cyrilzakka/clinical-trials huggingface dataset:
SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity

The study looks at how liraglutide works on participant's body weight. Researchers will look at how liraglutide can help children with obesity to lose weight. They will look at how much weight the children will lose, and if there are any side effects.

Participants will either get liraglutide or placebo. Which treatment the participants get is decided by chance. Liraglutide is a new medicine for children, but it can already be prescribed by doctors to adults with overweight or obesity. The participant will get 1 injection every day.

In addition to taking the medicine, the participants will have talks with the study staff about healthy food choices, how they can be more physically active and what can be done to help the participants to lose weight.

The study will last for about 96 weeks (almost 2 years). The participants will have 18 clinic visits and 10 phone or video calls with the study doctor/staff. Participant will have blood samples taken, have 1 test to check the heart, 1 hand X-ray taken and must fill in a diary between some of the visits.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, aged 6 to below 12 years at the time of signing informed consent
* Tanner stage 1-5 pubertal development at the time of signing informed consent
* BMI above or equal to 95th percentile, on gender and age-specific growth charts (CDC.gov)
* History of failing to lose sufficient weight with lifestyle modification as judged by the investigator

For subjects with type 2 diabetes at screening the following inclusion criterion apply in addition:

- Hemoglobin A1c (HbA1c) below or equal to 10.0 percent (86 mmol/mol) as measured by central laboratory at screening

Exclusion Criteria:

* A self-reported (or by parent(s)/LAR (legally acceptable representative) where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Treatment with any medication for the indication of obesity within the past 90 days before screening
* Type 1 diabetes
* Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes)
Validation of a Clinical Screening Grid for Syndromic Schizophrenia

Background:

Nowadays, despite a large number of studies about schizophrenia and genetics, clinical red flags for syndromic forms of schizophrenia remain poorly documented.

Methods: This study aims to validate a short clinical screening grid for syndromic forms of schizophrenia linked to a pathogenic Copy Variation Number (CNV). The investigators plan to include 150 patients with defined (DSM V) schizophrenia and aged 15 years and more. The clinical grid will be prospectively fulfilled for every patients on the basis of his/her medical history and clinical examination. Array comparative genomic hybridization (CGH-a) will be performed on jugal mucosae sample to detect precisely syndromic forms of schizophrenia linked to the presence of a pathogenic Copy Number Variation (CNV).

In subjects with no CNV that may explain the onset of schizophrenia, the investigators would like to complete the investigations with exome trio sequencing. With this type of very clinical approach, the investigators wish to determine which semiological elements should alert the psychiatrists as to the presence of a syndromic form. The objective is to propose at the end of this study a simple and reliable scale, usable in psychiatry consultation, to guide the genetic screening of forms of syndromic schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 15 years and more with a schizophrenia defined by the DSM V criterion
* Informed consent signed by the patient or he/she's legal representant

Exclusion Criteria:

* Pregnancy
* Current psychotic decompensation
* Patient with a known genetic syndrome
Development and Pilot Testing of a Novel Preschool Executive Function Curriculum

Executive function (EF) skills are a set of essential cognitive abilities that enable individuals to demonstrate their knowledge and talents, effectively complete tasks and navigate social interactions through flexible regulation of their thinking, behavior and emotions. EF is strongly linked to academic readiness and long-term educational outcomes. Children's EF is impacted by poverty-related experiences and is also impaired in the increasing number of children with developmental and emotional disabilities. Interventions targeting EF skills hold particular promise for improving children's educational trajectories by leveraging brain plasticity in the preschool period. We will directly target EF skills in preschoolers with poor EF. This project will address a key source of the achievement gap by meeting the needs of children at the highest risk, those who: 1) show early signs of EF impairment; 2) live in low-income communities and 3) are at risk for developmental and emotional disabilities (DD/ED). The intervention is a downward extension of Unstuck and On Target for elementary school (UOT; Cannon, Kenworthy, Alexander, Werner, \& Anthony, 2018), an EF intervention shown to be effective at increasing children's learning behaviors, as delivered by school staff. The research team will partner with key stakeholders to revise and iteratively refine UOT-P through a development trial, utilizing participant, teacher and parent feedback. The results of this trial will be leveraged to enable the team to apply for future federal funding for a randomized comparative effectiveness trial (NIH, Institute of Educational Sciences, Patient-Centered Outcomes Research Institute).


Eligibility Criteria:
Inclusion Criteria:

Enrolled as a student at a participating school site OR as a patient at a participating clinic site

* Chronological age between 3-6 years at enrollment
* English as a primary language
* Roughly age-appropriate core language skills as determined by referring school staff or provider
* Identified by school staff or provider as having problems with flexibility

Exclusion Criteria:

No longer enrolled at participating school or clinic site

• Insufficient English fluency or language skills to complete intervention
Efficacy and Safety of St. John´s Wort/Valerian Extract Versus Placebo in Children and Adolescents With ADHD

This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.

Study Design:

* Randomized
* Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
* Placebo Control
* Parallel Assignment

ADHD is a common childhood disorder associated with attention problems and disruptive behavior. Clinical evidence suggests that a herbal drug combination of St. John´s Wort /Valerian extract may be effective in treating ADHD symptoms in methylphenidate and atomoxetine naive patients. This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD.

Participants will be randomly assigned to receive either an herbal product or placebo twice a day for the duration of 8 weeks. Participants will come in for study visits after 2 and 8 weeks for the assessment of ADHD symptoms, performance and spontaneous movements. Side effects will be monitored continuously and also assessed by rating scales.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Diagnosis of ADHD
* Score of ADHDRS-IV-Parent Version ≥24
* Sufficient knowledge of the German language
* Written Informed Consent by parents and patients
* Ability to swallow study medication
* Sexually mature and active adolescents with highly effective methods of birth control:

  * contraception according to Pearl-Index \< 1
  * when use of oral contraceptives, additional methods of contraception (e.g. condoms) are necessary, i.e. double-barrier

Exclusion Criteria:

* Known hypersensitivity against St. John´s wort or Valerian root or one of the excipients
* Known hypersensitivity of the skin when exposed to sunlight
* All serious internal diseases, and for this reason: Current intake of the following medication:

  * Ciclosporin, Tacrolimus, Indinavir and other protease inhibitors in the anti-HIV treatment
  * Irinotecan and other cytostatics
  * anticoagulants of the Cumarin-type, Digoxin, Amitriptylin, Nortriptyline
  * Midazolam, Theophylline or other medication with photosensitive effects
* All severe psychiatric diseases except oppositional defiant disorders (according to items 21-28 SNAP-IV) and conduct disorders (according to items 41-45 SNAP-IV), and for this reason current intake of the following medication: antidepressants and other psychotropic medication
* Indication for hospitalization
* Suicidality (including suicidal thoughts): Score ≥3 in item 10 of MADRS
* Pregnancy, lactation
* IQ \< 70
* Positive screening for metabolites of illegal drugs in urine
* Previous medication with stimulants and/or atomoxetine
* Psychotropic co-medication
* Placement in an institution on official or judicial ruling
* Parallel participation in another clinical trial according to German Drug Law (AMG), or less than 4 weeks ago
* Patients requiring a primary medication with methylphenidate during the study period of 8 weeks
Qatar Diabetes Mobile Application Trial

Diabetes mobile technology is an emerging and rapidly expanding field that seeks to combine cutting edge behavioral insights with best practice in diabetes self management education to improve patient empowerment and deliver better patient outcomes.The question that arises is whether or not, diabetes mobile applications are effective in improving glycemic control, clinical outcomes, quality of life and overall patient satisfaction, in diabetic patients in Qatar. To answer this, we plan to enroll 90 diabetic patients into a custom-made diabetes app for Qatar (Droobi) (as intervention group) in comparison with 90 diabetic patients followed in the current standard care, matched in characteristics (as control group). We have the hypothesis that with utilization of the mobile application, patients will have improved glycemic control, improved self management and patient empowerment; together with improved patient-educator/doctor interaction.


Eligibility Criteria:
Inclusion Criteria:

* • Adults with T2DM (more than 18 yrs of age and younger than 60) who are able to provide consent

  * Arabic speaking and non-arabic speaking T2DM patients, who can communicate in Arabic and or English language.
  * Uncontrolled diabetes with HbA1c more than or equal to 8.5%
  * T2DM on insulin with or without any other oral medication
  * Subject must have a smart phone (must be an iOS (Apple) phone user) and must be interested in using a smart phone app.
  * Subject must have no visual impairment.
  * Minimal level of literacy (able to read and write in english or arabic).
  * To be able to communicate via chat with the mobile app team through the app as evidenced by at least weekly use of any of the social media such as WhatsApp, Viber, Facebook Messenger etc
  * Subject must be willing to utilize a mobile application for diabetes control

Exclusion Criteria:

* • Recent history (3 months) of stroke or Myocardial infarction.

