bioihbjkbjnl/mcl2 huggingface dataset:
Platelet Hyperreactivity Project
Condition: Platelet Reactivity
Study type: Observational

Summary: 
      The PHP study aims to delineate gene products involved in high on-treatment platelet
      reactivity in aspirin-treated cardiovascular patients.
    

Detailed description: 
      The PHP study aims to delineate gene products involved in high on-treatment platelet
      reactivity in aspirin-treated cardiovascular patients using a system biology approach that
      include proteomics analysis of selected platelet sub-fractions in patients displaying extreme
      phenotype.

      Main objective:

        -  to characterize the proteome profile of platelet hyperreactivity in aspirin-treated
           cardiovascular patients

      Secondary objectives:

        -  to characterize the platelet hyperreactivity phenotype in cardiovascular patients
           treated with aspirin

        -  to determine genetic polymorphisms associated with platelet hyperreactivity
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Symptomatic atherothrombotic patients treated with aspirin.
      
Biospecimen description: 
      Plasma Serum Platelets
    
Keywords: Aspirin; Blood platelets; proteomics; Platelet reactivity
Effect of Mental and Physical Training on Blood Pressure
Condition: Elevated Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Elevated blood pressure or prehypertension is highly associated with increased risk of
      developing hypertension, cardiovascular event, and type II diabetes. Many physically inactive
      young adults, particularly in Malaysia have blood pressure higher than normal range,
      therefore it is important to control the blood pressure within normal range as prophylactic
      measure. This experimental research will be carried out to study the effect of physical
      training (aerobic exercise) and mental training (mindfulness meditation) with diet as a
      control group on the systolic blood pressure, diastolic blood pressure and resting heart rate
      among young adult with elevated blood pressure living a sedentary lifestyle. Participant will
      be divided into 2 experimental groups (mental and physical training) and 1 control group
      (Dietary Approaches to Stop Hypertension -DASH diet plan) who need to complete the prescribed
      intervention for 6 weeks. Results will be analysed by repeated measures ANOVA followed by
      post-hic test.
    


Intervention name(s): Mental training; Physical training; Mental & physical training; DASH diet
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Mental training (guided mindfulness meditation by Jon Kabat-Zinn for 20 minutes, 3 times per week.; Physical training (continuous moderate-intensity training at 40-60% of participants' heart rate reserve for 20 minutes excluding warm-up/cool-down, 3 times per week.; Mental and physical training (combination of mindfulness mediation for 20-minutes, 3 times per week and continuous moderate-intensity training for 20 minutes, 3 times per week.; DASH diet ( (more vegetables, fruits and low-fat dairy foods and moderate amounts of whole grains, fish, poultry and nuts; and less than 3 grams of sodium daily) for 6-weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Condition: Tourette's Disorder
MeSH terms: Tourette Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of the current trial is to obtain long term efficacy, safety and tolerability data
      of once weekly aripiprazole in children and adolescents with Tourette's Disorder.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Aripiprazole tablets orally once daily.
Other intervention name(s): ABILIFY
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tourette's Disorder; Tic Disorders
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
Condition: Pertussis
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES: I. Compare the efficacy of 2 acellular pertussis vaccines vs. whole-cell
      pertussis vaccine vs. placebo in infants living in Italy.

      II. Compare the relative protection of each of the acellular vaccines vs. the whole-cell
      vaccine vs. laboratory-confirmed pertussis.

      III. Assess the relative efficacy of the acellular vaccines with respect to one another.

      IV. Assess the immunogenicity of acellular vs. whole-cell vaccines in the study population.

      V. Compare the frequency of adverse events with each vaccine. VI. Compare the frequency of
      adverse events attributable to the pertussis component in each of the 3 vaccines.

      VII. Assess alternative laboratory diagnostic techniques for pertussis in estimating vaccine
      efficacy, i.e., mucosal immune response, DNA probes, or antibody response to other components
      of the organism.

      VIII. Assess the relative efficacy estimates of each vaccine, using clinical criteria to
      compare the relative incidence rates in each vaccine group.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
      participating institution and randomly assigned to 1 of 3 vaccines and a placebo vaccine in a
      3:3:3:1 ratio.

      One group receives diphtheria-tetanus-pertussis (DPT) vaccine containing filamentous
      hemagglutinin (FHA), Pt-9K/129G, and 69 kDA outer membrane protein (OMP).

      A second group receives DPT containing FHA and OMP. The third group receives DPT containing
      whole-cell pertussis. The control group receives diphtheria-tetanus (DT) vaccine. All
      vaccines are administered as an intramuscular or deep subcutaneous injection at 6-12, 13-20,
      and 21-28 weeks of age. The first vaccine is given at week 12 if hepatitis B or other immune
      globulin was given at birth.

      All patients receive a DT booster at 11 months, and are followed every 4 weeks for
      approximately 20 months.
    

Intervention name(s): diphtheria-tetanus-pertussis vaccine containing whole-cell pertussis; diphtheria-tetanus vaccine
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Keywords: bacterial infection; immunologic disorders and infectious disorders; pertussis; rare disease
Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia
Condition: Androgenic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether cosmetic investigational product containing
      NGF-574H is safe and effective in the treatment of androgenic alopecia in asian adults.
    

Detailed description: 
      NGF-574H is a obtained by collection of paracrine factors secreted by human umbilical cord
      blood-derived mesenchymal stem cell that was exposed in vitro to an artificially designed
      environment mimicking alopecia state in hair follicles to prime the composition of the
      paracrine factors optimized for hair growth. This study is to assess and confirm whether
      NGF-574H is safe and effective in the treatment of androgenic alopecia in asian adults.
    

Intervention name(s): conditioned media of umbilical cord blood-derived stem cells; Placebo
Intervention type(s): Other; Other
Intervention description(s): Hair serum with 5% conditioned media of human umbilical cord blood-derived mesenchymal stem cells; Hair serum without conditioned media of human umbilical cord blood-derived mesenchymal stem cells
Other intervention name(s): NGF-574H
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Product group / Control(placebo) group
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: mesenchymal stem cells; conditioned media; NGF-574H; hair growth; androgenic alopecia; paracrine factors; umbilical cord blood
Phase II Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II trial is being developed following the completion of a Phase I study of the
      combination of temsirolimus and sorafenib in 25 first-line therapy patients with advanced
      hepatocellular carcinoma (December 2009 through April 2012). The maximum tolerated dose (MTD)
      and recommended phase II dose (RP2D) of the combination of temsirolimus is 10 mg IV weekly
      plus sorafenib 200 mg (oral, twice daily).
    

Detailed description: 
      The hypothesis of this single-arm phase II study is that the combination of temsirolimus and
      sorafenib will achieve a clinically-meaningful median time to progression (TTP) of at least 6
      months, with null hypothesis of less than or equal to 3 months, in first-line systemic
      therapy for patients with advanced Hepatocellular carcinoma (HCC). A randomized trial would
      be required to formally compare the efficacy of this combination to sorafenib alone and will
      be indicated if this phase II study achieves a median TTP of at least 6 months. An interim
      safety analysis will employ stopping rules after 30% of planned patients have been treated
      with at least one dose of protocol therapy to ensure the combination does not confer
      excessive toxicity.

      A key aspect of this study will be the requirement of histologic confirmation along with
      adequate archival tissue for correlative tissue analyses to explore new biomarkers of
      response to mammalian target of rapamycin (mTOR) inhibition. Circulating biomarker data
      including enumeration of circulating tumor cells (CTC) and measurement of the tumor marker
      Alpha-fetoprotein (AFP) will be performed at specific time points to evaluate for predictive
      value. Specimen banking of tissue, serum, and peripheral blood mononuclear cells will be
      undertaken to enable future novel biomarker studies. Modified RECIST will be performed in
      addition to standard RECIST 1.1 to explore for improved imaging predictors of response.
    

Intervention name(s): Temsirolimus; Sorafenib:
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg weekly will be administered intravenously over 30 to 60 minutes using an infusion pump starting on Cycle 1, Day 1 of study enrollment.; 200 mg tablet twice daily starting on Cycle 1, Day 1 of study enrollment after completion of temsirolimus infusion.
Intervention MeSH terms: Sirolimus; Sorafenib; Temsirolimus; MTOR Inhibitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced HCC; Temsirolimus; TORISEL; Sorafenib
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to assess the functional and esthetic outcomes in patients who
      had removal of a part of the lower jaw bone due to mouth cancer and reconstruction of the jaw
      bone with a bone ( fibula) from the leg at MSKCC between the years 1987 to 2014.
    


Intervention name(s): physical exam; questionnaires
Intervention type(s): Other; Behavioral
Intervention description(s): Patients will be examined by the treating physician or his/her designee (Fellow). The examining physician will complete an 11-item clinical examination form about the patient's clinical function. This examination assesses lip competence, tongue movement, oral mucosa, dental state, mouth opening, speech, drooling, diet, appearance, oral sensation, and shoulder movement. Where appropriate, the physician will ask the patient questions regarding items on the questionnaire to ensure the completeness and accuracy of the outcome assessment.; The participating patients will be asked to complete three questionnaires:
(1) The European Organization for Research and Treatment of Cancer (EORTC) Head and Neck questionnaire (EORTC H&N 35) to assess their quality of life as it relates to their mandible function and aesthetic appearance (2) The EORTC QLQ-C30, which assesses overall health-related quality of life (3) The FACE-Q Oncology Module: Mandibulectomy, which contains questions regarding both functional and aesthetic outcomes.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All eligible patients will be identified from the institutional databases. Preliminary
        queries indicate that approximately 61 patients are eligible and currently alive.
      
Keywords: Mandible Reconstruction; Fibula Osteomyocutaneous Free Flaps; Quality of Life; 15-244
Phase I Study to Investigate the Alcohol Interaction of DA8159
Condition: Healthy Volunteers; Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to to investigate the effects of alcohol on the pharmacokinetics of
      Udenafil tablet in healthy male volunteers
    


Intervention name(s): Udenafil; Alcohol
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 200mg Single Oral Dose of; Alcohol 39g / 240ml
Intervention MeSH terms: Udenafil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: DA-8159; Udenafil; Alcohol
Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      A comparison of Zolpidem Tartrate Extended-Release (Ambien CR)vs. Placebo in the Treatment of
      Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used Concomitantly with
      Escitalopram (Lexapro - antidepressant).
    


Intervention name(s): zolpidem tartrate
Intervention type(s): Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Intra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee; Arthralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I/IIa study to determine the safety and clinical effects of intra-articular injections
      of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.
    

Detailed description: 
      Open label, single-dose, dose-escalating phase I/IIa study to determine the safety and
      clinical effects of intra-articular injections of MTX-071 (Lopain) in patients with chronic
      osteoarthritic knee-joint pain.
    

Intervention name(s): Lopain
Intervention type(s): Drug
Intervention description(s): intra-articular injection
Other intervention name(s): MTX-071
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Efficacy and Safety of JS002 PFS and AI in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
Condition: Hyperlipemia
MeSH terms: Hyperlipidemia, Familial Combined; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized,
      double-blind, placebo-controlled study to evaluate the efficacy and safety of JS002 prefilled
      syringes and prefilled autosyringes in patients with primary hypercholesterolemia and mixed
      hyperlipidemia when combined with statin therapy.

      In this study, one dose group (150 mg) were set up in this study. 240 subjects are plan to be
      enrolled (the study drug will be assigned to a 2:1 :2:1ratio of JS002 PFS / placebo or JS002
      AI / placebo ).

      Each subject required a maximum of 6 weeks of screening, 12 weeks of treatment, and 8 weeks
      of follow-up.
    


Intervention name(s): JS002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JS002:150mg(1mL) Q2W PFS, Placebo: 1mL Q2W PFS.; JS002:150mg(1mL) Q2W AI, Placebo: 1mL Q2W AI.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single center, comparative pharmacokinetic, open-label, randomized,
      multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8
      mg tablets) to AMRIX® (cyclobenzaprine hydrochloride [HCl] extended-release [ER] capsules),
      30 mg.
    


Intervention name(s): TNX-102 SL 5.6 mg; Amrix 30 mg
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them.; Subjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it.
Other intervention name(s): cyclobenzaprine HCl; cyclobenzaprine HCl
Intervention MeSH terms: Amitriptyline; Cyclobenzaprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy of Sialic Acid GNE Related Thrombocytopenia
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Sialic Acid-Extended Release (SA-ER, aceneuramic acid, UX001) is an extended release
      formulation of sialic acid (SA, also known as N-acetylneuraminic acid or NANA). The SA-ER is
      currently studied as a substrate replacement therapy for patients with GNE myopathy. The
      investigators plan to study the SA-ER compound in a cohort of five patients with GNE-related
      thrombocytopenia.
    

Detailed description: 
      The investigators identified 5 affected individuals (3 males and 2 females from three
      families, age 19-40 years) with GNE-related thrombocytopenia . All subjects will receive 2
      gram SA-ER, three times per day for a total daily dose of 6 grams (6,000 mg). The dose should
      be administered with food (i.e. within 30 minutes of a meal or snack).

      Efficacy will be evaluated by improvement in clinical and laboratory assessments. Results
      from Baseline assessments will be compared with those of post-treatment assessments with
      efficacy conclusions based on improvement between Baseline and the last scheduled assessment.
      Safety will be evaluated by the incidence and frequency of adverse events, including
      clinically significant changes from Baseline to scheduled time points in:

        -  Vital signs.

        -  History and physical examination findings.

        -  Laboratory evaluations.

        -  Serum uric acid levels and urinary excretion of uric acid.
    

Intervention name(s): Sialic Acid-Extended Release
Intervention type(s): Drug
Intervention description(s): Oral drug of Sialic acid
Other intervention name(s): aceneuramic acid, UX001
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Congenital macrothrombocytopenia; Sialic acid; Bleeding
Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia
Condition: Neonatal Hyperbilirubinemia
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Interventional

Summary: 
      Hyperbilirubinemia is the most common problem seen in neonates, owing to severe complications
      in their lifetime. The study design of the study is pretest - a posttest experimental design.
      Criterion-based purposive sampling will be used for recruiting the neonates. In the study
      neonates will be selected according to the selection criteria and will be allocated into two
      groups using computer-based randomization.The Intervention group - neonates will receive
      tactile and kinesthetic stimulation for 15 minutes for 3 consecutive days, 1 hour after
      feeding twice daily along with Phototherapy, Control group - Phototherapy alone will be given
      along with conventional NICU care. Total serum bilirubin will be assessed as outcome measures
      daily once. Transcutaneous bilirubin will be assessed after every intervention.
    


Intervention name(s): Massage therapy; Kinaesthetic stimulation
Intervention type(s): Other; Other
Intervention description(s): Massage therapy includes stroking, kneading, rolling, tapping, vibration and effleurage over the face, chest ,abdomen and back. Massage therapy will be given for 5 minutes and will be repeated twice.; Kinaesthetic stimulation includes passive flexion and extension movements of shoulder joint, elbow joint, hip joint, knee joint and both lower limbs together. It will be given for 5 minutes in each intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise for Depression
Condition: Depression, Unipolar; Bipolar Disorder
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      A randomized single-blinded prospective study to evaluate the efficacy of an individualized
      supervised 8-week exercise program in subjects with moderate to severe depressive episodes
      compared to treatment-as-usual
    

Detailed description: 
      The purpose of this study is to assess the efficacy of a supervised and indvidualized 8-week
      exercise program compared to treatment-as-usual in subjects with a moderate or severe
      depressive episode in the context of unipolar depression or bipolar affective disorders.
      Numerous previous studies suggest that exercise may help to improve the symptoms of
      depression. Moreover, exercise was shown to enhance neuroplasticity in adults whereas
      depression results in decreased neuroplasticity. Here, we aim at elucidating whether a newly
      developed supervised, Internet-based, individualized exercise program of the Institute of
      Sports Science and the Department of Psychiatry and Psychotherapy at the University Mainz is
      more effective in reducing depressive symptoms than treatment-as-usual. Furthermore, this
      study will clarify if severely depressed subjects are able to adhere to an internet-based
      exercise therapy.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): After performance diagnostics, participants will complete an 8-week supervised, individualized exercise program. Training will include up to 3 aerobic training sessions and up to two resistance training units per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Unipolar depression; Bipolar affective disorder; Exercise; Internet-based intervention