bioihbjkbjnl/mcl2 huggingface dataset:
A Study Of Panobinostat In Children With Refractory Hematologic Malignancies
Condition: Lymphoblastic Leukemia, Acute, Childhood; Myelogenous Leukemia, Acute, Childhood; Hodgkin's Disease; Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Hematologic Neoplasms; Hodgkin Disease; Leukemia, Myeloid, Acute; Acute Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is for patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL),
      Acute Myelogenous Leukemia (AML), Hodgkin's Disease (HD) or Non-Hodgkin's Lymphoma (NHL).
      Panobinostat is a new drug that is considered investigational because it has not been
      approved in the United States by the Food and Drug Administration (FDA), or in any other
      country. Panobinostat is a histone deacetylase inhibitor (HDACi) and interferes with gene
      expression found in cells causing them to stop growing or die. Panobinostat has been used in
      several hundred adults who had leukemia, HD, NHL and other solid tumors. Panobinostat has not
      been given to children.

      This is a phase I study. In a phase I study, drugs are tested to the highest dose that can be
      safely given. Drugs are given at gradually increasing dosages until there are unacceptable
      side effects. The goal of the Phase I study is to find out the dose of panobinostat that can
      be safely given to children with relapsed ALL, AML, HD and NHL.
    


Intervention name(s): Panobinostat; Cytarabine; Panobinostat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dose will be assigned at study entry. Patients will take panobinostat orally 3 times a week given on a Monday, Wednesday, Friday schedule, every week. One course is 28 days (4 weeks). Patients will get 2 courses and may receive up to 8 courses total.; All patients will receive 70 mg of intrathecal cytarabine on day "0" of course 1. The day "0" dose must be given at least 24 hours prior to initiation of panobinostat. Omit the day "0" dose of intrathecal cytarabine if the patient received intrathecal therapy within 72 hours of treatment.
All patients will receive 70 mg of intrathecal cytarabine on day "29" of course 1-8 in conjunction with their disease evaluation.; Dose will be assigned at study entry. Patients will take panobinostat orally 3 times a week on a Monday, Wednesday, Friday schedule, every other week. Once course is 28 days (4 weeks). Patients will get 2 course and may receive up to 8 courses of therapy.
Other intervention name(s): LBH589; Ara-C; cytosine arabinoside; Cytosar; LBH589
Intervention MeSH terms: Cytarabine; Panobinostat
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapse; Lymphoblastic; Leukemia; Panobinostat; LBH589; Refractory; Hodgkin's; Non-Hodgkin's Lymphoma; Lymphoma; Myelogenous; Acute; Childhood; Pediatric; ALL; AML; NHL; HD
Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients (DSA Study)
Condition: Transplant; Failure, Kidney
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to demonstrate that increased dosages of mycophenolic acid in
      maintenance kidney transplant recipients may cause a reduction in donor-specific antibodies.
    

Detailed description: 
      The development of DSA post-transplant has been associated with chronic rejection and graft
      failure. EC-MPS is thought to be the key drug preventing both cellular and antibody mediated
      rejections. Several studies have shown that recipients receiving an optimal dose of EC-MPS
      have fewer antibody mediated rejections and may require a lower dose of calcineurin
      inhibitors and/or corticosteroids thus reducing side effects and extending graft survival.
    

Intervention name(s): Myfortic Escalation
Intervention type(s): Drug
Intervention description(s): Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of EC-MPS is achieved. Maximum dose will not exceed 2160 mg daily.
Other intervention name(s): Enteric-coated mycophenolate sodium
Intervention MeSH terms: Mycophenolic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney Transplantation; Mycophenolic Acid; Donor-Specific Antibodies; Kidney Rejection
Workplace Intervention: Activity Monitoring as a Tool for Corporate Wellness and Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Is a one-year intervention with Treadmill Desks associated with increased employee daily
      physical activity and decreased sedentariness.

      36 employees with sedentary jobs (87 + 27 kg, BMI 29 + 7 kg/m2) used a Treadmill Desk for one
      year. Daily Physical Activity, work performance, body composition, and blood variables were
      measured at Baseline and 6 and 12 months after the Treadmill Desk intervention.
    


Intervention name(s): Treadmill Desks; Treadmill Desks
Intervention type(s): Other; Other
Intervention description(s): Treadmill Desk were installed in subjects personal workspace.; Treadmill desks were installed in subjects personal workspace six months after phase I started.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia
Condition: Gastroparesis; Dyspepsia
MeSH terms: Gastroparesis; Dyspepsia
Study type: Interventional
Phase: Phase 2

Summary: 
      Researchers are looking at the effects of a cannabidiol medication on stomach function in
      people with gastroparesis (a paralyzed stomach) and people with dyspepsia (an upset stomach
      caused by improper functioning of the stomach's muscles or nerves).
    


Intervention name(s): Cannabidiol; placebo
Intervention type(s): Drug; Other
Intervention description(s): Cannabidiol and the matching placebo solution (excipients alone) will be provided in identical 100ml amber glass bottles. At the end of the treatment period, the treatment solutions will be tapered (10% volume each day) over 10 days.
In accordance with Food and Drug Administration guidance, prior to starting treatment and at end of 1 month treatment, we shall obtain serum transaminases (alanine and aspartate) and total bilirubin levels. These tests will also be performed if patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g., unexplained nausea, vomiting, right upper quadrant abdominal pain, fatigue, anorexia, or jaundice and/or dark urine); if such features develop the treatment will be interrupted or discontinued.; Cannabidiol and the matching placebo solution (excipients alone) will be provided in identical 100ml amber glass bottles. At the end of the treatment period, the treatment solutions will be tapered (10% volume each day) over 10 days.
In accordance with Food and Drug Administration guidance, prior to starting treatment and at end of 1 month treatment, we shall obtain serum transaminases (alanine and aspartate) and total bilirubin levels. These tests will also be performed if patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g., unexplained nausea, vomiting, right upper quadrant abdominal pain, fatigue, anorexia, or jaundice and/or dark urine); if such features develop the treatment will be interrupted or discontinued.
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers
Condition: Healthy
Study type: Observational

Summary: 
      To determine whether the bioavailability of the controlled-release test formulation is at
      least as high as that for the commercial reference drug.
    

Detailed description: 
      Serial sampling of venous blood
    

Intervention name(s): Oxycodone controlled-release test formulation; Immediate-release reference drug
Intervention type(s): Drug; Drug
Intervention description(s): single dose administration of test formulation under fasted conditions; single dose administration of reference drug under fasted conditions
Other intervention name(s): ALO-02; Roxicodone
Intervention MeSH terms: Oxycodone
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult volunteers
      
Keywords: Bioavailability; Oxycodone; Healthy Volunteers
ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the
      associated brain activation patterns in alcohol-dependent adults who had recently completed
      alcohol detoxification and were seeking further treatment for their alcohol dependence. The
      study was powered to to detect whether VIVITROL attenuates or blocks the BOLD signal
      increases in response to alcohol-related cues.

      In the double-blind portion, subjects received a single administration of study drug
      (VIVITROL 380 mg or placebo). Subjects who completed the double-blind portion could opt to
      continue to the open-label portion and receive 2 additional months of treatment with VIVITROL
      380 mg.
    

Detailed description: 
      The double-blind phase consisted of 6 visits over a 5- to 6-week period and included 2
      telephone contacts and 2 functional magnetic resonance imaging (fMRI) scans.

      The optional open-label extension included 2 visits approximately 1 month apart. Subjects who
      completed both phases participated in a total of 8 scheduled visits (including 2 fMRI scans
      and 2 telephone contacts) over a period of up to 14 weeks.

      At screening, eligible, consenting subjects were given an Actiwatch®-Score device. They were
      instructed to record their alcohol craving using this device throughout the double-blind
      phase. The Actiwatch was programmed to beep every 3 hours ±20 minutes, thereby signaling the
      subjects to enter their craving or desire to use alcohol, at that exact moment, on a scale of
      0 to 10 (with 0 being no craving at all and 10 being extreme craving). In addition, subjects
      entered any drug and/or alcohol use at the time of occurrence. The Actiwatch was not utilized
      in the open-label portion of the study.
    

Intervention name(s): VIVITROL 380 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered via intramuscular (IM) injection once during the double-blind phase and for 2 additional injections, 4 weeks apart, during the optional open-label extension.; Placebo matching VIVITROL 380 mg was administered by IM injection once during the double-blind phase, only.
Other intervention name(s): naltrexone for extended-release injectable suspension; Medisorb® naltrexone
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcoholism; addiction; alcohol detoxification
Apolipoprotein E Gene and Functional MRI
Condition: Dementia
MeSH terms: Dementia
Study type: Observational

Summary: 
      1. Apolipoprotein E gene (ApoE) is the most important genetic factor for Alzheimer disease
           (AD) and an important genetic factor for outcome of brain injury situations.

        2. Function magnetic resonance imaging (fMRI) is a powerful tool for study of both brain
           regional functions and brain network.

        3. Study about genetic contribution on fMRI is an emerging concept, which will help on
           understanding about how the genetics affecting the brain function.
    

Detailed description: 
      There are about 4-10% people aged and over 65 years suffering from dementia in Taiwan.
      Dementia caused by diverse diseases, including Alzheimer's disease (AD), fronto-temporal
      dementia (FTD), dementia with Lewy body (DLB), Parkinson's disease dementia (PDD) and
      vascular dementia (VaD), is a neurodegenerative disease characterized by memory impairment,
      cognitive dysfunctions, behavioral disturbances and various kinds of psychiatric
      manifestations. AD is the most common cause of dementia in the world. Although the real
      pathophysiology of AD is still obscure, the compelling evidence has shown genetic factor
      should play an important role in the occurrence of AD. There are three genes, in terms of
      amyloid precursor protein (APP), presenilin-1 (PS1) and presenilin-2 (PS2), linked in the
      familial AD. Mutations on these genes would result in familial AD, which account for only
      less than 5% of AD. The only one well-documented genetic risk factor for sporadic AD is
      apolipoprotein E, ε4 allele (ApoE4). ApoE gene contains three genetic polymorphisms, ε2, 3, 4
      and ApoE4 has been found associated with many brain injury situations, such as poor outcome
      for traumatic brain injury (TBI), Parkinson disease dementia (PDD). These findings might
      support ApoE to be important for brain functions but the real mechanisms remain further
      clarification. Functional magnetic resonance imaging (fMRI) is a powerful tool for study of
      both brain regional functions and brain network. To our knowledge, only few reports in top
      journals indicated genetic background is an important contributor for fMRI presentations.
      This could be a new filed of neuroscience. In this study, we will explore whether ApoE
      genetic polymorphisms affect the presentation of fMRI and realize some functions of ApoE in
      the brain. In addition, our data could enhance the new concept about the association between
      genetics and brain function.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        people aged 45-65 years taking health examination in TMU SHH no cognitive impairment by
        MMSE and AD8 screening
      
Biospecimen description: 
      DNA
A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil.
Condition: Contraception; Female Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study was to compare the contraceptive efficacy and safety of the
      transdermal patch to Triphasil.
    

Detailed description: 
      This is an open-label, multicenter, worldwide study to evaluate the contraceptive efficacy,
      safety, cycle control, compliance, and subject satisfaction of the transdermal patch compared
      with Triphasil. Fourteen hundred healthy women will receive study medication for either 6 or
      13 cycles. The first 33% of subjects (~265 transdermal patch subjects and 200 Triphasil
      subjects) will be expected to complete 13 cycles of medication. All subsequent subjects will
      be expected to complete 6 cycles. The ratio of subjects assigned to the transdermal patch arm
      of the study and to the Triphasil arm will be 4:3. At admission (Visit 1) study drug (plus 3
      reserve patches), diary cards and subject instructions for Cycle 1 are dispensed. The first
      patch will be applied and Triphasil pill will be taken on the first day of menses. Study
      medication and diary cards will be issued on day 28 of Cycles 1 (Visit 2) and 3 (Visit 3),
      and those continuing for 13 cycles will receive study drug again (plus 3 reserve patches) on
      day 28 of Cycles 6 (Visit 4) and 9 (Visit 5). Diary cards and empty medication packages will
      be collected at every visit. Final visits are on day 28 of Cycles 6 and 9. Diary card
      information is used to record compliance and bleeding information (to assess cycle control).
      Contraceptive efficacy was assessed by means of the Pearl Index and life table analysis
      (gross cumulative probability of pregnancy). Safety evaluations were based on adverse events,
      which were collected throughout the study, and changes in physical examinations, gynecologic
      examinations, vital signs, and laboratory results from prestudy to final visit. A transdermal
      patch, containing 6 mg NGM and 0.75 mg EE, delivering 250 ug NGM and 25 ug EE over 24 hours
      for 7 days, is worn for 1 week and replaced for 3 consecutive weeks.The fourth week is
      patch-free. A Triphasil pill is taken for 28 consecutive days at the same time each day.
    

Intervention name(s): norelgestromin + ethinyl estradiol; triphasil.
Intervention type(s): Drug
Intervention MeSH terms: Ethinyl Estradiol; Norelgestromin; Ethinyl Estradiol-Norgestrel Combination; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contraception; hormonal contraception; oral contraception; steroid, ethinyl estradiol, horgestimate, levonorgestrel contraception; transdermal.
This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine
Condition: Rotavirus Infection; Rotavirus Vaccines
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess if there is any immune interference between the
      Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant
      vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as
      compared to the currently licensed lyophilized formulation of the HRV vaccine when
      co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age
    


Intervention name(s): Rotarix; Pediarix; Hiberix; Prevenar 13
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.; Three doses administered intramuscularly according to a 0, 2, 4 month schedule.; Three doses administered intramuscularly according to a 0, 2, 4 month schedule.; Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Other intervention name(s): GSK Biologicals' PCV-free liquid formulation of oral live attenuated HRV vaccine.; GSK Biologicals' lyophilized formulation of oral live attenuated HRV vaccine.; GSK Biologicals' Diphtheria and tetanus toxoids and acellular pertussis adsorbed; hepatitis B (recombinant) and inactivated poliovirus vaccine.; GSK Biologicals' Haemophilus b conjugate vaccine (tetanus toxoid conjugate); Pfizer's Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 Protein)
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Immunogenicity; lyophilized formulation; United States; Reactogenicity; Safety; Porcine circovirus -free; Human rotavirus vaccine; liquid formulation; Healthy infants
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Condition: Bipolar I Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I
      disorder.
    

Detailed description: 
      The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120
      mg/day) in patients with bipolar I disorder.
    

Intervention name(s): SM-13496
Intervention type(s): Drug
Other intervention name(s): Lurasidone
Intervention MeSH terms: Lurasidone Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to investigate incremental cost effectiveness of
      Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of
      essential hypertensive patients.

      To investigate incremental cost effectiveness, primary variables are mean treatment cost and
      achievement rate to target blood pressure level at the end of double-blind treatment period.
    


Intervention name(s): Nifedipine (Adalat, BAYA1040); Amlodipine (Norvasc); Diovan
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amlodipine; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Arithmetic Training With the Kumon Method for Cognition in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      A randomized placebo-controlled trial of arithmetic training (with the Kumon Method) as an
      errorless learning method for improvement of cognition in schizophrenia. Outpatients were
      included after signing an informed consent. The trial consisted of 48 sessions of arithmetic
      training (twice a week, for 6 months) or placebo (nonspecific recreation, 48 sessions). The
      patients were evaluated with a neuropsychological battery at baseline, after 6 months (end of
      intervention) and after 12 months after baseline. The Positive and Negative Syndrome Scale
      (PANSS) and the Personal and Social Performance scale (PSP) were applied at baseline, after 6
      months (end of intervention) and 12 months after baseline. Primary outcome was the
      performance on three cognitive domains (attention, executive functions and working memory).
    


Intervention name(s): cognitive training; placebo
Intervention type(s): Other; Other
Intervention description(s): The Kumon method (www.kumon.com) of arithmetic calculation employs the errorless-learning (EL) strategy and consists of a structured, hierarchical series of exercises, beginning with simple ones (e.g. addition and subtraction) and then proceeding to more complex exercises (e.g. advanced algebra, calculus).; nonspecific recreation including befriending and free simple activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; cognition; arithmetic training; Kumon method