bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Mild to Moderate Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran)
      with nifedipine controlled-release tablets (Adalat）in the treatment of mild to moderate
      essential hypertension.
    


Intervention name(s): nifedipine CR tablets (Xin Ran); nifedipine CR tablets (Adalat)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dysport® Pediatric Lower Limb Spasticity Follow-on Study
Condition: Cerebral Palsy; Muscle Spasticity; Children
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study was to determine the long term safety and efficacy of
      repeated treatments with Dysport® used in the treatment of lower limb spasticity in children
      with dynamic equinus foot deformity due to cerebral palsy.
    


Intervention name(s): Botulinum toxin type A
Intervention type(s): Biological
Intervention description(s): Intramuscular (IM) injection on day 1 of each treatment cycle.
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Comparing MENOPUR in a Pen Formulation With a Powder and Solvent Formulation in Healthy Women
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 1

Summary: 
      MENOPUR is a human menotrophin product, with a combination of human follicle-stimulating
      hormone (FSH) and luteinizing hormone (LH) activity. Human chorionic gonadotrophin (hCG) is
      the major contributor to the LH activity in the product. MENOPUR is approved in more than 130
      countries for a variety of strengths and indications. In China, MENOPUR, 75 IU is approved
      for controlled ovarian hyperstimulation in relation to assisted reproductive technology
      (ART). The current trial is intended for supporting marketing authorization approval of a new
      formulation of MENOPUR in China.

      MENOPUR is currently available in China as a powder and solvent for solution for injection,
      containing 75 IU of FSH and 75 IU of LH activity. A new liquid formulation is developed by
      Ferring Pharmaceuticals for administration with a disposable pre-filled injection pen,
      containing 600 IU of FSH and 600 IU of LH activity. MENOPUR solution for injection in
      pre-filled pen, 600 IU/0.96 mL is the test product and MENOPUR powder and solvent for
      solution for injection, 75 IU is the reference product in this trial.
    


Intervention name(s): A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL; A MENOPUR powder including solvent for solution for injection, 75 IU
Intervention type(s): Drug; Drug
Intervention description(s): Single dose cross-over bioequivalence trial; Single dose cross-over bioequivalence trial
Other intervention name(s): Highly purified menotropin; Highly purified menotropin
Intervention MeSH terms: Pharmaceutical Solutions; Menotropins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Safety, Tolerability and PK, PD of HPG1860 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose
      Phase 1study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and
      food effect of HPG1860 orally administered in healthy subjects.
    

Detailed description: 
      In SAD and MAD studies, all subjects are randomized in a 3:1 ratio. In SAD study , there are
      6 cohorts (8 subjects/cohort) with dose levels of 10mg, 20 mg, 40 mg, 80 mg, 120 mg and 150
      mg respectively. Blood samples will be collected for safety, PK and PD assessments. After the
      completion of Cohort 2 (20 mg) in SAD study, following a 7-day washout period, the same 8
      subjects will receive another single oral dose of 20 mg HPG1860 after a standard high
      fat/high calorie breakfast (the fed condition). PK blood samplings will be collected and Cmax
      and AUC will be used for assessing the food effect. In MAD study, there are 3 cohorts (8
      subjects/cohort) with dose levels of 10mg, 30mg and 90 mg, respectively and dosing regimen is
      once daily for 14 consecutive days. Blood samples will be collected for safety, PK and PD
      assessments.
    

Intervention name(s): HPG1860
Intervention type(s): Drug
Intervention description(s): 6 subjects randomized to active compound and 2 subjects randomized to placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1 SAD: 6 cohorts Part 2 MAD: 3 cohorts
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluating Tools for Health Promotion and Disease Prevention
Condition: Coronary Heart Disease; Stroke; Diabetes; Breast Cancer; Ovarian Cancer; Colorectal Cancer
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the effect of familial risk assessment and prevention prompts
      tailored to familial risk on health behaviors and use of preventive services among adults who
      are members of primary care practices in the U.S.
    

Detailed description: 
      The purpose of this study is to evaluate the clinical utility of a new family history tool,
      Family Healthware™ by determining whether family history risk assessment and personalized
      prevention messages have any impact on health behaviors and use of medical services. The
      hypothesis to be tested is that patients who are provided with personalized prevention
      messages based on an assessment of their family history of disease will be more motivated to
      make behavior changes and use preventive health services than patients who do not have their
      family history assessed and who receive only generalized (not personalized) prevention
      messages. An additional hypothesis, tested when participants see their primary care physician
      during the study, is that providing a copy of the graphical family history, risk and
      prevention messages to the patient's physician will increase delivery of recommended
      preventive services (screening, referral, and health habit advice).

      The study will consist of enrolling approximately 8360 patients aged 35-65 years who attend
      primary care practices that are part of research networks affiliated with the three research
      centers. The practices will be randomized into two groups. Patients in practices randomized
      to Group 1 will complete a pre-test and the family history tool, and will receive
      personalized prevention messages based on their level of familial risk and current risk
      behaviors. After six months, Group 1 patients will complete a post-test. Patients in Group 2
      will complete the pre-test and receive standard prevention messages (appropriate for sex)
      about maintaining good health and preventing disease. After 6 months Group 2 patients will
      complete the post-test and the family history tool. The pre- and post-test will include
      assessment of risk factors, use of medical services (especially preventive services),
      interest in modifying health behaviors, risk perceptions, etc. The analysis will compare
      changes in health behaviors between patients in Groups 1 and 2 and will also examine
      differences by familial risk strata (average, moderate, high).
    

Intervention name(s): Familial risk assessment and personalized prevention messages
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: family history; familial risk; behavior change
Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?
Condition: Opioid-Induced Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 2

Summary: 
      Utilizing a double-blind, placebo-controlled design, the proposed work will evaluate the
      ability of an adjuvant anticonvulsant analgesic to diminish or reverse the opioid-induced
      hyperalgesia complicating the pain states suffered by Methadone-Maintained (MM) patients.
      Specifically, in a sample of MM patients, gabapentin, which has proven efficacy in treating
      neuropathic pain will be evaluated for its ability to ameliorate or diminish the
      opioid-induced hyperalgesia in these patients as reflected by changes on pain threshold and
      tolerance to both cold-pressor and electrical pain, at peak and through methadone blood
      levels. The results of this work will not only provide pharmacologic insight into the
      mechanisms underlying poor pain tolerance in this at-risk population, but also direction for
      the medical management of pain complicated by opioid-induced hyperalgesia.
    


Intervention name(s): Gabapentin;; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Gabapentin titrated to daily dose of 2400mg PO over 1 week with established dose taken daily for 5 weeks.; Placebo titrated over 1 week with established dose taken daily for 5 weeks.
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opioid-induced hyperalgesia; methadone; gabapentin; opioid addiction
Biomarkers in DNA Samples From Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine-Based Therapy
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Observational

Summary: 
      RATIONALE: Studying samples of DNA in the laboratory from patients who received
      fludarabine-based treatment may help doctors learn more about the effects of fludarabine on
      cells. It may also help doctors understand how well patients respond to treatment.

      PURPOSE: This research study is studying DNA samples from patients with chronic lymphocytic
      leukemia previously treated with fludarabine-based therapy.
    

Detailed description: 
      OBJECTIVES:

        -  To identify genetic characteristics associated with the efficacy and toxicity of
           fludarabine-based treatment in patients with chronic lymphocytic leukemia who
           participated on E2997.

        -  To validate these genetic characteristics with a cancer cell model system to confirm
           association and dissect the mechanism of effect.

      OUTLINE: Archived DNA samples are analyzed for genetic characteristics associated with the
      efficacy and toxicity to fludarabine-based treatment using Affymetrix 6.0 single nucleotide
      polymorphism arrays. The results are then compared with data of genes identified in a cancer
      cell model system, and with clinical data (response, toxicity, overall survival, and
      progression-free survival) associated with each patient sample.
    

Intervention name(s): DNA analysis; gene expression analysis; polymorphism analysis; laboratory biomarker analysis; medical chart review
Intervention type(s): Genetic; Genetic; Genetic; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled on E4402 from whom samples were submitted for research
      
Keywords: stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; B-cell chronic lymphocytic leukemia
Local Treatment by Thermic Destruction of Primitive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating
      with histological analysis of the specimen the percentage of tumor cells remaining in the
      area treated by the laser
    


Intervention name(s): Thermic destruction of tissue by Laser using the Novilase device
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma
Condition: Compartment Syndrome
MeSH terms: Compartment Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Compartment syndrome (CS) is a condition resulting from increased pressure within a
      compartment, which compromises circulation and can lead to critical limb ischemia. CS is one
      of the biggest medical challenges that our soldiers face after battlefield related injuries.
      Chronic or exercise-induced compartment syndrome (CS)rarely requires treatment; acute
      compartment syndrome is a medical emergency requiring surgery. Treatment of compartment
      syndrome is limited to fasciotomy, which relieves the pressure.The study purpose is to
      evaluate the feasibility and safety of the administration of marrow-derived autologous bone
      marrow concentrate and PRP gel generated by a point of care marrow separation system for the
      treatment of compartment syndrome. And to show this treatment possibly enhances wound
      healing, bone healing, perfusion, infection control, and the return of limb function in
      patients with CS.

      Stem Cell and regenerative medicine development efforts for therapeutic angiogenesis and
      wound healing have predominantly focused on the mechanism of action of a single stem cell
      population to achieve neovascularization and improve tissue perfusion. It is well documented
      that other cells, including platelets, are efficient carriers of growth factors (VEGF-PDGF,
      bFGF, and SDF-1) and play active roles in angiogenesis and wound healing. Arteriocyte's
      development efforts focus on concentration of autologous bone marrow-derived stem cells and
      platelets for delivery to the site of injury in a concentration sufficient to effect local
      tissue revascularization and repair. These products provide for the rapid, bedside
      preparation of autologous PRP and bone marrow stem cell concentrate.

      This clinical trial with the Magellan® System is for the preparation of autologous cell
      concentrate for the treatment of wound, tissue and bone healing, improved perfusion,
      infection control, and the return of limb function in patients at risk of amputation.
    


Intervention name(s): Magellan®
Intervention type(s): Device
Other intervention name(s): autologous cell concentrate; autologous Bone Marrow Cell Concentrate Using the Magellan® System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Magellan MAR01; Autologous Platelet Rich Plasma; Compartment Syndrome; Battlefield Trauma; Fasciotomy
5 Year Follow-up of Adolescents With Knee Pain
Condition: Patellofemoral Pain Syndrome; Knee Pain
MeSH terms: Patellofemoral Pain Syndrome
Study type: Observational

Summary: 
      The prevalence of adolescent knee pain is 33%, and patellofemoral pain (PFP) is the most
      common diagnosis with a nontraumatic onset. The 5-year prognosis of adolescent PFP compared
      with other types of knee pain is unknown.

      In 2011, a cohort of 2200 adolescents aged 15 to 19 years answered an online questionnaire on
      musculoskeletal pain. Of these, 504 reported knee pain, and 153 of these were clinically
      diagnosed with PFP. Now, after 5 years, the 504 adolescents, as well as 252 randomly selected
      adolescents who did not report knee pain in 2011, will be contacted again to gain insights
      into their prognosis.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In September 2011, students at 4 upper secondary schools in Aalborg were invited to answer
        an online questionnaire and to be part of the APA2011 cohort. From 2846 potential
        responders, 2200 adolescents responded to the questionnaire, corresponding to a response
        rate of 77%. A total of 504 adolescents indicating knee pain at least monthly were
        successfully contacted (a response rate of 83% of those who reported their telephone
        numbers) and were asked standardized questions on the telephone. This forms the cohort of
        504 adolescents with knee pain. In addition a random selected group of adolescents without
        knee pain in 2011 will be contacted and asked the same questions as those with knee pain.
Study Evaluating the Effect of Lecozotan SR on the QTc Interval
Condition: Alzheimer Disease; Healthy
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo- and moxifloxacin (open-label)-controlled,
      4-period crossover study.
    


Intervention name(s): Lecozotan SR; Moxifloxacin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Healthy Subjects
A Clinical Trial in Healthy, HIV-1-Uninfected Adult Participants to Compare the Safety, Tolerability and Immunogenicity of CH505TF gp120 Produced From Stably Transfected Cells to CH505TF gp120 Produced From Transiently Transfected Cells
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety, tolerability, and immunogenicity of
      CH505TF gp120 produced from stably transfected cells to CH505TF gp120 produced from
      transiently transfected cells in healthy, HIV-1-uninfected adult participants.
    

Detailed description: 
      This study will compare the safety, tolerability, and immunogenicity of two experimental HIV
      vaccines in healthy, HIV-1-uninfected adult participants. The study vaccines are called
      Stable CH505TF gp120 and Transient CH505TF gp120. The vaccines are mixed with an adjuvant
      called GLA-SE.

      Participants will be randomly assigned to two groups. Participants in Group 1 will receive
      Stable CH505TF gp120; participants in Group 2 will receive Transient CH505TF. Depending on
      their group, participants will receive Stable CH505TF gp120 or Transient CH505TF gp120 by
      injection at Months 0, 2, and 6.

      Additional study visits will occur at Months 0.5, 2.5, 6.5, 9, and 12. Study visits may
      include physical examinations, medical history, vaccine injections, blood and urine
      collection, risk reduction counseling, and questionnaires. Participants will also be
      contacted for health information at Month 18.
    

Intervention name(s): Stable CH505TF gp120; Transient CH505TF gp120; Glucopyranosyl Lipid Adjuvant-Stable Emulsion (GLA-SE)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Administered by IM injection in the deltoid of the non-dominant arm; Administered by IM injection in the deltoid of the non-dominant arm; Admixed with Stable CH505TF gp120 or Transient CH505TF gp120 for IM injection in the deltoid of the non-dominant arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis
Condition: Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, multicenter, evaluator blinded study to evaluate the safety,
      tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult
      patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent
      episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled
      and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose
      regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of
      treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation
      period visit) or at any time that a recurrence or clinical failure is suspected, up to the
      end of observation period.
    

Detailed description: 
      This is a randomized, multicenter, evaluator blinded study to evaluate the safety,
      tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult
      patients, from 18 to 65 years of age, with moderate to severe Vulvovaginal Candidiasis (VVC)
      and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion
      criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms:
      oral SCY-078 does regimen 1, or oral SCY-078 does regimen 2, or oral Fluconazole. After
      enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of
      cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that
      a recurrence or clinical failure is suspected, up to the end of observation period.

      Primary Objectives:

      * To evaluate the safety and efficacy of 2 dosing regimens of Oral SCY-078 in subjects with
      moderate to severe Vulvovaginal Candidiasis (VVC)

      Secondary Objectives:

      * To estimate the effect of Oral SCY-078 therapy in the rate and time to recurrence in
      subjects with a history of frequent episodes of VVC
    

Intervention name(s): SCY-078; Fluconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluconazole; Ibrexafungerp
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment