bioihbjkbjnl/mcl2 huggingface dataset:
Treatment Results and Health Care Consumption From a Web-based Support System in Behavioural Childhood Obesity Treatment
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This study aims to evaluate if a web-based support system with daily self-monitoring of
      weight, use of an activity measuring wrist-band, and communication between the clinic and the
      parents gives better results on degree of obesity compared with usual care. Changes in BMI
      standard deviation score (SDS) are compared between usual care (control) and usual care with
      complementary web-based support system (intervention).
    

Detailed description: 
      In this study children with obesity will be randomized to either usual care according to
      regular routine (control) or to usual care plus a web-based support system (intervention).
      Based on previous reviews on mobile health and obesity in combination with the investigators'
      experiences of childhood obesity treatment components were identified which the researchers
      hypothesize are of major importance for a web-based system for childhood obesity treatment:
      Frequent self-monitoring of weight and physical activity, goals for weight loss, and feedback
      from the treatment team. The system is based on a smart phone application connected to a
      scale and an activity measuring wrist-band. Data is automatically transferred from the
      accessories to the smart phone, where data is presented graphically. The data is further
      transferred to the clinic for support and communication between the clinic and the parents.
      The randomization will be done at the start of individual treatment and will last for 12
      months. The main aim is to evaluate if use of the web-based support system will give better
      results on degree of obesity compared with usual care.
    

Intervention name(s): Usual care; CLOSS
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The child and parent(s) at regular visits to the pediatric clinic for childhood obesity treatment; Usual care plus using mobile applications to register weight and physical activity as well as for communication with the clinic. A web-based support system enables health care professionals to follow the patient's daily objectively measured weight and physical activity online.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mobile Health; Self-Monitoring; Behavioural Treatment
Non-contrast Enhanced MRI in Patients With C3 Glomerulopathy (C3G) or Immune-complex Membranoproliferative Glomerulonephritis (IC-MPGN) Enrolled in the ACH471-205 Study
Condition: C3 Glomerulonephritis; C3 Glomerulopathy; Immune Complex Membranoproliferative Glomerulonephritis; IC-MPGN; Dense Deposit Disease
MeSH terms: Glomerulonephritis; Glomerulonephritis, Membranoproliferative
Study type: Interventional

Summary: 
      Functional and quantitative renal magnetic resonance imaging (MRI) has seen a number of
      recent advances, and techniques are now available that can generate quantitative imaging
      biomarkers with the potential to improve the management of kidney disease.

      However, there are knowledge gaps that must be addressed before renal MRI methods could be
      more widely adopted in clinical research and ultimately be transferred to clinical practice,
      including the biological basis of different MRI biomarkers, and how the application of these
      biomarkers will improve patient care.

      Among renal MRI techniques, renal diffusion weighted MRI (DWI) has been increasingly used in
      the last decade, showing high potential as a surrogate and monitoring biomarker for
      interstitial fibrosis in chronic kidney disease (CKD), as well as a surrogate biomarker for
      the inflammation in acute kidney diseases that may impact patient selection for renal biopsy
      in acute graft rejection.

      Within the ready-to-start ACH471-205 clinical trial, an Open-Label Phase 2 Proof-of-Concept
      Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative
      Glomerulonephritis (IC-MPGN) treated with ACH-0144471, aimed at evaluating the efficacy of 12
      months of oral ACH-0144471 in patients with C3G or IC-MPGN, patients will undergo baseline
      and 12-month follow-up renal biopsies, and renal function will be assessed over time by
      estimated or measured (when available) glomerular filtration rate (GFR). Adding
      multi-parametric NCE-MRI to the examinations under the ACH471-205 study protocol will give
      the opportunity to elucidate, in a well-defined cohort of patients, the potential of NCE-MRI
      as biomarker of renal microstructure and functional change.
    


Intervention name(s): Non contrast-enhanced magnetic resonance imaging
Intervention type(s): Device
Intervention description(s): Non contrast-enhanced magnetic resonance imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Non-contrast enhanced MRI; Diffusivity; Renal microstructure; Renal function; C3G; IC-MPGN
Efficacy of Bemiparin Versus Enoxaparin in the Treatment of DVT
Condition: Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Deep-vein thrombosis (DVT) is a common but under-diagnosed medical condition that occurs when
      a thrombus forms in one of the large veins, usually in the lower limbs, leading to either
      partial or complete blocked circulation. The condition may progress to severe health
      complications, such as pulmonary embolism (PE), if not diagnosed and treated in a timely and
      effective manner.

      The goal of the therapy for lower-extremity DVT is to prevent the extension of thrombus and
      pulmonary embolism in the short term and to prevent recurrent events in the long-term.
      Although anticoagulant therapy decreases the risk of recurrent thrombosis, the treatment also
      increases the risk for major hemorrhage.

      This trial aims to optimize the current medical knowledge on the effectiveness and safety of
      two low molecular weight heparins, bemiparin and enoxaparin in the treatment of deep vein
      thrombosis.
    

Detailed description: 
      The aim of this study is to demonstrate the therapeutic non-inferiority of bemiparin sodium
      (LMWH) versus enoxaparin sodium (LMWH) during a 7±2 days treatment period and a follow up of
      11 weeks observation period.

      Primary endpoint:

      The percentage of patients with an improvement in thrombotic burden at Visit 3 (Day 83)
      defined as a ≥4-point reduction in thrombus score (or at least halving the thrombus score,
      when the total score is ≤ 6), without confirmed symptomatic extension of recurrence of DVT,
      confirmed symptomatic PE, or VTE-related death at Visit 3 (Day 83 / Month 3), as measured by
      complete compression ultrasound (cCUS) by Duplex sonography according to a standardized
      protocol.

      Secondary endpoint:

      The secondary efficacy endpoints are defined as the:

      • Incidence of symptomatic venous thromboembolic events (VTE) at Visit 3 (Day 83:

        -  Recurrent DVT

        -  Pulmonary embolism

      Incusion criteria:

      Patients with acute deep-vein thrombosis of the leg (DVT) with symptoms of less than 14 days,
      confirmed by complete compression ultrasound (cCUS) within 48 hours prior study start.

      Patients who have given their signed declaration of consent and data protection declaration
      Males and females aged 18 years
    

Intervention name(s): Bemiparin sodium; Enoxaparin sodium
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous application daily for 7±2 days; subcutaneous for 7±2 days
Other intervention name(s): LMWH; CAS 874-98-4; LMWH; CAS 73334-07-3
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium; Bemiparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Deep vein thrombosis; DVT; Treatment; Low molecular weight heparin; Bemiparin; Enoxaparin
Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Identification and evaluation of endogenous markers for the assessment of CYP3A activity in
      female subjects using metabolomics
    

Detailed description: 
      Eligibility for participation of this study will be determined from demographic information,
      medical history, physical examination, electrocardiogram(ECG) and clinical laboratory tests
      within 3 weeks before study drug administration. Subjects suitable for this study will be
      admitted to the Clinical Trials Center, Seoul National University Hospital on the day before
      dosing, and they will be overnight-fasted from 9 p.m. of Day -1. Urine collection is
      scheduled from 24 hours before midazolam administration to 24 hours after administration.
      Subjects will be dosed midazolam by intravenous around at 9 a.m. of Day 1. Subjects will
      perform scheduled procedures including clinical laboratory tests, electrocardiograms and
      pharmacokinetic samplings. Subjects will be discharged on Day 2 and visit the Clinical Trials
      Center for period 2, ketoconazole administration. After 3 days of ketoconazole
      administration, midazolam will be dosed with ketoconazole on Day 4 of period 2. Subjects will
      perform scheduled procedure and on period 3 rifampicin will be dosed for 9 days and on Day 10
      of period 3 midazolam will be dosed with rifampicin. After subjects perform scheduled
      procedure, the study will be terminated 6-8 days after the end of period 3.
    

Intervention name(s): Midazolam; Ketoconazole; Rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Midazolam 3 mg IV; ketoconazole 400 mg PO; Rifampicin 600 mg PO
Other intervention name(s): Midazolam (Bukwang Pharm.Co., Ltd.); Kaszole (Skynewpharm Inc.); Rifampin (Yuhan Corp.)
Intervention MeSH terms: Rifampin; Ketoconazole; Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metabolite profiles; pharmacokinetics; CYP3A; metabolomics
Efficacy of Microfragmented Lipoaspirate Tissue in Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Increasing the success rate of rotator cuff healing remains a tremendous challenge for
      orthopedic surgeons, which encourage the development of new biological therapies. Among many
      approaches, activating resident progenitor cells with the Lipogems® product could be an easy,
      safe, practical and cost-effective new therapeutic strategy for increasing rotator cuff
      tendon healing.

      The primary goal of this study is to evaluate efficacy of infiltration of autologous
      micro-fragmented adipose tissue in arthroscopic rotator cuff repair, in terms of gain in
      post-operative Constant score.
    

Detailed description: 
      Increasing the success rate of rotator cuff healing remains a tremendous challenge for
      orthopedic surgeons, which encourage the development of new biological therapies. Among many
      approaches, the possibility of activating resident stem cells in situ, without the need of
      isolating them from biopsies and successive in vitro culturing, could represent a very
      promising therapeutic strategy. Along this line, it has been recently demonstrated that a
      lipoaspirate product, such as the Lipogems® product, contains and produces growth factors
      that may activate resident stem cells. Recently, it has been discovered that also the human
      rotator cuff contains a reservoir of progenitor cells, which can be isolated and expanded in
      vitro.

      The primary goal of this study is to evaluate efficacy of infiltration of autologous
      micro-fragmented adipose tissue in arthroscopic rotator cuff repair, in terms of gain in
      post-operative Constant score.

      Secondary goals are to evaluate efficacy of infiltration of autologous micro-fragmented
      adipose tissue in arthroscopic rotator cuff repairs, in terms of post-operative pain
      reduction, gain in post-operative strength in abduction and external rotation; estimate
      incidence of re-ruptures at 1 and 2 years post-operatively, quantify the amount of fatty
      degeneration of the supraspinatus at 1 and 2 years post-operatively.
    

Intervention name(s): arthroscopic rotator cuff repair; autologous micro-fragmented adipose tissue
Intervention type(s): Procedure; Procedure
Intervention description(s): arthroscopic rotator cuff repair; injection of autologous micro-fragmented adipose tissue (10 mL) after arthroscopic rotator cuff repair, in dry arthroscopy condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Chinese Subjects 18 to 59 Years
Condition: Influenza; Flu
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a blind-observer, monocenter, randomized, comparative, Phase IV study designed to
      evaluate the immunogenicity and safety of the Sanofi Pasteur Shenzhen Trivalent Influenza
      Vaccine (SP Shz TIV) versus the Trivalent Influenza Vaccine manufactured by Hualan Biological
      Engineering Inc (Hualan TIV) comparator in healthy Chinese participants aged 18 to 59 years.
    

Detailed description: 
      This study is designed to demonstrate the non-inferiority of the immune response in terms of
      geometric mean titers (GMTs) and seroconversion rates for the 3 strains (A/H1N1, A-H3N2, and
      B) after a single dose of either the SP Shz TIV or Hualan TIV. Vaccine immune responses will
      be assessed on Day 0 (pre-vaccination) and Day 28 post-vaccination. Solicited reactions will
      be collected from Day 0 up to Day 7 after vaccination, unsolicited non-serious adverse events
      (AEs) will be collected from Day 0 up to Day 28 post-vaccination, and serious AEs will be
      collected from Day 0 up to 6 months post-vaccination.
    

Intervention name(s): SP Shz TIV; Hualan TIV
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0; 0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0
Other intervention name(s): Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine; Hualan Trivalent Influenza Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Blind-observer, monocenter, randomized, comparative, Phase IV study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Flu
Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Determine if there is a difference in treatment response for adults with ADHD who are treated
      with Strattera versus those treated with a combination of Strattera and buspirone
    


Intervention name(s): Atomoxetine; Buspirone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Buspirone; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Compression Wear on Muscle Soreness
Condition: Muscular Regeneration; Repeated Bout Effect of WB-EMS
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The study address two main topics:

        1. The effect of compression garment on whole-body electromyostimulation (WB-EMS) induced
           muscle soreness in young adults

        2. The repeated bout effect of one intense session of WB-EMS as determined by various
           regeneration parameters
    

Detailed description: 
      Using a cross-over design we applied 2 intense WB-EMS training sessions either with or
      without subsequent wearing of compression garments (long tights) for 5 days at baseline and
      after a washout period of 4 weeks. Healthy young to middle aged athletes used compression
      garments immediately postexercise for 24 hours and further 12 h during the day. Blood
      samples, questionnaires, resting metabolic rate and performance test were applied prior and
      24, 48,72 and 96 h post-exercise consistently without wearing compression garments.
    

Intervention name(s): Compression
Intervention type(s): Other
Intervention description(s): Participants in the treatment group wear compression garment after intense WB-EMS application for 24 h, and 12 h for day 2, 3, 4 post WB-EMS.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness and Safety of Lidocaine for Scleroderma
Condition: Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally
      classified as one of the autoimmune rheumatic diseases. The disease is characterized by
      thickening and fibrosis skin, affecting vessels and many organs such as the esophagus,
      stomach, bowls, lung, heart and kidney. The exact cause or causes of scleroderma are still
      unknown, but scientists and medical investigators in a wide variety of fields are working
      hard to make those determinations. It is known that scleroderma involves overproduction of
      collagen.

      FLICKMAN et al, in 1973 published an article about the role of lidocaine at
      prolyl-hydroxylase activity decrease, which is an important enzyme of collagen production.
      Until now, there is only a case series showing the improvement of thickening skin (75%) and
      esophagus symptoms (66%) after intravenous lidocaine 2% during 10 days. So it is necessary a
      RCT to prove these findings.
    


Intervention name(s): Lidocaine 2% without vessel constrictor; Placebo - physiological solution 0,9%
Intervention type(s): Drug; Other
Intervention description(s): first 5 days: 20ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours
next 5 days: 30ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days; first 5 days: 20ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours next 5 days: 30ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: scleroderma; scleroderma - limited or diffuse types; lidocaine; effectiveness
Prospective Evaluation of Reduced Impedance Noninvasive Cortical Electrostimulation (RINCE) to Reduce Fibromyalgia Effects - Extension Study
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this open label study is to provide up to 24 active treatments of noninvasive
      cortical electrostimulation therapy only to those fibromyalgia patients who experienced
      inadequate pain reduction in a sham controlled double blinded lead in study, NPT-201
      (NCT01825954). The therapy will be provided by the NeuroPoint device using the same protocol
      as that used in active treatment arms of NPT-201. The study's primary outcome measure will be
      the patient's change from baseline in self-reported 24-hour average pain intensity. The study
      will provide active treatment to those participants who received sham therapy in NPT-201, and
      will test whether or not additional therapy applications might further improve pain in those
      participants who previously received active therapy, but did not achieve adequate pain
      relief.
    


Intervention name(s): RINCE
Intervention type(s): Device
Intervention description(s): The NeuroPoint device is used to deliver repeat applications of RINCE therapy
Other intervention name(s): RINCE therapy; RINCE therapy using the NeuroPoint device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain
Clinical Practice Guidelines and Impact of Audit and Feedback in the Emergency Department
Condition: Shock, Septic; Community Acquired Pneumonia
MeSH terms: Shock, Septic; Emergencies
Study type: Interventional

Summary: 
      This study will develop and test an intervention given to emergency medicine providers to
      improve adherence to clinical practice guidelines (CPGs) for pneumonia and sepsis.
    

Detailed description: 
      This study will be performed at Denver Health Medical Center, a 477-bed urban, safety-net,
      acute-care hospital located in Denver, Colorado. The adult ED is staffed by board-certified
      emergency physicians at all times. These physicians supervise the care of all patients being
      managed by resident physicians, nurse practitioners, physician assistants, and medical
      students. Approximately 430 patients are admitted to the hospital from the ED each year with
      community-acquired pneumonia (CAP) and severe sepsis (SS).

      Adherence to CPGs will be measured at the level of the attending emergency physician. All
      employed, attending emergency physicians working clinically in the adult ED at Denver Health
      Medical Center at the start of the study will be included.

      The investigators will use a step-wedge design to randomize physicians into clusters.
      Randomization of physicians into clusters and randomization of clusters to intervention
      timing will occur one week prior to delivery of the intervention to cluster one. he
      intervention will consist of monthly audit and feedback on adherence to CPGs for CAP and SS.
      Once a cluster enters its first intervention month, all physicians in that cluster will
      receive an email detailing their adherence to both CAP and SS CPG for every month since the
      start of the study. Adherence to the entire CPG as well as each component of the CPG will be
      provided. In addition, physicians will be shown the median prevalence of adherence for all
      physicians as well as where their adherence ranks among their physician group. Lastly, in a
      separate secure email, physicians will be given patient identifiers (i.e., name, MRN, date of
      visit) for each patient that received non-adherent care and will be told which component of
      care was not adherent to the respective CPG so that they can review the case themselves, if
      desired.
    

Intervention name(s): Feedback with Peer Comparison
Intervention type(s): Behavioral
Intervention description(s): Email detailing adherence to CAP and SS CPG for every month since start of study. Physicians will be provided individualized feedback and given patient identifiers for each patient that received non-adherent care.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Clinical Practice Guidelines