bioihbjkbjnl/mcl2 huggingface dataset:
Fluorouracil, Cisplatin, Cetuximab, and Radiation Therapy in Treating Patients With Esophageal Cancer That Can Be Removed by Surgery
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways.
      Some block the ability of tumor cells to grow and spread. Others find tumor cells and help
      kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy
      x-rays to kill tumor cells. Giving fluorouracil and cisplatin together with cetuximab and
      radiation therapy may kill more tumor cells.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of fluorouracil and
      cisplatin when given together with cetuximab and radiation therapy in treating patients with
      esophageal cancer that can be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the maximum tolerated dose of fluorouracil and cisplatin when administered
           with cetuximab concurrently with esophageal radiotherapy. (Phase I)

        -  To determine the complete histological response rate (after surgical resection). (Phase
           II)

      Secondary

        -  To determine progression-free survival and overall survival. (Phase II)

        -  To determine the rate of resection with negative margins (R0). (Phase II)

        -  To determine the overall tolerance to neoadjuvant therapy. (Phase II)

        -  To determine the postoperative morbidity and mortality. (Phase II)

      OUTLINE: This is a multicenter study. This is a dose-escalation study of cisplatin and
      fluorouracil.

      Patients receive cetuximab IV over 2 hours on day -7, then IV over 1 hour on days 1, 8, 15,
      22, and 29. Patients also receive cisplatin IV over 1 hour on day 1 or 2 and fluorouracil IV
      continuously on days 1-4, 8-11, 15-18, 22-25, and 29-32. Patients undergo radiotherapy 5 days
      a week for 5 weeks, beginning on day 1 of chemotherapy. Treatment continues in the absence of
      disease progression or unacceptable toxicity.

      Patients undergo surgery within 6-8 weeks after completion of chemoradiotherapy.

      After completion of study therapy, patients are followed at 1 month, every 4 months for 2
      years, and then every 6 months for 2 years.
    

Intervention name(s): cetuximab; cisplatin; fluorouracil; conventional surgery
Intervention type(s): Biological; Drug; Drug; Procedure
Intervention MeSH terms: Fluorouracil; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus; stage IIIA esophageal cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer; stage IV esophageal cancer
A Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP
Condition: B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, multicenter, dose escalation, phase Ib study to determine the
      recommended phase II dose (RP2D), by assessing the maximum tolerated dose (MTD), safety and
      preliminary efficacy of selinexor in adult patients with relapsed/refractory B-cell
      malignancies receiving either R-DHAOx (Group A) or R-GDP (Group B). This dose escalation
      phase will be followed by an exploratory expansion phase in the same population with 12
      patients enrolled in each group, who will receive selinexor at the RP2D.

      The "3+3" design will be applied for dose escalation. The escalation will be performed
      independently in two distinct groups:

        -  Group A : Oral selinexor + R-DHAOx for 3 cycles (3-week cycles)

        -  Group B: Oral selinexor + R-GDP for 3 cycles (3-week cycles)

      The choice of the conventional immunotherapy regimen which will be administered to each
      patient, R-DHAOx (Group A) or R-GDP (Group B), is left at the investigator's decision before
      patient's inclusion. Different dose levels for selinexor administration will be examined
      sequentially in each group by the Dose Escalation Committee (DEC): 4 doses of selinexor per
      3-week cycle at 20 mg flat (Dose Level -1, DL-1), 40 mg flat (DL1), 60 mg flat (DL2) or 80 mg
      flat (DL3) will be taken orally by the patient on D1, D3, D8 and D10 of each cycle (dosing
      weeks = week 1 and week 2 of each 3-week cycle). Dose escalation will begin at DL1 and will
      continue until the MTD is exceeded or until the highest dose level defined in the study (DL3)
      is reached.

      Dose escalation to the next planned dose level will be decided by the DEC based on the number
      of DLTs observed during the DLT assessment period.

      The dose escalation phase will be followed by an exploratory expansion phase in the same two
      groups (Groups A and B), depending on the decision of the Independent Data Monitoring
      Committee (IDMC) after review of safety data at the end of dose escalation part.

      Patients enrolled in the expansion phase will receive selinexor at the RP2D defined by the
      IDMC, together with either of the conventional regimen R-DHAOx or R-GDP (left at the
      investigator's choice).
    


Intervention name(s): selinexor; Rituximab; Dexamethasone; Oxaliplatin; Cisplatin; Cytarabine; Gemcitabine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): KPT-330
Intervention MeSH terms: Cytarabine; Dexamethasone; Rituximab; Gemcitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: selinexor; lymphoma; inhibitor of nuclear export
Environmental Exposure to Lead and Progressive Renal Insufficiency in Type II Diabetic Nephropathy
Condition: Diabetic Nephropathies; Diabetes Mellitus, Type II
MeSH terms: Kidney Diseases; Renal Insufficiency; Diabetic Nephropathies; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Background The relationship between long-term heavy lead exposure and chronic interstitial
      nephropathy is well recognized in the previous literatures. Several epidemiological studies
      have demonstrated a positive association between blood lead levels and the age related
      decreases of renal function in the general population and suggested that environmental
      low-level lead exposure may accelerate the progression of renal function in the healthy
      persons. In addition, previous our works suggest environmental lead exposure may correlate to
      progressive renal insufficiency and lead chelation therapy or repeated lead chelation may
      improve and slow the progressive renal insufficiency in non-diabetic patients with chronic
      renal diseases. However, Diabetes mellitus is increasing in prevalence worldwide and is
      currently estimated to affect more than 6.5 percent of the population of the United States.
      In addition, diabetes is the most common cause of end-stage renal disease in many countries,
      accounting for about 40 percent of cases. It is still unknown that the relationship between
      long-term environmental lead exposure and the progressive renal insufficiency in patients
      with type II diabetes and diabetic nephropathy.

      Methods Ninety patints with type II diabetes and diabetic nephropathy (serum creatinine
      levels between 1.5 mg per deciliter and 3.9 mg per deciliter) who have a normal body lead
      burden and no history of exposure to lead or other metals will be observed for 24 months.
      Then, about 50 subjects with high normal body lead burdens (at least 80 μg but less than 600
      μg) will be randomly assigned to the study and control groups. For three months, the 25
      patients in the study group will receive lead-chelation therapy with calcium disodium EDTA
      weekly until the body lead burden fallsl below 50 μg, and the 25 control group receive weekly
      placebo. During the ensuing 12 months, the renal function will be regularly followed up every
      3 months and EDTA mobilization tests will be assessed every 6 months. If body lead burden of
      the study group patients increase more than 60μg, the chelation therapy will be performed
      again until their body burden are less than 60 μg. The primary end point is an increase in
      the serum creatinine level to 2 times the base-line value during the observation period. A
      secondary end point is the change in renal function during the follow up period.
    


Intervention name(s): EDTA chelating agents
Intervention type(s): Drug
Intervention MeSH terms: Chelating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of the candidate malaria
      vaccine in HIV-infected infants and children
    

Detailed description: 
      This protocol posting has been updated due to protocol Amendment 2.
    

Intervention name(s): GSK Biological's Investigational Malaria Vaccine 257049; Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);; Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis).
Intervention type(s): Biological; Biological; Biological
Intervention description(s): All infants enrolled to group A will receive 3 doses of the experimental vaccine. The vaccine will be administered intramuscularly.; To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product.
The vaccine will be administered intramuscularly; To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product.
The vaccine will be administered intramuscularly.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Plasmodium falciparum; schedule; HIV; malaria vaccine; EPI; Africa
Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions
Condition: Asthma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet
      under fasted conditions.
    


Intervention name(s): Montelukast; Singulair
Intervention type(s): Drug; Drug
Intervention description(s): Chewable Tablet; 5 mg Chewable Tablet
Other intervention name(s): Singulair; Montelukast
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Remote Care: The Future of Cochlear Implants
Condition: Cochlear Implants
Study type: Interventional

Summary: 
      The purpose of this study is to see if remote programming visits for cochlear implants are
      possible.
    


Intervention name(s): remote CI programming
Intervention type(s): Other
Intervention description(s): provision of CI programming provided remotely via Zoom in a 2 hour session
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: telemedicine; service delivery model
Gut Microbiome and p-Inulin in Hemodialysis
Condition: End-Stage Renal Disease; Gut Microbiome Dysbiosis
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Dysbiosis
Study type: Interventional

Summary: 
      The Microbiome trial is a non-randomized, open-label, sequential, multi-center study of
      p-inulin for patients with hemodialysis-dependent end-stage renal disease.
    

Detailed description: 
      This primary objective of this exploratory study is to characterize the safety and
      tolerability of p-inulin (Prebiotin®, provided by JGI Medical) in altering the composition
      and function of the human gut microbiome, thereby reducing the generation of gut-derived
      uremic toxins, improving gut barrier function and attenuating systemic inflammation in
      patients treated with maintenance hemodialysis. The study also aims to assess the feasibility
      of conducting a full-scale trial of p-inulin. The primary efficacy parameters of the trial
      will be intra- and inter-participant variability in gut metabolites and bacterial
      composition. Secondary parameters of interest include tolerability and safety of p-inulin,
      willingness of hemodialysis patients to enroll in a study requiring repeated collection of
      stool samples, and participant adherence to agent treatment and specimen collection
      schedules.
    

Intervention name(s): p-inulin
Intervention type(s): Dietary Supplement
Intervention description(s): 12 week self-administered treatment phase
Intervention model: Sequential Assignment
Intervention model description: This is a sequential trial that included three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered. Eleven of the 13 participants in the p-inulin phase entered the post-treatment phase. The other two withdrew prior to the post-treatment phase.
Masking: None (Open Label)
Primary purpose: Other
Keywords: hemodialysis; p-inulin; gut microbiome
Closure of the Appendix Stump in Laparoscopic Appendectomy
Condition: Appendicitis, Surgery
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      Aimed to the study evaluate the superiority of intracorporal sutures and Hem-o-lok clips in
      terms of efficiency.
    

Detailed description: 
      Performed laparoscopic surgery for acute appendicitis. Appendiceal stump was closed by
      Hem-o-lok clips (Group I) and intracorporal knotting (Group II) in a randomize manner. Groups
      were compared for cost effectiveness.
    

Intervention name(s): clips; knotting
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Appendicitis; Laparoscopic Surgery; Cost Effectiveness
Reliability of Ultrasound Assisted Epidural Analgesia in Obese and Normal Weight Parturients
Condition: Pregnancy
Study type: Observational

Summary: 
      This study wants to investigate if ultrasound assisted epidural catheter insertion for labor
      analgesia is easier and safer to the standard epidural technique.
    

Detailed description: 
      This study has four specific aims:

        1. to evaluate congruity between palpatory technique and ultrasound lumbar evaluation to
           identify the correct spinal space;

        2. to compare between ultrasound evaluation and needle measure of skin-epidural space
           depth;

        3. to compare between longitudinal and transverse ultrasound epidural space depth in obese
           and normal parturients;

        4. to check the reduction of complications and failure rates of epidural analgesia with
           ultrasound assistance.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all women after thirty weeks of pregnancy, experiencing spontaneous or induced labor
      
Keywords: epidural analgesia; ultrasound; labor analgesia; labor
Randomized Study of Preoperative Dexamethasone for Quality of Recovery in VATS Lung Resection Patients
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed study is a randomized, double-blind, placebo-controlled evaluation if a small
      dose of IV dexamethasone during induction anesthesia in association to pre and postoperative
      intercostal nerve block, improves quality of recovery of thoracoscopic lung resection
      patients.
    

Detailed description: 
      This is a study composed by 2 groups of 50 patients undergoing VATS for lung cancer. All
      subjets will receive intraoperative intercostal nerve block with a maximum dose of 2 mg/kg of
      bupivacaine with epinephrine 1:200.000 at the beginning and at the end of procedure.

      The control group will receive a bolus dose of dexamethasone (0.1 mg/kg) and the placebo
      group saline solution. The study drug or placebo will be administered at the time of
      anesthetic induction (approximately 30 minutes before surgical incision). Patients will be
      evaluated daily with the quality of recovery questionary, visual analogue pain and portable
      spirometry. And, the patients will have pulmonary lung function assessed by portable
      spirometry.
    

Intervention name(s): Dexamethasone IV; Saline solution
Intervention type(s): Drug; Drug
Intervention description(s): It will be administered at the induction of the anesthesia
Other intervention name(s): Decadron
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Dexamethasone; Quality of recovery questionnaire; QoR-40; Lung cancer; Video-assisted thoracoscopic
The Effect of Nicardipine on Kidney Function During Orthognathic Surgery Under Hypotensive Anesthesia
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      Since nicardipine is known to protect kidney function, nicardipine infusion will result in
      better renal parameters measured in this study.
    


Intervention name(s): Nicardipine; remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): 0.1-0.5 ugkg/min during hypotensive anesthesia
Other intervention name(s): ultiva®
Intervention MeSH terms: Nicardipine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: healthy adult patients; ASA class I; hypotensive anesthesia
Efficacy and Safety of TMBCZG in Mild to Moderate Vascular Dementia
Condition: Vascular Dementia
MeSH terms: Dementia; Dementia, Vascular
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will be a 24-week multicentre, double-blind, placebo-controlled phase Ⅱa trial with
      4 treatment arms in China. Participants aged 55-80 years will be randomized to TMBCZG-high
      dose(84mg per day), TMBCZG- medium dose(56mg per day), TMBCZG- low dose(28mg per day) or to
      placebo. The primary endpoint will be VADAS-Cog and CDR-SB. Secondary outcomes included
      changes in MMSE and ADL. Patients' safety will be assessed by recording of adverse events,
      clinical examinations, electrocardiography and laboratory tests. The patients, caregivers,
      and investigators will be blinded to the treatment allocations.
    


Intervention name(s): TMBCZG; placebo
Intervention type(s): Drug; Other
Intervention description(s): 0.1g per pill which contains 14mg TMBCZG; 0.1g per pill which contains 0mg TMBCZG
Other intervention name(s): TianMaBianChunZhiGanPian; TianMaYouJiDuoSuanBianZhiGanPian(TMYJDSBZG)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Herbal therapy; Randomized controlled trial; Vascular Dementia
Apatinib in Combination With Stereotactic Body Radiation Therapy (SBRT) Treatment for Symptomatic Metastatic Prostate Cancer
Condition: Quality of Life
Study type: Interventional

Summary: 
      To study safety and efficacy of apatinib in combination of radiotherapy in patients with
      symptomatic bony disease prostate cancer (SBPC), based on the potential synergistic antitumor
      activity between Apatinib and Stereotactic Body Radiation Therapy (SBRT).
    


Intervention name(s): Apatinib; SBRT to symptomatic bony metastatic bony site(s)
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Apatinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Ivermectin Solution Bioequivalence Study - With Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to compare the pharmacokinetic and bioavailability profile
      (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin
      solution 1 mg/ml with a marketed reference formulation of Ivermectin 3 mg tablets when taken
      after a standard meal. The study is designed in accordance with the EU Note for Guidance on
      the Investigation of Bioavailability and Bioequivalence 2001.
    

Detailed description: 
      Ivermectin is an antiparasitic medicine (i.e. a medicine used to eliminate parasitic worms)
      for oral administration, and is approved in the US and some other countries in a tablet form.
      A new liquid formulation of ivermectin has been developed to facilitate dosing. This is a
      single dose, randomised, crossover study in healthy adult male and female volunteers, with
      doses taken 20 minutes after a standard breakfast. Doses will be separated by washout period
      of at least 14 days. Twenty-one blood samples will be taken from each volunteer over 144
      hours in each period. Concentrations of Ivermectin in plasma will be measured using a
      validated chromatographic assay (LC-MS/MS). Standard pharmacokinetic parameters will be
      obtained and bioequivalence on the basis of rate and extent of drug absorption will be
      assessed.
    

Intervention name(s): ivermectin
Intervention type(s): Drug
Intervention description(s): Each subject will receive single doses of (i) 30 ml ivermectin oral solution (30 mg) and (ii) 10 x 3 mg tablets of ivermectin (30 mg) in 2 separate dosing periods. Doses will be administered 20 minutes after a standard breakfast.
Other intervention name(s): Stromectol
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: therapeutic equivalency; pharmacokinetics; food; Healthy Volunteers