bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Dapagliflozin Taken Twice-daily
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5
      mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is
      beneficial in diabetes treatment, and if so, how it compares to treatment with metformin
      alone.
    


Intervention name(s): dapagliflozin; dapagliflozin; dapagliflozin; metformin; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2.5 mg tablet, taken orally, twice daily; 5 mg tablet taken orally, twice daily; 10 mg tablet taken orally, once daily; >/= 1500 mg total daily dose, tablets taken orally, twice daily; placebo
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes; metformin treated; inadequate control; metformin treatment alone
Long-term Safety and Efficacy of MEDITOXIN® in Treatment Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the long-term safety of repeated administrations of Meditoxin® in the
      treatment of moderate to severe glabellar lines.
    


Intervention name(s): MEDITOXIN®
Intervention type(s): Drug
Intervention description(s): 20U of Meditoxin® is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites.
Other intervention name(s): Neuronox®
Intervention MeSH terms: Botulinum Toxins, Type A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers
Condition: ECG Effects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr
      buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo
      in healthy male and female subjects.
    


Intervention name(s): Buprenorphine transdermal patch; Naltrexone tablet; Placebos (for TDS and for naltrexone and for moxifloxacin); Moxifloxacin tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Buprenorphine patch applied transdermally; Naltrexone tablet; 1 tablet taken orally every 12 hours; Matching placebos; Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17
Other intervention name(s): Butrans; ReVia; Avelox®
Intervention MeSH terms: Moxifloxacin; Naltrexone; Buprenorphine; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy subjects; Opioid; Transdermal; ECG
Randomized Controlled Trial Targeting Obesity-related Behaviors
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The intervention included biweekly access to group fitness classes, with (Group 1) or without
      (Group 2) weekly nutrition and physical activity education sessions. Outcome measures were
      assessed at baseline and immediately post intervention and included BMI, waist circumference,
      blood pressure, physical activity and dietary behaviors, and psychosocial variables.
    

Detailed description: 
      This 15-week randomized controlled pilot study consisted of two groups. All participants
      received access to two group fitness classes per week, which were offered free of charge at
      the Caswell County Parks and Recreation Building. Zumba classes were offered one night a
      week, and the other evening was a 'potluck night' designed to increase participants exposure
      to a variety of other fitness classes such as floor aerobics, kickboxing, line dancing, and
      African dancing. Participants in the intervention group (Group 1) were enrolled in Eat Smart,
      Move More, Weigh Less (ESMMWL) where they received on hour weekly education classes on
      healthy eating and physical activity. The ESMMWL curriculum is a 15-week weight-management
      program that is delivered by local educators. Published research data were used to identify
      strategies that would lead to weight loss and/or weight maintenance. The program uses the
      Theory of Planned Behavior, and as such informs, empowers, and motivates participants to live
      mindfully as they make choices about eating and physical activity. The program provides
      opportunities for participants to keep a journal of healthy eating and physical activity
      behaviors.
    

Intervention name(s): group fitness + education; group fitness classes only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 15 weeks biweekly group fitness + 15 weekly nutrition and physical activity education; 15 weeks biweekly group fitness
Other intervention name(s): Eat Smart, Move More, Weigh Less
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Randomized controlled trial; obesity; community-based participatory research; minority health; rural health; health promotion
Clinical Trial of Pirfenidone in Adult Patients With Neurofibromatosis 1
Condition: Neurofibromatosis
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a phase II, open label trial of oral Pirfenidone in 24 adult patients with
      neurofibromatosis type 1.

      Pirfenidone is a new, broad-spectrum anti-fibrotic drug, with proven in vitro and in vivo
      negative effects on fibroblast growth and collagen matrix synthesis. Human studies indicate
      promising therapeutic effects in arresting and reversing fibrosis in a variety of different
      conditions, where the excessive formation of fibrous tissue is a major pathogenic mechanism.
      Since the fibrous tissue is a significant component of neurofibroma, reduction of fibrosis
      could diminish tumor progression and lead to tumor shrinkage. Therefore, Pirfenidone is an
      excellent candidate for the treatment of plexiform neurofibromas and surgically unresectable
      tumors in patients with NF1.
    

