bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Magnetic Therapy and Moderate Aerobic Exercise on Post Thyroidectomy Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      Objectives; This study was conducted to investigate the effect of pulsed magnetic therapy and
      aerobic exercise on post thyroidectomy osteoporosis.

      Methods; Forty-five female patients, age ranged from 40 to 50 years old with osteoporotic
      changes in hip and pelvic region post thyroidectomy, were included in this study. They were
      selected from Endocrinology private clinics. They were assigned randomly into three groups,
      equal in number. Magnetic Therapy Group (group A); patients received the routine medical
      treatment (Bisphosphonates, Calcium, and Vitamin D) in addition to pulsed magnetic therapy on
      the pelvic region for 12 weeks (3 sessions/ week). Exercise group(group B); patients received
      the routine medical treatment in addition to moderate-intensity aerobic exercise for 12 weeks
      (3 sessions/week). Combined Magnetic Therapy and Exercise Therapy group (group C): patients
      received the routine medical treatment in addition to pulsed magnetic therapy and
      moderate-intensity aerobic exercise for 12 weeks. Evaluation of the three groups was
      performed at baseline and after 12 weeks of treatment by dual energy x-ray absorptiometry
      (DEXA).
    


Intervention name(s): patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks
Intervention type(s): Other
Intervention description(s): patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks(3 sessions/ week)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Almorexant in Primary Insomnia
Condition: Insomnia; Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to determine the minimum effective dose of ACT-078573 on sleep
      efficiency and to assess the effects of different doses of ACT-078573 on other PSG
      parameters.
    


Intervention name(s): almorexant; almorexant; almorexant; almorexant; almorexant
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 dose of 400 mg in two treatment sequences; 1 dose of 200 mg in two treatment sequences; 1 dose of 100 mg in two treatment sequences; 1 dose of 50 mg mg in two treatment sequences; 1 dose of 1000 mg in two treatment sequences
Other intervention name(s): ACT-078573; ACT-078573; ACT-078573; ACT-078573; ACT-078573
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label switchover study will assess the safety, efficacy, and pharmacokinetics of
      pegunigalsidase alfa (PRX-102) 2 mg/kg administered every 4 weeks for 52 weeks in Fabry
      patients previously treated with ERT: agalsidase alfa or agalsidase beta for at least 3
      years. Safety and efficacy exploratory endpoints will be evaluated throughout the study
      period and pharmacokinetics will be obtained on Day 1 and Week 52.
    

Detailed description: 
      This is an open-label switchover study to assess the safety, efficacy, and pharmacokinetics
      of pegunigalsidase alfa treatment of 2 mg/kg every 4 weeks in patients previously treated
      with enzyme-replacement therapy (ERT): agalsidase alfa or agalsidase beta, for at least 3
      years and on a stable dose (>80% labelled dose/kg) for at least the last 6 months. Following
      screening, patients will be enrolled and switched from their current ERT to receive
      intravenous (IV) infusions of pegunigalsidase alfa 2 mg/kg every 4 weeks for 52 weeks (total
      of 14 infusions). At the time of enrollment, premedication, if used for the agalsidase alfa
      or agalsidase beta infusions before enrollment, will be continued using the same
      premedication regimen during the first infusion with pegunigalsidase alfa and then will be
      gradually tapered down at the Investigator's discretion during the next infusions based on
      protocol-specified criteria. First infusions of pegunigalsidase alfa will be administered
      under controlled conditions at the investigation site. Based on the protocol-specified
      criteria, patients will be able to receive their pegunigalsidase alfa infusions at a home
      care setup once the Investigator and Sponsor Medical Monitor agree that it is safe to do so.
      Safety and efficacy exploratory endpoints will be assessed throughout the 52-week study. In
      the case of clear clinical deterioration, the treatment may be changed to 1.0 mg/kg every 2
      weeks at the Investigator's discretion and discussion with the Medical Monitor.
    

Intervention name(s): Pegunigalsidase alfa
Intervention type(s): Biological
Intervention description(s): Pegunigalsidase alfa 2 mg/kg every 4 weeks
Other intervention name(s): PRX-102; Recombinant human alpha galactosidase-A
Intervention model: Single Group Assignment
Intervention model description: Switch over study in patients previously receiving either agalsidase alfa or agalsidase beta and switched to pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Enzyme-Replacement Therapy; pegunigalsidase alfa; Fabry Disease
Effect of Radiation on Tissue for Delayed Breast Reconstruction
Condition: Breast Cancer
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of radiation therapy following
      mastectomy on skin and blood vessels and to use information gathered to determine an ideal
      time for breast reconstruction after radiation.
    

Detailed description: 
      In the setting of post-mastectomy radiation therapy delayed autologous reconstruction,
      favored by many attempts to avoid complications encountered with radiating the immediately
      reconstructed breast. The timing of delayed reconstruction is however not known. The goal of
      this proposal is to study the gross, structural and vascular changes in radiated mastectomy
      skin in addition to possible structural and flow changes of the underlying internal mammary
      vessels over time. We plan to use these objective findings as a basis for determining an
      ideal time frame for delayed autologous breast reconstruction.

      Sequential mastectomy skin specimens will be obtained from 20 patients undergoing
      post-mastectomy radiation therapy over a 24 month period and these specimens will be
      evaluated histologically. These same patients will also undergo serial examinations and
      photographic documentation of gross skin changes. Skin perfusion will be assessed by laser
      Doppler imaging and internal mammary vessel structure, and flow characteristics will be
      assessed by color Doppler sonography.

      Based on these studies, we will elucidate short and long term changes in radiated breast
      skin, showing inflammatory, structural and perfusion patterns that can be correlated with
      optimal conditions for reconstruction. This has the potential to dramatically change practice
      patterns of delayed reconstruction for many reconstructive surgeons and more importantly
      restore what patients loose with mastectomy in a consistent, timely fashion. There is also
      potential for improved outcomes of delayed breast reconstruction by decreasing the number of
      reconstructions performed too soon after completion of radiation.
    

Intervention name(s): Skin and blood vessel procedures
Intervention type(s): Procedure
Intervention description(s): Biopsies, skin blood flow studies and ultrasound studies will be performed as described.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
CESM ABMR Breast Cancer Screening Trial
Condition: Breast Cancer Screening
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This is a single institution, prospective screening trial of women at high risk for
      developing breast cancer, enriched with women with suspicious lesions on breast MRI which
      have been recommended for biopsy.

      Primary Aim: Measure and compare the diagnostic performance of CESM, ABMR, and standard
      breast MRI, using the following performance measures: cancer detection rate (CDR), biopsy
      rate, and cancer yield of biopsy (also known as positive predictive value 3 or PPV3).

      Secondary Aims:

        1. Compare screening performance outcome measures of sensitivity, specificity, and area
           under the receiver operating characteristic curve (AUC) for CESM, ABMR, and standard
           breast MRI. This will determine the feasibility of each modality as an alternative to
           standard breast MRI and provide valuable pilot data for designing a larger clinical
           trial to evaluate non-inferiority of either or both modalities.

        2. Breast cancer characteristics (size, histologic subtype, node-positivity, AJCC stage)
           will be assessed in the overall cohort, and stratified by mode of detection for each
           modality(screen-detected versus interval).
    


Intervention name(s): Contrast-enhanced Spectral Mammography (CESM)
Intervention type(s): Device
Intervention description(s): Dual energy mammography images obtained after the administration of an intravenous contrast agent
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women referred for a clinical breast MRI.
Creatine Monohydrate Supplementation and Vascular Endothelial Health
Condition: Endothelial Dysfunction; Oxidative Stress
Study type: Interventional

Summary: 
      To determine the effects of 4 weeks of creatine monohydrate supplementation on markers of
      macrovascular and microvascular function, cognitive performance, and physical performance.
    

Detailed description: 
      This is a randomized, double-blind (participant and principle investigator),
      placebo-controlled, crossover study.

      After a pre-screen telephone interview, potential participants will be invited to Florida
      State University for a "Screening visit". During this visit, individuals will be provided
      with a verbal and written explanation of the study. Individuals will complete an informed
      consent, a health history questionnaire and physical activity readiness questionnaire. If
      they meet study inclusion criteria, they will undergo anthropometric measurements and a
      venous blood draw to determine cardiovascular and kidney disease risk profile. If cleared for
      participation, participants will be asked to complete a "3-Day Food Log" prior to their next
      visit.

      Once qualified, participants will return to the laboratory to undergo their "Baseline Testing
      Visit". Following the completion of the first "Baseline Testing Visit", participants will be
      randomly assigned to one of two interventions: 1) creatine monohydrate; or, 2) maltodextrin
      "placebo". Participants will be given their supplement and asked to complete the
      supplementation protocol, complying with instructions given. Following the 4-week
      supplementation period, participants will return to the laboratory for their "Post-Supplement
      #1 Testing". During this visit, all procedures from the "Baseline Testing Visit" will be
      repeated.

      Once these measurements are completed, participants will be asked to return to their normal
      daily lifestyles for a 4-week "wash-out" period. During these 4-weeks, participants will be
      contacted weekly to ensure retention and to schedule the next visit. Following the washout,
      participants will return to the laboratory to undergo another "Baseline Testing Visit",
      completing the exact procedures as outlined previously. Following this, participants will be
      given their remaining supplement intervention. Following the intervention, participants will
      return to the lab for their final "Post-Supplement #2 Testing" to conclude the study.
    

Intervention name(s): Creatine monohydrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4 x 5g doses daily for 5 days, followed by 1 x 5g dose daily for 23 days.; 4 x 5g doses daily for 5 days, followed by 1 x 5g dose daily for 23 days.
Other intervention name(s): Maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Older adults; Flow mediated dilation
Target ADHD Executive Working Memory Study
Condition: ADHD
Study type: Interventional

Summary: 
      This study will assess whether or not a novel executive working memory training intervention
      for Attention-Deficit/Hyperactivity Disorder can engage frontoparietal brain network
      treatment targets and behavioral performance.
    

Detailed description: 
      This proposal seeks support for a 2-year milestone-driven R61 initial test of target
      engagement in n=62 ADHD diagnosed adolescents randomized to a 'sham training' placebo or to
      train 4 times each week using 4 different EWM exercises that have been combined into the
      format of a typical cognitive training intervention. Exercise difficulty levels in the active
      intervention will increase across 5 weeks to continually challenge EWM ability. EWM training
      will use a novel, remotely-supervised 'at home' computerized training approach. If R61 EWM
      training target engagement milestones are met, a 3-year R33 phase will begin. The R33 will
      replicate target engagement in another randomized placebo-controlled trial of n=90 new ADHD
      adolescents and attempt to establish a convincing link between the hypothesized targets and
      ADHD symptom expression. It also will characterize ADHD brain activity or EWM ability changes
      relative to typical levels seen in an n=40 non-ADHD control group.
    

Intervention name(s): EWM Training; Placebo Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Training tasks will target Executive Working Memory areas of the brain. Task difficulty will be adaptively increased across the 5 weeks of training based on session-to-session performance.; Computerized tasks with comparable engagement that do not tap executive working memory processes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Adolescents
Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting
Condition: Coronary Artery Disease; Internal Mammary-Coronary Artery Anastomosis; Coronary Artery Bypass; Blood Loss, Postoperative; Fibrinolysis
MeSH terms: Coronary Artery Disease; Hemorrhage; Postoperative Hemorrhage
Study type: Interventional

Summary: 
      Up to 15% of operations in cardio-pulmonary by-pass are complicated by excessive
      postoperative blood loss, which negatively affects the outcomes. Recently, it has been
      demonstrated that fibrin clot susceptibility to lysis is a modulator of postoperative blood
      loss after cardiac surgery for aortic stenosis. Earlier, a preliminary study showed a
      negative association of postoperative blood loss after coronary artery by-pass grafting
      (CABG) with fibrin clot lysis time, reflecting susceptibility to fibrinolysis.

      In CABG, postoperative blood loss may depend on the operative technique with respect to left
      internal mammary artery (LIMA) harvesting. LIMA is taken down in virtually all CABG
      procedures, but harvesting technical details remain at surgeons discretion (skeletonization
      without opening the pleural cavity vs. pedicled graft with pleura wide open).

      The investigators decided to test the hypothesis that fibrin clot properties modulate the
      postoperative drainage following CABG strongly enough to attenuate the influence of surgical
      technique by randomizing the patients undergoing CABG with regard to LIMA harvesting
      technique.
    


Intervention name(s): Skeletonized LIMA; Pedicled LIMA
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura; Standard CABG - no different form any other procedure of this type except LIMA will be taken down as a pedicled graft with opening the pleura
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial with parallel group design. Equal allocation.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Coronary Artery By-pass Grafting; CABG; Fibrin; Clot Lysis Time; CLT; Bleeding; Drainage; Rethoracotomy
Outcomes of Bariatric Surgery/UMMMC Bariatric Surgery Registry
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Observational

Summary: 
      The purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of
      bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric
      bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity
      and associated co-morbidities such as type 2 diabetes, sleep apnea and cardiovascular
      disease.
    

Detailed description: 
      See brief Summary
    

Intervention name(s): Observational Study
Intervention type(s): Other
Intervention description(s): This is an Observational study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        UMMMC Bariatric Surgery Patients
      
Keywords: Morbid Obesity; Obesity; Weight Loss; Bariatric Surgery
Pharmacokinetic Study of Topical GSK2894512 Cream
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the systemic exposure and pharmacokinetic parameters of GSK2894512
      following twice daily topical administration of 1% and 2% cream in adult subjects with AD,
      and will provide information about the systemic safety as well as local safety and
      tolerability following twice daily application to up to 35% body surface area (BSA) of
      affected skin of subjects with AD. It will be an open-label, sequential study consisting of 2
      cohorts. A cohort of 6 subjects (Cohort 1) will apply GSK2894512 (cream, 2%) to affected skin
      on an area ranging from 15 to 35% of the total BSA for 20 days plus a final dose on Day 21.
      Cohort 2 will consist of 6 subjects that will apply 1% cream. Cohort 2 will follow the same
      procedures as Cohort 1.
    


Intervention name(s): GSK2894512 Topical Cream
Intervention type(s): Drug
Intervention description(s): GSK2894512 will be supplied as white to off-white topical cream in doses of 2.0% (20 milligrams/gram [mg/g]) and 1.0% (10 mg/g)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PK; GSK2894512; Atopic Dermatitis
Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing a Randomized Controlled Trial (RCT)
Condition: Adolescents With Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The proposed research will test a new comprehensive disease management intervention with
      adolescents who have type 2 diabetes using a randomized controlled trial (RCT). Adolescents
      subjects with a history of Type 2 Diabetes and a parent caregiver will be consented,
      enrolled, and randomly assigned to either an 6-month intervention (N=44) or a "usual care"
      comparison (N=44). Recruitment will take place within the Vanderbilt Eskind Pediatric
      Diabetes Clinic. The intervention will include participation in a comprehensive disease
      management program that includes: (1) application of treatment algorithms, (2) phone
      assessment from a diabetes nurse practitioner and dietician to assess barriers and promote
      problem solving, treatment adherence and management, and (3) a behavioral
      Internet-administered self-management problem solving component. Outcomes include
      self-reported self-management behaviors (exercise, diet, medication adherence, etc.), blood
      pressure, weight/BMI, and glycated hemoglobin (A1C).
    


Intervention name(s): Comprehensive intervention (disease management program); Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component.; Will receive usual care and monthly phone calls as an active control.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Adolescents; Type 2 Diabetes; Behavioral Research
Bupivacaine or Radiofrequency for Shoulder Pain
Condition: Shoulder Pain; Rotator Cuff Impingement Syndrome; Impingement Syndrome; Adhesive Capsulitis; Rotator Cuff Injuries
MeSH terms: Shoulder Pain; Bursitis; Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Comparative study between pulsed radiofrequency in suprascapular nerve or bupivacaine block
      for chronic shoulder pain
    

Detailed description: 
      Prospective, randomized, comparative study of 40 participants with chronic shoulder pain
      allocated into two groups. Patients in group 1 underwent pulsed RF (180sec, with a fixed
      temperature at 42C, twice) on the suprascapular nerve, and the other group, 2, underwent
      nerve block with bupivacaine (5ml). After the procedure, patients were evaluated for 3 months
      regarding pain intensity, shoulder range of motion and dose of rescue opioids.
    

Intervention name(s): Suprascapular nerve block with bipuvacaine; Pulsed radiofrequency
Intervention type(s): Drug; Procedure
Intervention description(s): Suprascapular nerve block with Bipuvacaine: a 50mm 22G needle (Stimuplex, BBraun) was introduced up to the suprascapular fossa, guided by ultrasound, and the location was confirmed by motor stimulation with contraction of the supraspinatus and infraspinatus muscles. Next, 5 ml of 0.25% bupivacaine with adrenaline was injected.; After confirming the location, the needle mandrel was removed and the radiofrequency cannula was introduced through the needle, 2ml of 1% lidocaine without epinephrine was injected, followed by application of pulsed radiofrequency for 180sec at 42°C by radiofrequency (radiofrequency generator system BMS-50N, Bramsys).
Other intervention name(s): Suprascapular nerve block with local anesthetic; Pulsed radiofrequency in suprascapular nerve
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 - pulsed radiofrequency Group 2 - bupivacaine
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: shoulder pain; Pulsed radiofrequency; Bipuvacaine; Nerve block