bioihbjkbjnl/mcl2 huggingface dataset:
Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study
Condition: Adherence, Patient
Study type: Interventional

Summary: 
      The goal of the proposed study is to enhance adherence and retention in care for M/XDR-TB HIV
      patients through enhanced standard of care, targeted transition to outpatient medication
      self-administration prior to hospital discharge, and use of community adherence groups, with
      an overarching goal of promoting patient engagement in a care continuum.
    

Detailed description: 
      Tuberculosis (TB) remains the leading cause of morbidity and mortality worldwide among people
      living with HIV (1). Globally, the incidence of multidrug-resistant tuberculosis (MDR-TB) and
      extensively drug resistant tuberculosis (XDR-TB), the most drug-resistant forms of TB, has
      approximately doubled over the past fifteen years (1-3). Nowhere has this increased incidence
      generated more concern than in South Africa where interactions between TB and generalized HIV
      epidemics are causing 'explosive' TB incidence (4-6) and case-fatality are threatening to
      undermine the progress reached with antiretroviral therapy (ART) (7, 8).

      Medication adherence, a key predictor of outcomes in M/XDR-TB and HIV treatment, is
      understudied in high burden TB-HIV settings (9-11). Patient losses during transitions in the
      care continuum are frequent (12), increase mortality and limit control of the linked
      epidemics. Demands of M/XDR-TB HIV treatment are severe including extraordinary pill burden,
      severe adverse effects, lengthy treatment, isolation and stigma with few parallels in modern
      medicine (13-15).
    

Intervention name(s): Wisepill device
Intervention type(s): Device
Intervention description(s): Participants will receive a Wisepill device for TB and ART medications. Participants will receive an exit counselling session prior to being discharged.
Participants will select the content of a text message to be sent when missing a dose as measured by Wisepill non-opening during medication dose-window.
Participants will receive a post-discharge phone call by study staff for the purpose of identifying any early challenges or obstacles. All participants may receive a titrated Wisepill intervention (TWI) consisting of a text message, phone call, and/or study home visit triggered by medication non-adherence as detected by Wisepill non-opening.
All participants will receive a monthly counselling intervention (MCI). Adherence support groups (ASG) will be conducted on a monthly basis.
Other intervention name(s): Adherence Support Groups; Monthly Counselling Intervention; Home Visits; Titrated Wisepill Intervention; Exit Counselling for Discharged patients; Post Discharge Phone Calls
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Vision Screening for the Detection of Amblyopia
Condition: Amblyopia; Refractive Errors; Anisometropia; Strabismus; Ptosis
MeSH terms: Amblyopia; Strabismus; Refractive Errors; Anisometropia
Study type: Interventional

Summary: 
      INTRODUCTION. Amblyopia is defined as the loss of visual acuity (VA) in one or both eyes,
      without any obvious structural or pathological anomalies. Amblyopic eye should be able to
      regain some VA if treatment is initiated before the age of seven. It is the leading cause of
      monocular blindness in the 20- to 70-year olds with prevalence 2-5%. Amblyopia is mainly
      monocular, hence children are general asymptomatic. VA testing is the only reliable method of
      detecting amblyopia, and the fourth year of life is considered best for vision screening
      programs.

      AIM: The purpose of the study is to reduce the preventable vision loss. The main goal of the
      study is to evidence the problem of amblyopia in Zagreb and to release a model for formal,
      government directed vision-screening program as a Croatian public health policy.

      HYPOTHESIS. In Croatia, the prevalence and actual effect of amblyopia and amblyogenic
      factors, along with treatment efficacy is impossible to quantify, since no population-based
      studies have been performed regarding this issue. In addition, national screening of
      preschool children does not exist, while the school-entry screening is prescribed by law. The
      object of the study is to determine the prevalence of amblyopia in a 4-4.5 year old children
      of The Town of Zagreb, the efficacy of screening and effectiveness of treatment on reducing
      amblyopia prevalence. The primary hypothesis is defined: screening of visual acuity
      monocularly at distance and near in 4-4.5 year old children in Zagreb is effective in
      detecting amblyopia.

      PATIENTS AND METHODS: Monocular vision of about 7000 children/ year aged 4-4.5 for whom both
      parents gave consent is to be tested with Lea chart at near (40cm) and distance (3m) in the
      kindergartens of The Town of Zagreb. The criterion for referral to complete ophthalmological
      examination is VA <0.8.
    


Intervention name(s): Amblyopia screening
Intervention type(s): Other
Intervention description(s): Monocular vision testing at near (40cm) and distance (3m)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: amblyopia; amblyogenic factors; screening; preschool children; visual acuity; prevalence
Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia
Condition: Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The present study determined the effect of Xylose consumption on postprandial hyperglycemia
      in normal (n=25) and hyperglycemic subjects (n=50).
    

Detailed description: 
      In this double-blind crossover designed study, Participants were randomly assigned to consume
      a sucrose drink (Control, sucrose 50g + deionized water 100g) or a sucrose drink additionally
      containing 5 g (Test 1, sucrose : xylose = 10:1), 3.33 g (Test 2, sucrose : xylose = 15:1) or
      2.5 g (Test 3, sucrose : xylose = 20:1) of D-xylose with a week interval.
    

Intervention name(s): Test 1; Test 2; Test 3; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): sucrose : xylose = 10:1, sucrose 50 g + xylose 5 g + deionized water 95 g; sucrose : xylose = 15:1, sucrose 50 g + xylose 3.33 g + deionized water 96.67 g; sucrose : xylose = 20:1, sucrose 50 g + xylose 2.5 g + deionized water 97.5 g; sucrose 50 g + deionized water 100 g
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Xylose; prediabetes; postprandial hyperglycemia; glucose
Regimen Optimization Study
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress
      the immune system (called immunosuppressive regimens) to stop the immune system from
      attacking the transplanted kidney in order to limit damage to or the possibility of rejecting
      the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two
      immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate
      mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.
    

Detailed description: 
      Calcineurin inhibitor (CNI)
    

Intervention name(s): Thymoglobulin; Belatacept; mycophenolate mofetil(MMF); Corticosteroids; Everolimus(EVL); Tacrolimus(TAC)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): ATG; Nulojix; CellCept; Methylprednisolone; Prednisone; Certican®; Zortress®; Prograf
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Everolimus; Abatacept; Tacrolimus; Thymoglobulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assess the Efficacy and Safety of Rhinocort Aqua
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5
      years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and
      stuffy noses.
    


Intervention name(s): Budesonide; Budesonide; Budesonide; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 16mg Nasal Spray; 32mg Nasal Spray; 64mg Nasal Spray
Other intervention name(s): Rhinocort AQUA; Rhinocort AQUA; Rhinocort AQUA
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Allergic rhinitis; Paediatric; Nasal symptoms; Congestion; Rhinorrhea; Sneeze; budesonide; Rhinocort AQUA
Dose Finding Study for QAW039 in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to demonstrate a clinically significant improvement in Forced Expiratory
      Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled
      by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active
      comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging,
      multi-centre trial.
    


Intervention name(s): QAW039; Montelukast; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): QAW039 po; Montelukast 10 mg po; Placebo
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; QAW039
Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional

Summary: 
      Objectives:

      Primary Objective:

      To identify and preselect patients with chronic HBV mono infection, who are undetectable for
      anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02
      Phase1/1b First in Man (FIM) study.

      Secondary Objectives:

      To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients.

      Methodology:

      Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides
      for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single
      peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a
      central laboratory using a newly validated assay.
    


Intervention name(s): blood draw
Intervention type(s): Other
Primary purpose: Screening
Surufatinib Renal Impairment Study
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, multicenter, single-dose, single-period, sequential study to assess the effect
      of moderate renal impairment on the pharmacokinetics of surufatinib.
    

Detailed description: 
      An open-label, multicenter, single-dose, single-period, sequential study with the primary
      objective of assessing the effect of moderate renal impairment on the PK of surufatinib
      following administration of 300mg single oral dose. The secondary objective is to evaluate
      the safety in subjects with moderate renal impairment and subjects with normal renal function
      following a single oral dose of 300mg surufatinib.

      Approximately 16 subjects will be enrolled
    

Intervention name(s): Surufatinib; Surufatinib
Intervention type(s): Drug; Drug
Intervention description(s): Subjects to receive Surufatinib 300mg on Day 1; Subjects to receive Surufatinib 300mg on Day 1
Other intervention name(s): HMPL-012; HMPL-012
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      This is a multi-center, single arm, traditional feasibility study to allow a preliminary
      assessment of the safety and effectiveness of a new method of treating skin burns using
      Biodegradable Temporizing Matrix (BTM).
    

Detailed description: 
      This is a multi-center, single arm, traditional feasibility study to allow a preliminary
      assessment of the safety and effectiveness of BTM treatment. Patients with 10-70% TBSA burns
      will have BTM devices implanted in areas with deep partial or full thickness burns to treat
      at least 5% TBSA.
    

Intervention name(s): Biodegradable Temporizing Matrix
Intervention type(s): Device
Intervention description(s): The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: burns; autografts; humans; biodegradable polyurethane; dermal matrix; synthetic
Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to help overweight or obese children to maintain or reduce their
      body mass index (BMI) through the home-based parent training program the investigators
      developed called DRIVE. The investigators hypothesize that children from families that
      receive the DRIVE program will show greater maintenance or improvement in their BMIs than
      families who do not receive DRIVE.
    

Detailed description: 
      The DRIVE program (Developing Relationships that Include Values of Eating and Exercise) is a
      home-based parent training program with 15 sessions focused on improve family nutrition and
      physical activity and promoting positive parent-child interactions. The aim of this study is
      to pilot-test the development of a childhood obesity program that includes parenting and
      health information. Participants in this study will be recruited through community
      organizations based upon their obesity health risk. Only families whose children's BMI
      percentile is greater than or equal to 75 will be eligible to participate in this study These
      participants will be randomly assigned to either the control group, in which participants
      will receive health information via mail only, or the experimental group that will
      participate in 15 DRIVE sessions focusing on parent-child interactions, health and nutrition,
      and physical activity. Both groups will complete a baseline assessment, mid-point assessment,
      and post assessment in their home, which will measure parent and child height, weight, and
      waist circumference; parent attitudes towards health and nutrition; and parent and child food
      consumption and physical activity levels. Results from this study will provide information
      regarding the feasibility of implementing the DRIVE curriculum as well as its impact on
      parent and child body mass indexes, and parents' knowledge, and attitudes related to
      nutrition.
    

Intervention name(s): DRIVE Program
Intervention type(s): Behavioral
Intervention description(s): The DRIVE program (Developing Relationships that Include Values of Eating and Exercise) is a home-based parent training program, which involves 15 sessions focusing on parent-child interactions, health and nutrition, and physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: children; pediatric obesity; parent training; home-based; nutrition; physical activity; parent-child interaction; parenting
The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
Condition: Contraception
Study type: Observational

Summary: 
      This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of
      isotretinoin on the etonogestrel (ENG) contraceptive implant.
    

Detailed description: 
      The Investigators will enroll only women with an etonogestrel contraceptive implant in place
      who are initiating isotretinoin therapy through their dermatologist. The Investigators will
      monitor the subjects serum etonogestrel concentration during isotretinoin therapy but no
      medications will be provided through this study. No medical devices will be inserted as part
      of this study either.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Reproductive-aged women (18-45) who are under the care of a dermatologist for treatment of
        acne and planning to initiate therapy with isotretinoin. The women must have chosen an ENG
        contraceptive implant for their primary mechanism of birth control, placed at least four
        weeks prior to study enrollment, but in place no longer than three years.
Evaluation of the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 and IN-A001 in Healthy Caucasians
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and
      safety/tolerability of IN-C005 and IN-A001 after oral administration in healthy Caucasian
      subjects.
    

Detailed description: 
      [Part 1] To evaluate the pharmacokinetic (PK)/pharmacodynamic (PD) profiles and
      safety/tolerability of 100 mg IN-C005 versus 100 mg IN-A001 after multiple oral dosing in
      healthy Caucasian subjects

      [Part 2] To evaluate the PK/PD profiles and safety/tolerability of 50 mg IN-C005 versus 75 mg
      IN-C005 after multiple oral dosing in healthy Caucasian subjects
    

Intervention name(s): IN-C005 X mg; IN-A001 Y mg; IN-C005 Y mg; IN-C005 Z mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral capsule; Oral tablet; Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, open-label, multiple dosing, crossover study
Masking: None (Open Label)
Primary purpose: Treatment
Volunteering as an Intervention to Reduce Depression Among Adolescents
Condition: Depression; Adolescent Behavior; Depressive Symptoms
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of the present study is to test in a preliminary manner an innovative strategy
      for treating depression among adolescents (alongside existing therapy) using community
      volunteerism.
    

Detailed description: 
      The purpose of the present study is to test in a preliminary manner an innovative strategy
      for treating depression among adolescents (alongside existing therapy) using community
      volunteerism. In addition, this study will test a potential mechanism by which volunteering
      might decrease depressive symptoms: increasing psychosocial assets, specifically decreasing
      self-orientation and increasing an orientation toward others. This will be measured through
      self-report as well as using functional magnetic resonance imaging (fMRI). This study will be
      the first study to explore how neural response patterns are potentially altered by intense
      experiences with volunteerism among depressed adolescents.
    

Intervention name(s): Volunteer experience
Intervention type(s): Behavioral
Intervention description(s): Participants will be assigned to a meaningful volunteer experience from a menu of local options (e.g., volunteering at an animal shelter or in a library) for 30 hours.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; FMRI; volunteerism
Study of Pant Type Absorbing Urinary Incontinence Products
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      Pre-market feasibility clinical investigation designed to evaluate the clinical performance
      and safety of the investigational product in its intended target population
    

Detailed description: 
      The clinical clinical investigation is prospective, cross-over, interventional, multicentre
      and pre-market. The investigation aims to demonstrate the performance and safety of a new
      absorbing hygiene product (medical device) when used as intended in subjects affected with
      light to medium urinary incontinence compared to a reference (control) product representing
      standard of care.

      The study participants will be randomly assigned to one of 4 groups. Each group will receive
      a predefined pair of investigational and reference products (variants: either high waist or
      low waist) to be used in a predefined order (crossover design: investigational or reference
      product to be used first). Hence, each study subject will use two products (one
      investigational product and a corresponding reference product of the same variant) and act as
      its own control. The study subjects will use one product for 5 days and then switch to use
      the other product for 5 days.

      The primary endpoint for the investigation is the comparison in leakage performance of the
      investigation product with the reference product. There are also secondary endpoints
      regarding safety and product satisfaction and product preference.
    

Intervention name(s): RH1 (low waist); Reference variant 1 (low waist); RC2 (high waist); Reference variant 2 (high waist)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Investigational product variant 1 low waist; Reference product variant 1; Investigational product variant 2 high waist; Reference product variant 2
Other intervention name(s): TENA Silhouette Normal Low waist; TENA Silhouette Normal High waist
Intervention MeSH terms: Zinc Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects use one product for 5 days and then switch to another product for 5 days. One of the products is the investigational product and one is the reference product.
Masking: None (Open Label)
Primary purpose: Treatment