bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      Dutasteride and tamsulosin are to treat benign prostatic hyperplasia. Studies show that when
      given together, there is more improvement in symptoms than either drug alone. In this study,
      we are looking to see if 2 different formulations of tamsulosin in our combination capsules
      are the same after 7 days of dosing as the US commercial tamsulosin and dutasteride.
    


Intervention name(s): GI198745
Intervention type(s): Drug
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dutasteride; tamsulosin; benign prostatic hyperplasia
HAIC Sequential TAE Combined With Lenvatinib and Tislelizumab in Unresectable HCC
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with unresectable hepatocellular carcinoma will receive hepatic arterial infusion
      chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and
      tislelizumab.
    

Detailed description: 
      In recent years, more and more studies have found that the efficacy of hepatic arterial
      infusion chemotherapy (HAIC) alone or combined with targeted drugs (such as lenvatinib) in
      the treatment of advanced HCC is significantly better than that of targeted monotherapy. The
      principle of HAIC is that chemotherapeutic drugs are continuously pumped through the hepatic
      artery through a microcatheter, thereby killing tumor cells and causing tumor shrinkage and
      necrosis. Although continuous infusion of chemotherapeutic drugs through the hepatic artery
      can significantly improve the local drug concentration in the tumor, and reduce the toxic and
      side effects of drugs on the whole body while improving the therapeutic effect, the effect of
      HAIC is slow. The blood supply of HCC is 95%-99% from the hepatic artery, and abundant blood
      supply is conducive to the continuous growth of HCC. If transarterial embolization (TAE) can
      be used to block the blood supply of HCC immediately after HAIC treatment, theoretically, it
      should further promote the effect of HAIC on tumor cell necrosis, make the tumor quickly
      reach PR or even CR, obtain the opportunity of hepatic resection, and finally prolong
      patients' survival time. However, there is still a lack of literature reports on HAIC
      sequential TAE in the treatment of advanced HCC. Therefore, this project intends to carry out
      a prospective phase II clinical study to explore the safety and efficacy (ORR, DOR, PFS, OS)
      of HAIC sequential TAE combined with targeted (lenvatinib) and immunotherapy (tislelizumab)
      quadruplets, and to screen the best benefit population.
    

Intervention name(s): HAIC sequential TAE combined with lenvatinib and tislelizumab
Intervention type(s): Combination Product
Intervention description(s): Patients with unresectable hepatocellular carcinoma will receive hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab.
Intervention MeSH terms: Lenvatinib; Tislelizumab
Intervention model: Single Group Assignment
Intervention model description: The aim of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab in patients with unresectable hepatocellular carcinoma (HCC), and to explore the optimal benefit population.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; hepatic arterial infusion chemotherapy; lenvatinib; tislelizumab
Preliminary Biomechanical and Usability Study of an Active Ankle-Foot Orthesis for Stroke Survivors
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This research will present the biomechanical assessment of a robotic device for ankle
      assistance during gait on stroke's survivors with hemiparesis. Gait pattern through an
      optoelectronic motion capture system will be analyzed. Additionally, ergonomic and comfort
      aspects will be measured by an adapted spanish version of Quebec User Evaluation of
      Satisfaction with assistive Technology (QUEST)
    

Detailed description: 
      This research will present the biomechanical assessment of a robotic device for ankle
      assistance during gait on stroke's survivors with hemiparesis.

      The device is composed by a passive orthosis structure which allows one degree of freedom
      (DOF) among the sagittal plane and it includes two servomotors attached to the user's foot
      through velcro strips.

      Gait pattern through an optoelectronic motion capture system will be analyzed. Additionally,
      ergonomic and comfort aspects will be measured by an adapted spanish version of Quebec User
      Evaluation of Satisfaction with assistive Technology (QUEST)
    

Intervention name(s): Assisted gait with a motorized ankle foot orthosis
Intervention type(s): Device
Intervention description(s): The motorized ankle foot orthosis is a powered lower extremity assistance device with an actuated ankle joint. A novel control software has been design and implemented in this device, which allows precise joint movement and recording of data from training session.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Ankle foot orthosis; Gait; Active orthosis
Effect of Age on Propofol-BIS Response
Condition: Aging
Study type: Observational

