bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Anemia of Chronic Disease on Chronic Obstructive Pulmonary Disease Patients
Condition: Anemia; COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anemia; Chronic Disease
Study type: Interventional

Summary: 
      Hypothesis:

      The first part of the study is a survey on the prevalence of anemia of chronic disease (ACD)
      among COPD patients. The 2nd and 3rd part will test 2 null hypotheses (Ho): 1.serum
      inflammatory markers and plasma erythropoietin do not differ between COPD patients with and
      without ACD and 2. exercise capacity does not differ between COPD patients with and without
      ACD.

      Rationale-Aim:

      ACD is an immune driven disorder, developing in subjects suffering from chronic inflammatory
      diseases. COPD is a disorder very likely to be associated to ACD due to its systemic
      inflammatory dimension. Currently, data on the prevalence of ACD and on the level of
      inflammatory markers which are implicated in the pathogenesis of ACD in COPD subjects are
      limited and controversial. Furthermore, there is no data on the effect of ACD on exercise
      capacity of COPD subjects.

      Based to the aforementioned, this study has three goals:

        1. to determine the prevalence and the epidemiologic characteristics of ACD in a population
           of clinical stable COPD patients

        2. to investigate whether the levels of serum inflammatory markers and of plasma
           erythropoietin differ between COPD patients with ACD and without ACD

        3. to determine potential differences regarding the aerobic exercise capacity between these
           two groups, using the cardiopulmonary exercise testing (CPET).
    


Intervention name(s): maximal cardiopulmonary exercise testing; peripheral blood samples
Intervention type(s): Procedure; Procedure
Intervention description(s): Cardiopulmonary exercise testing (CPET) will be performed on a cyclic ergometer with continuous monitoring of a 12-lead electrocardiogram, heart rate and blood pressure. While breathing with a mask, the patients will perform a ramp protocol which includes 2-minutes free pedaling and progressive increase of power by 10, 15 or 20 watts/minute; power size will be selected after considering the patient' s daily activity and parameters of pulmonary function. CPET will be performed until exhaustion, unless the subjects reveal symptoms or signs indicating the exercise should stop (e.g. severe breathlessness).; Peripheral venous blood samples will be collected again in the morning after a fasting period of ≥12 hours. After immediate centrifugation, aliquots will be stored at -75˚C until analysis. Inflammatory markers and erythropoietin will be analyzed by flow cytometry and by enzyme-linked immunosorbent assay, using commercially available kits.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: COPD; anemia; exercise; cytokines; erythropoietin
Systemic and White Adipose Tissue Inflammatory Profile in Lean Versus Obese Individuals
Condition: Inflammation; Obesity; Inflammatory Response; Cardiovascular Risk Factor
MeSH terms: Inflammation
Study type: Observational

Summary: 
      This study will compare the systemic and white adipose tissue inflammatory profile of
      individuals who are classified as lean and obese. Blood and white adipose tissue samples will
      be collected in the fasted state to assess inflammatory status.

      There is evidence to suggest that markers of inflammation in the blood and white adipose
      tissue increase with increasing levels of obesity. However, the white adipose tissue total
      protein content and phosphorylation of proteins involved in inflammatory pathways has not
      previously been compared between lean and obese individuals.

      The investigators hypothesise that obese individuals will have increased levels of
      inflammation in the blood and white adipose tissue, compared to their lean counterparts.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): There is no intervention in this study
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Apparently healthy, recreationally active adults.
A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of
      two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at
      least three cigarettes per day.
    


Intervention name(s): varenicline
Intervention type(s): Drug
Other intervention name(s): Chantix, Champix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Impact of Sleep Disruption on the Menstrual Cycle
Condition: Sleep; Circadian Rhythm; Menstrual Cycle
Study type: Observational

Summary: 
      The purpose of this study is to investigate whether sleep disruption affects menstrual cycle
      timing
    

Detailed description: 
      Menstrual cycle dynamics were studied after sleep disruption
    

Intervention name(s): Disrupting or changing the timing or the duration of sleep
Intervention type(s): Behavioral
Intervention description(s): Disrupting or changing the timing or the duration of sleep
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy women with regular menstrual cycles
      
Biospecimen description: 
      Blood/plasma
    
Keywords: Sleep; Circadian rhythms; Menstrual cycle
Clinical Outcome at 5 Years After Implantation of the Liberty677MY Multifocal Intraocular Lens
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      The study will assess visual outcomes, light disturbances and patients' satisfaction after
      implantation with the Liberty677MY multifocal IOL, as well as protection of PCO development
      within 5 year follow-up.
    

Detailed description: 
      The Liberty677MY multifocal IOL is designed for restoring near, intermediate and distance
      vision. The technology of Liberty 677MY is based on the elevated phase shift technology
      (patent pending). Previous evaluations showed the strength of studied IOL both in laboratory
      and clinical conditions.

      Patients will be examined 5 years after implantation. The examination will include the
      measurement of the best corrected distance, intermediate and near visual acuity (assessed
      with Early Treatment Diabetic Retinopathy Study (ETDRS) charts), intraocular pressure
      (contact Goldman tonometry), biomicroscopic and fundocsopic examination, contrast sensitivity
      (CSV-1000), defocus curve, reading capability, pupilometry in different light conditions and
      PCO evaluation, Nd:YAG capsulotomy rate, photo-documentation of anterior segment. YAG
      capsulotomy will be indicated in case of posterior capsule opacification (PCO). The criteria
      for YAG capsulotomy will be visual acuity decreased 2 or more lines when using (ETDRS)
      charts. Details of all related and unrelated complications will be documented, including
      severity, time of onset, specific treatment and clinical outcome. The investigators will also
      record whether the capsulorhexis is on or partially off the optic.
    

Intervention name(s): Liberty677MY Multifocal IOL
Intervention type(s): Device
Intervention description(s): multifocal intraocular lens (IOL)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pseudophakic patients implanted with Liberty 677MY in 2014-2015 during the study under the
        ethical approval: 059823/2014/OTIG
Influence of Airway Clearance Techniques on GOR in Infants
Condition: Gastro-oesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Assisted Autogenic Drainage (AAD) or
      bouncing combined with Assisted Autogenic Drainage (BAAD), induces or aggravates acid and
      non-acid gastro-oesophageal reflux in infants under the age of one year. Infants, referred to
      the hospital for impedance-pH monitoring are included in this study.
    


Intervention name(s): AAD; BAAD
Intervention type(s): Other; Other
Intervention description(s): In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of AAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).; In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of BAAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the single-dose pharmacokinetics (PK) and pivotal
      bioequivalence of 3 compounds Darunavir (DRV), emtricitabine (FTC), and tenofovir alafenamide
      (TAF) in the presence of cobicistat (COBI) when administered as an fixed dose combination
      (FDC) (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide [D/C/F/TAF]) compared to the
      co-administration as the separate commercial formulations (DRV and F/TAF and COBI), under fed
      conditions, in healthy adult participants.
    


Intervention name(s): Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC; Darunavir; Emtricitabine/Tenofovir Alafenamide; Cobicistat
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive a single dose of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC tablet orally as per assigned treatment sequence.; Participants will receive a single dose of Darunavir orally as per assigned treatment sequence.; Participants will receive a single dose of Emtricitabine/Tenofovir Alafenamide tablet orally as per assigned treatment sequence.; Participant will receive a single dose of Cobicistat tablet orally as per assigned treatment sequence.
Other intervention name(s): TMC114/JNJ-48763364/JNJ-35807551/JNJ-63625328
Intervention MeSH terms: Tenofovir; Emtricitabine; Darunavir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Cobicistat; Emtricitabine tenofovir alafenamide; Cobicistat mixture with darunavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Treatment of Depressed Women Who Have Been Sexually Abused
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare Schema-Focused Therapy plus antidepressant medication
      and antidepressant medication alone for the treatment of major depression in women with a
      history of childhood sexual abuse.
    

Detailed description: 
      Schema-Focused (SF) Therapy is an extension of cognitive therapy that was developed to
      address the treatment needs of patients with long-standing mental disorders. SF therapy
      focuses on early maladaptive schemas (EMS): broad, pervasive themes regarding oneself and
      one's relationship with others, developed during childhood and elaborated throughout one's
      lifetime, which are dysfunctional to a significant degree. SF Therapy involves the
      identification of the particular EMS that is most relevant for each patient and attempts to
      modify the relevant schemas by altering the distorted views of self and others.

      Participants are assessed pretreatment, after 12 weeks, posttreatment, and 3 and 6 months
      posttreatment. The severity of depressive symptomatology is measured and a self-report Beck
      Depression Inventory is administered. At the end of the study and at the follow-up intervals,
      participants are given the Longitudinal Interval Follow-up Evaluation, an instrument that
      assesses the severity of depression and dysthymia symptoms.
    

Intervention name(s): Schema Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child Abuse, Sexual
Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
Condition: Low Back Pain; Lumbago; Modic I Discopathy
MeSH terms: Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The treatment of chronic low back pain is a major objective of public healthcare, because it
      causes an important number of sick leaves. A correlation between clinical observations and an
      inflammatory discopathy has been underlined, but there is currently any reference treatment.
      In this study, the main objective is to assess the efficacy of an intradiscal injection of
      corticoids versus local anaesthetic on the treatment of pain of patients with low back pain
      associated to a Modic I discopathy.
    

Detailed description: 
      This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids)
      trial.
    

Intervention name(s): Hydrocortancyl.; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive an intradiscal injection of hydrocortancyl.
Intervention MeSH terms: Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Lidocaine; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Discopathy; Modic I; Corticoids; Local Anaesthetic; Intradiscal injection
Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH
Condition: Nonalcoholic Steatohepatitis; Liver Diseases
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to explore the potential benefit of the medication,
      pentoxifylline, for the treatment of NASH.
    

Detailed description: 
      This is an investigational study looking at subjects who have been diagnosed with
      nonalcoholic steatohepatitis (NASH) or 'fatty liver disease'. There is currently no FDA
      approved available treatment for NASH. The purpose of this study is to explore the potential
      benefit of the medication, pentoxifylline, for the treatment of NASH. The effectiveness of
      this drug will be determined by taking blood samples and a liver biopsy. To determine if
      there is any effect of the medication, two-thirds of the patients participating in the study
      will receive pentoxifylline and one-third will receive placebo (sugar pill). Thus, an
      individual's chance of receiving the drug is 67%. In addition to receiving a study drug
      (placebo or pentoxifylline) the subjects will be encouraged to achieve modest weight loss
      (~1-2 lbs/week) via low-fat diet and exercise.

      The drug (Pentoxifylline) being studied is not approved for use in people who have NASH.
      Pentoxifylline is considered experimental in this study. Pentoxifylline has been safely used
      for the treatment of other medical conditions such as alcohol related liver disease and poor
      circulation. Pentoxifylline is a pill which is taken three times a day.
    

Intervention name(s): Pentoxifylline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400mg PO TID; 1 pill PO TID
Other intervention name(s): Trental; sugar pill
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fatty Liver Disease; Liver; NASH; Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease (NAFLD); Pentoxifylline
Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study
Condition: Prediabetic State
MeSH terms: Glucose Intolerance; Prediabetic State
Study type: Observational

Summary: 
      The purpose of this study is to determine if, in a subset of patients treated with a
      beta-blocker and diuretic, prediabetes is detectable to a greater extent through a 2-hour
      oral glucose tolerance test (OGTT) compared to fasting glucose measurement.
    

Detailed description: 
      Beta-blockers and diuretics have a well-established role in treating hypertension and are
      frequently used first-line. However, it is increasingly evident that these medications have
      harmful metabolic effects. The Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR
      - NCT00246519) study was a greater than 700 participant, randomized, parallel assignment
      trial, aimed at determining the genetic factors that influence response to both a
      beta-blocker (atenolol) and a diuretic (hydrochlorothiazide [HCTZ]). The PEAR trial design
      includes evaluation at baseline, after monotherapy with either medication, and after
      combination therapy with both medications. This pilot, PEAR sub-study aims to characterize
      the ability of two diagnostics tests (fasting glucose versus glucose 2-hours after an OGTT)
      to detect prediabetes development prior to blood pressure medication use, after monotherapy
      (with atenolol or HCTZ) and after combination therapy (with atenolol and HCTZ).
    

Intervention name(s): Oral glucose tolerance test
Intervention type(s): Other
Intervention description(s): For assessment of dysglycemia, 75 grams of glucose solution by mouth at 3 PEAR study visits for all enrolled participants: baseline, single drug therapy assessment, and dual drug therapy assessment.
Other intervention name(s): OGTT; Glucose tolerance diagnostic test; Glucose tolerance test; Glucola; Sugar beverage
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic, PEAR participants
      
Biospecimen description: 
      Serum and plasma
    
Keywords: Glucose; Glucose Tolerance Test; Insulin Resistance; Metabolic adverse effects; Hypertension; Beta-blocker; Atenolol; Diuretic; Hydrochlorothiazide; Blood pressure
Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy
Condition: Type 2 Diabetes Mellitus; Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Study for the effectiveness of intensive therapy aiming at the remission of diabetic
      nephropathy
    

Detailed description: 
      Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded,
      randomized intergroup comparison study.
    

Intervention name(s): Intensive multifactorial therapy; Standard therapy
Intervention type(s): Other; Other
Intervention description(s): Blood glucose control: HbA1c < 6.2% Blood pressure control: SBP < 125 mmHg, DBP: < 75 mmHg Lipid profile: T-cho < 180 mg/dl, LDL-cho < 100 mg/dl, HDL-cho >40 mg/dl Dietary intervention: TDEI < 30 kcal/kg/day, sodium < 5 g/day, protein < 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, multivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care; Blood glucose control: HbA1c < 6.9% Blood pressure control: SBP < 130 mmHg, DBP: < 80 mmHg Lipid profile: T-cho < 200 mg/dl, LDL-cho < 120 mg/dl, HDL-cho >40 mg/dl, Dietary intervention: TDEI < 25-30 kcal/kg/day, sodium < 6 g/day, protein < 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; nephropathy
Effect of a Proton Pump Inhibitor on the PK of Tepotinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was investigated in healthy participants (i) the effect of omeprazole (proton pump
      inhibitor) co-administration on the single dose pharmacokinetics (PK) of tepotinib under fed
      conditions, and (ii) the effect of food on the single dose PK of tepotinib after
      co-administration of omeprazole and tepotinib. Furthermore, the study assessed the safety and
      tolerability of tepotinib alone and upon co-administration of omeprazole.
    


Intervention name(s): Tepotinib; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Participants received single oral dose of 500 mg Tepotinib in Treatment A, B and C.; Participants received omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment B and C.
Intervention MeSH terms: Tepotinib; Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Proton Pump Inhibitor; Omeprazole; Tepotinib; Non-small cell lung cancer (NSCLC); Pharmacokinetics
A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis
Condition: Antithrombotic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To investigate safety of Single Doses of BMS-986177 in Patients with End Stage Renal Disease
      treated with hemodialysis
    


Intervention name(s): Enoxaparin; unfractionated heparin (UFH); BMS-986177
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose of Enoxaparin on specified days; Specified dose of UFH on specified days; Specified dose of BMS-986177 on specified day
Intervention MeSH terms: Heparin; Enoxaparin; Calcium heparin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment