bioihbjkbjnl/mcl2 huggingface dataset:
Sleepiness and Brain Function: The Effect of Armodafinil in Shift Work Sleep Disorder
Condition: Shift Work Sleep Disorder
MeSH terms: Sleep Wake Disorders; Parasomnias; Sleep Disorders, Circadian Rhythm; Sleepiness
Study type: Observational

Summary: 
      The investigators hypothesize that in patients with shift work sleep disorder, armodafinil
      will specifically increase brain activity in the frontal cortex parallel with improvements in
      deficits of fundamental mechanisms of attention.
    

Detailed description: 
      The current protocol will utilize a paradigm which is well suited to examine frontal
      attentional neuronal mechanisms by eliciting event related potential components known to
      reflect automatic stimulus detection as well as involuntary and voluntary attentional
      processes. The that end the proposed research has two specific aims. 1) Identify what areas
      of the frontal lobe and corresponding cognitive functions are impacted by excessive
      sleepiness in shift work sleep disorder and 2) identify specific brain areas affected by
      armodafinil and their role in improvement of fundamental attentional processes using a
      complex cognitive task targeting attentional control.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study population must be healthy night shift workers with a diagnosis of shift work sleep
        disorder.
The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite
Condition: Increased Energy Expenditure; Increased Satiety
Study type: Interventional

Summary: 
      The primary aim is to examine and compare the effects of hydrolyzed casein (HC), intact
      casein (IC) and intact whey protein (IWP) on diet-induced thermogenesis (DIT). Furthermore,
      to study the effects on appetite regulation assessed by subjective appetite sensations, ad
      libitum energy intake and appetite regulating hormones.

      Whey and casein differ in absorption and digestion rate, with whey being a fast protein and
      casein being a slow protein. When casein undergoes hydrolysis the absorption and digestion
      rates approaches the rates of whey. In the present study the importance of absorption rate
      and amino acid composition, in regards to energy expenditure and appetite regulation, will be
      examined. HC and IC have identical amino acid composition, but differ in absorption rate,
      whereas HC and IWP have similar absorption rates, but differ in amino acid composition. We
      hypothesize that consumption of HC will increase DIT and fat oxidation to a greater extend
      that IC. Moreover, that HC and IWP will increase satiety shortly after protein consumption,
      whereas IC will be more satiating after several hours.

      The study is a controlled, randomized, 3-arm crossover study. It consists of three visits in
      a respiratory chamber separated by at least two weeks. 26 healthy, overweight and obese (BMI
      27-35 kg/m2) young men will be enrolled and randomized to the order of the three protein
      supplements (HC, IC or IWP). At each visit protein supplements (containing either HC, IC or
      IWP) will be served as breakfast, lunch and dinner. Respiratory measures will be obtained
      over 24 hours and appetite will be assessed by visual analogue scales and appetite regulating
      hormones. Furthermore, ad libitum energy intake will be assessed.
    


Intervention name(s): Hydrolyzed casein; Intact casein; Intact whey protein
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 30 g protein/supplement, 4 supplements/visit; 30 g protein/supplement, 4 supplements/visit; 30 g protein/supplement, 4 supplements/visit
Other intervention name(s): Hyvital casein CMA 500, Friesland Campina; Miprodan 30, Arla Foods; Lacprodan SP-9225 Instant, Arla Foods
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Respiratory chambers; Energy expenditure; Appetite; Dairy proteins; Diet induced thermogenesis; Obesity
The Effect of Nefopam on Catheter-related Bladder Discomfort
Condition: Nefopam; Catheter-related Bladder Discomfort
Study type: Interventional

Summary: 
      In the present study, the investigators evaluated whether nefopam 20 mg reduce the
      catheter-related bladder discomfort in patients undergoing foley catheter insertion
    


Intervention name(s): Nefopam or saline
Intervention type(s): Drug
Intervention description(s): One hour before the end of the operation, the Nefopam group was received 20 mg of nefopam and the saline and the control group was received 20 ml of saline.
Intervention MeSH terms: Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Study of Lazertinib (JNJ-73841937) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of steady-state concentrations of
      lazertinib on the single-dose pharmacokinetics (PK) of probe substrates (midazolam,
      rosuvastatin, and metformin) in healthy adult participants.
    


Intervention name(s): Lazertinib; Midazolam; Rosuvastatin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lazertinib tablets will be administered orally, alone or in combination with probe substrates.; Midazolam (cytochrome P450 3A4 [CYP3A4] substrate) will be administered orally as a syrup as a part of probe substrates.; Rosuvastatin (breast cancer resistant protein [BCRP] substrate) tablet will be administered orally as a part of probe substrates.; Metformin (organic cation transporter 1 [OCT1] substrate) will be administered orally as a syrup as a part of probe substrates.
Other intervention name(s): JNJ-73841937; YH25448
Intervention MeSH terms: Metformin; Midazolam; Rosuvastatin Calcium; Lazertinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Alberta Project Promoting Active Living and Healthy Eating in Schools
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The objectives were to 1) make students eat healthier and be more active; and 2) prevent
      overweight and obesity. Children will therefore be less likely overweight or obese. Beginning
      in January 2008, the Alberta Project Promoting active Living and healthy Eating in Schools
      (APPLE Schools) was implemented in 10 schools throughout the Canadian Province, Alberta.
      Full-time School Health Facilitators were placed in each of the schools to implement what is
      know in Canada as Comprehensive School Health (CSH). In the United States, CSH is more
      commonly referred to as "Coordinated School Health", while the synonymous term "Health
      Promoting Schools" is often used in Australia and Europe. The project was evaluated annually
      in the spring from 2008 to 2011 and as of 2009 evaluations included the use of time-stamped
      pedometers. The comparison group included approximately 150 schools that were randomly
      selected to reflect the population of Alberta, Canada. Twenty of these randomly selected
      schools also participated in data collection which involved the use of time-stamped
      pedometers.
    

Detailed description: 
      The Alberta Project Promoting active Living and healthy Eating in Schools (APPLE Schools) is
      a quasi-experimental pre-post trial with a non-equivalent parallel control group. The
      intervention began in January 2008 and lasted through June 2011 and was implemented
      school-wide. As out primary interest is to reduce the prevalence of overweight and obesity in
      schools, the essential comparisons were across grade five students in differing calendar
      years. At each survey all grade five students were invited to participate. The current design
      allowed intervention effects to be assessed over time at the school-level. Surveys were
      administered in the spring of 2008, 2009, 2010, and 2011 in intervention schools. And in the
      spring of 2008 and 2011 in control schools.
    

Intervention name(s): Comprehensive School Health (CSH)
Intervention type(s): Other
Intervention description(s): APPLE Schools uses a CSH approach to health promotion which addresses health through four inter-related pillars 1) positive social and physical environments 2) teaching and learning 3) healthy school policy 4) partnerships and services. A key component of the APPLE Schools intervention was the placement of a full-time School Health Facilitator in each school. Their role was to facilitate the development and implementation of the project, to ensure that it met the schools' unique needs for health promotion, and that it aligned with the core principles of CSH.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Childhood; Physical activity; Nutrition; Health Promotion
Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A
      vaccinations in patients with Parkinson's disease. Patients, who have already participated in
      AFF008 will be involved and will be receive one boost immunization with AFFITOPE® PD01A. One
      study site in Vienna (Austria) will be involved.

      In addition, up to 8 patients will be offered participation within an untreated control
      group.
    


Intervention name(s): AFFITOPE® PD01A; Control
Intervention type(s): Biological; Other
Intervention description(s): s.c. injection; Untreated control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Telehealth Language Intervention for Children With Autism Ages 2-4 Years
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The main goal of this intervention is to increase caregivers' use of interactive play and
      communication strategies to improve the child's early sentence development using telemedicine
      and video-based feedback.
    

Detailed description: 
      Record was updated 11/2/2021 to include more detailed information about outcome measure time
      points. Specifically, secondary outcome measures will be collected more frequently over the
      course of the study (i.e., at baseline [before starting intervention], immediate follow-up
      [week 12], and long-term follow-up [3 months after intervention] assessments). No changes
      were made to outcome measures or how they are operationalized.
    

Intervention name(s): Toy Talk
Intervention type(s): Behavioral
Intervention description(s): Language modeling strategy encouraging caregivers to (1) talk about the toys the child is playing with, including the states, actions, and properties of the toys and (2) give the object its name using a lexical noun phrase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Pregabalin and dexmedetomidine have been introduced to manage postoperative pain. The present
      study aimed to evaluate the effect of the combination of two drugs on pain relief in patients
      undergoing total knee or hip arthroplasty under spinal anesthesia
    

Detailed description: 
      One hundred and twenty-four patients undergoing total knee or hip arthroplasty under spinal
      anesthesia were randomly assigned to either group C (n = 31, placebo), group P (n = 33,
      pregabalin), group PD (n = 29, pregabalin and dexmedetomidine) or group D (n = 31,
      dexmedetomidine). One hour before spinal anesthesia, patients received pregabalin 150 mg or
      placebo orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before
      induction of spinal anesthesia, followed by a continuous infusion of 0.5 μg/kg/hr or the same
      calculated volume of normal saline till completion of the surgery. Clinically relevant pain
      for 24 h after surgery including time to first analgesic request visual analog scale (VAS),
      ketorolac dose, and patient controlled analgesics (PCA) volume consumed were recorded.
    

Intervention name(s): Pregabalin; Dexmedetomidine; Placebo; Pregabalin and dexmedetomidine
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): One hour before spinal anesthesia, patients received pregabalin 150 mg capsule orally and the same calculated volume of normal saline till completion of the surgery; One hour before spinal anesthesia, patients received placebo and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery; One hour before spinal anesthesia, patients received placebo and the same calculated volume of normal saline till completion of the surgery; One hour before spinal anesthesia, patients received pregabalin 150 mg orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery.
Other intervention name(s): Lyrica; precedex; study drugs
Intervention MeSH terms: Pregabalin; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregabalin, dexmedetomidine, postoperative pain
Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy
Condition: Type 2 Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional

Summary: 
      The purpose of the real-world observational prospective study is to access the renoprotective
      effects of dulaglutide as well as to explore corresponding mechanisms in patients with Type 2
      Diabetic Nephropathy.
    

Detailed description: 
      Related studies have found that Glucagon-like peptide-1 (GLP-1) receptors are localized on a
      variety of tissues and cell types in addition to pancreatic β-cells, and GLP-1 and GLP-1
      receptor agonists can exert diverse effect on multiple organs and tissues, with pleiotropic
      potential physiological, pathophysiological as well as pharmacological implications. Multiple
      clinical trials suggest that GLP-1 receptor agonists can exert renoprotective effects and
      persuasively inhibit the progression of kidney disease in type 2 diabetic patients. The
      beneficial effects of GLP-1 receptor agonists on Type 2 Diabetic Nephropathy, independent of
      their hypoglycemic ability, might are mediated by anti-oxidative stress, anti-inflammatory
      and natriuresis properties. However, it is not clear whether the above-mentioned properties
      are involved in the EMT process of renal tubular epithelial cells.

      All participants meeting all eligibility criteria received routine medical consultations.
      During routine medical visits, patients were randomized into two groups (1.07:1) to receive a
      total duration of 12 months of hypoglycemic therapy - dulaglutide plus other hypoglycemic
      agents not including GLP-1 receptor agonists (intervention group), and other hypoglycemic
      agents not including GLP-1 receptor agonists (control group). A random number method was
      applied for grouping in this study. Dulaglutide and other hypoglycemic agents were
      administered according to the drug package insert. Of course, the investigators decided on
      other background treatments for hypertension, hyperlipidemia, or cardiovascular-related risk
      factors based on the latest guidelines throughout the trial.
    

Intervention name(s): Dulaglutide Injection
Intervention type(s): Drug
Intervention description(s): Dulaglutide injection was injected subcutaneously at standard dose and frequency for consecutive 12 months in patients with type 2 diabetes and diabetic kidney disease. Other hypoglycemic agents not including GLP-1 receptor agonists were used at standard dose and frequency for consecutive 12 months.
Other intervention name(s): Other hypoglycemic agents not including GLP-1 receptor agonists
Intervention MeSH terms: Dulaglutide; Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dulaglutide; diabetic nephropathy; renoprotective effects
Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study in which healthy adult volunteers will receive BRII-198 or placebo
      and will be assessed for safety, tolerability, and pharmacokinetics.
    


Intervention name(s): BRII-198; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BRII-198 given intravenously; Placebo given intravenously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COVID-19 phase I; monoclonal antibody
Advair Pediatric Once-Daily
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and
      comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of
      age with asthma.
    


Intervention name(s): FP 100mcg; FSC 100/50mcg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once-daily dosing; Once-daily dosing; Once-daily dosing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Mother Scented Simulated Hand for Mechanically Ventilated Preterm Neonates During Invasive Procedures?
Condition: Pain; Distress, Emotional
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study aimed to determine the effect of Mother-Scented Simulated Hand (MSSH) on promoting
      comfort among mechanically ventilated preterm neonates during invasive procedures.

      Research Hypotheses

        -  Preterm neonates who receive MSSHH exhibit higher levels of comfort during invasive
           procedures than those who receive standard care.

        -  Preterm neonates who receive MSSHH exhibit lower levels of pain and stress during
           invasive procedures than those who receive standard care
    

Detailed description: 
      A quasi-experimental, pre-posttest, two group, study was carried out in NICU of in Smouha,
      Alexandria. A sample of 62 mechanically ventilated neonates were randomly assigned to two
      equal groups; the study group wrapped with a warm MSSH during the invasive procedures while
      the control group received standard care of NICU. Two observers independently rated the
      neonates' level of comfort, distress, and pain during Endotracheal Suctioning (ETS) and heel
      prick using COMFORTneo Scale.

      On day one of mechanical ventilation, the neonates received the same standard care of the
      NICU, while they wrapped with a warm Mother-Scented Simulated Hand as follow; simulated hand
      was scented with mothers' body odor by placing it on the mothers' bare chest or behind the
      neck for one hour. Then, the MSSH was placed under a radiant warmer for a couple of minutes
      to reach the mothers' unique warm touch. Inside the incubator, the mechanically ventilated
      neonates were placed in a side-lying flexed fetal position, where they encircled with the two
      warm simulated human hand to contain them. Where the palm of one MSSH cupped the neonates'
      head, and the palm of the other hand cupped the lower part of body and extremities. The
      neonates were kept in such a position throughout the mentioned invasive procedures. Neonates'
      physiological response, comfort, distress, and pain levels were assessed the same way as the
      first day.
    

Intervention name(s): Mother-Scented Simulated Hand; NICU Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Preterm neonates wrapped with a warm Mother-Scented Simulated Hand during the invasive procedures; Neonates were placed in a side-lying position, while their extremities were flexed close to the body and wrapped with rolled sheets or towels to simulate the intrauterine posture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Simulated Hand; Comfort; Pain; Distress; Invasive procedures; Preterm Neonates
The Spanner Prostatic Stent and Patient's Quality of Life
Condition: Prostatic Obstruction
Study type: Interventional

Summary: 
      Acute urinary retention is considered one of the most common problems in the older age,
      especially those who have benign prostatic hyperplasia. Solving the problem of acute urinary
      retention using the Foley catheter still causes problems at the level of patient movement and
      the daily exercises. However, with the emergence of a new device, the spanner, investigators
      believe that many of the above mentioned problems can be resolved. This tool may provide more
      freedom for the patient.
    

Detailed description: 
      This research comes up to date with technological innovations in the field of health where
      investigators want to evaluate the efficacy of a new catheter (The Spanner) to reduce the
      acute urinary retention and to determine whether they are consistent with the daily life of
      the patient, compared to the Foley catheter previously used.

      The study include all patients with acute urinary retention due to prostatic obstruction.
      Subjects were excluded if they had prior surgery for prostate cancer, had any other urethral
      or bladder surgery, or if they were at high risk of developing bladder or kidney stones The
      study will be national community based study conducted in different hospitals in Saudi
      Arabia. Investigators will test two different types of stents in patients with acute urinary
      retention for a short period (not exceeding five days), find out the compatibility of these
      stents with the daily life of the patient and determine their impact on his quality of life
      using an appropriate questionnaire after each use.
    

Intervention name(s): Foley Catheter and The Spanner Insertion
Intervention type(s): Device
Intervention description(s): A Foley catheter will be inserted for 3-5 days, then a voiding trail will be attempted by the patient himself without the catheter. Then, the Spanner will be inserted into the same patient for another 3-5 days and an evacuation trail will be attempted also by the patient after removal of the Spanner. Treatment Satisfaction Questionnaire (TSQ) will be applied by the same person to the patient twice, once after removal of the Foley catheter and the second after removal of the Spanner.
Other intervention name(s): Foley Catheter; The Spanner
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary retention; Foley catheter; The Spanner; Quality of life