bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tuberculin Conversion Following BCG Vaccination
Condition: BCG Vaccination Reaction
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is an bridging study, observer-blind, randomized, controlled prospective
      intervention study. The primary objective is evaluate the safety of BCG Vaccine Vial (Bio
      Farma).
    

Detailed description: 
      This trial is bridging study, observer blinded, comparative, randomized study. Approximately
      220 subjects will be recruited, 110 subjects are the investigational arm and 110 subjects are
      the active comparator arm.

      The objective of the study is to evaluate the safety of BCG Vaccine Vial (Bio Farma), and
      assess the the local and systemic reactions within 90 days after vaccination in each group,
      and assess the tuberculin conversion in each group.
    

Intervention name(s): BCG vial vaccine; BCG ampoule vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Intradermal injection; Intradermal injection
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: BCG Vaccine; Safety of BCG Vaccine; Tuberculin Conversion
The Anemia Control Program: Early Intervention
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional

Summary: 
      The purpose of this study was to determine if a home-based intervention to foster child
      development improved behavior and development in infants with IDA.
    

Detailed description: 
      Iron-deficiency anemia (IDA) is associated with alterations in infant behavior and
      development that may not correct with iron therapy. The purpose of this study was to
      determine if a home-based intervention to foster child development improved behavior and
      development in infants with IDA. IDA and non-anemic infants were randomly assigned to a year
      of intervention or surveillance only. Infants were enrolled and began study participation at
      6 or 12 months. All infants were treated with oral iron and visited weekly to record iron
      intake, feeding, and health (surveillance). For infants randomized to intervention, the
      weekly home visit included an hour-long program fostering child development by supporting the
      mother-infant relationship. Psychologists, unaware of iron status or intervention assignment,
      assessed cognitive, motor, and social-emotional development (Bayley Scales) at the beginning,
      midpoint, and end of the year.
    

Intervention name(s): Home stimulation; Surveillance; Iron
Intervention type(s): Behavioral; Behavioral; Dietary Supplement
Intervention description(s): Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.; Weekly visits to the home over the course of one year to record iron intake, feeding, and health information.; Six-month-old infants treated orally for 1 y with 15 mg elemental Fe/d as ferrous sulfate. Twelve-month old infants treated orally for a minimum of 6 months with 30 mg elemental Fe/d.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: iron deficiency anemia; infant behavior; infant development
Effect of Non-alcoholic Beer in Cirrhosis
Condition: Endothelial Dysfunction; Nutritional Status; Quality of Life
MeSH terms: Fibrosis
Study type: Interventional

Summary: 
      The implementation of nutritional strategies targeting several variables at once could
      benefit patients with cirrhosis. Non-alcoholic beer has different compounds derived from hops
      that exert antioxidant, anti-inflammatory and nutritional properties. The aim of this study
      is to evaluate the effect of diet + exercise and non-alcoholic beer on nutritional status,
      endothelial function and quality of life in patients with cirrhosis.
    


Intervention name(s): Non-alcoholic beer; control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Treatment consisted of 330ml non-alcoholic beer per day, plus an individualized dietary program and an exercise program with a pedometer-based bracelet to reach at least 5000 steps/day during 2 + 8 weeks.; Treatment consisted of 330ml of water, plus an individualized dietary program and an exercise program with a pedometer-based bracelet to reach at least 5000 steps/day during 2 + 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cirrhosis; nutrition; sarcopenia; non-alcoholic beer
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)
Condition: Erosive Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to
      esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.
    


Intervention name(s): DWP14012 40mg; DWP14012 40mg placebo; Esomeprazole 40mg; Esomeprazole 40mg placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): DWP14012 40mg, tablet, orally, once daily for up to 8 weeks; DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks; Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks; Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
Other intervention name(s): Nexium 40mg; Nexium 40mg placebo
Intervention MeSH terms: Esomeprazole; Fexuprazan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Younger, Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young,
      healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory
      enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity
      typically occuring during SWS has been implicated in the consolidation effect. In this study
      we investigate if the consolidation effect can be amplified by the application of a weak
      transcranial oscillatory electric current within the frequency range of SWS in humans
      (0,7-0,8 Hz) during nocturnal SWS.
    


Intervention name(s): brain stimulation; SHAM
Intervention type(s): Device; Device
Intervention description(s): oscillating direct current brain stimulation; no stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: young healthy subjects; brain stimulation; tSOS; tDCS; sleep; memory; memory consolidation
Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
Condition: Peripheral Neuropathy; Neuropathic Pain
MeSH terms: Neuralgia; Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      The Exablate 4000 obtained CE Mark for the treatment of Neuropathic Pain in December 2012.
      The purpose of this post market study is to obtain real world data on the safety and
      performance of the Exablate treatment for neuropathic pain.

      The objective of this study is to capture the change in pain intensity, physical/emotional
      function, and pain impact for patients diagnosed with neuropathic pain who undergo an
      Exablate treatment.
    

Detailed description: 
      The purpose of this post market study is to obtain real world data on the safety and
      performance of the Exablate treatment for neuropathic pain.
    

Intervention name(s): Exablate treatment
Intervention type(s): Device
Intervention description(s): Exablate treatment for Neuropathic Pain
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Hormonal Contraceptives on Liver Proteins and Coagulation Factors: A Comparison of a Contraceptive Vaginal Ring and an Oral Contraceptive
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal
      contraceptives containing a progestin and an estrogen on liver proteins and coagulation
      factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring
      containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was
      compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and
      ethinyl estradiol.
    

Detailed description: 
      The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal
      contraceptives containing a progestin and an estrogen on liver proteins and coagulation
      factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring
      containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was
      compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and
      ethinyl estradiol.
    

Intervention name(s): Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive
Intervention type(s): Drug
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; ST 1435; Contraceptive Agents; Contraceptives, Oral; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Contraceptive agents; female
EXercise Continuation Incorporating Technology Enhancements (EXCITE) Study
Condition: Physical Inactivity
Study type: Interventional

Summary: 
      The purpose of this study is to inform the integration of mobile and social media components
      into larger interventions aimed at increasing adherence and maintenance of physical activity.
      Nearly half of the US population do not meet physical activity recommendations of ≥150
      minutes of moderate activity per week. The use of smartphones to "self track" data and upload
      that data to an online social network is becoming increasingly common and may be an effective
      way to motivate physical activity adherence and maintenance. We are proposing a two phase
      study to develop and evaluate a mobile health ("mHealth") intervention that includes the use
      of two existing technologies: 1) the RunKeeper mobile app to collect and upload exercise data
      (distance, pace, time), and 2) the RunKeeper.com online social network as a place to analyze
      uploaded data and engage with a coach and online community. Phase 1 (n=10) will iteratively
      develop the mHealth intervention and phase 2 (n=30) will pilot the mHealth intervention
      (participants will be randomized to either mHealth intervention (n=20) or control (n=10)) to
      collect feasibility, acceptability and preliminary efficacy data. All participants will
      attend a day-long ChiWalk/Run training to help them avoid potential injuries and meet their
      coach and community in-person. All participants will also be asked to wear a FitBit
      accelerometer from one week before the beginning of the intervention through one week after
      the end of the intervention to collect total physical activity data. This data will be
      uploaded automatically to the study data base. Primary outcomes will be total physical
      activity as collected by the FitBit accelerometer (and the RunKeeper mobile app for the
      intervention group) and secondary outcomes will be changes in psychological factors that may
      mediate adherence to physical activity.
    


Intervention name(s): ChiRunning training; unblinded accelerometer; participation in online social network; participation in study website; Technology support for behavior change
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: daily physical activity; exercise; social support; online social network
Metabolic Abnormalities in HIV Infected and Uninfected Young Women
Condition: HIV Infections; Hypercholesterolemia; Glucose Intolerance
MeSH terms: Hypercholesterolemia; Glucose Intolerance
Study type: Observational

Summary: 
      Though anti-HIV drugs can dramatically improve the health of people with HIV, some people
      taking these drugs develop serious long term effects in their metabolism. These effects
      include problems with bones, increased levels of blood sugar and lipids, and changes in body
      fat distribution. The purpose of this study is to see how many young women are experiencing
      these problems and how severe the problems are. This kind of study is the first step in
      determining how best to treat these problems.
    

Detailed description: 
      Patients on highly active antiretroviral therapy (HAART) regimens develop potentially
      deleterious metabolic effects, including insulin resistance, dyslipidemia, osteopenia and
      osteoporosis, and hyperlactatemia. Changes in body fat distribution and bone metabolism are
      also documented. There is considerable evidence that protease inhibitors (PI) can induce
      insulin resistance and increase triglyceride and cholesterol levels. It is now also clear
      that both metabolic changes and fat distribution abnormalities occur in PI-naive patients
      treated with nucleoside analogue reverse transcriptase inhibitors (NRTIs). In addition to
      class specific effects, there is emerging evidence that there are differences within each
      class of drug in the nature and magnitude of metabolic effects. This study will examine the
      metabolic effects of HAART in young women.

      Adolescent women aged 12 through 24 years will be recruited into each of 5 treatment strata:
      Stratum 1 - HIV uninfected; Stratum 2 - HIV infected but never had HAART; Stratum 3 - HIV
      infected on NNRTI regimen for 3 or more months and less than 2 weeks of PI therapy; Stratum 4
      - HIV infected on PI regimen for 3 or more months and less than 2 weeks of NNRTI therapy; and
      Stratum 5 - HIV infected on NRTI-only regimen for 3 or more months and less than 2 weeks of
      PI or NNRTI therapy. Participants in the study will have one study visit conducted over 1 or
      2 days. The study visit will include survey questionnaires, DEXA scanning, anthropometric
      measurements, and blood tests examining lactate, glucose, and lipid metabolism.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of up to 300 subjects may be enrolled in the study. The number of subjects in each
        study group will be as follow: 50 HIV negative subjects; 100 HIV positive subjects with no
        exposure to ART; and three groups of up to 50 HIV positive subjects each with different ART
        exposure histories.
      
Keywords: Treatment experienced; Treatment naive
Bed Rest Study SBI 2023
Condition: Healthy Aging; Physical Inactivity
Study type: Interventional

Summary: 
      The study will consist of three groups of subjects. Ten young male subjects (18-30 years)
      will lie supine for 21 days, 10 older male subjects (65+ years) will lie supine for 10 days,
      and a third group of 10 older male subjects (65+ years) will also lie supine for 10 days but
      will receive interventions (see below) to counteract the physical changes caused by supine
      lying. All three groups will be bedridden in the premises of Izola General Hospital. Subjects
      will be housed in 5-bed rooms at the hospital and will receive 24-hour medical care, proper
      hygiene, nutrition, passive exercise, Internet, a relaxing environment, and visits. After
      their stay, subjects return home but receive 21 days of care at local fitness centers.
      Rehabilitation consists of interval training, in which subjects perform high-intensity
      exercise for 4 times 5 minutes. A number of important health parameters are measured before,
      during, and after bed rest. Some of these measurements will be invasive (blood and muscle
      sampling), for which appropriate medical personnel, sterile instruments, and environment will
      be available. Measurements will include normal voluntary efforts (indoor cycling, various
      jumps, short stretches) and electrically evoked muscle contractions (electrical stimulation
      with single impulses). All tests are normal tests and come from normal lifestyles and routine
      medical examinations.
    


Intervention name(s): High protein diet; OGTT
Intervention type(s): Dietary Supplement; Diagnostic Test
Intervention description(s): Test the ability of high protein diet (1.4 g protein/kg/day) with branched chain amino acid and cysteine supplementation to decrease bed rest induced muscle atrophy, glutathione depletion and insulin resistance in old subjects.; Assessment of changes in insulin sensitivity (Oral Glucose Tolerance test and muscle insulin signalling: immunofluorescence and western blot of GLUT-4, IRS-1, MPP/TIMP, etc.) following bed rest in old and young subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effects of Rehabilitation on Muscle Fibre Composition and Capillaries in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in
      patients with chronic obstructive pulmonary disease (COPD). The aim of our study is to show a
      potential change in muscle fibre composition and in the amount of capillaries in quadriceps
      muscle from pre tob post 3-week rehabilitation. Pulmonary rehabilitation includes
      standardised exercise training, e.g. cycling and strength training for major muscle groups.
    


Intervention name(s): pulmonary rehabilitation
Intervention type(s): Other
Intervention description(s): 3-week rehabilitation including exercise training, breathing therapy, psychosocial support, medical treatment etc.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: muscle fibre; capillary; rehabilitation; exercise training
Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza
      vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern
      Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the
      Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety.

      Objectives:

        -  To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016
           seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH
           2015-2016 formulation, with the requirements of the Committee for Medicinal Products for
           Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed.

        -  To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016
           seasonal formulations
    

Detailed description: 
      All subjects will receive one dose of either QIV or TIV on Day 0. They will be monitored for
      safety and immunogenicity for up to Day 21 post-vaccination.
    

Intervention name(s): Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016; Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Quadrivalent influenza vaccine; Trivalent influenza vaccine
A Study to Compare Two Bioanalytical Assays for Tebipenem
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to compare the concentrations of tebipenem (TBP), the
      active moiety of tebipenem pivoxil hydrobromide (TBP-PI-HBr), as determined by two
      bioanalytical assays, a whole blood assay and a plasma assay, following a single oral dose of
      TBP-PI-HBr 600 milligram (mg) tablets in healthy adult participants.
    


Intervention name(s): TBP-PI-HBr
Intervention type(s): Drug
Intervention description(s): TBP-PI-HBr tablets.
Other intervention name(s): SPR994
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physical Therapy Following Total Hip Arthroplasty
Condition: Hip Osteoarthritis; Surgery
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      130 patients undergoing primary unilateral total hip arthroplasty through anterior approach
      were enrolled and randomized into one of two groups. One group received standard of care
      clinic-based physical therapy postoperatively (clinic PT) while the other group underwent
      progressive home-based exercises to do after surgery (home PT). Patient surveys with Hip
      Osteoarthritis Outcome Scores (HOOS) and SF12v2 scores for both groups were obtained before
      surgery as well as 6, 14, and 24 weeks postop. Patients had the option to crossover into the
      other study group at their 6-week follow-up visit.
    


Intervention name(s): total hip arthroplasty
Intervention type(s): Procedure
Intervention description(s): each patient is expected to undergo an anterior total hip arthroplasty procedure and some sort of physical therapy postoperatively
Other intervention name(s): physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: total hip arthroplasty; physical therapy
A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This 2-period, open-label, nonrandomized study will be conducted to determine the absolute
      bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its
      metabolite(s). Healthy male participants will receive a single 200-mg oral dose of
      ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of [14C]-ipatasertib.
      After a 4-day observation period and 10-day washout, participants will receive a single
      200-mg/100-mcCi oral dose of [14C]-ipatasertib with subsequent data collection for an
      additional 7 to 14 days until discharge criteria are met.
    


Intervention name(s): Period 1 treatment; Period 2 treatment
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg oral ipatasertib followed 1 hour later by 80-mcg/800-nCi intravenous [14C]-ipatasertib on Day 1 of study; 200-mg/100-mcCi oral [14C]-ipatasertib on Day 15 of study
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)