Detailed description: 
      Specific aims of this study are:

        1. To evaluate efficacy of Pirfenidone in NF1 patients with disfiguring or disabling
           plexiform neurofibroma (PN) and spinal neurofibromas (SN)

        2. To determine the acute, subacute and chronic toxicity of Pirfenidone in patients with
           NF1.
    

Intervention name(s): Pirfenidone
Intervention type(s): Drug
Intervention description(s): Capsule 800 mg TID, oral
Intervention MeSH terms: Pirfenidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NF1; plexiform neurofibroma
Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The HIP study is designed to follow the clinical experience of young hypertensive children
      receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11
      years old. The study is open label with no concurrent control group. To be eligible for HIP,
      children must have completed Study 328 without discontinuation due to a study drug-related AE
      and in the investigator's opinion, have an on-going clinical indication for an orally
      administered suspension of candesartan cilexetil to control blood pressure. Children will
      return to clinic every 3 months (more frequently at the investigator's discretion) for safety
      and efficacy evaluations. Safety will be monitored by serum chemistries, urinalyses,
      echocardiograms and by physical examinations at specified clinic visits. Blood pressure and
      heart rate will be measured at each clinic visit. Study drug is administered orally once a
      day. Investigators determine the efficacious dose ( 0.05 mg/kg; 0.2 mg/kg; 0.4 mg/kg) on a
      vist-by-vist basis depending on the child's BP response. It is anticipated that study dose
      will align closely with the effective anti-hypertensive dose determined in Study 328. If the
      child's hypertension is not well-controlled, dose adjustments up to a maximum of 0.4mg/kg/day
      and/or the addition of other antihypertensive medications are permitted, with the exception
      of other angiotensin receptor blockers. The HIP study offers eligible children up to two
      additional years of treatment with the liquid formulation of Atacand.
    


Intervention name(s): candesartan cilexetil
Intervention type(s): Drug
Intervention description(s): 0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose
Other intervention name(s): Atacand
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; renal disease; high blood pressure
A Phase Ib Study to Assess Safety and Efficacy of Oral Icaritin in Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      to assess the safety, tolerability，PK and efficacy profile of two doses (600mg,800mg,BID) of
      Icaritin in advanced solid tumor patients in China
    

Detailed description: 
      Estrogen receptor,ERa36, predominantly localizes on the plasma membrane and in the cytoplasm
      and mediates a membrane-initiated "nongenomic" signaling pathway. Membrane-initiated estrogen
      signaling has been linked to rapid responses to estrogen and generally activates signaling
      pathways like the mitogen-activated protein kinase/extracellular signal-regulated kinases
      (MAPK/ERK), phosphatidylinositol-3-kinase, and protein kinase C pathways. Preclinical study
      demonstrated that ERa36 was expressed in tumor cells and might be the driving force of breast
      cancer cell proliferation. 40% of breast cancer tumors which used to be considered as ER
      negative also express ERa36. In the former study the investigators found that 40% of
      ERa66-positive breast cancer patients express high levels of ERa36 in their tumors, and this
      subset of patients are less likely to benefit from tamoxifen treatment compared with those
      with ERa66-positive/ERa36-negative tumors.

      Icaritin is a newly discovered small molecule with selective ERa36 modulating capability and
      the potential as a very promising new drug to treat advanced breast cancer and hepatocellular
      carcinoma (HCC) by targeting this nongenomic pathway. Studies showed that it can inhibit the
      growth of cancer cells both in vitro and in vivo. The investigators have completed the
      preclinical pharmacokinetic, pharmacodynamic (PK&PD) and toxicity studies in animals and now
      move on to test it in a phase Ib clinical trial.
    

Intervention name(s): Icaritin
Intervention type(s): Drug
Intervention description(s): 600mg,800mg two doses, Bid, continuous dosing for 56 days, to assess the safety,tolerance,pharmacokinetics and efficacy of icaritin
Other intervention name(s): IC-162
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound-based Intima-Media Thickness Measurements
Condition: Carotid Artery Intima Media Thickness
Study type: Observational

Summary: 
      Develop a standard technique and demonstrate adequate precision for measurement of
      intima-media thickness (IMT) for routine clinical use.
    

Detailed description: 
      IMT is measured using software to analyze ECG-gated US image sequences acquired using a
      standard protocol. Two sonographers acquire images and measure IMT for 100 vessels. IMT
      technique standard deviation (SD) is determined by assuming normally distributed
      measurements, and dividing the SD of the 100 (paired) IMT differences by sqrt(2). This SD
      will be taken as measures of precision of the IMT technique.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        75 Men and 75 women, ages 35-65, being seen either at the Mayo Clinic Cardiovascular
        Clinic, or having an appointment for a carotid duplex ultrasound.
      
Keywords: Carotid artery; Common carotid artery; Measurement; Ultrasound
Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether implanting gold beads extraarticularly in
      five acupuncture-points around a knee improves pain, stiffness and function in patients with
      knee osteoarthritis.
    

Detailed description: 
      Osteoarthritis (OA) is one of the most common diagnoses made in general practice and among
      the most common causes of disability in older people. Acupuncture is a well-founded
      supplement or alternative to pharmacological and surgical treatment methods. The improvement
      is, however, often brief, so to preserve the initial effect the acupuncture has to be
      repeated at regular intervals.

      In veterinarian medicine implantation of gold-beads in acupuncture-points around a joint has
      been used mostly in dogs for at least 30 years in the treatment of OA. The effect measured on
      eating pattern, physical activity and signs of pain last for several years. It may be
      hypothesized that implanting gold in acupuncture points acts as a continuous acupuncture
      stimulation.

      The purpose of this one year randomised, controlled trial of middle-aged and elderly patients
      is to examine the effect of implanting gold beads extraarticularly in five acupuncture-points
      around a knee with OA.
    

Intervention name(s): Implantation of gold beads around a knee through needles; Sham implantation: Insertion of needles around a knee
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Acupuncture; Gold implantation; Osteoarthritis; Knee osteoarthritis; Double-blind, randomized controlled trial; Intervention; Family practice
Pantoprazole on Insulin Secretion in Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in
      drug-naïve patients with type 2 diabetes.
    

Detailed description: 
      Type 2 diabetes mellitus (T2DM) has become a major health problem worldwide with a high
      prevalence and related mortality, and a high rate of disability in the economically active.
      In Mexico the prevalence was 14.4% reported one of the highest in Latin America and estimated
      a cost of $ 778 million allocated for this disease in 2010, i.e., the tenth place worldwide.
      Within its pathophysiology are alterations in the secretion and insulin action, qualitatively
      and quantitatively, which implies a challenge for long-term metabolic control with the
      pharmacological arsenal available today. Since the function of pancreatic β cell decreases as
      a function of time and lack of control is essential metabolic find drugs that can preserve
      pancreatic cell mass and even promote neogenesis, with the aim of restoring the physiological
      secretion of insulin have been lost in the early stages of type 2 diabetes to achieve optimal
      glycemic control sustained over time to avoid complications and reduce the costs associated
      with the disease.

      Have been evaluated in animal models with promising results Proton Pumps Inhibitors (PPI) for
      the restoration of glucose and the preservation of pancreatic cell function, including
      promoting its growth through increased levels of gastrin, which appears to act as a growth
      factor. However, at present no such mechanisms have been evaluated in humans, it would be
      interesting to assess the effect of administration of a PPI such as pantoprazole is, on the
      phases of insulin secretion in patients with T2DM recent diagnosis.

      Material and Methods: Randomized, double-blind, placebo controlled clinical trial.
      Population: 14 drug-naive adults patients with T2DM and obesity.
      Hyperglycemic-hyperinsulinemic clamp to assess the phases of insulin secretion. Intervention
      for 45 days: pantoprazole 40mg or placebo.
    

Intervention name(s): Pantoprazole; placebo
Intervention type(s): Drug; Drug
Intervention description(s): The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days.; Placebo 40 mg dose.
Other intervention name(s): Pantozol
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Insulin; Pantoprazole
Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The effectiveness of a vaccine can be improved by using a "prime boost strategy" or by using
      an adjuvant. A prime boost strategy is the administration of one type of vaccine (the primer)
      followed by the administration of another type vaccine (the booster). An adjuvant is a
      substance that can enhance the immune response when given at the same time as a vaccine.

      This study will evaluate the safety of and immune response to a vaccine designed to be used
      as part of a prime boost strategy. The study will also evaluate the vaccine when given with
      an adjuvant. The vaccine in this study is not produced from live HIV or from infected cells.
      It does not contain HIV, and it cannot cause HIV infection.
    

Detailed description: 
      Prime-boost vaccine strategies are aimed at inducing different types of immune responses and
      enhancing the overall immune response, a result that may not occur with a single type of
      vaccine. This trial will evaluate the safety and immunogenicity of an HIV multi-epitope
      peptide cytotoxic T lymphocyte (HIV CTL MEP) vaccine developed as part of a prime-boost
      strategy and designed to be administered in combination with an HIV DNA vaccine.

      The HIV CTL MEP vaccine is a mixture of four synthetic peptides, each containing one of three
      different HIV CTL epitopes derived from env or gag. The use of multiple conserved CTL
      epitopes will address the extraordinary diversity found among HIV strains. The vaccine is
      administered with RC529-SE, an analogue of monophosphoryl lipid A. The vaccine/adjuvant
      combination will be evaluated with or without coadministration of granulocyte-macrophage
      colony-stimulating factor (GM-CSF).

      Participants will be randomly assigned to receive either the vaccine with the RC529-SE
      adjuvant, the vaccine with both adjuvants (RC529-SE and GM-CSF), or a placebo. The vaccine,
      adjuvants, and placebo will all be given as an injection into the upper arm. Participants
      will have 11 study visits. Study visits will include a physical exam, medical interview, and
      blood and urine tests. Participants will receive an injection at three of these visits: study
      entry and Months 1 and 3. Participants will be followed for 1 year after the last injection.
    

Intervention name(s): HIV CTL MEP administered with RC529-SE adjuvant; GM-CSF
Intervention type(s): Biological; Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV Preventive Vaccine; Granulocyte-Macrophage Colony-Stimulating Factor; AIDS Vaccines; HIV-1; HIV Seronegativity; Injections, Intramuscular; RC529; Epitopes; T-Lymphocytes, Cytotoxic
Effect of NRD135S.E1 in Peripheral Neuropathic Pain in Diabetic Patients
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, Phase 2a, randomized, double-blind, placebo (vehicle)-controlled,
      parallel-group, dose-finding study designed to evaluate the efficacy, safety and tolerability
      of NRD135S.E1 in adult patients with diabetes mellitus type 1 or 2 with neuropathic pain.
      Potential study patients will sign informed consent prior to undergoing any study-related
      procedure.
    

Detailed description: 
      Following screening, eligible patients will be enrolled and go through a week of washout of
      analgesic treatment. Patients who are still eligible following the washout will be randomized
      to one of four treatment groups: NRD135S.E1 at 10, 40, or 150 mg per day or placebo
      (vehicle).

      All four treatment groups will start study treatment with 1 week of single blind placebo
      (baseline week) followed by 3 weeks of the allocated double blind treatment (Weeks 1, 2, and
      3). All patients will be followed for 30 days after the last study drug administration. The
      total study duration per patient is 9 to10 weeks.

      Visit schedule: Screening (Days minus 14 to minus 8, Visit 1). Washout visit (Day minus 7,
      Visit 2). Randomization and start of placebo treatment (Day 1, Visit 3). Double blind
      treatment visits on Days 8 (Visit 4), 15 (Visit 5) and 29 (Visit 6). Follow up visit by
      telephone (Day 59, Visit 7).
    

Intervention name(s): NRD135S.E1; Placebo to match NRD135S.E1
Intervention type(s): Drug; Drug
Intervention description(s): A small chemical entity for treatment of neuropathic pain NRD135S.E1; Placebo capsule to match NRD135S.E1 capsules
Other intervention name(s): E1; Placebo for E1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects
Condition: Respiratory Syncytial Virus (RSV)
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral
      dose of [14C]EDP-938 in healthy male subjects.
    


Intervention name(s): EDP-938
Intervention type(s): Drug
Intervention description(s): [14C]EDP-938
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AME Study
Safety Study of PPI-1019 in Patients With Mild-Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, double-blind, inpatient study followed by outpatient,
      placebo-controlled, single-dose, dose-escalation evaluation of the safety and tolerability of
      PPI-1019 in patients with mild-moderate Alzheimer's disease (AD). Up to 12 sequential cohorts
      of 8 patients (6 active and 2 placebo) will be given a single PPI-1019 dose intravenously
      (IV) over 1 minute in order to determine a maximum tolerated dose (MTD). The MTD will be the
      dose immediately below the not-tolerated dose.
    


Intervention name(s): PPI-1019 (APAN)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Mild-moderate Alzheimer's disease