bioihbjkbjnl/mcl2 huggingface dataset:
Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance
      characteristics of a prototype mask system and to evaluate the usability of the mask system.
      The mask system will be assessed according to objective data recordings and user
      questionnaires. It is hypothesised that the prototype mask components will not pose a health
      risk (with regards to bioburden and impedance) and that the mask system will pass usability
      objectives to adequately deliver CPAP treatment.
    


Intervention name(s): Geelong Prototype Mask
Intervention type(s): Device
Intervention description(s): A nasal pillows prototype mask to be trialled with a PAP therapy device for a period of 6 weeks. Participants will wear the mask in place of their current mask for the duration of the trial.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: sleep; sleep apnea; OSA; CPAP
Cephalic Phase Insulin Secretion and Capillary Recruitment in Healthy Men
Condition: Microvascular Function
Study type: Interventional

Summary: 
      Forty healthy volunteers will undergo two nailfold-videocapillaroscopy exams with a 10-minute
      interval between them, after an 10-h overnight fast in a temperature controlled room. The
      subjects will be randomized in two groups: one will receive a sensorial stimulus during the
      interval (stimulus group - SG) and the other will receive no stimulus (control group - CG).
      The sensorial stimulus will be a breakfast meal, with excellent presentation and aroma,
      composed by favorite food items previously related by the individual for this meal. The meal
      will not be offered for immediate intake, it will be placed in front of the volunteer for
      perception of the smell and taste.

      Baseline microvascular parameters will be compared to the results after the interval. The
      investigators hypothesize that the SG will have greater capillary recruitment due to a
      possible effect of physiologically secreted insulin provoked by the sensorial stimulation
      (cephalic phase of insulin secretion).
    


Intervention name(s): Breakfast tray
Intervention type(s): Other
Intervention description(s): The sensorial stimulus will be a breakfast meal, with excellent presentation and aroma, composed by favorite food items previously related by the individual for this meal. The meal will not be offered for immediate intake, it will be placed in front of the volunteer for perception of the smell and taste.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Capillary recruitment; Cephalic Phase of Insulin Secretion; Dietary Intake
Randomized Trial of the Effects of Musical Training on Child Development in the Venezuela Orchestra Program (El Sistema)
Condition: Child Development
Study type: Interventional

Summary: 
      This study evaluates Venezuela's National System of Child and Youth Orchestras, better known
      as "El Sistema".
    

Detailed description: 
      The randomized control trial was conducted in 16 music centers in Venezuela between May 2012
      and November 2013, with a population of 6-14 year olds seeking entry to the program. During
      an application period (May-July 2012), 2,603 guardians (the experimental cluster) applied on
      behalf of 2,999 6-14 year olds. Approximately half of the guardians were randomly offered
      early admission in September 2012, with the rest offered admission in September 2013.
      Baseline and follow-up data were collected on outcomes which will be explored for full-group
      and specific sub-groups (children with less educated mothers, and boys or girls exposed to
      violence).
    

Intervention name(s): Treatment (Invited entry 2012); Control (Invited entry 2013)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Entry to music program offered in September 2012; Entry to music program offered in September 2013
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: child development; music training; self-regulation; exposure to violence
Comparison of Treatment Failure Criteria in HIV-Infected Children in Uganda
Condition: HIV
Study type: Interventional

Summary: 
      The main goal was to compare clinical and immunological versus clinical, immunological plus
      viral load criteria for switching to second-line ART by comparing 48 week treatment outcomes,
      including survival rates, viral suppression, failure to thrive, and AIDS-defining illnesses
      for treatment experienced children randomized to two switching criteria.
    

Detailed description: 
      The overall goal of the study was aimed at determining whether the use of the current WHO
      criteria alone (clinical and immunologic) to define treatment failure as the trigger for
      switching to second-line antiretroviral therapy leads to poorer 6 month and 12 month
      treatment outcomes when compared to combining clinical and immunologic parameters with viral
      load (VL) monitoring.

      In addition the study aimed at obtaining plasma samples from treatment experienced children,
      for future resistance testing. The results of this study may help guide WHO and national
      pediatric ART programs on the need for routine VL monitoring for children initiating HAART in
      resource limited settings, where virologic tests including resistance testing are not readily
      available or affordable.
    

Intervention name(s): Viral Load
Intervention type(s): Other
Intervention description(s): For the Clinical and Immunologic criteria, viral load was done retrospectively on stored plasma samples. Whereas for the Clinical, Immunologic and Virologic criteria, viral load was done in real-time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
2nd Pivotal Study rPhleum - Adults and Adolescents With Rhinoconjunctivitis +/-Controlled Asthma
Condition: Rhinoconjunctivitis; Allergic Asthma
MeSH terms: Asthma; Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate efficacy and tolerability of specific subcutaneous immunotherapy with a cocktail
      of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) in subjects with
      rhinoconjunctivitis caused by grass pollen with/without controlled asthma.
    


Intervention name(s): Grass pollen specific immunotherapy; Placabo
Intervention type(s): Drug; Drug
Intervention description(s): Strength 1 (0.78μg/mL)
Strength 2 (6.25μg/mL)
Strength 3 (50μg/mL)
Strength 4 (200μg/mL)
The subcutaneous injections will be administered at intervals of 7 (+ 7 days)during up-titration. For maintenance the injection intervals are prolonged to 4 weeks (+2). The double blind treatment period is 2 years, followed by 1 year open-label treatment for patients previously treated with verum and 3 years open-label treatment for patients previously recieved placebo.; Placebo will be administered in the same way as the test product. Placebo will be identical in terms of appearance to the IMP.
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: specific immunotherapy; SIT
Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
Condition: Hemorrhagic Fever, Ebola
MeSH terms: Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of
      different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly
      (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults.
    

Detailed description: 
      This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter,
      2-part, Phase 2 study of Ad26.ZEBOV and MVA-BN-Filo in healthy and HIV infected adults. In
      part 1, dose 1 vaccination with MVA-Bn-Filo will be followed by dose 2 vaccination with Ad26
      14 days later in the US. In part 2, two regimens will be investigated. The first regimen will
      be Ad26 dose 1 vaccination followed by MVA-BN-Filo dose 2, 28 days later and the second
      regimen will be MVA-BN-Filo dose 1 vaccination followed by Ad26.ZEBOV dose 2, 14 days later
      in Africa. The study consists of a Screening phase of up to 8 weeks (starting from the moment
      the participants signs the ICF), a Vaccination Phase, in which participants will be
      vaccinated at baseline (Day 1) followed by a dose 2 vaccination on Day 15 or 29, and a
      post-dose 2 follow-up phase of maximum 1 year post-dose 2 vaccination. Upon completion of
      6-month post dose 2 visit those participants who received active vaccine will enter long-term
      follow-up until the 1 year post dose 2 vaccination visit to assess long-term safety and
      immunogenicity.
    

Intervention name(s): Ad26.ZEBOV; MVA-BN-Filo; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles).; One 0.5 mL IM injection of (1x10*8 infectious units).; One 0.5 mL IM injection of 0.9 percent (%) saline.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Healthy; Vaccine; Ebola viruses; Ebola virus disease (EVD); Filoviruses; Hemorrhagic fever; Monovalent vaccine; Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vector; Safety; Immunogenicity
Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if CX157 is effective and safe in patients with
      treatment of treatment resistant depression over six weeks of treatment.
    

Detailed description: 
      The primary objective of this study is to examine the efficacy of CX157 Modified Release
      Tablet, 125 mg administered twice per day (BID) as compared to placebo in subjects with
      Treatment Resistant Depression (TRD). Secondary objectives are to evaluate the safety and
      tolerability of CX157 Modified Release Tablet, 125 mg BID in TRD subjects and characterize
      steady-state pharmacokinetic profile and explore pharmacodynamic relationships.
    

Intervention name(s): Placebo; CX157 (TriRima)
Intervention type(s): Drug; Drug
Intervention description(s): Placebo administered twice per day for six weeks.; One tablet administered twice per day (total daily dose of 250 mg) for six weeks.
Other intervention name(s): Sugar Pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TRD
Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine.
      This results in back pain and stiffness, and causes difficulty with daily activities.
      Physical activity and exercise are key components of the management of ankylosing
      spondylitis, however many adults with ankylosing spondylitis do not meet physical activity
      recommendations. This study aims to investigate the effects of a twelve week intervention
      designed to increase physical activity and exercise in adults with ankylosing spondylitis.
    

Detailed description: 
      Participants will be randomly allocated to one of two groups. An intervention group will
      receive individual consultations with a physiotherapist. The aim of the meetings will be to
      motivate and support participants on an individual basis, with the goal of increasing weekly
      physical activity. The second group, the control group, will continue with their current
      management strategies. All participants will be assessed at baseline, post-intervention
      (after twelve weeks) and after a three month follow-up period. The primary outcome measure
      will be free-living physical activity over one week.
    

Intervention name(s): Brief Intervention
Intervention type(s): Behavioral
Intervention description(s): 'Brief Intervention' is the term used to mean verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up. 'Brief Interventions' provide a structured way to deliver advice and involve the provision of formal help and follow-up. They aim to equip people with tools to change attitudes and handle underlying problems.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spondylarthropathies; Motor Activity; Physical Therapists; Accelerometry
A Study of the C3 Complement Inhibitor AMY-101 in Adults With Gingivitis
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase 2a Clinical Trial to Assess the Safety and Efficacy of Complement 3 Inhibitor Analog,
      AMY-101, in Adults with gingivitis.

      The study is a 3-month randomized, double-blind, split-mouth study of adults with existing
      chronic periodontal inflammation determined by the level of gingival index and bleeding on
      probing. The primary endpoint of change in gingival index will be evaluated at 21, 28 and 90
      days after initial treatment (baseline treatment). Subjects will also be followed at Day 3,
      7, 14, 21, 28 and 90 for safety evaluations. Change in bleeding on probing plaque index,
      pocket depth, clinical attachment level and GCF levels of pro-inflammatory cytokines and
      complement factors will be assessed as secondary outcome measures. Composition of subgingival
      biofilm will be assessed as an exploratory endpoint.

      Subjects who meet inclusion criteria will be enrolled in the study and sites will be
      randomized to treatment groups (AMY-101 or placebo) in split mouth design. After clinical
      assessments and sample collection at baseline, both test and placebo treatments will be
      administered to each of the interproximal papilla and will be repeated on Day 7 and 14.
    


Intervention name(s): AMY-101; Water for injection
Intervention type(s): Drug; Other
Intervention description(s): C3 complement inhibitor; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being performed to compare the systemic pharmacokinetic profiles of T4032 and
      Lumigan 0.01% given that T4032 has a different formulation (in terms of excipients) from the
      reference product.
    


Intervention name(s): Bimatoprost Ophthalmic
Intervention type(s): Drug
Intervention description(s): eyedrops
Intervention MeSH terms: Bimatoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Electrical Velocimetry (ICON Cardiometry ) Assessment of Hemodynamic Changes During Pediatric Thoracoscopic Surgery
Condition: Hemodynamics
Study type: Observational

Summary: 
      Advances in endoscopic equipment and technique have led to the use of minimally invasive
      thoracic surgery in an increasing number of pediatric surgical procedures. Logically,
      thoracoscopic surgery and anesthesia can induce significant physiologic changes,,
      derangements of normal respiratory physiology induced by the surgical approach and the
      installation of carbon dioxide into the thoracic cavity can lead to alterations of normal
      acid-base status. Finally, surgical procedures in the chest, surgical traction or
      insufflation pressures impairs venous return and/or cardiac function, especially in neonates
      and infants. In this study Electrical Cardiometry TM (ICON, Cardiotronic/Osypka Medical,
      Inc., La Jolla CA, USA) is used assess the effect of different intra-thoracic pressure
      (insufflation pressures 4,5 & 6 mmHg) during thoracoscopic surgeries in neonates and infants
      on hemodynamics using electrical velocimetry (ICON) as non-invasive monitoring technique.
    


Intervention name(s): Cardiotronic ICON continuous non-invasive cardiac output monitor.
Intervention type(s): Device
Intervention description(s): cardiac index, cardiac output & stroke volume measured and recorded with every change in intrathoracic pressure.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        infants and neonates who are a candidate for thoracoscopic surgeries, and suffer no
        congenital heart disease.
      
Keywords: pediatric; thoracoscopic; cardiometry; cardiac output; hemodynamics
Evaluating the Pharmacokinetic Interaction Between AD-2101 and AD-2102
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2101 and
      AD-2102 in healthy male subjects.
    

Detailed description: 
      To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination
      compared with the administration of AD-2101 and AD-2102.
    

Intervention name(s): AD-2101; AD-2102; AD-2101 + AD-2102
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AD-2101 16/5mg; AD-2102 25mg; AD-2101 16/5mg + AD-2102 25mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY3154207 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on
      the body. There will be 3 parts to this study.

      Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks for
      each participant. Each participant will receive two doses of LY3154207, if part A is
      completed.

      Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each
      participant. Part B includes collecting fluid from the spinal column to measure levels of
      LY3154207.

      Part C will include a single dose of LY3154207 given alone and then a second dose given along
      with itraconazole to look for change in LY3154207 levels. Part C will last about 3 weeks for
      each participant.

      Participants may only enroll in 1 of the 3 parts of the study.
    


Intervention name(s): LY3154207; Placebo; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally (twice daily on Day 3 and then once daily to Day 12) as a 10 mg/mL solution
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effect of Intraoperative Dexmedetomidine on Lung Protection Following Thoracic Aorta Surgery With Hypothermic Circulatory Arrest: a Randomized Clinical Trial
Condition: Chronic Dissecting Aneurysm of Thoracic Aorta; Chronic Nontraumatic Dissection of Thoracic Aorta; Dissecting Aneurysm of the Thoracic Aorta
MeSH terms: Aortic Dissection; Aneurysm; Aortic Aneurysm, Thoracic
Study type: Interventional
Phase: Phase 4

Summary: 
      Dexmedetomidine has been known to protect the lung against inflammation and oxidative stress
      in diverse clinical settings. The investigators aimed to investigate the lung protective
      effect of dexmedetomidine in patients undergoing thoracic aortic surgery with hypothermic
      circulatory arrest, which is associated with systemic inflammatory response, and oxidative
      stress.
    

Detailed description: 
      Patients will be divided into 2 groups; dexmedetomidine group and control group.
      Dexmedetomidine group will receive dexmedetomidine during and after thoracic artery surgery.
      And control group will receive the same amount of normal saline instead. Analyzing patients
      lung function and serum factors, which indicates the degree of systemic inflammatory
      responses and oxidative stress, The investigators will investigate the protective effect of
      dexmedetomidine on lung.
    

Intervention name(s): Dexmedetomidine; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12 hrs of aortic cross clamp off; IV loading and infusion of same volume of normal saline after induction until 12 hrs of aortic cross clamp off
Other intervention name(s): precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Protein Blends (Soy, Whey and Casein) for Muscle Synthesis
Condition: Muscle Synthesis
Study type: Interventional

Summary: 
      Soy protein is a high quality, plant-based protein that is comparable to milk, meat and eggs.
      Soy protein has a digestion rate (intermediate) compared to whey (fast) and casein (slow).
      This intermediate rate may allow soy protein to have an extended window of muscle protein
      synthesis that has not been monitored in previous studies. While most of the sports nutrition
      "recovery" products are dairy-based protein blends (high in branched-chain amino acids), soy
      protein offers additional benefits that can make an important contribution to these types of
      sports nutrition products. Soy protein contains approximately 300% more arginine and 30% more
      glutamine compared to whey protein and these two amino acids may bring additional benefits
      (immunity and hydration, respectively) to athletes. A "blend" of high-quality proteins (soy
      and dairy) may be the optimal sports nutrition product for athletes to consume following
      training.
    


Intervention name(s): Protein Blend
Intervention type(s): Other
Intervention description(s): Single intake of approximately 20 grams of total protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: muscle; synthesis; mTOR; antioxidant; inflammatory markers; soy protein; whey; casein