cyrilzakka/clinical-trials huggingface dataset:
Prospective Registry of Multiplex Testing (PROMPT)

This study is being done to learn more about how changes in certain genes may be linked to cancer. Some people with cancer got their disease because they inherited an abnormal (mutated) gene.

The researchers of this study want to better understand the risks that are linked to genetic changes in these less well-studied genes. By understanding these risks, we believe that doctors will be able to give better advice to families with mutations in these genes.

PROMPT (Prospective Registry of Multiplex Testing) is an Internet-based, patient-directed ascertainment study. It is a partnership between Memorial Sloan Kettering, University of Pennsylvania, Mayo Clinic, and Dana Farber Cancer Institute in collaboration with Ambry Genetics, GeneDx, Myriad Genetics, Pathway Genomics, and Quest Laboratories (5 laboratories providing multiplex panel testing commercially).

Eligibility Criteria:
Inclusion Criteria:

* Individual with deleterious (pathogenic) or likely deleterious (likely pathogenic) mutation in a cancer susceptibility gene OR
* Individual with a variant of uncertain significance (VUS) in a cancer susceptibility gene OR
* Family members, either tested or not tested, who are part of a family known to be transmitting a deleterious or likely deleterious mutation or a variant of uncertain significance in a cancer predisposition gene

Exclusion Criteria:

* Inability or refusal to participate in consent discussion
* Subject is less than 18 years old
Heart Failure Biomarkers

Systemic inflammation is closely associated with the development and progression of heart failure (HF). The study assessed the fibrin/albumin (FAR) ratio, a very important biomarker, as a prognostic indicator of HE. Study population is composed by patients who were addicted with heart failure diagnosed for the first time or already under treatment (NYHA class II-IV) and reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).

Prospective, observational, single-center study, which involves the enrollment of patients affected by heart failure of first diagnosis or already in therapy, who will be subjected to an analysis of the Albumin/fibrinogen ratio. Subjects will not be subjected to specific visits or services for the study: clinical and anamnestic data will be collected during routine visits.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Patients with newly diagnosed or already treated heart failure (NYHA class II-IV) with HFrEF and HFpEF with and without atrial fibrillation.
* Patients who sign the consent to participate in the study

Exclusion Criteria:

* Patients with infectious/autoimmune diseases, neoplasms, liver failure, renal failure (Cl creatinine \&lt; 30 mL/L), structural cardiomyopathies and pericarditis.
* Pregnant/breastfeeding women (verified by self-declaration)
An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects

This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study.

Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Nifedipine suppositories at various doses) will be administered at pre-determined intervals. During the study, blood samples will be obtained for plasma Nifedipine analysis.

After detrminig baseline resting anal pressure with a manometric test, coated Suppositories will be administered intra rectally. Subjects will take rectally a total of 3 Coated Suppositories per study. 90 minutes after each coated suppository insertion this suppository will be removed and a amnometric study will be performed:

The first dose will contain 4 mg of Nifedipine and the manomentric measurement performed afterwards will be used to determine baseline anal pressures.

The second dose will contain 12 mg of Nifedipine. The third dose will contain 24 mg of Nifedipine. The primary efficacy parameter is change in Resting Anal Pressure from baseline.

The secondary efficacy parameters include the following:

* The ratio of change in anal pressure to plasma Nifedipine level.
* The ratio of change in anal pressure to change in blood pressure.
* The ratio of change in anal pressure to change in heart rate.

Eligibility Criteria:
Inclusion Criteria:

Subjects meeting the following criteria will be eligible to participate in the trial:

* Signed written informed consent;
* Male or female subjects 18 to 55 years of age;

Exclusion Criteria:

Subjects are excluded from participation in the study if any of the following criteria apply:

Has a clinically significant history or presence of any of the following conditions:

* Known allergy to Nifedipine, polyethylene-glycol, Propylene-glycol or silicone.
* Active or past history of disease that requires medication or clinical follow up.
* Malignant disease within 5 years of screening;
* History of ano rectal disease.
* History of gastrointestinal disease.
* History of gastrointestinal bleeding.
* History of rectal surgery.
* History of gastrointestinal surgery.
* History of HIV.
* In need of chronic use of medication, with the exception of birth control medications.
* Currently uses medication for acute illness.
* Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
* Has received any investigational drug within 90 days of screening;
* Receipt of any investigational treatment (drug or device) within 90 days prior to screening;
WebMAP Mobile Self-management of Adolescent Chronic Pain

Approximately 5-8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, data show that most youth do not have access to this intervention. The investigative team's prior studies demonstrate that technology-delivered pain self-management (WebMAP program) can reduce barriers to care, is feasible, acceptable, and effective in reducing pain-related disability and improving anxiety and depression in youth with chronic pain. In this trial, the investigators propose an implementation project to address critical challenges in nationwide dissemination of the WebMAP pain self-management program. Using a hybrid effectiveness-implementation trial design, 8 clinics from across the U.S. will participate in a pragmatic randomized controlled trial with a stepped wedge design to sequentially implement WebMAP in the clinics following randomized usual care periods. Data will be collected from clinic records, web and app administrative tracking, and provider surveys to gather information on adoption and implementation following the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) public health impact framework. Individual patient-level pain outcomes will be collected from 140 patients to evaluate intervention effectiveness. The expected outcome of the project is to yield a strategic approach for a nationwide technology-delivered pain self-management intervention for youth with chronic pain that can be readily sustained in clinical settings.


Eligibility Criteria:
Inclusion Criteria:

1. child age 10-17 years,
2. has chronic pain defined as pain present for at least 3 months, and
3. has access to a smartphone or web-enabled device (e.g., laptop, computer, iPad).

Exclusion Criteria:

1. non-English speaking,
2. presently in a psychiatric crisis,
3. cognitive impairments or intellectual disabilities (has to be able to complete surveys independently),
4. does not have access to a smartphone, computer, or internet, and
5. is unable to read at the 5th grade level.
Incentive Spirometer Training and Oropharyngeal Motor Training for Pulmonary Dysfunction in Spastic Diplegic Children

Purpose of the study to determine the impact of incentive spirometer training and the oropharyngeal motor training or the combination of both for pulmonary dysfunction in spastic diplegic children

This is a prospective randomized controlled clinical trial, conducted at Kafr El sheikh Hospital.

* Forty-eight children of both genders.
* The study will include children (age 3-7 years) post selective pulmonary dysfunction.
* Children meeting the inclusion criteria will be randomly assigned to one of three groups:
* first Experimental Group: children in this group will receive incentive spirometer training.
* second Experimental Group:children in this group will receive oropharyngeal motor training. .
* third experimental Group: Patients in this group will receive combination of incentive spirometer training and oropharyngeal motor training
* Randomization will be achieved using computer-generated random numbers to ensure an equal distribution of patients between the two groups.

Conditions: Cerebral Palsy

Eligibility Criteria:
Inclusion Criteria:

* the children with spastic CP between the age from 3 to 7 years old.

Level I to IV on the gross motor function classification system (GMFCS) , who have the partial ability to maintain antigravity head and trunk postures.

* Cognitive and cooperative function allowing pulmonary function measurements.
* No history of psychiatric or neurological disorders rather than cp.

Exclusion Criteria:

* Any uncontrolled clinically significant medical conditions such as coexistent cardiac disease or respiratory disease
* Children with cognitive impairment who are unable to comply with the protocol required procedure
* Children who are taking medications that can affect respiratory function
* Children with presence or history of tracheostomy
PROgastrine COlon DEpistage

Dosage of progastrin in asymptomatic person participating in colon cancer screening

For anyone who will participate in colon screening at the Princess Grace Hospital of Monaco and who has signed the informed consent document. A blood test will be performed in addition to the screening test to assess the rate of progastrin.

Eligibility Criteria:
Inclusion Criteria:

* participant in colon cancer screening
* signing informed consent

Exclusion Criteria:

* any major medical, psychiatric or addictive illness that would affect the informed consent process
* The consent of a representative is not allowed in this study
Tumorspecific T-cell Immunity in Bladder Cancer as Prognostic Marker

Bladder cancer is generally susceptible to immunotherapeutic measures. The investigators will characterize 40 patients with muscle-invasive bladder cancer regarding the existence and frequency of tumorspecific T-cells and regulatory T cells. The found data will be correlated to clinical data such as the cancer-specific survival and the response to chemotherapy.

It is hypothesized that those patients with a high number of Tregs and no tumor-specific T-cells have a worse prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed muscle-invasive urothelial carcinoma
* Age \> 18 years
* Hemoglobin \> 10g/dl
* Signed Informed Consent
* Karnofsky index \< 70%

Exclusion Criteria:

* Clinically relevant second malignancy
* Severe comorbidities (e.g. NYHA III, end-stage renal disease)
* Chronic infectious disease (HIV, Tuberculosis)
* Immunosupression
* Severe psychiatric diseases
* Blood donation in the last 4 weeks
ARB, ACEi, DRi Effects on COVID-19 Course Disease

It is supposed to monitor hypertensive patients who are infected or have clinical manifestations of COVID-19 for 1 month after the onset of the disease. Three groups will be considered: 1. receiving ACE inhibitors 2. receiving ARBs 3. receiving DIR.

POEM (Patient-Oriented Evidence that Matters) intervention is performed as an open prospective randomized two medical centres trial in subjects suffering from COVID-19 who have been receiving iRAS, either ACEi, ARB or DRi as basic antihypertensive therapy.

COVID-19 is confirmed by a PCR test, the disease follow-up is divided into 2 periods: up to 12 weeks and up to 24 weeks.

Primary Outcome Measure: BP was known one week before COVID-19 and is tested during the disease onset on weeks 2, 4, 12, 24. Secondary Outcome Measures are clinical features. Subanalysis in patients with CKD is additionally performed for those who have CKD.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive person, stage 1-2

Exclusion Criteria:

* Hypertensive subjects, stage 3, HF (NYHA) 3-4
Effect of Myofascial Release on Dysphagia in Patients With Traumatic Brain Injury

The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Traumatic Brain injured Survivors. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.

Myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. It involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Traumatic Brain injured Survivors. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury.
* presence of no contraindication for enteral nutrition;
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to Myofascial Release;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Efficacy of a Tea Catechin Sports Drink for Enhancing Exercise-Induced Fat Loss

The primary objective of this trial is to evaluate the influence of consuming a tea catechin containing sports beverage on body fat mass during exercise-induced weight loss among overweight and obese men and women.

The study will include two screening/baseline visits and six treatment visits over 12 weeks. During the treatment phase of the study, subjects will be instructed to consume one bottle of sports drink (500 ml) daily (total consumption of tea catechins in the active group = 540 mg/d). Subjects will be asked to maintain a constant energy intake throughout the study period. Three-day diet records will be collected and analyzed at weeks 0, 6, and 12 to evaluate consistency of energy intake.

All subjects will engage in an exercise program with a goal of maintaining 180 min/week of low- to moderate-intensity exercise (e.g., walking and other aerobic activities, 4-6 days per week). Three of the weekly exercise sessions will be supervised and 1-3 will be unsupervised. Subjects will be asked to wear a pedometer and record their daily physical activity (steps) each night in a physical activity diary. Diaries will be collected at each visit and used to evaluate exercise compliance. Dual energy X-ray absorptiometry (DEXA) and computed tomography (CT) scans will be performed at baseline (week 0) and at the end of the treatment (week 12). Additionally, body weight and abdominal circumference will be assessed at every clinic visit during the study. It is anticipated that subjects will expend 1000-1800 kcal per week above their baseline level in deliberate physical activity. Accordingly, the control group is expected to lose 1.5 to 2.8 kg of body fat during the 12-week treatment period

Eligibility Criteria:
Inclusion Criteria:

* Men and women 21 to 65 years of age, inclusive
* Waist circumference ≥ 87 cm for women and ≥ 90 cm for men at screening
* Total cholesterol ≥ 200 mg/dL
* Provide written informed consent and authorization for protected health information

Exclusion Criteria:

* Volunteers with Body mass index ≥ 40.0 kg/m2 or \< 25.0 kg/m2;
* Recent weight loss of more than 4.5 kg;
* Recent use of any weight loss medications, supplements, or programs;
* History of weight-reducing surgery or an eating disorder
* Pregnancy
Nasal High Flow Therapy in Surgical Patients with Unrecognized Obstructive Sleep Apnea

In this study the investigators will determine whether using high flow oxygen in moderate-to-severe Obstructive Sleep Apnea patients following a major non cardiac surgery is more efficacious than usual care in preventing decrease in oxygen level in blood.

The POSA-II trial is a culmination of the investigator's program of research to prevent postoperative adverse outcomes in surgical patients with untreated Obstructive Sleep Apnea (OSA). It is a multi center open label, randomized clinical trial of nasal high-flow vs. usual care in patients with untreated moderate-to-severe OSA undergoing major non cardiac surgery. It is a proof of concept trial to show that nasal high-flow reduces severe desaturation, the causal mechanism for OSA-related adverse events, and to collect key feasibility data for a large international multi center trial with enough power to detect effects on the clinical outcomes. Eligible patients undergoing major non cardiac surgery with high-risk OSA will have a home sleep study. One hundred and ninety patients with moderate-to-severe Sleep Apnea will be randomized into either nasal high-flow or usual care group. Sleep studies, oximetry, electrocardiogram (ECG), and Troponin will be done preoperatively. Postoperatively, ECG and Troponin will be determined daily for the 1st three days, and nocturnal oximetry for the 1st 3 nights. Patients will be followed during their hospitalization and for 30 days postoperatively to ascertain any adverse outcomes. A blinded clinical events committee will adjudicate all components of the composite outcome.

Eligibility Criteria:
Inclusion Criteria:

* Adult, age ≥45 years, undergoing major elective non cardiac surgery under general and/or regional anesthesia with anticipated overnight stay or longer in hospital
* Patients with untreated moderate-to-severe Obstructive Sleep Apnea.
* STOP-Bang score 5 or higher

Exclusion Criteria:

* Predetermined need for postoperative CPAP therapy or ventilation,
* Cheyne-Stokes respiration or Central Apnea,
* Oxygen dependent due to moderate to severe chronic obstructive lung disease available Forced Expiratory Volume at 1 second of \< 50% predicted) or advanced interstitial lung disease,
* Pre-existing chronic hypercapnia or obesity hypoventilation syndrome, Intracranial and otolaryngological procedures, and
* Unable to use nasal high-flow (nasal/oral malformations, pre-existing tracheostomy, planned postoperative nasal packing).
Abdominal SepsiS Study: Epidemiology of Etiology and Outcome

The aim of the project is to perform a multinational, prospective, observational study on IAIs (IntraAbdominal Infections) in critically ill patients; special emphasis will be given to epidemiology and outcomes.

To investigate microbiology and/or drug resistance patterns related to: Geographical region, Source of IAI, Upper GI tract perforation (stomach \& duodenum), Lower GI tract perforation (jejunum, ileum, colon, rectum), Primary peritonitis, Peritoneal dialysis-related peritonitis, Intra-abdominal abscess, Pancreatic infection, Biliary tract infection, Typhlitis, Toxic megacolon.

To check the Origin of IAI: community-acquired, early-onset healthcare-associated, late-onset healthcare-associated.

To describe physician's antimicrobial prescription patterns related to a classification grid that stratifies IAIs according to disease expression, community or healthcare origin, and anatomical disruption.

To investigate outcomes (clinical response, need for surgical revision, length of hospitalization, and mortality) related to: Classification of IAI, Severity of acute illness at time of diagnosis (SOFA score) and clinical response after 48-72 hrs. (SOFA score), Processes of care (Time to 1st antimicrobial dose, Time to source control, Type of source control intervention (laparotomy, percutaneous drainage, high volume peritoneal lavage, restoration of anatomy and function), Need for (unplanned) surgical revision (uncontrolled infection source), Frequency of microbiological sampling and delay of results)), Pathogens involved and empirical antimicrobial coverage; special emphasis will be given, to coverage of multidrug resistant Enterobacteriaceae, Pseudomonas aeruginosa, enterococci and Candida species, Duration of antimicrobial therapy, Underlying conditions

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 yrs. of age)
* IAI treated with percutaneous or surgical procedure
* ICU admission (the patient should either be admitted to the ICU because of abdominal sepsis or should be admitted in the ICU for other reasons and subsequently developed abdominal sepsis as a complication during the ICU course)
* Informed consent (if required by local ethics committee)

Exclusion Criteria:

\<18 yrs
Effect of Single Colonoscopy on Colorectal Adenomas Detection

Individualized colonoscopy withdrawal time is determined based on the different grade of physician experience and quality of bowel preparation.


Eligibility Criteria:
Inclusion Criteria:

1. Greater than the age of 40;
2. Pathology and endoscopic data recorded available and detailed;
3. Whole bowel staining endoscopy is not done.

Exclusion Criteria:

1. Not reach the ileocecal junction;
2. Colorectal cancer;
3. Familial adenomatous polyposis;
4. Inflammatory bowel disease;
5. Part of the bowel resection.