bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate and compare the safety, reactogenicity,
      immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent
      influenza vaccine (TIV)in healthy adults age 50-64 years.
    

Detailed description: 
      Annual influenza epidemics are associated with serious excess morbidity and mortality,
      particularly among the elderly. Licensed trivalent inactivated influenza vaccines (TIVs) have
      been shown to reduce hospitalization and death following influenza in this vulnerable
      population, but their efficacy is lower than that observed in younger, healthy populations.
      In addition, recent studies have questioned the level of effectiveness of TIV in the elderly,
      suggesting that cohort studies have overestimated the benefits of immunization with current
      TIV formulations in this age group. In view of these considerations, it is widely accepted
      that improved and alternative vaccines are needed for control of seasonal and pandemic
      influenza.

      Currently available TIVs are prepared from viruses that are grown in embryonated hens' eggs.
      Alternative substrates for vaccine production are desirable in order to reduce the
      vulnerability of and to expand influenza vaccine supply. Recombinant DNA techniques allow for
      expression of the influenza hemagglutinin (rHA) by baculovirus vectors in insect cell
      cultures. Advantages of this technique include speed of production, absence of egg protein,
      and a highly purified product. Previous studies among healthy younger and older adults have
      confirmed that rHA vaccines are safe, well tolerated and immunogenic at dosages up to nine
      times higher than those contained in TIV. Dose-related increases in serum antibody levels
      after immunization also were observed.
    

Intervention name(s): FluBlok Influenza Vaccination; TIV (Fluzone) Influenza Vaccination
Intervention type(s): Biological; Biological
Intervention description(s): 0.5mL dose for intramuscular injection; 0.5mL dose for intramuscular injection
Other intervention name(s): FluBlok; rHA; rHA0; recombinant hemagglutinin; Fluzone; TIV
Intervention MeSH terms: Hemagglutinins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Influenza
Acupuncture or MBSR for Patients With Fatigue and MS
Condition: Fatigue; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional

Summary: 
      The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based
      stress reduction is more efficacious than usual care only to reduce fatigue in patients with
      multiple sclerosis.
    

Detailed description: 
      In multiple sclerosis, fatigue is the most common clinical symptom, reported by up to 97% of
      patients. No successful evidence-based therapy exists so far. The main aim of this trial is
      to evaluate whether additional acupuncture or mindfulness-based stress reduction is more
      efficacious than usual care only to reduce fatigue in patients with multiple sclerosis. We
      want to include 141 patients with multiple sclerosis and fatigue. Participants will be
      randomised into three groups to compare 1) usual care, 2) usual care plus standardised
      acupuncture, and 3) usual care plus mindfulness-based stress reduction. Treatment duration
      will be 12 weeks. The primary outcome is the Fatigue Severity Scale (FSS) after 12 weeks,
      follow-up measurement will be performed after 26 weeks. Secondary outcomes include other
      fatigue specific parameters, other MS specific parameters, cost, and physiological,
      immunological and functional magnetic resonance imaging parameters.
    

Intervention name(s): Usual care + acupuncture; usual care+mbsr; usual care
Intervention type(s): Other; Other; Other
Intervention description(s): Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care; Patients of this group receive mindfulness based stress reduction in addition to usual care; Patients in this group will follow the same treatment for fatigue they received at study entry
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis, fatigue
Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain
Condition: Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the efficacy of ataciguat versus placebo in
      reducing pain intensity in patients with neuropathic pain.

      The secondary objective is to assess the safety and tolerability of ataciguat versus placebo.
    

Detailed description: 
      This study consists of two consecutive 28 day treatment periods which are separated by a 2
      week medication free period and a safety follow-up period of 2 weeks after the second
      treatment period.
    

Intervention name(s): ataciguat (HMR1766); placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral administration 200mg once daily for 28 days; oral administration once daily for 28 days
Intervention MeSH terms: 5-chloro-2-(5-chlorothiophene-2-sulfonylamino)-N-(4-(morpholine-4-sulfonyl)phenyl)benzamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic neuropathy; painful pain; postoperative
24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes
Condition: Non-Insulin-Dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      A better glycemic control is associated with less complications (cardiac diseases, blindness,
      etcetera) for type 2 diabetic patients. The objective is to study if rosiglitazone may lead
      to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than
      with a sulphonylurea (glimepiride).
    


Intervention name(s): rosiglitazone-metformin fixed dose combination; metformin + glimepiride
Intervention type(s): Drug; Drug
Other intervention name(s): rosiglitazone-metformin fixed dose combination
Intervention MeSH terms: Metformin; Glimepiride; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes; rosiglitazone; metformin; glimepiride; glycemia
Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
Condition: Infertility; Poor Ovarian Response
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the present study is to examine the level of ovarian response and the
      pregnancy rates among poor ovarian responders treated with a novel treatment protocol with
      150μg corifollitropin alfa followed by 300IU hMG in a short GnRH agonist protocol.
    

Detailed description: 
      Corifollitropin alfa reaches maximum concentrations (Cmax), between 25 and 45 h after
      injection , a time interval which is significantly shorter as compared to treatment with
      rFSH. The investigators hypothesized that this rapid increase in the serum FSH concentration
      may result in a significantly higher exposure of the small antral follicles to constant high
      levels of FSH during the early follicular phase, securing not only the recruitment of the
      follicles, but also the continued growth.

      In the current study the investigators examine whether administration of corifollitropin
      followed by 300IU hMG in a short GnRH agonist protocol may result in acceptable pregnancy
      rates in poor ovarian responders fulfilling the "Bologna criteria"
    

Intervention name(s): Triptorelin; Corifollitropin alfa; hpHMG
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwards; Corifollitropin alfa 150μg (single dose) on day 2 or 3 of the cycle; 300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering
Intervention MeSH terms: Triptorelin Pamoate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Poor ovarian response; Poor ovarian responders; Bologna criteria for poor ovarian response
Pain and Stress Assessment and ROP Screening
Condition: Pain; Stress
Study type: Observational

Summary: 
      The study will measure the effects of eye exams on markers of stress in the urine. In
      addition, measurements will be taken to show the effects of stress on brain activity, O2
      sats, and blood flow.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premature infants undergoing SOC ROP eye exams
      
Keywords: Pain and stress assessment in premature infants
Effectiveness and Safety of Distal Left Transradial Access in Coronary Procedures.
Condition: Cardiovascular Diseases; Cardiomyopathies
MeSH terms: Cardiovascular Diseases; Cardiomyopathies
Study type: Observational

Summary: 
      To evaluate the effectiveness and safety of distal left radial (dLR) access in coronary
      procedures at a tertiary center in Trinidad and Tobago.
    

Detailed description: 
      An observational, retrospective study will be carried out. Roughly 111 patients were
      registered at EWMSC and Cardiac Angiograms were done via approached through the left radial
      access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms
      were also done via the anatomical snuff box. This study seeks to compare the results of
      Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.
    

Intervention name(s): cardiac catheterization
Intervention type(s): Procedure
Intervention description(s): An observational, retrospective study will be carried out. Roughly 111 patients were registered at EWMSC and Cardiac Angiograms were done via approached through the left radial access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms were also done via the anatomical snuff box. This study seeks to compare the results of Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Caribbean decent population of Trinidad and Tobago.
      
Keywords: Distal Radial Artery Angiogram; Anatomical Snuff Box Angiogram
Role of Cord Blood Hormones and Epinephrine in the Development of Transient Tachypnea of the Newborn
Condition: Wet Lung
MeSH terms: Transient Tachypnea of the Newborn
Study type: Observational

Summary: 
      In this prospective, cross-sectional study, the aim was to investigate the possible role of
      cord stress hormones; adrenocorticotropic hormone (ACTH), cortisol, epinephrine, sT3, sT4,
      and thyroid-stimulating hormone (TSH) in the development of Transient Tachypnea of the
      Newborn (TTN), via their modulatory effect on epithelial sodium channels and Na-K-ATPase.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Cesarean delivered, late preterm and term infants during the study period in Maternity
        Center of Ankara University
      
Biospecimen description: 
      Cord blood serum samples were stored.
    
Keywords: Fetal lung fluid; Pulmonary adaptation; Transient tachypnea of the newborn; Epinephrine; Stress hormones
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending, Subcutaneous, Single and Multiple Doses of SHP681 (Glucagon-like Peptide-2 [GLP-2] Analog-Fc Fusion) in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety and tolerability of single and multiple
      ascending subcutaneous (SC) doses of SHP681 in healthy adult participants.
    

Detailed description: 
      The study consists of a single ascending dose (SAD) portion and a multiple ascending dose
      (MAD) portion.

      The study duration for the SAD portion of the study consists of a screening period of up to
      28 days and 1 treatment period of 29 days. SAD portion of the study contains 5 cohorts and
      dose escalation will proceed sequentially to assess the following single SC doses of SHP681
      or SHP681 matched placebo: 0.2 milligram per kilogram (mg/kg), 0.5 mg/kg, 1 mg/kg, 2 mg/kg,
      and 4 mg/kg.

      The study duration of the MAD portion comprises of a screening period up to 28 days and a
      treatment period of 57 days for each cohort. MAD portion of the study contains 6 cohorts and
      dose escalation will proceed sequentially to assess the following SC doses of SHP681 or
      SHP681 matched placebo: 0.2 mg/kg, 0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 4 mg/kg once weekly for 5
      weeks till 5 cohorts and the 6th cohort will receive 4 mg/kg SHP681 or matched placebo every
      2 weeks over a 6-week period (3 doses).
    

Intervention name(s): SHP681; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive SC injection of SHP681 in the abdomen.; Participants will receive SC injection of placebo matched to SHP681 in the abdomen.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Eslicarbazepine Acetate Monotherapy Long Term Study
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a long term, open-label, safety extension study in subjects with partial onset
      seizures.
    

Detailed description: 
      This is a long term, multicenter, open-label, safety extension study in subjects with partial
      onset seizures who have just completed, discontinued, or exited the 18-week treatment phase
      of Protocols 093-045 or 093-046. The initial study duration is 1 year with the option of
      continuing study drug treatment post 1 year until a subject discontinues study, the study
      drug becomes clinically available in the subject's locale, or the sponsor terminates the
      study drug clinical development program.

      This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired
      by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to
      Sunovion Pharmaceuticals Inc.
    

Intervention name(s): Eslicarbazepine acetate
Intervention type(s): Drug
Intervention description(s): 800 to 2400 mg once daily (QD)
Other intervention name(s): SEP-0002093; BIA 2-093
Intervention MeSH terms: Eslicarbazepine acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seizures; Epilepsy; Anticonvulsant; Monotherapy; Epilepsy with simple or complete partial onset seizures
Effect of Music on Nursing Students' Skills, Anxiety
Condition: Music
Study type: Interventional

Summary: 
      Objectives: This study aimed to determine the effect of music on nursing students' skills,
      anxiety, self-confidence perception, and vital signs.
    

Detailed description: 
      Design: Single-blinded study with parallel groups. Setting: Faculty of Nursing. Participants:
      Sixty first-year students who took the Nursing Fundamentals course were randomly assigned to
      the intervention (n = 30) and control (n = 30) groups.

      Methods: Data were collected using the Student Information Form, Subjective Self-Confidence
      Assessment Tool, and State Anxiety Scale from April 6 to 11, 2022. The students in the
      intervention group listened to music for 15 min before and during the peripheral intravenous
      catheter placement skill practice, while no intervention was applied in the control group.
    

Intervention name(s): music
Intervention type(s): Other
Intervention description(s): The students in the intervention group listened to music for 15 min before and during the peripheral intravenous catheter placement skill practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blinded study with parallel groups.
Masking: Single (Participant)
Primary purpose: Other
Keywords: Nursing student; intravenous catheter; anxiety; music; self-confidence
Comparison Between Hypoglycemic Counter Regulatory Responses in Type 1 Diabetics vs Control Subjects
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in
      healthy control subjects with and without antecedent hypoglycemia
    

Detailed description: 
      Iatrogenic hypoglycemia is one of the main limiting factors for optimal glycemic management
      of diabetes. It causes recurrent morbidity in most people with type 1 diabetes and in many
      patients with type 2 diabetes and can be fatal. Episodes of hypoglycemia impair
      physiologically protective mechanism in subsequent episodes of hypoglycemia. This phenomenon
      is known as hypoglycemia-associated autonomic failure (HAAF), the clinical syndromes of
      defective glucose counter regulation and hypoglycemia unawareness.
    

Intervention name(s): Glucose clamp technique
Intervention type(s): Other
Intervention description(s): Hyperinsulinemic euglycemic and hyperinsulinemic hypoglycemic clamp procedure with infusion of insulin and glucose
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 9 diabetic subjects and 9 healthy control subjects will be randomized to undergo either first day 1 + day 2 (two consecutive episode of hypoglycemia) or first day 3 + day 4 (one episode of hypoglycemia).
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypoglycemia-Associated Autonomic Failure (HAAF)
Femoroacetabular Impingement RandomiSed Controlled Trial
Condition: Femoroacetabular Impingement
MeSH terms: Femoracetabular Impingement
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether surgical correction of hip impingement
      morphology via arthroscopic osteochondroplasty (shaving of bone) will provide improved
      clinical results (decreased pain and improved function) in adult patients with
      femoroacetabular impingement (FAI) compared to arthroscopic lavage (washing out of painful
      inflammation debris) and treating obvious damage of the hip joint.
    

Detailed description: 
      Femoroacetabular impingement (FAI) is a condition of the hip where there is a mismatch of the
      ball and socket in the hip joint. This mismatch creates abnormal contact in the hip which can
      cause patients to experience hip pain. This can eventually lead to hip damage and
      osteoarthritis. Hip arthroscopy, a form of minimally invasive surgery has become a popular
      treatment option. The investigators are conducting a definitive randomized controlled trial
      (RCT) to determine whether surgical correction of the impingement morphology via arthroscopic
      osteochondroplasty (shaving of bone) will provide improved clinical results (decreased pain
      and improved function) in adult FAI patients compared to arthroscopic lavage (washing out of
      painful inflammation debris) and treating obvious damage of the hip joint.

      Like most RCTs, FIRST is designed to demonstrate efficacy (i.e. that an intervention can work
      theoretically under optimal conditions). In order to address generalizability and improve
      external validity of the FIRST trial, we are including an external validation cohort using a
      "RCT with and Embedded ProspectIve Cohort design" (FIRST-EPIC). This pragmatic cohort will
      allow us to: 1) safeguard against bias attributable to patients declining to take part in the
      RCT; 2) corroborate or refute whether our efficacy (RCT) population represents the best case
      scenario (i.e. those with optimal response to osteochondroplasty); 3) evaluate effectiveness
      of osteochondroplasty and other standard of care treatments for FAI in patients with
      potentially distinct prognostic factors; and 4) evaluate the cost-effectiveness of the
      interventions.
    

Intervention name(s): Arthroscopic Lavage; Arthroscopic Osteochondroplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Lavage: inflammation debris caused from continual friction in the hip is washed out.; Osteochondroplasty: reshaping the hip ball and socket ("osteoplasty" or "rim trimming").
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FAI; randomized; hip arthroscopy; lavage; osteochondroplasty
To Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese
      participants after multiple doses are administered.
    


Intervention name(s): BMS-986177; Matched Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral Suspension; Oral Suspension
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other