cyrilzakka/clinical-trials huggingface dataset:
Prediction and Detection of Occult Atrial Fibrillation in Patients After Acute Cryptogenic Stroke and TIA

PROACTIA is a prospective, event-driven observational study. It aims to propose a composite scoring system in order to evaluate the risk of paroxysmal atrial fibrillation (PAF) in patients after acute cryptogenic stroke and transient ischemic attack (TIA).

It will be enrolled 250 participants of both sexes within two weeks after diagnosed cryptogenic stroke and/or TIA at Akershus University Hospital, Oslo area, Norway.

Evaluation of participants' comorbidity with CHADS2-VASc score, ECG, Holter ECG, echocardiography, detection of biochemical cardiac markers and screening for obstructive sleep apnea syndrome will be performed. All participants will be monitored with a continuous cardiac rhythm during one year by implantation of implantable cardiac rhythm monitors (ICRM). All patients without high bleeding risk will get prescribed oral anticoagulants (OAC) after detection of PAF.

A biobank will be established in order to store the sampled biological material.

Eligibility Criteria:
Inclusion Criteria:

- Patients diagnosed with cryptogenic stroke and/or TIA, in accordance to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification.

Exclusion Criteria:

* Patients with known or newly detected AF on initial examination including 24 h Holter ECG.
* Patients on oral anticoagulants (OAC) for non-AF indications.
* Patients with strong contraindications for OAC, even if the presence of underlying AF is detected.
* Patients with atrial- or ventricular thrombi, or atheromas of the aortic arch greater than 4 mm, detected by transesophageal echocardiography.
* Patients unable to sign the informed consent or with a life expectancy due to comorbidities of less than two years.
Transverse Abdominis Plane (TAP) Block Versus Transversalis Fascia Plane Block (TFPB) After Cesarean Delivery

Postoperative analgesia treatment methods are applied to the living in the operating room. It is a routine part of the process of these applications. It is necessary from medical and ethical perspectives. Postoperative analgesia applications are started in the preoperative period and continue in the postoperative period. The analgesic treatment to be used is shaped according to the application and experience of the anesthesiologist. The scientifically accepted developed method is multimodal analgesia protocols. These protocols cover a wide range from paracetamol to opioids, peripheral and central blocks (such as Transversalis Fascial Plane Block (TFPB) and Transversus Abdominis Plane (TAP) Block). The aim of this study is to continue the analgesia protocols applied in cesarean section surgeries on the first 24-hour pain scores, the amount of opioid consumed after surgery and the quality of obstetric recovery (ObsQoR-10) scale.

Postoperative analgesia treatment methods are applied to the living in the operating room. It is a routine part of the process of these applications. It is necessary from medical and ethical perspectives. Postoperative analgesia applications are started in the preoperative period and continue in the postoperative period. The analgesic treatment to be used is shaped according to the application and experience of the anesthesiologist. The scientifically accepted developed method is multimodal analgesia protocols. These protocols cover a wide range from paracetamol to opioids, peripheral and central blocks (such as Transversalis Fascial Plane Block (TFPB) and Transversus Abdominis Plane (TAP) Block). In this study, transversus abdominis plane block or transversalis fascial plane block was applied to the participants immediately after surgery. The aim is to continue the analgesia protocols applied to the cesarean section surgeries on the pain scores in the first 24 hours, the amount of opioid consumed after surgery and the quality of obstetric recovery (ObsQoR-10) scale.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years
2. Term pregnancies (37-42 weeks) and those planned to undergo elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

1. \<18 years
2. Emergency surgery
3. BMI \> 35 kg/m2 or anatomic conditions that would preclude spinal anesthesia
4. Increased susceptibility to bleeding or coagulation disorders (platelet count below 80,000× 10\^3/mm\^3 or INR \> 1.5)
5. Known allergy to any drug, such as local anesthetics, opioids, or NSAIDs
6. Other relevant maternal or neonatal clinical conditions requiring treatment and at the discretion of the investigators, such as gestational hypertension, impaired renal or hepatic function, postpartum hemorrhage
7. Chronic pain conditions and concomitant use of analgesics
HMB Enriched Amino Acids to Reverse Muscle Loss in Cirrhosis

