cyrilzakka/clinical-trials huggingface dataset:
Halt cardiomyOPathy progrEssion in Duchenne (HOPE-OLE)

This Phase 2, multi-center, open-label extension trial will provide CAP-1002 to participants who were randomized to the Usual Care treatment group of the HOPE-Duchenne study (NCT02485938) and completed 12 months of follow-up.

The trial will assess the safety and efficacy of two intravenous administrations of CAP-1002, each separated by three months.

Participants with documented enrollment in the Usual Care treatment group of the HOPE-Duchenne study and completion of study follow-up through Month 12 were eligible for this study.

Participants will undergo a targeted screening during a 30-day screening period, eligible subjects will then undergo baseline safety and efficacy assessments on Day 1 prior to their first infusion of CAP-1002.

All CAP-1002 infusions will be conducted in an outpatient setting at the investigative site on Day 1 and at Month 3. Participants will be observed in the outpatient setting for at least two hours post-infusion and then discharged the same day if medically cleared by the site Investigator.

Eligibility Criteria:
Inclusion Criteria:

1. Documented enrollment in the Usual Care Treatment Group of the HOPE-Duchenne trial and completion of trial follow-up through Month 12.
2. Willing and able to provide informed consent to participate in the trial if greater than or equal to (\>=) 18 years of age, and assent with parental or guardian informed consent if less than (\<) 18 years of age.
3. Adequate venous access for intravenous CAP-1002 infusions and routine blood collections in the judgement of the Investigator.
4. Assessed by the Investigator as willing and able to comply with the requirements of the trial.

Exclusion Criteria:

1. Left ventricular ejection fraction (LVEF) \< 35 percent (%) within 6 months of screening.
2. Planned or likely major surgery in the next 6 months after planned first infusion.
3. Risk of near-term respiratory decompensation in the judgment of the investigator, or the need for initiation of non-invasive ventilator support as defined by serum bicarbonate \>= 29 millimoles per liter (mmol/L) at screening.
4. History of non DMD-related chronic respiratory disease including, but not limited to, asthma, bronchitis, and tuberculosis.
5. Acute respiratory illness within 30 days prior to screening.
6. Known hypersensitivity to dimethyl sulfoxide (DMSO) or bovine products.
7. Treatment with investigational product \<= 6 months prior to first infusion.
8. History, or current use, of drugs or alcohol that could impair ability to comply with participation in the trial.
9. Inability to comply with the investigational plan and follow-up visit schedule for any reason, in the judgment of the investigator.
World Bleeding Disorders Registry

The WBDR is an international observational disease registry of patients with hemophilia. It will provide a platform for a network of hemophilia treatment centres (HTCs) around the world to collect uniform and standardized patient data and guide clinical practice. With informed consent from the patient, the WBDR stores anonymous data about the person's disease, such as hemophilia type and severity, symptoms, and treatment.

The WBDR is a prospective, global registry of patients diagnosed with hemophilia A and B. Following the success of a pilot study, implementation of the full scale WBDR is underway. The goals are to enroll at least 200 HTCs from more than 50 countries, and at least 10,000 people with hemophilia, during the first five years, aiming for representation of patients from around the world and from all levels of access to care. Minimal criteria for participation of HTCs include access to reliable internet, human resources for data entry and commitment to long-term enrolment and follow-up of patients. The WBDR database is being developed through a collaboration between the WFH, Karolinska Institute and Health Solutions.

By combining data from countries around the world, the WBDR will provide a large amount of real world data, on which researchers can address important scientific and clinical issues. The World Bleeding Disorders Registry (WBDR) is intended to fill existing gaps in knowledge by collecting real world data on the patient clinical experience around the globe.

Eligibility Criteria:
Inclusion Criteria:

* Patients of participating Hemophilia Treatment Centres with Hemophilia A or B, or von Willebrand Disease

Exclusion Criteria:

* none
Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.

We are performing the above prospective randomized trial in 1'000 patients undergoing cardiac surgery. The study will answer the question of whether preoperative treatment of anemia or iron deficiency indeed improves transfusion needs (primary outcome) and important clinical outcomes (secondary outcome) in a large group of cardiac surgical patients. The list of inclusion and exclusion criteria was deliberately chosen short so that this patient group largely reflects today's clinical practice .

* Trial with medical product

Anemic or iron deficiency patients are randomized into treatment and placebo groups. Treatment (see below) will be given the day before the operation (day -1) or a maximum of 2 days prior to the operation (day -2) in iron deficiency patients and a maximum of 3 days prior to the operation in anemic patients (day -3). The treatment will not be disclosed to the patient or the health care workers treating the patients during and after the operation.

Patients without anemia or iron deficiency will also be observed and the same postoperative measurements performed. They will serve as a natural comparison group.

Treatment:

Erythropoietin alpha (Eprex, Janssen-Cilag AG, Baar) 40'000 U sc. Ferric carboxymaltose (Ferinject, Vifor (International) AG, St. Gallen) 1000 mg in 100 ml sodiumchloride (NaCl) over 30 min.

Vitamin B12 (Vitarubin®-superconc., Streuli Pharma AG, Uznach) 1 mg sc. Folic acid (Acidum folicum, Streuli Pharma AG, Uznach) 5 mg po.

The current transfusion and coagulation guidelines of the University Hospital of Zurich are followed in both groups identically. Postoperatively on the regular ward a Hb transfusion trigger of 80 g/L is applied

Eligibility Criteria:
Inclusion criteria:

* Patients undergoing valve- and/or coronary bypass surgery
* Signed patient informed consent
* Only patients will be enrolled who won't have an emergency surgery on the same day

Exclusion criteria:

* Participation in another clinical trial within the last 4 weeks prior to enrollment
* Addiction or other disease that did not allow the patient to assess the nature, scope and possible consequences of the clinical tial
* Patients who do not sign the consent form or may not fully understand from inadequate knowledge of German.
* Patients who have not reached the age of legal majority
* Pregnant or lactating women
* Jehovah's Witnesses
* Patients with endocarditis
* Existing allergy or intolerance to ferric carboxymaltose or mannitol
the Antibacterial Effect of Zinc ,Silver and Fluoride

natural teeth will be filled with the 3 different material then the dentin sample will be collected ,bacterial culture and elementary analysis will be done

orthodontic patient with premolar indicated for extraction , teeth will restored with the different material 3 months before doing extraction

Eligibility Criteria:
Inclusion Criteria:

* patient need teeth extraction for orthodontic treatment

Exclusion Criteria:

* carious teeth deciduous teeth
Edge AI-deployed DIGItal Twins for PREDICTing Disease Progression and Need for Early Intervention in Infectious and Cardiovascular Diseases Beyond COVID-19 - Investigation of Biomarkers in Dermal Interstitial Fluid

The study will investigate, if inflammatory and cardio-circulatory biochemical biomarkers are detectable in dermal interstitial fluid (dISF) of heart failure patients, and if there are detectable kinetics of these biomarkers during a cardiopulmonary exercise test. For dISF extraction the PELSA System - an investigational device - will be used.


Eligibility Criteria:
Inclusion Criteria:

* Subject suffers from heart failure (according to ESC 2021 Heart Failure Guidelines).
* Age of subject is ≥18 years.
* Subject is female or male.
* Signed written informed consent.
* For female subjects:

  1. Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or
  2. If being of childbearing potential:

     1. Negative highly sensitive urine or serum pregnancy test before inclusion, and
     2. Practicing a highly effective birth control method (failure rate of less than 1%):

        1. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or
        2. progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or
        3. intrauterine device (IUD), or
        4. intrauterine hormone-releasing system (IUS), or
        5. bilateral tubal occlusion, or
        6. vasectomised partner, or
        7. heterosexual abstinence.
* Subject is capable to perform cardiopulmonary exercise testing.

