bioihbjkbjnl/mcl2 huggingface dataset:
Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study - Proof of Concept
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization
      of smartphones has opened up new possibilities which surpass the normal audio-only telephony.
      High quality and real-time video-telephony is now feasible. However until now this technology
      hasn't been deployed in the emergency respond service.

      In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate
      and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the
      emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the
      dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable.

      This technology hasn't been tested in a randomized controlled trial in real environment
      conditions yet. This is to be done in this study.
    

Detailed description: 
      Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization
      of smartphones has opened up new possibilities which surpass the normal audio-only telephony.
      High quality and real-time video-telephony is now feasible. However until now this technology
      hasn't been deployed in the emergency respond service.

      In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate
      and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the
      emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the
      dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable, and
      automated localisation of the caller.

      This technology hasn't been tested in a randomized controlled trial in real environment
      conditions yet. This is to be done in this study.
    

Intervention name(s): EmergencyEye
Intervention type(s): Device
Intervention description(s): EmergencyEye Smartphone App
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Test of EmergencyEye functionality in real environment, comparison with conventional emergency call.
Masking: Single (Care Provider)
Primary purpose: Other
An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and and PegIntron (Peginterferon Alfa-2b) in Combination With Ribavirin as Combined Treatment of Chronic Hepatitis C in Human Immunodeficiency Virus-1 Infected Patients
Condition: Hepatitis; Hepatitis C; Hepatitis C/ Human Immunodeficiency Virus Coinfection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome; HIV Infections; Coinfection; Hepatitis; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to demonstrate the noninferiority of Algeron in combination with
      ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic
      hepatitis C in Human Immunodeficiency Virus-1 infected patients
    

Detailed description: 
      The course of treatment in both groups shall be 12 weeks, and efficacy analysis, i.e. rate of
      rapid (after the 4th week) and early (after the 12th week) virologic response will be based
      on polymerase chain reaction data. For patients with treatment failure after the 12th week
      the antiviral therapy shall be discontinued. All patients who require further anti-viral
      treatment will receive a combination treatment with Algeron / PegIntron and ribavirin for
      another 36 weeks. Sustained virologic response will be assessed 24 weeks after last dose of
      study treatment.
    

Intervention name(s): Algeron; PegIntron
Intervention type(s): Drug; Drug
Intervention description(s): 1.5 µg/kg of body weight subcutaneously, once a week; 1.5 µg/kg of body weight subcutaneously, once a week
Other intervention name(s): Cepeginterferon alfa-2b; peginterferon alfa-2b
Intervention MeSH terms: Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Cepeginterferon alfa; Peginterferon; Treatment
Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous
      dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2
      drug products.
    


Intervention name(s): Denosumab CP4; Denosumab CP2
Intervention type(s): Drug; Drug
Intervention description(s): Denosumab produced by a process referred to as CP4, administered subcutaneously.; Denosumab produced by a process referred to as CP2, administered subcutaneously.
Other intervention name(s): XGEVA®
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: denosumab, bioequivalence
Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of a videotelephone-delivered
      patient-partner dual-focused cognitive behavioral stress management intervention on chronic
      fatigue syndrome (CFS) symptoms and related psychosocial and neuroimmune processes in
      patients diagnosed with chronic fatigue syndrome. Study tests the hypothesis that
      videophone-delivered patient-partner cognitive behavioral stress management (T-PP-CBSM)
      intervention improves patient CFS symptoms relative to a videophone-delivered patient-partner
      Health Information (PP-T- HI) condition.
    

Detailed description: 
      The study tests the effects of a 10-week patient-partner focused videophone-delivered
      cognitive behavioral stress management intervention (T-PP-CBSM) intervention (relaxation,
      stress awareness, cognitive restructuring, coping skills training, interpersonal skills
      training) versus a time-attention-matched 10-week patient-partner based videophone-delivered
      health information (T-PP-HI) (health behavior education on nutrition, sleep and other
      factors) in men and women with chronic fatigue syndrome (CFS) and their partners. The study
      evaluates the effects of T-PP-CBSM vs T-PP-HI on patient CFS symptoms, neuroimmune
      processes--diurnal cortisol regulation and immune regulation
      (pro-inflammatory:anti-inflammatory cytokine ratio ([IL-1β + IL-6 + TNF-α]:[IL-13 +
      IL-10])-and psychosocial functioning at 5 months and 9 months after intervention.
    

Intervention name(s): Patient-Partner Videotelephone-delivered Health Information (PP-T-HI); Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Ten (10) 90-min sessions of Health Information delivered via videophones; Ten (10) 90-min sessions of T-PP-CBSM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Videophone-delivered stress management intervention; Chronic fatigue syndrome; Symptoms; Neuroimmune processes; Psychosocial
Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients
Condition: Transplant
Study type: Observational

Summary: 
      Influenza virus is an important cause of morbidity in the transplant population and can lead
      to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for
      organ transplant patients, studies have shown that the standard inactivated influenza vaccine
      has poor immunogenicity in this population. The investigators plan to test the humoral
      response to vaccination and look at HLA upregulation
    

Detailed description: 
      OBJECTIVE AND HYPOTHESIS

        -  To test the specific humoral response of the influenza vaccine after islet cell
           transplantation

        -  To test the production of HLA alloantibodies after vaccination.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult islet cell transplant recipients
      
Keywords: flu shot; islet cell transplant recipients
At What Time Therapeutic Plasma Concentrations of Paracetamol Are Achieved in Two Marketed Formulations
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single centre, open label, randomised, two-way crossover study in healthy
      volunteers under semi-fed conditions. Two formulations of paracetamol, are being tested in
      this study to establish at what time point a therapeutic concentration of paracetamol in the
      blood is reached. Subjects will attend a screening visit to check if they are eligible for
      study participation then within 15 days they will check-in to the unit for a stay of
      approximately 48 hours (hrs). They will be given a single dose of one of the preparations on
      the first day and then the other preparation on the next day. Regular blood samples will be
      taken along with other assessments for safety.
    


Intervention name(s): Paracetamol formulation 1; Paracetamol formulation 2
Intervention type(s): Drug; Drug
Intervention description(s): formulation 1; Formulation 2
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: pharmacokinetics; paracetamol
Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional
Phase: Phase 4

Summary: 
      It has been proved that lithium carbonate can prolong slow wave sleep with few or no
      side-effects. The aim of the present study is to evaluate postoperative sleep quality of
      patients undergoing video assisted thoracic surgery taken 250mg lithium carbonate 6 hours
      after surgery.
    

Detailed description: 
      This study is a prospective, randomized, controlled (randomized, parallel group, concealed
      allocation), double-blinded trial. All patients undergoing video assisted thoracic surgery
      during morning will be randomized 1:1 to the treatment intervention with lithium carbonate
      250mg (Baoqing, Hunan, China) or calcium carbonate 500mg (Reneed, Beijing, China) 6 hours
      after surgery. The objective of the trial is to evaluate the lithium carbonate 250mg on the
      first postoperative night sleep quality. The patients received standardized general
      anesthesia supplemented by paravertebral nerve block. The ultrasound-guided approach for
      paravertebral nerve block was used with the patient in the lateral decubitus position, and
      the paravertebral nerve block was administered at the T4-T6 level according to the incision
      protocol at our center. General anesthesia for maintenance of propofol anesthesia, total
      intravenous anesthesia was administered by using propofol (Fresenius Kabi, Austria GmbH) at a
      plasma target concentration (Marsh pharmacokinetic model software) of 2.5-4 μg/ml.
      Remifentanil (0.2-0.5 μg/kg/min, Renfu, Yichang, China) was given to all patients during the
      operation. All patients accepted patient-controlled intravenous analgesia with 1 μg ml-1
      sufentanil (Renfu, Yichang, China). Duration of sleep was defined as the duration of all
      bispectral index data below 80 in the 12 hours of monitoring (from 20:00pm to 06:00am).
    

Intervention name(s): Lithium Carbonate 250 MG; Calcium Carbonate 500 MG
Intervention type(s): Drug; Drug
Intervention description(s): Patients undergoing video assisted thoracic surgery during the morning will take 250mg lithium carbonate 6 hours after surgery.; Patients undergoing video assisted thoracic surgery during the morning will take calcium carbonate 500mg 6 hours after surgery.
Intervention MeSH terms: Lithium Carbonate; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: bispectral index; lithium carbonate
Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in
      subjects with alcohol use disorder (AUD) who experience insomnia associated with alcohol
      cessation, compared to placebo.
    


Intervention name(s): V117957 tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): V117957 tablets taken orally at bedtime; Tablets to match V117957
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Glucocorticoid Treatment in Addison's Disease
Condition: Addison's Disease
MeSH terms: Addison Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Addison's disease is a rare condition which in most cases is caused by autoimmune destruction
      of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens.
      Unrecognized the disease is life threatening, but with proper treatment patients can live
      near normal lives.

      The conventional glucocorticoid replacement therapy renders the cortisol levels
      unphysiological, which may cause symptoms and long-term complications. Glucocorticoid
      replacement therapy is technically feasible by continuous subcutaneous hydrocortisone
      infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This study aims to further
      evaluate CSHI treatment in terms of metabolic effects, effects on health-related
      quality-of-life and sleep in an 8 months randomised open label clinical trial with crossover
      design.
    


Intervention name(s): Solu-Cortef (hydrocortisone); Cortef (hydrocortisone)
Intervention type(s): Drug; Drug
Intervention description(s): Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.; Oral treatment 3 times a day. Weight adjusted doses.
Other intervention name(s): Solu-Cortef; Cortef 5 mg
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Addison's disease; Glucocorticoid treatment; Continuous subcutaneous hydrocortisone infusion; CSHI; Quality of Life; Sleep
Reliabılıty,Validity Of The Turkish Version Of The Back Pain Function Scale
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      This study, we performed the Turkish version validity and reliability of the Back Pain
      Function Scale.
    

Detailed description: 
      Low back pain is defined as the pain that can occur in the region between the lower border of
      the scapula and the hip, sometimes spreading to the lower extremities, which causes activity
      limitation and is one of the most common health problems in the society. Appropriate use of
      assessment questionnaires is one of the most important steps in the evaluation of the
      functional level of the patient and in deciding on an effective treatment protocol. The
      purpose of our study is to determine the Turkish version, validity and reliability of Back
      Pain Function Scale. 180 patients with chronic low back pain were included in the study.
      Test-retest and internal consistency analysis were conducted to determine the reliability of
      the questionnaire. Test-retest results were evaluated using the Intraclass Correlation
      Coefficient method. Intraclass Correlation Coefficient results vary between 0.857 and 0.951,
      and the total Intraclass Correlation Coefficient value is found to be 0.961. These results
      indicate that the test-retest responses have a high degree of correlation. For internal
      consistency analysis, the Cronbach Alpha score was fou nd to be 0.910, indicating that the
      survey has high internal consistency. The total score obtained from the Back Pain Function
      Scale was assessed using the Pearson correlation analysis with the total scores obtained from
      the Roland Morris Disability Scale , Oswestry Disability Scale. Pearson's correlation
      coefficient was -0.840 with Oswestry Disability Scale of Back Pain Function Scale, Pearson's
      correlation coefficient was -0.803 with Roland Morris Disability Scale. The results show that
      the Back Pain Function Scale correlates perfectly with the Oswestry Disability Scale and the
      Roland Morris Disability Scale. In conclusion, Turkish version of Bac Pain Function Scale is
      valid and reliable.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with chronic back pain between the ages of 18-65
      
Keywords: validity, reliability, low back pain
ALC-919 For The Treatment Of Common Warts
Condition: Verruca Vulgaris
MeSH terms: Warts
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-center, randomized, double blind, vehicle-controlled phase 2 study of
      subjects 8 years of age and older with Common Warts (Verruca vulgaris) who desire treatment.
    

Detailed description: 
      This is a single-center, randomized, double blind, vehicle-controlled phase-2 study of
      subjects 8 years of age and older with Common Warts (Verruca vulgaris) who desire treatment.
      A total of four visits are planned including one baseline and three follow-ups. Screening
      will be done at Visit 1 (Baseline) and all safety and efficacy measurements will be made at
      all subsequent visits (Visits 2-4).

      The primary objective is to evaluate the efficacy of twice daily-applied ALC-919 vs. vehicle
      in male and female subjects 8 years of age and older with Common Warts (Verruca vulgaris).
      The primary outcome measure is complete resolution of lesions at the 12 week visit. Secondary
      outcome measures will include the change in lesion count at the 12 week visit, improvement in
      the Global Aesthetic Improvement Scale score at the 12 week visit and the safety and
      tolerability profile of the treatment arm compared to the vehicle arm at each study visit.
      The safety will be assessed using clinical cutaneous safety exams that will report scaling,
      dryness and erythema on a scale of 0-3 (0= absent, 1=mild. 2=moderate, 3=severe).
      Tolerability will be assessed by having subjects answer the treatment tolerability questions
      at each visit during the treatment period. The tolerability question will be assessed using a
      0-3 scale for itching, burning, and stinging.
    

Intervention name(s): 2014-ALC-919-US; Vehicle-Control Topical Solution
Intervention type(s): Drug; Drug
Intervention description(s): A topical solution to be applied twice daily for the treatment of Common Warts; A topical solution to be applied twice daily for the treatment of Common Warts
Other intervention name(s): ALC-919; ALC-Vehicle-Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sub-Acute Stroke Rehabilitation With AMES
Condition: Cerebrovascular Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The AMES device is designed to produce functional cortical changes by:(1) assisting the
      subject as he/she attempts to move the limb (assisted movement) and (2) enhancing movement
      sensation by vibrating the muscles during movement (enhanced sensation). The primary
      hypothesis is that the combination of assisted movement and enhanced sensation from muscle
      vibration can increase the amount of motor recovery in individuals disabled by a stroke.
    

Detailed description: 
      Approximately 700,000 U.S. citizens have a stroke each year with about half ending up with
      significant motor disabilities. There are an estimated 5 million stroke survivors in the
      U.S., making strokes the leading cause of long-term disability in the U.S.. Existing
      rehabilitation therapies have not been effective in returning all stroke survivors to full
      motor recovery.

      The AMES device was designed to be able to provide therapy for the hand (fingers/wrist). In
      this 18 treatment sessions, double-blinded, control study, AMES therapy will be provided in
      addition to the usual physician-ordered rehabilitation during the sub-acute period following
      a stroke. Those control subject who complete the Phase 1 placebo sessions will have the
      opportunity to cross-over to participate in a AMES treatment group for a Phase 2.
    

Intervention name(s): AMES device (test); AMES device (sham); AMES device (crossover)
Intervention type(s): Device; Device; Device
Intervention description(s): Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.; Eighteen treatment sessions for each qualifying subject limb using the AMES device (sham) in which the limb is moved, but no active assistance is provided by the subject and the vibration is delivered at a very low frequency to the shortening (i.e., rather than lengthening) muscle. Each treatment session to provide thirty minutes of the placebo form of AMES therapy.; Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed as soon as possible after the completion of Arm C-1 Sham Comparator.
Intervention MeSH terms: Methylamphotericin B
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single crossover for only the control group participants from the controlled part of the study.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sub-acute care; Robotics