bioihbjkbjnl/mcl2 huggingface dataset:
Use of Non Steroidal Antiinflammatory Drugs in Patients With Community Acquired Pneumonia
Condition: Community-acquired Pneumonia
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      To investigate exposure to nonsteroidal antiinflammatory drugs (NSAIDs) during outpatient
      management at the early stage of community-acquired pneumonia (CAP) requiring hospital
      consultation. Non-interventional observational study.
    

Detailed description: 
      Recent data suggests that such exposure to NSAIDs is associated with delay in CAP diagnosis
      and antibiotic prescription that influence CAP presention and outcome. The investigators'
      working hypothesis is that NSAIDs use may mask initial symptoms and delay antimicrobial
      therapy, thus predisposing to worse outcomes. All patients presenting at one of the three
      following locations (emergency department, ICU or pneumology ward) with a suspicion of
      community-acquired pneumonia will be screened for eligibility. Exposure or not to NSAIDs will
      be investigated. Clinical, biological and radioloigcal features and outcome of CAP will be
      compared with respect to NSAIDs exposure.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all adult patient presenting either to the emergency department or admitted directly to the
        ICU or the pneumology ward with a suspicion of CAP will be screened
      
Keywords: Pneumonia, Bacterial [C01.252.620]; Bronchopneumonia [C08.381.677.127]; Pleuropneumonia [C08.730.610.473]; Anti-Inflammatory Agents, Non-Steroidal
A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      First in human study to evaluate the safety, tolerability, and pharmacokinetics of
      PF-03716539. The potential of PF-03716539 to increase the concentrations of midazolam,
      darunavir and maraviroc will also be evaluated.
    


Intervention name(s): PF-03716539; PF-03716539; PF-03716539; Placebo; PF-03716539; PF-03716539; PF-03716539; Placebo; Midazolam; Midazolam + PF-03716539 (100 mg); Midazolam + PF-03716539 (50 mg); Darunavir; Darunavir + PF-03716539; Maraviroc; Maraviroc +PF-03716539; Maraviroc; Maraviroc +PF-03716539
Intervention type(s): Drug; Drug; Drug; Other; Drug; Drug; Drug; Other; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-03716539 10 mg oral solution, single dose; PF-03716539 25 mg oral solution, single dose; PF-03716539 3 mg oral solution, single dose; Placebo for 3 mg, 10 mg and 25 mg of PF-03716539 (single dose); PF-03716539 100 mg oral solution, single dose; PF-03716539 200 mg oral solution, single dose; PF-03716539 50 mg oral solution, single dose; Placebo for 50 mg, 100 mg and 200 mg of PF-03716539 (single dose); Midazolam 1 mg IV, single dose; Midazolam 1 mg IV, single dose plus PF-03716539 100 mg oral solution, single dose; Midazolam 1 mg IV, single dose plus PF-03716539 50 mg oral solution, single dose; Darunavir 600 mg tablet twice daily for 9 days (Days 1-9); Darunavir 600 mg tablet, single dose plus PF-03716539 50 mg oral solution, single dose (Day 10); Maraviroc 150 mg tablet once daily for 6 days (Days 1-6); Maraviroc 150 mg tablet, single dose plus PF-03716539 100 mg oral solution, single dose (Day 7); Maraviroc 225 mg tablet once daily for 6 days (Days 1-6); Maraviroc 225 mg tablet, single dose plus PF-03716539 200 mg oral solution, single dose (Day 7)
Other intervention name(s): Selzentry; Selzentry; Selzentry; Selzentry
Intervention MeSH terms: Maraviroc; Darunavir; Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: First in Human (FIH), PF-03716539, PK enhancer
Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis
Condition: Progressive Familial Intrahepatic Cholestasis (PFIC)
MeSH terms: Liver Diseases; Cholestasis; Cholestasis, Intrahepatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label study in children with Progressive Familial Intrahepatic Cholestasis
      (PFIC) designed to evaluate the safety and efficacy of LUM001, also known as Maralixibat
      (MRX). Efficacy will be assessed by evaluating the effect of LUM001 on pruritus and the
      biochemical markers of pruritus associated with PFIC.
    

Detailed description: 
      The study is divided into 5 parts: a 4-week dose escalation period, a 4-week stable dosing
      period, a 5-week stable dosing period, a 59-week long-term exposure period, and an optional
      follow-up treatment period for eligible participants who continue treatment with LUM001.
      Participants in the optional follow-up treatment period will continue to receive study drug
      until they are eligible to enter another LUM001 study or until LUM001 is available
      commercially, whichever occurs first.
    

Intervention name(s): LUM001 (Maralixibat)
Intervention type(s): Drug
Intervention description(s): LUM001 also known as Maralixibat (MRX) oral dose up to twice a day (BID).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bile duct diseases; Intrahepatic Cholestasis; Cholestasis; PFIC; Pruritus; Cholestatic Liver Disease
Open-label Safety and PK Study of BION-1301 in Japanese Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and
      pharmacodynamic of multiple doses of BION-1301 in Japanese healthy subjects.
    

Detailed description: 
      This is a Phase 1 study of BION-1301, a first-in-class humanized IgG4 anti-a
      proliferation-inducing ligand (APRIL) monoclonal antibody. This is a single-center,
      open-label study designed to evaluate safety, tolerability, pharmacokinetic, and
      pharmacodynamic of a single subcutaneous dose of BION-1301 in Japanese healthy subjects in 3
      dose level cohorts. The study will enroll up to 36 Japanese subjects across 3 dose level
      cohorts.
    

Intervention name(s): BION-1301
Intervention type(s): Drug
Intervention description(s): A solution for SC injection administered as a single dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Open-label, single ascending dose study in Japanese healthy subjects
Masking: None (Open Label)
Primary purpose: Treatment
NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Sleepiness
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the impact of Natalizumab (Tysabri) therapy on sleep
      efficiency, total sleep time and sleep latency, in Multiple Sclerosis (MS) patients receiving
      Natalizumab for 6 months relative to baseline.
    

Detailed description: 
      Natalizumab has been shown to positively impact fatigue and cognition. The mechanism by which
      this occurs is unknown. Change in quality of sleep is one possible etiology of these
      findings. This study will help to elucidate the mechanisms that lead to reduced
      fatigue/sleepiness and less cognitive dysfunction in MS patients who go on Natalizumab
      therapy. Understanding these factors may help neurologists better differentiate between the
      different therapeutic options for MS and how they may impact symptoms that negatively affect
      quality of life.
    

Intervention name(s): Natalizumab (Tysabri)
Intervention type(s): Drug
Intervention description(s): 300 mg IV every 4 weeks
Intervention MeSH terms: Natalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Accuracy Assessment of Beddr Oximeter
Condition: Oximetry
Study type: Observational

Summary: 
      Accuracy performance of Beddr oximeter
    

Detailed description: 
      This study will evaluate the accuracy of the Beddr sleepTuner oximeter compared to a transfer
      standard and multiple reference devices.
    

Intervention name(s): oximeter
Intervention type(s): Device
Intervention description(s): Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding transfer standard and reference devices to assess oximeter calibration and accuracy.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy adult volunteers, ranging in pigmentation from light to dark.
2-week Evaluation of Marketed Silicone Hydrogel Contact Lenses in Indian Population
Condition: Visual Acuity
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the clinical performance of two marketed
      silicone hydrogel contact lenses in an Indian population in the following areas:
      physiological characteristics, comfort characteristics and vision characteristics.
    


Intervention name(s): senofilcon A; lotrafilcon B
Intervention type(s): Device; Device
Intervention description(s): One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day; One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
Condition: HIV I Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure
      the infection, making it a life-long treatment that requires sustained patient compliance and
      imposes significant individual and societal financial burdens on healthcare services.
      Furthermore, ART side effects often require medication that increases the inconveniences and
      financial burdens of HIV management. Of further concern is the emergence of viruses resistant
      to ART that can result in treatment failure.

      ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV
      immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this
      study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.
    

Detailed description: 
      Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure
      the infection, making it a life-long treatment that requires sustained patient compliance and
      imposes significant individual and societal financial burdens on healthcare services.
      Furthermore,ART side effects often require medication that increases the inconveniences and
      financial burdens of HIV management. Of further concern is the emergence of viruses resistant
      to ART that can result in treatment failure.

      ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV
      immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this
      study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.
    

Intervention name(s): Vacc-4x; Sterile water
Intervention type(s): Drug; Drug
Intervention description(s): Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.; Sterile water is used in place of Vacc-4x and in place of Leukine
Other intervention name(s): Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop
      the growth of cancer cells. It also stops the patient's immune system from rejecting the
      donor's stem cells. The donated stem cells may replace the patient's immune cells and help
      destroy any remaining cancer cells (graft-versus-tumor effect).

      PURPOSE: This phase II trial is studying the side effects of giving fludarabine together with
      busulfan and antithymocyte globulin followed by donor stem cell transplant and to see how
      well it works in treating patients with multiple myeloma that has not responded to treatment.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To study the toxicity of reduced intensity conditioning comprising fludarabine
           phosphate, busulfan, and anti-thymocyte globulin followed by allogeneic hematopoietic
           stem cell transplantation in patients with refractory or relapsed multiple myeloma.

      Secondary

        -  To study the tumor response in these patients.

        -  To study the incidence of acute or chronic graft-versus-host disease in these patients.

        -  To study the incidence of infectious complications in these patients.

        -  To study relapse- or progression-free and overall survival of these patients.

        -  To study the biological mechanisms (i.e., taking graft, immunological recovery,
           antitumor activity, and chimerism).

      OUTLINE: This is a multicenter study.

      Patients receive reduced intensity conditioning comprising fludarabine IV on days -5 to -1,
      oral busulfan on days -4 and -3, and anti-thymocyte globulin IV on days -2 and -1. Patients
      undergo allogeneic hematopoietic stem cell transplantation on day 0.

      After completion of study therapy, patients are followed every month for 6 months and then
      every 3 months for 1½ years.
    

Intervention name(s): anti-thymocyte globulin; busulfan; fludarabine phosphate; allogeneic bone marrow transplantation; nonmyeloablative allogeneic hematopoietic stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Fludarabine; Fludarabine phosphate; Busulfan; Antilymphocyte Serum
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma; osteolytic lesions of multiple myeloma
Risk Factors for Barrett's Esophagus in Patients With BE, Gastroesophageal Reflux, or Gastrointestinal Bleeding
Condition: Precancerous Condition
MeSH terms: Barrett Esophagus; Precancerous Conditions
Study type: Observational

Summary: 
      RATIONALE: A study that evaluates DNA changes and other disease-related health information in
      patients with Barrett's esophagus, gastroesophageal reflux, or gastrointestinal bleeding may
      help doctors learn more about the risk factors for Barrett's esophagus.

      PURPOSE: This clinical trial is looking at DNA changes and other disease-related health
      information as risk factors for Barrett's esophagus in patients with Barrett's esophagus,
      gastroesophageal reflux, or gastrointestinal bleeding.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the role of several genetically determined factors that, in combination with CagA
           status, cigarette smoking, alcohol, and diet to varying degrees, result in an increased
           risk for Barrett's esophagus.

      OUTLINE: This is a controlled study.

      Patients complete questionnaires about demographics, medical history, smoking and alcohol
      history, current medications, frequency and chronicity of gastroesophageal reflux symptoms,
      and diet history.

      Blood and tissue are collected and analyzed by DNA-based assays and enzyme-linked
      immunosorbent assay for CagA status and polymorphisms in detoxifying enzyme systems, other
      xenobiotic metabolism pathways (e.g., CYP1A1, CYP2E1, CYP3A4, CYP3A5, NQO, NAT-2),
      inflammatory gene pathways (e.g., IGF, IGFBF3), and in DNA repair genes or p53 pathways
      (e.g., XRCC1, p53 gene).

      PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients coming in for EGD
      
Biospecimen description: 
      Blood samples only were collected
    
Keywords: Barrett esophagus
A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fasting Conditions.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets
      (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM
      Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of
      80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin)
      distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x 80
      mg tablet) in healthy adult subjects when administered under fasting conditions.
    

Detailed description: 
      This was an open-label, balanced, randomized, two-period, two-treatment, two-sequence,
      single-dose crossover bioequivalence study under fasting conditions. The total duration of
      the study, screening through study exit, was approximately 8 weeks with at least a 14-day
      washout period between doses. At study check-in, the subjects reported to the clinical site
      at least 36 hours prior to Day 1 dosing and were required to stay for 24 hours after Day 1
      dosing. Blood sample collections were obtained within 90 minutes prior to dosing (0 hour) and
      after dose administration at 0.167, 0.25, 0.333, 0.417, 0.5, 0.583, 0.667, 0.833, 1, 1.25,
      1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 60, 72, and 96 hours. A total
      of 30 blood samples were collected per study period for a total of 60 samples or 180 mL total
      volume.
    

Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): 80 Mg tablets
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized study evaluating the safety and efficacy of elagolix in the management of
      moderate to severe endometriosis-associated pain in adult premenopausal female participants.
    

Detailed description: 
      This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess
      the safety and efficacy of two doses of elagolix versus placebo in premenopausal 18 to 49
      year old women with moderate to severe endometriosis-associated pain. The study consists of 4
      periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to
      first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to
      12 months (if applicable). An electronic diary will be dispensed and training provided to
      record endometriosis-associated pain, uterine bleeding, and analgesic medication use for
      endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly
      throughout the study.
    

Intervention name(s): elagolix; placebo
Intervention type(s): Drug; Other
Intervention description(s): oral tablet; oral tablet
Other intervention name(s): ABT-620, elagolix sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gonadotropin-Releasing Hormone Antagonist; Endometriosis associated pain; Dysmenorrhea (DYS); Non-Menstrual Pelvic Pain (NMPP); Elagolix
AME Study of [14C]-YH4808 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the absorption, metabolism, and excretion (AME)
      kinetics of YH4808 and to determine and characterize metabolites present in plasma, urine,
      and feces in man following a single dose of [14C] YH4808 200 mg (~100 µCi ±20 µCi)
      administered as a single oral dose.
    

Detailed description: 
      Potential subjects will be screened to assess their eligibility to enter the study within 28
      days prior to Study Entry (ie, prior to Check-in [Day -1]). Subjects will be confined at the
      Clinical Research Unit (CRU) from Check in (Day -1) until Discharge Criteria have been met
      (as early as Day 6 and as late as Day 11). In this study design, physical examinations,
      electrocardiograms (ECGs), vital signs, How do you feel? (HDYF?) Inquiries, and clinical
      laboratory evaluations will be performed at Screening, at specified times during the study,
      and/or at Clinic Discharge. All AEs, whether volunteered, elicited, or noted on physical
      examination, will be recorded throughout the study (ie, from dosing on Day 1 until Clinic
      Discharge [Day 11]).
    

Intervention name(s): [14C]-YH4808 200 mg
Intervention type(s): Drug
Intervention description(s): [14C]-YH4808 200 mg (oral) on day1
Other intervention name(s): YH4808 200 mg (100 µCi)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.
Condition: Major Depression; Mental Health
MeSH terms: Sleepiness; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to determine if Provigil® (modafinil) at a dose of 200 mg
      once daily is safe and effective for treating symptoms of sleepiness and fatigue associated
      with Major Depressive Disorder when added to a SSRI.
    

Detailed description: 
      Approximately 100 male and female outpatients, who are between the ages of 18 and 65, will be
      enrolled at four sites in the United States. This study consists of two parts. The first part
      consists of 6 weeks of open label treatment with a selected SSRI & double blind treatment
      with Provigil or placebo (inactive medication).

      After the six week double blind treatment phase all patients will enter a four week open
      label treatment phase with Provigil. The dose of Provigil is not to exceed 400 mg and cannot
      be less than 100 mg per day. They will continue taking the prescribed SSRI.
    

Intervention name(s): Provigil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Depression