bioihbjkbjnl/mcl2 huggingface dataset:
Folinic Acid in Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      An examination of changes in urinary metabolites with use of folinic acid in children with
      autism spectrum disorder (ASD). Investigators will also measure behavioral measures and
      academic measures monthly at school with teachers and parents report.
    

Detailed description: 
      Children enrolled in Oak Hill School will enroll in this study and take folinic acid
      supplement twice a day for 12 weeks period. Behavioral measures and urinary metabolites will
      be collected pre and post treatment. Behavioral measures will be taken again at 16 weeks,
      after 4 weeks of not dosing.
    

Intervention name(s): folinic acid
Intervention type(s): Drug
Intervention description(s): subject will take folinic acid daily for 12 weeks
Other intervention name(s): leucovorin calcium
Intervention MeSH terms: Leucovorin; Folic Acid; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy Participants
Condition: Coronary Artery Disease; Healthy Participants
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effectiveness, safety and tolerability of
      BMS-986141 added on to aspirin or ticagrelor or the combination on thrombus formation in both
      healthy participants and participants with stable coronary artery disease.
    


Intervention name(s): Ticagrelor; BMS-986141; Aspirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Other intervention name(s): Brilinta; Acetylsalicylic acid (ASA)
Intervention MeSH terms: Aspirin; Ticagrelor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thrombosis; Coronary Artery Disease; Healthy Participants; Aspirin; Ticagrelor; Brilinta; BMS-986141
Mindfulness-Based Cognitive Therapy Effect on Depression and C-Reactive Protein Levels After 8 Weeks of Treatment
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study will investigate the efficacy of an 8-week course in Mindfulness-Based Cognitive
      Therapy (MBCT) for adults with major depressive disorder (MDD) by ;measuring change from
      baseline to completion of treatment at 8 weeks in terms of depression severity using the
      Hamilton Depression Ratings Scale. We will measure change in C-Reactive Protein, a measure of
      inflammation, over the same time period.
    

Detailed description: 
      This study will investigate the effectiveness of MBCT as a primary treatment for MDD. Twelve
      unmedicated subjects with MDD were enrolled in the study. All subjects with MDD underwent
      depression severity assessment at baseline and after the 8-week intervention was complete to
      measure change. In addition, the subjects underwent blood sampling at the same time points to
      measure C-Reactive Protein change over the 8 weeks.

      The primary goal of this pilot study is to determine the efficacy of MBCT as a primary
      treatment for adults with MDD. We will also measure change in the inflammatory biomarker
      C-Reactive Protein for an examination of the effects of depression treatment on this measure.
    

Intervention name(s): Mindfulness-Based Cognitive Therapy
Intervention type(s): Behavioral
Intervention description(s): Eight week course in mindfulness meditation training with elements of cognitive behavioral therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mindfulness-based cognitive therapy; depression; treatment; mindfulness meditation; psychotherapy
Dietary Supplements and Personal Energy Tracking Device to Promote and Maintain Healthy Weight
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Excessive body weight is becoming a concern around the world, for example over half of the
      American adult population is overweight or obese. The purpose of this study is to determine
      whether dietary supplements and shakes containing a combination of nutrients/ingredients
      individually shown in research studies to reduce hunger, enhance metabolism, reduce the
      body's ability to 'store' fat, and enhance energy, promote healthy body weight and
      composition over 12 weeks. A further study objective is to determine whether the inclusion of
      a personal, easy to use, energy tracking device for the measurement of daily energy intake
      and expenditure also helps with the promotion of healthy body weight and body composition.

      In this prospective, blinded study 120 volunteers who meet the entrance criteria including a
      BMI 25-35 kg/m2 and sign the informed consent form to participate in a 12 week long study
      will be recruited. All subjects will consume a multi-vitamin, mineral and fish oil
      supplement. Subjects will be randomly assigned to a control or experimental group and
      stratified by BMI 25-30 and >30-35 kg/m2, age, and gender with an equal number of subjects in
      each strata across groups. A subset of subjects will also wear a personal energy tracking
      device. Subjects will be instructed how to incorporate the shakes and supplements into their
      current diet and encouraged to incorporate fruits, vegetables, whole grains, and other
      healthy foods into their current meals and to exercise at least 30 minutes five days per
      week.
    


Intervention name(s): Dietary supplement containing vitamins, minerals, and herbs; Shakes with nutrients and herbs; Control dietary supplement; Isocaloric, isonitrogenous control shakes without herbs; Personal energy tracking tool
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Keywords: Overweight; Obese; Dietary Supplements; Shakes; Nutrition; Overweight and Obese Adults (BMI 25-35)
ADASUVE-Lorazepam Drug-Drug Interaction
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the safety and effects over time for giving both ADASUVE and
      lorazepam (intramuscular) compared to that of each agent given alone.
    

Detailed description: 
      The objective of this study is to compare the safety and pharmacodynamic profiles of
      concomitant administration of a single dose of ADASUVE and lorazepam (IM) compared to that of
      each agent administered alone. Respiratory pharmacodynamics will be monitored through
      recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures
      will include effects on blood pressure, heart rate, sedation and psychomotor measures of
      attention, information processing speed, reaction time, and coordination.

      Initially, 4 subjects will receive lorazepam 1 mg IM + ADASUVE 10 mg open label to validate
      the dose regimen. After the safety data are reviewed and the dose regimen confirmed, 18
      non-obese, healthy male or female volunteers between the ages of 18 and 50 will be enrolled
      in this double-blinded, double-dummy, randomized, 3-period cross-over drug interaction study.
    

Intervention name(s): Lorazepam 1 mg IM; Inhaled loxapine 10 mg; Inhaled Placebo; Placebo IM
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lorazepam 1 mg intramuscular; Inhaled Staccato loxapine 10 mg; Inhaler with no drug in it to mimic the ADASUVE inhaler; intramuscular placebo to mimic lorazepam 1 mg IM
Other intervention name(s): Ativan 1 mg IM; ADASUVE 10 mg; Staccato Placebo; Saline
Intervention MeSH terms: Lorazepam; Loxapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ADASUVE; inhaled loxapine; drug drug interaction; lorazepam; acute treatment of agitation
Blockade of Vascular Potassium Channels During Human Endotoxemia
Condition: Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Background: Activation of NO-synthase and vascular potassium (K) channels may play a role in
      the sepsis-induced attenuated sensitivity to norepinephrine. We examined whether various K
      channel blockers and NO-synthase inhibition could restore norepinephrine sensitivity during
      experimental human endotoxemia.
    


Intervention name(s): endotoxin; Potassium channel blockers: TEA, Quinin, Tolbutamide; L-NMMA
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Tolbutamide; Potassium Channel Blockers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endotoxemia; vascular potassium channels; cytokine; norepinephrine; regional blood flow,; inflammation,; ion channels,; nitric oxide synthase,; pharmacology.
Determining Responses to Two Different Vaccines in HIV and HCV Infected Individuals
Condition: HIV Infections; Hepatitis C
MeSH terms: Infections; Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      Infection with either HIV or hepatitis C virus (HCV) affects immune system responses. The
      purpose of this study is to investigate the immune responses to two different vaccine
      formulations in HIV-infected, HCV-infected, and HCV/HIV- coinfected individuals.
    

Detailed description: 
      Individuals with HCV and HIV coinfection are especially hard to treat, and as a result,
      account for a high rate of deaths each year. Because HCV and HIV share transmission routes,
      HCV/HIV coinfection is common. Liver disease has emerged as a significant cause of death in
      individuals coinfected with HCV and HIV. Currently, the mechanisms by which HCV and HIV
      interact in HCV/HIV-coinfected individuals, including how these infections affect immune
      responses, are poorly understood. Research suggests that vaccination may prevent other
      comorbidities associated with HCV/HIV coinfection; however, responses to new vaccine antigens
      have been shown to be impaired in HCV or HIV-infected individuals. The purpose of this study
      is to identify the innate and adaptive immune defects present in HCV-infected, HIV-infected,
      and HCV/HIV-coinfected individuals. This study will evaluate whether these innate and
      adaptive immune defects predict responses to HBV neoantigen in the form of both a
      diphtheria/tetanus toxoid immunization (Decavac)and a hepatitis A-hepatitis B immunization
      (Twinrix).

      This study will last approximately 24 weeks. Participants will be stratified to one of three
      arms, based on their HCV and HIV status:

        -  Arm A will enroll HCV-infected individuals who are HIV-uninfected

        -  Arm B will enroll HIV-infected individuals who are HCV-uninfected

        -  Arm C will enroll HCV/HIV-coinfected individuals

      Arms B and C will open for enrollment before Arm A. Opening of enrollment for Arm A will be
      determined by the accrual progress of Arms B and C as evaluated by the ACTG Scientific Agenda
      Steering committee.

      All participants will receive Decavac vaccination on Day 0, and a Twinrix vaccination on Days
      0, 7, and 21. Study visits will occur around Days 0, 7, and 21, and at Weeks 6, 8, 12, and
      24; all visits will include medical and medication history, blood collection, and a physical
      exam. Medication to treat HCV or HIV will not be provided by the study.
    

Intervention name(s): Twinrix; Decavac
Intervention type(s): Biological; Biological
Intervention description(s): Combined hepatitis A and hepatitis B immunization; Diphtheria and tetanus toxoid vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Treatment Experienced; Treatment Naive; Immunizations
Basal Bolus vs. Sliding Scale for Treatment of Diabetic Patients in Medical Wards
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      A comparison of two treatment approaches for hyperglycemia in diabetic patients hospitalized
      in the medical department. The first approach is called basal-bolus in which 4 insulin shots
      are given daily ( 3 short acting before meals and one long acting before bed time). The
      second approach is called sliding scale in which short acting insulin alone is given before
      meals and before bed time according to the patient's glucose values. The aim is to keep
      fasting glucose between 140-180 mg/dl.
    


Intervention name(s): Insulin, regular - act rapid; Insulin glulisine, Insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): 4 shots of regular insulin: 3 before meals and one at bedtime.; 1 shot glargine at bedtime 3 shots glulisine before meals
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine
Condition: Cocaine Abuse
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when
      administered to opioid-experienced cocaine abusers.
    

Detailed description: 
      There are no currently available pharmacologic treatments for cocaine abuse and/or dependence
      and the unmet medical need is growing. In collaboration with the National Institute on Drug
      Abuse (NIDA), Alkermes, Inc. is investigating a fixed-dose combination product consisting of
      ALKS 33 (also referred to as RDC-0313) and buprenorphine (ALKS 33-BUP) for the treatment of
      cocaine abuse and/or dependence (Grant Number R01DA031000).

      This is a randomized, double-blind, placebo-controlled, parallel design inpatient study.
      Eligibility will be established which includes responses to cocaine infusions at baseline,
      prior to study drug administration. Approximately 30 opioid-experienced cocaine abusers will
      be randomized 1:1:1 to receive study drug. Study drug will be administered once daily for 10
      consecutive days. Pharmacodynamic assessments and drug-drug interactions will be closely
      monitored during the study. Following study drug administration, subjects will receive
      cocaine infusions to evaluate the effect of treatment on the subjective effects and the PK/PD
      of cocaine. Subjects will be discharged from the clinical research unit 2 days after the last
      infusion of cocaine. Subjects will return for follow-up between 7 and 14 days after
      discharge. The full study will take subjects approximately 28 days, with 17 days of inpatient
      stay.
    

Intervention name(s): ALKS 33-BUP; ALKS 33; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sublingual administration, ALKS 33 + buprenorphine, administered once daily for 10 consecutive days.; Sublingual administration, ALKS 33 administered once daily for 10 consecutive days.; Sublingual administration, Placebo administered once daily for 10 consecutive days.
Other intervention name(s): ALKS 33-BUP: RDC-0313 + buprenorphine.; ALKS 33: RDC-0313.
Intervention MeSH terms: Buprenorphine; ALKS-33
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Opioid; Cocaine; Dependence; Abuse; Intravenous; Buprenorphine
Effects Of Plyometric Training Program On Speed And Agility In Young Cricketers
Condition: Physical Fitness
Study type: Interventional

Summary: 
      This study was to determine the effects of plyometric training program on speed and agility
      in young cricketer. There were two groups, one received plyometric training program and other
      received training training to improve speed and agility in young cricketers
    

Detailed description: 
      Plyometric training has been an effective method for the improvement of agility, sprinting,
      and jumping ability and it has also been reported to Improve running economy, joint
      stability, increased joint awareness and overall proprioception and decrease the severity of
      knee injuries. In the Plyometric exercise involves starting, stopping, and change of movement
      directions which contribute to agility development.The athletes use plyometric training
      techniques in many sports to improve explosive power and body strength. The plyometrics is a
      rapid stretch of muscle (eccentric) contraction straight away shortening (concentric)
      contraction in similar muscle tissue
    

Intervention name(s): Plyometric Training; Traditional Training
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Longitudinal Evaluation of Familial Frontotemporal Dementia Subjects
Condition: Familial Frontotemporal Dementia
MeSH terms: Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Observational

Summary: 
      This study is being done to learn more about normal thinking and behavior, mild thinking and
      behavior problems, Frontotemporal Dementia and other forms of dementia in families in which
      one or more relatives have a mutation associated with Frontotemporal Dementia.
    

Detailed description: 
      This multicenter study will enroll 300 members of familial Frontotemporal Dementia (FTD)
      families across 8 experienced FTD research centers with a known mutation in MAPT, PGRN, or
      C9ORF72 (100 mutation carriers with mild dementia or minimally symptomatic yet non-demented,
      100 asymptomatic mutation carriers, and 100 clinically normal relatives who are non-mutation
      carriers) to obtain annual assessments including T1-MRI, FLAIR, diffusion tensor imaging
      (DTI), ASL perfusion (ASLp), intrinsic connectivity functional MRI (icfMRI), MR spectroscopy
      (MRS), CSF, blood, and behavioral, neuropsychological and functional assessment, for a total
      of three assessments per participant.

      A primary goal of this study is to identify the most robust and reliable methods to track
      disease progression in familial FTD so that disease-modifying therapeutic trials can be
      designed appropriately.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Have a mutation, or be a relative of an individual with a mutation, in one of the three
        most common genes associated with Frontotemporal Dementia - microtubule associated protein
        tau (MAPT), progranulin (PGRN; also known as granulin or GRN), or chromosome 9 open reading
        frame 72 (C9ORF72).
      
Biospecimen description: 
      Blood - DNA, Plasma, Serum, Peripheral blood mononuclear cells, RNA, Cerebrospinal Fluid
    
Keywords: Frontotemporal Dementia; MAPT; PGRN; C9ORF72
Refractive Disorders and Seric Vitamin D Level in Children With Disabilities
Condition: Child, Only
MeSH terms: Refractive Errors
Study type: Observational [Patient Registry]

Summary: 
      The investigator want to determine the refractive status of 80 children with disabilities and
      of 81 healthy children from a witness group. The vitamin D level of the children will be
      dosed for making different correlations with visual acuity status.
    

Detailed description: 
      Refraction measurement will be done by the investigator in all 161 children. Visual acuity is
      checked, initial and after correction with proper correction. Vitamin D level is dosed from
      all the children in order to make correlations with the visual acuity, refractive status and
      risk for visual impairment.
    

Intervention name(s): Refraction measurement with auto-ref-keratometer Canon
Intervention type(s): Other
Intervention description(s): Refractive measurement and vitamin D level dosing
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        80 children with disabilities like ADHD, autism, Down syndrome, deafness, phocomelia and 81
        clinically healthy children
      
Keywords: disability, healthy
Liposomal Lidocaine Gel for Oral Topical Anesthesia
Condition: Anesthesia
Study type: Interventional
Phase: Phase 1

Summary: 
      This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated
      lidocaine on oral mucosa.
    

Detailed description: 
      This blinded cross-over study aimed to evaluate the efficacy of topical liposome-encapsulated
      2,5 and 5% lidocaine gel formulations on the palatal mucosa.
    

Intervention name(s): Lidocaine
Intervention type(s): Drug
Intervention description(s): 100 mg of the following formulations: Liposome-encapsulated 2,5% and 5% lidocaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.
Other intervention name(s): Topical anesthesia in the palatal mucosa
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: Lidocaine,; liposome encapsulation,; topical anesthesia,; palatal mucosa
Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects
      with Asthma
    

Detailed description: 
      This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter,
      parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo
      administration (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A
      follow-up visit was required only for subjects who had, in the opinion of the investigator, a
      clinically significant finding at Visit 6 /ET that would put the subject at risk. A final
      follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET. This
      study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by
      Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion
      Pharmaceuticals Inc.
    

Intervention name(s): Levalbuterol tartrate MDI; racemic albuterol MDI; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): levalbuterol MDI 90 mcg QID; racemic albuterol MDI 180 mcg QID; Placebo MDI QID
Other intervention name(s): Xopenex MDI
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: levalbuterol; pediatric; asthma