bioihbjkbjnl/mcl2 huggingface dataset:
Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors
Condition: Small-intestine Neuroendocrine Tumors (Carcinoid Tumors)
MeSH terms: Neuroendocrine Tumors; Carcinoid Tumor
Study type: Interventional

Summary: 
      Urinary measure of 5-hydroxyindolacetic acid (5HIAA) is an important marker for the diagnosis
      and follow-up of patients with small-intestine neuroendocrine tumors. Although this marker
      has good specificity, its sensitivity is moderate and its dosage is constraining, since it
      requires urine collection over 2-3 days and specific diet. Preliminary data suggested that
      overnight 5HIAA value may be representative of 24-hour 5HIAA value, and that plasma 5HIAA
      dosage could be a valuable alternative to urine 5HIAA dosage. The main objective of this
      study is to compare sensitivity and specificity of overnight 5HIAA value, 24-hour 5HIAA value
      and plasma 5HIAA value, in patients with small-intestine neuroendocrine tumors.
    

Detailed description: 
      This study primarily aims at comparing the sensitivity and specificity of overnight 5HIAA
      value, 24-hour 5HIAA value and plasma 5HIAA value, in patients with small-intestine
      neuroendocrine tumors. Secondary objectives include the correlation of 5HIAA values with
      chromogranin A, carcinoid syndrome and tumor burden and the evaluation of the compliance to
      the diet and its correlation with 5HIAA values.

      The study group will include patients with proven neuroendocrine tumors of various stages and
      functioning syndrome profile. A control group will be constituted with subjects having
      irritable bowel syndrome, in which a neuroendocrine tumor is ruled out. After providing
      informed consent, patients fitting with inclusion criteria will be included in the study.
      Patients will have to follow a specific diet, and interrupt/avoid certain medication, during
      the 2 days before and the 2 days during the sampling period. Whole urine samples will be
      collected during 2 consecutive days, in 4 parts (day1, night 1, day 2, night 2). Blood
      samples will be collected at the morning of days 2 and 3. Observance with diet and drug
      restriction will be evaluated at the morning of day 3.
    

Intervention name(s): blood sample withdrawn
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
14-C ADME (Absorption, Disposition, Metabolism and Excretion) Study in Man
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and
      Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.
    

Detailed description: 
      The Absorption, Disposition, Metabolism and Excretion of SLV337 will be investigated after a
      single dose of an oral suspension of 14C-SLV337.
    

Intervention name(s): SLV337 suspension; SLV337 capsule
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg experimental; 5 x 200 mg immediate release capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SLV337; Diabetes; Relative bioavailability; ADME
Diuretics, Hypertension, and Arrhythmias Clinical Trial
Condition: Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Arrest; Heart Diseases; Hypertension
MeSH terms: Hypertension; Cardiovascular Diseases; Heart Diseases; Heart Arrest; Death, Sudden, Cardiac; Death, Sudden
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether hypertensive patients with ECG abnormalities and receiving
      hydrochlorothiazide diuretics were at increased risk of sudden death.
    

Detailed description: 
      BACKGROUND:

      The Multiple Risk Factor Intervention Trial (MRFIT) revealed an unexpected subgroup finding:
      an association between diuretic therapy (especially with hydrochlorothiazide) and an
      increased rate of sudden death in hypertensive men with left ventricular hypertrophy and
      other ECG abnormalities. The Diuretics, Hypertension, and Arrhythmias Clinical Trial sought
      to determine whether the finding resulted from random variation or represented a serious
      toxic response to hydrochlorothiazide.

      DESIGN NARRATIVE:

      Randomized, double-blind. Following one month of withdrawal from all diuretics and repletion
      with oral potassium and magnesium, the study participants were randomized to two months of
      treatment with one of six treatment groups: hydrochlorothiazide; hydrochlorothiazide with
      oral potassium; hydrochlorothiazide with oral potassium and magnesium; hydrochlorothiazide
      and triamterene; chlorthalidone; or placebo. The main outcome measures were ventricular
      arrhythmias on 24-hour Holter monitoring and serum and intracellular potassium and magnesium
      levels.
    

Intervention name(s): hydrochlorothiazide; diet, potassium supplementation; diet, magnesium supplementation; triamterene; chlorthalidone
Intervention type(s): Drug; Behavioral; Behavioral; Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide; Chlorthalidone; Triamterene
Allocation: Randomized
Masking: Double
Clinical Trials for the Optimal Dosage of Tang Ning Tongluo Capsule
Condition: Accidental Exposure While Preparing Drug for Administration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history.

      aim： --establish the optimal dosage of traditional Chinese medicine Tang Ning Tongluo Capsule
      to treat type II diabetes mellitus.

      ---Preliminary evaluate the clinical efficacy and safety of Tangning Tongluo Capsule in the
      treatment of type II diabetes
    

Detailed description: 
      Preliminary evaluation on the clinical efficacy and safety of Tangning Tongluo Capsule in the
      treatment of type II diabetes, and provides basis for determining optimal dosage of Tangning
      Tongluo capsule.
    

Intervention name(s): TNTL capsule; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients were asked to taken drugs 3 times a day, with each time 3 grains; Patients were asked to taken drugs 3 times a day, with each time 3 grains
Other intervention name(s): Tang Ning Tongluo Capsule
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims
Condition: Bariatric Surgery Candidate
Study type: Observational

Summary: 
      Obesity is a public health phenomenon affecting more than 17% of women in France, and more
      than 20% of men and women in Champagne-Ardenne.

      Obese women are more likely to have an unplanned pregnancy, whereas these pregnancies are
      more at risk than women of normal weight and should be planned or considered after weight
      loss. These women are also often less well followed in terms of gynecology and especially on
      contraception.

      More and more patients are opting for bariatric surgery. However, bariatric surgery is not
      trivial. Indeed, the important loss of weight expected is at risk of nutritional
      deficiencies. In addition, a large number of patients are still obese during the months
      following surgery. This is why pregnancy is theoretically contraindicated within 12 or 18
      months postoperatively.

      Women with bariatric surgery must have been properly informed of these risks so that they can
      choose a contraceptive method, and that can be adapted to both their risk factors and the
      surgical technique performed.
    

Detailed description: 
      The purpose of this study is to describe contraception in obese women who have undergone
      bariatric surgery in Champagne-Ardenne.
    

Intervention name(s): data collection
Intervention type(s): Other
Intervention description(s): data collection
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women between 18 and 50 years, pre-menopausal, who undergone bariatric surgery at Reims
        University Hospital
Effect of Deproteinization on the Shear Bond Strength and Glue Penetration in the Enamel of Orthodontic Brackets
Condition: Orthodontic Appliance Complication
Study type: Observational

Summary: 
      The aim of this study was to evaluate the effects of enamel deproteinization on the initial
      shear bond strength (SBS) and on the bracket/adhesive failure mode of orthodontic brackets
      bonded with a self-etching primer (SEP) as a primary objective. As secondary objective a
      Raman microscopy study was performed to assess the resin penetration into the enamel
      according to the three bonding protocols.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patient with orthodontic treatment involving bicupids extractions
      
Biospecimen description: 
      NC
    
Keywords: glue penetration; orthodontic brackets; self-etching bracket
Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      The purpose of this study will be to determine whether an intravenous dose of dimenhydrinate
      (also known as Gravol), given before the induction of spinal anesthesia, will decrease the
      incidence of intraoperative nausea and vomiting in patients undergoing Cesarean delivery.

      This medication is commonly given during and after the surgery if required, but it is not
      known whether a preventative dose will decrease the overall incidence of these side effects.
    

Detailed description: 
      Nausea and vomiting remain one of the most common complications of Cesarean delivery. The
      results of this study will show whether or not we can improve our present anesthesia regimen,
      and improve the satisfaction of patients undergoing Cesarean deliveries, by reducing the
      incidence of nausea and vomiting. Our current practice is not to use any medication for
      preventing nausea and vomiting unless required. However, nausea and vomiting come quite fast
      and unexpectedly during the operation, and most of the time the medication we give does not
      work fast enough. We are planning to study the anti-nausea medication dimenhydrinate
      (commonly known as Gravol), which has been safely and widely used during pregnancy, labour
      and Cesarean deliveries, hoping that its use will decrease the incidence of this unpleasant
      occurrence.
    

Intervention name(s): Dimenhydrinate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): single dose, 25mg, IV, diluted in 9.5mL normal saline.; single dose, 10 mL normal saline, IV
Other intervention name(s): Gravol
Intervention MeSH terms: Dimenhydrinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cesarean Section; Dimenhydrinate; Gravol; Antiemetics
A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban
Condition: Bleeding
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the
      anticoagulation effect of Apixaban.
    


Intervention name(s): Andexanet; Placebo
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Andexanet alpha; Anticoagulation; Antidote; Apixaban; Anti-fXa inhibitor; PRT4445; Eliquis; Reversal agent
A Study to Explore the Pharmacokinetics of Rilpivirine With Rifabutin in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore the pharmacokinetics of different dosing regimens of
      rilpivirine in combination with rifabutin in healthy participants.
    

Detailed description: 
      This is a Phase I, open-label (the participant will know the identity of the treatment they
      receive), 3-period study to investigate the pharmacokinetic (what the body does to the
      medication) interaction of steady-state (constant concentrations in your blood resulting from
      a fixed dosing regimen) rilpivirine and steady-state rifabutin. Twenty healthy participants
      will be enrolled and will receive 3 different treatments (treatment A: rilpivirine 25 mg once
      daily administered daily for 11 days; treatment B: rilpivirine 50 mg once daily administered
      for 11 days + rifabutin 300 mg daily administered for 17 days; treatment C: rilpivirine (in a
      regimen to be determined based on an interim analysis of treatments A and B) administered for
      11 days + rifabutin 300 mg daily administered for 17 days). All 20 participants will be
      randomized (the study drug is assigned by chance) to receive treatments A (10 participants)
      and treatment B (10 participants) and there will be a washout period of at least 21 days
      between treatments A and B. After all participants have completed treatments A and B, there
      will be an interim analysis to decide upon the dosing regimen for rilpivirine in treatment C
      (the rilpivirine regimen in treatment C could be either once daily or twice daily with a
      total daily dose of rilpivirine between 25 and 75 mg). All 20 participants will receive
      treatment C. Safety and tolerability will be evaluated throughout the study.
    

Intervention name(s): Rilpivirine; Rifabutin
Intervention type(s): Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=25, 50, and will be determined after treatment A and B analysis form=tablet, route=oral. Once or twice daily with a total daily dose of rilpivirine between 25 and 75 mg will be administered for 11 days.; Type=exact number, unit=mg, number=150, form=capsule, route=oral. Two capsules daily will be administered for 17 days.
Intervention MeSH terms: Rilpivirine; Rifabutin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rilpivirine; Rifabutin; Pharmacokinetics; Healthy participants
Aortic Cross-Clamping and Systemic Inflammatory Response in Humans: Effect of Ischemic Preconditioning
Condition: Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm
Study type: Interventional

Summary: 
      Multiple organ dysfunction syndrome is a major cause of morbidity and mortality after
      abdominal aortic aneurysm (AAA) surgery. It is postulated that aortic cross-clamping during
      open AAA repair may cause ischemia-reperfusion (I/R) leading to the systemic releases of
      reactive oxygen species (ROS) and inflammatory cytokines which damage distant organs,
      including heart, kidney, and lung.

      Ischemic preconditioning, first described in cardiac surgery, is a mechanism whereby tissues
      exposed to a brief period of nonlethal I/R develop resistance to subsequent ischemic insult.
      Remote ischemic preconditioning (RIPC), is a phenomenon whereby brief periods of ischemia
      followed by reperfusion in one organ (usually skeletal muscle) provide systemic protection
      from prolonged ischemia. The mechanisms through which RIPC confer organ protection remains
      unclear.

      The hypothesis is that limb RIPC would reduce systemic inflammatory mediators produced by
      ischemia-reperfusion and thereby protect the remote organs.

      A single-center, prospective, randomized, parallel-group controlled trial is conducted on
      patients undergoing elective open infrarenal AAA repair. Written informed consent is obtained
      from each participant. The study protocol was reviewed and approved by the Research Ethics
      Committee of Rouen, France.

      Patients are divided in two groups : the sham-operated control group underwent surgery
      without RIPC and the RIPC group : Two cycles of intermittent crossclamping of the common
      iliac artery (right or left) with 10 minutes ischemia followed by 10 minutes reperfusion
      served as the RIPC stimulus, before prolonged ischemia.

      Blood samples are collected for analysis at the following time points: before surgery
      (baseline), 1, 3 and 24 h after cross-clamp release (reperfusion). The systemic inflammatory
      response is measured using the serum concentrations of TNF-alpha, and IL 1, 4, 6, 10.
      Cardiac, renal and pulmonary functions are evaluated with usual biological markers and
      clinical monitoring until 28 days after surgery.

      Aortic surgery is a perfect clinical model of ischemia-reperfusion which makes it possible to
      study the impact of RIPC in humans. This biological approach would help to better understand
      the mechanisms underlying this technique.
    


Intervention name(s): Remote ischemic preconditioning; Blood drawn
Intervention type(s): Procedure; Biological
Intervention description(s): Remote ischemic preconditioning is done for patients undergoing elective open infrarenal abdominal aortic aneurysm repair; Blood drawn is done for patients undergoing elective open infrarenal abdominal aortic aneurysm repair
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effects of CBN With and Without CBD on Sleep Quality
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, study to assess the safety and
      effects of CHI-560, CHI-563, CHI-564, & CHI-565 versus placebo on sleep quality in healthy
      adult participants ages 18-55 years.
    


Intervention name(s): CBN and CBD
Intervention type(s): Dietary Supplement
Intervention description(s): CBN and CBD in Gummy Format
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
Condition: Neurogenic Detrusor Overactivity; Overactive Bladder; Pharmacokinetics of Mirabegron
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics as well as the safety and
      tolerability of mirabegron OCAS tablets after single-dose administration at different dose
      levels in children and adolescents with NDO or OAB.
    


Intervention name(s): Mirabegron
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Myrbetriq; Betmiga; Betanis
Intervention MeSH terms: Mirabegron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Mirabegron; Neurogenic detrusor overactivity (NDO); Overactive bladder (OAB)
RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial
Condition: Vascular Access Complication
Study type: Interventional
Phase: Phase 3

Summary: 
      Increased use of radial access for cardiac catheterization is being advocated because studies
      have showed lower arterial access related complication rates and higher patient satisfaction
      as compared to femoral access. However, little is known on patients with prior coronary
      artery bypass graft (CABG). The RADIAL CABG Trial is a randomized-controlled trial proposed
      to test the hypothesis that bypass graft angiography and intervention via radial access
      provides lower vascular complication rates, similar contrast and equipment utilization and
      higher patient satisfaction when compared with transfemoral approach.
    

Detailed description: 
      This is a phase III, single-center, prospective, randomized trial that will compare resource
      utilization, clinical outcomes and patient satisfaction between radial and femoral access for
      patients with prior coronary artery bypass graft (CABG)surgery undergoing coronary and graft
      angiography and intervention. During clinically-indicated coronary angiography of patients
      with prior CABG, the amount resources used, radiation exposure to patients and operators,
      occurence of complications and patients satisfaction will be compared between the two
      treatment arms to determine whether compared to femoral approach radial access will result
      in:

        1. similar contrast utilization (primary endpoint)

        2. similar procedure time (secondary endpoint)

        3. similar fluoroscopy time (secondary endpoint)

        4. similar radiation exposure of the patient - measured as DAP [dose area product] and AK
           [air kerma] (secondary endpoint)

        5. similar radiation exposure of the operators using portable radiation dose measuring
           devices (secondary endpoint)

        6. similar number and types of catheters and guidewires used (secondary endpoint)

        7. reduction in vascular access complications (secondary endpoint)

        8. reduction in overall complications (vascular access complications,injury, bleeding,
           death, emergency coronary bypass surgery, stroke, acute myocardial infarction)
           (secondary endpoint)

        9. higher patient satisfaction as measured by standardized survey 24-hours after the
           procedure (secondary endpoint)
    

Intervention name(s): Radial access versus femoral access for coronary angiography and intervention
Intervention type(s): Procedure
Intervention description(s): Radial access or femoral access for coronary angiography and intervention in patients with prior coronary artery bypass grafts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Radial access; Femoral access; Coronary angiography; Coronary artery bypass graft
Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With ADHD
Condition: Attention Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study was to examine the feasibility and efficacy of computerized
      cognitive exercises from Scientific Brain Training (SBT), compared to the computer game
      Tetris as an active placebo, in a pilot study of adolescents with
      Attention-deficit/hyperactivity disorder (ADHD).
    

Detailed description: 
      Objective: To examine the feasibility and efficacy of computerized cognitive exercises from
      Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo,
      in a pilot study of adolescents with Attention-deficit/hyperactivity disorder (ADHD).

      Method: Eighteen adolescents with ADHD were randomized to treatment or control intervention
      for seven weeks. Outcome measures were cognitive test, symptom and motivation questionnaires.
    

Intervention name(s): Scientific Brain Training (SBT); Tetris
Intervention type(s): Other; Other
Intervention description(s): Cognitive training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment