bioihbjkbjnl/mcl2 huggingface dataset:
Study of Single-dose DS-3201b in Participants With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, parallel design, single-dose pharmacokinetic (PK) study to
      assess the safety, tolerability, and PK of a single dose of 50 mg of DS-3201b in participants
      with normal and impaired hepatic function.
    


Intervention name(s): DS-3201b
Intervention type(s): Drug
Intervention description(s): 1 dose of 50 mg DS-3201b
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 1, open-label, parallel design, single-dose PK study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; DS-3201b; Enhancer of zeste homolog (EZH) inhibitor
Muscle Property, Alignment and Joint Loading in People With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Knee osteoarthritis (KOA) is a common chronic painful musculoskeletal condition among older
      adults. It poses great challenge to the health care system due to its inability to be cured.
      Understanding factors associated with disease progression in KOA should assist the
      development of novel prevention/rehabilitation strategies. This study investigate factors
      including muscle properties, lower limb alignment and joint loading in patients with knee
      osteoarthritis before and after a six-week exercise program.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Comprehensive exercise program including strengthening, stretching, gait modification etc.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: muscle tension; alignment; knee osteoarthritis; loading
Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
Condition: Intravitreal Bevacizumab Injection; Pars Plana Vitrectomy; Tractional Retinal Detachment; Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Detachment; Dissociative Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated
      with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from
      fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and
      techniques are used.

      Bevacizumab is an anti VEGF antibody which has been used to induce regression of ocular
      neovascularization. Its intraocular injection has been increasingly used for treatment of
      choroidal neovascularization (CNV) associated with age related macular degeneration (AMD)
      with fairly good success.Also it has been shown to be effective for treatment of PDR
      complicated with vitreous hemorrhage and iris neovascularization. We hypothesized that if
      anti-angiogenic agents, such as bevacizumab are injected into the vitreous cavity before
      vitrectomy in cases of PDR; there may be partial regression of neovascularization resulting
      in less intraoperative (and postoperative) hemorrhage. This can make the operation easier and
      shorter and lessen the need for intraocular cautery..

      In this study diabetic patients who are candidated for vitrectomy with similar complexity
      scores will be randomized to preoperative injection or no injection of 2.5 mg Bevacizumab .In
      the injection group, 2.5 mg of bevacizumab (0.1 ml of commercially available Avastin vial,
      Genentech, inc. South San Francisco, CA) will be injected into the vitreous 3-5 days before
      operation.

      During each operation, the number of endodiathermy applications, backflush needle
      applications and the duration of surgery will be recorded by an independent observer. Also,
      type of tamponade, post operation vitreous hemorrhage and 3 months postoperative visual
      acuities wil be recorded. all these parameters will be compared in two groups.
    

Detailed description: 
      Eligibility criteria:

      Diabetic tractional retinal detachment-complexity score between 4 and 8

      Main outcome measures:

      best corrected visual acuity-anatomic condition of the retine(re-attachment of the retina)
    

Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention description(s): one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy
Other intervention name(s): Brand name of Bevacizumab is Avastin
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intravitreal Bevacizumab injection; Pars plana vitrectomy; tractional retinal detachment; Diabetic retinopathy
Infant TB Infection Prevention Study
Condition: Tuberculosis
MeSH terms: Infections; Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium
      tuberculosis infection in HIV-exposed uninfected (HEU) infants.
    

Detailed description: 
      The purpose of this trial is to determine whether isoniazid (INH) reduces the risk of
      Mycobacterium tuberculosis (MTB) infection in HIV-exposed but uninfected (HEU) children, as
      well as to determine epidemiologic and immunologic correlates of MTB infection in HEU.
    

Intervention name(s): Isoniazid
Intervention type(s): Drug
Intervention description(s): HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.
Other intervention name(s): INH
Intervention MeSH terms: Isoniazid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: M. tuberculosis infection; isoniazid; HIV-exposed infants
A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines
Condition: HIV Infections
MeSH terms: Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160
      envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit
      recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity
      compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts
      with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two
      priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity
      of the three subunit vaccines when administered as boosters.

      Secondary: To examine the safety of administering the individual subunit vaccines in
      combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone.

      In a previous study of candidate HIV vaccines, the evidence suggested that administration of
      a booster vaccination with a different vaccine preparation may produce a better immune
      response than administration of HIVAC-1e vaccine alone.
    

Detailed description: 
      In a previous study of candidate HIV vaccines, the evidence suggested that administration of
      a booster vaccination with a different vaccine preparation may produce a better immune
      response than administration of HIVAC-1e vaccine alone.

      Seventy healthy volunteers are randomized to one of four groups. Groups A and D receive one
      initial immunization with HIVAC-1e followed by two boosts with subunit gp120 and Env 2-3,
      respectively, at months 8 and 12. Group B receives two immunizations with HIVAC-1e at months
      0 and 8 followed by a single boost with subunit gp120 at month 12. Group C receives three
      doses of subunit gp120 only at months 0, 8 and 12. (Per 10/01/92 amendment, boosts with
      VaxSyn (gp160) have been eliminated.) Subjects are followed for 18 months.
    

Intervention name(s): rgp120/HIV-1 SF-2; Env 2-3; HIVAC-1e; gp160 Vaccine (MicroGeneSys)
Intervention type(s): Biological; Biological; Biological; Biological
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; HIV-1; HIV Envelope Protein gp160; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Safety and Blood Levels After a Single Injection of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goals of this clinical study are to characterize and compare the safety, tolerability,
      blood levels of UPB-101 when given to healthy Japanese and non-Japanese non-East Asian
      (NJNEA) adults. Eligible participant will be assigned to one of the 4 planned dosing
      treatment groups. Treatment groups 1, 2 and 3 will consist of Japanese adults who will be
      administered a single subcutaneous (SC) dose of UPB-101 (at 3 different strengths). Treatment
      group 4 will consist of NJNEA participants who will receive a single SC dose of UPB-101. All
      treatment groups will enroll and run in parallel.
    

Detailed description: 
      This is a randomized, open-label, parallel group, ethno-bridging study comparing the
      pharmacokinetics and safety of a single dose of UPB-101 in healthy Japanese and NJNEA adults.
      The study will include 4 planned dosing treatment groups. Treatment groups 1, 2 and 3 will
      consist of Japanese adults who will be administered a single subcutaneous (SC) dose of
      UPB-101 (at 3 different strengths). Treatment group 4 will consist of NJNEA participants who
      will receive a single SC dose of UPB-101. All treatment groups will enroll and run in
      parallel. Japanese participants will be enrolled and randomized on Day 1 into treatment
      groups 1, 2 or 3 and NJNEA participants will be assigned to treatment group 4.

      Eight participants will be enrolled per treatment group, all will receive a single dose of
      UPB-101. Thus, a total of 32 male and female participants will be enrolled in the study (24
      Japanese participants in treatment groups 1-3 and 8 NJNEA participants in treatment group 4).
    

Intervention name(s): UPB-101
Intervention type(s): Drug
Intervention description(s): UPB-101 Subcutaneous injection
Other intervention name(s): Formerly ASP7266
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All treatment groups will enroll and run in parallel. Japanese participants will be enrolled and randomly assigned, on Day 1, to treatment groups 1, 2 or 3. NJNEA participants will be assigned to treatment group 4.
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, and Pharmacokinetic Study of CORT113176 in Healthy Participants
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a safety, tolerability, and pharmacokinetic study in 2 cohorts of healthy male
      participants with an option for an additional cohort. Cohorts 1 and 2 will receive once daily
      by mouth CORT113176 150 mg and 300 mg, respectively, for 14 days under fed conditions.
      Progression from Cohort 1 to Cohort 2 will be done based on the safety and tolerability
      outcome in Cohort 1 and after Cohort 1 has received the study drug for at least 7 days. The
      optional Cohort 3 may receive a higher dose that will not exceed CORT113176 450 mg once daily
      by mouth for 14 days under fed conditions. The progression from Cohort 2 to the optional
      cohort (Cohort 3) will be based on the same precautions as with the progression from Cohort 1
      to Cohort 2. Each participant will undergo safety evaluations. Pharmacokinetics of CORT113176
      will be assessed in plasma and cerebrospinal fluid (CSF) samples. Pharmacodynamic assessments
      will include the measurement of serum cortisol.
    


Intervention name(s): CORT113176; Placebo matching CORT113176
Intervention type(s): Drug; Drug
Intervention description(s): CORT113176 lipid capsule formulation for oral administration; Placebo matching CORT113176 lipid capsule formulation for oral administration
Intervention MeSH terms: Cortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women
Condition: Postmenopause
Study type: Interventional

Summary: 
      Alleged benefits experienced after the consumption of soy in Asian countries have been
      attributed to the isoflavone content of soy products. Amongst other benefits, isoflavones are
      believed to relieve menopausal symptoms and are therefore often consumed in supplement form
      in Western countries. These supplements contain relatively high amounts of isoflavones and
      are on the market in different compositions. The question is whether supplements with
      different compositions exert similar effects or whether the effects differ substantially.
    

Detailed description: 
      Intervention study with two substudies; each substudy is a double blind placebo controlled
      crossover intervention study. The first substudy has two groups: 'high daidzein' supplement
      versus placebo (n=18) and vice versa (n=18); the second substudy also has two groups 'high
      genistein' versus placebo (n=18) and vice versa (n=18).
    

Intervention name(s): High daidzein supplement; High genistein supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 8 weeks exposure to the supplement, daily 100 mg of isoflavones; 8 weeks exposure to the supplement, daily 100 mg of isoflavones
Other intervention name(s): Phyto soya forte - Arkpharma; Mega Soja - Springfield
Intervention MeSH terms: Genistein; Daidzein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: isoflavone; supplement; daidzein; genistein; gene expression
Evaluation of a Patient Portal Intervention to Address Diabetes Care Gaps
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the usability of a novel patient portal intervention
      designed to: (a) notify patients when selected, clinically meaningful, evidence-based
      diabetes monitoring & preventative care (e.g., annual diabetes eye exam) become due and (b)
      allow patients to initiate orders for the care. In addition, the investigators will assess
      pre-post change on secondary psychosocial outcomes (e.g., self-efficacy).
    

Detailed description: 
      Up to 60 adult patients with type 1 or 2 diabetes mellitus will be enrolled and given access
      to a new feature within the patient portal at Vanderbilt University Medical Center. The new
      feature will be available via the patient portal native app (i.e., My Health at Vanderbilt
      (MHAV) app) for mobile devices (smartphone or tablet). The new feature will allow patients
      to: (1) receive notifications when the patient is due for certain types of diabetes
      monitoring and preventative care and (2) initiate an order for the care.

      Study participants will complete questionnaires electronically via email at three time
      points: baseline (T0), immediately after first use of the intervention (T1), and three-month
      follow-up (T2) to as assess study outcomes including usability and pre-post change in
      secondary psychosocial outcomes.
    

Intervention name(s): Diabetes Care Gaps Patient Portal Intervention
Intervention type(s): Other
Intervention description(s): The Diabetes Care Gaps Patient Portal Intervention involves a new feature embedded with the My Health At Vanderbilt (MHAV) native app (on Epic's MyChart platform) for mobile devices that allows patients to: (a) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (b) initiate an order for the care. Automated notifications will be sent to patients if, according to the evidence-based guidelines, the patients are due for a hemoglobin A1C blood test, microalbumin urine test, diabetes eye exam, or pneumonia vaccination. Once notified patients can initiate orders for the care within the MHAV app. The patient will receive confirmation when the order has been processed and will be provided instructions to receive the relevant care.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes Mellitus; Medical Informatics; Preventative Care
Pathophysiology of Martorell Hypertensive Ischemic Leg Ulcer (HYTILU)
Condition: Hypertensive Ischemic Leg Ulcer; Calciphylaxis
MeSH terms: Leg Ulcer; Calciphylaxis; Ischemia; Ulcer
Study type: Observational

Summary: 
      Martorell hypertensive ischemic leg ulcer is a severe type of skin necrosis (skin infarction)
      which occurs in long-term hypertensive subjects.

      Calciphylaxis (calcific uremic arteriolopathy) is a severe type of skin necrosis (skin
      infarction) which occurs in subjects with end-stage kidney disease or after kidney
      transplantation.
    

Detailed description: 
      Comparative study including

        -  20 consecutive patients with Martorell HYTILU

        -  10 consecutive patients with Calciphylaxis (calcific uremic arteriolopathy)

        -  20 patients with venous ulcer

      The following parameters are measured in the blood serum:

      White blood count; c-reactive protein; creatinine; calcium (total); free (ionized) calcium;
      phosphate; albumin; 25-hydroxyvitamin-D; 1-25-dihydroxyvitamin-D; homocysteine; cystatin C
      alphafetoin, osteoprotegerin; fibroblast growth factor 23 (FGF-23); globular arrest 1 (GLA-1)

      The following parameters are measured in samples of diseased (necrobiotic) skin:

      alphafetoin, osteoprotegerin; fibroblast growth factor 23 (FGF-23); globular arrest 1 (GLA-1)
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        n=20: Having Martorell hypertensive ischemic leg ulcer (as defined above) or n=10: Having
        Calciphylaxis (calcific uremic arteriolopathy (as defined above) or n=20: Having a venous
        ulcer (as defined above) (controls)
      
Biospecimen description: 
      Blood serum (2 tubes); blood plasma in citrate (2 tubes); blood plasma in heparin (2 tubes)
      Diseased skin tissue in formalin for paraffin embedded H-E histology; Diseased skin tissue
      snap frozen Diseased skin tissue in "RNA later" tube (1 tube)
    
Keywords: Martorell hypertensive ischemic leg ulcer; Calciphylaxis (calcific uremic arteriolopathy); Ischemic subcutaneous arteriolosclerosis; Hypertension; Diabetes; Medial calcinosis; Wound healing
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      Single-arm, interventional pivotal clinical trial collecting patient data from use of the
      AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a
      high-velocity saline stream to resect and remove prostate tissue in males suffering from
      Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) with prostate
      volumes between 80 mL and 150 mL. The primary endpoints for safety and effectiveness will be
      measured at 3 months post-treatment. Treated subjects will be followed out to 60 months to
      collect long-term clinical data.
    


Intervention name(s): Aquablation
Intervention type(s): Device
Intervention description(s): The procedure is performed with the AquaBeam System. It is designed to utilize a high-velocity sterile saline waterjet as the cutting medium, which is projected through a nozzle positioned within the prostatic urethra. The Aquablation procedure integrates real-time ultrasound imaging with a robotically executed surgeon guided high-velocity waterjet to resect prostate tissue.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lower Urinary Tract Symptoms (LUTS); AQUABEAM; Aquablation; Benign Prostatic Hyperplasia (BPH)
Long-term Effect of a 3-month Supplementation With Holo-BLG on House Dust Mite Induced Allergic Rhinoconjunctivitis
Condition: Dust Mite Allergy; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Dust Mite Allergy
Study type: Observational

Summary: 
      The aim of the study is to investigate the long-term effect of a lozenge containing
      beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols (holo-BLG) in people with
      allergic rhinoconjunctivitis caused by house dust mites and the associated symptoms (symptom
      type and severity) during exposure to house dust mites in an Allergen Exposure Chamber (AEC).

      In particular, the study aims to evaluate whether the improvements in symptoms of house dust
      mite-induced rhinoconjunctivitis observed after 3 months of supplementation with holo-BLG can
      still be detected 7 to 8 months after the last intake.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        study participants must have been participated in the in the predecessor study
        (supplementation phase with holo-BLG) including complete intake of the holo-BLG lozenge for
        3 months and must have been included in the final analysis set of the predecessor study
Cerament Treatment of Fracture Defects
Condition: AO 41-B2 and AO 41-B3 Tibia Fractures
MeSH terms: Fractures, Bone; Tibial Fractures
Study type: Interventional

Summary: 
      The aim of the study is to compare fracture healing, quality of life, pain, and cost of care
      of the use of CERAMENT™|BONE VOID FILLER as bone graft substitute to the use of autologous
      cancellous bone graft (iliac crest) in the treatment of patients with tibia fractures treated
      by internal fixation and void reconstruction.
    


Intervention name(s): CERAMENT™|BONE VOID FILLER; Autologous cancellous bone graft
Intervention type(s): Device; Procedure
Intervention description(s): ceramic bone void filler; autologous cancellous bone graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tibia fracture; bone graft; iliac crest; bone graft substitute; Cerament; void filler; quality of life; pain; costs of care