bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Because ziprasidone has not been extensively studied and is not widely accepted in the
      severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and
      relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who
      need a change of medication because of ineffectiveness or side effects will be changed to
      ziprasidone and followed with detailed assessments for eight weeks.

      The hypothesis is that they will improve and have fewer side effects.
    

Detailed description: 
      Ziprasidone has been found in studies and practice to be efficacious and tolerated well but
      has not been well studied or well accepted in the very severely ill in State Hospitals. This
      study aims to fill that gap by examining 75 patients with schizophrenia or schizoaffective
      disorder who require a change of medication because of poor response or unacceptable side
      effects.

      After signing consent and having a baseline assessment they will, if necessary, be reduced to
      one antipsychotic then started on ziprasidone, increasing to 160mg the second day. The one
      antipsychotic they had been on will be reduced over a week and stopped. The ziprasidone can
      be increased to 240mg after three weeks if necessary.

      The study will last eight weeks with efficacy assessed by Clinical Global Impressions (CGI),
      Positive and Negative Syndrome Scale (PANSS) every two weeks and Brief Assessment of
      Cognition, Calgary Depression Scale for Schizophrenia, Personal Evaluation of Transitions in
      Treatment and Medical Outcomes Study Cognitive Questions at the beginning and end. Side
      effects will be measured by movement disorder scales (Simpson-Angus scale for Parkinsonism
      (SANRS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Scale (BAS)), ECG
      and weight and blood metabolic measures.

      The hypothesis is that ziprasidone will be generally effective and that side effects
      especially metabolic indices will be reduced.
    

Intervention name(s): ziprasidone
Intervention type(s): Drug
Intervention description(s): Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks
Intervention MeSH terms: Ziprasidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Ziprasidone
Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      Shear stress maybe the most crucial local factor affecting atherogenesis. The present study
      investigated the effect of exposure to increased shear stress promoted by Enhanced External
      Counterpulsation (EECP) on the progression of subclinical atherosclerosis and the underlying
      inflammation- related molecular mechanisms
    

Detailed description: 
      Hypercholesterolemic subjects with subclinical atherosclerosis will be randomized into two
      groups: standard treatment group and standard treatment plus EECP intervention group. The
      results of ultrasound examination and markers of inflammations will be compared.
    

Intervention name(s): Enhanced External Counterpulsation (EECP); Simvastatin
Intervention type(s): Device; Drug
Intervention description(s): EECP one hour per day, 5 hours a week for a total of 35- 36 hours over a 7 week period; Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment
Other intervention name(s): EECP; Statin
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atherosclerosis; Vascular Endothelium; Counterpulsation, External
Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate the clinical effectiveness of MK0812 in the treatment of Arthritis.
    


Intervention name(s): MK0812 / Duration of Treatment: 12 Weeks; Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Early Rabies Vaccine Immunization in Primary School Children
Condition: Rabies Prevention
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 3

Summary: 
      700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to
      receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of
      0.1mL into the skin in the deltoid region. In a subset of 100 children blood was taken for
      rabies virus neutralizing antibody determination on day 49. All subjects were randomized to
      receive 2 booster doses (the recommended vaccination schedule for pre-immunized individuals
      in case of an exposure) on days 0 and 3, one, three or five years later. Blood was taken
      before and after booster for up to one year.Safety and tolerability of the vaccine was
      assessed and persistence of immune response up to 1 year after the booster doses.
    


Intervention name(s): rabies vaccine
Intervention type(s): Biological
Intervention description(s): intradermal vaccination
Other intervention name(s): PCECV, Rabipur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Rabies; PCECV; pre-exposure immunization; intradermal; children
Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted as a single-center, randomized, double-blind, placebo-controlled,
      ascending dose study in up to 8 sequential cohorts of healthy subjects. Each cohort will
      enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo as a
      single oral dose after a fast of at least 10 hours.
    


Intervention name(s): ITI-333; Placebo
Intervention type(s): Drug; Other
Intervention description(s): ITI-333 oral solution; Matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential ascending doses. Parallel (active, placebo) within each cohort
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation
Condition: Pharmacokinetics of Solifenacin Succinate; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy volunteers comparing two different liquid formulations of solifenacin with
      each other and with the tablet formulation.
    

Detailed description: 
      Subjects will be randomized to one of six treatment sequences. The treatments will be
      separated by a minimum of 13 days between dosing.

      Study drug will be administered after an overnight fast, and food will be restricted for an
      additional four hours after dosing. Except for the water provided with dosing, water will be
      restricted only during the hour before and the hour after dosing.

      Subjects will stay at the study site for the first three days of each treatment period.
      Subjects will return to the study center each morning at the same time of the day for Days 4
      through 11 of each study period for the pharmacokinetic blood draw and vital signs. Subjects
      will be in the study for at least 40 days.
    

