bioihbjkbjnl/mcl2 huggingface dataset:
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents
Condition: Pertussis; Tetanus; Diphtheria
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced
      diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose
      in adolescents in Japan.

      Primary Objective:

        -  To assess the immunogenicity of Tdap (SP306) when administered as a single dose in
           Japanese adolescents

      Secondary Objective:

        -  To assess the safety of Tdap vaccine when administered as a single dose in Japanese
           adolescents.
    

Detailed description: 
      All participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0 and
      undergo immunogenicity assessment from blood samples provided prior to, and 28 days
      post-vaccination. Tolerability and safety will be monitored up to 28 days post-vaccination.
    

Intervention name(s): (ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): ADACEL®; Tdap Vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pertussis; Tetanus; Diphtheria; Acellular pertussis; ADACEL®; Tdap vaccine
Phase 1 Oral Solution Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioavailability of Apixaban solution administered
      through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban
      solution administered orally in healthy subjects
    


Intervention name(s): Apixaban
Intervention type(s): Drug
Other intervention name(s): BMS-562247
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity
Condition: Obesity; Vitamin D Deficiency; Hypertension
MeSH terms: Hypertension; Obesity; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Hypothesis: Vitamin D supplementation lower renin-angiotensin system activity in obesity.

      Specific Aim: To investigate whether Vitamin D supplementation in obesity improves the
      vascular sensitivity to angiotensin II.
    

Detailed description: 
      Vitamin D deficiency and obesity are international epidemics that have both been associated
      with increased activity of the renin-angiotensin system (RAS). Because increased RAS activity
      is associated with cardiovascular disease, interventions to lower RAS will have favorable
      public health impacts.

      This study aims to evaluate whether the supplementation of Vitamin D in obese subjects will
      lower local tissue RAS activity. RAS activity will be evaluated by cross-sectional
      measurement of RAS components and by quantifying the vascular response to an infusion of
      angiotensin II. Subjects will be studied while Vitamin D deficient, and will return for
      repeat study following Vitamin D supplementation, for comparison.
    

Intervention name(s): Vitamin D (cholecalciferol)
Intervention type(s): Dietary Supplement
Intervention description(s): cholecalciferol 15,000 IU daily for 30 days
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Obesity; Renin Angiotensin System; Vitamin D deficiency; Hypertension
"Unifuzol®" in Patients With Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study is a multicenter, randomized, double-blind, placebo-controlled study of the
      safety and efficacy of the drug Unifuzol® (L-arginine) in patients with obliterating
      atherosclerosis of the lower extremities. The study recruits patients 40-79 years old with a
      confirmed diagnosis of chronic ischemia of the lower limb and a stable symptom of
      intermittent claudication that occurs when walking a distance of 100-299 meters. L-arginine
      improves microcirculation due to activation of nitrogen monoxide production and stimulates
      capillary blood flow, thus can probably improve the quality of life of patients with
      intermittent claudication. The criterion for treatment efficacy will be an increase in the
      maximum walking distance measures before and on the next day after the end of treatment
      course.
    


Intervention name(s): L-arginine 1.4% 500 ml; L-arginine 1.4% 250 ml + placebo 250 ml; Placebo solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Infusion of L-arginine 1.4% solution by 500 ml (2 vials 250 ml each) IV daily for 10 days; Infusion of L-arginine 1.4% solution 250 ml IV daily for 10 days and placebo infusion by 250 ml IV daily for 10 days.; Infusion of Ringer's solution by 500 ml (2 vials 250 ml each) IV daily for 10 days
Other intervention name(s): Unifuzol® 1.4%; Unifuzol® 1.4% 250 ml and placebo 250 ml; Ringer's solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Peripheral Arterial Disease; Arterial Occlusive Disease; intermittent claudication
Effects of a Motor Imagery Exercise Protocol in Patients With Fibromyalgia
Condition: Fibromyalgia; Pain, Chronic; Image, Body; Psychological Distress
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the efficacy of a novel approach with a motor
      imagery-based exercise program versus conventional rehabilitative approach in fibromyalgia
      syndrome (FM): reduction of pain was set as the primary outcome.
    

Detailed description: 
      Evidence about the therapeutic efficacy of exercise intervention programs in FM is still low
      and many authors suggested improving standardized exercise prescription for FM to achieve
      optimal results. In the literature, as an alternative approach, rehabilitative protocols in
      Group Music and Imagery seem to improve well-being and reduce anxiety in women with FM and
      suggest that Music and Imagery may help diminish pain intensity and depression. A
      rehabilitative approach should also consider the psychological and emotional aspects and,
      when possible, be accompanied by cognitive-behavioral therapy. The purpose of this research
      is to evaluate the possible efficacy of a novel approach with a motor imagery-based exercise
      program versus conventional rehabilitative approach in FM syndrome: the reduction of pain was
      set as the primary outcome as well as taking into account the patient's psychological and
      emotional condition. This study was designed as a double-blind, randomized, controlled trial.
    

Intervention name(s): Motor Imagery physical therapy; Conventional physical therapy
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibromyalgia; Pain; Imagery
Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
Condition: Single Ventricle Heart Disease After Fontan Surgery
MeSH terms: Heart Diseases; Univentricular Heart
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will investigate the cardiovascular effects of sildenafil on patients with Fontan
      circulation. Recent studies suggest that sildenafil may improve exercise in patients with
      Fontan circulation. However, why this occurs is not known. The study will used specialized
      catheters to measure pressure and volume. The measure of pressure and volume leads to more
      detailed analysis of heart function. Patients will receive either sugar pill or sildenafil
      prior to catheterization. It is believed that sildenafil will improve relaxation and
      contraction of the heart.
    

Detailed description: 
      Modifications to surgical procedures and medical treatment have led to a rapidly declining
      mortality rates in patients with single-ventricle heart disease (SV). However, SV patients
      still suffer from lower quality of life, decreased exercise capacity, worse
      neurodevelopmental outcomes and many other morbidities. While patients with SV circulation
      only make a small portion of all congenital heart diseases, 2-4 %, they require a great deal
      of resource utilization.

      Standard medical treatments for adult heart failure have not had the same success in the SV
      population. Phosphodiesterase 5 (PDE5) inhibitors have recently become a frequently used
      medication class in patients with SV heart disease to treat pulmonary hypertension, heart
      failure, as well as "Fontan" failure (i.e., plastic bronchitis and protein-losing
      enteropathy). While there have been findings of improved measures of exercise capacity and
      some reports of improved symptoms of heart failure, the physiologic mechanisms behind these
      findings are not completely understood. There have been reports, indicating that the
      phosphodiesterase five inhibitors improve ventricular function in biventricular circulation
      patients and animal models. The aim of our study was to investigate the effect of acute PDE5
      inhibition on ventricular function in SV patients after the final palliative surgery, the
      Fontan procedure.
    

Intervention name(s): Cardiac catheterization
Intervention type(s): Diagnostic Test
Intervention description(s): All patients will receive a dobutamine infusion during catheterization. Patients were 1:1 randomized to a single dose of 1 mg/kg of sildenafil (max dose of 20 mg) or placebo 30-90 min prior to beginning of catheterization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Single ventricle; Fontan; Sildenafil; Pressure-Volume Loops
Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      At present, there are no therapeutic agents that can minimize severe hypoglycemia (low blood
      sugar) and its effects on long-term brain function. The aim of this study is to determine
      whether the human brain is able to use medium chain fatty acids (MCFA) and/or their
      metabolites as an alternative fuel source during acute hypoglycemia in patients with Type 1
      Diabetes Mellitus (T1DM). The hypothesis is that medium chain fatty acids will provide a
      rapidly absorbed, non-carbohydrate fuel that will improve cognitive performance during
      episodes of hypoglycemia (low blood sugar.)
    

Detailed description: 
      Twelve subjects between the ages of 18 years and 55 years who have had Type 1 Diabetes
      Mellitus for more than five years and have had tight control of their diabetes as determined
      by screening blood work will be invited to participate. Each study subject will undergo two
      hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with
      intravenous insulin and glucose.) In these hypoglycemic clamp studies, cognitive testing will
      be performed during 90 minutes of normal blood glucose followed by 90 minutes of
      hypoglycemia. During the hypoglycemic period, either the MCFA or a placebo will be
      administered. Each subject will experience both conditions. The order in which the MCFA is
      given will be randomized.
    

Intervention name(s): Medium chain fatty acid (Octanoic and Decanoic acid); Splenda (Placebo Control)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Octanoic acid(67%) and Decanoic acid (27%); MCFA 50g total at 25 minute intervals with front loading of 20g then 10g for three administrations.; Placebo drink will consist of dietary sweetener Splenda mixed in water at a concentration of 1g/100mL. An unsweetened cherry flavor Koolaid mix will be added at a concentration of 0.3g/100mL of the Splenda drink to enhance flavor.
Other intervention name(s): Medium Chain Triglycerides; Octanoic and Decanoic acid; Fractionated coconut oil
Intervention MeSH terms: Decanoic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Medium Chain Fatty Acid; Hypoglycemia
Aliskiren for Immunoglobulin A (IgA) Nephropathy
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 3

Summary: 
      Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in
      the world. Current treatment with angiotensin converting enzyme (ACE) inhibitor and
      angiotensin receptor blocker (ARB) is not entirely effective. Aliskiren, a direct renin
      inhibitor, acts on the rate limiting step of the renin-angiotensin axis. In addition to
      lowering the blood pressure, recent study in diabetic nephropathy suggests an independent
      anti-proteinuric effect. The investigators plan to conduct a randomized placebo-control
      cross-over study to evaluate the safety and efficacy of aliskiren in the treatment of IgA
      nephropathy. The investigators plan to recruit 57 patients with biopsy-proven IgA nephropathy
      and persistent proteinuria despite conventional therapy. They will be randomized to aliskiren
      for 16 weeks or no treatment, followed by cross over to the other arm after a washout period.
      Proteinuria, albuminuria, renal function, serum and urinary markers will be quantified. This
      study will explore the potential anti-proteinuric effect of aliskiren in the treatment of IgA
      nephropathy, which has no specific treatment at present.
    


Intervention name(s): Aliskiren; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aliskiren 300 mg daily oral; starch tablet, 300 mg/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: proteinuria; renal failure; glomerulonephritis
Study of Decitabine in Combination With Sequential Rapamycin or Ribavirin in High Risk AML Patients
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the response to chemotherapy with the drug decitabine combined with rapamycin in
      the treatment of relapsed or refractory acute myeloid leukemia in patients of all ages, and
      in the treatment of newly diagnosed leukemia in those who are older than 65 when diagnosed.
    

Detailed description: 
      To determine the efficacy of decitabine followed by Rapamycin in previously untreated elderly
      patients not able to receive standard chemotherapy or in patients with relapsed or refractory
      AML, through measurement of Complete Remission (CR), Complete Remission Incomplete Platelet
      Recovery (CRp), Partial Remission (PR), and event free and overall survival (Arm A).

      To determine the safety of administration of decitabine with escalating doses of Ribavirin in
      elderly leukemia patients or patients with relapsed/refractory disease with M4/M5 subtypes
      anticipated to express high eukaryotic translation initiation factor 4E (eIF4E) at diagnosis
      (Arm B).

      To establish effect of these sequential treatments on expression of phosphoinositide
      3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/Akt /mTOR) pathway proteins and
      on eukaryotic translation initiation factor 4E (eIF4E) activation through Western blot and
      phospho-flow methodologies.

      To correlate the clinical response with baseline expression of phospho-p70S6
      Kinase/phosphorylated protein kinase B (pAKT) and with the in vitro inhibitory effects of
      mammalian target of rapamycin (mTOR) inhibition with rapamycin or ribavirin on the level of
      downstream effectors.

      To determine whether a leukemia stem cell phenotype is inhibited by the sequential
      administration of decitabine/rapamycin or decitabine/ribavirin.
    

Intervention name(s): Decitabine
Intervention type(s): Drug
Other intervention name(s): Dacogen; 5-aza-2'-deoxycytidine
Intervention MeSH terms: Decitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced COPD
Condition: Advanced COPD (GOLD Stage 3 or 4) With Cachexia
MeSH terms: Wasting Syndrome; Cachexia
Study type: Interventional

Summary: 
      This study will evaluate the use of a medical food, oral serum-derived bovine
      immunoglobulin/protein isolate (SBI), in helping patients with advanced COPD with cachexia (a
      wasting syndrome) improve their nutritional status and gain weight. The medical food is in
      powder form and is mixed with a liquid such as water or orange juice and consumed by
      swallowing. The primary hypothesis is that SBI protein isolate (SBI) will improve the
      nutritional status of cachexic patients with advanced stages of COPD.
    


Intervention name(s): Serum bovine immunoglobulin (SBI) medical food; Placebo (for serum bovine immunoglobulin)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Serum bovine immunoglobulin (SBI) is an FDA regulated, orally administered prescription medical food intended for the nutritional management of patients who are unable to absorb necessary nutrients as a result of therapeutic or chronic medical problems.
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GOLD, COPD, cachexia, BMI
Patient-controlled Sedation Versus Target-controlled Infusion in Orthopaedic Surgery Under Central Neuraxial Block
Condition: Patient-controlled Sedation
Study type: Interventional

Summary: 
      Orthopaedic surgeries involving the legs can be done under nerve block, where patients will
      be numb of pain at the operated site but awake during surgery. Sedation can be given to allay
      anxiety and provide comfort throughout the surgery. Sedation can be given by the anaesthetic
      doctors by using target-comtrolled infusion pump, or self-administered by patients by means
      of specialised machines. This study compares two method of administration of sedation,
      patient-controlled sedation (PCS) versus target-controlled infusion sedation (TCIS) by
      anaesthetic doctors, in people undergoing orthopaedic surgeries under nerve block.
    

Detailed description: 
      Central neuraxial block (CNB) is one of the mainstays of anaesthesia methods in various
      disciplines particularly orthopaedic surgeries. However the state of consciousness can
      potentially cause patient anxiety thus sedation is often utilized as a mean to improve
      patient satisfaction and increase patient acceptance of CNB.

      Conventionally, the anaesthesiologist administers sedatives for the patients. Propofol is the
      commonly used drug for sedation due to its favourable pharmacokinetic profile, which results
      in fast induction, easy control of depth of sedation and rapid recovery. It can be infused by
      using target-controlled infusion (TCI) devices where the anaesthetists titrates propofol by
      setting desired target plasma and effect site concentration. However it is difficult to judge
      precisely patient requirements for adequate patient sedation, comfort and analgesia as
      patients' needs differ.

      Patient-controlled sedation (PCS) is a valid option, initially adapted from post surgery
      patient-controlled analgesia. It allows patients to titrate sedative medication to their
      comfort and therefore present an option that addresses the needs of patients with strong
      desire to maintain sense of control during procedures.

      This study was designed to compare total propofol requirement between PCS versus TCI sedation
      (TCIS), complications and patient satisfaction, in patients undergoing lower limb orthopaedic
      surgery under CNB.
    

Intervention name(s): patient-controlled sedation
Intervention type(s): Other
Intervention description(s): Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study to Examine the Effect of Particle Size on Bioequivalence and Bioavailability
Condition: Chronic Obstructive Pulmonary Disease (COPD); Rheumatoid Arthritis; Atherosclerosis
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to measure the amount of study drug that is in your blood after
      you receive a different type of tablet in each of four study visits.
    


Intervention name(s): GW856553
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inflammation
Compound to Control Presbyopia Symptoms
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 1

Summary: 
      Low dose compose to control presbyopia symptoms
    

Detailed description: 
      A los dose compound including pilocarpine, brimonidine and oxymetazoline was use to control
      presbyopia symptoms compared to pilocarpine and brimonidine in low doses.
    

Intervention name(s): PBO to control presbyopia symptoms
Intervention type(s): Combination Product
Intervention description(s): Low dose PBO to control presbyopia symptoms
Other intervention name(s): Pilocarpine; Brimonidine; Oxymetazoline
Intervention MeSH terms: Brimonidine Tartrate; Oxymetazoline; Pilocarpine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilocarpine, brimonidine, oxymetazoline (PBO) compound was instilled in the non-dominant eye of presbyopic patients, while in the dominant eye pilocarpine or brimonidine were instilled.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment