cyrilzakka/clinical-trials huggingface dataset:
Pediatrics HOT COVID-19 Database in NY Tristate

New York City (NYC) has become the epicenter of the worldwide pandemic caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). By collecting and summarizing the experience with other major health care providers in the tristate (New York (NY), New Jersey (NJ) and Connecticut (CT)) are, the investigators are uniquely positioned to inform the rest of the country about what to expect and how to manage children and young adults with hematological, oncological or stem cell transplant diagnoses during the pandemic.

The subjects are all pediatric hematology, oncology or stem cell transplant (HOT) children and young adults who are tested for SARS-CoV-2. The investigators will collect data including demographics, clinical characteristics, clinical courses, outcomes from the medical record.

Other information about finances, mental health, and nutrition will be ascertained by questionnaires. The subjects will be asked to allow the researchers to abstract information from their medical record, participate in an interview or telephone call (their choice) to answer questionnaires, and to provide a stool sample at three time points.

The creation of an integrated database of COVID-19 pediatric and young adult patients will better inform the pediatric hematology, oncology, and stem cell transplant community about this disease specifically related to patients undergoing HOT therapy and provide valuable evidence to develop standardized and clinically appropriate approaches to their care.

Eligibility Criteria:
Inclusion Criteria:

* Hematologic, Oncologic or Stem Cell Transplant Diagnosis
* Tested for COVID-19
* Age up to 21 years of age

Exclusion Criteria:

* Unwillingness to participate
Phenotypic and Genetic Correlates of Diabetes (Non-Type 1) in Young Non-Obese Asian Indians in North India and A Study to Evaluate the Efficacy of Sitagliptin (DPP-4 Inhibitor) in a Sub-group of the Study Population

This is a phase IV study of 3.5 years duration to evaluate the phenotypic and genetic correlates of diabetes (non-Type 1 in young non-obese Asian Indians in North India and pilot case control study to evaluate the efficacy of sitagliptin (DPP-4 inhibitor) in a sub-group of the study population.

A phase IV on T2DM with BMI \< 25 kg/m2 and age 14-40 years.

Primary Objectives:

* To investigate phenotype (body composition, anthropometry, pancreatic imaging and endocrine function, insulin resistance, autoantibodies, and other biochemical variables) and genetic (known mutations and polymorphisms) correlates in young (age 14-40 years) diabetic patients (non-type 1).

Secondary Objectives:

* To study anthropometric and body fat distribution including truncal fat, subcutaneous and intra-abdominal fat in non-obese young patients with diabetes (non-type 1).
* To study whether insulin secretion, insulin resistance or a combination of both is/are the predominant defect(s) in non-obese young diabetics (non-type 1).
* To study the prevalence of autoimmunity and/or specific genetic abnormalities in this subgroup of diabetics.
* To estimate approximate prevalence of diagnostic subcategories based on the sample of population, and profile of complications in each category.
* To propose rational use of specialized investigations (e.g. GAD65, HNF-1α mutations etc) while investigating a newly diagnosed young diabetic.
* To determine the rational therapeutic option and prognosis in this sub-population of diabetics based on anthropometric, biochemical, and etiological profiles.
* Sample size: 205 patients to be enrolled and 120 patients to be enrolled for sub group study

Eligibility Criteria:
Inclusion Criteria:

* Young (18 to 40 years) patients with diabetes (not on insulin therapy) during the past 6 months and having BMI \<25 kg/m2.
* Drug naïve patients
* Patients on mono-therapy with metformin (\< 1g/day).

Exclusion Criteria:

* Type 1 diabetes
* Type 2 Diabetes on any other oral hypoglycemic agent other than metformin
* Pregnancy or lactation
* Insulin or Sulfonylurea treatment within the past 3 months
* Has received any investigational drug with the past 60 days
* History of prior allergy or hypersensitivity to any drug (unless approved by investigator)
* HbA1c \< 7.5% or \> 8.5%.
* Unstable glycemic control, requiring addition of 2nd oral agent/insulin or frequent up-titration of dose of metformin.
* Any patient on insulin.
* Females of child bearing potential who are not using adequate contraception during the study period.
* Insulin dependent or history of ketoacidosis requiring hospitalization
* Acute infections
* Advanced end-organ damage (CLD, CRF etc.)
* Diabetes with clinically significant or advanced end-organ damage
A Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer

The goal of this randomized trial is to investigate whether the addition of a reminder app to standard care leads to a reduction of dermatitis and oral mucositis during radio(chemo)therapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN). The primary endpoint is the rate of patients experiencing grade ≥2 radiation dermatitis at 60 Gy of radiotherapy. 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. If the addition of a reminder app to standard care will result in a significant reduction of radiation toxicity, it could become a helpful tool for these patients.

The goal of this trial is to investigate whether the addition of a reminder app to standard care leads to a reduction of dermatitis and oral mucositis during radio(chemo)therapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN).

This is a randomized, active-controlled, parallel-group trial, which will compare the following treatments of radiation dermatitis (primary endpoint) and oral mucositis in patients with SCCHN: Standard care supported by a reminder app (Arm A) vs. standard care alone (Arm B). The primary endpoint is to investigate the rate of patients experiencing grade ≥2 radiation dermatitis at 60 Gy of radiotherapy, the minimum planned total dose for all patients receiving definitive or adjuvant radiotherapy for locally advanced SCCHN with curative intention. In addition, the following endpoints will be evaluated: Radiation dermatitis grade ≥2 at the end of radiation treatment (EOT), radiation dermatitis grade ≥3 at 60 Gy and EOT, quality of life, pain, and radiation-induced oral mucositis grade ≥2 and grade ≥3 at 60 Gy and at EOT. According to sample size calculations, 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. The impact of the reminder app will be considered clinically relevant, if the rate of grade ≥2 radiation dermatitis can be reduced from 85% to 65%.

If the addition of a reminder app to standard care will result in a significant reduction of radiation dermatitis and oral mucositis, it could become a helpful tool for patients during radiotherapy of for SCCHN.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma of the head-and-neck (SCCHN)
* Indication for definitive or adjuvant radio(chemo)therapy
* Possession of and ability to use a smart phone
* Age ≥18 years
* Written informed consent
* Capacity of the patient to contract

Exclusion Criteria:

* Nasopharynx cancer
* Pregnancy, Lactation
* Treatment with epidermal growth factor receptor (EGFR)-antibodies (either given or planned)
* Expected non-compliance
A Phase 2 Study of JNT-517 in Adolescent Participants with Phenylketonuria

The goal of this Phase 2, randomized study is to assess the safety, tolerability, and pharmacokinetics (PK) of oral JNT-517 in adolescents (12 to less than 18 years of age) with PKU. Participants will receive either JNT-517 or placebo and will be blinded to their treatment assignment. Participants will have a 4 in 5 (or 80%) chance of receiving JNT-517. The study will last for up to 63 days including a Screening period, Treatment period and Follow-up period for safety.

Participants will:

* Take 75 mg JNT-517 or a placebo BID (2x per day) for 28 days
* Visit the clinic or have a mobile health nurse visit your home for checkups and tests
* Collect urine sample at home and bring to clinic on specified days
* Keep a food diary 3 days before each study visit


Eligibility Criteria:
Key Inclusion Criteria:

1. Males and females 12 to less than 18 years of age, inclusive on Day 1.
2. Clinical diagnosis of PKU.
3. Ability to swallow tablets.
4. Average of 2 plasma Phe levels during the Screening period greater than 360 μM and no plasma Phe level less than 300 μM.
5. Body weight equal or greater than 45 kg and body mass index less than 40 kg/m2.
6. Females of childbearing potential must practice sexual abstinence or agree to use 2 highly effective contraceptive methods.
7. Capable of giving signed informed consent (emancipated minors) or parent/legal guardian to provide informed consent and the participant to give assent and confirm ability to comply with study procedures.

Key Exclusion Criteria:

1. Any acute or chronic medical condition that would prevent the participant from complying with the procedures or place the participant at risk if they participate in the study.
2. Positive for hepatitis B or C or human immunodeficiency virus.
3. Any history of malignancy in the last 5 years, excluding nonmelanoma skin cancer.
4. Any history of liver disease.
5. Any history of cataracts or more than minimal cataracts observed during the Screening ophthalmologic examination.
6. Any surgical or medical conditions that may affect study drug absorption, distribution, metabolism, or excretion.
7. Creatinine clearance less than 90 mL/min by Cockcroft-Gault formula.
8. History of drug or alcohol abuse in the last year
9. Current, recent, or suspected infection within 14 days of Screening of SARS CoV 2/COVID 19.
10. Participation in another investigational drug trial within 30 days or, if known 5 half-lives of investigational drug (whichever is longer).
11. Unable to tolerate oral medication.
12. Allergy to JNT-517 or any component of the investigational product.
13. Received greater than 50 mL of blood or plasma within 30 days of Screening or greater than 500 mL of blood or plasma within 60 days of Screening.
The Effect of Taking Break During Colonoscopy Session on Adenoma Detection, a Prospective, Randomized Control Study

Recent research has suggested that endoscopist fatigue may significantly affect the polyp detection rate. There have been no studies on interventions that may reduce endoscopist fatigue and therefore improve colonoscopy performance.

We want to determine whether a break in the middle of colonoscopy session would maintain a more stable adenoma detection rate

In recent years, there has been a dramatic increase in the volume of endoscopic procedures performed in most endoscopy centers. With the growing awareness of colorectal cancer screening, there is increasing demand for colonoscopy which has increased the workload of endoscopists in every healthcare system. There are studies showing that physician fatigue impairs quality of care and performance in other medical specialties such as anesthesia and surgery. Colonoscopy by nature is repetitive and frequently prolonged which can promote distractibility and fatigability. Studies from western countries have showed that afternoon colonoscopies are associated with lower adenoma detection rate (ADR) compared with the morning colonoscopies and physician fatigue has been hypothesized as a potential contributor. Previous studies also showed that the polyp detection rate decreases hour-by-hour throughout the day and the colonoscopy completion rate appears to decline with successive procedures due to endoscopist fatigue. The most recent study using the queue position as a surrogate marker for endoscopist fatigue had showed that both the later colonoscopy start time and increasing number of preceding endoscopic procedures are associated with decreasing polyp detection rate. It is not surprising that endoscopist fatigue may contribute to a significant decline in the effectiveness of colonoscopy and yet it is probably not realistic to reduce the number of colonoscopy procedures per session given the heavy clinical demand. There have been no studies on any intervention that may improve the performance of colonoscopy. It would be reasonable to postulate that taking a break half way through the colonoscopy session may alleviate endoscopist fatigue and hence improve the polyp detection rate. This study aims to evaluate the effect of introducing a break in the middle of a colonoscopy session on the quality of colonoscopy performance.

Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent colonoscopies in the afternoon session at the endoscopy unit in AHNH were eligible for inclusion in this study.

Exclusion Criteria:

* Emergency inpatient colonoscopy
* Patient with history of colorectal cancer , FAP or IBD
Prosthetic Complications of Screw Retained Restoration

On of the main fixed prosthetic options of completely edentulous patients is the screw-retained implant supported prosthesis which was constructed on transmucosal abutments with its encountered problems such as: hardness to make it passively seated with multiple screw fracture and loosening problems and multiple encountered veneer material fracture and so there effect on patient satisfaction with multiple maintenance recalls.so, the investigators want to try a new technique of fabrication which was proposed for reducing the problems of lack of passivity which is the intraoral luting cement technique on titanium bases with reduced screw number but, with luting cement problems as de-cementation and cement biological effects on soft tissues and bone and there effect on number of patient recall visits and maintenance and so there effect on patient satisfaction


Eligibility Criteria:
Inclusion Criteria:

* - Completely edentulous patients
* Patients with completely edentulous ridges have an opposing natural dentition or implant supported overdenture
* Completely edentulous patients (with the above mentioned criteria) who have proper amount of attached gingiva (≥2 mm) or to be created
* Completely edentulous patients (with the above mentioned criteria) who have no history of bruxism
* Completely edentulous patients (with the above mentioned criteria) who were free or controlled diabetic assessed by measuring glycosylated haemoglobin (HbA1c). (lesser than or equal to 6.4 percent )

Exclusion Criteria:

* - Patients having a medical condition that absolutely contraindicates implant placement.
* Patients with uncontrolled diabetes, assessed by measuring glycosylated haemoglobin (HbA1c). (greater than to 6.4 percent )
* Potentially uncooperative patients who are not willing to go through the proposed interventions. - Moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day).
* Patients who are having complete lower denture
* Patients who have history of bruxism
Effects of Lactobacillus Plantarum PS128 in Patients With Tourette's Syndrome

To evaluate whether supplementing with PS128 can improve the symptoms and quality of life related to Tourette's disease in children.

This is a randomized double-blind healthy control study and the implementation period is after Institutional Review Board (IRB) approval to December 31, 2022.

Experimental group: 80 subjects who meet the criteria for the admission of Tourette's disease will be enrolled. They will consume the PS128 or placebo capsules every day, 2 capsules at a time, for 12 weeks. Healthy control group: 40 subjects of the same age as the experimental group will be included, without any intervention measures, only collect stool sample once.

Eligibility Criteria:
Inclusion Criteria:

* Age 4-18 years old
* Tourette's disease is diagnosed
* Make sure it is not caused by medication or other diseases
* Cause major interference in social interaction, study or work
* The healthy control group is not diagnosed with Tourette's disease, and is judged by PI

Exclusion Criteria:

* Have taken antibiotics within a month or are receiving antibiotic treatment
* Used probiotic products in powder, capsule or tablet form within two weeks (except yogurt, yogurt, Yakult and other related foods)
* Patients who have undergone hepatobiliary gastrointestinal surgery (except for colorectal polypectomy and appendectomy)
* Inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
* Those with a history of cancer
* Those who are allergic to lactic acid bacteria products
* Those who are not suitable to participate judged by PI
Mindfulness-Based Stress Reduction Versus Lifestyle Intervention for Long-Haul Covid-19 Parosmia

Olfactory dysfunction (OD) is a defining symptom of COVID-19 infection. As the number of total, confirmed novel coronavirus SARS-CoV-2 (COVID-19) cases exceeds 45 million in the United States, it is estimated that up to 85% of infected patients will experience at least some olfactory dysfunction.

Therefore, we propose a Pilot single-site clinical trial to explore the efficacy of MBSR for Covid-19-related smell distortion (parosmia)

The perception of distorted smell in the presence of a familiar odor is referred to as parosmia. Parosmia can severely impair appetite and quality of life as familiar smells can trigger a foul smell. Parosmia is increasingly recognized as a long COVID symptom. Intranasal and oral corticosteroids, theophylline, Vitamin A, and omega-3 have all been proposed as treatment options for post-viral OD. Budesonide steroid irrigation paired with olfactory training, another avenure for treating olfactory loss, has shown some benefit compared with olfactory training alone. However, these treatments have demonstrated limited efficacy for patients with parosmia.

Mindfulness-based stress reduction (MBSR) is a psychological therapeutic intervention that emphasizes the focused, non-judgmental awareness of present-moment experiences without efforts being made to alter or avoid them. It is a practice that is embedded in mind/body and integrative medicine to cultivate psychological and emotional resilience. MBSR improves anxiety, depression, insomnia, and other psychological outcomes in clinical trials. Although MBSR is one of the most widely practiced and extensively studied meditation programs in the world, its mechanism of benefit for patients with parosmia has not yet been assessed.

In this phase II trial, patients will be allocated 1:1 to receive either a mindfulness-based stress reduction course or a lifestyle management course. The courses will meet virtually once per week for 8 consecutive weeks as well as a one-time 4 hour virtual retreat.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18 to 65 years
* Reside within the continental United States
* Ability to engage in virtual group sessions for 2 hours either Tuesday or Wednesday evenings for 8 consecutive weeks and the 1/2 day Weekend Retreat.
* Clinically diagnosed or subjective parosmia of at least 3 months duration after COVID- 19 infection

Exclusion Criteria:

* Clinically diagnosed olfactory dysfunction secondary to non-COVID-19 viral infection, genetic abnormalities, congenital dysfunction, trauma, nasal polyps, or neurodegenerative disorders.
* Availability less than 4 months from time of enrollment
* Residency outside the continental United States
* History of substance abuse, PTSD, thoughts of self-harm, or other active poorly controlled psychiatric or psychological conditions
* Sinus surgery in the 6 weeks prior to enrollment
Myofascial Therapy in Patients With Hemophilic Arthropathy

Designing a treatment protocol using myofascial therapy for the treatment of pain and restrictions on mobility in patients with hemophilic arthropathy of the knee and ankle.

Pilot with a small number of patients for assessment the effectiveness and safety of the treatment protocol created.

Randomized clinical trial to assess the effectiveness of treatment with myofascial therapy in patients with hemophilia.

Describe the differences in terms of the dependent variables (range of motion, pain and flexibility) in patients with hemophilia who have carried out the treatment.

Report the relationship between the clinical characteristics of patients and the results obtained after the treatment period.

Phase I pilot study with 5 patients with hemophilia for assessment by myofascial therapy protocol designed for this purpose.

Phase II. Randomized, prospective longitudinal clinical study in patients with hemophilia, to assess the efficacy of an intervention with myofascial therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of hemophilia A and B.
* Patients older than 18 years.
* Patients with a diagnosis of hemophilic arthropathy of the knee and ankle.
* Patients on prophylactic regimen with FVIII / FIX.

Exclusion Criteria:

* Patients without walking ability.
* Patients with a diagnosis of other congenital coagulopathy (eg von Willebrand disease).
* Patients who have developed antibodies to FVIII / FIX (inhibitors).
* Patients with neurological or cognitive impairments that impede understanding of questionnaires and physical test.
* Patients who have not signed the informed consent document.
Expression of Sodium-glucose Co-transporter 2 in Human Heart

The aim of the study is to evaluate the expression of Sodium Glucose Co-transporter 2 (SGLT2) in myocardium from patients with aortic stenosis. 2 groups of patients will be defined: Group A with diastolic heart failure and Group B without heart failure. The expression of SGLT2 will be measured on small myocardium specimens harvested during aortic valve replacement operation. This study should allow us to better understand the effect of glifozines in human heart failure.


Eligibility Criteria:
Inclusion Criteria:

* adults over 18 years-old
* Patient with surgical aortic valve stenosis, with or without heart failure, in two equal-sized groups (40 subjects in each group)
* Subjects affiliated with a social security health insurance plan
* Subject able to understand the objectives and risks of the research and to give dated and signed informed consent

Exclusion Criteria:

* Infective endocarditis in aortic stenosis
* Severe coronary pathology associated with aortic stenosis
* Impossible to give the subject informed information (subject in emergency situation, difficulties in understanding the subject, ...)
* Subject under legal protection
* Subject under guardianship or curatorship
* Pregnancy and/or breastfeeding