bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of flexibly dosed JNJ-42847922 (20
      milligram [mg] or 40 mg) compared to flexibly dosed quetiapine extended-release (XR) (150 mg
      or 300 mg) as adjunctive therapy to an antidepressant drug in delaying time to all-cause
      discontinuation of study drug over a 6-months (24 weeks) treatment period, in participants
      with major depressive disorder (MDD) who have had an inadequate response to current
      antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or
      serotonin-norepinephrine reuptake inhibitor (SNRI).
    


Intervention name(s): JNJ-42847922; Placebo Matching to JNJ-42847922; Quetiapine XR; Placebo Matching to Quetiapine XR; Selective Serotonin Reuptake Inhibitor (SSRI); Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-42847922 capsule orally.; Participants will receive placebo capsule matching to JNJ-42847922 orally.; Participants will receive quetiapine XR capsule orally.; Participants will receive placebo capsule matching to quetiapine XR orally.; Participants will receive SSRI antidepressant (such as, citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, vilazodone or vortioxetine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).; Participants will receive SNRI antidepressant (such as duloxetine, milnacipran, levomilnacipran, venlafaxine, desvenlafaxine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).
Other intervention name(s): MIN-202;; Seltorexant
Intervention MeSH terms: Norepinephrine; Quetiapine Fumarate; Serotonin; Selective Serotonin Reuptake Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to analyze the ameliorative effects of oral probiotics on
      bacterial vaginosis.
    

Detailed description: 
      To analyze the oral Lactobacillus rhamnosus with Lactobacillus acidophilus or Lactobacillus
      rhamnosus with Lactobacillus plantarum could be ameliorative effects for bacterial vaginosis.
    

Intervention name(s): probiotics
Intervention type(s): Dietary Supplement
Intervention description(s): Two capsules for daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Parallel, open lable Study
Masking: None (Open Label)
Primary purpose: Supportive Care
Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled study of multiple
      ascending iv doses of MEDI341 in male and female subjects with Parkinson's Disease.
    

Detailed description: 
      The study will include up to 3 cohorts, with 12 subjects in each, for a total of up to 36
      randomised subjects.

      The study comprises a screening period of up to 49 days, an 8-week double-blind treatment
      period, and a 13-week follow-up period. Each subject will receive three 60 minute iv
      infusions of MEDI1341 or placebo during the 8-week treatment period, with 4 weeks between
      infusions. The overall study duration (enrolment, treatment, and follow-up periods) will be
      up to 28 weeks per subject.

      A Dose Escalation Committee will review data from each cohort to allow progression to the
      next higher dose cohort in the study.
    

Intervention name(s): MEDI1341; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Intravenous infusion over 60 minutes; Intravenous infusion over 60 minutes
Other intervention name(s): TAK-341
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are randomised to one of two groups within a cohort of 12 subjects (N=9 MEDI1341; N=3 Placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
β-cell Function in Type 1 Diabetes May Not Be As Low As Presumed
Condition: TYPE 1 DIABETES
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Enhancing endogenous insulin production in type 1 diabetic patients (T1DP) can improve
      glycemic control and decrease complications and rates of mortality. However, it can be
      succesfull even if sufficient β-cell function is present. We aimed to evaluate the extent of
      β-cell function by determining fasting levels of C-peptide and those after meal stimulus.
    

Detailed description: 
      Background and aims: Enhancing endogenous insulin production in type 1 diabetic patients
      (T1DP) can improve glycemic control and decrease complications and rates of mortality.
      However, it can be succesfull even if sufficient β-cell function is present. We aimed to
      evaluate the extent of β-cell function by determining fasting levels of C-peptide and those
      after meal stimulus.

      Materials and Methods: One hundred and thiryfive T1DP were planned to enrolı to the study.
      Ethics comittee of our hospital approved the study protocol, which was in accordance with the
      Helsinki Declaration. Fasting C-peptide levels of all participants and stimulated (at 90 th
      minute post mixed meal) C-peptide levels of 54 will be measured by using an
      electrochemiluminescence assay. Two categorizations will be done using fasting (the first
      categorization ) and at 90th minute post mixed meal test (the second categorization) of
      C-peptide levels. For the first categorization; the groups will be classified as follows:
      patients with undetectable ≤0.1 ng/mL (group 1); with minimal 0.1-0.8 ng/ml (group 2); and
      with sustained ≥0.8 ng/mL(group 3) C-peptide levels. For the second categorization, groups
      will be as follows: patients with undetectable ≤0.1 ng/mL (group 1); with minimal 0.1-0.8
      ng/ml (group 2); and with sustained ≥0.8 ng/mL (group 3) C-peptide levels which increased at
      the 90th minute after the meal ≥150% of fasting C-peptide level.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with type 1 diabetes
      
Biospecimen description: 
      Serum c-peptide levels
    
Keywords: β-CELLS,; MIXED MEAL TEST,; C-PEPTİDE
Application of Percutaneous Electrolysis, Percutaneous Neuromodulation and Eccentric Exercise
Condition: Supraspinatus Tendinitis
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The supraspinatus muscle tendinopathy show a big impact, however, there is a lack of
      awareness about the options of the physiotherapist treatment. It is necessary to do studies
      about effectiveness of therapeutic percutaneous electrolysis (EPTE®). This technique enables
      treatment of the tendinopathies and the broken muscle fibrilare. It is base on the
      application of galvanic current through a acupuncture needle. To analyze the effectiveness of
      therapeutic percutaneous electrolysis (EPTE®) in the treatment of supraspinatus muscle
      tendinopathy. Single center randomized controlled trial, parallel treatment design. A
      specialist physician will be diagnosed the supraspinatus muscle tendinopathy. Participants
      will be randomly assigned to receive treatmen for 4 weeks: EPTE® associated with eccentric
      exercises or dry needling with the same eccentric exercises. Both interventions were
      performed under ultrasound guidance with a portable ultrasound (General Electric LogicE).
      Data will be collected by a blinded evaluator.
    

Detailed description: 
      Eccentric exercises of the supraspinatus muscle were performed in 3 sets of 10 repetitions.
      Participants were asked to perform the exercise program on an individual basis twice every
      day for 4 weeks. The eccentric program consisted of 3 exercises, focusing on the
      supraspinatus, infraspinatus, and scapular muscles. Participants were asked to do a normal
      abduction (concentric phase) and a slow return to the initial position (eccentric phase)
      included first the concentric phase, and the eccentric phase was slowly conducted. The
      exercise program was taught by a physiotherapist in the first session and monitored in the
      subsequent sessions.
    

Intervention name(s): EPTE® group; Dry needling group
Intervention type(s): Other; Other
Intervention description(s): Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.; The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises devices at home.
Other intervention name(s): EPTE + EXER; DN + EXER
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A specialist physician will be diagnosed the supraspinatus tendinopathy.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: tendinopathy; electrolysis; exercise; dry needling
Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a
      treatment for type II diabetes mellitus, a disease that occurs when the body is unable to
      effectively use glucose. RSG XR, the investigational drug used in this study, is an
      extended-release form of RSG.

      This study tests whether RSG XR safely provides clinical benefit to people with mild to
      moderate Alzheimer's disease (AD) when combined with one of the currently approved AD
      medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this
      study tests a new way to treat AD by testing whether one's genetic makeup affects the
      response to the study drug. Clinical data suggesting that RSG may benefit AD patients was
      first seen in a small study performed at the University of Washington and then from a larger
      GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG
      once daily for 6 months scored significantly better on 3 tests of memory and thought than
      those who did not receive RSG. In the GSK study, those that appeared to benefit most from
      treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused
      them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene
      may have two copies, one from each parent, or they may have only one APOE e4 gene meaning
      that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4,
      from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same
      level of thinking ability while those with two copies of the APOE e4 gene, continued to
      worsen during the 6-month treatment. The current study will more directly test the
      effectiveness or RSG XR on people who either have or lack the APOE e4 gene.
    

Detailed description: 
      A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate
      the effects of rosiglitazone (extended release tablets) as adjunctive therapy to
      acetylcholinesterase inhibitors on cognition and overall clinical response in APOE
      e4-stratified subjects with mild to moderate Alzheimer's disease (REFLECT-3)
    

Intervention name(s): Rosiglitazone Extended Release 2mg; Rosiglitazone Extended Release 8mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Rosiglitazone Extended Release 2mg OD; Rosiglitazone Extended Release 8mg OD; Placebo
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adjunctive therapy; moderate; Alzheimer's disease; apolipoprotein E; mild; rosiglitazone; cognition
Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis
Condition: Progressive Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether cyclic oral methylprednisolone once every
      month has an effect on the intrathecal inflammation in patients suffering from progressive
      multiple sclerosis.
    

Detailed description: 
      Multiple Sclerosis (MS) is a chronic inflammatory demyelinating disease of the central
      nervous system (CNS). It is presumably T-cell mediated and it is the most common
      non-traumatic cause of disability affecting young people. 85 % of the MS causes starts out as
      relapsing remitting MS (RRMS) and 15 % as primary progressive MS (PPMS). It has been found
      that after 10 years 40-45 % of the RRMS patients will convert to a more progressive state of
      disease, secondary progressive MS (SPMS).

      Until recently it has been believed that the progression seen in MS occurred because of
      axonal loss and neurodegeneration could occur independently of inflammation. Now
      neuropathology studies shows that there is a close association between inflammation and
      neurodegeneration in all stages of MS - also the progressive forms of MS.

      Osteopontin (OPN) is an extracellular matrix protein with chemokine, cytokine and intergrin
      properties. It has multiple immunological functions and is secreted by activated macrophages,
      leukocytes and activated T lymphocytes. It is present in extracellular fluids and is
      up-regulated at sites of inflammation. Increased levels of OPN where reported in the
      cerebrospinal fluid (CSF) in patients with MS.

      The main aim of this study is to analyze the effect of cyclic oral methylprednisolone on the
      intrathecal inflammation in patients suffering from progressive multiple sclerosis measured
      by OPN in the CSF. Second the investigators will look at other aims of intrathecal
      inflammation, neurodegeneration, demyelination and safety.
    

Intervention name(s): methylprednisolone
Intervention type(s): Drug
Intervention description(s): 500 mg of methylprednisolone taken in 3 days every month
Other intervention name(s): Medrol
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; methylprednisolone; osteopontin; inflammation; demyelinating
A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the
      maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with
      an atypical antipsychotic.
    


Intervention name(s): ABT-288; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): See Arm Description for details.; See Arm Description for details.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Trial of effects of minocycline as "add-on" therapy to adults with asthma with a history of
      requiring at least one episode of oral steroid therapy to control the disease.
    

Detailed description: 
      This is a double-blind, placebo-controlled crossover study of adult asthmatics given
      minocycline 150 mg po BID or placebo as add-on therapy for eight weeks each. Each eight week
      arm is separated by a four week wash-out. Spirometry is performed at the baseline and end of
      each arm. Daily symptoms scores, peak flow rates, and oral steroid requirements are recorded.
      A standardized asthma quality of life symptoms assessment is made every four weeks (AQLQ,
      Juniper).
    

Intervention name(s): minocycline; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): addition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen.; Addition of oral placebo capsule in addition to standard of care regimen
Other intervention name(s): Minocin; oral placebo capsules
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blind, placebo-controlled. crossover study
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: minocycline; asthma; oral corticosteroids
Effect of Garlic Tablet Some Indicators Related to Atherosclerosis
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether garlic in adjunct to conventional medical
      treatment is effective in improving carotid intima media thickness (CIMT), Flow mediated
      dilation (FMD) and plasma lipid profile or c-reactive protein of coronary artery disease
      (CAD) patients.
    


Intervention name(s): Garlic
Intervention type(s): Dietary Supplement
Intervention description(s): Garlic tablet in adjunct to medical treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: CAD; CIMT; FMD
Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
Condition: Sarcoma; Central Nervous System Tumor
MeSH terms: Sarcoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II, open, prospective clinical trial, historically controlled. The objective is to
      evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment
      based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor
      lysate) in patients affected of metastatic or relapsed sarcomas or (Central Nervous System)
      CNS tumors.
    

Detailed description: 
      Phase I/II, open, prospective clinical trial, historically controlled. Patients affected of
      metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors will be included. The
      patients will receive standard treatment and experimental treatment based on a cellular
      therapy with vaccination with autologous dendritic cells pulsed with tumor lysate. The
      immunization schedule includes 4 monthly vaccines, 4 bimonthly and quarterly remaining
      vaccines. The vaccines will be administered intradermally in combination with standard
      treatment for each type of tumor.
    

Intervention name(s): dendritic cells; Surgery as needed by the patient´s tumor and stage; Chemotherapy as needed by the patient´s tumor and stage; Radiation therapy as needed by the patient´s tumor and stage
Intervention type(s): Biological; Procedure; Drug; Radiation
Intervention description(s): vaccines with dendritic cells pulsed with tumor lysate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dendritic cell vaccination; sarcoma; central nervous system tumor; childhood; adolescent; immunotherapy
Serious Game for Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      In this study the investigators aim to assess the feasibility and acceptability of a serious
      game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease
      previously operated for deep brain stimulation of the sub thalamic nucleus.
    


Intervention name(s): Serious game
Intervention type(s): Other
Intervention description(s): Rehabilitation with serious game
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Gait and balance disorders; serious game