bioihbjkbjnl/mcl2 huggingface dataset:
Postoperative Pain Control Following Vitreoretinal Surgery
Condition: Retinal Detachment; Proliferative Vitreoretinopathy; Retinoschisis
MeSH terms: Retinal Detachment; Vitreoretinopathy, Proliferative; Retinoschisis; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate if patients receiving a steroid (triamcinolone
      acetonide) combined with local anesthesia and antibiotic following retina surgery have better
      postoperative pain control those receiving local anesthesia and antibiotic alone.
    

Detailed description: 
      Currently, patients undergoing vitreoretinal surgery at the Emory Eye Center and Emory
      University Hospital receive a injection of local anesthesia behind the eye (retrobulbar) at
      the start of surgery to minimize discomfort felt during the surgery. At the end of surgery
      all patients receive a periocular antibiotic and steroid injection. Some patients also
      receive a retrobulbar injection of local anesthesia (bupivicaine) at the conclusion of
      surgery in order to decrease postoperative pain and discomfort.

      It has been our observation that when the local anesthesia is combined with a steroid
      (triamcinolone acetonide) in a retrobulbar injection at the conclusion of surgery, patients
      tend to be pain free for longer intervals then when local anesthesia is used alone. The
      objective of this study is to evaluate if patients receiving triamcinolone acetonide combined
      with local anesthesia and antibiotic compared to those receiving local anesthesia and
      antibiotic alone do better with postoperative pain control.

      All eligible patients undergoing vitreoretinal surgery at the Emory Eye Center and Emory
      University Hospital will be offered enrollment. About 60 patients will be invited to
      participate in this study. Patients will undergo standard of care surgery. At the conclusion
      of surgery, patients will receive a retrobulbar antibiotic and anesthetic as standard of
      care. Half of the patients will receive this mixture plus steroid and the other half will
      receive this mixture plus saline. On postoperative day 1, patients will be given a
      questionnaire to assess pain. Pain levels in the two groups will be compared.
    

Intervention name(s): Triamcinolone; Bupivicaine Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Retrobulbar anesthesia; Retrobulbar anesthesia
Other intervention name(s): Kenalog; Triamcinolone Acetonide; Marcaine
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Bupivacaine; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Retina; Vitreoretinal; Surgery
The VALIDATE-D Study
Condition: Type 2 Diabetes; Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers
      renin-angiotensin system activity.
    

Detailed description: 
      This study aims to evaluate whether vitamin D receptor agonist therapy (calcitriol) in
      diabetes lowers renin-angiotensin system (RAS) activity in a manner similar to an ACE
      inhibitor. This is a physiology study, focused on evaluating hormonal changes in the
      circulating and tissue RAS when compared to placebo.

      Subjects with type 2 diabetes and obesity and normal kidney function will undergo evaluation
      of their circulating and renal-vascular RAS activity and urinary protein at baseline, after
      withdrawing interfering medications, while on a controlled electrolyte diet, and in
      controlled posture settings. They will then randomly receive a study medication (calcitriol
      or placebo) for 3 weeks followed by a re-assessment of their RAS parameters. The main
      outcomes that will be evaluated following calcitriol/placebo include measures of the
      circulating renin activity (primary), as well as measures of the renal-vascular RAS (renal
      plasma flow) and urine protein (secondary)

      The primary outcome is the change in the plasma renin activity when sodium restricted, before
      and after intervention. Secondary outcomes include the change in renal plasma flow and urine
      protein when sodium loaded, before and after intervention.
    

Intervention name(s): Calcitriol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks.; Subjects will receive placebo for 3 weeks.
Other intervention name(s): 1,25-dihydroxyvitamin D3
Intervention MeSH terms: Calcitriol; Dihydroxycholecalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults
Condition: Compare Bioequivalence Patches Previously Used in the NP101-007 Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research is to:

        1. Compare two study patches having minor differences in patch components

        2. Compare the pharmacokinetics (PK - how the body absorbs, metabolizes and eliminates
           medication) of NP101 (study patches) versus a currently approved oral formulation of
           Imitrex

        3. Collect resistance data during application of NP101 (study patch)
    


Intervention name(s): NP101; sumatriptan succinate
Intervention type(s): Drug; Drug
Intervention description(s): comparison of NP101 with minor patch modifications; tablet, 100 mg
Other intervention name(s): Imitrex
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Chest Imaging, Breath, and Biomarkers in a Screening Trial
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      The investigators would like to see if lung cancer screening with chest x-rays,computer aided
      detection (CAD)and a lose dose CT scan can detect lung cancer in early stages when it is more
      responsive to treatment. The investigators would also like to see if early detection will
      reduce the incidence of symptomatic advanced lung cancer compared to no screening in former
      and current smokers with or without a family history of lung cancer who are 40-75 years old.
    

Detailed description: 
      The fight against lung cancer is waged on three major fronts: prevention, detection and
      treatment. Our goal is to determine if chest x-rays,computer aided detection (CAD)and a CT
      scan can detect disease earlier when treatment is more effective. If we improve the detection
      of disease, we will see if screening reduces the incidence of symptomatic advanced lung
      cancer relative to no screening in people at high risk to develop lung cancer.
    

Intervention name(s): chest x-ray with or without CAD, lose dose CT scan
Intervention type(s): Device
Intervention description(s): PA view, low dose CT scan
Other intervention name(s): CAD; computer aided detection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care physicians or any other physician may refer potential candidates.
        Additionally, subjects may see marketing materials and contact the research team directly.
        There is no restriction to the area of residence of subjects.
      
Biospecimen description: 
      Blood draw includes 2 10 mL red top tubes for serum retrieval, and 2 7 mL EDTA tubes for
      plasma and buffy coat retrieval
    
Keywords: lung cancer; chest x-ray; CT scan; computer aided detection (CAD); screening; smokers
Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of six months treatment of two
      insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women
      affected by polycystic ovary syndrome. The study group includes 40 patients, randomly
      allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 1500 mg/day).
      The investigations include menstrual pattern and hirsutism score evaluation, hormonal assays,
      oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at baseline
      and after six months of treatment.
    


Intervention name(s): metformin 1500 mg; myoinositol 1500 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Inositol; Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome; myoinositol; metformin; glucose-insulinemic metabolism; menstrual pattern; insulin-lowering therapies
Investigating Social Competence in Youth With Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Our treatment, SENSE Theatre, combines several well-documented, effective behavioral
      strategies and theatre techniques. The proposed project will extend previous findings showing
      improving improvement in memory for faces. The multisite randomized control trial will
      include a large sample of 240 children with autism spectrum disorder (ASD) randomly assigned
      to the experimental (SENSE Theatre) or an active control condition (Tackling Teenage
      Together).
    

Detailed description: 
      Recent findings from a randomized control trial (RCT) show immediate between-group effects
      and evidence of target engagement on the hypothesized mechanism of action, memory for faces,
      which was evaluated by neuropsychological and event-related potential (ERP) measures.
      Moreover, the RCT demonstrated treatment effects on social communication skills that
      generalized to home and community settings. Finally, maintained treatment effects were
      observed on communication symptoms. The proposed project will extend these findings and
      provide a stronger test of efficacy using a multisite RCT of SENSE Theatre with a large
      sample of participants with ASD (8 to 16 years) randomized to an experimental and an active
      control group. The RCT will assess target engagement of memory for faces and functional
      change in social interaction with peers. Thus, the overarching aim of the study is to
      determine whether detected changes in face memory and social interaction are due to the SENSE
      Theatre treatment and the extent to which these changes generalize and maintain. If predicted
      results occur, it will provide strong empirical support for a community-based treatment that
      has generalized effects on a set of core deficits that otherwise have life-long consequences
      for children and adolescents with ASD.

      8/18/2021: Record was updated to delete the outcome measure "Computer memory for faces" as it
      was not included as a primary outcome variable in the IRB approved protocol dated 9/13/2017.
    

Intervention name(s): SENSE Theatre; Tackling Teenage Together
Intervention type(s): Behavioral; Behavioral
Intervention description(s): SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).; The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism
Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity
Condition: Moderate Chronic Plaque Psoriasis; Severe Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Hulio is a monoclonal antibody currently approved as a biosimilar to European Union approved
      and United States (US)-Licensed Humira.

      This is a multicenter, randomized blinded, parallel group, interchangeability study in
      subjects with moderate to severe chronic plaque psoriasis, undergoing repeated switches
      between Humira and Hulio. The study is designed to confirm the pharmacokinetic equivalence of
      alternating between the use of Humira and Hulio and, Humira without such alternation or
      switch, in accordance with the US Food and Drug Administration Guidance for Industry,
      Considerations in Demonstrating Interchangeability with a Reference Product.

      The study will also assess safety, efficacy and immunogenicity between these two groups.
    


Intervention name(s): Humira 40 MG in Prefilled Syringe; Hulio 40 MG in Prefilled Syringe / Humira 40 MG in Prefilled Syringe
Intervention type(s): Biological; Biological
Intervention description(s): Humira (40 mg every other week); • Subjects will receive Humira (initial dose of 80 mg [2 × 40 mg]; Day 1 administered subcutaneously (SC), followed by 40 mg SC given every other week starting 1 week after the initial dose (last dose at Week 10).
Hulio (40 mg every other week) at Week 12 and Week 14
Humira (40 mg every other week) at Week 16 and Week 18, and
Hulio (40 mg every other week) at Week 20, Week 22, Week 24 and Week 26.
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adalimumab; pharmacokinetics; plaque psoriasis
Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether IPX159 is safe and effective in treating
      symptoms of RLS in subjects with Restless Legs Syndrome.
    

Detailed description: 
      IPX159 was developed as an extended release formulation to reduce the fluctuation in nefopam
      concentration compared to IR and to reduce the incidence of peak or rate related side
      effects.
    

Intervention name(s): IPX159; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Moderate to severe idiopathic RLS
Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
Condition: Uncontrolled Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This is a prospective, single-arm, non-randomized and open label feasibility study. The study
      is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal
      denervation in patients with uncontrolled hypertension.
    


Intervention name(s): Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system
Intervention type(s): Device
Intervention description(s): The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Complement Inhibitor Eculizumab in Clinical Islet Transplantation
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a dual centre, single arm, exploratory study of the possibility to use eculizumab
      (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the
      islets in patients with diabetics accepted for islet transplant.
    

Detailed description: 
      This is a dual centre, single arm, exploratory study of the possibility to use eculizumab
      (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the
      islets in patients with diabetics accepted for islet transplant. Ten patients from 2 centres
      (Uppsala University Hospital and Karolinska University Hospital in Stockholm) will be
      transplanted. The purpose of the study is to investigate if selective complement inhibition
      by eculizumab combined with standard anticoagulation during and after transplantation can
      further reduce the extent of early tissue loss after portal infusion of islets.
    

Intervention name(s): Eculizumab
Intervention type(s): Drug
Intervention description(s): Intravenous infusion (1200 mg) over 35 minutes. Consecutive infusions (900 mg) on Days 1, 7 and 14.
Other intervention name(s): Soliris
Intervention MeSH terms: Eculizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Hormonal Effects on Tc-99m Sestamibi Uptake in the Breast
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This study is to examine the effects of menstrual cycle, hormone therapy, and the use of
      tamoxifen on Tc-99m sestamibi uptake.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
      
Keywords: Breast; Menstrual Cycle; Breast Cancer; Hormone; MBI; Molecular Breast Imaging; Breast Imaging
Pharmacokinetics and Relative Bioavailability of 11634 Immediate Release Tablet in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Characterisation of the relative bioavailability of the IR-tablet vs. oral drinking
           solution (no primary endpoint in a statistical sense)

        -  Safety and tolerability of the IR-tablet formulation and solution

        -  PK profile of the single ascending doses of the IR-tablet formulation (including
           analysis of dose proportionality)
    


Intervention name(s): BI 11634 tablet; BI 11634 drinking solution
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Behavioral Therapy Plus Naltrexone for Alcoholism
Condition: Alcoholism; Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare cognitive behavioral therapy with a time-limited motivational
      enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this
      randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence,
      will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo
      for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse
      will be evaluated in all four groups along with measures of alcohol craving, biological
      measures of alcohol consumption, drinking consequences, changes in self-confidence for
      avoiding alcohol, and medication compliance. All study participants will be assessed for
      measures of outcome variables at 3 and 6 months after completing the treatment protocol.
    


Intervention name(s): naltrexone (Revia); cognitive behavior therapy; motivational enhancement therapy
Intervention type(s): Drug; Behavioral; Behavioral
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcoholism; Alcohol Dependence; Naltrexone; Cognitive Behavioral Therapy
Functional Neuroimaging in Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and
      after 8 weeks
    


Intervention name(s): Oral administration of escitalopram during 8 weeks
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nitrous Oxide for Acute Migraine Pain in the Emergency Room (ED)
Condition: Migraine; Pain
MeSH terms: Migraine Disorders; Emergencies
Study type: Interventional

Summary: 
      BACKGROUND Migraine headaches account for 8-18% of all headaches seen in pediatric emergency
      rooms. Standard treatment includes IV pain medications, anti-emetics, and IV fluids. Nitrous
      oxide has analgesic properties similar to those of opioids and is easy to administer. It has
      been shown in two small studies to be effective in treating migraine headaches.

      RESEARCH QUESTION Does nitrous oxide act as a safe, less invasive, and effective treatment of
      acute migraine headaches in children and adolescents presenting to an Emergency Department?

      DESIGN This is a prospective non-randomized self-controlled study. Repeated measures will be
      taken to examine change in pain scores before and after nitrous oxide treatment.

      METHODS Each participant will be given nitrous oxide until he/she reports a pain score of
      zero or up to fifteen minutes. Study subjects will be asked to rate their pain on a scale of
      0-10 before the treatment and after the treatment at multiple time-points.
    


Intervention name(s): Nitrous Oxide
Intervention type(s): Drug
Intervention description(s): Once consent is obtained, the research assistant will notify the charge RN and MD of the patient's study participation. The patient will then be placed in a treatment room and nitrous oxide will be administered per the existing protocol. Each participant will be given nitrous oxide until he/she reports a pain score of zero or up to fifteen minutes. Study subjects will be asked to rate their pain on a scale of 0-10 before the treatment and after the treatment, the time duration of administering nitrous oxide will be recorded. In addition, the pain scores at 30, 60, 90, and 120 minutes post baseline measurement will be collected in order to evaluate the sustained effect of nitrous oxide in treating acute migraine pain. Someone from the study will also make a follow-up phone call 24 - 48 hours to see if pain relief persisted.
Intervention MeSH terms: Nitrous Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Pediatric; Adolescent; Nitrous Oxide
The Engineer-Built System, Video-Game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      There are 3 phases of this project. First phase is to study the satisfaction in healthy
      children aged 10-15 years old when they are playing our computer games. The sample size of
      this phase was 10. In addition, we will ask the occupational therapist to play and comment
      our game for further development.
    


Intervention name(s): The engineer-built system, video-game based Kinect sensor
Intervention type(s): Device
Intervention description(s): There are 3 computer games using Kinect sensor to detect movement of trunk and upper extremities of the children.
Intervention model: Single Group Assignment
Intervention model description: In the first phase, we will test our video-game based Kinect sensor in healthy children aged 10-12 years old. The healthy children and the occupational therapists have to reply the satisfaction form and comment our game for further improvement. The sample size of this phase is 10.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: video-game based Kinect sensor; upper extremities