bioihbjkbjnl/mcl2 huggingface dataset:
Safety of Intra-Articular Sc-rAAV2.5IL-1Ra in Subjects With Moderate Knee OA
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      This study seeks to determine the safety of three different doses of sc-rAAV2.5IL-1Ra
      delivered by intra-articular injection into one knee joint of patients with moderate OA of
      the knee.
    


Intervention name(s): sc-rAAV2.5IL-1Ra
Intervention type(s): Drug
Intervention description(s): Self-complementing, recombinant AAV carrying IL-1Ra cDNA produced by the Research Institute at Nationwide Children's Hospital.
Other intervention name(s): AAVIL-1Ra; IL-1Ra
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Liquid vs. Tablet Buprenorphine - 6
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the steady-state pharmacokinetics and
      bioavailability of buprenorphine sublingual tablets vs. sublingual solution.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: opioid dependence
Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy
Condition: Bowel Preparation Scale; the Amount of Air Bubble; Adenoma Detection Rate
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      To evaluate the efficacy, visibility of low volume polyethyleneglycol-simeticone (2-LPEG-S)
      for colonoscopy.
    

Detailed description: 
      In this randomized controlled study, consecutive outpatients scheduled for elective
      colonoscopy were randomized into two groups. Group A patients (n = 300) used only 2 L PEG
      before colonoscopy. Patients in group B (n = 300) were additionally advised to simeticone
      plus 2 L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston
      Bowel Preparation Scale by a single endoscopist who was blinded to the intervention.
      Visibility was blindly assessed for the amount of air bubbles and adenoma detection rate
      (ADR). Difficulty of procedure, and adverse events were also evaluated.
    

Intervention name(s): 2L PEG; 2L PEG+simethicone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Simethicone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
Condition: Menopausal Syndrome; Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the anti-atherosclerotic and anti-climacteric
      action of natural drug Karinat based on phytoestrogen-rich botanicals in perimenopausal
      women.
    


Intervention name(s): Karinat; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Sugar pill manufactured to mimic Karinat 500 mg tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: perimenopause; phytoestrogen; atherosclerosis; intima-media thickness
Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional

Summary: 
      The Primary objective of this study is to compare serum levels of Macrophage-Colony
      Stimulating Factor (M-CSF) in a population of patients with multiple myeloma (MM), in a
      population of patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and in
      a control population.
    


Intervention name(s): blood samples; Bone marow samples
Intervention type(s): Biological; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Multiple Myeloma; bone lesions; Macrophage-Colony Stimulating Factor
Food Design for Improved Day-long Glycaemic Regulation
Condition: Poor Glycemic Control
Study type: Interventional

Summary: 
      The study focus is on the possible improvement in glucose tolerance at a second standardized
      meal that can be achieved when preceded by a test meal with a low GI and a high GP.
    

Detailed description: 
      A study in healthy subjects using spaghetti as the test breakfast and a white wheat bread as
      the reference. Glycaemia, insulinaemia, NEFA, TG and subjective appetite are studied up to
      the time of the lunch meal that is served 4h after breakfast. After lunch the blood sampling
      continues for 2 hours.
    

Intervention name(s): Reference; Test product
Intervention type(s): Other; Other
Intervention description(s): the reference product used; The test Product used
Other intervention name(s): WWB; Pasta
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      This single-centre, examiner-blind, randomized, stratified, two-treatment, parallel group
      clinical study will evaluate the efficacy of a 0.454% w/w stannous fluoride dentifrice
      compared to a reference dentifrice to control gingivitis (gingival bleeding and visual signs
      of gingival inflammation) in dentally and periodontally healthy adult volunteers over 12
      weeks use in a Chinese population.
    

Detailed description: 
      This clinical study will be carried out in healthy adult volunteers with moderate gingivitis.
      Treatment effect will be determined by evaluating the efficacy, in a Chinese population, of a
      dentifrice containing 0.454% w/w stannous fluoride to control gingivitis and supra-gingival
      plaque following 6 and 12 weeks twice daily brushing, compared to a fluoride control
      dentifrice. During the 12 week treatment period, participant will brush with their allocated
      study product twice daily.
    

Intervention name(s): Stannous fluoride; Sodium monofluorophosphate
Intervention type(s): Other; Other
Intervention description(s): Experimental dentifrice containing 0.454% w/w stannous fluoride & 0.0721% w/w sodium fluoride containing1450 parts per million (ppm) fluoride; Dentifrice containing 0.14% w/w sodium monofluorophosphate containing1400 ppm fluoride
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Emergency Contraception and Body Weight: Pilot Study
Condition: Contraception; Body Weight
MeSH terms: Body Weight; Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to determine how body weight changes the drug level of
      an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This
      emergency contraceptive is available to women without a prescription, but has recently been
      found to not work as well to prevent pregnancies in women of higher body weight. The overall
      goal of this research is to improve the effectiveness of contraception for women, no matter
      their weight.
    

Detailed description: 
      To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based
      emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test
      whether doubling the dose of LNG-EC in obese women increases total and free LNG serum
      concentrations.

      We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG
      orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG.
      Total and free LNG PK parameters were obtained via serum samples through an indwelling
      catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and
      free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.
    

Intervention name(s): ECx1; ECx2
Intervention type(s): Drug; Drug
Intervention description(s): At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation.; At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
Other intervention name(s): Next choice; Emergency Contraception; Next choice; Emergency Contraception
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Emergency contraception; Obese BMI; Normal BMI
A Drug-Drug Interaction Study of Losartan and PA21
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if Losartan potassium is affected by PA21.
    


Intervention name(s): PA21 and Losartan with Food; No PA21; Losartan with food; PA21 with food and Losartan 2 hours later
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.; The maximum dose of Losartan will be 100 mg/day.; The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-drug interaction; Pharmacokinetics; PA21
Simufilam (PTI-125), 100 mg, for Mild-to-moderate Alzheimer's Disease Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A two-year safety study of simufilam (PTI-125) 100 mg oral tablets twice daily for
      participants of the previous simufilam studies as wells as additional new mild-to-moderate
      Alzheimer's disease subjects for a total of 200 participants. All participants will receive
      simufilam 100 mg tablets twice daily for one year, followed by a 6-month randomized,
      double-blind period where subjects will either continue on active treatment or be switched to
      placebo. The study concludes with an additional 6-month open-label treatment period. Clinic
      visits are every month or month and a half in the first year, and every 3 months in the
      second year with an additional visit at Month 13. Cognition and neuropsychiatric symptoms are
      evaluated.
    

Detailed description: 
      The objectives of this study are to build the safety database for simufilam (PTI-125) and to
      investigate its effects on biomarkers, cognition and neuropsychiatric symptoms during
      12-month twice-daily administration in mild-to-moderate AD patients. Additional objectives
      are to assess differences in cognition and neuropsychiatric symptoms between active and
      placebo arms in the 6-month randomized period. All subjects will undergo lumbar puncture at
      screening for baseline testing of cerebrospinal fluid (CSF) total tau and Abeta42, and the
      first 50 subjects will also provide a CSF sample at Month 6 or Month 12 for evaluation of
      change from baseline in CSF biomarkers. CSF will not be required of subjects with prior CSF,
      PET or MRI evidence of Alzheimer's disease. Plasma biomarkers will be evaluated in all
      subjects. Safety will be assessed by blood tests, electrocardiograms, adverse event
      monitoring and, at Months 12 and 24, full physical examinations.
    

Intervention name(s): Simufilam 100 mg oral tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Simufilam 100 mg oral tablet for b.i.d. administration; Matching placebo oral tablets
Other intervention name(s): PTI-125; Sumifilam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Approximately two hundred (200) patients will be enrolled into the study. All participants will receive open-label simufilam 100 mg b.i.d. for a year. At Month12, participants will be randomized (1:1) to continue taking simufilam 100 mg b.i.d. or to be switched to placebo for 6 months. At Month 18, all participants will enter a final 6-month treatment period of open-label simufilam 100 mg b.i.d.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 4

Summary: 
      To report the short term anatomic and visual acuity response after intravitreal injection of
      bevacizumab (Avastin, Roche, Rio de Janeiro, Brazil) in patients with choroidal
      neovascularization secondary to age-related macular degeneration.
    

Detailed description: 
      We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to
      age-related macular degeneration who were treated with at least two (initial and one month
      after) intravitreal injection of 1.25 mg bevacizumab and had a follow-up of at least 2
      months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT)
      imaging and ophthalmoscopic examination at baseline and follow-up visits.
    

Intervention name(s): bevacizumab
Intervention type(s): Drug
Intervention description(s): 1.25mg
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bevacizumab; AMD; Complications; Visual acuity; OCt; Age Macular Degeneration
Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Atorvastatin calcium and celecoxib may stop the growth of tumor cells by blocking
      some of the enzymes needed for cell growth. Giving atorvastatin calcium together with
      celecoxib may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving atorvastatin calcium together with
      celecoxib works in treating patients with rising PSA levels after local therapy for prostate
      cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the effect on the biological activity, as assessed by prostate-specific
           antigen (PSA) response, of atorvastatin calcium and celecoxib in patients with D0
           prostate cancer.

      Secondary

        -  To document the safety and feasibility of atorvastatin calcium and celecoxib in patients
           with early-stage prostate cancer.

        -  To evaluate the effects of the combination of atorvastatin calcium and celecoxib on
           nuclear factor-kB (NFkB), extracellular signal-regulated kinase (ERK), prostaglandin E2
           (PGE2), and IL6 in peripheral blood mononuclear cells (PBMC).

      OUTLINE: This is a multicenter study.

      Patients receive oral atorvastatin calcium once daily and oral celecoxib twice daily on days
      1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or
      unacceptable toxicity.

      Patients may undergo blood sample collection at baseline and after completion of study
      therapy for correlative studies.

      After completion of study therapy, patients are followed up every 3 months for 2 years.
    

Intervention name(s): atorvastatin calcium; celecoxib; laboratory biomarker analysis
Intervention type(s): Drug; Drug; Other
Intervention MeSH terms: Celecoxib; Atorvastatin; Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV prostate cancer; stage III prostate cancer; recurrent prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer
Safety and Efficacy Evaluation of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL
Condition: Vascular Lesion; Pigmented Lesions
Study type: Interventional

Summary: 
      Multi-center, Prospective, Open-Label with Before-After Study Design. Each subject will
      receive a single treatment. Treatment presets will be determined by the SMART Camera system
      and approved by the physician. Follow-up will take place at 1 month following the treatment.
      Skin and lesion attributes will be examined by the SMART system and the physician
    

Detailed description: 
      At least 40 healthy subjects in 2 sites, aged 21-80 years old with visible textural lesions
      including but not limited to Lentigines, Rosacea, and Age spots / Telangiectasia on the face
      or décolletage that wish to improve their skin appearance. Each patient should have at least
      3 treatment areas (e.g. left cheek, right cheek, forehead, nose, chin, upper/lower
      décolletage) that contains at least one type of lesion
    

Intervention name(s): IPL with smart diagnostic handpiece
Intervention type(s): Device
Intervention description(s): treatment with IPL following diagnostic with SMART system
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignmen
Masking: None (Open Label)
Primary purpose: Other
Hepatic Impairment Study: Pharmacokinetics in Healthy and Hepatically Impaired Subjects
Condition: Pain; Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Review differences between how a healthy person and how a person with liver problems handles
      the study drug.
    

Detailed description: 
      Evaluate the pharmacokinetic (PK) profile of SKY0402 in subjects with moderate hepatic
      impairment compared with age-, gender-, and weight-matched control subjects with normal
      hepatic function.
    

Intervention name(s): SKY0402 300mg in healthy patients; SKY0402 300mg in hepatically impaired patients
Intervention type(s): Drug; Drug
Intervention description(s): SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in healthy patients; SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in hepatically impaired patients
Other intervention name(s): Healthy and Hepatic Impaired subjects will receive SKY0402.; Healthy and Hepatic Impaired subjects will receive SKY0402.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis
Condition: Proteinuria; Focal Segmental Glomerulosclerosis
MeSH terms: Proteinuria; Glomerulosclerosis, Focal Segmental
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of prednisone and tripterygium wilfordii
      in treated Focal Segmental Glomerulosclerosis (FSGS).
    

Detailed description: 
      Primary FSGS is a leading cause of end stage renal disease in adults, with complete loss of
      kidney function in 50% of patients over 10 years. Steroids, which are currently used to treat
      the disease, are effective in part of patients. Over the past decade, a number of studies
      have reported therapeutic efficacy for treatment with high-dose and over 6mo prednisone in
      patients with FSGS. These studies show that the total effective rates were only around 50%.
      But this therapy had taken some side effects of prednisone. Except these studies, in recent
      studies suggest that Tripterygium Wilfordii may be effective for passive Heymann nephritis,
      podocyte injury in nephrosis rats induced y puromycin aminonucleoside, and so on. FSGS is a
      podocytepathy. There was no-data of Prednisone and Tripterygium Wilfordii treatment of
      Chinese adult patients with idiopathic FSGS.
    

Intervention name(s): tripterygium wilfordii (TW)
Intervention type(s): Drug
Intervention description(s): Pre 30mg/d +TW 120 mg/d, po for 12 weeks
Other intervention name(s): tripterygium wilfordii
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Focal Segmental Glomerulosclerosis; Prednisone; Tripterygium Wilfordii
Study to Compare the Pharmacokinetics of AC 1202 and Two Doses of AC-SD-01 on Ketone Body Production
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of
      acetoacetate) levels after single dose administration of AC-1202 and 2 doses of AC-SD-01.
    


Intervention name(s): AC-1202; AC-SD-01 (50 g); AC-SD-01 (75 g)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 60 g AC-1202 mixed in 240 mL of water at Hour 0 Day 1; 50 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1; 75 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 16 healthy subjects enrolled, each subject will receive 1 dose of each treatment, with a 2 day washout in between.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy volunteer; AC-1202; AC-SD-01; Pharacokinetic; ketone body
A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of an intra-articular injection of AMPION™
      in adults with pain due to osteoarthritis of the knee
    

Detailed description: 
      A Randomized, Placebo-Controlled, Double-Blind Study To Evaluate The Efficacy And Safety Of
      An Intra-Articular Injection Of AMPION™ In Adults With Pain Due to Osteoarthritis Of The Knee

      The primary trial objective is to evaluate the efficacy of 4 mL of AMPION™ versus 4 mL
      placebo intra-articular (IA) injection in improving knee pain, when applied to patients
      suffering from OA of the knee.

      The secondary trial objective is evaluation of the safety of an intra-articular injection of
      AMPION™.
    

Intervention name(s): 4 mL injection of AMPION™; 4 mL injection of Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 4 mL Injection of Ampion; 4 mL Injection of Placebo
Other intervention name(s): Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; Osteoarthritis of the Knee