bioihbjkbjnl/mcl2 huggingface dataset:
PPAR-COMBO With Sulfonylurea
Condition: Metabolics Diabetes Nos
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the
      Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type
      2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.
    


Intervention name(s): Muraglitazar
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study to Evaluate a Pharmacokinetic Drug Interaction Between Eperisone Hydrochloride and Aceclofenac in Healthy Male Subjects
Condition: Acute Low Back Pain
MeSH terms: Low Back Pain
Study type: Observational

Summary: 
      A randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a
      pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy
      male subjects.
    


Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Acute low back pain
Stem Cells From Human Exfoliated Teeth in Treatment of Type 2 Diabetes
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To evaluate the safety and efficacy of Stem Cells From Human Exfoliated Teethtransplantation
      in patients with type 2 diabetes to provides scientific basis for further clinical studies to
      verify the safety and efficacy of type 2 diabetes.On the basis of maintaining the original
      treatment, intravenous drip of Stem Cells From Human Exfoliated Teeth.
    

Detailed description: 
      Basic treatment:

      The original treatment regimen was maintained. During the study period, insulin dose could be
      adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs
      remained unchanged (except when side effects of drugs or insulin preparations were stopped or
      patients still had frequent hypoglycemia).

      Stem cell therapy:

      Dosage: Stem Cells From Human Exfoliated Teeth were calculated at 0.1IU/kg body weight .

      Course of treatment: 3 times, respectively at the time of enrollment, 1 week after enrollment
      and 4 weeks after enrollment.
    

Intervention name(s): Stem Cells From Human Exfoliated Teeth
Intervention type(s): Biological
Intervention description(s): Basic treatment:
The original treatment regimen will be maintained during the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped, but patients still had frequent hypoglycemia).
Stem cell therapy:
Usage: drip slowly, 50ml normal saline first, then Stem Cells From Human Exfoliated Teeth (during 60 min), then 50ml normal saline.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of HSK3486 in the Induction of General Anesthesia
Condition: Induction and Maintenance of General Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, single-blind, propofol injectable emulsion
      parallel-controlled Phase III clinical study. A total of patients undergoing elective surgery
      are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a
      2:1 ratio.
    


Intervention name(s): HSK3486; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): The initial Induction dose of HSK3486 is 0.4 mg/kg. The initial maintenance dose of HSK3486 is 0.8 mg/kg/h; The initial Induction dose of propofol is 2.0 mg/kg. The initial maintenance dose of propofol is 5.0 mg/kg/h
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Atorvastatin in Pulmonary Hypertension
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Clinical effect and tolerability of atorvastatin versus placebo in patients with Pulmonary
      Hypertension: double-blinded, randomised, prospective phase II study for 6 months with
      adjusted doses of Atorvastatin
    

Detailed description: 
      PAH is characterized by dyspnea, fatigue, and lower extremity edema as a result of heart
      failure. Several research have proved that inflammation may participate in the pathogenesis
      of PAH. As atorvastatin inhibits inflammation and has beneficial effects on blood vessels in
      other types of cardiovascular disease. Therefore, atorvastatin may similarly benefit patients
      with PAH. Experimental data suggest that statins attenuates pulmonary hypertension in animal
      experiments. In addition, non-controlled clinical studies suggest that atorvastatin is
      effective and safe in patients with pulmonary hypertension.

      Participants in this study will be randomly assigned to receive 6 months of daily placebo
      tablets or daily atorvastatin in a double-blind fashion. The study will compare the safety
      and efficacy of placebo and atorvastatin.
    

Intervention name(s): Atorvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients were assigned to receive 10 mg of atorvastatin for 6 months (supplied by JiaLin Pharmaceutical Co., Beijing, China). The dose was adjusted to 5mg daily if serum transaminase levels increased by less than three times the upper limit of normal or creatine kinase levels increased to less than five times the upper limit of normal. If serum transaminase and creatine kinase levels remained normal and low-density lipoprotein level greater than 3.4mmol/L after 4 weeks of therapy, the dose of drug was increased to 20mg once daily.; Patients were assigned to receive 10 mg of placebo for 6 months (supplied by JiaLin Pharmaceutical Co., Beijing, China). The dose was adjusted to 5mg daily if serum transaminase levels increased by less than three times the upper limit of normal or creatine kinase levels increased to less than five times the upper limit of normal. If serum transaminase and creatine kinase levels remained normal and low-density lipoprotein level greater than 3.4mmol/L after 4 weeks of therapy, the dose of drug was increased to 20mg once daily.
Other intervention name(s): atorvastatin: a'le(bland names); matching placebo: a'le(brand name)
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension
Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which
      is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in
      adults affected with Osteogenesis Imperfecta (OI).
    

Detailed description: 
      The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which
      is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in
      adults affected with Osteogenesis Imperfecta (OI). Osteogenesis imperfecta is an inherited
      disorder of type I collagen, a major component of bones, and is characterized by multiple
      fractures and deformities. OI affects approximately 1-2 of every 10,000 individuals.
      Virtually all of the studies of potential treatments for OI have evaluated the effects of
      medications only on children with OI. There is no cure for osteogenesis imperfecta and there
      is no established medical therapy for adults with the disorder. There are very limited data
      concerning the usefulness of parathyroid hormone therapy in OI. An effective anabolic therapy
      for the treatment of adult patients with OI could be a valuable asset to the affected
      patients. In this study, the working hypothesis is that individuals affected with OI who are
      treated with Forteo will experience increased spine and hip bone mineral density and an
      increase in bone strength. Although Forteo is not expected to change the defect in the
      collagen produced, but is postulated to increase the quantity of bone formed and improve bone
      strength.

      This will be a placebo controlled, double blinded trial; half the patients will receive
      Forteo 20 ug/day SQ. Adult patients (age at least 18 yrs) with OI will be enrolled for a
      treatment duration of 18 months. Blood, urine, and bone density/strength tests will be done
      during the study to assess efficacy and safety.
    

Intervention name(s): Teriparatide (FORTEO); Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily
Other intervention name(s): FORTEO
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Osteogenesis Imperfecta; Brittle Bone Disease; Fragility Fractures
Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461)
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the long-term persistence of binding antibody
      responses against V1V2 and gp120 in subjects who were vaccinated with the envelope
      glycoprotein 120 (gp120)-negative factor (Nef)Tat/ Adjuvant System 01B (AS01B) (GSKSB732461)
      vaccine candidate. Other immune parameters like the HIV-specific cluster of differentiation
      (CD4+) T cell and CD8+ T cell responses will also be evaluated.
    

Detailed description: 
      GlaxoSmithKline (GSK) contributes to the public-private pox-protein partnership (P5) which is
      currently assessing the safety, immunogenicity and clinical efficacy of a prime-boost regimen
      aimed at preventing HIV transmission (http://www.hvtn.org/en.html). The booster component of
      the candidate vaccine used in this program consists of two gp120 clade C proteins
      administered with an adjuvant. In order to inform the selection of the adjuvant in future
      studies, data on long-term persistence of immunity after vaccination with gp120/AS01 would
      prove useful. The present study was designed to address this question using a cohort of
      volunteers vaccinated several years ago with a candidate vaccine containing gp120 and AS01.
    

Intervention name(s): Blood sampling
Intervention type(s): Procedure
Intervention description(s): Blood samples will be taken during the single study visit at Year 14 for the assessment of: HIV testing, antibody determination, cell mediated immune (CMI) responses and exploratory characterisation.
Intervention model: Single Group Assignment
Intervention model description: Descriptive mono-centric study with one single group.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: gp120; HIV infections; RV144; gp120-NefTat/AS01B vaccine candidate; V1V2
Doppler Ultrasound Compared With Stethoscope to Assess Heart Rate (HR)
Condition: Neonatal Resuscitation
Study type: Interventional

Summary: 
      This is a prospective randomized controlled trial comparing heart rate measurement by Doppler
      ultrasound or auscultation with a stethoscope in newborn infants who require stabilization or
      resuscitation immediately after birth. Enrolled subjects will be randomly assigned to have
      their heart rate (HR) obtained by stethoscope (ST) or by Doppler ultrasound (DO). Neonates
      will be resuscitated in accordance with the Neonatal Resuscitation Program (NRP) guidelines.
    

Detailed description: 
      Obtaining a baby's heart rate (HR) is an important part of neonatal resuscitation in the
      delivery room and helps the medical team decide how to treat the baby. When babies do not
      breathe well on their own, the medical team places electrocardiogram (ECG) leads on the
      baby's chest to obtain an accurate HR rapidly that can be seen by the entire team. Before the
      ECG leads are placed on the baby's chest, the Neonatal Resuscitation Program (NRP) guidelines
      suggest that medical team members listen to the baby's HR using a stethoscope for 6 seconds.
      However, it can take longer than 6 seconds for medical team members to obtain a HR which can
      delay a baby's care. The purpose of this study is to determine if Doppler ultrasound is a
      useful, alternative tool, aside from a stethoscope, that can be used to quickly obtain a
      baby's HR, particularly in high-risk babies. The primary objective will be the time that it
      takes to obtain a baby's HR by Doppler ultrasound as compared to listening to a baby's HR
      with a stethoscope. With this study, the investigators will be able to understand if Doppler
      ultrasound is a useful tool in the resuscitation of babies who are high risk.
    

Intervention name(s): Handheld fetal doppler ultrasound
Intervention type(s): Procedure
Intervention description(s): Handheld fetal doppler ultrasound will be used to assess heart rate in high-risk neonates.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Doppler ultrasound; heart rate; neonatal resuscitation
Probiotics, Immune Function, and the Brain in Alcohol Consumers
Condition: Alcohol; Use, Problem
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot project is a brief, open-label clinical trial of probiotics as an intervention in
      heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease may
      stand to benefit from probiotics, but no clinical trials to date have addressed this
      population. This study will recruit heavy drinkers to complete an open-label within-subjects
      trial. The study will investigate effects of probiotics on specific biomarkers in healthy
      heavy drinkers who currently are not seeking to change their alcohol use (i.e., are
      non-treatment-seeking).
    

Detailed description: 
      This pilot project is a brief, open-label clinical trial of probiotics as an intervention to
      reduce systemic and neural inflammation in heavy drinkers. Heavy drinkers who do not yet show
      significant signs of liver disease also may stand to benefit from probiotics, but no clinical
      trials to date have addressed this population. This study will recruit 15
      non-treatment-seeking heavy drinkers to complete an open-label within-subjects trial. Aim 1
      is to demonstrate proof-of-concept for beneficial effects of probiotic use on inflammatory
      processes. Aim 2 is to examine effects of probiotic use on brain metabolites correlated with
      neuroinflammation using magnetic resonance spectroscopy. Aim 3 is to gather preliminary data
      on acceptability and feasibility of the probiotic intervention in non-treatment-seeking heavy
      drinkers.
    

Intervention name(s): Seed DS-01 Daily Synbiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Daily administration of Seed DS-01 Daily Synbiotic (dietary supplement)
Intervention model: Single Group Assignment
Intervention model description: Single group, open label trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: alcohol use; probiotics; heavy drinking; brain; immune function
A Comparator Trial on the Relative Efficacy of Two Triglyceride Forms of Fish Oil
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      The health benefits of omega-3 fatty acids have been extensively examined in many published
      studies, and these benefits have been observed in patients with a diversity of conditions and
      diseases, including cardiovascular disease (e.g. atrial fibrillation, atherosclerosis,
      thrombosis, inflammation, sudden cardiac death, etc.), age-related cognitive decline,
      periodontal disease, rheumatoid arthritis, etc. These fatty acids may also be beneficial to
      healthy individuals, in terms of preventative health benefits. The balance between omega-6
      long chain fatty acids and their omega-3 counterparts is important in health maintenance. An
      omega-6:omega-3 ratio of 1:1 or 2:1 is recommended for optimal health, yet the average ratio
      in the North American population is estimated to be as much as 10:1 or even 20:1. A 2014
      study of the dietary habits of U.S. adults revealed that, in general, North Americans do not
      meet the recommended omega-3 fatty acid intake from foods alone. Supplementation may need to
      be considered, in order to help this population meet their daily needs. Both the Academy of
      Nutrition and Dietetics and the American Heart Association suggest a prudent approach in
      recommending an increased intake of omega-3 fatty acids. Although both organisations
      recommend a preference for obtaining omega-3 fatty acids through fish consumption, both also
      recognise that supplementation may also be required in order to meet target values,
      particularly in at-risk populations.

      Several omega-3 fish oil supplements exist on the market each with their own ratios of EPA
      and DHA and are available in varying forms including ethyl ester and high triglyceride forms.
      Differences in product formulation have been shown to have varying health effects.
    


Intervention name(s): Fish Oil; Fish Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1000mg fish oil per capsule (325mg EPA + 225mg DHA); 1000mg fish oil per capsule (300mg EPA + 200mg DHA)
Other intervention name(s): Ultimate Omega; Meg-3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
An Open-Label Trial of Memantine in the Treatment of Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesize that memantine may be a safe and effective treatment for moderate to severe
      binge eating disorder associated with obesity.

      During this 12-week, open-label, outpatient study, male and female subjects between the ages
      of 18 and 65 years who have moderate to severe binge eating disorder and are obese will be
      treated with open-label memantine. Following this 12-week treatment phase, subjects may be
      eligible to continue into an extension phase which will last an additional 12 weeks. During
      the extension phase subjects will continue open-label memantine treatment.
    

Detailed description: 
      Binge eating disorder is a newly recognized disorder characterized by recurrent episodes of
      binge eating without extreme behaviors to lose weight characteristic of bulimia nervosa or
      anorexia nervosa and it is associated with overweight and obesity in both clinical and
      community populations. Preliminary clinical data from a recent, small, 5-week, open-label
      therapeutic trial in obese patients with binge eating disorder in Germany found memantine to
      be effective in weight reduction and reduction of binge episodes.

      We plan to study 15 male and female subjects between the ages of 18 and 65 years who have
      binge eating disorder (with 3 or more binge days per week in the 2 weeks prior to baseline)
      and have a body mass index (BMI) between 30 and 50 kg/m2. During the 12-week treatment phase
      subjects will receive open-label memantine titrated up to 20mg/day, or the subjects maximum
      tolerated dose. Upon completion of the treatment phase, subjects will either taper their
      study medication and return for a final post-taper visit or continue on their current dose of
      study medication in the 12-week extension phase.
    

Intervention name(s): memantine
Intervention type(s): Drug
Intervention MeSH terms: Memantine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Binge eating; Obesity; Eating disorder
Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort
Condition: HIV Infections
MeSH terms: HIV Infections; Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this project is to determine the incidence of osteoporosis in the
      investigators' population of HIV-infected patients and to assess the efficacy and security of
      zoledronic acid, whose efficacy in post-menopausal women with high fracture risk treatment
      and in Paget's disease treatment has already been demonstrated.
    

Detailed description: 
      The lower bone mineral density that has been described in patients with HIV-infection has not
      meant an increase of long term complications. Nevertheless, it could involve an increase if
      the associated co-morbidity in the future, taking in care that in general population
      osteoporosis increases 4 times the pathologic fracture risk. That is why it is necessary to
      know the real prevalence of osteoporosis in this population of patients so the real
      dimensions of the problems can be defined.

      This project wills to determine the incidence of osteoporosis in our population of
      HIV-infected patients and to assess the efficacy and security of zoledronic acid. If the
      annual use of endovenous zoledronic acid obtains equivalent results to those obtained with
      oral and weekly alendronate in other studies with the same population, its use would be
      justified because of its posology benefits. The annual administration can improve compliance
      in patients who are receiving a big quantity of drugs, as HIV-infected patients do, and who
      probably have to be treated for life. Moreover, its elimination is renal so there is absence
      of interactions with antiretroviral drugs what makes of zoledronic acid a very promising
      alternative. Finally, there is no risk of digestive intolerance because of its parenteral
      administration and it has a better posology than oral bisphosphonates.
    

Intervention name(s): Zoledronic acid; Lifestyle modifications; Zoledronic acid
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Zoledronic Acid 5mg/year; Lifestyle modifications; Zoledronic acid (5mg/2years)
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoporosis; HIV infection; Bisphosphonates; Zoledronic acid