bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating Prevenar Immunogenicity in High Risk Children
Condition: Vaccines, Pneumococcal Conjugate Vaccine
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with
      immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.
    

Detailed description: 
      This study will require 24 months to be completed. Each child will participate for a period
      of time according to age of the 1st dose of vaccination: infants up to 6 months of age will
      be evaluated for 5 months; infants between 7 to 11 months will be evaluated for 3 months;
      children between 12 months up to 9 years of age will be evaluate for 2 months
    

Intervention name(s): pneumococcus conjugate vaccine
Intervention type(s): Biological
Intervention description(s): Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pneumococcus conjugated vaccine
Study of DHT-Gel to Treat the Symptoms of Low Testosterone in Men 55-80
Condition: Hypogonadism; Late Onset Hypogonadism; Low Testosterone
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether DHT-Gel, when applied daily to the skin, can
      relieve the symptoms of low testosterone in men aged 55-80. These symptoms include reduced
      muscle strength, increase fat mass, low libido, feeling blue or moody
    

Detailed description: 
      Background - In the context of hypogonadism, androgen supplementation is clearly beneficial,
      particularly in younger males. The benefits of therapy in men with milder degrees of
      hypogonadism, and elderly males with testosterone deficiency, are less clear-cut. Several
      options are available for androgen replacement in adult men. Oral testosterone, intramuscular
      injections, subcutaneous implants and transdermal therapy have all been used. Each mode of
      delivery has advantages and drawbacks. Several alkylated derivatives of T are available for
      oral or sublingual use, including methyl testosterone and fluoxymesterone. However, they are
      not recommended for use as replacement therapy because of their associated adverse effects.

      Study Design - This is a multi-center, double-blind, placebo-controlled, parallel group,
      randomized study of DHT-Gel versus placebo gel in male subjects ages 55-80 years inclusive
      with low serum testosterone and symptoms compatible with the clinical diagnosis of
      hypogonadism. Total enrollment for this study will be approximately 120 subjects (40 subjects
      for each treatment group). Subjects will be treated with 35 mg/day DHT, 70 mg/day DHT, or
      placebo gel for 6 months. All subjects will apply the gel once daily. Up to 9 months of study
      participation, including up to 2 months of screening and a 1-month follow-up period, will be
      required by the protocol.

      The primary efficacy endpoint in this study is change in body composition as determined by
      DEXA scan. Secondary endpoints in this study include change in sexual libido, and overall
      function and mood, and normalization of serum androgen levels. A subset of sites will perform
      strength assessments, which will include handgrip dynamometry, and upper and lower body
      strength tests.
    

Intervention name(s): Dihydrotestosterone (0.7%) in hydroalcoholic gel
Intervention type(s): Drug
Intervention description(s): transdermal gel, 0.7% DHT, 0.35 mg/day or 0.70 mg/day total daily dose (or placebo gel), applied twice per day
Intervention MeSH terms: Dihydrotestosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: libido; depression strength; testosterone; dihydrotestosterone
Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence
Condition: Laser Therapy; Urinary Incontinence,Stress; Pilates Method
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      The present study is a clinical intervention applied to patients with urinary incontinence,
      with the intention of verifying the effects of the Pilates method associated or not with
      photobiomodulation with static magnetic field. The sample will consist of women with stress
      urinary incontinence from Bento Gonçalves attended at the school clinic of Faculdade
      Cenecista de Bento Gonçalves.
    


Intervention name(s): Pilates; Photobiomodulation
Intervention type(s): Other; Other
Intervention description(s): The solo Pilates method will be applied twice a week for 12 weeks using the following exercises:
20 Breaths, Double leg stretch, Single leg stretch, Leg circles, Hip lift on ball, Abdominal tightening on ball, Alternating two supports, Side bend, Side kick - side kick, Side kicks, Shell and Swan and Neck pull stretches; in the tenth session, we evolved some exercises: The saw, Swan dive, Book close series, Hip lift on the ball and Front pulls; in the eighteenth session we changed again some exercises for: Leg pull back, Rolling like a Ball, Swimming, Roll over and Leg pull front.; Applications of FBM or placebo (MR4 ACTIVet PRO Laser Shower Portable, MRM, USA) will last for 115s and will deliver 60 J at each point. The mode of application, with the patient supine on a stretcher, with the grouping probe held stationary in contact with the skin, at a 90-degree angle, in the pubic mound and in the perineum region.
Other intervention name(s): Pilates exercise; Pilates Methods
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immediate vs. Delayed Postpartum Etonogestrel Implant
Condition: Continuation Rate of Contraceptive Implant
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators are examining if there is a difference in continuation rates of the
      etonogestrel contraceptive implant between women who have the device placed immediately after
      delivery, before leaving the hospital, and women who have the device placed at the routine
      6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30
      in each group. All participants will follow-up at the same postpartum clinic 6 weeks after
      delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete
      a brief survey. The investigators hypothesize that continuation rates of Implanon will be
      higher in the immediate postpartum placement arm than in the delayed placement arm.
    


Intervention name(s): Etonogestrel implant
Intervention type(s): Drug
Intervention description(s): This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
Other intervention name(s): Implanon; Nexplanon
Intervention MeSH terms: Etonogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Etonogestrel Implant; Implanon; Nexplanon; Long Acting Reversible Contraception
Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To investigate in vitro the effect of triglyceride rich lipoproteins (TGRL) obtained in type
      2 diabetic women in the fasting state and following a randomized isocaloric lipid rich
      breakfast on control human platelets

      Randomized Comparison of butter versus chocolate spread in 2 groups of 15 patients
    


Intervention name(s): butter based breakfast; Chocolate spread based breakfast
Intervention type(s): Other; Other
Intervention description(s): ingestion of proteins : 5 g, lipids 20 g, glucides 57 g; ingestion of proteins 7 g, lipids 20 g, glucides 56 g
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: chylomicrons; Very Low Density Lipoprotein; saturated fat; platelet function; type 2 diabetes; post prandial phase
An Extension Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an extension study of HCV-05-002. The objective of this study is to evaluate the
      safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for
      an additional 36 weeks in patients with chronic hepatitis C genotype 1 infection.
    


Intervention name(s): Celgosivir
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Celgosivir; HCV; Genotype 1; Non-responders; End of Treatment Response; Sustained Viral Response
Targeting Reconsolidation to Prevent Return of Fear
Condition: Fear of Flying
Study type: Interventional

Summary: 
      The overall aim of this project is to determine if using a cue to trigger (and reactivate)
      the fear memory 10 minutes prior to exposure treatment sessions leads to less anxiety in
      patients with a fear of flying. The long term goals are to establish if targeting the
      reconsolidation of fear with a reminder of the fear is effective for human clinical
      populations in reducing relapse (return of fear). In this investigation, the investigators
      propose to treat 64 patients diagnosed with a fear of flying (FOF) using virtual reality
      exposure therapy (VRE). All patients in the study will receive exactly the same exposure
      treatment using a virtual airplane.
    

Detailed description: 
      Prior to each VRE session, the investigators will test a brief, easy-to-implement
      manipulation that triggers the fear memory and presumably allows it to be changed in a way
      that prevents the fear from returning later (i.e., prevents relapse). The investigators
      propose to randomly assign eligible participants to 1 of 2 conditions: 1) VRE therapy
      preceded by a reminder of the feared stimulus (a VR clip of a virtual airplane taxiing and
      taking off) presented 10 minutes prior to all VRE therapy sessions, or 2) VRE therapy
      preceded by a neutral cue (a VR clip of a virtual living room) presented 10 minutes prior to
      all VRE therapy sessions. Participants will be evaluated pre- and post-treatment and at a 3
      month and 6 month follow-up visit to assess long-term effects.
    

Intervention name(s): Virtual Reality Exposure Therapy
Intervention type(s): Behavioral
Intervention description(s): Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment.
Other intervention name(s): exposure therapy; fear of flying treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: reconsolidation; fear of flying; virtual reality; virtual reality exposure therapy
VIO Imaging for Skin Tissue Assessment (VISTA)
Condition: Skin Condition; Skin Diseases; Skin Lesion; Skin Abnormalities
MeSH terms: Skin Abnormalities; Skin Diseases
Study type: Interventional

Summary: 
      To demonstrate the safety and effectiveness of the VIO device in obtaining in vivo images
      that show tissue features including epidermis, dermis, collagen, blood vessels, and/or
      pigment.

      To demonstrate that the tissue features identified on the images obtained with the VIO device
      align with the corresponding pathology images procured from the skin biopsy.

      To evaluate the ability of blinded readers to correctly identify tissue features on images
      obtained with the VIO device.
    


Intervention name(s): VIO
Intervention type(s): Device
Intervention description(s): Skin conditions that are candidates for skin biopsies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of ASP1585 to Evaluate the Bioequivalence Between ASP1585 Granules and ASP1585 Capsules
Condition: Healthy; Urine Phosphorus Excretion
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence between ASP1585 granules and
      ASP1585 capsules after repeated oral administration of ASP1585 granules or ASP1585 capsules
      under open-label conditions in non-elderly healthy male subjects. In addition, the safety of
      these products is assessed.
    


Intervention name(s): ASP1585
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Bixalomer; Kiklin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP1585; Bioequivalence; Pharmacodynamic; Phosphate binder; Bixalomer; urinary phosphorus excretion
Multimodal Intervention Program for Patients With Metabolic Syndrome
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to identify the psychological, emotional and lifestyle variables
      that can have an influence on the different components of metabolic syndrome (MetS) and
      develop a program for change lifestyle in this patients.
    


Intervention name(s): Multimodal intervention program; Lifestyle counseling
Intervention type(s): Behavioral; Other
Intervention description(s): The intervention is structured as follows:
Review of previous session (20 min) Agenda and goals (5 min) Presentation of the topic to be worked (15 min) Training (60 min) Summary and feedback (15 min); The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Metabolic syndrome; Mediterranean diet; Stress; quality of life; psychological factors
Bioavailability of LY03004 and Risperdal® Consta®
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the bioavailability of LY03004 compared to Risperdal Consta as well
      as the evaluate the safety and tolerability and preliminary efficacy of LY03004 with repeat
      injections
    

Detailed description: 
      -  To assess the relative bioavailability of LY03004 compared to Risperdal® Consta® at 25
           mg following multiple intramuscular injections at steady-state;

        -  To evaluate the safety and tolerability of LY03004 following repeated intramuscular
           injections

        -  To evaluate the preliminary efficacy of LY03004 following repeated intramuscular
           injections
    

Intervention name(s): LY03004; Risperdal® Consta®
Intervention type(s): Drug; Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Novel and Scalable Internet Supplemented Weight Loss Treatment in Primary Care
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Motivational interviewing and nutritional counseling for weight loss in primary care.
    

Detailed description: 
      Overweight and obese participants will be recruited through local primary care offices. This
      study will test the effectiveness of motivational interviewing and nutritional counseling for
      weight loss. The treatment will be supplemented by internet support.
    

Intervention name(s): motivational interviewing and nutrition
Intervention type(s): Behavioral
Intervention description(s): Motivational Interviewing and Nutritional Counseling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and immunogenicity of ProQuad when administered
      concomitantly and nonconcomitantly with Tripedia and Comvax.
    


Intervention name(s): Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Comparator: Tripedia; Comparator: Comvax; Comparator: Varivax; Comparator: M-M-R II
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): A single 0.5 mL subcutaneous injection at Day 0; A single 0.5 mL intramuscular injection (at Day 0 or Day 42); A single 0.5 mL intramuscular injection (at Day 0 or Day 42); A single 0.5 mL subcutaneous injection at Day 0; A single 0.5 mL subcutaneous injection at Day 0
Other intervention name(s): ProQuad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine:

        -  The safety of tirzepatide and any side effects that might be associated with it.

        -  How much tirzepatide gets into the bloodstream and how long it takes the body to remove
           it.

        -  How tirzepatide affects the levels of blood sugar.

      This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC)
      injections just under the skin. The study will last about 16 weeks (total), including
      screening and follow-up. This study is for research purposes only and is not intended to
      treat any medical conditions.
    


Intervention name(s): Tirzepatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC.; Administered SC.
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Oral Curcumin for Radiation Dermatitis
Condition: Radiation-induced Dermatitis
MeSH terms: Dermatitis; Radiodermatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to determine whether curcumin, an ingredient of some foods, can
      prevent or reduce the severity of skin reactions (dermatitis) caused by radiation therapy.
      Dermatitis is a common side effect of radiation treatment, but few effective treatments have
      been developed for it. Curcumin is a natural compound found in both turmeric and curry
      powder. It has been used for centuries as a spice (curry), a food coloring and as a food
      preservative. Curcumin is non-toxic and has been found to enhance the functions of normal
      tissues..
    

Detailed description: 
      Radiation is a toxic agent and a widely accepted form of treatment for various types of
      cancer. Approximately half of all women with breast cancer receive radiation therapy. Despite
      advances in medical technology, radiation therapy still causes severe skin effects. Radiation
      dermatitis occurs in approximately 90% of patients and ranges in severity from mild redness
      to more severe skin changes. Dermatitis is a common side effect of radiation treatment, but
      few effective treatments have been developed for it; currently, there is no standard
      treatment for the prevention of radiation-induced dermatitis. Curcumin is a natural compound
      found in both turmeric and curry powder. It has been used for centuries as a spice (curry), a
      food coloring and as a food preservative. Curcumin is non-toxic and has been found to enhance
      the functions of normal tissues.
    

Intervention name(s): Curcumin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week; 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
Other intervention name(s): Curcumin C3 Complex
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Oral Curcumin; Radiation Dermatitis; Breast Cancer Patients
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective: To compare the efficacy and safety of DVS-233 SR versus placebo treatment
      in reducing the relapse rate of depressive symptoms in subjects with major depressive
      disorder (MDD), and to compare the percentages of relapse in terms of time to relapse between
      DVS-233 SR and placebo treatment groups by using survival analysis.

      Secondary Objective: To assess the response of subjects on DVS-233 SR versus placebo for the
      clinical global evaluation, functionality, general well-being, pain, and absence of symptoms
      (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] < 7).
    


Intervention name(s): DVS-233 SR
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Homeopathic Medication and Nutritional Oriented Diet to Treat Overweight Pregnant Women With Mental Disorder
Condition: Overweight; Pregnancy; Mental Disorder
MeSH terms: Overweight; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of homeopathic treatment in pregnant
      women with overweight and class I obesity with suspicion of a mental disorder.
    

Detailed description: 
      The weight gain during pregnancy has been reported as an important factor of being overweight
      after delivery and comorbidities. There are a lot of restrictions to treat pregnant women due
      to fetus development. Homeopathy presents itself as an integrative medicine that could treat
      with less collateral effects improving general health. The investigators are going to test
      the effects of homeopathy.
    

Intervention name(s): Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos; Homeopathy and Nutritional oriented diet
Intervention type(s): Drug; Drug
Intervention description(s): CH 12 preparation, 6 drops, twice a day, 4 days per week, until the end of pregnancy. One medication per appointment.; Homeopathy 6 drops twice a day 4 days per week, active and placebo and Balanced nutritional oriented diet for both groups.
Other intervention name(s): Sulphur; Puls; Lyc; Lack-t; Conium-m; Nux-v; Calc-c; Sep; Phosphorus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Homeopathy; overweight; obesity; mental disorder; pregnancy; Overweight pregnant women with suspicious mental disorder