cyrilzakka/clinical-trials huggingface dataset:
Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With BMI≥45

The classic RYGB is in most patients with a BMI ≥45 technically not feasible. Two alternatives are the Extended Pouch Gastric Bypass and the One Anastomosis gastric bypass. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.

Obesity is of increasing incidence worldwide. With it come major social-economical, medical and psychological problems which lead to high healthcare costs. Bariatric surgery is the most efficient treatment for morbid obesity, with the Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (GS) being the most performed.

The RYGB is preferable since this technique seems to lead to more reduction of obesity related comorbidities (DM2) and more weightloss in the long term. However, the RYGB is technically less feasible in patients with a BMI ≥45, due to less intra-abdominal space (excess fat in mesenterium) to connect the anastomosis tension-free.

An alternative for the RYGB are the Extended Pouch gastric bypass (EPGB) and the One-Anastomosis gastric bypass (OAGB). These techniques both involve an extended pouch which makes it easier to connect the anastomosis tension-free.

Furthermore, the extended pouch in the EPGB and OAGB could provide slower passage of food and stretches less on the longer term than the 'normal size'pouch in the RYGB, possibly leading to more weightloss (1,2).

Previous studies comparing the EPGB and RYGB showed more weightloss in patient undergoing EPGB and less weight gain in the long term (3). Other studies comparing the OAGB, RYGB and GS showed non-inferiority or even superiority of the OAGB for weightloss and remission of obesity related comorbidities as diabetes mellitus type 2 (DM2) and obstructive sleep apnea syndrome (OSAS) (4,5,6,7).

Theoretically the OAGB is a simpler procedure which reduces the risk of internal herniation and anastomotic leakage, since only one anastomosis is made (6,8) Only performing one anastomosis leads to less operating time, shorter time of anesthesia, and less usage of staple material. Which possibly makes this a safer and cheaper procedure.

Both techniques, EPGB and OAGB, seem to be adequate alternatives for the RYGB in patients with a BMI of 45 or higher. As of yet, the two techniques haven't been compared one to one. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.

Eligibility Criteria:
Inclusion criteria:

* BMI≥45
* Bariatric guidelines Fried
* Age 18-65
* Dedication to guided preoperative program
* Intention to follow full postoperative program

Exclusion criteria:

* Secondary bariatric procedure
* Medical(-related) cause for morbid obesity or fast weight gain (e.g. Cushing or medication related)
* Inflammatory Bowel Disease (M. Crohn or Colitis Ulcerosa)
* Renal function disorder (MDRD \<30) or liver disease
* Anticipated absence of yearly medical follow up
* Does not speak Dutch language
* Pregnancy
Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis

Autologous stromal vascular fraction (SVF) injected into joints of 20 patients with grade 2, 3, or 4 radiographic OA severity will be safe and feasible as assessed by lack of treatment associated adverse events. Improvements in joint function as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) are anticipated.

The proposed study is a single center, unblinded, non randomized, phase I/II trial in which the patients will be treated with a single dose of autologous stromal vascular cells (SVF) isolated from 500 ml of adipose tissue extracted from the infraumbilical area. The cellular product will be administered via intra-articular injection into patients with moderate to severe osteoarthritis (OA). Administration will be performed by injection into the synovial space. The dosing regimen will consist of two intraarticular injection of autologous SVF into the index knee. Total injection volume will be about 30 mL in two 15 mL aliquots via a 23 gauge needle inserted 1.5 cm. deep into the intraauricular space of the knee. The total number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7).

The purpose of this study will be to define the safety and efficacy of SVF therapy in improving joint function and the quality of life in patients with OA of the knee. We plan to enroll twenty subjects for treatment for an adequate sample size for safety analysis with signals of efficacy. The primary safety outcome will be tabulation of adverse events related to treatment. Efficacy will be quantified at 3, 6 and 12 months by the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Eligibility Criteria:
Inclusion Criteria:

Age \>18 years and ability to understand the planned treatment.

Idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification

Ability and willingness to undergo liposuction

Exclusion Criteria:

Pregnant women or cognitively impaired adults.

Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.

Inflammatory or postinfectious arthritis.

More than 5 degrees of varus or valgus deformity.

Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.

Intraarticular corticosteroid injection within the previous 3 months.

A major neurologic deficit.

Serious medical illness with a life expectancy of less than 1 year.

Prior admission for substance abuse

Body Mass Index (BMI) of 40 kg/m2 or greater

Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent

In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy

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Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients

The objective of this study is to evaluate the supplementation with tocotrienol, a vitamin E compound on inflammation, oxidative stress, and microbiota on Chronic Kidney Disease patients.

In Chronic Kidney Disease (CKD), inflammation and oxidative stress are common statuses, which are aggravated by renal replacement therapy such as hemodialysis. Currently, intestinal microbiota imbalance has been associated with both inflammation and oxidative stress. In this regard, strategies in the management of this framework are necessary. It has been observed that vitamin E plays an important role in the modulation of transcription factors involved in inflammation such as NF-kB and Nrf2, acting on cell membrane protection and tissue recovery. Its benefits have been proven both in renal and intestinal health, however, studies analyzing the vitamin E supplementation in the modulation of intestinal microbiota with consequent effect on CKD and its reflexes are scarce. Thus, the current randomized, double-blind, placebo-controlled study will evaluate the effects of vitamin E supplementation on the modulation of the expression of nuclear cytokine (NF-kB e Nrf2), activators and inhibitors, as well as, on inflammation and oxidative stress and on the modulation of the intestinal microbiota in patients CKD.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease
* Aged from 18 to 60 years
* Must be able to swallow capsules

Exclusion Criteria:

* Pregnant patients
* Smokers
* Using antibiotics in the last 3 months
* Using antioxidant supplements in the last 3 months
* Usual intake Autoimmune
* Hemodialysis started less than 6 months for hemodialysis patients
Improvement of Live Babies Rates After ICSI, Using cpFT

Demonstrate the improvement of the live births rate after ICSI by supplementing the pre-ICSI incubation medium of oocytes and that of preimplantation embryos with cpFT at the 1st embryo transfer for women under 37 years old.

Supplementation of the incubation medium with cFEE should improve the implantation rate and ART outcome.

As in France ICSI is widely used to achieve good fertilization rates, we decided to use ICSI to fertilize the egg, and the peptide:

1. to improve chromosome segregation during meiosis, and
2. to improve in vitro embryogenesis after ICSI. Hence the protocol includes an oocyte preincubation step prior to ICSI and a co incubation of the embryo with the molecule during blastocyst formation.

Hence our protocol includes:

1. - a preincubation of the decoronized oocytes with the peptide prior to ICSI, and
2. - a coincubation of the developing embryo with the molecule.

The principal criteria will be the live baby rate after the first embryo transfer (using the best embryo). As the oocyte loses its strength as the women is getting older, the main criteria will be evaluated for women under 37 years old.

Randomization: every couple will be randomly assigned to the Control or the Treated group.

Treated group: After egg retrieval, the oocyte will be decoronized and incubated prior to ICSI procedure into CSCM-C (Irvine) medium supplemented with the molecule.

Control group: similar protocol of incubation but without the molecule. After ICSI the zygote will be incubated until the blastocyste stage in CSCM-C medium (Irvine).

Embryo transfer will be limited to only one blastocyst, fresh or delayed after cryopreservation.

Eligibility Criteria:
Inclusion Criteria:

* Couples eligible for a first attempt at Assisted Reproduction (AMP).
* Couples asking for Assisted Reproductive Technology, and requiring an ICS procedure.
* Women aged 18 to 36 inclusive.
* Men aged 18 to 58 inclusive
* Use of CSCM-C culture medium from Biocare / Irvine, exclusively.
* People affiliated to a Social Security scheme

Exclusion Criteria:

* Lack of consent
* Early menopause.
* Couples under IVF or Intra Uterine Insemination treatment.
* People unable to follow protocol visits in France.
* Couple with a contraindication to treatment with ART.
* Women with a contraindication to treatment with ART or an associated pathology such as: hypertension, risk of eclampsia, family genetic problems, diabetes, uterine partitions, synechiae adhesions, adenomyosis or any other contraindication judged as such by the investigator.
* ART with donation of gametes or embryos.
* Participant under guardianship or guardianship
The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients

A prospective, open label, study designed to assess the affect of the Reflux Band® UES Assist Device (Reflux Band) on reflux in patients that have undergone lung transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable lung transplant patients(single lung, double lung, or re-transplant) as defined by stable FEV1 over the prior two visits
* 13 Abnormal pH impedence or esophagram or documented gastric reflux at pre-transplant evaluation
* Patient must be willing and able to provide informed consent
* Understands the clinical study requirements and is able to comply with follow-up schedule

Exclusion Criteria:

* Currently being treated with another investigational medical device and/or drug
* Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)
* Previous head or neck surgery / radiation
* Carotid artery disease, thyroid disease, or history of cerebral vascular disease
* Nasopharyngeal cancer
* Suspected esophageal cancer
Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome

Corticotherapy accelerates maternal postpartum recovery in women with class I HELLP syndrome. The benefit of faster and better recovery would be observed in fewer complications, less utilization of blood products and shorter hospital stay.

Patients with Class I HELLP Syndrome will be recruited for use os dexamethasone or placebo in the puerperium. Effects such as clinical course (blood pressure and diureses), laboratorial behaviour and complications will be compared. Duration of hospitalization will also be accessed.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum women with Class I HELLP syndrome

Exclusion Criteria:

* Chronic users of corticosteroids
* Patients with chronic conditions affecting the laboratory parameters involved in the HELLP syndrome
* Women who had received antenatal corticosteroids to treat HELLP syndrome were excluded
Diagnosis and Treatment of ACS in the ED: The Impact of Rapid Bedside cTnI Testing on Outcomes

In a randomized, controlled clinical trial, point-of care testing at the bedside using the cardiac biomarker troponin I in ED patients with possible ACS will be compared to traditional testing of this assay for myocardial necrosis obtained in the central laboratory. Our hypothesis: point-of-care testing for troponin I will decrease the time for disposition of patients with possible ACS in the emergency setting and decrease the time required for administering appropriate therapies for these patients.

Cardiac troponin I is routinely used in the emergency department as a risk stratification tool for detecting myocardial necrosis in patients with possible acute coronary syndrome. It is our hypothesis that having bedside, point-of-care testing for TnI in the ED will decrease time needed to disposition patients to home from the ED or send to the cardiac catheterization laboratory or intensive care setting. Similarly, having point-of-care testing in the ED should decrease the time required to deliver anti-platelet drugs such as aspirin and glycoprotein IIb/IIIa inhibitors and anti-thrombin agents such as heparin to high risk patients found to have a positive TnI test. This will be evaluated in a randomized, controlled clinical trial of 2000 patients. Half will have the test performed in the ED at the bedside (point-of-care) while the other half will receive the usual lab results obtained from the central lab (typically requiring 1.5-2 hours to return).

Eligibility Criteria:
Inclusion criteria

* Age \>21 years old
* Chest pain or other symptoms that lead to drawing cardiac bio-markers for possible ACS diagnosis

Exclusion criteria

* Presentation with chest pain in the presence of a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation)
* Presentation with ECG diagnostic for STEMI
A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors

The purpose of this study is to evaluate the safety of the study drug LY3381916 administered alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054).


Eligibility Criteria:
Inclusion Criteria:

* Dose escalation phase: Participant must have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic.
* Dose expansion B1: Metastatic TNBC participants who have not received prior PD-1/L1 treatment.
* Dose expansion B2: Metastatic NSCLC participants who have progressed on prior PD-L1/L1 treatment.
* Dose expansion B3: Metastatic clear cell carcinoma RCC who have progressed on prior PD-L1/L1 treatment.
* Have adequate organ function.
* Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Are able and willing to provide required, newly acquired tumor biopsies.
* Have discontinued previous treatments for cancer.
* Are able to swallow capsules.

Exclusion Criteria:

* Currently enrolled in a clinical study.
* Have known symptomatic central nervous system metastases or carcinomatous meningitis.
* Have a serious concomitant systemic disorder.
* Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C.
* Have a significant cardiac condition.
* Have previously received an indoleamine- 2,3-dioxygenase (IDO) inhibitor.
* Have an active autoimmune disease or currently require immunosuppression of \>10 milligrams of prednisone or equivalent per day.
* Have interstitial lung disease or (noninfectious) pneumonitis, participants with a history of (noninfectious) pneumonitis that required steroids to assist with management.
Lotta Alla Sepsi Ospedaliera - Fighting Hospital Sepsis

Sepsis is widespread (1.8 million cases annually worldwide) and accounts for a very high mortality: 20-25% of all severe sepsis, 40-70% of all septic shock. The Surviving Sepsis Campaign (SSC) recommends a first 6 hours "resuscitative bundle" to improve patient's outcome. Despite this, the bundle is poorly performed, because of a superficial knowledge of the guidelines and several difficulties in their clinical implementation. In recognition of this, a "sepsis six" bundle is designed to facilitate early intervention with just three diagnostic and three therapeutic steps to be delivered by staff within 1 h.

The aim of our study is to evaluate if an Educational and Organizational Intervention (EOI) could improve septic patient's outcome in no Critical Care Units. The second endpoint is to evaluate if the compliance to the "sepsis six" bundle could improve after this sort of intervention.

Methods 39 Medical Wards and 12 Emergency Departments, belonging to 12 hospitals, were voluntarily enrolled. Through the collaboration of 12 Multidisciplinary Teams (MT), we took a Pre-EOI picture of the human resources (i.e. doctors to patients ratio) and of the organisational structures (i.e. laboratory's opening hours) of each hospital. For six months, each unit enrolled was asked to fill in a Clinical Checklist for every patient suspected for severe sepsis or septic shock; so that the Pre-EOI "sepsis six" bundle compliance could be evaluated. Then, we planned several pre-agreed educational meetings for all of the doctors and nurses belonging to the enrolled wards. In the meanwhile the MT worked to overcome any impediment to a better septic patient management. Finally, the educated medical staff was asked to fill in again the same Clinical Checklist used in the Pre-EOI phase; so that the Post-EOI "sepsis six" bundle compliance could be evaluated and a comparison with the Pre-EOI phase could be done.

Hypothesis This is the first study aimed to analyze the impact of an Educational and Organizational Intervention in the outcome of septic patients managed in no Critical Care Units. We guess that the differences showed in human resources and organizational structures among the hospitals could have a role in the "sepsis six" bundle compliance and in the patient's outcome, but only a comparison with data collected from the clinical checklist and patient's outcome will confirm our guess. Likewise, we believe that an educational intervention could improve the septic patient's management, but we need the Post-EOI phase conclusion to demonstrate or not our hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Any patient having a SIRS due to Sepsis and at least on of the following criteria: Systolic Blood Pressure \< 90 mmHg and/or serum lactate \> 4 mg/dl and/or organ failure

Exclusion Criteria:

* Age \< 18 years
Zenith® TX2® Low Profile TAA Endovascular Graft

The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.


Eligibility Criteria:
Inclusion Criteria:

* Meets one of the following

  * Descending thoracic aneurysm with diameter ≥ 5.0 cm
  * Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year
  * Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

* Life expectancy less than 2 years
* Pregnant of breastfeeding or planning on becoming pregnant within 60 months
* Unwilling to comply with the follow-up schedule
* Less than 30 days beyond primary endpoint for other investigative drug or device study
* Receiving home oxygen
* Myocardial infarction within the last 3 months
* Stroke within the last 3 months
* Diagnosed or suspected congenital degenerative collagen disease
* Systemic infection
* Bleeding diathesis, uncorrectable coagulopathy, or refuses blood transfusion
* Allergy to polyester, polypropylene, nitinol, or gold
* Previous placement of a thoracic endovascular graft
* Prior open repair involving the descending thoracic aorta
Women With Chest Pain and Normal Coronary Arteries Study

The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain, coronary endothelial dysfunction and unblocked coronary arteries.

Coronary endothelial dysfunction (CED) is a condition in which the layers of cells around the heart do not function properly and is believed to be key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for future cardiovascular events, such as heart attack and stroke.

A coronary angiogram allows physicians to see if any of the arteries in the heart are blocked, usually by fatty plaque. In many instances, angiograms in women experiencing chest pain do not show evidence of coronary disease (free of significant plaque build-up). Currently, there is no standard of care treatment plan for patients with normal coronary arteries, despite symptoms of chest pain, and as a result these patients may not receive medical treatment. However, these women often return to their physicians more than once with chest pain and go through a similar battery of tests.

Endothelial function testing will be performed on women without significant coronary disease in order to help identify women who may be likely to develop coronary artery disease (CAD) and who would benefit from aggressive lifestyle (dietary counseling, exercise) or medical (treatment with aspirin and cholesterol and blood pressure lowering medications) interventions.

Eligibility Criteria:
Inclusion Criteria:

1. Female gender
2. Age 30 or greater
3. Present with symptoms suggestive of Angina (Typical or "Atypical")
4. Abnormal myocardial perfusion scan
5. Referred for angiography
6. Normal (0% stenosis) versus Nonobstructive coronary artery disease (CAD) (\<50% stenosis)
7. Evidence of endothelial dysfunction.

Exclusion Criteria:

1. Coronary vasospasm known or documented in cardiac catheterization
2. Obstructive CAD (greater than 50% stenosis) known or documented in cardiac catheterization
3. Pregnancy
4. Established CAD, history of revascularization with percutaneous transluminal coronary angioplasty (PTCA)/stent or coronary artery bypass graft (CABG)
5. Contraindications to magnetic resonance imaging (MRI)
6. Cardiac catheterization for valvular disease
7. Cardiac catheterization for heart failure assessment/biopsy
8. Known congestive heart failure (CHF)/hypertrophic obstructive cardiomyopathy (HOCM)/dilated cardiomyopathy (DCM)
9. Acute Renal Failure
10. Chronic renal failure (estimated glomerular filtration rare (eGFR) \<30 ml/min/1.73m\^2) or on hemodialysis
11. Known single kidney
12. History of peptic ulcer disease, known gastrointestinal bleed, known contraindication to aspirin
13. Known contraindication to statin
14. Known contraindication to adenosine (asthma, high degree atrial ventricular (AV) block)