bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicenter, randomized, double-blind, parallel-group, placebo-controlled study will
      evaluate the efficacy and safety of bitopertin in combination with SSRI in participants with
      obsessive-compulsive disorder. Participants will be randomized to receive either bitopertin
      30 milligrams (mg) or bitopertin 10 mg or placebo orally daily in addition to their
      background therapy with an SSRI. Participants will be allocated to one of two strata.
      Participants in Stratum 1 will start study drug on Day 1. Participants in Stratum 2 will
      receive placebo from Day 1 (placebo lead-in) and will then start study drug at the Week 2
      visit. Participants in both strata will receive the study drug in addition to their
      background therapy with an SSRI until Week 16.
    


Intervention name(s): Bitopertin; Placebo; SSRI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Bitopertin once daily orally.; Placebo matched to bitopertin once daily orally.; Participants will continue their background SSRI treatment as per standard of care at the same dose taken during the 8 weeks prior to Day 1. Protocol does not enforce any particular SSRI drug or regimen.
Other intervention name(s): RO4917838
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection
Condition: Influenza Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human
Study type: Interventional

Summary: 
      The Purpose of this study is to evaluate the effects of 5 months catechin consumption on the
      prevention of influenza infection.
    

Detailed description: 
      Catechins are the major components of tea flavonoids and are reported to possess
      physiological activities such as antiviral effects. Recent experimental studies have revealed
      that tea catechin extracts prevent influenza infection, but few studies have been conducted
      on the clinical effects of tea catechin consumption on the prophylaxis of influenza
      infection. Based on these backgrounds, we designed a prospective randomized controlled study
      to evaluate the effects of 5 months tea catechin consumption on the prophylaxis of influenza
      infection.
    

Intervention name(s): tea catechin extracts
Intervention type(s): Dietary Supplement
Intervention description(s): Tea catechin extracts 540 mg/day, are consumed for 5 months.
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: tea catechin extracts; influenza infection; prophylaxis; supplements; adults over 20 years old; both men and women
Bone Remodeling Around HA-coated Acetabular Cups.
Condition: Coxarthrosis
MeSH terms: Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to investigate the influence of HA-coating on bone remodeling around
      the cup in cementless THA.

      100 patients gave informed consent to participate in a controlled randomized study between
      porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation.
      The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a
      modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral
      Density (BMD) determined by DEXA scanning.

      Measurements revealed no difference between the two groups after 3 years, neither in clinical
      outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above
      normal regained more bone mineral than patients with normal weight. This finding supports the
      assumption that load is beneficial to bone remodeling. Advantages of better sealing of the
      bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be
      anticipated for the 7 or 12 year follow-up examinations
    

Detailed description: 
      This study was designed to investigate the influence of HA-coating on bone remodeling around
      the cup in cementless THA.

      100 patients gave informed consent to participate in a controlled randomized study between
      porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation.
      The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a
      modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral
      Density (BMD) determined by DEXA scanning.

      Measurements revealed no difference between the two groups after 3 years, neither in clinical
      outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above
      normal regained more bone mineral than patients with normal weight. This finding supports the
      assumption that load is beneficial to bone remodeling. Advantages of better sealing of the
      bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be
      anticipated for the 7 or 12 year follow-up examinations
    

Intervention name(s): porous coated Trilogy®; Trilogy Calcicoat®
Intervention type(s): Device; Device
Intervention description(s): THA; THA
Other intervention name(s): Zimmer; Zimmer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: THA
Prospective Study of Dietary Factors, BMI, and Risk of Asthma in Children
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma is a common illness among children in the United States. While there are many known
      causes of asthma, including tobacco smoke, pollen, dust, or other allergens, the exact cause
      of asthma in some individuals remains unknown. This study will examine the role that specific
      dietary factors and body mass index (BMI) play in the development of childhood asthma.
    

Detailed description: 
      Asthma prevalence has steadily increased in the United States since the early 1980s, but the
      exact cause of this increase remains unknown. It is estimated that at least 8% of Americans
      have asthma. Although anti-inflammatory medications have proven effective for decreasing
      asthma exacerbations, there are few treatment options available to prevent the initial onset
      of the disease. Dietary factors and BMI may play a role in the development of asthma.
      Specifically, individuals who eat foods containing antioxidants (e.g., vitamin C, vitamin E,
      and carotenoids), n-3 polyunsaturated fatty acids (e.g., fish oils), and vitamin D may have a
      decreased risk of developing asthma, while individuals with higher BMI ratios may have an
      increased asthma risk. The purpose of this study is to evaluate the relationship among
      dietary factors, BMI, and the incidence of asthma among children.

      This study will enroll children participating in the Growing Up Today study and children of
      nurses who are participating in the Nurses Health Study II. Researchers will analyze
      participants' previously completed questionnaires on dietary intake, physical activity,
      height, weight, and the presence of physician-diagnosed asthma. All participants with
      physician-diagnosed asthma will receive an additional asthma questionnaire. A small portion
      of these participants will also have their medical records reviewed by study researchers, and
      mothers of these children will be asked to complete a questionnaire. Additionally, a
      questionnaire will be sent to and completed by children who do not have asthma and their
      mothers.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        U.S. children
      
Keywords: Diet; Body Mass Index; BMI
Acute Hemodynamic Changes During Paracentesis
Condition: Tense Ascites; Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Ascites
Study type: Observational

Summary: 
      The aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense
      ascites using non-invasive inert gas rebreathing.
    


Intervention name(s): routine therapeutic paracentesis
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing routine therapeutic paracentesis due to refractory tense ascites at a
        university hospital.
Bioavailability of Ibuprofen Enantiomers Compared With Standard Brufen Sirup in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacokinetics (relative bioavailability), safety and tolerability
    


Intervention name(s): Ibuprofen syrup; Brufen syrup
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see if rosuvastatin helps to reduce the number of heart
      attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.
    


Intervention name(s): 10mg Rosuvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: End Stage Renal Failure
Effect of a Rehabilitation Program to Improve Quality of Life in Women Diagnosed With Endometriosis (Physio-EndEA Study)
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      Given (1) the high volume of women on reproductive age that have a clinical diagnosis of
      endometriosis and (2) the poor management of symptoms that medical treatment usually
      achieves, new therapeutic interventions need to be evaluated in order to improve pain and
      quality of life in those patients. Therefore, 'Physio-EndEA' study has been designed to
      evaluate whether therapeutic exercise could help on the management of endometriosis-related
      symptoms
    

Detailed description: 
      Background: Prevalence of endometriosis is approximately 10% of women of childbearing age.
      Pain, considered in its multiple versions (dysmenorrhea, dyspareunia, dyschezia, dysuria and,
      in general, chronic pelvic pain) is the most common and disabilitating symptom in affected
      women. Usual care, consisting on palliative pharmacological treatment in combination with
      surgery, is clearly insufficient and physical therapies need to be explored in order to
      reduce pain and to improve quality of life in affected women.

      Objective: The overall objective of 'Physio-EndEA' study will be to explore potential short
      and mid-term benefits of a rehabilitation program on the quality of life of symptomatic
      women.

      Methods: A total of 26 symptomatic endometriosis women will be recruited. Inclusion criteria
      includes: aged 18-50, clinical diagnosis of endometriosis and interested in improving
      lifestyle while exclusion criteria includes: diagnosed chronic disease or orthopaedic issues
      that would interfere with ability to participate in a physical activity program. Women will
      be randomized to either intervention (n=13) or usual care group (n=13). Intervention group
      will receive twice weekly session for 9 weeks and control group will receive recommendations
      about healthy lifestyle and usual care.

      Discussion: This study attempts to improve the quality of life of symptomatic endometriosis
      women by reducing musculoskeletal and occupational impairments. Findings will offer a new
      therapeutic approach for a better pain control.
    

Intervention name(s): Lumbopelvic, stretching, aerobic and relaxation exercises
Intervention type(s): Behavioral
Intervention description(s): Intervention program will comprises brisk walks and small choreographies, global and analytical stretching exercises, as well as lumbopelvic stabilization exercises (with intensity and volume progression)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pain; Therapeutic exercise; Physiotherapy; Rehabilitation; Quality of life
Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
Condition: Dengue Fever; Dengue Hemorrhagic Fever; Dengue Virus
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study used 3 different formulations of tetravalent CYD dengue vaccine.

      The primary objective of the study was to evaluate the neutralizing antibody response after 2
      doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and
      Month 6.

      The secondary objectives were:

        -  To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine.

        -  To describe the neutralizing antibody responses to each of the 3 vaccine formulations.

        -  To describe vaccine viremia after the first and second dose of each of the 3 vaccine
           formulations in a subset of participants.
    

Detailed description: 
      All participants provided blood samples for immunogenicity assessments, while vaccine viremia
      was assessed in a subset of participants in each group.

      Safety was assessed in all participants as follows: solicited adverse event (AE) prelisted in
      the diary card were collected for 7 days after vaccination for solicited injection site
      reactions and 14 days for solicited systemic reactions , unsolicited AEs were collected for
      28 days after vaccination, and serious adverse event (SAE) information collected throughout
      the study up to 6 months after vaccination.
    

Intervention name(s): Tetravalent CYD Dengue Vaccine , 5555 formulation; Tetravalent CYD Dengue Vaccine , 5553 formulation; Tetravalent CYD Dengue Vaccine, 4444 formulation
Intervention type(s): Biological; Biological; Biological
Intervention description(s): A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.; A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively; A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Dengue fever; Dengue hemorrhagic fever; Dengue virus
Nurtured Heart Parenting Intervention for Child Behavioural Problems
Condition: Parent-Child Relations; Child Behavior Problem
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      Behavioural problems are prevalent in children, yet the consequences can be significant for
      the child, family and wider society. Effective intervention is paramount in reducing the
      impact of childhood behavioural problems. The Nurtured Heart Approach (NHA; Glasser & Easley,
      2016) is an atheoretical parenting intervention which aims to reduce childhood behavioural
      problems. Although used in clinical practice, there is little empirical research on the
      effectiveness of the NHA. The aims of the study were to examine whether the NHA reduced
      parent-reported child behavioural problems, reduced negative parenting practices, and
      increased parental reflective functioning.

      The study used a multiple baseline single case design. Parents of children with behavioural
      problems were recruited from CAMHS waiting lists. The NHA was delivered in a guided self-help
      format, using the Transforming the Intense Child workbook (Glasser, 2016) and weekly phone
      calls. Data collection involved psychometric measures of parent-reported child behavioural
      problems, parenting practices and parental reflecting functioning. Measures were repeated
      throughout baseline and intervention phases. A follow-up four weeks after the intervention
      included final measure administration and a change interview. The data were graphed and
      visually analysed. Supplementary analysis included reliable and clinically significant
      change, Tau-U and percentage exceeding the median. Framework analysis was used to analyse the
      change interview.
    


Intervention name(s): Transforming the Intense Child Workbook (Glasser, 2016)
Intervention type(s): Behavioral
Intervention description(s): The NHA was delivered in a guided self-help format, using the Transforming the Intense Child workbook (Glasser, 2016) and weekly phone calls.
Intervention model: Single Group Assignment
Intervention model description: Single case design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: child behavioural problems; parent training; Nurtured Heart Approach; guided self-help; single case design
Active Prevention of Upper Limb Musculoskeletal Disorders in Thermal Environment (MUSKA).
Condition: Musculoskeletal Disorders
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The main objective of this work is to demonstrate superiority to three months of a
      standardized short course of SPA Therapy of 6 days associated with personalized health
      education program compared to conventional therapy in the management of MSDs on the
      functional capabilities of the employees in their daily lives (personal or professional)
    

Detailed description: 
      Musculoskeletal disorders are the leading occupational disease in industrialized countries.
      The symptoms are varied, their multiple risk factors, work organization may be involved.
      Musculoskeletal disorders affect the muscles, tendons and nerves of the mainly upper limbs
      (neck, shoulder, elbow, wrist and hand). Pain or functional impairment are common to all
      these disorders.The proposed study is part of an active preventive approach in addressing
      current employees with latent or symptomatic upper extremity MSD linked to a hyper
      solicitation. This study provide them 6 days SPA therapy (before or after work) combined with
      a health education program to help improve their lives over time.
    

Intervention name(s): SPA Therapy
Intervention type(s): Other
Intervention description(s): Immersion bath and shower ( 1 treatment ) Underwater shower with localized massage on the painful area ( 1 treatment ) or equivalent underwater massage Illutations ( 1 treatment ) or equivalent ( poultice ) Mobilization Pool ( 1 care) Education to exercise
Other intervention name(s): Non pharmacological intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Upper limb musculoskeletal disorders; Spa treatment; Randomized controlled trials; Education; Self- management; Self-care; Exercise; Non pharmacological treatment
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled
      Esketamine in participants with treatment-resistant depression (TRD) in the course of Major
      Depressive Disorder (MDD). The study is to determine the efficacy and dose response of three
      Esketamine doses, compared with placebo.
    

Detailed description: 
      This is a randomized, multiple dose, placebo-controlled, double-blind, multicentre study of
      Esketamine DPI, inhalation powder delivered via dry powder inhaler (DPI) in participants with
      TRD in the course of MDD. There are 3 study phases: Screening phase, a two weeks double-blind
      treatment phase and a 6-week follow-up phase. Participants are to be randomized in 1:1:1:1
      ratio to receive placebo or one of the three doses of Esketamine DPI. Participants from each
      group will receive different dosing sequences, consider as a single dose, corresponding to
      low, medium, high Esketamine dose or placebo. Participants will undergo one cycle of
      treatment consisting of four doses of Esketamine DPI or placebo over 14-day period.
      Participants safety will be monitored throughout the study.
    

Intervention name(s): Esketamine DPI - low dose; Esketamine DPI - medium dose; Esketamine DPI - high dose; Placebo DPI
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to low Esketamine dose.; Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to medium Esketamine dose.; Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to high Esketamine dose.; Placebo DPI is to be administered via dry powder inhaler.
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment