cyrilzakka/clinical-trials huggingface dataset:
Mycobiome Evaluation in Children With Autism & GI Symptoms

This study's primary aim is to explore the potential differences in the gut mycobiome of children with autism spectrum disorder compared to otherwise healthy children. The secondary objective of this study is to evaluate whether the presence of specific species of fungi (e.g. Candida tropicalis, C. albicans, or Saccharomyces cerevisiae), in stool: 1) correlates with increased gastrointestinal symptoms; 2) correlates with evidence of increased behavioral problems (as assessed by the Aberrant Behavior Checklist or Social Responsiveness Scale-2); or 3) plays the same role as a constituent of commensal gut microflora as in normal controls. The scale indicates severity of social deficits in the autism spectrum as mild, moderate or severe. Additionally, the study aims to compare the fecal and oral fungi in these children because many fecal mycobiota are felt to originate in the oropharynx.


Eligibility Criteria:
Inclusion Criteria:

* for autistic children with GI symptoms: confirmed diagnosis of autism spectrum disorder (ASD) and its severity (DSM-5: 299.00) by Autism Diagnostic Interview (ADI-R), Social Communication Questionnaire (SCQ), and Autism Diagnostic Observation SChedule-2 (ADOS-2); substantial gastrointestinal symptoms (as indicated by score of greater than 7 on the Gastrointestinal Symptoms Severity Index)
* for autistic children without GI symptoms: confirmed diagnosis of autism spectrum disorder (ASD) and its severity (DSM-5: 299.00) by Autism Diagnostic Interview (ADI-R), Social Communication Questionnaire (SCQ), and Autism Diagnostic Observation SChedule-2 (ADOS-2)
* for controls: healthy children

Exclusion Criteria:

* severe sensory impairment
* brain injury
* major psychiatric illness (e.g., psychotic disorders that might interfere with assessment). (however, children with common psychological problems such as depression and attention deficit hyperactivity disorder will not be excluded, given that doing so would result in a sample of children with ASD that would be unrepresentative of the pediatric ASD population as a whole.)- children who appear genetically syndromic (based on exam in the pediatric GI clinic)
* taking immunosuppressive medications
* abnormal screening labs
* GI diseases
* allergy to antibiotics
* fever or a pre-existing adverse event monitored in the study
* known history of hepatitis B/C or HIV
* known pregnancy
* use of probiotics in the last 60 d
* use of oral antibiotics/anti-fungal during the previous 2 weeks
* indwelling catheters/prosthetic devices
Feasibility Study for Treating Trichotillomania With Wearable Device and App System

Trichotillomania is characterized by recurrent hair pulling resulting in hair loss causing significant distress and impairment which persists despite repeated attempts to stop. Behavioral based therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior have proven effective. In an effort to enhance awareness, a wrist worn motion detection device was created. In this study, we will test the feasibility of the HabitAware device and accompanying app as a system for delivering self-administered habit reversal training (HRT).


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Speak fluent English
3. Current diagnosis of TTM
4. Score above the normative mean on the automatic pulling subscale of the MIST-A
5. Not on psychotropic medication or on a stable dose (i.e., same dose for past 6 weeks)

Exclusion Criteria:

1. Currently receiving psychotherapy
2. Other psychiatric condition requiring more immediate care
3. Have previously used any behavior awareness devices (e.g. Keen)
Health, Aging and Later-Life Outcomes

The purpose of this pilot research is to test the feasibility of two interventions focused on either reducing total calorie intake or reducing the total time that calories are ingested each day in older adults. Participation in this research will involve visits to our clinic for testing and weekly intervention visits (in-person or remote depending on group assignment) for nine months with total participation lasting about a year.

This pilot study is part of a larger planning process to design a full-scale randomized trial to evaluate the long-term effects of caloric restriction (CR) and time restricted eating (TRE) on the health of older adults. The specific objective of the HALLO-P is to collect data to inform the design of the full-scale randomized trial to evaluate the long-term effects of caloric restriction and time restricted eating in older adults. The pilot is a 9-month clinical trial. The pilot data will be used to refine recruitment criteria, estimate recruitment yields, and refine intervention approaches.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling men and women residing in Forsyth County, NC or surrounding counties
* obesity (BMI = 30 - \< =40 kg/m2) or are overweight (BMI = 27 - \<30 kg/m2 with an indication for weight loss (e.g., hypertension, hyperlipidemia, elevated waist girth, controlled diabetes)

Exclusion Criteria:

* persons for whom the interventions are potentially unsafe
* history of eating or nutritional disorders
* those who are likely to drop out due to severe chronic illness or other reasons
* who show inability to perform self-monitoring activities required by the interventions
* those doing shift work because disturbances in circadian cycles may interfere with TRE
* uncontrolled or previously undetected diabetes because disease management may interfere with the interventions
* certain medical treatments may complicate outcome interpretation
Improving Uptake of Pediatric Vaccines Through Religious Conferences and Vaccines-in-a-van in Aceh, Indonesia

The goal of this cluster, randomized controlled trial is to study the impact of mobile vaccine clinics and religious conferences on pediatric vaccination coverage. The main questions will be: does vaccination coverage change in geographic areas with the mobile vaccine clinics vs those areas without mobile vaccine clinics; and does vaccination coverage change in geographic areas with religious conferences on vaccination vs those areas without religious conferences. In repeated surveys, adult participants will respond about their children's vaccination status. Participants will not be individually randomized to the interventions. Rather, their geographical area will be randomized.

This project seeks to create a paradigm shift in how the public views and utilizes vaccination services. Currently, community health centers remain the default setting for vaccination, and clinicians the default administrators. However, the general population may have difficulty accessing these clinics or trusting traditional vaccination providers, particularly if they are members of marginalized communities that have experienced medical discrimination. This project applies a two-pronged approach by addressing issues of trust and ease of access among the general population. This project is innovative by: a) mobilizing religious communities to discuss vaccines (to counter reported lack of information about vaccines among unvaccinated families) and b) training more community health workers in vaccination and in physically delivering vaccines through a "Vaccine-in-a-van" concept to facilitate ease in accessing vaccines. By mobilizing these individuals in the community settings where people live, work, worship, and learn, this project will expand vaccine information and services.

More specifically, this project plans to work with local health leaders in a low vaccination community in Aceh, Indonesia to identify social institutions that are part of children and families' daily lives; these could include houses of worship, schools, or community centers. This project will fund a mobile vaccine delivery unit to go to these locations to physically bring vaccines to the people and to link them with existing immunization clinic infrastructure. This project will also work towards changing the culture of child health and vaccination through substantial discussions and conversations with multiple levels of religious leaders at conferences.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18+, and
* Proficient in Bahasa Indonesia, and
* Plan to live in neighborhood for next year
* Parent of child \<5, or
* Planning to have a child within next year
A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

The purpose of this study is to assess safety and performance with the use of the BiZact™ device in tonsillectomy procedures in children and adolescents.

A prospective, multi-center, single arm, study of BiZact™ on children and adolescents undergoing tonsillectomy.

Study Visits:

* Screening/Baseline
* Surgery, Day 0
* Post-Op Follow-up Day 1 - Day 7, Day 10, \& Day 14 (Home assessments)
* Post-Op Follow-up Day 28 (Office Visit)

Eligibility Criteria:
Inclusion Criteria:

1. Children and adolescent subjects 2-12 years of age at the time of the procedure, inclusive
2. Scheduled to undergo tonsillectomy
3. The subject and subject's Legally Authorized Representative (LAR) is willing to participate and consents to participate, as documented by signed informed consent form and/ or assent form (as applicable)

Exclusion Criteria:

1. Subjects undergoing:

   1. Tonsillectomy as a result of cancer
   2. Unilateral tonsillectomy
2. Subjects with:

   1. Known Bleeding disorders
   2. History of peritonsillar abscess
   3. Craniofacial disorders
   4. Down's syndrome (Trisomy 21)
   5. Cerebral palsy
   6. Major heart disease (including but not limited to; right-sided heart failure, left-sided heart failure, congestive heart failure, coronary artery disease, arrhythmias, chronic heart failure, acute heart failure, etc.)
   7. Current tobacco use
3. Subjects unable to comply with the required study follow-up visits
4. Female subjects pregnant at time of procedure
5. The subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.
6. The subject is participating or has participated in any drug or device research study within 30 days of enrollment.
Double-Blind, Trial to Evaluate the Safety and Efficacy of MRX-6 Cream 2%

Randomized, double-blind, parallel group, placebo-controlled, multicenter, efficacy and safety study in subjects with mild to moderate atopic dermatitis.

Following the double blind period, subjects will be allowed to continue treatment with topical MRX-6 Cream 2% in an open-label extension. Demonstrate the efficacy of MRX-6 Cream 2% compared to Vehicle for the treatment of the signs and symptoms of atopic dermatitis and demonstrate the safety of MRX-6 Cream 2% for the treatment of the signs and symptoms of atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects, ≥2 years of age and ≤17 years of age, of any race or ethnicity
* Must have clinical diagnosis of mild to moderate atopic dermatitis (AD) at both Screening and Baseline Visits, defined as IGA score of 2 or 3 (Hanifin and Rajka, Rothe 1980)
* Must have AD affecting ≥ 5% total body surface area (TBSA) at Baseline
* History of AD for at least 3 months prior to Baseline
* Informed consent/assent in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline (21 CFR §50.25\[c\]) and applicable regulations, before completing any study-related procedures

Exclusion Criteria:

* Use of topical corticosteroids within 7 days prior to Baseline
* Use of systemic corticosteroids, topical calcineurin inhibitors, photo-therapy (eg, PUVA, UVB) or immunosuppressive therapy (eg, cyclosporine) within 14 days prior to Baseline
* Subjects that require systemic therapy for the treatment of atopic dermatitis
* Use of systemic anti-infective or antibiotic treatment within 14 days prior to Baseline
* Subjects who present with clinical conditions other than AD that may interfere with the evaluation (eg, generalized erythroderma, acne, Netherton's Syndrome, psoriasis)
* Secondary infection of AD (bacterial, viral or fungal) within the skin area under study or open skin infections in any area at Baseline
* Women of childbearing potential who are lactating or pregnant as determined by urine pregnancy test at Screening. • History of MRX-6 cream 2% sensitivity or to any component of the test article
* History of severe anxiety and/or depression; any history of suicide attempt
* Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history
* Subjects with any screening clinical laboratory result outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician
* Subjects who, in the opinion of the Investigator, would be non compliant with the visit schedule or study procedures
* Participation in any other investigational trial within 6 weeks of Baseline, or during study conduct
* Chronic condition(s) which are either unstable or not adequately controlled
* Use of non-sedating anti-histamines within 7 days of first dose or at any time during study conduct
* Drug or alcohol abuse, mental dysfunction, or other condition limiting the subject's ability to be compliant with study-related procedures
Clinical Response of Syrup Hydryllin® in Pakistani Subjects With Cough in Routine Practice

A cough is one of the most common medical complaints accounting for as many as 30 million clinical visits per year. It is the single most prevalent symptom on presentation to a physician's office. Up to 40% of these complaints result in a referral to a pulmonologist. Although, the cough is an essential defense mechanism, still, chronic cough may cause significant morbidity and substantially affect the quality of life and psychosocial wellbeing.

Globally, the prevalence of acute cough is 9 to 64%, whereas chronic cough is \>10% in most countries or regions, ranging from 7.2%-33%. In Pakistan, a few studies have examined chronic cough resulting from specific occupations, such as those involving brick kilns, textile work, or gem cutting. Additionally, 15.8% of subjects in a periurban area of Karachi City, Pakistan with cough lasting ≥ 2 weeks were found to have pulmonary TB. Overall, to estimate the prevalence and incidence of different coughs, there is no data available based on the local population, and the data assessing the quality of life of patients with different coughs is not available. Locally, few studies were conducted on cough syrups with a small sample size. However, no real data is available for the symptomatic management of cough about the patient's quality of life related to different coughs. The current study is designed to assess the response of different strengths of Syrup Hydryllin ( Syrup Hydryllin \& Hydryllin Sugar-Free (Diphenhydramine, Ammonium Chloride, Menthol, Aminophylline) and Syrup Hydryllin DM (Dextromethorphan \& Diphenhydramine) in the symptomatic management of cough in routine practice by physicians. The study's main objective is to assess the quality of life of the subjects suffering from the different types of cough.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a clinical history of cough.
* Patients aged ≥12 and ≤70 years inclusive of either sex.
* The patient will be screened for COVID-19
* The patient will be prescribed the study drug following an approved package insert
* Written informed consent before participation in study-specific procedures

Exclusion Criteria:

* Known hypersensitivity to Hydryllin product, the metabolites, or formulation excipients.
* Covid Patients with moderate and severe condition requires hospitalization or/and associated with the complications.
* Patients who have a contra-indication (refer to the Syrup Hydryllin prescribing information).
* Pregnant (assessed on LMP)
* Breastfeeding women (assessed on interview).
Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication

National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues for stroke prevention in non valvular atrial fibrillation is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.


Eligibility Criteria:
Inclusion Criteria:

* Female and male subjects ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation
* Who are treated with Vitamin K antagonists (VKA) with issues for at least the 4 previous weeks (issues are assessed on medical judgment)
* Who start treatment with rivaroxaban to prevent stroke or non-CNS (central nervous system) systemic embolism
* With anticoagulation therapy planned for at least 6 months

Exclusion Criteria:

* Contra indication to the use of Xarelto as described in the Summary of Product Characteristics (SmPC); key contra indications are:

  * Hypersensitivity to the active substance or to any of the excipients listed in SmPC section 6.1.
  * Lesion or condition at significant risk of major bleeding
  * Concomitant treatment with any other anticoagulant agent
  * Clinically significant active bleeding
  * Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
  * Pregnancy and breast feeding
Effect of Nutritional Supplementation on Nutritional Status & Rehospitalization in Malnourished Elderly Patients

The primary outcome is the mean difference in energy and protein as well as a selection of micronutrients (calcium, vitamin D, and Vitamin B12) after 12 weeks of intervention between standard care plus nutritional supplementation vs standard care.

The secondary outcomes are body weight, nutritional status, body composition, physical performance, vitamin D level, and nonelective hospitalization

The Study Hypothesize:

The hypothesize that outpatients who receive nutrient-dense drinks (NDD) will have increased body weight, better nutritional status, better body composition, higher vitamin D level, better physical performance and reduced non-elective hospitalization than those receiving standard care after 12 weeks of intervention.

1. Study Design: Randomized Controlled Trial, Randomized and controlled intervention trial with 2 treatments in parallel

   1. Treatment 1: nutrient-dense drinks on top of standard care
   2. Treatment 2: standard care only (reference)
2. Location and time study: Geriatric outpatient clinic and internal medicine outpatient clinic in Cipto Mangunkusumo National Hospital Jakarta. The study will be conducted on July 2022 to October 2023.
3. Study subject: elderly outpatients (aged 60 years old or more) who visit outpatient clinics will be screened for their eligibility as participants of this study.
4. Sample Size: sample size for each group is 41 participants per group (for two groups a total of 82 participants). To anticipate a dropout of 20% a minimum of 98 participants (rounded to 100 participants in total) is the minimum sample size of our study.
5. Data collection : Energy and nutrient intake, particularly protein calcium, vitamin D, and vitamin B12, Nutritional status based on full form Mini Nutritional Assessment, Vitamin D level, lean body mass (using Bioelectrical Impedance Analysis), physical performance will be measured by Shor Physical Performance Battery, handgrip strength, medical history, data on the demographic status and clinical data will be retrieved from the medical record and the attending physicians, body weight and anthropometric measurements, intervention: Nutrient Dense-Drink + Standard Care

Eligibility Criteria:
Inclusion Criteria:

* older patients (60-years or older)
* Malnourished or at risk of malnourished (based on Mini Nutritional Assessment score)

Exclusion Criteria:

* Impaired kidney function (eGFR less than 30 ml/min/1.73 m2)
* Unwillingness to participate
Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography

The aim of this study is to demonstrate that positron emission tomography imaging with Rubidium-82 (radioactive tracer) can non-invasively detect and quantify changes in renal blood flow (renal perfusion) and renal vascular resistance in both healthy subjects and patients with renal insufficiency. Ultimately, the results of this study will contribute to a better understanding of the role of positron emission imaging in the evaluation of patients with renal diseases.

2. Hypothesis

1. We hypothesize that RBF assessed with rubidium PET is on average lower in patients with CKD. To test our hypothesis, RBF of patients with CKD and coronary artery disease (CAD) risk factors, a population characterized by renal microvascular rarefaction, will be compared to RBF of healthy controls.
2. We hypothesize that RVR assessed with rubidium PET correlates with echographic measurements of renal resistance index (RI), the current non-invasive method of choice.
3. We hypothesize that RBF quantification with rubidium PET is technically reproducible, meaning that the variation on the measurements of RBF purely attributable to technical factors (camera, positioning, tracer injection, etc.) is relatively small. To test this hypothesis, two PET scans will be acquired within a short time period.

3. Objectives and Endpoints 3.1. Primary Objective

1) To compare RBF of patients with CKD and CAD risk factors to healthy controls 3.2. Secondary Objectives

1. To compare RVR of patients with CKD and CAD risk factors to healthy controls
2. To evaluate the correlation between RVR measured with PET to renal RI as measured with echography
3. To evaluate the repeatability and reproducibility of in vivo measurements of RBF and RVR

Eligibility Criteria:
Inclusion Criteria:

Control Group

1. Age ≥ 18 years and \< 80 years
2. Signed informed consent
3. No medical history of renal disease

CKD Group

1. Age ≥ 18 years and \< 80 years
2. Signed informed consent
3. GFR between 30 and 45 mL/min/1.73m2 measured within the last 3 months
4. At least two cardiovascular disease risk factors such as hypertension, smoking, diabetes, obesity, and dyslipidemia

Exclusion Criteria:

Control Group

1. Hypertension
2. Diabetes
3. Dyslipidemia
4. Active smoking within the last 12 month
5. Left ventricular ejection fraction \<45%
6. BMI \>45 kg/m2
7. Severe aortic stenosis

CKD Group

1. Left ventricular ejection fraction \<45%
2. BMI \>45 kg/m2
3. Severe aortic stenosis
4. Changes in medical therapy within the last 4 weeks
5. Documented renal artery stenosis
6. Known structural cause of CKD including polycystic kidney disease, obstruction, or other post-renal causes
7. Pregnancy or breastfeeding
8. Renal failure requiring dialysis within the last 90 days
Role of Proteomics in Diagnosing Sarcoidosis

Sarcoidosis is a multi-systemic disorder, meaning that it can involve any organ in the body and that its clinical presentation is highly variable. In 90% of all sarcoidosis cases the lungs are affected. It is difficult to give a concise definition of sarcoidosis due to the fact that its exact cause is still unknown. Consequently, diagnosing the disease is also rather difficult. Up till now, sarcoidosis is generally diagnosed by using general clinical methods to evaluate the status of the lung including a chest X-ray, lung biopsy and bronchoalveolar lavage (BAL). However, some of these methods are considered to be rather invasive and, even more important, non-conclusive. Therefore, the current study has been designed to evaluate the use of a new technique, called SELDI-TOF mass spectrophotometry, for the diagnosis of sarcoidosis. This technique enables the analysis of all enzymes present in the blood of sarcoidosis patients which may hopefully lead to creating a disease-specific protein-profile that may facilitate the recognition of sarcoidosis. Moreover, these results will be compared with other currently used laboratory parameters.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pulmonary sarcoidosis stage I-IV

Exclusion Criteria:

* Non-smoking
* No treatment for extra-pulmonary symptoms of sarcoidosis