bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Yoga in Pregnancy on Cardio-respiratory Adaptation to Challenge
Condition: Yoga; Pregnancy; Autonomic Nervous System
Study type: Interventional

Summary: 
      Yoga has received considerable attention for its potential therapeutic benefits over the past
      decades and it gradually became object of scientific scrutiny. There is currently extensive
      literature supporting its use as a non-pharmacological tool for managing a variety of medical
      problems. A few studies have also explored potential beneficial effects of practising yoga
      during pregnancy on maternal and neonatal outcomes. An association between prenatal yoga and
      decreased incidence of fetal growth restriction, preterm delivery, and labor abnormalities
      resulting in operative delivery have been reported.

      Exact mechanisms by which yoga could improve perinatal outcomes have not been elucidated yet.
      One of such mechanisms could be the positive effect of yoga on autonomic nervous system
      (ANS). Maternal cardiovascular system undergoes profound changes during pregnancy and ANS
      plays a central role in adaptation to pregnancy-related hemodynamic changes. Increase in
      peripheral vascular resistance that characterises hypertensive disorders in pregnancy with
      fetal growth restriction is mediated by substantial increase in sympathetic vasoconstrictor
      activity. Effects of yoga on ANS outside of pregnancy have already been investigated in
      several studies. Heart rate variability (HRV) indices, used as a one of proxy measures for
      ANS activity, showed significant shifts towards parasympathetic dominance following yoga
      sessions. Another objective means of assessing ANS activity is measurement of phase
      synchronisation between cardiovascular and respiratory systems following acute challenge. The
      higher the cardiorespiratory synchronisation after acute challenge is, the higher is the
      ability of ANS to flexibly adapt to challenge.

      The objectives of the study are:

      I. To examine whether there is a short-term shift in autonomic balance to the parasympathetic
      branch of the ANS and ability of the cardiovascular and respiratory respiratory systems to
      flexibly adapt to acute psychological challenge following sessions in pregnancy.

      II. To investigate potential long- term effects of yoga practice during pregnancy on HRV and
      cardio-respiratory synchronisation following acute psychological challenge.
    


Intervention name(s): weekly yoga classes; walk
Intervention type(s): Other; Other
Intervention description(s): Weekly 90 min pregnancy-adapted yoga classes lead by certified yoga instructors.; 20-30 min easy walking
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: yoga; pregnancy; cardiorespiratory synchronisation; hearth rate variability
The Effect of Menu Labels on Calories Ordered in Hispanics
Condition: Food Selection
Study type: Interventional

Summary: 
      Most studies on menu labels have been conducted in mostly non-Hispanic white individuals, and
      how menu labels affect calories and macronutrients ordered in Hispanics is not clearly
      understood. This study evaluated the impact of menu labels on calories and macronutrients
      ordered in Hispanics.
    

Detailed description: 
      According to review studies, calorie labels on menus is not effective in reducing the number
      of calories ordered or consumed. Adding contextual information such as the energy needs per
      meal or interpretive information such as minutes of walking needed to burn the food calories
      or rank-ordering the food items from the lowest to the highest calorie content may be more
      effective in making food selections with fewer calories. Most studies on menu labels have,
      however, been conducted in mostly non-Hispanic white individuals, and how menu labels affect
      food choices in Hispanics in not well understood. This study evaluated the impact of menu
      labels on calories and macronutrients ordered in Hispanics by randomly assigning the
      participants to a menu with no labels (no labels), a menu with rank ordered calorie labels
      and a statement on the energy needs per meal (calorie labels), and a menu with rank ordered
      exercise labels (exercise labels). Calories and macronutrients ordered by the participants
      was assessed.
    

Intervention name(s): Calorie Labels; Exercise Labels; No Labels
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.; Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.; Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A
Condition: Contraception
Study type: Interventional

Summary: 
      The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device
      consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and
      bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial
      pilot of 15 women, there were no complications during the 12 months. This observational pilot
      study of 50 women will determine that the early expulsion rate is not greater than 10% and
      that there is patient and physician acceptance, so that we can plan a larger randomized
      controlled trial for efficacy and safety.
    


Intervention name(s): IUB
Intervention type(s): Device
Intervention description(s): intrauterine contraceptive device
Other intervention name(s): SCu380A IUB™
Intervention model: Single Group Assignment
Intervention model description: intrauterine contraceptive device IUB
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: intrauterine device, contraception
Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma
Condition: Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This research study is being done to see if combining the investigational chemotherapy drug,
      MEDI-551 with the known anti-myeloma drugs, Lenalidomide and Dexamethasone will reduce your
      myeloma cancer stem cells.
    

Detailed description: 
      To explore the effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer
      stem cells (CSCs). Myeloma CSCs will be assessed by a clonogenic assay from the bone marrow
      and flow cytometry from peripheral blood.
    

Intervention name(s): Lenalidomide, Dexamethasone, and MEDI-551
Intervention type(s): Drug
Intervention description(s): Patients will receive Lenalidomide and dexamethasone as per standard of care. Patients with a clinical response after 2 cycles will get 2 cycles of MEDI-551.
Intervention MeSH terms: Dexamethasone; Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Validation of a Scale of Well-being at Work
Condition: Adjustment Disorder
MeSH terms: Adjustment Disorders
Study type: Interventional

Summary: 
      The main objective of this work is to explore the psychometric properties of scale of
      well-being at work called "Serenat" in order to validate it. Secondary objectives are to
      study the influence of socio-demographic characteristics of the subjects on the results of
      Serenat and to describe the results on subjects monitored among an adult psychiatric
      population.
    

Detailed description: 
      This is a cross sectional survey. 200 subjects were selected among people having consulted an
      occupational doctor to validate the scale in the general population (study 1), and 50
      subjects among a psychiatric population for the ancillary study (study 2).

      The Serenat Scale is a self-report questionnaire composed of 20 items. All items are scored
      on a four point Likert scale ranging from 0 (strongly disagree) to 3 (strongly agree)
      resulting in a range of 0 to 60. The 20 items are related to different domains. 10 items
      explore psychological balance at work: relaxation (item 1), sleep quality (item 2),
      concentration (item 3), form (item 4), sense of security (item 5), satisfaction (item 6),
      quality of relationships and contacts at work (item 7), voltage or aggressiveness (item 8),
      optimism for the future from a professional point of view (item 9), life balance (item 10).
      10 items are related to working conditions and organization of work: comfort of the working
      environment (item 11), time constraint (item 12), sense of competence (item 13), decision
      latitude (item 14), interest at work and variety of tasks (item 15), recognition (item 16),
      professional support (item 17), communication and transfer of information (item 18), human
      conflict (item 19), satisfactory work schedules (item 20).
    

Intervention name(s): filling of Serenat at baseline (T1); Serenat at baseline T1 and 3 others questionnaires; filling of Serenat, HADS, STAY-Y and BDI at baseline T1
Intervention type(s): Other; Other; Other
Intervention description(s): Patients who consult occupational doctor complete the serenat questionnaire.The time taken to complete the serenat scale is about 5 minutes.; Subjects who consult occupational doctor complete the 4 questionnaires.The time taken to complete the 4 questionnaires is about 15 minutes.; Patients who consult a psychiatrist in a stress anxiety unit complete the 4 questionnaires.
Other intervention name(s): filling of Serenat at T1 (baseline); Serenat and 3 others questionnaires at T1; filling of Serenat at baseline T1 and T2 (one week later)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: mental health; well-being at work; screening; psychosocial risk; psychometrics; questionnaire; job stress
A Family Centered Intervention to Promote Optimal Child Development
Condition: Developmental Delays
Study type: Interventional

Summary: 
      This is a randomized controlled trial aimed at assessing the effectiveness of a patient
      decision aid (PDA) and text message reminder in promoting early intervention referral
      completion when infants and toddlers are identified with a developmental concern in the
      pediatric medical home. Subjects will be randomized to one of two study arms- (1)
      intervention (2) control condition. Subjects in the intervention arm will watch a video PDA
      and will receive a text message reminder approximately 7 to 14 business days after enrollment
      if they agree to the early intervention referral.
    


Intervention name(s): Patient Decision Aid
Intervention type(s): Other
Intervention description(s): Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Children; Developmental Delays; Early Intervention (EI); Patient Decision Aid (PDA)
Evaluate Effects of Meropenem-Vaborbactam on QT/QTc in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Thorough-QT (TQT) study in healthy volunteers will be conducted in two phases. Phase One
      will be used to identify a safe supratherapeutic dose to be used in the TQT study (Phase
      Two). Phase Two will be a 4-way crossover TQT study. Thirty-two subjects will receive all 4
      of the following treatments in randomized sequence.

        1. meropenem-vaborbactam 4 g (meropenem 2 g- vaborbactam 2 g) therapeutic dose infused
           intravenously over 3 hours

        2. meropenem-vaborbactam supratherapeutic dose to be determined infused intravenously over
           3 hours.

        3. Placebo (normal saline) to match meropenem-vaborbactam volume infusion over 3 hours

        4. Moxifloxacin 400 mg positive control (oral; open-label)
    

Detailed description: 
      This Thorough-QT (TQT) study in healthy volunteers will be conducted in two phases. Phase One
      (n=15) will be used to identify a safe supratherapeutic dose to be used in the TQT study
      (Phase Two). Phase Two will be a randomized, placebo and positive-controlled, 4-way crossover
      TQT study. Thirty-two subjects will receive all 4 of the following treatments in randomized
      sequence.

        1. meropenem-vaborbactam 4 g (meropenem 2 g- vaborbactam 2 g) therapeutic dose infused
           intravenously over 3 hours

        2. meropenem-vaborbactam supratherapeutic dose to be determined infused intravenously over
           3 hours.

        3. Placebo (normal saline) to match meropenem-vaborbactam volume infusion over 3 hours

        4. Moxifloxacin 400 mg positive control (oral; open-label)
    

Intervention name(s): meropenem-vaborbactam; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Meropenem-Vaborbactam being studied for effects on TQT; Placebo; Active Comparator
Other intervention name(s): Vabomere; Saline; Moxi
Intervention MeSH terms: Moxifloxacin; Meropenem; Vaborbactam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This was a multiple centers, single-dose, open-label, randomized two-sequence crossover,
      two-period study to evaluate the pharmacokinetics (PK) of single doses of Diazepam Buccal
      Film (DBF) compared with Diastat® Rectal Gel (DRG) under fed conditions in adult male and
      female participants on a stable concomitant regimen of anti-epileptic drugs for the treatment
      of epilepsy.
    

Detailed description: 
      Period 1 was a randomized, 2-sequence, crossover study in which participants received DBF and
      DRG following a moderate-fat meal in a randomized sequence with a washout period of 28 days
      between doses. DBF dose was based on body weight according to the currently recommended dose
      regimen (derived by Aquestive from population PK modeling in healthy volunteers). DRG dose
      was based on body weight according to the current product labeling for DRG.

      Period 2: Participants who completed Period 1 were asked to participate in a second period on
      a voluntary basis during which volunteers received a second dose of DBF administered at the
      same dose and in exactly the same manner as the earlier dose of DBF with the exception that
      DBF was administered following a high-fat meal.
    

Intervention name(s): Diazepam Buccal Film; Diastat® Rectal Gel (Valeant Pharmaceuticals USA)
Intervention type(s): Drug; Drug
Intervention description(s): Diazepam Buccal Film administered on inner aspect of the cheek at the recommended dose regimen (10 mg to 17.5 mg according to body weight) following ingestion of a moderate fat meal and following ingestion of a high-fat meal.; Diastat Rectal Gel administered rectally according to product label administration and dosing instructions (10 mg to 20 mg according to body weight) following ingestion of a moderate-fat meal.
Other intervention name(s): DBF; DRG
Intervention MeSH terms: Diazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study consisted of 2 periods. In Period 1 , participants received a single dose of Diazepam Buccal Film or Diastat Rectal Gel in a randomized sequence following a moderate fat meal with a 28-day washout between doses. Subjects who completed Period 1 were asked to participate in a second period (Period 2) on a voluntary basis. Those subjects who agreed to participate in Period 2 received a second dose of DBF in exactly the same dose and manner as the earlier dose with the exception it was administered following a high fat meal.
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Diaphragm in Chronic Obstructive Pulmonary Disease Patients by Ultrasound in Relation to Severity
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The study of the diaphragm is an important point in the assessment of COPD patients.

      Ultrasonographic evaluation of the diaphragm is considered a simple, non-invasive, available
      bedside technique. Ultrasonography can be used for evaluation of the site, structure, and
      motion of the diaphragm, assessment of excursion, and thickness.

      The aim of the study is ultrasonographic assessment of the diaphragm in COPD patients and its
      relation to disease severity
    

Detailed description: 
      The study was conducted on eighty patients, forty COPD patients who were diagnosed and
      classified into four groups according as following: The first group: included 10 patients
      with a mild stage. The second group: included 10 patients with a moderate stage. The third
      group: included 10 patients with a severe stage. The fourth group: included 10 patients with
      a very severe stage. The study also included forty healthy individuals of the same age and
      sex as COPD patients. All participants gave their informed consent for inclusion before
      sharing in the study. Every person was submitted to: Full medical history, Clinical
      examination,Chest x-ray, spirometry and ultrasonographic assessment of diaphragm function
      (thickness and excursion)
    

Intervention name(s): ultrasonography
Intervention type(s): Device
Intervention description(s): ultrasound assessment of diaphragm function
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        40 COPD patients and 40 age matched healthy control
      
Keywords: ultrasonography, diaphragm, COPD, Fayoum
Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
Condition: Partial Seizures (With or Without Secondary Generalized Seizures); Primary Generalized Tonic-clonic Seizures
MeSH terms: Neoplasm Metastasis; Epilepsy; Seizures
Study type: Observational

Summary: 
      The objective of this study is to identify the following in adolescent epilepsy participants
      with partial-onset seizures (with or without secondary generalized seizures) or primary
      generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:

        1. unknown adverse drug reactions (ADRs);

        2. occurrence of ADRs;

        3. factors that are likely to affect safety and efficacy;

        4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse
           events, and falls as priority investigation items;

        5. occurrence of psychiatric adverse events as priority investigation items (eg,
           aggression).
    


Intervention name(s): Fycompa
Intervention type(s): Drug
Intervention description(s): The usual oral dosage for adults and children 12 years of age or older is initially 2 milligrams (mg) once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer. The maintenance dose is 8 mg once daily in the absence of concomitant antiepileptic drugs that accelerate the metabolism of this product, or 8 to 12 mg once daily in the presence of such concomitant drugs. The dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants with epilepsy who will receive Fycompa per the approved indication in routine
        clinical practice
      
Keywords: adolescent epilepsy participants; partial seizures; primary generalized Tonic-clonic seizures
A Study to Test Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of Zampilimab in Healthy Participants
Condition: Healthy Study Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)
      of zampilimab in healthy study participants.
    


Intervention name(s): Zampilimab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single intravenous dose of zampilimab at a pre-specified time point.; Participants will receive matching placebo at a pre-specified time point to maintain the blinding.
Other intervention name(s): UCB7858; PBO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy study participants; UCB7858; zampilimab; Phase 1