bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Evaluation of a Commercial Preparation Containing Lactobacillus Casei DG on the Reduction of the Painful Symptoms Related to the Irritable Bowel Syndrome (IBS). A Pilot Clinical Study
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of a treatment with Lactobacillus casei
      DG in the reduction of the painful symptoms in patients affected by irritable bowel syndrome.
      After that, the secondary object is to evaluate if the reduction of painful symptoms is
      related to a relevant reduction of trypsin and tryptase in colonic mucosa.
    


Intervention name(s): Lactobacillus casei DG
Intervention type(s): Dietary Supplement
Intervention description(s): Lactobacillus casei DG (24 billion of live cells per pill) - 2 pills b.i.d. for 4 weeks
Other intervention name(s): Enterolactis plus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lactobacillus casei DG; Irritable Bowel Syndrome
Pneumococcal Vaccine in Untreated CLL Patients
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether patients with chronic lymphocytic leukaemia
      (CLL) will benefit from vaccination with a 13-valent conjugated pneumococcal vaccine,
      Prevenar13, compared with a conventional 23-valent capsular polysaccharide vaccine in terms
      of immune response.
    


Intervention name(s): Prevenar 13; Pneumovax
Intervention type(s): Drug; Drug
Intervention description(s): 13-valent pneumococcal conjugated vaccine; 23-valent pneumococcal polysaccharide vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome
Condition: HIV (Human Immunodeficiency Virus); Metabolic Syndrome; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Metabolic Syndrome; Syndrome; Weight Loss
Study type: Interventional

Summary: 
      Obese HIV-positive women with Metabolic Syndrome (HIV-MS) and obese HIV-negative women with
      Metabolic Syndrome will be studied before and after achieving moderate (6%-8%) diet-induced
      weight loss. The investigators hypothesize that health markers will improve in both groups
      but that the improvement will be blunted in the women with HIV-MS.
    


Intervention name(s): Dietary Intervention
Intervention type(s): Behavioral
Intervention description(s): The nutrition curriculum will involve weekly group and individual sessions. The initial calorie goal will be ~750 kcal below the resting energy equivalent, and adjusted as needed to achieve weight loss targets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIV; Metabolic Syndrome; Obesity; Treatment Experienced
Probiotic Supplementation as Prophylactic for Group B β-hemolytic Streptococcus (GBS) Infection
Condition: Genitourinary; Infection, Complicating Pregnancy
MeSH terms: Infections; Pregnancy Complications
Study type: Interventional

Summary: 
      Streptococcus agalactiae, a Group B β-hemolytic streptococcus (GBS), is the leading cause of
      severe neonatal infection in developed countries. There is growing scientific interest in
      probiotic supplementation in pregnancy as possible prophylaxis for GBS infections and urine
      culture positivity.
    

Detailed description: 
      There is strong scientific evidence that supports the correlation between bacterial vaginosis
      (BV), a term used to define a change in the vaginal ecosystem, and spontaneous preterm birth.
      Antibiotic treatments are recommended to counteract both the presence of S. agalactiae and
      the onset of BV. The latter, however, are not without risks, as they can in turn cause
      alterations in the vaginal microbiota and is associated with an increased risk of
      miscarriage.

      Recent research have shown that probiotic treatment can help reduc the risk of preterm birth
      and positivity of Group B β-hemolytic streptococcus (GBS) infection.

      The present study aimed to assess the efficacy and safety of a probiotic iNatal® (probiotic
      mixture containing 10 ml CFU of Enterococcus faecium L3, 3 billion CFU of Bifidobacterium
      animalis subsp. lactis BB-12, 3 billion CFU of Lactococcus lactis SP38, 3 billion CFU of
      Lacticaseibacillus casei R0215) in pregnant wemen in 24 to 36 weeks of gestation as
      prophylaxis of GBS infections and urine culture positivity.

      This was a retrospective, observational, controlled and single centre study.
    

Intervention name(s): Probiotic iNatal®
Intervention type(s): Dietary Supplement
Intervention description(s): iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Probiotic supplement group
Masking: None (Open Label)
Primary purpose: Supportive Care
Study of the Impact of the Regular Consumption of Polyphenol-rich Grape Juice on the Biological Parameters of Oxidative Stress and on Endothelial Function in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      Many epidemiological and clinical studies have suggested the negative effect of oxidative
      stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably in
      patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers.

      Polyphenols, notably those present in red grapes, have a certain antioxidant effect. Dietary
      supplementation with polyphenols in high-risk patients could diminish the harmful
      consequences of oxidative stress.

      The aim of this study is to show that the daily consumption of grape juice rich in
      polyphenols " R@isol ", has a positive impact on the oxidation/antioxidation balance in
      healthy volunteers.
    


Intervention name(s): Grape juice R@isol; Commercially-available grape juice
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Cognition Intervention Study Dortmund- Continued (Coco)
Condition: Cognitive Function
Study type: Interventional

Summary: 
      The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study
      Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch
      versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive
      functions in the afternoon. The present Coco study connect this two previous studies and
      investigates the effect of having school lunch versus skipping it on children's basal and
      executive cognitive functions later in the afternoon.
    

Detailed description: 
      Because of cerebral particularities, children may react highly sensitive to variations of
      nutrient supply. Therefore, an optimised composition of meals at favourable mealtime should
      be considered for optimal cognitive performance. The increasing implementation of all-day
      schools in Germany requires the children's catering for lunch at school. However, the number
      of 'meal skippers' is increasing among children and adolescents. Thus, the effect of skipping
      lunch at school on cognitive functioning is examined in this experimental cross-over trial.
      As prior intake of food can have an influence on the physiological effect of test meal, the
      children's dietary intake in the mid-morning is standardized. The intervention is integrated
      in everyday school life:

      9.15 a.m. standardized snack within the frame of the regular break, 9.45 a.m. to 12.25 p.m.
      everyday school life, 12.25 p.m. either lunch (control) or water as a beverage (intervention
      of 'skipping meal'), 12.45 p.m. to 1.15 p.m. regular lunch break, 1.15 p.m. to 14.10 p.m.
      regular school lesson. 14.15 p.m. computerized tests of executive cognitive and basal
      (alertness) functioning, 3 p.m. lunch for the 'skipping meal'-group. Parameters of cognition
      with relevance to everyday school life are measured by a computerized test program developed
      by the Institute of Working Learning and Aging (ALA). Usual eating behaviour, sleep
      behaviour, physical activity and parental education were determined as control variables by
      questionnaires for children, parents.
    

Intervention name(s): Having lunch/skipping lunch; Skipping lunch/having lunch
Intervention type(s): Other; Other
Intervention description(s): Lunch ad libitum on test day 1 and no lunch on test day 2. Water at libitum was constantly available on both days.; No lunch on test day 1 and lunch ad libitum on test day 2. Water at libitum was constantly available on both days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Having Lunch; Skipping Lunch
Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a one-year multi-centre, double blind, placebo controlled, randomized trial
      investigating oral vitamin D3 (Colecalciferol) as an add-on treatment to interferon-beta-1b
      for Multiple Sclerosis (MS). Not less than one month after initiation of therapy with
      interferon beta 1b, MS patients will be randomised to once weekly treatment with peroral
      colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 0.5 mg of vitamin
      D3, or to once weekly peroral treatment with matching placebo. The hypothesis is that vitamin
      D suppresses clinical and MRI activity of MS.
    

