bioihbjkbjnl/mcl2 huggingface dataset:
Decreasing Body Dissatisfaction in Male College Athletes: A Randomized Controlled Trial of the Male Athlete Body Project
Condition: Health Behavior
Study type: Interventional

Summary: 
      Body Dissatisfaction (BD) is associated with marked distress and often precipitates
      disordered eating symptomology (Milligan & Pritchard, 2006). BD in male athletes is an
      important area to explore, as research in this field often focuses on eating disorders in
      female athletes (e.g., Becker et al., 2012; Varnes et al., 2013). The current body of
      literature regarding male college athletes suggests that they experience pressures associated
      with both societal muscular ideals and sport performance (Galli et al., 2015). While there is
      a clear association between drive for muscularity and BD in collegiate male athletes (Galli
      et al., 2015), no study to date has conducted research aimed to attenuate the effect of BD in
      this population. The current study seeks to investigate a BD intervention for male college
      athletes. Participants will be randomized to an adapted version of the standardized Female
      Athlete Body Project (i.e., the Male Athlete Body Project) or an assessment only control
      condition. All participants will complete baseline and post-treatment measures of BD,
      negative affect, internalization of an athletic ideal, drive for muscularity, sport
      confidence, eating pathology, and unhealthy weight-control behaviors. Study aims are to
      determine if the Male Athlete Body Project intervention group reduces BD and related factors
      post-treatment, and to investigate whether these differences are maintained at 1-month follow
      up. Results will inform mental health and sport clinicians, coaches, and other personnel
      involved in an athlete's care about successful strategies for decreasing BD.
    


Intervention name(s): Male Athlete Body Project
Intervention type(s): Behavioral
Intervention description(s): Participants who meet eligibility criteria and consent to the study will be randomized to one of two conditions: intervention condition (i.e., Male Athlete Body Project) or an assessment only control condition. The intervention groups will take place at IIT. Participants who accept randomization to condition will complete baseline questionnaires after randomization (immediately prior to Session 1 in the intervention condition and after being randomized to the assessment only control condition). Questionnaires will be repeated immediately post-intervention (intervention condition)/after a 3-week interval (control). All participants will be asked to complete the questionnaires again, 4 weeks after the previous round of questionnaires. The 3, 80-minute group sessions will be separated by 1 week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of Grass SLIT Treatment on Birch Pollen Induced Allergic Rhinitis - a Pilot Evaluation
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study is a Phase IV, single center, placebo-controlled, parallel study design
      conducted using the Environmental Exposure Unit (EEU). The study will aim to be determine
      whether there are any benefits from Grastek® for the treatment of birch-pollen induced
      allergic rhinoconjunctivitis. Grastek® is a Health Canada and FDA approved sublingual
      immunotherapy (SLIT) for the treatment of grass-pollen induced allergic rhinoconjunctivitis.
      The EEU provides a closed environment in which participants are exposed to a predetermined,
      controlled, constant level of airborne pollen. 96 participants will complete this study and
      will either receive Grastek® or placebo in a 1:1 ratio. The study will consist of a screening
      visit, a pre-treatment pollen exposure visit, 60 days of treatment with Grastek® or placebo,
      two treatment visits and a follow-up pollen exposure visit.
    


Intervention name(s): Grastek®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): one tablet daily for four months; one tablet daily for four months
Other intervention name(s): sugar pill
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rhinitis; allergy
Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy
Condition: Limb Ischemia; Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Ischemia
Study type: Interventional

Summary: 
      Several pathophysiological theories have been proposed for the development of diabetic
      chronic complications. In recent years, the use of stem cells (totipotential, hematopoietic
      or endothelial lineages) has been reported as an adjunctive modality of treatment for
      ischemia models in animals and humans. Nevertheless, there are no reports in the use of stem
      cells for the treatment of human sensorimotor peripheral diabetic neuropathy. We performed
      this study to evaluate the effect of autologous hematopoietic CD34+ cell transplantation on
      nerve conduction velocity in patients with type 2 diabetes mellitus.
    


Intervention name(s): Hematopoietic stem cell transplantation
Intervention type(s): Biological
Intervention description(s): Intramuscular application of CD34+ hematopoietic stem cells (with a minimum of 2 million CD34+ cells/kg) into the gastrocnemius muscles after stimulation with subcutaneous filgrastim 600 micrograms/kilogram a day for 4 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nerve conduction velocity; hematopoietic stem cell transplantation
Assessment of Asthma Knowledge Perception in Parents of Asthmatic Children. Pilot Study by Means of Q-KAP ( Questionnaire on Knowledge, Attitudes and Practices )
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The aim of this study is to assess the knowledge, the attitudes and the practices of parents
      of asthmatic children.
    

Detailed description: 
      The aim of this study is to assess the knowledge, the attitudes and the practices of parents
      of asthmatic children.

      The study proposes the validation of Q- KAP by means of the recruiting of 390 parents of
      asthmatic children, recruited in the outpatient clinic of Pediatric Allergology & Pulmonology
      (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and
      Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM
      CNR), Italy.

      Q-KAP will be given to one of the parents during their children medical examination. Q-KAP is
      a multiple answer questionnaire investigating on knowledge, attitudes and practices for what
      concerns Asthma.

      At the end of the recruitment time, data will be stored and analyzed in a dataset.

      The expected result is the identification of a tool able to assess knowledge, attitudes and
      practices of asthmatic children parents, but also the identification of a tool able to
      identify two groups of parents (well-experienced and bad-experienced) to assess if there is a
      link between a low degree of knowledge and a bad control of the disease.
    

Intervention name(s): Q-Kap
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        390 asthmatic children, recruited in the outpatient clinic of Pediatric Allergology &
        Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of
        Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of
        Palermo (RDRC-IBIM CNR), Italy.
The Intelligent Cardiopulmonary Rehabilitation System: A Feasibility Study
Condition: Cardiac Rehabilitation
Study type: Observational

Summary: 
      The Intelligent Cardiopulmonary Rehabilitation System (ICRS) was developed to automatically
      control the resistance of pedaling in combination with the conventional stationary bike by
      monitoring the user's heart rate for clinical use. To test its feasibility, 8 healthy
      participants were recruited to complete 12 sessions (3 times per week for 4 weeks) of indoor
      cycling on the stationary bicycle with ICRS. Subjects were received cardiopulmonary exercise
      testing (CPET) before and after the biking sessions.The 60-80% of heart rate reserve (HRR) of
      each participant was determined according to their first CPET results. The algorithm of ICRS
      was designed to enable the bicycle to adjust its training intensity in accordance with the
      subject's 60-80% HRR which was detected by wearing a wristband heart rate monitor during
      cycling. With ICRS, the participants' heart rates during training were expected to fall in
      the 60-80% HRR, increasing their cardiopulmonary fitness after 12 sessions of indoor cycling.
    


Intervention name(s): ICRS
Intervention type(s): Device
Intervention description(s): The ICRS enables a stationary bike to automatically adjust the pedaling resistance (i.e. training intensity) according to the subject's heart rate. The training intensity is determined by monitoring whether the subject is able to maintain a 50-70 cycles/min cadence with 60-80% HRR. Subjects heart rate was detected by a wearable device for heart rate, synching with the stationary bike.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Healthy subjects
      
Keywords: cardiac rehabilitation; cardiorespiratory fitness; aerobic exercise; endurance training
A Study of the MASEI in the Treatment of Anti-TNF Blocker to Peripheral Tendonitis in Patients With Spondyloarthritis
Condition: Spondyloarthropathy
MeSH terms: Spondylitis; Spondylarthritis; Tendinopathy; Spondylarthropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy
      of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein injection
      (Yisaipu®) in the treatment of peripheral enthesitis in active axial spondyloarthritis(SpA)
      patients.
    

Detailed description: 
      Mardird sonographic enthesis index (MASEI) was one of the most wide used scoring systems for
      peripheral enthesitis and the only one based on OMERACT definition of enthesopathy by EULAR.
      The primary purpose is to assess the MASEI to discover the value of US in diagnosis and
      prognosis. The second prupose is to assess different maintaining treatment programme in SpA
      patients with improvement of MASEI. The trial will include 96 patients with stable NSAIDs
      therapy, and at the first stage they will receive 24-week full-dose of Yisaipu®. Then at the
      second stage the patients who achieve low disease activity (LDA, ASDAS<2.1) at 24th week will
      be randomizedly divided into three group: full-dose of Yisaipu® group, half-dose of Yisaipu®
      group and placebo group. And the blind stage will last for 24 weeks. Patients who complete
      the 48-week therapy or achieve disease-flare criteria during the blind stage would finish the
      study.
    

Intervention name(s): 50mg etanercept; 25mg etanercept; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week; Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 25mg per week
Other intervention name(s): 50mg Yisaipu®; 25mg Yisaipu®
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mardird sonographic enthesis index; Spondyloarthropathy; Ultrasonics; Etanercept
Study to Evaluate the Effect of Repeat-Dose Rifampin on the Pharmacokinetics (PK) of PF-06651600
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Evaluate the Effect of Repeat-Dose Rifampin on the pharmacokinetics (PK) of
      PF-06651600.
    


Intervention name(s): PF-06651600; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): 50 milligram (mg) tablet; 600 mg provided as two 300 mg capsules.
Other intervention name(s): Rifadin®.
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-06651600; Rifampin; Drug-drug interaction study; Pharmacokinetics
The SNEC DSAEK EndoGlide Clinical Trial
Condition: Bullous Keratopathy
MeSH terms: Corneal Edema
Study type: Observational

Summary: 
      The purpose of this study is to determine the clinical safety and efficacy of the EndoGlide
      as a donor insertion device in DSAEK surgery. The investigators hypotheses is that the
      Endoglide will cause less endothelial damage compared to the investigators previous technique
      of glide insertion but will have the same low complication rate as the previous device. Hence
      the investigators aim to evaluate the surgical efficacy of the EndoGlide to enable consistent
      double coiling of the donor lenticule in DSAEK surgery with minimal endothelial touch.
      Evaluate ease of insertion of the EndoGlide through a 4 to 4.5mm scleral tunnel wound.
      Evaluate ability of the EndoGlide to consistently effect complete wound sealing, so as to
      stabilize anterior chamber with an AC maintainer in position. Evaluate ease of donor
      pull-through from the EndoGlide chamber into the AC and to evaluate spontaneous uncoiling of
      the donor in the AC. Evaluate clinical efficacy and safety outcomes in EndoGlide assisted
      DSAEK surgery in study patients with corneal decompensation requiring DSAEK surgery, in terms
      of postoperative visual acuity, primary graft failure rate, donor dislocation rate,
      endothelial cell loss, and deturgescence of the host cornea and donor lenticule as measured
      by corneal thickness parameters with the Visante AS-OCT. The investigators will perfprm a
      prospective Phase II clinical trial using the EndoGlide for donor insertion in 100 corneal
      patients referred to the SNEC Corneal Clinics of the study investigators with moderate
      degrees of corneal decompensation from a variety of disorders which require DSAEK corneal
      transplantation surgery, with or without concurrent cataract surgery, to restore visual
      acuity.
    


Intervention name(s): Endoglide
Intervention type(s): Device
Intervention description(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Bullous Keratopathy
      
Keywords: Endoglide; Endothelial Keratoplasty; Donor Insertion; DSAEK; Corneal Transplant; Patients with Bullous Keratopathy
Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
Condition: Infant Development
Study type: Interventional

Summary: 
      The objective of this randomized study is to test the hypothesis that scores on the Bayley
      Scales of Infant Development-III (Bayley-III) are higher than scores on the Bayley Scales of
      Infant Development-II (BSID-II) in the same group of infants who were born very preterm.
    

Detailed description: 
      The objective of this randomized crossover study is to test the hypothesis that scores on the
      Bayley Scales of Infant Development-III are higher than scores on the Bayley Scales of Infant
      Development-II in the same group of infants who were born very preterm. First, however, the
      investigators must demonstrate that significant "learning" does not occur when the tests are
      administered 4-8 weeks apart. The investigators hypothesize that scores on the Bayley-III
      will be higher than scores on the BSID-II, irrespective of the order in which the tests are
      administered.
    

Intervention name(s): Bayley Scales of Infant Development-II; Bayley Scales of Infant Development-III
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Individually administered test, designed to evaluate the developmental functioning of infants and small children, between 1 and 42 months of age. The purpose of the test is to identify infants and children with developmental delay. BSID-II was published in 1993. BSID-II provides normative data from two scales - Mental Development Index (MDI), and Psychomotor Development Index (PDI).; Individually administered test, designed to evaluate the developmental functioning of infants and small children, between 1 and 42 months of age. The purpose of the test is to identify infants and children with developmental delay. BSID-III was released in 2006. BSID-III provides normative data from five scales - Cognitive, Language, Motor, Social-Emotional, and Adaptive.
Other intervention name(s): BSID-II; Bayley-III; BSID-III
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Agerelated Macular Degeneration (AMD) Who Received Anti-VEGF Agents (IRIS Registry)
Condition: Age-related Macular Degeneration (AMD)
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      In this cross-sectional study of patients with wet AMD who received ≥1 anti-VEGF injection
      (excluding brolucizumab), evidence was generated to describe the period prevalence of
      specific ocular AEs. The study was conducted using the IRIS Registry, and all results were
      based on the study period from 01/01/2019 to 12/31/2019.
    

Detailed description: 
      This was a retrospective cohort study of eyes in adult patients with a diagnosis of wet AMD
      who were treated with anti-VEGF agents from 01/01/2019 to 12/31/2019.

      IRIS Registry data from 01/01/2019 to 12/31/2019 for patients with a diagnosis of wet AMD who
      were treated with ≥1 anti-VEGF agent (excluding brolucizumab) were included.

        -  Identification period: Patients fulfilling the selection criteria during the period from
           01/01/2019 to 12/31/2019 were identified

        -  Index date: 01/01/2019

        -  Study Period: 01/01/2019 to 12/31/2019

        -  Pre-index period: 01/01/2018 to 12/31/2018

        -  Post-index period: 01/01/2019 to 12/31/2019
    

Intervention name(s): Aflibercept; Ranibizumab; Bevacizumab
Intervention type(s): Other; Other; Other
Intervention description(s): intravitreal injection; intravitreal injection; intravitreal injection
Other intervention name(s): EYLEA®; LUCENTIS®; AVASTIN®; off-label use
Intervention MeSH terms: Bevacizumab; Ranibizumab; Aflibercept
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        IRIS Registry data from 01/01/2019 to 12/31/2019 for patients with a diagnosis of wet AMD
        who were treated with ≥1 anti-VEGF agent (excluding brolucizumab) were included.
Acthar Gel in Participants With Pulmonary Sarcoidosis
Condition: Sarcoidosis, Pulmonary
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out if Acthar Gel is safe and effective to treat
      pulmonary sarcoidosis.

      Participants will be randomly assigned (like flipping a coin) to receive a shot under their
      skin of Acthar Gel or a matching placebo gel that has no drug in it. They will receive their
      assigned shot twice a week for 24 weeks.

      All participants who complete the 24-week treatment period will be eligible to receive Acthar
      Gel for 24 more weeks, even if they were originally in the placebo group.
    


Intervention name(s): Acthar Gel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL); Placebo gel for SC injection
Other intervention name(s): H.P. Acthar Gel; Repository Corticotropin Injection; Matching Placebo
Intervention MeSH terms: Adrenocorticotropic Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Ascending Doses of AZD5069 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore the safety and tolerability of AZD5069 at
      steady-state, following twice a day oral dosing in healthy subjects.

      AZD5069 is being developed by AstraZeneca and this study is being carried out on behalf of
      the sponsor by Quintiles Drug Research Unit at Guy's Hospital, London. This is the second
      time that AZD5069 will be administered to humans in clinical trials. We are conducting this
      study to determine whether AZD5069 is safe and well tolerated by healthy males and females at
      different dose levels over an 8-day dosing period. We will also be studying how quickly
      AZD5069 is absorbed into and cleared by the body. It is planned that there will be up to 3
      dose groups in the study and each group will consist of up to 12 volunteers, with 9 receiving
      the active drug and 3 receiving placebo. The study involves 3 visits over approximately 8
      weeks, and will include 1 residential visit lasting 10 nights and a follow up.
    


Intervention name(s): AZD5069; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral suspension dose of AZD5069. Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7; oral suspension dose of matched placebo. Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Phase I; multiple ascending dose; Safety; Tolerability; Healthy Volunteer
6x3 Crossover, Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers
Condition: Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Open Label, Single Subcutaneous Dose 6x3 Crossover Study to Investigate the
      Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in
      Healthy Volunteers
    


Intervention name(s): Somatropin
Intervention type(s): Drug
Intervention description(s): LG Somatropin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other