cyrilzakka/clinical-trials huggingface dataset:
Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Population of Adult Obese Patients

This project aims first to determine the prevalence of sarcopenia in a population of obese people of extended age group (18-70 years). In a second step, the factors determining and / or predisposing to sarcopenic obesity will be identified as well as plasmatic and urinary biomarkers specific to this phenotype.

Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients.

Biological collection to identify plasma, serum, genetic, urinary and faecal biomarkers associated with sarcopenic obesity

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70 years
* Sex: men and women
* Patient followed in clinical nutrition benefiting from a metabolic assessment for optimization of clinical and paraclinical management
* Patient meeting the criteria of obesity defined by BMI\> 30 kg / m²
* Major patient with free, informed and signed consent
* Patient covered by the social security scheme

Exclusion Criteria:

* Patient with cancer or severe chronic disease (renal failure, respiratory failure, liver failure)
* Patient with neuromuscular disease
* Patient with a total inability to walk
* Minor patient
* Refusal of the patient to participate in the study
* Pregnant or lactating women
* Patient deprived of liberty or under guardianship.
A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China

This non-interventional, multi-center, prospective post-approval study aims to provide safety and effectiveness data of Xolair® in Chinese adolescents with Chronic Spontaneous Urticaria who remain symptomatic despite H1 antihistamine treatment. The study period is 16 weeks which contains a 12-week treatment period and 4-week safety follow-up.

The study period is 16 weeks which contains a 12-week treatment effect evaluation period and 4-week safety follow up. The primary objective is to evaluate the safety of Xolair® in a real-world setting in Chinese adolescent patients with Chronic Spontaneous Urticaria who remain symptomatic despite H1 antihistamine treatment over a 16-week study period. The secondary objectives are to evaluate the effectiveness (measured by ISS7, UAS7, UCT) of Xolair® and the quality of life (measured by CDLQI) of Chinese adolescent patients over a 12-week treatment period. Data will be collected in conjunction with routine care visits at the site, at Week 4, 8, 12 (recommended scheduled visits). Routine clinical assessments will be conducted, and safety information will be collected. Safety information includes AE/SAE collection, including but not limited to lab tests, vital signs, weight, physical examination etc. No extra study visits, examinations, laboratory tests or procedures other than activities performed in clinical practice will be mandated.

Eligibility Criteria:
Inclusion Criteria:

The patient should meet all of the following criteria:

1. Diagnosed with CSU refractory to H1-AH at approved doses as defined by all of the following:

   * The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to enrollment despite current use of second-generation H1-AH (at locally approved doses)
   * UAS7 score (range 0-42) ≥ 16 and ISS7 (range 0-21) ≥ 8 as captured in the UPDD during the 7 days prior to treatment initiation with Xolair®
2. Willing and able to complete a daily symptom Diary (UPDD) for the duration of the study, and having no more than 3 missing diary entries in the screening period.
3. Planned to receive Xolair® treatment according to the approved label in China at the time of screening.

Exclusion Criteria:

The patient should not meet any of the following criteria:

1. Use of other investigational drugs for CSU treatment within 5 half-lives, or within 30 days (for small molecules) prior to screening or until the expected pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
2. History of hypersensitivity to any of the anti-IgE drugs or their excipients or to drugs of similar classes (i.e. to murine, chimeric, or human antibodies).
3. Any other skin disease associated with chronic itching that might influence, in the investigators opinion, the study evaluations and results. (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.)

Other protocol-defined inclusion/exclusion criteria may apply at the end.
Hospital Onset Diarrhoea Investigation

This service evaulation aims to investigate how common diarrhoea is in hospital patients on medical, surgical and elderly care wards, what it is due to and how it is managed.

Latest National Health Service (NHS) England guidelines for the assessment of Clostridium difficile infection (CDI) cases recommend that acute hospitals collect data on the prevalence of hospital-onset diarrhoea in their organisations, and how it is managed, including if patients are appropriately tested for CDI.

The aims of this multi-centre service evaluation are therefore to:

* Determine the prevalence of hospital-onset diarrhoea on adult medical, surgical and care of the elderly wards in the NHS
* Investigate how hospital-onset diarrhoea is managed, including whether patients are tested for CDI according to Department of Health (DoH) England standards
* Investigate the aetiology of hospital-onset diarrhoea on adult medical, surgical and care of the elderly wards in the NHS, based on previously described causes

Data will be collected at participating centres on two days, one between 11-15/Jan/2016 and one between 6-10/Jun/2016. Hospitals will be able to choose locally which two days. On those days investigators from the local Microbiology and/or Infection Prevention teams will screen all patients on pre-identified wards, who have been admitted for ≥72 hours, for hospital-onset diarrhoea. For all patients that meet the definition of hospital-onset diarrhoea their medical notes and charts will be reviewed, to ascertain potential causes and how they have been managed.

This service evaluation should help participating hospitals to investigate hospital-onset diarrhoea in their own institutions, as well as generating a dataset that is representative of the problem across the NHS, and therefore of use to other centres.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to hospital for ≥72 hours at the time of data collection for the service evaluation
* Presence of hospital-onset diarrhoea (defined as ≥ 2 episodes of unformed stools (Bristol Stool Chart type 5-7) during the day before the service evaluation, with the onset of the diarrhoea being more than 48 hours after admission to hospital)

Exclusion Criteria:

* Patients admitted to the ward for ≤72hour at the time of data collection for the service evaluation
* Patients with diarrhoea since admission or in whom it developed within the first 48 hours of admission
* Patients receiving end of life care
A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery

Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac surgery and cardiopulmonary bypass. We have developed an assay for tranexamic acid. We have developed an alternative dosing schedule for tranexamic acid. The objective of this preliminary study is to determine if this new dosing schedule can achieve the desired plasma concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic acid plasma concentrations relative to the current dosing schedule.

Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac surgery and cardiopulmonary bypass. The current dosing regimen for tranexamic acid was empirically derived based upon pharmacokinetics in normal patients receiving the drug. We have developed an assay for tranexamic acid and found that the plasma concentration of tranexamic acid varies greatly between patients and also over time within each patient, especially in patients with renal insufficiency. We have developed an alternative dosing schedule for tranexamic acid that incorporates the effects of renal function on tranexamic acid concentrations. The objective of this preliminary study is to determine if this new dosing schedule can achieve the desired plasma concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic acid plasma concentrations relative to the current dosing schedule. The results of this study will be used in a larger subsequent study of what level of plasma tranexamic acid concentration is needed to prevent bleeding and transfusion of blood products in patients undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or greater having cardiac surgery.

Exclusion Criteria:

* Age less than 18 years old.
* Since tranexamic acid is not approved for pregnant patients, those extremely rare patients that are pregnant and having cardiac surgery will be excluded from the study
Comparison Between Pioglitazone and SES With type2 DM

Drug-eluting stents have been shown to decrease restenosis, but were associated with an increased rate of death, as compared with bare-metal stents. Recently, thiazolidinediones effectively reduced restenosis and the risk of repeat target vessel revascularization. We conducted a study to compare the performance of a drug-eluting stent with that of a bare-metal stent with pioglitazone in patients with type 2 diabetic mellitus.

The study is a prospective cohort trial involving 38 type 2 diabetic patients referred for coronary stenting who were assigned to either the sirolimus-eluting stent group or the pioglitazone group. Quantitative coronary angiography will be performed at study entry and at six months follow-up to evaluate in-stent late luminal loss and the percentage of the luminal diameter and the rate of restenosis. We also analyze major adverse cardiac events at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus who had received coronary stenting were eligible for the study.

Exclusion Criteria:

* spastic angina pectoris
* congestive heart failure
* hepatic dysfunction
* chronic renal disease
* recent stroke
* impaired glucose tolerance
* insulin dependent diabetes mellitus
* familial hypercholesterolemia
* thyroid dysfunction
* adrenal dysfunction
* an intolerance of aspirin, ticlopidine, heparin, pioglitazone, stainless steel, or contrast material.
Leukocytes and Cardiovascular Perioperative Events-2

The potential use of regulatory T cells as preoperative risk stratification tool is evaluated in order to improve clinical risk stratification and reduce perioperative morbidity and mortality.

Annually, there are more than 200 million surgeries worldwide. The POISE study revealed 5% of patients undergoing a non-cardiac surgery suffer perioperative myocardial infarcts going along with a perioperative mortality rate of about 11,6%. Possibilities to preoperatively identify patients at risk are limited and prophylactic interventions are not yet established or controversial.

Selected leukocyte subpopulations have been demonstrated to be associated with higher risk for cardiovascular events.

The aim of this study is to evaluate the potential use of regulatory T cells as preoperative risk stratification tool in order to improve clinical risk stratification and reduce perioperative morbidity and mortality. Therefore, high-risk cardiovascular patients scheduled for major non-cardiac surgery will be recruited. Blood will be drawn at predefined time points before surgery and up to three days postoperatively. Leukocytes will be analyzed by flow cytometry. During 30 day follow up adverse cardiovascular events will be recorded. ECGs will be recorded preoperatively and on post-OP day 3. High-sensitive cardiac Troponin T will be measured prior to the operation and on post-OP day one to three. The patient chart will be screened for cardiovascular events up to day 30. A telephone interview will be performed to detect cardiovascular events after discharge until post-OP day 30.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Coronary heart disease
* Non-cardiac surgery
* Inpatient treatment
* Informed consent

Exclusion Criteria:

* 17 years of age or younger
* Known pregnancy or breastfeeding
* Missing informed consent
* Ambulatory or day-case surgery
* Emergency surgery
* Acute or chronic leukemia
* Current aplasia or leukopenia
* Current GM-CSF treatment
* Carotid artery surgery
* History of splenectomy
* Current intravenous or oral Cortisone treatment
* History of organ transplantation
* Current immunosuppressive medication
* Chemotherapy completed less than 14 days ago
* Entity which is part of the composite endpoint diagnosed within past 28 days
Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis

Immunomodulation is effective in treating patients with myasthenia gravis (MG), but prior studies have not adequately defined if plasma exchange (PLEX) in superior to intravenous immunoglobulin (IVIG) in the treatment of myasthenia gravis. This study aimed to determine if PLEX was superior to IVIG in the treatment of patients with myasthenia gravis.

Patients with MG requiring immunomodulation are randomized to IVIG or PLEX and treated with a full course of immunomodulation. The quantitative myasthenia gravis score (QMGS) will be evaluated as the primary efficacy parameter at day 14 to determine if PLEX is superior to IVIG.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* diagnosis of moderate-severe MG (defined as a Quantitative Myasthenia Gravis Score QMGS \>10.5)
* worsening weakness requiring a change in therapy judged by a neuromuscular expert

Exclusion Criteria:

* Worsening weakness secondary to concurrent medications (e.g. Aminoglycosides)
* Worsening weakness secondary to infection
* Change in corticosteroid dosage in the 2 weeks prior to screening
* Other disorders causing weakness or fatigue
* Known absolute IgA deficiency (risk of anaphylactic reaction to IVIG)
* History of anaphylaxis or severe systemic response to IVIG or albumin
* Pregnancy or breastfeeding
* Active renal failure precluding volume of IVIG (risk of volume overload with IVIG) as judged by the investigators
* Clinically significant cardiac disease precluding IVIG volume as judged by the investigators
* Known hyperviscosity or hypercoaguable state (risk of stroke with IVIG)
* Known coagulopathy with bleeding
* On another current study medication or protocol within 4 weeks of screening
* Patients with known refractory status to either IVIG or PLEX
* Poorly controlled or severe hypertension (exacerbation by IVIG)
* Patient refuses treatment with either IVIG or PLEX
* Patient refuses follow-up with electrophysiological studies
* Patient unable or unwilling to give informed consent
Pediatric Headche Assessment Using HIT 6

The study is a prospective cohort study. The study population will include 100 children aged 6-18 years suffering from headaches who visited the Pediatric Neurology Clinic at Bnai Zion Medical Center and completed both the PED-MIDAS and HIT-6 questionnaires, starting from November 2022 until the end of the study period. Data will be collected from medical records and from the two questionnaires completed by the children during their clinic visit.

Abstarct Background: Headache is one of the most common complaints in children and adolescents and is a leading cause of functional impairment in teenagers and young adults. The most common primary headaches being migraine and tension-type headache. Headaches negatively impact children\&#39;s lives in various ways, with the effect varying according to the severity of the pain, the duration of the attack, and the response to treatment. To assess the degree of impact of headaches on daily functioning, the PED-MIDAS questionnaire was developed, tested, and validated in children aged 4-18 years, however, children often face difficulties in completing the questionnaire. The HIT-6 questionnaire, on the other hand, is user friendly however is validated only for adults.

Research Objectives: To compare the PED-MIDAS and HIT-6 questionnaires in their ability to assess the degree of impact of headaches on daily functioning.

