bioihbjkbjnl/mcl2 huggingface dataset:
Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Influenza
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T
      combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6,
      10, and 14 weeks of age.
    


Intervention name(s): DTaP-HB-PRP~T combined vaccine; Tritanrix-HepB/Hib™ vaccine; Oral poliomyelitis vaccine (OPV)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; Oral co-administered with study vaccine.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Hepatitis B Hansenula (HB); Haemophilus influenzae type b
Evaluation of Perioperative Celecoxib for Hip Arthroscopy
Condition: Hip Labral Tears
Study type: Interventional

Summary: 
      Celecoxib is commonly used for perioperative pain control for certain orthopaedic procedures.
      It has been shown to be successful in assisting in pain control for knee arthroscopy. It has
      not previously been studied in hip arthroscopy. This is a double blinded randomized
      controlled trial to determine the efficacy of celecoxib in perioperative pain control for hip
      arthroscopy.
    

Detailed description: 
      This study examines the efficacy of perioperative dose of celecoxib in pain management after
      hip arthroscopy. Perioperative administration of celecoxib has been shown to improve pain
      control after knee arthroscopy, but this has not yet been studied in the hip. In this study,
      patients are randomized to receive either 400mg celecoxib or placebo 1 hour prior to
      undergoing hip arthroscopy surgery. Postoperatively, patients are monitored for pain on the
      VAS scale, narcotic use, and meeting discharge criteria. The study will enroll 100 patients.
      Patients are approached for informed consent on the day of surgery. Pain scores, narcotic
      use, and time to discharge in the celecoxib group are compared to the placebo group.
    

Intervention name(s): Celecoxib; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Received 400mg celecoxib prior to surgery
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hip arthroscopy
Dexmedetomidine and Liver Transplantation
Condition: Dexmedetomidine, Liver Transplantation, Allograft Function, Survival
Study type: Interventional
Phase: Early Phase 1

Summary: 
      1.1. Background 1.1.1. Perioperative ischaemia/reperfusion (I/R) injury during liver
      transplantation is strongly associated with early allograft dysfunction, graft loss, and
      mortality.

      1.1.2. Hepatic I/R injury also causes remote damage to other organs including the renal and
      pulmonary systems.

      1.1.3. Dexmedetomidine, a selective α2-adrenoceptor agonist which is widely used as an
      adjuvant to general anaesthesia, has been widely shown in preclinical studies to provide
      organoprotection by ameliorating the effects of I/R injury in a range of tissues (including
      the liver). However, prospective clinical evidence of any potential benefits in improving
      outcomes in liver transplantation is lacking.

      1.2. Objectives 1.2.1. To investigate the hypothesis that perioperative treatment with
      dexmedetomidine reduces the incidence of early allograft dysfunction and primary graft
      non-function in deceased donor liver transplantation.

      1.2.2. The impact of dexmedetomidine on postoperative renal and pulmonary function will also
      be examined.

      1.3. Study Design This is a prospective, single-centre, randomised, parallel-group study.

      1.4. Setting Departments of Anesthesiology, Renji Hosptial, Shanghai Jiao Tong University
      School of Medicine, Shanghai, 200127, China.

      1.5. Patients 200 patients (18-65 years) scheduled to undergo liver transplantation under
      general anaesthesia.

      1.6 Intervention 1.6.1. For the patients in the treatment group, a loading dose of
      dexmedetomidine will be given after induction of anaesthesia (1μg/kg over 10 min) followed by
      a continuous infusion (0.5μg/kg /h) until the end of surgery.

      1.6.2. For patients in the placebo group, an equal volume loading dose of 0.9% saline will be
      given after the induction of anaesthesia followed by an equal volume continuous infusion
      until the end of surgery.

      1.6.3. All other supplements, e.g. opioids, sedatives and muscle relaxant, will be identical
      in the both arms and administered according to routine clinical practice.
    


Intervention name(s): Dexmedetomidine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine, a selective α2-adrenoceptor agonist which is widely used as an adjuvant to general anaesthesia; Saline, a kind of crystalloid widely used in clinical treatment
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, non-randomized extension to study AC-066A401. The study will assess
      safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a
      means for continuing treatment after ending participation in study AC-0066A401.
    


