bioihbjkbjnl/mcl2 huggingface dataset:
A Peer E-mentoring Intervention to Improve Employment
Condition: Cerebral Palsy; Spina Bifida; Juvenile Arthritis; Spinal Cord Injury; Muscular Dystrophy; Physical Disability
MeSH terms: Muscular Dystrophies; Arthritis, Juvenile; Spinal Cord Injuries; Cerebral Palsy; Spinal Dysraphism
Study type: Interventional

Summary: 
      Despite the strong business case of hiring people with disabilities, a significant proportion
      of youth with disabilities leave high school and neither work nor continue their education
      and are unprepared to meet the demands of a work environment. Although youth with
      disabilities have much to gain from employment readiness programs, they are often excluded
      from, or have limited access to school and community vocational programs. One encouraging
      approach to address gaps in vocational programming is through peer mentoring, which may
      facilitate a smoother transition to adulthood by offering support to enhance coping skills.
      Despite the increase in online communities, little is known about their impact on vocational
      mentoring for youth with physical disabilities and their parents. The purpose of this study
      is to develop, implement and assess the feasibility of an online peer mentor employment
      readiness intervention for youth with physical disabilities and their parents to improve
      their self-efficacy, career maturity and social support.
    

Detailed description: 
      Our primary OBJECTIVE is: (1) to develop, implement and assess the feasibility of an online
      peer mentor employment readiness intervention for youth with physical disabilities and their
      parents to improve their self-efficacy, career maturity and social support.

      A mixed methods feasibility randomized controlled trial design will be conducted to develop
      and assess the usability of "Empowering youth towards Employment" intervention. Youth (aged
      15-25) with physical disabilities and their parents will be randomly assigned to a control or
      experimental group (12-week, interactive intervention, moderated by peer mentors). A
      qualitative thematic analysis will be conducted to analyze the content of discussion forums.
      Interviews with youth, parents and mentors will also be conducted about their experiences in
      the intervention.
    

Intervention name(s): Empowering youth towards employment
Intervention type(s): Behavioral
Intervention description(s): Experimental: Empowering youth towards employment This is a behavioural e-mentor intervention. Trained mentors will facilitate employment readiness learning and engage youth in discussions over a 12-week period. Each week the mentors will introduce a new employment topic and will engage youth in a discussion and answer questions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Open Label Prostate Cancer Study
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to investigate the safety and tolerability of AZD3514 when
      given orally to patients with castration-resistant prostate cancer (CRPC)
    


Intervention name(s): AZD3514
Intervention type(s): Drug
Intervention description(s): Patients will be given AZD3514 orally as a single dose, and then multiple once daily dosing following a 5-9 day washout.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate Cancer; Tumour; Castration Resistant; Prostate Androgen Receptor Down Regulator; Metastatic
Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections
Condition: Skin Diseases, Infectious; Skin Diseases, Bacterial
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III
      studies in patients with complicated skin and skin structure infections.
    


Intervention name(s): TR-701 200 mg; TR-701 300 mg; TR-701 400 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral TR-701 200 mg for 5 to 7 days; oral TR-701 300 mg for 5 to 7 days; TR-701 400 mg for 5 to 7 days
Intervention MeSH terms: Tedizolid phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Skin; Infection; Complicated Skin and Skin Structure Infection
Music in Urgent and Emergent Settings
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Interventional

Summary: 
      The purpose of this study is to study the impact of Live Preferential Music on the patient
      perception of pain and management of pain syndromes in the ED.
    

Detailed description: 
      The purpose of this study is to study the impact of Live Preferential Music on the patient
      perception of pain and management of pain syndromes in the ED. This study follows a
      prospective experimental design where patients will be assigned to two groups: one that
      receives the music intervention and one that does not receive music intervention.
    

Intervention name(s): Live Preferential Music
Intervention type(s): Other
Intervention description(s): Trained musicians will play live preferential music to ED patients who consent to participate.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized
Masking: Single (Participant)
Primary purpose: Health Services Research
Guanidinoacetic Acid With Creatine Compared With Creatine Alone for Tissue Bioenergetics, Hyperhomocysteinemia and Exercise Performance
Condition: Energy Metabolism
MeSH terms: Hyperhomocysteinemia
Study type: Interventional

Summary: 
      Co-administration of creatine and guanidinoacetic acid (GAA) has been recently put forward as
      an advanced dietary strategy to optimize tissue bioenergetics. The investigators hypothesized
      that creatine-GAA mixture would result in more powerful rise in brain and skeletal muscle
      creatine, as compared to creatine supplementation alone.
    

Detailed description: 
      Targeting energy-demanding tissues in health and disease continues to be a challenging task
      in human nutrition and biomedicine. Impaired bioenergetics accompanies many different
      conditions, including cardiometabolic diseases, neurodegenerative disorders or high-intensity
      exercise, with various dietary interventions developed to restore cellular energy. Creatine
      is recognized as a beneficial and safe energy-boosting agent in both athletic and clinical
      environments. However, its effectiveness in specific conditions seems to be fairly restrained
      due to its limits in transportability and performance. Guanidinoacetic acid (GAA), a
      metabolic precursor of creatine, appears as a novel energy-enhancing supplement, with GAA
      being superior to creatine in facilitating creatine concentrations in the human brain and
      skeletal muscle. This perhaps happens due to GAA interaction with cellular transporters
      previously dismissed as untargetable carriers by other similar therapeutics. On the other
      hand, GAA loading remains under scrutiny due to its hyperhomocysteinemia-inducing potential,
      and possible neurotoxic effects. Co-administration of creatine and GAA has been recently
      proposed as a better strategy comparing to administration of each compound per se. Besides
      providing a competitive advantage for enhanced levels of tissue creatine, GAA-creatine
      mixture might also diminish side effects related to isolated GAA administration. However, no
      human studies so far evaluated the effects of this mixture. In the present study, the
      investigators compared the impact of 4-week co-administration of GAA and creatine vs.
      creatine administration alone on serum biomarkers, exercise performance and tissue
      bioenergetics in healthy young men.
    

Intervention name(s): GAA-creatine; Creatine
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis
Condition: Relapsing Forms of Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the change in patient-reported outcomes, physician
      assessment of a change as well as safety and tolerability in patients with Relapsing Forms of
      Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of
      two treatment arms: fingolimod vs. standard of care DMT.
    


Intervention name(s): Fingolimod; Standard MS DMTs
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg/day oral capsule
Other intervention name(s): GILENYA™; Avonex®,; Copaxone®,; Rebif®,; Betaseron®,; Extavia®
Intervention MeSH terms: Fingolimod Hydrochloride; Interferon beta-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsing Forms of Multiple Sclerosis; Disease Modifying Therapy; fingolimod; Patient Reported Outcomes
Comparison of Harmonic Scalpel and Ligasure Devices in Laparoscopic Morbid Obesity Surgery
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery
      especially in gastric bypass surgery patients.
    

Detailed description: 
      The investigators' department performs 150 gastric bypass surgeries annually. Surgeons use
      both harmonic scalpel and ligasure sealing device in cases. Aim is to compare both of these
      devices over coming each other. Benefits ease of these devices are compared.
    

Intervention name(s): Harmonic scapel; Ligasure
Intervention type(s): Device; Device
Intervention description(s): different surgical devices used in the obesity surgery; Bipolar vessel sealing system used in obesity surgery
Other intervention name(s): ultrasonic dissector; Bipolar Vessel sealing device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: laparoscopy; obesity; harmonic scalpel; ligasure
A Health Economic Evaluation of Using N-Terminal Pro Brain Natriuretic Peptide (NT-Pro BNP) in Acute Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Cardiac biomarkers have dramatically impacted the way HF patients are evaluated and managed.
      In fact, the role of biomarkers has developed to better differentiate HF against other
      diseases and, to timely initiate and influence more accurate diagnosis (rule out) and
      treatments, to predict the onset of future HF, to risk-stratify affected patients, and to
      serve as a tool to guide intensity of therapy. NT-proBNP has become validated biomarkers with
      highest guideline recommendation (class I) and independent predictors for re-hospitalization
      and mortality in HF patients. However, many Indonesian cardiologists do not use of those
      biomarkers, mostly due to limited available cardiac biomarkers for the cost effective heart
      failure management. We evaluate 2 alternative treatments which one that more cost-effective
      between biomarker's guided therapy and without biomarker.
    

Detailed description: 
      With growing demands on limited health care budgets, optimal resource allocation in HF
      patients is essential. Although NT pro BNP is proposed to be effective for the evaluation and
      management patients with heart failure, no data exist about cost-effectiveness analysis that
      are based on practice patterns endorsed by universal coverage systems in Indonesia (Jaminan
      Kesehatan Nasional). Because NT-proBNP therapy guidance in HF is believed to create
      additional costs, it is not yet broadly applicable. Its why we need to elaborate this issue.
    

Intervention name(s): NT-Pro BNP
Intervention type(s): Diagnostic Test
Intervention description(s): . AHF patients who met inclusion and exclusion criteria were randomly assigned to 2 groups, NT-pro BNP group and control group. In the NT-pro BNP group, serial NT-pro BNP levels at admission and pre-discharge was measured, the latter with the target of decrease ≥ 30% NT-pro BNP level. Randomised patients were followed during treatment up to 90 days post-discharge to assess short-term outcomes and costs.
Other intervention name(s): Natriuretic peptide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acute Heart Failure; Cost; NT-pro BNP
Dynamic Imaging of the Hip for Pre-operative Planning
Condition: Femoroacetabular, Impingement
Study type: Interventional

Summary: 
      One of the leading causes of hip arthritis is femoro-acetabular impingement which means the
      hip joint is deformed such that the hip joint jams in the front when the hip is bent all the
      way forward. This can lead to significant damage to the hip joint and may result in the need
      for a total hip replacement. However, if detected early, this deformity can be treated
      surgically by reshaping the hip joint. If the hip joint could be better visualized before
      surgery, then surgeons would be able to develop less invasive surgical techniques to correct
      this deformity.
    

Detailed description: 
      In this study, we are trying to develop a way to help surgeons visualize the hip joint before
      surgery in order to assist with pre-operative planning. This will be done by comparing the
      dynamic hip images in patients with femoroacetabular impingement to the hip images of healthy
      volunteers with no hip problems.
    

Intervention name(s): Motion analysis; Computed Tomography
Intervention type(s): Procedure; Diagnostic Test
Intervention description(s): Participants will undergo a motion analysis procedure: a dynamic assessment of the movement in their hip.; Participants will undergo computed tomography (CT) scan of their hip.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: femoroacetabular, impingement
A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
Condition: Chronic Kidney Failure; Vascular Graft Occlusion
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Graft Occlusion, Vascular
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will look at the safety profile (unwanted effects) of the long-lasting
      anticoagulant PEG-hirudin (SPP200) and compare these unwanted effects to those of
      unfractionated heparin, commonly used in haemodialysis to avoid clotting of the graft and of
      the haemodialysis machine.
    


Intervention name(s): PEG-hirudin
Intervention type(s): Drug
Intervention MeSH terms: Hirudins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Haemodialysis; PEG-Hirudin; Vascular graft occlusion; Renal replacement therapy; Hemodialysis
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb)
      VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender (TG)
      persons who have sex with men, in North America, South America, and Switzerland.
    

Detailed description: 
      This study will evaluate the safety, tolerability, and efficacy of the VRC01 antibody in
      preventing HIV-1 infection in men and transgender (TG) persons who have sex with men, in
      North America, South America, and Switzerland.

      Participants will be randomized to receive VRC01 mAb by intravenous (IV) infusion at a dose
      of 10 mg/kg or 30 mg/kg every 8 weeks, or to receive control infusions every 8 weeks. All
      participants will receive the VRC01 antibody or placebo by IV infusion at Weeks 0 (study
      entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. For 3 days following each infusion,
      participants will be asked to record and report any symptoms to study researchers.

      In addition to the infusion visits, participants will attend study visits at Weeks 4, 8 + 5
      days, 12, 20, 28, 36, 44, 52, 60, 68, 76, 80, 88, 96, and 104. All study visits will include
      blood collection and HIV testing and counseling. Select study visits will include a medical
      history review, physical exam, urine collection, pregnancy testing for participants capable
      of becoming pregnant, risk reduction counseling, and an interview/questionnaire.
    

Intervention name(s): VRC01; Placebo for VRC01
Intervention type(s): Biological; Biological
Intervention description(s): Administered by IV infusion; total dose will vary based on participant's weight; Sodium Chloride for Injection USP, 0.9%; administered by IV infusion
Other intervention name(s): Human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV-1 Infections
To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia
Condition: Alopecia; Male Pattern Hair Loss
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a randomized, double-blind, placebo-controlled, parallel group, phase 2 study to
      evaluate the efficacy, safety and tolerability of KX-826 in male subjects with androgenetic
      alopecia.
    

Detailed description: 
      KX-826 is a new investigational androgen receptor (AR) antagonist for the treatment of male
      pattern hair loss (androgenetic alopecia). A total of 120 subjects will be randomized to one
      of four cohorts: 2.5 mg BID, 5 mg QD, 5mg BID of KX-826 or placebo (BID or QD) for 24 weeks.
      The primary endpoint of the study is to assess the changes from baseline in non-vellus TAHC
      （Target Area Hair Counts）at Week 24 in comparison to placebo
    

Intervention name(s): KX- 826 dosed at 2.5mg; KX-826 dosed at 5mg; KX-826 dosed at 5mg; Matching placebo to KX-826
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2.5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks; 5mg of the investigational drug to be applied topically to scalp once daily for 24 weeks; 5mg of the investigational drug to be applied topically to scalp twice daily for 24 weeks; Placebo applied topically to scalp twice daily or once daily for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Hair loss; Hair thinning; Baldness
Muscular Training-induced Changes in COPD
Condition: Chronic Obstructive Pulmonary Disease; Healthy
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The current protocol is developed in the context of a large Research and Innovation (R&I)
      program aiming the promotion of daily life physical activity in chronic patients registered
      at clinicaltrials.gov (NCT02976064) and approved by the ethical committee of the Hospital
      Clinic de Barcelona (HCB/2016/0883). The project is partly supported by the Smart Innovation
      Strategies promoted by the EU Commission (COMRDI15-1-0016). Specifically, the protocol uses
      retrospective information collected between 2005-2008 as part of the EU project Biobridge
      (LSHG-CT-2006-037939).

      The aims of the current analysis of the retrospective information are 1) to assess
      training-induced changes in muscle oxygen saturation (StO2) assessed by near-infrared
      spectroscopy (NIRS) during constant-work rate cycling exercise (CWRE) as a useful marker of
      the effects of training at limb muscle level in patients with chronic obstructive pulmonary
      disease (COPD), and 2) to further explore underlying mechanisms of skeletal muscle
      dysfunction as a characteristic systemic effect of COPD, potentially modifiable with
      preventive interventions as endurance muscle training.

      Methods: Incremental exercise (VO2 peak) and CWRE at 70% baseline peak work rate, before and
      after 8-week of endurance exercise training, were done in healthy sedentary subjects and COPD
      patients. NIRS was used to assess StO2 in the left "vastus internus" during the CWRE (before
      an after training program) (objective 1); and blood samples and muscle biopsies of the
      quadriceps were obtained at rest (before an after training program) (objective 2).
    


Intervention name(s): Exercise training
Intervention type(s): Other
Intervention description(s): All subjects performed a supervised 8-week, 5 days-week of endurance exercise training program in cycle-ergometer Each session included 5 minutes of warm-up and cool-down pedalling at 30% of peak work-rate (WR) and 50 minutes of interval training. The interval training combined 2 minutes of high-intensity pedalling and 3 minutes of active rest. Work-rate progress during the 8-week period was tailored on individual basis, according to subjects' symptoms, to maximize the training effect. During the first 2 weeks, high intensity pedalling interval was at least 70% of peak WR and active rest interval was at least 40% of peak WR. Thereafter, work-rate was increased by approximately 5% every week up to a maximum of 100% of peak WR during the last 2 weeks for the high intensity period and 50% of peak WR for the active rest. The cycling rate during the sessions was maintained at 60-70 rpm.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise training; Muscle dysfunction; COPD