bioihbjkbjnl/mcl2 huggingface dataset:
PROState Cancer Patients Initiating Hormone Therapy: Effect of Exercise on CARDIOvascular Health (PROSCARDIO)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This study evaluates whether exercise can reduce treatment-related adverse effects in
      prostate cancer patients initiating androgen deprivation therapy. Half of recruited
      participants completed a 3-month exercise intervention, while the other half did not perform
      any supervised exercise. It was anticipated that exercise would have a positive effect on
      body composition, cardiorespiratory fitness and quality of life.
    

Detailed description: 
      Androgen deprivation therapy (ADT) is routinely used as first-line treatment for locally
      advanced and metastatic prostate cancer. However, it is associated with many side effects
      such as increased fat mass and reduced skeletal muscle mass, cardiorespiratory fitness and
      metabolic health. Ultimately, these negative changes induced by ADT contribute to reduced
      health-related quality of life (HRQoL). This study evaluates whether 3-months of exercise can
      mitigate treatment toxicity in prostate cancer patients initiating ADT.

      In a parallel groups, prospective, randomised controlled design, participants were randomly
      allocated to a standard care control group or standard care plus exercise group. The exercise
      group completed 3-months of combined aerobic and resistance training. The standard care group
      did not receive any supervised exercise or specific physical activity recommendations.
      Outcomes were assessed at baseline, 3-month (post-intervention), and 6-month (follow-up)
      endpoints.
    

Intervention name(s): Standard care plus exercise
Intervention type(s): Other
Intervention description(s): The exercise was supervised by exercise science staff in the exercise science facilities at the University of East Anglia, UK. Participants competed two weekly sessions for 12 weeks upon initiating ADT. Each session lasted ~60 min and included aerobic interval exercise on a cycle ergometer (Monark 824E; Varberg, Sweden) followed by resistance training. In addition to the supervised exercise sessions, patients were advised on how to increase their habitual physical activity levels and were encouraged to engage in 30 minutes of self-directed exercise on three days each week (e.g. brisk walking, cycling, home-based resistance training).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After baseline measures were collected, participants were randomly allocated (1:1) to standard care or standard care plus exercise using a randomisation sequence created by an independent researcher (nQuery, Statistical Solutions, USA). Treatment allocation was concealed from the research team until after baseline measurements were collected.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prostate Cancer; Androgen deprivation therapy; Exercise
An Exploratory Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-old Adults
Condition: Healthy
MeSH terms: Virus Diseases; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess a trend for the prophylactic efficacy of a single dose
      of 1*10^11 virus particles (vp) of adenovirus serotype 26 respiratory syncytial virus
      pre-fusion F protein (Ad26.RSV.preF) administered intramuscularly to adults aged 18-50 years
      in the respiratory syncytial virus (RSV) challenge model in terms of reduction of nasal wash
      viral load compared to placebo.
    


Intervention name(s): Ad26.RSV.preF; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1*10^11 vp in single-use vials.; Placebo will be administered as sterile 0.9% saline for injection.
Other intervention name(s): JNJ-64400141
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effectiveness and Safety of Autologous ADRC for Treatment of Degenerative Damage of Knee Articular Cartilage
Condition: Knee Joint Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System
      (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front
      abdominal wall. ADRC will be administered one-time intraarticularly. This is a single arm
      study with no control. All patients receive cell therapy.
    

Detailed description: 
      Patients with verified diagnosis knee joint osteoarthritis (degenerative damage of knee
      articular cartilage) will undergo knee arthroscopic debridement. 28 days later patients will
      will undergo liposuction from front abdominal wall under local anesthesia. After that
      autologous ADRC will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc)
      from harvested adipose tissue. Extracted ADRC will be administered one-time intraarticularly.
    

Intervention name(s): Arthroscopic surgery; Liposuction; ADRC isolation; Intraarticular administration of autologous ADRC
Intervention type(s): Procedure; Procedure; Device; Other
Intervention description(s): ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Damage of articular cartilage; Cartilage degeneration; Intraarticular injection; ADRC; Adipose-derived regenerative cells; Adipose tissue; Stem cells
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 10773 Tablets
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with
      repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics
      of BI 10773 after multiple dosing, including dose proportionality and assessment of steady
      state.
    


Intervention name(s): BI 10773 Placebo; BI 10773; BI 10773 Placebo; BI 10773; BI 10773 Placebo; BI 10773 Placebo; BI 10773; BI 10773
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): po taken fasting with 240 mL water; po taken fasting with 240 mL water; po taken fasting with 240 mL water; po taken fasting with 240 mL water; po taken fasting with 240 mL water; po taken fasting with 240 mL water; po taken fasting with 240 mL water; po taken fasting with 240 mL water
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Different Therapeutical Modalities Associated to Hamstring Flexibility Training
Condition: Range of Motion, Articular
Study type: Interventional

Summary: 
      The purpose of this study is to compare the acute effect of the use of different thermal
      modalities associated to the training of passive flexibility of the hamstring muscles in the
      amplitude of motion of the knee extension.
    

Detailed description: 
      Context: In the literature there is a disagreement of results and protocols regarding the use
      of thermal modalities associated with the training of flexibility of the hamstring muscles.
      Most studies on the subject, used the heat and cryotherapy prior to stretching these.
      Therefore, the investigators aimed to conduct an experimental study using the therapeutics
      term concomitant arrangements to passive static stretching these muscles.

      Methods: Clinical trial randomized crossover, which will a sample of 42 subjects (healthy
      young men, aged 20 to 30 years). Were divided into 3 groups (Group 1 passive static
      stretching hamstrings, Group 2 heat + passive static stretching hamstrings and Group 3
      cryotherapy + static stretching hamstrings passive) with 14 subjects each. Where the
      participants will control themselves, since all carry out the three interventions, only at
      different times. Each action will be performed every 7 days. Individuals will be subjected to
      active test of the range of motion of knee extension (goniometer) and hamstring muscle
      strength (dynamometer).
    

Intervention name(s): Flexibility training with or without different thermal modalities
Intervention type(s): Procedure
Intervention description(s): Flexibility training of the hamstring muscles by passive static stretching of the hamstring muscles in 10 30-second repetitions, with a 10-second pause between each repetition associated with or without short-wave heating or cryotherapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pliability; Cryotherapy; Hot temperature; Hyperthermia, induced; Randomized Controlled Trial; Hamstring muscles; Muscle stretching exercises
Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)
Condition: Rotavirus; Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate whether V260 is effective and well tolerated in
      Japanese healthy infants.
    


Intervention name(s): Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™); Comparator: Comparator: Placebo (unspecified)
Intervention type(s): Biological; Biological
Intervention description(s): Rotateq orally administered 3 times; Placebo orally administered 3 times
Other intervention name(s): RotaTeq™; V260
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Gastroenteritis; Rotavirus
Evaluation of the Effectiveness of Night Orthosis in Treating Women With Symptomatic Osteoarthritis in the Interphalangeal Joint of the Dominant Hand
Condition: Hand Injuries
MeSH terms: Osteoarthritis; Hand Injuries
Study type: Interventional

Summary: 
      Evaluation of the effectiveness of using a night orthosis for II and III or fingers of the
      dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control group.
    

Detailed description: 
      Objective: To evaluate the effectiveness of using a night orthosis for II and III or fingers
      of the dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control
      group.

      Methods: Through a randomized controlled clinical trial with blind assessment and follow-up
      of six months. Fifty-Two participants were randomized into two groups: group orthosis and
      control, and made a night orthosis II and or III fingers, thermoplastic will be used as a
      treatment for participants orthosis group. The participants underwent four evaluations at
      time 0, 45 days, 90 days and 180 days after its inclusion in the study. The variables studied
      were: the visual analog scale of pain, grip and pinch strength, questionnaires Cochin and
      Australian/Canadian Hand Osteoarthritis Index and functional Pick-up test.
    

Intervention name(s): Orthosis
Intervention type(s): Device
Intervention description(s): use orthosis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Autism Spectrum Disorders (ASD) Characterization Study
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      The overarching aim of the study is to characterize children and adults with ASDs, and
      compare them with age-matched controls in relation to their functioning in family, academic,
      employment, and social spheres. Subjects will be comprehensively assessed in multiple
      non-overlapping domains of functioning, using psychiatric, cognitive, and psychosocial
      instruments.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children and adults with ASDs.

        Controls: healthy volunteers who have never been diagnosed with an Autism Spectrum
        Disorder.
      
Keywords: Autism Spectrum Disorder; ASD; Autism; Asperger's Syndrome; PDD-NOS; Pervasive Developmental Disorders- Not Otherwise Specified; Adults; Children
Medifast 5 & 1 Plan
Condition: Obesity; Body Weight; Weight Loss; Overweight; Nutrition Disorders
MeSH terms: Overweight; Nutrition Disorders; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of the Medifast 5 & 1 Plan to a
      food-based, reduced-energy diet plan. The study will be conducted over 52 weeks, including a
      26-week weight-loss phase and a 26-week weight-maintenance phase. 120 participants will be
      enrolled, with 60 randomized to the Medifast 5 & 1 Plan and 60 randomized to food-based,
      reduced-energy diet plan. Multiple measures will be performed at baseline, 26 weeks, and 52
      weeks, including anthropometry, body composition, blood pressure, blood assays, and appetite
      sensations.
    


Intervention name(s): Food-based, Reduced Energy Diet Plan; Medifast 5 & 1 Plan
Intervention type(s): Behavioral; Other
Intervention description(s): Control participants will be provided with a 1000-kcal/d meal plan based on regular foods selected and procured by participants. Food lists, sample menus, and portion size references will be provided.; Participants randomized to the Medifast group will enroll online in the Medifast 5 & 1 Plan. This plan consists of 5 portion-controlled, nutritionally-balanced Medifast Meals plus one Lean & Green Meal each day. Medifast Meals come in individual packets that are mixed with water and microwaved or refrigerated, and are available in a wide variety of foods and flavors. There are >70 Medifast Meal choices, and Medifast Meals may be used interchangeably, so any five Medifast Meals can be chosen for the 5 & 1 Plan. The Medifast 5 & 1 Plan provides approximately 800 to 1,000 kcal/d. The Lean & Green Meal consists of a lean meat plus salad and/or vegetables selected by the participant. Intervention participants will have online access to Medifast dietitians, Medifast trainers, a Medifast message board, and a Medifast chat room, allowing them to interact with others on the Medifast 5 & 1 Plan.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; overweight; weight loss; randomized controlled trial; Medifast
Effectiveness of Dextrose Injection for Osgood-Schlatter Disease
Condition: Osgood-Schlatter Disease
MeSH terms: Osteochondrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Objective: To examine the potential of dextrose injection versus lidocaine injection versus
      supervised usual care to change pain/function/activity levels in adolescent athletes with
      Osgood-Schlatter Disease (OSD).
    

Detailed description: 
      Patients and methods: Girls ages 9-15 years old and boys ages 10-17 years old will be
      assigned to either therapist-supervised usual care, or to double-blind injection of 1%
      lidocaine solution with or without 12.5% dextrose. Injections will be administered monthly
      for three months. All subjects will then be offered dextrose injections monthly as needed.
      Change in the Nirschl Pain Phase Scale (NPPS) will serve as the primary outcome measure.
    

Intervention name(s): Dextrose Injection; Lidocaine Injection; Usual Care
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): 12.5 Dextrose in 1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon.; 1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon.; Therapist supervised exercises that are standard of care for Osgood-Schatter Disease as well as relative rest and gradual resumption of pain-limited sport.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osgood-Schlatter; Tendinosis; Apophysitis; Enthesopathy; Dextrose.
Evaluation of Green Dot a Primary Prevention Intervention
Condition: Sex Offenses
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the statewide application of Green Dot among high
      schools students. We hypothesize that students in high schools with Green Dot will over time
      report lower rates of sexual violence (SV) compared with students in comparable high schools
      randomized not to have Green Dot. This reduction in sexual violence will be mediated through
      a reduction in social norms supporting sexual violence (measured with violence acceptance
      scales) and an increase in bystander behaviors.
    

Detailed description: 
      "Green Dot" is a bystander intervention program that empowers students to actively question
      peer support for sexual violence (SV) and become change agents who play a significant role in
      preventing sexual violence. The purpose of this study is to evaluate the statewide
      application of Green Dot among high schools students. We hypothesize that students in high
      schools with Green Dot will over time report lower rates of SV compared with students in
      comparable high schools randomized not to have Green Dot. A high school based controlled
      intervention trial is being used to test the efficacy of Green Dot. Both panel and cohort
      survey methods will be used to provide baseline and prospective data on student's attitudes
      supporting SV, bystander behaviors and violence victimization and perpetration. In 13
      Kentucky regions, 2 demographically comparable high schools were recruited to participate in
      Green Dot intervention either as the intervention or control site. Schools were randomly
      assigned to the intervention. Study Population includes all students in participating high
      schools invited to complete anonymous panel surveys beginning spring 2010 through 2014. This
      state-wide, population-based, multi-site controlled intervention trial provides an empirical
      test of a promising intervention, which, if proven effective, could result in the primary
      prevention of SV and a reduction in the health and academic consequences of SV.
    

Intervention name(s): Green Dot Bystander Intevention; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention allocated at the school level; Awareness Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Safety and Tolerability Study of JNJ-72537634 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety and tolerability of JNJ-72537634 compared
      with placebo in healthy participants after administration of single and multiple day doses.
    


Intervention name(s): JNJ-72537634; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Participants in Cohort 1 and 3 will receive Dose 1 and participants in Cohort 2 and 4 will receive Dose 2 of JNJ-72537634 as oral capsule.; Participants will receive matching placebo as oral capsule in all cohorts.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
EffectiveNess of Low-dose Aspirin in Prevention of Cancer in the Stomach and Oesophagus (GastrointEstinal Cancer Prevention) - United Kingdom ("ENgAGE - UK"): Study to Evaluate the Risk of Cancer in the Stomach and Oesophagus Among New Users of Low-dose Aspirin Using the THIN Database in the UK
Condition: Prevention of Oesophagus Cancer and Stomach Cancer
MeSH terms: Gastrointestinal Neoplasms; Stomach Neoplasms; Esophageal Neoplasms
Study type: Observational

Summary: 
      Researchers already did studies in low-dose Aspirin for the prevention of heart and blood
      vessels disease and for the prevention of cancer of the colorectum. In this study, they want
      to learn whether an effect for the prevention of oesophagus cancer and stomach cancer goes
      along with the use of low-dose ASA on patients taking this medicine for the prevention of
      heart and blood vessels disease compared to non-use. To find this out electronic medical
      records stored in primary care database in the UK, The Health Improvement Network (THIN),
      will be used.
    


Intervention name(s): Acetylsalicylic Acid(BAYE4465, Aspirin )
Intervention type(s): Drug
Intervention description(s): Administration according to clinical practice
Intervention MeSH terms: Aspirin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The source population will be constituted (inclusion criteria) by individuals who are aged
        40-89 years in the THIN database in the UK, who are enrolled with the primary care doctor
        (PCP) for at least 2 years, or have a history of computerized prescriptions for at least 1
        year prior to start date and who are free of low-dose ASA and cancer to become a member of
        the source population.
Light, Exercise Intensity and Mood in Overweight
Condition: Overweight, Obesity Grade I
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to determine if an exposure to light in the morning has a
      positive influence on self-chosen exercise intensity on a bicycle ergometer in overweight and
      obese patients.
    


Intervention name(s): Phillips Energy Light HF3319
Intervention type(s): Device
Intervention description(s): Exposure to Light administered with Phillips Energy Light HF3319.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Special Access Program IMVAMUNE®
Condition: Vaccination
Study type: Interventional
Phase: Phase 4

Summary: 
      Prophylactic smallpox vaccination for personnel actively working with or in the vicinity of
      replicating vaccinia virus
    


Intervention name(s): IMVAMUNE®
Intervention type(s): Biological
Intervention description(s): IMVAMUNE® liquid -frozen, containing 1 x 10E8 TCID50 MVA-BN® per 0.5 mL dose
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention