bioihbjkbjnl/mcl2 huggingface dataset:
Double-blind Randomized Controlled Trial in Severe Alcoholic Hepatitis
Condition: Alcoholic Hepatitis; Alcoholic Liver Disease
MeSH terms: Hepatitis A; Hepatitis; Liver Diseases; Hepatitis, Alcoholic; Liver Diseases, Alcoholic
Study type: Interventional
Phase: Phase 3

Summary: 
      The treatment of severe forms of alcoholic hepatitis (AH) constitutes a major challenge for
      clinicians involved in the management of severe alcoholic liver disease. In patients with
      Maddrey function higher than 32, compelling evidence from data has shown that corticosteroids
      improve short-term survival. However, novel strategies or molecules are required in light of
      the fact that approximately 40 % of patients continue to die at 6 months. A double-blinded
      randomized controlled trial of 101 patients has showed that Pentoxifylline improves survival
      of patients with severe AH, as compared to placebo. In terms of mechanisms, the effect of
      pentoxifylline is related to prevention of hepatorenal function whereas corticosteroids
      induce an early improvement in liver function. When considering these differences of
      mechanisms, many clinicians suggest that the addition of pentoxyfilline to corticosteroids is
      an attractive option that needs to be tested in patients with severe AH.
    

Detailed description: 
      The aim of the present study is to determine whether or not the adjunction of Pentoxifylline
      to corticosteroids would improve 6-month survival of patients with severe alcoholic
      hepatitis. This multicenter, randomized, double-blinded, controlled, phase 3 trial was
      conducted in 24 centers located in France and Belgium. Alcoholic hepatitis was biopsy-proven.
      All eligible patients were randomly assigned in a 1:1 ratio to receive corticosteroids +
      Pentoxifylline or corticosteroids + Placebo. The primary outcome of the study was 6-month
      survival. Assuming a two-sided type I error of 0.05, a randomization ratio of 1:1 between the
      2 groups, 6-month survival of 64% in the Placebo and Corticosteroids group and of 78 % in the
      Pentoxifylline and Corticosteroids group, we estimated that with 268 randomized patients (134
      in each group), the study would have a power of 80% to detect this increase in 6-month
      survival in the Pentoxifylline and Corticosteroid group.
    

Intervention name(s): Pentoxifylline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg prolonged-released tablets 3 time per day for 1 month.; prolonged-release tablets 3 time per day for 1 month
Other intervention name(s): TORENTAL 400MG
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
New Triple Hop Test Quality Assessment Tool
Condition: ACL Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      This study will develop a new jump assessment tool for the Triple Hop Test, and will test its
      reliability on adolescent and adult, healthy and post- anterior cruciate ligament (ACL)
      population.

      Creating a new assessment test for a jump test that incorporates the known movement
      components that are important after an ACL injury can improve patient evaluation, decision
      for return to sport activity and injury prevention.
    

Detailed description: 
      Study population- Adults, women and men aged 20-45, boys and girls aged 12-15. uninjured
      population: non symptomatic subjects, without major injury in their history. Injured
      population: ACL injured subjects, 9-12 month after beginning of treatment/surgery.

      Stages of study:

      stage 1- The investigators will create a new high-quality literature-based assessment test
      for the triple hop test (NTHT). The test will have 10 sections, its score ranges from 0 to 14
      points and a high score means poor performance.

      Stage 2- Performing reliability tests between and within the testers for NTHT. The tests will
      be done with the help of video photography of NTHT.

      Stage 3- Performing NTHT and THT tests on healthy adult and adolescent subjects and on ACL
      adult and adolescent subjects, assessing the NTHT by watching video performance.
    

Intervention name(s): new triple hop test
Intervention type(s): Other
Intervention description(s): New jumping assessment will be performed in all included study groups. This new assessment includes quality evaluation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 subgroups performing jump test
Masking: None (Open Label)
Primary purpose: Screening
Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function
Condition: PMV
MeSH terms: Cough
Study type: Interventional

Summary: 
      The patients with prolonged mechanical ventilation (PMV) have the risk of ineffective
      coughing and infection due to diaphragm weakness, making it more difficult to wean. This
      study aimed to explore the intervention of abdominal weight training (AWT) with/ without
      cough machine (CM) on lung function, respiratory muscle strength and cough ability in these
      patients.
    

Detailed description: 
      Methods 40 patients with PMV were randomly assigned to three groups: AWT group (n=12), AWT+CM
      group (n=14) and control group (n=14). The effectiveness on pulmonary function, respiratory
      muscle strength and cough ability were compared among these three groups.
    

Intervention name(s): cough machine (CM); abdominal weight training (AWT)
Intervention type(s): Device; Device
Intervention description(s): Cough machine training is based on the cough assist machine Comfort Cough II (CC20), in which the inhalation and exhalation times are adjusted to 1-3 seconds, and the positive and negative pressure of the lower pressure 10-15 cmH2O is gradually increased to 30-40 cmH2O for the first time, 4-6 cycles/time, repeated 4-6 times, twice a day, five days a week, until the subject is weaned off the ventilator or transferred out of the ward. A modified Borg scale was used as an indicator of perceived dyspnea.; abdominal weight exercise training (sandbag) is maintained for 30 minutes; the starting weight is 1kg to 2kg, and the previous day's weight is maintained each day as well as adding 0.5kg daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: AWT group (n=12), AWT+CM group (n=14) control group (n=14).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prolonged mechanical ventilation; weaning ventilator; abdominal weight training; cough machine
Pilates-based Core Strengthening on Patellofemoral Pain Syndrome
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      Patellofemoral pain syndrome (PFPS) is one of the most common musculoskeletal pain conditions
      that tend to become a chronic problem. PFPS is common among young adolescents, particularly
      in physically active individuals aged 12 to 17 years old with more prevalence among females,
      as it affects females 1.5 - 3 times when compared to males.
    

Detailed description: 
      Adolescents with PFPS usually complain of retro-patellar pain (behind the kneecap) or
      peripatellar pain (around the kneecap) and crepitation in the knee joint, and also there is
      discomfort while sitting with a flexed knee for a long time. Symptoms are usually exacerbated
      by activities that increase the load on patellofemoral joints such as weight-bearing
      activities, squatting, walking up or downstairs, and running.

      PFPS takes place whenever the muscles around the knee fail to keep the kneecap properly
      aligned, leading to abnormal lateral tracking of the patella.Overuse such as running and
      jumping sports, the trauma of kneecaps such as fracture, dislocation, or knee surgery may
      also predispose to PFPS.
    

Intervention name(s): Pilates exercises; Traditional physical therapy program
Intervention type(s): Other; Other
Intervention description(s): Side kick internal/ external rotation with Pilate's band; strength, flexibility
Other intervention name(s): Pilates band; strengthening exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: patellofemoral pain syndrome; Pilates exercises; functional status
Prevention of Post Traumatic Stress Disorder by Early Treatment
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      To prospectively evaluate the effect of early treatment (cognitive therapy (CT),
      cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of
      post-traumatic stress disorder in recent survivors of traumatic events.
    

Detailed description: 
      Consecutive civilian trauma survivors will be contacted, by phone, within five days of
      admission to Hadassah University Hospital in Jerusalem and asked about their early
      psychological responses to the event. A short telephone interview will be administered to
      consenting subjects, to evaluate the presence of acute stress disorder (ASD). Subjects with
      ASD (full or partial) and those who so desire will be invited to clinical assessment, which
      will take place within the next two weeks. Survivors with significant symptoms of
      post-traumatic stress disorder will be randomized to five arms of twelve-week long treatment:
      CBT, CT, SSRI/placebo and waiting list (WL) and start treatment immediately. Subjects will be
      allowed to decline one form of therapy. WL subjects will start therapy 12 weeks later. All
      subjects who had clinical interview will be interviewed again at four and seven months - and
      14 months following trauma (phone interview).
    

Intervention name(s): Cognitive Behavioral Therapy; Cognitive Therapy; Escitalopram; Placebo
Intervention type(s): Procedure; Procedure; Drug; Other
Intervention description(s): 12 weekly 1.5 hours weekly session of cognitive behavioral therapy (Prolonged Exposure); 12 weekly 1.5 hours weekly session of cognitive therapy without exposure; Twelve weeks of treatment with Escitalopram at Max. daily dose of 20mg; Twelve weeks of treatment with placebo pills resembling the original Escitalopram 10mg tablets but containing no active substance
Other intervention name(s): SSRI
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Traumatic Events; Post-traumatic Stress Disorder; Treatment (psychological); Treatment (pharmacological); Prevention; SSRIs
Egg Consumption and Muscular Adaptations
Condition: Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      Eggs may be a viable alternative to various types of supplemental proteins given its similar
      ratings on various measures of dietary protein quality.

      The investigators hypothesis is that whole eggs would create a greater improvement in
      skeletal regulatory markers, hormonal responses and body composition than egg white ingestion
      in resistance-trained men.
    

Detailed description: 
      The aim of this investigation was to compare the effects of whole egg versus egg white
      ingestion (daily and after training sessions) during 12 weeks of resistance training on
      skeletal muscle regulatory markers, hormonal responses and body composition in
      resistance-trained men. Specific aims of the study are to:

      To investigate the extent to which both whole egg and egg white ingestion will improve
      anabolic factors, fat free mass, fat mass and decrease catabolic markers after 12 weeks of
      resistance training in resistance-trained men.
    

Intervention name(s): Whole egg and resistance training; Egg whites and resistance training
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This intervention consisted of whole egg consumption concomitant with 12 weeks of resistance training. Subject ingested three whole eggs per day immediately after resistance training.; This intervention consisted of egg white consumption concomitant with 12 weeks of resistance training. Subject ingested an isonitrogenous quantity of six egg whites per day immediately after resistance training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Pain Response During Examination for Retinopathy of Prematurity
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional

Summary: 
      Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have
      ophthalmologic examination for ROP at 6 weeks old. They will be randomized blindly to receive
      2 ml of 12.5% dextrose in water (D12.5W) orally five minute before examination (intervention
      group) or nothing (control). NIPS scale will be applied two minutes before examination and
      two minutes after examination.
    


Intervention name(s): suck 12.5% dextrose in water 5 minutes before the procedure
Intervention type(s): Behavioral
Intervention description(s): Newborns will suck 2 ml of D12.5W 5 minutes before eye exam for ROP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prematurity; retinopathy of prematurity; pain; very low birth weight infants
Extended Treatment With PEG-Intron® and Rebetol® in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a controlled, randomized, parallel-groups, open-label, multinational study designed
      to evaluate the efficacy and safety of PEG-Intron® (pegylated interferon alfa-2b) plus
      Rebetol® (ribavirin) in subjects with chronic hepatitis C. It is designed to evaluate whether
      72 weeks of treatment with PEG-Intron plus Rebetol is more effective than 48 weeks of
      treatment in subjects with Genotype 1 chronic hepatitis C who exhibit a slow response to
      treatment.
    


Intervention name(s): Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®); Combination of pegylated interferon alfa-2b and ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks
200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks; Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strength), subcutaneous, dose of 1.5 micrograms/kg, weekly for 72 weeks.
200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 72 weeks
Other intervention name(s): (a) SCH 54031; PEG-Intron; PegIntron; ViraferonPeg.; (b) SCH 18908; Rebetol; REBETOL.; (a) SCH 54031; PEG-Intron; PegIntron; ViraferonPeg.; (b) SCH 18908; Rebetol; REBETOL.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mediators of Kidney-Bone Communication in Childhood
Condition: Fasting Blood Measures; Body Scans
Study type: Observational

Summary: 
      An identified hormone linking bone and kidney function is Fibroblast Growth Factor-23
      (FGF23). Data on the variation of FGF23 levels for bone and mineral metabolism in children
      are scarce. Currently it is assumed that meeting mineral requirements for the skeleton serves
      the body's overall needs. However, it is not clear as to whether this is true, particularly
      with growth. The contribution of dietary factors directly linked with the bone/kidney axis
      through measurement of intake (via 24hr recall) and kidney nutrient clearance (via serum and
      urinary analysis) will be included in investigations. Findings will serve as a springboard
      for delineating more specific mechanisms by which these systems become disordered and are
      influenced by diet. It is expected that adequacy of nutrients known to have a central role in
      bone function will optimize the hormonal milieu through crosstalk with the kidney.

