bioihbjkbjnl/mcl2 huggingface dataset:
Study Proposal for Web Based Intervention to Promote the Safe Usage of Dating Applications in Young Adults
Condition: Sex, Unsafe; Adolescent Behavior; Behavior, Sex
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of a program in promoting the safe usage of dating
      applications amongst young adults in Hong Kong. One group will receive the program regarding
      dating applications and the other group will receive a placebo program regarding health and
      exercise.
    

Detailed description: 
      Dating applications are a popular platform to meet new people; however, they have been
      associated with risks such as unsafe sexual behavior and privacy concerns in young adults.

      The study design is an open-labeled cluster randomized controlled trial with an intervention
      and a placebo control arm. The intervention group will receive a web-based intervention
      developed through focus group discussions, crowdsourcing contest, and a Peer-Vetted Creative
      Production (PVCP) workshop comprising of four short videos, a risk assessment tool, and a
      scenario game. The control group will receive a web-based resource with similar multimedia
      elements on health and exercise.

      Based on the Information, Motivation, and Behavioral Skills (IMB) Model, the primary outcome
      of this study is self-efficacy in using dating applications measured by the General Self
      Efficacy Scale. Secondary outcomes include change in attitudes regarding risk perception
      measured by the Risk Propensity Scale and depression symptoms.
    

Intervention name(s): Intervention - Dating application topic; Control - Health and exercise topic
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will consist of multimedia content to promote the safe usage of dating applications and raise awareness of the risks associated with dating application usage. The intervention will be delivered one-time in a classroom setting.; The placebo control will consist of multimedia content regarding exercise and healthy living. It will be delivered once-time in a classroom setting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Peer-led, dating applications, young adults, sexual behavior
Denver Health Asthma Management Program
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This is a Comparison Effectiveness Research (CER) study in a population of 13 to 40 year-old
      individuals with persistent asthma comparing differing levels of texting interventions with
      each other and with a usual care group. The two texting interventions include 1) texting only
      the individual with asthma and 2) texting the individual with asthma and an important person
      in that individual's life such as a parent or spouse. These two texting groups will be
      compared to a group receiving usual asthma care at Denver Health.
    

Detailed description: 
      This is Phase 2 of a two-phase pilot project to build and study a texting program for
      patients at Denver Health who have persistent asthma. The overall goal of the program is to
      provide educational support for asthma care between clinic visits and to survey for evidence
      of poorly controlled asthma, which would prompt clinic recall. Phase 1 used a focus
      group/interview methodology to inform Phase 2 and allow Phase 2 to be more patient-centered.
      Based on results of focus groups/interviews, the investigators will conduct a three-arm trial
      among 13- to 19-year-olds and a two-arm trial among 20- to 40-year-olds. For the 13- to
      19-year-old group, a 'usual care' group will be compared to two intervention groups: 1) a
      subject group receiving text messages about asthma care and 2) a group of subjects and their
      'significant other', such as a parent, who will also receive the text messages. Overall,
      Phase 1 findings suggested the 20- to 40-year-old group was more reluctant to involve a
      significant other and therefore for this group a 'usual care' arm will be compared to an arm
      where only the patient receives the text messages, but not a significant other. Other
      features built into Phase 2 upon recommendation from the focus group/interview phase include
      a midpoint survey and tailoring the amount of texting a patient receives based on the level
      of asthma control elicited by administration of the validated tool, the Asthma Control Test
      (ACT).
    

Intervention name(s): Denver Health Asthma Management Program; Person of Support
Intervention type(s): Other; Other
Intervention description(s): text message (SMS) support including educational, motivational, and resource content.; Subjects in the adolescent cohort will designate a support person (e.g. parent) to receive messages from the Denver Health Asthma Management Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Bioavailability Study Comparing 2 Vamifeport Oral Formulations in Fasted Versus Fed State in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Two different vamifeport oral formulations will be administered in fed and fasted state to
      assess the vamifeport food-drug interaction and to assess the relative bioavailability (the
      proportion of drug entering the circulation) of 2 different vamifeport oral formulations in
      healthy adult participants.

      Participants will be randomly allocated to one of four treatment sequences, with four dosing
      periods each, where different combinations of both formulations will be administered
      following fasted and fed state.

      The total study duration for each participant is up to 7 weeks and 4 days.
    


Intervention name(s): Vamifeport Formulation 1; Vamifeport Formulation 2
Intervention type(s): Drug; Drug
Intervention description(s): Vamifeport Formulation 1 is available as 60 mg oral capsules; Vamifeport Formulation 2 is available as 60 mg oral capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
An Initial Study of AZD7325 in Adults With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety, tolerability and blood pharmacodynamics of treatment
      with oral administration of AZD7325 at 5 mg BID, 15 mg BID, and placebo BID, in adults with
      Fragile X Syndrome. The study also will also investigate measures of efficacy and biomarkers
      during treatment.
    


Intervention name(s): AZD7325 (High-Dose); AZD7325 (Low-Dose); Placebo oral capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15mg PO BID; 5mg PO BID; Placebo will be dosed similar to AZD7325, in terms of dosage form, frequency and duration.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine
Condition: Pandemic Influenza; Prevention
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      A single center, randomized and double-blind phase II clinical trial is to be conducted in
      adults to evaluate the safety and immunogenicity of an inactivated pandemic influenza vaccine
      (whole-virion, aluminium-adjuvanted).
    

Detailed description: 
      The vaccine to be investigated is producted in embryonated hen's eggs using an H5N1 reference
      strain NIBRG-14 which was prepared by NIBSC. The strain is a reassortant between
      A/Vietnam/1194/2004 and A/PR/8/34 by reverse genetics.

      Total 400 volunteers aged from 18 to 60 years old are to be enrolled with 100 subjects in
      each group. The eligible volunteers will receive two doses vaccine of 5μg，10μg or 15μg
      haemagglutinin antigen. The schedule is day 0,14 or day 0,28. The subjects will donate their
      blood samples for the detection of HI antibody and microneutralization antibody. Local and
      systematic adverse reactions will be recorded during the study.
    

Intervention name(s): pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): two-dose regimen with 14 days apart: 5 microgram per dose; two-dose regimen with 28 days apart: 5 microgram per dose; two-dose regimen with 28 days apart: 10 microgram per dose; two-dose regimen with 28 days apart: 15 microgram per dose
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Blocking Tumor Necrosis Factor in Ankylosing Spondylitis
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Necrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The Division of Rheumatology at University of California San Francisco is conducting a
      research study on the treatment of ankylosing spondylitis (AS) with a new therapy currently
      used for people with other forms of arthritis. The drug, called Enbrel (or etanercept), is a
      protein that is given twice weekly by injection underneath the skin. It blocks the action of
      tumor necrosis factor-alpha (TNF-alpha), a substance that may be involved in AS, rheumatoid
      arthritis, and other inflammatory conditions. We will randomly assign patients to receive
      either the drug or a placebo (inactive treatment) for 4 months. The results we will monitor
      include morning stiffness, spinal mobility, activities of daily life, and safety of the drug.
    

Detailed description: 
      In this Phase II clinical trial we will use tumor necrosis factor receptor p75 fusion protein
      (TNFR:Fc, or etanercept) to treat patients with ankylosing spondylitis (AS). TNFR:Fc is an
      antagonist of tumor necrosis factor (TNF), a cytokine that researchers have shown to play a
      possible role in disease pathogenesis of ankylosing spondylitis, rheumatoid arthritis, and
      vasculitis, as well as other inflammatory conditions.

      TNFR:Fc consists of two molecules of the extracellular portion of the p75 receptor, each
      consisting of 235 amino acids. The two receptors are fused to the Fc portion of human IgG1,
      which consists of 232 amino acids. The gene fragments encoding the truncated TNFR and the Fc
      portion of human IgG1 are expressed in a Chinese hamster ovary cell line.

      Recent observations from animal and human studies suggest that tumor necrosis factor-alpha
      (TNF-alpha) may play a role in disease activity in AS and other seronegative
      spondyloarthropathies. This study aims to test the efficacy of TNFR:Fc used in conjunction
      with standard medications in the treatment of AS. We will give patients either 25mg of
      TNFR:Fc or placebo subcutaneously twice a week for 4 months. Outcome measures will include
      measures of function, pain, morning stiffness, patient global assessment, and swollen joint
      count, as well as safety measures.
    

Intervention name(s): Anti-Tumor Necrosis Factor
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Spondylitis; Etanercept; ENBREL; Tumor necrosis factor-alpha
Safety and Efficacy Study of Human Autologous Hair Follicle Cells to Treat Androgenetic Alopecia
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of this study is to assess the safety of performing injections of human
      autologous hair follicle cells. The study will also measure the impact these injections will
      have on hair growth.

      20 patients will be selected for participation in this study (10 males and 10 females) based
      on their health status, current/past medications, and ability to adhere to protocol-related
      requirements. All patients will have evidence of mild to moderate androgenetic alopecia (AGA)
      involving the vertex area of the scalp as defined by the Ludwig (female) or Norwood (male)
      scales.

      At the first visit and after completing informed consent, patients provide a blood sample
      that will be tested for human immunodeficiency virus (HIV), hepatitis, and syphilis one week
      before having a biopsy from the back of their scalp. The provided scalp biopsy is then
      processed to isolate hair follicle cells which are then replicated. Patients return to the
      clinic for injections of their own replicated cells (autologous cells) in medium (verum) and
      medium alone (control) into two pre-selected treatment areas in their scalp. Assessments of
      the safety/tolerability of these injections will take place over the next 60 months both at
      in-clinic visits and telephone follow-up visits. At these visits patients will have their
      overall health assessed as subjective and objective assessments of the areas that were
      injected either with verum or control. During the first 24 months of follow-up, digital
      images will be taken of the scalp and of the two treatment areas injected with either verum
      or control. Furthermore at 6, 12, and 24 months post-injection, four patients (2 male and 2
      female) at each time point will provide biopsies of the injection sites for histopathological
      analysis. At the 60 month time point, any patients not previously providing biopsies for
      histopathological analysis will provide biopsies. Total duration of patient participation is
      approximately 63 months.
    


Intervention name(s): Human autologous hair follicle cells; Cell medium
Intervention type(s): Other; Other
Intervention description(s): Human autologous hair follicle cells suspended in cell medium; Cell medium
Other intervention name(s): autologous hair follicle cells; hair follicle cells; verum; control; placebo; cell transportation medium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alopecia; Alopecia, Androgenetic; Androgenetic Alopecia
CASH- Children Active to Stay Healthy
Condition: Childhood Obesity; Inflammation
MeSH terms: Obesity; Pediatric Obesity; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of high intensity interval exercise
      (HIIE) on inflammation and endothelial dysfunction found in children with obesity. Our
      working hypothesis is that, compared with obese children prescribed moderate exercise, obese
      children prescribed HIIE will demonstrate greater improvements in endothelial function and
      inflammatory markers following a 6-week exercise intervention.
    

Detailed description: 
      Obesity, even in children, is generally accompanied by a state of chronic inflammation. To
      combat childhood obesity, clinicians and scientists recommend lifestyle interventions that
      include increased physical activity and exercise in an attempt to promote weight loss and,
      consequently, decrease comorbidities associated with excess adiposity. More importantly, it
      appears that the influence of regular exercise may offer children with obesity a multitude of
      health benefits, independent of weight loss. However, the intensity of exercise required to
      elicit significant health benefits is still unclear. Therefore, the aim of the present
      project is to study the influence of high intensity interval exercise (HIIE) on the existing
      inflammatory state found in obesity. Specifically, the proposed project will examine
      endothelial function and markers of inflammation, such as TNFa, IL-6, hsCRP, and adiponectin,
      in children with obesity before and after an exercise intervention. The data will then be
      used to determine if changes in these values differ in magnitude based on the intensity of
      exercise. Children with obesity will be randomized into either moderate exercise or HIIE
      groups, and attend sessions 3 times per week for 6 weeks. The moderate group will cycle
      continuously for 30 minutes at 65%-70% of maximal heart rate and the HIIE group will perform
      ten, 2-minute bouts at 90%-95% of maximal heart rate. Outcome measures of body composition,
      aerobic capacity, blood lipids, glucose metabolism, endothelial function, and inflammation
      will be measured pre- and post-intervention. Results may help in establishing exercise
      protocols not only for children with obesity, but also other inflammatory diseases such as
      diabetes, cancer, and arthritis.
    

Intervention name(s): Moderate exercise; High Intensity Interval Exercise
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood obesity; Inflammation; Endothelial function; Exercise
Growth Hormone Use in Adults With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The main research question this protocol aims to answer is whether treatment with growth
      hormone will impact body composition, quality of life, and energy balance in PWS adults, and
      if there is a loss of effects after cessation of treatment for at least 12 months.
    

Detailed description: 
      The main research question this protocol aims to answer is whether treatment with growth
      hormone will impact body composition, quality of life, and energy balance in PWS adults, and
      if there is a loss of effects after cessation of treatment for at least 12 months. Specific
      outcomes to be evaluated are as follows:

      • Increased IGF-1 as a function of human growth hormone dosage compared with baseline.

        1. Improvement of indicators or risk factors for co-morbid diseases [diabetes (by measuring
           insulin and glucose levels), cardiovascular disease (by measuring lipids and fatty
           acids), and pulmonary function] in participants.

        2. Improvement in quality of life measures as indicated by ratings on established behavior
           checklists in participants.

        3. Changes in body composition (decreased fat, increased lean body mass and bone density)
           as determined by DEXA in participants.

        4. Increased energy expenditure as determined by whole-room calorimeter measures (8 hour
           energy expenditure, RMR, TEF, mechanical work); diet records, physical activity monitors
           and strength measures.
    

Intervention name(s): Nutropin AQ
Intervention type(s): Drug
Intervention description(s): 0.0125 mg/kg/day
Other intervention name(s): Growth Hormone
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Neurosurgery Patient Outcomes in Treating Spinal Disorders
Condition: Symptomatic Lumbar Disc Herniation; Symptomatic Grade I Lumbar Spondylolisthesis
MeSH terms: Intervertebral Disc Displacement; Spondylolisthesis; Spinal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The creation of a multi-center cooperative research group encompassing academic and
      community-based spinal practices . . .
    


Intervention name(s): Lumbar Discectomy; Single-level lumbar fusion
Intervention type(s): Procedure; Procedure
Intervention description(s): Microsurgical removal of disc that is compressing a nerve root; pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of dapivirine
      gel (0.05%) administered rectally to HIV-1 seronegative adults.
    

Detailed description: 
      This study will evaluate the safety and pharmacokinetics (PK) of dapivirine gel (0.05%)
      administered rectally to HIV-1 seronegative adults.

      Participants will be randomized to receive a single dose of either rectally administered
      dapivirine gel (0.05%) or placebo gel at study entry (Day 0). Following a minimum 2-week
      washout period, participants or study staff will administer daily rectal doses of the
      assigned gel for 7 consecutive days under direct observation in the clinic.

      Participants will be in the study for approximately 40 days, and they will attend 16 study
      visits. Study visits may include behavioral assessments, physical examinations, blood and
      urine collection, and pelvic and anorectal sample collection. Some visits will include
      intensive PK sampling. Study staff will contact participants 1 week after Visit 16 for
      follow-up safety monitoring.
    

Intervention name(s): Dapivirine gel; Placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): Dapivirine gel (0.05%); administered rectally; Universal HEC placebo gel; administered rectally
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention