bioihbjkbjnl/mcl2 huggingface dataset:
Relationship Between Obstructive Sleep Apnea and Coronary Atherosclerosis
Condition: Coronary Artery Disease; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
Study type: Observational

Summary: 
      Obstructive sleep apnea (OSA) is a respiratory disorder of sleep characterized by recurrent
      episodes of complete or partial upper airway obstruction, leading to intermittent oxygen
      deprivation. This results in sympathetic activation and surges in blood pressure, production
      of vasoactive substances, as well as activation of the inflammatory and procoagulant
      pathways. Epidemiological evidence indicates the prevalence of OSA is higher in patients with
      coronary artery disease than in the general population. The investigators recently showed
      that 65.7% and 41.9% of the Singapore patients admitted with myocardial infarction were found
      to have previously undiagnosed OSA and severe OSA, respectively. In a 10-year follow-up
      epidemiological study, OSA was independently associated with a higher prevalence of fatal and
      non-fatal cardiovascular events among the otherwise healthy general population. The
      investigators further showed that in patients who have undergone primary percutaneous
      coronary intervention for acute myocardial infarction, OSA was an independent predictor of
      future adverse event rates. Despite the observed association between OSA and adverse
      cardiovascular outcomes, the underlying pathophysiological mechanisms remain unclear. In this
      proposal, the investigators aim to elucidate the relationship between OSA and composition of
      coronary atherosclerotic plaques.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 21 to 80 years who are scheduled to undergo either an elective, urgent or
        emergent diagnostic coronary angiography are eligible
      
Keywords: Thin-cap fibroatheroma; Vulnerable plaque; Coronary artery disease; Obstructive sleep apnea; Intravascular Ultrasound
Assessment of Fetal Position in Active Labor
Condition: Education
Study type: Observational

Summary: 
      Vaginal exams are used routinely in labor to assess cervical dilation and position of the
      baby (facing anterior, facing to the right or left side, facing towards maternal spine). This
      technique has a widely variable accuracy rate (24.0-85.6%). Ultrasound has been used to help
      confirm or correct the vaginal assessment by obstetricians, but has not been used to assess
      the utility of immediate feedback to improve the accuracy of vaginal assessment by physicians
      in training. The investigators plan to use ultrasound assessment to determine if this
      education is effective in increasing accuracy in the resident population.
    

Detailed description: 
      Residents will be informed of the study through an education session (as a group) and then be
      consented individually. Each resident will complete 15 baseline exams, 20 exams with
      immediate ultrasound confirmation, and 15 exams for post-test baseline. Exams will take place
      periodically throughout the year. Both 3rd and 4th year residents will be assessed during the
      same time period by the MFM fellows. Ultrasounds will follow the vaginal exam as closely as
      possible to prepare for delivery. A picture of the fetal position (with no name or MRN) for
      documentation to be taken during the SOC ultrasound and kept in the research chart for the
      resident.

      In training feedback is not always standard. This teaching tool, consistent and standard
      feedback with regard to the correlation between vaginal exam and ultrasound, would allow the
      resident to learn to assess fetal position more accurately.

      Information from the maternal chart (history and delivery information) will be collected as
      de identified. Data will be recorded on the data collection sheet which is labeled with a
      code number linking the resident participant only.

      Data collected from the residents will be assigned a random Code numbers used to link the
      subject to their data.

      Code and identifiers will be kept separate. Paper copies will be kept in a locked cabinet, in
      a locked office, in a locked suite.
    

Intervention name(s): Vaginal assessment
Intervention type(s): Procedure
Intervention description(s): Vaginal assessment of position prior to delivery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        3rd and 4th year Ob, Gyn Residents
Role of Leptin in the Neuroendocrine and Immune Response to Fasting
Condition: Fasting
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study will be to determine whether giving leptin (r-metHuLeptin) to a
      person when he or she is fasting will reverse changes in metabolism, and hormone levels, and
      immune function associated with fasting, which decreases leptin levels.
    

Detailed description: 
      Leptin is a hormone secreted by fat cells under normal conditions and acts in the brain to
      decrease appetite and increase energy use. Leptin levels usually go down with fasting. This
      study will evaluate the secretion of an investigational agent called leptin in lean and
      overweight individuals while fasting and investigate the potential role of leptin as a
      regulator of immune function and mediator of the neuroendocrine response to food deprivation
      in humans. Data derived from these studies will provide insights into the mechanisms
      underlying altered hormone levels and immune function in malnutrition and obesity and thus
      may provide the basis for future therapeutic interventions for obesity.

      Comparison: fed state vs. fasting state vs. fasting + leptin state
    

Intervention name(s): r-metHuLeptin; placebo
Intervention type(s): Drug; Other
Intervention description(s): recombinant human leptin; placebo (no active drug)
Other intervention name(s): metreleptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: leptin; fasting; reproductive; neuroendocrine; immune function; energy deficiency associated with short-term fasting
Awareness and Knowledge of the Surgical Safety Checklist Among Operational Staff in University Teaching Hospital, Kathmandu, Nepal: A Cross-sectional Questionnaire
Condition: Surgical Checklist
Study type: Observational [Patient Registry]

Summary: 
      The introduction of the World Health Organization Surgical Safety Checklist (WHO SSC) is a
      priority to promote surgical safety. However, little is known regarding awareness and
      knowledge of the WHO SSC in developing countries. This study aimed to obtain region-specific
      information for the introduction of the checklist in a core medical institution in Nepal.

      The present research was a cross-sectional study using data from a survey conducted at the
      Tribhuvan University Teaching Hospital (TUTH) in Kathmandu, Nepal. A questionnaire was
      distributed to 150 healthcare professionals working in the operating theatre. Responses to
      the questionnaire were analysed descriptively and regression analyses identified factors
      associated with awareness of the checklist.
    


Intervention name(s): questionnaire survey
Intervention type(s): Other
Intervention description(s): questionnaire survey
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        health professionals in operation room
Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism
Condition: Iron Deficiency Anemia; Subclinical Hypothyroidism
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases; Hypothyroidism
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine whether iron deficiency anemia can be an indication for the treatment of
      subclinical hypothyroidism.
    

Detailed description: 
      51 Patients presented to our university outpatient internal medicine clinic who are found to
      have iron deficiency anemia coexisting with subclinical hypothyroidism have been included in
      this study. Patients were randomly assigned to oral iron or oral iron plus levothyroxin
      therapy. The physician and the patients did not know who received oral iron only or oral iron
      plus levothyroxine treatment. Hematologic parameters as well as serum iron, ferritin and iron
      binding capacity were being measured at the beginning and 3 months after treatment in both
      groups.
    

Intervention name(s): Ferrous sulfate tablets 325 mg, po, TID; Ferrous sulfate plus levothyroxine
Intervention type(s): Drug; Drug
Intervention description(s): Combination of ferrous sulfate tablet 325mg plus levothyroxine tablet 25 micrograms, po, TID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: iron deficiency anemia; anemia; hypothyroidism; subclinical hypothyroidism
Immune Profile in Subjects With New Onset Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      It is hypothesized that early changes in the immune system in New Onset Type 1 Diabetes
      Mellitus (NOT1D) subjects can be detected in immune cells from the inguinal lymph nodes
      (iLN), which will be distinct from changes observed in peripheral blood derived immune cells.
      Therefore this study will assess and compare the molecular immune profile of cells derived
      from the iLN in healthy and NOT1D subjects, to understand the immunological processes that
      may lead to beta cell destruction. It is a multi-center, non-drug treatment study. Up to 15
      subjects in each group, namely healthy subjects and NOT1D subjects, will be evaluated in the
      study. A data look will be carried out after the recruitment of a cohort of up to 5 healthy
      subjects, to determine if the quality and quantity of cells derived from aspirate or core
      biopsy or from peripheral blood are likely to be sufficient to continue the study to meet its
      primary objective. An interim analysis will be carried out after the recruitment of 5
      evaluable healthy subjects and 5 evaluable NOT1D subjects. The primary purpose of this
      interim analysis will be to facilitate decision making and study design for a potential
      follow-up interventional study.
    


Intervention name(s): Inguinal lymph node fine needle aspirate biopsy; Inguinal lymph node core biopsy; Peripheral blood collection; Pre- and post-biopsy questionnaire
Intervention type(s): Procedure; Procedure; Procedure; Other
Intervention description(s): Inguinal lymph node will be localized by ultrasonography and sampled by 21-gauge needle and a 5 mL syringe using to and fro needle movement while applying 1 mL suction with the syringe. Up to 2 fine needle aspirate passages will be obtained, to derive immune cells.; Inguinal lymph node will be localized by ultrasonography and following fine needle aspirate, an incision will be made. Up to five core biopsies will be obtained, to derive immune cells.; Blood sample (30 mL) will be collected, to derive immune cells.; All subjects will be asked to complete a questionnaire about their expectations/experiences of undergoing the biopsy procedures.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Biomarker; Immune Profile; Biopsy; Leukocyte subsets; Inguinal lymph nodes; Type 1 Diabetes Mellitus
Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)
Condition: Concussion
Study type: Interventional

Summary: 
      The purpose of this study is to establish the tolerability of mindfulness and yoga therapy in
      the post-concussion period.
    

Detailed description: 
      Athletes and patients aged 15 - 60 will receive standard sports concussion evaluations at the
      Duke Sports Science Institute (SSI) and will learn about the study by the primary clinicians
      evaluating sports concussion at the SSI. Subjects will receive yoga training either at their
      home or at the Center for Living Campus at Duke. Subjects will complete their yoga
      assignments for 5 consecutive days, along with a symptom checklist. On the 6th day, subjects
      will complete the symptom checklist and mail all checklists to the study team in a stamped
      envelope. We expect to enroll 20 subjects.

      If a subject has significant worsening of their symptoms and wishes to discontinue the study,
      they are requested to contact the study PI, Joel Morgenlander, MD. At that time, Dr.
      Morgenlander will document the specific reasons for discontinuation of the protocol. All
      follow-up care for their concussion will be through the provider they are already seeing for
      concussion. There is no significant risk to the athlete for participation except possible
      transient increase in their concussion symptoms. Benefits include possible hastening of
      recovery from their concussive symptoms and receiving training in mindfulness and yoga from a
      certified yoga instructor.
    

Intervention name(s): Mindfulness and Yoga Training
Intervention type(s): Behavioral
Intervention description(s): Centering and Breathing- Practice begins by turning attention to the breath to help participants make the transition from the busy, doing, outward focus of daily life into the mindful, balanced, internal focus central to yoga practice.
Practices:Breath awareness, the relaxed abdominal breath. Posture Practice-Warm up with the range-of-motion sequence to take the major joints of the body through their full range of motion.This is done lying down with the head on the floor; the head can be supported by a small, folded towel if desired.
Practices: Knee-to-chest sequence, Arms and Shoulders, Gentle Spinal Twist, Apanasana.
Standing Poses for Strength and Balance, to enhance function and confidence. Practices: Mountain Pose, Flying Crane Sequence, Tree Pose, Warrior 2 and Side Angle.
Relaxation- Practice concludes with guided relaxation to quiet the mind and calm the body.
Practices: Seated Mountain Pose, even breath, extended exhalation,Yoga Nidra.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Yoga; Mindfulness
The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome
Condition: Turner Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purposes of this study are to learn whether treatment with an androgen type hormone will
      improve the visual-spatial problems associated with Turner syndrome, and to evaluate the
      effect growth hormone, with and without androgen, has on growth.
    

Detailed description: 
      Turner syndrome is associated with short stature, multiple physical stigmata, absent pubertal
      development, and increased learning problems. This study is designed to (1) examine the
      effects of sex steroids (androgen and estrogen) on multiple variables including growth rate,
      GH binding protein, IGF-I, IGFBP3, and cognitive function in the setting of supplemental
      growth hormone administration and (2) to investigate any synergistic or additive effects of
      the androgen and estrogen combination versus each alone, on the above variables.
    

Intervention name(s): estrogen; androgen; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants were started on ethinyl estradiol at a daily dose of 50ng/kg at the beginning of the 3rd year of the study. The estrogen was continued until study end.; Oxandrolone or placebo capsule, .06mg/kg/day, orally, for 2 years; an inactive substance
Intervention MeSH terms: Estrogens; Androgens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Turner syndrome; estrogen; androgen; growth hormone
A Mail and Video-based Weight Loss Trial in Breast Cancer Survivors
Condition: Breast Cancer Survivorship; Obesity
MeSH terms: Breast Neoplasms; Weight Loss
Study type: Interventional

Summary: 
      Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC
      breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical
      activity, and 4)quality of life in women randomized to receive the modified LEAN intervention
      compared to women randomized to wait-list control (i.e., the wait-list control will receive
      the modified LEAN intervention after completing the 6-month study).
    

Detailed description: 
      The purpose of the study is to evaluate the effects of modifying the LEAN intervention
      (NCT02110641) to make it more cost effective by reducing or eliminating the counseling
      sessions. To guide the modification of the intervention one or more focus group sessions with
      former LEAN participants will be conducted. The purpose of these meetings will be to gain
      input on enhancing the LEAN book.

      The LEAN book will be central to the modified intervention, but the LEAN book will be
      modified based on feedback from the focus group(s) and experience gained from the LEAN study.
      The reading level of the LEAN book will also be assessed to ensure acceptability to those
      with a low literacy level.

      Once these changes have been finalized, the efficacy of the modified program will be tested
      using the methods described in the Brief Summary.
    

Intervention name(s): LEAN book/videos
Intervention type(s): Behavioral
Intervention description(s): The intervention focuses on achieving long lasting lifestyle changes to achieve weight loss and maintenance. Women randomized to the weight loss program will receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study on the Safety of Drug BAY1817080 at Different Doses and the Way the Body Absorbs and Eliminates the Drug in Japanese Healthy Adult Male Participants
Condition: Endometriosis Related Pain; Overactive Bladder; Diabetic Neuropathic Pain; Refractory or Unexplained Chronic Cough
MeSH terms: Neuralgia; Endometriosis; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers in this study want to learn about the safety of drug BAY1817080 at different
      doses and the resulting blood levels of the study drug in Japanese healthy adult male
      participants. Study drug BAY1817080 is a drug under development with a goal to suppress pain
      and chronic cough. It works by binding to and blocking proteins expressed on the sensory
      nerves of the womb tissue, bladder or airway which are oversensitive in the patients with
      endometriosis (a condition where the tissue that usually grows inside the womb grows outside
      of the womb), overactive bladder (a condition that causes a sudden urge to urinate often or
      more frequently) and long-standing cough with or without clear causes.

      Participants in this study will receive either the study drug or placebo tablets (a placebo
      looks like the test drug but does not have any medicine in it). The dosage will be either one
      single dose of study drug/placebo received on only one day or multiple doses of study
      drug/placebo received twice daily for 13 days plus one dose in the morning of the 14th day.
      The total study duration for each participant will be usually no more than 42 days. Blood
      samples will be collected from the participants to monitor the safety and measure the blood
      level of the study drug.
    


Intervention name(s): BAY1817080; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Three different doses over the course of study; Matching Placebo to BAY1817080
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Refractory or unexplained chronic cough; Healthy volunteers; P2X3 receptor antagonist
Phase 1 Study of Daewon-ES(B) & Megace in Healthy Male Volunteers Under Fasting and Fed Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(B) 625mg/5ml and
      Megace 800mg/20ml in healthy male volunteers under fasting and fed condition.
    


Intervention name(s): Megace; DW-ES(B)
Intervention type(s): Drug; Drug
Intervention description(s): 800mg; 625mg
Intervention MeSH terms: Megestrol Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Indwelling vs Immediate Removal of Foley Catheter After Robotic Assisted Laparoscopic Sacrocolpopexy: a Prospective Study
Condition: Urinary Retention
MeSH terms: Urinary Retention
Study type: Interventional

Summary: 
      This is a prospective, comparative randomized study. Our study population includes women with
      pelvic organ prolapse undergoing a robotic assisted laparoscopic sacrocolpopexy.

      The two groups will include the study group, who will have their Foley catheter removed 6
      hours post-op, and the control group who will have an indwelling Foley catheter overnight.
      The two groups will be assigned according REDCap randomization system.
    


Intervention name(s): No Foley
Intervention type(s): Other
Intervention description(s): Patients will have Foley catheter removed 6 hours post-op.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Soft and Hard Tissues Evaluation Around Immediately Placed New Implant Design
Condition: Peri-implant Mucositis; Dental Implant Failed
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      patients were randomly divided into Maxi-Z plus dental implant group versus Maxi-Z implant
      group
    

Detailed description: 
      after tooth extraction implants will be placed immediately and provisional restoration will
      be placed in both groups to detect the advantaged and drawbacks of newly designed Maxi-Z plus
      dental implant versus Maxi-Z dental implant
    

Intervention name(s): platform switching; platform amtching
Intervention type(s): Procedure; Procedure
Intervention description(s): reduced implant abutment interface; matched implant abutment interface
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Maxi-Z plus dental implant
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: platform switched implants; platform matched implants