bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults
Condition: Type2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic
      and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or
      Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults
    


Intervention name(s): Evogliptin→Evogliptin+Empagliflozin→Empagliflozin; Empagliflozin→Evogliptin→Evogliptin+Empagliflozin; Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin; Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD, Empagliflozin : Empagliflozin 25mg QD; Empagliflozin : Empagliflozin 25mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD; Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD, Dapagliflozin : Dapagliflozin 10mg QD; Dapagliflozin : Dapagliflozin 10mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD
Other intervention name(s): Suganon; Jardiance; Suganon; Jardiance; Suganon; Forxiga; Suganon; Forxiga
Intervention MeSH terms: Dapagliflozin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.
Condition: Deep Vein Thrombosis; Chronic Portal Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Open randomized therapeutic study to assess the efficacy of Xarelto 15mg/day in the
      recurrence of thromboembolic event compared to an untreated group in patients with chronic
      portal vein thrombosis without high risk thrombophilia.
    

Detailed description: 
      Chronic portal vein thrombosis (PVT) is a rare disease, affecting young patients,
      characterized by permanent obstruction of the portal vein trunk causing portal hypertension.
      In 60-70% of cases it is related to high risk, moderate or mild prothrombotic risk factors.

      Accordingly, there are 2 types of complications from PVT :(i) gastrointestinal haemorrhage
      related to portal hypertension; and (ii) recurrent thrombosis.

      Recurrent thrombosis its most dreaded complication as it may lead to intestinal infarction
      with a related mortality of 20-60% and a high risk of intestinal insufficiency.

      Gastrointestinal haemorrhage related to portal hypertension occurs in 20% patients/year. It
      is less frequent in patients treated with medical or endoscopic prophylaxis for variceal
      bleeding.

      Retrospective data shows that anticoagulation does not worsen the prognosis, and may
      conversely improve it. Thus, in patients at risk for gastrointestinal bleeding due to portal
      hypertension and a mild or moderate risk of recurrent thrombosis, the benefit-risk ratio of
      anticoagulation therapy is unclear.

      The aim of this open randomised trial is to assess the efficacy of Xarelto 15mg/day, a new
      oral factor Xa inhibitor, in the recurrence of thromboembolic event and the risk of major
      bleeding compared to an untreated group in patients with chronic portal vein thrombosis
      without high risk thrombophilia.

      The hypothesis of the trial is that treatment with Xarelto® would reduce the risk of
      recurrence of acute deep vein thrombosis (DVT) regardless location, with limited increase in
      the risk of hemorrhage in patients with chronic portal thrombosis and no high-risk factors
      for thrombosis recurrence

      This is a national, multicentric, interventional study. 17 french centers already agreed to
      participate.

      296 patients will be included on a 3 years period with 2 to 4 years treatment period. All
      data will be collected after informed consent will be obtained.
    

Intervention name(s): Xarelto
Intervention type(s): Drug
Intervention description(s): 15mg/day oral administration during 2 to 4 years (based on the recruitment date).
Other intervention name(s): Rivaroxaban
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thrombosis
Combined Low Frequency Frontal and Temporal rTMS Treatment in Chronic Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by
      hearing loss and leading to the phantom auditory perception of sound in the absence of an
      external or internal acoustic stimulus.
    

Detailed description: 
      Tinnitus is the phantom auditory perception of sound in the absence of an external or
      internal acoustic stimulus. It is a frequent problem which can interfere significantly with
      the ability to lead a normal life. Treatment is difficult. Most available therapies focus on
      habituation rather than treating the cause. Tinnitus is thought to be generated in the brain,
      as a result of functional reorganization of auditory neural pathways and tonotopic maps in
      the central auditory system, following damage to the peripheral auditory system.
      Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders
      such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect
      of low-frequency rTMS can be enhanced by low frequency rTMS of the right dorsolateral
      prefrontal cortex (DLPFC). In the proposed study we investigate whether low frequency rTMS of
      the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled
      trial.
    

Intervention name(s): Combined frontal and temporal rTMS; Temporal low frequency rTMS
Intervention type(s): Device; Device
Intervention description(s): Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 1000 stimuli of 1Hz rTMS over the right DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold); Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tinnitus; chronic subjective tinnitus; transcranial magnetic stimulation; sensation disorders; hearing disorders
Hemin in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done because we want to learn if hemin can increase the production of
      heme oxygenase 1. Heme oxygenase 1 (HO-1) is an enzyme which protects cells from physical,
      chemical, and biologic stress. Hemin is produced from red blood cells and is approved by the
      Food and Drug Administration for treating acute porphyria, which is an inherited condition
      caused by an enzyme deficiency.
    

Detailed description: 
      Heme-oxygenase 1 (HO-1) degrades heme, protects cells against oxidative stress, and is
      beneficial in several experimental models but has not been pharmacologically activated in
      humans. The objectives of this study were to evaluate the effects of hemin on HO-1 activity
      in healthy subjects. Hemin is the most powerful inducer of HO-1. Hemin is FDA-approved to
      treat acute intermittent porphyria. In addition, hemin has also been used to treat
      thalassemia intermedia, myelodysplastic syndrome, and to control liver allograft failure due
      to recurrence of erythropoietic prototheria. Our hypothesis is that compared to placebo,
      hemin will increase HO-1 in humans. Ten healthy subjects will be randomized to hemin (n = 5,
      Panhematin®, Ovation Pharmaceuticals, 3 mg/kg i.v. in 25% albumin) or placebo (n = 5, 25%
      albumin) infusion. HO-1 activity will be assessed before and after (4, 6, 24, and 48 hours)
      infusions.
    

Intervention name(s): Hemin infusion; placebo infusion
Intervention type(s): Drug; Drug
Intervention description(s): Hemin (Panhematin®, Ovation Pharmaceuticals, Deerfield, IL) will be administered through a large-caliber peripheral vein at a dose of 1.25 mL/kg and at a rate of 60 mL/hour. To enhance stability, Panhematin® will be diluted in ~ 132 mL of 25% albumin to obtain a hemin concentration of 2.4 mg/mL.; 25 % albumin will be administered through a large-caliber peripheral vein at a dose at a rate of 60 mL/hour.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: hemin, heme oxygenase, humans, HO-1
Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess impact on left ventricular reverse remodeling defined as a change in left
      ventricular ejection fraction in heart failure patients with reduced ejection fraction (and
      previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric
      carboxymaltose vs. placebo
    


Intervention name(s): Ferric Carboxymaltose; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ferric carboxymaltose will be administered according to product specification dosing; IV nacl 0.9%
Other intervention name(s): injectafer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of High Omega-3 Fish Intake on Lipid Peroxidation
Condition: Omega-3 Fatty Acids; Lipid Peroxidation
Study type: Interventional

Summary: 
      The overall goal of this project is to identify an appropriate level of high omega-3 fish
      (salmon) consumption that will promote optimal omega 3 nutritional status without increasing
      the level of lipid oxidation in the body.
    

Detailed description: 
      Studies have demonstrated that the intakes of fatty fish and fish oils are associated with
      decreases in cardiovascular disease and other chronic disease states. This is related to the
      long chain omega-3 fatty acid (n-3) content of fish and fish oil, specifically
      eicosapentaenoic acid and docosahexaenoic acid. Although the consumption of high n-3 fish is
      recommended in the 2005 US Dietary Guidelines for Americans, no specific consumption levels
      are made for the fatty acid eicosapentaenoic acid (EPA) and/or the fatty acid docosahexaenoic
      acid (DHA) or total fish intake.

      Consumption of high n-3 fish or dietary supplementation of fish oil will lead to increased
      levels of these fatty acids in plasma lipoproteins, cell and tissue lipid. This change in
      membrane lipid is thought to be responsible for the anti-inflammatory effects of n-3. Because
      highly unsaturated fatty acid are subject to peroxidation, the level of fish intake that is
      sufficient to modify membrane n-3 content and the exact level that enhances peroxidation is
      unknown.

      We will perform a dose-response feeling study in which varied levels of fish (salmon) will be
      provided in random order separated by 4 or more week washout periods. We will assess the
      level of cell membrane enrichment with n-3 and the effect on lipid peroxidation outcomes.
    

Intervention name(s): Omega-3 fish oil provided by salmon
Intervention type(s): Dietary Supplement
Intervention description(s): Eating 3 different amounts of provided salmon twice a week for four weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open randomised phase II study evaluating the anti-tumour activity, safety and
      pharmacology of two dose regimens of IPH2101, a human monoclonal anti-KIR antibody, in
      patients with multiple myeloma in stable partial response after a first line therapy.
    

Detailed description: 
      Development of new treatments for diseases such as multiple myeloma is a focus for research.
      The research being conducted is on treatment called Anti-KIR, which activates the body's own
      cells to kill tumor cells. This is different from many other treatments where chemicals are
      given to kill tumor cells.The primary objective of the study is to evaluate the clinical
      activity of two different dose regimens (0.2 mg/kg, leading to an intermittent saturation of
      NK receptors and 2mg/kg leading to a sustained saturation of NK receptors) of IPH2101
      administered as a single agent in multiple myeloma patients who achieved, after the
      completion of any first line treatment, including conventional or high dose chemotherapies, a
      stable partial or very good partial response (PR or VGPR).
    

Intervention name(s): IPH2101
Intervention type(s): Drug
Intervention description(s): One infusion of IPH2101 every 4 weeks
Other intervention name(s): Fully human anti-KIR monoclonal antibody (1-7F9)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was an extension study of NCT00537082. This study was designed to evaluate the
      efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720)
      to relapsing multiple sclerosis.
    

Detailed description: 
      A decision was made to switch all patients on fingolimod 1.25 mg/day to fingolimod 0.5 mg/day
      in an amendment to the study protocol. The study became open-label with all patients
      receiving fingolimod 0.5 mg/day on 22 Feb 2010.

      The efficacy data for Months 0-6 in this study report is from the core study NCT00537082.
    

Intervention name(s): Fingolimod
Intervention type(s): Drug
Intervention description(s): Fingolimod was supplied in capsules.
Other intervention name(s): Gilenya; Imsera
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FTY720; multiple sclerosis; MS
Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable Hepatitis B Virus DNA
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, open-labelled, prospective 96-week study comparing the antiviral
      efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining
      lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.
    

Detailed description: 
      Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those
      of Lamivudine in nucleoside-naïve CHB patients. The switch from Lamivudine to Entecavir in
      patients who have undetectable hepatitis B virus DNA (HBV DNA < 60 IU/mL) may lead to more
      prolonged viral suppression to undetectable level by PCR method, compared to patients with
      continuous lamivudine treatment. The results of this study will provide a rationale for
      switch treatment from one antiviral to another one, especially from LAM to ETV.
    

Intervention name(s): Entecavir; Lamivudine
Intervention type(s): Drug; Drug
Intervention description(s): entecavir 0.5 mg QD; lamivudine 100 mg QD
Other intervention name(s): Baraclude 0.5mg; Zeffix 100mg QD
Intervention MeSH terms: Lamivudine; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis B; Lamivudine; Entecavir
Pain Control in Bariatric Patients: EXPAREL(R) vs. the On-Q(R) Pain Ball
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to compare the effectiveness of two local pain control methods in
      bariatric patients by assessing the amount of postoperative pain and amount of postoperative
      pain medications needed. This information was used to determine which local anesthetic
      provided the best pain control.
    

Detailed description: 
      The investigators have previously utilized the On-Q® pain ball to obtain local control by
      continuous delivery of bupivacaine to pain fibers at the incision site. On-Q makes use of an
      implanted catheter and a continuous infusion pump that the patient carries with them
      typically for 48-72 hours after surgery. EXPAREL is a long-acting liposomal delivery vehicle
      that extends the life of bupivacaine in the surgical site for up to 72 hours. It can be
      injected in all trocar sites and offers another potential solution to patient pain control
      without the need for a catheter and the hardware needed to deliver the local anesthetic.
      Patient NRS (numerical rating scale) scores for postoperative pain and total medication
      consumed were used to assess the differences between the two treatment groups.
    

Intervention name(s): EXPAREL; On-Q Pain Ball
Intervention type(s): Drug; Drug
Intervention description(s): bupivacaine HCl 0.25%
Other intervention name(s): bupivacaine liposome injectable suspension; bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bariatric surgery, postoperative pain
Comparison of the Efficacy Between Transurethral Coagulation and Transurethral Resection of Ulcer in Bladder Pain Syndrome Patients
Condition: Bladder Pain Syndrome
MeSH terms: Cystitis, Interstitial; Syndrome; Somatoform Disorders
Study type: Observational

Summary: 
      On the EAU (European Association of Urology) guidelines, the ulcer type bladder pain syndrome
      (BPS) should be treated with transurethral resection (TUR) or coagulation (TUC) of ulcer.

      But, Up to date, there was no study to compare the therapeutic efficacy of TUR with TUC in
      ulcer type BPS patients.

      We assume TUR have a more therapeutic effect than TUC.
    


Intervention name(s): Transurethral Coagulation (TUC); Transurethral Resection(TUR)
Intervention type(s): Procedure; Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients will be enrolled diagnosed with bladder pain syndrome by ESSIC proposal.
      
Keywords: Bladder Pain Syndrome; Transurethral Resection of Ulcer; Transurethral Coagulation of Ulcer
Galectin-3 Level in Ankylosing Spondylitis Patients
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      Forty-five AS patients and 35 healthy controls were enrolled in this study. Patients
      diagnosed with AS according to Modified New York criteria were included in the study.
      Clinical and laboratory measurements, duration of symptoms, age and body mass index (BMI) of
      AS patients were performed and compared with age and BMI matched control group.
    

Detailed description: 
      Detailed histories of all participants were obtained, and systemic and rheumatologic
      examinations were performed. We excluded all participants who had a history of
      hyperlipidemia, liver, renal, hematological, familial thyroid, neoplastic, autoimmune
      infectious diseases and receiving anti-inflammatory drugs.

      We measured serum galectin-3 levels using a commercial chemiluminescent microparticle
      immunoassay. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to
      assess disease activity in AS patients.
    

Intervention name(s): Serum galectin-3 concentration was measured.
Intervention type(s): Other
Intervention description(s): Serum galectin-3 concentration was measured using a commercial chemiluminescent microparticle immunoassay.
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Ankylosing spondylitis patients and healthy controls
Jugular Venous Oxygen Saturation During Therapeutic Hypothermia After Cardiac Arrest
Condition: Hypoxic Brain Injury; Hypothermia
MeSH terms: Brain Injuries; Heart Arrest; Hypothermia
Study type: Observational

Summary: 
      The purpose of this study is to understand what happens to cerebral metabolism during
      therapeutic hypothermia for hypoxic brain injury following cardiac arrest.
    

Detailed description: 
      Latest international guidelines recommend the use of therapeutic hypothermia in patients who
      have had cardiac arrest and remain in coma after return of spontaneous circulation. This is
      recommended essentially to limit the cerebral injury caused by cardiac arrest and possibly
      amplified upon reperfusion. At times, although a spontaneous circulation has returned,
      cerebral oxygenation may remain inadequate due to inadequate perfusion pressure, and
      hypothermia, by reducing cardiac output and cerebral blood flow could actually aggravate this
      phenomenon. The rewarming period is thought to be at greatest risk of inadequate oxygenation
      for the increase in metabolic demand. With this study we aim to understand what happens to
      cerebral oxygenation and metabolism during therapeutic hypothermia for cardiac arrest through
      cerebrovenous oxygen saturation monitoring and in particular, to see whether through this
      type of monitoring we could recognize otherwise unnoticed periods of inadequate cerebral
      oxygenation.
    

Intervention name(s): retrograde jugular venous cannulation
Intervention type(s): Procedure
Intervention description(s): Retrograde cannulation of jugular vein and intermittent sampling of venous blood from cerebral circulation before, during and after hypothermia.
Other intervention name(s): SjO2, cerebrovenous oxygen saturation
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients who are in coma after cardiac arrest, admitted to the Intensive Care Unit of
        a University Teaching Hospital and undergoing therapeutic hypothermia
      
Biospecimen description: 
      whole blood
    
Keywords: jugular venous oxygen saturation; hypothermia