bioihbjkbjnl/mcl2 huggingface dataset:
Assessing the Impact of Acupuncture Therapy on Medical Resident Well-Being: Feasibility and Acceptance
Condition: Exhaustion; Syndrome
Study type: Interventional

Summary: 
      This feasibility study develops methods for larger-scale research, evaluating the
      acceptability and perceived impact of a group acupuncture and acupressure intervention, as
      well as suitability of a self-report instrument. During their weekly training program, eleven
      OB residents at NYU Lutheran Medical Center will receive three sessions of auricular
      acupuncture therapy. (This resident population was previously anonymously surveyed and all
      expressed interest in participating in such a study). The Professional Quality of Life Scale
      (ProQOL) will be administered at 6 time points. A brief survey will also be given to assess
      participants' acceptance of the intervention as well as applicability of the ProQOL
      instrument. Additional feasibility-related outcomes include protocol compliance/withdrawals,
      adverse events, and time taken to complete intervention and surveys.
    


Intervention name(s): Auricular Acupuncture Therapy
Intervention type(s): Behavioral
Intervention description(s): Acupuncture treatment will be the NADA protocol, a well-known and commonly used protocol that has previously been studied for stress relief in health care workers.In this protocol, 5, ½" needles are inserted in each auricle and retained while the group relaxes for 20 minutes. It will be conducted by two acupuncturists credentialed at NYU Lutheran (TK and AG).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Medical Residents; Well-Being; Stress/Burnout in Medical Residents
Temporomandibular Joint in Patients With Rheumatoid Arthritis
Condition: Temporomandibular Joint Disorders; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Observational

Summary: 
      the investigators study aimed to evaluate temporomandibular joint involvement in rheumatoid
      arthritis patients and healthy individuals 142 participants were recruited in two groups: 72
      patients with Rheumatoid Arthritis (RA), and 70 healthy controls. All participants were
      tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies. TMD
      diagnosis was determined according to the standardized and validated diagnostic criteria for
      TMD (DC/TMD): myalgia, arthralgia, articular disc, displacement, degenerative joint disease,
      and headache attributed to TMD. Bruxism, a probable sleep and/or awake bruxism diagnosis was
      determined based on self-report and several clinical findings.
    


Intervention name(s): seropositivity of rheumatoid factor
Intervention type(s): Diagnostic Test
Intervention description(s): All participants were tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies
Other intervention name(s): anticitrullinated protein antibodies
Intervention MeSH terms: Rheumatoid Factor
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        142 participants were recruited in two groups: 72 patients with Rheumatoid Arthritis (RA),
        and 70 healthy controls
      
Keywords: Rheumatoid arthritis; Temporomandibular joints; Bruxism
The Effects of a Synbiotic Addition on Eradication Therapy of Helicobacter Pylori Infection in Children
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Helicobacter Infections
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effects of the synbiotic Bifidobacterium animalis
      ssp. lactis B94 plus inulin addition to the standard triple therapy on Helicobacter pylori
      infection eradication rates in children.
    

Detailed description: 
      The study aims to evaluate the effects of the synbiotic Bifidobacterium animalis ssp. lactis
      B94 plus inulin addition to the standard triple therapy on the eradication rates of
      Helicobacter pylori (H. pylori) infection in children. The subjects are children between 6 to
      16 years old who had biopsy proven H. pylori infection. The subjects will be randomly
      classified into two groups. The first group will receive the standard triple therapy
      consisting of amoxicillin oral tablet (50 mg/kg/day) + clarithromycin oral tablet (15
      mg/kg/day) + omeprazole oral capsule (1mg/kg/day). The second group will receive the standard
      triple therapy and Bifidobacterium animalis ssp. lactis B94 (5000000000 colony forming
      units/dose) plus inulin (900 mg) containing sachet for 14 days, concurrently. Eradication
      will be determined by 14-Carbon-urea breath test 4-6 weeks after therapy discontinuation. The
      eradication rates, the occurrence of side effects and the alterations of initial symptoms
      will be compared between the groups.
    

Intervention name(s): Bifidobacterium Animalis Oral Product; Amoxicillin Oral Tablet; Clarithromycin Oral Tablet; Omeprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The synbiotic group will receive this product.; 50mg/kg/day B.I.D.; 15 mg/kg/day B.I.D.; 1 mg/kg/day
Other intervention name(s): Bifidobacterium lactis; Amoxicillin; Clarithromycin; Omeprazole Capsule
Intervention MeSH terms: Amoxicillin; Clarithromycin; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori infection; Children; Synbiotic; Standard Triple Therapy
Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare Cinitapride tablets with domperidone tablets
      (motilium), and to evaluate the efficacy and safety of Cinitapride tablets in the treatment
      of mild to moderate functional dyspepsia.
    


Intervention name(s): Cinitapride; domperidone
Intervention type(s): Drug; Drug
Intervention description(s): cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks; 10 mg for each dose ,30 mg/daily, for 4 weeks
Intervention MeSH terms: Domperidone; Cinitapride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cinitapride; efficacy; safety; mild to moderate functional dyspepsia
Software Treatment for Actively Reducing Severity of ADHD - Follow Up
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This is an exploratory study to assess potential maintenance of clinical benefit (cognition
      and symptoms) following 4 weeks of at-home digital therapy in ADHD children.
    

Detailed description: 
      The study will be a blinded (investigators and outcome assessors), randomized (from parent
      study Akili-001R), parallel group, follow-up study of the sustained effects of 4-weeks of
      treatment with either AKL-T01 (EVO Multi) game-based digital therapy or AKL-T09 (EVO Words)
      game-based digital therapy.

      The trial will consist of 4 visits: Screening (to be conducted at the same time as the
      end-of-study visit for the parent study Akili-001R), FU-Day 28 visit (conducted in clinic),
      and FU-Day 56 and FU-Day 84 visits (conducted remotely via electronically captured parent
      reported outcomes).
    

Intervention name(s): EVO
Intervention type(s): Device
Intervention description(s): videogame-like digital therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD
AZD1386 Japanese Multiple Ascending Dosing Study
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, double-blind, randomised, parallel group, placebo controlled study
      to assess the safety, tolerability and pharmacokinetics of AZD1386 when given as multiple
      doses to 32 (24 healthy young and 8 healthy elderly) Japanese subjects. For young healthy
      subjects (aged ≥20 to ≤45 inclusive) 3 consecutive multiple ascending dose panels are
      planned. For elderly healthy subjects (aged ≥65 to≤80 inclusive) 1 multiple dose panel is
      planned.
    


Intervention name(s): AZD1386; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral admin. of doses at 11 days through a 12 days period.; Oral admin. of doses at 11 days through a 12 days period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Japanese; MAD; Multiple ascending dose; Chronic pain
Peripheral Stem Cell Transplantation With or Without Stromagen Following Chemotherapy in Treating Women With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Peripheral stem cell transplantation may allow doctors to give higher doses of
      chemotherapy and kill more tumor cells. It is not yet known whether Stromagen improves the
      success of stem cell transplantation in women with breast cancer.

      PURPOSE: Randomized phase I/II trial to study the effectiveness of Stromagen during stem cell
      transplantation following chemotherapy in treating women with metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety of expanded mesenchymal stem cells (Stromagen) infusion
      and autologous CD34+ peripheral blood stem cells transplantation after high dose chemotherapy
      in women with metastatic breast cancer. II. Compare the time to neutrophil and platelet
      engraftment in patients receiving different doses of Stromagen. III. Evaluate the immune
      reconstitution of these patients after this therapy.

      OUTLINE: This is a randomized, placebo controlled, blinded study. Patients are randomly
      assigned to one of three treatment arms. All patients undergo mobilization of peripheral
      blood stem cells (PBSC) using cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours
      on day 1, and filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until
      completion of leukapheresis. PBSC and bone marrow cells are collected and CD34 positive cells
      are then selected. About 4 weeks later, patients receive high dose chemotherapy.
      Cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24
      hours are administered on days -7 to -4. Patients then receive placebo or one of two doses of
      expanded mesenchymal stem cells (Stromagen) IV on day -1 and CD34+ selected PBSC IV over 2
      hours on day 0. Patients are followed at 6 weeks and 12 weeks, than at 1 year.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): filgrastim; carboplatin; cyclophosphamide; paclitaxel; thiotepa; in vitro-treated bone marrow transplantation; in vitro-treated peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Carboplatin; Thiotepa
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer
Abdominal Belt Use to Treat Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic
      mechanical-postural low back pain.

      Methods: A randomized controlled trial was carried out, involving 60 consecutively selected
      patients with chronic low back pain randomly allocated to an intervention group (use of
      abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at the
      baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the inclusion.
      The patients were assessed for: pain (VAS); functional capacity (Roland Morris), patient
      satisfaction (Likert scale); and number of anti-inflammatory pills ingested.
      Intention-to-treat analysis was also used.

      Hypothesis - abdominal belt will improve pain in chronic low back pain patients
    


Intervention name(s): Abdominal belt
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Abdominal belt; Chronic low back pain; Pain; Functional capacity
Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance
Condition: Methadone-maintenance Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics
      of MOA-728 in subjects on stable methadone maintenance.
    


Intervention name(s): MOA-728
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Methadone
Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      A comparison of three products for oral nicotine replacement with respect to pharmacokinetics
      after multiple-doses of nicotine.
    

Detailed description: 
      This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™
      lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to
      steady-state nicotine pharmacokinetics, during 12 hours after start of the first
      administration. Multiple doses of each treatment are given once hourly during five separate
      treatment visits scheduled in a crossover setting with randomized treatment sequences. The
      study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20
      cigarettes daily during at least one year preceding inclusion. Subjects and study personnel
      will be aware of which treatment is administered at a given visit.
    

Intervention name(s): Oral Nicotine; Nicotine Lozenge; Nicotine gum
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Nicotine either self-administered or provided by study personnel within 12 hours; Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours; Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours
Other intervention name(s): generic Nicotine; NiQuitin™; Nicorette®
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation, Nicotine pharmacokinetics
Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.
Condition: Tick-borne Encephalitis
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety and immunogenicity of three different
      concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.
    


Intervention name(s): Tick-borne encephalitis vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
A Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of JNJ-404118413 in Healthy Male Patients
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of JNJ-40411813 on rapid eye movement
      sleep and deep sleep; safety, tolerability and pharmacokinetics (what the body does to the
      study medication) of JNJ-40411813.
    

Detailed description: 
      This is a double-blind (neither physician nor participants knows the treatment that the
      participant receives), placebo-controlled (effect of the study medication will be compared
      with the effect of placebo [inactive substance]), comparator-controlled (effect of the study
      medication will be compared with the effect of FDA approved and marketed active substance
      [citalopram]), and 3-way crossover (method used to switch participants from one treatment arm
      to another treatment arm) study. This study will be double-blinded for treatment with placebo
      and JNJ-40411813; however, it will be open label (all people know the identity of the
      intervention) for treatment with citalopram. This study will consist of screening phase
      (within 28 days prior to the start of study medication), treatment phase, and follow-up phase
      (approximately 14 days after the last administration of study medication). Participants will
      be randomly assigned to 1 of 6 sequences (Sequences 1, 2, 3, 4, 5, and 6) to receive
      JNJ-40411813, citalopram, and placebo. Each sequence consists of 3 treatment periods (Period
      1, Period 2, and Period 3) and each subsequent treatment period will be separated by a wash
      out period (no treatment) of at least 7 days. Approximately, 18 participants will be enrolled
      in this study (3 participants in each sequence). Safety will be evaluated by the assessment
      of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical
      examination which will be evaluated throughout the study duration. The total duration of
      study participation for a participant will be approximately 10 Weeks.
    

Intervention name(s): JNJ-40411813; Placebo; Citalopram
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.; Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.; Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Healthy; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; JNJ-40411813; Positive allosteric modulator
Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse
      potential. The purpose of this study is to examine the effectiveness of
      buprenorphine/naloxone that is given at less than daily intervals, in order to prevent
      withdrawal symptoms associated with stopping opioid abuse.
    

Detailed description: 
      Buprenorphine and naloxone are often combined to decrease withdrawal symptoms in opioid
      dependent individuals. Buprenorphine/naloxone is usually given daily to individuals who are
      attempting to stop opioid abuse; however, research suggests that individuals may be more
      inclined to take medication if it is given in less than daily intervals. The purpose of this
      study is to examine the opioid blockade effects of buprenorphine/naloxone that is
      administered in less than daily doses to opioid dependent individuals.

      This study will last 11 weeks. Participants will stay in a residential research unit for the
      duration of the study. Participants will be randomly assigned to receive different doses of
      daily, sublingual buprenorphine/naloxone. After a minimum of 2 weeks on each dose,
      participants will undergo challenge sessions on each weekday for 1 week (Monday through
      Friday). Challenge sessions will consist of increasing doses of intramuscular hydromorphone.
      During the challenge session week, buprenorphine/naloxone will be given only on Monday; a
      placebo will be given the rest of the week. Challenge sessions will examine the blockade
      effects of buprenorphine/naloxone at 2, 26, 50, 74, and 98 hours after the last active dose
      of buprenorphine/naloxone.
    

Intervention name(s): Buprenorphine/naloxone
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Opioid Dependence
Eye Tracking and Simulated Postpartum Hemorrhage
Condition: Simulation of Physical Illness
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      Eye tracking is the process of measuring an individual's eye movements in order to reflect
      their attentional behavior by using a device called an eye- tracker.

      This study uses eye-tracking methodology to observe the gaze patterns of participants to a
      high fidelity simulation scenario of postpartum hemorrhage acting in the role of leader to
      evaluate the relationship between eye-tracking patterns and leadership and team behavioral
      and technical skills.
    

Detailed description: 
      This study will include 5 groups of anesthesia trainees consisting of 5 participants each.
      Each group will practice a standardized high-fidelity scenario on postpartum hemorrhage (PPH)
      which will be repeated for four times. All the scenarios will be video recorded.

      All groups will receive a technical briefing on the PPH guidelines before the scenario, and
      after having assigned to each participant a role (leader anesthesiologist, junior
      anesthesiologist, obstetrician, and midwife) they will practice a standardized 15 minutes
      scenario with a high fidelity manikin. A debriefing with an expert debriefer will be
      performed after each scenario.

      The participant acting as the leader will practice the scenario while wearing a pair of
      eye-tracking glasses (Tobii Pro Glasses 50 Hz wearable wireless eye-tracker). All the
      eye-tracking video-recordings will be stored and analyzed by using a Tobii Pro Lab Software.
      Specific areas of interest (AOI), to define regions of a displayed stimulus, and to extract
      metrics specifically for those regions will be selected. Number and duration of fixations,
      visit counts and their duration for each area of interest and for each scenario will be
      examined. Eye-tracking metrics will be mapped as gaze plots and heat maps. Two independent
      observers will review the scenario video recordings and will assing a score to the leader and
      team behavioral and technical skills. These scores will be correlated to eye tracking
      metrics.
    

Intervention name(s): Tobii Pro Glasses 50 Hz wearable wireless eye tracker
Intervention type(s): Device
Intervention description(s): This system can measure eye movements using cameras integrated into the eyeglasses which record the corneal reflection of infrared lighting to track pupil position, mapping the subject's focus of attention on video recordings of the subject's field of vision (gaze).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        anesthesia trainee