bioihbjkbjnl/mcl2 huggingface dataset:
Point-of-care-Ultrasound for Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Patients with obstructive sleep apnea (OSA) are at risk for respiratory dysfunction in the
      perioperative environment. The study is designed to evaluate if point-of-care-ultrasound
      (POCUS) measurements of upper airway anatomy may identify patients with OSA and their
      severity.
    

Detailed description: 
      Obstructive sleep apnea (OSA) is characterized by recurrent collapse of the pharyngeal airway
      during sleep, resulting in substantially reduced (hypopnea) or complete cessation (apnea) of
      airflow despite ongoing breathing efforts. OSA has long been recognized as a heterogeneous
      disorder with potentially multiple contributing pathophysiological causes but with
      significant impact to perioperative morbidity. Various OSA phenotypes exist but, the
      predominant feature is a narrow and collapsible upper airway anatomy and is an interplay
      between pharyngeal soft tissue, genioglossus muscle tone and the bony anatomy and accounts
      for up to two-thirds of the variation in the AHI. Identification of moderate-severe OSA is
      crucial to prevent potential life-threatening cardiopulmonary complications
      perioperatively.(1) However, a large proportion of patients with OSA remain undiagnosed at
      the time of surgery.(2) Current screening tools are mainly questionnaire based and are
      largely sensitive but not specific (3) resulting in many false positives, unnecessary
      increased resource utilization, cost burden, and legal implications. Gold standard laboratory
      polysomnography(PSG) study is expensive and not widely available. Point-of-care ultrasound
      (POCUS) is a readily available, portable, noninvasive tool that has been used for airway
      evaluation and may be useful for OSA screening.(4-8) Study investigators want to evaluate the
      various POCUS measures of OSA in the perioperative population and correlate these
      measurements with the PSG based severity of OSA (based on apnea-hypopnea index -AHI) to find
      out the best measure or a combination of measures to diagnose the incidence and severity of
      OSA.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting for surgeries who meet eligibility criteria.
Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2)
Condition: Status Epilepticus
MeSH terms: Status Epilepticus
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Children with seizures are frequently seen in the emergency department. The drug lorazepam,
      which is commonly used, is not labeled by the US Food and Drug Administration for children
      for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that a
      study comparing diazepam, a drug that is labeled by the FDA for this indication, with
      lorazepam be performed. The study will show whether one drug is more effective and safe than
      the other.
    

Detailed description: 
      Textbooks and expert opinion recommend both diazepam and lorazepam as initial therapy for
      children in status epilepticus (SE) and provide recommended doses that are commonly used.
      However, unlike diazepam, lorazepam is only FDA-approved for treatment for SE in patients
      over 18 years of age. Despite this fact, many experts support the use of lorazepam over
      diazepam in pediatric SE. Increased duration of action, increased effectiveness in
      terminating SE, and a lower incidence of respiratory depression have been cited as potential
      advantages of lorazepam over diazepam. However, data to support firm recommendations for one
      medication over another are lacking. Thus, either diazepam (FDA-approved) or lorazepam can be
      considered first-line agents for pediatric SE, and the physician's choice of agent depends on
      local practice patterns and individual treatment styles. In the prehospital (Emergency
      Medical Services) setting, diazepam is commonly chosen because of a longer shelf life without
      refrigeration.

      The purpose of this study is to determine the differences in efficacy and safety between
      these two commonly used benzodiazepines, as requested by the FDA under the Best
      Pharmaceuticals for Children Act, using the Exception from Informed Consent provided by the
      FDA.
    

Intervention name(s): lorazepam or diazepam
Intervention type(s): Drug
Intervention description(s): Administration instructions will ask to deliver 0.04 ml per kilogram of child's weight of the study medication up to a maximum of 1.6 ml. 0.04 ml/kg (maximum dose 1.6 ml) will deliver 0.1 mg/kg of lorazepam (maximum dose 4 mg) and 0.2 mg/kg of diazepam (maximum dose 8 mg). Half of this dose can be repeated in 5 minutes if the patient is still convulsing.
The medication will be administered as a slow IV push.
Other intervention name(s): Ativan; Valium
Intervention MeSH terms: Diazepam; Lorazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Motivational Interventions for Lifestyle and Exercise in College Students
Condition: Alcohol Consumption
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      Engagement in substance-free activities, such as exercise, has an inverse relationship to
      substance use in college students. While exercise has numerous physical and mental health
      benefits, the majority of college students are sedentary, infrequently engaging in exercise.
      Although exercise interventions to date often suffer from significant attrition and poor
      adherence, motivational interventions for exercise are beginning to show promise. In this
      pilot study we propose to develop and evaluate a novel exercise intervention combining
      Motivational Enhancement Therapy (MET) with contingency management (CM) in sedentary college
      students who use alcohol.
    


Intervention name(s): MET + CM for Exercise; MET + Exercise Contracting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Motivational Enhancement Therapy seeks to resolve ambivalence regarding exercise and increase intrinsic motivation to exercise. Contingency management offers tangible rewards for completing verified exercise.; Motivational Enhancement Therapy seeks to resolve ambivalence regarding exercise and increase intrinsic motivation to exercise. Exercise contracting consists of weekly appointment to set specific goals for exercise in the upcoming week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; college students; Sedentary college students
Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this interventional Randomized clinical is to compare the effect of Metformin
      alone, Cabergoline alone and Metformin and Cabergoline in combination in a sample of Iraqi
      female patients with polycystic ovary syndrome. The main questions to answer are:

        1. What are the effects of the tested regimens on Body mass index (BMI)?

        2. What are the effects of the tested regimens on hormonal status?

        3. What are the effects of the tested regimens on uterine artery resistive index ?

        4. What are the effects of the tested regimens on some inflammatory markers?

      Participants will be separated into two groups:

        1. Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days
           duration.

        2. Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose
           per/week).

        3. Group 3 (MD): 25 Pateins, Received metformin 500 mg per oral twice daily for 90 days
           duration and Dostinex (Pergolin) as 0.5 mg per oral (single dose per/week).

      Researchers will compare Group 1 (M), Group 2 (D), Group 3 (MD) to observe the effect of the
      tested treatment regimens on Body Mass Index, Hormonal status, uterine artery resistive
      index, and some inflammatory markers that are IL-18, Anti-GAD Antibody and GnRH Antibody.
    


Intervention name(s): Metformin Hydrochloride 500 MG; Cabergoline 0.5 MG; Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration; Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration; Metformin Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration
Cabergoline Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration
Intervention MeSH terms: Metformin; Cabergoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: polycystic ovary syndrom; hormones; endometrial resistive index; metformin; Cabergoline
Ketamine Infusion for Comorbid PTSD and Chronic Pain
Condition: PTSD; Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate the effectiveness of low dose IV ketamine infusion
      in the treatment of patients with PTSD and comorbid chronic pain.

      Hypothesis: A single ketamine infusion should be associated with significantly greater
      reduction in core PTSD symptom levels after the treatment and such an effect is not only due
      to its analgesic properties but also through unknown mechanism of action that maybe related
      to NMDA/AMPA receptor modulation.
    

Detailed description: 
      To date, treatment options (i.e. psychotherapy, antidepressant medications) for patients with
      PTSD, are relatively few, and considering their limited efficacy, novel therapies have gained
      interest among researchers and treatment providers alike. Among patients with chronic pain
      about one third suffer from comorbid PTSD, which further complicates their already
      challenging pharmacological regimens. Low dose ketamine infusion has shown promise in PTSD,
      and in treatment of chronic pain, however they have not been studied in comorbid population
      and under rigorous control conditions. The investigators compared the effects of a single
      dose of either ketamine (0.5 mg/kg) or ketorolac (15 mg) over a 40-minute of IV infusion in
      chronic pain patients with and without PTSD, in double blind, randomized study. Measures were
      collected before, during, 1 day and 7 days after the infusion.
    

Intervention name(s): A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.
Intervention type(s): Drug
Intervention description(s): Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
Intervention MeSH terms: Ketorolac; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patient with and without PTSD were randomized to receive either ketamine or ketorolac. Single IV infusion of ketamine hydrochloride (0.5 mg/kg) was administered over 40 minutes. Ketorolac 15 mg was reconstituted in 500 cc of normal saline administered over 40 minutes.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; chronic pain; ketamine infusion
Blood Flow Restriction Training in Pre-frail and Frail Older Adults
Condition: Frailty
MeSH terms: Frailty
Study type: Interventional

Summary: 
      Frailty is most often defined as a syndrome of physiological decline in late life,
      characterized by marked vulnerability to adverse health outcomes. Intervention such as
      exercise, especially resistance exercise, has proven to be effective to improve frail
      condition in the elderly in the previous literature. However, blood flow restriction (BFR)
      training, a new resistance exercise training method, need merely lower resistance power and
      shorter training duration compared with traditional resistance exercise. Previous researches
      also demonstrated BFR can increase muscle mass and muscle strength in the healthy elderly but
      the effect of BFR training on the pre-frail or frail elderly is unknown. The aim of this
      study will test the effect of BFR training on muscle strength and functional performance in
      pre-frail or frail elderly. Participants aged over 60 years old with clinical frailty score
      between 3 to 5 will be recruited. Participants will be assigned to two groups using
      randomized block design with BFR training and control group. Structured questionnaire and
      physical function measurement will be used to assess the pre-intervention condition and
      outcome of different interventions. The participants will be assessed before training
      (pre-test), 3 weeks after training, and 6 weeks after training (post-test), and followed up
      at one and three months after training. Physical function measurement will include hand grip,
      muscle mass over trunk and extremity, muscle strength of lower extremity, gait speed and
      timed up and go test. Two-way repeated measures analysis of variance will be used to test the
      pre-test, 3-week, post-test and follow-ups difference between the two groups.
    


Intervention name(s): Blood flow restriction resistance training; Resistance training
Intervention type(s): Other; Other
Intervention description(s): The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction.; The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blood flow restriction; Resistance exercise; Frailty
A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is extension part of the P04280 (placebo-controlled, double-blind, randomized
      study of chronic treatment with infliximab in approximately 140 patients, NCT00202852). This
      study will be conducted at 6 study centers in South Korea. After completion of the last
      follow-up visit at Week 30 and code break in main double-blind trial, subjects randomized to
      the placebo group and those who were treated with an infliximab-containing regimen who
      maintained clinical response at the time of study completion will be provided with open-label
      infliximab for treatment of their conditions and additional safety data will be collected.
    


Intervention name(s): Infliximab + methotrexate (MTX)
Intervention type(s): Biological
Intervention description(s): Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
Other intervention name(s): Remicade; SCH 215596
Intervention MeSH terms: Infliximab; Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reproductive Function and Mood in Women With Bipolar Disorder
Condition: Bipolar Disorder; Mental Health
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      This study will determine the effect of medication for bipolar disorder on the reproductive
      function and whether mood changes occur during the menstrual cycle in women with bipolar
      disorder.
    

Detailed description: 
      Bipolar disorder is a serious condition that can have devastating effects on social and
      psychological functioning. Evidence suggests that medications for bipolar disorder may
      influence reproduction function among women. This study will determine reproductive function
      and mood changes in women who are currently on medication for bipolar disorder.

      This study will comprise women with bipolar disorder and age- and body mass index
      (BMI)-matched healthy controls. Participants will have their reproductive function and mood
      changes assessed for 3 consecutive menstrual cycles. Daily, participants will report about
      their mood, sleep patterns, life events, and any psychiatric medications; this information
      will be entered into a computerized system named ChronoRecord. In addition, participants will
      measure their basal body temperature and collect their urine every morning to assess for
      ovulation. Blood collection will occur at study entry and between Days 3 and 6 of every
      menstrual cycle to determine levels of reproductive hormones. Participants will be asked to
      fast for 12 hours prior to every blood collection. During the first month of the study, an
      extra study visit will occur. Participants will undergo a physical exam for determination of
      excessive hair growth (hirsutism) and BMI. Additionally, insulin resistance will be measured,
      and participants will be asked to complete a questionnaire that will be used to determine
      their past and current menstrual function, as well as the reproductive and psychiatric
      history of their families.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women diagnosed with Bipolar Disorder, between 18-40 years of age, who are currently
        treated with a mood stabilizing agent for a period of at least 3 months and are not taking
        birth control pills currently. Participants must be willing to travel to Stanford
        University (near San Francisco, CA) at their own expense for study visits.
      
Keywords: Women; Mood; Menarche; Menstruation
Short-term Outcomes of ERAS Protocol in RAME for Esophageal Cancer
Condition: Esophageal Cancer Patients
MeSH terms: Esophageal Neoplasms
Study type: Observational

Summary: 
      This single-center, retrospective cohort study aimed to evaluate the short-term outcomes of
      enhanced recovery after surgery (ERAS) protocol in perioperative robotic-assisted McKeown
      esophagectomy (RAME) among esophageal cancer patients.
    


Intervention name(s): ERAS protocol
Intervention type(s): Procedure
Intervention description(s): Patients with esophageal cancer have undergone RAME using ERAS protocol and conventional management strategy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with esophageal cancer undertaking resection by RAME were included. According to
        different perioperative management strategies, all eligible patients were divided into the
        ERAS group and conventional group.
Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants
Condition: Diphtheria; Polio; Pertussis; Hepatitis B
MeSH terms: Hepatitis B; Whooping Cough; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a follow-up of Study A3L10 (NCT00315055)

      Immunogenicity

        -  To describe the antibody persistence following a primary series vaccination of either
           DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.

        -  To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP~T.

      Safety

      - To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP~T.
    


Intervention name(s): DTaP-IPV-HB-PRP~T vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 mL, intramuscular (IM)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; Polio; Diphtheria; Pertussis; H.influenzae type b
Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia
Condition: Misophonia
Study type: Interventional

Summary: 
      Despite increasing recognition of misophonia, there are currently no evidence-based
      treatments to help those who are suffering. Therefore, the primary purpose of this study is
      to assess the acceptability, feasibility, and preliminary efficacy of a treatment for
      misophonia. This study will be conducted in two phases. In the Phase 1, participants will
      receive a treatment the investigators believe can help manage symptoms of misophonia: The
      Unified Protocol. This treatment uses evidence-based psychological principles (e.g., managing
      attention or behavior) in a flexible manner and will focus on developing skills to help
      reduce the distress and impairment associated with Misophonia. After treatment, patients will
      provide feedback about their experience. The investigators will use this feedback to revise
      the treatment as indicated. In Phase 2, participants will receive the revised treatment and
      provide feedback on their experience. Throughout treatment in either phase, participants will
      provide daily and weekly information about their symptoms.

      The aims of this study are (1) to explore the acceptability and feasibility of the Unified
      Protocol for individuals who experience Misophonia and (2) to examine whether this treatment
      helps reduce symptoms associated with Misophonia.
    


Intervention name(s): Unified Protocol for Transdiagnostic Treatment of Emotional Disorders; Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Please see arm/group descriptions; Please see arm/group descriptions
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Misophonia; Treatment
The Role of Pollen Starch Granules in Pollen Challenge Studies in the Fraunhofer Environmental Exposure Unit
Condition: Asthma; Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      The aim of the study is to explore the contribution of pollen starch granules to the induced
      symptoms and airway inflammation in patients with allergic rhinitis and mild asthma in a
      controlled pollen exposure(pollen challenge room at the Fraunhofer ITEM). Starch granules are
      released from the pollen grains and are considered to be the allergen carriers of the pollen.
      The hypothesis is proposed that pollen starch granules are important in the induction of
      airway inflammation and airway hyperresponsiveness.
    


Intervention name(s): exposure to grass pollen/starch granules
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic