bioihbjkbjnl/mcl2 huggingface dataset:
Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine safety and tolerability of daily tenofovir use in
      HIV-uninfected men.
    

Detailed description: 
      This study will assess the clinical and behavioral safety and tolerability of oral daily TDF
      use as pre-exposure prophylaxis (PrEP) to prevent HIV infection in uninfected men.
    

Intervention name(s): tenofovir disoproxil fumarate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): study product taken daily; study product taken daily
Other intervention name(s): Viread
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Impact of Udenafil on Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Dyspnea; Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Dyspnea; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Pulmonary hypertension (PH) is a serious complication of COPD which is associated with
      shorter survival, more frequent exacerbation, and increased use of health resources. There is
      no effective pharmacological treatment for COPD-associated PH. Therefore, the investigators
      wanted to evaluate the effect of udenafil, a phosphodiesterase- 5 (PDE-5) inhibitor, on
      exercise capacity of severe COPD patients.
    

Detailed description: 
      Study design

        -  prospective, single arm, open-label study

        -  Udenafil 50mg qd po for 8 weeks
    

Intervention name(s): Udenafil
Intervention type(s): Drug
Intervention description(s): Udenafil 50mg qd po
Other intervention name(s): Zydena
Intervention MeSH terms: Udenafil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Udenafil; Chronic obstructive pulmonary disease; pulmonary hypertension; Phosphodiesterase 5 inhibitors; Exercise; Dyspnea
Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to evaluate the efficacy and tolerability of single-week
      regimen of irinotecan plus capecitabine in the first-line or second-line treatment of
      advanced colorectal cancer.
    

Detailed description: 
      Irinotecan and capecitabine are approved to be the effective drugs for the advanced
      colorectal cancer patients. However, the combination of these two drugs are not regularly
      recommended due to the severe diarrhea as the most common adverse event.This study was
      designed to explore whether the single-week regimen of irinotecan plus capecitabine improves
      efficacy and does not increase the toxicity in advanced colorectal cancer patients in China.
    

Intervention name(s): irinotecan, capecitabine
Intervention type(s): Drug
Intervention description(s): Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days.
Intervention MeSH terms: Capecitabine; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastases; neoplasm
A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
Condition: Osteogenesis Imperfecta, Type I; Osteogenesis Imperfecta Type III; Osteogenesis Imperfecta Type IV
MeSH terms: Osteogenesis Imperfecta
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to select a suitable dose of BPS804 by measuring the
      strength/quality of bone using a special type of CT scanner. Participants will be treated for
      12 months and followed up for a further 12 months.
    

Detailed description: 
      This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in
      February 2021.
    

Intervention name(s): setrusumab; Calcium; Vitamin D; zoledronic acid (optional)
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): Intravenous infusion; tablets; capsules; Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Other intervention name(s): BPS804
Intervention MeSH terms: Vitamin D; Zoledronic Acid; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, Dose-finding Study, incorporating an open-label substudy
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteogenesis Imperfecta; Brittle Bone Disease
A Study of HM10760A (Long-acting Erythropoietin (EPO)) in Healthy Korean Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study design:

        -  Randomized, double-blind, placebo-controlled, sequential dose escalation

        -  Six ascending dose cohorts are planned

      Primary Objective:

        -  To evaluate the safety profile of single escalating intravenous dose levels of HM10760A
    

Detailed description: 
      Secondary objectives:

        -  To evaluate the dose response relationship of a single IV dose of HM10760A on
           pharmacodynamic parameters including hemoglobin, reticulocyte count, and reticulocyte
           hemoglobin content

        -  To evaluate the pharmacokinetic profiles of single IV dose levels of HM10760A

        -  To determine the pharmacologically active dose(PAD) of HM10760A

        -  To assess the immunogenicity of a single IV dose of HM10760A
    

Intervention name(s): HM10760A or Placebo
Intervention type(s): Drug
Intervention description(s): 0.04 mcg/kg to 2.0mcg/kg once intravenously
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Erythropoietin; Long acting; EPO
A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies
Condition: Acute Myeloid Leukemia; Multiple Myeloma; Diffuse Large B-cell Lymphoma
MeSH terms: Leukemia, Myeloid; Multiple Myeloma; Leukemia, Myeloid, Acute; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess safety and tolerability, describe the dose-limiting toxicities, determine the
      maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose)
      in the absence of establishing the MTD, and a recommended dose for further evaluation of
      MEDI7247 in patients with selected hematological malignancies who have relapsed after, or are
      refractory to prior standard therapy, and for whom there is no standard salvage regimen
      available.
    


Intervention name(s): MEDI7247
Intervention type(s): Drug
Intervention description(s): The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MEDI7247; Acute Myeloid Leukemia; Multiple Myeloma; Diffuse Large B-cell Lymphoma; AML; MM; DLBCL
Comparative Study Menaquinone-7
Condition: Bioavailability
Study type: Interventional

Summary: 
      The objective of this study is to investigate the absorption of menaquinone-7 from a
      nutrient-enriched dairy product compared to a general dairy product enriched with
      menaquinone-7 and a menaquinone-7-containing supplement.
    

Detailed description: 
      In an earlier study, beneficial effects of a nutrient-enriched dairy product on vitamin
      K-status were observed. The study product contained menaquinone-7 (MK-7) and omega-3 fatty
      acids for vascular health and extra minerals and antioxidants to support general health. It
      was the first time that such low dose of MK-7 (50 µg) could significantly improve vascular
      and general vitamin K-status already after short-term treatment. From the results of this
      study, it was assumed that the matrix of the dairy product and/or other components in the
      product, in which the vitamin was offered, contributed to optimal absorption and availability
      of vitamin K2. In this new study, the uptake and efficacy of MK-7 from the nutrient enriched
      product is investigated and compared to the uptake and efficacy from a MK-7-containing
      supplement and a basic dairy product enriched with MK-7.
    

Intervention name(s): MK-7 containing capsule; basic yogurt enriched with MK-7; nutrient-enriched yogurt with MK-7
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as ixabepilone and ketoconazole, work in
      different ways to stop tumor cells from dividing so they stop growing or die. Giving
      ixabepilone with ketoconazole may kill more tumor cells.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of giving
      ixabepilone together with ketoconazole and to see how well they work in treating patients
      with advanced solid tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the effect of ketoconazole on the pharmacokinetics of ixabepilone in patients
           with advanced solid tumors.

      Secondary

        -  Determine the safety of ixabepilone when administered alone and in combination with
           ketoconazole in these patients.

        -  Determine, preliminarily, the antitumor activity of this regimen in these patients.

      OUTLINE: This is an open-label, dose-escalation study of ixabepilone.

      During course 1, patients receive oral ketoconazole on days 0-5 and ixabepilone IV over 3
      hours on day 1. During course 2 and subsequent courses, patients receive only ixabepilone IV
      over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or
      unacceptable toxicity.

      Cohorts of at least 3 patients receive escalating doses of ixabepilone during course 1 until
      the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that
      at which 2 of 3 patients experience dose-limiting toxicity. At least 12 patients are treated
      at the MTD.

      PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study.
    

Intervention name(s): ixabepilone; ketoconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketoconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis
Condition: Osteoarthritis; Shoulder Pain
MeSH terms: Osteoarthritis; Shoulder Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This study seeks to expand the current literature in demonstrating potentially efficacious,
      conservative treatments in the management of glenohumeral osteoarthritis (OA) and will
      compare ultrasound-guided injections of hyaluronic acid vs. platelet-rich plasma. We aim to
      obtain information measuring potential benefits of these interventions and to observe for any
      adverse events.
    

Detailed description: 
      Glenohumeral OA accounts for approximately 2-5% of all chronic shoulder pain and may be
      classified into primary and secondary forms. Primary glenohumeral OA is caused by
      degenerative joint disease, inflammatory arthropathies, and neuropathic arthropathy secondary
      to syringomyelia or diabetes. Secondary glenohumeral OA is caused by trauma, postoperative
      changes after arthroscopy or capulorraphy, and osteonecrosis. Hyaluronic acid is found in
      synovial joint fluid and has viscoelastic, chondroprotective, and possibly anti-inflammatory
      properties. It has been shown to increase joint lubrication. Platelet-rich plasma contains
      growth factors that have been shown to promote tissue regeneration. The aim of this study is
      to determine whether injections of hyaluronic acid or platelet-rich plasma can be used
      reliably to decrease pain, restore function, and improve quality of life in patients
      suffering from glenohumeral OA. Patients will be randomized to receive either an injection of
      hyaluronic acid or an injection of platelet-rich plasma. Outcomes will be assessed via
      questionnaires for up to 52 weeks post-procedure.
    

Intervention name(s): PRP; Hyaluronic Acid; Ultrasound
Intervention type(s): Biological; Drug; Device
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Disease Management on Development of End Stage Renal Disease in Type 2 Diabetic Patients With Nephropathy
Condition: Type 2 Diabetes Mellitus; DM Nephropathy
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Disease management using a multidisciplinary team to achieve and maintain optimal metabolic
      and cardiovascular risk factors control in Type 2 diabetic patients with nephropathy reduces
      the incidence of end stage renal disease (ESRD) and improves clinical outcomes compared to
      usual clinic-based care
    

Detailed description: 
      Diabetic patients consume over 10% of health care costs in most developed countries. Over 80%
      of these resources are used to treat diabetic complications and late stage diseases. Over 30%
      of patients admitted to the medical wards in Hong Kong's public hospitals have diabetes,
      mainly due to cardiovascular and renal complications. Diabetes is now the leading cause of
      end stage renal disease (ESRD), accounting for 30-50% of patients on renal replacement
      therapy (RRT). In Hong Kong, the number of patients receiving RRT have increased by 50% in
      the last 5 years but the number of patients with ESRD due to diabetes have doubled. Between
      10% and 15% of patients attending medical clinics in local public hospitals either receive
      insulin or anti-diabetic drugs. In both community and hospital settings, between 30% and 50%
      of diabetic patients have albuminuria, which is by far the most powerful predictor for early
      mortality, cardiovascular morbidity and renal disease. Local published data show that 3-10%
      of diabetic patients died or developed clinical endpoints yearly.

      There are now overwhelming evidence supporting the beneficial effects of optimal control of
      cardiovascular risk factors on clinical outcomes in diabetic patients. However, there are few
      studies to examine the most effective way to translate these scientific evidence collected in
      closely monitored clinical trial situations into daily clinical practice. Results from this
      multi-centre, randomized study will provide important information to health care policy
      makers regarding the cost effectiveness of disease management using a multidisciplinary team
      to deliver a structured care model in light of the growing diabetes epidemic and the
      constraints of finite resources and the need for equity.
    

Intervention name(s): Multidisciplinary team care
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; DM Nephropathy; Structured care
Peak Impact Forces and Metabolic Cost During Mid-Forefoot Striking in Shod Versus Barefoot Runners
Condition: Healthy
Study type: Observational

Summary: 
      This experimental study will compare impact forces and metabolic cost in runners (N=20; ages
      18-45 years, who already use a forefoot strike running gait) in two treadmill running test
      sessions (shod vs barefoot running)
    

Detailed description: 
      Specific Aim 1: To identify if differences in metabolic cost exist between barefoot versus
      cushioned shod FM strikers during an acute bout of running exercise. Hypothesis: The
      metabolic cost will be higher in the cushioned shod runners with forefoot and midfoot strike
      compared to the barefoot runners.

      Specific Aim 2: To identify if differences in peak impact forces exist between barefoot
      versus cushioned shod runners in forefoot-midfoot (FM) strikers.

      Hypothesis: Peak impact forces will be higher in the barefoot runners with a forefoot and
      midfoot striking running style compared to the cushioned shod runners with a forefoot and
      midfoot striking running style.
    

Intervention name(s): running with normal running shoes and barefoot
Intervention type(s): Other
Intervention description(s): shod condition: normal running shoes barefoot condition: running with no shoewear
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        trained runners (men and women) who run with a FM strike (self-reported and verified in the
        laboratory).
      
Keywords: runners; mid-foot strike; fore foot strike; metabolic costs; trained runners (men,women) with a FM strike; shod running; barefoot running
The Brain, Neurological Features and Neuropsychological Functioning in Adults With Phenylketonuria: A Pilot Study
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional

Summary: 
      Newborn screening and early treatment prevent the most severe manifestations of
      phenylketonuria (PKU). However, executive functioning deficits, attention deficit disorder,
      slow processing speed, and visual-motor problems commonly occur. Many adults with this
      disorder also suffer depression and anxiety. Using advanced electroencephalogram (EEG) and
      magnetic resonance imaging (MRI) techniques, including novel MR spectroscopy (MRS) we hope to
      discover why this distinct constellation of deficits occurs in PKU. Adult subjects with PKU
      will undergo EEG and comprehensive MRI evaluations, including a novel method of MR
      spectroscopy to determine brain phenylalanine levels. In addition, they will receive
      neurological and neuropsychological examinations and dietary evaluation.
    


Intervention name(s): MRI
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Phenylketonuria; MRI; Neuropsychological functioning; Neurological functioning; EEG
Rapid Diagnosis of Myocardial Damage and Coronary Stenosis With Magnetic Resonance Imaging (MRI)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Coronary Stenosis; Infarction
Study type: Observational

Summary: 
      The hypothesis is that single-shot imaging of myocardial infarction is possible in atrial
      fibrillation using MRI late enhancement technique
    

Detailed description: 
      50 outpatients in Jonkoping County with a diagnosis of in-hospital myocardial infarction, are
      asked to participate in this study comparing segmented true FISP late enhancement with
      single-shot trueFISP late enhancement for the diagnosis of myocardial damage. The study does
      not intervene regarding treatment but is a comparison of the diagnostic power of the two MRI
      techniques.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patient with an in-hospital diagnosis of myocardial infarction having permanent atrial
        fibrillation.
      
Keywords: Myocardial infarction; MRI late enhancement; Atrial fibrillation
Analysis of B Cells From Autoimmune Individuals
Condition: Lupus Erythematosus; Rheumatoid Arthritis; Type 1 Diabetes
MeSH terms: Arthritis; Arthritis, Rheumatoid; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This observational study aims at finding out if individual with autoimmunity exhibit
      increased numbers of B cells that express two types (instead of one type) of antibodies, and
      if B cells of individuals genetically susceptible to autoimmunity display defects in the
      biological process of tolerance, which removes B cells that participate in autoimmunity.
    

Detailed description: 
      Peripheral blood B cells of SLE patients are analyzed by flow cytometry to determine the
      frequency of B cells co-expressing immunoglobulin kappa an lambda light chains. This
      frequency is correlated to the disease activity.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult males and females with a diagnoses of lupus erythematosus, rheumatoid arthritis, or
        type 1 diabetes
      
Biospecimen description: 
      whole blood, umbilical cord blood
MyPhonak App Junior Pediatric Usability and Benefit Investigation
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      ESolutions functions for children and young people with the myPhonak app is a prospective
      study to investigate whether the myPhonak app can improve speech understanding in children
      with hearing aids. The study is linked to randomized patient and test allocation carried out.
    


Intervention name(s): MyPhonak Junior App
Intervention type(s): Device
Intervention description(s): The primary objective is to evaluate the effects on speech intelligibility of resulting from the changes that children and adolescents (aged 7 to 17 years) make to the volume control, directionality and noise reduction of the hearing of the hearing aids using the myPhonak app. First, in a controlled laboratory environment under the guidance of the principal investigator is tested. Then, using sound scenarios, the child is allowed to try out two programs with the aid of using the app and the volume control, respectively. After this, the speech comprehension of sentences in noise is tested in the individual programs using the Oldenburg Sentence Test (OLSA).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other