bioihbjkbjnl/mcl2 huggingface dataset:
ICS/LABA Adherence and COPD Exacerbation
Condition: Pulmonary Disease; Chronic Obstructive
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness
      of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months
      after initiation of therapy between COPD patients who are adherent to the index medication
      and those who are non-adherent.
    

Detailed description: 
      This retrospective, observational study will assess the effectiveness of ICS/LABA combination
      therapies among COPD patients new to the ICS/LABA combination therapies in the US, comparing
      those who are adherent to the index medication and those who are non-adherent. Adherence will
      be measured using the proportion of days covered with the index medication. Medical and
      pharmacy claims data will be used as the data source.
    

Intervention name(s): Non-Interventional Study
Intervention type(s): Other
Intervention description(s): Non-Interventional Study
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        ICS/LABA patients with administrative claims data from health plans in the Northeast,
        Midwest, South and West United States.
      
Keywords: COPD; Chronic Bronchitis; Pulmonary Emphysema
Comparison Study of PF530 and Betaferon in Healthy Subjects
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety, tolerability, and blood levels of two
      interferon beta-1b products, Betaferon and PF530, in healthy volunteers.
    

Detailed description: 
      This is a double-blind, randomised, two-treatment cross-over study in healthy adult subjects
      to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of PF530 and
      Betaferon. Half of the subjects will be randomised to receive PF530 first and Betaferon
      second, and the other half will be randomised to receive the drugs in reverse sequence. Each
      study participant will complete two 7-day study periods (Period 1 and Period 2), separated by
      a 14-day washout period. In Part I of the study, 12 subjects will be enrolled for an initial
      assessment. In Part II, up to 36 additional subjects may be enrolled.
    

Intervention name(s): Interferon beta-1b (PF530, Betaferon)
Intervention type(s): Drug
Intervention description(s): Single subcutaneous administration
Other intervention name(s): PF530, Betaferon
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Mercilon.
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study was to compare the contraceptive efficacy and safety of the
      transdermal patch to Mercilon.
    

Detailed description: 
      This is an open-label, multicenter, international study to evaluate the contraceptive
      efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal
      patch compared with Mercilon. Fourteen hundred healthy women will receive study medication
      for either 6 or 13 cycles. The first 265 transdermal patch subjects and the first 200
      Mercilon subjects will be expected to complete 13 cycles of medication. All subsequent
      subjects will be expected to complete 6 cycles. The ratio of subjects assigned to the
      transdermal patch arm of the study and to the Mercilon arm will be 4:3. At admission (Visit
      1) study drug, diary cards and subject instructions for Cycle 1 and replacement patches for
      Cycles 1 to 6 are dispensed. The first patch will be applied and Mercilon pill will be taken
      on the first day of menses. Study medication and diary cards will be issued on day 28 of
      Cycles 1 (Visit 2) and 3 (Visit 3), and those continuing for 13 cycles will receive study
      drug again on day 28 of Cycles 6 (Visit 4) and 9 (Visit 5). Diary cards and empty medication
      packages will be collected at every visit. Final visits are on day 28 of Cycles 6 and 9.
      Diary card information was used to record compliance and bleeding information (to assess
      cycle control). Contraceptive efficacy was assessed by means of the Pearl Index and life
      table analysis (gross cumulative probability of pregnancy). Safety evaluations were based on
      adverse events, which were collected throughout the study, and changes in gynecologic
      examinations, vital signs, and laboratory results from prestudy to final visit. A transdermal
      patch, containing 6 mg NGM and 0.75 mg EE, delivering 250 ug NGM and 25 ug EE over 24 hours
      for 7 days, is worn for 1 week and replaced for 3 consecutive weeks.The fourth week is
      patch-free. A Mercilon pill is taken for 21 consecutive days followed by a 7-day pill-free
      week.
    

Intervention name(s): norelgestromin + ethinyl estradiol; mercilon
Intervention type(s): Drug
Intervention MeSH terms: Ethinyl Estradiol; Norelgestromin; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contraception; hormonal contraception; oral contraception; steroid, ethinyl estradiol, progestin contraception; transdermal.
Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study in which healthy adult volunteers will receive BRII-196 or placebo
      and will be assessed for safety, tolerability, and pharmacokinetics.
    


Intervention name(s): BRII-196; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BRII-196 given intravenously; Placebo given intravenously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COVID-19 phase I; monoclonal antibody
A2 GUM Post-Market Effectiveness Study
Condition: Protein Intolerance
Study type: Interventional

Summary: 
      This is a post-market, real-life effectiveness study of A2 growing up milk on toddlers' gut
      comfort.
    

Detailed description: 
      This post-market study primarily aims to assess the real-life effectiveness of a
      newly-launched A2 milk on toddlers' gut comfort via evaluating individual GI symptoms and
      GI-related behaviors compared with other milk products and milk alternatives.
    

Intervention name(s): Toddler milk
Intervention type(s): Dietary Supplement
Intervention description(s): Commercially available toddler milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nutrition; Toddlers; A2; B-casein; Gut comfort; Growing up milk
A Study To Evaluate Whether Food Affects The Plasma Drug Levels Of A 35 mg Single Dose Of PF-04447943 Taken Orally In Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the plasma drug levels of PF-04447943 when taken as a
      35 mg tablet after a high fat meal compared to when taken after fasting. Healthy adult
      volunteers will receive a single dose of the drug once when fasted and again when fed. The
      safety and tolerability of the drug will be monitored.
    


Intervention name(s): PF-04447943; PF-04447943
Intervention type(s): Drug; Drug
Intervention description(s): 35 mg tablet of PF-04447943 taken in the fed state in Period 1 followed a week later by administration of the same tablet and dose taken in the fasted state in Period 2; 35 mg tablet of PF-04447943 taken in the fasted state in Period 1 followed a week later by administration of the same tablet and dose in the fed state in Period 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: pharmacokinetics, single dose, crossover, fed vs fasted state
The Safety, Tolerability, and Pharmacokinetics (PK) of SR750 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety, tolerability, and PK of SR750 in healthy volunteers.
    

Detailed description: 
      This study is a randomized, double-blinded, placebo-controlled, 2-part Phase I study to
      evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending
      doses of SR750 in healthy volunteers. This study includes 2 parts:

      Part A is a double-blind, randomized, placebo-controlled, single-dose escalation study of
      SR750 in healthy volunteers.

      Part B is a double-blind, randomized, placebo-controlled, repeated-dose escalation study of
      SR750 in healthy volunteers.
    

Intervention name(s): SR750 tablet; matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): The volunteers will be orally administrated by single or multiple dose of SR750 tablet with 240 mL water.; The volunteers will be orally administrated by single or multiple dose of matching placebo with 240 mL water.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects Of GW876008 On The Bowel In Patients With Irritable Bowel Syndrome
Condition: Irritable Colon
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if GW876008 in Irritable Bowel Syndrome patients will
      reverse stress-induced hypersensitivity, by looking at thresholds for perception and pain.
    


Intervention name(s): GW876008
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: IBS; stress; CRF1
ASYMMETRIC LACK OF KNEE FLEXION AS A SYMPTOM OF DLM IN CHILDREN
Condition: Highlights a New Clinical Sign Which Point Out a Meniscus Posterior Luxation Because of a MCA-type DLM
MeSH terms: Joint Dislocations
Study type: Observational

Summary: 
      Highlighted during the clinical examination of a knee flexion asymmetry, and related to the
      intraoperative meniscal observations on DLM.

      Search for a link between asymmetric bending defect and posterior shift in MCA-type DLM.

      Analysis of all patients with symptomatic DLM.
    


Intervention name(s): Find a link between lack of knee flexion and meniscal posterior luxation fixed
Intervention type(s): Diagnostic Test
Intervention description(s): Measure the full flexion angle of the knee using a goniometer. Measure the heel-buttom distance. All measurements are carried out in bilateral and comparative ways.
Search for the meniscal position on MRI and intraoperatively: no shift, anterior, medial, posterior shift.
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children with a discoid lateral meniscus symptomatic and surgical care.
      
Keywords: discoid lateral meniscus; children; instability; arthroscopy; repair; lack of flexion; flexion block knee
To Determine if There Are Pharmacokinetic Interactions at Plasma or Intracellular Level Between Nucleosides and Tenofovir
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate if there are pharmacokinetic interactions between
      the NRTI 3TC and ABV, and the TDF nucleotide. For this purpose, the intracellular and plasma
      levels of 3TC and ABV will be compared in patients given these nucleosides with TDF and 30
      days after the interruption of the TDF.
    

Detailed description: 
      There is clear evidence of pharmacokinetic interaction between ddI+TDF. However, the
      interaction between TDF and other NRTIs, mainly at intracellular level, has not been so well
      studied.

      Since all the NRTIs are anabolized at intracellular level by numerous kinases, and are
      transported by passive carrier systems, the interaction may be between TDF and other NRTIs.

      This study aims to investigate the pharmacokinetic interactions between the TDF and the
      nucleosides abacavir (ABV) and lamivudine (3TC) at plasma and intracellular level.

      With this objective, intracellular and plasma levels will be analysed in a group of patients
      that receive the combinations 3TC +TDF, ABV+TDF and 3TC+ABV+TDF together with lopinavir/rtv
      or nevirapine. Subsequently, in a second phase of the study, in the group of patients given
      ABV and/or 3TC + TDF + lopinavir/rtv, the pharmacokinetic determinations will be repeated
      after a 4-week interruption of the TDF .
    

Intervention name(s): Patients in treatment with 3TC + TDF + LPV/rtv, stop tenofovir during 4 weeks; Patients in treatment with ABV + TDF + LPV/rtv, stop tenofovir during 4 weeks; Patients in treatment with 3TC + ABV + TDF+ LPV/rtv, stop TDF during 4 weeks
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3TC (300 mg/24 h, 1 tablet/24 h) + Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h); ABV (300 mg/12 h, 1 tablet/12 h)+ Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h); 3TC (300 mg/24 h, 1 tablet/24 h)+ ABV (300 mg/12 h, 1 tablet/12 h)+ Lopinavir/ritonavir (400 mg/12 h, 3 tablets/12 h).
Other intervention name(s): Epivir; Kaletra; Ziagen; Kaletra; Epivir; Ziagen; Kaletra
Intervention MeSH terms: Tenofovir; Lamivudine; Abacavir
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intracellular concentrations; Plasma concentration; Abacavir; Tenofovir; Lamivudine (3TC); Pharmacokinetic interactions
Postprandial Effects of Mixed Herbs and Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects
Condition: Healthy
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This study aims to investigate the effect of mixed of herbs and spices on gene expression of
      pathways associated with glucose homeostasis, oxidative stress, inflammation and its
      interrelation with circulating miRNA, in the postprandial phase in healthy human subjects.
    


Intervention name(s): High fat challenge breakfast; High fat challenge breakfast with mixed-spices
Intervention type(s): Other; Other
Intervention description(s): In this intervention, subjects are asked to consume high fat breakfast without mixed-spices. Standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20; In this intervention, subjects are asked to consume high fat breakfast with mixed-spices. Standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Spices; Functional food; Cardiometabolic risk; Metabolic syndrome; Inflammation; Peripheral blood mononuclear cell; Acute; miRNA
Plasma Myeloperoxidase Levels in Patients With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      The investigators sought to assess whether plasma myeloperoxidase (MPO) levels differ among
      patients with stable and unstable CAD patients and control subjects, and correlate with
      inflammatory and clinical risk factors such as ox-LDL, NO,leptin, adiponectin, sPLA2,
      Lp-PLA2, homocysteine and 3-nitrotyrosine in the patients.
    

Detailed description: 
      Elevation of the leukocyte enzyme myeloperoxidase (MPO) in stable coronary artery disease
      (CAD) patients in contrast to unstable CAD patients is controversial and its relationship
      with some inflammatory and noninflammatory markers such as oxidized LDL (ox-LDL) and nitric
      oxide (NO) in the CAD patients has not been evaluated yet. Evaluation of these relationships
      is the aim of the study.Also the relationships between MPO and some other inflammatory
      biomarker such as leptin, adiponectin, sPLA2, Lp-PLA2, homocysteine and 3-nitrotyrosine are
      examined. This study includes 50 stable CAD, 50 unstable CAD patients and 50 controls. Plasma
      MPO, ox-LDL, leptin, adiponectin, sPLA2 levels are determined using enzyme
      immunoassay.Homocysteine and 3-nitrotyrosine are measured using HPLC-fluorescence method.
      Plasma total NO and other risk factors such as lipid profile, hypertension, smoking, diabetes
      mellitus and familial history of CAD are also determined in the patients. Results are
      statistically analysed and the association between all markers are assessed.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All subjects are diagnosed angiographically following chest pain, clinical manifestations
        or suspected changes on ECG at Isfahan Cardiovascular Research Center in Iran
      
Biospecimen description: 
      Plasma
    
Keywords: coronary artery disease
Clinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent During In-office Bleaching
Condition: Tooth Bleaching
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.
    

Detailed description: 
      A randomized clinical trail will be done to evaluate the effect of a desensitizing agent ACP
      oral care gel in comparison to a control group on hypersensitivity after bleaching using a
      visual analogue scale.
    

Intervention name(s): ACP oral care gel; glycrin
Intervention type(s): Other; Other
Intervention description(s): a desensitizing agent will be applied on tooth before and/or after bleaching; glycrin will be applied on tooth surface before and/or after bleaching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption
      in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper
      arms/shoulders using an application site rotation or a combination of application sites.
    

Detailed description: 
      To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption
      in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper
      arms/shoulders using an application site rotation or a combination of application sites.
    

Intervention name(s): Testosterone Gel 1.62%; Testosterone Gel 1.62%
Intervention type(s): Drug; Drug
Intervention description(s): 5 grams administered using an application Site Rotation; 5 grams administered using an a combination of Application sites
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: testosterone, hypogonadal, males
Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception
Condition: Contraceptive Usage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether NEA TDS is effective in the prevention of
      pregnancy. The safety of this product will also be evaluated.
    

Detailed description: 
      An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone
      Acetate Transdermal Delivery System.
    

Intervention name(s): Norethindrone Acetate
Intervention type(s): Drug
Intervention description(s): Norethindrone Acetate Transdermal Delivery System
Other intervention name(s): NEA TDS
Intervention MeSH terms: Norethindrone; Norethindrone Acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: contraception; pregnancy
A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1
Condition: Hepatitis C, Chronic, Healthy Volunteer
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo controlled, 3 part study will assess the safety,
      tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with
      chronic hepatitis C genotype 1. In Part A, cohorts of healthy volunteers will be randomized
      to receive single ascending doses of RO5303253 or placebo. In Part 2, healthy volunteers will
      receive a single dose of RO5303253 or placebo in a cross-over design (with a washout period
      of at least 7 days) to assess food effects on pharmacokinetics. In Part 3, patients with
      chronic hepatitis C will be randomized ro receive either RO5303253 or placebo for 5 days.
    


Intervention name(s): Placebo; RO5303253; RO5303253; RO5303253
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C); Cohorts receiving single ascending doses; Single dose; Multiple doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Growth and Tolerance of Cow's Milk-Based Infant Formulas
Condition: Growth
Study type: Interventional

Summary: 
      This clinical trial will evaluate the growth, tolerance, and iron status of infants who
      consume an investigational infant formula containing a nutrient-rich whey protein compared to
      a previously marketed infant formula.
    


Intervention name(s): Previously marketed infant formula; Previously marketed formula using a similar protein
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
M-CPP and Fenfluramine in Cocaine Addicts - 3
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate predictive value of M-CPP and fenfluramine
      challenges for outcome.
    


Intervention name(s): M-CPP
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: cocaine dependence