bioihbjkbjnl/mcl2 huggingface dataset:
Pre-Release VIVITROL for Opioid Dependent Inmates
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Naltrexone is a medication that has been shown to help prevent relapse to opioid addiction
      and it has been reported to be clinically effective in parolee populations although it is
      rarely used. Recently a depot formulation with one-month duration has received FDA approval
      for the treatment of alcoholism and opiate dependence. This means that rather than having to
      take medication daily, individuals can receive one injection that lasts for approximately 30
      days. The purpose of this study is to determine whether this monthly injection of naltrexone
      is practical and useful in the prevention of relapse to opioids and re-incarceration when
      administered to inmates prior to release from prison. The investigators will also monitor HIV
      risk behaviors to determine whether the intervention reduces risky behaviors associated with
      intravenous drug abuse and the spread of viruses such as HIV and hepatitis C. Volunteers will
      be randomized to receive an injection of depot naltrexone prior to release from prison or to
      contact study personnel in the community following release. Participants assigned to receive
      naltrexone in prison will receive 1 injection in prison, and 5 additional monthly injections
      for 5 months upon release. Participants assigned to contact study personnel upon release will
      receive all 6 injections in the community at RIH after their release from the ACI. Patients
      in both groups will be given identical follow up monthly for six months including measures of
      opiate use by self-report, and urine tests. An additional scheduled urine test will take
      place each month between monthly visits. There will also be a 12-month follow-up period for
      participants in both groups, which will consist of 2 visits, spaced 6 months apart, meaning
      that participants will be enrolled in the study for a total of about 18 months. All
      participants will be asked to complete brief questionnaires at follow-up visits to assess
      things such as services received, drug use, and depression.
    


Intervention name(s): naltrexone for extended release injectable suspension
Intervention type(s): Drug
Intervention description(s): VIVITROL (naltrexone for extended-release injectable suspension) is supplied as a microsphere formulation of naltrexone for suspension, at a dose of 4cc (380mg of naltrexone base), administered by intramuscular injection to the buttocks (alternating sides monthly) for six months.
Other intervention name(s): VIVITROL
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Group Toilet Training of Healthy Children, in Daycare Centers (CRCT)
Condition: Toilet Training; Child, Preschool
Study type: Interventional

Summary: 
      Evaluation of a new method of toilet training (TT), meaning TT in group in daycare centers,
      guided by a TT expert. Children are included based on signs of readiness for TT.
    

Detailed description: 
      A cluster randomized controlled trial (CRCT) was established in daycare centers. Clusters of
      participants (per daycare center) were randomly allocated to an Intervention group or a
      Control group.

      Evolution of the TT process was monitored in the daycare center until the child was
      considered to be fully toilet trained (or 'clean') during the day (this means wearing
      undergarments, conscious of the need to void and initiating toilet behavior without reminder
      of the parents with a maximum of one leakage a day [9]).

      Daycare workers evaluated the TT process of all participating children on a weekly basis.
      Parents were asked to fill in an online questionnaire when their child was completely toilet
      trained.
    

Intervention name(s): Group toilet training in daycare; Individual toilet training at home
Intervention type(s): Other; Other
Intervention description(s): During the training, children wore underpants, were informed about potty training, were encouraged to drink often and were asked regularly if they felt the need to void. Tutors looked for elimination signals in the child and quickly responded by putting the child on the potty when he/she expressed the need to void or to defecate. Children were positively rewarded. Parents received a leaflet containing practical tips concerning TT and their child's successes of the past two days. They were asked to continue TT at home during the following weekend and longer if necessary. Daycare workers were asked to pay more attention on the TT during the following days and weeks to ensure the effect of the intervention.; Parents were encouraged to start TT their child, because they were considered as being ready to initiate TT. Children did not receive any intervention, but parents were asked to start TT in their own manner. Parents were allowed to search for information on methods of TT with their relatives, internet, books,...
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Method
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) in Healthy Japanese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled study to investigate the safety, tolerability,
      pharmacokinetics and pharmacodynamics of single oral doses of Risdiplam in healthy Japanese
      participants.
    


Intervention name(s): Risdiplam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral doses of Risdiplam will be administered on Day 1.; Single oral doses of Risdiplam matching placebo will be administered on Day 1.
Other intervention name(s): RO7034067
Intervention MeSH terms: Risdiplam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
CB3 Pilot (Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia)
Condition: Aphasia; Primary Progressive Aphasia; Dementia; Communication; Alzheimer Disease
MeSH terms: Alzheimer Disease; Aphasia; Aphasia, Primary Progressive; Pick Disease of the Brain; Frontotemporal Dementia
Study type: Interventional

Summary: 
      This study will evaluate evidence-based treatments for adults with mild Primary Progressive
      Aphasia (PPA). The aim of the study is to help identify efficacious communication and quality
      of life interventions for those with PPA and their care-partners.

      Participants with a diagnosis of PPA and their actively-engaged care partners will be
      involved in the study for 12 months. Each participant will receive a iPad equipped with the
      necessary applications and features for the study. Participants will complete evaluations,
      speech therapy sessions with a speech and language therapist, and sessions with a licensed
      social worker or related clinician. They will have access to Communication Bridge, a
      personalized web application to practice home exercises that reinforce treatment strategies.
      There are no costs to participate in this study.
    

Detailed description: 
      This study will evaluate evidence-based treatments for adults with mild Primary Progressive
      Aphasia (PPA). The aim of the study is to help identify efficacious communication and quality
      of life interventions for those with PPA and their care-partners.

      Participants with a diagnosis of PPA and their actively-engaged care partners will be
      involved in the study for 12 months. Each participant will receive a iPad equipped with the
      necessary applications and features for the study. Participants will complete evaluations,
      speech therapy sessions with a speech and language therapist, and sessions with a licensed
      social worker or related clinician. They will have access to Communication Bridge, a
      personalized web application to practice home exercises that reinforce treatment strategies.
      There are no costs to participate in this study.
    

Intervention name(s): Communication Bridge™
Intervention type(s): Behavioral
Intervention description(s): Evidence-based speech language therapy treatment will be compared and contrasted.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dexamethasone and Ondansetron Versus Placebo for Postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators want to test if it is indicated to associate dexamethasone and ondansetron
      in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.
    

Detailed description: 
      Obese patients having bariatric surgery have frequently postoperative nausea and vomiting
      (PONV). We want to test if it is indicated to associate dexamethasone and ondansetron in
      obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.

      Two groups to be studied: one will receive 4 mg dexamethasone at the end of the anesthetic
      induction and 4 mg ondansetron at the end of the surgical procedure, one will receive normal
      saline.

      One hundred twenty consecutive patients meeting the inclusion and exclusion criteria and who
      give written informed consent to participate in the study will be randomly assigned to one of
      two experimental groups using a 1:1 ratio.

      Patients will be continuously monitored in the post anesthesia care unit (PACU) and the
      medical floor for a total of 24 hours post operatively. Episodes of nausea, vomiting and
      administration of rescue therapy for either nausea or vomiting will be recorded and time
      stamped. In addition, severity of nausea will be evaluated by the patient using a standard
      verbal response scale (VRS) ranging from 0-10, 0 being no nausea and 10 being severe nausea.
      Rescue therapy for PONV episodes will consist of 4 mg ondansetron followed by 0.625 mg
      droperidol if necessary.
    

Intervention name(s): Dexamethasone and Ondansetron; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting; Placebo
Intervention MeSH terms: Dexamethasone; Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anesthesiology; Complications; Closed-loop
SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance
Condition: Overweight; Obesity
MeSH terms: Overweight; Insulin Resistance
Study type: Interventional

Summary: 
      Background of the study:

      A sedentary lifestyle and obesity are well known risk factors of type 2 diabetes. The major
      focus of current guidelines for type 2 diabetes prevention is on energy balance. Physical
      activity guidelines recommend at least 30 minutes/day of moderate to vigorous physical
      activity (MVPA). However, no advice is given how the other 23.5 hours of the day should be
      spent. Several recent epidemiologic studies suggest that excessive sitting, independent of
      moderate to vigorous physical activity, has detrimental health effects. Another possibility
      to sit less is by increasing low intensity physical activities as slowly walking and
      standing. A recent published study of Duvivier and colleagues suggests that sitting less and
      replacing it by slowly walking and standing has a better effect on insulin action and
      cardiovascular risk factors than the combination of one hour MVPA per day and sitting the
      rest of the day in healthy subjects (Duvivier et al. PLOS ONE 2013). Until now this research
      is not performed in subjects with overweight/obesity.

      Objective of the study:

      To assess the effect of low intensity physical activity on plasma insulin levels, cognition
      and mood in subjects with overweight/obesity

      Study population:

      21 subjects between 40-80 years old with overweight/obesity

      Intervention:

      2 activity regimes of 4 days: a sitting regime and a "sit less" regime
    


Intervention name(s): Physical activity regime
Intervention type(s): Behavioral
Intervention description(s): Information already included in arm descriptions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Insulin Resistance; Cognition; Affect; Insulin; Lipids
Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
Condition: Colorectal Cancer; Colorectal Neoplasm
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Aims:

        1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT)
           versus colonoscopy every 10 years for the reduction of colorectal cancer-related
           mortality at 10 years in average-risk population.

        2. To determine the compliance and complications associated with both strategies.

      Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias,
      Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia).

      Study groups:

        -  Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive
           result.

        -  Group II: colonoscopy.

      Sample-size calculation: 27,749 subjects in each study group (total: 55,498).
    


Intervention name(s): Immunochemical fecal occult blood test; Colonoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.; Every 10 years, with sedation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Colorectal cancer; Screening; Prevention; Fecal occult blood test; Colonoscopy; Colorectal neoplasm; Randomized clinical trial
Market Potential of Carbon Dioxide Nasal Spray
Condition: Nasal Congestion
Study type: Interventional
Phase: Phase 2

Summary: 
      Carbon dioxide (CO2) is a naturally occurring gas that readily diffuses across body tissues
      and membranes. Data from earlier clinical studies conducted in 975 subjects with allergic
      rhinitis have shown that nasally administered CO2 may provide relief of the associated
      symptoms. Symptom relief has been shown to occur as soon as 10 minutes after administration,
      and may persist for four to six hours.

      This study aims to assess the consumer appeal of a prototype CO2 delivery device, as well as
      evaluate its perceived effectiveness for nasal congestion. Properly consented subjects who
      qualify and choose to participate in the clinical study will be administered nasal CO2 under
      medical supervision, wait a period of 1 hour in clinic, and then be dispensed a device for
      self-treatment at home. Subjects will return to the clinic on day 7 for final evaluation and
      completion of assessment questionnaires.
    

Detailed description: 
      This study will be conducted in two parts. In the first part of the study, recruited subjects
      with nasal congestion will view a description of a new treatment option (concept). Interested
      subjects will be offered the opportunity to enter the clinical trial. Subjects who consent
      and are found otherwise eligible will then receive one dose of CO2 in the study clinic under
      medical supervision. Afterward, subjects who wish to continue will be allowed to take the
      administration device home for an additional six days of use (study part 2).

      During the at-home use portion of the study, subjects will use a diary to record the number
      of times the product was used and their nasal congestion symptoms before and after use.

      At the end of the study period, subjects will return to the study center for global
      assessment of their impressions of treatment and to answer questions designed to estimate
      market acceptability. Subjects may be asked to participate voluntarily in a market research
      focus group following their participation in this study.
    

Intervention name(s): Carbon Dioxide
Intervention type(s): Drug
Intervention description(s): Nasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carbon Dioxide, Allergy symptoms
Effects of Segmental Stabilization on the Anticipatory Postural Adjustment of Subjects With Lumbar Pain
Condition: Lumbar Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      This study aims to verify the effects of a segmental stabilization exercise program on the
      anticipatory postural adjustment of subjects with chronic lumbar pain. The effects will be
      assessed by means of superficial electromyography focused on the registry of the onset of
      multifidius and deltoid (anterior and posterior) activity during a repetitive shoulder
      ﬂexion/extension.
    


Intervention name(s): Segmental Stabilization Exercises; Home Exercises
Intervention type(s): Other; Other
Intervention description(s): The stabilization program focuses on the reestablishment of motor control and coordination between deep and superficial trunk muscles. The exercise program is based on the following criteria progression: 1) Precise contraction of the transverse abdominal and multifidus muscles, keeping the lumbar spine in a neutral position (as the middle way between maximum flexion and extension, repeated three times); 2) Keep the neutral position for 10 repetitions of 10 seconds; 3) Perform exercises with lower limbs in different postures.; Home exercises include passive stretching and active mobilization of the spine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Post-Marketing Safety Study in Japan of Shock and Anaphylaxis After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in Persons in at High Risk of Severe COVID-19
Condition: SARS-CoV-2
MeSH terms: COVID-19; Anaphylaxis
Study type: Observational

Summary: 
      The goal of this study is to confirm the onset status of hypersensitivity reactions including
      shock and anaphylaxis observed after vaccination with this drug in persons with underlying
      diseases who are considered to have a high risk of severe exacerbation of COVID-19 and
      explore risk factors.
    

Detailed description: 
      Data collected from the JDMC Claims Database between May 2021 to November 2021.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population was selected from participants who were registered to receive the
        mRNA-1273 vaccine in the Pep Up vaccination history Database whose start date of
        observation in the claim database was within 6 months or more before vaccination with
        mRNA-1273 vaccine, and those who met the definition of underlying disease based on the
        claim data for 6 months.
      
Keywords: mRNA-1273; mRNA-1273 vaccine; SARS-CoV-2; SARS-CoV-2 Vaccine; Coronavirus; Virus Diseases; Messenger RNA; COVID-19; COVID-19 Vaccine; Moderna
A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections
Condition: Invasive Fungal Infections
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or
      probable deep tissue fungal infections.
    


Intervention name(s): voriconazole
Intervention type(s): Drug
Intervention MeSH terms: Voriconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss
Condition: HIV Infections; Cachexia; Anorexia; AIDS Wasting Syndrome; HIV Wasting Syndrome
MeSH terms: HIV Wasting Syndrome; Wasting Syndrome; Syndrome; Anorexia; Weight Gain; Cachexia
Study type: Interventional
Phase: Phase 2

Summary: 
      Explore weight gain in HIV-positive patients who have weight loss associated with
      AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either
      megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate
      oral suspension original formulation
    


Intervention name(s): Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL; Megestrol acetate oral suspension 40 mg/mL
Intervention type(s): Drug; Drug
Intervention description(s): Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose); Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)
Other intervention name(s): Megace ES; Megace
Intervention MeSH terms: Megestrol; Megestrol Acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss; Cachexia; Anorexia; Megestrol acetate oral suspension; Nanocrystal dispersion; Nanocrystal technology; Body weight changes; AIDS wasting; HIV wasting; Emaciation; Megace ES; Megace; Treatment Experienced