bioihbjkbjnl/mcl2 huggingface dataset:
Analysis of Blood-based Biomarkers of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to analyze markers of inflammation in blood and in induced
      sputum for the purpose of identifying molecular markers of specific asthma phenotypes. The
      investigators' specific interest is demonstrating that periostin levels are higher than
      normal in blood. The investigators already have solid preliminary data to support this
      hypothesis, and our goal here is to replicate preliminary findings and extend them by
      examining further the characteristics of the asthma subgroup with elevated periostin levels.
    

Detailed description: 
      This is a cross-sectional study in patients with asthma and healthy controls in which we will
      analyze markers of inflammation in blood and in induced sputum for the purpose of identifying
      molecular markers of specific asthma phenotypes. Our specific interest in demonstrating that
      periostin levels are higher than normal in blood. We already have solid preliminary data to
      support this hypothesis, and our goal here is to replicate preliminary findings and extend
      them by examining further the characteristics of the asthma subgroup with elevated periostin
      levels. In this regard, we propose detailed phenotyping of the asthmatic subjects and the
      healthy controls, including measures in induced sputum, exhaled air and detailed physiologic
      measures including measures of airflow, lung volumes, and methacholine responsiveness. In
      earlier work we have found that periostin is a marker of Th-2 driven asthma, and we will use
      the data collected here to further explore this possibility. The biospecimens collected here
      will also allow us to expand existing plasma, DNA, RNA, and sputum samples in the UCSF Airway
      tissue bank, so that we can continue to build this resource for future research questions.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Asthmatics and Non-asthmatics
      
Biospecimen description: 
      sputum, saliva, DNA, RNA, Plasma, serum
    
Keywords: Asthma
36-Month Clinical Evaluation of a Universal Adhesive
Condition: Non-Carious Cervical Lesions
MeSH terms: Uterine Cervical Diseases
Study type: Interventional

Summary: 
      The aim of this clinical trial was to evaluate and compare the performance of a universal
      adhesive with different adhesive strategies in the restoration of non-carious cervical
      lesions (NCCLs) over a 36-month period.
    

Detailed description: 
      One hundred sixty-five NCCLs in 35 patients (13 female, 22 male) with at least 3 lesions were
      included in this study. Three groups were formed according to adhesive strategies used
      (n=55): selective-etch mode; etch-and-rinse mode (ER); or self-etch (SE) mode of a universal
      adhesive, Single Bond Universal. The same nanofilled resin composite, Filtek Ultimate was
      used for all restorations by a single operator. The restorations were evaluated by two
      calibrated examiners at baseline and at 6-, 12-, 18-, 24- and 36- months in accordance with
      the modified USPHS criteria. The Chi-square test was used for intergroup, the Cochran Q test
      was used for intragroup comparison.
    

Intervention name(s): Scotchbond Universal Adhesive (3M ESPE)
Intervention type(s): Device
Intervention description(s): Adhesive system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Non-Carious Cervical Lesions; Universal adhesive
Embryo Development Using Two Commercial Single-step Media
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      This prospective study with sibling oocytes will evaluate the efficiency of two commercial
      single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms
      of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates.
      Embryos will be cultured continuously for up to 6 days under identical conditions.
    


Intervention name(s): embryo culture in different single-step media
Intervention type(s): Other
Intervention description(s): Half of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: single-step media; embryo development; blastocyst formation; embryo utilization
Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)
Condition: Stable Angina
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2a, multicenter, randomized, double-blind, placebo-controlled study in adults with
      stable angina to evaluate the effect of erenumab (AMG 334) compared to placebo on exercise
      time during an exercise treadmill test.
    


Intervention name(s): Erenumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of erenumab 140 mg infused over approximately 60 minutes.; A single dose of a matching volume of placebo infused over approximately 60 minutes.
Other intervention name(s): AMG 334; Aimovig™
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Angina; Stable Angina; Cardiovascular Disease; Exercise-induced Angina
A Study of Multiple Oral Doses of IX-01 in Healthy Men
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of IX-01 after
      multiple doses, and to determine how the body handles IX-01.
    


Intervention name(s): Placebo; IX-01
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety Study to Evaluate BMS-830216 in Healthy Subjects
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety profile, tolerability, and
      pharmacokinetics of single oral doses from 10 mg up to 1200 mg of BMS-830216 (pro-drug of
      BMS-819881) in healthy subjects
    


Intervention name(s): BMS-830216; Placebo; BMS-830216; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules, Oral, Single Dose, 1 day; Capsules, Oral, 0mg, Single Dose, 1 day; Capsules, Oral, Single Dose on Day 1, Period 1 and Day 1, Period 2, 2 days; Capsules, Oral, 0mg, Single Dose, on Day 1, Period 1 and Day 1, Period 2, 2 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Single Ascending Dose Challenge Study to Determine Safety and Reactogenicity of an Influenza Challenge Virus
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a non-controlled, open-label, single-center, dose-escalation study to determine the
      safety, infectivity, and immune responses elicited from of the potential influenza virus
      challenge strain. The study objective is to determine the dose with the optimal safety
      profile and infectivity rate of the viral challenge strain in healthy volunteers for use in
      subsequent challenge intervention studies to test potential influenza vaccines and/or
      therapeutics.
    


Intervention name(s): Live, wild-type A/California/H1N1 2009 influenza virus
Intervention type(s): Biological
Intervention description(s): Live, wild type influenza A virus that was inoculated and manufactured in allantoic fluid of SPF embryonated hen eggs
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of the Immunogenicity of Vaccination With Multiple Synthetic Melanoma Peptides With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, phase II study of a vaccine comprising melanoma peptides and a tetanus
      helper peptide, administered in GM-CSF-in-adjuvant. Patients will be randomized to receive
      one of two different vaccine regimens. Patients will be stratified by stage of disease (IIB
      versus III versus IV).
    

Detailed description: 
      Each vaccination will be administered over a 6-week period (days 1, 8, 15, 29, 36, 43).
      Patients will be randomized into one of two groups, Group A or Group B.

      Group A will receive 4 class I MHC-restricted synthetic melanoma peptides (1 each restricted
      by HLA-A1, -A3, and two restricted by HLA-A2) and a tetanus helper peptide.

      Group B will receive the 12 class I MHC-restricted synthetic melanoma peptides (4 each
      restricted to HLA-A1, -A2, and -A3) and a tetanus helper peptide.

      All vaccines will contain GM-CSF-in-adjuvant and will be administered intradermally and
      subcutaneously. Concurrent with the first three of these vaccinations, each patient will also
      receive an additional set of 3 identical vaccinations in a distal site, the response to which
      will be evaluated at the draining lymph node. This node will be harvested using lymphatic
      mapping and sentinel node biopsy methods and will be referred to as the sentinel immunized
      node (SIN).
    

Intervention name(s): 4-peptide and 12-peptide melanoma vaccines
Intervention type(s): Biological
Intervention description(s): Each vaccination will be administered over a 6-week period (days 1, 8, 15, 29, 36, 43). Patients will be randomized into one of two groups, Group A or Group B.
Group A will receive 4 class I MHC-restricted synthetic melanoma peptides (1 each restricted by HLA-A1, -A3, and two restricted by HLA-A2) and a tetanus helper peptide.
Group B will receive the 12 class I MHC-restricted synthetic melanoma peptides (4 each restricted to HLA-A1, -A2, and -A3) and a tetanus helper peptide.
All vaccines will contain GM-CSF-in-adjuvant and will be administered intradermally and subcutaneously. Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 identical vaccinations in a distal site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods and will be referred to as the sentinel immunized node (SIN).
Other intervention name(s): MELITAC 4.1; MELITAC 12.1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: melanoma; peptide; vaccine; adjuvant; advanced
Pregabalin In Adolescent Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to evaluate the long-term safety of pregabalin in
      adolescent patients who participated in the previous fibromyalgia study (A0081180) and who
      wish to recieve open-label pregabalin
    


Intervention name(s): pregabalin
Intervention type(s): Drug
Intervention description(s): Oral capsule 75-450 mg/day
Intervention MeSH terms: Pregabalin
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study Between Levocetirizine Oral Disintegrating Tablet (ODT) and Levocetirizine Immediate Release Tablet (IRT)
Condition: Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomized 2-way cross-over study to evaluate
      bioequivalence study between levocetirizine ODT and levocetirizine IRT in healthy Japanese
      male subjects. Approximately 48 subjects will participate in this study to receive a single
      dose treatments of levocetirizine ODT 5 milligram (mg) or levocetirizine IRT 5 mg. In Part 1,
      subjects will randomized in 1:1 ratio (12 in each Period) in Period 1 and 2 to receive single
      dose of levocetirizine ODT 5 mg with water or single dose levocetirizine IRT 5 mg with water
      in fasted state. In this part, comparison of bioavailability of levocetirizine ODT and
      levocetirizine IRT when taken with water in the fasted state will be assessed. In Part 2,
      subjects will be randomized in 1:1 ratio (12 in each Period) in Period 1 and 2 to receive
      single dose levocetirizine ODT 5 mg without water or single dose levocetirizine IRT 5 mg with
      water in fasted state. In this part, comparison of bioavailability of levocetirizine ODT
      without water and levocetirizine IRT with water in the fasted state will be assessed. There
      will be at least a 5-day wash out period between the intervention periods. The duration of
      each subject's participation in each part will be approximately 7 weeks from screening to
      follow-up.
    


Intervention name(s): Levocetirizine IRT 5 mg; Levocetirizine ODT 5 mg
Intervention type(s): Drug; Drug
Intervention description(s): Levocetirizine IRT will be available as film-coated tablets. Subjects will receive a single dose of 5 mg levocetirizine IRT. Subjects will receive levocetirizine IRT with 150 mL water in both Part (1 and 2).; Levocetirizine ODT will be available as oral disintegrating tablet. Subjects will receive a single dose of 5 mg levocetirizine ODT. In Part 1, subjects will receive levocetirizine ODT with 150 mL water and in Part 2 subjects will receive levocetirizine ODT without water.
Intervention MeSH terms: Cetirizine; Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is 2-way crossover 2 part study. In Part 1, comparison of bioavailability of levocetirizine ODT and levocetirizine IRT taken with water in the fasted state will be done and In Part 2, comparison of bioavailability of levocetirizine ODT without water and levocetirizine IRT with water in the fasted state will be done.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral disintegrating tablet; Levocetirizine; Immediate release tablet; Bioequivalence; Japanese subjects
Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects
Condition: Advanced Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of
      Fluzoparib in Healthy male Adults.
    


Intervention name(s): Fluzoparib; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): PARP inhibitor; proton pump inhibitor
Intervention MeSH terms: Fluzoparib; Omeprazole
Intervention model: Single Group Assignment
Intervention model description: repeated oral doses of Omeprazole on the pharmacokinetic profile of a single dose of Fluzoparib
Masking: None (Open Label)
Primary purpose: Other
A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM
Condition: Seizure; Epilepsy; Cerebral Malaria
MeSH terms: Malaria; Malaria, Cerebral; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20%
      and leaving one third of survivors with long term neurologic and psychiatric sequelae.
      Seizures occur commonly with CM and are associated with an increased risk of death and
      neuropsychiatric disabilities. In this Malawi-based, safety and feasibility study of enteral
      levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy
      studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity
      of pediatric CM.
    

Detailed description: 
      Cerebral malaria (CM) affects ~3 million children each year, primarily in sub-Saharan Africa.
      Antimalarial medications can rapidly clear P. falciparum parasites, but mortality rates
      remain high (12-25%). Survivors do not escape unscathed--~30% experience neurologic sequelae
      including epilepsy, behavioral disorders and gross neurologic deficits. Acute seizures occur
      commonly in CM and are associated with higher neurologic morbidity and mortality. Seizure
      management in malaria endemic regions is challenging because the available antiepileptic
      drugs (AED) induce respiratory suppression and assisted ventilation is unavailable. More
      optimal seizure control may improve neurologic outcomes in pediatric CM survivors, especially
      if the medication used is affordable and can be delivered safely and easily in resource
      limited settings. The investigators conducted a dose- escalation study detailed elsewhere
      (NCT01660672) to determine the optimal dose for use in this safety and feasibility study of
      enteral levetiracetam (LVT) for seizure control in children with CM and seizures admitted to
      Queen Elizabeth Central Hospital in Blantyre, Malawi. Enteral LVT given via nasogastric tube
      (NGT) rather than an intravenous (IV) formulation will be used since LVT has excellent
      enteral bioavailability and IV formations are not affordable in most malaria-endemic regions.
      LVT 40mg/kg followed by 30mg per kg Q12 hourly. Children admitted with cerebral malaria and
      seizures will be randomized to LVT vs. standard of care with phenobarbital as needed
      comparing seizure control, safety, and neurological outcomes.
    

Intervention name(s): Oral Levetiracetam; Standard AED
Intervention type(s): Drug; Drug
Intervention description(s): liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days; Active comparitor, Standard AED
Other intervention name(s): Keppra; Standard regimen of AED therapy
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to learn more about how the kidneys control the blood levels of
      phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this
      information to design improved treatment strategies for phosphorus-related problems for the
      millions of patients with chronic kidney disease.
    

Detailed description: 
      Phosphorus is a mineral found in dairy products, nuts, and meat that is essential for bone
      health and many other important functions inside the body's cells. The kidneys are
      responsible for keeping the blood levels of phosphorus normal. Healthy kidneys do this by
      spilling excess phosphorus into the urine. In patients with chronic kidney disease, the
      kidneys are unable to spill an adequate amount of phosphorus so that excess phosphorus can
      accumulate in the walls of blood vessels leading to heart disease, their leading cause of
      death. A recently discovered hormone called FGF-23 helps control the blood levels of
      phosphorus by "telling" the kidney how much phosphorus to spill in the urine. The purpose of
      this study is to learn more about how FGF-23 helps the kidneys control the blood levels of
      phosphorus. The ultimate goal is to use this information to design improved treatment
      strategies for phosphorus-related problems for the millions of patients with chronic kidney
      disease.
    

Intervention name(s): Lanthanum Carbonate; Low Phosphorus Diet; Unrestricted Phosphorus Diet; Placebo
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): Lanthanum carbonate 1000mg 3x/day; Low phosphorus diet will consist of 800 mg of phosphorus per day.; Unrestricted diet will contain 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.; Lanthanum Carbonate placebo given three times a day with meals.
Other intervention name(s): Neutraphos
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: phosphate, phosphorus, FGF-23, PTH, 1,25D
Phase 2B Dose Ranging Study of Locteron Plus Ribavirin to Treat HCV
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study was to assess in subjects with chronic hepatitis C (treatment-naïve,
      genotype 1) receiving weight-based doses of ribavirin the virologic response to 3 dose levels
      of Locteron™, dosed every 2 weeks, in comparison with PEG-Intron™ dosed weekly.
    

Detailed description: 
      The aim of SELECT-2 study was to compare the safety and efficacy of Locteron to PegIntron.
      SELECT-2 was a 72-week Phase 2b, multicenter, international trial of treatment-naïve
      genotype-1 chronic HCV subjects who were randomized 1:1:1:1 and dosed with one of three doses
      [640ug (n=29), 480ug (n=29), 320ug (n=28)] of q2week Locteron or weekly doses of 1.5ug/kg
      PEG2b (n=30). Subjects received these regimens in combination with weight-based ribavirin
      (800-1400 mg) for up to 48 weeks. Subjects and staff were blinded to Locteron dose for the
      first 12 weeks. Subjects without early virologic response by 12 weeks, and without viral
      negativity by 24 weeks, discontinued treatment for lack of efficacy. Adverse events including
      flu symptoms and depression, Beck Depression Inventory (BDI), Short Form-36, HCV RNA and
      safety labs were measured at standard intervals at clinic visits through Week 72. In
      addition, daily subject self-reports of flu symptoms using an electronic subject reporting
      tool (ePRO) were collected for the first 12 weeks.
    

Intervention name(s): ribavirin; Locteron™ (controlled-release interferon alpha 2b); PEG-Intron™
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Co-administered in all arms: oral ribavirin, 200 mg capsules. Subjects with body weight < 65 kg: 800 mg/day; Subjects with body weight 65-85 kg: 1000 mg/day; Subjects with body weight > 85 kg: 1200 mg/day.; investigational controlled-release recombinant interferon alpha 2b formulated in 1500/77/23 PolyActive microspheres as a lyophilized powder, reconstituted with carboxymethyl cellulose immediately before subcutaneous injection every other week as part of the treatment of chronic hepatitis C; commercially available pegylated interferon alpha 2b injected subcutaneously weekly in a dose of 1.5 ug/kg as part of the treatment of chronic hepatitis C
Other intervention name(s): Ribasphere®; Locteron; PolyActive; BLX-883; 12 kDalton pegylated interferon
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: treatment naive; genotype 1