bioihbjkbjnl/mcl2 huggingface dataset:
Risk Factors for the Leakage of Anticancer Drugs to Systemic Circulation by Transcatheter Arterial Chemoembolization
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Hepatocellular carcinoma (HCC) is the most common malignant tumor of the liver. Transcatheter
      arterial chemoembolization (TACE) is the traditional method for the palliative management of
      patients with HCC. Few previous studies had demonstrated that the serum level of anticancer
      drug from patients treated by TACE was similar to those treated by systemic chemotherapy. The
      defense ability of the patient treated by TACE may thus be influenced by the leakage of
      anticancer drug to the systemic circulation. Since more than 80% patients with HCC also have
      liver cirrhosis, the toxicity for those anticancer drugs with hepatic transformation will be
      increased caused by the cirrhotic liver. The severity of pancytopenia in cirrhosis will be
      exacerbated by the effect of bone marrow suppression caused by anticancer drugs. Patients are
      at high risk for infection and hemorrhage. Therefore, it is of clinical importance to prevent
      or decrease the leakage of anticancer drugs to systemic circulation in patients treated by
      TACE. The procedures of TACE performed by previous studies were not constant and the
      distributions of tumor vessels were not evaluated in detail. The possible risk factors for
      the leakage of anticancer drug have not been investigated. This project will collect 60
      patients with HCC including 30 patients with hepatitis B and 30 patients with hepatitis C.
      The blood levels of anticancer drugs (epirubicin, mitomycin C and cisplatin) will be
      determined within one hour and at the third day after TACE.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        hepatocellular carcinoma caused by hepatitis B or C
      
Biospecimen description: 
      plasma
    
Keywords: epirubicin; mitomycin C; cisplatin; Hepatocellular carcinoma
Pulmonary Involvement in Scleroderma: A Clinical Study of the Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients With Lung Involvement
Condition: Scleroderma, Systemic
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Interventional

Summary: 
      Researchers from the Division of Pulmonary and Critical Care Medicine at University of
      California, San Francisco (UCSF) are conducting a study to evaluate whether mycophenolate
      mofetil (an immunosuppressive medication, trade named CellCept) is safe and effective for
      preventing the lung damage from scleroderma from getting worse.
    

Detailed description: 
      The proposed study is designed to evaluate the safety and efficacy of mycophenolate mofetil
      (CellCept) for the treatment of symptomatic pulmonary alveolitis due to systemic sclerosis
      (SSc). This study utilizes a prospective, open-label, experimental design.

      Primary Hypothesis: The alveolitis in patients with SSc, as defined by decreased forced vital
      capacity (FVC), bronchoalveolar lavage (BAL), and High Resolution Chest Tomography (HRCT) is
      responsive to 1 year of daily mycophenolate mofetil therapy.

      Secondary Hypothesis: Quality of life, six-minute walk and single-breath diffusing capacity
      for carbon monoxide (DLCO) improve in patients with SSc mediated alveolitis after therapy
      with mycophenolate mofetil. This response to therapy is associated with a change in the
      inflammatory cytokine profile present in BAL fluid.
    

Intervention name(s): Mycophenolate mofetil
Intervention type(s): Drug
Intervention MeSH terms: Mycophenolic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Scleroderma, Systemic
Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Condition: Kidney Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular
      filtration rate estimated 30 days after kidney transplant.
    

Detailed description: 
      French study, prospective, multicenter, open, randomized into two parallel groups:

      Group A: NeoRecormon ® 30000 UI: 4 injections Group B: control group without administration
      of the medical product

      Period of recruitment: 18 months Duration of participation of each patient: 90 days Total
      duration of the test: 21 months.

      Main objective : Assessing the effect of epoetin beta on the glomerular filtration rate
      estimated 30 days after kidney transplant.

      Secondary objectives:

      Comparing the 2 groups at all times J0 to J90:

        -  The evolution of renal function

        -  The survival of patients and grafts

        -  The time of onset and incidence of acute rejection proved by biopsy

        -  The correction of anemia

        -  The need for transfusions

        -  The need for EPO

        -  Quality of Life

        -  The safety processing
    

Intervention name(s): epoetin beta (NeoRecormon ®)
Intervention type(s): Drug
Intervention description(s): comparison of administration of high dosage of epoetin vs no administration of epoetin
30000 UI: 4 injections
Other intervention name(s): Neorecormon
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: kidney failure; kidney transplant; graft function; haemoglobin; epoetin
A Study to Evaluate Whether Verapamil Has an Effect on the Uptake and Elimination of Solifenacin and Tamsulosin When Administered in a Combination Tablet
Condition: Drug-Drug Interaction (DDI); Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates the effect of the co-administration of verapamil on the steady-state
      pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a combination tablet,
      EC905.
    

Detailed description: 
      The effect of the co-administration of verapamil on the steady state PK of solifenacin
      succinate and tamsulosin HCl OCAS (Oral Controlled Absorption System) is evaluated in this
      study.

      Verapamil has been chosen to represent the effect of moderate CYP3A4 inhibitors on the
      combined administration of solifenacin and tamsulosin given as combination tablet EC905.

      Subjects are admitted to the clinic on Day -1. From Days 1-10, they receive one daily dose of
      EC905 to obtain steady state, followed by 20 days (Days 11-30) combined dosing of EC905 and
      verapamil.

      On Day 10 a 24-hour PK profile is obtained for solifenacin/tamsulosin. After the last dosing
      on Day 30, a post-dose 24-hour PK profile for solifenacin/tamsulosin and verapamil is
      obtained.

      Additionally, vital signs, safety ECG (Electrocardiogram) measurements, safety laboratory
      assessments, adverse events and concomitant medications are monitored throughout the
      investigational period.

      Subjects return for an ESV (End of Study Visit) 10 days after the last dosing.
    

Intervention name(s): EC905; verapamil
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): tamsulosin OCAS and solifenacin
Intervention MeSH terms: Verapamil; Tamsulosin; Solifenacin Succinate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; Verapamil; Tamsulosin OCAS; Solifenacin; Pharmacokinetics; EC905
A Single and Repeated Dose Escalation of RBD1016 in Subjects With Chronic Hepatitis B Virus (HBV) Infection
Condition: Chronic Hepatitis b
MeSH terms: Infections; Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single (Part A) and repeated dose
      (Part B) escalation, phase I clinical study to evaluate the safety, pharmacokinetics (PK) and
      preliminary pharmacodynamics (PD) of RBD1016 in subjects with chronic HBV infection.
    

Detailed description: 
      The study consists of two parts. Part A is the single dose escalation study where subjects
      with chronic HBV infection will be assigned to receive single dose of RBD1016 or placebo .
      Part B is the multiple dose escalation study where subjects with chronic HBV infection will
      be assigned to receive two doses of RBD1016 or placebo.
    

Intervention name(s): RBD1016; Placebo; Entecavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): subcutaneous injection; subcutaneous injection; Take orally.
Other intervention name(s): RBD1016 injection
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CHB; chronic hepatitis B infection
Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer
Condition: Advanced Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      In France, lung cancer is responsible for more than 30000 each year. Progress was made in
      treatment of lung cancer in the last five years due to targeted therapies and to strategical
      evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of
      this strategical evolution. It is based on maintaining continuous therapeutical pression in
      order to preserve the therapeutical benefit obtained by the first line (induction
      chemotherapy). Several clinical trials showed that maintenance strategies increase the
      duration of controlled disease.

      There is two types of maintenance strategies:

        -  Continuous maintenance : prolongation of the treatment initially associated with platin
           until progression

        -  Switch maintenance : introduction of a new treatment after the end of induction
           chemotherapy

      The aim of this study is to compare two maintenance strategies

        -  A continuous maintenance by pemetrexed

        -  A switch maintenance or a continuous maintenance according to the response of induction
           chemotherapy.
    


Intervention name(s): Cisplatin; Pemetrexed; Cisplatin; Gemcitabine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 75 mg/m²; 500 mg/m²; 80 mg/m²; 1250 mg/m²
Intervention MeSH terms: Cisplatin; Gemcitabine; Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non Small Cell Lung Cancer; IFCT; Maintenance; Switch
Time Restricted Eating Pilot - Bariatrics
Condition: Time Restricted Feeding
Study type: Interventional

Summary: 
      Bariatric surgery patients have a variable course of weight loss, maintenance and regain.
      Time restricted eating is an approach that may help individuals lose weight and improve
      metabolic functioning. We propose a pilot 12-week trial of a 10-hour time restricted eating
      intervention among post-bariatric surgery patients. The intervention would consist of weekly
      sessions for 4 weeks, followed by one session every two weeks through 12 weeks, with weight
      change as the primary outcome.
    

Detailed description: 
      We propose a pilot 12-week trial of a 10-hour time restricted eating intervention among
      post-bariatric surgery patients. The intervention would consist of weekly sessions for 4
      weeks, followed by one session every two weeks through 12 weeks, with weight change as the
      primary outcome. We will provide behavioral weight loss education to the patients and monitor
      how many calories they are taking in once per week.
    

Intervention name(s): Time restricted feeding
Intervention type(s): Behavioral
Intervention description(s): We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.
Intervention model: Single Group Assignment
Intervention model description: Non-controlled, single arm intervention study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bariatrics
Inflammation-Induced CNS Glutamate During Breast Cancer Treatment
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to try and provide data linking the impact of increased
      inflammatory cytokines as a result of chemotherapy and their relationship with increased
      levels of CNS glutamate and related behavioral and cognitive consequences in breast cancer
      patients. The investigators will use neuropsychiatric assessments, blood sampling and
      Magnetic Resonance Spectroscopy (MRS) to collect study data.
    

Detailed description: 
      Approximately 70% of women with breast cancer experience behavioral and/or cognitive symptoms
      during treatment with chemotherapy and approximately 30% of women continue to experience
      these symptoms months to years after treatment completion. There is mounting data to suggest
      that inflammation may be involved and indicate that chemotherapy-treated breast cancer
      patients exhibit higher inflammatory markers than non-chemotherapy-treated patients, and
      inflammatory markers including interleukin (IL)-6 and soluble tumor necrosis factor (sTNFR2)
      have been associated with chemotherapy-induced depression and fatigue.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female breast cancer patients who are chemotherapy treated and non chemotherapy-treated and
        medically healthy women without breast cancer in the control group
      
Biospecimen description: 
      Cytokine Multiplex, CRP, TRP, KYN, mRNA analysis, methylation analysis, and gene analysis
    
Keywords: Cognitive dysfunction; Inflammation; Fatigue; Decreased motivation
Direct Comparison of TG and WFO LASIK
Condition: Keratomileusis, Laser In Situ; Contrast Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      To compare the efficacy to different profiles, direct head-to-head studies had been
      conducted. In one previous review study revealed that TG LASIK provided patient with better
      uncorrected visual acuity (UCVA) than WFO LASIK and WFG LASIK. In recent previous
      contralateral eye studies also showed that TG LASIK induced less postoperative higher-order
      aberration than WFO LASIK. However, these studies included only low-to-moderate myopia
      patients, for patients with high myopia (spherical equivalent > 6D), the effect of TG LASIK
      comparing with WFO LASIK had not been reported before.

      The aim of our study is to analyze and compare the visual performance of TG LASIK and WFO
      LASIK in high myopia and low-to-moderate myopia patients, , particularly UCVA, corrected
      distance visual acuity (CDVA), contrast sensitivity (CS), and wavefront aberration.
    


Intervention name(s): Topoguided LASIK; Wavefront optimized LASIK
Intervention type(s): Device; Device
Intervention description(s): Topoguided ablation profile on dominant eye; Wavefront optimized ablation profile on non-dominant eye
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Blood Transfusion on Endothelial Function
Condition: MDS; Anemia
Study type: Observational

Summary: 
      Blood transfusion is often used to treat patients with Anemia. The period of storage of blood
      products prior to use for transfusion may vary. Prolonged storage of blood products may
      result in changing their biochemistry.

      This study aims to look into whether the transfusion of "old" blood, which is stored for more
      than 7 days, as compared to the transfusion of "Fresh" blood, which is stored for less than 7
      days, will affect endothelial function.
    

Detailed description: 
      Endothelial function assessed pre and post transfusion. The EndoPAT uses a unique bio-sensors
      that are placed on the fingertips to measure pressure. The test takes about 20-25 minutes.
      During the procedure the participant will have biosensors placed on the index finger of each
      hand. The nondominant arm will have a blood pressure cuff applied with sufficient pressure
      for five minutes. At the end of the test the device will provide a reading that assesses the
      level of endothelial function/dysfunction.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who come to IV therapy or Oncology day Unit requiring a blood transfusion
      
Keywords: Blood transfusion; Storage Lesion; Endothelial dysfunction; Nitric Oxide
Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness
Condition: Consciousness Disorder
MeSH terms: Consciousness Disorders
Study type: Interventional

Summary: 
      Altered gamma activity has been observed in several neurological and psychiatric disorders,
      including a reduction in gamma synchronization in patients with disorders of consciousness.
      Modulation of gamma oscillations with rhythmic stimulation has been used as a possible
      therapeutic tool. Hence, we try to use acoustic and electric stimulation at gamma frequency
      to restore brain oscillation and thereby to improve conscious awareness in patients with
      disorders of consciousness.
    

Detailed description: 
      We propose a matched-pair parallel study in patients with disorders of consciousness to
      investigate whether combined acoustic and trigeminal nerve stimulation can modulate brain
      oscillations, as measured by electroencephalography (EEG), and whether the brain activity
      changes are coupled with improvements in consciousness.
    

Intervention name(s): DC-Stimulator, NeuroConn, Germany
Intervention type(s): Device
Intervention description(s): Neurostimulation device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: disorders of consciousness; electric stimulation
Icosabutate - A Phase I, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose,
      Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects

      Objective:

        -  To assess the safety and tolerability of single ascending oral doses of icosabutate in
           healthy subjects

        -  To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects
    


Intervention name(s): icosabutate
Intervention type(s): Drug
Intervention description(s): Single dose at each dose levet
Other intervention name(s): PRC-4016
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Phase I pharmacokinetics and safety study
Phase 1/2 Study of the ERK1/2 Inhibitor BVD-523 in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndromes
Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is being performed to assess the safety, tolerability, and preliminary clinical
      effects of BVD-523 given orally, twice daily for 21-day cycles, in patients with Acute
      Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS).
    

Detailed description: 
      The study is being performed to assess the safety and tolerability of BVD-523 given orally,
      twice daily for 21-day cycles.

      Part 1 of the study will establish dose limiting toxicities (DLT), maximum tolerated dose
      (MTD), and the recommended Phase 2 dose (RP2D).

      In Part 2 of the study, additional patients with particular tumor types and/or cancers
      harboring specific genetic mutations will be recruited for treatment at the Recommended Phase
      2 Dose (RP2D). Patients may also be assessed pharmacodynamic measures in healthy or malignant
      tissues, using biomarker assays for phosphorylation, cytotoxic or cytostatic measures.
    

Intervention name(s): BVD-523
Intervention type(s): Drug
Intervention description(s): Oral, multiple escalating doses, twice daily, for 21 days in each treatment cycle
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult Male Volunteers
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      HM71224 is a potent small molecule inhibitor of Bruton's tyrosine kinase (BTK). BTK is a
      member of the Tec family of non-receptor protein tyrosine kinases. BTK is mostly expressed in
      hematopoietic cells such as B cells, mast cells and macrophages. BTK plays key roles in
      multiple cell signaling pathways including B-Cell Receptor (BCR) and Fc receptor (FcR)
      signaling cascades and is an essential mediator not only in B-cell dependent but also in
      myeloid cell dependent inflammatory arthritis. HM71224 has been selected as a novel
      therapeutic agent for the treatment of autoimmune diseases such as rheumatoid arthritis (RA).

      In view of the above, further development of HM71224 for the treatment of RA is warranted. In
      this first-in-man (FIM) study, a single and multiple dose escalation design will be employed,
      in which the primary objective is to evaluate the safety and tolerability of the compound.
      The biomarkers included as pharmacodynamic (PD) variables are chosen as they are indicators
      for any effects of HM71224 on the expected mode of action (pBTK, pPLCγ, and pERK).
    

Detailed description: 
      Primary objective

        -  To evaluate the safety and tolerability, and if possible maximum tolerated dose (MTD) of
           HM71224 after single and multiple ascending dose administration in healthy subjects.

      Secondary objective

        -  To determine the PK of HM71224 and selected metabolites (M1 and M2) following single and
           multiple oral dose administration of HM71224.

        -  To assess the PD effects of HM71224 on the biomarkers pBTK, pPLCγ, and pERK.

        -  To assess whether the PK of HM71224 is affected by food.
    

Intervention name(s): HM71224 single ascending dose; HM71224 food effect; HM71224 Multiple ascending dose
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis