cyrilzakka/clinical-trials huggingface dataset:
OAGB-MGB Conversions for Post-operative Complications

Laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB) is a relatively new bariatric procedure and is gaining ground over the surgical approach for morbid obesity as a safe and effective operation. Revision of MGB/OAGB was never studied before as multicenter data collection: we collected data from 21 italian centers who perform MGB/OAGB to evaluate patients' conditions which determinated the conversion from this procedure to another kind of bariatric technique.

MGB / OAGB has been shown to be an effective and safe bariatric technique. Despite that, the complications of this procedure have already been extensively described in the literature. Our goal is to collect data from 21 Italian centers that practice MGB / OAGB to evaluate the reasons and complications that led surgeons to revise this surgery with a subsequent bariatric procedure. For this reason we have analyzed the data provided by the centers on 8676 patients undergoing MGB / OAGB, focusing attention on phenomena such as GERD, anastomotic stenosis, bleeding and marginal ulcers which are the most frequent causes of re-intervention. We also evaluated the changes in BMI between the primary procedure and the revision procedure to ensure that the bariatric purpose of the surgical program was maintained.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent to OAGB-MGB who needed conversion to other bariatric procedure

Exclusion Criteria:

* Patients underwent to OAGB-MGB who needed conversion to other bariatric procedure in emergency within 48/72 hours after the first surgery
Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics

Gluococorticoids are commonly prescribed to treat a number of diseases including the majority of inflammatory diseases. Despite considerable inter-personal variability in responses to glucocorticoids between asthmatics, an insensitivity rate of about 30% and the risk of adverse side effects of glucocorticoid therapy, no assay is currently performed to determine sensitivity in severe and non-severe asthmatics prior to treatment. The purpose of this study is to perform a whole blood ex vivo stimulation assay to interrogate known glucocorticoid receptor (GR) up- and down-regulated genes to indicate glucocorticoid sensitivity and compare the results between severe and non-severe asthmatics.


Eligibility Criteria:
Inclusion criteria:

To be eligible for the study, subjects must meet all of the following criteria:

* Age ≥ 18 years old
* Physician diagnosis of asthma confirmed through medical record documentation.
* Documented history of 12% FEV1 reversibility post-bronchodilator and/or Methacholine PC 20 score of 16mg/ml or less.
* Non-smoker for \> 6 months before enrollment into the trial
* Less than 5 pack year smoking history defined as the average packs smoked per day multiplied by the years of active smoking.
* Willing and able to adhere to the study visit schedule and other protocol-specified procedures.

Exclusion criteria:

Subjects meeting any of the following criteria may not be enrolled in the study:

* Existence of lung disease (other than asthma)
* Recent asthma exacerbation requiring hospital admissions, unexpected healthcare visits, or prednisone courses in the previous 4 weeks.
* Non-English speaking.
* Participation in another interventional research trial
* Self-reported pregnancy
* Inability or unwillingness to provide consent
* Febrile illness (\>38.0˚ C or 100.4˚ F) within 24 hours of visit.
A National Prospective Cohort of Patients With Idiopathic Nephrotic Syndrome Beginning in Childhood.

Pediatric idiopathic nephrotic syndrome (INS) is a rare disease for which the optimal therapeutic strategy has not yet been defined. A network of clinicians treating complicated forms of this disease (grouped within the Société de Néphrologie Pédiatrique, SNP) exists, but to date there is no prospective cohort following up these patients that would facilitate the development of cohort-nested trials. This absence of structured follow up makes it difficult to set up prospective studies.

The main objective is to create a prospective cohort of pediatric INS patients to collect cases treated in SNP centers, to study their epidemiological characteristics, and to provide a basis for comparison for future cohort-nested trials.

In this study, data from patients with INS will be recorded prospectively, regularly and systematically. The cohort will be composed of patients followed by pediatric nephrologists affiliated with the SNP. Metropolitan France, Reunion Island and Mayotte are the geographical areas concerned. It is planned to integrate other French overseas departments and territories, in particular the West Indies.

This is therefore a prospective, multicenter, cohort follow-up study. The data will be centralized via a secure website dedicated to the study.

Data will be obtained from:

* Medical record data (hospitalization/consultations) as part of routine clinical follow-up for patients with active disease. This information will be medically validated and integrated into the database with the help of clinical research staff.
* A telephone interview for annual follow-ups for patients whose absence of active disease no longer requires a systematic medical visit. This structured interview will be administered by telephone by the study's clinical research staff.
* Self-administered or hetero-administered quality of life questionnaires (PEDS-QL), self-administered or hetero-administered treatment compliance questionnaires (Morisky's Score), and questionnaires on the aesthetic impact of treatments (Ferriman's Score). These questionnaires will be centralized and reported to the database by the study's clinical research staff.

