bioihbjkbjnl/mcl2 huggingface dataset:
A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with
      Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label
      conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study.
      Those patients that meet the response criteria will continue the blind phase of the study up
      to a year. During that period, patients that respond to atomoxetine will be randomized to
      continue the treatment with atomoxetine or with placebo (neither the patients nor
      investigators know if patients receive atomoxetine or placebo).
    


Intervention name(s): atomoxetine hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral 40-100 mg/day; Oral delivery of matching placebo
Other intervention name(s): Strattera; LY139603; atomoxetine
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Adult; long term; maintenance of response; Attention Deficit Hyperactivity Disorder
Bioequivalence Evaluation of Two Film-Coated Formulations of Valsartan 160 mg
Condition: Healthy
Study type: Interventional

Summary: 
      This was a randomized, single-blind, two-period, two sequence cross-over study under fasting
      condition, with a one-week wash-out period, to compare the pharmacokinetic profiles and
      bioavailability of two formulations (the test and reference) of valsartan 160 mg film-coated
      caplets.
    

Detailed description: 
      In the first period, subjects received either the test formulation (160 mg valsartan
      film-coated caplets produced by PT Dexa Medica, Palembang, Indonesia) once daily, or the
      innovator film-coated tablets (Diovan® 160, Novartis Farmaceutica S.A., Barbera del Valles,
      Spain for Novartis Pharma AG, Basel, Switzerland) once daily as the reference formulation. In
      the subsequent period, after a one-week wash-out period, they received the alternate drug.

      At the night before starting the study, subjects were instructed to fast from any food and
      drink but mineral water for 9 hours before the drug administration. In the morning after, at
      the dosing day, each of the 48 subjects then swallowed (without chewing) one dose of
      valsartan 160 mg of the test formulation or of the reference formulation, with 200 mL of
      water. As much as 5 mL of blood samples for drug assay were drawn again from each subject, at
      0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 16, 24, 36, and 48 hours after dosing.

      The concentrations of valsartan in plasma were assayed using a validated high performance
      liquid chromatography with fluorescence detector (HPLC-FL) method. Pharmacokinetic
      parameters, including the area under the concentration-versus-time curve (AUC) from time zero
      to the time of last quatifiable concentration (48 hours after dosing) (AUC-t), AUC from time
      zero extrapolated to infinity (AUC-inf), maximum concentration (Cmax), time to reach the
      maximum concentration (tmax), and half-life (t1/2), were assessed in this study.
    

Intervention name(s): Valsartan 160 mg film-coated caplets (test formulation); Valsartan 160 mg film-coated caplets (reference formulation)
Intervention type(s): Drug; Drug
Intervention description(s): In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered.; In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered.
Other intervention name(s): Valsartan 160 mg of PT Dexa Medica; Diovan® 160
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: antihypertensive; bioequivalence; formulation; pharmakokinetic; valsartan; subjects; Fasting conditions
Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether combining FOLFIRINOX chemotherapy and
      stereotactic radiotherapy in patients with locally advanced pancreatic cancer leads to an
      increase in survival.
    


Intervention name(s): stereotactic radiotherapy
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: locally advanced pancreatic cancer; chemotherapy; stereotactic radiotherapy
My Meal Plate - Promoting the Health Literacy of Patients
Condition: Nutrition, Healthy
Study type: Interventional

Summary: 
      This study was to investigate the results on health literacy through the program of my meal
      plate.
    

Detailed description: 
      Subjects were randomized to the intervention group and control group. The primary outcome was
      the Health Literacy on my Plate.
    

Intervention name(s): Health literacy program
Intervention type(s): Other
Intervention description(s): Health literacy program was the health education related to healthy plate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: health literacy
A Study Comparing Three Formulations of Ibuprofen in Healthy Subjects
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomised, 3-period, 3-sequence single-dose crossover study to
      determine the comparative pharmacokinetic profile of the Test Investigational Medicinal
      Product (IMP) Ibuprofen 200 mg soft gel capsule (lipid formulation) with that from the
      reference products Nurofen® 200 mg tablet and ibuprofen 200 mg soft gel capsule following
      single dose administration in healthy male and female subjects.

      The study comprises of a pre-study screen (within 14 days of the first dose), followed by 3
      Treatment Periods (1, 2 and 3) and a post study follow up (3 - 7 days after the last dose).
      Each Treatment Period is of 1 day in duration, from the afternoon before dosing (Day -1)
      until 12 hours (h) post-dose (Evening of Day 1). Study drug is administered on the morning of
      Day 1 following an overnight fast. PK samples will be collected pre-dose and up to 12 h
      post-dose (x15 samples) for the measurement of ibuprofen. Safety is evaluated at specified
      times throughout the study. There is at least 48 h between dose administrations.
    


Intervention name(s): REFERENCE 1: Nurofen® 200 mg tablet; REFERENCE 2: Ibuprofen 200 mg soft gel capsule; ibuprofen 200 mg soft gel capsule
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ibuprofen; healthy volunteer study; pharmacokinetics
Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation
Condition: Leg Length Inequality
MeSH terms: Leg Length Inequality
Study type: Interventional
Phase: Phase 1

Summary: 
      Limb-length discrepancy can be due to many causes. These are divided into three groups:
      congenital (from birth), developmental (from a childhood disease or injury that slows or
      damages the growth plates), and posttraumatic (from a fracture that leads to shortening of
      the bone ends). There are three ways to equalize the limb-length discrepancy: use a shoe
      lift, shorten the long leg, lengthen the short leg. Most patients do not like wearing a lift
      greater than 2 cm (3/4 in). For discrepancies greater than 2 cm but less than 5 cm (2 in),
      shortening of the long leg can be considered, especially for tall persons. For growing
      children, this can be easily accomplished with a small, minimally invasive, uncomplicated
      procedure called epiphysiodesis.The investigators aim to evaluate if injection of bone marrow
      derived mesenchymal stem cells can shorten the treatment period by acceleration of bone
      regeneration during distraction osteogenesis.
    

Detailed description: 
      Distraction osteogenesis has been widely utilized to treat leg length discrepancy, deformity,
      nonunion, osteomyelitis, and bone loss. It has been found that most difficult conditions can
      be resolved with this method. In this study the aim is to observe if mesenchymal stem cell
      transplantation can enhance new bone formation during distraction osteogenesis.Patients
      undergo bone distraction , and about 2-3 weeks after distraction mesenchymal stem cell are
      injected at the callus site. In the case of large bone gap, mesenchymal stem cells are seeded
      on bone matrix and then placed in the bone gap. Each patient is assessed at interval time of
      1 month for 6 months post surgery by X-Ray and at month 6 post surgery by computed
      tomography(CT) scans.
    

Intervention name(s): cell and RPR injection
Intervention type(s): Biological
Intervention description(s): mesenchymal cells and Plasma reach Protein are injected to the callus center
Other intervention name(s): cell therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: distraction; osteogenesis; limb length discrepancy; callus
Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia
Condition: Lipoprotein Lipase Deficiency, Familial; Hyperlipoproteinemia Type I; Chylomicronemia, Familial; Hypertriglyceridemia
MeSH terms: Hyperlipoproteinemia Type I; Hypertriglyceridemia; Hyperlipoproteinemias; Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess safety and efficacy of CAT-2003 in patients with
      chylomicronemia. The study will evaluate the effects of CAT-2003 on fasting total and
      chylomicron triglyceride levels, as well as postprandial total and chylomicron triglyceride
      clearance.

      This is a single-blind study. All patients will receive placebo for 1 week, and CAT-2003 for
      12 weeks during the 13 week treatment period.
    


Intervention name(s): CAT-2003; Placebo
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Part A: 30 patients suffering from active rheumatoid arthritis despite continued treatment
      with methotrexate will receive once daily two capsules containing either GLPG0259 (25
      mg/capsule) or matching placebo, for 12 weeks. In the course of the study the patients will
      be examined for severity of disease, as well as for any adverse effects that may occur. If
      needed, dosing may be split to one capsule twice daily, or reduced to one capsule of 25 mg.

      Part B: If results of Part A suggest test medication to have a therapeutic advantage over
      placebo and to be well-tolerated, more patients will be recruited for Part B, where various
      dosages will be assessed. These dosages will be established based on results from Part A.
    


Intervention name(s): GLPG0259 oral capsule; Placebo; GLPG0259 (Part B); Placebo (Part B)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Two capsules, each containing 25 mg of GLPG0259 (i.e. 50 mg/day), to be given once daily; in case of adverse events the dose may be split over two administrations, or reduced to 25 mg/day (one single capsule); Placebo capsules; two capsules to be taken in the morning, in case of adverse events the dose may be split over two administrations, or reduced to one single capsule; Capsule, dosage to be established based on results of Part A; Capsules, dosage to be established after Part A, and matching GLPG0259 (Part B)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methotrexate-refractory
Bioequivalence Study of 8 mg Perindopril Tert-butylamine / 2.5 mg Indapamide Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide Film-coated Tablets in Healthy Volunteers
Condition: Bioequivalence; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is a comparative bioavailability study performed to assess bioequivalence
      between a Test medication (PERINDOPRES® DUO, 8 mg perindopril tert-butylamine / 2.5 mg
      indapamide tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a
      Reference medication (marketed medicinal product Noliterax® 10 mg /2.5 mg, 10 mg perindopril
      arginine / 2.5 mg indapamide film-coated tablets [manufactured by Servier (Ireland)
      Industries Ltd]) in healthy volunteers.
    


Intervention name(s): PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets; Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets
Intervention type(s): Drug; Drug
Intervention description(s): Oral, generic fixed-dose combination of perindopril tert-butylamine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure); Oral, innovative fixed-dose combination of perindopril arginine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure)
Intervention MeSH terms: Perindopril; Indapamide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two-period, two-sequence, cross-over single dose study
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; perindopril; indapamide; healthy subjects; pharmacokinetics
BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348)
      will be asked to participate in this long term extension study with BAY63-2521. The aim of
      the long term study is to collect additional information to evaluate the safety and
      tolerability of BAY63-2521. Patients will be treated with open label medication on their
      individual optimal dose between 0,5 mg - 2,5 mg tid.
    


Intervention name(s): Riociguat (Adempas, BAY63-2521)
Intervention type(s): Drug
Intervention description(s): BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study
Intervention MeSH terms: Riociguat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic thromboembolic Hypertension; PH; soluble Guanylate Cyclase Stimulator; sGC
Agreement of hrHPV Type Between Self-collected Sample From Vaginal Fornix and Physician Collected Sample From the Cervical Surface
Condition: Human Papillomavirus Infection; Self Sampling; Vaginal Discharge
MeSH terms: Papillomavirus Infections; Vaginal Discharge
Study type: Interventional

Summary: 
      Hygeia Touch Inc. developed a safe and comfortable vaginal self-sampling device "Hygeia Touch
      Self Sampling Kit for Women" to self-collect the vaginal discharge sample for high-risk Human
      Papillomavirus (hrHPV) detection.

      This clinical trial aimed to evaluate the agreement of hrHPV detections between vaginal
      self-sampling using "Hygeia Touch Self Sampling Kit for Women" and physician sampling, and
      these results will be applied for TFDA registration approval.
    

Detailed description: 
      Primary end-point:

        1. Agreement of hr-HPV types, including types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,
           59, 66, and 68, between the physician-collected sample and self-collected sample

        2. Agreement of the presence of hr-HPV between the physician-collected sample and
           self-collected sample

      Secondary end-point:

        1. Percentage of the valid sample between self-collected and physician-collected specimens

        2. Agreement of all (N = 27) HPV types between the paired samples

        3. Adverse events associated with sample collection

        4. Questionnaire of the appreciation and satisfaction of using self-collecting vaginal
           discharge sample using "Hygeia Touch Self Sampling Kit for Women" through a short movie
           and a brief illustration

        5. Correlation between histological diagnosis and HPV types
    

Intervention name(s): Self sampling kit for collecting discharge from vaginal fornix
Intervention type(s): Device
Intervention description(s): A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.
Other intervention name(s): Hygeia Touch Self Sampling Kit for Women
Intervention model: Single Group Assignment
Intervention model description: Two samples were collected, one by the study investigator using a cervical swab and another one by the patient using the study device immediately after viewing the instruction video and illustration. The association of the self-collected sample and the physician-collected sample was blinded to the laboratory personnel.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cervical screening; human papillomavirus typing; self sampling
Imaging Based Dosimetry for Individualized Internal Emitter Therapy
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma, Non-Hodgkin
Study type: Observational

Summary: 
      The goal of this study is to develop imaging based methods to accurately determine the energy
      absorbed (absorbed dose) by tumor tissue and bone marrow after radioimmunotherapy with I-131
      tositumomab . The administration of the radioactive, iodine-131 labeled, monoclonal antibody
      I-131 tositumomab, (also known as Bexxar) is part of the patient's clinical treatment
      protocol. For the absorbed dose measurement, investigators at the University of Michigan are
      evaluating a new Nuclear Medicine SPECT/CT imaging system . This new camera combines a CT
      imaging system in addition to a Nuclear Medicine SPECT scanner. CT scans allow the doctors to
      see a high quality picture of your internal organs. The Nuclear Medicine SPECT scanner allows
      the doctors to see the uptake of the radioactive I-131 including the tumor sites. The
      improved imaging using the SPECT/CT enables more accurate calculation of the energy absorbed
      by tumor tissue and bone marrow. Using the results from these calculations and clinical
      follow up data, the researchers will investigate the relationship between the absorbed dose
      to the tumor and the patient's tumor response as well as the relationship between the
      absorbed dose to the bone marrow and the bone marrow toxicity. These relationships can
      potentially be used in the future by doctors to help determine how much radioactive I-131 to
      administer to each patient to get optimal results.
    


Intervention name(s): SPECT/CT imaging
Intervention type(s): Device
Intervention description(s): Patients will undergo scanning on the above system.
Other intervention name(s): Siemens Symbia SPECT/CT system
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinically stable patients undergoing I-131 Tositumomab (Bexxar) for treatment of
        Non-Hodgkin Lymphomas
      
Keywords: SPECT/CT; Dosimetry; Radiation absorbed dose; Non-Hodgkin's Lymphoma; I-131 tositumomab radioimmunotherapy
Urinary Kidney Injury Molecule-1 (KIM-1) Excretion As Biomarker for Injury in Kidney Transplant Recipients
Condition: Kidney Transplant Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to determine if measuring the level of a protein called Kidney
      Injury Molecule-1 (KIM-1) in the urine will help healthcare providers detect any problems
      with the transplanted kidney before the laboratory investigations that are used on a routine
      basis do. This approach may allow the doctor to intervene at an earlier point of a rejection
      episode and may thereby prolong survival of the transplant kidney.
    

Detailed description: 
      SPECIFIC AIMS:

        1. To investigate the role of urinary Kim-1 excretion as a marker of delayed graft
           function, acute kidney allograft rejection and/or virus-induced allograft nephropathy
           and/or calcineurin-inhibitor nephrotoxicity.

        2. To determine the role of urinary Kim-1 excretion in predicting long term outcome after
           kidney transplantation compared to standard diagnostic tests.

        3. To determine the role of reduction in urinary Kim-1 excretion after a rejection episode
           and/or viral infection as a marker of repair of renal tubules.

      HYPOTHESIS:

      Monitoring of urinary KIM-1 in kidney transplant recipients will facilitate the detection of
      delayed graft function, acute allograft rejection or infectious causes of proximal tubular
      injury, allowing earlier intervention with better long-term graft survival. Detection of
      urinary KIM-1 will precede increases in serum creatinine to detect acute graft injury and
      urinary KIM-1 will decrease faster than serum creatinine and will predict responsiveness (or
      lack thereof) to intervention more accurately.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult and pediatric patients with chronic renal failure who are listed at Mount Sinai
        Hospital for a deceased donor kidney transplant and/or who are in the process of having a
        living donor evaluation are eligible to participate. One urine sample will be sent for
        KIM-1 measurement before transplantation, once the patient or the caregiver of the patient
        consents to participation in the study. The next specimen of urine will only be collected
        status post kidney transplant in the immediate post-operative phase and on routine visits
        thereafter. The study does not require obtaining any extra blood or urine specimens, but
        uses urine that would otherwise be discarded.
      
Biospecimen description: 
      Urine
    
Keywords: Rejection; Infection; Side effect of immunosuppressive drug (nephrotoxicity)