bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea
Condition: Respiratory Depression; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Insufficiency
Study type: Observational [Patient Registry]

Summary: 
      The sole objective in this study is to evaluate if routine amounts of opioids given for
      tonsillectomy in children have greater amounts of respiratory depression in children with
      documented obstructive sleep apnea when compared with patients that do not have obstructive
      sleep apnea
    

Detailed description: 
      Ventilatory suppression in children following opioid administration is of obvious concern,
      especially following routine surgical procedures (i.e. adenotonsillectomy). It is thought
      that patients with obstructive sleep apnea (OSA) have increased sensitivity to opioids, and
      especially in opioid naïve patients. Recent evidence in adults suggests that patients with
      moderate to severe OSA may not predispose patients to increased opioid sensitivity in the
      form of respiratory depression when compared with patients that do not have OSA. It is well
      known that OSA in children is significantly different from OSA in adults (e.g. gender
      predilection, central vs. peripheral causation). The manifestation and etiologies are very
      different in pediatric OSA making it a vastly different disease process.
    

Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention description(s): identification of respiratory parameter changes following administration of fentanyl in children with and without OSA
Other intervention name(s): respiratory changes, CO2, RR, TV
Intervention MeSH terms: Fentanyl
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We are assessing the effect of fentanyl on children with and without OSA based on the OSA
        18 questionnaire and PSG resepctively. Children must be otherwise healthy as stated above
        in the eligibility criteria
      
Keywords: pediatrics; opioids; obstructive sleep apnea
The Effect of Birth Ball Exercise on Labor Pain, Delivery Duration, Birth Comfort, and Birth Satisfaction
Condition: Childbirth Problems; Labor Pain; Birth Disorder
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      It has been reported that the birth ball has benefits such as decreasing the perception of
      labor pain, reducing the anxiety level, shortening the duration of the first stage of labor,
      increasing the satisfaction of birth, and facilitating the descent of the fetal head, but the
      literature is quite limited. So, this randomized controlled experimental study aimed to
      examine the effect of birth ball exercise on labor pain, delivery duration, birth comfort,
      and birth satisfaction.
    

Detailed description: 
      This randomized controlled experimental study aimed to examine the effect of birth ball
      exercise on labor pain, delivery duration, birth comfort, and birth satisfaction. The sample
      of the study consisted of 120 primiparous pregnant women presented to the delivery room
      between November 2021 and April 2022. Pregnant women were randomly assigned to the
      Intervention Group (IG, n=60) or the Control Group (KG, n=60). After the cervical dilatation
      reached at 4 cm, the pregnant women in the IG performed birth ball exercises, adhering to the
      birth ball guide created by the researcher. No intervention was made in the control group
      other than standard midwifery care practices.

      A Personal Information Form,a Visual Analog Scale (VAS), the Childbirth Comfort Questionnaire
      (CCQ), a Labor and Postpartum Follow-up Form, and the Mackey Childbirth Satisfaction Rating
      Scale (MCSRS) were used for data collection. Women in both groups underwent VAS when cervical
      dilatation was 4 cm and 9 cm, and the CCQ was applied when dilatation was 8 cm. The MCSRS was
      administered two hours after delivery.
    

Intervention name(s): birth ball exercise
Intervention type(s): Other
Intervention description(s): birth ball exercise used in childbirth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Birth pain; labor duration; birth comfort; birth satisfaction; birth ball
Acute and Short-term Chronic Effects of Galvus (Vildagliptin) in Diabetes Type 2 Obese Women
Condition: 1- Microvascular Function; 2-oxidative Stress; 3-inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The prevalence of obesity and type 2 diabetes mellitus (T2DM) has increased progressively in
      the past decades, and consequently, a higher incidence of cardiovascular diseases is
      observed. As this process develops, the endothelial dysfunction is present at early stages of
      the atherosclerotic disease. Studies conducted at BioVasc/UERJ show the occurrence of
      endothelial and microvascular dysfunction in obese carriers, even in the absence of
      dysglycemia. New concepts indicate the endothelium as a possible therapeutic target, and
      drugs which act not only on diabetes mellitus pathophysiology but also acting as direct
      cardiovascular protectors bring new therapeutic possibilities. The dipeptidyl-peptidase-4
      inhibitors (DPP4), such as vildagliptin, are drugs used on the T2DM treatment. Its incretin
      mimetic and insulinotropic effects are already well established and several other studies
      show its effectiveness in reducing glycated hemoglobin, even in monotherapy.

      Currently, fat rich foods are being increasingly introduced in the western way of life and
      recent evidence suggests that the postprandial lipemia (LPP) is related to cardiovascular
      risk. A better glucose control using vildagliptin can reduce the oxidative stress, and
      consequently promote a better microvascular and endothelial reactivity. However, vildagliptin
      can have an additional cardiovascular protective action, not only because of its effect on
      glycemia and oxidative stress reduction, but maybe because of its direct effect on intestinal
      peptides with postprandial lipemia reduction. To test this hypothesis, we will proceed the
      following exams: venous occlusion pletysmography, nailfold videocapilaroscopy and
      laser-Doppler flowmetry aiming to evaluate vascular reactivity on muscle and at cutaneous
      site. Anoter group of patients with the same clinical charactherisitics will use metformin,
      in order to compare its effects with those obtained from the use of Vildaglitpin. Our purpose
      is to determine whether vildagliptin, evaluated in obese and diabetic women, has vascular
      protective effects, and whether the regulatory mechanisms of these actions correlate with
      oxidative stress, inflammatory markers and intestinal peptides in baseline state and after a
      lipid overload.
    


Intervention name(s): Vildagliptin
Intervention type(s): Drug
Intervention description(s): Vildagliptin 50mg/pill will be administered at 10 AM and at 6 PM also for 30 days.
Other intervention name(s): Vildagliptin (galvus)
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: endothelial function; microvascular function; incretins; diabetes mellitus; postprandial lipemia
Safety and Pharmacokinetics of MK-2060 in Older Participants With End-Stage Renal Disease on Hemodialysis (MK-2060-004)
Condition: Renal Dialysis; Kidney Failure, Chronic
MeSH terms: Kidney Failure, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and
      pharmacodynamics (PD) of MK-2060 after intravenous (IV) administration of single and multiple
      doses in older adult participants with end-stage renal disease (ESRD) on hemodialysis (HD).
    


Intervention name(s): MK-2060; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part 1: Single doses (8 mg, 20 mg, or 40 mg) of MK-2060 will be administered via IV infusion on Day 1.
Part 2: Three doses of 25 mg of MK- 2060 administered via IV infusion on Days 1, 3 and 5; Followed by single doses of 25 mg of MK-2060 administered via IV infusion on Days 8, 15, and 22.; Part 1: Single dose of placebo will be administered via IV infusion on Day 1. Part 2: Three doses of placebo administered via IV infusion on Days 1, 3 and 5; Followed by single doses of placebo administered via IV infusion on Days 8, 15, and 22.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose
      of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with
      ADHD.
    


Intervention name(s): NRP104; NRP104; NRp104; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): NRP104 30mg capsule once daily in a.m.; NRP104 50mg capsule once daily in a.m.; NRP104 70mg capsule once daily in a.m.; Placebo
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Two Different Methods of Resin Composite Application In Class II Restorations
Condition: Class II Dental Restorations
Study type: Interventional

Summary: 
      Three clinical groups will be evaluated. Each group of patients will undergo one method of
      Resin Composite application (multi-layer technique 'control group' - bulk-fill Technique -
      Sonicfill technique). The restored teeth will be followed-up till one year. A comparison is
      going to be made between the three groups in relation to the modified United Sates Public
      Health Service (USPHS) criteria of good restorations.
    

Detailed description: 
      The modified USPHS criteria include the evaluation of seven characteristics of the
      restorations: color match, marginal integrity, surface texture, wear of both restoration and
      antagonist, recurrent dental caries, fracture or detachment, and gingivitis around the
      abutment.
    

Intervention name(s): Bulk fill; SonicFill
Intervention type(s): Procedure; Procedure
Intervention description(s): This is one of the composite restoration application techniques; This is the recent intervention under evaluation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bulk fill; SonicFill; resin composite application; class II restoration
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like
      medicine tablet or capsule, but contains no active medicine) is safe and effective when taken
      together with another antidepressant.
    

Detailed description: 
      A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III
      Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an
      Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response
      to Antidepressant Therapy
    

Intervention name(s): TC-5214; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, oral, twice daily for 8 weeks; Tablet, oral, twice daily for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD; Depression; Safety; add-on therapy
Naturalistic Study Into the Hangover Effects of MDMA
Condition: Hangover
Study type: Observational

Summary: 
      The aim of the study is to compare hangover effects of MDMA users versus those who used other
      drugs, or alcohol only at New Year's Eve. The week after New Years Eve, every day
      participants complete a questionnaire about the presence and severity of potential hangover
      symptoms. At day 1, demographics and alcohol and drug use at New Years Eve were recorded. On
      day 7, the Brief Symptom Inventory (BSI) is completed to asses last weeks mood. After 4
      weeks, after a drug-free week, the BSI is completed again to serve as a reference.
    

Detailed description: 
      A convenience sample was invited by e-mail to participate in the study, via the organizer of
      a private New Years Party.It was attempted to include as much participants as possible.
      Hence, no sampling method was applied when recruiting participants.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Recreational poly-drug users who were guests at a privat New Years Eve party
      
Keywords: hangover; next day effects; MDMA; Alcohol
Breathe: Slow Paced Breathing to Lower Blood Pressure
Condition: High Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the nature of the physiological reasons for the
      decreases in resting blood pressure that can result from systematic practice of
      computer-guided breathing exercises or meditative relaxation.
    

Detailed description: 
      In this randomized clinical trial, persons with moderately elevated blood pressure were
      trained in either computer-guided breathing exercises or meditative relaxation to breathing.
      The computer-guided breathing exercise involves listening to tones of ascending and
      descending pitch to which breathing is entrained to low frequencies over a 15 minute
      interval. The meditative relaxation involves passive attention to natural breathing for the
      same duration. Participants will perform these breathing exercises daily at home for four
      weeks. Before and after the intervention, respiratory, cardiovascular, and urinary endogenous
      digitalis-like factors will be systematically recorded to determine the extent to which
      chronic neuroendocrine changes underlie the reductions in blood pressure.
    

Intervention name(s): Guided Breathing; RESPeRATE
Intervention type(s): Behavioral; Device
Intervention description(s): The participant will engage in daily 15 min sessions of meditative relaxation that involves quiet attention to breathing pattern with no attempt to manipulate breathing pattern; The participant will be trained to perform a guided breathing task that involves a chest expansion sensor, battery-powered microcomputer, and earphones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hypertension; high blood pressure; meditation
Assesment of the Impact of a Nutritional Prevention Programme for Employees in Staggered Hours.
Condition: Shift-work; Eating Behavior
Study type: Interventional

Summary: 
      Staggered work affects about 20% of French employees and its health risks are now well known.
      They concern physical health (sleep disorders, weight gain, cancer, cardiovascular disorders,
      nutritional problems, etc.) and psychological health. Faced with these "alarming" findings,
      it is necessary to find ways of improvement and levers of action to prevent them.

      This project aims to set up and evaluate a nutritional health prevention programme for the
      benefit of employees in staggered hours from CITEO. CITEO is a company of social mediation.

      The objectives of the project are twofold: to evaluate the impact of working conditions in
      shifted schedules on food behavior and on to improve their eating behaviors.

      How? Focusing on the pleasure of eating through a nutritional prevention program in which
      various and varied actions will be proposed but always adapted to the life of the company
      (example: culinary demonstration, physical activity, provision of baskets of Fruits, etc.).
    


Intervention name(s): Nutritional prevention programme
Intervention type(s): Behavioral
Intervention description(s): The nutritional prevention programme will offer a wide range of food and physical activity activities adapted to the life of the company (example: culinary demonstration, physical activity, provision of fruit baskets, etc.) .
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Validation of the IgA1 Detection Method With Gradient Glycosylation by Mass Spectrometry as a Potential Marker of Renal Involvement in Pediatric Rheumatoid Purpura
Condition: Rheumatoid Purpura; Pediatric ALL
MeSH terms: IgA Vasculitis; Purpura
Study type: Observational

Summary: 
      In this ancillary study on the FoxTreg cohort, the study investigators will select variables
      to input and thus develop two models (Linear Discriminant Analysis and Decision Tree). The
      aim of this study is to validate the method in terms of repeatability, reproducibility,
      control of pre-analytical conditions and sample conservation, to complete the screening of
      IgA glycosylation in individuals of the FoxTreg cohort and to refine the glycopeptide
      signature to predict renal involvement.
    


Intervention name(s): Mass Sepctrometry
Intervention type(s): Other
Intervention description(s): Mass spectrometry (LC/MS) of purified immunoglobulins
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is an ancillary study on the patient biobank of the FoxTreg study (NCT02317133). All
        these patients had given their consent for blood sampling and the conservation of
        biological samples within the Biological Resources Center (CRB) of Nîmes. A total of 97
        patients were recruited, forming three groups:

          -  Group A (n = 30): patients with active Rheumatoid Purpura according to the criteria of
             EULAR / PRES / PRINTO 2010 [Ozen et al. 2010].

          -  Group B (n = 30): patients in remission of Rheumatoid Purpura according to the
             criteria of EULAR / PRES / PRINTO 2010 [Ozen et al. 2010].

          -  Group C (n = 37): age-matched control subjects free of infectious / inflammatory /
             autoimmune pathology.

        For this "FoxIgA-2020" study, only sera collected from these patients not analyzed in the
        "FoxIgA" study will be used.

        Thus 52 samples will be analyzed for the FoxIgA-2020 study:

          -  10 sera from group A

          -  14 sera from group B

          -  28 sera of group C
      
Biospecimen description: 
      Blood samples already in existence
A Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration in Healthy Japanese Adult Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) of
      rilpivirine/Tenofovir/Emtricitabine (RPV/TFV/FTC) after a single-oral administration of
      Complera (the fixed-dose combination of RPV, FTC, Tenefovir disoproxil fumarate [TDF]) to
      healthy Japanese adult male participants.
    

Detailed description: 
      This is a single center, open-label, single oral dose study in healthy Japanese adult male
      participants. The study consists of 3 phases; a screening phase up to 27 days (Day -28 to Day
      -2), an in-patient phase from Day -1 to Day 3 (dosing day is Day 1), and a follow-up
      assessment phase from Day 4 to the last follow-up assessment scheduled on Day 15 or at the
      time of early withdrawal. All participants will receive a single oral dose of one Complera
      tablet on Day 1 within 5 minutes after completion of the standardized breakfast.
      Pharmacokinetics of RPV/TFV/FTC will be assessed as the primary objective of the study.
      Safety of each participant will be assessed throughout the study.
    

Intervention name(s): Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDC
Intervention type(s): Drug
Intervention description(s): Fixed dose combination tablet contains 25 milligram (mg) of Rilpivirine, 300 mg of Tenofovir Disoproxil Fumarate (TDF) and 200 mg of Emtricitabine (FTC).
Other intervention name(s): Complera
Intervention MeSH terms: Tenofovir; Emtricitabine; Rilpivirine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Rilpivirine; Tenofovir; Emtricitabine; Tenofovir Disoproxil Fumarate
Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation
Condition: Psychomotor Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional

Summary: 
      Compare the effects of intravenous midazolam and ketamine on emergence agitation after
      sevoflurane anesthesia
    

Detailed description: 
      Emergence agitation is self-limiting aggressive behavior that develops in the early period of
      awakening from anesthesia. A high level of preoperative anxiety is a risk factor for
      emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to
      the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation
      between midazolam group and ketamine group.
    

Intervention name(s): Midazolam; Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): preoperatively injected intravenous 0.1 mg/kg midazolam; Preoperatively injected intravenous 1mg/kg ketamine
Other intervention name(s): Ketamine HCl
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: child, ketamine, midazolam