Loss of skeletal muscle mass or sarcopenia is the most common and potentially reversible complication in cirrhosis that increases morbidity and mortality before, during and after liver transplantation. No proven treatments exist for the prevention or reversal of sarcopenia in cirrhosis, primarily because the mechanisms responsible for this are unknown. Based on compelling preliminary studies and those of the co investigator, investigators hypothesize that the mechanism of reduced skeletal muscle mass in cirrhosis is due to a myostatin mediated impaired mTOR (mechanistic target of rapamycin) signaling resulting in reduced protein synthesis and increased autophagy. Investigators further postulate that leucine, a direct stimulant of mTOR, will reverse the impaired mTOR phosphorylation in the skeletal muscle of cirrhotics. The consequent increase in protein synthesis reduced autophagy will result in an increase in skeletal muscle mass. Investigators will test these hypotheses by quantifying the response to acute and long term (3 month) administration of hydroxymethyl butyrate (HMB) enriched essential amino acid compared with an isonitrogenous isocaloric non-essential balanced amino acid mixture (does not stimulate protein synthesis) in cirrhotic patients. Fractional protein synthesis rate (FSR) in skeletal muscle, responses of the molecular regulatory pathways of skeletal muscle protein synthesis, and autophagy flux will be quantified in the acute and long term protocols. Tracer studies using L-\[D5\]-phenylalanine (Phe) as a primed constant infusion (prime 2µmol.kg-1.hr-1; constant 0.05 µmol.kg-1.hr-1) with and L \[ring-D2\] tyrosine, forearm plethysmography, and sequential skeletal muscle biopsies (total of 3 per study subject) will be used to quantify these outcomes. Anthropometric, clinical and body composition measures will be additional outcome measures for the long term intervention. Expression of regulatory signaling proteins, myostatin, IGF-1 (insulin like growth factor) , phospho-Akt, phospho-AMPK (activated protein kinase), phospho-mTOR and phospho-p70s6k will be quantified by Western immunoblots. Autophagy flux will be measured by quantifying expression of the autophagosome proteins.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cirrhosis of the liver
* Child-Pugh score of 5-8

Exclusion Criteria:

* Recent gastrointestinal bleeding (\<3m)
* Active infection
* Overt encephalopathy
* Renal failure on dialysis
* Pedal edema
* Uncontrolled diabetes (HbA1C \> 7.9mg/dL)
* Advanced cardiac, lung, kidney disease
* Metastatic cancer
* Medications that alter muscle protein metabolism
* Pregnancy
* Recent bowel resection or gastric bypass surgery,
* INR \>1.7, platelets \<60,000/ml, serum creatinine \>2mg/dL
* Medications that interfere with blood clotting
Implementation Science to Improve School Ethos for Mental Health

The objective of the study is to identify the challenges and opportunities existing within the school ethos in implementing evidence-based interventions to improve youth mental health and to identify the most appropriate implementation strategies for improving mental health among young people in schools at Chennai, a city in Southern part of India, a low- and middle- income country setting.

The study team will approach the schools where the proposed study will take place and will obtain the needed permission to conduct the study in the school premises. Information about the study to all the potential participants will be disseminated through the school management. All the potential participants can approach the study team to learn more about the study and participate in the study. Potential participants approaching the study team will be explained in detail about the project and informed consent and /or assent will be obtained. The participants will be selected based on the proposed inclusion and exclusion criteria of the study.

After the recruitment of the participants, iIn-depth, semi-structured, individual interviews lasting approximately an hour will be conducted in either English or Tamil. This will be conducted by trained qualitative researchers. Interviews will be audiotaped and transcribed verbatim. A qualitative descriptive approach will guide all aspects of the qualitative methods we employ to derive a comprehensive description of participants' experiences that is both deep and meaningful. The IDI guide will be developed following an extensive literature search and discussions with experts in the field, for understanding the participants. The interviews will be conducted by two members of the research team. Face-to-face interviews or online interviews will be conducted after ensuring that the participant is comfortable, and all external disturbances will be taken care or minimized

Eligibility Criteria:
Inclusion Criteria:

* Students between 12-18 years of age
* Teachers 25-60 years of age
* Parents 25-60 years of age
* Management 25-60 years of age
* Mental health professionals 25-60 years of age
* School counsellors 25-60 years of age
* Education department - Government of Tamil Nadu 25-60 years of age
* Health department - Government of Tamil Nadu 25-60 years of age

Exclusion Criteria:

* Not willing to provide informed consent
* Can not speak either English or Tamil (native language)
Study of BMS-275183 in Patients With Pre-treated Non-small Cell Lung Cancer

The purpose of this clinical research study is to learn if BMS-275183 can shrink or slow the growth of the cancer in subjects with non-small cell lung cancer (NSCLC). The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic pretreated NSCLC
* Measurable disease
* Adequate hematologic, hepatic and renal functions
* ECOG Performance Status of 0-2

Exclusion Criteria:

* Inability to swallow capsules
* Recent significant cardiovascular disease
* Woman who are pregnant or breastfeeding
Phase 1 Study of ULSC in Patients With Polymyositis (PM) and Dermatomyositis (DM)

This study will investigate Umbilical Cord Lining Stem Cells (ULSC) as an investigational medicinal product and its use in patients with polymyositis (PM) or dermatomyositis (DM) to see if a single intravenous (IV) infusion of allogeneic umbilical cord lining stem cells (ULSC) safe, tolerable, and feasible to administer.


Eligibility Criteria:
Inclusion Criteria:

1. Adult, male or female, age ≥18 years old
2. Diagnosis of definite or probable DM or PM, according to the criteria of Bohan and Peter
3. Patients with PM will either be positive for a myositis-associated antibody or have undergone evaluation to exclude mimics, as deemed appropriate by the Investigator (See Note below).
4. Signs informed consent.

Exclusion Criteria:

1. A diagnosis of inclusion body myositis, juvenile DM or PM, myositis in the context of significant overlap with another systemic autoimmune rheumatologic disease.
2. Non immune myopathies.
3. Cancer associated myositis.
4. Hypersensitivity to study product components. History of hypersensitivity to dimethyl sulfoxide (DMSO).
5. Pregnant or lactating women.
6. Concomitant severe cardiac, pulmonary disease, active infection or other conditions that preclude assessment of safety and efficacy of the study product.
7. Patients with predominant muscle atrophy secondary to uncontrolled or chronic DM or PM, based on clinical, biochemical, and/or radiologic assessment, despite previous optimized treatment.
8. Anticipated need for surgery during the trial period.
9. A history of prevalent noncompliance with medical therapy.
10. Recipient of an organ transplant.
11. Neutropenia (absolute neutrophil count\<1,800/mm3 \[or \<1,000/mm3 in African-American subjects\]).
12. Severe impairment in renal function (estimated glomerular filtration rate \<30 ml/kg\*min).
13. Recent or planned use of vaccination with live attenuated viruses.
14. Active cancer or prior diagnosis of cancer within the past 2 years (patients with basal and squamous cell cancer of skin will not be excluded).
15. Condition that would impair an assessment of muscle strength, including neurological disorders such as Parkinson's disease or severe musculoskeletal condition.
16. Any other condition that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration, or follow-up.
17. History of Atrial septal defect or ventricular septal defect
Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)

This is a study to determine whether albuterol or oxandrolone, alone or in combination, are able to increase strength and muscle mass in patients with FSHD. It also will determine if albuterol given in "pulsed" fashion will have more effect than when given continuously.

Patients will be randomized to 1 of 4 groups: placebo, pulsed albuterol, oxandrolone, or both pulsed albuterol and oxandrolone. Treatment will continue for 52 weeks unless unacceptable side effects occur. Patients will undergo testing of muscle function. All patients will return for follow-up assessments at Weeks 4, 12, 26, and 52.

Eligibility Criteria:
Inclusion criteria:

* Presence of 4q35 "small fragment" of less than 40 kb by standard DNA testing
* Weakness of the facial muscles, including frontalis, orbicularis oculi, or orbicularis oris
* Weakness of scapular stabilizers or foot dorsiflexors
* Ambulatory
* Weakness grade 2 or worse in the arm using upper extremity grading scale

Exclusion criteria:

* Prior use of oral beta-2 agonists for a period of at least 1 year or within the past 3 months
* Concurrent use of other sympathomimetic agents, antidepressants, or beta-2 receptor blockers
* Pregnancy
* Known hypersensitivity to anabolic steroids
* Any medical or psychological condition that would interfere with the study
* Requirement for a wheelchair
Soluble ST2 in Patients With Heart Failure"