Eligibility Criteria:
Inclusion Criteria:

* Patient under 18 years of age
* With idiopathic nephrotic syndrome (according to SPN criteria) beginning after January 1, 2018
* Child seen at least once in consultation or hospitalization by a pediatrician member of the Society of Pediatric Nephrology
* Residing in France
* Consent signed by parents and patient's agreement to participate (if of age)
* Affiliated to a social security system.

Exclusion Criteria:

* Refusal of the patient or legal representatives to participate in the cohort
Eravacycline Combination Therapy for MRAB

The goal of this observational study is to learn about the eravacycline combination therapy in multidrug-resistant acinetobacter gaumannii pneumonia. The main question is to evaluate the the effectiveness and safety.

Participants will be given Eravacycline and Polymyxin，or other antibiotcs that the Investigator considered suitable. During the clinical trial, participants will be monitored for blood drug concentrations and drug concentrations in the ELF (Epithelial Lining Fluid。Clinical efficacy rate and microbiological clearance rate will be assessed at the same time


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old;
2. Meets the diagnostic criteria for pneumonia specified by the Chinese Medical Association Respiratory Branch.
3. CRAB is identified or predominant pathogenic bacteria, and drug sensitivity test indicates that Eravacycline is sensitive to the strain;
4. Patients expected to receive Eravacycline for ≥4 days;
5. Has already signed the informed consent

Exclusion Criteria:

1. Pregnant or lactating;
2. Concurrent intracranial infection, urinary tract infection, or bloodstream infection;
3. Individuals in a moribund state;
4. The investigator believes there is any medical history, current condition, treatment, laboratory abnormalities, or other circumstances that may affect the trial results, interrupt the trial process (or the subject's inability to complete all trial requirements, operations, and visits), or increase the subject's risk with the experimental medication. Patients with terminal illnesses or evidence of immediately life-threatening diseases are excluded;
5. Patients with a history of allergic reactions to tetracyclines or any excipients in the investigational drug formulation
Effects of Ramadan Observance in Male Patients With Chronic Obstructive Pulmonary Disease

Purpose: To analyze the effects of Ramadan observance (RO) on pulmonary variables, exercise performance and postural balance in patients with chronic obstructive pulmonary disease (COPD).

Methods: Twenty COPD patients (age=72.7 ± 4.1 yr, non-smokers, without cardiac or neuromuscular complications) were evaluated. Tests performed one week before Ramadan (C), and during the second (R-2) and the fourth weeks of Ramadan (R-4) included standard spirometry, a quality of life questionnaire (VQ11), a 6-min walking test (6MWT), measurement of maximal voluntary contraction force of the quadriceps (MVC), Timed Get Up and Go (TUG), Berg Balance Scale (BBS) and Unipedal Stance (UST).

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide ; prevalence is high in Tunisia, with 7.8 % and 4.2 % of the population in disease stages 1 and 2 respectively . Patients with COPD show an impaired exercise tolerance, often with severe dyspnea, a decreased ability to participate in the activities of daily living, and a poor health-related quality of life.

The common practice of those observing Ramadan is to have two meals per day: a large meal shortly after sunset and a much lighter one immediately before dawn. Ramadan observance (RO) is characterized by many changes in diet and sleep patterns , often with a decrease in the time available for nocturnal sleep . Studies in athletes have shown altered muscle metabolism , hormonal changes , and an impaired physical performance depending on the time of day at which test sessions were performed . Sometimes there are disturbances of cognitive function , and Patel et al noted decreases in postural control even in young adults, due to momentary lapses of attention after sleep deprivation . Such changes are of particular concern in elderly patients with COPD, since their ability to carry out the activities of daily living may initially be marginal, and any disturbances of balance and cognitive function associated with RO could increase the risk of falls .

To date, only one previous study has examined the effects of Ramadan observance in patients with COPD ; this report focused almost exclusively upon changes in medication use during RO. Most Muslim patients with COPD observe Ramadan (for example, 93% in Turkey ), but little is known about the clinical and physiological effects of such fasting in COPD .Thus, the aim of the present study was to analyze the effects of RO on pulmonary variables, exercise performance and postural balance in patients with COPD.

Eligibility Criteria:
Inclusion Criteria:Clinically stable individuals with a functional diagnosis of COPD according to the global strategy for the diagnosis, management and prevention of COPD guideline were selected

* medication remained unchanged during Ramadan).Smokers

Exclusion Criteria:

* those with cardiovascular or neurological disease, lower extremity musculoskeletal problems and visual deficits that could affect postural control were excluded
Efficacy of AposTherapy® in Knee OA

A prospective, interventional, randomized, double-arm clinical evaluation study to examine the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the long-term at 12 months post-treatment, with the primary efficacy assessment based on improvement in knee pain score and improvement in function in patients following diagnosis of knee osteoarthritis (OA).


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from symptomatic unilateral or bilateral knee OA at the medial compartment for at least six months;
* Fulfilling the ACR clinical criteria;
* Having radiographically assessed OA of the knee with a Kellgren-Lawrence grade more than or equal to grade 2; and,
* Having VAS-Pain ≥ 3, on a scale between 0-10.
* Patients who have a shoe size between US 4 and US 12

Exclusion Criteria:

* Patients suffering from acute septic arthritis.
* Patients who received a corticosteroid injection within 3 months of the study.
* Patients who received hyaluronic acid (HA) injections within 6 months of the study
* Patients suffering from avascular necrosis of the knee.
* Patients with a history of knee buckling or recent knee injury.
* Patients who have had a joint replacement or other major surgery to the knee, hip or ankle (ipsilateral or contralateral side).
* Patients suffering from neuropathic arthropathy.
* Patients with an increased tendency to fall.
* Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure.
* Patients with a history of pathological osteoporotic fracture.
* Patients suffering from symptomatic degenerative arthritis in lower limb joints other than the knees.
* Patients with referred pain in the knees from primary back or hip joint pain.
* Patients with neurological deficits to the lower extremity (ex. foot drop)
* Patients whose shoe size is less than US 4 and greater than US 12
* Patients who have had arthroscopy within 6 months of the study
* Patients with inflammatory arthropathy
A Study for Patients With Head and Neck Cancer

This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* You must have head and neck cancer that has returned and cannot be treated with surgery or other types of treatment. OR You must have head and neck cancer that was just found and has spread to other parts of your body.
* You must have a performance status of 0,1 or 2. This means that you must at least be able to get around, be able to take care of yourself and must be up and about most of the day.
* Your test results must show that your liver, kidneys and blood cells are working normally.
* You must understand and sign the form that gives your agreement to willingly be part of the study.
* You must be at least 18 years of age.

Exclusion Criteria:

* You cannot have previously been given other treatment for cancer that has spread to other parts of your body.
* You cannot have a serious sickness that might keep you from finishing the study (for example a bad infection).
* You cannot have any extra fluid in your chest or bowel area unless your doctor tells you it can be drained before you join the study.
* You cannot have any cancer called nasopharyngeal cancer, paranasal sinus cancer, lip cancer, or salivary gland cancer.
* If you are taking high dose aspirin or other medicines called non-steroidal anti-inflammatory drugs and cannot stop taking them for at least 5 days, you cannot be in the study. Your doctor or a member of the study team can explain which drugs are non-steroidal anti-inflammatory drugs.
Virtual Reality vs Inperson Simulation: A Non-inferiority Study

The purpose of this study is to determine if Virtual Reality (VR) can elicit emotional responses that are captured via physiological biometrics such as heart rate variability and skin conductance levels. As a non-inferiority study the investigators anticipate the technologies will elicit an emotional not inferior to those responses of an in-person simulations of workplace scenarios (i.e medical error and workplace harassment).


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* Personnel working or volunteering at Lucile Packard Children's Hospital (LPCH) or Stanford Health Care (SHC) facilities

Exclusion Criteria:

* Patients who do not consent
* Are currently taking beta blockers or other chronotropic heart medication(s)
* Have a history of severe motion sickness
* Currently have nausea
* Currently experiencing seizures
* Are clinically unstable
Conservative Versus Aggressive Discectomy for Primary Disc Herniation With Radiculopathy

Summary: This is a prospective randomize study to compare conservative and aggressive discectomy for treatment of disc herniation with radiculopathy.

Study hypothesis: The investigators believe that conservative discectomy could preserve a higher disc space and has a better long-term outcomes.

objectives:to compare the effect of two type surgery(conservative discectomy and aggressive discectomy)on disc herniation with radiculopathy after long-term follow-up.

methods:the patients who were confirmed suffer from disc herniation with radiculopathy and failed to nonsurgical treatment will be divided into two groups, and will be follow up 3\~6 years for seeking the effect on disc space preservation and recurrent.

outcome measures:the rate of pain release and patients satisfaction were measured by SF-36,ODI,VAS,score post-OP. the height of disc was measured on X-ray film by the end point.

Eligibility Criteria:
Inclusion Criteria:

* Duration of symptoms: 6 or more weeks.
* Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy.
* Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising.
* Tests: MRI to confirm diagnosis and level(s).

Exclusion Criteria:

* Previous lumbar spine surgery.
* Not a surgical candidate for any of these reasons: Overall health which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months.
* Possible pregnancy.
* Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no clinical signs or symptoms of the malignancy for at least 5 years.
* Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.
* Age less than 18 years.
* Cauda Equina syndrome or progressive neurological deficit (usually requiring urgent surgery).
* Unavailability for follow-up (planning to move, no telephone, etc.) or inability to complete data surveys.
* Symptoms less than 6 weeks.
* Patient currently enrolled in any experimental "spine related" study.
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Laparoscopic Cholecystectomy

The aim of this study is to compare between the efficacy of ultrasound guided erector spinae plane block and ultrasound guided quadratus lumborum block in managing acute postoperative pain in patients undergoing laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* aged 21-65 years
* both genders
* American Society of Anesthesiology (ASA) class I-II
* Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* Patient refusal.
* Coagulopathy.
* History of allergy to local anaesthetic.
* History of liver or renal pathology affecting drug elimination
* Mental dysfunction or cognitive disorders.
* Use of medication such as gabapentin-pregabalin that could affect pain perception.
* Body Mass Index \> 40 kg/m2.
Ivacaftor (Kalydeco) and Insulin in Cystic Fibrosis (CF)

This study is aimed at better understanding the impact of ivacaftor upon insulin and incretin secretion and glucose tolerance in patients with Cystic Fibrosis with a glycine (G551D) mutation. Investigators hypothesize that treatment with ivacaftor improves insulin secretion in individuals with CF.

Cystic Fibrosis Related Diabetes (CFRD) is associated with worse nutritional status, greater pulmonary function decline, and increased mortality, highlighting its relevance in Cystic Fibrosis (CF). CFRD arises primarily from compromised insulin secretion - traditionally considered a by-product of pancreatic exocrine tissue damage and fibrosis. Recent developments in the field of diabetes are propelling a re-examination of this basic explanation. The impact of the cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, ivacaftor, upon insulin secretion and glucose regulation has not been examined, but improved glucose tolerance has been appreciated anecdotally. This study aims to understand the impact of ivacaftor therapy upon blood glucose and insulin and incretin secretion.

Eligibility Criteria:
Inclusion Criteria:

* 6 yrs or older with cystic fibrosis
* at least one G551D CFTR mutation or other non-G551D gating mutation, or residual function CFTR mutation such as, but not limited to, R117H mutation, for which ivacaftor is to be initiated.
* Plan to initiate ivacaftor treatment for FDA approved indications by clinical care team or as part of an ongoing study of ivacaftor for other CFTR mutations, including gating mutations, or residual function mutations.
* not pregnant

Exclusion Criteria:

* established diagnosis of non-CF related diabetes (ie., Type I diabetes)
* history of clinically symptomatic pancreatitis in past year
* prior lung or liver transplant
* severe CF liver disease
* fundoplication-related dumping syndrome
* medical co-morbidities that are not CF-related or are unstable per the Investigator opinion
* acute CF pulmonary exacerbation within 4 weeks prior to study procedures
* treatment with oral or intravenous corticosteroids within 4 weeks of study
* hemoglobin \<10g/dL within 90 days of GPA test or at Screening
* abnormal renal function within 90 days of GPA test or at Screening
* long-standing CFRD with fasting hyperglycemia, elevated HbA1C (\>8) beyond time surrounding diagnosis of CFRD, significant basal insulin requirement
* inability to perform study specific procedures (MMTT, GPA).
Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults

Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at pH 3.5 and 7.1 and to compare the bio-availability of sublingual TNX-102 2.4 mg at pH 3.5 and 7.1 and cyclobenzaprine (5 mg tablets, or 2.4 mg iv).


Eligibility Criteria:
Inclusion Criteria: Healthy adults

* Male or female
* Non-smoker
* 18-65 years old
* BMI \> 18.5 and \< 30.0
* With medically acceptable form of contraception (female only)
* With signed informed consent

Exclusion Criteria:

* Any clinically significant abnormality including ECG abnormalities or vital sign abnormalities (systolic blood pressure \< 90 or \> 140 mmHg, diastolic blood pressure lower \< 50 or \> 90 mmHg, or heart rate \< 50 or \> 100 BPM)
* Any abnormal laboratory test (including positivity for Hep B, Hep C, HIV, and Hemoglobin \< 128 g/L (males) or \< 115 g/L (females) and hematocrit \< 0.37 L/L (males) or \< 0.32 L/L (females))
* History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests
* Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication
* Positive pregnancy test, breastfeeding or lactating
* Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors
* Participation in an investigational study within 30 days prior to dosing
* Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within30 days), or of \> 499 mL (within 56 days) prior to dosing.