bioihbjkbjnl/mcl2 huggingface dataset:
Reduce Bolus Injection of Bivalirudin
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      There are fewer studies on the bleeding risk of the currently administered bivalirudin bolus
      injection dose and the safety of bivalirudin in patients with CKD. A non-inferiority,
      randomized, stratified controlled trial study has been conducted to evaluate the
      non-inferiority and safety of the low dose (80%) bolus injections of bivalirudin in patients
      with or without CKD.This study will provide a safe, effective and economical anticoagulation
      strategy.
    


Intervention name(s): Bivalirudin; Bivalirudin
Intervention type(s): Drug; Drug
Intervention description(s): 0.75mg/kg+ 1.75 mg/kg▪h for the duration of PCI;; 0.6mg/kg+ 1.75 mg/kg▪h for the duration of PCI;
Intervention MeSH terms: Hirudins; Bivalirudin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bivalirudin; bolus injection; activated clotting time; Renal insufficiency
NuMask Versus Traditional Mask Ventilation During Routine Care
Condition: Apnea
Study type: Observational

Summary: 
      The direct objective of this study is to determine whether an experienced provider can more
      adequately and/or easily ventilate an anesthetized patient with the NuMask device as compared
      to traditional bag-valve-mask ventilation. These are approved masks, being used in the
      patients routine care. The researchers believe that mean tidal volumes obtained by
      experienced providers when manually ventilating anesthetized patients with the NuMask device
      will be larger than when using the traditional bag-valve-mask.
    


Intervention name(s): NuMask; Traditional mask
Intervention type(s): Device; Device
Intervention description(s): The NuMask is a relatively new mask ventilation device that has been registered with the FDA and used in the United States since 2006.; A traditional air inflated facemark used to ventilate patients
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients selected will be undergoing elective surgery at the University of Utah
A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease
Condition: Sialorrhoea
MeSH terms: Sialorrhea; Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether OC (oxybutynin and clonidine) oral solution
      is effective in reducing saliva secretion in patients suffering from Parkinson's Disease with
      excessive salivation.
    

Detailed description: 
      Sialorrhea is excessive flow of saliva associated with its unintentional loss from the mouth,
      commonly known as drooling. Sialorrhea may result from any combination of hypersecretion,
      problems swallowing or sensorimotor problems containing saliva in the mouth. It is commonly
      found in people with neurological dysfunction such as Parkinson's Disease, leading to social
      isolation and embarrassment. In general, treatment options are limited because of the
      underlying chronic disease. The objective of the proposed low-dose, new combination drug, OC
      Oral solution is to develop a new treatment option that can be used to titrate saliva
      secretion rates to a level that is low enough to prevent unintentional loss (i.e. drooling)
      but not so low as to cause an uncomfortably dry mouth.
    

Intervention name(s): oxybutynin and clonidine oral solution treatment A; oxybutynin and clonidine oral solution treatment B; oxybutynin and clonidine oral solution treatment C; oxybutynin and clonidine oral solution treatment D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo
Other intervention name(s): OP-014; OP-014; OP-014; Placebo
Intervention MeSH terms: Mandelic Acids; Clonidine; Pharmaceutical Solutions; Oxybutynin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: oxybutynin; clonidine; OC Oral Solution; sialorrhoea; Parkinson's disease
Mechanisms of Weight Loss With SGLT2 Inhibition
Condition: Type 2 Diabetes; Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effect of canagliflozin, a medication
      approved by the FDA for the treatment of type 2 diabetes, on body weight and metabolism in
      people with type 2 diabetes who are overweight or obese.

      Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than
      absorb, glucose. Canagliflozin is also often associated with weight loss.

      The study population will generally be type 2 diabetics, ages 18-75 years old, who are
      overweight or obese.
    


Intervention name(s): Canagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.; Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Other intervention name(s): Invokana
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Canagliflozin; Obesity; Weight Loss; Body Weight; Body Weight Changes; Overweight; Sodium-glucose transporter subtype 2 inhibitor
Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
Condition: Cryopyrin-associated Periodic Syndromes; Familial Cold Autoinflammatory Syndrome; Muckle-Wells Syndrome; Neonatal Onset Multisystem Inflammatory Disease
MeSH terms: Cellulitis; Eosinophilia; Cryopyrin-Associated Periodic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will provide long-term safety, efficacy and tolerability of ACZ885 in CAPS
      patients that completed the CACZ885D2307 study
    


Intervention name(s): ACZ885
Intervention type(s): Biological
Other intervention name(s): Canakinumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Cryopyrin-associated periodic syndromes (CAPS); Familial Cold Autoinflammatory Syndrome (FCAS); Muckle-Wells Syndrome (MWS); Neonatal Onset Multisystem Inflammatory Disease (NOMID); children, systemic autoinflammatory disease; CIAS-1 gene; NALP-3; NLRP3; ACZ885; canakinumab; human monoclonal anti-human interleukin-1 antibody; autosomal dominant; familial autoinflammatory syndrome; childhood immunizations vaccinations
A Clinical Study to Investigate if SAR425899 Binds to the Liver and Pancreas in Overweight to Obese Type 2 Diabetes Mellitus Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objectives:

      To assess in overweight to obese T2DM patients:

        -  The glucagon receptor occupancy of SAR425899 at two dose levels in the human liver with
           positron-emission tomography (PET) imaging using [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 as a
           tracer compound.

        -  The GLP-1 receptor occupancy of SAR425899 at two dose levels in the human pancreas with
           PET imaging using [68Ga]Ga-DO3A-VS-Cys40-Exendin-4 as a tracer compound.

        -  Pharmacodynamic effects on fasting plasma glucose and biomarkers of lipid metabolism.

        -  Pharmacokinetic parameters for SAR425899 after repeated subcutaneous (SC) doses in
           plasma.

        -  Safety and tolerability of SAR425899.
    

Detailed description: 
      Study duration is approximately 7 weeks with a 20 days treatment period.
    

Intervention name(s): SAR425899; [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer); [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous; Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous; Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Intervention MeSH terms: Exenatide; Glucagon
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Role of Auditory Cortical Oscillations in Speech Processing and Dyslexia
Condition: Dyslexia
MeSH terms: Dyslexia
Study type: Interventional

Summary: 
      This study aims at investigating the role of low-gamma activity in phonemic encoding and its
      implication in dyslexia. Indeed, a phonological deficit, i.e. a difficulty in perceiving the
      sounds of speech, is strongly suspected in dyslexia but has never been conclusively
      associated with a specific underlying mechanism.

      The study employs transcranial alternating current stimulation in adults with and without
      dyslexia to exploit the effect of the stimulation on phonemic processing and neural activity
      measured with electroencephalography. In doing so, it would be possible to establishing a
      causal link between gamma oscillations and the phonological deficit in dyslexia.
    


Intervention name(s): Transcranial alternating current stimulation
Intervention type(s): Device
Intervention description(s): Focal transcranial stimulation over auditory cortex by means of 5 electrodes delivering an electric current (max. 2mA). In addition to active stimulation, also a placebo (sham) stimulation is employed as a control condition. All subjects included in the study receive all tACS stimulation conditions.
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
High Vitamin K Intake Diet Intervention Effect on Cardiovascular Risk Percentage in Young Adults
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare the effect of a high vitamin K diet
      intervention on vitamin K, insulin, osteocalcin serum levels and the cardiovascular risk
      percentage in normal weight and overweight or obese young adults. The main questions it aims
      to answer are: • Does a diet intervention containing 500mcg of vitamin K increases serum
      vitamin K levels? • Are vitamin K serum levels after the 500mcg of vitamin K diet
      intervention associated with insulin and osteocalcin serum levels or the cardiovascular risk
      percentage in normal weight and overweight or obese young adults? Participants will have to
      follow a diet intervention that contains 500mcg of vitamin K, given as a cyclic menu for 6
      weeks. Also, participants will have to assist weekly to nutritional monitoring and to report
      any situation they observed regarding the intervention during this study. Researchers will
      compare normal weight and overweight or obese groups with diet intervention with normal
      weight and overweight or obese groups without diet intervention and only dietetic
      recommendations to see if vitamin K serum levels, insulin, osteocalcin and the cardiovascular
      risk percentage improve after the 6 weeks diet intervention.
    


Intervention name(s): vitamin K diet
Intervention type(s): Other
Intervention description(s): 500mcg of Vitamin K intake provided by the selection of vitamin k rich foods in the menu.
Intervention MeSH terms: Vitamin K
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vitamin K; diet intervention; Cardiovascular disease; overweight and obesity; young adults
Carotid Intima-media Thickness in Japan Statin Treatment Against Recurrent Stroke(J-STARS Echo)
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      Carotid ultrasound can reveal the intima-media complex thickness(IMT), that has been reported
      to be a marker of atherosclerosis as well as a risk of cardiovascular events, and to be
      attenuated by 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins)
      . This substudy of J-STARS will observe the temporal profile of carotid IMT prospectively in
      the patients with prescription of pravastatin and the control.
    


Intervention name(s): Statin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: stroke; brain ischemia; cerebrovascular accident; statin; hydroxymethylglutaryl-CoA Reductase Inhibitors; cholesterol; hypercholesterolemia; hyperlipidemia; multicenter studies; prospective studies; endpoint determination; randomized controlled trials; recurrence; pravastatin; plaque; tunica intima; tunica media; ultrasonography; carotid arteries
Efficacy of Epoetin Alfa in Patients With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 2

Summary: 
      Friedreich's ataxia is a rare genetic disorder characterized by severe neurological
      disability and cardiomyopathy. Friedreich's ataxia is the consequence of frataxin deficiency.
      Although several drugs have been proposed, there is no available treatment. It was recently
      demonstrated that erythropoietin can increase the intracellular levels of frataxin in an
      in-vitro model.

      The present project is aimed at testing the possible therapeutic approach of erythropoietin,
      which is an already available and commercialized drug. The investigators will perform both
      in-vitro and in-vivo tests, in order to asses its efficacy and safety in patients. The
      results will be useful to plan further clinical trials.
    

Detailed description: 
      Friedreich ataxia (FRDA) is an inherited recessive disorder characterized by progressive
      neurological disability. FRDA is the consequence of frataxin deficiency. Although several
      drugs have been proposed for FRDA, there is no available treatment. Recently it was shown
      that recombinant human erythropoietin (rhu-EPO) administration increases frataxin expression
      in cultured human lymphocytes of FRDA patients. It is therefore of primary importance to test
      extensively rhu-EPO's ability in increasing frataxin levels in-vitro and in-vivo. In addition
      rhu-EPO is an already available and commercialized drug approved for the treatment of anaemia
      associated with chronic renal disease, heart failure and cancer. Towards this overall
      purpose, we will perform an acute clinical trial in FRDA patients with rhu-EPO and will
      assess its effect in-vivo on frataxin expression. In addition, rhu-EPO's safety in FRDA
      patients based on laboratory parameters and neurological indexes will be tested. The results
      will be useful to gain new insight in the role of rhu-EPO in FRDA, and in the future, it may
      be useful to plan further clinical trials.
    

Intervention name(s): Epoetin alfa
Intervention type(s): Drug
Intervention description(s): Patients that will satisfy all inclusion/exclusion criteria will be sequentially treated with three single Epoetin alfa administrations. The first time the dose will be 600U/KG BW s.c. in a single administration. The outcome measures will be assessed. A washout period of 1 month will be necessary to eliminate any carry-over effect. A second administration of 1200U/KG BW s.c. will be performed. Outcome measures will be again assessed.
Other intervention name(s): Eprex 40.000 IU
Intervention MeSH terms: Epoetin Alfa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FRDA; Erythropoietin; Epoetin alfa
Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using
      3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy
      before surgery in treating locally advanced breast cancer.

      PURPOSE: This clinical trial is studying how well positron emission tomography using
      3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one
      breast who are receiving chemotherapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the efficacy of positron emission tomography (PET) utilizing 3'-deoxy-3'-(18F)
           fluorothymidine (^18F-FLT) to correctly identify response to neoadjuvant chemotherapy in
           women with locally advanced unilateral breast cancer.

        -  Correlate PET-^18F-FLT results with histological response.

      Secondary

        -  Evaluate the correlation of early changes in tumor uptake of ^18F-FLT after the first
           course of chemotherapy with complete response after treatment completion.

        -  Evaluate the correlation of early changes in tumor uptake of ^18F-FLT with histologic
           response in biopsies obtained after 1 course of chemotherapy.

        -  Determine if the initial intensity of tumor uptake is a predictive value of response to
           chemotherapy.

        -  Determine if initial intensity of tumor uptake of ^18F-FLT varies according to
           histologic type of tumor, indices of proliferation, and tumor cellularity before
           therapy.

        -  Determine if the tumor uptake of ^18F-FLT during therapy varies according to histologic
           type of tumor, indices of proliferation, and tumor cellularity before therapy.

        -  Evaluate the role of TK1 on the kinetics of ^18 F-FLT.

        -  Analyze serum.

        -  Research biomarkers of genomics, transcription, and proteomics.

        -  Evaluate the toxicity of ^18F-FLT.

      OUTLINE: This is a multicenter study.

      Patients receive 3'-deoxy-3'-(18F) fluorothymidine (^18F-FLT) IV and undergo positron
      emission tomography (PET) before the first and second courses of neoadjuvant chemotherapy.
      Patients receiving bisequential chemotherapy undergo ^18F-FLT-PET before the change in drugs
      (usually the fourth or fifth course). All patients undergo a final ^18F-FLT-PET after the
      last chemotherapy course but before surgery.

      After completion of study therapy, patients are followed for 1 month.
    

Intervention name(s): 3'-deoxy-3'-[18F]fluorothymidine
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: stage II breast cancer; stage IIIA breast cancer
A Study to Evaluate the Pharmacokinetics (How it Moves Into, Through and Out From the Body) of a New Gadolinium-based Contrast Agent (GBCA) After Injection and How Safe it is in Participants With Normal and Impaired Renal Function
Condition: Contrast Enhancement in Magnetic Resonance Imaging
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers in this study want to learn how a new contrast agent for magnetic resonance
      imaging (MRI) called BAY1747846 moves into, through and out of the body (pharmacokinetics)
      after injection in participants with normal and impaired renal function. Impaired renal
      function is a condition where the kidneys do not work as well as they should.

      BAY1747846 belongs to the class gadolinium-based contrast agents (GBCAs). The way the body
      removes GBCAs including BAY1747846 from the blood is through the kidneys. So, when the
      kidneys are not working normally, it takes longer to remove BAY1747846 out of the body.

      The participants in this study will either have normal renal function, or will have mild or
      moderate impaired renal function. The participants will receive BAY1747846 one time through a
      needle into a vein.

      During the study, the participants will visit the study site about 6 times. The participants
      will stay at the study site for up to 9 days. Each participant will be in the study for up to
      7 months. During the study, the doctors will:

        -  check the participants' overall health

        -  take blood and urine samples

        -  ask the participants about what medications they are taking and what adverse events they
           are having An adverse event is any medical problem that a participant has during a
           study. Doctors keep track of all adverse events that happen in studies, even if they do
           not think the adverse events might be related to the study treatments.
    


Intervention name(s): BAY1747846
Intervention type(s): Drug
Intervention description(s): Solution for intravenous (IV) injection, single dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science