1. The aim of this study was to explore the relationship between peripheral circulating serum soluble suppression of tumorigenicity-2 (sST2) levels and inflammatory biomarkers in patients with heart failure
2. Additive role of sST2 to NPs in of heart failure patients

Heart failure (HF), a complex and heterogeneous medical syndrome characterized by structural and functional cardiac abnormalities and hemodynamic disruptions, represents the end-stage manifestation of numerous cardiovascular disorders . HF is categorized into three groups based on the measurement of the left ventricular (LV) ejection fraction (LVEF) according to the European Society of Cardiology (ESC) Guidelines issued in 2021: HF with reduced ejection fraction (HFrEF, LVEF ≤ 40%), HF with mildly reduced ejection fraction (HFmrEF, LVEF 41-49%), and HF with preserved ejection fraction (HFpEF, LVEF ≥ 50%) .

Quantifying concentrations of circulating biomarkers plays a major role in most cardiovascular (CV) diseases, including (HF) .

An ideal biomarker in HF should be measured non-invasively and at low cost, highly sensitive to allow for the early detection of the disease .

N-terminal pro-B-type natriuretic peptide (NT-proBNP) released by cardiac muscle tissue in response to abnormal volume load is an established indicator for the diagnosis and prognosis of HF .

However, there are important limitations to natriuretic peptide (NP) testing in HF .

Soluble suppression of tumorigenicity-2 (sST2) is the circulating form of the interleukin-33 membrane receptor released in response to inflammation, fibrosis in various organs, and myocardium stress .

Soluble (s)ST2 has been proposed as a useful biomarker for heart failure (HF) patient management. Myocardial damage or mechanical stress stimulate sST2 release. ST2 competes with a membrane bound receptor (ST2 ligand, or ST2L) for interleukin-33 (IL-33) binding, inhibiting the effects induced by the ST2L/IL-33 interaction so that excessive sST2 may contribute to myocardial fibrosis and ventricular remodelling.

So biomarkers such as NT-proBNP and sST2 could potentially be used as surrogates for clinical outcomes in patients with HF and may be useful in monitoring disease progression and assessing the response to therapy .

Eligibility Criteria:
Inclusion Criteria:

* patients 18-80 years.
* Both sexes will be included.
* including signs and symptoms of HF (e.g., elevated jugular venous pressure and altered apical beat position), altered LVEF (\< 40%; 40%-49%; ≥ 50%)

Exclusion Criteria:

* Patients \<18 years
* Patients with documented evidence of cardiogenic shock .
* Patients with Acute coronary syndrome within 30 days.
* chronic kidney disease patients with glomerular filtration rate \< 30
* Patients with interstitial pulmonary fibrosis .
Ordered Eating and Acute Exercise

There is well documented evidence that ingesting dietary carbohydrate in large amounts tends to increase postprandial glucose. In healthy populations, this is not necessarily a problem, but continuous exposure to high levels of glucose-hyperglycemia-is a defining characteristic and risk factor for type 2 diabetes mellitus. Consuming a carbohydrate-rich food as the final food in a meal sequence has been shown to significantly reduce postprandial glucose excursions in both diabetes patients and in healthy controls. The exact mechanisms behind this phenomenon are not well understood, but one proposed course is simply that the vegetable and protein already being digested slows the rate of glucose rise.

Despite the findings, little-to-no research has examined how manipulating the order of foods in a meal impacts subsequent exercise responses. In this experimental crossover study, each participant will undergo two acute feeding conditions (carbohydrate-rich foods first vs. last in a meal), which will be followed by exercise 60 minutes later. We will observe the effects of meal order on postprandial glucose, substrate/fuel utilization, and subjective perceptions at rest and during 30 minutes of exercise.


Eligibility Criteria:
Inclusion Criteria:

* Currently physically active (scheduled exercise at least three days per week for 30 minutes each time over the last three months)
* Ability to perform moderate-to-high intensity running for at least 30 minutes

Exclusion Criteria:

* Any allergy or other condition that would prohibit the consumption of poultry, rice, or broccoli
* Any injury or disease (cardiovascular disease, diabetes, pulmonary disease except controlled asthma) precluding physical exercise
* Currently pregnant
* Implanted electrical devices such as a pacemaker.
Prevention of C.Difficile Infections With Oral Vancomycine in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant

Clostridium difficile (CD) infection are an important cause of morbi-mortality in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT). The VANCALLO trial aims at evaluating oral vancomycine reducing the risk of CD infection relying on a placebo controlled 1:1 randomized design, including one interim analysis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥15 ans
* Hospitalization since less than 72 hours, for an allogeneic stem cell transplant, whichever the indication and conditioning
* For men and women of reproductive age: use of contraceptives
* Informed consent
* Healthcare insurance

Exclusion Criteria:

* Know allergy or history of adverse events with vancomycine
* Pregnancy
* Clostridium difficile infection within 30 days prior to inclusion or at inclusion
* History of total colectomy and/or inflammatory bowel disease
* Progressive diarrhea at inclusion, whichever the etiology
* Digestive decontamination protocol for the stem cell transplant procedure
* Participation to another drug clinical trial or being in the exclusion period from a prior clinical trial participation
Ultra Processed Foods Consumption and Impact in Rheumatic Diseases.

Ultra-processed foods (UPF) represent one of the mainstays of today's diet. They are defined by the NOVA classification system. It was demonstrated that UPF consumption was associated with activity of inflammatory bowel diseases with underlying mechanisms not fully identified yet. It is suspected that UPF constituents could modify the gut microbiota, increase intestinal barrier permeability and directly engage immune surveillance systems, effects that could individually or synergistically increase the risk of immunomediated diseases. As some pathophysiological mechanisms are shared among IBD and rheumatic diseases, we have wondered if UPF consumption could be associated with increased risk of rheumatic disease and/or with their activity.

Our primary aim will be to study the pattern of UPF consumption in patients with rheumatic diseases. Our secondary objectives will be to study the activity of diseases according to UPF consumption.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* chronic rheumatic disease (Rheumatoid arthritis, spondyloarthritis, osteoarthritis)
* ability to perform questionnaires

Exclusion Criteria:

* Judicial protection measure
* Refusal to participate in the study
* Suffering from 2 rheumatic disease simultaneously
Confocal Fluorescence Microscopy of the Human Airways in Diagnostics of Lung Transplantation

Bronchoscopy-guided tissue sampling is a central technique in many diseases including diagnosing and staging lung cancers, diagnosing interstitial lung diseases, and acute and/or chronic rejections following lung transplantation. Confocal fluorescence microscopy is a novel technique used for real-time microscopic imaging of proximal and distal airways, microvessels, and inflammatory cells. We hypothesize that confocal fluorescence microscopy images of airways and alveolar structures during standard bronchoscopy could help recognize and classify the presence or absence of acute or chronic rejection in lung transplant recipients.

Bronchoscopy-guided tissue sampling is a central technique in many diseases including diagnosing and staging lung cancers, diagnosing interstitial lung diseases, and acute and/or chronic rejections following lung transplantation. Confocal fluorescence microscopy is a novel technique used for in vivo microscopic imaging of proximal and distal airways including bronchial and alveolar walls, microvessels, and inflammatory cells. We hypothesize that confocal fluorescence microscopy images of bronchiolar and alveolar structures during standard bronchoscopy could help recognize and classify the presence or absence of acute or chronic rejection in lung transplant recipients.

The objectives and outcomes of this study are:

1. To assess the safety of confocal microscopy imaging in pediatric patients
2. To create diagnostic criteria for fibered confocal fluorescence microscopy image interpretation of acute and chronic rejections following lung transplantation
3. To determine the sensitivity and specificity of confocal imaging in these patient groups compared to the transbronchial biopsies
4. Correlate confocal images to FEV1 results
5. Correlate with CXRs and/or CT images

Eligibility Criteria:
Inclusion Criteria:

* to be older than six years of age
* to be undergoing surveillance or clinically indicated bronchoscopies with transbronchial biopsy as part of their routine care
* to be willing and able to comply with study procedures and provide written informed consent/assent to participate in the study

Exclusion Criteria:

* to be unwilling to consent
* to be unable to safely tolerate a bronchoscopic procedure
* to have any contraindications to short-acting anesthetic agents
* to have any contraindications to transbronchial biopsies