bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to evaluate the effect of selexipag on the physical
      activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using
      a wearable wrist device (actigraph). The actigraph will collect data on daily life physical
      activity in the patient's real environment. In addition, the PAH symptoms and their impacts
      will be assessed by using an electronic patient reported outcome measure in the patient's
      real environment. Patients will be assigned randomly to either selexipag or placebo.
    

Detailed description: 
      This study is designed as exploratory with the purpose to generate hypotheses on new
      endpoints
    

Intervention name(s): Selexipag; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablets for oral use; one tablet (200 mcg) to eight tablets (1600 mcg) are administered depending on the individual tolerability.; Matching film coated tablets
Other intervention name(s): ACT-293987; Uptravi
Intervention MeSH terms: Selexipag
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: daily life; physical activity; actigraphy; PAH-SYMPACT
Time-Effect of Montelukast Protection
Condition: Exercise-Induced Asthma; Asthma
MeSH terms: Asthma; Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to verify MNT time of onset of protection against EIB in asthmatic
      children by evaluating different time intervals between dosing and challenge, after a
      single-dose and after three days of once a day MNT administration.
    

Detailed description: 
      Within few days after a baseline exercise challenge, children was randomized to a double
      blind, placebo-controlled, three day doses, crossover study design. In practice each eligible
      patient was randomized by a computer-generated schedule to receive in sequence double-blind
      treatments with placebo or MNT (5 mg). Patients in sequence 1 received MNT, then crossed over
      to matching placebo; vice versa the case was for patients in sequence 2. Placebo and active
      treatments were separated by a 7-10 day wash-out period. Each child was assigned to one out
      of seven groups in order to perform the exercise challenge at different time intervals from
      drug administration which occurred always at 8.00 A.M. On day one the challenge was performed
      in the different groups 1, 2, 3, 4, 5, 6, and 8 hours after drug administration,
      respectively. Then treatment was continued as a single day dose for three consecutive days
      and a third challenge was then performed at the same time of the day.
    

Intervention name(s): Montelukast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast 5 mg; capsules of matching placebo
Other intervention name(s): Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; exercise-induced bronchoconstriction; montelukast; clinical protection; children; time effect
The Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni in Patients With Type II Diabetes Mellitus
Condition: Benefits of a Capsules of Moringa Oleifera and Stevia Rebaudiana Bertoni in Patients With Type 2 Diabetes Mellitus Before and After 45 Days of add-on Therapy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study was the evaluation of cardiovascular and renal benefits of moringa
      oleifera and stevia rebaudiana Bertoni in patients with type 2 diabetes mellitus before and
      after 8 weeks of add-on therapy.
    

Detailed description: 
      The investigators performed a non-randomized single-arm clinical trial with a before and
      after design, carried out from November 2016 and May 2017.

      Intervention consisted of the administration of a daily consummation of 425 ml of drink
      containing the extracts of 1,38mg of leaves extracts of moringa oleifera and 23,46 mg of
      stevia rebaudiana Bertoni leaves extracts lasting 45 days. Before and after intervention, the
      following were done by the participants: bioelectrical impedance analysis (BIA), blood
      pressure measurements, fasting blood sugar, HbA1c, lipid profiles, liver function tests,
      kidney function tests, urinary excretion of albumin tests and full blood counts. These were
      followed by morphological workup including Electrocardiograms (ECGs), transthoracic heart
      ultrasounds and Ambulatory Blood Pressure Measurements (ABPM), also done before and after
      intervention.

      Clinical evaluation with fasting blood sugar control, blood pressure controls and urinary
      excretion albumin tests were done for safety purposes.
    

Intervention name(s): MOROLSTEVER1
Intervention type(s): Dietary Supplement
Intervention description(s): The intervention consisted of a daily consummation of 425 ml of drink containing the extracts of 1,38mg of leaves extracts of moringa oleifera and 23,46 mg of stevia rebaudiana Bertoni leaves extracts lasting 45 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diastolic function; Blood pressure profile; moringa oleifera; Stevia rebaudiana bertoni; Diabetes mellitus
Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure.
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine whether transendocardial delivery of
      allogeneic human bone marrow-derived mesenchymal precursor cells (MPCs [rexlemestrocel-L]) is
      effective in the treatment of chronic heart failure (HF) due to left ventricular (LV)
      systolic dysfunction.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy and safety of a single transendocardial
      delivery in the cardiac catheterization laboratory of human bone marrow-derived allogeneic
      MPCs (rexlemestrocel-L) for improvement in clinical outcomes (heart failure major adverse
      cardiac events [HF-MACE]), preventing further adverse cardiac remodeling (left ventricular
      end systolic volume [LVESV] and left ventricular end-diastolic volume [LVEDV]), and
      increasing exercise capacity (six-minute walking test [6MWT]) in patients with chronic HF due
      to LV systolic dysfunction of either ischemic or nonischemic etiology who have received
      optimal medical/revascularization therapy.
    

Intervention name(s): Allogeneic Mesenchymal Precursor Cells (MPCs); Sham Comparator
Intervention type(s): Biological; Other
Intervention description(s): Rexlemestrocel-L consists of human bone marrow-derived allogeneic MPCs isolated from bone mononuclear cells with anti-STRO-3 antibodies, expanded ex vivo, and cryopreserved; The sham procedure will be staged to script and will not include actual cardiac mapping or delivery of rexlemestrocel-L.
Other intervention name(s): MPCs; rexlemestrocel-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Heart Failure; CHF; Left Ventricular Systolic Dysfunction; Ischemic Heart Failure; Nonischemic Heart Failure; Stem Cells; Allogeneic Mesenchymal Precursor Cells
A Clinical Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery.
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with
      placebo and morphine in patients with acute postoperative pain following abdominal surgery
    


Intervention name(s): SHR8554 Injection; SHR8554 Injection; Placebo; Morphine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): SHR8554 Injection; high dose; SHR8554 Injection; low dose; Saline Solution; Morphine
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Torrent Pharmaceutical Ltd's Esomeprazole Magnesium Delayed Release Capsules
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Delayed Release
      Capsule 1 × 40 mg and Nexium 1× 40 mg of AastraZeneca LP, USA. Dosing periods of studies were
      separated by a washout period of 7 days.
    

Detailed description: 
      An Open Label, Randomized, 2 -Period, 2-Treatment, 2 Sequence, Crossover, Single-Dose
      Bioequivalence Study of Esomeprazole Delayed Release Capsule 40 mg [Test Formulation, Torrent
      Pharmaceutical Ltd., India]Versus Nexium 40 mg Delayed Release Capsule containing
      Esomeprazole 40 mg. [Reference Formulation, AastraZeneca LP, USA] in Healthy Human Volunteers
      Under Fed Conditions.
    

Intervention name(s): Nexium 40 mg DR Capsules of AstraZeneca LP, USA; Torrent's Esomeprazole Magnesium DR Capsules 40 mg
Intervention type(s): Drug; Drug
Intervention description(s): oral, cross over; oral, cross over
Other intervention name(s): esomeprazole magnesium delayed release capsules; esomeprazole magnesium delayed release capsules
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The disposition of a number of drugs has been reported to be altered in patients with Cystic
      Fibrosis (CF). Changes in pharmacokinetic parameters observed included increased volumes of
      distribution and increased clearance of renally eliminated drugs. The purpose of this this
      study is to characterize the pharmacokinetics of IV lansoprazole and its metabolites in
      normal healthy children and children with Cystic Fibrosis (CF) ages 2 to < 10 years. It is
      suspected that children with CF will have a more rapid clearance as compared to healthy
      children.
    

Detailed description: 
      Cystic fibrosis (CF) impacts 1:2500 Caucasian newborns and results from a defect in the
      cystic fibrosis transmembrane conductance regulator chloride channel (CFTR) responsible for
      electrolyte regulation. Between 25 to 81% of the CF population have gastro-esophageal reflux
      disease (GERD), and proton pump inhibitors (PPIs) are frequently prescribed for this
      condition. Moreover, PPIs are commonly used in patients with CF to allow for better gastric
      acid stabilization so that pancreatic enzyme efficacy is optimized and nutritional status is
      improved. Lansoprazole is a PPI that is widely used for acid-related disorders including
      GERD.

      The disposition of a number of drugs has been reported to be altered in CF. Changes in
      pharmacokinetic parameters observed in patients with CF include increased volumes of
      distribution and increased clearance of renally eliminated drugs. To date, the
      pharmacokinetics of PPIs in patients with CF have not been characterized.

      This study is a pilot study to evaluate and compare the pharmacokinetics of a single dose of
      IV lansoprazole in CF and normal children 2 to < 10 years of age. A goal of 12 evaluable
      subjects ranging from 2 to < 10 years of age including both males and females with CF ∆F508
      genotype will be recruited from CF clinic or inpatient. As a comparison group, six evaluable
      subjects who are normal, healthy children of similar demographic profile (age, gender, and
      race) will be recruited.

      After informed consent/assent is obtained, screening procedures will be completed within 30
      days of study participation. The pre-study screen includes an age-appropriate physical exam,
      medical history (current medication/herbal use), vital signs (non-crying sitting blood
      pressure and heart rate), height, weight, AST, ALT, and CBC. Subjects will be studied during
      a current hospitalization or scheduled for an approximately 12-hour study visit.
    

Intervention name(s): Lansoprazole
Intervention type(s): Drug
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis
First Clinical Study of the Safety and Blood Levels of a Human Monoclonal Antibody (2217LS) Against Lyme Disease Bacteria in Healthy People
Condition: Lyme Disease
MeSH terms: Lyme Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a research study of the investigational drug 2217LS in healthy volunteers.
      Investigational means 2217LS is a new drug that has not been approved for the treatment of
      any disease. 2217LS is human antibody designed to provide protection from Lyme disease. Lyme
      disease is a disease carried by infected ticks and can cause the infection to spread to the
      joints, heart and nervous system in humans.

      This is the first time 2217LS will be given to humans. This is not a study of how well 2217LS
      works against Lyme disease. The only purposes of this study are to: 1) Learn about the safety
      and tolerability of a subcutaneous (SC [under the skin]) injection of 2217LS when
      administered to healthy volunteers. 2) Find out how much 2217LS is in the blood of healthy
      volunteers after receiving 2217LS SC.

      In this study, groups of healthy volunteers will be given different doses of 2217LS by SC
      injection. Volunteers will stay in the study unit for a total of 4 overnights. The planned
      duration of participation is up to 14 months. Study personnel will monitor their safety using
      standard procedures like physical examinations, electrocardiograms, questions about possible
      side effects, blood and urine tests. The amount of 2217LS in their blood will also be
      measured.
    


Intervention name(s): 2217LS; 0.9% Sodium Chloride (NaCl)
Intervention type(s): Biological; Other
Intervention description(s): Fully Human Monoclonal Antibody; Subcutaneous injection
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized, partial-blind, placebo controlled, sequential, dose escalation study, consisting of four cohorts of 10 subjects. Each cohort will have a sentinel group consisting of 2 subjects randomized 1:1 to receive 2217LS or placebo. Sentinel subjects will be dosed first. If judged safe and well tolerated by the Principal Investigator (PI) and if the stopping rules have not been met, the remaining 8 subjects in the cohort will be randomized 7:1 to 2217LS or placebo, respectively and dosed no less than 24 hours after dosing of sentinel subjects has been completed.
For each cohort, safety and pharmacokinetic (PK) data will be reviewed by the PI, Independent Medical Monitor (IMM) and Sponsor prior to dosing the next cohort. A minimum of 7 days of safety data and available PK data from a minimum of 8 subjects from the preceding cohort must be reviewed. Dosing of the next cohort may proceed upon agreement between the PI, IMM and Sponsor, if the stopping rules have not been met.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: LYME; Lyme bacteria; Borrelia burgdorferi (B. burgdorferi); Human Monoclonal Antibody; Outer surface protein A (OspA)
Sun Protection Factor Assay
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987517
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-046)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HDL Lipidomic, Proteomic and Functional Changes in Women After Eating Eggs
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The objective of this randomized, single blinded cross-over study is to investigate effects
      of daily egg versus yolk-free egg substitute consumption on High Density Lipoprotein (HDL)
      composition and function in a population of overweight and obese postmenopausal women.
    

Detailed description: 
      The investigators hypothesize that after 4 weeks of daily consumption of whole egg versus
      yolk-free egg will result in differences in the HDL composition and profile of lipids and
      proteins (lipidome and proteome), which will be associated with changes in HDL functionality.
      It is further hypothesized that it will be possible to discriminate between responders and
      non-responders to eggs in terms of increasing both apolipoprotein A-1 (ApoA-I) content in the
      plasma, corresponding with more protective HDL particles; and increasing HDL functionality
      (cholesterol efflux and anti-oxidant capacity).

      Subjects will consume an egg free diet during study protocols, except for the egg meal
      provided by the study. The study is comprised of two 4-week feeding periods with a 4-week
      washout between testing periods. While on the study, subjects will consume the equivalent of
      two eggs for breakfast, either whole egg or yolk-free egg. Following a 2-week low-egg lead-in
      period, subjects will be randomly selected to start on either arm and cross over to the other
      arm after the 4-week washout period.

      Measured results will be compared between the baseline and the 4-week end point for each arm.
      Additional comparisons may be made between 4-week endpoints.
    

Intervention name(s): Whole egg; Yolk-free egg
Intervention type(s): Other; Other
Intervention description(s): Subjects will be provided with the equivalent of 2 whole eggs daily.; Subjects will be provided with the equivalent of 2 yolk-free eggs daily.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls
Condition: Cervical Intraepithelial Neoplasia; Cervical Cancer; Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection
MeSH terms: Persistent Infection; Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen
      Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the
      immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in
      girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to the
      standard 3-dose schedule (0,1,6 months). Meanwhile, this study tries to compare the
      difference of safety and immunogenicity among different schedules (0-6m vs 0-1-6m).
    

Detailed description: 
      Totally 750 healthy girls of 9-17 years and 225 healthy young women of 18-26 years were
      enrolled. The subjects of 9-14 years will be stratified into 2 subset. Subjects in each
      subsets will be randomly assigned into the standard 0-1-6m schedule group or an alternative
      0-6m group. All subjects of 15-26 years of age will receive the standard 0-1-6m schedule.
      Participants were actively monitored for adverse events for 1 month after each injection.
      Severe adverse events during the trial were followed up. Serum samples from all the subjects
      would be collected on day 0, 6m, 7m to evaluate the immunogenicity.
    

Intervention name(s): 3 doses of HPV 16/18 bivalent vaccine; 2 doses of HPV 16/18 bivalent vaccine
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants would receive 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months); Participants would receive 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human Papilloma Virus 16; Human Papilloma Virus 18; vaccine; adolescent girl; bridging trial; non-inferiority
Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, controlled trial studying the effects of various antimicrobial
      treatments on the intestinal microbiome of small children. The participating children with
      acute otitis media are treated wither with amoxicillin, amoxicillin-clavulanate or without
      antibiotics. The children with allergy to amoxicillin receive a course of macrolide and they
      will be monitored as a separate group. The main outcomes of this trial are the changes in the
      intestinal microbiome after the treatment.
    

Detailed description: 
      Antimicrobial treatment of acute otitis media has been proven efficacious in children. It has
      been suggested that antimicrobial treatment makes a lot of harm to intestinal microbiome and
      may thus have effects on the child's health and wellbeing. However, data on these changes and
      their magnitude is scanty. This is a randomized, controlled trial studying the effects of
      various antimicrobial treatments on the intestinal microbiome of small children. The
      participating children with acute otitis media are treated wither with amoxicillin,
      amoxicillin-clavulanate or without antibiotics. The children with allergy to amoxicillin
      receive a course of macrolide and they will be monitored as a separate group. The main
      outcomes of this trial are the changes in the intestinal microbiome after the treatment.
    

Intervention name(s): Amoxicillin; Amoxicillin-Potassium Clavulanate; Macrolide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The children with acute otitis media will be treated with amoxixillin mixture, 100mg/ml, 40mg/kg/d, divided to two daily doses for 7 days.; The children with acute otitis media will be treated with amoxixillin-clavulanate mixture, 80mg/ml, 45mg/kg/d, divided to two daily doses for 7 days.; The children with acute otitis media with a know allergy to amoxicillin or amoxicillin-clavulanate will be treated with macrolide and monitored separately
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: children; intestinal microbiome; microbiota; antimicrobial course; amoxicillin; amoxicillin-clavulanate; macrolide