bioihbjkbjnl/mcl2 huggingface dataset:
Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms
Condition: Chronic Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      This study aims to compare the efficacy of a single session psychological treatment,
      "Empowered Relief" (ER), with the current standard of care, group Cognitive Behavioral
      Therapy (CBT) specifically on individuals with chronic low back pain who have pain-specific
      distress as indexed by pain catastrophizing scores.
    

Detailed description: 
      This is a randomized 3-arm study comprised of 2 active psychological treatments (ER & CBT)
      and a health education (HE) arm that controls for time and attention. Study goals are to
      provide scientific evidence to demonstrate the efficacy of ER, and also provide a comparison
      of said efficacy against the current gold standard group treatment for PC -- manualized
      8-session pain-CBT.
    

Intervention name(s): "Empowered Relief" (ER); Cognitive Behavioral Therapy (CBT); Health Education (HE)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): "Empowered Relief (ER)": A single-session skills-based approximately 2-hr group intervention to treat chronic pain.
Format of intervention: Therapist-delivered PowerPoint presentation with experiential exercises. Experienced senior level psychologist and two (2) additional doctoral level psychologists will conduct the ER sessions.
Content of intervention: ER Participants have the 'ER Relaxation Resource' app (guided relaxation audiofile) loaded on their apple or android electronic device.; Format of intervention: 8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total). The group is run weekly for 8 consecutive classes. Each class is 2 hours with a midpoint break (16 hours total intervention time).
Content of intervention: The protocol and materials were developed with funding from NIH/NCCAM R01 AT006226 (Dan Cherkin, PI) [1& 2], and include content from a pain-CBT program developed by Drs. Ehde, Dillworth, and Turner [3].
Participants receive a workbook with homework and a copy of The Pain Survival Guide: How to reclaim your life © 2005 by Turk & Winter [4] for optional reading.; Format of intervention: The HE class will be instructor taught and will involve a PowerPoint presentation and handouts. Two additional providers will be identified and trained to conduct the sessions. Selected instructors will have substantial health education experience.
Content of intervention: HE content will include basic information such as nutrition and interacting with the healthcare system; these relatively 'inert' topics are unlikely to impart any specific effects typically found with a true psychobehavioral intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The design is a randomized 3-arm study comprised of 2 active psychological treatments (ER & CBT) and a health education (HE) arm that controls for time and attention.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Medical and Physiological Benefits of Reduced Sitting
Condition: Metabolic Syndrome; Physical Activity; Insulin Resistance; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Insulin Resistance
Study type: Interventional

Summary: 
      The most important objective of this randomized controlled trial in subjects with increased
      cardiovascular and metabolic risk factors is to investigate whether only reduced daily
      sitting improves human cardiovascular and metabolic health during a six-month intervention.
      It is hypothesized and expected that only reduced sitting, without formal physical activity
      or exercise training, affects favorably cardiovascular and metabolic health.
    


Intervention name(s): Reduced sitting
Intervention type(s): Behavioral
Intervention description(s): Subjects are guided to limit their sitting time during the day for 1 hour/day, by adding light activity with the help of an activity monitor. Subjects are not encouraged to increase their moderate to vigorous physical activity levels.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A parallel-group randomised controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Physical Activity; Metabolic Syndrome; Insulin Sensitivity; Cardiovascular Risk Factor; Sedentary Lifestyle; Accelerometry
The Role of Peptide-loaded Dendritic Cells to Augment the Therapeutic Effect of Interleukin-2
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized,
      this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapy
      represents an approach to treatment based on the immune response to cancer antigens.

      The principal objective of the study is to identify whether a dendritic cell-based vaccine
      can increase the moderate therapeutic effect of bolus high dose IL-2 in patients with
      metastatic melanoma. For this purpose,patients with metastatic melanoma who have a certain
      blood type (HLA-A201+) will be treated systemically with high dose IL-2. In one group of
      patients, the IL-2 will be preceded by three doses of autologous dendritic cell pulsed with
      melanoma antigens appropriate for their blood type. Two cycles of three DC vaccines will be
      administered every 14 days by intra-lymph node injections, followed by high dose IL-2
      treatment. Responding patients will receive additional DC vaccines at 1 month and 2 months
      intervals.

      In a second group, patients will receive the standard high dose IL-2 protocol within a
      comparable period of time.

      Each group will include 12 patients.

      A complete evaluation of evaluable lesions will be performed prior to accrual, after initial
      3 DC vaccines, six weeks after first IL-2 treatment, after a total of 6 DC vaccines and 6
      weeks after second cycle of IL-2 treatment.
    


Intervention name(s): Immunotherapy treatment for melanoma
Intervention type(s): Procedure
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the effect and safety of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose
      twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years
      old in need for inhaled glucocorticosteroid treatment. To compare the efficacy of budesonide
      Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks to that of fluticasone
      Diskus® 50 μg/dose and 100 μg/dose twice daily for 6 week.
    


Intervention name(s): budesonide; fluticasone
Intervention type(s): Drug; Drug
Other intervention name(s): Pulmicort® Turbuhaler®
Intervention MeSH terms: Fluticasone; Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; bronchial
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
Condition: Candidemia
MeSH terms: Candidiasis; Candidemia; Candidiasis, Invasive
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective, open label study to assess the pharmacokinetics, safety & efficacy of
      anidulafungin when used to treat children (aged 1 month - <18 years) with invasive
      candidiasis, including candidemia (ICC).
    

Detailed description: 
      Prospective, open label study to assess the pharmacokinetics, safety & efficacy of
      anidulafungin when used to treat children (aged 1 month - < 18 years) with invasive
      candidiasis, including candidemia (ICC). To participate in the study, at the time of
      enrollment subjects must (1) have either a confirmed diagnosis of ICC or mycological evidence
      highly suggestive of Candida sp or (2) in infants 1 month to < 2 years only, be at high risk
      of candidiasis. All subjects meeting screening criteria receive IV anidulafungin. Subjects
      will be stratified by age (1 month - < 2 years; 2 years - < 5 years; 5 years - < 18 years).
      Subjects may be switched to oral fluconazole, provided that the pre-specified criteria are
      met. Subjects with microbiologically confirmed ICC must have a minimum total treatment
      duration of 14 days. The maximum allowed treatment duration of anidulafungin is 35 days; the
      maximum total treatment duration for the study is 49 days. At selected centers, anidulafungin
      pharmacokinetics will be assessed in the first 6 subjects age 1 month - < 2 years to confirm
      the recommended dosage regimen. A population PK-PD analysis will be performed in all other
      enrolled subjects. Subjects will be followed for safety through 6 week FU visit. Efficacy for
      subjects with confirmed ICC will be assessed at EOIVT, EOT, 2-week FU and 6-week FU visits.
    

Intervention name(s): Anidulafungin; Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days for subjects with microbiologically confirmed ICC and 5 days for subjects at risk of candidiasis; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day).
Maximum treatment duration with anidulafungin is 35 days.; Subjects may be switched to oral fluconazole [6-12 mg/kg/day (not to exceed 800mg/day] provided they meet specified criteria. Maximum total treatment duration is 49 days.
Other intervention name(s): Eraxis; Diflucan
Intervention MeSH terms: Fluconazole; Anidulafungin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anidulafungin; pediatrics; candidemia; invasive candidiasis; safety
Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is:

        -  To assess safety of Afalaza drug within 12 months in patients with symptoms of benign
           prostatic hyperplasia (BPH) and risk of progression.

        -  To assess efficacy of Afalaza drug within 12 months in patients with symptoms of benign
           prostatic hyperplasia and risk of progression.
    


Intervention name(s): Afalaza; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Safety and Efficacy; Safety and Efficacy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Alpha-1-Antitrypsin-Deficiency in COVID-19
Condition: Covid19
MeSH terms: COVID-19; Alpha 1-Antitrypsin Deficiency
Study type: Observational

Summary: 
      The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical
      course of patients that received AAT infusion for clinical indication is monitored.
    

Detailed description: 
      The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical
      course of patients that received AAT infusion for clinical indication is monitored. Clinical
      outcomes, blood inflammatory markers, and virus load are monitored.
    

Intervention name(s): AAT( Alpha 1 Antitrypsin)
Intervention type(s): Drug
Intervention description(s): AAT administration based on clinical indication
Other intervention name(s): AAT administration based on clinical indication
Intervention MeSH terms: Alpha 1-Antitrypsin; Protein C Inhibitor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All COVID-19 patients without need for invasive ventilation
      
Biospecimen description: 
      Serum, RNA, DNA, EDTA plasma
Comparison of a Novel 12-Lead Wireless Electrocardiogram (ECG) and a Standard Wired ECG
Condition: Healthy
Study type: Observational

Summary: 
      To determine if there is a difference between wireless ECG and wired ECG findings.
    

Detailed description: 
      The aim of the study is to compare ECG recordings from the Signalife Fidelity 100 Wireless
      12-lead ECG Monitor System to that of the GE 5000 Wired 12-lead ECG Monitor System during
      rest and while walking. We hypothesize that ECG recordings from the wireless system will be
      equivalent to recordings from the standard wired system.
    

Intervention name(s): Recom Model 100; GE 5000 ECG Monitor System
Intervention type(s): Device; Device
Intervention description(s): Battery Operated, Ambulatory, Digital Wireless ECG Monitor System; Wired ECG system
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy individuals Age 18-64
      
Keywords: ECG; EKG; healthy subjects; electrocardiography, ambulatory
A Relative Bioavailability Study of Acetaminophen Extended Release Gel Tabs 650 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional

Summary: 
      The study was to compare single-dose oral bioavailability of acetaminophen 650 mg extended
      release geltabs (containing acetaminophen 650 mg) of OHM Laboratories Inc. (subsidiary of
      Ranbaxy Pharmaceuticals Inc., USA) with Tylenol 8 hour extended release gel tabs (containing
      acetaminophen 650 mg) of McNeil Consumer & Speciality Pharmaceuticals, U.S.A in healthy,
      adult, male human subjects under fasting condition.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomised, two-treatment, two-period,
      two-sequence, single dose, crossover bioavailability study comparing acetaminophen 650 mg
      extended release gel tabs (containing acetaminophen 650 mg) of OHM Laboratories Inc.
      (subsidiary of Ranbaxy) with Tylenol 8 hour extended release gel tabs (containing
      acetaminophen 650 mg) of McNeil Consumer & Speciality Pharmaceuticals in healthy, adult,
      human, male subjects under fasting condition.

      The treatments were assigned to the study subjects according to SAS generated randomization
      schedule. Each subject received a single oral dose either Test or Reference product in each
      period with 240ml of water at ambient temperature after an overnight fast of at least 10
      hours under supervision of a trained study personnel.

      During the course of the study, safety parameters inclusive of vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical,
      serology parameters and urine analysis) at base line were assessed. Laboratory parameters of
      hematology and biochemistry were repeated at the end of the study.
    

Intervention name(s): Acetaminophen
Intervention type(s): Drug
Intervention description(s): Extended release Gel tabs 650 mg
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Rhodospirillum Rubrum and Cholesterol
Condition: Cholesterol Metabolism
Study type: Interventional

Summary: 
      The primary objective of the study is to examine for the first time the LDL cholesterol
      lowering effect of oven-dried Rhodospirillum rubrum in humans.
    

Detailed description: 
      Objectives:

      Secondary objectives are to investigate the effects on other CVD risk parameters: total
      cholesterol, triacylglycerol, HDL-C, glucose and blood pressure. Safety will be monitored by
      measurements of markers for liver, kidney and heart function.

      Study design:

      The study is a 4-weeks randomized, double-blind placebo-controlled trial with a parallel
      design using 3 doses oven-dried Rhodospirillum rubrum. Prior to and after the intervention
      period, a 2-week run-in and run-out period takes place, during which all subjects will
      consume placebo capsules.

      Study population:

      Eighty (N=80) healthy men with a slightly elevated fasting serum total cholesterol
      concentration (between 5.0-8.0 mmol/l) will complete the study.

      Intervention:

      During the intervention period of 4 weeks, men will receive either placebo or capsules
      containing 0.25 gr, 0.5 gr or 1.0 gr oven-dried Rhodospirillum rubrum per day.
    

Intervention name(s): Rhodospirillum rubrum; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules containing oven-dried Rhodospirillum rubrum; Capsules containing microcrystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure two different formulations of BG00012 to determine
      how much of each formulation of BG00012 reaches the blood stream and how long it takes the
      body to get rid of it, when given as a single dose.
    


Intervention name(s): BG00012
Intervention type(s): Drug
Intervention description(s): Sequence 1: Oral 240 mg BG00012 Standard Formulation & Following 7 day washout period, 240 mg BG00012 API.
Sequence 2: 240 mg BG00012 API & Following 7 day washout period, 240 mg BG00012 Standard Formulation.
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteer
Efficacy and Safety of DA-9401 on Improvement of Sperm Motility
Condition: Spermatocele
MeSH terms: Spermatocele
Study type: Interventional

Summary: 
      This study was conducted to investigate the effects of daily supplementation of Allium cepa
      L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) on improvement of sperm motility.
    

Detailed description: 
      This study was a 12 weeks, multi-center, randomized, double-blind, placebo-controlled human
      trial. Twenty subjects were randomly divided into Allium cepa L. and Cuscuta chinensis Lam.
      Extract Mixtures (DA-9401) or a placebo group. sperm motility profiles before and after the
      intervention.
    

Intervention name(s): DA-9401; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo for 12 weeks.
Other intervention name(s): capsules (4cap/d, 2.16 g/d) for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: sperm motility, Clinical Trial , DA-9401
Comparison of Effect of Equi-MAC Anesthetics on PSI
Condition: Anesthesia
Study type: Interventional

Summary: 
      The aim of this study is to compare the patient state index values produced by equi-MAC of
      sevoflurane and desflurane in patients undergoing single-agent volatile anesthesia.
    

Detailed description: 
      There have been several studies comparing electroencephalogram-derived indices produced by
      sevoflurane and desflurane. However, to the best of our knowledge, there has been no study
      which compared the two inhaled anesthetics using patient state index. Therefore, the aim of
      this study is to compare the patient state index values produced by sevoflurane and
      desflurane at equi-MAC in patients undergoing single-agent inhalation anesthesia.
    

Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): Throughout the study period, anesthesia is maintained with sevoflurane of age-corrected equivalent minimum alveolar concentration.; Throughout the study period, anesthesia is maintained with desflurane of age-corrected equivalent minimum alveolar concentration.
Other intervention name(s): Sevorane; Suprane
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: patient state index; sevoflurane; desflurane; minimum alveolar concentration
Counseling for Primary Care Office-based Buprenorphine
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The major goal is to determine whether adding cognitive behavioral therapy to physician
      management will increase the efficacy of buprenorphine/naloxone treatment in an office-based
      primary care setting.
    

Detailed description: 
      To evaluate the need for drug counseling aimed at reducing illicit drug use and increasing
      buprenorphine/naloxone adherence, the proposed study compares manual-guided Physician
      Management (PM) and PM combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)
      in a 24 week randomized clinical trial of buprenorphine/naloxone in a heterogeneous
      population of opioid dependent patients (N=140) in a primary care clinic. PM, consistent with
      federal regulations, is designed to reflect usual care by primary care physicians and
      includes referral to ancillary services. CBT will be provided by skilled psychologists in
      weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and
      increasing buprenorphine/naloxone adherence. The study will test the hypothesis that that the
      addition of CBT to PM will lead to decreased illicit drug use, durable effects after
      counseling has been discontinued, improved buprenorphine/naloxone adherence and will
      demonstrate incremental cost-effectiveness in patients receiving buprenorphine/naloxone
      maintenance in primary care. Primary outcome measures include reductions in illicit opioid
      use and abstinence achievement, as assessed by weekly urine toxicology testing and self
      report. Secondary outcome measures include retention in treatment, reductions in cocaine use
      and HIV risk, decreased criminal activity and improved health and employment status.
      Utilization and costs of services, spillover effects in the PCC, and patient and staff
      perceptions of benefits and problems associated with primary care agonist maintenance
      treatment will also be evaluated. The results of this study will help define the role of
      professional evidence-based drug counseling in expanding access to treatment with
      buprenorphine/naloxone.
    

Intervention name(s): Manual-guided Physician Management (PM); Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Manual-guided Physician Management (PM) PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services.; CBT is provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing Buprenorphine adherence.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Buprenorphine; Buprenorphine/naloxone; Counseling; Primary care