bioihbjkbjnl/mcl2 huggingface dataset:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining chemotherapy and radiation therapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation
      therapy in treating patients who have limited-stage small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the complete and overall response rates in patients with limited stage small
           cell lung cancer treated with induction chemotherapy comprising paclitaxel, topotecan,
           and etoposide followed by consolidation chemoradiotherapy.

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the overall and failure-free survival of patients treated with this regimen.

        -  Determine the overall (partial and complete) response rate in patients treated with this
           induction chemotherapy regimen.

      OUTLINE: This is a multicenter study.

        -  Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral
           topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also
           receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and
           continuing until blood counts recover.

        -  Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and
           85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo
           radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks.

      Patients with rapid disease progression discontinue study therapy.

      Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and
      then annually for 5 years.

      PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 10 months.
    

Intervention name(s): filgrastim; carboplatin; etoposide; paclitaxel; topotecan hydrochloride; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Radiation
Intervention MeSH terms: Paclitaxel; Etoposide; Carboplatin; Topotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: limited stage small cell lung cancer
Safety and Efficacy Study of AB002 (E-WE Thrombin) in End Stage Renal Disease Patients on Chronic Hemodialysis
Condition: End Stage Renal Disease; Thrombosis
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the safety and efficacy of AB002 (E-WE thrombin) in patients with end
      stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two
      cohorts. Within each cohort the patients will be randomized to receive either AB002 (E-WE
      thrombin) or placebo (at a ratio of 2:1 active: placebo).
    


Intervention name(s): AB002 Dose 1; AB002 Dose 2; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AB002 (E-WE thrombin) 1.5 mcg/kg administered on Day 1 as a single intravenous infusion; AB002 (E-WE thrombin) 3.0 mcg/kg administered on Day 1 as a single intravenous infusion; placebo administered on Day 1 as a single intravenous infusion
Other intervention name(s): E-WE thrombin Dose 1; E-WE thrombin Dose 2
Intervention MeSH terms: Thrombin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hemodialysis
Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Atrial Flutter
Study type: Interventional

Summary: 
      The objective of the study is to demonstrate the safety and feasibility of the Adagio
      Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing
      Persistent Atrial Fibrillation.
    


Intervention name(s): Cryoablation System
Intervention type(s): Device
Intervention description(s): Pulmonary Vein Isolation, Posterior Wall Isolation. May Include Mitral Line ablation, AF Driver ablation, and Cavo-tricuspid Isthmus ablation as indicated
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure
Condition: Acute Renal Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Study type: Interventional

Summary: 
      The purpose of this protocol is to evaluate the safety of a selective cytopheretic device
      (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute renal
      failure (ARF).
    

Detailed description: 
      Acute renal failure is a condition where the kidneys are not capable of producing adequate
      urine. Therefore, another way to remove waste from the body is needed to hopefully allow time
      for the kidneys to heal. One method of removing waste from the body is called Continuous
      Renal Replacement Therapy (CRRT) or variations of that therapy. This study will evaluate the
      safety of the device while it is connected to the CRRT tubing for up to 7 days. Patients will
      be followed up until day 60 following the treatment.
    

Intervention name(s): Selective cytopheretic device (SCD)
Intervention type(s): Device
Intervention description(s): The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Renal Failure; Acute tubular necrosis; Continuous Renal Replacement Therapy; Selective cytopheretic device
Local Tolerability and Pharmacokinetic Evaluation of Cyclops Dry Powder Hydroxychloroquine Inhalation in Healthy Volunteers
Condition: Covid19
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      Rationale:

      This protocol describes a study on the local tolerability of dry powder hydroxychloroquine
      using the Cyclops in healthy volunteers.

      Objective:

        -  Primary objective is to assess the local tolerability of dry powder hydroxychloroquine
           sulphate via the Cyclops at different dosages.

        -  Secondary objective is to investigate systemic pharmacokinetic parameters of dry powder
           hydroxychloroquine sulphate via the Cyclops at different dosages.

      Study design: single center, ascending dose study Study population: twelve healthy volunteers

      Main study parameters/endpoints:

      The local tolerability of the inhalation of dry powder hydroxychloroquine sulphate (5, 10 and
      20 mg) defined by a lung function deterioration (a drop of forced expiratory volume in 1
      second (FEV1) of >15%), cough, or any other reported adverse event. Pharmacokinetic
      parameters will be derived from calculated actual inhaled dose (dose minus remainder in
      inhaler after inhalation) and in blood samples drawn pre-dose, at 0.5 and 2 and 3.5 hrs after
      inhalation. The inspiratory parameters during the inhalation maneuver are critical to explore
      predictors for drug exposure. The following parameters will be measured/calculated: dPmax
      (maximum pressure drop), Vi (inhaled volume), Ti (total inhalation time), PIF (peak
      inspiratory flow rate), MIF (mean inspiratory flow rate) and the FIR (average flow increase
      rate between 20% and 80% of PIF).

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: The participants included are healthy volunteers. They will receive three
      different doses of hydroxychloroquine sulphate using the dry powder inhaler (DPI) with (at
      least) seven days in between doses. Before using the dry powder inhaler (DPI), they will
      receive instructions and their inspiratory flow will be tested. To investigate local
      tolerability, lung function tests will be performed, and the occurrence of adverse events
      will be scored. Furthermore, before each test dose an indwelling cannula will be inserted and
      blood samples will be taken before and after each test dose. Four blood samples will be
      collected with each inhaled dose. Finally, five ECGs will be obtained to monitor for QT
      prolongation, one at the screenings visit, one at base-line and one after each inhalation.
    


Intervention name(s): inhaled hydroxychloroquine
Intervention type(s): Drug
Intervention description(s): ascending dose of iHCQ
Intervention MeSH terms: Hydroxychloroquine
Intervention model: Single Group Assignment
Intervention model description: Healthy volunteers
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device
Condition: Intracranial Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device
      in the treatment of unruptured, wide-neck intracranial aneurysms.
    


Intervention name(s): Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intracranial aneurysm; brain aneurysm
Effects of Riboflavin on Faecalibacterium Prausnitzii and the Gut Microbiota
Condition: Gut Microbiota
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to investigate comprehensively the effect of riboflavin
      supplementation on the abundance of F. prausnitzii and on other members of the gut microbiota
      in faeces of healthy volunteers. Additionally it will be assessed whether riboflavin
      supplementation affects the abundance of potentially pathogenic bacteria such as adherent
      invasive E. coli (AIEC). Finally, the effect of riboflavin supplementation on the production
      of Short Chain Fatty Acids, the release of gut hormones and potential changes in glucose
      homeostasis and appetite perception will be assessed.
    


Intervention name(s): Riboflavin Dose 1; Riboflavin Dose 2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Other intervention name(s): Vitamin B2; Vitamin B2
Intervention MeSH terms: Vitamins; Riboflavin; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gut Microbiota; Riboflavin; Vitamin B2; oGTT; Faecalibacterium prausnitzii
Randomized Double Blinded Study Evaluating CACICOL20 Efficiency Versus Placebo Corneal Chronic Ulcers Healing
Condition: Corneal Ulcer
MeSH terms: Corneal Ulcer; Ulcer
Study type: Interventional

Summary: 
      CACICOL20 is a biodegradable nanopolymer engineered to mimic glycosaminoglycans such as
      heparan sulfates. Applied to the corneal lesion, it replaces damaged heparan sulfates in the
      matrix scaffold. CACICOL20 binds to matrix proteins such as collagen and cytokines or
      endogenous growth factors of the cellular microenvironment. CACICOL20 provides a protective
      function and restores the matrix architecture. This produces a suitable spatial environment
      for cells to respond properly to the cascade of signals needed for tissue regeneration to
      resume.

      The ophthalmic solution, CACICOL20, used for corneal ulcers is very well tolerated both
      locally and generally, as proved by a pilot study which as been conducted at the "Hôpital des
      XV-XX" in Paris (France). It reduces the pain significantly and increases corneal ulcer
      healing (all ulcers treated were resistant to all other usual therapies).

      Therefore, the accuracy of a Randomized multicentric double blinded study to evaluate the
      efficacy of CACICOL20 versus placebo for chronic corneal ulcer healing has been shown and
      will begin mid-may 2010. In this study, CACICOL20 will be applied every 2 or 4 days for 3
      months.

      The aim of the study is a double blinded comparison of complete chronic corneal ulcers
      healing rate within 3 months in 3 groups of patient double blinded randomized between
      CACICOL20 instillations distribution and physiological salt solution instillations
      distribution.

      The main judgment criteria is healing rate within 3 months defined as corneal ulcer complete
      closure.
    


Intervention name(s): CACICOL20; Placebo
Intervention type(s): Device; Device
Intervention description(s): CACICOL20 is a solution of dextran & poly(carboxymethylglucose sulphate)in physiological salt serum. CACICOL20 is presented in 0.33 mL strip. One drop is instilled at each application to impregnate cornea.; It is the placebo of CACICOL20, containing dextran in physiological serum salt. It is presented, like CACICOL20, in a 0.33 mL strip. One drop is delivered at each application.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CACICOL20
Effect of Hepatitis C Clearance on Insulin Resistance
Condition: Insulin Resistance; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic hepatitis C infection has been linked to insulin resistance, which is the essential
      component of metabolic syndrome and type 2 diabetes mellitus. Resistin; an adipokine, has
      been demonstrated to stimulate the secretion of several inflammatory factors known to play a
      role in the induction of insulin resistance. we investigated the changes in insulin
      resistance after hepatitis C clearance in the era of direct antivirals.
    

Detailed description: 
      the link between hepatitis C infection and insulin resistance has been established. Insuli
      resistance has been linked to poor response to interferon based therapy. recently, direct
      acting antiviral drugs are approved for hepatitis C elimination with high potency and safety.
      The aim of the study is to: 1. Determine the prevalence of insulin resistance among
      non-diabetic patients with chronic HCV infection. 2. Explore the impact of treatment with
      DAAs on insulin resistance among chronic HCV infected patients. 3. Investigate the role of
      insulin resistance as a potential prognostic factor for the response to DAAs. 4. Explore the
      utility of resistin as a potential biomarker IR among HCV infected patients.
    

Intervention name(s): Sofosbuvir 400 milligram; Daclatasvir 60 milligram; Ribavirin 400 milligram; Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single daily dose of 400 milligrams; single daily dose of 60 milligrams for 12 weeks; weight based dose, 1200 mg for weight > 75 kilogram, and 1000 milligram if weight < 75 kilograms for 12 weeks; single daily dose for 12 weeks
Other intervention name(s): Soflanork 400 milligram; Gratisovir 400 milligram; Daklanork 60 milligram; Daktavira 60 milligram; Riba 400 milligram; HARVONI; Soflanork plus
Intervention MeSH terms: Ribavirin; Sofosbuvir; Ledipasvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL.
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a randomized study investigating the bioequivalence of COREG CR to its
      components, COREG and Lisinopril (ZESTRIL). PK samples will be obtained throughout the study
      to investigate the PK of COREG CR FDC to COREG and Lisinopril
    


Intervention name(s): COREG CR; Lisinopril
Intervention type(s): Drug; Drug
Other intervention name(s): COREG CR
Intervention MeSH terms: Lisinopril; Carvedilol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: COREG CR
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
Condition: Trigeminal Neuralgia; Headache Disorders
MeSH terms: Ganglion Cysts; Trigeminal Neuralgia; Neuralgia; Headache Disorders; Headache
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have
      enough effect with the available pharmaceutical treatments and are offered surgery. There are
      different types of procedures and most of them are complex with a risk for complications. The
      researchers want to start a pilot study on 10 patients with a new surgical technique using
      neuronavigation. The target will be a neural structure (sphenopalatine ganglion) which has an
      important role in facial pain. There have been a few trials trying to block this structure in
      trigeminal neuralgia, but none using this new approach with botulinum toxin. The researchers
      technique requires local anesthesia only (awake patient). The researchers believe that this
      treatment can become a "low threshold"-treatment for patients who do not have enough effect
      with pharmacological treatment and a better alternative to other complex surgical approaches.
      Using this new neuronavigation system the researchers can reach this neural structure with
      high precision.
    


Intervention name(s): Botulinum Toxin Type A
Intervention type(s): Drug
Other intervention name(s): Botox; BTA
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nerve block; Sphenopalatine Ganglion Block; Botulinum Toxins, Type A
Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6
Condition: Gastric Cancer Stage IV; Peritoneal Carcinomatosis; Intraperitoneal Paclitaxel; mFOLFOX6
MeSH terms: Stomach Neoplasms; Carcinoma; Peritoneal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for
      decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic
      chemotherapy. Intraperitoneal chemotherapy in combination with systemic chemotherapy is under
      many clinical trials mainly in Japan, and are showing promising results.

      This is Korea's first clinical trial on Intraperitoneal Paclitaxel with Systemic mFOLFOX6
      chemotherapy.
    


Intervention name(s): Paclitaxel; mFOLFOX6 regimen
Intervention type(s): Drug; Drug
Intervention description(s): Intraperitoneal application of Paclitaxel Phase 1: Dose determination of Paclitaxel (Recommended Dose) Starting from 40mg/m² upto 100mg/m² maximum
Phase 2: Intraperitoneal Paclitaxel with recommended dose; Systemic mFOLFOX6: 5-FU(2400mg/m²), Oxaliplatin(100mg/m²), Leucovorin(100mg/m²)
Other intervention name(s): (Genexol®)
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric cancer; Peritoneal carcinomatosis; Intraperitoneal chemotherapy; Paclitaxel; FOLFOX
Clinical and Histological Evaluation of the Picosure 755nm Laser With Cap Array for Facial Rejuvenation
Condition: Facial Rejuvenation
MeSH terms: Facies
Study type: Interventional

Summary: 
      The purpose of this study is to assess treatment of facial rejuvenation using the standard
      hand piece and a Lens Array for the 755nm Alexandrite laser.
    


Intervention name(s): 755nm Laser with Cap Array
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to look at how radiolabelled NXL104 is taken up, broken down and removed by the body
      when given as an injection into the blood stream.
    

Detailed description: 
      An Open Label Single-Dose Study in Healthy Male Subjects Designed to Assess the Mass Balance
      Recovery, Metabolite profile and Metabolite Identification of [14C]NXL104.
    

Intervention name(s): [14C]NXL104
Intervention type(s): Drug
Intervention description(s): 500mg/100mL intravenous solution
Intervention MeSH terms: Avibactam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mass Balance; Metabolite Identification and Profiling; Metabolite profile and Identification of [14C]NXL104; Mass Balance Recovery
A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics of two formulations of MK-1006. The primary
      hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum
      concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and
      film coated tablet (FCT) formulations of MK-1006 will be similar.
    


Intervention name(s): MK-1006 DFC; MK-1006 FCT
Intervention type(s): Drug; Drug
Intervention description(s): Each dry filled capsule contains 20 mg MK-1006; Each film coated tablet contains 40 mg of MK-1006
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment