cyrilzakka/clinical-trials huggingface dataset:
D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer

A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of D-0316 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive

This is a phase II, open label, single arm study assessing the safety and efficacy of D-0316 (Firstly, D-0316 was orally given 75mg for a cycle(21 days), if tolerated, the dose will be increased to 100mg. Otherwise, the dose will be maintained at 75mg.) in patients with a confirmed diagnosis of Epidermal Growth Factor Receptor mutation positive and T790M mutation positive NSCLC,who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) agent. The primary objective of the study is to assess the efficacy of D-0316 by assessment of Objective Response Rate according to RECIST 1.1 by an Independent Central Review.

Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years.
* Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
* Radiological documentation of disease progression while on a previous continuous treatment with an first or second generation of EGFR TKI e.g. gefitinib or erlotinib.
* patients must also have confirmation of tumour T790M mutation status (confirmed positive) after disease progression on the prior EGFR TKI.
* Eastern cooperative oncology group performance status (ECOG PS) of 0-1.
* a minimum life expectancy of 12 weeks.
* At least one lesion, not previously irradiated during the study screening period, that can be accurately measured at baseline according to RECIST 1.1.
* Agree to use routine adequate and effective contraceptive measures during the entire study period and within 6 weeks after the last dose pre-menopausal fertility possible; Female patients need to exclude pregnancy (ie negative pregnancy test) and in non-lactation period.

Exclusion Criteria:

* Treatment with a first or second generation of EGFR-TKI within 10 days of study entry; previous treatment with a third generation of EGFR-TKI.
* Unresolved toxicities from prior therapy.
* Unstable spinal cord compression/brain metastases.
* Severe/uncontrolled systemic diseases, including uncontrolled hypertension, bleeding diatheses or infection.
* QTcF≥470 msec（female）or QTcF≥450 msec（male）during the screening period.
* Severe respiratory diseases such as interstitial lung disease, severe asthma, pulmonary embolism, etc.
* previous treatment with 2 or more lines of Chemotherapy or immunotherapy.
Effect of High-flow Nasal Oxygen on Extubation Outcome

The purpose of this study is to determine whether high flow nasal cannula is effective in lowering the reintubation rate after extubation for high risk patients in medical intensive care unit

The study hypothesis is that Optiflow may reduce the extubation failure rate for high risk patients in medical intensive care unit.In the intervention group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive high-flow nasal cannula (Optiflow Airvo2, Fisher \& Paykel Healthcare Ltd., New Zealand) after extubation. The oxygen concentration (FiO2) will be set to reach an oxygenation target similar to control patients (see below), while the gas flow rate will be set at 50 L/min.In the control group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive standard oxygen therapy including nasal cannula or oxygen mask after extubation. The FiO2 will be set to obtain a arterial oxygen saturation (SpO2) between 92% and 98% (or between 88% and 95% in hypercapnic patients). NIPPV or intubation will be applied in both group if respiratory distress noted. High flow nasal cannula will be tried before NIPPV or intubation in the control group patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients mechanically ventilated for \> 48 hours and at least one of the following:
* \> 65 y/o
* Cardiac failure as the primary indication of mechanical ventilation
* COPD
* Bronchiectasis
* Old pulmonary tuberculosis with destructive lung
* Chronic renal failure
* Neuromuscular disease
* BMI \> 30
* Inability to manage respiratory secretions
* ARDS

Exclusion Criteria:

* Presence of tracheostomy
* Recent facial trauma
* Active gastro-intestinal bleeding
* Planned NIPPV support after extubation
Effects of OM-174 in Adult Patients With Solid Tumors

Methods Patients received OM-174 twice weekly for a total of 5, 10 or 15 injections of either 600, 800 or 1000 µg/m². Pharmacokinetic analysis and cytokine dosages were performed. Natural Killer cells activity and toll-like receptors 4 polymorphism analysis were also performed.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a histologically proven solid tumor, refractory to conventional treatment or for which no such treatment existed.
* At least one month since the last chemotherapy
* Life expectancy above 3 months
* Written informed consent
* Age above 18

Exclusion Criteria:

* Patient's refusal
* Infection
* Brain metastasis
* Autoimmune disease
* Regular use of steroids
* Patient included in another protocol
* Chemotherapy or radiotherapy less than 6 weeks ago
* Immunotherapy less than 8 weeks ago
Hematopoietic Cell Transplantation With Post-transplantation Cyclophosphamide in MDS

This study is conducted to evaluate the feasibility and efficacy of post-transplantation cyclophosphamide with myeloablative or reduced-intensity conditioning regimen for allogeneic hematopoietic cell transplantation (HCT) in patients with myelodysplastic syndrome (MDS).

* Conditioning regimen A) Busulfan 3.2 mg/kg/day i.v. daily For 4 days (days -7 to -4) in patients aged \< 55 years For 2 days (days -7 and -6) in patients aged ≥ 55 years B) Fludarabine 30 mg/m2/day i.v. daily on days -7 to -2 (for 6 days)
* Harvest and infusion of donor hematopoietic cells Harvested peripheral blood mononuclear cells of donors via leukapheresis will be infused to recipients on day 0. Additional infusion on day 1 can be made based on the judgement of attending physician.
* GVHD prophylaxis A) Cyclophosphamide 50 mg/kg/day i.v. daily on days 3 and 4 (for 2 days) B) Cyclosporine: 1.5 mg/kg i.v. every 12 h hours beginning on day 5 and changed to oral dosing when oral intake is possible. If there is no evidence of GVHD, the dosage will be tapered beginning on day 90 and discontinued on day 180. C) MMF: 15 mg/kg p.o. 3 times daily with a maximum daily dose of 3.0 g beginning on day 5

If there is no active GVHD, Cyclosporine and MMF will be discontinued without taper at day 180 and 35, respectively.

Eligibility Criteria:
Inclusion Criteria:

* MDS defined by WHO classification, chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML) evolving from MDS A. IPSS \> 1.0 or bone marrow blast ≥ 5% at any time points before HCT or B. AML progressed from MDS or C. CMML
* Patients receiving first HCT
* Patients with appropriate hematopoietic cell donors A. HLA-matched sibling donor B. Unrelated donor C. HLA-mismatched familial donor
* 15 years old or older
* Adequate performance status (Karnofsky score of 70 or more)
* Adequate hepatic and renal function (AST, ALT, and bilirubin \< 3.0 x upper normal limit, and creatinine \< 2.0 mg/dL).
* Adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiogram
* Signed and dated informed consent must be obtained from both recipient and donor.

Exclusion Criteria:

* Presence of significant active infection
* Presence of uncontrolled bleeding
* Any coexisting major illness or organ failure
* Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
* Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
* Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Comparison of Flow Controlled Ventilation and Volume Controlled Ventilation

Flow-Controlled Ventilation is designed to ventilate the patient with constant flows during both inspiration and expiration. During inspiration, the pressure rises linearly from a set positive end-expiratory pressure (PEEP) to a set positive inspiratory pressure (PIP), and then falls linearly from PIP to end-expiratory pressure (EEP) during expiration. There are no flow interruptions during the Flow-Controlled Ventilation cycle, and the rate of change of pressure and volume in the lungs is equal, allowing for higher tidal volumes at lower pressures. The user sets the inspiratory flow rate and the ratio of inspiratory to expiratory time, providing full control over the ventilation cycle. However, this results in two unusual features: During inspiration, the ventilator creates positive pressure to direct gas into the patient's lungs through the endotracheal tube (ETT). When the intratracheal pressure (airway pressure) reaches the set PIP value, the ventilator switches from inspiration to expiration. By reversing the flow, it utilizes the Bernoulli effect to create negative pressure, facilitating expiration. Despite the presence of negative pressure on the ventilator side, the pressure in the patient's airway remains positive at all times.

Volume-controlled ventilation is a mode that is volume-controlled, time-cycled, time-triggered, and pressure-limited. In volume-controlled ventilation, high pressures are sometimes necessary to reach the target tidal volume. This can lead to barotrauma, atelectrauma, and volutrauma in the lungs. Therefore, to avoid high pressures, low tidal volume ventilation is preferred.

For Microscopic Laryngeal Surgeries, patients are intubated with a small sized endotracheal tube which results with higher pressures. We think that flow controlled ventilation will improve the ventilation during the surgery with lower pressures.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo elective microscopic laser surgery
* ASA status I and II

Exclusion Criteria:

* Surgery time more than 2 hours
* Patients with difficult intubation
* Patients with chronic lung diseases
* BMI \> 25
Evaluation of ClearLLab LS Screening Panel

This is a multi-center study to evaluate the clinical performance of ClearLLab LS screening panel with specimens from subjects for the diagnosis of hematologic malignancies.

This study aims to evaluate the clinical accuracy of ClearLLab LS screening panel in the diagnosis of hematologic malignancies. The residual specimens, which from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematologic diseases work-up, will be tested by ClearLLab LS screening panel. ClearLLab LS screening panel is CE-IVD marked immunophenotyping reagents under the European Union (EU) regulation, and this study is aimed to validate its clinical performance in Chinese population.

Eligibility Criteria:
Inclusion Criteria:

* Residual whole blood, bone marrow, or lymph node tissue samples from subjects with hematologic tumor-related symptoms and/or signs that are clinically recommended for Flow Cytometry Immunophenotyping

Exclusion Criteria:

* Specimens and/or spent samples that are visibly hemolyzed
* Specimens and/or spent samples that are visibly clotted
* Specimens and/or spent samples collected in Ethylene Diamine Tetraacetic Acid (EDTA) anticoagulant older than 24 hours from time of collection
* Specimens and/or spent samples collected in Heparin or Acid Citrate-Dextrose (ACD) anticoagulant older than 48 hours from time of collection
* Samples with insufficient volume to complete the protocol tests
* Samples from subjects with known myeloid malignancies or multiple myeloma
Soy Estrogen Alternative Study (SEA)

To conduct a three-armed trial assessing the effect of soy phytoestrogens on menopausal complaints, plasma lipids and lipoproteins, vaginal bleeding and endometrial proliferation, and health related quality of life.

BACKGROUND:

The results of many studies indicate that estrogen replacement therapy (ERT) reduces the risk of coronary heart disease (CHD) in postmenopausal women. However, less than 9 percent of these women choose to take ERT because of unwanted side effects and concerns about increased risk of cancer associated with ERT. Therefore, alternative therapies are needed.

The isoflavonoids found in soy protein (specifically genistein) have many properties that may reduce the risk of coronary heart disease. These include favorable effects on plasma lipids and coronary artery vasomotion. Furthermore, genistein is a tyrosine kinase (TK) inhibitor with inhibitory effects on thrombin activity and TK receptor-linked mitogens that may be associated with atherogenesis and neointimal formation after angioplasty.

DESIGN NARRATIVE:

Randomized, double-blind, placebo-controlled. The women were randomized into one of three groups: placebo, conjugated equine estrogens, or soy supplementation. Primary endpoints were the impact on menopausal complaints such as hot flushes, mood lability, anxiety, sleep disturbances; effects on plasma lipids and lipoproteins, including lipoprotein (a); effects on vaginal bleeding and endometrial proliferation; changes in health-related quality of life. Secondary endpoints included: assessment of the impact of these interventions on the progression of carotid artery intimal medial wall thickening as assessed by B-mode ultrasonography; bone density and bone turnover; additional measures to monitor the compliance and safety of the intervention such as mammography, anticipated or known side effects of hormone replacement therapy, blood levels of genistein, and clinical outcomes such as hospitalizations, physician visits, and symptoms. The study ended in December, 1998.

The study was a subproject within a program project on coronary atherosclerosis in females, primarily monkeys. Dr. Thomas B. Clarkson was the P.I. The subproject dollars were estimated based on the CRISP dollars assigned to the study which were approximately 12 percent of the total program project dollars and were broken down as follows: FY 1996 - 219,254; FY 1997 - $217,000; FY 1998 - $221,000.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
Perimenopausal/menopausal women, ages 45 to 55.
A Multiple Ascending Dose Study of Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

This multiple ascending dose study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.

NP10679 is a pH dependent inhibitor of the GluN2B subtype of the NMDA receptor. Compounds of this drug class are hypothesized to be beneficial in a number of central nervous system disorders, including brain ischemia associated with stroke, subarachnoid hemorrhage, severe pain, major depression and substance abuse disorders. This study uses a double blind, adaptive design approach to evaluate the safety, tolerability and pharmacokinetics of 5 once daily doses of NP10679 when delivered intravenously in three escalating dose levels in comparison to placebo

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 18 to 55 years
* Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
* If of child bearing potential (both men and women) must agree to use 2 forms of contraceptive methods for the duration of study.

Exclusion Criteria:

* Clinical laboratory values greater than or equal to 2 times the upper limit of normal.
* Recent history (within 2 yrs) or current tobacco use.
RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

The purposes of this study are:

1. To evaluate the long-term safety of dabigatran etexilate
2. To assess the effect of a knowledge translation intervention on patient outcomes


Eligibility Criteria:
Inclusion criteria:

Participation in RE-LY, requires long term anticoagulation, provides written informed consent

Exclusion criteria:

Permanent discontinuation of dabigatran during RE-LY
MyoGene: Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle

Rationale: Proteins released from muscle during and shortly after exercise, often referred to as myokines, may be central to our understanding of the cross-talk during and after exercise between skeletal muscles and other organs, in particular the liver. So far only a few myokines are identified (e.g. IL-6, IL-8, IL-15, TNF-alpha). Taking into account the role of these several known myokines in developing insulin resistance, revealing new putative myokines might provide valuable information and a direction for future research on the pathogenesis and treatment of type 2 diabetes mellitus.

Objective: The objective of the present study is to identify novel myokines, expression of which is altered in skeletal muscle after a single bout of exercise.

Study design: experimental study. Study population: Ten healthy, male subjects between 40 and 60 years of age and BMI \< 30 kg/m2, will participate in this study.

Intervention: A single exercise bout that consists of one hour one-legged cycling on a adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as control for the exercising leg.

Main study outcomes: Main study outcomes include upregulation of genes in skeletal muscle after exercise (with a focus on genes encoding myokines) and changes of blood plasma levels of selected proteins after exercise.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-60 years
* Male gender
* BMI \< 30 kg/m2

Exclusion Criteria:

* Exercising regularly (\> 2 times a week, \> 3 hour in total per week)
* Unstable body weight (weight gain or loss \> 3 kg in the past three months)
* Following, or have recently followed a (weight-loss) diet
* Donated or intended to donate blood 2 months before until two months after the study
* Medical condition that can interfere with the study outcome (i.e. cardiovascular disease, pulmonary disease)
* Systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg
* Use of medications known to interfere with gene expression in the muscles (i.e. statins, fenofibrate).
* Use of antithrombotic therapy (marcoumar, sintromitis).
* Diagnosed diabetes mellitus type 1 or 2.
* Drugs or alcohol abuse ( \> 3 glasses of alcoholic beverages a day).
* (Chronic) injuries of the locomotor system that can interfere with the intervention
* Participated in another study within the last six months
Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting

This study will be a quality improvement project to review the effectiveness and barriers to effectiveness of a new clinical program in the emergency room to provide substance use screening followed by brief motivational interviewing and referral to treatment for patients who meet criteria for problem substance use. This study will consist of a chart review of the results of the screens performed by substance use counselors and correlating them to institutional variables such as wait time in the emergency room and length of stay as well as to patient variables obtained by chart review such as medical diagnosis and sociodemographic variables.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and older Presentation to UAB Emergency Department

Exclusion Criteria:

* Younger than 19 Prisoners
Survey of Housestaff Attitudes Toward Patient Care and Safety

Background: The occurrence of medical errors and their deleterious effects on quality of care delivered are widely recognized phenomena in healthcare today. This has spurned an aggressive nationwide campaign to improve the quality of care all hospitals throughout the country. Currently, there are numerous reports of quality improvement initiatives across medical centers in the United States. However, a review of the literature failed to identify any publications regarding targeted resident/housestaff involvement in hospital quality improvement and safety related activities.

Purpose: To investigate and track housestaff attitudes on patient care, patient safety, communication and overall quality within the institution.

Objective: To investigate, analyze and publish the results of this prospective study. The information obtained will help us and others understand whether proactive attempts to change housestaff culture can indeed change attitudes towards the better with regards to patient care and safety. It is assumed that improved attitudes ultimately translates into improved care and safety.

Methods: Each residency coordinator in each clinical department will be asked to distribute a survey, which has already been validated for this type of investigation, to each resident in the respective program (see attachment).

The Vice-President of Medical Affairs will provide a cover letter to help with the process. After a week, a reminder will be distributed by the coordinators to each resident asking them to fill out the survey. The surveys will be filled out anonymously. However, each participant will be asked to note their sex, department and year of postgraduate training. This process will be repeated every eight months until June of 2010. The Housestaff Quality council (HQC) has already distributed and collected this survey. The results of those surveys will be used in a retrospective part of this study. The results of (HQC) survey will be used to establish a baseline of the housestaff attitudes at the New York Presbyterian Hospital-Weill Cornell.

Data will be stored on a password protected computer. The Institutional Review Board (IRB), Office of Human Research Protection and Food and Drug Administration and all appropriate federal oversight agencies may have access to those files.

Each residency coordinator in each clinical department will be asked to distribute a survey, which has already been validated for this type of investigation, to each resident in the respective program

Eligibility Criteria:
Inclusion Criteria:

* Members of housestaff working at New York Presbyterian Hospital - Weill Medical College of Cornell University Exclusion Criteria: Not meeting the inclusion criteria