bioihbjkbjnl/mcl2 huggingface dataset:
Expansion to Interdisciplinary HIV Prevention in Women
Condition: HIV; AIDS; Fetal Alcohol Syndrome; Alcohol Related Neurodevelopmental Disorder
MeSH terms: Fetal Alcohol Spectrum Disorders; Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      This trial will pilot test intervention strategies to increase utilization of HIV testing and
      gain knowledge for designing a clinical trial to evaluate prevention strategies to reduce HIV
      sexual transmission in the general population in Russia. The study will assess whether
      external (cost, convenience) or internal factors (low perception of own risk, reluctance to
      identify a partner as at-risk, fear of stigma) drive Russian women's reluctance to be tested
      and if peer support impacts their decision. A randomized experimental manipulation, comparing
      opt-in vs. bundled opt-out testing approaches, followed by focus group discussions, followed
      by a second-chance testing offer will be used to inform these questions. The answers will
      enable the international research team to engineer and then test an HIV testing promotion
      strategy in Russia. The project will collect preliminary data for a larger study to develop
      an evidence-based program to reduce the HIV transmission in this high risk population.
    

Detailed description: 
      A mixed methods research design combining qualitative and quantitative data collection
      methods will be used to increase the understanding of barriers to HIV testing, identify
      promising strategies to increase testing, generate research hypotheses, and design a future
      randomized clinical trial to evaluate HIV prevention targeted to at-risk women in the general
      population in Russia. The qualitative methods include structured interviews and a focus group
      participation to assess women's reasons for being the tested and possible prevention
      strategies. The quantitative methods include observation/recording of women's testing
      behaviors.
    

Intervention name(s): Opt-in or Opt-out testing; Focus Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Study participants will be offered a health screening onsite.; Study participants will be invited to participate in a focus group discussion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Prevention; HIV; AIDS; Fetal Alcohol Syndrome (FAS); Alcohol Related Neurodevelopmental Disorder (ARND)
Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of a fixed combination of
      vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes
    


Intervention name(s): Vildagliptin; Metformin; Vildagliptin + Metformin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes; vildagliptin; metformin; hemoglobin A1c
Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study
Condition: Travelers' Diarrhea
MeSH terms: Dysentery; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine
      System to actively immunize against Enterotoxigenic Escherichia coli disease in a field
      setting.
    


Intervention name(s): TD Vaccine System; TD Vaccine System
Intervention type(s): Biological; Biological
Intervention description(s): heat labile enterotoxin of E. coli (LT); placebo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention of Travelers' Diarrhea
Influence of Oxytocin on Romantic Jealousy
Condition: Sexual Infidelity; Emotional Infidelity; Jealousy
Study type: Interventional

Summary: 
      The aim is to evoke romantic jealousy between couples and investigate whether oxytocin has
      effect on it.
    

Detailed description: 
      In a double-blind, between- subject placebo (PLC) controlled design,investigators plan to
      test the effect of intranasal oxytocin on romantic jealousy evoked by the Imaginary of
      Partner's Infidelity Task and Cyberball Game in romantically attached subjects.
    

Intervention name(s): Sexual Infidelity Condition; Emotional Infidelity Condition; Neutral Condition; Player in Jealousy Condition; Player in Non-Jealousy Condition
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Oxytocin effect; romantic jealousy; Arousal Rating; Jealousy Rating
Effect Of Delta Sodium on the Postoperative Outcomes in Liver Transplant Recipients
Condition: Liver Transplant; Complications; Perioperative/Postoperative Complications; Electrolyte Disturbance
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      We analyzed the association of delta sodium levels with their effect on post liver transplant
      outcomes in consecutive patients undergoing liver transplantation. Records were analyzed for
      electrolytes and outcome measures, and data was analyzed.
    

Detailed description: 
      Preoperative hyponatremia was identified in patients. The mean change in sodium in
      hyponatremic patients was compared with inpatients with normal sodium levels. The impact of
      the delta sodium levels with short-term outcomes, such as duration of intubation, intensive
      care unit length of stay were analyzed with univariate and multivariate logistic regression
      analyses.
    

Intervention name(s): Collecting sodium reports and outcome measures
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Liver transplant recipients more than 18 years in ILBS during study period
      
Keywords: liver transplantation; perioperative sodium; sodium
A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group
      study designed to evaluate the effects of RO5459072 treatment on disease activity and
      symptoms of Sjogren's syndrome in adult participants with moderate to severe primary
      Sjogren's syndrome. The total duration of the study for each participant will be
      approximately 18 weeks (including screening).
    


Intervention name(s): Placebo; RO5459072
Intervention type(s): Drug; Drug
Intervention description(s): Matching-placebo capsules will be administered orally, 2 times a day with food.; RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day with food.
Intervention MeSH terms: Petesicatib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Homeopathic Cold Remedy for Children Study
Condition: Upper Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      A randomized controlled trial of a commercially available homeopathic cold remedy will be
      conducted. A total of 400 children, 2-5 years old, diagnosed with an upper respiratory tract
      infection will be randomized to receive either the homeopathic remedy or placebo. Parents of
      study children will administer 5 ml of the study medication up to 6 times per day as needed
      to treat cold symptoms. One hour after giving a dose the parent will rate change in symptoms
      (for up to the first 10 doses). In addition, parents will rate their child's overall symptom
      severity and functional status over the first 3 days of the cold. It is postulated that
      children receiving the active homeopathic remedy will have better symptom relief and that
      their symptom severity and functional status will improve more rapidly than those receiving
      placebo.
    


Intervention name(s): Hyland's Cold 'n Cough 4 kids; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 ml PO q4h prn cold symptoms; liquid made to look like the active homeopathic remedy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: children; upper respiratory tract infections; homeopathy
Effect of L. Reuteri on Bowel Movements in Children (BIOWELL Study)
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      A randomized, multicenter, placebo-controlled, double blind study in two parallel groups
      testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938
      compared to placebo in increasing the number of spontaneous bowel movements in infants and
      children with functional constipation.
    

Detailed description: 
      Functional constipation in infants up to 4 years of age is defined according to Rome III
      criteria (Hyman 2006). The diagnose must include 1 month of at least two of the following
      criteria: two or fewer defecations per week; at least 1 episode per week of incontinence
      after the acquisition of toilet skills; history of excessive stool retention; history of
      painful or hard bowel movements; presence of a large faecal mass in the rectum; history of
      large-diameter stools that may obstruct the toilet.

      Accompanying symptoms may include irritability, decreased appetite and/or early satiety. The
      accompanying symptoms disappear immediately following passage of a large stool.

      There is a growing interest for the use of probiotics in functional constipation as research
      suggests that probiotics could provide beneficial support in the traditional treatment
      arsenal although the mechanisms of actions are not completely understood.

      Wu et al have demonstrated that Lactobacillus reuteri DSM 17938 may have a region-specific
      intestinal effect on gut motility and therefore could be beneficial in treatment of
      constipation

      Lactobacillus reuteri DSM 17938 has shown significant favourable effects in adults (Ojetti
      2014) and young children as described above (Coccorullo 2010, Olgac 2013). These studies
      require confirmation however. The present clinical study has been designed to strengthen the
      current available data that L. reuteri DSM 17938 has beneficial effects in infants and young
      children with functional constipation.

      We hypothesize that daily oral supplementation with the probiotic Lactobacillus reuteri DSM
      17938 will effectively increase the number of spontaneous bowel movements in infants/children
      diagnosed with functional constipation according to Rome IV.
    

Intervention name(s): L.reuteri; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Each day, at about the same time, the subjects will be given 5 drops (1x10^8 CFU) of the study product in connection with feeding; Same formulation as study product, without probiotics.
Other intervention name(s): Lactobacillus reuteri
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: constipation; Lactobacillus reuteri; probiotics
Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty
Condition: Bone Loss
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 4

Summary: 
      Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after
      uncemented total hip arthroplasty?
    

Detailed description: 
      Periprosthetic bone loss after total hip arthroplasty is the main factor in limiting the
      longevity of implants used for treatment of osteoarthritis. Bone loss leads to implant
      destabilization. Bisphosphonates, given for approximately 6 months after THA man prevent this
      bone loss and lead to longer implant fixation and lower incidence of aseptic prosthesis
      loosening. We perform a clinical trial with risedronate to investigate if we can influence
      periprosthetic bone loss around a uncemented femoral stem.
    

Intervention name(s): Risedronate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months); Placebo given once weekly start on 2nd postoperative day for 26 weeks (6 months)
Intervention MeSH terms: Risedronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periprosthetic bone loss risedronate bisphosphonates
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by
      HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus
      pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to
      one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after
      4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable
      metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be
      switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of
      taspoglutide 10mg once weekly. The anticipated time on study treatment is 1-2 years, and the
      target sample size is 100-500 individuals.
    


Intervention name(s): metformin; pioglitazone; placebo; taspoglutide; taspoglutide
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): >1500 mg/day or maximum tolerated dose (MTD); >= 30 mg/day; sc once weekly; 10 mg sc once weekly;; 20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
Intervention MeSH terms: Metformin; Pioglitazone; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia
Condition: Pneumonia; Child; Prognosis
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      In this study, investigators aimed to develop and validate a risk score to predict severe
      outcomes (e.g., mortality and ICU admission) in children who were admitted to the Children's
      Hospital of Fudan University between 2017 and 2022 due to community-acquired pneumonia (CAP).
      The objectives were as follows.

        1. Develop a risk prediction model based on demographic, comorbidity, clinical
           characteristics, laboratory data, and chest radiographic reports to predict severe
           outcomes among children hospitalized with CAP;

        2. Develop a risk scoring system and determine the cut-off point;

        3. Externally validate the easy-to-use risk score.
    


Intervention name(s): exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reports
Intervention type(s): Other
Intervention description(s): epidemiological data (e.g., age, sex, and residential area), clinical characteristics (e.g., fever, cough, and wheeze), laboratory data (e.g., white blood cell, c-reaction protein, and procalcitonin), and chest radiographic reports (e.g., X-ray, CT, and ultrasound)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This was a retrospective cohort study of children aged between > 29 days and 18 years old
        who were admitted to the Children's Hospital of Fudan University in Shanghai, China from
        January 1, 2017 to December 31, 2022. Children were enrolled if they were hospitalized with
        signs and symptoms of lower respiratory tract infection and radiographic evidence of
        pneumonia.
The Effect of Pre-Frontal tDCS on Sleep Propensity During an Afternoon Nap: RCT
Condition: Sleep
Study type: Interventional

Summary: 
      Transcranial Direct Current Stimulation (tDCS) is a safe, non-invasive brain stimulation
      technology that has demonstrated the ability to temporarily increase or decrease activity in
      specific regions of the brain. The researchers are investigating the effect of this
      technology on sleep propensity by applying two different types of stimulation as well as sham
      (Placebo) stimulation during three different afternoon naps. The researchers are subsequently
      hoping to recruit healthy volunteers without medical, or sleep problems who have a regular
      sleep schedule to participate in the study
    

Detailed description: 
      Recent studies have demonstrated that there are cortical direct current (DC) changes that
      accompany sleep onset and transitions between sleep states in a stereotyped manner. In these
      studies it was determined that negative potential shifts occurred prior to and at the
      transition from wakefulness to sleep and at transitions between Rapid Eye Movement sleep
      (REM) sleep, and Non-Rapid Eye Movement (NREM) sleep. In a subset of experiments it was
      demonstrated that the same DC potential shifts occur during the transition from wake to sleep
      in an afternoon nap. The recorded DC potential shifts occurred predominantly in the
      pre-frontal cortex (F3, F4), with spread into central areas. No current literature exists
      that explores whether tDCS could be used to modulate cortical activity prior to sleep,
      resulting in either increased or decreased sleep propensity.

      The application of focal, non-invasive brain stimulation has already led to novel and
      effective treatments for neuropsychiatric disease with minimal side effects (Most well
      studied in depression and repetitive Transcranial Magnetic Stimulation or, rTMS). Should the
      application of tDCS modulate sleep propensity it would represent a novel study paradigm with
      the potential to lead to a completely novel treatment for sleep disturbance. With this small
      pilot study, we propose taking the first step in exploring the utility of tDCS in modulating
      sleep propensity. We propose to recruit 15 healthy non-treatment seeking participants from
      the community and expose them to three total nap conditions in a randomized counter balanced
      fashion, with 10 minutes of either, Anodal, Cathodal, or Sham tDCS stimulation occurring
      prior to each nap opportunity.
    

Intervention name(s): transcranial Direct Current Stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): tDCS will be delivered using a Chattanooga Ionto™ Iontophoresis System - Phoresor.
Other intervention name(s): Chattanooga Ionto™ Iontophoresis System - Phoresor.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Sleep; Transcranial Electric Stimulation
Viaskin Pertussis Vaccine Trial
Condition: Whooping Cough
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a Phase I, first in human, monocenter study, aiming at assessing the safety and
      immunogenicity of a genetically detoxified pertussis toxin (PT) when administered via the
      cutaneous route with Viaskin patches to healthy volunteers at 2 different doses of 25 mcg or
      50 mcg PT protein compared to Viaskin placebo.

      Two cohorts of 30 subjects will be successively enrolled. Safety of the product will be
      assessed throughout the 10-week study and its immunogenicity will be assessed at regular
      intervals with collection of blood samples for immunological analyses.

      Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will
      receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal
      recall of their immunity against pertussis.
    


Intervention name(s): Viaskin PT 25 mcg; Viaskin PT 50 mcg; Viaskin PT Placebo; Boostrix™
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14).; Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14).; Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14).; Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal recall of their immunity against pertussis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Pertussis; Epicutaneous ImmunoTherapy (EPIT); Vaccine; Viaskin PT