  * Patients with proliferating retinopathy
  * Patients with an acute illness during the past 2 weeks.
  * Patients who plan to be away for more than 3 months.
  * Patients with CKD requiring dialysis.
  * Hypoglycemia unawareness.
  * More than one episode of severe hypoglycemia in the previous 6 months.
  * Female patients who are planning for pregnancy in the coming 6 months.
Ultrasonic Evaluation of Carbon Dioxide Laser Effects on Patients With Genitourinary Syndrome

The aim of the study was to evaluate the efficacy of vaginal Carbon Dioxide Laser treatment in patients with Genitourinary Syndrome of Menopause on the improvement of Vulvovaginal Atrophy (VVA) and stress urinary incontinence (SUI) by objective parameters and in particular to assess the ultrasound measurement of specific vaginal parameters in order to evaluate a new objective tool of assessment.


Eligibility Criteria:
Inclusion Criteria:

* Age \<75 years, menopause (naturally, pharmacologically or surgically induced, at least 12 months)
* Negative Papanicolaou test (PAP) performed within 12 months before enrolment. and one of the following:
* Presence of vulvovaginal atrophy \[vaginal health index (VHI) \< 15\]
* Initial Urinary Incontinence based on patient history = 1 (according to the "Stamey incontinence score of Stress Urinary Incontinence" - min. 0 = no incontinence, max. 3 = severe incontinence)
* Standardized stress provocation test

Exclusion Criteria:

* Age \>45 years
* The presence of vaginal lesions (active or in the previous 30 days).
* genitourinary tract infection.
* abnormal uterine bleeding.
* use of hormone replacement therapy up to 6 months before enrolment.
* history of photosensitivity disorder or use of photosensitizing drugs.
* genitals prolapse (grade II - III according to the Pelvic Organ Prolapse Quantification)
* a serious or chronic condition that could interfere with study compliance.
The ITA Model of Integrated Treatment of Eating Disorders

This is a naturalistic study implementing a routine assessment to monitor the evolution of the patients with eating disorders being treated in various centers of "ITA salud mental" in Spain.

"ITA salud mental" offers integrated treatment for eating disorders including outpatient, inpatient and day hospital care. The routine assessment implemented to this aim includes both general measures to gauge the therapeutic progress (CORE system) and measures specific for eating disorders (EAT, BITE), which are administered from the beginning to the end of treatment in different time points combined with clinical data included in the patients' health record such as diagnosis, body mass index, previous treatments, and chronicity.

According to its naturalistic nature, this study will accept all participants who are admitted into the care system offered by "ITA salud mental" between November 2, 2017 and October, 2nd., 2020, meeting the inclusion/exclusion criteria and signing informed consent (n = 800 is an estimation). These patients will be followed on three-week bases until October, 30th., 2020, and less intensively on three-month bases until October 2025 to monitor symptoms and to record possible adverse effects.

The analysis of these data will permit to evaluate the therapeutic effects of this integrated treatment and the factors which might influence the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of an eating disorder: Anorexia Nervosa, Bulimia Nervosa, Binge and other eating disorders Not Otherwise Specified.
* Treated in one of the centers of "ITA salud mental".

Exclusion Criteria:

* Not willing to participate (not signing informed consent).
Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects

The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the GORE® HELEX® Septal Occluder.

Ostium secundum atrial septal defects present as a persistent communication between the atria and are a common congenital cardiac anomaly accounting for approximately 10% of all congenital heart disease. They are one of the most common congenital heart defects to present in adulthood. Untreated, ASDs produce right heart volume overload and progressive impairment over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure, pulmonary hypertension, and potential paradoxical embolism. In the U.S. alone it is estimated that approximately 10,000 new patients per year can be expected to have an ASD. Successful surgical repair of ASD has been performed for 50 years with continued improvement in technique and outcomes. King and Mills reported the first transcatheter closure of ASD in 1976, but the delivery system was quite large and impractical, especially for younger patients. With time, improvements in design concepts and materials discoveries have led to improved results in transcatheter closure systems. Several devices are now available commercially for transcatheter ASD closure.

Eligibility Criteria:
Inclusion Criteria:

* ASD less than or equal to 17 mm.

Exclusion Criteria:

* Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events.
* Unable to accommodate device delivery catheter.
Site Preservation After Tooth Extraction

This study is mainly targeted affected teeth which could not be retained, and patients are willing to undergo implant repair at the later stage. After teeth extraction, Geistlich Bio-Oss ® Particles or Bio-Oss ® Collagen are immediately implanted in the teeth extraction socket and covered with Bio-Gide ® collagen membrane for site preservation.Through postoperative follow-up, postoperative clinical and imaging objective indicators, combined with the subjective evaluation of surgeons and patients, and compared with conventional extraction treatment method, the study is aimed to evaluate the effectiveness of different site preservation of alveolar crest preservation, in order to reduce the alveolar bone width and height loss, effectively reduce alveolar bone absorption, or even achieve bone incrementation, thus to get the ideal site preservation effect, to improve the oral implant success rate, improve implant aesthetic score and patient satisfaction, provide more clinical standard reference of the clinical application of site preservation.


Eligibility Criteria:
Inclusion Criteria:

* patients willing to performed site preservation with Geistlich Bio-Oss ® Particles + Bio-Gide ® collagen membrane after tooth extraction;
* patients willing to performed site preservation with Geistlich Bio-Oss ® Collagen + Bio-Gide ® collagen membrane after tooth extraction;
* patients willing to performed no site preservation after tooth extraction and only conventional healing.

Exclusion Criteria:

* patients unwilling to sign the informed consent form and the letter of authorization;
* patients has a potential systematic diseases;
* patients had previously been treated with radiation therapy;
* patients can not re-visit on time.
Collection of Human Tissue Samples From the Neck Region for Characterization of Its Molecular and Biochemical Signatures

The purpose of the study is to gather tissue (from the neck region), specimens (blood and urine) and medical record data from many patients and store them in one place so that scientists have the information they need to conduct research and learn about new ways to predict, identify and treat illness, specifically those related to obesity and diabetes.

This protocol is designed to actively collect biospecimens (specifically, tissue from the neck region) and clinical data for donation to the TRI-MD, specifically, Dr. Sparks' laboratory. These specimens and data will be available to Dr. Sparks for future research activity in accordance with the Florida Hospital and Translational Research Institute for Metabolism and Diabetes (TRI) policies.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and older presenting for surgery in the neck area
* Able to provide informed consent

Exclusion Criteria:

* Unable to provide informed consent
EFFECT of CRYOTHERAPY on KINEMATIC GAIT PARAMETERS in PATIENTS with CHRONIC PATELLOFEMORAL PAIN SYNDROME

this study show the EFFECT OF CRYOTHERAPY ON KINEMATIC GAIT PARAMETERS IN PATIENTS WITH CHRONIC PATELLOFEMORAL PAIN SYNDROME and review its reliability.

Participants were randomly allocated into two equal groups (A and B ) were done by a blinded independent researcher who opened enclosed envelopes containing computer generated randomization serially number index cards using statistical package for social science (SPSS),program (version 20 for windows ,spss, Chicago Illinois,USA) There were no dropouts among the participants throught the study after randomization.

Sixty patients from both genders were participated in this study. they were selected from the outpatient clinic of Faculty of Physical Therapy ,Cairo University with a PFPS.

The Patients of both genders with their ages were ranging from 18 to 40 years old and their BMI was from 20 to 25 kg/m2.

Thirty patients with PFPS, Their ages ranging from 18 to 40 years old ,Their BMI was from 20 to 25 kg/m2 received treatment in form of Traditional treatment (Strengthening exercise, Stretching, ultrasound and electrotherapy). The treatment performed three time a week for 4 weeks.

Thirty patients with PFPS, Their ages ranging from 18 to 40 years old ,Their BMI was from 20 to 25 kg/m2 received treatment in form of Traditional treatment (Strengthening exercise, Stretching, ultrasound and electrotherapy) with cryotherapy, The treatment performed three time a week for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The patients were diagnosed as patellofemoral pain by an orthopedist.
* The participants were eligible to be included if they had bilateral PFPS or unilateral PFPS.
* Duration of knee pain is 4-5 weeks during 6 months prior to study. (Collins et al., 2010).
* Their ages were ranging from 18 to 40 years (Clin Rheumatol et al., 2012).
* Their BMI was ranging from(20 to 25 kg/m2) (Fischer et al., 2009)

Exclusion Criteria:

* • Rheumatoid Arthritis or other systemic rheumatic diseases.

  * Dementia, psychosis.
  * Active substance abuse disorder; acute or chronic disease, injury, deformity.
  * Operation of the lower limb and knee.
  * Severe hearing or visual impairment.
  * Hospitalization for a cardiovascular condition, cerebral infarction or arrhythmia in the previous 3 months.
  * Recent history of 3 or more falls.
  * Current participation in another OA intervention study.
  * Uncontrolled diabetes mellitus.
  * Intra-articular knee injections in the previous 6 months.
  * Contraindications to cryotherapy application those that feel a high level of discomfort or pain during the application.