bioihbjkbjnl/mcl2 huggingface dataset:
A Relative Bioavailability Study of Fentanyl 25 μg/h Transdermal System
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the rate and extent of absorption of fentanyl 25 μg/h transdermal system (test)
      and Duragesic (reference) administrated as 1 x 25 μg/h single transdermal system application.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

      Official Title: Randomized, 2-way crossover, bioequivalence study of Fentanyl 25 μg/h
      transdermal system and Duragesic 25 μg/h transdermal system administrated as 1 x 25 μg/h
      single application in the healthy subjects

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Fentanyl 25 μg/h transdermal system, single application; Duragesic 25 μg/h transdermal system single application
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Corium International, Inc formulated products; B: Active comparator Subjects received Jassen Pharmaceutica Products, L.P. formulated products
Other intervention name(s): Fentanyl; Fentanyl
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Fentanyl; Healthy subjects
Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV
Condition: HIV-1 Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      We propose to test our primary hypothesis that treatment with Peg-IFN-α-2b will result in a
      decrease in integrated HIV DNA in peripheral blood and tissue in chronically HIV-infected
      immune-reconstituted individuals (see section 3.1) in a prospective, interventional, 1-arm,
      open label clinical trial. To this end, we propose to enroll 25 HIV-1-infected subjects
      (please refer to power calculations in section 10.1 below) currently stably suppressed (> 1y
      with VL < 50 copies/ml) on ART and with CD4 count > 450 cells/µl.

      We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b, in the presence of HIV
      reactivation (i.e.: ART interruption), will result in activation of intrinsic and/or
      immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir
      in chronically HIV-infected, immune-reconstituted individuals.
    


Intervention name(s): Pegylated Interferon alpha 2b
Intervention type(s): Drug
Intervention description(s): 1µg/kg/week
Other intervention name(s): Pegintron
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; Interferon alpha; Integrated DNA; Latent reservoir
Study of EB-001 in Facial Scar Reduction
Condition: Mohs Surgery
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of EB-001 in improving wound healing and
      reducing scar formation in patients undergoing Mohs surgery for skin lesions in the forehead
      area following a single treatment of EB-001 when injected into the muscles underlying the
      incision area.
    

Detailed description: 
      This study will evaluate the safety and efficacy of EB-001 in improving wound healing and
      reducing scar formation in patients undergoing Mohs surgery for skin lesions in the forehead
      area following a single treatment of EB-001 when injected into the muscles underlying the
      incision area.

      The safety objective is to determine the safety and tolerability of single treatment of
      EB-001 when injected into facial muscles underlying a surgical wound during Mohs surgery.

      The efficacy objective is to evaluate the efficacy of a single treatment of EB-001 when
      injected into the facial muscles (frontalis) underlying the surgical wound in improving wound
      healing, and reducing scar formation.
    

Intervention name(s): EB-001; 0.9% Sodium Chloride Injection
Intervention type(s): Drug; Drug
Intervention description(s): Injection of EB-001 into area of scarring (forehead); Injection of Saline into area of scarring (forehead)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of CCX140-B in Subjects With FSGS
Condition: FSGS; Focal Segmental Glomerulosclerosis; Glomerulosclerosis
MeSH terms: Glomerulosclerosis, Focal Segmental
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate
      the Safety and Efficacy of CCX140-B in Subjects with FSGS to be conducted in the North
      America, Europe and Australia
    

Detailed description: 
      A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate
      the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis
      (FSGS) to be conducted in the North America, Europe and Australia. The aim of this study is
      to evaluate the effect of treatment with CCX140-B, a selective antagonist of C-C chemokine
      receptor type 2 in subjects with focal segmental glomerulosclerosis on urinary protein
      excretion as assessed by changes in urine protein to creatinine ratio (UPCR)
    

Intervention name(s): Placebo; CCX140-B; CCX140-B; CCX140-B
Intervention type(s): Other; Drug; Drug; Drug
Intervention description(s): Three placebo tablets, taken twice daily (BID), per os, for 84 days (12 weeks); One 5 mg CCX140-B tablet and 2 placebo tablets in the morning; 3 placebo tablets in the evening; per os, for 84 days.; Two 5 mg CCX140-B tablets and 1 placebo tablet, taken BID; per os, for 84 days.; Three 5 mg CCX140-B tablets, taken BID; per os, for 84 days.
Other intervention name(s): CCX140-B Placebo; Group B; Group C; Group D
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized, placebo-controlled, Phase 2
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Trio Laser Module for Hair Removal Treatment
Condition: Hair Removal Treatment
Study type: Interventional

Summary: 
      The study is aimed to assess the safety and efficacy of hair removal treatments, using the
      Trio Laser Module (Alma Lasers).

      The study will include 36 subjects that will undergo axilla and bikini line hair removal
      treatments. Safety and efficacy will be evaluated 3- months after the last treatment.
    


Intervention name(s): Hair removal treatment
Intervention type(s): Device
Intervention description(s): Axilla and bikini line hair removal treatments using the Trio Laser Module (Alma Lasers).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aldosterone, Microvascular Function and Salt-sensitivity
Condition: Abdominal Obesity; Metabolic Syndrome; Sodium-sensitivity; Insulin Resistance; Hypertension
MeSH terms: Obesity; Metabolic Syndrome; Insulin Resistance; Obesity, Abdominal; Hypersensitivity
Study type: Interventional

Summary: 
      Currently, the incidence of obesity and obesity-related disorders is reaching epidemic
      proportions, which entails an increasing burden for health care systems. The association of
      obesity with other risk factors for type 2 diabetes mellitus and cardiovascular disease, such
      as insulin resistance and hypertension, is often referred to as the metabolic syndrome.
      During recent years, salt-sensitivity of blood pressure has emerged as an additional
      cardiovascular risk factor that is related to obesity and other key components of the
      metabolic syndrome. The underlying pathophysiological mechanisms of these interrelationships
      are complex and incompletely elucidated. Microvascular dysfunction has been proposed as a
      link between insulin resistance and hypertension in obese individuals. In addition,
      impairment of microvascular function was found to be associated with salt-sensitivity of
      blood pressure. Increased aldosterone levels, as observed in obese individuals, might be a
      cause of microvascular dysfunction-induced salt-sensitivity and insulin resistance.
      Aldosterone not only gives rise to sodium-retention in the distal tubule of the kidney, but
      was also found to impair endothelial function and thus lower NO-availability, which is
      characteristic of microvascular dysfunction. In addition, elevated aldosterone levels are
      associated with both hypertension and insulin resistance, which is illustrated in patients
      with primary aldosteronism, but also in the general population.

      The investigators hypothesize that increased aldosterone levels in obese individuals lead to
      impairment of microvascular function through reduction of NO-availability. This microvascular
      dysfunction is suggested to play a central role in the pathogenesis of salt-sensitive
      hypertension and insulin resistance.
    


Intervention name(s): Low-sodium diet; High-sodium diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 50 mmol NaCl per 24h; 250 mmol NaCl per 24h
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis and Intermittent Asthma
Condition: Allergic Rhinitis; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate
      nasal spray) in comparison with placebo in improving the quality of life of subjects with
      moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary
      objective is to evaluate the efficacy of Nasonex in relieving the subject's symptoms of
      allergic rhinitis and asthma.
    

Detailed description: 
      The primary objective is to explore the efficacy of mometasone furoate nasal spray (MFNS) in
      comparison with placebo in improving the quality of life of subjects with moderate to severe
      persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma
      Questionnaire (Global Summary Score). In addition, there are two secondary objectives. The
      first secondary objective is to evaluate the efficacy of MFNS in improving the quality of
      life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma
      as measured by the Rhinasthma Upper Airways Score, the Rhinasthma Lower Airways Score, and
      the Rhinasthma Respiratory Allergy Impact Score. The second secondary objective is to
      evaluate the efficacy of MFNS in relieving the subject's symptoms of allergic rhinitis and
      asthma as measured by the Total 5 Symptoms Score (T5SS) and the Global Symptom Score
      (T5SS+asthma symptoms) and by the use of rescue medication on demand.
    

Intervention name(s): Mometasone furoate nasal spray (MFNS); Placebo nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.; Placebo nasal spray once daily (two puffs per nostril) in the morning.
Other intervention name(s): Nasonex Nasal Spray; Placebo
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluate Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI7352 in Healthy Volunteers
Condition: Painful Osteoarthritis of the Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate safety, tolerability, pharmacokinetics and immunogenicity of
      MEDI7352 in healthy participants.
    

Detailed description: 
      The study will comprise:

        -  A Screening Period of up to 36 days (approximately 5 weeks);

        -  A Treatment Period of 6 weeks where participants will be given 1 dose of study treatment
           every 2 weeks (4 doses in total). Participants will be required to stay in the Clinical
           Unit from Days -1 to 8 (Visit 2), from Days 14 to 15 (Visit 6), from Days 28 to 29
           (Visit 9), and from Days 42 to 50 (Visit 12). In addition, participants will have
           multiple visits to the Clinical Unit to complete the study assessments;

        -  A Follow-up Period of 42 days (6 weeks) where participants will also have multiple
           visits to the Clinical Unit to complete the study assessments, and;

        -  A final Follow-up Visit after 42 days after the Treatment Period.

      Participants will receive fixed multiple subcutaneous (SC) doses of MEDI7352 or placebo on 4
      occasions; one dose every 2 weeks on Days 1, 15, 29 and 43, under fasted conditions.
    

Intervention name(s): MEDI7352; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A dose of MEDI7352 will be administered as two 1.5 mL injections in the abdomen. Following an overnight fast of at least 8 hours, each participant will receive a single dose of MEDI7352 on 4 occasions.; Matching placebo will be administered as two 1.5 mL injections in the abdomen. To maintain the double-blind requirements, the placebo volume administered will be equivalent to the MEDI7352 volume administered for each dosing. Following an overnight fast of at least 8 hours, each participant will receive matching placebo on 4 occasions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: MEDI7352; Bi-specific fusion protein; Multiple doses; Subcutaneous route; Pharmacokinetics; Immunogenicity
Effects of Post-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals
Condition: Heroin Dependence; Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders; Heroin Dependence; Drug-Seeking Behavior
Study type: Observational

Summary: 
      The purpose of this study is to determine whether knowledge of post-session hydromorphone
      (HYD) availability reduces drug seeking behavior in heroin dependent individuals.
    

Detailed description: 
      Drug dependence is often characterized by severe drug seeking behavior. Learning to
      understand, predict, and control this maladaptive choice behavior may lead to improved
      prevention and treatment strategies. HYD is a drug that is currently used as a cough
      suppressant and to relieve pain. The purpose of this study is to determine the extent to
      which opioid drug seeking behavior by heroin dependent individuals can be reduced by
      environmental factors, including supplemental opioid drug availability, drug price, and
      alternative non-drug reinforcers. Specifically, this study will determine whether knowledge
      of post-session HYD availability influences drug seeking behavior in heroin dependent
      individuals, who are maintained on buprenorphine during their participation.

      Participants in this observational study will take part in multiple trials in which they have
      the opportunity to choose either HYD or money. On the first two experimental days, prior to
      choice sessions, participants will receive a sample of the drug doses that can be chosen.
      During test sessions, participants will have 12 opportunities to choose either drug or money.
      Participants will use a computer to earn choices. Respiration rate, oxygen saturation, heart
      rate, and blood pressure will be monitored throughout choice trials. Supplemental HYD will be
      made available following some choice sessions. Self-report questionnaires will be completed
      at different times during the study. Participants will be maintained on buprenorphine
      throughout the study, with a minimum 2-week lead before the experiment, and a fixed 3-week
      detoxification after study completion.
    

Intervention name(s): Hydromorphone
Intervention type(s): Drug
Intervention MeSH terms: Hydromorphone
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Heroin dependent research volunteers
      
Biospecimen description: 
      Whole Blood
    
Keywords: Behavioral economics; Drug self administration; Opioid
Nicotine Pharmacokinetics of THS Single Use of a Regular or a Menthol Stick Compared to CIG
Condition: Smoking, Tobacco
Study type: Interventional

Summary: 
      The purpose of this study is to describe the nicotine pharmacokinetic (PK) profile during and
      after single use of THS (Induction heating technology, with either a regular or menthol
      stick) compared to singular CIG smoking in healthy adult subjects. In addition,
      pharmacodynamic effects (subjective effects) will be evaluated to provide further insights on
      product acceptance and likelihood to use the THS again. Safety will be assessed throughout
      the study.
    


Intervention name(s): P1R stick; P1M stick; CIG
Intervention type(s): Other; Other; Other
Intervention description(s): Regular flavor tobacco stick; Mentholated flavor tobacco stick; Subjects' preferred brand of commercially available, regular or mentholated cigarettes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Nicotine; Nicotine-containing products; Heated tobacco; Smoking; Tobacco; Tobacco Heating System; Pharmacokinetics
Patient Satisfaction With Perioperative Anesthetic Care
Condition: Anesthesia
Study type: Observational

Summary: 
      The doctor-patient relationship, medical competence and patient expectations influence
      patient satisfaction with anesthesia. Preoperatively all patients are routinely assessed by
      an anesthesiologist. However, in many centers, the anesthesiologist who performs the
      preoperative evaluation will not necessarily be the anesthesiologist who provides the
      intraoperative service. This study evaluated the effect of this practice on patient
      satisfaction, level of confidence and anxiety among adult patients undergoing elective
      surgery.
    

Detailed description: 
      Background: The doctor-patient relationship, medical competence and patient expectations
      influence patient satisfaction with anesthesia. Preoperatively all patients are routinely
      assessed by an anesthesiologist. However, in many centers, the anesthesiologist who performs
      the preoperative evaluation will not necessarily be the anesthesiologist who provides the
      intraoperative service. This study evaluated the effect of this practice on patient
      satisfaction, level of confidence and anxiety among adult patients undergoing elective
      surgery.

      Methods: 100 patients scheduled for elective surgery under general anesthesia were randomly
      divided into 2 equal groups: In Group A patients were evaluated and anesthetized by the same
      anesthesiologist. In Group B the preoperative assessment and actual anesthesia was performed
      by two different anesthesiologists. On the first postoperative day all patients completed a
      questionnaire designed to evaluate their sense of preoperative security (confidence) and
      their overall satisfaction with the anesthetic experience.
    

Intervention name(s): Pre operative evaluation and anesthesia administration by the same anesthesiologist
Intervention type(s): Other
Intervention description(s): Pre operative evaluation and anesthesia administration by the same anesthesiologist (instead of two different anesthesiologists, as routinely performed in our medical center)
Intervention MeSH terms: Anesthetics
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled for elective surgery under general anesthesia between 12.2018 and
        03.2019
      
Keywords: anesthesia; patient satisfaction; continuity of care
Reduction of Staph Aureus Carriage by Non-Antibiotic NOZIN® Nasal Sanitizer® Antiseptic
Condition: Infectious Disease
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      The purpose of this study is to determine the extent to which bacterial growth in the
      nostrils by S. aureus, a common bacteria that is found in hospital environment, can be
      reduced by NOZIN® Nasal Sanitizer® antiseptic nasal swabs during the course of a typical
      10-hour work period in participants known to have S. aureus in their nose passages.
    

Detailed description: 
      The purpose of the proposed pilot study is to employ a repeated sampling protocol to test the
      effectiveness of a currently marketed, over-the-counter topical preparation to reduce
      carriage of Staphylococcus aureus (S. aureus) in the nasal vestibules of health professionals
      working in an outpatient clinical setting. The product to be tested is the NOZIN® Nasal
      Sanitizer® antiseptic produced by Global Life Technologies Corp. It is an alcohol-based,
      non-antibiotic antiseptic preparationl

      The study has one primary Specific Aim:

      To determine the extent to which colonization of the vestibular region of the nares by S.
      aureus can be reduced by a regimen of nasal topical applications of the alcohol-based
      antiseptic during the course of typical 10-hour work day in subjects known to exhibit S.
      aureus nasal carriage.

      A secondary aim of the study will be to evaluate the concurrent effectiveness of the
      antiseptic applications on a measure of general bacterial colonization within the vestibules
      of each subject.
    

Intervention name(s): Nozin® Nasal Sanitizer®; Placebo
Intervention type(s): Other; Other
Intervention description(s): The treatment agent tested was the alcohol and natural oil preparation that comprises the commercially available over-the-counter (OTC) product, NOZIN® Nasal Sanitizer® antiseptic, by Global Life Technologies Corp, with the addition of benzalkonium chloride (0.13%), as described for the patented and safety-tested formulation.; The placebo preparation, utilized to account for the potential mechanical effects of the application process, was phosphate buffered saline (PBS).
Other intervention name(s): Nozin® Nasal Sanitizer® antiseptic; Sham
Intervention MeSH terms: Anti-Infective Agents, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: nasal sanitizer®; S. aureus; general bacteria; nasal carriage; decolonization