bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients
Condition: Pathological Processes
MeSH terms: Pathologic Processes
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to characterize the safety, efficacy and pharmacokinetic
      profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient
      population.
    

Detailed description: 
      Pediatric patients referred for magnetic resonance imaging (MRI) of the liver or central
      nervous system (CNS) will be stratified by age to one of two groups (2 through 11 and 12
      through 18 years of age).
    

Intervention name(s): MRI; MRI; Gadoversetamide
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): contrast enhanced MRI; contrast enhanced MRI; Subjects will receive a single dose of Optimark(0.1 mmol/kg)as a bolus thru a peripheral IV line at 1-2 mL/sec followed by a saline flush during their medically necessary MRI .
Other intervention name(s): gadoversetamide; gadoversetamide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: brain, spine, liver, MRI, Pediatric
ALGRX 4975 in the Treatment of Tennis Elbow
Condition: Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 2

Summary: 
      Tennis elbow is a painful condition that results from repetitive arm movement with overuse of
      muscles, e.g. when playing tennis. A single injection of ALGRX 4975 has the potential to
      reduce pain for a period of weeks to months. This study will test the efficacy and safety of
      ALGRX 4975 in the treatment of patients with tennis elbow.
    

Detailed description: 
      Lateral epicondylitis (tennis elbow) is a painful condition that affects 4 to 7 adults per
      1000 annually and tends to involve the subject's dominant side. It typically results from
      repetitive arm movement with over use of muscles leading to small tears in the tendons
      attaching muscles of the forearm to the epicondyles that may progress to tendonitis. Pain on
      or around the lateral epicondyle may radiate down the subject's arm. Gripping or extending
      the wrist often intensifies the pain.

      More than 40 possible treatments have been proposed, reflecting a lack of consensus about
      optimal management. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat
      tennis elbow, but there are no trials to date that have compared them with other painkillers
      and one study found no clinically important benefit over placebo. Use of corticosteroid
      injections provides mixed results in relief of pain and at times insufficient evidence to
      support their use. Although complications associated with steroid injection are relatively
      uncommon, when a complication does occur, it can result in severe and disabling consequences
      for the subject. A small proportion of subjects fail to respond to only one injection of
      corticosteroid and some subjects who initially improved at four weeks had worse symptoms by
      six months.

      This study has been designed to evaluate the safety and efficacy of a single soft tissue
      injection of ALGRX 4975 at a dose of 100 µg in comparison to placebo in subjects with acute
      LE.
    

Intervention name(s): ALGRX 4975
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Acute lateral epicondylitis; Tennis elbow; Capsaicin
Caregiver Study Dr. Phillips
Condition: Alzheimer Disease; Dementia
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional

Summary: 
      This study will examine whether a performing arts class will improve the well-being of
      primary unpaid caregivers of people with dementia
    

Detailed description: 
      This study used sample size analysis to determine the adequately sized intervention group and
      control group, well-defined statistical methodology, and a well-documented intervention that
      can be easily replicated. The intervention has been developed by Dr. Phillips Center for the
      Performing Arts leadership with assistance from AMS Planning & Research.
    

Intervention name(s): Performing Arts Instruction
Intervention type(s): Behavioral
Intervention description(s): Professionally delivered performing arts curriculum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Alzheimer Disease; Dementia; Caregiver; Performing Arts
mHealth Biometrics for Sedentary People (MotivateLJMU)
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators aim to undertake a feasibility randomised controlled trial (RCT) to
      investigate whether mHealth technology, allowing biometric informed feedback and coaching on
      exercise and PA, can be effective in previously sedentary individuals. The overall objective
      is to have an evidence-based exercise and PA intervention ready to evaluate in a future RCT.
    

Detailed description: 
      Participants will be recruited from Liverpool John Moores University, and other local
      office-based businesses. Participants will be randomised to either online exercise resources
      only (n=50) or exercise counselling + mHealth (n=50).This is a pilot parallel group,
      randomised controlled trial whereby consenting participants will complete baseline testing
      (T1) before starting a 12-week exercise intervention supported by online resources only
      (online resources intervention) or online resources and a programme of exercise counselling
      enhanced with mobile health (mHealth) technology (mHealth intervention). Participants will
      repeat baseline assessments (i) 6-weeks into the intervention (T2) and, (ii) immediately
      post-intervention (T3). Testing at baseline and following the 12-week intervention will
      include changes in physical activity, blood pressure, body composition and glycaemia control
      (n=20).

      Both groups will have access to online resources throughout the 12-week programme. The
      intervention group will be provided with exercise counselling and to support this they will
      also be provide with a wristwatch that can monitor everyday activity and their heart rate, a
      smartphone app and access to a website. The intervention group will also participate in 4
      consultations with an exercise specialist to plan their exercise programme and be updated on
      their progress towards physical activity targets. Weekly text message updates will also
      provide feedback to the intervention group with participants able to respond to these
      updates.
    

Intervention name(s): Active Control; mHealth technology assisted exercise counselling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will complete a 3-month exercise and physical activity intervention supported by online recourses; Participants will complete a 3-month exercise and physical activity intervention supported by online recourses, exercise counselling sessions and mHealth technology
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled trial
Masking: None (Open Label)
Primary purpose: Prevention
Characteristics of Patients With Neovascular Age-related Macular Degeneration Enrolled in the Brolucizumab Patient Support Services Program
Condition: Age-related Macular Degeneration (AMD)
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD
      who enrolled in the brolucizumab Patient Support Services (PSS) program. Evidence was
      generated to describe their baseline demographic and clinical characteristics.
    

Detailed description: 
      The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD
      who enrolled in the brolucizumab Patient Support Services (PSS) program.

      PSS data was obtained from patients with wet AMD who enrolled in the program for the index
      period 10/10/2019 to 04/30/2020.

        -  Identification period of the index period: 10/10/2019 to 04/30/2020

        -  Index date: Date of enrollment in the PSS program

        -  Study Period: 10/10/2019 to 04/30/2020
    

Intervention name(s): All participants
Intervention type(s): Other
Intervention description(s): All the particpants enrolled in the brolucizumab Patient Support Services (PSS) program
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study included patients with wet AMD
      
Keywords: Primary plan,; AMD characteristics,; brolucizumab
Comparison Between Different Filling Pressures in Diagnostic Outpatient Hysteroscopy
Condition: Hysteroscopy
Study type: Interventional

Summary: 
      The aim of this study is to compare different filling pressures
    

Detailed description: 
      This study is a prospective double blinded randomised controlled trial. 240 women will be
      randomly divided into 3 groups, each containing 70 women. Randomisation will be performed
      using a computer generated random numbers and sealed envelopes.

      Full history will be taken followed by general and local examination. The procedure will be
      done in the lithotomy position. Hysteroscopy will be done using a 5mm outer diameter
      continuous flow hysteroscope with a French working channel and a 30 degrees direction of view
      provided by Techno GmbH and CO. The hysteroscope will be introduced using the vaginoscopy
      technique, in which no speculum will be used. The cervix will be detected and the external os
      will be identified using the hysteroscope. The hysteroscope will be introduced in the uterine
      cavity. Saline will be used as the distension medium and the pressure will be set at 80mm Hg
      until the hysteroscope is introduced in the uterine cavity. After the hysteroscope is
      introduced into the uterine cavity, the filling pressure will remain at 80mm Hg in group1,
      will be reduced to 50mm Hg in group 2 and to 30mmHg in group 3. Randomisation will be double
      blind; neither the operator nor the patient will know the pressure during the procedure, a
      third party will set the pressure according to the computer generated random numbers.

      The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions
      septa, congenital malformations or submucous fibroids will be noted.
    

Intervention name(s): Filling pressure 80; Filling pressure 50; Filling pressure 30
Intervention type(s): Device; Device; Device
Intervention description(s): After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg.; After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg.; After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Hysteroscopy; Filling pressures
Tolerability of BIBR 953 ZW IV and Bioavailability of BIBR 1048 Tablet and Solution in Healthy Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Two substudies to assess (1) the tolerability of BIBR 953 ZW intravenous infusion at 0.1, 1
      and 5 mg BIBR 953 ZW and (2) the absolute bioavailability of 100mg BIBR 1048 administered as
      'acid free' tablet formulation (TF1) and (3) the bioavailability of the 100 mg tablet of BIBR
      1048 relative to the tartaric acid solution of 100 mg dose strength and (4) the absolute
      bioavailability of the 100 mg tartaric acid solution of BIBR 1048 MS.
    


Intervention name(s): BIBR 953 ZW IV; BIBR 1048 MS tablet; BIBR 1048 MS oral solution; BIBR 953 ZW IV Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Effects of ONO-2506PO in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to establish the presence of an effect of treatment with
      ONO-2506PO in patients with Alzheimer's Disease, based upon cognitive and global scales.
    


Intervention name(s): ONO-2506PO
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Skin Health in Young Adults - Preventing Indoor Tanning and Promoting Sun Protection
Condition: Skin Neoplasms
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      This is a pilot randomized controlled trial of an Internet-based skin cancer prevention
      intervention as compared to a standard of care control in 80 non-Hispanic white females ages
      20-30.
    


Intervention name(s): Indoor tanning intervention; Standard of care control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6 Web-based modules that focus on preventing skin cancer through sun protection and indoor tanning reduction using the Theory of Planned Behavior and Prospect Theory; One website with content similar to those available in dermatology offices on skin cancer prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Disease Progression
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two
      doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with
      symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT )
      (development of toxicity during prolonged AZT therapy), demonstrated disease progression
      after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months
      of AZT therapy.

      As useful as AZT appears to be in the treatment of patients infected with HIV, it is
      associated with significant toxicity in some patients, and it does not prevent ultimate
      progression to AIDS and eventual mortality. Thus, there is a clear need for new
      antiretroviral drugs, and ddC is one such promising agent.
    

Detailed description: 
      As useful as AZT appears to be in the treatment of patients infected with HIV, it is
      associated with significant toxicity in some patients, and it does not prevent ultimate
      progression to AIDS and eventual mortality. Thus, there is a clear need for new
      antiretroviral drugs, and ddC is one such promising agent.

      Patients receive oral ddC for 48 to 177 weeks.
    

Intervention name(s): Zalcitabine
Intervention type(s): Drug
Intervention MeSH terms: Zalcitabine
Primary purpose: Treatment
Keywords: Zalcitabine; Drug Evaluation; Acquired Immunodeficiency Syndrome; AIDS-Related Complex
Evaluation of the Residual Antimicrobial Efficacy of One Test Material Based on a Modification of ASTM E1115-11 Test Method
Condition: Hand Hygiene
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the residual antimicrobial effectiveness of one test product when tested using a
      modification of the methodology of the standardized ASTM E115-11 (2017)
    


Intervention name(s): Chlorhexidine Gluconate
Intervention type(s): Drug
Intervention description(s): Product used in accordance with manufacturers Hand Hygiene instructions
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if sexual dysfunction symptoms and quality of life
      measures in patients with Multiple Sclerosis may be improved in patients that are prescribed
      Tysabri.
    

Detailed description: 
      Patients will be naive to Tysabri at the baseline for this study then their sexual
      dysfunction, fatigue, and quality of life measures will be measured using scaled
      questionnaires.
    

Intervention name(s): Tysabri ® (Natalizumab)
Intervention type(s): Drug
Intervention description(s): IV, monthly
Intervention MeSH terms: Natalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Multiple Sclerosis; Sexual Dysfunction; Quality of Life
Evaluation of the IY TCM Program in Norwegian School and Day-care Settings
Condition: Behavior Problem
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether training teacher and staff in the Incredible
      Years (IY) Teacher Classroom Management (TCM) program reduce behavior problems and promote
      social competence in student aged 6-8 years (school) and in children aged 3-6 year
      (day-care). To examine group differences from baseline to 8-9 months after, a
      quasi-experimental control group design with pre- and post-measurements was used.
    

Detailed description: 
      Evaluation of the Incredible Years (IY) Teacher Classroom Management (TCM) program
      implemented as a school-wide preventive intervention in regular school and day-care settings,
      have the potential to change negative behaviors in children aged 3 - 8 year. Forty-four
      schools were recruited; comprising 1518 students aged 6-8 year, and 91 day-care units
      comprising 1049 children aged 3-6 year. Multilevel analyzes were used to examine group
      differences pre-post changes for behavior problems measured with the Sutter-Eyberg Student
      Behavior Inventory-Revised (SESBI-R) and the Teacher Report Form (TRF), as well as group
      differences pre-post change for social behavior measured the Social Skills Rating System
      (SSRS). For secondary findings, group differences pre-post changes for teacher- student and
      teacher-children relationship were measured with the Student-Teacher Relationship Scale
      (STRS) (teachers N= 444), and teacher-parents interactions were measured with the
      Teacher-Parent Involvement Questionnaire (INVOLVE-T/P) (parents N = 2109), as well as group
      differences pre-post change for teachers self- and collective efficacy measured the Norwegian
      Teacher Self-Efficacy Scale (NTSES) and the Collective Efficacy Scale (CES) (teachers N =
      3240).
    

Intervention name(s): IY TCM
Intervention type(s): Behavioral
Intervention description(s): The Incredible Years Teacher Classroom Management program is a manualized program for teachers and staff in school and day-care settings to strengthen teacher classroom management strategies, to reduce negative behavior and promote prosocial behavior, as well as school readiness in children. Two qualified IY TCM group-leaders (facilitators) train teachers and staff in groups through six full-day workshops (a total of 42 hours).Workshop 1: Building Positive Relationships with Students, Workshop 1b: Preventing Behavior Problems -The Proactive Teacher, Workshop 2: The Importance of Teacher Attention, Coaching and Praise, Workshop 3: Motivating Children Through Incentives, Workshop 4 & 5: Decreasing Inappropriate Behavior and Workshop 6: Emotional Regulation, Social Skills & Problem Solving.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Behavior Problem; Social Competence; Student; Children
An Open-Label Food Effect Study of Telotristat Etiprate
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of
      telotristat ethyl and its metabolite LP-778902 relative to administration of single dose
      telotristat etiprate in the fasted state in healthy adult male and female subjects.
    


Intervention name(s): Telotristat etiprate; Telotristat etiprate
Intervention type(s): Drug; Drug
Intervention description(s): 2 × 250 mg (as free base) telotristat etiprate tablets (fed conditions /high-fat / high caloric meal); 2 × 250 mg (as free base) telotristat etiprate tablets (fasted conditions)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RDEA3170 and Febuxostat Combination Study in Gout Subjects
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic
      (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to
      febuxostat administered alone in adult subjects with gout.
    


Intervention name(s): RDEA3170 15 mg; RDEA3170 10 mg; RDEA3170 2.5; RDEA3170 5 mg; Febuxostat 40 mg; Febuxostat 80 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Febuxostat; Verinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment