bioihbjkbjnl/mcl2 huggingface dataset:
CPR Quality and Use of Feedback for OHCA
Condition: Out-Of-Hospital Cardiac Arrest
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest
Study type: Observational

Summary: 
      The purpose of this study is to investigate the quality of cardio-pulmonary
      resuscitation(CPR) delivered by EMS professionals and whether this quality can be improved by
      implementing real-time feedback during the event and an oral post-event debriefing procedure
      based on the actual event performance data.
    

Detailed description: 
      The aim of this study is to investigate whether CPR quality can be improved by implementing
      real-time feedback and immediate oral structured post-event debriefing in out-of-hospital
      cardiac arrest (OHCA).

      The objectives of this study is to assess the current quality of CPR delivered by emergency
      medical services (EMS) during OHCA events in the Capital Region of Denmark. Furthermore, to
      investigate if CPR quality can be improved by applying real-time feedback during OHCA
      resuscitation attempts and to investigate if structured oral post-event debriefing delivered
      immediately after a resuscitation attempt and based on data from the defibrillator can
      further improve CPR quality

      The hypothesis of this study is that adding real-time and post event feedback can improve the
      compression rate, compression depth, overall CPR hands-on time (CPR fraction), and recoil
      with at least 15% in total for both interventions.

      Using a prospective study design data is retrieved from the standard defibrillator (ZOLL X
      series) through ZOLL RescueNet® Case Review (software for post-event review, analysis, and
      debriefing) from ZOLL Medical Corporation, Massachusetts, United States of America.

      The study consists of three consecutive phases. Phase one with no feedback / debriefing
      available for EMS. Phase two with real-time feedback during the event and phase three which
      adds post-event debriefing to real-time feedback. We expect to be able to include at least
      500 cases in each phase.
    

Intervention name(s): Real time feedback; Post-event debriefing
Intervention type(s): Other; Behavioral
Intervention description(s): Real-time feedback on chest compression depth, chest compression rate and recoil available to EMS while performing CPR. Feedback is delivered as visual text, numeric and graphical presentations on the defibrillator with audio tones for rate.; Structured oral post-event debriefing based on objective performance data from the resuscitation attempt. The debriefing is conducted as hot/immediate self-directed debriefing session with a maximum length of 10 minutes.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients in OHCA in the Capital Region of Denmark who receive CPR by or under
        supervision of EMS professionals with the standard EMS defibrillator attached.
      
Keywords: OHCA; Feedback; CPR quality
PTG-100 for Patients With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent
      inflammatory injury to the small intestine that occurs when people with celiac disease eat
      food products containing gluten.

      This is a clinical research study to determine the safety and efficacy of PTG-100 in
      preventing gluten-induced inflammatory injury to the small intestine in patients with celiac
      disease. 30 patients will receive either placebo (fake drug) or PTG-100 (real drug) in
      capsule form twice daily for 42 days. They will also receive a gluten challenge twice daily
      in the form of a cookie or equivalent. An upper gastrointestinal endoscopy and exam including
      small bowel mucosa biopsy will be performed at the start of the treatment period and again at
      the end. Blood samples will be routinely taken to evaluate safety and the drug's mechanism of
      action throughout the study, and symptoms will be recorded using the celiac symptoms index
      (CSI) survey.
    


Intervention name(s): PTG-100; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PTG-100, 600mg taken twice daily in capsule form for 42 days; Placebo taken twice daily in capsule form for 42 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      Otherwise healthy subjects who are currently bein maintained on either methadone or
      buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at
      least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs
      between BI 201335 and either methadone or buprenorphine/naloxone.
    


Intervention name(s): BI 201335; BI 201335
Intervention type(s): Drug; Drug
Intervention description(s): BI 201335 for 9 days; BI 201335 for 9 days
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of JNJ-40411813 as Supplementary Treatment to an Antidepressant in Adults With Depression and Anxiety Symptoms
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and overall safety and tolerability of
      treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety
      symptoms being treated with an antidepressant.
    

Detailed description: 
      This is a multicenter, double-blind (neither physician nor patient knows the treatment that
      the patient receives), placebo-controlled study in adult patients with Major Depressive
      Disorder (MDD) with anxiety symptoms of relevant severity. The study will consist of 3
      phases: a screening phase of up to 2 weeks, an 8-week double-blind treatment phase, and a
      2-week post-treatment (follow up) phase. Patients will continue to take the same daily dose
      of their antidepressant (as directed by the investigator) at the same time of day, from
      screening through the end of the study, including the post-treatment phase. The total study
      duration for each patient will be approximately 12 weeks.
    

Intervention name(s): JNJ-40411813; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Type= range, unit= mg, number= 25 to 150, form= capsules, route= oral administration. JNJ-40411813 will be administered twice daily during 8 weeks, following fixed and flexible schedules in which the dose can range from 25 mg to 150 mg.; Form= capsule, route= oral administration. Matching placebo will be administered twice daily during 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Anxiety symptoms; JNJ-40411813
Mass Balance and Pharmacokinetics Study of Derazantinib in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, two-part, open-label, single centre, single arm study in healthy male
      subjects to investigate the oral PK, intravenous (IV) PK, mass balance, bioavailability and
      metabolites profiling and identification of derazantinib.
    


Intervention name(s): Derazantinib capsule; [14C]-Derazantinib solution for infusion; [14C]-Derazantinib capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300 mg derazantinib oral administration (3x100 mg capsules); 100 μg [14C]-derazantinib intravenous administration; 300 mg [14C]-derazantinib oral administration (3x100 mg capsules)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)
Condition: Muscle Relaxation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, pharmacokinetics, and safety of Org
      9426 in maintenance of muscle relaxation in adult subjects undergoing general elective
      surgery.
    


Intervention name(s): Rocuronium bromide (Org 9426); Rocuronium bromide (Org 9426); Sevoflurane; Propofol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.6 mg/kg injection intubation dose; 0.9 mg/kg injection intubation dose; 0.5-2.0% intravenous maintenance anesthesia; 4-10 mg/kg/hr maintenance anesthesia
Other intervention name(s): SCH 900085; SCH 900085; Sevofrane; Diprivan
Intervention MeSH terms: Bromides; Propofol; Sevoflurane; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuromuscular Blocking Agents
A Study to Evaluate the Mass Balance Absorption and AME of VBR
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and
      excretion of [14C] Vebicorvir in healthy male subjects
    


Intervention name(s): Vebicorvir (VBR)
Intervention type(s): Drug
Intervention description(s): 300mg Vebicovir containing 2 µCi [14C]VBR.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CHB; HBV; hepatitis B
Effects of Mental Stimulation in Patients With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment (MCI)
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to learn if activities that challenge the brain (mentally
      stimulating activities) can improve memory and other types of thinking in patients with Mild
      Cognitive Impairment. The study will compare the effects of different methods of mental
      stimulation.
    


Intervention name(s): mentally stimulating activities
Intervention type(s): Behavioral
Intervention description(s): The study will compare the effects of different methods of mental stimulation. The intervention involves 6 classroom-style educational sessions and 10 mental stimulation studies involving computerized memory tasks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of 6 Weeks High-intensity Interval Training Among Spinal Cord Injury
Condition: INCOMPLETE SPINAL CORD INJURY (ASIA D)
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The training consists of 6 weeks of functional electrical stimulation leg cycling exercise
      (FES-LCE) program. The training program comprises of 2 visits per week. Each visit consists
      of FES-LCE for 45 minutes. Throughout the 6 weeks program, there will be testing/assessment
      sessions on week 1, week 3 and week 6. The FES will be applied via surface electrodes and the
      stimulation intensity based on the participant's tolerance level.
    


Intervention name(s): Functional Electrical Stimulation Leg Cycling Exercise
Intervention type(s): Other
Intervention description(s): FES- leg cycling for 45 minutes (3 min warm up + 40 min HIIT + 2 min cooldown). The FES will be applied via surface electrodes and the stimulation intensity based on your tolerance level.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIGH INTENSITY INTERVAL TRAINING; INCOMPLETE SPINAL CORD INJURY; MUSCLE STRENGTH; CARDIO-RESPIRATORY FITNESS
Protein Ingestion and Muscle Carnitine Uptake
Condition: Muscle, Skeletal
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of a protein-carbohydrate beverage on the
      absorption of an orally ingested bolus of L-carnitine, compared to flavoured water and
      carbohydrate-only controls, and to determine whether increasing plasma carnitine availability
      can impact upon insulin-stimulated muscle carnitine uptake.
    


Intervention name(s): Flavoured water; Flavoured water + carbohydrate; Flavoured water + carbohydrate + protein
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Efficacy of Local Direct Median Nerve Block
Condition: Carpal Tunnel Syndrome; Anesthesia, Local
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome is the most common compressive neuropathy. Carpal tunnel release is
      indicated when failed conservative treatment. Although it can be done either with local
      anesthesia or brachial plexus block, there is no gold standard of anesthetic choice. The
      study is conducted to compare the efficacy of two methods and we hypothesized that the local
      direct median nerve block has effectiveness in intraoperative pain control not inferior to
      brachial plexus block in endoscopic carpal tunnel release.
    

Detailed description: 
      The study is randomized-control trial conducted in single center (Orthopaedic department,
      Faculty of medicine, Thammasat university) The patients with failed conservative treatment of
      carpal tunnel syndrome confirmed by EMG are enrolled and ramdomized with computerized
      block-of-4 method.The local direct median nerve block is done by the surgeon and brachial
      plexus block in done by single anesthesiologist after that the patient will be operated with
      1-portal endoscopic carpal tunnel release (Agee technque) by single surgeon. Immediate
      postoperative the blinded observer will ask the patient about interaoperative pain in visual
      analog scale then the pateint is asked to record the 2-hr, 4-hr ,6-hr and 12-hr postoperative
      pain in case record form.The patient will return the case record form at 2-week and also
      stitched off the wound then next follow up will be 4, 12, 24 weeks to assess functional
      outcome (Thai version Bonton questionaire)
    

Intervention name(s): Endoscopic carpal tunnel release under local direct median nerve block; Endoscopic carpal tunnel release under brachial plexus block
Intervention type(s): Procedure; Procedure
Intervention description(s): local direct median nerve block is performed by surgeon using the 1%xylocaine with adrenaline 12 mL(5 mL subcutaneous at incision site and 7 mL over median nerve) (maximum dose 7 mg/kg) before the endoscopic carpal tunnel release(1-portal Agee technique); brachial plexus block under ultrasound-guided is performed by experienced single anesthesiologist using the 1%xylocaine with adrenaline 15 mL (maximum dose 7 mg/kg) before the endoscopic carpal tunnel release(1-portal Agee technique)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endoscopic carpal tunnel release
Impact of Multidisciplinary Self-care Management of Diabetic Nephropathy on Quality of Life, Self-care Behavior, Glycemic Control, and Renal Function.
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional

Summary: 
      Diabetic Kidney Disease (DKD) is becoming a global health concern that affects largely the
      elderly population. Despite advances in pharmacological and management strategies, DKD remain
      associated with high morbidity and mortality. Patients living with such chronic disease, are
      expected, on daily basis to manage their self-care activities. Patients' non-adherence to the
      treatment is thought to be the major cause for the poor control and the occurrence of
      complications. Previous researchers have shown that multidisciplinary management of chronic
      disease can improve patients' self-care and outcomes. However, none of these programs was
      centered on self-care and targeted patients with DKD. A multidisciplinary self-care
      management program could improve the outcomes of patients with DKD, and delay the progression
      of the disease.

      The aim of the study is to investigate the effect of a multidisciplinary self-care management
      program on self-care behavior, quality of life, medication adherence, glycemic control and
      renal function, in adults with DKD.

      The study will use a cross-over design. 32 adult with DKD, will be randomly recruited from
      the Vaud University Medical Center, nephrology department and will be enrolled in the program
      for 12 month. All variables will be measured at baseline, three, six, nine and 12 month. We
      will measure the patients' self-care behavior, quality of life, adherence to the
      anti-hypertensive medication taking using, the Revised Summary of Diabetes Self-Care
      Activities questionnaire, the Audit of Diabetes-Dependent Quality of life questionnaire and
      the Medication Events Monitoring System. We will assess the patients' glycemic control by
      measuring the glycated hemoglobin and the renal function by measuring the serum creatinine
      and the microalbumin creatinine ratio.

      The study will clearly show if a multidisciplinary self-care management program will improve
      the health outcomes of patients with DKD and will allow us to recommend the establishment of
      such a program.
    


Intervention name(s): Self-care management program
Intervention type(s): Behavioral
Intervention description(s): The self-care management consists of the usual care with an additional multidisciplinary self-management program that includes additional home and clinic visits and telephone follow-ups made by the self-care management nurse and clinic visits to the dietician.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diabetic nephropathies; Nursing; Multidisciplinary; Self-care; Quality of Life
VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Condition: Ciliary Body and Choroid Melanoma, Medium/Large Size; Extraocular Extension Melanoma; Iris Melanoma; Metastatic Intraocular Melanoma; Recurrent Intraocular Melanoma; Recurrent Melanoma; Stage III Melanoma; Stage IV Melanoma
MeSH terms: Melanoma; Uveal Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial is studying how well VEGF Trap works in treating patients with recurrent
      stage III or stage IV melanoma that cannot be removed by surgery. Combinations of biological
      substances in VEGF Trap may be able to carry tumor-killing substances directly to melanoma
      cells. It may also stop the growth of melanoma by blocking blood flow to the tumor.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the antitumor response rate (complete and partial response) in patients with
      recurrent inoperable stage III or IV melanoma treated with VEGF Trap.

      II. Compare the progression-free survival of patients treated with this regimen vs historical
      controls.

      SECONDARY OBJECTIVES:

      I. Determine the overall survival of patients treated with this regimen. II. Determine the
      toxicity and tolerability of this regimen in these patients. III. Determine the impact of
      this regimen on laboratory correlates including anti-VEGF Trap antibody testing and
      pharmacokinetics in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days for at
      least 6 courses in the absence of disease progression or unacceptable toxicity.

      Blood samples are collected at baseline, prior to course 2, and 60 days after completion of
      study treatment for pharmacokinetic and pharmacodynamic studies. Samples are analyzed by
      enzyme-linked immunosorbent assay.

      After completion of study treatment, patients are followed periodically for 5 years.
    

Intervention name(s): ziv-aflibercept; pharmacological study
Intervention type(s): Biological; Other
Intervention description(s): Given IV; Correlative studies
Other intervention name(s): aflibercept; vascular endothelial growth factor trap; VEGF Trap; Zaltrap; pharmacological studies
Intervention MeSH terms: Aflibercept; Endothelial Growth Factors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Evaluation of a New and Current Tablet of ASP015K
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the bioequivalence of a new tablet versus a
      current tablet of ASP015K under fasting conditions after single oral administration in
      healthy male subjects.
    

Detailed description: 
      This is an open-label, randomized, single dose, 2-way crossover designed study. Forty
      non-elderly healthy male subjects will receive an ASP015K small tablet or an ASP015K current
      tablet in each period under fasted conditions. If the bioequivalence between two tablets
      cannot be demonstrated because of an insufficient number, an add-on subject study will be
      conducted as needed. The design of the add-on subject study will be the same with that of the
      initial study.
    

Intervention name(s): peficitinib
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): ASP015K
Intervention MeSH terms: Peficitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ASP015K; bioequivalence study; JAK inhibitor
A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study
Condition: Vocal Cord Dysfunction
MeSH terms: Vocal Cord Dysfunction
Study type: Interventional

Summary: 
      Vocal Cord Dysfunction (VCD) is characterized by involuntary closure of the vocal cords while
      inhaling. Children and adolescents with VCD may experience multiple symptoms, including
      difficulty breathing, coughing, wheezing, neck tightness, and voice changes. There is limited
      information on optimal management of VCD. In our proposed study, we will use
      cognitive-behavioral therapy (CBT) techniques to change how patients respond to their VCD
      symptoms. Measurements of airflow during breathing as well as symptom frequency and intensity
      will be examined prior to and following a series of four therapy sessions with a clinical
      psychologist that are focused on teaching patients strategies to decrease symptom reactivity.
    


Intervention name(s): Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques
Intervention type(s): Behavioral
Intervention description(s): At the four therapy sessions, subjects will work with the psychologist to identify the triggers of their VCD episodes, learn to self-monitor symptoms and reactions, and be taught breathing retraining/relaxation techniques. The goal is to decrease patterns of subjects' thinking or behaviors that exacerbate distress from VCD symptoms.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: paradoxical vocal fold motion; cognitive-behavioral therapy