bioihbjkbjnl/mcl2 huggingface dataset:
The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems
Condition: Common Infant Feeding Problems
Study type: Interventional

Summary: 
      This clinical trial will determine if the formula given to infants experiencing fussiness,
      crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve
      symptoms.
    


Intervention name(s): Marketed milk-based lactose-containing infant formula; Marketed milk-based lactose-free infant formula; Marketed soy-based lactose-free infant formula
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine whether using losartan and amlodipine together will be non-inferior
      in lowering blood pressure than amlodipine alone.
    


Intervention name(s): Losartan (+) amlodipine; Placebo to match losartan/amlodipine tablets; Amlodipine camsylate; Placebo to match amlodipine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.; One tablet containing placebo, orally, once daily, for 8 weeks.; 2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.; 2 tablets containing placebo, orally, once daily, for 8 weeks.
Other intervention name(s): COZAAR XQ™
Intervention MeSH terms: Losartan; Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; Uncontrolled hypertension; High blood pressure; Uncontrolled high blood pressure; Untreated high blood pressure; Untreated hypertension; Essential hypertension
Electrical Stimulation and Expression of VEGF and NO in Diabetic Foot Ulcer
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      This study aimed to investigate the effect of low intensity cathodal direct current on the
      release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic
      foot ulceration.
    

Detailed description: 
      Twenty type 2 diabetic patients with foot ulceration and 13 age-matched healthy subjects were
      enrolled. Patients were randomly assigned to electrical stimulation (ES, n=10) or sham ES
      (placebo, n=10) groups. ES group received cathodal direct current for 1 h/day, 3 days/week,
      for 4 weeks (12 sessions). Blood sample was collected for VEGF and NO measurement in the
      first and last treatment sessions before and after intervention. Wound surface area (WSA) and
      skin temperature were measured at 1st, 6th, and 12th session.
    

Intervention name(s): Electrical Stimulation (BTL-5000 series, United Kingdom); placebo
Intervention type(s): Device; Device
Intervention description(s): Direct current ES; the intervention procedure was the same as that the ES group, but the current intensity was zero
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Relative Bioavailability of Different Oral Viramune Extended Release Formulations Compared to Viramune® Oral Suspension in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the relative bioavailability of different oral Viramune Extended Release
      (ER) formulations compared to Viramune® Immediate Release (IR) tablet
    


Intervention name(s): NVP ER 300 mg (KCR 20%) Medium Release; NVP ER 300 mg (KCR 25%) Medium Release; NVP ER 300 mg (KCR 30%) Slow Release; NVP ER 400 mg (KCR 25%) Medium Release; NVP ER 300 mg (KCR 40%) Slow Release; NVP ER 300 mg (ECR 20%) Fast Release; NVP ER 400 mg (KCR 20%) Medium Release; NVP ER 400 mg (KCR 30%) Slow Release; NVP ER 400 mg (KCR 40%) Slow Release; NVP ER 400 mg (ECR 20%) Fast Release; Nevirapine immediate release (IR) 200 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Nevirapine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
Condition: Gastric Ulcer (GU); Duodenal Ulcer (DU); Anastomotic Ulcer (AU); Non-erosive Reflux Esophagitis Disease (NERD); Reflux Esophagitis (RE); Zollinger-Ellison Syndrome
MeSH terms: Zollinger-Ellison Syndrome; Gastrinoma; Gastroesophageal Reflux; Esophagitis, Peptic; Esophagitis; Stomach Ulcer; Duodenal Ulcer; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and
      efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in
      Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are
      suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU),
      non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison
      syndrome.
    


Intervention name(s): D961H sachet 10 mg; D961H capsule 10mg; D961H capsule 20 mg
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric ulcer (GU); Duodenal ulcer (DU); Anastomotic ulcer (AU); Non-erosive reflux esophagitis disease (NERD); Reflux esophagitis (RE); Zollinger-Ellison syndrome
Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients
Condition: Constipation, Signs and Symptoms, Digestive
MeSH terms: Constipation; Signs and Symptoms, Digestive
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through
      population PK in paediatric patients with opioid induced constipation (OIC) or at risk of
      OIC.
    


Intervention name(s): Naloxegol
Intervention type(s): Drug
Intervention description(s): Opioid Antagonist
Other intervention name(s): Moventig
Intervention MeSH terms: Naloxegol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Constipation; Colonic Inertia; Dyschezia; Pharmacokinetics; Naloxegol; Paediatric; Opioids; Opioid induced constipation; OIC; Phase 1
Teen Asthma Project
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Aims of this study are:

        1. To determine the feasibility of implementing the intervention using a peer-assisted
           asthma day camp for adolescents with asthma.

        2. To determine patterns of change in knowledge, attitudes toward asthma, self-efficacy,
           perception of barriers, and self-management behaviors, asthma control and quality of
           life over time among peer leaders.

        3. To test the following hypothesis:

             -  Adolescents participating in a peer-assisted asthma camp program will report
                improved knowledge, attitudes toward asthma, self-efficacy, and self-management
                behaviors, decreased perception of barriers, and increased asthma control and
                quality of life at 3-, 6- and 9-months post-intervention compared with the
                adult-led camp group.

        4. To examine the moderating effect of personal factors (e.g., age, sex, socioeconomic
           status, race, illness status, family support) on intervention outcomes such as
           self-management behaviors, asthma control and quality of life in adolescents with
           asthma.

        5. To examine the effect of the peer-assisted camp program on self-reported health care
           utilization including emergency department visits, days of hospitalization, outpatient
           visits by comparing between baseline and 9-months post-camp data and between the
           peer-led camp and the adult-camp programs.
    


Intervention name(s): Peer-assisted asthma self-management program; Adult-led asthma self-management program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention group: An asthma self-management program (Power Breathing™) was implemented by trained peer leaders at an asthma day camp. The program consisted of 3 sessions (appx. 45-60 min/session): basic asthma education (pathophysiology, triggers); psychosocial issues of asthma; and asthma self-management (peak flow monitoring and medication). The program was delivered by trained peer leaders paired for each small group of 6-8 teens. Group activities involved discussion, strategic thinking, knowledge-testing games and role plays.; Control group: The group attended an adult-led day camp where 2 NPs and a MD offered didactic asthma education based on the Power Breathing™ program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Adolescents; Peer leader program; asthma camp; asthma control; quality of life; self-efficacy; knowledge; attitudes; barrier perceptions
Study to Assess the Pharmacodynamics/Pharmacokinetics After Repeated Dosing of D961H 10 mg and Omeprazole 10 mg in Japanese Healthy Male Subjects
Condition: Pharmacodynamics Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacodynamics (intragastric pH) after repeated
      oral administration of D961H 10 mg and omeprazole 10 mg in Japanese healthy male subjects who
      are classified by the genotype of CYP2C19 by the assessment of percentage of time with
      intragastric pH>4 during 24 hours after dose on day 5.
    


Intervention name(s): D961H; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Oral, capsule; Oral, tablet
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Healthy volunteer; Japanese males; homo-EM/hetero-EM/PM
Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The purpose of this study is to compare the reaction time (as measured by braking reaction
      time in seconds during simulated driving) under glare and no-glare conditions in subjects
      implanted with ACRYSOF® IQ intraocular lenses (IOLs) to subjects implanted with clear IOLs.
      This study will enroll subjects previously implanted with IOLs in both eyes for at least 3
      months.
    

Detailed description: 
      Subjects completed 2 visits to the investigational site.
    

Intervention name(s): Clear clip-on glasses; Blue light filter clip-on glasses; ACRYSOF® IQ IOL; Clear IOL
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Clip-on glasses with no blue light filtering properties used as a placebo; Clip-on glasses with blue light filtering properties similar to ACRYSOF® IOLs; AcrySof IQ Aspheric Natural IOL Model SN60WF with UV and blue light filtering properties, previously implanted; Clear IOL, previously implanted
Intervention MeSH terms: Methamphetamine; beta-Endorphin; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Cataract; Intraocular lens (IOL); AcrySof
Observational Study of HIV Infection in Participants of Seroconvert During Dapivirine Vaginal Ring Trials
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Observational

Summary: 
      The purpose of this trial is to determine if exposure to ARV-containing investigational
      products in IPM clinical trials will impact the natural history of HIV infection as measured
      by the virologic, immunologic and clinical outcomes of participants who become HIV-positive
      during the IPM 027 trial.
    


Intervention name(s): No Investigational Product
Intervention type(s): Drug
Intervention description(s): This study is observational in nature and no investigational product will be used.
Groups: ARV-Treated Participants, ARV-Naive Participants
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Both microbicide and placebo recipients in IPM 027 who have become HIV infected (HIV-1 or
        HIV-2) while participating in IPM 027 will be offered enrolment in IPM 007 at the exit
        visit of IPM 027, i.e. approximately 6 weeks after identification of HIV seroconversion.

        This study includes all active IPM clinical research centres that enrol participants for
        IPM microbicide trials.
      
Keywords: HIV Infections; Anti-HIV Agents; HIV-1
PREMIER: Lifestyle Interventions for Blood Pressure Control
Condition: Heart Diseases; Hypertension
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effectiveness of advice versus two multicomponent lifestyle interventions to
      control blood pressure in participants with Stage 1 hypertension or higher than optimal blood
      pressure.
    

Detailed description: 
      BACKGROUND:

      A large body of data has been collected over the years documenting that on the one hand,
      reduced sodium intake, increased physical activity, weight loss, and moderate alcohol
      ingestion (Comprehensive Intervention) have been associated with a modest reduction of both
      systolic and diastolic blood pressure in with high normal and Stage 1 hypertension. On the
      other hand, the Dietary Approaches to Stop Hypertension (DASH) study has shown that a diet
      rich in fruits, vegetables, low-fat dairy products, and decreased saturated fat, total fat,
      and cholesterol (DASH intervention) reduced both diastolic and systolic blood pressure in
      similar baseline blood pressure groups.

      DESIGN NARRATIVE:

      A multicenter study to determine the BP-lowering effects of two multi-component lifestyle
      intervention programs compared with advice only. Eight hundred and ten men and women were
      randomly assigned to one of three treatment arms: (A) advice only; (B) comprehensive
      lifestyle intervention, in which participants received an intensive behavioral intervention
      program to facilitate achieving current lifestyle recommendations for BP control (reduced
      salt intake, increased physical activity, reduced alcohol intake, and weight control or
      weight loss if needed); and (C) comprehensive lifestyle intervention plus the DASH diet, in
      which participants received a behavioral intervention program to promote the DASH dietary
      pattern in addition to the same lifestyle recommendations for BP control. Participants were
      followed for 18 months. The primary outcome variable was systolic blood pressure measured at
      six and 18 months after randomization. Other variables included diastolic blood pressure,
      dietary adherence, physical activity, and onset of hypertension over the 18 months of
      follow-up.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): diet, sodium-restricted; diet, fat-restricted; exercise; diet, reducing; alcohol drinking
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Primary purpose: Prevention
Effectiveness of Echogenic and Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block
Condition: Upper Extremity Injury Trauma
MeSH terms: Arm Injuries
Study type: Interventional

Summary: 
      In this prospective, randomized, double blinded study, the needle tip and needle shaft
      visibility of echogenic and nonechogenic needle were compared in ultrasound guided
      infraclavicular brachial plexus block. Sixty patients scheduled for upper extremity surgery
      were included in the study. Patients were randomised into two groups, group E (Echogenic) and
      group NE (Nonechogenic) with 30 subjects in each group. Under ultrasound guidance
      infraclavicular brachial plexus block was performed. In Group E, Pajunk Sonoplex echogenic
      needle was used and in Group NE, Stimuplex Braun nonechogenic needle was used. The subjective
      assessment for needle tip/shaft visibility as scored by the performer and the objective
      assessment from the recorded block procedure video were noted.
    

Detailed description: 
      The aim of the investigators study was to find out the better among the echogenic and
      nonechogenic needle in needle tip/shaft visibility and the block success rate in ultrasound
      guided infraclavicular brachial plexus block. Sixty patients were randomized into two groups,
      Group E (echogenic group) and Group NE (nonechogenic group) with thirty patients in each
      group. The ultrasound imaging of each nerve block was video recorded for later analysis.
      Recording commenced from skin puncture and stopped at the time of final needle removal (total
      block time). After each block the performer was asked to subjectively score the percentage
      time he had visualized the needle tip and needle shaft on a 5 point scale (1 = 0%-20%, 2 =
      20%-40%, 3 = 40%- 60%, 4 = 60%-80%, 5 = 80%-100%). The recorded video was later analysed by
      an investigator. An objective measurement of percentage needle tip visibility and needle
      shaft visibility was calculated for each nerve block using the formula,

      Time in view (needle tip) / total block time x 100

      Time in view (needle shaft) / total block time x 100

      The subjective assessment for needle tip/shaft visibility as scored by the performer and the
      objective assessment from the recorded block procedure video were noted. Other block
      parameters were also compared.
    

Intervention name(s): Echogenic needle - Pajunk sonoplex echogenic needle; Non Echogenic needle - Stimuplex Braun Nonechogenic needle
Intervention type(s): Device; Device
Intervention description(s): Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries; Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Effect of Darapladib on Cantharidin-Induced Inflammatory Blisters in Subjects With Type 2 Diabetes Mellitus (T2DM)
Condition: Atherosclerosis
MeSH terms: Atherosclerosis; Blister; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an exploratory, open-label, single sequence, two part study (Part A and an
      optional Part B). The aim of this study will be to assess whether systemic inhibition of
      Lipoprotein associated phospholipase A2 (Lp-PLA2) in humans, effected by 11 days of once
      daily dosing to steady state with 160 milligrams (mg) of enteric coated (EC) darapladib, will
      specifically reduce the number of macrophages and/or result in a higher proportion of M2
      macrophages in skin blisters induced by cantharidin (a chemical agent that causes blisters).
      In Part A of the study, a cohort of 8 subjects with type 2 diabetes mellitus will be
      recruited. In Part B of the study, a cohort of 8 additional healthy subjects with matching
      age (+/- 24 months) and gender to Part A may be recruited.
    


Intervention name(s): Darapladib
Intervention type(s): Drug
Intervention description(s): EC tablet with a unit dose strength of 160 mg administered once daily orally for 11 days.
Intervention MeSH terms: Darapladib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cellular accumulation; macrophage phenotype; cantharidin blister; M1/M2; inflammatory mediators; Type 2 diabetes mellitus; darapladib; cytokines
A Study of a Probiotic in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study was to assess the clinical effect of Lactobacillus sakei
      supplementation in children with atopic dermatitis.
    

Detailed description: 
      Probiotics were also shown to reduce severity of AEDS when administered to infants with early
      onset AEDS. In contrast, only a few studies have evaluated the therapeutic effectiveness of
      probiotics on the groups of older children with established AEDS. In these studies,
      administration of Lactobacillus strains to unselected children aged 1 year and over was
      associated with improvement in the clinical severity of eczema. The purpose of this study was
      to evaluate the clinical efficacy in AEDS of a newly identified probiotic strain,
      Lactobacillus sakei KCTC 10755BP, which showed the most potent inhibitory activity against S
      aureus growth among Lactobacillus species in our preliminary experiment. We administered L
      sakei to an unselected group of children aged 2 to 10 years with moderate and severe AEDS and
      evaluated the clinical outcome at the end of the intervention. In addition, we also measured
      levels of serum chemokines as activity markers for AEDS to provide a more objective evidence
      for the beneficial role of this probiotic.
    

Intervention name(s): probiotic L sakei KCTC 10755BP; microcrystalline cellulose (placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks; freeze-dried, 50,0000,0000 colony-forming units, twice daily, for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: atopic dermatitis; chemokines; probiotics
Bioequivalence Study for Metoprolol Succinate ER Tablets 50 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol
      Succinate Extended-Release Tablets 50 mg under fasting conditions
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose,
      crossover, oral bioequivalence study of Metoprolol Succinate Extended-Release tablets 50 mg
      of Dr. Reddy's Laboratories Limited,under fasting conditions
    

Intervention name(s): Metoprolol Succinate
Intervention type(s): Drug
Other intervention name(s): TOPROL-XL®
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment