bioihbjkbjnl/mcl2 huggingface dataset:
Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity
Condition: Apnea
MeSH terms: Apnea
Study type: Interventional

Summary: 
      Investigators hypothesized that the timing of caffeine administration in either prophylaxis
      or treatment of apnea of prematurity will affect the apnea response to caffeine
    

Detailed description: 
      It will be a randomized control trial, patients will be randomly assigned to receive caffeine
      in a loading dose of 20 mg/kg (equivalent to 10 mg/kg caffeine base) and a maintenance dose
      of 10 mg/kg/day (equivalent to 5 mg/kg caffeine base) either as a prophylaxis group (1) or
      therapeutic group (2). Prophylactic caffeine (group 1) will be defined as caffeine prescribed
      for preterm infants within the first 72 hours of life prior to manifest apnea , therapeutic
      caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or
      after the first 72 hours of life .

      Preparation and administration of caffeine will be performed by a Neonatal intensive care
      unit (NICU) nurse.

      Statistical Evaluation:

      Statistical analyses will be performed with the Statistical Package for Social Sciences-SPSS
      version 16 software (SPSS Inc, Chicago, Illinois). For categorical variables, the X2 test
      will be used. For group comparisons, the Student T test will be used in normal distribution
      and the Mann-Whitney U test will be used in case of abnormal distribution.

      For repeating measurements, variance analyses and Friedman variance analyses will be used.
      For descriptive statistics, percent, minimum-maximum-median, mean, and standard deviation
      will be used in accordance with the type and distribution of the variable. A P value <.05 was
      considered statistically significant. Informed consent will be obtained from parents, and the
      study will be approved by the local ethical committee.
    

Intervention name(s): Prophylactic caffeine citrate; Therapeutic caffeine citrate
Intervention type(s): Drug; Drug
Intervention description(s): Prophylactic caffeine (group1) will be defined as caffeine prescribed for preterm infant within the first 72 hours of life prior to manifest apnea . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) .; Therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base).
Intervention MeSH terms: Caffeine; Caffeine citrate; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: caffeine; apnea; preterm infant
Lubiprostone for Children With Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is for children with constipation.

      Children who completed 3 months of treatment in the earlier study (NCT02042183):

        -  were invited to participate

        -  will receive lubiprostone for 9 more months

        -  will see if lubiprostone safely relieves their constipation if taken for a whole year
    


Intervention name(s): Lubiprostone
Intervention type(s): Drug
Intervention description(s): 12 or 24 mcg soft capsules for oral administration
Other intervention name(s): Amitiza®
Intervention MeSH terms: Lubiprostone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Efficacy of Lithium Carbonate in Spinal Cord Injury Patients With Neuropathic Pain
Condition: Neuropathic Pain; Neuralgia; Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Neuralgia; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of
      patients with spinal cord injury.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blinded trial. Sixty spinal cord injured
      subjects with neuropathic pain will be randomized into two groups. The subject in the
      Treatment Group will receive lithium carbonate tablet, while the Control Group will receive
      placebo tablet. Neither the subjects nor the physicians know which group the subjects are
      allocated.

      Each subject will receive 6 weeks of oral lithium carbonate or placebo. In the Treatment
      Group, the dose will be adjusted according to the serum lithium level. While in the Control
      Group, the dose will be adjusted based on the dummy serum level report.

      The outcome will be assessed during visits at 1 week, 2 weeks, 6 weeks and 12 weeks, and a
      phone call follow-up at 24 weeks from the start of the medication. The primary outcome
      measure is the severity level of pain. The efficacy and safety will be analyzed by comparing
      the results of the Treatment Group with those of the Control Group
    

Intervention name(s): Lithium Carbonate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 250 mg/tablet, 6 weeks course of oral administration; placebo tablet, 6 week course of oral administration
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Chronic HIV Infection and Aging in NeuroAIDS (CHAIN)
Condition: HIV; Aging
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The purpose of this study is to find the best tests to use to investigate the differences
      between older and younger people with HIV disease. Test to be included will measures of
      memory, learning, activity levels, sleep patterns, emotional well-being and sexual health.
    

Detailed description: 
      Advances in the treatment of chronic HIV disease over the last 20 years have resulted in
      dramatic declines in morbidity and mortality. However, emerging data suggest that chronically
      infected patients may be aging prematurely, and/or experience increased incidence of
      age-related conditions. These phenomena are poorly understood. The overall goal of the CHAIN
      project is to support the expansion of innovative research on the effects of chronic HIV
      infection, co-morbidities, and aging on the central nervous system (CNS). We propose the
      initiation of a clinical portion to better understand the nature of the aging process in
      HIV-infected patients, with an emphasis on brain disease. This is a pilot, feasibility study
      to inform the design of a larger, prospective cohort study.

      We plan to enroll 20 older HIV-infected patients (more than 50 years old) and 20 younger
      controls (20-40 years old), matched for gender and race/ethnicity. Participants will undergo
      a series of tests, at one comprehensive assessment. Demographic and medical history data will
      be abstracted from the medical record. Each participant will undergo a medical history and
      physical examination, and a battery of tests designed to evaluate neuropsychological
      function, activity, sleep patterns, frailty, emotional well-being and sexual health. These
      will consist of self-administered questionnaires and neuropsychological tests, as detailed in
      the Methods section. Innovative measures will be included such as an activity monitor worn by
      participants, and a Wii balance board to assess standing balance. Participants will be asked
      to keep a diary and wear the activity monitoring device for one month. Plasma and serum
      samples will be collected on one occasion for future testing of potential biomarkers.
    

Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        University of Nebraska Medical Center HIV Clinic
      
Biospecimen description: 
      plasma
    
Keywords: HIV; Aging; Neuropsychological function; Activity; Sleep patterns; Frailty; Emotional well-being; Sexual health
Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH
Condition: THCCOOH; Pharmacokinetics; Metabolism; Cannabis
Study type: Observational

Summary: 
      A study on the fate and elimination of 11-Nor-Delta9-carboxy-9-tetrahydrocannabinol was up to
      now not conducted, except of one single experiment in which (lacking) psychopharmacological
      activity was tested after intravenous infusion of 20 mg in a human individual. In this study,
      however, the authors did not trace the above questions due to analytical and methodological
      deficits.

      Aim of the study is to determine the pharmacokinetics of THCCOOH and THCCOOH-Glu after
      intravenous ad-ministration of 5 mg THCCOOH in healthy individuals
    

Detailed description: 
      To determine the pharmacokinetics of THCCOOH after intravenous administration of THCCOOH (5
      mg) and its formed glucuronide in healthy individuals in order to improve the possibilities
      for the assessment of unfitness to drive. For these purposes the following criteria will be
      studied:

      THCCOOH

        -  Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma
           concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)

        -  Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution of (Vc) Formed
           THCCOOH-glu

        -  Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma
           concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)

        -  Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution (Vc)
    

Time perspective: Prospective
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
Condition: Candidiasis, Vulvovaginal
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the novel oral agent VT-1161 is safe and
      effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast
      infection). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal
      growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the
      fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole
      antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this
      results in many of the side effects associated with the azole antifungals. The safety profile
      of the class similarly limits use in chronic treatment of non-life-threatening fungal
      infections. VT-1161 has been design to be safer and more active against the fungal species
      typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).
    


Intervention name(s): VT-1161; Fluconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to investigate safety and tolerability of single and multiple ascending
      inhaled doses of AZD4818 in healthy Japanese male volunteers.
    


Intervention name(s): AZD4818; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Phase I; Japan; Japanese; inhalation
"Beverage Hydration Index" of Commercial Therapeutic Beverages
Condition: Healthy
Study type: Interventional

Summary: 
      The "beverage hydration index" (BHI) assesses the hydration potential of any consumable fluid
      relative to water. The BHI is a relatively new metric. Our purpose was to assess the BHI of
      beverages never previously tested, including an amino acid-based oral rehydration solution
      (AA-ORS), a glucose-containing ORS (G-ORS) and a sports drink (SD) compared to water
      (control).
    

Detailed description: 
      The "Beverage Hydration Index" (BHI) was created to assess the degree to which beverages
      "hydrate", by measuring fluid retention after ingesting a 1 liter bolus and comparing it to
      water. Drinks with carbohydrates and electrolytes would traditionally be expected to score
      higher on the BHI due to glucose-sodium cotransport at the gut and osmolality approaching
      isotonicity with blood. One recent study reported that an oral rehydration solution (ORS)
      scored better than water, but a "sports drink" did not. No "optimal" BHI beverage composition
      has been described, nor has an optimal osmolality. Recently, a hypotonic amino acid-based
      rehydration beverage was developed to take advantage of amino acid-sodium cotransport, thus
      obviating the need for carbohydrate. However, the BHI of this beverage has not yet been
      assessed. The purpose of this investigation was to assess the hydration potential of this
      novel beverage in comparison to a commercially available carbohydrate-containing sports drink
      and oral rehydration solution.
    

Intervention name(s): enterade; Pedialyte; Gatorade; Water
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Subjects will consume enterade, which is an amino acid-based oral rehydration solution.; Subjects will consume Pedialyte; Subjects will consume Gatorade; Subjects will consume water as the control beverage
Intervention model: Single Group Assignment
Intervention model description: Repeated-measures design with generalized latin square arrangement. Each participant will complete 4 separate trials.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: fluid balance; dehydration; rehydration; electrolytes; urine
Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level in Patients With Erosive Oral Lichen Planus
Condition: Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional

Summary: 
      Oral lichen planus (OLP) is a chronic inflammatory disease affecting the skin, mucous
      membranes,s and rarely scalp and nails. It is a T-cell-mediated autoimmune disease.
      Traditional treatment for OLP is topical steroids commonly used to treat mild to moderately
      symptomatic lesions. Recent treatment modalities for oral lichen planus include
      micronutrients such as antioxidants including vitamin E that modify the immune system
      function. The aim of this study is to evaluate the efficacy of adjunctive oral systemic
      vitamin E therapy on salivary nitric oxide levels in patients with erosive oral lichen
      planus.
    


Intervention name(s): Topical corticosteroid and Vitamin E; Topical corticosteroid
Intervention type(s): Drug; Drug
Intervention description(s): 26 patients who will administrate topical corticosteroid: triamcinolone acetonide 1% oral gel "Kenacort-A Orabase" * three times daily for 8 weeks applied after meals and at night with avoidance of foods and drinks for 30 minutes after the application. In addition to one capsule of 400 mg oral systemic vitamin E supplement* will be prescribed once daily at the morning; 26 patients will administrate topical corticosteroid: triamcinolone acetonide 1% oral gel "Kenacort-A Orabase" three times daily for 8 week that will be applied after meals and at night with avoidance of foods and drinks for 30 minutes after the application
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effectiveness of PACE Label on Reducing Food Consumption and Increasing Physical Activity Levels
Condition: Health Behavior
Study type: Interventional

Summary: 
      Background: More people are at the risk of chronic disease as the prevalence of obesity
      increases. It is therefore essential to find ways of helping consumers to make a lower
      calorie food choice. Current evidence indicates that current food labelling is changing food
      choices and consumption, but it is of limited effectiveness. Purpose: The purpose of this
      study is to assess the efficacy of physical activity calorie equivalent (PACE) food labelling
      on food selection and consumption using a randomised experimental design in pop-up café.
      Method: This study as a randomised controlled experimental trial (RCT) was conducted in a
      research kitchen at Loughborough University. Participants were blinded to the exact purpose
      of the study and randomised to either exposure to PACE labelling plus calorie food labelling
      or calorie labelling only and asked to select food/drinks for their consumption, in the
      pop-up café up to a maximum value cost of £10. The study outcomes were the amount of money
      spent, the number of calories selected, and the amount of food consumed after exposure to the
      two different types of food labels.
    


Intervention name(s): PACE label
Intervention type(s): Behavioral
Intervention description(s): There were 34 food and drinks choices available for consumption in the pop up café. The labels were displayed next to the food/drink item in the pop up café. The food items were kept in the same position for each participant kitchen to simulate the café environment. Then researchers changed the labels on the display according to the randomisation allocation of each participant. After randomsation participants were informed that they have £10 to spend in the pop-up café and that they could eat the food they selected in a private social eating room.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, use different ways to
      stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the
      growth of tumor cells by blocking the enzymes necessary for their growth.

      PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed disodium
      in treating young patients with recurrent solid tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of pemetrexed disodium in children and adolescents
           with refractory solid tumors.

        -  Determine the dose-limiting toxic effects of this drug in these patients.

        -  Determine the pharmacokinetics of this drug in these patients.

      Secondary

        -  Determine, preliminarily, the antitumor activity of this drug in these patients.

        -  Correlate the presence of the C677T polymorphism of the methylenetetrahydrolate
           reductase gene, the presence of a polymorphism in the enhancer region of the thymidylate
           synthase (TS) gene promoter (2R and 3R tandem repeats), the presence of a polymorphism
           within one of those repeats, and the presence of a functional polymorphism in the
           3'-untranslated region with toxicity in patients treated with this drug.

        -  Correlate homocysteine and methylmalonic acid levels at study entry with toxicity in
           patients treated with this drug.

        -  Correlate various gene expression profiles with response in patients treated with this
           drug.

      OUTLINE: This is a dose-escalation study.

      Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21
      days in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of pemetrexed disodium until the maximum
      tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
      of 3 or 2 of 6 patients experience dose-limiting toxicity.

      PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 1 year.
    

Intervention name(s): pemetrexed disodium
Intervention type(s): Drug
Intervention MeSH terms: Pemetrexed
Primary purpose: Treatment
Keywords: unspecified childhood solid tumor, protocol specific
Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease
Condition: Fatty Liver
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Moderate exercise with a low fat and/or a moderate fat with low processed carbohydrate diet
      will have a greater effect on slowing disease progression and reversing hepatic steatosis
      and/or necro-inflammation in the liver of adult patients with NAFLD and NASH when compared to
      a regular healthy diet alone.
    


Intervention name(s): Mod Fat/Low Processed Carb Diet and Moderate Exercise; Low Fat Diet and Moderate Exercise; Moderate Exercise Only
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Follow a moderate fat with low processed carbohydrate diet with moderate exercise at the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks); Follow a low fat diet along with moderate exercise at the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks); No special dietary meal plan. Moderate exercise in the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
Other intervention name(s): Low Carb / Mod Fat; Low Fat; Mod exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NAFLD; NASH