bioihbjkbjnl/mcl2 huggingface dataset:
Kangaroo Care and Premature Infant Sleep
Condition: Premature Birth of Newborn
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      90 preterm infants were randomly assigned to kangaroo care (skin-to-=skin, chest-to-chest)
      group (n=50) or control (remained in incubator, prone (n=40) for a pretest period of 2- 3
      hours, then fed, then KC group was placed in KC and control group remained in incubator for a
      2-3 hr test period. EEG measures of sleep, HR, and RR were taken. .
    

Detailed description: 
      The neonatal intensive care unit (NICU) environment is not conducive to sleep, and infant
      sleep in incubators is fragmented. Sleep contributes to brain maturation so interventions to
      foster sleep are needed. During Kangaroo Care (KC) behavioral indicators of Quiet Sleep have
      been observed but, not confirmed by objective electroencephalographic (EEG) analysis.The
      purpose was to determine the effects of Kangaroo Care (KC) on EEG-based sleep using Nihon
      Koden polysomnography and cardiorespiratory patterns by comparing KC sleep to incubator
      sleep.. A randomized controlled study with 90 preterms (KC = 50; control = 40) in which KC
      infants received 2-3 hours of KC between feeds after a comparable pretest period in an
      incubator and control infants remained in an incubator during the 2-3 hour pretest and test
      periods. In the incubator infants were inclined, prone, and nested; in KC infants were
      inclined, prone, and chest-to-chest underneath a blanket. The medically stable preterm
      infants were a mean 32 weeks postmenstrual age.
    

Intervention name(s): Kangaroo Care
Intervention type(s): Other
Intervention description(s): skin-to-skin, chest-to-chest placement of diaper clad preterm infant up against his mother's chest and covered by a receiving blanket folded into fourths for 2-3 hours from one feeding to the next.
Other intervention name(s): skin-to-skin contact
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: kangaroo care; sleep; heart rate; respiratory rate; preterm infant
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-56136379 in Healthy Japanese Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics
      (PK) of JNJ-56136379 in healthy Japanese adult participants following oral administration of
      single doses from 25 milligram (mg) up to 600 mg, in fasted conditions.
    


Intervention name(s): JNJ-56136379; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive a single oral dose (tablets) of JNJ-56136379 on Day 1.; Participants will receive matching placebo tablets on Day 1.
Intervention MeSH terms: JNJ-56136379
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
SENSIMED Triggerfish Discomfort During IOP Monitoring
Condition: Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring
      with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens
    


Intervention name(s): SENSIMED Triggerfish
Intervention type(s): Device
Intervention description(s): Ocular Telemetry Sensor for IOP monitoring
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy subjects and glaucoma patients
Effects of Grapefruit or Grapefruit Juice on Anthropometry, Dietary Intakes, Appetite, and Metabolic Profile in Overweight and Obese Young and Middle-Aged Adults
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This trial examines the effects of grapefruit or grapefruit juice on anthropometry, dietary
      intakes, appetite, and metabolic profile in overweight and obese young and middle-aged
      adults.
    


Intervention name(s): diet (grapefruit or grapefruit juice)
Intervention type(s): Behavioral
Intervention description(s): weight loss diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: obesity; diet; weight loss; metabolic syndrome
A Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy Subjects
Condition: Healthy Volunteers
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary
      purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after 2
      weeks of dosing of PF-06427878 in overweight-obese, otherwise healthy adult subjects.
    


Intervention name(s): Placebo; PF-06427878
Intervention type(s): Drug; Drug
Intervention description(s): Placebo as suspension administered every 8 hours, with food; 500 mg suspension administered every 8 hours, with food
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Hyperlipidemia
Safety Study of LY3041658 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety of LY3041658 in healthy
      participants, including first generation Japanese. The study will also investigate how the
      drug is processed and affects key immune cells. Study participation will last 4 months.

      Protocol amended in January, 2016 to include first generation Japanese participants.
    


Intervention name(s): LY3041658 (SC); LY3041658 (IV); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC; Administered as slow IV infusion; Administered as slow IV infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: antibody; autoimmune
Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 4

Summary: 
      An open-label, drug-drug interaction study with TPOXX and phosphate binders.
    

Detailed description: 
      A postmarketing open-label, 5 period crossover, drug-drug interaction study of orally
      administered TPOXX when coadministered with 4 different phosphate binders in healthy adult
      subjects.
    

Intervention name(s): TPOXX
Intervention type(s): Drug
Intervention description(s): oral antiviral and phosphate binders
Other intervention name(s): sevelamer carbonate oral tablet; sucroferric oxyhydroxide chewable tablet; calcium acetate oral tablet; lanthanum carbonate chewable tablet; TPOXX oral tablet
Intervention MeSH terms: Tecovirimat; Sevelamer; Calcium acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 5 period crossover
Masking: None (Open Label)
Primary purpose: Other
The Genetics of Evoked Responses to Niacin and Endotoxemia: The GENE Study
Condition: Healthy Volunteers
MeSH terms: Endotoxemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine genetic factors that affect responses to niacin
      therapy and endotoxemia in healthy volunteers.
    

Detailed description: 
      Niacin is a vitamin that has beneficial effects on cholesterol (a type of fat in the blood)
      when used in high doses. Different people respond differently to cholesterol lowering doses
      of niacin, some people have a side effect termed flushing (similar to a hot flash) while
      others do not and some people have more pronounced effects on cholesterol. Endotoxin or
      lipopolysaccharide (LPS) is a small part of bacteria (that is no longer living) that can
      cause many of the effects similar to bacterial infections in humans. However, it can be
      administered in very small amounts to produce a mild inflammatory response much the same as a
      'flu-like" illness. Within 1 ½ -3 hours after giving LPS by vein, a response consisting of
      fever, chills, headache, nausea and vomiting and generalized aches and pains will occur which
      lasts up to 6-8 hours. In addition to the flu like symptoms, the inflammation causes changes
      in cholesterol, triglycerides and glucose clearance. Different people respond differently to
      endotoxin and inflammation. We are performing this study to see if there are genetic factors
      that predict how people will respond to niacin and to endotoxin and its inflammatory
      response.
    

Intervention name(s): Immediate Release Niacin, Extended Release Niacin, Endotoxin
Intervention type(s): Drug
Intervention description(s): Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
Other intervention name(s): Niacor; Niaspan
Intervention MeSH terms: Niacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Bile Acids and Gut Microbiota as Potent Coronary Atheroma Risk Factors: a Prospective Study in Human
Condition: Coronary Disease
MeSH terms: Coronary Disease; Coronary Artery Disease
Study type: Observational

Summary: 
      The purpose of this study is to describe the composition of bile acids and the gut microbiota
      comparing two populations: patients with coronary atheroma and the healthy subjects.

      Our hypothesis is based on the demonstration of the anti atherogenic and anti inflammatory
      effect of certain bile acids, and the role of the gut microbiota in the metabolic regulation.
    

Detailed description: 
      Atherosclerosis is the main cause of cardiovascular diseases which remain the first cause of
      death worldwide. The prevention of risk factors can reduce the development of cardiovascular
      diseases. The final goal of our study is to find new protective or new risk factors that can
      be modulated to reduce the incidence of cardiovascular events.

      Gut microbiota and its main metabolite, the bile acids, are implicated in the metabolic
      regulation. Some bile acids, especially the secondary bile acids, transformed from the
      primary bile acids by the bacteria of the gut microbiota, are now demonstrated in murine
      experimental atherosclerosis models, to be anti inflammatory and anti atherogenic molecules.

      We want to compare the pool of bile acids and the composition of gut microbiota between the
      coronary patients and the healthy subjects to identify the potential protective or
      deleterious bacteria / bile acids.

      All patients admitted for a scheduled coronary angiogram will be included, then divided into
      two groups: coronary or healthy, based on the presence or the absence of atheroma during the
      coronary angiogram.

      Feces and blood samples, and clinical and biological data, will be collected during the
      patient's hospitalisation. No additional exam will be performed. The blood sample will be
      collected during the coronary angiogram or during a routine blood test.
    

Intervention name(s): No intervention; Healthy subject
Intervention type(s): Other; Other
Intervention description(s): Collecting blood and feces samples; Collecting blood and feces samples
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Tertiary care center: cardiology unit.
      
Keywords: Coronary disease; Bile acids; Gut microbiota; Risk factors; Atherosclerosis
The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters
Condition: Dermis Density; Trans Epidermal Water Loss (TEWL); Skin Hydration; Wrinkles; Dermis Thickness
Study type: Interventional

Summary: 
      Placebo controlled double-blind multi-dose comparative study of the effects of coenzyme Q10
      and collagen formulation with improved water-solubility in healthy adults.

      One group (test group) will receive investigational product - test syrup (daily dose 10 mL:
      fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A:
      920 μg, biotin: 150 μg) and the other (placebo group) placebo syrup without those active
      ingredients. Participants will test continuous administration of placebo or investigational
      product for 12 weeks in order to demonstrate and assess multiple-dose effects on skin
      condition and signs of skin aging.
    


Intervention name(s): Test syrup containing CoQ10 and collagen; Placebo syrup
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Test group will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg); continuous administration of investigational product for 12 weeks.; Placebo group will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks.
Intervention MeSH terms: Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease?
Condition: Congenital Heart Defects
MeSH terms: Acute Kidney Injury; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to assess the ability of Levosimendan to reduce the postoperative
      acute kidney injury in pediatric patients undergoing surgery for congenital heart disease
      (CHDs). Young children, between the age of 1 to 12 months, with congenital heart disease in
      need of elective heart surgery will be included in this study.

      The trial will contain two study groups, 35 patients in each. One group will receive
      Levosimendan and the second group will receive Milrinone as a heart muscle-strengthening
      agent during and after the operation. Milrinone is currently used as the drug of choice in
      many pediatric cardiac surgery centers. It remains to see if Levosimendan can exert a kidney
      protecting function in addition to its heart muscle-strengthening properties.

      The primary objective of this study is to investigate the preventive effect of Levosimendan
      on postoperative acute kidney injury in pediatric patients undergoing surgery for their CHDs.
      Creatinine levels postoperatively will be the primary endpoint. Creatinine, the common marker
      of kidney injury, will be measured daily.

      The treatment with Levosimendan or Milrinone will be started during the operation (after
      initiation of cardiopulmonary bypass) and will last 24 hours. Blood samples will be obtained
      at six occasions perioperatively. Patients will be followed 4 days after termination of
      treatment (totally 5 days).

      The duration of study will be 30 days (24 hours treatment + 4 days follow up +
      30-days-mortality registration).

      Creatinine is the primary outcome in this study. Inflammatory biomarkers and other relevant
      biomarkers will comprise the secondary outcome variables.
    


Intervention name(s): Levosimendan; Milrinone
Intervention type(s): Drug; Drug
Intervention description(s): The drug infusion will be started after initiation of cardiopulmonary bypass and will continue for 24 hours.; The drug infusion will be started after initiation of cardiopulmonary bypass and will continue for 24 hours.
Other intervention name(s): Simdax
Intervention MeSH terms: Simendan; Milrinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
Condition: Toothache
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium
      extended-release tablet, compared to placebo in postsurgical dental pain.
    


Intervention name(s): Naproxen Sodium ER (BAYH6689); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery; Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dental Pain; Analgesia
A Study of REPLAGAL® in Treatment-naive Chinese Participants With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The main aim of the study is to assess the safety of REPLAGAL. Study participants will
      receive REPLAGAL as an intravenous infusion every other week for 52 weeks. Participants will
      visit their study clinic many times throughout the study.
    


Intervention name(s): REPLAGAL
Intervention type(s): Biological
Intervention description(s): Participants will receive REPLAGAL infusion intravenously.
Other intervention name(s): Agalsidase Alfa; TAK-675
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Development and Evaluation of a Sleep-coaching Program
Condition: Insomnia
Study type: Interventional

Summary: 
      In the present study, a 4-week sleep coaching program is developed and evaluated in members
      of the German armed Forces. The aim of the program is to provide an efficient tool to prevent
      sleep disorders, and to improve mild sleep disorders, with a special focus on insomnia.
    

Detailed description: 
      In the present study, a sleep-coaching program for small groups of a maximum of eight
      participants is developed. The program is comprised of four different sessions and is
      provided to member of the German armed forces. One session lasts approximately 1.5 hours and
      sessions are applied on a weekly basis. Each session deals with a different topic, addressing
      all major categories of sleep disorders (insomnia, hypersomnia, circadian rhythm disorders,
      sleep-related breathing disorders) and teaching ways of self-help and information on when to
      seek medical treatment. The program is evaluated by a cross-over study design with treatment
      and waiting control groups. After the treatment group has finished the course, the waiting
      group attends the sleep coaching session. All subjects fill in sleep logs and several
      questionnaires prior to (t0) and after the treatment group has finished the sleep coaching
      (t1), after the waiting group has finished the course (t2), and in a 3-month follow-up
      session (t3). Furthermore, sleep is recorded according to the AASM-standard criteria for two
      consecutive nights each at the time-points t0, t1, and t2. Subjective and objective sleep
      quality will be compared across the time-points, and between groups. In total, at least 48
      participants are included in study.
    

Intervention name(s): sleep-coaching
Intervention type(s): Behavioral
Intervention description(s): Sleep-coaching with elements of cognitive behavioral therapy for insomnia and general information about sleep
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Antidepressive Effect on 5 Herz (Hz) rTMS Over Dorsomedial Prefrontal Cortex and Left Dorsolateral Prefrontal Cortex
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study evaluates the efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS)
      over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex on Major
      Depressive Disorder (MDD).
    

Detailed description: 
      Major Depressive Disorder (MDD) affects a significant percentage of the national population
      (17-20%) in 2:1 ratio in women compared to men. Repetitive Transcranial Magnetic Stimulation
      (rTMS) is an effective neuromodulation technique for the treatment of Major Depressive
      Disorder and it has demonstrated favorable clinical effects when applied over the Left
      Dorsolateral Prefrontal Cortex (LDLPFC); however there is evidence that other areas of the
      prefrontal cortex such as the Dorsomedial Prefrontal Cortex (DMPFC) could be ideal for rTMS
      treatment targets during the presence of MDD, given its association with deficient cognitive
      processes during the course of the illness. There is also evidence of the use of 5Hz
      frequency with the same clinical effectiveness from other frequencies such as 10 Hz and 20 Hz
      when applied to the LDLPFC. However, there are no current research that have addressed the
      use of this frequency on DMPFC.
    

Intervention name(s): repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): Subject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS
Other intervention name(s): Transcranial Magnetic Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The purpose to this study is to valuate the clinical effects of 5Hz rTMS over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder
Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children
Condition: Vaccines, Pneumococcal; Vaccines, Pneumococcal Conjugate Vaccine
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal
      carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the
      rate of penicillin-resistant pneumococci in nasopharyngeal carriage.
    

Detailed description: 
      This study will require 6 months to be completed (3 months for nasopharyngeal samples
      collection; 3 months dor analysis). Each child will participate for a 1 day period.
    

Intervention name(s): pneumococcus conjugate vaccine 7 valent to reduce carriage
Intervention type(s): Biological
Intervention description(s): plain polisacaride vaccine 23 valent to reduce carriage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pneumococcus conjugated vaccine 7 valent