cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Motor Skills, Balance, Dual Task, and Social Adaptation in Individuals with Autism

The aim of our study is to evaluate motor skills balance, dual task and social adaptation skills in individuals with autism. Our study will be conducted in Bartın Lider Special Education and Rehabilitation Center after ethics committee approval. The sample number determined by power analysis will be included in the study. Socio-demographic characteristics (age, height, body weight, body mass index, education level, exercise and smoking habits, etc.) of the individuals who voluntarily participated in the study will be obtained. The individuals participating in the study will be divided into two groups as individuals with normal motor development and individuals with autism spectrum disorder and the same assessment scales will be used. These assessment scales are TUG, 10 meter walking test, Vineland Adaptive Adaptation Scale, Bruininks-Oseretsky Motor Competence Test. According to the evaluation results, motor skills, functional balance, dual task and social adaptation skills of individuals with autism will be compared with individuals with normal motor development.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with ASD by a physician
* Children are receiving education in a special education and rehabilitation center
* No vision problems
* Ability to receive and execute commands
* No cognitive problems
* No walking problems

Exclusion Criteria:

* Individuals with concomitant secondary diseases
* Individuals who have undergone surgery in the last six months
Effect of Triflow Breathing Training

This study aims to explore whether an 8-week Triflow breath training program reduced the anxiety levels and improved the heart rate variability and quality of life of patients receiving hemodialysis. To investigate the effect of the triflow respiration training on the improvement of heart rate variability, anxiety, and the quality of life in hemodialysis patients.

Method:This research adapted the cluster randomization design. The participants were divided into the first group of patients undergoing hemodialysis every Monday, Wednesday, and Friday and the second group undergoing dialysis every Tuesday, Thursday, and Saturday. The experimental group and the control group were randomly assigned by a coin toss. The investigators conducted the study for eight weeks and investigated the effects of respiration training on the improvement of heart rate variability, anxiety, and quality of life in hemodialysis patients. Patients in the experimental group receive the triaflow respiration training three times a week for eight weeks during hemodialysis. Data were collected by a heart rate variability monitor, State-Trait Anxiety Inventory and WHOQOL-BREF at baseline and after a 8-week respiration training.

Eligibility Criteria:
Inclusion Criteria:

1. Long-term hemodialysis is required to treat patients with end-stage renal disease diagnosed by a physician.
2. Blood older than or equal to 65 years old and under 80 years old with diabetes Dialysis patients.
3. Hemodialysis has been accepted for more than three months and is still under treatment and half There were no hospitalizations for other comorbidities during the year.
4. Those who are conscious and have no serious mental symptoms, can talk and express and agree to Subject to respirator training and questionnaires.
5. Available country and Taiwanese communicators.
6. The average score of the Situational Trait Anxiety Scale is greater than 20 points.

Exclusion Criteria:

1. Patients with low blood pressure during dialysis can not raise the bed to 30 degrees.
2. Blindness and hearing or long-term bedridden.
3. There are cases of irregular heartbeat.
4. The Daily Activity Scale is less than or equal to 60 points (the study uses the Barthel Index).
L-Carnitine as an Osmo-metabolic Agent for Peritoneal Dialysis

A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is to evaluate the possibility to formulate PD solutions containing L-carnitine as an osmotic agent to partially replace glucose.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Have a diagnosis of ESRD and have been on Automated Peritoneal Dialysis (glucose 1.5 or 2.5 % w/v) for at least 3 months
* Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing
* Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)
* Have not experienced peritonitis episodes in the last 3 months
* Have Kt/V urea measurement \> 1.7 per week in a previous test performed within 6 months that should be confirmed at Baseline Visit
* Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit
* Have a D/P Creatinine ratio at Peritoneal Equilibration Test (PET) between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Baseline Visit
* Have a D/P Glucose ratio at Peritoneal Equilibration Test (PET) between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at Baseline Visit
* Be treated by the participating clinical Investigator for a period of at least three months
* Have understood and signed the Informed Consent Form.

Exclusion Criteria:

* Have a history of drug or alcohol abuse in the six months prior to entering the protocol
* Be in treatment with androgens
* Have Diabetes Mellitus (as defined by the American Diabetes Society, objectively documented by a fasting plasma glucose and HbA1c determinations)
* Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT \> 2 times the upper normal limit)
* Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
* Have a history of congestive heart failure and clinically significant arrhythmia
* Have an history of epilepsy or any NCS disease
* Have malignancy within the past 5 years, including lymphoproliferative disorders
* Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug, particularly if patient's life expectancy is less than 1 year
* Have a history of L-Carnitine therapy or use in the month prior to entering the protocol
* Have used any investigational drug in the 3 months prior to entering the protocol
* Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means
Statins in Cerebral Blood Flow and Neuronal Activity--A Pilot Study

Specific Aim: Demonstrate that statins have an effect on cerebral blood flow and neuronal activity

A number of recent of recent studies suggests that statins, typically used to lower blood cholesterol have an effect on the brain. Patients treated with statins may have increased blood flow in the brain resulting in increased activity of the brain's neurons. The neuronal system is linked to memory. Brain magnetic resonance imaging (MRI) with magnetic resonance spectroscopy (MRS) and magnetic resonance perfusion (MRP) will be used to assess changes in neuronal activity in patients receiving statins vs. patients not receiving statins.

This is a single-site non-randomized pilot study. The study will include twenty (20), healthy consenting patients between the ages of 45 and 65 who are candidates for statin therapy as determined by their cardiologist(s). Two imaging visits will be required, one magnetic resonance imaging with Magnetic Resonance Spectroscopy and Magnetic Resonance Perfusion at baseline and one magnetic resonance imaging with magnetic resonance Spectroscopy and Magnetic Resonance Perfusion three months later as described.

Patients will have selected their course of clinical treatment prior to recruitment. Ten patients will have elected to start statin therapy with Lipitor and ten patients will have elected to initially lower their cholesterol levels with diet, independent of their participation in the study.

Participants on the "statin arm" will receive a dose of 20 mg per day of Lipitor and will receive a baseline brain Magnetic Resonance Imaging with Magnetic Resonance Spectroscopy and Magnetic Resonance Perfusion prior to receiving Lipitor and follow-up brain Magnetic Resonance Imaging with Magnetic Resonance Spectroscopy and Magnetic Resonance Perfusion three months after beginning Lipitor.

Participants on the "diet arm" will receive a baseline brain magnetic resonance imaging with Magnetic Resonance Spectroscopy and Magnetic Resonance Perfusion at the beginning of the study and follow-up brain magnetic resonance imaging with magnetic resonance spectroscopy and magnetic resonance perfusion three months later.

Eligibility Criteria:
Inclusion Criteria:

1. Otherwise healthy adults, male or female
2. Age 45-65,
3. Prior to treatment with any statin at a moderate or high dose -

Exclusion Criteria:

1. Previous cerebral vascular accident,
2. Traumatic brain injury,
3. Subarachnoid hemorrhage,
4. Vascular dementia,
5. Alzheimer's Disease A
6. Any other known vascular pathologies of the brain.
7. Patients taking and/or receiving other known cerebrovascular enhancing medication/herbs and/or treatment (examples: tPA, gingko, triple H therapy, stenting procedures, etc.)
8. Previous neurosurgery or intracranial procedures.
9. Contraindication to MRI (pacemaker, neurostimulator, other surgical implants or metals which would contraindicate MRI).
Induction of Labor in Term Pregnancies With Unfavourable Cervix

This is a prospective randomized trial comparing two prostaglandin E2 (dinoprostone) agents used for labor induction in pregnant women with term pregnancies and unfavorable cervix.

This prospective randomized trial includes pregnant women with term pregnancies, indication for labor induction and an unfavorable cervix. These women are randomized into two groups: one group is induced using an intracervical prostaglandin E2 (PGE2, dinoprostone) formulation, the other using an intravaginal PGE2 formulation. Main outcome is time period between beginning of labor induction to delivery, and a reduction of four hours is considered clinically significant.

Eligibility Criteria:
Inclusion Criteria:

* term pregnancies (\> 37 weeks gestation)
* unfavourable cervix (Bishop score \<6)
* indication for labor induction
* absence of uterine contractions
* reassuring cardiotocography

Exclusion Criteria:

* ruptured membranes
* scar uterus (previous caesarean section or uterus surgery)
* pregnancy complications: intrauterine growth restriction; oligohydramnios, pre-eclampsia, non-reassuring/pathological cardiotocography, cholestasis in pregnancy, diabetes mellitus, multifetal pregnancy, breech presentation
Using Cumulase for Denudation of Cycles With ≤ 8 Cumulus-oocytes Complexes

The cumulus-corona-oocyte complex (COCs) surrounds each oocyte and must be removed prior to intracytoplasmic sperm injection (ICSI). This is traditionally achieved with a bovine-derived hyaluronidase followed by mechanical denudation through pipetting. A human recombinant hyaluronidase (Cumulase) has been developed to circumvent the problems and concerns associated with the animal origin and lack of purity of the bovine-derived form of the enzyme. whether cumulase offers a higher chance for success after ICSI for women with 8 COCs or lower remains an open question.


Eligibility Criteria:
Inclusion Criteria:

* ICSI indicated partcipants

Exclusion Criteria:

* severe medical disease
Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

Late tricuspid regurgitation (TR) is a common complication after left-sided valve surgery (LSVS), which usually progresses slowly and results in right heart failure at terminal stage. Over the past 3 decades, with the advances in minimally invasive surgical techniques, operative mortality after reoperation for severe TR has significantly decreased from 30% to 3-8%, leading to a gradual shift from medical therapy alone to surgery in those patients. However, there has been no consensus on the clinical benefit of minimally invasive tricuspid surgery over medical therapy for severe TR after LSVS.

In this multi-center randomized controlled trial, patients with severe TR after LSVS will be recruited. The patients will be randomly assigned to surgery plus medical therapy (surgery group) or medical therapy alone (control group). The primary outcome will be a composite of all-cause mortality, re-admission for right heart failure or the composite. Furthermore, echocardiography-based measurement of right heart function, New York Heart Association functional class, liver and kidney function, and quality of life will be compared between the 2 groups. All outcomes will be assessed at baseline and 6, 12 and 24 months after randomization.

Eligibility Criteria:
Inclusion Criteria:

1. Severe tricuspid regurgitation, as assessed by the clinical site echocardiographer using the transthoracic echocardiography.
2. A history of LSVS, including one or multiple procedures of aortic and/or mitral valve repair and/or replacement.
3. Left ventricular ejection fraction (LVEF) \>45%, systolic pulmonary artery pressure \<60 mmHg with pulmonary vascular resistance \<6 woods unit.
4. Age ≥ 18 years.
5. Able to sign Informed Consent forms.

Exclusion Criteria:

1. TR due to: infective endocarditis, congenital tricuspid valve malformation, secondary to correction of congenital heart disease.
2. Left-sided valve dysfunction or coronary artery disease requiring concomitant procedures.
3. Prior surgical or percutaneous tricuspid valve intervention.
4. Evidence of an acute myocardial infarction in the prior 90 days
5. Contraindications to cardiopulmonary bypass or the expected operative mortality \>30% (calculated by the Society of Thoracic Surgeons score or the EuroSCORE II).
6. Any comorbidity with life expectancy \<2 years
7. Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study protocol.
8. Pregnancy at the time of randomization.
PostNAPS: FI, Nutrition, and Psychosocial Health Among Women of Mixed HIV Status and Their Infants in Gulu, Uganda

PostNAPs was a continuation of the PreNAPs study. 246 women were enrolled in the postnatal period with the primary scientific objective of determining whether food insecurity was an independent risk factor for poor maternal nutritional or psychosocial outcomes or for sub-optimal infant feeding practices.


Eligibility Criteria:
Inclusion Criteria:

* Postpartum women \>18 years of age
* Attended antenatal care at Gulu Regional Referral Hospital
* Participated in the PreNAPS study
* Infants that were born to women participating in the PreNAPS study

Exclusion Criteria:

* Women \<18 years of age
* Women not participating in the PreNAPS study
Efficacy of Hysteroscopic Bubble Test, Flow Test and Peristalsis Test.

Fallopian tube (FT) function is complex. One of the main functions is transport of sperms for fertilization and transport of the embry for implantation. Hysteroscopic access to "Darwish Hysteroscopic Triad" allows excellent way to assess FT patency. This study compares three ways of assessing FT patency separably or in combination: flow test, bubble flow test and peristalsis test. Combined bubble flow test and peristalsis test is recently published and coined (Darwishscope)1.

This study includes infertile women subjected to combined hysteroscopy and laparoscopy UGA. During hysteroscopy, on each side, three patency test are done successively: flow test, bubble flow test and peristalsis test. Gold standard diagnosis of tubal patency and status is concomitant laparoscopy.

Eligibility Criteria:
Inclusion Criteria:

* infertile women
* Probably patent FT as proved by a previous hysterosalpingography or laparoscopy.
* Office setting.
* Postmenstrual
* Non use of hormones or hormonal contraceptives.

Exclusion Criteria:

Premenstrual period. Pathologic FT.
Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)

SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.

SENSE-II/AROUSE is a prospective, multicenter, non-randomized, observational registry study of consecutive cases of SE. We aimed to include university hospitals as well as non-university hospitals to enhance generalizability of the findings.

Currently, 13 high-volume medical centers in Belgium, Austria, Germany, United Kingdom, Switzerland, No common management protocol will be imposed on the participating centers. However, most institutions have established a local protocol that is closely related to the most recent guidelines for the management of SE published by the American Epilepsy Society (AES) in 2016.

We will exclude patients with anoxic status epilepticus after cardiac arrest and patients younger than 18 years.

Clinical and EEG Data will be collected prospectively from the admission of the patient to the discharge. Data collection will be performed using Research Electronic Data Capture (REDCap) electronic data capture tools hosted at Erasme Hospital in Brussels, Belgium.

To reach sufficient statistical power for multivariate analysis, a cohort size of 3000 patients is targeted.

The main objective of the study is to document patient characteristics, treatment modalities, EEG features and outcome of adults treated for SE and identify predictors of outcome. The data collected in this study could also identify gaps and opportunities for the management of this medical emergency. Lacking adequate prospective controlled trials, this will help both decision-making in clinical practice and designing future clinical trials.

Moreover, EEG data will help for a better electroencephalographic definition of SE, possible SE, and some boundary conditions, such as ictal-interictal continuum.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or above
* Patients admitted for management of Status Epilepticus as their primary diagnosis
* Patients admitted for another primary diagnosis but identified with Status Epilepticus during their acute hospital stay

Exclusion Criteria:

- Patients with post-cardiac arrest SE
Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck

This is a Phase II study of imatinib (Glivec) administered as a daily oral treatment in patients with recurrent/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.

Patients with relapsing and/or metastatic adenoid cystic carcinoma of the salivary gland of the head and neck are usually poor responders to conventional cytotoxic chemotherapy.

The investigation of proliferation pathways involving tyrosine kinase receptors such as c-kit receptor (KIT) and PDGF receptor may allow to identify a molecular target for novel therapeutic approaches in patients with adenoid cystic carcinoma who failed locoregional treatment.

Several publications in the literature and the pathological study we conducted in Institut Gustave Roussy show that KIT overexpression is observed in at least 80-90% of the cases of adenoid cystic carcinoma, supporting the investigation of imatinib in patients with adenoid cystic carcinoma overexpressing KIT.

Imatinib is an orally administrated, well tolerated compound that could be given on an outpatient schedule to patients with relapsing/metastatic adenoid cystic carcinoma of the head and neck.

Because of the infrequent occurrence of salivary gland malignancies, a multicenter trial will be mandatory and the study will include at least 2 centers represented by Institut Gustave Roussy, Villejuif; and Hôpital Georges-Pompidou, Paris.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven adenoid cystic carcinoma overexpressing KIT (by immunohistochemistry) with recurrent disease documented by computed tomography (CT) scan or magnetic resonance imaging (MRI).
* Presence of at least one dimensionally measurable target lesion (contrast enhancing lesion with the largest diameter \>= 2 cm, based on CT or MRI scan done within 4 weeks before the start of treatment).
* Patients able to swallow an oral compound.
* World Health Organization (WHO) performance status \< 2.
* Life expectancy of \>= 3 months.
* Aged \>= 18 years.
* Normal hematological (neutrophils \>= 1.5 x 10\^9 cells/l, platelets \>= 100 x 10\^9 cells/l), hepatic (bilirubin \< 1.5 times the upper limit of the normal range; alkaline phosphatase and transaminases \<= 2.5 x the upper limit of the normal range) and renal (serum creatinine \<= 150 mmol/l) functions.
* Written informed consent.

Exclusion Criteria:

* Abnormal cardiac function with history of ischaemic heart disease in the past 6 months and/or abnormal 12 lead electrocardiogram (ECG).
* Previous or current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma.
* Concomitant treatment with warfarin or any other anticoagulants.
* Unstable systemic diseases or active uncontrolled infections.
* Patients (male and female) not using effective contraception if of reproductive potential.
* Females pregnant or lactating or positive beta human chorionic gonadotropin (bHCG) at baseline
Durham Housing Authority (DHA) Community Health Advisor (CHA) Smoking Cessation Project

Recent policy from the U.S. Department of Housing and Urban Development (HUD) mandates that all public housing units go smoke-free by August 2018. Residents in public housing units have little access to proven cessation interventions and support is imperative to increase quitting success and is currently lacking in these communities;' thus this mandate is causing stress without providing resources to quit. Using a Community Engaged Research (CEnR) approach, we propose to partner the Durham County Department of Public Health and the Durham Housing Authority to develop sustainable Community Health Advisor tobacco cessation program that can be implemented in public housing communities. To achieve this goal, we plan to build on our previous collaborations to 1) form a team of previously identified DHA residents who are activated to support smoking cessation among public housing residents who can serve as Community Health Advisors and deliver cessation interventions in DHA properties, and 2) co-develop and pilot test a Community Health Advisor smoking cessation program to promote linkages with cessation services and to provide cessation education to DHA residents. This collaboration builds on our previous work to understand barriers and identify solutions for supporting smoking cessation among DHA residents. We will work with Community Health Advisors to develop an intervention and conduct a pilot study with up to 30 participants, Our primary outcomes are feasibility and acceptability of the co-development cessation intervention. We will collect survey data for the pilot in REDCap. Potential risks of study participation include breach of confidentiality with regard to identifiable personal information and questions that might make participants feel uncomfortable.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* current smoker (smoked in the last seven days)
* planning on quitting in the next 6 months
* speak English
* currently living in DHA property

Exclusion Criteria:

* less than18 years of
* cognitive impairment
* planning to move from the property in the next 2 months