Research Methods: The study is a prospective cohort study. The study population will include 100 children aged 6-18 years suffering from headaches who visited the Pediatric Neurology Clinic at Bnai Zion Medical Center and completed both the PED-MIDAS and HIT-6 questionnaires, starting from November 2022 until the end of the study period. Data will be collected from medical records and from the two questionnaires completed by the children during their clinic visit.

Research Importance: Children often struggle with completing the PED-MIDAS questionnaire because it requires them to recall the number of days their functioning was impaired over the three months prior to completing the questionnaire. This may lead to inaccurate completion and, consequently, an assessment that does not reflect the true impact. This created the need to compare the PED-MIDAS with the HIT-6 and examine whether it can serve as a better alternative.

Eligibility Criteria:
Inclusion Criteria:

* Chldern age 6-18 years with headache for at least 3 months.
* Children able to fill the questionnaire

Exclusion Criteria:

* Children with shoreter headaches.
* Children who are not able to fill the questionnaire
Reveal In-Office Implants

The purpose of this study is to gather evidence about the safety and feasibility of performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office or clinic setting rather than the traditional hospital operating room, cardiac catheterization or electrophysiology (EP) laboratory setting.


Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated for continuous arrhythmia monitoring with an Insertable Cardiac Monitor (ICM)
* Patient is willing to undergo implant in clinic setting with only local anesthetic and/or oral anti-anxiety medications for sedation
* Patient is 18 years of age or older
* Patient is willing and able to provide consent and authorize the use and disclosure of health information
* Patient is willing and able to comply with the protocol including the required follow-up

Exclusion Criteria:

* Patient has reduced immune function or is otherwise at high risk for infection
* Patient has had a recent (within 30 days) or otherwise unresolved infection
* Patient is implanted or indicated for implant with a pacemaker, Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), or hemodynamic monitoring system
* Patient is participating in another clinical study that may have an impact on the study endpoints
* Patient's life expectancy is less than 1 year
* Patient is pregnant
* Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure
Pain Compared Between the First and the Second Surgery in Staged BTKA

postoperative pain and analgesic consumption between the first and the second surgery would be compared in patients undergoing staged bilateral total knee arthroplasty (BTKA).

postoperative pain and analgesic consumption is compared between the first and second total knee arthroplasty (TKA) operation.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective bilateral staged total knee arthroplasty at a 1-week interval under spinal anesthesia,
* age \<=85
* American Society of Anesthesiologists physical status of I to II

Exclusion Criteria: any contraindication to spinal anesthesia or femoral nerve block such as coagulopathy; conversion to general anesthesia; preexisting pain syndrome; abnormal liver function or renal test results; severe heart, liver, or renal disease; history of stroke or neurologic deficits; psychiatric disorder; chronic opioid use; drug dependency; allergy to study medications; inflammatory joint disease; previous surgery on or trauma of the knee; difference in preoperative VAS score of ≥ 20 (at rest and at maximum knee flexion) between each side of the knee; body mass index of ≥ 40 kg/m2; and inability to comprehend the VAS or to use patient-controlled analgesia (PCA.
MAC vs TIVA Ambulatory Breast Augmentation

hypothesis: the combination of LA with remifentanil and ketofol \[monitored anesthesia care (MAC)\] for ambulatory breast augmentation may result in results in better QoR on day of surgery as compared with total i.v. anesthesia (TIVA) . The purpose of this study was to compare the QoR after MAC using remifentanil and ketofol with TIVA during ambulatory breast augmentation .

Breast augmentation surgery is commonly performed on an ambulatory basis under under general anesthesia (GA) with propofol and remifentanil or local anesthesia (LA). Although surgeons perform this operation comfortably under GA, Patients have anxiety and fear of complications due to GA. In addition, they expect a good postoperative quality of recovery (QOR) including ability to resume common activities (work and daily activities) without suffering from moderate to severe pain.

The LA is advantageous over GA in that airway instrumentation is not necessary, favorable recovery profile, decrease postoperative pain and vomiting, increase patient satisfaction and decrease the cost . However, patient anxiety or pain often leading to conversion of LA to GA, which suggests the concomitant use of i.v. sedatives and analgesics as a supplement to LA.

The combination of remifentanil and ketofol (propofol, ketamine) for sedation during regional anesthesia and LA has been shown to be a safe, effective technique, capable of maintains adequate analgesia with conscious sedation, haemodynamic stability, and achieves lower incidence of postoperative nausea and vomiting with shorter recovery times.

Eligibility Criteria:
Inclusion Criteria:

* ASA I, II

Exclusion Criteria:

* ASA III