bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery.
Condition: Primary Open Angle Glaucoma; Glaucoma, Open Angle, Pseudo-exfoliative; Cataract Unilateral Pending Extraction
MeSH terms: Glaucoma; Cataract; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      The objective of this study is to demonstrate the ability of the Hydrus Implant to lower
      intraocular pressure in glaucoma patients undergoing cataract surgery.
    

Detailed description: 
      This is a post-market, prospective, single-masked, randomized, controlled, multicenter
      clinical trial comparing Cataract Extraction (CE) surgery + Hydrus Implant vs CE surgery
      alone for the reduction of intraocular pressure (IOP) in patients with a positive diagnosis
      for open angle glaucoma (POAG) or pseudoexfoliative glaucoma. Eligible patients will be
      scheduled for cataract surgery. At the time of the procedure, qualified subjects will be
      randomized into 1 of 2 treatment groups: Hydrus Implant with cataract surgery or cataract
      surgery alone. Post-operative follow up will be conducted at regular intervals.
    

Intervention name(s): Hydrus Implant; IOL placement
Intervention type(s): Device; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: POAG; PXG; IOL Surgery; CE Surgery
Using an Electronic Personal Health Record to Empower Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Project Summary:

      An electronic personal health record (ePHR) could maximize patient/clinician collaboration
      and consequently improve patient self-management and related health outcomes. The purpose of
      the proposed project is to examine the feasibility, acceptability, and impact of an ePHR that
      has been modified using a patient- and family-centered approach and incorporates the
      experiences, perspectives, and insights of patients and family members actually using the
      system. Comparison of patients with the ePHR intervention to a group of "care as usual"
      patients will be performed. The investigators Specific Aims are: (1) To improve the
      application of patient- and family-centered care elements in an existing ePHR, based on
      feedback from a pilot study of patients and their families. The modified ePHR will be tested
      in a pilot group of patients with hypertension and their families. (2) To implement and test
      the effectiveness of the modified ePHR with patients being treated for hypertension by a team
      of physicians, mid-level practitioners, nurse clinicians, and support staff in two ambulatory
      settings. Outcome measures will include patient activation and perception of care,
      quantifiable biological markers, patient-physician communication, and congruence of treatment
      with guidelines, particularly medication management; (3) To monitor the shift in provider and
      support staff awareness and incorporation of patient- and family-centered care as a result of
      implementation of the ePHR using questionnaires and focus groups. If successful, this ePHR
      could be implemented in additional locations in the Southeast.
    


Intervention name(s): Electronic personal health record
Intervention type(s): Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Keywords: personal health records
Structural and Metabolic Determinants of Sarcopenia and the Efficacy of Concentric vs. Eccentric Exercise Training
Condition: Healthy
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The first goal of this study is the follow young and older people over a period of 8 weeks to
      define the processes responsible for loss of muscle length and width in age-related muscle
      wasting (sarcopenia) and allow us to look at age-related differences in tendon. Secondly, we
      will assess two different exercise interventions for reversing human sarcopenia; one which
      involves shortening of the muscle and the other which involves lengthening, whilst also
      studying why these exercises work the way they do. This project will have significant
      implications for our understanding of the control of skeletal muscle and tendon size in
      humans, particularly in relation to sarcopenia and the surrounding health issues.
    


Intervention name(s): Concentric Exercise Training; Eccentric Exercise Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 weeks concentric exercise training, 3 x per week, 60% 1-RM; 4 x 12-15 repetitions, 2 min rest between sets; 8 weeks eccentric exercise training, 3 x per week, 60% 1-RM; 4 x 12-15 repetitions, 2 min rest between sets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: volunteers; young (18-30 y); older (65-75 y); age groups
Digital Parent Training for Disruptive Behaviors in Children
Condition: Disruptive Behavior; Aggression Childhood; Anger; Non-Compliance, Patient; Irritable Mood
MeSH terms: Aggression; Problem Behavior
Study type: Interventional

