cyrilzakka/clinical-trials huggingface dataset:
BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study

The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and abraxane. Each of these drugs are currently used in pancreatic cancer.

The experimental part of the study is combining these drugs together in FOLFOX-A.

More active treatments are desperately needed in pancreatic cancer. The regimen of FOLFIRINOX increases survival as compared to gemcitabine but at a cost of increased toxicity. Irinotecan is responsible for much of the toxicity of FOLFIROX but may not contribute significantly to the regimen's activity. Abraxane is a new agent in pancreatic cancer. This albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of paclitaxel though binding of albumin to SPARC in pancreatic cancer stroma. The investigators therefore propose a pilot study of FOLFOX (fluorouracil, leucovorin and oxaliplatin) combined with abraxane to establish the safety and preliminary activity of FOLFOX-A. Patients with inoperable (metastatic and locally advanced) pancreatic cancer will be eligible since the primary outcome is to establish the safety of FOLFOX-A.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed pancreatic ductal adenocarcinoma.
* Metastatic or locally advanced disease.
* No prior treatment for pancreatic cancer
* Radiographically measurable disease.
* No major surgery within 4 weeks of the start of study treatment. Patients must have recovered from the side effects of any major surgery at the start of study treatment. Laparoscopy and central venous catheter placement are not considered major surgery.
* Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A
* Preexisting neuropathy \> grade 1.
* No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible.
* ECOG performance status 0 or 1.
* Age ≥ 18 years of age.
* Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment.
* Required Initial Laboratory Values:

  * Neutrophils ≥ 1,500/μl
  * Platelet count ≥ 100,000/μl
  * Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
  * Total bilirubin ≤ 1.5 x ULN
  * AST (SGOT) \& ALT (SGPT) ≤ 3.0 x ULN

Exclusion Criteria:

-Patients with known brain metastases
Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months)

A study to compare the effect of once-daily atomoxetine versus placebo in treating symptoms of ADHD in adults for up to 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients with ADHD ages 18-54.
* Patient must have ADHD symptoms that cause problem(s) in the home setting.

Exclusion Criteria:

* Have failed to respond to an adequate trial of treatment with an ADHD stimulant medication, bupropion, or other nonstimulant medication.
* Are taking any antipsychotic medication or mood stabilizers within 8 weeks of Visit 1
Validation Study of G4 User Interface

The purpose of this simulated useability study is to demonstrate the user interface and software design mitigate potential safety concerns.

These are the detailed descriptive planned outcomes of this useability study.

* To demonstrate that human-interface design mitigations lead to effective, efficient, and safe use.
* Validate that foreseeable misuse does not lead to a safety hazard or patient injury.
* Validate the effectiveness and comprehension of critical warnings and alerts, including vibratory, auditory, and textual cues.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of diabetes mellitus
Evaluation of the Efficacy and Safety of Risperidone Injections Given Once a Month to Adults With Schizophrenia or Schizoaffective Disorder

The purpose of this study is to assess the effectiveness and safety of long-acting risperidone given as a once monthly injection to adult patients with schizophrenia or schizoaffective disorder.

Risperidone, taken by mouth on a daily basis, has been an effective treatment for schizophrenia and schizoaffective disorder. Risperidone is also available in a long-acting injectable form so that patients can take their medicine by bi-weekly injections. This study will assess the effectiveness and safety of long-acting risperidone injection given once a month instead of every two weeks (based on previous studies with dosing every 2 weeks). During the four-week lead-in phase, patients will receive one 50-milligram injection every two weeks for two doses. Patients continue to take their prescribed dose of risperidone tablets (from 2 to 6 milligrams per day) for the first 14 days. After the first month, patients will receive one 50-milligram injection once a month for 48 weeks. This dose can be increased to 75 milligrams if patient meets relapse criteria, and is willing to stay in the trial. Patients will be asked questions to help determine how well the monthly injections are working. Laboratory tests (including drug levels), physical examinations and adverse event reporting will be performed to determine the safety of the monthly injections. Risperidone oral tablets, 2 to 6 milligrams per day, for first 2 weeks; long-acting risperidone intramuscular injections, 50 mg in 2 milliliters of liquid, every 2 weeks for 1 month, then injections once a month for 48 weeks. Monthly injection dose may be increased to 75 mg in 2-mL if needed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* stable with respect to disease symptoms and other medical conditions
* stable on antipsychotic therapy with oral risperidone 2 to 6 milligrams per day for 8 weeks before study
* if female, using birth control.

Exclusion Criteria:

* Hospitalized within 8 weeks of beginning the study
* at risk to self or others
* presence of liver or kidney damage
* use of oral antipsychotic drugs other than risperidone within the past 8 weeks, of injected antipsychotics within the past 6 months, of long-acting risperidone in an earlier study, of investigational drugs within the past 30 days, or of electroconvulsive therapy within the past 12 months
* pregnant or breast-feeding
* if female, not using birth control
* abusing drugs or alcohol.
Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure

This is an observational study to evaluate the clinical impact of respiratory virus in the patients with acute respiratory failure


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 19 years
* Written informed consent by the patient or legally authorized representative
* Critical illness consistent with acute respiratory failure, to be enrolled within 24 hours of presentation

Exclusion Criteria:

* No informed consent
* A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability
Acute Ischemic Apoplexy Syndrome Specificity and Acupuncture Intervention Research

This project optimizes the TCM Symptoms and Symptoms Scale. A curative effect evaluation system of acupuncture in the treatment of acute ischemic stroke is formed to provide clinical evidence by the following indexes: neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the patients' head MRI, Plasma BDNF, MMP-9 and other biomarkers.

Based on the previous work, this project optimizes the TCM Symptoms and Symptoms Scale. Through the cohort study method, 194 patients with acute ischemic stroke were evaluated for neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the patients' head MRI. , Plasma BDNF, MMP-9 and other biomarkers, screen TCM syndromes related to stroke outcome indicators, and adopt targeted comprehensive acupuncture and moxibustion program intervention and follow-up to establish a stroke-specific intervention outcome prediction model with TCM characteristics. A curative effect evaluation system of acupuncture and moxibustion in the treatment of acute ischemic stroke is formed to provide clinical evidence.

Eligibility Criteria:
Inclusion Criteria:

* (1) It meets the diagnostic criteria in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2014"; with the support of brain CT or MRI imaging examination, the vital signs are stable, the state of consciousness is clear, and the GCS\>8 points; （2）.Onset is less than 2 weeks; （3）. There is no indication for thrombolysis, or the patient do not accept thrombolysis; （4）. For moderate to severe patients, the National Institute of Health Stroke Scale (NIHSS) ≥ 4 points;（5）.Glasgow coma standard (GCS)\>7 points;（6）.No serious disability before admission, and modified Rankin Scale (mRS) ≤ 3;（7）. The patient himself or his immediate family members signed the informed consent form.

Exclusion Criteria:

- (1) Cerebral hemorrhage or subarachnoid hemorrhage; (2) Cerebellar and brainstem infarction (including lacunar infarction); (3) Cerebral herniation is formed upon admission; (4) Patients with severe heart, lung, liver, and kidney diseases; (5) Severe upper gastrointestinal bleeding occurred after the onset; (6) The patient has participated in other clinical trials within the past 3 months; (7) Patients with mental illness, or those with severe cognitive impairment (MMSE score ≤9 points) (8) Those with a pacemaker, a metal foreign body at the treatment site, or a severe bleeding tendency.

(9) The investigator believes that other diseases accompanied by the patient may interfere with the correct evaluation of neurological function, or participating in this trial may cause other complications in the patient.
Nasal Pillows vs. Nasal Masks at High CPAP Pressure

The aim of this evaluation is to test:

1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks
2. Patient mask type preferences at high pressures


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to give written informed consent
* Patients who can read and comprehend English
* Patients being treated for OSA for \>6 months
* Patients ≥ 18 years of age
* Patients using nasal mask systems with fixed pressure ≥ 12 cm H2O
* Patients who can trial the trial masks up to 14 nights
* Patients naive to pillows mask systems

Exclusion Criteria:

* Patients using an inappropriate mask system
* Patients using Bilevel flow generators
* Patients who are pregnant
* Patients who have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)
Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS

The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.

Approximately 340 therapy-naïve MS patients with relapsing-remitting form of the disease will be randomized to receive Avonex alone or Avonex plus methylprednisolone (MP). Patients will receive MP as 500 mg po for 3 days every month or matching placebo. The patients are followed on a 3-monthly basis for 4 years with disability as the primary parameter of efficacy over that time.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy
* Disability EDSS score of 4.0 or less at baseline
* Clinical activity as defined by at least one relapse in the last year

Exclusion Criteria:

* Relapse in the month prior to enrolment
* Treatment with immunosuppressive drugs for MS
* History of major depression
* Former severe reactions to corticosteroids
* Pregnant women
* Diabetes mellitus, and drug or alcohol dependency
* Known or suspected allergy to trial products
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients

The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Chinese origin, with known or suspected brain or spine diseases

Exclusion Criteria:

* Pregnancy
* Lactation
* Conditions interfering with MRI
* Allergy to any contrast agent or any drugs
* Participation in other trial
* Require emergency treatment
* Severely impaired liver and kidney functions
Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures

The objective of this proposal is to study circulating and echocardiographic markers of pulmonary vascular and right ventricular remodeling in patients with a WHO-2 diagnosis of pulmonary hypertension after mitral valve procedures. The investigators are proposing the study will be impactful for the early detection and prediction and of residual pulmonary hypertension (PH) that would otherwise be undetected and fatal with no curative treatment.

The investigators will enroll 3 groups: Group 1: Patients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures. Group 2: Patients with no PH undergoing open and interventional mitral valve procedures. Group 3: Patients with established diagnosis of WHO-1-4 groups of PH undergoing right heart catheterization. Groups 2 and 3 will serve as controls. All procedures will be performed at the main UAB Hospital cardiac surgical operating rooms and at the cardiac angiographic suites. The investigators will collect a total of 3 blood samples; the first sample will be obtained on arterial cannulation before the initiation of the intervention, the second sample will be collected upon the end of the procedure prior to leaving the procedure room, and the third sample will be collected on the day of discharge from the hospital. A comprehensive echocardiogram at the 3 corresponding time points of the blood samples obtained; before, and after the intervention and before discharge.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years/old

Exclusion Criteria:

* Patients with ejection fraction (EF) \< 35%
* Patients with severe tricuspid valve regurgitation
* Transplant patients
* Patients scheduled for ventricular assist devices
* Patients with a diagnosis of heart failure with preserved ejection fraction
* Any aortic valvular disease
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on the results of MRD evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T)
* Age 15-65 yrs (\*55-65 years if biologically younger according to general condition)
* Written informed consent

Exclusion Criteria:

* Severe comorbidity or leukemia associated complications
* Late relapse of pediatric ALL or ALL as second malignancy
* Cytostatic pre-treatment
* Pregnancy
* Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
* Participation in other clinical trials interfering with the study therapy
Ovarian Screening Study

The objectives of this study are:

* To identify women at increased risk for developing ovarian cancer
* To detect ovarian cancers at an early stage
* To investigate the role of tumor membrane fragments as tumor markers for early ovarian carcinoma

In the year 2001 approximately 23,400 women in the USA are expected to be diagnosed with ovarian carcinoma and 13,900 will die of the disease. This means that within the USA more women die annually from ovarian cancer than all other gynecologic malignancies combined. Within the Commonwealth of Kentucky approximately 250 women per year develop ovarian carcinoma.

Survival for patients with ovarian cancer is directly related to the stage of disease at diagnosis. Unfortunately, the majority of women present with advanced disease (Stage III and IV) and most of these patients will die of the disease.

The aim of screening for ovarian cancer is to reduce the morbidity and mortality by detecting the disease at an early stage since ovarian cancer detected when disease is confined to the ovary (Stage I) is associated with a dramatically improved 5-year survival. Disease confined to the ovary may be cured in over 90% of patients, in some cases without the need for chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic women over the age of 45 with one or both ovaries.
* Women over the age of 25 with one or both ovaries and any of the following:

  * A personal history of breast, colon or endometrial cancer or breast cancer gene (BRCA) 1 or 2 positive
  * First-degree relative (mother, sister, daughter) with ovarian or breast cancer
  * Two family members with either breast and/or ovarian cancer
  * Mother, sister, daughter, grandparent with a positive BRCA1 or BRCA2 genetic test result.
  * Past use of fertility drugs such as Clomid or Pergonal for more than a year.

Exclusion Criteria:

* Women who are symptomatic of ovarian cancer
Epidural Morphine for Postoperative Analgesia After Total Knee Arthroplasty

Single femoral nerve blockade combined with patient-controlled intravenous analgesia are used for postoperative analgesia for patients after TKA in the hospital of the investigators. Although this method provides acceptable analgesia, the incidence of opioid-associated side effects is relatively high. Low-dose epidural morphine is commonly used in postoperative analgesia after cesarean section, and the effect of single dose morphine lasts more than 20 hours, with low incidences of itching, nausea, vomiting, and respiratory depression. The investigators hypothesize that, for patients undergoing TKA, the addition of low-dose epidural morphine to single femoral nerve block and intravenous opioids can improve the postoperative analgesia, reduce the consumption of intravenous opioids and decrease opioid-associated side effects.

Total knee arthroplasty (TKA) is an important therapy for patients with serious knee osteoarthritis in order to improve quality of life and relieve pain. But a large number of patients who undergo this surgery experience moderate to severe postoperative pain. Previously, the investigators used single femoral nerve blockade combined with patient-controlled intravenous analgesia for postoperative analgesia for patients after TKA. Although this method provides acceptable analgesia, the incidence of opioid-associated side effects is relatively high. Low-dose epidural morphine is commonly used in postoperative analgesia after cesarean section, and the effect of single dose morphine lasts more than 20 hours, with low incidences of itching, nausea, vomiting, and respiratory depression. The investigators hypothesize that, for patients undergoing TKA, the addition of low-dose epidural morphine to single femoral nerve block and intravenous opioids can improve the postoperative analgesia, reduce the consumption of intravenous opioids and decrease opioid-associated side effects.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age of 18 years or older);
* American Society of Anesthesiologists classification I-III;
* Scheduled to undergo unilateral TKA under combined spinal and epidural anesthesia.

Exclusion Criteria:

* Age higher than 90 years old;
* Presence of any contraindication to neuraxial block or peripheral nerve block;
* Continuous use of opioid analgesics during the last month;
* Unable to understand Numeric Rating Scale for pain evaluation or existence of language barrier;
* Severe renal insufficiency (requirement of renal replacement therapy);
* History of asthma;
* Recruited in another clinical trials.
CQDSA in Evaluation of Prognosis After EVAR

Re-hospitalization or re-intervention is sometimes necessary to treat type I and type III endoleaks after EVAR for its persistent increasing of pressure in aneurysm lumen. Color-coded quantitative digital subtraction angiography (CQDSA) provides an easy and quick way to post-process the traditional digital subtraction angiography (DSA) which converts the peak time of the maximal contrast medium intensity into a single polychromatic image. With the help of CQDSA, a quantitative evaluation of the endoleak hemodynamics and a risk analysis of the type I or type III endoleak could be performed during the EVAR procedure. This approach may offer an objective assessment of the needs for immediate re-intervention, conservative therapy or treatment endpoint in the future.

Intra-procedural DSA series are transferred to a research workstation to generate the color-coded images and make quantitative measurements. Region of interest (ROI) measurements are performed equivalently in the endoleak and the aorta after the image generation. There are three kinds of ROIs including a small circle area with the shortest time to peak, a circle area with peak contrast intensity and the whole endoleak area. The ROI and a reference at the same latitude within the aorta are selected to undergo measurement which reflected the endoleak hemodynamics of the endoleak to the utmost extent.

The following parameters will be acquired through the CQDSA for analysis.

1. Time-versus-ROI contrast intensity graph. The graph contains one endoleak ROI flow curve and one reference aortic flow curve (Ref). The x-axis shows time from 0 second to the maximum frame time of the image. The y-axis shows the sum of pixel intensities, namely total contrast, representing the contrast concentration within the ROI.
2. ROI Peak/Ref Peak. It is the ratio of intensity peak between the endoleak and the reference in the aorta.
3. ROI TTP (Time to peak). Peak time of ROI in the vicinity of endoleak entry.
4. ROI AUC/Ref AUC. Area under curve (AUC) is calculated through Time-versus-ROI contrast intensity graph. The parameter here is the ratio of ROI AUC in endoleak to the reference.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present type I or/and type III endoleak after EVAR for AAA and complete at least 3 months' follow up.

Exclusion Criteria:

* Patients who

  1. undergo surgeries which involve the segment covered by EVAR;
  2. present connective tissue disease, such as Marfan's Syndrome or vasculitis.
  3. present abdominal aortic dissection.
  4. present AAA rupture.
  5. die from non aneurysm-reltated reasons or are lost during follow up.