Exclusion Criteria:

* Subject is breastfeeding.
* Subject suffers from an addiction or from a disease that prevents the subject from recognizing nature, scope, and consequences of the study.
* Subject is treated with immunosuppressive drugs at enrolment.
* Subject requires renal replacement therapy.
* Subject has a known colonisation or infection with multi-drug-resistant pathogens.
* Subject has an open wound in or near the sampling area.
* Subject has any type of tattoo or piercing anywhere in or near the sampling area.
* Subject shows an inability to comply with all the study procedures and follow-up visits.
* Subject is unwilling to consent to saving and propagation of pseudonymised medical data for study reasons.
* Subject is legally detained in an official institution.
* Subject is dependent on the sponsor, the investigator or the study sites.
* Subject participates in a study according to AMG/CTR that investigates immunosuppressive or anticoagulant drugs at the time of this study.
Inspiratory Muscle Strength Training in Adults With Obesity

The purpose of this study is to determine whether inspiratory muscle strength training reduces blood pressure in adults with obesity.

Obesity affects four-in-ten American adults and is associated with hypertension and greater all-cause mortality. Irrespective of weight loss, aerobic exercise reduces arterial blood pressure (BP) and improves cardiometabolic health. However, nearly half of adults with obesity do not perform aerobic exercise because of low leisure time availability and exertional dyspnea secondary to high chest wall mass-related inspiratory muscle dysfunction. In other clinical populations, emerging data demonstrates time-efficient high-resistance inspiratory muscle strength training (IMST) reduces BP and improves respiratory muscle function. Therefore, the investigators will determine whether eight weeks of daily high-resistance IMST reduces BP, improves respiratory muscle function, and concomitantly reduces exertional dyspnea in a randomized, double-blinded, sham-controlled (i.e., very low-resistance IMST) clinical trial among adults with obesity

Eligibility Criteria:
Inclusion Criteria:

- Body mass index 30 - 40 kg/m2

Exclusion Criteria:

* Not weight stable (\<5% change in body mass over the past six months)
* Overt cardiovascular, neurological, renal, liver, and/or metabolic illness (e.g., diabetes mellitus)
* Current, or history of uncontrolled, Stage 2 hypertension (blood pressure \>140 / 90 mmHg; anti-hypertensive medications are permitted)
* Diagnosed obstructive sleep apnea
* Previous bariatric surgery
* Diagnosis or signs (e.g., values below the lower limit of normal) of overt airway disease(s)
* Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes, vaping)
* Pregnant (self-reported and confirmed via urine pregnancy test), lactating (self-reported), or post-menopausal (self-reported) females
* Prisoners
* Per the POWERbreathe® company:

  * Patients who have undergone recent abdominal surgery and those with abdominal hernia.
  * Asthma patients who have a very low symptom perception and suffer from frequent, severe exacerbations or with an abnormally low perception of dyspnea.
  * If a patient is suffering from a ruptured eardrum or any other condition of the ear.
  * Patients with marked elevated left ventricular end-diastolic volume and pressure.
  * Patients with worsening heart failure signs and symptoms after training.
  * If an individual is suffering from a cold, sinusitis or respiratory tract infection, it is advised that they do not use the POWERbreathe device.
A Study on the Inter-Hemispheric Alpha Ratio in Kids With ADHD (SHARK)

Investigate the hypothesis that children with ADHD have difficulty with the allocation of visio-spatial attention related to an inability to control posterior alpha brain oscillations. A paradigm will be used in which the aim is to address covert attention as similar recent studies did in adults with ADHD.


Eligibility Criteria:
Inclusion Criteria:

For both groups

* Age between 7 and 10 years of age.
* Estimated IQ above 80.
* Psychopharmaca- naïve or -free.

For the ADHD-group - A diagnosis of ADHD, classified by the DSM-IV.

Exclusion Criteria:

* (Co-morbid) psychiatric disorder (major depression, bipolar disorder, psychotic disorder, chronically motor tic disorder or Gilles de la Tourette, Conduct disorder, autism spectrum disorder, eating disorder, anxiety disorder).
* Neurological disorders (e.g. epilepsy) currently or in the past.
* Cardiovascular disease currently or in the past.
* Serious motor or perceptual handicap.

For the no ADHD-group

- No diagnosis of ADHD, classified by the DSM-IV.
Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma

No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical T1-2 N0 patients with incidental pathologic lymph node metastasis following initial surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally advanced ESCC, we initiated this randomized controlled trial (RCT).


Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven squamous cell carcinoma.
2. Tumours are located in the thoracic oesophagus.
3. Age is between 18 years and 70 years.
4. ECOG performance status of 0 or 1.
5. Patients with resectable cT1-4aN+M0 or T3-4aN0M0 disease and residue disease is found after neoadjuvant chemotherapy plus surgery or cT1-2N0M0 and pathologically proven T1-2N+M0 after upfront surgery.
6. No metastatic cervical lymph nodes.
7. R0 resection is achieved by the minimally invasive esophagectomy (MIE) or open McKeown approach with total two-field lymph nodes dissection or three-field lymph nodes dissection.
8. No prior therapy was administered against other cancers.
9. Adequate bone marrow function: white blood cell count ≥ 4×109/L; absolute neutrophil count (ANC) ≥ 1.5×109/l; platelets ≥ 100×109/L; haemoglobin ≥ 9 g/dl.
10. Adequate liver function: serum bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 × ULN (ULN as per institutional standard).
11. Adequate renal function: glomerular filtration rate ≥ 60 ml/min calculated using the Cockcroft-Gault formula.
12. Normal thyroid function.
13. Written consent is obtained.

Exclusion Criteria:

1. Patients receive neoadjuvant chemoradiation therapy.
2. Patients with pathological complete response (pCR).
3. No. of lymph node dissection \< 15.
4. Patients with clinical stages T1-2N+M0 and receive upfront surgery.
5. Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receive induction chemotherapy.
6. Patients requiring systemic steroid medication.
7. Patients with severe postoperative complications and not suitable for adjuvant therapy.
8. Synchronous or metachronous (within 5 years) double cancers.
9. Patients ever received immunotherapy.
10. Active infection requiring systemic therapy.
11. Patients ever received organ transplant or allogenic haemopoietic stem cell transplantation.
12. Patients with human immunodeficiency virus (HIV) infection.
13. Psychiatric disease.
14. Pregnant or lactating women or women of childbearing potential.
15. Hypersensitivity for Sintilimab.
REGULarity of Physical ActivitieS (REGUL'APS)

In French primary schools, children participate in 3 compulsory hours of physical education (PE) each week unless they have a medical contra-indication. But, there is no scientific evidence (randomized trial) that a weekly physical activity splitting up of these 3 hours of PE brings or not the same effects, particularly to prevent overweight or obesity.

Regul'aps is a cluster randomized controlled trial which wants to evaluate whether splitting up the 3 hours into 3 or 4 sessions (vs. 1-2 sessions) of PE per week has an effect on speed of a BMI increase and on health-related quality of life (HRQoL) over the school year.

Study hypothesis: reduction of speed of increase of BMI and an increase of HRQoL


Eligibility Criteria:
Inclusion Criteria:

* All teachers under the cover of the headmasters in charge of classes from grades 2 to 5 in 2 counties in the Lorraine region of France (Meurthe-et-Moselle and Vosges \[District of Golbey\])
* headmasters or teachers had to agree to modify the organisation of PE sessions

Exclusion Criteria:

* Classes composed only of 2d grade
* Set schedule of physical educational sessions
Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy

Bioelectrical impedance analysis measures body mass (the amount of muscle and fat in the body) and the level of hydration to help researchers identify patients who are losing muscle mass during radiation therapy. This information may help researchers make decisions about nutritional supplementation and the placement of feeding tubes in patients receiving radiation therapy.

PRIMARY OBJECTIVES:

I. To validate body composition estimates derived from the seca (SECA) medical body composition analyzer (mBCA) bioelectrical impedance analysis (BIA) scale by comparing with computed tomography (CT) measured lean and fat body mass.

SECONDARY OBJECTIVES:

I. Evaluate sensitivity of mBCA to detect changes in body composition during treatment.

II. Identify whether BIA-estimated loss of lean body mass (LBM) during treatment predicts development of sarcopenia.

III. Determine whether BIA-derived estimates of body water correlate with requirements for intravenous (IV) hydration and unplanned hospital admissions.

