cyrilzakka/clinical-trials huggingface dataset:
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease

This study compares mechanical sphincter augmentation (LINX Reflux Management System) to double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to gastroesophageal reflux disease (GERD).

Prospective, multicenter, 2:1 randomized, cross-over, two arms

* Control arm: Double-dose PPI \[Omeprazole 20 mg BID (twice a day)\]
* Treatment arm: LINX Reflux Management System Up to 20 study centers throughout the U.S. will participate. Approximately150 patients will be enrolled into the study. Subjects will be randomized 2:1 into the double-dose PPIs arm (100 subjects) and the LINX arm (50 subjects).

Eligibility Criteria:
Key Inclusion Criteria:

1. Patient seeks consultation for lack of satisfactory symptom response to once daily PPIs.
2. Age≥ 21 years old.
3. Abnormal distal esophageal pH determined by total % time pH \<4 or DeMeester Score. Testing to be completed off GERD medications for at least 7 days, with the exception of antacids, which may be taken up until the morning of assessment.
4. Suitable surgical candidate (i.e. is able to undergo general anesthesia and laparoscopic surgery).
5. Patient has provided written informed consent for participation in the randomized study.

Key Exclusion Criteria:

1. Currently taking double-dose PPIs (twice daily dosing).
2. Hiatal hernia \>3cm as determined by endoscopy.
3. Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or \<70% (propulsive) peristaltic sequences.
4. Esophagitis Grade C or D (Los Angeles classification).
5. Body mass index \>35.
6. Diagnosed with an esophageal motility disorder LES.
7. Esophageal stricture or gross esophageal anatomic abnormalities
8. History of/or known Barrett's esophagus.
9. Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials.
Long-term Use of Drugs That Could Prevent the Risk of Serious COVID-19 Infections or Make it Worse

The COVID-19 emerging disease due to a novel coronavirus (SARS-CoV-2), started in Wuhan, China, last December, 2019. In the past three months, the virus has spread rapidly worldwide to reach the pandemic threshold.

Research has since been carried out and is intensifying in order to describe the clinical characteristics of infected patients, to identify the prognostic factors of acute respiratory distress syndrome \[ARDS\] and the death; and to assess the effectiveness of new antivirals and therapeutic strategies to treat COVID-19.

Treatments currently being investigated include:

* Potentially effective treatments: (hydroxy)chloroquine, Remdesivir, Lopinavir, Ritonavir +/- IFN-ß-1a (currently evaluated in the European discovery trial), methylprednisolone in patients with ARDS;
* Potentially harmful treatments: antihypertensives such as converting enzyme inhibitors and angiotensin receptor antagonists.

We made the hypothesis that (1) patients receiving ARBs or ACEi's have a higher risk to present a serious COVID-19 infection disease and (2) patients receiving synthetic AMD (e.g. HCQ and CQ) have a lower risk to present a serious covid19 infection disease.

Using data from the French insurance health database (SNDS) and hospital discharge database (PMSI), our objectives are

* Main objective: To assess the risk of moderate to serious COVID-19 infections in patients using synthetic anti-malarial drugs (AMD) or anti-hypertensive drugs (Angiotensin receptor-blocking/Angiotensin-converting-enzyme inhibitors).
* Secondary objective : To examine the risk of moderate to serious COVID-19 infections according of age, sex, co-morbidities, level of exposure of AMD, geographical locations and underlying comorbidities.

This in order to:

* To prevent moderate to serious COVID-19 infections in at-risk population (diabetes, elderly, respiratory failure population) using synthetic AMD.
* To prevent moderate to serious COVID-19 infections in at-risk population stopping angiotensin receptor-blocking and angiotensin-converting-enzyme inhibitors.

Details for "Study design" section

Time perspective : Retrospective and prospective cohort study using French National Health Database Data source

Enrollment:

* 70,000 patients treated by synthetic AMD
* 13 million patients treated by ARBs or ACEi's from the French national health insurance database (SNDS) and the French national hospital discharge database (Programme de Médicalisation des Systèmes d'Information, PMSI)

Eligibility Criteria:
Inclusion Criteria:

All adults (18 years of age and older) registered in the French national health insurance database (SNDS) receiving between January 1, 2020, and May 31, 2020:

1. Synthetic anti-malarial drugs (AMD): Participants will be identified by the prescription of at least one synthetic AMD (chloroquine and hydroxychloroquine, ATC P01D1 and M01C respectively)
2. Anti-hypertensive drugs: Participants will be identified by the prescription of at least one Angiotensin receptor-blocking or Angiotensin converting- enzyme inhibitors, ATC C09A-D

No Exclusion Criteria
Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis

We planned this multicenter randomized controlled trial to study the role of a prophylactic biliary stent in recurrence of stones and biliary complications in patients awaiting cholecystectomy after biliary stone clearance

Patients with cholelithiasis can have presence of concomitant choledocholithiasis (CDL) in upto 30%. These stones may remain asymptomatic or cause obstructive jaundice and complications like cholangitis and pancreatitis. In situations where there is a failure of CDL clearance during endoscopic retrograde cholangiography (ERC), biliary stenting is recommended to prevent complications. However, the role of prophylactic biliary stenting in situations where CDL clearance has been achieved, and the patient is awaiting cholecystectomy is debatable. One retrospective study showed benefit while a small prospective study and a retrospective study did not show benefit of prophylactic biliary stenting. Moreover, a randomized controlled trial addressing this question is lacking. Hence, we planned this multicenter randomized controlled trial to study the role of a prophylactic biliary stent in recurrence of stones and biliary complications in patients awaiting cholecystectomy after biliary stone clearance.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80 years
* Cases of cholelithiasis with concomitant CDL in whom CBD clearance is achieved will be included.

Exclusion Criteria:

* Informed consent not available
* Patients opting for single stage surgery
* Previous hepatobiliary surgery
* Failure to completely clear CDL on ERC
* Concomitant benign biliary strictures (like chronic pancreatitis, portal cavernoma cholangiopathy, post cholecystectomy, primary biliary cholangitis related)
* Previous cholecystectomy patients
* Associated malignancy
* Coagulopathy(INR\>1.5, platlets\<1lac)
* Severe cholangitis
Mineralocorticoid Receptor Antagonists in End Stage Renal Disease

End stage renal disease (ESRD) patients exhibit an extraordinarily high annual mortality. Cardiovascular (CV) causes account for almost half of all-cause mortality. Increased left ventricular mass (LVM) is a common finding in ESRD patients on dialysis and is an independent predictor of survival. Yet, to date there is no established medical treatment to reduce CV morbidity and mortality in ESRD patients on hemodialysis. Blockade of aldosterone action by means of mineralocorticoid receptor antagonists (MRA) provides cardioprotection and improves outcome in heart failure patients. Furthermore, the MRA spironolactone has recently been shown to reduce LVM in patients with mild-to-moderate chronic kidney disease (CKD). The investigators here hypothesize that spironolactone treatment is cardioprotective by reducing LVM in ESRD patients on dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Hemodialysis treatment for at least 3 months
* At least 3 dialysis sessions per week
* Written informed consent

Exclusion Criteria:

* Contraindications for cardiac magnet resonance imaging (CMR)
* Mineralocorticoid receptor antagonist treatment within the last 6 months
* Estimated life expectancy \< 12 months as judged by the nephrologist
* History of hyperkalemia, defined as pre-dialysis potassium \> 6.5 mmol/l occurring ≥ 3 times within the last 3 months prior to enrolment.
* High risk to develop hyperkalemia defined as pre-dialysis potassium \> 6.0 mmol/l
* Hypotension (systolic blood pressure \< 100 mmHg)
* Planned kidney transplantation (living donor) within the prospected study duration
* Any acute illness within the last 4 weeks precluding a study participation as judged by the nephrologist
* Non-amenorrheic women with child bearing potential without reliable contraception, pregnancy/lactation
* Allergy/hypersensitivity to spironolactone
* Non-compliance suspected or demonstrated
Tramadol Clinical Efficiency and Tolerance Correlated to O-desmethyltramadol/Tramadol Ratio (CLINCYTRAM)

Tramadol is a grade II analgesics as World Health Organization definition. It can both be an agonist on mu receptors, which provides it a low opioid action, and also be a Serotonin-norepinephrine reuptake inhibitor, which act on neuropathic pain.

Tramadol is metabolized by P450 2D6 cytochrome (CYP2D6) in O-desmethyltramadol (O-dt) which is the most active form on the pharmacologic side (analgesic effect 2 to 4 times more powerful than tramadol itself).

In caucasian population, 5 to 10% of patients are genetically qualified as "poor metabolizer phenotype"; this status is correlated to a lower analgesic efficiency compared to "rapid metabolizer".

A multicenter study, CYTRAM, is under publication and allowed measurement of blood ratio O-dT/tramadol as a way to know the phenotype of CYP2D6 to detect "poor metabolizer phenotype" status.

Indeed, blood ratio O-dT/tramadol threshold under 0.1 detects " poor metabolizer phenotype " status for postoperative patients treated by tramadol, with a good sensibility (87,5%) and specificity (83.8%).

Which impacts for current practice? The next step is to know if this blood ratio is linked to an analgesic efficiency and a good tolerance for tramadol. A "poor metabolizer phenotype" patient would have no benefit of tramadol posology increasing. Therefore, phenotype detection, thank to blood ratio, could allow to switch quickly tramadol to another analgesic treatment for "poor metabolizer phenotype" patients.

The main objective of the study is to forge a link between O-dT/tramadol ratio and analgesic efficiency. Secondary objectives investigate side effects and frequency related to O-dT/tramadol ratio and pain relief, and also impact of CYP2D6 - inhibitor treatments on the blood ratio.

If there is a correlation between this blood ratio and treatment efficiency and tolerance, O-dT/tramadol ratio's detection will allow a better adaptation for some treatments metabolized by CYP2D6. Therefore, this evolution will contribute to health quality and health safety improvement.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old treated by tramadol for at least 48h
* Tramadol posology between 100 and 400 mg/d (oral treatment) and until 600 mg/d (veinous treatment), recommended dosage
* Patients with nociceptive pain, definite etiology, combined or not with neuropathic pain
* Caucasian patient
* Patient able to give his/her informed consent
* Patient able to estimate himself/herself pain with pain scale for at least 48h

Exclusion Criteria:

* Age \< 18 years old
* Patient with chronic pain (\>3 month) or not definite
* Tramadol posology \>400 mg/d (oral treatment) or \> 600 mg/d (veinous treatment)
* Patients with absolute Tramadol contraindication
* Chronic endstage kidney failure antecedent (Cl cockcroft \< 10mL/min) and liver failue antecedent
* Concomitant analgesic treatment, except paracetamol or stopped less than 48h ago
* Pregnant or breast-feeding patient
Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition.

Endometrial hyperplasia without atypia is a condition usually caused by excessive stimulation of the uterine lining (endometrium) by estrogens, and may cause irregular bleeding as a presenting symptom, but rarely may progress to endometrial cancer, which makes treatment important. The only treatment approved so far is medroxyprogesterone acetate tablets (progesterone), also known as Provera.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of simple or complex endometrial hyperplasia without atypia
* Normal pap smear within one year

Exclusion Criteria:

* Diabetes
* Family history of endometrial cancer
* Contraindications for the intrauterine device
Marrow Cellution™ Vs. Traditional BMA Harvest Project

Six patients with diagnosed bone loss of the hip who have consented to minimally invasive repair will be approached to participate in the study. Participants will have the liquid portion of bone marrow collected using the Zimmer Biomet Biocue system, which is the standard system used by physicians at The Ohio State University, and the novel Marrow Cellutions system™. Bone marrow liquid will be collected from the surgical hip using the Zimmer Biomet Biocue system, and the Marrow Cellutions system™ will be used to collect bone marrow liquid from the non-surgical hip. Following collection, the bone marrow liquid will be processed using the respective systems to concentrate the cells and molecules found in the bone marrow liquid. As part of the standard of care for this arthroscopic procedure, concentrated bone marrow liquid processed using the Zimmer Biomet Biocue system will be delivered to the surgical site as an adjunct to promote healing. Concentrated bone marrow liquid prepared with the Zimmer Biomet Biocue system is given as part of the standard of care for patients undergoing minimally invasive treatment for bone loss of the hip; therefore, the target population for this study are individuals between the ages of 18-50 years with confirmed bone loss of the hip who have consented to minimally invasive repair. In addition to the concentrated bone marrow liquid prepared using the Zimmer Biomet Biocue system, patients will also have bone marrow liquid collected from the non-surgical hip using the Marrow Cellutions™ system. Only concentrated bone marrow liquid produced with the Zimmer Biomet Biocue system will be given to the patient. All concentrated bone marrow liquid produced with the Marrow Cellutions™ system will be sent to the laboratory for analysis. Additionally, white blood cells will be concentrated into an autologous protein solution (APS) using the Zimmer Biomet Plasmax system from blood collected using a routine blood draw. All protein solution produced will be sent to the laboratory for analysis. No protein solution will be given to the patient. As the bone marrow liquid collection using the Marrow Cellutions™ system and the blood draw to produce protein solution using the Zimmer Biomet Plasmax system are being performed for research,

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Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 - 50
* patients undergoing hip arthroscopy for subchondral bone cysts and/or avascular necrosis

Exclusion Criteria:

* patients with a history of hematologic issues including anemia and sickle cell anemia
* patients with a history of leukemia, lymphoma, or other bone marrow related diseases
* patients with diabetes
* patients with a history of bone marrow aspirate
Co-Administration Of Methotrexate And CP-690,550

This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate the effects of CP-690,550 on the PK of MTX and to evaluate the short-term safety and tolerability of co-administration of CP-690,550 and MTX.


Eligibility Criteria:
Inclusion Criteria:

* Adults diagnosed with moderate to severe RA (Rheumatoid Arthritis)
* Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
* Treatment with an oral stable weekly dose of Methotrexate (MTX) (15-25 mg/week, administered as a single dose \[SD\]) for a minimum of 4 doses (4 weeks)

Exclusion Criteria:

* Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.2 x 109/L; Platelet count \<100 x 109/L
* Evidence or history of clinically significant infections within the past 6 months (eg, those requiring hospitalization, requiring parenteral antimicrobial therapy, or those with recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the trial.
* Total bilirubin, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) more than 1.2 times the upper limit of normal at the Screening visit, or a history of clinically significant elevated liver function tests (LFTs) while on current MTX dose or chronic liver disease, recent or active hepatitis.
ProduceRx: Improving Weight and Cardiovascular Risk in Adults With Food Insecurity and Obesity

This is a pilot randomized controlled trial to assess the effects of providing produce vouchers during behavioral weight loss treatment in 40 adults with obesity and food insecurity. Participants will be randomized to ProduceRx (12 weekly sessions of in-person, behavioral weight loss counseling (BWL) + produce prescriptions) or a waitlist control (WLC).

The proposed investigation is a single-site, pilot RCT to assess the effect of BWL and produce vouchers (ProduceRx) on diet quality, weight loss and cardiovascular risk factors among adult participants with food insecurity and obesity. Adults (N=40) will be randomized to a 12-week program that provides weekly, 30-minute BWL sessions + produce vouchers (n=20) or WLC (n=20). Outcomes will be assessed at baseline and at 12 weeks and include questionnaires, and measurements of weight, height, and cardiometabolic risk factors (blood pressure, waist circumference, and pulse). Participants will also be asked to complete two 24-hour dietary recalls.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. BMI ≥ 30 kg/m2
3. Food insecurity as assessed by the two-item "hunger vital sign"
4. Subjects must:

   1. have reliable telephone or Internet service to communicate with study staff
   2. plan to remain in the Philadelphia area for the next 6 months or more
5. Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent.

Exclusion Criteria:

1. Pregnant, nursing, or plans to become pregnant in the next 6 months
2. Serious medical risk such as uncontrolled diabetes, cancer, congestive heart failure, or recent cardiac event (e.g., myocardial infarction or stroke within the past 6 months)
3. Clinically significant hepatic or renal disease
4. History of (or plans for) bariatric surgery
5. Current psychiatric disorder that significantly interferes with daily living
6. Self-reported alcohol or substance abuse within the past 12 months
7. Use in past 3 months of medications known to induce significant weight loss (i.e., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
8. Loss of ≥ 10 lb of body weight within the past 3 months
9. Participation in a structured weight loss program in the prior 6 months
10. Inability to walk 2 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming)
11. Participant from same household
12. Inability to attend treatment and/or assessment visits
13. Lack of capacity to provide informed consent
14. Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study
Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)

The aim of the study is to assess the safety \& immunogenicity of a pandemic influenza vaccine administered at 2 different time points. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

* Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
* History of vaccination with investigational influenza pandemic vaccine.
* History of administration of an experimental/licensed vaccine
* Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51; from 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the candidate vaccines
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* History of hypersensitivity to vaccines.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* History of chronic alcohol consumption and/or drug abuse.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the candidate vaccine or during the study.
* Lactating women.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
* Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.