cyrilzakka/clinical-trials huggingface dataset:
Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

The purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diarrhea ≥3 days but \<30 days duration.
* No visible blood in stool.

Exclusion Criteria:

* Use of any antibacterial, antiparasitic or antiviral drugs within 5 days of enrollment.
* Females who are pregnant, suspected of being pregnant or breastfeeding.
* Serious systemic disorders incompatible with the study.
* History of hypersensitivity to nitazoxanide.
* Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness according to the investigator's judgment.
* Patients known to have or suspected of having AIDS or other immune deficiencies.
Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence

Chronotropic incompetence consists of an insufficient increase in heart rate during effort, and its presence is recognized as a common feature in patients with heart failure due to left ventricular systolic dysfunction, apparently suggesting a worse prognosis. Little is known about the possible benefits of its reversal in such patients.

The investigators working hypothesis is that the modulation of chronotropic response, as obtained by means of atrial rate-adaptive pacing may improve functional capacity in persons with chronic heart failure and chronotropic incompetence.

To explore this hypothesis,the investigators will enroll 20 patients with NYHA II/III heart failure, low left ventricular ejection fraction (\<40%) and chronotropic incompetence (Maximal heart rate \<80% of predicted value in a symptom-limited incremental test), who already underwent implantation of dual-chamber implantable defibrillator for prevention of sudden cardiac death. The study will have a randomized, double-blind, cross-over design.

The procedures, to be carried out at one month from each reprogramming (VVI backup pacing vs. AAI-R "active" pacing), will comprise: blood sampling for NT-proBNP, incremental symptom-limited cardiopulmonary exercise testing (CPX), constant-workload cardiopulmonary test (50% of max WR), quality-of-life questionnaire, 24-hour ECG monitoring.

The primary end-point will be peak oxygen consumption on CPX. Secondary end-points will include acute response to reprogramming, and data derived from constant-WR tests, Holter monitoring and QoL.


Eligibility Criteria:
Inclusion Criteria:

* NYHA II/III chronic heart failure on optimal medical therapy
* Sinus Rhythm
* Left ventricular ejection fraction less than 40 %
* Chronotropic incompetence on maximal exercise testing (maximum heart rate \< 80% of predicted value)
* Age 18-75
* carrier of dual chamber ICD device
* Informed Consent

Exclusion criteria:

* Unable to perform cardiopulmonary exercise testing (for any reason)
* Absolute contraindication to maximal exercise testing
* Moderate to severe anemia (Hb\<10 g/dL)
* Diagnosis of Sick Sinus Syndrome or high-degree atrioventricular block
* recent hospitalization for acute decompensated heart failure (\<1 month)
* recent acute coronary syndrome (\<3 months)
* Active neoplastic disease
* Active myocarditis / endocarditis
* Acute decompensated heart failure during study
Teaching Academic Success Skills to Students With Autism Spectrum Disorders in Clinical Setting

The goal of the study is to develop an academic EF intervention, Teaching Academic Skills to Kids (TASK), for high functioning (i.e., IQ score ≥80) middle-school youth with ASD and EF deficits.

Aim 1: Use focus group methodology and advice from expert consultants to develop the TASK intervention targeting academic EF skills for middle school youth with ASD that is tailored to the unique needs of these individuals (e.g., content specific to ASD EF deficits, incorporate evidence-based teaching principles and methods for ASD).

Aim 2: Examine the feasibility and acceptability of TASK in 3 open trials to assess initial feasibility and efficacy.

The goal of the study is to develop an academic EF intervention, Teaching Academic Skills to Kids (TASK), for high functioning (i.e., IQ score ≥80) middle-school youth with ASD and EF deficits.

Aim 1: Develop the TASK intervention targeting academic EF skills for middle school youth with ASD that is tailored to the unique needs of these individuals (e.g., content specific to ASD EF deficits, incorporate evidence-based teaching principles and methods for ASD). A methodologically rigorous, well-integrated iterative and collaborative design process with input from multiple stakeholders, including school mental health professionals, teachers, parents, and youth with ASD, will be utilized.

Aim 2: Examine the feasibility and acceptability of TASK in 3 open trials including the feasibility of: 1) implementing the measurement protocol, 2) operationalizing intervention delivery, 3) assessing both trained and untrained areas of functioning, 4) assessing whether improvements in academic EF skills (proposed mechanism of treatment) are related to functional educational outcomes (e.g., homework behaviors, grades), and 5) exploring the data for potential treatment moderators (e.g., gender, severity). It is hypothesized that TASK will be feasible, acceptable (attendance, satisfaction), and will result in improved academic EF skills associated with reduced academic impairment and homework problems.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism spectrum disorder
* IQ \>80
* 7th grade at time of intervention
* mainstreamed classroom
* executive functioning problems identified on parent or teacher BRIEF-2

Exclusion Criteria:

* danger to self or others
Evaluation of the Effectiveness and Safety of Supratube Device

Purpose of the trial:

Trial design: Two-parallel arm, double-blind, individually randomized controlled trial.

Primary endpoint:

Clinical evaluation of sinus, oropharyngeal, tracheal, bronchial or pulmonary infections during orotracheal intubation and hospital admission.

Secondary endpoints:

Volume of oropharyngeal secretions aspirated per unit of time (for 24 hours) by the SupraTube and Complications during the use of the SupraTube device: erosions, lacerations, Bleeding, displacement, migration, need for withdrawal.

Inclusion criteria:

* Adult patient
* Orotracheal intubation ≤ 72 hours
* Hospitalized in ICU
* integrity of upper airways

Exclusion criteria:

* International patients
* Coagulopathic patients
* oncology patients
* patients with maxillofacial surgery
* Absence of close responsible family member
* Tracheostomy, shock, local or systemic non-controlled infection

Trial treatment:

Intervention:

Aspiration of secretions with the supranav device

Control:

Usual respiratory care

Expected sample size, enrollment and expected number of centers:

Sample size = 108

Recruitment start date:

Recruitment end date:

Follow-up end date:

Number of centers: 2

Statistical considerations:

* Intention to treat analysis
* The primary outcomes will be analyzed using


Eligibility Criteria:
Inclusion Criteria:

* Intubated adult patients with mechanical ventilation.
* To have a closest responsible relative
* Integrity of the airways

Exclusion Criteria:

* Need of orofacial, cervical or respiratory tract surgical procedures
* Patients with tracheostomy
* Shock,
* Local or systemic uncontrolled infection
* Blood dyscrasia, neoplastic diseases
* Physiological alteration
* Acute or chronic decompensated pathology that is not controlled at the time of selection.
The Effect of Different Sensory Conditions on Sensory Interaction in Balance

The ability of humans to maintain spatial orientation and balance control relies on accurate and complete sensory information. This study aims to investigate the effects of different sensory conditions on the sway index (balance). Adults with normal hearing, vision, and balance abilities will perform the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), a test from the Biodex Balance System, under varying sensory conditions. The first sensory condition involves situations where the cursor indicating the individual's center of gravity on the device is either visible or hidden. The second condition examines whether the eyes-closed state during the test is achieved through voluntary eye closure or by external equipment (e.g., goggles or eye patches). The values obtained will allow comparisons of the effects of different sensory conditions on the sway index. The study will be conducted between January 2025 and March 2025 at the Bezmialem Vakıf University Cardiac Physiotherapy and Rehabilitation Education and Research Laboratory with healthy young adults. Participants will be selected voluntarily, and the assessments will be conducted in compliance with the guidelines of the Declaration of Helsinki.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18 and 45.
* Providing informed consent to participate in the study after receiving detailed information about the research.

Exclusion Criteria:

* Having visual or hearing impairments.
* Presence of musculoskeletal, neurological, or orthopaedic conditions (e.g., lower extremity alignment disorders, excessive anteversion, severe pes planus) that could affect the study results.
* Having mental or physical problems severe enough to impair communication.
* Participation in any rehabilitation program within the past six months.
Application of Desferal to Treat COVID-19

In this study, defined cases of COVID-19 with mild, moderate or severe pneumonia will be treated with standard treatment regimens in combination with IV injection of Deferoxamine. Improvement in clinical, laboratory and radiological manifestations will be evaluated in treated patient compared to control group.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of COVID-19 Disease,

Exclusion Criteria:

Previous history of allergy to Deferoxamin, Pregnancy, kidney dysfunction,
Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease

Chronic graft-versus-host disease (cGVHD) can be hard to diagnose, difficult to manage and contributes significantly to morbidity and mortality in hematopoietic stem cell transplantation patients.

The research will look into identifying and validating cGVHD biological indicators (=bio-markers) which will be evaluated whether they can predict a future development of the disease.

The study hypothesis is that a number of previously reported cGVHD bio-markers, known to be present at the time of cGVHD diagnosis, will also be present at earlier time points, before cGVHD develops.

Following validation, the bio-markers will be beneficial for finding those patients who are in higher risk to develop cGVHD.

By identifying the higher-risk group, which is more likely to develop cGVHD, a pre-emptive therapy might be applied in order to prevent or reduce the prevalence of the disease.


Eligibility Criteria:
Inclusion Criteria:

1. Allogeneic hematopoietic stem cell transplantation for any malignant or non-malignant disease.
2. Age 0-17.99 years at the time of transplantation.
3. Bone marrow, peripheral blood stem cell and umbilical cord blood (including single or double cord blood) as the graft source.
4. Any conditioning regimen with any chemotherapy / radiation therapy combination. Haploidentical donor transplants with post-transplant cyclophosphamide are also allowed.
5. Use of serotherapy is permitted.
6. Any graft-versus-host disease prophylaxis is permitted, including post-HSCT cyclophosphamide.
7. If participant weighs between 0-20 kg, participant must be able to provide 15 ml of whole blood at each time point.
8. If participant weighs over 20 kg, participant must be able to provide 1ml/kg of whole blood, up to a maximum of 23 mL for the pre-conditioning sample and 32 mL for samples at day +100, 6-months, 12-months, +/- the cGVHD sample.
9. Written informed consent from parents.
10. Assent from study participant when appropriate.
11. Participation on other clinical trials is acceptable.

Exclusion Criteria:

1. Autologous HSCT.
2. Patients referred to a Bone Marrow Transplant (BMT) center from a non-BMT center, where it is anticipated (at the discretion of the center PI) that adequate follow up according to the rules of this protocol can not be met, including the requirement for a reassessment by the BMT center at the time of cGVHD diagnosis.
3. Ex-vivo T-cell depletion of graft source (e.g. CD34 selection).
4. Second (or greater) allogeneic transplants (first allogeneic transplant where a previous autologous transplant was performed is permitted).
5. Syngeneic transplants.
Safety and Preliminary Efficacy of JK500 Cell Injection in Relapsed/Refractory Pediatric Acute Myeloid Leukemia

This study is a prospective, single-center, single-arm exploratory clinical study, aiming to complete the preliminary clinical observation of 12 children with relapsed/refractory acute myeloid leukemia treated with JK500 cell injection to evaluate the safety of clinical infusion and the initial efficacy of JK500 cell injection in the treatment of children with relapsed/refractory acute myeloid leukemia.

The Main components of JK500 cell injection are regenerative natural killer (NK) cells derived from human embryonic stem cells and 0.9% sodium chloride solution.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≤18, male or female;
2. Patients diagnosed as acute myeloid leukemia (AML) according to the revised World Health Organization (WHO) criteria in 2016;
3. Patients who failed to achieve CR after two standard-dose induction therapy or had recurrence within six months after CR;
4. The subject or the guardian of the subject must fully understand the purpose, nature, method and possible adverse reactions of the test, agree the subject as the subject, and sign the informed consent.

Exclusion Criteria:

1. Acute promyelocytic leukemia, chronic myelocytic leukemia, acute mixed-cell leukemia or known central nervous system leukemia;
2. AML associated with congenital syndromes such as Down syndrome, Fanconi's anemia, Bloom's syndrome, Koch's syndrome, or congenital aplastic anemia;
3. The subjects have active virus infection, and during the screening period, the serum virology test is performed, and the human immunodeficiency virus (HIV) antibody is positive, hepatitis B surface antigen or E antigen is positive, hepatitis C antibody is positive, or treponema pallidum antibody is positive;
4. Presence of active systemic infection; Participated in a drug trial within the past 4 weeks;
5. Patients who suffered from a clinically significant disease within 28 days before receiving the study product or underwent a major surgical operation within 28 days before receiving the study product, or are expected to need major surgery during the trial;
6. children with liver and kidney dysfunction, including:

   1. Serum creatinine \>2× upper limit of normal reference value;
   2. Serum total bilirubin \> 2× upper limit of normal reference value;
   3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2× upper limit of normal reference values
7. Children who have used live attenuated vaccine 4 weeks before administration or plan to use live attenuated vaccine within 6 months after administration;
8. Have any other conditions that may cause the subject to be unable to complete the study or present a significant risk to the subject in the opinion of the Investigator.
Study on Pharmacokinetics

The purpose of this study is to assess the effect of the coadministration of multiple doses of BMS-663068 on the systemic exposure of rosuvastatin.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form

   * Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.
2. Target Population

   * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results.
3. Age and Reproductive Status

   * Men and women of non-childbearing potential, ages 18 to 50 years, inclusive. Women must have documented proof that they are not of childbearing potential. Women must not be breastfeeding.
   * Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding
* Any significant acute or chronic medical illness
* History of rhabdomyolysis or biliary disorders, including Gilbert's disease or Dubin-Johnson disease
* Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration)
* Alcohol intake exceeding 2 standard drinks per days; however, no alcohol is allowed 1 week prior to the start of study drug administration and for the duration of the study
* Any other sound medical, psychiatric, and/or social reason as determined by the investigator
Artificial Intelligence in Diagnosis of DFNA9

To study the positive predictive value of Audiogene v.4.0 open source online machine learning tool in accurately predicting DFNA9 (DeaFNess autosomal dominant ninth) as top 3 gene loci in a large series of genetically confirmed c.151C\>T,p.Pro51Ser (p.P51S) variant carriers in COCH (coagulation factor C Homology).

DFNA9 is an autosomal dominant hereditary adult-onset and progressive sensorineural hearing loss which is associated wit vestibular deterioration.

Today, artificial intelligence plays an increasing role in diagnosis of Mendelian hearing losses and in fitting of cochlear implants. An application of this kind is the open source program, Audiogene v4.0, which was elaborated by the Center for Bioinformatics and Computational Biology, University of Iowa City, Iowa, USA. The shape of the audiogram (audioprofile) is easily recognizable in many autosomal dominantly inherited hearing losses. Machine learning based software tools, such as Audiogene v4.0, which was originally developed for prioritizing loci for the Sanger sequencing, could help the clinicians in early diagnosis of DFNA9. This tool only need subjects' age and hearing thresholds (decibel hearing loss (dB HL)) at frequency range of 0.125 - 8 kHz (kiloHerz), left, right or binaural average in order to predict top 3 gene loci according to the data entered in the program.

Goal: to use auditory data of a large series of genetically confirmed p.P51S variant carriers causing DFNA9, which were previously collected for the genotype-phenotype correlation study which terminated recently.

All individual left and right sided hearing thresholds (ranging from 0.125 to 8kHz, with the exception of 1.5 kHz) as well as binaural averaged thresholds were run through Audiogene v4.0.

Descriptive statistics were assessed and statistical analysis was carried out to check for possible differences between age or hearing thresholds between the carrier group with accurate prediction against the carrier group with inaccurate prediction.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years
* genetically confirmed c.151 C\>T, p.Pro51Ser variant carrier in COCH gene
* not contra-indication for audiometric testing

Exclusion Criteria:

* \<18 years
* no carrier status for c.151C\>T, p.Pro51Ser
* no auditory data available
Anti TNF α Improves Endothelial Dysfunction in IBD Patients

Study hypothesis - this study will assess the presence of endothelial dysfunction in patients with Crohn's disease before and after 12 weeks treatment of anti TNF α.

Crohn's Disease (CD) is a life long disease that mainly affects young adults. There is evidence That gut tissue injury is the result of an abnormal immune response that involved multiple non immune cellular systems including the intestinal microvascular endothelial cell. Moreover, clinical studies have shown that 1-7% of irritable bowel disease (IBD) patients suffer from arterial and venous thromboembolic complication.

Chronic inflammation has a major role in the development and propagation of endothelial dysfunction, which can lead to coronary artery disease.

Endothelial dysfunction has been described in patients with various and diverse chronic inflammatory conditions. Over the last few years, dysfunction of vascular endothelium has been widely recognized as the first step in the development of atherosclerosis. Several inflammatory mediators, such as C-reactive protein (CRP), Tumor Necrosis Factor α, (TNF α), nitric oxide (NO), vascular endothelial growth factor, CD-40, interleukin-6 (IL-6), which are up-regulated in IBD, also are known to impact vascular impact.

The normal endothelium produces a vasodilatatory response to ischemia referred to us as reactive hyperemia. Shear stress on the blood vessel wall leads to the production and release vasodilatation. With endothelial dysfunction there is often either a blunted vasodilatatory in response to ischemic event, and chronic inflammation.

The hypothesis of this study is that patients with Crohn's disease have an increased incidence of endothelial dysfunction, which can be corrected or improved by treatment with anti TNF α.

The purpose of our study was to assess endothelial function in patients with Crohn's Disease, before and after treatment (steroids, immunomodulators, and anti TNF α). This study assessed the presence of endothelial dysfunction in patients with Crohn's disease and evaluated the possible role of tumor necrosis factor (TNF)-α in the pathophysiology of this abnormality.

In this study we will preformed an endothelial function test before and after treatment by Endopath device from Itamar medical, FDA approved.

Safety- Each subject will be screened by clinical history, physical examination, electrocardiogram, chest X-ray, Mantoux test (PPD), routine chemical analysis, and biomarkers.

The study protocol has been approved by the local institutional review board.

Eligibility Criteria:
Inclusion Criteria:

* Non smoker
* No history of IHD or other known risk factors for IHD

Exclusion Criteria:

* Patients who had been treated with anti TNF α 4 weeks before the study
* As well as those who received corticosteroids within 1 week before the study.
* DM, IHD, CRF, SMOKER