bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Repaglinide Combined With Insulin in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug
      (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately
      controlled on the current OAD therapy.
    


Intervention name(s): repaglinide; isophane human insulin; insulin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 mg (tablets) before each main meal; Injection s.c. (under the skin) at bedtime; Injection s.c. (under the skin) twice daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Repaglinide; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Assess the Immunogenicity and Safety of the Trivalent Virosomal Influenza Vaccine, Formulation of 2012-2013, in Healthy Subjects Aged Over 3 Years Old to 18 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in young healthy
      subjects. Subjects aged equal to or over 9 years old and less than 18 years old will receive
      one dose of vaccine (0.5 mL) by intramuscular injection into the upper arm. Subjects aged
      equal to or over 3 years old and less than 9 years old will received two doses of vaccine
      (0.5 mL) by intramuscular injection into the upper arm separated by 4 weeks (28 days). Safety
      outcomes included immediate reactions at the time of vaccination, solicited local and
      systemic reactions within 7 days after each vaccination, unsolicited adverse events observed
      since first vaccination to 28 days after the last dose of vaccination, and serious adverse
      events during the observation. Sera prepared from blood samples will be collected from each
      subject immediately prior to, and 4 weeks after each vaccination. Anti-hemagglutinin (HA)
      antibody titers will be determined using the WHO hemagglutination inhibition reference
      technique. The central laboratory who is responsible for antibody titrations will not be
      aware of the background of blood samples (e.g., pre- or post-serum), it is also called
      observer-blinded. All subjects will be followed, either by clinical visit or by telephone
      contact, for 8 weeks after the last vaccination for safety reasons.
    


Intervention name(s): AdimFlu-V
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Active Comparator-Controlled Study to Assess Safety and Efficacy of ISIS-FXIRx in Total Knee Arthroplasty
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is:

        -  To assess the safety and efficacy profile of ISIS-FXIRx, including incidence of bleeding
           and VTE, in patients undergoing total knee arthroplasty.

        -  To compare the efficacy and safety profile of ISIS-FXIRx in patients who achieve less
           than or equal to 0.2 U/mL FXI activity levels to that of enoxaparin.
    


Intervention name(s): ISIS-FXIRx Dose #2; ISIS-FXIRx Dose #3; Enoxaparin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Group B: ISIS-FXIRx dose #2 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.; Group C: ISIS-FXIRx dose #3 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.; Enoxaparin (40mg) will be administered by subcutaneous injection the evening prior to total knee arthroplasty (optionally), 6 to 8 hours after surgery, followed by daily injections for at least 8 additional days post surgery (a total of at least 9 consecutive days). [Except for Canadian region, in which the subcutaneous injection of enoxaparin the evening prior to total knee arthroplasty is expected, resulting in a total of at least 10 consecutive days of enoxaparin.]
Other intervention name(s): ISIS-FXIRx; ISIS-FXIRx; Lovenox; Clexane
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: total knee arthroplasty; Prophylaxis
A Phase I, Single-Center Study of PDC-APB in Healthy Volunteers
Condition: Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess
      the safety and tolerability of PDC-APB by intramuscular (IM) injection compared to placebo.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess
      the safety and tolerability of PDC-APB by intramuscular (IM) injection compared to placebo.
      In this First-in-Human study it is anticipated that up to 5 dose levels (2.5 mg, 10 mg, 0.125
      mg, .375 mg and 1.0 mg PDC-APB) will be studied in sequential cohorts. Each cohort will
      enroll 8 subjects, 6 subjects randomized to active treatment and 2 randomized to placebo, in
      a double-blind manner. A sentinel group of 2 subjects in each cohort will be randomized to
      active (1 subject) or placebo (1 subject). If the dose is tolerated in the sentinel group,
      the remaining 6 subjects in the cohort will be treated (5 active and 1 placebo).

      Safety will be assessed in each cohort before starting treatment at the next higher dose
      level. If the study treatment is tolerated and there are no findings that necessitate
      stopping the study, the next cohort will be treated at the next higher dose level, in the
      same manner. This process will continue until the highest intended dose (1 mL) is reached, or
      side effects that limit further dose escalation are observed.
    

Intervention name(s): PDC-APB; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Active
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo
      for the treatment of moderate to severe facial acne vulgaris.
    


Intervention name(s): 50 mg P005672-HCl; Placebo; 100 mg P005672-HCl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): P005672-HCl administered as an oral capsule(s) once daily; Dose-matched Placebo capsule administered as an oral capsule(s) once daily; P005672-HCl administered as an oral capsule(s) once daily
Other intervention name(s): WC3035, Sarecycline; Inactive; WC3035, Sarecycline
Intervention MeSH terms: Sarecycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acne
Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
Condition: Smoking Cessation
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to determine whether or not varenicline will help people
      with cardiovascular disease quit smoking and to confirm it is safe in these patients.
    


Intervention name(s): placebo; Varenicline
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg placebo twice daily by mouth for 12 weeks; 1 mg twice daily by mouth for 12 weeks
Other intervention name(s): Chantix, Champix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared
      with placebo in participants with episodic migraine and who have previously failed 2 to 4
      classes of oral prophylactic treatments.
    


Intervention name(s): Atogepant 60 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Atogepant tablets.; Atogepant matching placebo tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Episodic migraine
Analysis of Brain Tumors Using Matrix Assisted Laser Desorption/Ionization Mass Spectrometry
Condition: Brain Diseases
MeSH terms: Brain Diseases
Study type: Observational

Summary: 
      We are collecting brain tissue specimens and blood samples from patients at Vanderbilt
      University Medical Center who are undergoing intracranial surgery to remove brain tissue,
      including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery
      for other non-cancerous types of brain tissus. These specimens will then be studied using a
      novel microscopic laser-directed protein mass spectrometric analysis, looking for unique
      protein signatures.
    

Detailed description: 
      We are collecting brain tissue specimens and blood samples from patients at Vanderbilt
      University Medical Center who are undergoing intracranial surgery to remove brain tissue,
      including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery
      for other non-cancerous types of brain tissus. These specimens will then be studied using a
      novel microscopic laser-directed protein mass spectrometric analysis. Data from different
      brain tissues including tumors of different histological sub-types will be analyzed for
      unique protein signatures. These protein signatures will then be statistically correlated
      with clinical data including time to tumor progression and response to therapy.

      The goal of this study is to determine molecular patterns that will be more predictive of
      tumor behavior, thus leading to an improved understanding of the basic biology of these
      poorly understood cancers. This in turn, may lead to more refined therapies and improved
      outcomes.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Age 2 years through Age 85 years old
      
Biospecimen description: 
      Brain Tissue
Efficacy of Faslodex in Treatment of SLE Clinical, Serologic, and Molecular Studies
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      SLE(Systemic Lupus Erythematosus) is an autoimmune disese that primarily occurs in women(9:1
      compared to men). The disease is activated by genetic and environmental factors, yet the
      female gender is the strongest risk factor. The sex hormone estrogen has been proven in the
      past to be an enhancer of the immune response. Estrogen serves as a ligand for two specific
      receptor proteins. Lab studies that we have already done have shown estrogen significantly
      increases these two ligands in the T cells from SLE females, but not in T cells from normal
      women. These estrogen-dependent increases are blocked by the estrogen receptor antagonist ICI
      182,780. The objective of this research is to investigate if ICI 182,780 alters disease
      progression and/or activity in females with SLE and may provide a new treatment for women
      with SLE. This is based on previous work we have done.
    

Detailed description: 
      This is a double-blind study, involving (goal) 20 women with SLE. All will be premenopausal
      with regular menstrual cycles. Patients will meet at least four of the criteria of the
      American Colleges of Rheumatology for classification of SLE. Disease activity will be
      determined by SLE disease activity index called SLEDAI scores. Patients can take meds to
      control their disease, but none will be able to take birth control pills/patches, or hormone
      replacement at the time of the study. The pharmacy will be in control of the blind and 10
      will get ICI 182,780 (Faslodex) and 10 will get placebo. Lab will be drawn before each
      injection and a bone density will be done on injection 1 and 12, the injections will be
      monthly, depending on the female's cycle. A visit will be done at month 15 to evaluate
      SLEDAI, and draw lab as well. Each vs will have a SLEDAI done with the clinical evaluation.
      The injection is 250mg/5cc, which is divided into 2 injections of 2.5cc each, given IM, on
      day 4-10 of each cycle.
    

Intervention name(s): ICI 182,780 (Faslodex)
Intervention type(s): Drug
Intervention MeSH terms: Fulvestrant
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata
Condition: Cholera
MeSH terms: Cholera
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to confirm the safety and immunogenicity of the oral killed
      bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal,
      India.
    

Detailed description: 
      Cholera remains to be a serious public health problem worldwide. In the mid-1980s following
      technology transfer from Sweden, Vietnamese scientists developed and produced an oral killed
      monovalent cholera vaccine for Vietnam's public health programs. A 2-dose regimen of this
      vaccine has been shown to be safe and efficacious. Subsequently, a bivalent vaccine was
      developed containing the newly emergent O139 V. cholerae. This vaccine has several advantages
      over the existing Swedish vaccine. It confers protection against the El Tor biotype in
      younger children, is considerably less expensive, does not require a buffer during
      administration and does not require strict cold chain requirements. However, this vaccine is
      not licensed for use in countries other than Vietnam.

      Through IVI, an agreement between VABIOTECH in Hanoi and Shantha Biotechnics PVT, LTD in
      India has been reached that will make the bivalent vaccine available in India. A double-blind
      randomized phase III trial in a cholera-endemic area would be necessary to demonstrate the
      efficacy of this vaccine in other settings. This would pave the way for the introduction of
      the vaccine into the national immunization programme in India and the internationalization of
      this vaccine and licensure in other countries where it is needed. Prior to the phase III
      trial, a phase II study will be performed among adults and children.
    

Intervention name(s): killed whole cell oral cholera vaccine; Heat Killed E. coli
Intervention type(s): Biological; Biological
Intervention description(s): Bivalent oral killed cholera vaccine: each dose of this vaccine contains:
Inactivated V.Cholerae Inaba (569B), Classical biotype - 25.109 cells
Inactivated V.Cholerae Ogawa (Cairo 50) Classical biotype - 25.109 cells
Inactivated V.Cholerae Inaba (Phil 6973) El Tor biotype - 50.109 cells
Inactivated V.Cholerae O139 - 50.109 cells
each 1.5 mL dose given orally, two doses given 14 days apart; Escherichia coli K12 strain placebo: each dose of placebo contains heat-killed E. coli K12 strain in an amount whose optical turbidity is identical to that for the cholera vaccine.
Each 1.5 mL dose given orally, two doses given 14 days apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: watery diarrhea; cholera vaccine
Bifeprunox in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.
      Extension to study S154.3.001.
    


Intervention name(s): bifeprunox
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: open-label study in the treatment of schizophrenia
Evaluation of the Efficacy and Tolerance of B-Back® on the Burnout Syndrome
Condition: Efficacy and Tolerance of B-Back® on the Burnout Syndrome
MeSH terms: Syndrome; Burnout, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to determine the efficacy and the tolerance of the food
      supplement B-Back®, containing α-casozepine, taurine, eleutherococcus senticosus and
      Extramel®, on the burnout syndrome.
    

Detailed description: 
      The burnout syndrome currently concern all the professional categories. In 2010 the WHO
      estimated that the three countries with the most important work-related depression are Unites
      States, Ukraine and France. The direct and indirect costs of work-related stress for the
      insurance program were not insignificant.

      The purpose of this study is to determine the efficacy of the food supplement B-Back®
      proposed in order to improved the symptoms of the burnout syndrome : stress, fatigue,
      emotional imbalance, anxiety, sleep, etc.

      The main objective is to determine the efficacy of B-Back® on the symptoms suggestive of the
      burnout syndrome by using the Burnout Measure Short version (BMS-10). The others objectives
      were to evaluate the tolerance of the product, to evaluate the efficacy of B-Back® on the
      symptoms suggestive of the burnout syndrome by using the Maslach Burnout Inventory,
      depression, and the global quality of professional and family life, sleep,and fatigue
      (energy).
    

Intervention name(s): Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel); B-Back® placebo (without active compounds)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 tablets/day after breakfast during 12 weeks; 2 tablets/day after breakfast during 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Burnout syndrome; Depression work-related; Food supplement
Vascular Impact of Omega-3 in Metabolic Syndrome
Condition: Essential Hypertension; Metabolic Syndrome
MeSH terms: Hypertension; Essential Hypertension; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The overall aims of the present project are to investigate the impact of a nutritional
      approach based on omega-3 from vegetal origin on vascular function in hypertension associated
      with metabolic syndrome.
    


Intervention name(s): omega-3 from vegetal origin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6 months of supplementation with omega-3 from vegetal origin; 6 months of supplementation with placebo
Other intervention name(s): Cyclodextrin/Camelin oil; Cyclodextrin/Starch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and NIHSS of Stroke Patients
Condition: Cerebral Stroke; Malondialdehyde; Oxidative Stress
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an interventional randomized, controlled trial in analyzing the effects of
      astaxanthin supplementation on plasma malondialdehyde levels and NIHSS of acute ischemic
      stroke patients. According to published studies, it was hypothesized that acute ischemic
      stroke patients who were given astaxanthin would have lower plasma malondialdehyde levels and
      lower NIHSS score compared to the control group.
    

Detailed description: 
      There were a total of 24 subjects, with 12 subjects in the intervention group and 12 subjects
      in the control group.The participants were divided into an interventional group and a control
      group. The interventional group was given astaxanthin supplementation 2 x 8mg per day for 7
      days, while the control group was given placebo.
    

Intervention name(s): Astaxanthine; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Other intervention name(s): Astaxanthine 8mg; Astaxanthine placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Astaxanthin and Placebo
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Astaxanthin; Antioxidant; Plasma Malondialdehyde; NIHSS score; Ischemic Stroke
Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      To evaluate the clinical efficacy of the extended release formulation of tacrolimus
      (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with
      cyclosporine A because of side effects and/or non-responsiveness.
    


Intervention name(s): Extended release tacrolimus (Advagraf®)
Intervention type(s): Drug
Intervention MeSH terms: Tacrolimus
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with severe atopic dermatitis, who can not be treated adequately with Cycloporin A
        because of side effects and/or non-responsiveness.
Stem Cell Transplant for High Risk Central Nervous System (CNS) Tumors
Condition: Glioblastoma; Astrocytoma; Pineoblastoma; Rhabdoid Tumor; Supratentorial Neoplasms
MeSH terms: Glioblastoma; Astrocytoma; Rhabdoid Tumor; Pinealoma; Supratentorial Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary goal of this study is to determine if a stem cell transplant in patients with
      newly diagnosed high risk CNS tumors (glioblastoma multiforme [GBM], high grade astrocytoma,
      pineoblastoma, rhabdoid tumor, supratentorial primitive neuroectodermal tumor [PNET])
      increases overall survival.
    


Intervention name(s): Stem Cell Transplant
Intervention type(s): Procedure
Intervention description(s): Group A: recurrent medulloblastoma, recurrent germ cell tumor
Cytoxan treatment
Stem cell autologous harvest
Group B: GBM, high grade astrocytoma, rhabdoid tumors, pineoblastoma, or supratentorial PNET
Carboplatin and Etoposide treatment
Autologous stem cell harvest
The preparatory regimen used for Stem Cell Rescue #1 will be Carboplatinum, VP-16 and Thiotepa. If the patient has recuperated his ANC to >1,000 within 50 days after Stem Cell Rescue #1, (sustained without G-CSF support) a neuroradiographic evaluation will be performed. If there is lack of progression, the patient will then proceed to Stem Cell Rescue # 2 with Cyclophosphamide and Melphalan, followed by stem cell rescue.
Intervention model: Single Group Assignment
Intervention model description: high dose chemotherapy with stem cell rescue thiotepa, carboplatin & etoposide
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: brain tumor; medulloblastoma; germ cell tumor; CNS tumor; glioblastoma; astrocytoma; pineoblastoma; rhabdoid tumor; supratentorial PNET; high grade astrocytoma