      This effort will allow ongoing investigation in detecting and treating disturbances in
      mineral metabolism related to kidney disease, specifically in the pediatric population and
      broaden the understanding of kidney disease itself, as well as that of chronic diseases in
      which kidney health is of importance, such as diabetes and osteoporosis. Findings of this
      research may stress the importance of achieving dietary adequacy essential for establishing
      optimal body composition trajectories, particularly puberty.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy boys ages 7-11y
      
Biospecimen description: 
      Plasma DNA collected to obtain ancestry informative markers and single nucleotide
      polymorphisms involved in mineral metabolism
Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate
Condition: Colonic Adenoma; Colonic Polyp; Colonoscopy
MeSH terms: Adenoma; Colonic Polyps
Study type: Interventional

Summary: 
      This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy.
      The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV)
      to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps
      (average number of polyps) in routine colonoscopy.

      This is a prospective comparative study, on 2000 patients, 1000 in each group (with and
      without ECV)
    

Detailed description: 
      This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy.
      The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV)
      to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps
      (average number of polyps) in routine colonoscopy.

      Number of patients:

      2000 patients, 1000 in each group (with and without ECV). To limit the risk of bias, the
      investigators will random two teams of 12 endoscopists matched in number, volume of activity
      and Adenoma Detection Rate (evaluated over a period of the year preceding the study).

      Both periods of study will be approximately 3-4 months in length. In order to achieve a
      perfect balance between the two groups of patients, an inclusion tracking chart will be
      initiate and will be carefully controlled. Rebalancing will be done for both periods of study
      to obtain 500 patients per group and per period (= 2000 patients included).

      Inclusion of 500 consecutive colonoscopies in each team of investigators, a "colonoscopy with
      ECV" team, a "colonoscopy without ECV" team then switch and inclusion of 500 new consecutive
      colonoscopies in each team, ie 2000 colonoscopies in total.

      The selection of the team that will begin with ECV (Team A) and the team that will finish
      with ECV (Team B) will be chosen at random before the start of the study.

      A comparison of the two colonoscopy groups with ECV vs without ECV will be made for each team
      (the investigator will be his own control) and then on the overall population after the end
      of the trial.
    

Intervention name(s): Endocuff Vision (ECV) second generation
Intervention type(s): Device
Intervention description(s): Colonoscopy performed with the use of "Endocuff Vision (ECV) second generation" at the tip of the scope
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Adenoma Detection Rate; Endocuff; Colonoscopy
Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia
Condition: Benign Prostate Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      Benign prostatic hyperplasia (BPH) is a common problem among aging Caucasian men that
      produces significant morbidity and hea1th care costs. It is likely that BPH is just as common
      among Chinese men. Debate exists as to whether currently available surgical and
      pharmacological options for BPH are appropriate for men in the watchful-waiting stage of this
      condition. Evidence suggests that the consumption of soy isoflavones is related to lower
      rates of BPH among Asian men. The advantages of soy isoflavones over conventional therapies
      may include better patient compliance, improved safety and lower cost. Despite the fact that
      soy isoflavones are safe and contain a health-conferring ingredient with a defined mechanism
      of action, no randomised control trial has been performed using isoflavones to treat BPH.
      Therefore, a randomised control trial is proposed to test the tolerability and effectiveness
      of soy isoflavones (Soylife) verses placebo in 182 men with defined watchful waiting BPH over
      a period of 12 months. In this trial, patients who fulfill the inclusion criteria, will
      either be given 40mg of soy isoflavones capsule (once daily) or a placebo capsule. They will
      be reviewed every three months with maximal urine flow rate, international prostate symptoms
      score and quality of life measured. Baseline tests include RFT, LFT, FBC, MSU, PSA and
      testosterone and to be repeated at 6th month and 12th month. The investigators hypothesize
      that this intervention will reduce lower urinary tract symptoms and slow the progression of
      the disease.
    


Intervention name(s): isoflavones (Soylife 25); placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40mg of soy isoflavones capsule (once daily); starch placebo
Other intervention name(s): Soylife 25
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: complementary & alternative medicine; randomized control trial; uroflowmetry; quality of life; benign prostate hyperplasia