bioihbjkbjnl/mcl2 huggingface dataset:
Brain and Meditation (BAM) Study
Condition: Stress; Behavior
Study type: Interventional

Summary: 
      This study is a randomized controlled trial to test the impact of an app-based meditation
      program on perceived stress and behavioral correlates of stress with known neurobiological
      correlates. Healthy adult participants between the ages of 25-65 will be enrolled in the
      study for about 4-5 months.
    

Detailed description: 
      Participants will be randomized into one of two groups: the intervention group or the
      waitlist control group. The intervention group will use a mobile health app for four weeks.
      Participants will complete pre-intervention, weekly, post-intervention, and 3-month follow-up
      surveys and tasks.

      Primary Objective: Test for hypothesized group differences in perceived stress during
      participation in a 4-week meditation program and at 3-month follow-up.

      Secondary Objective: Within the meditation group, determine whether reductions in perceived
      stress are associated with changes in hippocampal-dependent behavior.
    

Intervention name(s): mHealth Meditation
Intervention type(s): Behavioral
Intervention description(s): Participants will receive access to the 4-week Healthy Minds Program (HMP) Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
Other intervention name(s): mobile health app
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy minds program; mobile health
Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants
Condition: Neurodevelopmental Disorder; Bilateral Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal; Neurodevelopmental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective randomized controlled trial comparing dexmedetomidine sedation with
      caudal anaesthesia, and general sevoflurane anaesthesia with caudal anaesthesia for inguinal
      herniotomies in neonates and infants below 3 months of age.

      The investigators will compare the efficacy and adverse events associated with each of these
      techniques and neurodevelopmental outcomes of the infants in each group at 6 months and 2
      years of age.
    

Detailed description: 
      Several epidemiologic studies have suggested that children exposed to general anaesthesia
      (GA) in early childhood may be at increased risk of subsequent learning disabilities and
      behavioural problems. Animal studies have shown that exposure to GA agents during critical
      neuro-developmental windows induces neuronal apoptosis. All commonly used anaesthetic agents
      induce neurotoxicity with the exception of dexmedetomidine, a highly specific alpha-2 agonist
      which has been shown to be neuroprotective.

      GA is the current standard of care for inguinal hernia repair in infants at KKH. The
      investigators recently demonstrated that dexmedetomidine sedation with caudal block is a
      feasible alternative for inguinal hernia repair in infants below 3 months of age. This
      prospective randomized controlled trial will compare the early and long-term outcomes of
      infants following inguinal hernia surgery using dexmedetomidine sedation with caudal block
      versus GA with caudal block.

      This study aims:

        1. To compare the neurodevelopment at 6 months and 2years, of infants randomized to
           dexmedetomidine sedation with caudal block with those randomized to GA with caudal block
           for inguinal hernia surgery before 3 months of age.

        2. To compare the efficacy of dexmedetomidine sedation with caudal block versus GA with
           caudal block for inguinal hernia surgery, in terms of duration of anaesthesia, duration
           of surgery and surgeon's satisfaction with intraoperative conditions.
    

Intervention name(s): Dexmedetomidine sedation; General sevoflurane anaesthesia; Caudal anaesthesia; Inguinal hernia surgery
Intervention type(s): Drug; Drug; Procedure; Procedure
Intervention description(s): Patients receive dexmedetomidine sedation; Patients receive general sevoflurane anaesthesia with endotracheal intubation; single shot caudal anaesthesia; Infant inguinal hernia repair.
Other intervention name(s): Dex; Gas; Caudal; Inguinal herniotomy
Intervention MeSH terms: Dexmedetomidine; Anesthetics; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexmedetomidine sedation; General anaesthesia; Neurodevelopment; Infants; Neonates
Sodium Bicarbonate Supplementation in Combat Sports Athletes
Condition: Supplementation; Sport
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to verify the effect of 10-day sodium bicarbonate (NaHCO3) and
      placebo (PLA) supplementation on physical and specific performance capacity, as well as
      concentrations of the selected biochemical blood markers in trained combat sports athletes,
      in a randomised, double-blind, placebo-controlled trial.
    

Detailed description: 
      Sodium bicarbonate (NaHCO3) was proposed as an ergogenic agent, because it improves
      high-intensity and resistance exercise performance. Until now the major limitation to NaHCO3
      supplementation has been the gastrointestinal (GI) side effects. Therefore, this study aims
      to examine the effect of chronic, progressive-dose NaHCO3 ingestion on physical capacity and
      specific performance capacity, and concentrations of the selected biochemical blood markers
      in trained combat sports athletes, in a randomised, double-blind, placebo-controlled trial.
    

Intervention name(s): Sodium bicarbonate supplementation; Placebo treatment
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The experimental procedure for each athlete included a 10-day NaHCO3 supplementation in a progressive-dose regimen in order to reduce the likelihood of gastrointestinal side effects (from 25 to 100 mg ∙ kg-1). NaHCO3 was administered in the form of unmarked disk-shaped tablets (Alkala T, SANUM, Poland). The tablets were ingested with at least 250 mL of water and could be either swallowed or dissolved in the mouth. On training days the supplements were taken in the morning, in the evening and 1.5 hours before training session. On rest days the supplements were taken in the morning, in the afternoon and in the evening.; The experimental procedure for each athlete included a 10-day placebo administration. Placebo was ingested with at least 250 mL of water. On training days the supplements were taken in the morning, in the evening and 1.5 hours before training session. On rest days the supplements were taken in the morning, in the afternoon and in the evening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sodium bicarbonate; NaHCO3; Combat Sports; Physical capacity; Dummy test
Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery
Condition: C.Surgical Procedure; Gastrointestinal
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      Postoperative nausea and vomiting (PONV) are common in patients, especially in patients at
      high risk. PONV may result in prolonged hospital stay and threaten patients' life. Because
      the etiology of PONV is very complex, there is an increasing focus on combining antiemetics
      from different classes for PONV prophylaxis. Fosaprepitant is a neurokinin-1 (NK-1) receptor
      antagonist to prevent PONV. Palonosetron is a 5-HT3 receptor antagonist with high efficacy
      and sustained action for PONV prophylaxis. Dexamethasone belongs to corticosteroid and also
      has the ability to reduce the incident of PONV. This study aims to use the combination of
      these three drugs in high-risk patients to test whether triple therapy is better than
      combination of palonosetron and dexamethasone to prevent PONV.
    

Detailed description: 
      This trial is a prospective, randomized controlled study with blinded participant, care
      provider, investigator, and outcomes assessor. 1154 patients aged 18 to 75 years undergoing
      laparoscopic gastrointestinal surgery will be enrolled.Triple therapy of palonosetron and
      dexamethasone plus fosaprepitant will be administered in the intervention group, and double
      therapy of palonosetron and dexamethasone will be used in the control group. The anxiety of
      patients will be evaluated. The primary outcome is proportion of participants with PONV
      during the first 24 postoperative hours. Secondary outcomes are as follow: proportion of
      participants with PONV,emetic episodes, nausea, with rescue antiemetic medication; the scores
      of QOR-15; pain scores;time to first flatus after surgery; time to first defecation after
      surgery; recovery time; health related quality of life; proportion of participants with
      adverse events.
    

Intervention name(s): palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl; palonosetron, dexamethasone, and 0.9% NaCl
Intervention type(s): Drug; Drug
Intervention description(s): palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, fosaprepitant 150mg dissolved in 0.9% NaCl 150ml, iv.drip,; palonosetron 0.075 mg, iv, dexamethasone 5mg, iv, 0.9% NaCl 150ml, iv.drip,
Other intervention name(s): Triple therapy; double therapy
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Palonosetron; Fosaprepitant; Aprepitant; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: postoperative nausea and vomiting, fosaprepitant,
Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety
      of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.
    


Intervention name(s): LDT600 (Telbivudine)
Intervention type(s): Drug
Intervention description(s): LDT600 (Telbivudine)
Intervention MeSH terms: Telbivudine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Chronic hepatitis B,; telbivudine,; pharmacokinetics,; safety,; tolerability,; pediatric
A Randomized, Double-blind Clinical Trial to Evaluate the Safety and Efficacy of the X5 HairLaser for the Treatment of Androgenetic Alopecia in Males
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The overall purpose of this clinical investigation is to collect data to support a marketing
      application for over the counter use of the X5 HairLaser with an indication for hair growth.
      The goal of this protocol is to demonstrate that the intended users of the X5 HairLaser can
      safely and effectively perform self-use application by following written instructions.
    


Intervention name(s): X5 HairLaser; X5 Hair Laser Sham Device
Intervention type(s): Device; Device
Intervention description(s): Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.; Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.
Intervention model: Parallel Assignment
Primary purpose: Treatment
Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple dose safety and pharmacokinetics in healthy male subjects
    


Intervention name(s): PF03635659; PF03635659; PF03635659; PF03635659; PF03635659
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Inhaled doses of 200 mcgQD; Inhaled doses of 600 mcg QD; Inhaled doses of 1000 mcg QD; Inhaled dose to be decided based on all available data from previous cohorts. It will run if maximum tolerated dose is not identified from previous cohorts or if a lower dose is required to be investigated.; Inhaled dose to be decided based on all available data from previous cohorts. It will run if maximum tolerated dose is not identified from previous cohorts or if a lower dose is required to be investigated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Multiple dose safety and pharmacokinetics study
Effects of Peri Partum Integrated Nursing Care Versus Routine Care in Placenta Previa : A Randomized Controlled Trail
Condition: Placenta Previa Total; Nursing Role
MeSH terms: Placenta Previa
Study type: Observational

Summary: 
      At our institution, the annual number of placenta previa was 494 cases (1.7%); of whom 95
      cases (19.2%) were proved to have a placenta accreta. Perioperatively, they are subjected to
      regular care of a tertiary university hospital. This study aims to determine the
      effectiveness of peri partum integrated nursing care for the patients with placenta previa
      versus routine care.
    

Detailed description: 
      Study design:

      Experimental design: (randomized control trail)

      Setting:

      This study will be conducted at Woman's Health Hospital, Assiut University, emergency
      department and inpatient department.

      Sample:

      A convenience sample will be used, the total sample will include (100) patients with placenta
      previa, divided into two group1:1

        -  group 1: 50 patients study group

        -  group2: 50 patients control group
    

Intervention name(s): Integrated Nursing care of placenta previa
Intervention type(s): Procedure
Intervention description(s): Phase I :( preparation phase) Phase II: (Implementation phase) includes Preoperative care , intraoperative care and postoperative care by a nurse.
Phase III: (Evaluation phase)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant Placenta previa
      
Keywords: placenta previa; Nursing; antepartum hemorrhage; randomized trial
A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
Condition: Alzheimer's Disease; Huntington's Disease
MeSH terms: Alzheimer Disease; Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Dimebon will not exhibit abuse potential when compared to placebo or a positive control
      (alprazolam).
    

Detailed description: 
      The main purpose for this study is to determine whether dimebon exhibits abuse potential.
    

Intervention name(s): dimebon; dimebon; dimebon; placebo; alprazolam; alprazolam
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral tablet; 20 mg dimebon, single dose; Oral tablet; 40 mg dimebon, single dose; Oral tablet; 60 mg dimebon, single dose; Oral tablet or capsule; placebo, single dose; Oral capsule; 1 mg alprazolam, single dose; Oral capsule; 3 mg alprazolam, single dose
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: oral single-dose 6-way crossover recreational drug users abuse potential pharmacodynamics safety
Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy
Condition: Obesity; Pregnancy; Gestational Diabetes
MeSH terms: Diabetes, Gestational
Study type: Observational

Summary: 
      Background :

      Apelin and its receptor APJ have been implicated in pathologies including cardiovascular
      disease, diabetes and obesity. Little is known about the function of the apelinergic system
      during gestation.

      Objective :

      The main objective of this study is to compare apelinemia in fasting normal weight and obese
      women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).

      Strategy and method:

      A prospective research evaluating will be conducted to compare apelinemia in fasting normal
      weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).

      A third group will be created to check if gestational diabetes is not a confounding factor in
      obesity (group of obese women with gestational diabetes).

      Investigators will try to see if apelinemia is correlated to lipidic and glycemic markers.

      Samples will be collected in the cord blood to compare maternal and neonatal apelinemia and
      to see if neonatal apelinemia is correlated to the child's weight and birth size and to the
      weight of the placenta.

      Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.

      Two days after delivery, obese and not obese women will be fasted and plasma and colostrum
      will be collected. Investigators will compare apelin levels in the colostrum between these 2
      groups and then investigators will try to see if apelin level is correlated in the colostrum
      and in maternal plasma.
    

Detailed description: 
      Background :

      Apelin and its receptor APJ have been implicated in pathologies including cardiovascular
      disease, diabetes and obesity.

      Little is known about the function of the apelinergic system during gestation.

      In a previous study, investigators evaluated in mice this system at the feto-maternal
      interface in insulin-resistant obese female (HF) mice. Maternal apelinemia was decreased at
      term and fetal apelinemia was sixfold higher than maternal level. Ex-vivo, the placenta
      releases high amount of apelin at E12.5 and E18.5. In HF pregnant mice at term, apelinemia as
      well as placental apelin and APJ mRNA levels were increased whereas placental release of
      apelin was drastically reduced.
    

Intervention name(s): blood sample
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women between 18 and 42 years old, pregnant, between 35 and 40 WG.
      
Biospecimen description: 
      Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.
    
Keywords: apelin; colostrum; plasma; glycemic markers; lipidic markers; pregnancy; postpartum
Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK),
      safety and efficacy of sotagliflozin following daily oral administration for 29 days in
      participants with type 1 diabetes mellitus (T1DM).
    


Intervention name(s): Sotagliflozin; Placebo; Sotagliflozin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants received sotagliflozin once daily for 29 days. Pioneer Group participants were to have completed dosing prior to any study drug administration in Expansion Groups.; Participants received placebo-matching sotagliflozin tablets once daily for 29 days.; Participants received sotagliflozin once daily for 29 days; pioneer participants completed dosing prior to dosing any other study participants.
Other intervention name(s): LX4211; LX4211
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Kinesio Taping on Pain and Quality of Life in Pregnancy-Related Low Back Pain
Condition: Pregnancy-related Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Pregnant women may experience pregnancy-related low back pain and this pain may negatively
      affect function. There are studies in the literature that Kinesiotape applications improve
      pain. There is no study examining the effect of Kinesiotape application in addition to
      exercise on pregnancy-related low back pain and function. At the end of our study, we will
      compare the effects of Kinesiotape application for a total of 8 sessions for 4 weeks on pain
      and function.
    

Detailed description: 
      Kinesio tape (KT) application is a physiotherapy method whose use has increased in recent
      years in the treatment of chronic pain. Kinesio tape, an alternative method to support
      fascia, muscles and joints, Dr. Developed by Kenzo Kase. Although the therapeutic effects of
      the KT method are still unclear, the putative therapeutic effects include facilitating muscle
      activity, providing sensory stimuli to the skin, muscles or facial structures, and regulating
      joint range of motion (ROM) . KT method increases blood and lymph circulation by lifting the
      skin, and prevents pain by reducing nociceptive stimuli . KT has been administered to
      pregnancy to improve low back pain. In addition to publications showing that KT can reduce
      pregnancy-related low back pain, there are studies showing that it has no effect compared to
      the control group . The aim of this study is to examine the effect of 8 sessions of KT
      applied in addition to 4-week core stabilization exercises on pain and quality of life in
      pregnant women with pregnancy-related low back pain.
    

Intervention name(s): Kinesio tape application and Core stabilization home program; Core stabilization home program
Intervention type(s): Other; Other
Intervention description(s): Participants in the kinesiotape group will receive 2 sessions of kinesiotape per week, in addition to the core stabilization home program, 5 days a week for 4 weeks.; Core stabilization exercises will be given to the participants as a home exercise program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Core stability and pelvic floor exercises will be compared with kinesiotape application.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pregnancy; Low back pain; Function; Kinesiologic tape; core stabilization