bioihbjkbjnl/mcl2 huggingface dataset:
Music Therapy for Women, Delivered Via Cesarean Section
Condition: Cesarean Section; Postpartum Period
Study type: Interventional

Summary: 
      Musical therapy is a type of therapy which is performed under a regular method by adjusting
      the physiological and psychological effects of musical tones and melodies in accordance with
      various situations. Therefore, the study was carried out as a randomized controlled trial in
      order to evaluate the effect of music therapy on the level of pain and anxiety in the
      postpartum period in women who delivered via cesarean section.
    

Detailed description: 
      Objectives: The study was carried out in order to determine the effect of music therapy on
      the level of postpartum pain and anxiety in women who delivered via cesarean section.

      Design, setting and subjects: The randomized controlled trial was conducted on 126 women who
      delivered via cesarean section in a tertiary hospital. The subjects were allocated to three
      groups (n=42 each) Interventions: In the experimental group 1 (once a day) and group 2 (twice
      a day) were made to listen to music for 30 minutes for two consecutive days. The control
      group routine care of 30 min a day in bed rest. The Personal Information Form, Visual Analog
      Scale, State-Trait Anxiety Inventory were administered to participants. In the analysis of
      the data, one-way ANOVA, paired t-test, Kruskal Wallis-H and Wilcoxon tests were used.

      Main outcome measures: State anxiety level and pain level.
    

Intervention name(s): Music Therapy
Intervention type(s): Behavioral
Intervention description(s): Music Therapy
Other intervention name(s): musicotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Design, setting and subjects: The randomized controlled trial was conducted on 126 women who delivered via cesarean section in a tertiary hospital. The subjects were allocated to three groups (n=42 each) Interventions: In the experimental group 1 (once a day) and group 2 (twice a day) were made to listen to music for 30 minutes for two consecutive days. The control group routine care of 30 min a day in bed rest. The Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory were administered to participants.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: cesarean section; Music therapy; Anxiety; Pain
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY
      conjugate vaccine when administered with routine infant vaccinations to healthy infants.
    


Intervention name(s): Meningococcal ACWY Conjugate Vaccine; DTaP-IPV-HBV; Hib; Rotavirus; Pneumococcal 7-valent Conjugate Vaccine; HAV; MMR-V; DTaP
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Other intervention name(s): Menveo; Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; ActHIB® (Haemophilus influenzae type b Conjugate Vaccine); RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent; Prevnar®; Havrix® (Hepatitis A Vaccine, Inactivated); ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine); Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal; meningitis; vaccine; infants; Meningococcal meningitis; Meningococcal disease
Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to describe the safety and immunogenicity of Pneumococcal
      Conjugate Formulations in healthy adults 18 through 49 years of age.
    


Intervention name(s): Candidate-1; Candidate-2; Candidate-3; Candidate-4; Candidate-5; Candidate-6; Candidate Control; 13vPnC; PCV15
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Biological; Biological
Intervention description(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; 13-valent pneumococcal conjugate vaccine; 15-valent pneumococcal conjugate vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Obstructive sleep apnea (OSA) is common and has major health implications but treatment
      options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep
      (called "slow wave sleep"), potentially via an increase in the stimulus required to arouse
      from sleep. Here the investigators test the idea that the medication called "tiagabine"
      improves slow wave sleep and reduces OSA severity. The investigators will also test whether
      tiagabine raises the arousal threshold (more negative esophageal pressure), and whether
      detailed OSA "phenotyping" characteristics can predict the improvement in OSA severity with
      this intervention.
    

Detailed description: 
      The current study tests the primary hypothesis that tiagabine improves sleep apnea severity
      in patients with moderate-to-severe sleep apnea (apnea hypopnea index measured in supine
      non-REM sleep; hypopneas defined by 3% desaturation or arousal). The investigators test three
      secondary hypotheses that tiagabine:

        1. increases the proportion of total sleep time in slow wave sleep

        2. raises the non-REM arousal threshold (more negative esophageal pressure) via (1).

        3. is preferentially effective in patients whose OSA phenotype predicts that an increase in
           the arousal threshold is sufficient to resolve OSA versus those without such favorable
           physiology. Favorable physiology is defined here as having a low ventilatory drive at
           which stable breathing is theoretically feasible ("stable Vdrive" is <100% above eupneic
           ventilatory drive) due to any combination of a "high" upper airway muscle response,
           "good" passive anatomy (high Vpassive), and "low" steady-state loop gain (see Owens RL
           et al SLEEP 2014; Wellman A et al J Appl Physiol 2011, 2013; Eckert DJ et al 2013
           AJRCCM).
    

Intervention name(s): Tiagabine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GABA reuptake inhibitor; Placebo comparator
Other intervention name(s): Gabitril
Intervention MeSH terms: Tiagabine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: arousal threshold; phenotype; tiagabine; slow wave sleep
Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of and adherence to a vaginal matrix ring
      (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in
      adolescent and young adult females.
    

Detailed description: 
      This study will evaluate the safety of and adherence to a vaginal matrix ring (VR) containing
      dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and
      young adult females.

      The study will enroll healthy, HIV-uninfected adolescent and young adult females between 16
      and 21 years of age. Participants will be randomized to one of two sequences of one VR
      containing 25 mg of dapivirine to be inserted monthly for 24 weeks and one 200 mg FTC/300 mg
      TDF oral tablet taken daily for 24 weeks. After completing the randomized sequence of two
      study product use periods, participants will then select between the two study products to
      use in the final 24 weeks of the trial. Participants will be able to choose either or neither
      study product during the third product use period. The study includes approximately 76 weeks
      of follow-up per participant.

      Participants will attend monthly study visits, which may include behavioral
      assessments/counseling; physical and pelvic examinations; and blood, urine, and pelvic sample
      collection.
    

Intervention name(s): Dapivirine vaginal ring; FTC/TDF
Intervention type(s): Device; Drug
Intervention description(s): Vaginal ring containing 25 mg of dapivirine; Tablet containing 200 mg FTC/300 mg TDF
Other intervention name(s): Emtricitabine/Tenofovir Disoproxil Fumarate; Truvada
Intervention MeSH terms: Tenofovir; Emtricitabine; Dapivirine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the
      efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified
      (IGIV-C) as a corticosteroid (CS)-sparing agent in subjects with CS-dependent Myasthenia
      Gravis (MG).
    

Detailed description: 
      This study consists of 2 phases: IGIV-C Run-in Phase and Corticosteroid Tapering/IGIV-C
      Maintenance Phase.

      In the Run-in Phase, subjects will receive a total of 3 doses of IGIV-C (1 loading dose of 2
      g/kg and 2 maintenance doses of 1 g/kg) while maintaining a stable dose of corticosteroids.

      In the CS Tapering/IGIV-C Maintenance Phase, subjects will continue 1 g/kg IGIV-C and begin a
      prescribed CS tapering regimen where the CS dose is decreased every 3 weeks.

      Approximately 60 subjects are planned to be enrolled in the study across multiple centers in
      North America and Europe. The total duration of study participation for each subject is up to
      45 weeks.
    

Intervention name(s): IGIV-C; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Run-Phase: 1 loading dose of 2 g/kg IGIV-C and 2 maintenance doses of 1 g/kg IGIV-C
Corticosteroid Tapering/IGIV-C Maintenance Phase: 1 g/kg IGIV-C every 3 weeks for up to 36 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
Condition: Postsurgical Pain
MeSH terms: Hernia, Ventral; Pain, Postoperative
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Three-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety,
      Pharmacokinetics, and Preliminary Efficacy Study of CA-008 (Vocacapsaicin) in Patients
      Undergoing Ventral Hernia Repair
    


Intervention name(s): CA-008 (vocacapsaicin); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single administration of CA-008 (vocacapsaicin) versus placebo; Single administration of CA-008 (vocacapsaicin) versus placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Feasibility of a Multi-Level School Intervention for LGBTQ Youth
Condition: Sexual Minority Stress Experiences Among LGBTQ Youth
Study type: Interventional

Summary: 
      The goal of this R21 grant is to test the feasibility of a theoretically informed,
      LGBTQ-affirming intervention (Proud & Empowered; P&E). Although LGBTQ adolescents experience
      disparities in behavioral health outcomes compared to their heterosexual peers, interventions
      are scarce. For example, LGBTQ adolescents are 3 to 4 times more likely to meet criteria for
      an internalizing disorder and 2 to 5 times more likely to meet criteria for externalizing
      disorders than their heterosexual peers. Our intervention seeks to address disparate
      behavioral health problems such as depression, anxiety and trauma symptomology. Our goal will
      be achieved by completing two specific aims: 1) Assess the feasibility, including
      recruitment, enrollment, fidelity of service delivery, satisfaction, safety, and retention,
      of the intervention in a randomized control trial with four schools, 2) Obtain preliminary
      estimates of intervention effects on key behavioral health symptoms for LGBTQ youth and
      school climate (norms, attitudes, beliefs, behaviors) at the school level in preparation for
      a larger efficacy trial. This innovative R21 application brings together a team of nationally
      recognized minority stress and prevention science experts and responds to a nationally
      established public health need for research from the Institute of Medicine, the National
      Institutes of Health, and the National Gay and Lesbian Task Force.
    


Intervention name(s): Proud & Empowered!
Intervention type(s): Other
Intervention description(s): Proud & Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Muscle Mass During Space Exploration
Condition: Muscle Loss
Study type: Interventional

Summary: 
      The investigators will test the following hypotheses:

        1. Bedrest will blunt the anabolic response to a mixed nutrient meal, facilitating a loss
           of muscle mass and functional capacity that is only partially restored during
           rehabilitation.

        2. Enriching daily meals with leucine will promote protein synthesis and maintain the
           anabolic response to mixed nutrient meal ingestion. This will preserve lean muscle mass
           and function during bedrest and facilitate the recovery of functional and metabolic
           capacity during rehabilitation.
    

Detailed description: 
      Our long-term goal is to identify, prevent and remedy defects in the metabolic pathway that
      contribute to the loss of muscle mass and function during exposure to microgravity.
      Demographic data indicate that the average age of shuttle crew members has increased from
      40.7 yrs in 1995 to 46.7 yrs in 2007 with an increasing number of astronauts over 50 yrs of
      age. We contend that the loss of muscle mass and function during spaceflight is facilitated
      by an age-associated, progressive impairment in the ability to mount an anabolic response to
      standard mixed nutrient meals. We propose that enriching daily meals with a low-volume
      leucine supplement will reduce the deleterious effects of microgravity on skeletal muscle and
      facilitate recovery during rehabilitation.

      We will employ our established 14 day bed rest protocol to model the skeletal muscle
      unloading that occurs during microgravity. We will also examine recovery of muscle mass and
      functional capacity during a 7 day rehabilitation period. We will study 2 groups: CON
      (Bedrest/Recovery + Placebo; n=15), LEU (Bedrest/Recovery + Leucine; n=15). We will assess a)
      markers of translation initiation, b) muscle protein synthesis, c) muscle mass and body
      composition and d) strength and aerobic capacity.
    

Intervention name(s): Leucine; Alanine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3-4g Leucine added to daily meals; Powered amino acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention: leucine
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
TISSUE SHRINKAGE DEPENDS ON FORMOL SOLUTION IN DIFFERENT GASTRIC LOCATIONS
Condition: Shrinking Stomach
Study type: Interventional

Summary: 
      Generally % 10 formol solution is use to do fixation to all specimens after the surgical
      operations for the pathological evaluation. It is known that the formol solution cause amount
      of shrinkage in the tissue volume . This effect of formol solution had researched in
      colon,breast and prostate previously. But there is no evidence about stomach. The purpose of
      this research is that find out the formol effect to the gastric tissue and detect the
      shrinkage percent.
    

Detailed description: 
      All gastric specimens which removed after Laparoscopic Sleeve Gastrectomy will open from the
      major curvature and spread down to the table.in operating room..3 cm x 3 cm three tissue
      samples will collect from the specific locations. These three locations are ; fundus( 1 cm
      from the top of staple line) , corpus (middle of the major curvature , antrum ( 1 cm far from
      the bottom of staple line ). All these points 5 mm far from the major curvature. 6 samples
      will prepare totally. 2 samples for each location ; one mucosa and one all layer of gastric
      wall for each location .These 3 points will examine about wall thickness(mucosa-
      submucosa-muscularis propria -serosa ) After saving the measurements in operating room;the
      gastric specimen will deliver to a pathologist to put the specimen into the % 10 formol
      solution. After 24 hours ;pathologist will save all of new measurements same in operating
      room. The measurements of sample are ;height , length , width . After the completion of the
      measurements the investigator will compare the results found in operating room in fresh
      specimen with pathologist 's results after formol. After that the investigator will be able
      to decide the shrinkage of gastric tissue in % 10 formol solution.
    

Intervention name(s): shrinkage
Intervention type(s): Procedure
Intervention description(s): shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: shrinkage; formol; stomach; gastric wall
Effect of Cimetidine on the PK of Imeglimin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to
      16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed
      by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily
      for 6 days.
    


Intervention name(s): Imeglimin; Cimetidine
Intervention type(s): Drug; Drug
Intervention description(s): 2 singles oral doses of imeglimin 1,500 mg (one at day 1 and one at day 8); 400 mg of cimetidine bid from Day 5 to Day 10
Intervention MeSH terms: Cimetidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; Drug-drug interaction
PHOspholamban RElated CArdiomyopathy STudy - Intervention
Condition: Phospholamban R14del Mutation-related Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 3

Summary: 
      Phospholamban (PLN) R14del mutation carriers may develop dilated cardiomyopathy (DCM) and/or
      arrhythmmogenic cardiomyopathy (ACM). Analogous to other inherited cardiomyopathies, the
      natural course of the disease is age-related ("age-related penetrance"); after a
      presymptomatic phase of variable length many PLN R14del-carriers progress to overt disease,
      and are diagnosed with either DCM or ARVC. PLN is a regulator of the sarcoplasmic reticulum
      Ca2+-ATPase (SERCA2a) pump in cardiac muscle and thereby important for maintaining Ca2+
      homeostasis. Cardiac fibrosis appears to be an early manifestation of disease. The
      investigators hypothesize that treatment of presymptomatic PLN R14del-carriers with
      eplerenone, which by virtue of its mineralocorticoid(aldosterone)-blocking properties is a
      strong antifibrotic agent, reduces disease progression and postpones onset of overt disease.
    

Detailed description: 
      In the Netherlands ≈15% of idiopathic dilated cardiomyopathy (DCM) and ≈10% arrhythmogenic
      right ventricular cardiomyopathy (ARVC) patients carry a single (founder) mutation in the
      gene encoding Phospholamban, PLN R14del. Analogous to other inherited cardiomyopathies, the
      natural course of the disease is age-related ("age-related penetrance"); after a
      presymptomatic phase of variable length many PLN R14del-carriers progress to overt disease,
      and are diagnosed with either DCM or ARVC. PLN is a regulator of the sarcoplasmic reticulum
      Ca2+-ATPase (SERCA2a) pump in cardiac muscle and thereby important for maintaining Ca2+
      homeostasis. Cardiac fibrosis appears to be an early manifestation of disease. The
      investigators hypothesize that treatment of presymptomatic PLN R14del-carriers with
      eplerenone, which by virtue of its mineralocorticoid(aldosterone)-blocking properties is a
      strong antifibrotic agent, reduces disease progression and postpones onset of overt disease.
    

Intervention name(s): Eplerenone
Intervention type(s): Drug
Intervention description(s): eplerenone (inspra; pfizer) one tablet (50mg standard dosis; 25mg reduced dosis) per day
Other intervention name(s): Inspra
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phospholamban; cardiomyopathy; Eplerenone; presymptomatic