bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a randomized, double-blind, active control study of the enzyme replacement therapy
      (ERT) drug PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal
      function. Patients who had been treated for approximately 1 year with agalsidase beta and who
      had been on a stable dose of that product for at least 6 months were randomized in a 2:1
      ratio to either switch to PRX-102 or to continue treatment with agalsidase beta. Both
      treatments were delivered by intravenous infusions every two weeks, at a dosage of 1 mg/kg.
    

Detailed description: 
      This was a randomized, double-blind, active control study examining the safety and efficacy
      of pegunigalsidase alfa (PRX-102) in Fabry disease patients with impaired renal function.
      Participants had to have been taking the licensed ERT drug agalsidase beta (Fabrazyme®) for
      at least 1 year prior to study entry, and to have been on a stable dose of that product for
      at least the last 6 months. Since the disease expresses itself differently in males and
      females, gender could have an impact on the therapeutic effect; thus, there was additionally
      a requirement that no more than 50% of the patients could be female.

      Following screening, eligible patients were randomized in a 2:1 ratio to either switch to
      PRX-102 or continue treatment with agalsidase beta, with randomization stratified according
      to whether the urine protein-to-creatinine ratio (UPCR), a measure of kidney function, was
      above or below a specified threshold. Both products were administered as an intravenous
      infusion every 2 weeks, at a dosage of 1 mg/kg, for up to 24 months. Both patients and study
      staff were blinded as to which treatment was being given.

      Patients who completed the study were invited to continue in a long-term open-label extension
      study, PB-102-F60, in which all participants would receive PRX-102 1 mg/kg every 2 weeks.
    

Intervention name(s): PRX-102 (pegunigalsidase alfa); agalsidase beta
Intervention type(s): Biological; Biological
Intervention description(s): PRX-102 1 mg/kg every 2 weeks; agalsidase beta 1 mg/kg every 2 weeks
Other intervention name(s): pegunigalsidase alfa; Recombinant human alpha galactosidase-A; Fabrazyme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glomerular filtration rate; Proteinuria; PRX-102; pegunigalsidase alfa; Fabry Disease
VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after
      single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single
      dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10
      days.
    


Intervention name(s): VNRX-5133; VNRX-5022; Metronidazole; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): β-lactamase inhibitor; Approved β-lactam antibiotic; Approved antibiotic and antiprotozoal medication; Placebo (matching VNRX-5133 + VNRX-5022)
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1: Cross-over Part 2: Parallel
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Pharmacokinetics
The Effect of Whey Protein Supplementation on Vascular and Cognitive Function in Older Adults
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The "hardening of the arteries" observed with aging raises blood pressure and contributes to
      poor brain blood flow and loss of cognitive function (i.e. attention, memory, solving
      problems, making decisions). Cognition is the most important determinant of overall health
      status, quality of life, functional ability and independence in older adulthood.
      Nutraceutical strategies have received considerable attention as they may improve
      cardiovascular health with far fewer side effects compared to drugs. In this regard, dairy
      products are particularly attractive. Higher dairy consumption is associated with lower blood
      pressure and improved memory in adults. Milk proteins have natural blood pressure lowering
      effects. Studies conducted in animals have demonstrated that whey protein (a component of
      milk protein) may also increase artery elasticity. This is important given the strong
      association between artery elasticity, brain blood flow, and risk for cognitive decline.

      The investigators propose to conduct a randomized double-blind placebo controlled study
      comparing the effects of whey protein supplementation or carbohydrate placebo on measures of
      artery elasticity, brain blood flow, and cognitive function in older adults. Whey protein may
      be a novel dietary therapy to improve both artery health and brain health in older adults.
    

Detailed description: 
      Participants will be randomly assigned to receive either 50 g whey protein isolate or placebo
      each day for 12 weeks.
    

Intervention name(s): Whey protein supplement; Carbohydrate supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Supplements will be provided in powder form and mixed into beverages to be consumed twice per day (after breakfast and after dinner).; Supplements will be provided in powder form and mixed into beverages to be consumed twice per day (after breakfast and after dinner).
Other intervention name(s): 100% whey protein isolate; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Whey Protein; Arterial Stiffness; Neurovascular Coupling; Cerebrovascular Reactivity; Hemodynamics; Blood Flow; Pulsatility
Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients
Condition: Single Ventricle
MeSH terms: Univentricular Heart
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot study is aimed at assessing the short-term effects of Tadalafil on the hemodynamic
      response to exercise and exercise capacity in patients with Fontan circulation. Data
      regarding effect size and drug tolerability will be used in the design of a randomized
      multicenter trial. The long-term goal of this investigation is to systematically evaluate the
      effect of tadalafil therapy on exercise performance, quality of life, and delay of functional
      deterioration in patients with single ventricle physiology.
    


Intervention name(s): Tadalafil Citrate; Sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): If allocated to the treatment arm, the patient will be given tadalfil citrate, 0.8-1 mg/kg/day in 1 daily dose. Maximum dose 40 mg. All patients will receive either study drug or placebo for a total of 20 days.; If allocated to the placebo arm, the child will be given a similar appearing medication; the placebo will be a mixture of Ora-Sweet® and Ora-Plus® in a 1:1 ratio. All patients will receive drug for 20 days
Other intervention name(s): Cialis; Ora sweet
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fontan; Tadalafil; Exercise performance
A Relative Bioavailability and Food Effect Study of New Formulations
Condition: Chronic Inflammatory Disorder; Arthritis, Rheumatoid
MeSH terms: Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to assess the effect of 3 formulations on the relative
      bioavailability of LY3009104. Participants will receive single dose of LY3009104 on 4
      separate occasions with and without food. Safety evaluation and serial pharmacokinetic (PK)
      samples will be collected during each treatment period. Approximately 5 to 7 days of washout
      period between each treatment and a follow-up visit will occur approximately 5 to 7 days
      after the last dose of study drug.
    


Intervention name(s): LY3009104
Intervention type(s): Drug
Intervention description(s): Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of
      TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never
      received treatment for their hepatitis C infection.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention) study to assess the
      antiviral activity, safety, tolerability and pharmacokinetics (explores what the body does to
      the medication) of TMC435350 hereafter referred to as TMC435. Approximately 40 participants
      will be divided in 5 groups as per the genotype (8 participants each group). The study will
      include a screening phase (up to 6 weeks), treatment phase (7 days) and a follow-up phase
      (30-35 days after the last dose of study medication). Safety evaluations will include
      assessment of adverse events, clinical laboratory tests and cardiovascular safety.
    

Intervention name(s): TMC435
Intervention type(s): Drug
Intervention description(s): From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
Intervention MeSH terms: Simeprevir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; TMC435
Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether sedation with a combination of pethidin
      hydrochlorid plus midazolam intravenously (i.v.) is superior to propofol i.v. alone in
      relation to blood pressure drops during an transesophageal echocardiographic examination
      (TEE).
    

Detailed description: 
      Randomisation is done immediately after information of the patient and obtaining of the
      informed consent. The average time for a TEE study is about 30 minutes. Data collection
      occurs during this time frame. ECG monitoring and data collection (blood pressure, heart
      rate, SO2) for the study protocol starts 6 minutes before the application of the sedation. At
      -6, -4, -2 minutes before the application of the sedation, baseline data are collected. The
      average systolic blood pressure of these three measures is taken as the reference blood
      pressure. This is the reference value to calculate the blood pressure drop during the
      examination. Blood pressure, pulse oxymetry, heart rate are taken every 2 minutes until the
      examination (TEE) is finished. The questionnaire (for second end points) is filled out by the
      patient within two hours after the examination. The patient will be followed for the duration
      of about one hour after the examination, if he is from the outpatient clinic. Patients from
      the hospital (inpatients) will be followed routinely in the clinic.
    

Intervention name(s): pethidin hydrochlorid, midazolam; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Pethidin hydrochlorid: 25 mg iv. at the beginning of the examination Midazolam: 1-2 mg iv. at the beginning of the examination. Repetitive given in a dosis of 1 mg iv. until a total amount of 7 mg iv.; 50 years and over: initial dose of 50-60 mg Propofol iv. Followed by bolus of 20-30 mg iv. until sedation is achieved.
< 50 years: initial dose 30-40 mg Propofol iv. Followed by bolus of 10-20 mg until sedation is achieved.
Other intervention name(s): Pethidin hydrochlorid = Meperidine (USA); Midazolam = Dormicum; Propofol = Propofolum = Diprivan = Disoprivan
Intervention MeSH terms: Midazolam; Meperidine; Propofol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Sedation in TEE; Blood pressure drop during TEE; Safety of sedation in TEE
Drug Interaction Study of Darunavir/Ritonavir and Lopinavir/Ritonavir on GSK2248761 PK and CYP450 Probe Drugs
Condition: Healthy Subjects; Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of GSK2448761 on CYP450 metabolic probes
      and to evaluate the 2-way interaction between GSK2448761 and two ritonavir-boosted protease
      inhibitors that are commonly used in HIV-infected subjects.
    


Intervention name(s): darunavir/ritonavir; lopinavir/ritonavir; Midazolam; Dextromethorphan; Flurbiprofen; GSK2248761
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): DRV/RTV 600/100mg; LPV/RTV 400/100mg; Midazolam 3mg; Dextromethorphan 30mg; Flurbiprofen 50mg; NNRTI under investigation
Intervention MeSH terms: Ritonavir; Lopinavir; Darunavir; Flurbiprofen; Midazolam; Dextromethorphan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: probes; NNRTI; drug interaction; protease inhitibor
Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects
Condition: Postbariatric Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study will examine the safety and tolerability, as well as the effects of
      orally administered mizagliflozin on post prandial glucose and insulin levels in subjects
      diagnosed with post-bariatric hypoglycemia (PBH).
    

Detailed description: 
      This is a Phase 2 randomized, sequential crossover single ascending dose study in PBH
      subjects to determine the effect of two mizagliflozin formulations This study will examine
      single doses of mizagliflozin in either a liquid or encapsulated formulation. Subjects will
      be randomly assigned to one of two treatment arms. Safety, tolerability and pharmacodynamic
      response to mizagliflozin will be assessed in subjects during a mixed meal tolerance test
      (MMTT).
    

Intervention name(s): Mizagliflozin
Intervention type(s): Drug
Intervention description(s): Encapsulated or Liquid Formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Unilateral Dual TAP (Transverses Abdominal Plane) Blok i Forbindelse Med Laparoskopisk Nyre Operation
Condition: Laparoscopic Nephrectomy; TAP Block
Study type: Interventional

Summary: 
      Unilaterally Dual TAP (Transversus abdominis plane) block after radical nephrectomy,
      assessment of benefit and opioid reduction.

      Transverses Abdominal Plane (TAP) Block is a relatively new regional technique which
      infiltrates local anesthetic between the internal oblique and transverse abdominis muscles
      and provides analgesia to the parietal peritoneum as well as the skin and muscles of the
      anterior abdominal wall (1). An Ultrasound-guided bilateral dual transversus abdominis plane
      block (Dual TAP block) had been reported by Boerglum et al (2,3), in which regional
      anesthesia postoperatively can be provided to the upper (Th6-Th9) and the lower (Th10-Th12)
      abdominal wall bilaterally using a four-point single-shot technique.

      Pain has a wide spectrum of effects on the body. Inadequately controlled postoperative pain
      may have harmful physiologic, psychological consequences which potentially increase the
      morbidity and mortality (4,5). It has been recognized that inadequately treated postoperative
      pain may lead to chronic pain which is often misdiagnosed and neglected (6,7). Chronic
      postsurgical pain reported in 20% of patients, 6 months after nephrectomy (8).

      Hypothesis: The use of unilaterally dual TAP block will reduce the VAS score for pain and the
      need of morphine postoperatively after radical nephrectomy.

      Purpose: To evaluate the analgesic efficacy of unilaterally dual TAP block as an adjuvant to
      routine analgesic. To assess the difference in morphine usage in the first 48 hours after
      radical nephrectomy with or without applying of unilaterally dual TAP block.
    


Intervention name(s): TAP block
Intervention type(s): Drug
Intervention description(s): Patients will be scheduled to receive routine analgesic and an unilaterally dual TAP block with 2 points injections of 15 ml of 0,375 % Ropivacain( in total 30 ml 0,375% Ropivacain) in the same side of nephrectomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on
      insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients
      with type 1 diabetes.
    


Intervention name(s): Liraglutide; Liraglutide; continuous insulin therapy
Intervention type(s): Drug; Drug; Other
Intervention description(s): after optimal treatment on insulin alone 10 patients with type 1 diabetes are treated for four weeks with Liraglutide : in the first week at 0.6 mg sc and after one week optitration to the recommended 1.2 mg sc pr day.; after optimal treatment with insulin alone, 10 type 1 diabetic patients are treated with Liraglutide at a dose of 0.6 mg sc. After one week the dose is optitreted to the recommended 1.2 mg sc pr. day.; after optimal treatment with insulin, patients continue on insulin for four weeks
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: patients with type 1 diabetes mellitus
Gender Differences in Response to Cues in Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Observational

Summary: 
      The purpose of this study is to evaluate whether men and women respond differently to seeing
      items related to cocaine use or to remembering stressful events. Four groups of individuals
      will be recruited to participate in this study: men with cocaine dependence, women with
      cocaine dependence, men without cocaine dependence, and women without cocaine dependence.

      Hypothesis #1: Cocaine-dependent women will demonstrate smaller increases in neuroendocrine,
      but greater increases in heart rate and more cocaine craving and subjective distress when
      exposed to stress as compared to cocaine-dependent men and non cocaine-dependent men and
      women.

      Hypothesis #2: Cocaine-dependent men will demonstrate greater increases in neuroendocrine,
      but greater increases in heart rate and more cocaine craving and subjective distress when
      exposed to cocaine-related cues as compared to cocaine-dependent women and non
      cocaine-dependent men and women.

      Hypothesis #3: Cocaine-dependent women will demonstrate greater increases in heart rate and
      more cocaine craving and subjective distress when exposed to stress inducing stimuli as
      compared to their own responses to a cocaine-related cue.

      Hypothesis #4: The neuroendocrine response to a stress hormone (corticotropin releasing
      hormone; CRH) will be greater in cocaine-dependent women as compared to cocaine-dependent
      men.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        There will be four primary sources of recruitment for cocaine dependent subjects: (1)
        patients referred from the Center for Drug and Alcohol Programs (CDAP) intake coordinator,
        (2) individuals presenting to CDAP for either inpatient or outpatient treatment, (3)
        individuals presenting to the Charleston Center for inpatient or outpatient treatment, (4)
        and individuals presenting to the Dorchester Alcohol and Drug Commission (DADC) for
        treatment. Control subjects will be recruited from the Charleston community
      
Keywords: HPA axis
Costoclavicular vs Paracoracoid Approach to Infraclavicular Brachial Plexus Block: a Feasibility Study
Condition: Upper Limb Injury
MeSH terms: Arm Injuries
Study type: Interventional

Summary: 
      Patients for upper limb surgeries who are candidates for infraclavicular block will be
      screened. Two techniques of infraclavicular block will be compared. Measured outcomes are
      performance times, block onset times, patient satisfaction, quality of block, and requirement
      for supplementary analgesia.
    

Detailed description: 
      Infraclavicular brachial plexus block under ultrasound guidance is used for surgeries on the
      upper limb. Traditionally, the block is performed at the lateral infraclavicular fossa where
      the cords are variable in position relative to the axillary artery. A recently introduced
      technique is the costoclavicular approach where the cords are viewed as relatively more
      superficial and clustered together compared to the traditional technique. Those meeting the
      inclusion criteria and will consent to participate in the study will be randomized to have
      either an infraclavicular block in the paracoracoid approach (Group 1) or an infraclavicular
      block in the costoclavicular approach (Group 2). All groups will have the same injectable
      volume (35 mls) and local anesthetic concentration (ropivacaine 0.5%). There will be 35 study
      patients for each group for a total of 70 patients.
    

Intervention name(s): Ropivacaine; Ultrasound
Intervention type(s): Drug; Device
Intervention description(s): Local anesthetic; Ultrasound guided block
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research