bioihbjkbjnl/mcl2 huggingface dataset:
Elasticity of the Hoffa's Fat Pad in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis; Elasticity Imaging Techniques
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      Knee osteoarthritis (OA) is a common problem in clinical settings. Knee OA is well known for
      its association with the wear and tear of the cartilage and osteophyte formation. Evidence
      has suggested the importance of the infrapatellar fat pad, known as Hoffa's fat pad, during
      the development of knee OA. Some studies have demonstrated the protective role of the
      infrapatellar fat pad, whereas others have suggested an inflammatory role such as increased
      fibrosis and proinflammatory cytokine levels. Ultrasound is exceptionally convenient in the
      assessment of the musculoskeletal system, and elastography is a tool to evaluate tissue
      texture. Therefore, in this study, we investigated the Hoffa's fat pad in knee OA patients by
      using elastography.
    

Detailed description: 
      This was an observation study that included a control group. We enrolled 20 patients with
      knee OA, as well as 10 healthy individuals. The Western Ontario and McMaster Universities
      Osteoarthritis Index (WOMAC) and Kellgren-Lawrence X-ray grading were employed to determine
      disease severity. All the study participants received elastography assessment, including
      strain and shear wave elastography in the knee extension and flexion position. The strain
      elastography contained color mapping that enabled the calculation of the relative texture and
      strain ratio. The shear wave elastography revealed the qualitative velocity, which was
      measured 3 times. Each patients with knee OA received elastography examination twice: once
      before hyaluronic acid injection and once 1 month after the injection.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        individuals with knee osteoarthritis diagnosis is classified as K-L grading I - IV
        individuals in control group has no knee pain or osteoarthritis history
A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults
Condition: Respiratory Synctial Virus Infections
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity
      and immunogenicity of 2 doses of the RSV investigational vaccine, when administered
      intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.
    


Intervention name(s): GSK3389245A_LD GROUP; GSK3389245A_HD GROUP; Bexsero; Placebo
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm; 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm; 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm; 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
Other intervention name(s): Meningococcal group B Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Reactogenicity; Safety; Respiratory syncytial virus (RSV); Vaccine; Immunogenicity
Prospective Study on Intensive Early Rheumatoid Arthritis Treatment
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis: Early intensive treatment with anti-TNF agent plus methotrexate plus high dose
      prednisone may increase remission rate and may induce stable remission in Rheumatoid
      Arthritis Objective: to evaluate induction of remission using adalimumab, prednisone and
      methotrexate and maintenance of remission after discontinuation of adalimumab and prednisone
    

Detailed description: 
      Treatment group A 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg
      weekly + prednisone 50 mg/d tapered to 6.25 mg 6 - 12 months: Adalimumab 40 mg eow plus
      methotrexate 20 mg weekly group B 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly
      titrated to 20 mg weekly + placebo 6 - 12 months: Adalimumab 40 mg eow + methotrexate rapidly
      titrated to 20 mg weekly

      Follow up period - Open Label phase:

      Patients achieving clinical remission will be than treated only with MTX and observed for
      another 12 months period. Patients who do not achieve clinical remission or patients who will
      experience a relapse of the disease will be treated according to standard of care (SOC)
      modalities.
    

Intervention name(s): adalimumab, plus prednisone; adalimumab plus placebo
Intervention type(s): Drug; Drug
Intervention description(s): adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo or prednisone 50 mg/po day then reduced to 6.25/po day; adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo daily for 6 months
Other intervention name(s): humira (adalimumab); deltacortene (prednisone); humira (adalimumab)
Intervention MeSH terms: Prednisone; Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rheumatoid arthritis; clinical remission
The Effect of Selected Fibres and Flours in Flat Bread on Post-prandial Blood Glucose Responses
Condition: Healthy
Study type: Interventional

Summary: 
      Identify one or more flat bread mixes that produce a reduction in positive incremental area
      under the curve (iAUC) of post-prandial glucose relative to the control product.
    

Detailed description: 
      This study was a double-blind, randomised, balanced incomplete block design exploratory study
      of efficacy, with 11 active treatments compared to a control product in 42 healthy subjects
      to see if a mix of active ingredients (viscous fibres and flours) lowered the post-prandial
      glucose (PPG) response in capillary blood (finger prick) over a two and three hours period,
      relative to the control product. Every subject received the control and 4 out of the 11
      treatments on five separate test days.
    

Intervention name(s): Control; Active 2; Active 3; Active 4; Active 5; Active 6; Active 7; Active 8; Active 9; Active 10; Active 11; Active 1
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): 100 g high fibre flour; 98 g high fibre flour + 2 g guar gum; 88 g high fibre flour + 2 g guar gum + 10 g legume flour; 83 g high fibre flour + 2 g guar gum + 15 g legume flour; 96 g high fibre flour + 4 g guar gum; 86 g high fibre flour + 4 g guar gum + 10 g legume flour; 81 g high fibre flour + 4 g guar gum + 15 g legume flour; 94 g high fibre flour + 6 g guar gum; 98 g high fibre flour + 2 g konjac mannan; 96 g high fibre flour + 4 g konjac mannan; 100 g low fibre flour; 85 g high fibre flour + 15 g legume flour
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: guar gum; konjac mannan; blood glucose; legume flour
Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful?
Condition: Induced Abortion
Study type: Interventional

Summary: 
      This is a randomized, single-blind study using oxytocin 5U i.v. during surgical abortion in
      one arm of the study, and no medication in the other arm of the study. Comparison is done
      between the two groups measuring the following outcomes: pain, nausea and blood loss. The
      investigators' hypothesis is that there will be no significant differences between the two
      groups.
    

Detailed description: 
      All women seeking surgical abortion before 12 weeks of pregnancy will be invited to
      participate in the study. We will include 400 patients. Written consent is given. Pain is
      measured on a VAS-scale (1-10) 2 hours post operatively and repeated 2 days postoperatively.
      Nausea is categorized in 4 groups, from 1 (no nausea) to 4 (pronounced nausea with
      vomiting)and is registered together with bloodloss also during the hospital stay (2 hours)
      and 2 days postoperatively. The two groups will be compared.
    

Intervention name(s): oxytocin
Intervention type(s): Drug
Intervention description(s): 5 U i.v. during surgical abortion
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: first trimester abortion; oxytocin
Evidence Based Amputee Rehabilitation (EBAR) Program
Condition: Amputation Stumps; Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to determine if an evidence based exercise intervention improves
      the functional mobility of diabetic amputees (single lower leg amputation) who have already
      completed standard rehabilitation and prosthetic training.
    

Detailed description: 
      Subjects who pass all eligibility requirements will then undergo baseline testing by an
      examiner who will remain blinded to subject group assignment. Baseline testing will include
      the AAS, six-minute walk test, and both the AMPPro and AMPnoPro.

      After baseline testing has been completed, subjects will be randomly assigned to either the
      intervention or wait list control. Randomization will occur in blocks of 20 such that for
      each panel of 20 subjects, 50% will be randomized to the intervention and 50% will be
      randomized to wait list control. Randomization will be performed using a random-number table
      to assign treatment group to status to each subject's unique identification number.
      Randomization status will be concealed by recording status on a card that is folded in half
      so that the group assignment is inside the fold. The cards will be placed in envelopes
      bearing identification numbers. When a subject has completed all baseline measures, the
      envelope with that subject's ID number will be opened and the subject will be assigned to a
      group.

      Subjects assigned to the intervention group will undergo clinical strength testing. An
      individualized program will be developed for each subject based on his or her AMP test
      results and clinical strength testing. Subjects will then attend rehabilitation sessions 3
      times per week for 8 weeks. Each session will last approximately 45 minutes including any
      required rest periods. Subjects will perform endurance, balance and strengthening exercises
      at each session. Every 6th session, subjects in the intervention group will perform a
      six-minute walk test, AMPPro and complete the AAS questionnaire. The results of each AMPPro
      test will be reviewed and the therapeutic exercise program revised according.

      After follow-up testing, subjects assigned to the wait list condition will be eligible to
      attend the 8-week rehabilitation program. Wait list subjects in the exercise phase will also
      receive the same exercise intervention described above. They will also perform a six-minute
      walk test, AMPPro and complete the AAS questionnaire every 6th session.
    

Intervention name(s): EBAR Program
Intervention type(s): Other
Intervention description(s): Evidence Based Amputee Rehabilitation Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Artificial Limbs; Evidence based medicine; Exercise; Outcomes research; Physical therapy
Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved
      Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and
      psychological assessment. This non-invasive device is able to rapidly raise the core body
      temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating
      element. The change in body temperature may change the sympathetic nervous system's activity
      and thereby reduce Fibromyalgia pain.
    


Intervention name(s): AVACEN Thermal Exchange System
Intervention type(s): Device
Intervention description(s): Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.
Other intervention name(s): AVACEN Treatment Method (ATM) (previously known as the AVACEN Thermal Exchange System [TES] or the AVACEN Thermal Exchange Method [TEM])
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibromyalgia; Pain; Non-Invasive; Arthritis; Rheumatoid Disease
An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease
Condition: Stable Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the drug characteristics of Ticagrelor, and to
      determine if 4 weeks treatment will reduce the blood clotting.
    


Intervention name(s): ticagrelor; clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Drug oral treatment; Drug oral treatment
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Stable Coronary Artery Disease; Platelet Aggregation
Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the drug-drug interactions between BI 201335 and BI 207127 as well as their
      combined effect on CYP probe drug substrates and on tenofovir and raltegravir in treatment
      naive or prior treatment relapse patients with chronic hepatitis C infection.
    


Intervention name(s): midazolam; BI 201335; tenofovir; caffeine; tolbutamide; tolbutamide; midazolam; caffeine; pegylated interferon; BI 201335; BI 201335; BI 207127; BI 207127; BI 201335; BI 207127; ribavirin; ribavirin; ribavirin; pegylated interferon; ribavirin; caffeine; tolbutamide; BI 207127; midazolam; BI 201335; BI 207127; ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): CYP3A probe drug; HCV protease inhibitor; nucleoside analogue; CYP1A2 probe drug; CYP2C9 probe drug; CYP2C9 probe drug; CYP3A probe drug; CYP1A2 probe drug; HCV treatment; HCV protease inhibitor; HCV protease inhibitor; HCV polymerase inhibitor; HCV polymerase inhibitor; HCV protease inhibitor; HCV polymerase inhibitor; HCV treatment; HCV treatment; HCV treatment; HCV treatment; HCV treatment; CYP1A2 probe drug; CYP2C9 probe drug; HCV polymerase inhibitor; CYP3A probe drug; HCV protease inhibitor; HCV polymerase inhibitor; HCV treatment
Intervention MeSH terms: Tolbutamide; Interferons; Tenofovir; Ribavirin; Midazolam; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Revisiting Parental Survey for Screening for Obstructive Sleep Apnea in Patients Undergoing Polysomnography
Condition: Sleep Apnea
MeSH terms: Sleep Apnea Syndromes
Study type: Observational

Summary: 
      The investigators are proposing a study where the investigators would give a survey to the
      parents of patients having a sleep study. The survey would contain questions relating to
      symptoms of sleep apnea and then the investigators would correlate the parent answers to the
      results of the sleep study.
    


Intervention name(s): Sleep apnea symptom survey
Intervention type(s): Other
Intervention description(s): Parents or caregivers will complete a questionnaire regarding possible sleep apnea symptoms.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are having a sleep study at NCH.
      
Keywords: sleep study; NCH
Effects of Angiotensin Receptor Antagonist on Prohibiting Cardiovascular Events on Hemodialysis Patients
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Cardiovascular disease is a leading cause of mortality in patients on hemodialysis therapy
      (HD), accounting for 30 to 50% of all death. Although angiotensin receptor blockers (ARBs)
      are effective for patients with diabetes and chronic kidney disease in reducing or preventing
      cardiovascular diseases, there has been no decisive study that demonstrated treatment with
      ARBs is effective in patients on HD.
    


Intervention name(s): candesartan or valsartan or losartan
Intervention type(s): Drug
Intervention MeSH terms: Losartan; Valsartan; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemodialysis
Effect of Tegoprazan or RAPA113 on Pharmacodynamics/Pharmacokinetics of Clopidogrel in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the influence of tegoprazan or RAPA113 on the
      pharmacodynamics/Pharmacokinetics of following co-administration of tegoprazan or RAPA113 and
      clopidogrel in healthy male volunteers.
    

Detailed description: 
      Evaluation Criteria:

        -  Primary outcome Pharmacodynamic assessments using P2Y12 assay

        -  Secondary outcome Pharmacokinetics assessments on Cmax,ss, AUCτ,ss, tmax,ss, Cmin,ss ,
           CLss/F of Clopidogrel

        -  Safety assessments with adverse event monitoring including subjective/objective
           symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
    

Intervention name(s): Clopidogrel 75mg; Tegoprazan 50 mg; RAPA113
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clopidogrel 75 mg tablet; Tegoprazan 50 mg tablet; RAPA113 tablet
Other intervention name(s): Plavix; K-CAB
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Feeding Versus Conventional Feeding
Condition: Ileostomy - Stoma
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare early feeding vs conventional feeding after
      stoma reversal. The main question it aims to answer are:

      • whether it is beneficial to start oral feeding within 12hrs after stoma reversal

      Participants will be randomly assigned two groups either early feeding or conventional group
    


Intervention name(s): early feeding; conventional feeding
Intervention type(s): Other; Procedure
Intervention description(s): oral feeding within 12hours after stoma reversal; oral feeding after 48hours of NBM after stoma reversal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Food on the Pharmacokinetics of Decitabine/Tetrahydrouridine Combination Capsules in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to investigate the effect of a high fat meal on the pharmacokinetics of
      decitabine and THU in healthy adults when administered as a modified release formulation of
      the 2 drugs in combination.
    

Detailed description: 
      This study is to evaluate the relative pharmacokinetics of oral decitabine and
      tetrahydrouridine (THU) after a high-fat, high-calorie (FDA standard) meal as compared to
      decitabine and THU under fasting conditions in healthy adult male and female subjects. In
      addition, this study is to compare the pharmacokinetic parameters between male and female
      subjects, and also to capture safety information for the decitabine and THU combination in
      healthy subjects after oral dosing.
    

Intervention name(s): Decitabine
Intervention type(s): Drug
Intervention description(s): Capsules containing a combination of decitabine and THU
Other intervention name(s): EPI01; Tetrahydrouridine
Intervention MeSH terms: Decitabine; Tetrahydrouridine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label, randomized, three-block, four-period study to evaluate the relative pharmacokinetics of three test formulations of decitabine and THU in a modified release THU and decitabine combination capsule (EPI01) in healthy male and female adults
Masking: None (Open Label)
Primary purpose: Other