bioihbjkbjnl/mcl2 huggingface dataset:
Giving Immunizations Through Vaccine Education
Condition: HPV Vaccines
Study type: Interventional

Summary: 
      This study will test the effectiveness of clinician-focused health IT-based decision support,
      family-focused health IT-based decision support, and a combination of both efforts, in
      increasing HPV and other adolescent vaccine rates among adolescent girls. We hypothesize that
      a combination of clinician-focused clinical decision support and family-focused decision
      support will be most effective.
    

Detailed description: 
      -  Clinician-focused intervention includes an electronic health record-based decision
           support mechanism including reminders, education, audit and feedback on vaccination
           success.

        -  Family-focused intervention includes vaccine reminders and informational telephone calls
           prompted by the electronic health record.
    

Intervention name(s): Family Decision Support; Clinician Decision Support; Family Decision Support and Clinician Decision Support; Control
Intervention type(s): Behavioral; Behavioral; Other; Other
Intervention description(s): Family-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record.; Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.; This will be a combination of the family-focused decision support (telephone reminder calls) and clinician-focused decision support (clinical alerts).; Usual care
Other intervention name(s): Clinical Decision Support; Family Focused Intervention; Clinical Decision Support; Clinician Focused Intervention; Family Decision Support; Clinician Decision Support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Clinical Decision Support Systems
ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant Treatment
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will
      investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with major
      depressive disorder having inadequate response to ongoing antidepressant treatment. Patients
      will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or matching
      placebo. The anticipated time on study treatment is 6 weeks.
    


Intervention name(s): Placebo; RO4995819; RO4995819; RO4995819
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): matching placebo to RO4995819 oral once daily for 6 weeks; 5 mg oral once daily for 6 weeks; 15 mg oral once daily for 6 weeks; 30 mg oral once daily for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
First-in-human Study of VE303 in Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to evaluate safety and tolerability of a range of doses of VE303 in
      healthy adult volunteers. The study also evaluated pharmacokinetics of intestinal
      colonization by the VE303 strains and pharmacodynamics of recovery of the gut microbiota
      after administration of antibiotics followed by a course of VE303.
    

Detailed description: 
      VE303 is a rationally-defined bacterial consortium candidate being developed for the
      prevention of recurrent C. difficile infection. VE303 consists of 8 types of clonal human
      commensal bacteria strains selected for their ability to provide colonization resistance to
      C. difficile and manufactured under GMP conditions.
    

Intervention name(s): VE303; Oral Vancomycin
Intervention type(s): Drug; Drug
Intervention description(s): The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.; Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
Intervention MeSH terms: Vancomycin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This Phase 1a/1b, first-in-human, open-label, single-center, dose-escalation study will evaluate the safety and microbiota changes induced by ingestion of VE303 following administration of oral vancomycin and VE303 administered without vancomycin pre-treatment in healthy adult subjects. Approximately 48 subjects are anticipated for enrollment, unless intermediate cohorts are required, in which case, up to an additional 18 subjects (for a total of approximately 66 subjects) may be enrolled.
Masking: None (Open Label)
Primary purpose: Other
Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome (TCM- IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a 20- herb formulation, as a well
      characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to
      identify efficacious and safe dosage of the formulation in treating IBS.
    

Detailed description: 
      The Specific aims of the project are:

        1. To determine whether a 20- herb formulation improves pain/ discomfort and disturbed
           bowel frequency in patients with Irritable Bowel Syndrome who have been disappointed
           with current conventional Western medicine.

        2. To identify an optimal dosage of the 20- herb formulation that is safe and well
           tolerated for up to 8 weeks of treatment, among 2 dosages. This is determined by relief
           of symptoms of IBS in a dose escalation, placebo-controlled double- blind randomized
           clinical trial, in conjunction with indices of safety and tolerability.
    

Intervention name(s): 20-herb formulation; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two daily dosages will be investigated. The lowest dosage condition will be 17gm daily, followed by an escalation to 34gm. Participants will be treated for 8 weeks; Placebo herb formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IBS
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate markers, mechanisms and define general predictors for
      immunological health by comparing influenza vaccine responses in monozygotic and dizygotic
      twins.
    

Detailed description: 
      The investigators plan to study the response to different influenza vaccines much more
      broadly and deeply across different age groups and with different vaccine modalities and to
      probe the influence of genetics on these responses using monozygotic and dizygotic twins. On
      an investigational basis, the investigators plan to compare various immunological responses,
      identify age-specific biomarkers or clusters of markers, quantify the frequency of
      influenza-specific T-cells pre- and post-vaccination, and determine the effective breadth of
      T-cell repertoire to an influenza vaccine within an individual as a function of age and to
      what degree this is genetically determined.

      Twin group B will will be randomly assigned to receive a single dose of inactivated vaccine,
      either the trivalent inactivated influenza vaccine (TIV) or intranasal live, attenuated
      influenza vaccine (LAIV). Twin Groups C-E will receive a single administration of TIV. Group
      F, elderly participants, will be randomly assigned to receive a single dose of inactivated
      vaccine, either the standard dose or the high-dose TIV. Blood samples to conduct the assays
      described will be taken at pre-immunization, Days 7-10 and 28 post-immunization.

      Groups A, C and E were not enrolled for this year of the five year annual study.
    

Intervention name(s): TIV; High-Dose TIV; LAIV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Influenza Virus Vaccine Suspension for Intramuscular Injection; High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe; Live, attenuated influenza vaccine for Intranasal Spray
Other intervention name(s): Fluzone® standard TIV; High-Dose Fluzone® TIV; FluMist®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Inactivated influenza vaccine; Live, attenuated influenza vaccine; Adult and elderly identical twins; Adult fraternal twins
Investigation of the Efficiency of Spinal Mobilization in Patients With Adolescent Idiopathic Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      In this study, it was aimed to evaluate the effect of spinal mobilization techniques applied
      in addition to core stabilization exercises in Adolescent Idiopathic Scoliosis (AIS)
      patients.

      Consecutive adolescents with idiopathic scoliosis, aged 10 to 16 years, without a brace, and
      with a Cobb curvature of 10 to 25 degrees were randomly divided into two groups using the
      closed envelope method: Spinal mobilization and core stabilization exercise were applied to
      the experimental group; Only core stabilization exercises were applied to the control group.

      Both groups received interventions twice a week for 10 weeks. Outcome measurements were made
      before treatment and after 10 weeks of treatment.
    

Detailed description: 
      This study was a randomized controlled trial in which participants and assessor were blinded.
      This study was carried out in Amasya University Ruhi Tingiz Physical Therapy and
      Rehabilitation Hospital Rehabilitation Unit between August 2022 and January 2023. Ethics
      committee approval was obtained from Amasya University (E-76988455-050.01.04-83314) on
      05.08.2022 to conduct the study. Before the study, face-to-face interviews were conducted
      with the all participants and parents and informed about the subject and purpose of the
      study. Verbal and written consent was obtained from the all participants and parents.

      Sample size: The sample of the study was calculated with the G*Power 3.1 program, and the
      effect size (d=1.0) was calculated according to the double-tailed hypothesis method, taking
      into account the study. (d=1.0; α=0.05; 1-ß=0.80). Confidence interval was determined as 80%
      and margin of error was 5% (α=0.05). As a result of the calculation, it was determined that
      there should be 17 adolescent scoliosis patients for the control group, 17 for the
      experimental group, and a total of 34 adolescent scoliosis patients. Considering the possible
      data losses of the participants, we planned to include a total of 40 participants, 20 in both
      groups.
    

Intervention name(s): Spinal mobilization; Core stabilization exercise
Intervention type(s): Other; Other
Intervention description(s): Spinal mobilization and core stabilization exercise; Stabilization exercises for the spine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent idiopathic scoliosis; Core stabilization exercises; Spinal mobilization; Manual therapy; Pulmonary function
Effects of ELDOA Versus Post Facilitation Stretching Technique in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study aims to assess whether Elongation Longitudinaux Avec Decoaption Osteo Articulaire
      versus post assistance extending strategy have effects on knee torment. and to check its
      impact on actual capacity.
    

Detailed description: 
      A randomized controlled trial will be conducted at Safi Teaching Hospital, Faisal Teaching
      Hospital and Allied Hospital Fsd after the synopsis has been approved. Patients will be
      enrolled using a simple random sampling technique. Patients with Knee Osteoarthritis will be
      chosen based on pre-established inclusion and exclusion requirements. Patients will receive
      Elongation Longitudinaux Avec Decoaption Osteo Articulaire, and post-facilitation stretching
      techniques. Two tools will be used to find out the comparison of both groups; Numeric Pain
      Rating Scale; for knee pain and Lower Extremity Functional Scale; to check the ability of the
      patient to perform the everyday task and for evaluation of functional impairments for
      patients with a disorder of lower extremities.

      The assessment will need to be done at baseline and follow up will be 15 days after
      treatment. Each patient will be asked to give their informed consent. Statistical Package of
      Social Sciences Version 20 will be used for data entry and analysis.
    

Intervention name(s): Elongation Longitudinaux Avec Decoaption Osteo Articulaire; Post Facilitation Stretching
Intervention type(s): Other; Other
Intervention description(s): It creates tension in the spine and stretch the fascia and is a myofascial stretch technique and manual physical therapy tool; Post Facilitation Stretching effectively decreases hamstring muscle tightness while also increasing popliteal angle range. Post-facilitation exercise can help to relieve knee pain. It effectively raises ROM or aligns collagen fibers due to the muscle contraction performed immediately before stretching.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Comparative; Elongation Longitudinaux Avec Decoaption Osteo Articulaire; Post Facilitation Stretching Technique; Knee Osteoarthritis; Randomized Control Trial
Effectiveness of Counseling on Use of Postpartum Family Planning.
Condition: Contraceptive Usage
Study type: Interventional

Summary: 
      Family planning (FP) is the most supported, reasonable public health service to prevent both
      maternal and newborn mortality and decrease the risk of adverse maternal, perinatal, and
      infant outcomes. The World Health Organization's (WHO) recommend of waiting at least 2 years
      after a live birth before attempting the next pregnancy as short interval between pregnancies
      increase risk of preterm labor; low birth weight; fetal, early neonatal and infant death; and
      serious maternal outcomes.
    

Detailed description: 
      So WHO recommends postpartum family planning (PPFP) for healthy birth spacing. PPFP is
      divided into three stages immediate: within 48 hours following delivery, early: within the
      first 6 weeks after delivery, late: within 12 months postpartum. Fertility can return as soon
      as 45 days after delivery for non-breastfeeding women, and among women who are not
      breastfeeding exclusively, fertility can return before the return of menses. Providing PPFP
      instantaneously following delivery may be likeable for women who prefer effective postpartum
      protection as the return of fertility may be hard to expect. So Promoting PPFP use was
      documented in different communities, interventions included conversational, SMS, brochure and
      video-based contraceptive education in antenatal or postnatal visits. However, the unmet need
      for FP is high in the postpartum period, ranging from 32 to 62% in low and middle-income
      countries depending on the definition used. that is why WHO recommends that all women should
      be offered counselling within 6 weeks postpartum so we will study the impact of post-partum
      counselling pre and post-discharge on intent and use of a reliable family planning method.
    

Intervention name(s): postpartum contraception method counselling
Intervention type(s): Other
Intervention description(s): It will be face-to-face counseling with females about the use of postpartum contraception methods within 6 weeks postpartum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
A Clinical Trial Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects
Condition: Hypertension; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic interaction and safety between
      BR1019-1 and BR1019-2 in healthy adult subjects.
    


Intervention name(s): BR1019-1; BR1019-2; BR1019-1 + BR1019-2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.; Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.; Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mobile Health Intervention for Family Smoking Cessation in Romania
Condition: Telemedicine: Smoking Cessation App Only; Telemedicine: Smoking Cessation Counseling; Telemedicine: App + Counseling; Usual Care
Study type: Interventional

Summary: 
      The objectives of this study are to determine in a randomized controlled trial (RCT) whether
      a mobile health (mHealth) couples intervention shows promise in increasing smoking cessation
      among pregnant couples who smoke and to build mHealth research capacity in Romania. The
      intervention will be novel in its use of the unique functionality of smartphones, its
      emphasis on the dyadic efficacy for smoking cessation, and the focus on pregnant couples. Our
      aims are to (1) Test the implementation feasibility, acceptability, and initial efficacy of a
      culturally-adapted mHealth smoking cessation intervention among couples during pregnancy and
      postpartum in Romania. (2) Develop mHealth research capacity by enhancing individual and
      institutional research capabilities in Romania and expanding the existing international
      research network.
    


Intervention name(s): Smoke Free Together - App-only; Smoke Free Together - Telemedicine counseling only; Smoke Free Together - app + telemedicine
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Pregnant smokers and their life partners will use a smoking cessation app.; Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation; Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mHealth; Mobile health; Telehealth; Pregnancy; Tobacco; Cessation
Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
Condition: Dysmenorrhea; Pain
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea
      will improve pain report from baseline. In addition, we will determine whether cross-organ
      influences from the uterus on bladder pain sensitivity change from baseline after reduced
      menstrual pain experience over six months. Finally, a battery of quantitative sensory tests
      and EEG measures of sensory sensitivity will be used to evaluate mechanisms associated with
      improvements in menstrual and bladder pain.
    

Detailed description: 
      Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity
      and cytokine concentrations producing moderate to severe pelvic pain in more than 20% of
      reproductive-age women. One out of every five of those women in turn will experience chronic
      pelvic pain (CPP) which may be in part due to cross-organ neural sensitization.

      In this study we will establish whether prophylactic and adequate dosages of naproxen are
      capable of reducing menstrual pain more than *** use.
    

Intervention name(s): Naproxen
Intervention type(s): Drug
Intervention description(s): Participants will take naproxen 500mg BID before and for the first 3 days of their period.
Intervention MeSH terms: Naproxen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cross-organ sensitivity; bladder pain; NSAID; visceral pain
Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin
Condition: Type 2 Diabetes Treated With Insulin; Obesity; Adolescent Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      To compare the efficacy and effect on glycemic control of Dulaglutide versus Liraglutide in
      obese Type 2 diabetic adolescents using metformin
    

Detailed description: 
      To observe the efficacy, effect on glycemic control, impact on BMI and incidence of adverse
      effects of Dulaglutide and to compare it to Liraglutide in individuals aged thirteen to
      eighteen who have Type 2 diabetes mellitus and are obese.
    

Intervention name(s): Dulaglutide; Liraglutide
Intervention type(s): Drug; Drug
Intervention description(s): Dulaglutide injections; Liraglutide injections
Other intervention name(s): Group DUL; Group LIR
Intervention MeSH terms: Liraglutide; Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment