bioihbjkbjnl/mcl2 huggingface dataset:
Incidence of BRUE Among the Hospitalized Infants: Towards a Change in Medical Practices?
Condition: Brief Resolved Unexplained Events (BRUE)
MeSH terms: Brief, Resolved, Unexplained Event
Study type: Observational

Summary: 
      The malaise of the infant represents a polymorphic pathology in its clinical presentation.

      Due to the young age of the patients concerned and the parental anxiety generated, hospital
      management is necessary, for clinical and paraclinical evaluation and monitoring.

      The practice of complementary examinations is guided by personal and family history, and the
      precise description of the discomfort as well as clinical examination of the child and
      assessment of his vital parameters.

      However, in view of the particular terrain represented by infants under one year of age, a
      number of tests are carried out systematically, and therefore empirically, because they are
      not guided by the clinic.

      These various tests can be invasive, anxiety-provoking for parents and generate a significant
      additional cost during hospital management.

      An evaluation of the indication and interest of these tests is necessary in order to propose
      a homogeneous clinical and paraclinical management of the discomfort of the infant, in
      particular of discomforts of type BRUE (Brief Resolved Unexplained Events), as described in
      the 2016 American Academy of Pediatrics (AAP) recommendations.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Infant less than one year old, admitted to the paediatric emergencies of the CHRU of Nancy
        between 11/01/2019 and 04/30/2020 for discomfort
Effects of Yoga on Menopausal Symptoms in Women With Breast Cancer
Condition: Menopause; Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Women with breast cancer and breast cancer survivors are often bothered by menopausal
      symptoms to a special degree. Treatment options for those symptoms are currently limited as
      hormone replacement therapy is often prohibited. Yoga has been shown to reduce menopausal
      symptoms as well as symptoms associated with breast cancer. Therefore, this study aims to
      investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with
      breast cancer and breast cancer survivors.
    


Intervention name(s): Yoga; Usual care
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study on the Safety of the Drug BAY2395840 at Different Doses, the Way the Body Absorbs, Distributes and Excretes the Drug Including the Effect of Its Formulation (Tablet or Liquid) and the Effect of Food on the Absorption, Distribution or Excretion of the Drug in Healthy Male Participants
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a better way to treat people who have endometriosis, a condition
      in which tissue similar to the lining of the uterus starts to grow in places outside of the
      uterus. The study treatment, BAY2395840, is being developed to help block certain proteins
      from causing inflammation and pain in people with endometriosis. But, this is the first time
      that researchers will study BAY2395840 in humans.

      In this study, the researchers will learn how safe BAY2395840 is for the participants to
      take. They will also learn what happens to BAY2395840 in the body. The study will include
      about 56 healthy adult men.

      All of the participants will take increasing doses of BAY2395840, or a placebo. A placebo
      looks like a treatment but does not have any medicine in it. Some of the participants will
      take their study treatment 1 time under diet 1 conditions. The other participants will take
      their study treatment 7 times with diet 1 or diet 2.

      The participants will take BAY2395840 or the placebo as tablets or as a liquid by mouth. The
      participants will stay at the study site for up to 11 days . After that, they will visit the
      study site 1 more time. Each participant will be in the study for up to about 14 weeks.

      During the study, the doctors will collect blood and urine samples and check the
      participants' overall health and heart health. The participants will answer questions about
      how they are feeling, what medications they are taking, and what adverse events they are
      having. An adverse event is any medical problem that a participant has during a study.
      Doctors keep track of all adverse events that happen in studies, even if they do not think
      the adverse events might be related to the study treatments.
    


Intervention name(s): BAY2395840 tablet; BAY2395840 oral solution; Placebo oral solution; Placebo tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablets, oral administration; solution, oral administration; Placebo matching BAY2395840, oral administration; Placebo matching BAY2395840, oral administration
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure how much of the drug gets into the bloodstream and
      how long it takes the body to remove it when given to participants with hepatic (liver)
      impairment compared to participants with normal hepatic function. Information about any side
      effects that may occur will also be collected. This study will last approximately 28 days,
      not including screening.
    


Intervention name(s): Evacetrapib
Intervention type(s): Drug
Other intervention name(s): LY2484595
Intervention MeSH terms: Evacetrapib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effectiveness of Preoxygenation With Positive Airway Pressure: a Comparison of the Supine and 25° Head up Position
Condition: Intubation;Difficult
Study type: Interventional

Summary: 
      Several techniques such as positive airway pressure and head-up tilt during preoxygenation
      have shown to prolong non-hypoxic apnea period compared to conventional technique. However,
      uniform recommendations have not yet been made. Therefore, in the present study the
      investigators attempted to find out the effect of combination of 5 cmH2O CPAP and 25° head up
      position during preoxygenation.
    

Detailed description: 
      In this study 60 non-obese healthy adult patients were divided into three groups; Group C
      receiving preoxygenation in conventional technique, Group S receiving preoxygenation with 5
      cmH2O CPAP and Group H receiving preoxygenation in 25° head-up position with 5 cmH2O CPAP.
      After 3 min of preoxygenation, anesthesia was induced and trachea intubated. After confirming
      the tracheal intubation by direct visualization, all patients were left apneic in supine
      position with the tracheal tube exposed to atmosphere till the SpO2 dropped to 92%. The
      primary outcome compared between the groups was the non-hypoxic apnoeic period (time to fall
      SpO2 to 92%).
    

Intervention name(s): 5 cmH2O CPAP; head-up position
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: apnea; CPAP; Preoxygenation
Changes in Cerebrovascular Reactivity During Cognitive Activation After Cardiopulmonary Bypass: Relation With Intraoperative Embolic Load and Postoperative Neuropsychological Dysfunctions
Condition: CABG-Patients
Study type: Interventional

Summary: 
      The study aims to evaluate neuropsychological disorders in CABG patients. Measurements are
      performed 1 day before, 6 days, 6 months and 3-5 years after the surgery. The relation with
      cerebrovascular reactivity and embolic load (measured by transcranial Doppler
      Ultrasonography) is evaluated. Two surgery techniques (on- and off-pump CABG) are compared.
    


Intervention name(s): Determination of neuropsychological status
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Trial Twice Daily Application of LEO 124249 Ointment 30 mg/g in Treatment of Mild to Moderate Inverse Psoriasis
Condition: Inverse Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2a trial testing twice daily administration of LEO 124249 ointment 30 mg/g in
      the treatment of mild to moderate inverse psoriasis. Patients will be treated for 6 weeks,
      and the efficacy and safety will be compared with the treatment of LEO 124249 ointment
      vehicle.
    

Detailed description: 
      Single country, Multi-center, prospective, randomised, double-blind, 2 arms parallel-group,
      vehicle-controlled, 6 weeks, phase 2a trial in subjects with mild to moderate inverse
      psoriasis. LEO 124249 ointment 30 mg/g and LEO 124249 ointment vehicle treatments will be
      compared with regards to efficacy and safety.
    

Intervention name(s): LEO 124249 ointment 30 mg/g; LEO 124249 ointment vehicle
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Propofol on Early Recovery of Hunger After Surgery
Condition: Ambulatory Surgery; Anesthesia; Energy Expenditure; Food Intake
Study type: Interventional
Phase: Phase 4

Summary: 
      Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover,
      this aspect of post-operative period is often required for discharging patients from hospital
      after ambulatory surgery. Indeed, this item is part of a multi-parameter score (Chung score)
      whose validation evaluates patient's ability to return home.

      The impact of anesthetics on hunger is largely unknown but few studies suggest an orexigenic
      effect of propofol compared to halogenated gases. These studies had neither the power nor the
      methodology to answer the question. The aim of our study is to evaluate the impact of
      propofol versus sevoflurane on early recovery of hunger after ambulatory surgery.
    


Intervention name(s): propofol; Sevoflurane
Intervention type(s): Drug; Drug
Other intervention name(s): diprivan, 2,6-bis(propan-2-yl)phénol; Sevorane, 1,1,1,3,3,3-hexafluoro-2-(fluorométhoxy)propane
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety, tolerability, pharmacokinetics of DC371739 after a
      single-dose oral administration in healthy Chinese subjects, and to explore the maximum
      tolerated dose, also the pharmacokinetics of urine and feces.
    

Detailed description: 
      This is a randomized, double-blind , placebo-controlled, single-dose study in 43 male healthy
      subjects assigned to one of the six dose groups (30mg、50mg、100mg、 200mg、400mg and 600mg).
      30mg dose group is the pilot group with 3 subjects. Each of the other dose groups will
      include 8 subjects (7 for DC371739 and 1 for placebo). Subjects will be admitted for
      treatment on day -1 and receive a single dose of study drug or placebo on day 1. Subjects
      from different dose groups were enrolled in turn, the next dose group was conducted on the
      premise that the D6 safety evaluation was completed after the administration of the previous
      dose group with the result was tolerance. Blood samples will be collected for each group
      after administration for pharmacokinetic data analysis. Urine and feces were collected in
      three dose groups of 100 mg, 200 mg and 400 mg respectively to explore the pharmacokinetic
      characteristics of urine and feces.
    

Intervention name(s): DC371739; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants received one of 6 dose levels of DC371739 administered as single oral doses.; Placebo orally administered
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hyperlipidemia
A Study of LY3045697 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of LY3045697 after a
      single dose, and to determine how long LY3045697 remains in the body. Two cohorts (groups) of
      9 participants each will participate in 3 dosing periods. These participants will receive
      placebo in one period only. A third cohort of 9 will participate in 2 dosing periods and
      participants will receive either 2 dose levels of LY3045697 or 1 dose level of LY3045697 and
      placebo by the end of both periods.
    

Detailed description: 
      Cohort 3 added per protocol amendment (April, 2013).
    

Intervention name(s): LY3045697; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Metabolic Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The study investigated the effect of rosiglitazone and placebo on carotid intima media
      thickness in patients with insulin resistance syndrome and/or type 2 diabetes.
    

Detailed description: 
      RAS Rosiglitazone and Atherosclerosis Study: A 1 year randomised, double-blind, parallel
      group, placebo controlled study to evaluate the efficacy of rosiglitazone on the progression
      of intima-media thickness in the carotid artery in subjects with insulin resistance syndrome
      and/or type 2 diabetes mellitus
    

Intervention name(s): Rosiglitazone
Intervention type(s): Drug
Intervention description(s): study drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rosiglitazone; Type 2 diabetes; intima media thickness; Insulin resistance
Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance and Type 2 Diabetes in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome
Condition: PCOS
MeSH terms: Polycystic Ovary Syndrome; Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      Metformin is the first-line therapy for PCOS with high metabolic risk, yet a large proportion
      of patients cannot tolerate it due to associated gastrointestinal adverse events. The
      alternative pharmacological strategy when metformin cannot be tolerated is not well
      established in this population. Our aim was to evaluate whether sitagliptin (SITA) preserves
      metabolic profile in metformin (MET) intolerant PCOS with high metabolic risk.
    


Intervention name(s): Sitagliptin; Lifestyle intervention
Intervention type(s): Drug; Behavioral
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: metformin intolerance; PCOS; Sitagliptin; beta cell function
Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a dose escalation study with 8 planned dose levels. The study is a 4-period
      crossover design where each healthy volunteer will be randomised to receive three dose levels
      of ODM-106 (single doses) and one dose of placebo. The study will look at the
      pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects
      the body) of ODM-106.
    

Detailed description: 
      Eight planned dose levels of ODM-106 will be compared with placebo.There will be 2 panels of
      subjects with 4 dose levels in each panel. Subjects will be randomised to receive 3 dose
      levels of active treatment (single doses) and 1 dose of placebo. The dose levels will be
      escalated from the smallest dose upwards within the study and within the study subject. A
      third panel of 8 subjects may be included to investigate further dose levels of ODM-106,
      investigate the effect of taking ODM-106 with food or to compare two different formulations
      of ODM-106. For an individual subject, the study will consist of a screening period (maximum
      4 weeks), 4 study treatment periods with a wash-out period between each study treatment
      administration and a post-treatment period of about 2 weeks.

      The study duration for an individual will be approximately 12-16 weeks. Blood samples will be
      collected for the assessment of the concentration of ODM-106 and its metabolite.Plasma
      samples and cumulative urinary samples will be collected for metabolite screening. Safety
      will be assessed by a 12-lead electrocardiogram (ECG), continuous ECG monitoring, Holter ECG,
      supine and orthostatic blood pressure and heart rate, body temperature, physical examination,
      electroencephalogram (EEG), laboratory safety assessments and adverse events. Sedation and
      psychomotor tests and a quantitative EEG will also be performed.
    

Intervention name(s): ODM-106; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.; Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline
Condition: Cognitive Decline
MeSH terms: Metabolic Syndrome; Inflammation; Cognitive Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to determine if the metabolic syndrome is a risk factor for
      cognitive decline and if this association is modified by inflammation.
    

Detailed description: 
      The metabolic syndrome is a clustering of several commonly occurring disorders that include
      abdominal obesity, high triglycerides, low HDL cholesterol, high blood pressure, and insulin
      resistance. This study was conducted to determine if, as hypothesized, the presence of the
      metabolic syndrome is associated with more cognitive decline and greater risk of developing
      cognitive impairment, and whether this risk is affected by the level of inflammatory markers
      in the blood.

      This 5-year prospective observational study was conducted from 1997 to 2002 at community
      clinics in two locations. A total of 2632 black and white participants, aged 70 to 79 years,
      were recruited from the 3075 participants in the Health, Aging and Body Composition (ABC)
      study conducted during the same period. Participants were screened for presence of metabolic
      syndrome, cognitive status, inflammatory markers, and a clinic examination was administered,
      when the study began and at the year 3 and 5 follow-up visits.
    

Observational model: Natural History
Time perspective: Prospective
Keywords: Metabolic Syndrome; Alzheimer's Disease; Cognitive Impairment; Inflammation
Effectiveness of Internet Delivered Cognitive Behavior Therapy (CBT) for Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The study will recruit 80 out-patients diagnosed with Irritable Bowel Syndrome from a
      gastroenterological clinic. The recruitment will be consecutive with all patients receiving
      the diagnosis being offered to participate. After recruitment and 3 week baseline measure of
      IBS symptoms they will be randomised to either 10 weeks of internet delivered CBT or waiting
      list. After treatment IBS-symptoms are measured again to assess treatment effectiveness. All
      patients on waiting list are offered the same treatment as patients randomised to treatment.

      All patients are assessed 12 months after completion of treatment.

      Patients in treatment condition are hypothesized to experience significant reduction IBS
      symptoms and quality of life compared to patients on waiting list.
    


Intervention name(s): Internet delivered cognitive behavior therapy
Intervention type(s): Behavioral
Intervention description(s): 10 weeks of internet delivered cognitive behavior therapy targeted at reducing experience of IBS symptoms and improving quality of life. Patients are offered guidance via email by a therapist.
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IBS; CBT; Internet treatment; Cognitive behavior therapy
Gestational Diabetes: the Prevention
Condition: Pregnancy
MeSH terms: Diabetes, Gestational
Study type: Interventional

Summary: 
      To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic
      activities) aerobic and muscular tonification, on control to the prevention to Gestational
      Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic.
    

Detailed description: 
      A clinical, randomized controlled trial was used. 342 pregnant women without obstetric
      contraindications accepted informed consent for inclusion in the study. Finally, 257 were
      studied, 101 in intervention group (IG, n= 101) and 156 in control group (GC, n= 156). A
      physical exercise program three times per week during pregnancy was developed. The duration
      of session was 60 minutes and 50 minutes in land and water, respectively.
    

Intervention name(s): Exercise group
Intervention type(s): Behavioral
Intervention description(s): Combined two land aerobic sessions and one aquatic activities session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregnancy, exercise, gestational diabetes