IV. Explore associations between body composition and symptom burden during treatment.

OUTLINE:

Patients undergo bioelectrical impedance analysis with seca mBCA and CT or positron emission tomography (PET) at baseline, weekly for 6-7 weeks during standard of care radiation therapy (RT), and at 10-12 weeks after completion of RT.

After completion of study, patients are followed up every 3 months for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented head and neck cancer (clinical stage I-IVB; Tx,1-4, N0-3).
* Patients dispositioned to receive radiation therapy (dose \>= 60 gray \[Gy\]).
* Patients may receive radiation as either primary therapy or post-operatively.
* Patient received staging positron emission tomography/computed tomography (PET/CT) scan during 60-day period prior to initiating therapy.
* Negative pregnancy test for women of child bearing potential.

Exclusion Criteria:

* Previous radiation treatment for head and neck mucosal primary cancers (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity).
* Patients with pacemaker, implanted cardiac defibrillator, or vagal nerve stimulator.
* Pregnant or breast-feeding females.
* Patients weighing over 660 lbs (300 kg).
* Patients with other medical conditions known to cause sarcopenia, including New York Heart Association (NYHA) class III-IV heart failure, oxygen-dependent pulmonary disease, advanced human immunodeficiency virus infection, cirrhosis, end stage renal disease, or inherited/congenital disorders of metabolism.
* Patients receiving palliative irradiation.
Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus

This study compares patients' acceptability and safety of two established endoscopic methods for treating dysplastic Barrett's esophagus: radiofrequency ablation versus hybrid argon plasma coagulation.

Both endoscopic radiofrequency ablation (RFA) and argon plasma coagulation (APC) are established treatment modalities for dysplastic Barrett's esophagus. Recently, a modification of the APC method has emerged, which involves a submucosal injection of saline preceding the thermal ablation (hybrid-APC; h-APC). This allows to increase the procedure's safety and presumably reduces the patients' post-procedural discomfort. Although both RFA and h-APC are characterized by high effectiveness in eradicating Barrett's segments, limited data compares the patient-related aspects of the procedures. To fill this knowledge gap, we set out a single-center randomized-controlled trial to compare procedural acceptability, safety, and impact on the quality of life, of the two methods.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects over 18 years
* Histologically and endoscopically proven Barrett's esophagus requiring ablation therapy according to the current guidelines
* General health status sufficient to perform an endoscopic procedure (ASA I-III)

Exclusion Criteria:

* Primary or secondary coagulopathy, with INR\>1.5 and/or platelet count of \<75,000.
* Anticoagulation therapy (e.g. warfarin) for high-risk condition and unable to withhold the medication temporarily
* Recent myocardial infraction or other significant cardiovascular event within 6 months prior to recruitment
* Patients under long-term care and/or within nursing facilities (e.g. psychosocial disorders, mental retardation)
* Any history of esophageal resection surgery
* Esophageal varices
The Effect of Body Mass Index (BMI) on Inpatient Stroke Rehabilitation Outcome: A Prospective Study From an East-Asian Cohort

Research has shown that rehabilitation at almost any Body Mass Index (BMI) level leads to positive functional outcomes. Some data demonstrating that gains are often more rapid at BMI above "normal". The aim of this study is to investigate the association between BMI and the functional progress of all patients admitted to Tan Tock Seng Tertiary Rehabilitation Center.


Eligibility Criteria:
Inclusion Criteria:

* clinical strokes (ischaemic or haemorrhagic) diagnosed by acute neurologists or neurosurgeons and confirmed on computerized tomography (CT) or Magnetic resonance imaging (MRI) brain imaging
* aged 18 years and above
* admitted directly from acute stroke units
* able to provide informed consent by self or by next of kin in incompetence patient
* must receive physical therapy (either physiotherapy, occupational therapy or speech therapy) at least 5 times a week with each session at least 30 minutes

Exclusion Criteria:

* rehabilitation was not the primary reason for the inpatient admission
* failure to complete the rehabilitation program due to either an acute transfer off rehabilitation or a discharge against medical advice
* incomplete or missing Body Mass Index (BMI) or Functional Independence Measure (FIM) data
* patients who were not of Asian ethnicity