Summary: 
      This is an open pilot trial of web-based parent training for tantrums and disruptive behavior
      in children. Parents will be asked to complete a battery of tests to assess their children'
      behaviors before and after the intervention. Children will undergo a psychiatric evaluation
      as part of screening. The intervention will be delivered online via an app over a period of 6
      weeks. It consists of 8 self-guided courses that take approximately 10 minutes to complete
      and include text and animated parent-child simulations. Parents will also complete 3 one-hour
      videoconferencing sessions with a study clinician. During the intervention, parents will be
      taught various strategies for managing situations that can be anger provoking for their
      child. This study is conducted to examine whether a digitally-delivered version of
      parent-management training can be used to reduce behavioral problems including anger
      outbursts, irritability, aggression and noncompliance.
    


Intervention name(s): Parent Management Training
Intervention type(s): Behavioral
Intervention description(s): The online digital parent training (DPT) program consists of 8 self-guided courses that take approximately 10 minutes to complete and include text and animated parent-child simulations. The courses are designed to closely parallel the content of existing evidence-based parent management training approaches that exist in numerous parenting books.
Other intervention name(s): Digitally-delivered Parent Management Training; PMT
Intervention model: Single Group Assignment
Intervention model description: Open feasibility trial
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial to Compare the Pharmacokinetics of DP-R208
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of
      DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in
      comparison to each component administered alone in healthy male volunteers
    


Intervention name(s): DP-R208; Candesartan cilexetil; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Investigational product is prescribed to all of randomized subjects; Investigational product is prescribed to all of randomized subjects; Investigational product is prescribed to all of randomized subjects
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DP-R208
Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors
Condition: Survivorship; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      This clinical trial studies a mobile health fitness program for adolescent and young adult
      childhood cancer survivors. Adolescent and young adult childhood cancer survivors are at risk
      to have negative late effects from treatment and to develop chronic health conditions. A
      sedentary lifestyle may increase the risk of cardiovascular disease, osteoporosis, and early
      mortality. Physical activity reduces the risk for cardiovascular disease and early mortality,
      improves cardiorespiratory fitness, muscular fitness, bone health, and body composition, and
      it is also positively associated with quality of life. Programs and technologies that promote
      physical activity are important because health behaviors adopted by adolescent and young
      adult childhood cancer survivors are likely to continue into adulthood. A mobile health
      fitness application may motivate adolescent and young adult childhood cancer survivors to
      engage and maintain physical activity.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Evaluate the feasibility of the technology-enhanced (electronic accelerometer + app + 8
      weekly group sessions) fitness program in a pilot randomized clinical trial.

      SECONDARY OBJECTIVES:

      I. Determine the effectiveness of the technology-enhanced fitness program on participants'
      cardiorespiratory fitness and muscular fitness.

      II. Examine the effects of the program on secondary outcomes of health related quality of
      life (HRQOL) and fatigue.

      OUTLINE:

      Participants are randomized to 1 of 2 arms.

      ARM I (Intervention): Participants attend 8 group meetings weekly, wear an electronic
      accelerometer, engage in private social support messaging within the app and Facebook private
      groups, and then use the mobile app for 4 weeks without in-person groups.

      ARM II (WAITLIST CONTROL [WLC]): After the 6 month assessment, participants receive the
      FitSurvivor intervention as in arm I.
    

Intervention name(s): Exercise Intervention; Internet-Based Intervention; Monitoring Device; Quality-of-Life Assessment
Intervention type(s): Behavioral; Behavioral; Device; Other
Intervention description(s): Participate in fitness program; Engage in private social support messaging and Use the mobile app; Wear an electronic accelerometer; Ancillary studies
Other intervention name(s): Monitor; Quality of Life Assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Pediatric Epilepsy Study
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as
      monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of
      age.
    


Intervention name(s): oxcarbazepine
Intervention type(s): Drug
Intervention MeSH terms: Oxcarbazepine
Primary purpose: Treatment
Keywords: partial seizures
A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      immunogenicity of single escalating doses PF-06342674.
    


Intervention name(s): Placebo; PF-06342674 Dose A; PF-06342674 Dose B; PF-06342674 Dose C; PF-06342674 Dose D; PF-06342674 Dose E; PF-06342674 Dose F; PF-06342674 Dose G; PF-06342674 Dose H; PF-06342674 Dose I; PF-06342674 Dose J
Intervention type(s): Drug; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Placebo; Single SC Dose; Single SC Dose; Single SC Dose; Single SC Dose; Single SC Dose; Single IV Dose; Single SC Dose; Single IV Dose; Single SC Dose; Single IV Dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; RN168; Healthy Volunteers
A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, non-randomized, single-center study to assess the residency of
      GSK2894512 in the skin of healthy adult male volunteers with normal barrier function. The
      study will have two parts, Cohort 1 (Part A) followed by Cohort 2 (Part B). The study will
      assess the residence time in human skin . The primary objective is to evaluate the residency
      time in skin following topical application of two formulations of GSK2894512 Cream. The total
      study duration will be of 15 days including 1 to 7 days of treatment period, 8 to 14 days of
      post treatment period and 1 day of follow up. The screening period will be up to 28 days
      prior to Baseline (Day 1).
    


Intervention name(s): Combination therapy GSK2894512 Cream A + GSK2894512 Cream B; Combination therapy Vehicle Cream A + Vehicle Cream B
Intervention type(s): Drug; Drug
Intervention description(s): GSK2894512 Cream A, 1% (10mg/g) will be topically applied daily for 7 days as a thin layer onto an area of the volar region of one forearm (up to 1.5% body surface area) and GSK2894512 Cream B, 1% (10mg/g), will be topically applied daily for 7 days to the opposite forearm from Cream A, onto an area of the volar region of one forearm (up to 1.5% body surface area). Both the creams will be weighed to deliver approximately 3mg drug per 1cm^2 of skin.; Vehicle creams A and B will be supplied in individual tubes. Both the creams will be topically applied on Day 1 only to a separate area (at least 1.3 cm from study drug) of the forearm from where drug is applied.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: atopic dermatitis; FLIM; chronic plaque psoriasis; healthy volunteers; GSK2894512; Skin residency
An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor
Condition: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the study is to assess the performance of a new subcutaneous glucose sensor
      over a seven-day sensor life when used with currently marketed Medtronic Diabetes devices. In
      addition performance will be calculated for use of the new sensor with proposed new devices
      using new calibration algorithms.
    

Detailed description: 
      The first generation Medtronic MiniMed Subcutaneous Glucose Sensor (Sof-Sensor) was
      originally approved by the FDA for commercialization as part of the Continuous Glucose
      Monitoring System (CGMS) on June 15, 1999 (PMA 980022). The Sensor is composed of a
      microelectrode with a thin coating of glucose oxidase beneath several layers of biocompatible
      membrane. This same sensor was used as part of subsequent continuous glucose monitoring (CGM)
      systems, such as the Guardian REAL-Time and Paradigm REAL-Time sensor augmented insulin pump.
      The current configuration of sensor has undergone in vitro and in vivo testing. A new
      second-generation glucose sensor (herein referred to as the Comfort Sensor) has been
      developed. The first-generation glucose sensor was approved with reported sensor accuracy
      (MAD) of 18%; it was labeled for a maximum use duration of 72 hours, using only the abdomen
      as an insertion site. The new sensor is shorter and has a smaller diameter, with a smaller
      gauge introducer needle. The new sensor inserter is designed to be used with the new sensor.
      The objectives of this study are to 1) Assess performance of the Comfort Sensor when used
      over a period of seven days with currently available devices, and 2) Assess performance of
      the Comfort Sensor when used over a period of seven days using new calibration algorithms
      (post-processed with algorithm for future devices). Accuracy data will be calculated based on
      comparing calibrated glucose sensor values to a "gold standard" (YSI plasma glucose values)
      in adult subjects during in-clinic testing, and on comparing calibrated glucose sensor values
      to glucose meter values during in-home testing. The devices that will be used for gathering
      sensor data during this study will be: 1) the Comfort Sensor, 2) the MiniLink (Transmitter),
      3) the Guardian REAL-Time Display Device and 4) the CGMS iPro.
    

Intervention name(s): Sensor wear
Intervention type(s): Device
Intervention description(s): All subjects to wear sensors
Other intervention name(s): Enlite Sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: diabetes; glucose sensor; CGM
A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to characterize the immunogenicity & safety of 2 doses of GSK's
      avian flu vaccine GSK 1557484A given according to different regimens to adults aged 18 to 64
      years
    

Detailed description: 
      A Phase 2, open-label, randomized, parallel group, multi-centered study designed to evaluate
      the immunogenicity and safety of a 2-dose series of avian influenza vaccine plus AS03
      adjuvant according to different regimens, in adults aged 18-64 years. All subjects will
      receive active study vaccine; no subjects are to receive placebo. A total of 312 subjects
      will be enrolled in this study at approximately 3 study centers in Canada. All subjects will
      attend formal study center visits for safety and immunogenicity assessments on Days 0, 21,
      42, and 182. Additional formal study center visits will be scheduled at additional timepoints
      for subjects in particular dose groups. In addition, a telephone call will be conducted for
      all subjects on Day 51
    

Intervention name(s): Influenza A (H5N1) Virus Monovalent Vaccine
Intervention type(s): Biological
Intervention description(s): Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: H5N1; immunogenicity; influenza; Avian; pandemic; vaccines; human; safety
Marginal Periosteal Pedicle Flap - Platelet Rich Fibrin Barriers in Treating Periodontal Intrabony Defects
Condition: Periodontal Pocket
MeSH terms: Periodontal Pocket
Study type: Interventional
Phase: Phase 2

Summary: 
      The use of autogenous graft materials has been recorded to be a gold standard in regenerative
      therapy. This study directed toward evaluation of two autogenous regenerative materials,
      marginal periosteal pedicle graft (MPP) and platelet rich fibrin (PRF) as membrane barriers
      for treating intrabony defects. In spite of its reported significant clinical outcomes, the
      limited availability of the periosteum makes it necessary to evaluate other autogenous
      alternatives such as PRF that could offer predictable outcomes.
    

Detailed description: 
      Material and methods: 10 patients with sever chronic periodontitis and at least single ≥4 mm
      intrabony defect had participated in this randomized clinical study. Subjects were randomly
      divided into2 groups, Group 1(MPP) defect coverage with xenograft defect fill(10
      patients),Group 2(PRF) defect coverage with xenograft defect fill(10 patients).Clinical and
      radiographic measurements were carried out at 3,6 and 9 months postoperatively.
    

Intervention name(s): Regenerative therapy
Intervention type(s): Procedure
Intervention description(s): Periosteal pedicle, Platelets rich fibrin
Other intervention name(s): Guided tissue regeneration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Trial of Montelukast for Treatment of Acute Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      The primary rationale for this study is to evaluate the effect of once daily montelukast on
      duration of acute illness in infants with first-time bronchiolitis.
    


Intervention name(s): montelukast sodium; sucrose
Intervention type(s): Drug; Other
Intervention description(s): 4mg granules daily for 14 days; table sugar as placebo daily for 14 days
Other intervention name(s): singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bronchiolitis; montelukast; leukotriene inhibitor
Anesthetic Blockades and Migraine
Condition: Chronic Migraine; Pain
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of
      headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The
      aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic
      blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs)
      in different areas. We hypothesize that those patients receiving real GON anesthetic blockade
      will receive greater improvements in pain nociception. We will conduct a double-blind,
      randomized, parallel and placebo-controlled clinical trial where one group will be treated
      with bilateral GON blockade with bupivacaine 0,5% and the other group will be treated with
      placebo.
    


Intervention name(s): Anesthetic blockades with bupivacaine; Isotonic saline injection
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bupivacaine; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: migraine,; pressure pain,; anesthetic blocks; patients