bioihbjkbjnl/mcl2 huggingface dataset:
Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) in Smokers - Longitudinal Study
Condition: Chronic Obstructive Pulmonary Disease; Cardiovascular Disease; Lung Cancer
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases
Study type: Observational

Summary: 
      This is a longitudinal observational study to identify and validate protein biomarkers for
      COPD (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and
      ex-smokers attending primary care. Special emphasize is to correlate biomarkers to different
      phases of COPD, to progression of the disease, and to treatment of the disease. Furthermore,
      linkage between COPD, cardiovascular disease, and lung cancer will be investigated by
      identifying protein biomarkers.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic in Malmö, Sweden
      
Keywords: COPD; Primary Care; Smoking; Smokers; ex-Smokers; Lung Cancer; Cardiovascular Disease; Proteomics; Biomarkers; Biobank; Disease Staging; Gold Stage
A Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Formulations in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study aims to determine the oral bioavailability of a single dose of a new
      vapendavir tablet formulation and compare it to that of the previous vapendavir capsule
      formulation. The safety of both drug products will also be assessed.
    


Intervention name(s): Vapendavir 300 mg tablet; Vapendavir 132 mg capsules
Intervention type(s): Drug; Drug
Intervention description(s): tablet - single dose; 2 capsules - single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioavailability Study; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen
A Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of 1.0 Mg Luminate® (Alg-1001) As A Treatment For Non-Exudative Macular Degeneration
Condition: Dry Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and exploratory efficacy of 1.0mg of Luminate® in patients with
      Intermediate Non-Exudative Macular Degeneration
    

Detailed description: 
      Approximately 40 eligible subjects who have been diagnosed with intermediate Non-Exudative
      AMD, that require treatment will be enrolled and randomized (1.7:1) to one of 2 treatment
      groups:

      Treatment Group 1: 25 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be injected
      intravitreally with 1.0mg of Luminate® Treatment Group 2: 15 Non-Exudative AMD subjects with
      BCVA of 20/40 - 20/200 will be treated with a sham injection

      At the 16-week visit, the study will be unmasked to the sponsor and injecting investigator
      (observing investigators will remain masked). Subjects in the treatment group will receive a
      2nd dose of Luminate®. Subjects in the control group will be offered the opportunity to
      crossover to treatment with a single dose of Luminate®.
    

Intervention name(s): Risuteganib; Sham
Intervention type(s): Drug; Other
Intervention description(s): Subjects injected intravitreally with 1.0mg of Luminate®; Sham injection
Other intervention name(s): ALG-1001, Luminate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Transpyloric Feeding in Severe Bronchopulmonary Dysplasia
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Study type: Interventional

Summary: 
      Bronchopulmonary dysplasia (BPD) is the most common complication of extreme preterm birth. It
      impacts 10,000-15,000 infants in the US annually, including approximately 50% of infants with
      birth weight < 1000g. BPD is associated with multiple long-term adverse outcomes including
      chronic cardiopulmonary and neurodevelopmental impairments. Infants with severe BPD, defined
      as a need for ≥ 30% inspired oxygen and/or mechanical respiratory support at 36 weeks
      postmenstrual age (PMA), suffer the greatest burden of these chronic sequelae. Recurrent
      episodes of hypoxemia and prolonged exposure to supplemental oxygen are linked to the
      development of these impairments. Gastroesophageal reflux (GER) contributes to these
      mechanisms by exacerbating pulmonary inflammation and inducing bronchospasm. Unfortunately,
      clinically available methods to diagnose GER in infants are unreliable. Moreover, acid
      suppressive agents are both ineffective and carry high risk of serious life-threatening
      morbidity. Simple transpyloric feeding has promise, but has not been evaluated in BPD.

      This study will pilot N-of-1 trials to assess whether transpyloric feeds reduce airway
      complications of GER and and whether this methodology can aid in identifying individual
      infants with severe BPD who are likely to benefit from prolonged use of transpyloric feeds.

      Aim 1. To determine for each enrolled infant with severe BPD whether transpyloric compared to
      gastric feeds reduce the number of daily intermittent hypoxemic events (primary outcome) and
      improve a validated BPD severity score (secondary outcome).

      The investigators hypothesize that 80% percent of enrolled infants will have significantly
      fewer daily intermittent hypoxemic events with transpyloric compared to gastric feeds and
      will have this feeding method formally recommended.

      Aim 2. To pool results from multiple N-of-1 trials to determine whether transpyloric compared
      to gastric feeds reduce airway complications of GER in infants with severe BPD.

      The investigators hypothesize that transpyloric compared to gastric feeds will be associated
      overall with a 15% reduction in number of daily intermittent hypoxemic events.
    


Intervention name(s): transpyloric feeding; gastric feeding
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study To Evaluate The Safety, Pharmacokinetics/Pharmacodynamics (PK/PD) and Food Effect Of LC51-0255
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To evaluate the safety and tolerability of LC51-0255 in healthy male subjects

        2. To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in
           healthy male subjects

        3. To evaluate bioavailability of LC51-0255
    

Detailed description: 
      For safety and tolerability assessement, subjects will be monitored by collection of adverse
      events, physical exams, vital sign, 12-Lead ECG, Continuous ECG monitoring, Holter
      monitoring, blood chemistry and hematology panels, pulmonary function tests, optical
      coherence tomography (OCT) during the study.
    

Intervention name(s): LC51-0255; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg; 0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effects of Salbutamol on Mannitol Induced Cough Responses in Healthy Controls
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aim is to investigate if changes in osmolarity using mannitol challenge can evoke
      coughing healthy controls with no evidence of bronchoconstriction (PC20>16mg/ml or mannitol
      PD15 > 635 mg, or < 10% incremental fall in FEV1 between consecutive mannitol doses) and if
      salbutamol can affect this. This is a double-blind, placebo-controlled analysis in healthy
      controls assessing the effects of salbutamol on mannitol induced cough.
    

Detailed description: 
      The study will have a maximum of 4 visits separated by at least 24 hours. The first 2 visits
      will determine eligibility. All eligible subjects will be invited back for a third and a
      fourth visit.

      Screening Period (Visits 1 and 2) - For All Subjects Eligible subjects will be identified
      during the initial screening procedures with measures of spirometry, hyperresponsiveness to
      methacholine, complete history, physical examination, allergen skin test, and mannitol cough
      challenge. The screening procedures will be conducted over 2 separate visits.

      Effects of Salbutamol (Visit 3 and 4) - For Healthy Control Subjects, Twenty subjects with no
      evidence of asthma will return for visit 3 and 4. These visits must be at least 24h apart and
      no longer than 7 days. Health controls will first receive salbutamol 2.5mg or saline placebo
      via a nebuliser and 15 mins later the forced expiratory volume at one second (FEV1) measured.
      Subjects will then undergo a mannitol cough challenge exactly like the previous mannitol
      cough challenges. These data will be used for determining the effects of salbutamol on
      mannitol-induced cough.

      Visit Windows Each visit must be separated by a minimum of 24 hours, and a maximum of 7 days.
      Study visits can be performed in the morning or afternoon, however for each subject the
      timing should be consistent with Visits 2 at the same time of day ± 2 hours
    

Intervention name(s): Salbutamol 5mg/mL; Sodium Chloride 0.9% Inhl 3Ml
Intervention type(s): Drug; Drug
Intervention description(s): Nebulized salbutamol given prior to Mannitol-Induced Cough Challenge; Nebulized 0.9% saline given prior to Mannitol-Induced Cough Challenge
Other intervention name(s): Ventolin nebuliser; Placebo Comparator
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: albutamol or placebo will be delivered following a mannitol cough challenge in a randomized, double-blind crossover design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part dose-finding trial of MK-7680 in participants with Hepatitis C Virus (HCV)
      infection of genotype (GT)1 (Part I) and GT3 (Part 2). The primary hypothesis is that daily
      administration of a safe and well tolerated dose of MK-7680 will produce a decrease in HCV
      viral load.
    

Detailed description: 
      Parts 1 and 2 will each consist of 4 panels. In the first panel, a 200 mg dose of MK-7680
      will be administered. In each of the following 3 panels, higher or lower doses of MK-7680
      will be administered. Each panel will only begin once the safety and tolerability data from
      the preceding panel have been evaluated.
    

Intervention name(s): MK-7680
Intervention type(s): Drug
Intervention description(s): MK-7680 10 mg and 100 mg capsules
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Endoscopic Tattooing and Colorectal Cancer
Condition: Safety and Efficacy of Tattooing Substance
Study type: Interventional

Summary: 
      Endoscopic tattooing to facilitate colorectal lesions' identification during laparoscopic
      surgery is a reliable and widely used technique.

      India Ink is the standard option for colonic tattoing. Different studies have been reported
      significant complications, of which the most common is peritonitis, due to ethylene glycol,
      phenols and animal-derived gelatine contained in the ink. This local inflammatory reaction is
      the principal reason of the formation of the adhesions detected during the laparoscopy, that
      make the intervention more difficult. To prevent infection or inflammatory local reaction
      India ink solution has to be sterilized and diluted, a cumbersome process. In the last years
      wide diffusion of another endoscopic ink, Sterile Carbon Particle Suspension, has reduced
      these complications. Sterile Carbon Particle Suspension is a prepackaged, sterile,
      FDA-approved formulation of pure carbon particle in suspension, that eliminates the need for
      preinjection preparation.

      In an attempt to evaluate safety and efficacy of endoscopic tattooing in colorectal surgery
      using two different types of ink, a randomized clinical trial has been designed. Two types of
      endoscopic ink were evaluated: Sterile Carbon Particle Suspension (Experimental group) and
      India Ink (Control group) and.
    


Intervention name(s): endoscopic tattooing
Intervention type(s): Procedure
Intervention description(s): The tattoo has to be placed 1 or 2 cm distal to the lesion and tattooing has to be performed in at least 2 of the 4 quadrants of the bowel. A 0.5-1 mL saline bleb has to be raised submucosally and then a similar quantity of India Ink or Sterile Carbon Particle Suspension has to be injectiected into that bleb.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      This study evaluated changes in healthcare resource utilization (HCRU) and costs of care
      within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially
      insured and Medicare Advantage (MA) lives in the U.S among adult patients with heart failure
      with reduced ejection fraction (HFrEF) (cohort 1) and adult patients with chronic heart
      failure (CHF) (cohort 2).
    

Detailed description: 
      This was a non-interventional, retrospective cohort study using secondary data sources from
      the Optum Clinformatics® Data Mart (CDM) and 100% files of the CMS Medicare RIFs.

      Two study cohorts were constructed to include adult Heart Failure with reduced ejection
      fraction (HFrEF) patients who newly initiated sacubitril/valsartan (Cohort 1) and adult
      Chronic Heart Failure (CHF) patients who newly initiated sacubitril/valsartan (Cohort 2).

      The date of first prescription fill for sacubitril/valsartan during the cohort identification
      period was defined as index date. A 12-month washout period was employed to ascertain the
      "new user" status. The Healthcare Resource Utilization (HCRU) and costs of care outcomes will
      be measured within both the 12 months post-index period and the 12 months pre-index period.
    

Intervention name(s): sacubitril/valsartan
Intervention type(s): Drug
Intervention description(s): Two study cohorts were constructed to include adult HFrEF patients who newly initiated sacubitril/valsartan (Cohort 1) and adult CHF patients who newly initiated sacubitril/valsartan (Cohort 2).
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        adult patients with heart failure with reduced ejection fraction (HFrEF) and adult patients
        with chronic heart failure (CHF)
      
Keywords: Heart failure,; Medicare Advantage,; Commercial,; HFrEF,; Chronic heart failure
Human Skin Test Model in Colostomists
Condition: Colostomy Stoma
Study type: Interventional

Summary: 
      The aim of the study is to investigate the correlation in peel force when peeling off a
      standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin
      compared to pre-stripped healthy abdominal skin in colostomists.
    


Intervention name(s): Hydrocolloid strip; Strata strip
Intervention type(s): Other; Other
Intervention description(s): An adhesive strip made of hydrocolloid adhesive; An adhesive strip made of the Strata adhesive
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Risk Assessment Tool for Graft Survival in Pediatric Kidney Transplantation
Condition: Kidney Transplant Failure and Rejection; Pediatric Kidney Disease
MeSH terms: Kidney Diseases
Study type: Observational

Summary: 
      Registry study in which data of all pediatric kidney recipients in the Netherlands
      (registered in the Nederlandse Orgaan Transplantatie Registry) are studied to develop a risk
      calculator for graft loss.
    

Detailed description: 
      The pre-transplantation parameters of all recipients are used to do a multivariable
      regression analysis.

      The B-coefficients of this analysis will be used to develop a risk calculator that predicts
      graft survival after transplantation per year of transplantation.
    

Intervention name(s): None, transplantation recipients
Intervention type(s): Other
Intervention description(s): None, observational
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All pediatric kidney recipients that received their kidney <18 years in the Netherlands
Combined THC and CBD Drops for Treatment of Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      There are many reports about efficacy of Cannabis in Crohn's disease but no controlled
      trials. The aim of the proposed trial is to investigate the efficacy of oil containing the
      cannabinoids THC and CBD given by mouth for induction of remission in Crohn's disease.
    

Detailed description: 
      The investigators have recently published a retrospective observational study about the
      beneficial effect of cannabis in Crohn's disease. The investigators have also concluded a
      double blind placebo controlled study of Inhaled cannabis in the treatment of Crohn's
      disease. Both studies have shown significant symptomatic improvement of disease. However,
      objective parameters of inflammation were not measured. The question arises as to whether the
      observed improvement is merely symptomatic or due to a real change in inflammation. In
      addition, administration per os is a healthier option than smoking but the efficacy of oral
      cannabis was not investigated.

      The aim of the proposed study in to evaluate the efficacy of drops of cannabis oil in crohn's
      disease patients compared to placebo. Treatment success will be defined as a decrease of at
      least 100 points in CDAI after 8 weeks of treatment.

      Secondary aims:

        1. Remission of disease i.e CDAI of less the 150 points.

        2. Improvement of at least one point in Endoscopic disease activity index

        3. Improvement of CRP and calprotectine

        4. Improvement of blood cytokine levels

        5. Improvement of at least 30 points in quality of life as measured by the SF 36. In
           addition the investigators will monitor side effects by questionnaires addressed to the
           patients and to a significant relative of the patients.
    

Intervention name(s): THC 5mg/ml and CBS 50mg/ml; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): olive oil containing THC and CBD; olive oil without cannabis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Crohn's disease; IBD Cannabis; THC; CBD
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single
      dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting
      conditions.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence,single dose,
      crossover, oral bioequivalence study of Eszopiclone tablets 3 mg of Dr. Reddy's Laboratories
      limited, and 'LUNESTA' tablets 3 mg Mfg for Sepracor Inc. USA in healthy adult human subjects
      under fasting conditions.
    

Intervention name(s): Eszopiclone Tablets 3 mg
Intervention type(s): Drug
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer
Condition: Advanced Triple-Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer
    

Detailed description: 
      A Phase II, Single-center, Randomized Study of Vinorelbine Plus Apatinib Versus Vinorelbine
      as Second-Line or Third-Line Treatment in Patients With Advanced Triple-Negative Breast
      Cancer (NAN trail)
    

Intervention name(s): Vinorelbine; Apatinib
Intervention type(s): Drug; Drug
Intervention description(s): Experimental: 20 mg/m2, D6, D13, D20 Active Comparator: 25 mg/m2, D1, D8, D15; 250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.
Other intervention name(s): NVB
Intervention MeSH terms: Apatinib; Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to investigate the bioequivalence of Genpharm's
      clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the
      Biaxin® filmtab® (Abbott Laboratories USA) administered under fasting conditions. Sixty-four
      (64) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were
      randomized, in this two-period, two-treatment crossover bioequivalence study conducted by
      Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada.

      Statistical analysis of the data reveals that 90% confidence intervals are within the
      acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters
      AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets
      are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered
      under fasting conditions.
    


Intervention name(s): Clarithromycin; Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose 500 mg immediate-release oral tablet; Single-dose 500 mg immediate-release oral dose
Other intervention name(s): Biaxin®; Biaxin® Filmtabs
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment