bioihbjkbjnl/mcl2 huggingface dataset:
OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTS
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the plasma pharmacokinetics of two formulations
      of PF 05221304 in healthy adults.
    


Intervention name(s): PF-05221304 Formulation A; PF-05221304 Formulation B
Intervention type(s): Drug; Drug
Intervention description(s): 50mg; 50mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Buprenorphine Disposition and Cyclosporine
Condition: Healthy
Study type: Interventional

Summary: 
      The determine the effect of cyclosporine on buprenorphine disposition
    

Detailed description: 
      Subjects studied on four occasions:

        1. Intravenous buprenorphine

        2. Sublingual buprenorphine

        3. Cyclosporine, then intravenous buprenorphine. Subjects then take oral cyclosporine twice
           daily, until

        4. Sublingual buprenorphine; continue oral cyclosporine twice daily for 5 days
    

Intervention name(s): buprenorphine
Intervention type(s): Drug
Intervention description(s): Session 1 Intravenous buprenorphine: 0.2 mg over 1 hr Session 2 Sublingual buprenorphine: 2 mg Session 3 Intravenous buprenorphine 0.2 mg over 1 hr beginning 1 hr after starting cyclosporine Session 4 Sublingual buprenorphine: 2 mg after cyclosporine.
Intervention MeSH terms: Buprenorphine
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: buprenorphine; CYP3A
Drug-durg Interaction of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      The drug-drug interaction study had been designed to investigate the effect of ZSP1273 on the
      pharmacokinetics of digoxin, Rosuvastatin and the effect of Itraconazole and Probenecid on
      the pharmacokinetics of ZSP1273
    


Intervention name(s): Digoxin; Rosuvastatin; ZSP1273; Itraconazole; Probenecid
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral; oral; oral; oral; oral
Intervention MeSH terms: Itraconazole; Probenecid; Digoxin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
TNF Alpha in Refractory Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study was to investigate whether the administration of etanercept to
      patients with severe asthma improved their asthma related quality of life and a measure of
      the degree of reactivity of the airways
    

Detailed description: 
      Although steroid dependent asthma represents a small population of patients with asthma, they
      consume a disproportionately large amount of the health resource burden attributed to asthma.
      Treatment options in this group are extremely limited; the development of effective
      treatments for this group of patients should be a priority, not only for increasing
      individual patient quality of life but for long term reduction of health spending.

      This randomised, double blind, placebo controlled, cross over trial will investigate the
      efficacy of a soluble TNF receptor, etanercept, in severe, steroid dependant asthma.
    

Intervention name(s): Etanercept
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Refractory
To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hyperlipidemia, Familial Combined; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high
      cholesterol.
    


Intervention name(s): Comparator: ezetimibe/simvastatin + niacin (ER); Comparator: Placebo to ezetimibe/simvastatin; Comparator: niacin (ER) tablet; Comparator: ezetimibe (+) simvastatin; Comparator: Placebo to Niacin (ER); Comparator: ezetimibe/simvastatin and niacin (ER); Comparator: ezetimibe and simvastatin; Comparator: Placebo to niacin (ER)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks; ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks.; niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks; ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks.; Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks.; ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be ~40 additional weeks for a total of 64 weeks; ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks; Niacin (ER) (Pbo) tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Early Characteristics of Autism
Condition: Autism; Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will identify factors that distinguish children with autism from children with
      developmental delay and those with normal development and study the efficacy of intensive
      behavioral therapy in children with autism.
    

Detailed description: 
      Children with autism often suffer from social, educational, and functional problems. By
      understanding the social, linguistic, psychological, and physiological differences that
      distinguish between autistic children, developmentally delayed children, and children with
      typical development, researchers may be able to recognize autism early in life so that
      children with autism can be helped as early as possible and their long-term outcome can be
      improved.

      Children in this study will be enrolled for 2 years. They will receive annual evaluations
      throughout the two-year period. They will undergo a magnetic resonance imaging (MRI) scan and
      will complete various activities to determine brain functioning. In addition, children with
      autism will take part in intensive behavioral therapy at least 4 hours every day for the
      duration of the study. Communication and social behavior scales, an early development
      interview, observations of parent/child interaction, and neuropsychological, cognitive, and
      adaptive behavioral measures will be used to assess participants.
    

Intervention name(s): Intensive behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): Participants will undergo a magnetic resonance imaging (MRI) scan and will complete various activities to determine brain functioning. In addition, children with autism will take part in intensive behavioral therapy at least 4 hours every day for the duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism; Developmental Delay Disorders
A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label randomized 2arm study will investigate the pharmacokinetics,
      pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients
      with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients
      will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in
      combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals
      during treatment and on the 3 weeks of follow-up.Target sample size is < 50 individuals.
    


Intervention name(s): folic acid; methotrexate; tocilizumab [RoActemra/Actemra]; tocilizumab [RoActemra/Actemra]
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): >/= 5 mg po weekly; 7.5 - 25 mg weekly (oral or parenteral); 162 mg sc weekly (QW)for 12 weeks; 162 mg sc every other week (Q2W) for 12 weeks
Intervention MeSH terms: Folic Acid; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Qi Zhi Tong Luo Capsule in Vascular Cognitive Impairment
Condition: Vascular Cognitive Impairment; Qi Zhi Tong Luo Capsule; Randomized Controlled Trial
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Qi Zhi Tong Luo (QZTL) capsule, a traditional Chinese herbal medicine, which was used to
      treat stoke-related symptoms, include trouble speaking, paralysis and trouble walking. This
      study aimed to evaluate the efficacy and safety of QZTL capsule in the treatment of vascular
      cognitive impairment. This study was designed as randomized, double-blind, parallel,
      placebo-controlled, multicentre trial. It consisted of a single-blind run-in period using
      placebo only (2 weeks) and a double-blind treatment phase after randomization (24 weeks), and
      follow-up 12 weeks after withdrawal.The primary efficacy variables included changes from
      baseline in the Clinical Dementia Rating scale-Sum Box (CDR-SB) and the Mini-mental State
      Examination (MMSE) after 24 weeks of treatment. The secondary efficacy measurements include
      the Clock Drawing Test (CDT), Hopkins Verbal Learning Test (HVLT) and Ability of Daily Living
      (ADL).
    


Intervention name(s): Qi Zhi Tong Luo capsule; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Patients were receiveed Qi Zhi Tong Luo Capsule 4 capsules, 2 times per day for 24 weeks. QZTL capsule, a traditional Chinese medicine. Each capsule was weighted 0.5g.; Patients were allocated to placebo, 4 capsules, 2 times per day for 24 weeks.To preserve blinding, the placebo had an identical taste and appearance to the experimental drugs. Placebo (batch number: 20140805) were produced by Shanxi Zhendong Pharmaceutical Co., Ltd.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigating Interventions to Reduce Residual Opioids in the Home Following Legitimate Opioid Prescribing in Children.
Condition: Opioid Use, Unspecified
Study type: Interventional

Summary: 
      The overall objective of this study is to evaluate strategies to reduce unused opioids
      prescribed for pediatric acute post-surgical pain management.
    

Detailed description: 
      Prescription opioids are abused by an estimated 12.5 million Americans, and accidental opioid
      overdose is the leading cause of injury death in the US. Many of these drugs originate from
      leftover prescription opioids related to postoperative overprescribing, lack of proper
      disposal, and unsafe home storage. Governmental guidelines indicate that leftover
      prescription opioids should be preferentially returned to a drug take back site; however,
      many people do not utilize these programs due to travel distance, lack of transportation, or
      other factors.

      The aims are to quantify the amount of unused opioids in the home following painful pediatric
      surgical procedures, investigate the impact of formal interventions on disposal of residual
      opioids in the home following these surgeries, and to identify current behaviors of
      adolescents and their family members in the handling of unused prescribed opioids.
    

Intervention name(s): Medication take back; Medication home disposal
Intervention type(s): Other; Other
Intervention description(s): Patients will be provided with formal education about medication take back programs for left-over prescription medications. They will be provided with directions to the closest medication take back facility to their home, and directions to the closet medication take back facility near their post-operative clinic site, and instructed to dispose of any left-over oxycodone medication (at completion of analgesic therapy) through participating in medication take back.; Patients and their families will be provided with formal education about how to use the medication home disposal kit: Dispose Rx, provided with a Dispose Rx home disposal kit, and instructed to dispose of any left-over oxycodone prescription medications with this kit following completion of analgesic therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Usual care (control)
Intervention #1: provision of formal education on medication take back
Intervention #2: provision of formal education on medication home disposal of residual opioids, and provision of a medication home disposal kit.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: opioid stewardship
Peanut Epicutaneous Phase II Immunotherapy Clinical Trial
Condition: Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity; Hypersensitivity, Immediate
MeSH terms: Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Food allergy occurs when the immune system reacts against foods. The immune system is the
      part of the body that protects us from illness and germs, but it can also cause allergies.
      Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries.
      There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be
      severe and life threatening. The only way that you can prevent an allergic reaction is to
      avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and
      people can be accidently exposed to peanut proteins. Treatment for accidental exposure
      include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin)
      which must be carried at all times. DBV Technologies has developed an epicutaneous delivery
      system, a patch that puts the peanut protein on the skin.
    

Detailed description: 
      This study will evaluate whether peanut epicutaneous immunotherapy can protect individuals
      who are allergic to peanuts from having severe allergic reactions, when accidentally exposed
      to peanuts. The study also looks at the safety of the treatment and the effects it has on the
      immune system.
    

Intervention name(s): Placebo Viaskin® Patch; Low-dose DBV712 Viaskin® Patch; High-dose DBV712 Viaskin® Patch
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.; 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.; 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peanut Allergy; Food Allergy; Viaskin peanut patch; Allergen Immunotherapy; Epicutaneous Immunotherapy; Whole peanut extract; Allergenic product; Immediate hypersensitivity
Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)
Condition: Symptomatic Gastroesophageal Reflux Disease (sGERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole
      extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux
      disease (sGERD).
    


Intervention name(s): rabeprazole sodium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed.; One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed.
Other intervention name(s): rabeprazole sodium extended release
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease; GERD
An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)
Condition: Refractory Partial Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese
      patients with refractory partial seizures which are uncontrolled with other anti-epileptic
      drugs (AEDs). Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per
      day). The dose of E2007 will be adjusted during 6 weeks. Subsequently, the dose will be fixed
      and maintained during 4 weeks.
    


Intervention name(s): E2007
Intervention type(s): Drug
Intervention description(s): The dose of E2007 will start from 2 mg and will be increased by 2 mg every week up to 12 mg (the maximum dose). The dose will be adjusted during 6 weeks (i.e., titration period). Subsequently, the dose will be fixed and maintained during 4 weeks (Maintenance period). Patients must visit study site at Weeks -4, 1, 2, 3, 4, 5, 6, 8, 10 and 14 to confirm.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seizures; epilepsy
An Indicator of Successful Peripheral Nerve Block
Condition: Temperature Change, Body
MeSH terms: Body Temperature Changes
Study type: Observational

Summary: 
      The aim of the study was to investigate whether a color changing nail polish would be an
      indicator to assess infraclavicular brachial plexus block success based on skin temperature
      differences before and after performed the block.
    

Detailed description: 
      After performed the block, sensory and motor block assessments will be carried out by blinded
      observer every 5 min after needle removal for 30 min in the regions of the radial, median,
      ulnar, and musculocutaneous nerves of the forearm. Skin temperature measurements will be
      performed from both the anesthetized side and the contralateral arm before the procedure and
      every 5 min for 30 min by a blinded observer. Before the block, the color changing nail
      polish will be applied to all hand nails of the patient. An independent observer will
      photograph the reaction of the nail polish (i.e. color change) in both hands immediately
      after application of nail polish and at two minute intervals for 30 min after performing the
      block. Two blinded observers were reviewed the digital photographs. They were asked to
      compare the colors of nail polish in both hands and to score the difference based on a
      three-point scale (0: absolutely no difference, 1: I am not sure, 2: indisputable difference)
    

Intervention name(s): color change in nail polish
Intervention type(s): Other
Intervention description(s): The determination of color change in nail polish will be based on differences in skin temperature before and after the block.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults between 18 and 65 years of age with infraclavicular brachial lexus block for
        elective elbow, forearm, wrist, or hand surgery , were selected in the study.
A Pilot Study of Motor Control Exercise and Patient Education for the Management of Chronic Low Back Pain in Rural Nigerian Community.
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The main purpose of this pilot single-blind randomized clinical trial is to assess the
      feasibility of implementing motor control exercise and patient education for the management
      of chronic low back pain (CLBP) in a low resource rural Nigerian community.
    

Detailed description: 
      This study will determine whether supervised exercise training emphasizing motor control
      exercise (MCE) approach and a designed patient education (PE) program based on the
      psychosocial approach will be feasible and acceptable in reducing pain intensity and
      functional disability among rural dwellers with CLBP in Nigeria.

      Participants will be recruited and assigned to one of three intervention groups that include
      MCE group, PE group, or MCE plus PE gr using a simple random technique based on an electronic
      randomization table generated by a computer software program. Blinded assessment of all
      clinical outcomes will be performed at baseline and 6 weeks after randomization.

      Primary outcomes include pain intensity and functional disability while secondary outcomes
      include overall treatment satisfaction.

      Data will be analyzed using descriptive statistics, paired t-test, and ANOVA. All statistical
      analyses will be performed on SPSS (version 24.00) at an alpha level of 0.05.
    

Intervention name(s): Motor Control Exercise; Patient Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exercise aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement.
In addition, participants will perform stretching exercises aiming at targeting the postural muscles and connective tissue around the lower back, pelvis and lower limb that tend to get shortened in chronic LBP, and they will be advised to perform aerobic exercise in the form of overground walking at desirable speed at home.; Patient education to enable patients to better understand their pain, change any unhelpful beliefs about LBP, and integrate self-management and active coping strategies that deals with fear avoidance behavior and catastrophic thought.
In addition, participants will perform stretching exercises aiming at targeting the postural muscles and connective tissue around the lower back, pelvis and lower limb that tend to get shortened in chronic LBP, and they will be advised to perform aerobic exercise in the form of overground walking at desirable speed at home.
Other intervention name(s): Specific Stabilisation Exercise; Psychosocial Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rural dwellers; Patient Education; Exercise