bioihbjkbjnl/mcl2 huggingface dataset:
Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peripheral Neuropathy (DPN).
Condition: Diabetic Neuropathy, Painful; Diabetic Neuralgia; Diabetic Polyneuropathy; Diabetic Mononeuropathy
MeSH terms: Peripheral Nervous System Diseases; Neuralgia; Diabetic Neuropathies; Polyneuropathies; Mononeuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200
      mg of RWJ-333369 given twice daily by mouth compared with placebo in the treatment of
      Diabetic Peripheral Neuropathy (DPN).
    

Detailed description: 
      Diabetes mellitus is the most common cause of neuropathy in the Western World, with up to 50%
      of patients developing neuropathy as a long-term complication of the illness, of whom 10%
      experience pain. Diabetic neuropathy most often affects the lower extremities and may be
      severe if inadequately treated. Blood glucose control is a critical treatment element, and
      several medications have been demonstrated to be effective in treating Diabetic Peripheral
      Neuropathy (DPN), including antiepileptic drugs, antidepressants and opioid analgesics. These
      medications are often limited by incomplete pain relief and side effects. This is a
      randomized (study medication is assigned by chance), double-blind (neither the Investigator
      or the patient know the name of the assigned study medication), placebo-controlled,
      crossover, parallel-group, multicenter study to determine the effectiveness and safety of 200
      mg of RWJ-333369 given twice daily by mouth for 4 weeks compared with placebo in patients
      with DPN. The study hypothesis is that 200 mg of RWJ-333369 given twice daily by mouth for 4
      weeks will be more effective than placebo in reducing pain due to DPN, as measured by average
      daily DPN pain scores. Patients will receive 200 mg of RWJ-333369 or matching placebo
      tablets, given in equally divided doses twice daily by mouth with or without food, for 4
      weeks in each of the 2 treatment periods.
    

Intervention name(s): placebo; RWJ-333369 (carisbamate)
Intervention type(s): Drug; Drug
Intervention description(s): twice daily for 4 weeks; 200 mg tablet twice daily for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes mellitus; diabetic microvascular injury; painful polyneuropathy.
A Study to Compare the Effects of a Test and Reference Formulation of LY900014 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study of healthy participants evaluated the concentration of a test LY900014 and a
      reference LY900014 formulation in the bloodstream and how it affected the blood sugar levels.
      The whole study, including screening, took up to 8 weeks to complete.
    


Intervention name(s): LY900014
Intervention type(s): Drug
Intervention description(s): Administered SC
Other intervention name(s): Ultra-Rapid Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Very Intensive Variable Repetitive AmbulatioN Training
Condition: Stroke
Study type: Interventional

Summary: 
      The overall objective of this subproject is to evaluate the individual and paired
      contributions of intensity and variability of stepping training on lower extremity (LE)
      function, health and community participation in patients with chronic hemiparesis
      post-stroke.
    

Detailed description: 
      The overall objective of this subproject is to evaluate the individual and paired
      contributions of intensity and variability of stepping training on lower extremity (LE)
      function, health and community participation in patients with chronic hemiparesis
      post-stroke. Using a RCT design/Intervention Efficacy paradigm, Aim 1 will investigate the
      independent and combined (paired) contributions of intensity and variability of stepping
      training on locomotor function, with secondary measures of health and community mobility. For
      Aim 2, we will evaluate the independent and combined effects of intensity and variability of
      stepping training on non-walking LE tasks. In Aim 3, we will evaluate the cost effectiveness
      of providing these interventions to accelerate motor recovery and health. Our central
      hypothesis is that results of this study will provide a theoretical foundation for
      implementation of physical therapy interventions which can facilitate short-term gains in
      locomotor function, and contribute to long-term improvements in health, function and
      participation through increased community mobility.
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): Variable conditions of stepping practice
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 arm RCT - high intensity variable, high intensity forward, low intensity variable
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: locomotion
Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors
Condition: Advanced Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study evaluating the safety, tolerability and preliminary efficacy of
      IBI322 in cancer subjects who failed standard treatment.
    

Detailed description: 
      Phase 1a/Ib study will be conducted to evaluate the tolerability, safety, PK, PD,
      immunogenicity and preliminary antitumor activity of IBI322 in China. Phase 1a is dose
      escalation and plans to enroll approximately 38-60 subjects with advanced malignant solid
      tumors who failed the standard treatment. Phase Ib is dose expansion, and plans to enroll
      approximately 180 subjects with advanced malignant tumors.
    

Intervention name(s): IBI322
Intervention type(s): Biological
Intervention description(s): Recombinant anti-human CD47/PD-L1 bispecific antibody injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oncology
Biopsy Study for Sculptra (Poly-L-Lactic Acid)
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The primary objective of this study involves research to evaluate new collagen (the elastic
      fibers that provide skin with its strength and resilience) formation in the skin following
      injections of Sculptra (Poly-L-Lactic Acid or PLLA). The secondary objectives of the study
      are to better understand the human skin responses to Sculptra and to assess the safety of
      Sculptra injections.
    


Intervention name(s): Poly-L-Lactic Acid Injection
Intervention type(s): Device
Intervention description(s): 0.05 mL of poly-l-lactic acid will be injected as depot at three (3) points (a total of 0.15 mL).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Nitric Oxide, Endothelin-1, and the Patency of Ductus Arteriosus in Preterm Infants
Condition: Patent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent
Study type: Observational

Summary: 
      BACKGROUND Patent ductus arteriosus (PDA) is a frequent clinical event in preterm infant. The
      cardiopulmonary functions of these preterm babies may be adversely affected by the patency of
      ductus arteriosus. Ductal tissues are sensitive to the constricting effect of endothelin-1
      and the dilating effect of prostaglandins, inflammatory mediators, and concentration of
      oxygen.

      OBJECTIVE To examine the role of endogenous nitric oxide (NO) and endothelin-1 (ET-1) in the
      pathogenesis of patent ductus arteriosus of the preterm infants. We hypothesize that the
      patency of ductus arterious in preterm infants is probably due to inappropriate production of
      endogenous nitric oxide and the interaction with various inflammatory mediators and
      prostaglandins, which is different from those of term infants. In addition, the secretion of
      endothelin is probably decreased. The purpose of this study is to monitor the changes of
      these substance sequentially, and to evaluate the relationship among endothelin-1, endogenous
      nitric oxide, and inflammatory mediators in the pathophysiology of patent ductus arteriosus
      in preterm infants.

      METHODS AND MATERIALS

        1. Inclusion criteria:

             1. Preterm infants with gestational age less than 32 weeks or birth weight less than
                2000 gm.

             2. Informed consent

        2. Numbers of study population:

           With 80-100 evaluable infants (40-50 patients in PDA and non-PDA groups, respectively)

        3. Blood sample, collecting on day 1,3,7 after regular echocardiographic evaluation, is
           assessed for inflammatory mediator (IL-8, IL-10), nitric oxide metabolites (nitrite and
           nitrate), endothelin-1, and cGMP

        4. Statistical analysis: Student t-test testing the differences of clinical data, Wilcoxon
           signed rank test for comparing data obtained between the PDA and non-PDA patients, the
           PDA patients before and after intravenous indomethacin, and those who are responsive or
           refractory to the therapy.
    


Observational model: Defined Population
Time perspective: Other
Keywords: Preterm infant, Patent ductus arteriosus, Nitric oxide,Endothelin-1
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects
Condition: SARS-CoV-2
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a phase I, randomized, placebo-controlled, observer-blind study, for evaluation of
      safety and immunogenicity of SARS-CoV-2 mRNA vaccine (BNT162b1) in Chinese healthy
      population.
    

Detailed description: 
      The participants were screened for 2 weeks (Day -14 to Day 0) before randomization, and
      received 1 dose of SARS-CoV-2 vaccine (BNT162b1) or placebo intramuscularly (IM) on Day 1 and
      Day 22, respectively. After randomization, the study for each participant lasted for
      approximately 12 months.
    

Intervention name(s): BNT162b1; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Intramuscular injection; Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Protection against COVID-19; Coronavirus Disease 2019; Coronavirus infection; Vaccine; RNA Vaccine; Virus Diseases
Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine
      combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil
      and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic
      hepatitis B.

      The primary hypothesis is that subjects treated with combination therapy will see their viral
      DNA count decrease in an amount greater than subjects treated with monotherapy. The secondary
      hypothesis is that subjects treated with combination therapy will have a higher HBeAg
      conversion rate compared to historical controls of subjects treated with lamivudine or
      adefovir dipivoxil monotherapy.
    


Intervention name(s): Hepsera; Hepsera and lamivudine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lamivudine; Adefovir dipivoxil; Adefovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B
Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
Condition: Active Cocaine Users
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Cocaine-use disorders continue to be a significant public health concern, yet no effective
      medications have been identified. The goal of this study is to establish a research platform
      for the development of medications for treatment of cocaine abuse and dependence. This study
      will incorporate choice self-administration procedures between drug and a non-drug
      alternative reinforcer presented during maintenance on d-amphetamine, which has been
      previously shown to reduce cocaine use.
    


Intervention name(s): Cocaine; Sustained Release d-Amphetamine
Intervention type(s): Drug; Drug
Other intervention name(s): Dexedrine Spansule SR
Intervention MeSH terms: Cocaine; Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy of VR Distraction During Local Anesthesia in Children
Condition: Virtual Reality; Anesthesia, Local; Pain
Study type: Interventional

Summary: 
      The aim of this study is to compare between active distraction (video game) and passive
      distraction (cartoon video) using a Virtual Reality ( VR ) device, in reducing injection pain
      and anxiety associated with local anesthesia in children.
    

Detailed description: 
      This comparative study is a double blinded controlled randomized clinical trial which
      includes 82 healthy 6-10 years old children with positive and definitely positive behavior
      according to Frankl Rating Scale with no known allergy to local anesthesia, no emergency
      dental treatment, no previous treatment from the same researcher and no previous experience
      in using the Virtual Reality ( VR ) device.

      the participants will be allocated and treated at department of pediatric dentistry, faculty
      of dentistry, Tishreen university and a written consent will be obtained from the parents.

      The random-numbers table will be used to divide 82 participants in to two groups:

        1. The active distraction group, which will be receiving the injection of local anesthesia
           while using the VR device with a video game and a Play Station 4 ( PS4 ) controller.

        2. The passive distraction group, which will be receiving the injection of local anesthesia
           while using VR device watching a cartoon video.

      All the participants will receive an inferior alveolar nerve block with semi supine position.
    

Intervention name(s): active distraction; passive distraction
Intervention type(s): Device; Device
Intervention description(s): The subject receives the injection of local anesthesia while playing a game on a mobile phone mounted on the VR device using a PS4 controller.; The subject receives the injection of local anesthesia while watching a cartoon on a mobile phone mounted on the VR device.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the participants will be divided into ( active distraction group) and ( passive distraction group )
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: virtual reality; local anesthesia; pain; distraction
Calcium and Lipid Metabolism
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      We hope to determine if supplementing the diet of women who habitually consume low levels of
      calcium, with 1500 mg of calcium a day for three months will increase fat oxidation and
      decrease fat storage. We will also measure concentrations of lipids, glucose, hormones and
      enzymes associated with fat and carbohydrate metabolism to determine alterations and
      mechanism of the metabolic changes.
    

Detailed description: 
      The incidence of obesity has rapidly increased in recent years and reached epidemic
      proportions in the United States. Recent epidemiological data has shown an inverse
      relationship between calcium intake and body fat and emerging research suggests that
      inadequate dietary calcium consumption may increase obesity. Studies in mice have shown that
      an increase in dietary calcium consumption creates a shift in the utilization of energy
      stores from carbohydrates to fat and a shift in the partitioning of energy from storage (as
      fat) to expenditure (as heat).

      We will give 1500 mg of calcium a day for three months to women who habitually consume low
      levels of dietary calcium. The following measurements will be made before and after calcium
      supplementation: body fat by DEXA, lipolysis by infusion of stable isotopes of
      1,1,2,3,3-[2H5] glycerol , hepatic glucose production by infusion of stable isotopes of
      6,6-[2H2] glucose, lipogenesis by measurement of fatty acid synthase activity (14C
      radiochemical assay) , mRNA expression ( Real Time Polymerase Chain Reaction) and protein
      content (ELISA), indirect calorimetry measurement of non-protein respiratory quotient (NPRQ),
      energy expenditure, fat and carbohydrate oxidation. Serum calcium, glucose, cholesterol,
      triglycerides, LDL, HDL, parathyroid hormone, leptin, free fatty acids, adiponectin,
      1,25(OH)2D, 25(OH)D and urinary calcium excretion will also be measured.
    

Intervention name(s): Calcium Carbonate
Intervention type(s): Dietary Supplement
Intervention description(s): 1500 mg per day
Intervention MeSH terms: Calcium Carbonate; Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Calcium carbonate; Dietary Supplements; Lipolysis
The Effect of Switching to Aripiprazole on Heart Health in Overweight and Obese Patients With Schizophrenia
Condition: Overweight; Hyperlipidemia; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Overweight; Hyperlipidemias; Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 2-year study proposing to examine the effects of aripiprazole on heart health
      factors such as serum lipids, serum leptin, fasting blood sugar, body weight and blood
      pressure. This study also examines the safety of switching to aripiprazole with respect to
      changes in the clinical state, preexisting or emergent side-effects, how the brain processes
      information and changes in social functioning and quality of life.
    

Detailed description: 
      This is a 2-yr study proposing to examine the effects of switching subjects from conventional
      and atypical antipsychotic agents to Aripiprazole on cardiovascular health indices in
      overweight and obese patients with Schizophrenia or Schizoaffective disorder. Thirty
      partially remitted patients with Positive and Negative Syndrome Scale (PANSS) score of less
      than 100, who have body mass index (BMI) of 26 or higher will be switched from their existing
      antipsychotic to aripiprazole over 2-3 weeks period using a clinician determined
      cross-tapering approach.The objective of the study is to examine cardiovascular health
      indices such as serum lipids, serum leptin, fasting blood sugar, body weight and blood
      pressure. This study also examines the safety of switching to Aripiprazole with respect to
      changes in clinical state, preexisting or emergent side-effects, how brain processes
      information and changes in social functioning and quality of life.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective disorder; Aripiprazole; Obese; Overweight; Heart Health; Antipsychotic; Heart Health Factors; Cardiovascular Health Indices; Cardiovascular health
Metabolic Effects of Treatment of Chronic Periodontitis in Non-diabetic Subjects
Condition: Periodontitis; Prediabetes
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      This study was aimed at assessing the effects of non-surgical periodontal treatment (NSPT) of
      chronic periodontitis on insulin sensitivity, glucose tolerance, and serum C-reactive
      protein(CRP) level amongst non-diabetic subjects.
    

Detailed description: 
      Subjects with chronic periodontitis will undergo non-surgical periodontal treatment (NSPT)
      consisting of a complete scaling, polishing, root planning, and the irrigation of periodontal
      pockets with a 10% povidone iodine solution. Periodontal parameters (plaque index, gingival
      bleeding index, pocket depth, and clinical attachment loss), insulin sensitivity using KITT,
      glucose tolerance using oral glucose tolerance test and serum CRP level by immunoturbidimetry
      will be measured before and 3 months after the NSPT.
    

Intervention name(s): non-surgical periodontal treatment
Intervention type(s): Procedure
Intervention description(s): One session of complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: periodontitis; diabetes; prevention; impaired glucose tolerance; insulin resistance
Culturally Sensitive Depression Care Management for Latino Primary Care Patients
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether telephonic depression care management can
      improve depression outcomes for Latino primary care patients who are enrolled in Medicaid and
      are receiving an antidepressant from their primary care doctor.
    


Intervention name(s): telephone depression care management
Intervention type(s): Behavioral
Intervention description(s): 1 call per week for first 4 weeks
1 call every other week for next 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: depression; primary care; Latino; telephone; care management
Transition From Alendronate to Romosozumab (AMG 785)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the percent change from baseline in lumbar spine
      bone mineral density (BMD) following multiple-dose administrations of romosozumab in
      postmenopausal women with low BMD previously treated with alendronate.
    


Intervention name(s): Romosozumab
Intervention type(s): Drug
Intervention description(s): Administered by subcutaneous injection
Other intervention name(s): AMG 785; EVENITY™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AMG 785, bone mineral density, alendronate