bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, active
      comparator (Cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and
      safety of GDC-0853 in participants with moderate to severe active RA and an inadequate
      response to previous methotrexate (MTX) therapy (Cohort 1) or MTX and tumor necrosis factor
      (TNF) therapy who may have also had exposure to no more than one non-TNF inhibitor biologic
      (Cohort 2).
    


Intervention name(s): GDC-0853; Adalimumab; Folic Acid; MTX; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive GDC-0853 at low, mid, or high doses, orally once or twice daily for 12 weeks in Cohort 1 or 2.; Participants will receive adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks.; Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.; Participants will receive stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines).; Participants will receive placebo matched to adalimumab, subcutaneously Q2W and/or placebo matched to GDC-0853, orally once or twice daily for 12 weeks in Cohort 1 or 2.
Other intervention name(s): RO7010939
Intervention MeSH terms: Folic Acid; Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Decreasing Unused Opioids in the Home Post Supracondylar Fracture Repair
Condition: Pain Management
Study type: Observational

Summary: 
      Over the past two decades, the misuse of prescription opioids has significantly increased. A
      recent systematic review reported as much as 67% to 92% of opioids dispensed on discharge
      post-surgery go unused. This culture of overprescribing is consistently observed across
      surgical specialties. Less frequently observed is the potential for opioid use and misuse in
      children and adolescents post-surgery. The research to date in this area has been poorly
      performed with heterogenous data collection, analysis and reporting, as well as large loss of
      patients to follow-up.

      The investigators' previous prospective observational deception study identified three areas
      of concern:

        1. There is a culture of postoperative opioid over-prescribing at discharge as demonstrated
           by heterogenous opioid dosing and duration of treatments across practitioners for single
           procedures

        2. This overprescribing is in excess of patients' home-requirements and results in
           significant quantities of leftover opioids

        3. There is a culture of inappropriate storage and lack of safe disposal of prescribed
           opioids in the community
    

Detailed description: 
      This study focuses on addressing and minimizing pediatric surgical over-prescribing. It aims
      to reduce the amount of opioids prescribed by focusing prescribers and families on regular
      use of simple non-opioid analgesics, as well as decreasing the amount of opioids prescribed
      and dispensed.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any child (0-18 years) who has undergone a supracondylar fracture repair at The Hospital
        for Sick Children.
Metacognitive Therapy for Patients With Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder.
      However, the majority of treated patients remain symptomatic. The metacognitive therapy by
      Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this
      study is to investigate this approach with a randomized controlled trial by comparing
      metacognitive therapy with exposure and response prevention for obsessive-compulsive
      disorder.
    


Intervention name(s): Metacognitive Therapy; Exposure and Response Prevention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Metacognitive Therapy for OCD according to Wells (1997); Exposure and Response Prevention for OCD according to Kozak & Foa (1997)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aprepitant Triple Therapy for the Prevention of CINV in Nondrinking and Young Women Who Received Moderately Emetogenic Chemotherapy
Condition: Gastrointestinal Neoplasms; Chemotherapy-induced Nausea and Vomiting
MeSH terms: Gastrointestinal Neoplasms; Digestive System Neoplasms; Nausea; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to study whether adding Aprepitant to Palonosetron and
      dexamethasone can further prevent the incidence and severity of nausea and vomiting caused by
      FOLFIRI or FOLFOX chemotherapy regimen among gastrointestinal malignancy patients with high
      risk factors of chemotherapy-associated adverse events.
    

Detailed description: 
      The purpose of this study is to study whether adding Aprepitant to Palonosetron and
      dexamethasone can further prevent the incidence and severity of nausea and vomiting caused by
      FOLFIRI or FOLFOX chemotherapy regimen after curative effect among gastrointestinal
      malignancy patients with high risk factors of chemotherapy-associated adverse events.This
      study will observe and evaluate the incidence and severity of nausea and vomiting as well as
      the effectiveness of corresponding treatment(with or without Aprepitant) during Day 1 to Day
      5 from the beginning of chemotherapy.
    

Intervention name(s): Aprepitant; Palonosetron; Dexamethasone; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Aprepitant is manufactured by Merck & Co. for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) and for prevention of postoperative nausea and vomiting. It was approved by the FDA in 2003; Palonosetron is a 5-HT3 antagonist used in the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). It is used for the control of delayed CINV-nausea and vomiting and there are tentative data to suggest that it may be more effective than granisetron.; Dexamethasone is a type of corticosteroid medication. It is used in the treatment of many conditions, including rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive lung disease, croup, brain swelling, and along with antibiotics in tuberculosis.; In the current clinical trial, placebo oral tablet is provided as a substance for Aprepitant with no active therapeutic effect.
Intervention MeSH terms: Dexamethasone; Aprepitant; Palonosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effect of Different Duration of Dry Needling on Muscles Strength of Flexor Forearm Muscles of Dominant Hand in Healthy Subjects
Condition: Dry Needling
Study type: Interventional

Summary: 
      Dry needling is typically used to treat muscles, ligaments, tendons, subcutaneous fascia,
      scar tissue, peripheral nerves, and neurovascular bundles for the management of a variety of
      neuromusculoskeletal pain syndromes.However, there are contradictory research articles about
      the optimal duration of dry needling per session.
    

Detailed description: 
      Dry needling is 'an invasive technique used by physical therapists to treat myofascial pain
      that uses a dry needle, without medication or injection, which is inserted into areas of the
      muscle known as trigger point defines dry needling as including both muscular and connective
      tissues, but not neural stimulation. The paper reads, 'dry needling is a skilled intervention
      that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial
      trigger points, muscular, and connective tissues for the management of neuromusculoskeletal
      pain and movement impairments.

      The dry needling is reported to improve the level of pain, muscle strength, and flexibility.
      However, the optimal duration of dry needling to improve muscle strength is still Unknown.
    

Intervention name(s): dry needling; kinesio taping
Intervention type(s): Device; Other
Intervention description(s): the dry needle inserted to area of pain; kinesio taping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dry needling; kinesio tapping; Healthy adults
A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the feasibility of conducting a study of oral
      risperidone followed by paliperidone palmitate for once monthly (PP1M) and paliperidone
      palmitate for every 3 months (PP3M) in rwandan healthcare facilities with mental healthcare
      capabilities.
    


Intervention name(s): Risperidone 3 mg; Paliperidone Palmitate 50 mg eq.; Paliperidone Palmitate 75 mg eq.; Paliperidone Palmitate 100 mg eq.; Paliperidone Palmitate 150 mg eq.; Paliperidone Palmitate 175 mg eq.; Paliperidone Palmitate 263 mg eq.; Paliperidone Palmitate 350 mg eq.; Paliperidone Palmitate 525 mg eq.
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive 3 mg oral risperidone tablets once daily for up to one Week.; Participants will receive 50 mg eq. PP1M intramuscular injection for 17 Weeks.; Participants will receive 75 mg eq. PP1M intramuscular injection for 17 Weeks.; Participants will receive 100 mg eq. PP1M intramuscular injection for 17 Weeks.; Participants will receive 150 mg eq. PP1M intramuscular injection for 17 Weeks.; Participants will receive 175 mg eq. PP3M intramuscular injection for 24 Weeks.; Participants will receive 263 mg eq. PP3M intramuscular injection for 24 Weeks.; Participants will receive 350 mg eq. PP3M intramuscular injection for 24 Weeks.; Participants will receive 525 mg eq. PP3M intramuscular injection for 24 Weeks.
Other intervention name(s): R092670; R092670; R092670; R092670; R092670; R092670; R092670; R092670
Intervention MeSH terms: Risperidone; Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Treatment of Rheumatoid Arthritis With Roxithromycin
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the clinical efficacy, safety, and tolerability of
      roxithromycin in patients with rheumatoid arthritis.
    

Detailed description: 
      This was 6-month, monocentre, randomized, double-blind, placebo-controlled study. We treated
      100 patients with rheumatoid arthritis with either once-daily oral roxithromycin (300 mg) or
      daily oral placebo for 6 months. The primary efficacy variable was the percentage of patients
      who had a 20 percent improvement according to American College of Rheumatology (ACR) criteria
      (an ACR 20 response) at six months. Secondary outcome measures were 50 percent improvement
      and 70 percent improvement according to ACR criteria (an ACR 50 response and an ACR 70
      response, respectively).
    

Intervention name(s): Roxithromycin
Intervention type(s): Drug
Intervention MeSH terms: Roxithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Roxithromycin,Rheumatoid arthritis,Macrolides
Efficacy of Zinc in the Treatment of Bronchiolitis and Prevention of Wheezing Respiratory Illness in Children Less Than Two Years Old
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 3

Summary: 
      1. Bronchiolitis is a leading cause of morbidity and mortality in children. It is an acute,
      infectious illness of the lower respiratory tract resulting in obstruction of the
      bronchioles. The etiology is viral in the majority of the cases and RSV is the most commonly
      isolated agent. The disease is more common in younger children under 2 years of age. Children
      often receive unnecessary antibiotics and often require hospitalization. An episode of
      bronchiolitis can be followed by recurrent wheezing episodes. RSV bronchiolitis in the first
      year of life is one of the most important risk factors for the subsequent development of
      asthma in both developed and developing countries. Thus, bronchiolitis is a global public
      health problem. Zinc supplementation has been shown to be effective in both preventing and
      treating pneumonia. However, no study has particularly examined the effect of zinc on ARI
      associated with wheezing. This study aims to investigate whether zinc (20 mg/day) reduces1.
      the duration of bronchiolitis in children.2. the severity of bronchiolitis in children.3. the
      rate of hospitalization for bronchiolitis.3. future episodes of wheezing in children.
    


Intervention name(s): Zinc sulphate 20 mg
Intervention type(s): Drug
Intervention MeSH terms: Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Zinc treatment; Bronchiolitis; Wheezing; Children aged 2 months to 23 months; Diagnosed case of acute bronchiolitis
Comparison of Two Flow Rates of HHHFNC to Prevent Extubation Failure in Preterm Infants
Condition: Prematurity, Mechanical Ventilation
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This is a randomized controlled trial (RCT) to evaluate the influence of two flow rates (6
      liter/min versus 3 liter/min) of Heated-Humidified High-Flow-Nasal-Cannula (HHHFNC) on rates
      of extubation failure in mechanically ventilated preterm infants.
    

Detailed description: 
      HHHFNC has been proposed as an alternative to nasal continuous positive airway pressure
      (nCPAP) in neonatal intensive care units (NICUs) for preventing extubation failure. In a
      recent international survey on periextubation practices in extremely preterm infants, nCPAP
      was the most common type of respiratory support used (84%) followed by nasal intermittent
      positive pressure ventilation (55%) and HHHFNC (33%). Moreover, HHHFNC appears to have
      efficacy and safety similar to those of nCPAP when applied immediately post-extubation to
      prevent extubation failure in preterm infants. and resulted in significantly less nasal
      trauma in the first 7 days post-extubation than nCPAP. However, the best flow rates of HHHFNC
      to prevent extubation failure remains to be known.

      This RCT aims to compare the efficacy and safety of postextubation respiratory support via
      HHHFNC at two different flow rates (6 L/min. versus 3 L/min) regarding successful extubation
      after a period of endotracheal positive pressure ventilation. We hypothesized that
      postextubation respiratory support via HHHFNC at a flow rate of 6 L/min. will result in a
      greater proportion of preterm infants being successfully extubated after a period of
      endotracheal positive pressure ventilation compared with HHHFNC at a flow rate of 3 L/min.
    