Intervention name(s): Solifenacin Succinate Formulation A; Solifenacin Succinate Formulation B; Solifenacin Succinate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral suspension; oral suspension; oral tablet
Other intervention name(s): YM905; YM905; VESIcare; YM905
Intervention MeSH terms: Solifenacin Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Solifenacin succinate; VESIcare; Healthy Volunteers; YM905
Assessment of the Effect of BI 201335 on the QT Interval in Healthy Female and Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate that BI 201335 does not prolong the QT interval more than placebo.

      To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects
      (double-blind, randomised, placebo-controlled) before inclusion of female subjects in the
      cross-over part of the trial.
    


Intervention name(s): BI 201335 low dose; BI 201335 placebo; Moxifloxacin; BI 201335 high dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to find out if there is any benefit to adding Simvastatin to Interferon-beta-1a
      in patients with Multiple Sclerosis.
    

Detailed description: 
      This is a multi-centre, double blind, placebo controlled, randomised, parallel group, phase 4
      study. Following three months treatment with Interferon beta 1a (Avonex) patients will be
      randomised for treatment with simvastatin or placebo as an add-on to interferon -beta-1a
      (AvonexÒ). Patients will start treatment with 40 mg peroral simvastatin daily or identically
      appearing placebo for one month. Hereafter, patients will escalate dosage to 80 mg daily. The
      patients will be examined clinically at baseline and at, 3, 4, 6, 9, 12 and 15 months.
      Patients who attend visit 5 (15 months) before the last patient has attended this visit will
      be asked to attend additional visits (visits 6+) until the last patient has attended visit 5.
      Clinical examination will be performed, for applicable patients, at 3 month intervals until
      the end of the study. This will be a maximum of two years, i.e. no more than eight additional
      visits. Laboratory assessments will be performed at screening 3, 4, 6, 9, 12 and 15 months
      after baseline, and for applicable patients additionally at 3 month intervals until end of
      study. MRI will be performed (T1-weighted and T2-weighted) at randomisation (3 months after
      baseline) and 12 months hereafter.
    

Intervention name(s): Interferon-beta-1a; Simvastatin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dosage and frequency as per label; dosage and frequency as per Biogen Idec protocol; dosage and frequency the same as simvastatin as per Biogen Idec Protocol
Other intervention name(s): Avonex
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Combination therapy; Simvastatin; Multiple Sclerosis; Interferon-beta-1a
Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT)
Condition: Thromboembolism
MeSH terms: Thromboembolism
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the
      prophylaxis of venous thromboembolic events after unilateral knee replacement surgery.
    

Detailed description: 
      Approximately 200 patients undergoing unilateral knee replacement will be entered into the
      study and randomized to receive either enoxaparin 30 mg sq bid, PRT054021 15 mg po bid, or
      PRT054021 40 mg po bid for 10 to 14 days, at which time patients will undergo venography.
    

Intervention name(s): Betrixaban; Enoxaparin
Intervention type(s): Drug; Drug
Intervention description(s): Capsule; Administered subcutaneously
Other intervention name(s): Lovenox
Intervention MeSH terms: Enoxaparin; Betrixaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of Venous Thromboembolism
Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation
      challenge in children with bronchial asthma.
    


Intervention name(s): Methacholine Chloride (SK-1211)
Intervention type(s): Drug
Intervention MeSH terms: Methacholine Chloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip
Condition: Epidural Anesthesia
Study type: Interventional

Summary: 
      Epidural analgesia for childbirth may fail to provide adequate pain relief. At NYULMC, to
      maximize the likelihood that epidural analgesia will work well, the gravity flow technique is
      used when performing epidural procedures.

      The gravity flow technique is not well known, and is therefore used in only a few hospitals.
      The purpose of this study is to quantify the reliability of the gravity flow technique to
      accurately validate the position of the epidural needle tip when performing lumbar epidural
      analgesia in laboring women.
    

Detailed description: 
      The purpose of this study is to quantify the reliability of the gravity flow technique to
      accurately validate the position of the epidural needle tip when performing lumbar epidural
      analgesia in laboring women. This gravity flow technique was first described 26 years ago in
      1991, and has been at NYU Langone for 15 years, since 2002. The technique has not been
      formally studied and this study is designed to enable assessment of the success rate of the
      gravity flow technique.
    

Intervention name(s): Cold Stimulus (ice) Test
Intervention type(s): Diagnostic Test
Intervention description(s): Standard of care epidural will be inserted. The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen at 15 minutes and if necessary at 30 minutes after the epidural is inserted. Hypesthesia to cold will be taken a sign of successful lumbar epidural block.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Pomegranate Juice on Oxidative Stress in Patients With type2 Diabetes
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction: Diabetes mellitus a chronic diseases, is the most common and important
      metabolic disease in human. Increased free radicals production due to hyperglycemia produces
      oxidative stress which worsens the disease and its complications. Pomegranate juice has
      antioxidant and antiatherosclerotic properties. The present study was planned to evaluate the
      effects of pomegranate juice consumption on glycemic control, lipid profile,blood pressure
      and oxidative stress in patients with type 2 diabetes
    


Intervention name(s): pomegranate juice; lifestyle modification
Intervention type(s): Dietary Supplement; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pomegranate; diabetes; oxidative stress
Phase 1A Safety Trial of Inhaled PK10571 (GB002)
Condition: Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1A randomized double blind placebo controlled single ascending dose and
      multiple ascending dose trial of inhaled PK10571 (GB002) in healthy adult subjects.
    

Detailed description: 
      This is a first-in-human, single-center, randomized, double-blind, placebo-controlled,
      two-part study in healthy adult males and females of non-childbearing potential.
      "Double-Blind" means neither the study subject nor the investigator knows if PK10571 or
      placebo is being given. "Placebo" means a capsule filled with a powder that does not contain
      the active drug, PK10571. Because the safety profile of PK10571 in humans is unknown and this
      is the first clinical study to assess PK10571 in humans, a single-ascending dose design will
      be used in Part A of the study going from a low dose to higher doses based on safety. Part B
      will be a multiple-ascending dose design to be run only after review of safety and
      measurement of drug levels in the blood from Part A.

      In the single ascending dose study (Part A) up to five doses may be given to different groups
      of study subjects based on safety and measurement of drug levels in the blood. Subjects will
      be randomized into one dose cohort to receive either PK10571 or placebo. Within each cohort,
      6 subjects will receive active drug and 2 subjects will receive placebo.

      In the multiple ascending dose study (Part B), up to three doses of PK10571 will be tested.
      The daily dose will be administered daily for 7 days with close clinical monitoring. The dose
      for the first cohort of Part B will be determined by review of the safety and drug levels
      from Part A by the Safety Review Committee. The dose interval for the first cohort of Part B
      (i.e., once daily, twice daily, or up to three times daily) will be determined by review of
      the safety and drug levels in the blood from Part A by the Safety Review committee.
      Subsequent doses and dosing intervals will be determined by review of the safety and drug
      levels from the prior cohort.
    

Intervention name(s): GB002; Generic Dry Powder Inhaler; Placebo
Intervention type(s): Drug; Device; Drug
Intervention description(s): Inhaled GB002; dry powder inhaler used for inhalation of active drug or placebo; Inhaled placebo
Other intervention name(s): PK10571
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
FH Detection in Children by Salivary Test
Condition: Hyperlipoproteinemia Type II
MeSH terms: Hyperlipoproteinemias; Hyperlipidemias
Study type: Observational

Summary: 
      Familial Hypercholesterolemia is a common cause of premature coronary heart disease, it is
      present in 1 per 500 to 1 per 250 people of the general population. Studies on families of
      Hypercholesterolemia have shown that children with Hypercholesterolemia have a major increase
      in risk of coronary heart disease after the age of 20. The difference between
      Hypercholesterolemia and normal children in their atherogenic profil begin at the age of
      Nowadays , systematic screening techniques are not well implemented whereas their are clear
      World health organization guidelines.

      International studies show treatment must be initiated early as at the age of eight years
      old.

      In pediatry, Parents can be reluctant to practice blood test on their children. In order to
      allow more patients to be diagnosed and treated early enough to prevent major complications
      we need to find an non invasive test.

      The main objective is to define the level of detection of cholesterol in saliva with two
      enzymatic tests. Furthermore we aim to evaluate the performance of salivary detection of
      cholesterol in children.
    


Intervention name(s): salivary sample; blood test
Intervention type(s): Biological; Biological
Intervention description(s): spit of saliva in a tube; 2millilitter blood test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Familial Hypercholesterolemia children group Control children group
      
Biospecimen description: 
      saliva and blood
    
Keywords: familial hypercholesterolemia; Healthy Volunteers
Glioblastoma Response Prediction to Apatinib
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Observational

Summary: 
      Anti-angiogenic therapy is an important treatment strategy for recurrent glioblastoma. Our
      previous study provided evidence for a potential benefit of apatinib, a humanized monoclonal
      antibody against VEGFR-2, when added to temozolomide chemotherapy in patients with recurrent
      glioblastoma. Some patients showed durable responses and prolonged survival, with recorded
      survival times of over 30 months in 6.4% patients. However, a subset of patients progressed
      in 2 months. There is a strong need to better predict and monitor apatinib treatment response
      to prevent patients from adverse effects of ineffective therapy. In this study, whole genome
      sequencing and RNA-sequencing of formalin-fixed, paraffin-embedded tumor materials from the
      participants who received apatinib and temozolomide treatment will be performed to identify
      the response biomarkers and patients who may benefit most from apatinib, avoiding unnecessary
      potential toxicity and cost for those who are unlikely to benefit from the drug.
    


Intervention name(s): genetic characteristic
Intervention type(s): Other
Intervention description(s): the underlying genetic characteristics that prodicting response
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Neuro-oncology Department, Sanbo Bran Hospital Capital Medical University
      
Keywords: Vascular Endothelial Growth Factor Receptor 2; Biomarkers; glioblastoma