bioihbjkbjnl/mcl2 huggingface dataset:
Acute Preoperative Stress and Hypotension After Spinal Anesthesia. SAS for "Salivary Amylase and Stress "
Condition: Planned Cesarean Section
MeSH terms: Hypotension
Study type: Observational

Summary: 
      Spinal anesthesia is the technique of choice for planned cesarean section. It is associated
      with a high frequency of maternal hypotension. Hyperactivity of the sympathetic system
      assessed with the LF/HF ratio (heart rate variability analysis) predicts the severity of
      maternal hypotension after spinal anesthesia. Increased LF/HF ratio may be explained by
      maternal stress that can be measured with salivary amylase. The goal of this study is to
      assess the relationship between salivary amylase and severity of maternal hypotension after
      spinal anesthesia for planned cesarean section.
    

Detailed description: 
      Salivary amylase, heart rate variability, Spielberger state-trait inventory are assessed on
      the morning of surgery, on the surgical ward, and repeated in the operating room, before
      performing spinal anesthesia. Spinal anesthesia use hyperbaric bupivacaine (11 mg),
      sufentanil (5 µg) and morphine (100 µg). Prophylactic treatment of hypotension uses a
      continuous infusion of ephedrine (0.6 mg/ml) and phenylephrine (10 µg/ml). Rate of the
      continuous infusion is adapted to keep maternal systolic blood pressure between 95-105% of
      preinduction values. Total dose of ephedrine and phenylephrine infused from spinal anesthesia
      to delivery of the newborn is recorded (about 20 minutes for the estimated time frame).
      Association between stress markers and total dose of vasoactive drugs will be tested with the
      Spearman's correlation coefficient.

      The study is observational. The subjects do receive a therapeutic intervention but the
      investigator does not assign patients to this intervention since this intervention is a
      routine care (spinal anesthesia for planned cesarian section) that would have been performed
      in the absence of the study.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women undergoing planned cesarean section
      
Biospecimen description: 
      Salivary samples
    
Keywords: Stress; Anxiety; Cesarean Section; Spinal anesthesia; Hypotension
A Study to Compare the Bioavailability of Copegus and Vilona® in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This prospective, randomized, single-blind, cross-over study will compare the bioavailability
      of Copegus (ribavirin) administered as tablets and ribavirin administered as capsules in
      healthy volunteers. Volunteers will be randomized to receive a single dose of 400 mg of
      ribavirin either as a capsule or as tablets; after a washout phase volunteers will be
      crossed-over to the other treatment. The anticipated time on study treatment is 10 days.
    


Intervention name(s): ribavirin [Copegus]; ribavirin [Vilona]
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of 400 mg tablets; Single oral dose of a 400 mg capsule
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to demonstrate the efficacy and safety of omalizumab compared
      with placebo, on top of SoC (anti-histamine and nasal corticosteroid) in adult and adolescent
      patients with severe Japanese cedar pollinosis, whose symptoms were inadequately controlled
      despite the current recommended therapies (nasal corticosteroids plus one or more medications
      out of anti-histamine, leukotriene receptor antagonist, or prostaglandin D2/thromboxane A2
      receptor antagonist) in the previous 2 Japanese cedar pollen seasons.
    


Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Omalizumab were administered by subcutaneous injection. Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) were determined by serum total IgE level (IU/mL) and body weight (kg) measured at the screening epoch according the dosing table.; Placebo were administered by subcutaneous injection. Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) were determined by serum total IgE level (IU/mL) and body weight (kg) measured at the screening epoch according the dosing table.
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cryptomeria, omalizumab, seasonal allergic rhinitis
Development and Validation of a Scale to Measure Fear of ACTivity in Patients With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      Low motivation to exercise is one of the barriers to participation in cardiac rehabilitation.
      Fear of activity after a cardiac event is associated with low levels of physical activity.
      This study aimed to develop and validate a scale to measure fear of activity in patients with
      coronary artery disease.
    

Detailed description: 
      Low motivation to exercise is one of the barriers to participation in cardiac rehabilitation.
      Fear of activity after a cardiac event is associated with low levels of physical activity.
      This study aimed to develop and validate a scale to measure fear of activity in patients with
      coronary artery disease. A scale for Fear of ACTivity in patients with CAD (Fact-CAD) was
      created through semi-structured focus group interviews with patients. Face and content
      validity of Fact-CAD was verified. The scale was applied to 250 patients who had myocardial
      infarction, coronary artery bypass grafting or percutaneous coronary intervention within the
      last 12 months. Psychometric analysis included model fit, unidimensionality, reliability,
      local dependency, differential item functioning and external construct validity. Analyses
      were performed using the Rasch Analysis Model.
    

Intervention name(s): Psychometric analysis
Intervention type(s): Other
Intervention description(s): Psychometric analysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: coronary artery disease; physical activity; cardiac rehabilitation; validation studies; psychometrics
Usability and Satisfaction Test to the Wearable Walking-assist Robot (GEMS-H) in the Community-dwelling Healthy Adults
Condition: Gait Disorders in Old Age
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the userbility and satisfaction of one-off
      functional gait training with the Gait Enhancing and Motivating System-Hip type (GEMS-H) on
      locomotor function in normal adults including the elderly.
    

Detailed description: 
      The GEMS-H is a hip-type assist device developed by the Samsung Advanced Institute of
      Technology. The GEMS-H is worn around the waist and fastened at the waist and thighs by a set
      of belts with velcro to assist motion at the hip joints. The device weighs 2.1kg, and has 2
      brushless direct current motors running on a rechargeable lithium ion battery. The normal
      operation time for the device is 2 hours. The GEMS-H is available in three sizes to fit
      various waist/hip sizes: small, medium, and large. The width of each version can be adjusted
      further to fit individual body size within the circumference range. Also, the thigh frames
      are available in three sizes (large, medium, and small) for different leg lengths. It is
      controlled through a custom built application on a hand held tablet.
    

Intervention name(s): Training with Gait Enhancing and Motivating System (GEMS-H) Robot
Intervention type(s): Device
Intervention description(s): Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with device.
Other intervention name(s): Training with GEMS-H
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Wearable hip assist robot; Gait; User test; Robot gait training; Elderly
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age
Condition: Measles-Mumps-Rubella
MeSH terms: Measles; Rubella; Mumps
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®)
      in the US by generating immunogenicity and safety data in contrast to the US standard of
      care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six
      years of age.
    

Detailed description: 
      The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred
      to as Inv_MMR vaccine and Com_MMR vaccine respectively. 2 lots of the comparator vaccine
      (Com_MMR_L1 and Com_MMR_L2) will be used, but the 2 lots will be analysed as a pool.

      The Inv_MMR vaccine will be administered as a second dose to children who already received a
      first dose Com_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely
      co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or
      Varivax®), some children will receive one dose of these vaccines along with either of the MMR
      vaccines.
    

Intervention name(s): Priorix; M-M-R II; Kinrix; ProQuad
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One dose administered subcutaneously in the triceps region of the right arm.; One dose administered subcutaneously in the triceps region of the right arm.; One dose administered by deep intramuscular injection in the upper left deltoid.; One dose administered subcutaneously in the triceps region of the left arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Measles, mumps and rubella diseases; Immunogenicity
An Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of REGN1193
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy
      volunteers.
    


Intervention name(s): REGN1193; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mindfulness and Yoga or Resistance Exercise Training Fpr Parkinson's Patients
Condition: Resistance Training; Yoga
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The investigators propose to compare the effects of a 16-week specially designed yoga program
      to a power-based resistance training program on affect trait mindfulness, anxiety,
      depression, functionality, and quality of life. As secondary measures, we propose to compare
      the effects of these exercise programs on measures of executive function (EF), sleep, disease
      stage, motor symptoms, muscle quality, rigidity, strength, power, and mobility.
    

Detailed description: 
      Yoga has long been recognized as a therapeutic intervention for improving mindfulness and
      psychological well-being. Yoga represents a unique exercise activity that employs
      mindfulness-based practices and various balance postures to improve physical and mental
      health. Yoga is a gentle form of exercise that can be easily adapted to populations suffering
      from physical and mental limitations and has been shown to improve physical and psychological
      functioning in individuals with PD. Though research continues to support the positive
      psychological effects of yoga, it is unclear whether this is due to the unique
      mindfulness-rooted approach of yoga or general increases in physical activity.

      Power-based resistance training has had promising results in the PD community. Improvements
      in balance, gait, and increases in leg muscle power and strength have been shown in PD
      patients after power training interventions. Although power training is a beneficial exercise
      modality in the treatment of motor symptoms, the effects of power training on nonmotor
      symptoms have yet to be established.
    

Intervention name(s): Yoga; High-speed Resistance Training
Intervention type(s): Other; Other
Intervention description(s): A standard yoga program will be provided using Hatha poses.; Each session will consist of three sets of 10 repetitions each with 1.5 to 2-minute rest periods between sets. Participants will be instructed to control the concentric and eccentric velocity of each exercise, with each phase lasting approximately two to three seconds
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We will compare Yoga and circuit resistance tarining impacts on mindfulness, anxiety, cognition, muscle structure, and physical performance in people with Parkinson's disease.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease
Vaginal Postpartum Pain Management Protocol Comparison
Condition: Pain; Post Partum Depression; Opioid Use; Breast Feeding
MeSH terms: Depression, Postpartum
Study type: Interventional

Summary: 
      Untreated postpartum pain has been associated with increased risk of opioid use, postpartum
      depression and development of persistent pain. In this study the investigators will
      investigate whether a scheduled administration of analgesics is superior to administration of
      analgesics based on patient request following a vaginal delivery.
    

Detailed description: 
      More than two million women deliver vaginally every year in the United States (US). Along
      with the joy and happiness of having a new member in the family, women may suffer from
      cramping pain and lower abdomen discomfort following uterine involution; perineal pain due to
      perineal trauma or episiotomy; and nipple pain from breastfeeding or breast engorgement.

      A stepwise approach using multimodal combination of medications can effectively provide an
      individualized pain management for women in their postpartum period. The first step includes
      non-opioid analgesics (as paracetamol and NSAIDs), step two adds milder opioids (as codeine,
      tramadol and oral morphine), and step three incorporates stronger opioids (as parenteral
      morphine).

      In this study the investigators will investigate whether a scheduled administration of
      analgesics is superior to administration of analgesics based on patient request following a
      vaginal delivery.
    

Intervention name(s): Paracetamol 1000 Mg Oral Tablet; Ibuprofen 400Mg Tab; Paracetamol 1000 Mg Oral Tablet; Ibuprofen 400 mg; MIR
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.; The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.; The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.; The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.; At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet).
Other intervention name(s): Acetaminophen; Acetaminophen
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Women following a vaginal delivery, with no exclusion criteria to participate in the study, will be addressed. After receiving all the information about the study, women who choose to participate will be consented.
All participants will be randomized to either scheduled analgesic administration (study group) or analgesic administration per women's request (control group) as accustomed at the investigator's unit.
Masking: None (Open Label)
Primary purpose: Treatment
Enhancing Empathy in Medical Communication Through Perspective-Taking
Condition: Patient Satisfaction
Study type: Interventional

Summary: 
      Background: Empathy is critical to clinician-patient communication and patient outcomes.
      Perspective-taking, an intervention demonstrated in other contexts to induce empathy, has
      never been studied in a medical context. As a first step in evaluating its potential clinical
      value, the studies described below assess perspective taking in a series of clinical skills
      examinations. These examinations are simulated clinical encounters: students encounter and
      are evaluated by standardized patients (SPs)--actors trained to take on patient roles. Though
      not real clinical encounters, clinical skills examinations have been demonstrated to test
      clinical competency well enough to be incorporated into the licensure examination of the
      National Board of Medical Examiners.

      Objective: To assess if perspective-taking improves the satisfaction of standardized patients
      in three clinical skills examinations.

      Hypothesis: Students receiving a perspective taking intervention will receive better
      standardized patient satisfaction scores than control students.

      Design and Setting: Three randomized, controlled studies. Studies 1 and 3: Junior medical
      students(N = 503), 6-station clinical skills examination. Study 2: physician assistant
      students (N = 105), 3-station clinical skills examination.

      Intervention: The intervention students received a perspective-taking instruction prior to
      their examination asking them to put themselves in their "patients" shoes and to imagine what
      they were thinking and feeling. The control students received standard pre-examination
      instructions. Simulated patients were blind to study condition. Main Outcome Measure:
      Simulated patient satisfaction scores.
    

Detailed description: 
      These studies assess the interaction of students and simulated patients (actors)--no real
      patients were involved.
    

Intervention name(s): Perspective taking instruction
Intervention type(s): Behavioral
Intervention description(s): Students were asked to take the perspective of their standardized patients during clinical skills examinations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: medical communication; empathy; medical education; standardized patients; enhancing "patient" satisfaction
Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Moderate Drinkers
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics of Egalet® morphine when
      administered with alcohol and compare to administration with water.
    

Detailed description: 
      Outcome: Pharmacokinetic parameters
    

Intervention name(s): Morphine sulphate
Intervention type(s): Drug
Intervention description(s): Extended release tablet combined with alcohol or water
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Xenogenous Collagen Matrix Graft With or Without Enamel Matrix Proteins Derivative for Root Coverage
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the reduction of gingival recession of single Miller
      Class I and II defects treated by coronally advanced flap with subepithelial porcine collagen
      matrix graft and / or enamel matrix proteins.
    


Intervention name(s): Mucograft; Emdogain; Coronally Advanced flap
Intervention type(s): Device; Device; Procedure
Intervention description(s): Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.; Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.; Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingival Recession; Coronally advanced flap; Periodontal regeneration
Impact of Resected Gastric Volume on Postoperative Weight Loss After Laparoscopic Sleeve Gastrectomy for Morbid Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Observational

Summary: 
      Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve
      gastrectomy for morbid obesity. Observational study with a mathematical method to approximate
      the calculation of the resected gastric volume after a sleeve gastrectomy and see the outcome
      on weight loss.
    


Intervention name(s): Gastric volume resected in sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Misure of resected gastric volume and outcome
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        final group from which data have been considered 92 patients (47females and 45 males)
      
Keywords: Sleeve gastrectomy; Morbid obesity; Resected gastric volume
A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795
Condition: Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety and tolerability of single and multiple
      subcutaneous (SC) doses of JNJ-75220795.
    


Intervention name(s): JNJ-75220795; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-75220795 will be administered subcutaneously.; Matching placebo will be administered subcutaneously.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment