bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility Study to Use Biosensing Devices to Monitor PA and Resp. Function in Smokers w and w/o Resp. Symptoms/COPD
Condition: Signs and Symptoms, Respiratory; Mobile Applications; Activity Trackers; Respiratory Function Tests
MeSH terms: Signs and Symptoms, Respiratory
Study type: Observational

Summary: 
      This study examines the feasibility and acceptability of using mobile applications and
      biosensing (mHealth) devices in detecting vitality parameters in current smokers with and
      without respiratory symptoms/COPD (e.g., heart rate, blood oxygenation, steps/motion) for a
      future big-scale study.
    

Detailed description: 
      The study is designed to investigate feasibility of using mHealth devices to improve the
      treatment, assessment, compliance, and outcomes in smokers with and without respiratory
      symptoms/COPD. The study aims to reveal and address the anticipated barriers to the
      acceptance and implementation of mHealth devices in this patient population and clinical
      setting. As is well documented, the more attention patients receive from medical personnel,
      the better their clinical outcomes. Here we are attempting to use device-driven monitoring
      applications, interactive reminders, and teaching modules to deliver a constant positive
      feedback loop to patients to improve their health decisions.

      Objectives of the study:

      To assess the feasibility of using mHealth devices in current smokers with and without
      respiratory symptoms/COPD.

      To assess the utility (i.e., validity and reproducibility) of mHealth devices in detecting
      vitality parameters in current smokers with and without respiratory symptoms/COPD (e.g.,
      heart rate; blood oxygenation; steps/motion; FEV1, FVC, and their ratio; peak expiratory flow
      [PEF]).
    

Intervention name(s): Anamed OEM device; Air Next mobile spirometry device
Intervention type(s): Device
Intervention description(s): Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Residents of City of Almaty aged 40-59 who smoke conventional cigarettes with a minimum of
        10 pack-year smoking history
Enhanced Child Friendly Space Interventions for Children
Condition: Psychosocial Stressors; Child, Only; Mental Health Wellness 1; Child Development
Study type: Interventional

Summary: 
      A 3-arm randomised controlled trial will be conducted to compare the effectiveness of a new
      enhanced Child Friendly Space service package with the basic Child Friendly Space service
      implementation, and to a waitlist control condition, within the West Nile refugee response in
      Uganda.
    

Detailed description: 
      A Child Friendly Space (CFS) is an acute phase humanitarian intervention designed to provide
      children with a safe, supportive, and stable environment early after the onset of crisis that
      will promote their social and emotional well-being, as well strengthen the existing systems
      of protection required to support children in reaching developmental milestones. Typically,
      CFSs house a range of structured and unstructured activities led by trained animators in a
      community-designated safe area.

      The basic service package offers a mixture of recreational and non-formal education
      activities over a twelve-week period. Each session lasts around 1.5 - 3 hours. Structured
      activities offered include basic literacy and numeracy lessons, life skills exercises, health
      and hygiene sessions, and traditional song and dance. Many activities are centered around
      various forms of play that enable expression and age-appropriate skill development.
      Unstructured free play and playground time is allocated throughout the daily session.

      The enhanced service package provides 40 sequential sessions selected by CFS program staff in
      advance and implemented over a twelve-week period. Activities are meant to build upon and
      reinforce one another and are organized into seven psychosocial themes: 1) Building
      community: "Our space together", 2) Emotional learning: "My feelings", 3) Wellbeing and
      coping: "Feeling good", 4) Social support: "My friends and family", 5) Relating to others:
      "Being a good friend", 6) Protection and boundaries: "My safety", and 7) Building on
      strengths: "All my supports". Each session takes approximately 1.5 - 2 hours to facilitate
      and will conclude with 1-1.5 hours unstructured free play time.
    

Intervention name(s): Child Friendly Space
Intervention type(s): Behavioral
Intervention description(s): Child Friendly Spaces (CFS) are one of the most widely used interventions to provide Mental Health and Psychosocial Support (MHPSS) as well as provide a protective environment for children in humanitarian settings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: resilience; child protection; child development
A Trial of YPEG-rhGH in Children With Short Stature
Condition: Idiopathic Short Stature; Small for Gestational Age; Turner Syndrome
MeSH terms: Dwarfism; Turner Syndrome; Gonadal Dysgenesis
Study type: Interventional
Phase: Phase 2

Summary: 
      To explore the dose-response relationship between pharmacokinetics and pharmacodynamics of Y-
      Shaped Pegylated growth hormone injection (YPEG-GH) in children with short stature
      (idiopathic short stature (ISS), small for gestational age (SGA), Turner syndrome (TS)).

      To evaluate its tolerability, safety and efficacy and to provide evidence for dose selection
      and titration for future clinical development and clinical application in these population.
    


Intervention name(s): YPEG-rhGH; YPEG-rhGH; rhGH; rhGH
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): YPEG-rhGH, 140μg/kg, s.c., once a week, for 52 weeks; YPEG-rhGH, 280μg/kg, s.c., once a week, for 52 weeks; rhGH, 245μg/kg/week, divided into 7 subcutaneous injections, once daily, for 52 weeks; rhGH, 470μg/kg/week, divided into 7 subcutaneous injections, once daily, for 52 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Growth hormone; Somatotropin; Short stature; Idiopathic short stature; Small for gestational age; Turner syndrome
A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage
Condition: Intracerebral Hemorrhage; Obstructive Hydrocephalus
MeSH terms: Cerebral Hemorrhage; Hydrocephalus; Hemorrhage
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine if usage of early lumbar drainage leads to less
      shunt surgery and less catheter associated complications in patients with communicating
      hydrocephalus after intracerebral hemorrhage with severe ventricular involvement.
    

Detailed description: 
      All patients requiring external ventricular drain (EVD) for treatment of acute obstructive
      hydrocephalus receive intraventricular fibrinolysis with rt-PA via the ventricular catheter.
      Lumbar drainage (LD) is inserted at a timepoint, when communication between the internal and
      the external CSF-spaces is recognizable on CT ("opening" of third and fourth ventricle and
      aqueduct).
    

Intervention name(s): Lumbar drainage
Intervention type(s): Procedure
Intervention description(s): Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intracerebral hemorrhage; intraventricular hemorrhage; hydrocephalus; Intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus
First-in-human Trial With Single-dose C5a-neutralizing AON-D21 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate safety, tolerability, pharmacokinetics and
      pharmacodynamic parameters after single ascending intravenous doses of AON-D21 in healthy
      male subjects.
    

Detailed description: 
      This study will potentially include 5 sequential cohorts with 8 subjects per cohort, then 40
      enrolled subjects in total. Within each dose group 6 subjects will be randomized to receive
      AON-D21 and 2 subjects will be randomly assigned to placebo.
    

Intervention name(s): Intravenous AON-D21; Intravenous placebo
Intervention type(s): Drug; Drug
Intervention description(s): AON-D21 is a Pegylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors.; Isotonic glucose solution identical in appearance to AON-D21.
Other intervention name(s): AON-D21; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Five groups of participants will be assigned to receive AON-D21 or placebo in ascending dose order. Doses will be escalated based on safety and pharmacokinetic data.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis Trial) EU
Condition: Angioplasty, Transluminal, Percutaneous Coronary; Coronary Arteriosclerosis
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to
      facilitate hemostasis in patients undergoing diagnostic or interventional procedures.
    

Detailed description: 
      Multi-center (up to 6 European sites), non-blinded, non-randomized, feasibility study with a
      2-month enrollment period and 30-day clinical follow-up.

      60 patients (plus up to 36 "roll-in" device training patients) undergoing diagnostic or
      interventional coronary or peripheral procedures utilizing a 7F arterial puncture in the
      common femoral artery. Patients are excluded if they have a previous target artery closure
      with any closure device, recent myocardial infarction or thrombolytic therapy, treatment with
      thrombin-specific anticoagulants or low molecular weight heparin, fluoroscopically visible
      calcium or atherosclerosis ≤ 1 cm of puncture site, or planned target site access ≤ 30 days.
    

Intervention name(s): 7F Ensure Medical Vascular Closure Device
Intervention type(s): Device
Intervention description(s): Vascular Closure Device
Other intervention name(s): Ensure Medical Vascular Closure Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Closure Device; Angiography; Angioplasty; Hemostasis; Heart Catheterization; Coronary Angiography
An Efficacy and Safety Study of Autologous Cluster of Differentiation 34 (CD34+) Hematopoietic Progenitor Cells Transduced With Placebo or an Anti- Human Immunodeficiency Virus Type 1 (HIV-1) Ribozyme (OZ1) in Participants With HIV-1 Infection
Condition: HIV-1
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of administration of a
      cell-delivered ribozyme gene transfer product to participants with chronic (lasting a long
      time) Human Immunodeficiency Virus Type 1 (HIV-1) infection (a life-threatening infection
      which you can get from an infected person's blood or from having sex with an infected
      person).
    

Detailed description: 
      This is a randomized (study drug assigned by chance), double-blind (neither the participant
      nor the physician know the study medication drug name), placebo (an inactive substance that
      is compared with a drug to test if the drug has a real effect in a clinical trial) controlled
      study to investigate safety and efficacy of administration of autologous cluster of
      differentiation 34 (CD34+) cells transduced with placebo or an anti-HIV-ribozyme (OZ1) in
      participants with HIV-1 infection. The total study duration will be 100 weeks and will
      include following visits: screening, pre-infusion Days 1-7, Day 8, Week 1, 4, 8, 12, 16, 20,
      24, 25, 26, 27, 28, 30, 32, 34, 36, 38, 40, 41, 42, 43, 44, 45, 46, 47, 48, 52, 56, 60, 64,
      68, 72, 76, 80, 84, 88, 92, 96 and 100. Before the administration of CD34+ final cell
      product, a number of procedures will be performed, including the injection of granulocyte
      colony-stimulating factor (G-CSF) to mobilize the CD34+ cells, apheresis and the transduction
      of the CD34+ cells with either OZ1 or placebo. Participants will be divided into two groups:
      one group will receive OZ1-containing CD34+ cells, the other group will receive CD34+ cells
      alone and will receive a single intravenous infusion (a fluid or a medicine delivered into a
      vein by way of a needle) of CD34+ cells transduced with either placebo or OZ1 gene transfer
      product. The final cell product contains approximately 2-20 x 10^7 cells/kilogram autologous
      CD34+ cell suspension transduced with either placebo or OZ1 gene transfer product. Primary
      efficacy will be assessed primarily by the amount of HIV ribonucleic acid (RNA) (viral load).
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Placebo; OZ1; CD34+ cells
Intervention type(s): Other; Genetic; Genetic
Intervention description(s): Single intravenous infusion of placebo.; Single intravenous infusion of OZ1.; Autologous CD34+ cells.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gene Therapy; Anti-HIV-1 Ribozyme; OZ1; HIV-1 Infections
Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients
Condition: Ischemic Stroke; Hemorrhagic Stroke
MeSH terms: Stroke; Ischemic Stroke; Hemorrhagic Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether M2 macrophages are safe and feasible in the
      treatment of non-acute stroke patients
    

Detailed description: 
      Our primary hypothesis is that autologous M2 macrophage transplantation via intrathecal
      introduction is feasible and safe after non-acute stroke. Our secondary hypothesis is that
      autologous M2 macrophage transplantation is associated with improved neurological outcome
      after non-acute stroke
    

Intervention name(s): M2 macrophage introduction
Intervention type(s): Other
Intervention description(s): Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients
Intrathecal introduction of autologous M2 macrophages
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BАbykids Spray In Common Cold
Condition: Common Cold; Rhinitis Viral
MeSH terms: Rhinitis; Common Cold
Study type: Interventional

Summary: 
      The purpose of this post market clinical investigation is to demonstrate that Healsea®
      Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic
      saline solution used as Placebo in children above 2 years.
    

Detailed description: 
      Healsea® Babykids is an isotonic saline solution based nasal spray supplemented with a
      natural Symbiofilm® extract (0.04%) isolated from marine bacteria. Symbiofilm® has in vitro
      antibiofilm activity and protects in vitro human nasal epithelial cells viability after
      Rhinovirus, Adenovirus, coronavirus OC43 and flu infection.

      Healsea® Babykids is a nasal spray indicated in children above 2 years to clean and moisten
      the nose during colds and rhinitis.

      The common cold is an acute viral infection of the upper respiratory tract, involving, to
      variable degrees, sneezing, nasal congestion and discharge (rhinorrhea), sore throat, cough,
      low-grade fever, headache, and malaise. Acute viral rhinitis is generally self-limiting. In
      children where the illness is not self-limiting and extends beyond 7-10 days, many agree that
      a bacterial infection is likely. Bacterial over infections and progression to a chronic state
      are favoured by the formation of biofilms, which facilitate bacterial growth and persistence
      as well as reducing antibiotic efficacy.

      The aim of this study is to demonstrate that Healsea® Babykids alleviates symptoms of the
      acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo.

      The study comprises 2 parts:

      - Part 1 (Day 1-Day 11): treatment of the acute phase

      • with Healsea® Babykids, 2 puffs in each nostril 2 times per day with a minimum of
      7-day-treatment period (14 intakes of Healsea® Babykids) up to 10 days (20 intakes of the
      investigational device).

      or • with isotonic nasal spray (Placebo), 2 puffs in each nostril 2 times per day with a
      minimum of 7-day-treatment period (14 intakes of Placebo) up to 10 days (20 intakes of the
      investigational device).

      - Part 2 (up to Day 15/Day 18): follow-up phase.

      The study comprises two visits:

        -  Visit 1 (V1) at Day 1

        -  End of study visit (Visit 2, V2) between Day 15 and Day 18
    

Intervention name(s): Healsea Babykids; Placebo
Intervention type(s): Device; Device
Intervention description(s): 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .; 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial double blind
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nasal spray; supplemented isotonic saline solution; infectious rhinitis; children
Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes
Condition: Diabetes; Hypertension; Dyslipidemia
MeSH terms: Diabetes Mellitus; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Our study intends to test the efficacy of pharmacist-led group interventions on a weekly
      basis for 4-weeks, then on a monthly basis for 5 additional months to achieve concomitant
      reductions in hemoglobin A1c, lipids and blood pressure.
    

Detailed description: 
      Our project intends to study the 6-month efficacy of a pharmacist-led group intervention
      program that simultaneously target diabetes, hypertension and dyslipidemia. We hypothesize
      that pharmacist-led group interventions on a weekly basis for 4-weeks then on a monthly basis
      for 5 additional months may achieve concomitant reductions in hemoglobin A1c, lipids and
      blood pressure. We are proposing a pilot randomized controlled study to test the efficacy and
      feasibility of this approach.
    

Intervention name(s): MEDIC
Intervention type(s): Other
Intervention description(s): Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Group Intervention; Pharmacotherapy; Behavioral Modification; Diabetes
The Effect of ProHydrolase® on the Amino Acid, Intramuscular Anabolic Signaling, and Endocrine Response to Resistance Exercise in Trained Males
Condition: Amino Acids
Study type: Interventional

Summary: 
      To examine the amino acid absorption following acute resistance exercise between three
      supplemental treatments: 1) Whey Protein + ProHydrolase (WPH) 2) Whey Protein (W) and 3)
      Non-Caloric Placebo (PL). To examine three supplemental treatments (WPH, W, PL) in
      conjunction with acute resistance exercise on the mTORC1 complex pathway. To examine three
      supplemental treatments (WPH, W, PL) in conjunction with acute resistance exercise on
      circulating concentrations of endocrine biomarkers.
    


Intervention name(s): ProHydrolase®; Whey protein; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects received 250mg of ProHydrolase® with 25g whey protein mixed together in a drink; Subjects received 25g of whey protein powder mixed to together in a drink; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Amino Acids; Intramuscular Anabolic Signaling; Endocrine Response; Resistance Training
Behavioral Intervention for HIV and HCV-Uninfected Injection Drug Users
Condition: HIV Infections; Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to test whether a six-session behavioral intervention for HIV
      and HCV seronegative injection drug users is effective in reducing sexual and injection risk
      behaviors that could lead to primary HIV and HCV infection.
    

Detailed description: 
      CIDUS III/DUIT is a five-city (Baltimore, Chicago, Los Angeles, New York, and Seattle)
      randomized controlled trial to develop and evaluate the efficacy of a six-session behavioral
      intervention for HIV and HCV uninfected injection drug users between the ages of 15 and 30
      years. The primary goals of the intervention are to:

        1. decrease the shared use of syringes and other injection paraphernalia,

        2. decrease sexual risk behaviors associated with HIV and HCV infection, and

        3. decrease the incidence of hepatitis C virus (HCV) infection.

      The intervention arm consists of six small-group training and skills-building sessions to
      teach and reinforce peer education activities around decreasing sex and injection risk
      behaviors for HIV and HCV infection. In the fifth session, participants practice peer
      education around sex or injection risk behaviors within their community. The control arm
      consists of six video and discussion sessions to control for attention. Prior to study
      enrollment, all participants in both arms receive HIV and HCV testing with client-centered
      pre- and post-test counseling to also control for the demand for risk reduction information.
      Behavioral assessments (by audio computer assisted self interviewing) and blood draws (for
      serologic testing) occur at baseline, 3 and 6 month follow-up. 3285 participants completed
      the baseline visit, of whom 1564 tested HIV and HCV seronegative and returned for test
      results making them eligible to enroll in the intervention trial. Of the eligible
      participants, 854 were randomized into the trial. 606 and 591 returned for 3 and 6 month
      follow-up assessments, respectively, and 712 participants completed at least one follow-up
      visit.
    

Intervention name(s): Peer Education Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: IV Drug users; HIV; hepatitis C virus; HIV Seronegativity