bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients
Condition: Scar Prevention; Scar Reduction
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine the safety of AZX100 Drug Product and to determine
      whether it was effective in preventing or reducing scars that were made from trocars
      following arthroscopic shoulder surgery.
    


Intervention name(s): Placebo; AZX100
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the Placebo-only arm were dosed intradermally with placebo (saline) in three trocar sites on Day 9 (plus/minus 2 days) and Day 21 (plus/minus 2 days) after arthroscopic shoulder surgery. In the AZX100-placebo arm, 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.; AZX100 Drug Product 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: AZX100; Patient and Observer Scar Assessment Scale; POSAS; Visual Analog Scale; VAS; Trocar; Scarring; Scar reduction; Scar prevention
Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI
Condition: Post Procedural Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      This study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning
      in patients presenting with a NSTEMI/Unstable angina undergoing PCI.
    

Detailed description: 
      Patients presenting with Non ST elevation acute coronary syndromes (NSTEACS) - NSTEMI and
      Unstable angina patients are enrolled in this study.

      Eligible patients are approached, with patient information sheets and are consented for
      involvement into the study. Patients are randomised to intervention or control. Patients
      randomised to intervention will receive 3 x 5 minutes of forearm ischaemia (with the cuff
      inflated to 200 mmHg) separated by 5 minutes of reperfusion between each cuff inflation,
      prior coronary angiography.

      This protocol of episodic forearm ischaemia/reperfusion has been demonstrated to confer
      remote ischaemic preconditioning-induced protection.

      Prior to the intervention, a blood sample will be taken to measure serum troponin T and CK-MB
      (baseline level). Following PCI patients will be reviewed on the wards and their ongoing
      recovery will be assessed and reviewed prior to discharge from the study. Troponin T and
      CK-MB levels will be measured for the 24 hours after PCI, at various time points (6 hour, 12
      hour, 24 hour) as a measure of the degree of myocardial damage, and levels compared between
      the different treatment groups.

      Primary end point

      Myocardial injury (Peri-procedural Myocardial Infarction and Injury) measured by cTnT and
      CK-MB release over 24 hours after primary PCI.
    

Intervention name(s): Remote Conditioning; Sham protocol
Intervention type(s): Device; Device
Intervention description(s): A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times.; An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
Other intervention name(s): RIC; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effect of Intravenous Zanamivir on Cardiac Conduction in Healthy Volunteers
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Approximately 40 healthy subjects will be enrolled. Each subject will participate in the
      study for approximately 9 weeks. There will be four treatment sequences with a 5-7 day
      washout between treatments. Subjects will be admitted to the clinical unit on Day-1 of each
      dosing period and will remain in the unit until Day 2. Each subject will receive a single
      dose of each of the four treatments on Day 1 of each treatment period in a randomized
      fashion. Subjects will be discharged from the clinical research unit after the completion of
      all assessments on Day 2 of each period and return approximately 5-7 days later for the next
      dose period. Serial pharmacokinetic samples will be collected for up to 24 hours following
      each treatment.
    


Intervention name(s): 600 mg zanamivir + moxifloxacin placebo; 1200 mg zanamivir + moxifloxacin placebo; zanamivir placebo + moxifloxacin placebo; zanamivir placebo + 400 mg moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): zanamivir 600 mg IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose; zanamivir 1200 mg IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose; zanamivir placebo IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose; moxifloxacin 400 mg administered orally x 1 dose + zanamivir placebo IV over 30 min x 1 dose
Intervention MeSH terms: Moxifloxacin; Zanamivir; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: 12-lead ECG; cardiac repolarization; QTc; influenza; GR121167; zanamivir
Safety, Tolerability and Pharmacokinetics of ARCT-810 in Healthy Adult Subjects
Condition: Ornithine Transcarbamylase Deficiency
MeSH terms: Ornithine Carbamoyltransferase Deficiency Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-810 in
      healthy adult subjects.
    

Detailed description: 
      This is a single ascending dose study of ARCT-810 in which approximately 30 subjects are
      planned to be enrolled. The length of each study participant is approximately 8 weeks from
      screening to last study visit.

      Study participants will be allocated to one of the five different study groups (also called
      cohorts), to test different doses of ARCT-810. There will be 6 participants in each group.
      Within each cohort, subjects will be randomized 2:1 to receive ARCT-810 or placebo as an IV
      infusion.
    

Intervention name(s): ARCT-810; Placebo
Intervention type(s): Biological; Other
Intervention description(s): ARCT-810 is an investigational medicinal product comprising OTC mRNA formulated in a lipid nanoparticle (LNP) under development.; The placebo for this study is 0.9% sterile saline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV
Condition: HCV
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective study was conducted at Ain Shams University Hospital, Internal Medicine,
      Hepatology and Gastroenterology Department, and Tropical Medicine Department.

      To compare the efficacy of the combination of sofosbuvir and simeprevir for 12 weeks with the
      combination of sofosbuvir and ribavirin for 24 weeks in Egyptian patients with HCV-related
      Child A cirrhosis.
    


Intervention name(s): Sofosbuvir-Simeprevir; Sofosbuvir-Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): -Sofosbuvir-Simeprevir group included 50 patients who received sofosbuvir 400 mg orally once-daily plus simeprevir 150 mg orally once-daily for 12 weeks.; -Sofosbuvir-Ribavirin group included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.
Intervention MeSH terms: Ribavirin; Sofosbuvir; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV treatment
Effect of a Component of Fish Oil on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
Condition: Asthma; Exercise-Induced Bronchoconstriction
MeSH terms: Asthma; Inflammation
Study type: Interventional

Summary: 
      The primary aim of this study will be to evaluate the effects of Lyprinol® supplementation on
      airway inflammation and the bronchoconstrictor response to dry air hyperpnea in individuals
      with asthma. The investigators hypothesize that Lyprinol® supplementation, compared to
      placebo, will significantly attenuate airway inflammation and hyperpnea-induced
      bronchoconstriction in asthmatic individuals.
    

Detailed description: 
      Our research group has shown, on numerous occasions that fish oil has a markedly protective
      effect in suppressing airway inflammation and exercise-induced bronchoconstriction in elite
      athletes and asthmatic individuals. Purified fish oil and the marine lipid fraction PCSO-524™
      (Lyprinol™) have both been used in supplementation studies in asthma [2, 10, 11]. While fish
      oil is a rich source of the omega-3 fatty acids eicosapentaenoic acid (EPA) and
      docosahexaenoic acid (DHA), Lyprinol® is a patented extract of stabilized lipids from the New
      Zealand green-lipped mussel, Perna canaliculus, combined with olive oil and vitamin E. EPA
      and DHA are the main ingredients of fish oil, and thus there will be similarities between
      Lyprinol and fish oil in terms of mechanism of action. Thus, we are aiming to show that
      Lyprinol® can modulate these inflammatory eicosanoids to exert anti-inflammatory effects.
    

Intervention name(s): Lyprinol; Placebo (Olive Oil)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 8 capsules (1 capsule=50mg n-PUFA, 100mg olive oil) per day for 3 weeks; 8 capsules (1 capsule = 100mg olive oil) per day for 3 weeks
Other intervention name(s): Olive Oil
Intervention MeSH terms: Lyprinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Asthma; Exercise-Induced Bronchoconstriction; lipids; n-3 PUFA; airway inflammation; Bronchoconstriction
Colorado-Oregon Altitude Study
Condition: Acute Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigating the utility of prophylactic treatment with iron sucrose and/or erythropoietin
      on the prevention of acute mountain sickness in fit, young, healthy individuals.
    


Intervention name(s): Erythropoietin; Iron sucrose (Venofer); Sterile Sodium Chloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): use of erythropoietin to stimulate red blood cell development prior to ascent to altitude; use of iron sucrose to stimulate red blood cell development prior to ascent to altitude; sham treatment with sterile saline
Intervention MeSH terms: Epoetin Alfa; Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Study of ACUVUE® ADVANCE® PLUS Contact Lenses.
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to
      process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process
      qualification (postPQ).
    


Intervention name(s): Acuvue Advance Plus prePQ; Acuvue Advance Plus postPQ
Intervention type(s): Device; Device
Intervention description(s): silicone hydrogel contact lens manufactured prior to equipment process qualification activities.; silicone hydrogel contact lens manufactured after equipment process qualification activities.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Comparison of Two Crosslinked Hyaluronate for the Treatment of Osteoarthritis Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of this study is to compare the safety and effectiveness between two BDDE-crosslinked
      hyaluronate, HYAJOINT Plus and Durolane, for the Treatment of Knee Osteoarthritis Pain.
    


Intervention name(s): HYAJOINT Plus; Durolane
Intervention type(s): Device; Device
Intervention description(s): 60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.; 60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; synovial fluid supplement; hyaluronic acid
Growth Hormone's Effect on Endothelial Progenitor Cells
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      To assess the effect of short-term low-dose growth hormone therapy on the mobilization of
      endothelial progenitor cells from the bone marrow within a group of healthy adults.
    

Detailed description: 
      We are proposing a pilot study to assess the effect of the administration of recombinant
      human growth hormone on the number of endothelial progenitor cells (EPC's) in the peripheral
      circulation. An increase in the number of EPC's is viewed as beneficial, as it has been
      postulated that they provide an endogenous repair mechanism to counteract endothelial injury.
      Additionally, a reduced number of EPC's has been found to independently predict
      atherosclerotic disease progression. Mechanisms proposed for enhancing the number of
      circulating EPC's and their function include an increase in proliferation, mobilization from
      the bone marrow, or prevention of EPC apoptosis. Thus, a pharmacologic manipulation of the
      number of EPC's in the peripheral circulation could potentially serve as a mechanism by which
      endothelial function, and thus vascular health, may be improved.
    

Intervention name(s): Growth Hormone
Intervention type(s): Drug
Intervention MeSH terms: Hormones
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Growth Hormone; Cardiovascular System; Endothelial Progenitor Cells
Preventing Cognitive Decline
Condition: Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The study aims to understand the mechanisms and training effects of evidence-based body-mind
      training on improving cognitive performance and preventing cognitive decline.
    

Detailed description: 
      Subjective cognitive decline (SCD), the self-reported perception of memory or cognitive
      problems, is a risk factor for the cognitive decline and development of Alzheimer's (AD) and
      often happens in midlife. Recently, few mind-body interventions have suggested promising
      effects in preventing cognitive decline. However, these interventions often require longer
      training time (months to years) to achieve modest benefits, making them less optimal for
      rapidly learning and achieving desirable outcomes. One mechanism for cognitive decline and AD
      may involve deficits in self-control networks, and autonomic nervous system (ANS) and these
      deficits can be ameliorated through body-mind interventions. This study aims to investigate
      the modulation effects of a novel body-mind intervention on SCD using an evidence-based
      preventive intervention - integrative body-mind training (IBMT).
    

Intervention name(s): IBMT mindfulness; health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management; Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: mindfulness vs. health education
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Inspiratory Muscle Training in Patients With Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether inspiratory muscle training could improve
      and/or prevent the deterioration of inspiratory muscle strength, clinical cardiopulmonary
      outcome, systemic immunologic responses and quality of life in patients with bronchiectasis.
    

Detailed description: 
      Inspiratory muscle training is reportedly beneficial in patients with diverse chronic
      cardio-pulmonary diseases. It can increase inspiratory muscle strength and endurance,
      improves exercise capacity and quality of life (QOL), and decreases the perception of dyspnea
      (POD) for adults with stable chronic obstructive pulmonary disease (COPD). Though the
      pathophysiology in COPD and bronchiectasis are different, there are some similarities in
      clinical presentation. In COPD patients, lung hyperinflation induces functional weakness of
      the inspiratory muscle and increases elastic load to breathing and intrinsic positive end
      expiratory pressure. Patients with bronchiectasis shows reduced ratio of FEV1/FVC, reduced
      FEV1, and normal or slightly reduced FVC, which indicate that airways are blocked by mucus.
      However, there has been no study that used IMT as a training modality to determine its effect
      in bronchiectasis. The clinical relevance of increased respiratory muscle strength per se by
      IMT alone is unknown. This study tried to evaluate the feasibility and effectiveness of
      home-based threshold training and examined if the effects of IMT extends to clinical outcomes
      such as activities of daily living and QOL in bronchiectasis patients.
    

Intervention name(s): Inspiratory muscle training
Intervention type(s): Other
Intervention description(s): A pressure threshold device (Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA) was used for the inspiratory muscle training program. The individualized training program was started at an intensity of 30% MIP, which was increased by 2 cmH2O each week, but the maximal intensity did not exceed 50% of MIP. Patients were encouraged to perform IMT for 30 minutes per day, at least 5 days a week for 8 weeks.
Other intervention name(s): Pulmonary Rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Creatine Effect on Brown Adipose Tissue Activation
Condition: Diet-induced Thermogenesis; Brown Adipose Tissue Activation
Study type: Interventional

Summary: 
      Pre-clinical studies indicate that creatine may play a substantial role in diet-induced
      thermogenesis and may have a profound effect on energy balance. A recent retrospective study
      of BAT activation on PET-CT scans in humans showed a positive association with the estimated
      renal creatinine clearance and BAT activation, possibly linking creatine metabolism in humans
      to BAT activity. In humans, so far little options are available to activate brown adipose
      tissue. The most potent intervention to activate BAT is via cold, which has previously been
      shown to have metabolic effects in humans. Provided the potential health benefits of brown
      adipose tissue activation in humans, and provided the role of brown fat in diet induced
      thermogenesis, we here aim to determine whether creatine monohydrate supplementation can
      increase diet-induced thermogenesis and activate brown adipose tissue in humans.
    


Intervention name(s): Creatine monohydrate; placebo cellulose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5 grams of creatine monohydrate, four times daily, for 9 consecutive days.; oral ingestion of placebo containing 20 gram cellulose daily
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A double-blind, randomised, controlled, cross-over intervention trial.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Brown adipose tissue; Creatine monohydrate; Diet-induced thermogenesis
RSV F Dose-Ranging Study in Women
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of multiple
      formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of
      child-bearing age.
    


Intervention name(s): Low dose RSV F Antigen; High dose RSV F Antigen; Dose 1 of Aluminum Adjuvant; Dose 2 of Aluminum Adjuvant; Dose 3 of Aluminum Adjuvant; Dose 4 of Aluminum Adjuvant; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment