left atrial thrombosis;
* Age greater than 75 years;
* Severe (e.g. decompensation of vital functions) or acute (e.g. pneumonia) somatic conditions;
* Malignant growth in the hematogenic dissemination stage.
Randomized Controlled Study for Analyzing Clinical Benefit of Pain Focused Sedation With Combination of Fentanyl and Propofol During Endoscopic Retrograde Cholangiopancreatography (ERCP)

The investigators study is the randomized controlled study for analyzing clinical benefit of pain focused sedation with combination of fentanyl and propofol during Endoscopic retrograde cholangiopancreatography (ERCP). The investigators will assess recovery time and adverse effect during ERCP as the primary end point between two group. The investigators will also access satisfaction score for endoscopist and patients as the secondary end point.


Eligibility Criteria:
Inclusion Criteria:

* The patients who scheduled for ERCP

Exclusion Criteria:

* The patients with ASA physical classification V
* The patients with history of sulfite, egg or soy bean allergy
* The patients during pregnancy or latency period
* The patients who informed consent could not be obtained
* The patients who were under 20 years old