Detailed description: 
      The patients will be examined clinically at baseline and at 6, and 12 months. Laboratory
      assessments will be performed at screening and 1, 2, 3, 6, 9 and 12 months after baseline.
      MRI will be performed (T1-weighted and T2-weighted) at randomization and 12 months
      thereafter. Sample size is 80 patients: two groups with 40 patients in each group. The
      primary statistical analyses will be based on the intent-to-treat (ITT) population which
      consist of all randomized patients who have started study medication. The primary efficacy
      variable MRI T2 BOD will be analyzed using ANCOVA with MRI T2 BOD at baseline as covariate.
      The incidence (with corresponding 95% confidence interval) of hypercalcaemia (mild, moderate
      and severe), laboratory abnormalities, dose adjustments, and significant adverse events will
      be calculated. The vitamin D status (proportion of patients with P-PTH <20 ng/l and S-OH(D)2
      >85 nmol/l) at 6 and 12 months will be analyzed using logistic regression.
    

Intervention name(s): colecalciferol
Intervention type(s): Drug
Intervention description(s): Once weekly peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) that contain 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D3 for a duration of 12 months
Other intervention name(s): (Dekristol®, Swiss-Caps, Switzerland)
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MS; vitamin D; environment
Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)
Condition: Chronic Hepatitis C(CHC)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients
      with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.
    


Intervention name(s): MP-424; RBV(24 weeks); IFN beta(24 weeks); RBV(48 weeks); IFN beta(48 weeks)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): MP-424: 750mg every 8 hours (q8h) for 12 weeks; RBV: 600 - 1000mg/day based on body weight for 24 weeks; IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks; RBV: 600 - 1000mg/day based on body weight for 48 weeks; IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 weeks
Intervention MeSH terms: Interferon-beta
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Feron
Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy
Condition: Intubation, Endotracheal; Anesthesia, General; Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine whether orotracheal intubation in morbidly obese
      patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the
      Macintosh direct laryngoscope.
    


Intervention name(s): GlideScope; Macintosh direct laryngoscope
Intervention type(s): Device; Device
Intervention description(s): Orotracheal intubation; Orotracheal intubation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Alcohol and Sex Risk Intervention for MSM Supplement
Condition: Heavy Drinking and Sexual Risk Behavior
Study type: Interventional

Summary: 
      Open pilot trial to test the feasibility and efficacy of a brief intervention with text
      messaging to reduce sexual risk behavior and heavy drinking among MSM
    

Detailed description: 
      This study seeks to develop and provide an initial test of a brief intervention to reduce
      alcohol use and sex risk behavior among among men who have sex with men. The study seeks to
      recruit MSM who are non-monogamous, have engaged in unprotected anal intercourse over the
      past 3 months, and who have engaged in heavy drinking defined as > 14 drinks per week or at
      least 1 heavy drinking episode (5+ drinks on a single occasion) in the past month. All
      participants will complete baseline measures about past month behavior and if eligible will
      be assigned to the intervention condition. This intervention consists of a single brief
      in-person intervention coupled with 4 weeks of text messaging related to individualized goals
      about alcohol use and sexual behavior. Follow-up assessments are scheduled for within 1 week
      of completion of the text messaging component of the intervention. Primary outcomes are
      feasibility and acceptability of the intervention and message components. Secondary outcomes
      are changes in frequency of unprotected intercourse and heavy drinking episodes.
    

Intervention name(s): Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM
Intervention type(s): Behavioral
Intervention description(s): Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use
Other intervention name(s): Intervention to reduce heavy drinking and sex risk among MSM
Intervention model: Single Group Assignment
Intervention model description: Open pilot study to test feasibility of intervention
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: heavy drinking; sexual risk behavior
Childhood Schistosomiasis: a Novel Strategy Extending the Benefits/Reach of Antihelminthic Treatment
Condition: Schistosomiasis
MeSH terms: Schistosomiasis
Study type: Observational

Summary: 
      Objective and Hypotheses: This project has the overall objective of implementing and
      evaluating new approaches to reducing the current and future burden of urinary
      schistosomiasis in young children using the antihelminthic drug Praziquantel. The project
      aims to (1) determine the operational health benefits of treating schistosome infections
      early on re-infection and morbidity reduction, (2) determine if gut or urine microbiome
      structure (species diversity or abundance) is a risk factor for S. haematobium infection or
      morbidity, and (3) elucidate the factors and underlying mechanisms mediating the
      reduction/reversal of schistosome-related morbidity and resistance against
      infection/re-infection in young children.
    

Detailed description: 
      This study aims to refine current paediatric treatment of schistosomiasis using the drug
      Praziquantel (PZQ) to improve the current and future health of pre-school children and
      infants. Praziquantel is cheap, highly efficacious and safe, presenting a realistic
      opportunity of using a pre-existing tool in a modified way to benefit child health and
      development. The study will focus on children aged 3 to 5 years of age, comparing the impact
      of early vs. later treatment with PZQ on the current and future health status of the
      children. By killing worms PZQ stops the morbidity related to the presence of worms and eggs
      such as anaemia, abdominal pain, diarrhoea and blood in the urine as well as induced immune
      responses associated with reduced re-infection rates. Therefore the study will investigate
      the immediate health benefits of treating pre-school children and infants and the effects of
      treatment on re-infection rates.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Zimbabwean pre-school children male and female
      
Keywords: paediatric schistosomiasis; morbidity; immunology
Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Controlled trial of the efficacy and safety of valproate, versus risperidone in children,
      ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or hypomanic episode.
    

Detailed description: 
      The objective of this study was to study the efficacy and safety of valproate, versus
      risperidone in children, ages 3-7 yr. with Bipolar I or II Disorder, mixed, manic or
      hypomanic episode.
    

Intervention name(s): Risperidone; Valproic Acid; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Liquid risperidone; Liquid valproic acid
Other intervention name(s): Risperdal; Valproate
Intervention MeSH terms: Valproic Acid; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Beet Root Supplement Trial
Condition: Trained or Competitive Cyclists
Study type: Interventional

Summary: 
      To examine the effects of two forms of beetroot juice supplementation on exercise performance
      in trained cyclists.
    


Intervention name(s): Beetroot juice; Beetroot powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Beet root; exercise performance; cyclists
Ultrasound Guided Pudendal Block in Transurethral Prostatectomies
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The pudendal nerve conveys sensory, motor, sympathetic fibres to the perineum, bladder neck
      and proximal urethra. Pain management during transurethral procedures is a major
      concern.Patients who have been catheterized under anesthesia complained of urgency in the
      postoperative period because of catheter-related bladder irritation. We want to investigate
      that the effect of pudendal block to postoperative pain, bladder spasm and patient comfort in
      transurethral prostatectomies
    

Detailed description: 
      Outcome measures USG guided transperineal pudendal block success Postoperative pain score
      (VAS score) Postoperative bladder spasm (Severity of bladder discomfort will record as
      severe(behavioral responses such as strong vocal response, flailing limbs),moderate (not
      accompanied by any behavioral responses) and no bladder discomfort.

      Postoperative patient's comfort (poor, sufficient, good)
    

Intervention name(s): Pudendal nerve block
Intervention type(s): Procedure
Intervention description(s): the pudendal nerve block is going to be performed to the medial of ischial tuberosity with USG guidance in lithotomy position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pudendal nerve block; postoperative pain; bladder spasm
A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the effectiveness of QAV680 against placebo in treating the symptoms
      of seasonal allergic rhinitis in an Environmental Exposure Chamber.
    


Intervention name(s): QAV680; QAV680; Mometasone Furoate
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Seasonal Allergic Rhinitis; Environmental Exposure Chamber; nasal lavage
Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A
      prolonged QT interval is a risk factor for arrhythmias.
    


Intervention name(s): PF-00232798; PF-00232798; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 600 mg oral solution once daily x 7 days; 300 mg oral solution once daily x 7 days; Oral solution once daily x 7 days; 400 mg tablet single dose
Intervention MeSH terms: Moxifloxacin; PF 232798
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PF-00232798; CCR5; QT; QTc; pharmacokinetics