Summary: 
      Recently, reports appeared of an 88-yr-old octogenarian exhibiting bispectral index (BIS)
      value of 46 before anaesthesia induction, and a 91-yr-old nonagenarian fully conscious at BIS
      value of 52 after propofol anaesthesia recovery. BIS algorithm was heuristically derived from
      a database of mostly "relatively fit, young healthy" volunteers. To date there are no studies
      precisely quantifying BIS response to propofol concentrations among different age groups
    

Detailed description: 
      Objective: Recently, reports appeared of an 88-yr-old octogenarian exhibiting bispectral
      index (BIS) value of 46 before anesthesia induction, and a 91-yr-old nonagenarian fully
      conscious at BIS value of 52 after propofol anesthesia recovery. BIS algorithm was
      heuristically derived from a database of mostly "relatively fit, young healthy" volunteers.
      To date there are no studies precisely quantifying BIS response to propofol concentrations
      among different age groups.

      Methods: Investigators set Propofol estimated plasma concentrations (Cp) to gradually reach
      3.5 microg·mL-1 over 3.5 min in 80 patients, five male and five female, divided by age
      decades from vicenarian (20-29 yr) to nonagenarians (90-99 yr). BIS values were fitted
      against Cp in our newly devised logistic model and traditional sigmoid Emax model. Raw BIS
      electroencephalography and measured propofol arterial samples determined whether changes are
      pharmacodynamic or pharmacokinetic asserted.

      Propofol link to FDA site at FDA's Drugs@FDA web site.
      https://www.accessdata.fda.gov/scripts/cder/drugsatfda:
      http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        80 patients, five male and five female, divided by age decades from vicenarian (20-29 yr)
        to nonagenarians (90-99 yr)
METhotrexate Therapy Effects in the Physical Capacity of Patients With ISchemic Heart Failure (METIS Trial)
Condition: Heart Failure; Myocardial Ischemia
MeSH terms: Heart Failure; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity
      in patients with symptomatic ischemic heart failure.
    

Detailed description: 
      Recent studies have showed the importance of proinflammatory mediators in the heart failure.
      However, there is a lack of benefit of therapies that tried to neutralize these mediators.

      Methotrexate has adenosine-mediated anti-inflammatory effects in rheumatoid arthritis and
      psoriasis. Methotrexate limits infarct size via this adenosine-dependent mechanisms in heart
      of dogs (J Cardiovasc Pharmacol. 2004 Apr;43(4):574-9). A recent trial showed that this drug
      reduced proinflammatory mediators in patients with heart failure (Am Heart J. 2006
      Jan;151(1):62-8).

      These data suggest that methotrexate may improve physical capacity in patients ischemic heart
      failure reducing inflammation, but a randomized clinical trial is necessary to prove it.
    

Intervention name(s): Methotrexate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
All patients will have evaluated at the baseline and after 12 weeks: physical capacity by the 6-minutes walk test, quality of life by the Brazilian edition SF-36 and inflammatory marker by C-reactive protein. They also will be tested for ALT, AST, blood cell count, creatinine, and prothrombin time at baseline, after 6 weeks and after 12 weeks.; Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
All patients will have evaluated at the baseline and after 12 weeks: physical capacity by the 6-minutes walk test, quality of life by the Brazilian edition SF-36 and inflammatory marker by C-reactive protein. They also will be tested for ALT, AST, blood cell count, creatinine, and prothrombin time at baseline, after 6 weeks and after 12 weeks.
Other intervention name(s): Rheumatrex; Trexall; Control
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; Myocardial Ischemia; Methotrexate; Inflammation; Anti-Inflammatory Agents; Inflammation Mediators
Post Ten Year Follow up Assessment of a Phase I Trial of Angiogenic Gene Therapy
Condition: Coronary Artery Disease; Ischemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
Study type: Observational

Summary: 
      The primary aim of the study is to assess and follow-up subjects that received
      AdGVVEGF121cDNA in IRB protocol #0794-894 entitled "Phase I Study of Direct Administration of
      a Replication Deficient Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121 cDNA to the
      Ischemic Myocardium of Individuals with Diffuse Coronary Artery Disease" and IRB protocol
      #0297-693 entitled "Phase I Study of Direct Administration of a Replication Deficient
      Adenovirus Vector (AdGVVEGF121.10) Containing the VEGF121 cDNA to the Ischemic Myocardium of
      Individuals with Diffuse Coronary Artery Disease Via Minimally Invasive Surgery".
    

Detailed description: 
      A research coordinator from Weill Cornell Medical College will survey the medical records of
      all 31 subjects, and obtain contact information for all living subjects. Living subjects will
      be called by the research coordinator at Stony Brook University Medical Center and invited to
      participate in the current follow-up study, which will entail a full medical chart review. If
      the potential subject is interested, he/she will be invited to Stony Brook University Medical
      Center where Dr. Rosengart or a designated co-investigator conducts the informed consent
      process. However, subjects who are unable to travel to Stony Brook University Medical Center
      will be mailed the consent form. Those who consent to participate will compile their medical
      records and send them to Stony Brook University Medical Center. The research coordinator at
      Stony Brook will conduct a chart review in order to collect information regarding the
      subject's medication, evaluation and surgical history over the past 10 years. This
      information will include cardiac health evaluations such as 99mTc-sestamibi SPECT, treadmill
      exercise tolerance test and cardiac specific blood tests. These parameters will be compared
      to evaluations done at baseline and evaluations done at the subject's last visit as a
      participant of either Institutional Review Board (IRB) protocol #0794-894 or #0297-693.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        These subjects have clinically significant coronary artery disease (CAD) and have received
        direct myocardial injection of AdGVVEGF121.10 expressing the human vascular endothelial
        growth factor (VEGF) 121 cDNA to induce therapeutic angiogenesis.
      
Keywords: Diffuse Coronary Artery Disease; Ischemic Myocardium; Ischemia
Women SHARE Study: Reducing Sexual Risk
Condition: Alcohol and Substance-Related Mental Disorders; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases; Mental Disorders
Study type: Interventional

Summary: 
      This study will investigate whether BI and technology extenders are feasible and acceptable
      for female patients at a reproductive health center (ages 18-29).
    

Detailed description: 
      This study will assess the feasibility and acceptability, and obtain initial evidence of the
      efficacy, of the BI and technology extenders. At-risk women drinkers (N = 50) recruited from
      a reproductive health care clinic will be assessed, randomly assigned to the integrated BI or
      control (a Centers for Disease Control and Prevention-produced brochure with information
      about alcohol and women's health), and reassessed at 3 months to determine impact on alcohol
      use, condom use, and number of partners as well as hypothesized mediators.
    

Intervention name(s): Brief Intervention (BI) with Technology Extender; Brochure
Intervention type(s): Behavioral; Other
Intervention description(s): One, 45-60 minute BI, followed by three months of access to technology extenders; Brochures provided one time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures
Condition: Fracture, Closed, Comminuted, Healing
MeSH terms: Fractures, Bone; Femoral Fractures; Fractures, Closed
Study type: Interventional
Phase: Phase 3

Summary: 
      This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal
      femur fractures using a device developed by the investigators.

      The hypothesis is that patients with femoral diaphysis treated with the electromagnetic
      stimulation have less non-union after six months than patients treated with a placebo device.
    

Detailed description: 
      The inclusion criteria were: patients of any sex, age between 18 and 60 years, with a closed
      fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet;
      treated with open or closed reduction and intramedullary reamed blocked nail.

      Patients were excluded if they had a pathological fracture, an open fracture from another
      etiology, or if they were treated after 10 days from the day of fracture.

      64 patients were included.

      Randomization took place six weeks after fracture day, allocating participants to either one
      of two groups: group A (electromagnetic stimulation) or group B (placebo).

      Each group had a device exactly the same. Patients used the device during one hour every day
      for eight weeks.
    

Intervention name(s): Electromagnetic stimulation; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Electromagnetic stimulation with a new device produced by the investigators for this study.; This is a device that look exactly the same to the electrostimulation device, but that does not generate the electromagnetic field. It is a placebo device.
Other intervention name(s): "Consolidator"
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Electromagnetic device
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity and Safety of TNFa Kinoid in Rheumatoid Arthritis With Secondary Resistance to TNFa Antagonists
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this trial is to demonstrate that active immunization with anti-TNFα kinoid
      (TNF-K) is able to induce polyclonal anti-TNFα antibodies in RA patients who were previously
      treated with anti-TNFα mAb but have lost susceptibility to therapy.
    


Intervention name(s): TNFa Kinoid; TNF kinoid
Intervention type(s): Biological; Biological
Intervention description(s): TNFa kinoid; IM administration 2 or 3 injections within 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; anti-drug antibodies; Rheumatoid arthritis with secondary loss of efficacy to anti-TNFa antagonists and anti-drug antibodies
A Study to Investigate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of PF-06700841 in Healthy Participants
Condition: Heathy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, fixed-sequence, 2-period study to investigate the effect of multiple oral
      doses of itraconazole on a single oral dose of PF-06700841 PK in healthy participants. The
      study will consist of two treatment periods in one fixed sequence.
    


Intervention name(s): PF-06700841; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): PF-06700841 oral tablets in 5mg and 25mg provided for a 30mg dose; 200 mg oral solution administered as 20 milliliters(mL) (10 mg/mL)
Other intervention name(s): Sporanox®
Intervention MeSH terms: Itraconazole; PF-06700841
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Safety and Effectiveness Pilot Study of PRF-108 and PRF-110 in Healthy Volunteers
Condition: Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel
      formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers.
      PRF-108 and PRF-110 are designed to deliver slow release of ropivacaine over 72 hours.
    

Detailed description: 
      This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel
      formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers.
      PRF-108 and PRF-110 are designed to deliver slow release of ropivacaine over 72 hours.

      The purpose of this study is to investigate the safety (side effects if any occurs)
      associated with the single administration of PRF-108 or PRF-110 and evaluate their analgesic
      effect in an experimentally induced pain model compared with ropivacaine Solution 0.5% and
      Vehicle Gel.
    

Intervention name(s): PRF-108; Placebo; Ropivacaine; PRF-110
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ropivacaine; PRF-108 Placebo; Solution
Other intervention name(s): ropivacaine
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Experimental Pain Model
Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Observational

Summary: 
      SPOCS is an international, multicenter, prospective observational cohort study with bi-annual
      study visits over a 3-year follow-up designed to systematically describe the comprehensive
      SLE patient-journey regarding clinical features, disease progression and treatment patterns,
      SLE outcomes, health status assessments (PROs), and health care resource utilization (HCRU)
      in a general population of moderate-to-severe SLE patients.
    

Detailed description: 
      SPOCS is an international, multicenter, prospective observational cohort study with bi-annual
      follow-up over 3-years maximum follow-up of patients with SLE confirmed by American College
      of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC)
      classification criteria, who have moderate-to-severe disease by SLEDAI-2K criteria (Modified
      SLEDAI-2K score ≥4 and/or SLEDAI-2K score ≥6 points, at least one life-time positive serology
      of anti-nuclear antibody (ANA) or double-stranded deoxyribonucleic acid antibody (dsDNA), and
      6-month minimum treatment duration with systemic SLE treatment beyond NSAIDS and analgesics.
      Participants will be followed as per local routine clinical practice. SPOCS is an
      observational study with no requirement for protocolized treatment interventions.
    

Intervention name(s): Standard of Care
Intervention type(s): Other
Intervention description(s): Participants will be followed as per local routine clinical practice
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a diagnosis of SLE confirmed by ACR or SLICC classification criteria with
        moderate-to-severe disease by SLEDAI-2K criteria (Modified SLEDAI-2K score ≥4 or SLEDAI-2K
        score ≥6 points), a historic or current positive serology for ANA or dsDNA, and a 6-month
        minimum treatment duration with systemic SLE treatment beyond NSAIDS and analgesics
      
Biospecimen description: 
      type I IFN gene signature test (type 1 interferon gene test)
    
Keywords: Systemic Lupus Erythematosus Disease
A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      It is thought that treating Multiple Sclerosis with Novantrone for a short period of time
      prior to treatment with Copaxone may enhance the onset effect of Copaxone.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neurology Clinics