bioihbjkbjnl/mcl2 huggingface dataset:
Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This 3-part study will be conducted to evaluate the interaction of vadadustat with sevelamer
      carbonate, calcium acetate, and Auryxia in healthy male and female participants. A total of
      18 participants will be enrolled in each part of the study. Part 1 of the study will be
      conducted to assess the effect of a single oral dose of sevelamer carbonate (1600 milligrams
      [mg]) on the pharmacokinetics (PK) of a single oral dose of vadadustat (300 mg). Part 2 of
      the study will be conducted to assess the effect of a single oral dose of calcium acetate
      (1334 mg) on the PK of a single oral dose of vadadustat (300 mg). Part 3 of the study will be
      conducted to assess the effect of a single oral dose of Auryxia® (2 grams) on the PK of a
      single oral dose of vadadustat (300 mg).
    


Intervention name(s): Vadadustat; Sevelamer carbonate; Calcium acetate; Auryxia®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 x 150 mg oral tablets; 2 x 800 mg oral tablets; 2 x 667 mg oral gelcaps; 2 x 1 gram tablets (210 mg ferric iron equivalent to 1000 mg ferric citrate)
Intervention MeSH terms: Calcium; Sevelamer; Calcium acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; Pharmacokinetics; Phosphate binders; Sevelamer carbonate; Calcium acetate; Auryxia®; Vadadustat
Superior Trunk Block Applied for Upper Arm Surgery
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Nerve blocks applied with ultrasonography are currently used for many post-operative pain and
      operations. Providing adequate area analgesia is the primary goal of clinicians, as early
      mobilization is suggested after shoulder and arm surgery.

      In this study aimed to investigate the effect of superior trunk block application on
      postoperative analgesic and motor functions.
    


Intervention name(s): superior trunk block; intravenous patient-controlled analgesia
Intervention type(s): Procedure; Drug
Intervention description(s): Local anesthetic injection will be applied to the superior trunk of the brachial plexus accompanied by ultrasonography.; Analgesics will be given using a patient-controlled analgesia device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Quality of Cardiopulmonary Resuscitation Guided by AED vs Telephone-assistance
Condition: Cardiopulmonary Resuscitation
Study type: Interventional

Summary: 
      The aim of this research is to evaluate and to compare the quality of cardiopulmonary
      resuscitation (CPR) among untrained laypeople under two different scenarios: automated
      external defibrillator (AED) guided CPR or dispatcher-assisted CPR. Secondarily, to evaluate
      the quality of the dispatcher-assisted instructions provided from the emergency call center.
    

Detailed description: 
      A simulation study will beperformed. 42 volunteers selected by non-probabilistic sampling
      will be randomized in two scenarios of cardiac arrest on mannequin: (A) AED-guided CPR and
      (T) dispatcher-assisted CPR. Simulations last 9 minutes. The quality of CPR will be evaluated
      by metric monitoring of the chest compressions and timing of actions. A peer's content
      analysis of the telephone instructions will be performed using a checklist.
    

Intervention name(s): AED; Telephone
Intervention type(s): Device; Device
Intervention description(s): Instructions provided by an AED; Instructions provided by emergency Call Center (telephonically) with the help of an AED.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
OC000459 Dose Finding Study in Hay Fever Sufferers.
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate a range of dose levels for efficacy in the
      control of symptoms of allergic rhinitis
    

Detailed description: 
      This will be a randomised, double blind, placebo controlled, parallel group evaluation of
      OC000459 given orally for eight days. Four dose levels will be studied and compared to
      placebo. They will be studied in treatment groups of 18 to 21 subjects. The placebo group
      will also consist of 18 to 21 subjects. There will be a screening period of up to six weeks.
      There will be a follow up one to three weeks after the last dose of study drug.
    

Intervention name(s): OC000459; OC000459; OC000459; OC000459; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets twice daily for 8 days
Dose level 1; Tablets twice daily for 8 days
Dose level 2; Tablets twice daily for 8 days
Dose level 3; Tablets twice daily for 8 days
Dose level 4; Tablets twice daily for 8 days
Dose level 5
Intervention MeSH terms: Indoleacetic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergic rhinitis; human; clinical trial; efficacy; safety; challenge test
A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to assess if esreboxetine can improve the cognitive function of
      patients with fibromyalgia. Cognitive function is defined as the ability to concentrate,
      remember things and make decisions or problem solve. The study is also designed to assess if
      there is a difference in cognitive function between fibromyalgia patients and matched control
      subjects.
    


Intervention name(s): Esreboxetine; Esreboxetine
Intervention type(s): Drug; Drug
Intervention description(s): Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing; Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia
Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This multicenter, randomised, phase 3 study is to evaluate the survival benefit of
      maintenance capecitabine plus best supportive care versus best supportive care for metastatic
      nasopharyngeal carcinoma patients after disease controlled with TPC palliative chemotherapy.
    

Detailed description: 
      Firstly diagnosed metastatic nasopharyngeal carcinoma patients will receive 4-6 cycles of
      palliative chemotherapy with taxol,cisplatin and capecitabine. After disease controlled, they
      will be randomly assigned to maintenance capecitabine plus best supportive care(BSC) or BSC
      alone. The primary end point is progression-free survival, the secondary end points are
      overall survival, duration of response, objective response rate, adverse effects and quality
      of life.
    

Intervention name(s): capecitabine; Best supportive care (BSC)
Intervention type(s): Drug; Other
Intervention description(s): capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops.; Best supportive care and following-up every 6-8 weeks
Other intervention name(s): Xeloda
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasopharyngeal carcinoma; metastasis; capecitabine
Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers
Condition: Pain Threshold; Mood
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The following study is designed to determine the analgesic efficacy of smoked marijuana (0,
      1.98, and 3.56% THC) and oral THC (0, 10, and 20 mg) in the Cold-Pressor Test (CPT), a
      laboratory model of pain which has predictive validity for clinical use of analgesics. Oral
      THC (dronabinol) is known to have a slower onset and longer duration of action compared with
      smoked marijuana. Therefore, the analgesic effects of oral THC is expected to peak later and
      last longer than effects produced by smoked marijuana.
    

Detailed description: 
      Laboratory animal studies have demonstrated the analgesic effects of drugs which act on the
      cannabinoid system, however, these effects have et to be clearly elucidated in humans. To
      better understand the potential clinical application of cannabinoids for pain management, the
      following study is designed to determine the analgesic efficacy of smoked marijuana (3.56%
      THC) and oral THC (20 mg) in the Cold-Pressor Test (CPT), a laboratory model of pain which
      has predictive validity for clinical use of analgesics. Non-treatment seeking marijuana
      smokers will be recruited for a five-session study during which the analgesic, subjective,
      and physiologic effects of cannabinoids will be evaluated. Determining the efficacy of
      cannabinoids in an experimental model of pain will provide important endpoints (i.e., dose,
      route of administration, time course) or this effect to further investigate the potential
      role for clinical use of smoked marijuana and/or oral THC as analgesics.
    

Intervention name(s): Placebo capsules; Inactive marijuana (0% THC); Low dose Dronabinol; High dose Dronabinol; Low THC marijuana; High THC marijuana
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo capsules; Inactive marijuana cigarettes (0% THC) provided by NIDA; Dronabinol 10mg; Dronabinol 20mg; marijuana cigarettes (1.98% THC) provided by NIDA; Marijuana cigarettes (3.56% THC) provided by NIDA
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: oral thc; cannabis; pain; analgesic effects; dronabinol
Evaluation of the Effectiveness of Spa Treatment in Swieradow Zdroj With Special Regard to the Action of Radon Waters
Condition: Osteoarthritis; Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      Observation conducted during the 21 days of treatment in the health resort of
      Swieradow-Zdroj. In a treatment of applied therapy: radon therapeutic baths and inhalations,
      kinesiotherapy. Study group with degenerative joints and disc disease participating in
      therapy. The control group was selected by the spa workers, also suffering from a
      degenerative disease of the movement organs not using the spa's treatment base. In both of
      these groups, appropriate pre- and post-treatment studies were performed.
    

Detailed description: 
      The observation was conducted during 21 days of medicinal stays in the health resort of
      Swieradow-Zdroj. The treatment included a comprehensive therapy: radon therapeutic baths and
      inhalations, kinesiotherapy.

      The study group consisted of patients with degenerative joints and disc disease participating
      in therapy. On the day of admission to the SPA the patients were subjected to subjective and
      objective examination. Laboratory tests (lipids profile, CRP, smear blood morphology, TAS-
      total antioxidative potential, metalloproteinase 8) were performed before treatment on day 5
      and after 18 days. In addition, before and after treatment, standard scales were used to
      assess pain intensity: MCGill scale and VAS scale and anxiety and depression levels - HADS
      scale.

      The control group was selected by the spa workers, also suffering from a degenerative disease
      of the movement organs not using the spa's treatment base. In this group also made the same
      study.
    

Intervention name(s): Radon therapeutic baths and inhalations; Kinesiotherapy
Intervention type(s): Radiation; Procedure
Intervention description(s): The natural water with low mineralized content plays a major therapeutic role with the parameters of Rn 303,1-441,5 Bq/l. In the treatment rooms (inhalation, cabins with baths and swimming pool) measurement of alpha radiation was 184,4-450,0 MeV. The measurements were analyzed every 3 months at the Institute of Occupational Medicine in the Department of Radiation Protection in Lodz, Poland. Among the types of treatments used in the therapy there was: comprehensive radon bath - with the temperature of 37 °C, duration 15 min., the treatments were performed every 2nd day, whereas radon inhalations lasted 15 min. with the temp. 37 °C- treatments were performed every 2nd day from Monday to Friday. Baths and inhalations were performed interchangeably and the total number of radon treatments during one stay was 15.; It is the therapeutic treatment of disease by passive and active muscular movements (as by massage) and of exercise. It is the core element of physiotherapy/physical therapy. Kinesiotherapy - duration of 30-45 min,
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Aerobic Exercise in Patients With Essential Hypertension
Condition: Aerobic Exercise; Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Observational

Summary: 
      The goal of this observational study is to evaluate the effects of a supervised aerobic
      exercise training program on weight loss, functional capacity, quality of life (QoL), and
      depression levels in patients with essential hypertension.
    

Detailed description: 
      Patients who chose the treatment type according to personal preferences were divided into two
      groups: Group 1(n:91) exercised for six weeks, five sessions per week under the supervision
      of a medical doctor in the aerobic exercise laboratory, and group 2(n:47) was advised to
      maintain dietary habits and physical activity levels. Body weight, serum lipid levels,
      functional capacity, QoL, and depression level of all the participants were evaluated at
      baseline and 6 weeks later.
    

Intervention name(s): Supervised Aerobic Exercise
Intervention type(s): Other
Intervention description(s): Group 1 exercised for six weeks, five sessions per week under the supervision of a medical doctor in the aerobic exercise laboratory.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Essential Hypertension
      
Keywords: supervised aerobic exercise; functional capacity; quality of life; depression level; essential hypertension
Hypertension in Black Americans: A Life Course Approach
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension
MeSH terms: Hypertension; Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To investigate the relationship between life-stress factors associated with socioeconomic
      conditions and hypertension.
    

Detailed description: 
      BACKGROUND:

      Increasingly, researchers are recognizing that risk for cardiovascular disease (CVD) in
      adulthood is rooted in the social and material life conditions of childhood, and that these
      childhood conditions may predict risk for CVD above and beyond traditional adulthood
      indicators of socioeconomic status (SES) such as education, occupation or income. Nowhere is
      this life course perspective on CVD risk more important than in the case of African
      Americans, especially the generation that "came of age" in the U.S. South in the late 1950s
      and 1960s, the peak years of the modern Civil Rights Movement. While some African American
      members of this age cohort were able to take advantage of the new opportunities for economic
      advancement, some others were not, resulting thereafter in different life course trajectories
      of exposure to social and economic hardship. The relationship between variations in these
      social and economic life course trajectories, and CVD risk (specifically hypertension) in
      adulthood, has not been investigated in African Americans.

      DESIGN NARRATIVE:

      The study uses the Pitt County, (NC) cohort, a community sample of African Americans (N=1784,
      66 percent female, 80 percent response rate) who were between 25-50 years of age at baseline
      in 1988. Normotensives in the baseline sample were re-examined in 1993 (N=1195, 66 percent
      female, 85 percent response rate). In addition to measuring blood pressure, extensive data on
      psychosocial, behavioral, and anthropometric characteristics were obtained at both times. The
      study re-examines the original cohort in 2001; the anticipated sample size is 1142
      individuals (717 women and 425 men). Starting from age 20, respondents' reported exposure to
      three domains of socioenvironmental stressors will be assessed: (1) adverse socioeconomic
      conditions; (2) low levels of social integration; and (3) racial discrimination. Taken
      individually, and then collectively, the greater the cumulative life course exposure to these
      stressors, the greater the risk for adult hypertension is expected to be. The primary
      analyses will focus on the relationship between pre-1988 exposures and 1988 blood pressure
      status (retrospective analyses), and the relationship between pre-1988 exposures and changes
      in blood pressure status between 1988 and 2001(prospective analyses).
    

Time perspective: Retrospective
Bioequivalence Study to Compare Chenodeoxycholic Acid Capsules (250mg Chenodeoxycholic Acid) Versus Chenodeoxycholic Acid Leadiant 250 mg Hard Capsules (250mg Chenodeoxycholic Acid)
Condition: Cerebrotendinous Xanthomatoses
MeSH terms: Xanthomatosis, Cerebrotendinous; Xanthomatosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence
      study to compare Chenodeoxycholic acid capsules (250mg chenodeoxycholic acid) [dose: 1 x 02
      capsules] versus Chenodeoxycholic acid leadiant 250 mg hard capsules (250mg chenodeoxycholic
      acid) [dose: 1 x 02 capsules] in healthy subjects under fasting conditions.
    


Intervention name(s): Chenodeoxycholic acid; Chenodeoxycholic acid leadiant
Intervention type(s): Drug; Drug
Intervention description(s): Two capsules were administered orally; Two capsules were administered orally
Intervention MeSH terms: Chenodeoxycholic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope
Condition: Anesthesia; Intubation; Difficult or Failed; Cricoid Pressure; Pulmonary Aspiration During Anesthetic Induction
Study type: Interventional

Summary: 
      Recently, left paratracheal pressure was introduced as an alternative method to prevent
      pulmonary aspiration instead of cricoid pressure. Criocoid pressure is known to worsen
      glottic visibility when using Pentax.However, the effects of left paratracheal pressure on
      glottic view when using Pentax are not studied yet. In this study, the subjects are divided
      into two groups (group I: left paratracheal pressure applied before intubation, group II:
      conventional cricoid pressure applied before intubation). Investigators will assess the
      glottic view during intubation using Pentax.
    

Detailed description: 
      Primary outcome

      - Duration of intubation

      Secondary outcomes

        -  POGO (percentage of glottic opening) score before and after application of each
           intervention

        -  Glottic grade by Cormack Lehane

        -  The success rate in first attempt

        -  Intubation difficulty scale

        -  Hemodynamics during intubation

        -  Postoperative airway complications
    

Intervention name(s): Paratracheal pressure; Cricoid pressure
Intervention type(s): Procedure; Procedure
Intervention description(s): To apply paratracheal pressure, the thumb was placed over the left side of the trachea cephalad to the clavicle and medial to the sternocleidomastoid muscle.; To apply cricoid pressure, the crocoid cartilage was compressed with a single-handed three-finger maneuvre towards the vertebral bodies.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double blinded clinical trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Paratracheal pressure; Glottic view; Cricoid pressure; Pentax
Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of multiple doses of
      evolocumab when given as an add-on to stable statin therapy.
    

Detailed description: 
      Participants receiving low-to-moderate-dose statins were randomized in a 1:3 ratio to receive
      subcutaneous placebo or evolocumab and enrolled sequentially into one of 5 dose-escalation
      cohorts:

        1. Evolocumab 14 mg/placebo once weekly (QW) × 6 doses

        2. Evolocumab 35 mg/placebo once weekly (QW) × 6 doses

        3. Evolocumab 140 mg/placebo every 2 weeks (Q2W) × 3 doses

        4. Evolocumab 280 mg/placebo every 2 weeks (Q2W) × 3 doses

        5. Evolocumab 420 mg/placebo every 4 weeks (Q2W) × 2 doses.

      Participants receiving high-dose statins were randomized 1:3 to receive subcutaneous placebo
      or evolocumab 140 mg every 2 weeks × 3 doses (Cohort 6).

      Participants diagnosed with familial hypercholesterolemia (HeFH) were randomized 1:2 to
      receive subcutaneous placebo or evolocumab 140 mg every 2 weeks × 3 doses (Cohort 7).
    

Intervention name(s): Evolocumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AMG145; Multiple Dose; Statin; Ascending