bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male Patients
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to verify the superiority of ramosetron hydrochloride (Irribow Tablets) to placebo
      for male patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate
      its safety.
    


Intervention name(s): Ramosetron; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Irribow; YM060
Intervention MeSH terms: Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diarrhea; IBS; Colonic disease; YM060
Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin
      (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM)
      aged at least 6 years to less than 18 years.

      Secondary Objectives:

        -  To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on:

             -  Percentage of patients reaching International Society of Pediatric and Adolescent
                Diabetes (ISPAD) recommended target of HbA1c < 7.5%,

             -  Fasting blood glucose (FBG),

             -  Nocturnal blood glucose (BG),

             -  24-hour blood glucose profile based on 8-point self-monitoring of blood glucose
                (SMBG) values,

             -  Daily total insulin dose and basal insulin dose,

             -  Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal
                symptomatic hypoglycemia.

        -  To assess the safety and tolerability of insulin glargine versus NPH insulin based on
           the occurrence of treatment-emergent adverse events (TEAEs).

        -  To assess anti-insulin and anti-glargine antibody development in both groups.

        -  To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin
           glargine in selected sites with approximately 45% of insulin glargine population to rule
           out accumulation tendency of insulin glargine after repeated dosing
    

Detailed description: 
      The study duration for each patient is 28 weeks +/- 7 day broken down as follows:

        -  Screening phase: up to 2 weeks

        -  Run-in phase: 1 week

        -  Treatment phase: 24 weeks

        -  Follow-up: 1 week
    

Intervention name(s): Insulin glargine (HOE901); NPH insulin
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:aqueous solution for injection
Route of administration: Subcutaneous; Pharmaceutical form:aqueous solution for injection
Route of administration: Subcutaneous
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain; Breakthrough Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate
      release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic
      pain.
    


Intervention name(s): Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Intervention type(s): Drug
Intervention description(s): Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second, followed by 2 double-blind crossover treatment periods (in randomized order). For the double-blind treatment period of the study involving FBT administration, a patient is randomly assigned to receive FBT at the 200, 400, 600, or 800 mcg strength found to be successful during open-label titration. For the double-blind treatment period of the study to which a patient is randomly assigned to receive immediate-release oxycodone, the patient will receive immediate-release oxycodone at the strength (15, 30, 45, or 60 mg) found to be successful during open-label titration.
Intervention MeSH terms: Fentanyl; Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Breakthrough pain; Opioid-tolerant; Chronic pain
Development of Endothelial Biomarkers
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The main objective is to develop and validate new endothelial function markers discriminating
      and reproducible by assessing the ability to reveal changes in endothelial function in
      response to positive and negative nutritional stimuli.
    

Detailed description: 
      The study will be randomized (on the order of taking the products: a single dose of lipids or
      a single dose of flavonoids), single-blinded, cross-over for each population (healthy and
      metabolic syndrome).
    

Intervention name(s): Induction of endothelial function variations
Intervention type(s): Behavioral
Other intervention name(s): Improvement with cocoa polyphenol dose; Induction of dysfunction with lipid dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Endothelium biomarkers; Atherosclerotic disease; Endothelial function; Nutritional stimuli
AV Node Isolation in Atrial Fibrillation vs. Modulation by "Pace and Ablate" Strategy
Condition: Atrial Fibrillation; AV Node Ablation; Escape; Rhythm
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      AV-node ablation (AVNA) is a common therapy option for rate control strategy of permanent
      atrial fibrillation with numerous side effects. The investigators hypothesised that an
      isolation of the AV node is concomitant with less occurrence of new bundle brunch blocks,
      more frequent preservation and higher rate of escape rhythm compared to AVNA. This
      retrospective study includes 20 patients being treated with AV-node isolation (AVNI) and 40
      historical AVNA-controls. Among others these two methods were compared regarding escape
      rhythm, delta QRS, procedure time, ablation points, fluoroscopy time and total dose area
      product (DAP).
    


Intervention name(s): AV-node isolation; AV-node ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): Abaltion performed in the right atrium isolating the AV-node from the atrium; Right sided ablation of the AV-node
Other intervention name(s): AVNI; AVNA
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to Heart- and Diabetes Centre NRW for AV-node ablation/isolation.
Ankle Sprain Rehabilitation With the Wii Balance Board
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional

Summary: 
      Physical activity and in particular sport is beneficial to health. Nevertheless, some of
      these activities may create a risk of injury. Ankle sprain is the most common sport related
      injury. Sports that are causing the highest number of ankle sprains are: football (30%),
      handball-basketball-volleyball-rugby (24%), gymnastics sports (6%), skiing (6%), cycling
      (6%), athletics (4%) and contact sports (4%). A recent study in the Netherlands identified a
      total of 1.3 million sports injuries. 47% of these patients required medical care. The total
      costs (direct and indirect) were assessed 84.240.000 EUR per year.

      Prospective studies demonstrated that athletes with a ankle sprain have a twofold risk of
      re-injury during the first year after the trauma, and in half of patients with an ankle
      sprain recurrence this could lead to instability or chronic pain of the ankle.

      The Wii Balance Board ® is a tool that is increasingly used in the field of health. In some
      hospitals, therapists are beginning to use it for the rehabilitation of patients after
      surgery, fractures or strokes.

      Patients are asked to complete their physical therapy session by practicing "sports" via
      video games such as skiing, bowling or hula hoop. Currently, there are no randomized
      controlled studies that publish on the effectiveness of this tool. Recently, a study
      investigated the efficacy of the Wii Balance Board ® to improve balance, strength, joint
      mobility and level of physical activity. After 10 weeks of training, people an increased
      strength and balance was found. However, these results still require statistical
      confirmation. Thus this objectives of this study are

        -  To assess the efficacy of exercise training with the Wii Balance Board ® Platform

        -  To evaluate the effectiveness of physical therapy (based on current guidelines)

        -  To compare these two types of care (conventional physiotherapy versus Wii) to a control
           group (non-treatment).
    


Intervention name(s): Physical Therapy; Wii Balance Board
Intervention type(s): Other; Other
Intervention description(s): These patients have a standardized conventional therapy (i.e. 9 sessions of physical therapy over 6 weeks); These patients get an instruction about how to install and use the Wii Balance Board ®. After the instruction they get the equipment for 6 weeks.
Other intervention name(s): physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ankle sprain; Balance; Gait
First-In-Human Phase I Trial of Ningetinib ( CT053PTSA ) in the Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, single-arm, single-center, open-label, dose-escalation Study evaluating
      the safety and efficacy of CT053PTSA in patients with Advanced Solid Tumors
    

Detailed description: 
      This is a dose-escalation study. The primary purpose is to determine the dose limiting
      toxicity (DLT), maximum tolerated dose (MTD) and recommend doses and regimen of CT053PTSA for
      further studies.
    

Intervention name(s): CT053PTSA
Intervention type(s): Drug
Intervention description(s): CT053PTSA will be administered daily in fasting state
Other intervention name(s): Ningetinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transcranial Magnetic Stimulation in Children With Stroke
Condition: Hemiparesis; Neonatal Stroke; Ischemic Stroke; Hemorrhagic Stroke; Thrombotic Stroke
MeSH terms: Stroke; Ischemic Stroke; Paresis; Hemorrhagic Stroke; Thrombotic Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study of repetitive transcranial magnetic stimulation (rTMS) to test
      tolerance and efficacy in children who have hemiparesis from acquired or presumed perinatal
      stroke.
    

Detailed description: 
      The investigators will begin to test the hypothesis that rTMS will be tolerated and will
      result in improved hand strength and mobility when compared with sham stimulation.

      Aim 1: To determine whether 1 Hz rTMS applied to the hemisphere opposite the infarct
      (contralesional or healthy hemisphere) is tolerated by children ages 6-18 years who have
      chronic motor sequelae from a stroke.

      Aim 2: To determine whether 8 sessions of inhibitory 1 Hz rTMS to the contralesional healthy
      hemisphere improves grip strength and hand mobility when compared with sham stimulation in
      controls.
    

Intervention name(s): Transcranial Magnetic Stimulation; Sham Magnetic Stimulation
Intervention type(s): Device; Device
Intervention description(s): Transcranial Magnetic Stimulation, repetitive at 1Hz; Sham Magnetic Stimulation
Other intervention name(s): MagStim; MagStim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Childhood stroke; Perinatal stroke; Pediatric stroke; Presumed perinatal stroke; Children who have hemiparesis
Evaluation of the Efficacy of Polybutester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted; Postoperative Complications
Study type: Interventional

Summary: 
      This study aimed to evaluate the efficacy of polybutester sutures on postoperative
      complications in lower impacted third molar surgery.
    

Detailed description: 
      After extraction of the bilateral lower third molars (35 patients), two different types of
      sutures were used on each side. Group 1( Polybutester suture) , group 2 (Polypropylene
      suture). Measurements to evaluate edema, trismus, and pain (using the VAS scale) had been
      taken pre-procedure and post-procedure( 2nd and 7th day )
    

Intervention name(s): Polybutester suture; Polypropylene suture
Intervention type(s): Device; Device
Intervention description(s): After third molar surgery this suture used for primary closure.; After third molar surgery this suture used for primary closure.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Polybutester; Polypropylene; Pain; Edema; Trismus
Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients
Condition: Spinal Curvatures
MeSH terms: Spinal Curvatures
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      During the surgical procedure of scoliosis correction, large surgery extent and long-lasting
      strong nociceptive stimulation lead to postoperative pain formation of greater intensity
      compared with other orthopedic interventions. In these patients, duration of postoperative
      symptoms is longer, and may lead to persistent pain formation due to developing neuroplastic
      changes in the central nervous system.
    

Detailed description: 
      Instrumentation in correction operations for spinal deformities as vertebral fusion,
      congenital and traumatic scoliosis, carries a 0.5-5% risk of injuring the spinal cord during
      spinal surgery.

      These complications are generally results of complex factors such as direct effects of
      compression on the spinal cord, distraction, the effects of spinal ischemia or arterial
      hypotension.

      The purpose of the wake-up test is to monitor voluntary motor function of the lower limbs
      once the vertebrae have been instrumented and distracted. The depth of anesthesia is
      gradually lightened up to the point where patients are able to respond to verbal commands. As
      the voluntary movement of lower extremities is demonstrated, the depth of anesthesia is
      increased to complete the surgery.
    

Intervention name(s): Group A amantadine sulfate; Group B ringer lactate
Intervention type(s): Drug; Other
Intervention description(s): infusion solution for slowly intravenous application 3 hours preoperative; infusion solution for intravenous application 3 hours preoperative
Other intervention name(s): PK-Merz Infusion amantadine sulfate; ringer lactate; Lactated ringer
Intervention MeSH terms: Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the role of preoperative administration of Amantadine Sulphate on the duration of wake up test and postoperative opiod consumption in patients undergoing major spine deformities corrective surgeries.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effects of an Exercise Program for Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      exercise program in the pulmonary function and cardiorespiratory fitness in children with
      asthma and respiratory symptoms
    

Detailed description: 
      This study aims to analyze the effects of an exercise program in the pulmonary function,
      cardiorespiratory fitness, diet quality index, physical activity, body composition, muscle
      function, agility, and psychological health in a group of children with asthma and
      respiratory symptoms
    

Intervention name(s): Exercise program
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Respiratory symptoms; Exercise program; Functional capacity; Body composition
When to Perform Bladder Catheterization in Fast-track Hip and Knee Arthroplasty
Condition: Postoperative Urinary Retention (POUR)
MeSH terms: Urinary Retention
Study type: Interventional

Summary: 
      Approximately 40 % of all patients undergoing fast-track total hip or knee arthroplasty needs
      intermittent bladder catheterization after surgery, as they are transient incapable of
      voluntary bladder emptying (postoperative urinary retention - POUR). The currently used
      interventional threshold for urinary bladder catheterization are a bladder volume of
      approximately 500 ml., but no evidence exists for this threshold. At the same time, the
      current knowledge suggest, that a bladder volume up to 1000 ml. for 2-4 hours are safe in
      humans, and as the use of urinary bladder catheterization are increasing the risk of
      complications, the investigators are hypothesizing that increasing the interventional
      threshold for urinary bladder catheterization after fast-track total hip or knee
      arthroplasty, will reduce the number of patients needing urinary bladder catheterization,
      without increasing the incidence of urological complications - including urinary tract
      infections.
    


Intervention name(s): increased interventional threshold for urinary bladder catheterization (800 ml); Current used interventional threshold for urinary bladder catheterization (500 ml); Intermittent bladder catheter
Intervention type(s): Procedure; Procedure; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Postoperative urinary retention; Fast-track total hip (THA) and knee arthroplasty (TKA); Urinary bladder volume
Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure
Condition: Acute-On-Chronic Liver Failure; Cirrhosis and Chronic Liver Disease
MeSH terms: Liver Diseases; Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure
Study type: Observational

Summary: 
      Acute-on-chronic liver failure (ACLF) is an ailment with high incidence of multiorgan failure
      (MOF) and consequent mortality. Systemic inflammation and susceptibility to infection are
      characteristic pathophysiological features. Prostaglandin E2 (PGE2) could subdue systemic
      inflammation and alleviate liver injury in mice model. However, there are no studies
      evaluating PGE2 as a predictor of early mortality.This study is designed to investigate
      whether plasma PGE2 and its receptors are associated with development of MOF and predict
      short-term mortality in patients with acute-on-chronic liver failure. By the way, we will
      also measure several other potential predictive factors (C-reactive protein,severe
      hyponatremia, Second infections,Diabetes mellitus,High density
      lipoprotein,interleukin-10,serum bile acids,ferritin,the neutrophil to lymphocyte
      ratio,soluable urokinase plasminogen activator receptor,vWF-Ag levels and FVIII-to-PC
      ratios).
    


Intervention name(s): plasma suPAR, PGE2 measurement. Other biomarkers were just recorded from clinical laboratory.
Intervention type(s): Diagnostic Test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The cohorts will be selected from Provincial General Hospital
Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)
Condition: Sphincter of Oddi Dysfunction
MeSH terms: Sphincter of Oddi Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-label single center study of duloxetine in patients with SOD who have failed to respond
      to the standard treatments.

      This protocol is designed to explore the tolerability and efficacy of Duloxetine in the
      management of patients with known or suspected Sphincter of Oddi dysfunction (SOD).
    

Detailed description: 
      SOD is a disorder involving the bile duct or pancreas causing a burning pain or cramping in
      the epigastric (upper stomach) area that can radiate (spread) to the back or under the right
      shoulder blade. This discomfort is thought to be caused by tightening of the Sphincter of
      Oddi, which is the muscle opening that controls the flow of bile and juices from the pancreas
      (enzymes) into the small intestine. It can also be caused by contractions of the common bile
      duct (the duct that allows bile from the liver into the small intestine).

      The purpose of this research is to study how well a medication called Duloxetine works when
      used to treat pain associated with SOD. Duloxetine (also called Cymbalta) is a medication
      approved by the FDA for the treatment of depression and for the treatment of pain caused by
      nerve damage associated with diabetes. However, for the purposes of this research, Duloxetine
      is considered investigational (experimental) since it will test how well this medication
      works for the treatment of pain associated with SOD. (Cymbalta replaced with Duloxetine in
      remainder of consent as requested).

      PRIMARY OBJECTIVE

      ● Treatment effect as measured by the global assessment of change (PGIC) after 3 months of
      treatment with duloxetine.

      SECONDARY OBJECTIVES

        -  Toleration of the medication as measured by the duloxetine compliance rate;

        -  Safety as recorded by adverse events (AEs)

        -  Effect of treatment on pain reduction as measured by a pain burden assessment tool
           (RAPID 3 & RAPID 1-Month);

        -  Effect of treatment on quality of life (QOL) as measured by the SF-36.
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): A preliminary, open-label single center study of duloxetine in patients with SOD
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SOD; Common Bile Duct Diseases; Sphincterotomy; Cholangiopancreatography, Endoscopic Retrograde