bioihbjkbjnl/mcl2 huggingface dataset:
To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Postherpetic Neuralgia
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 3

Summary: 
      Investigate the Efficacy and Safety of HSK16149 capsules in Chinese Postherpetic Neuralgia
      Following 12 Weeks Treatment in Comparison to Placebo
    


Intervention name(s): HSK16149 20mg BID; HSK16149 40mg BID; Placebo BID
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HSK16149 20mg, orally twice a day, treatment period; 12-weeks fixed dose; HSK16149 40mg, orally twice a day, treatment period; 12-weeks fixed dose; Placebo, orally twice a day, treatment period; 12-weeks fixed dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Investigation of Efficacy and Safety of EPOGAM
Condition: Atopic Dermatitis; Neurodermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Neurodermatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study it will be investigated if patients with atopic dermatitis responding to EPOGAM
      treatment, show a significant increase of dihomo-gamma-linolic acid in the blood.
    

Detailed description: 
      Patients with atopic dermatitis will receive EPOGAM 1000 for 12 weeks. Clinical symptoms of
      the disease will be assessed using the SCORAD score. Dihomo-gamma-linolic acid levels in the
      blood will be measured with GC-MS.
    

Intervention name(s): EPOGAM 1000
Intervention type(s): Drug
Intervention description(s): One capsule of EPOGAM 1000 contains 932-1073 mg Oenothera seminis oleum, equivalent to 80 mg gamma-linolic acid. Children (2-12 years) take 2 capsules in the morning and evening, whereas persons over 12 years take 3 capsules in the morning and evening. The duration of the treatment is 12 weeks.
Other intervention name(s): Oenothera seminis oleum; Evening Primrose Oil; EPOGAM
Intervention MeSH terms: Evening primrose oil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate
Condition: Arthritis; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objectives are to determine the relationship between blood levels of CDP6038 and
      suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV)
      infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of
      CDP6038 will also be evaluated.
    

Detailed description: 
      The secondary objectives of the study include determination of the absolute bioavailability
      of CDP6038 given via sc administration compared with iv infusion; assessment of the
      immunogenicity potential of single dose CDP6038 and assessment, on an exploratory basis, of
      other relevant systemic biomarkers and changes in clinical response.
    

Intervention name(s): CDP6038; CDP6038; CDP6038; Placebo IV; Placebo SC; CDP 6038 SC; Methotrexate
Intervention type(s): Biological; Biological; Biological; Other; Other; Drug; Drug
Intervention description(s): Single dose:
1 mg/kg CDP6038 IV; Single dose:
0.1mg/kg CDP6038 IV; Single dose:
1.0mg/kg CDP6038 SC; Single dose:
Placebo IV; Single dose:
Placebo SC; Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo; Individual stable doses of methotrexate.
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: CDP6038
O(6)-Benzylguanine in Treating Patients With Malignant Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I trial to study the effectiveness of O(6)-benzylguanine given before surgery
      to patients who have malignant glioma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the dose of O6-benzylguanine (O6-BG) that produces total depletion of tumor
           O6-alkylguanine-DNA alkyltransferase (AGT) levels in more than 90% of patients with
           cerebral anaplastic astrocytoma or glioblastoma multiforme.

        -  Determine the qualitative and quantitative toxicities of O6-BG in this patient
           population.

      OUTLINE: This is a dose escalation study.

      Part I: The first cohort of 10 patients receives O6-benzylguanine (O6-BG) IV over 1 hour at
      dose level 1 beginning 6 hours prior to surgery. If at least 3 of 10 patients in the first
      cohort have detectable levels of O6-alkylguanine-DNA alkyltransferase (AGT), then a second
      cohort of 10 patients receives O6-BG as above at dose level 2. Dose escalation continues
      until at least 8 of 10 patients have undetectable AGT activity. At this point, 4 additional
      patients are accrued. If at least 11 of 14 patients at this dose level have undetectable
      levels of AGT, then this dose level constitutes the biologic modulatory dose of O6-BG. If
      less than 11 of 14 patients have undetectable levels of AGT, then 10 additional patients are
      treated at a higher dose. If at any time 3 or more patients at a dose level have detectable
      AGT activity, accrual is stopped at that dose level and patients are treated at the next
      higher dose level. (Part I closed to accrual effective 7/10/2000)

      Part II: An additional cohort of 14 patients receives O6-BG at dose level 5 beginning 18
      hours prior to surgery.

      PROJECTED ACCRUAL: Part I of this study closed to accrual effective 7/10/2000. A total of 14
      patients will be accrued for part II of this study at a rate of 3 patients per month.
    

Intervention name(s): O6-benzylguanine
Intervention type(s): Drug
Intervention MeSH terms: O(6)-benzylguanine
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult glioblastoma; adult anaplastic astrocytoma; adult giant cell glioblastoma; adult gliosarcoma
Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release Formulations
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability
      of PF-06700841 following single and multiple oral doses as modified release (MR) formulations
      in healthy, adult participants under fasted and fed conditions. The objective of Part A is to
      evaluate the relative bioavailability and food effect of 2 new MR formulations, MR1 and MR2.
      The objective of Part B is to evaluate the PK and safety/tolerability of MR3 formulation
      following multiple dose administration over a 7-day period. Overall, results from both parts
      will facilitate further development of an MR formulation for future clinical studies.
    


Intervention name(s): PF-06700841 IR; PF-06700841 MR1; PF-06700841 MR2; PF-06700841 MR3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Immediate release formulation; Modified release formulation 1; Modified release formulation 2; Modified release formulation 3; Matching placebo
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part A is a partial cross over study with 4 periods; the first three periods are IR, MR1, MR2 in fasted condition and the fourth arm is either MR1 or MR2 in fed condition.
Part B is a multiple ascending dose study
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate the efficacy and safety of three experimental drugs compared with
      telaprevir (a licensed product) in people with hepatitis C virus infection who have not had
      treatment before.
    

Detailed description: 
      The primary purpose of this study is to demonstrate that treatment with ABT-450/ritonavir
      (r)/ABT-267 and ABT-333 administered with or without ribavirin (RBV) has non-inferior
      efficacy compared to treatment with telaprevir and pegylated interferon alpha-2a (pegIFN) and
      RBV and to compare the safety of these regimens in treatment-naive hepatitis C virus (HCV)
      genotype (GT) 1a- and 1b-infected adults.
    

Intervention name(s): ABT-450/r/ABT-267, ABT-333; Ribavirin; Telaprevir; Pegylated Interferon alpha 2-a (PegIFN)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Tablet; Film-coated tablet; Pre-filled syringe
Other intervention name(s): Viekira Pak; ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; ABT-333 also known as dasabuvir; Holkira Pak
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; Interferon Free; Hepatitis C Treatment Naive; Hepatitis C Virus; Hepatitis C Genotype 1
A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant
Condition: End-stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Death
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for
      preventing acute rejection (AR) after transplantation among recipients of Donated after
      Cardiac Death (DCD) kidney transplant.

      Secondary Objectives:

        -  To evaluate delayed graft function (DGF), graft and patient survival after kidney
           transplant.

        -  To evaluate adverse events of Thymoglobuline® throughout the study.

        -  To explore possible risk factors of AR and DGF in patients with DCD kidney transplant.

        -  To evaluate AR and DGF under different risk stratifications and explore an description
           optimal induction therapy regimen for recipients of DCD kidney transplant.
    

Detailed description: 
      The total study duration per patient is 6.5 months.
    

Intervention name(s): Rabbit Anti-thymocyte Immunoglobulin; Tacrolimus; Methylprednisolone; Mycophenolate mofetil; Mycophenolate Na; prednisone
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: creamy-white powder
Route of administration: intravenous; Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: powder
Route of administration: intravenous; Pharmaceutical form: capsule
Route of administration: oral; Pharmaceutical form: capsule
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral
Other intervention name(s): Thymoglobuline
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Tacrolimus; Thymoglobulin; Antilymphocyte Serum; Immunoglobulins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Objective:

             -  Compare the bioequivalence of a test topiramate formulation (Torrent
                Pharmaceuticals Limited) to an equivalent oral dose of the commercially available
                topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26
                adult subjects under fasted conditions.

        -  Clinical Design:

             -  Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human
                adult subjects.
    


Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention description(s): Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Effect of High Versus Low-level Laser Therapy in Patients of Lumber Radiculopathy
Condition: Lumbar Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      To Compare the effects of high-level laser therapy (HLLT) and low-level laser therapy (LLLT)
      on pain in patients with lumbar radiculopathy.
    


Intervention name(s): High-level laser therapy; Low-level laser therapy
Intervention type(s): Other; Other
Intervention description(s): This group received High-level laser therapy along with conventional physiotherapy treatment 3 times per week for 6 weeks.; This group received Low-level laser therapy along with conventional physiotherapy treatment 3 times per week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HLLT, Laser therapy , LLLT, Lumber radiculopathy, Sciatica
A Study To Understand How The Body Reacts To A Low Dose Of PF-06427878 When Given In A Vein To Healthy, Adult, Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30
      minutes to healthy, adult, males.
    


Intervention name(s): PF-06427878
Intervention type(s): Drug
Intervention description(s): Intravenous, 100 micrograms, single dose, 30 minute infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cytokine Levels in Conversion Disorder
Condition: Conversion Disorder
MeSH terms: Conversion Disorder; Hysteria; Dissociative Disorders
Study type: Observational

Summary: 
      The aim of this study is whether the proinflammatory cytokine levels in patients with
      conversion disorder is increased or not changed in the acute phase and subacute - chronic
      periode, compared with controls.
    


Intervention name(s): conversion disorder
Intervention type(s): Other
Intervention description(s): Proinflammatory cytokine levels in conversion disorder
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
      
Keywords: conversion; cytokine; inflammation
Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor
Condition: Pregnancy Related
Study type: Interventional

Summary: 
      The aim of this study is to compare the effect of epidural analgesia versus low-dose spinal
      analgesia in parturient in the late first stage of labor regarding time needed to perform the
      block, duration of the intra- and postoperative analgesia and incidence of procedure related
      adverse events.
    


Intervention name(s): Epidural Anesthesia; Spinal Analgesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL.; Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      SPECIFIC AIMS

        1. To determine whether pioglitazone will reduce levels of asymmetric
           dimethylarginine(ADMA) in patients with diabetes.

        2. To determine whether nitric oxide(NOx) products are increased with pioglitazone
           treatment.

        3. To determine whether pioglitazone reduces oxidative stress (F2-isoprostanes).
    

Detailed description: 
      The primary purpose of this study is to determine whether treatment with pioglitazone can
      reduce serum levels of asymmetric dimethylarginine (ADMA) in patients with adult diabetes.
      Recent research has found that elevated serum ADMA is associated with increased
      cardiovascular events and mortality, particularly in people with diabetes (Boger 2005,
      Zoccali 2006, Ueda 2007). ADMA, by mediating nitric oxide (NO) availability, may trigger
      pro-atherogenic effects. High plasma concentration of this substance has been associated with
      intima-media thickening, left ventricular hypertrophy and all-cause and cardiovascular
      mortality in patients with end-stage renal disease, and associated with increased
      cardiovascular events in patients with diabetes (Kryzazanowska 2007). The result of higher
      levels of ADMA and reduced output of NO increases vasoconstriction, increases inflammation,
      and interferes with endothelial function. Preliminary studies indicate that pioglitazone may
      reduce ADMA levels, and thus lower cardiovascular risk.Thus, this protocol will test whether
      pioglitazone can reduce ADMA levels in adult patients with diabetes.
    

Intervention name(s): Pioglitazone then Placebo; Placebo then Pioglitazone
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will take the pioglitazone 30mg tablet daily for 3 months. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take a placebo.; Subjects will take the placebo for the first 12 weeks of the study. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take the pioglitazone 30mg tablet daily for 3 months.
Other intervention name(s): Actos, Glustin, Zactos; Actos, Glustin, Zactos
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiovascular risk; biological markers
Asthma Patient Education in the Emergency Room
Condition: Asthma
MeSH terms: Asthma; Emergencies
Study type: Interventional

Summary: 
      The objective of this randomized trial is to assess the effectiveness of an intervention
      involving education, self-efficacy, and social support in improving quality of life outcomes
      among 296 adult asthma patients treated in the emergency room. The main outcome will be a
      comparison of within-patient change in quality of life between enrollment and 8 weeks.
      Secondary objectives will be to assess the effectiveness of the intervention in decreasing
      the need for rescue inhaled beta agonists, in improving peak flow meter rates, and in
      decreasing the number of days lost from work or school due to asthma. These outcomes will be
      measured again at 16 weeks to determine if benefits are sustained. Additional outcomes at 16
      weeks and 1 year will be to assess the effectiveness of the intervention in decreasing urgent
      resource utilization for asthma and cost effectiveness.
    

Detailed description: 
      BACKGROUND:

      Many urban asthma emergency room patients lack effective self-management. Most current
      training programs are administered in outpatient settings and have low attendance rates for
      emergency room patients. There is a great need to develop effective programs that can be
      easily administered in the emergency room for patients who, in many cases, are not present in
      other settings to receive education. This proposal builds on preliminary studies and is
      tailored to provide emergency room patients with basic education during "a teachable moment"
      when they may be most receptive to asthma information.

      DESIGN NARRATIVE:

      Patients will be recruited from two New York City urban emergency rooms or inpatient settings
      and randomized to the intervention or control groups. Intervention patients will receive a
      protocol focusing on asthma self-management, education, self-efficacy, and social support,
      with telephone reinforcement for 8 weeks. Control patients will receive standard emergency
      room education about asthma.
    

Intervention name(s): Asthma Education in Adults; Standard Emergency Room Asthma Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention involves enhancing asthma education, asthma self-efficacy and asthma-related social support and is administered during a single in-person session in the ED (or hospital for admitted patients) followed by telephone reinforcement.; Participants will receive standard emergency room education about asthma.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Headache Inducing Effect of Cromakalim in Migraine Patients
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.
    


Intervention name(s): Levcromakalim; Saline
Intervention type(s): Drug; Drug
Intervention description(s): To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients; To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.
Intervention MeSH terms: Cromakalim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Levcromakalim
Calcium Phosphate and Incretins
Condition: Healthy Men
Study type: Interventional

Summary: 
      The study was conducted to investigate the effect of a calcium phosphate supplementation on
      the secretion of incretins.
    


Intervention name(s): calcium phosphate; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): the subjects consumed for 3 weeks a bread enriched with 1 g pentacalcium phosphate per day; the subjects consumed a bread without pentacalcium phosphate
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: calcium phosphate; incretins; human study