Intervention name(s): HHHFNC 6 liter minute; HHHFNC 3 liters/min
Intervention type(s): Device; Device
Intervention description(s): Infants allocated to HHHFNC at 6 L/min. will be extubated to a HHHFNC flow of 6 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.; Infants allocated to HHHFNC at 3 L/min. will be extubated to a HHHFNC flow of 3 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of cytochrome P450 3A4 inhibition by
      Itraconazole on the pharmacokinetics of BMS-986256.
    


Intervention name(s): BMS-986256; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Itraconazole
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cytochrome P450 3A4 Inhibition
Longitudinal Study of Neighborhood Predictors of CVD
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To examine how neighborhood-level factors interact with individual characteristics to predict
      incidence of cardiovascular disease and all-cause mortality.
    

Detailed description: 
      BACKGROUND:

      There are few comprehensive databases that allow for a longitudinal examination of how
      neighborhood-level factors may interact with individual characteristics to predict incident
      cases of cardiovascular disease (CVD) and all-cause mortality. This cross-institutional
      project joins investigators from Karolinska Institutet in Sweden and Stanford University,
      known for their expertise in immigrant health and social inequalities in CVD.

      DESIGN NARRATIVE:

      The study examines how neighborhood social characteristics (e.g., neighborhood socioeconomic
      status (SES), social disintegration, socioeconomic and ethnic segregation, social capital),
      physical environments (e.g., geocoded assets including goods and services contributing to
      health such as educational and recreational resources; barriers to health including
      pollution, industries, waste dumps, criminal activity, alcohol and fast food outlets) and
      individual factors (e.g., SES, cardiovascular disease {CVD} risk factors, country of birth
      and social networks) may interrelate to predict CVD [morbidity and mortality] and all-cause
      mortality. Data will be used from a newly created, comprehensive set of Swedish databases,
      MigMed and MigSALLS. MigMed (1990-2002) includes data for the entire Swedish population of 6
      million women and men aged 25 and older, of whom 600,000 are first generation immigrants.
      Their addresses have been geocoded, yielding 9,677 neighborhoods, which will be reduced to a
      smaller number of defined units by cluster analyses. MigMed includes an annual assessment of
      individual-level sociodemographic and health indicators. Data will also be analyzed from
      MigSALLS (1988-2002), which includes more in-depth data from face-to-face interviews with a
      representative sample of approximately 18,000 women and men aged 25-74, of whom 2,000 are
      first generation immigrants. MigSALLS contains similar individual- and neighborhood-level
      factors as MigMed, as well as extensive information on factors that may mediate relationships
      between neighborhoods and CVD outcomes (e.g., CVD risk factors such as smoking, weight,
      physical activity, and blood pressure). Information from these two datasets will be matched
      to hospital and death records (300,000 deaths and 140,000 incidence cases of CVD expected
      between 1988-2002), thus creating one of the largest databases in the world involving men and
      women from diverse SES levels and countries of origin.
Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Based on the investigators clinical experience in patients with chronic disease (Hui, Hui,
      and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui
      2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a
      pilot study that investigates if acupuncture combined with patient education will relieve
      fatigue in patients who have completed primary treatment for breast cancer.
    

Detailed description: 
      Patients will be randomly assigned to one of the two groups. Our hypothesis is that patients
      in the acupuncture/education group will experience greater relief of fatigue than those in
      the standard care group.
    

Intervention name(s): Acupuncture and patient education
Intervention type(s): Procedure
Intervention description(s): Acupuncture involves the insertion of extremely thin needles, much thinner than those used for drawing blood, into very specific acupuncture points. Patients will receive a total of 8 acupuncture treatments, each lasting 50 minutes. Patient education will be delivered to individuals over the course of approximately 50 minutes for each of the four sessions; topics will include acupressure, nutrition, exercise, stress management, and lifestyle advice.
Other intervention name(s): Traditional Chinese Medicine, Integrative East-West Medicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cancer; Acupuncture