Intervention name(s): ACT-385781A (Actelion Epoprostenol); Flolan®
Intervention type(s): Drug; Drug
Intervention description(s): per Prescribing Information; per Prescribing Information
Intervention MeSH terms: Epoprostenol; Tezosentan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension; PAH; EPITOME-1
Anthocyanin-rich Blackcurrant and Vascular Function
Condition: Vascular Stiffness; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Regular consumption of fruits and vegetables may improve human health and reduce the risk of
      chronic diseases, such as heart disease, certain cancers and type 2 diabetes, but the active
      components and the underlying mechanisms are poorly understood. Berry fruits are abundant in
      anthocyanins and this study aims to test the hypothesis that ingestion of an anthocyanin-rich
      blackcurrant beverage will improve markers of cardiovascular health (health of blood vessels,
      inflammation and platelet function). Further, the study will investigate the anthocyanin
      bioavailability from the blackcurrant beverage.
    


Intervention name(s): Beverage: Spray dried blackcurrant powder dissolved in water; Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)
Intervention type(s): Other; Other
Intervention MeSH terms: Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: anthocyanins; bioavailability
To Compare and Evaluate the Efficacy and Safety of Ganilever PFS(Prefilled Syringe) and Orgalutran®
Condition: Controlled Ovarian Stimulation
Study type: Interventional
Phase: Phase 4

Summary: 
      to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in
      infertility women for assisted reproductive technologies
    


Intervention name(s): Ganirelix acetate
Intervention type(s): Drug
Intervention MeSH terms: Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression
Condition: Atypical Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Pilot Study to get a first indication whether Duloxetine may be effective for
      depressed patients with Atypical Features.
    

Detailed description: 
      This Open Pilot Study will assess whether Duloxetine is effective for patients with Atypical
      Features. 20 patients having Major Depressive Disorder with Atypical Features or Dysthymic
      Disorder will receive Duloxetine in open fashion for 8 weeks. Dose will begin with 20 mg/d
      and increase to PDR maximal dose of 120 mg/d, if tolerated.
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): Day 1-7: 20 mg/d; day 8-24: 30 mg/d; day 15-28: 60 mg/d; day 29-56: 120 mg/d.
* dose raises will occur only if pt. is tolerating the previous dose and not remitting.; dose may be lowered or increased in 30 mg increments if pt. has difficulty tolerating.
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atypical Depression; Major Depressive Disorder; Dysthymic Disorder; Atypical Features; Duloxetine
Effects of California Walnuts on Vascular Function in Postmenopausal Women
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the potential acute cardiovascular benefits of California Walnuts in
      postmenopausal women of ages 55-70.

      Primary outcome measures:

        -  Vascular function

        -  Platelet reactivity

      We hypothesize that the consumption of California walnuts will improve vascular function and
      platelet reactivity.
    

Detailed description: 
      Epidemiological studies have shown that consumption of high amounts of plant foods, such as
      nuts, fruits and vegetables, appears to be protective against chronic diseases including
      heart disease, stroke, diabetes mellitus and metabolic syndrome. In recent years, numerous
      studies indicate that consumption of walnuts mainly containing α-linolenic acid (ALA),
      L-arginine and polyphenols beneficially alters vascular function and reduces inflammatory
      biomarkers. Recent studies have reported that consumption of walnuts is associated with
      beneficial effects in prevention of chronic diseases by favorably altering human serum
      profiles (i.e. decrease in LDL cholesterol and triglycerides and increase in HDL cholesterol
      and apolipoprotein A1) which are closely involved in the development of cardiovascular
      disease (CVD). In addition, recent reports by Dr. Ros and his colleagues indicate that
      addition of walnuts to a high-fat meal can improve endothelial function. This favorable
      influence on vasoactivity has been attributed to the antioxidant and anti-inflammatory
      properties of components of walnuts.

      Due to their age and menopausal status, postmenopausal women in particular, are at a greater
      risk population for developing CVD. Males tend to show greater rates of CVD than
      pre-menopausal women, while women following menopause show an increase in the rates of CVD.
      This increase is associated with endothelial dysfunction and decreased vasodilation which are
      apparently expressed after menopause and become worse with age. In this study, we will define
      the effects of consuming California walnuts on vascular health.

      We hypothesize that consumption of California walnuts, which are particularly rich in ALA,
      L-arginine and polyphenols, will improve endothelial function and platelet reactivity in an
      at-risk population of postmenopausal women 50-70 years of age.
    

Intervention name(s): Walnuts; Walnuts; Walnuts; Walnuts
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Consumption of 5 g of walnuts.; Consumption of 20 g of walnuts.; Consumption of 30 g of walnuts.; Consumption of 40 g of walnuts.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Postmenopausal
Effect of An Oral Absorbent AST-120 in Late-stage Chronic Kidney Disease (CKD) Patients.
Condition: Chronic Kidney Disease; AST-120
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Recent research work has directed especial attention toward a distinct group of uremic
      retension molecules, called "protein-bound uremic toxins". The prototypes of this group of
      uremic toxins are indoxyl sulfate and p-cresol. These uremic toxins can promote production of
      free radical and impair antioxidant system and exerts direct toxicity on different cells and
      organs, including mesangial, tubular, endothelial cell and osteoblasts. Accumulation of these
      protein bound uremic toxins results in glomerular sclerosis and interstitial fibrosis of
      kidneys of uremic rats and confer skeletal resistance to parthyroid hormone in uremic
      patients. In hemodialysis, high serum p-cresol level is associated with higher cardiovascular
      mortality.

      AST-120 (Kremezin) is a carbonated oral absorbent extensively used in Japan and Korea. It has
      superior adsorption ability for certain small-molecular weight organic compounds known to
      accumulate in patients with CKD. In uremic rats and CKD patients, oral administration of
      AST-120 decreased the elevated pretreatment levels of serum indoxyl sulfate. In Japan, it was
      reported that AST-120 suppressed the increase in serum creatinine levels, prevented
      proteinuria, improved uremic symptoms, and, consequently, led to the postponement of dialysis
      therapy.

      Value of AST-120 on the outcome of late-stage CKD patients is still unknown. We hypothesized
      AST-120 through reduction of level of indoxyl sulfate and p-cresol can improved the
      morbidity- mortality of CKD patients.

      The principal aim of this prospective cohort study is to investigate the effectiveness of
      AST-120 in incidence of dialysis and mortality of late-stage CKD patients. Determination of
      this relationship can help to establish new therapeutic strategy in the treatment of
      late-stage CKD patients.
    


Intervention name(s): AST-120
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Opioid Use After Traumatic Injury in Adolescents
Condition: Opioid Use; Traumatic Injury; Adolescent Behavior; Substance Abuse Disorder
MeSH terms: Substance-Related Disorders; Wounds and Injuries
Study type: Observational

Summary: 
      Currently, 1 in 8 adolescents continue to receive prescription opioids a year or more after
      injury. By longitudinally surveying patients, we can identify risk factors and pathways to
      nonmedical opioid use. Furthermore, by assessing whether pain management and mental health
      treatment after injury moderates sustained opioid use and prescription opioid misuse, we can
      create targeted interventions to reduce future nonmedical opioid use in adolescents.
    

Detailed description: 
      This is a prospective cohort study that will follow participants for 2 years and administer
      surveys to adolescents both traumatically injured and uninjured on prescription opioid usage,
      substance use, utilization of pain management and mental health services, and mental and
      physical health condition conditions.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Traumatically injured patients admitted to either Eskenazi Hospital or Riley Hospital,
        between the ages of 12 and 20.
      
Biospecimen description: 
      Saliva will be collected at baseline only for the purpose of analyzing genetic data on each
      participant.
Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema
Condition: COPD; Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Observational

Summary: 
      To evaluate if tiotropium (Spiriva)induced bronchodilation of inspiratory capacity in
      patients with moderate to severe copd subjected to metronome paced hyperventilation induced
      dynamic hyperinflation is dependent upon the extent of underlying emphysema as determined by
      high resolution-thin section CT lung.
    

Detailed description: 
      We will analyze post hoc, data that was previously published: Gelb AF et al.Chest
      2006;131:690-695. We have shown that tiotropium increases resting inspiratory capacity
      thereby providing lung volume protection against metronome paced hyperventilation induced
      dynamic hyperinflation. End point will be to correlate increase in tiotropium induced FEV
      1(L) and inspiratory capacity with extent of underlying emphysema as scored by lung CT ( Gelb
      AF et al:Chest 1996; 109: 353-359)in 29 patients with COPD. We will also correlate the
      decrease in inspiratory capacity following metronome paced hyperventilation induced dynamic
      hyperinflation with extent of lung CT scored emphysema.
    

Intervention name(s): tiotropium
Intervention type(s): Drug
Intervention description(s): 18ug capsule daily for 30 days
Other intervention name(s): Spiriva
Intervention MeSH terms: Tiotropium Bromide
Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with moderate to severe copd from tertiary care pulmonary clinic
      
Keywords: copd; emphysema; tiotropium; lung function; dynamic hyperinflation
Octreotide Efficacy and Safety in First-line Acromegalic Patients
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Acromegaly is a clinical and metabolic disease caused by growth hormone (GH)
      hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is
      associated with bony and soft tissue overgrowth. Goals of therapy are to eradicate the tumor,
      suppress GH secretion, normalize IGF-I levels, and preserve normal pituitary function.

      This study will evaluate the safety and efficacy of octreotide as primary therapy for the
      treatment of acromegaly and as therapy for patients with acromegaly and a pituitary
      macroadenoma or microadenoma.
    


Intervention name(s): Octreotide
Intervention type(s): Drug
Other intervention name(s): SMS995
Intervention MeSH terms: Octreotide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acromegaly; Otreotide; Tumor reduction
Effect of Anesthetics on Microcirculation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
Condition: Microcirculation; Anesthetic Complication Spinal
Study type: Interventional
Phase: Phase 4

Summary: 
      Volatile anesthetics, such as sevoflurane and desflurane, are commonly used in patients
      undergoing cardiac surgeries including off-pump coronary artery bypass. However, the effect
      of volatile anesthetics on microcirculation in patients undergoing off-pump coronary artery
      bypass has not been well conducted.
    

Detailed description: 
      This is a prospective randomized clinical trial investigating the effect of sevoflurane vs.
      desflurane on tissue microcirculation in patients undergoing off-pump coronary artery bypass
      surgery. Eligible patients are going to be randomized to receive sevoflurane or desflurane,
      as a maintenance anesthetic, during the surgery. Tissue oxygen saturation and
      microcirculatory changes, such as an occlusion and recovery slope, during vascular occlusion
      test will be recorded during the surgery. The primary end point of the study is the
      difference in tissue oxygen saturation between the groups.
    

Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): Sevoflurane use as main anesthetic drug during the surgery; Desflurane use as main anesthetic drug during the surgery
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: off-pump coronary artery bypass; sevoflurane; desflurane; tissue oxygen saturation
Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy
Condition: Vertebrogenic Radiculopathy L5, S1
MeSH terms: Radiculopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the efficacy and safety of Neuromultivit (solution for
      injections) in treatment of vertebrogenic radiculopathy L5, S1 in comparison with standard
      therapy. The patients are randomised into two groups: standard therapy group and standard
      therapy plus Neuromultivit group.
    

Detailed description: 
      Group 1 (50 patients) receive Neuromultivit (2 ml per day, i.m.) for 7 days, then
      -Neuromultivit (2 ml per day, i.m.) every other day for 10 days and standard therapy for 20
      days.

      Group 2 (50 patients) receive only standard therapy for 20 days.

      Standard therapy involves:

        -  Voltaren (100 mg prolonged-released film-coated tablets once daily) for 20 days

        -  Sirdalud (2 mg tablets three times a day) for 20 days
    

Intervention name(s): Neuromultivit; Voltaren; Sirdalud
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Diclofenac; Tizanidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of EDP 305 in Healthy Subjects and Subjects With Presumptive NAFLD
Condition: Presumptive NAFLD
MeSH terms: Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled study will assess the safety, tolerability,
      and pharmacokinetics of single and multiple orally administered doses of EDP-305 in healthy
      adult subjects, and adult subjects with presumptive NAFLD (i.e., obese subjects with or
      without prediabetes or T2DM).
    

Detailed description: 
      The first phase assesses single ascending doses for EDP 305 (active drug or placebo) in
      healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

      The second phase assesses multiple ascending doses (active drug or placebo) for 14-days in
      healthy subjects and also in subjects with presumptive NAFLD (i.e., obese subjects with or
      without prediabetes or T2DM).

      Each cohort within each phase will enroll a total of 8 subjects who will be randomized to
      receive EDP-305 or placebo. The cohort assessing food effect will enroll 10 subjects
      randomized to receive EDP-305 or placebo.
    

Intervention name(s): EDP 305; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): placebo to match EDP 305
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: First-in-human; Single Ascending Dose; Multiple Ascending Dose