cyrilzakka/clinical-trials huggingface dataset:
Pancreatic Cancer Models Developed From EUS Guided Biopsy Tissue

Pancreatic cancer is a very aggressive cancer. Over the past 40 years there has not been much progress made in reducing deaths from this cancer. Recently, new models of pancreatic cancers have been generated from mouse and human tissues. These models have used larger pieces of tissues taken from surgical removal of pancreatic cancers.

The purpose of this study is to determine whether these new pancreatic cancer models can be generated from the small biopsies we take to make the diagnosis of the pancreatic mass.

The Endoscopic Ultrasound guided pancreatic biopsy tissue collected for only research purposes will be used to generate organoids in a in-vivo and in-vitro setting.

The development of these methods may help scientists identify new treatments for pancreatic cancer and to potentially develop more personalized approaches to treating pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are scheduled for an EUS-FNB of pancreatic mass(es) suspicious for pancreatic ductal adenocarcinoma performed by a member of the Stony Brook Interventional Endoscopy Section of the Division of Gastroenterology and Hepatology

1. Age ≥ 18 years
2. Literate and able/willing to provide informed consent for participation in research.

Exclusion Criteria:

1. Age \< 18 years
2. Not literate or unable/unwilling to provide informed consent for EUS-FNB research biopsies
3. Pregnancy as determined by serum or urine HCG test performed as standard of clinical care for all women of childbearing age and documented on subjects' electronic medical record
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).

Primary Objective of the study:

* To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular (CV) risk participants with hypercholesterolemia

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
* To evaluate the effect of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab

The maximum study duration was 62 weeks per participant, including a 2-week screening period, 52-week randomized treatment period, and 8-week follow-up period.

Eligibility Criteria:
Inclusion criteria:

* Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks to 6 weeks prior to screening (Week -2)

Exclusion criteria:

* Age \<18 or legal age of adulthood, whichever was greater
* Participants without established CHD or CHD risk equivalent
* LDL-C \<70 mg/dL (\<1.81 mmol/L) and participants with a history of documented cardiovascular disease
* LDL-C \<100 mg/dL (\<2.59 mmol/L) and participants without a history of documented cardiovascular disease
* Not on a stable dose of LMT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (Week -2) and from screening to randomization
* Fasting serum triglycerides \> 400 mg/dL (\>4.52 mmol/L)

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Atropine in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

To test the hypothesis that increasing the sinus node rate with atropine treatment prior to exercise will reduce exercise-triggered ventricular ectopy compared to baseline in patients with CPVT.

This is a prospective cross-over trial that will enroll eligible patients with CPVT and perform a baseline treadmill exercise tolerance test (ETT) followed by a repeat treadmill ETT with I.V. atropine administered immediately prior to exercise. Atropine is a parasympathetic blocker and results in sinus tachycardia, which is expected to reduce the diastolic interval thereby reducing delayed after depolarizations and ventricular ectopy compared to baseline. Both ETTs will be performed on the same day with two hours of rest scheduled between ETTs. The primary analysis will be a paired comparison of the number of ventricular ectopic beats recorded during exercise (and recovery) at baseline and following pre-treatment with atropine. Secondary endpoints will include the presence of ventricular ectopy (yes/no), complex ventricular ectopy (couplets or greater, yes/no), and the number of runs of complex ventricular ectopy.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 6 years
* Able to provide written informed consent
* Clinical diagnosis of CPVT
* Able to exercise on a treadmill
* Successful completion of a minimum of 2 exercise stress tests without adverse events

Exclusion Criteria:

* Contraindication to treadmill stress testing according to Vanderbilt University Medical Center's clinical protocols (unstable angina, decompensated congestive heart failure, severe hypertension (≥ 170/90 mmHg), acute myocardial infarction (\<4 days), moderate to severe aortic stenosis, acute pulmonary embolism, severe pulmonary hypertension, outflow tract obstruction, hypertrophic cardiomyopathy, left main coronary stenosis, left bundle branch block)
* Females who are pregnant
* In the judgement of the investigator, any clinically significant ongoing medical or surgical condition that might jeopardize the subject's safety or interfere with the conduct of the study
Adjuvant Radiotherapy for Resected Hepatocellular Carcinoma With MVI

Positive micro vascular invasion in early stage hepatocellular carcinoma(HCC) leads to early recurrence after surgery. Adjuvant external radiotherapy will be applied in those patients to see if disease free survival and overall survival could be approved.

Hepatocellular carcinoma(HCC) ranks the 6th most common cancer and is the 2nd leading cause of cancer-related death globally. Surgical resection remains the most efficient therapy in early stage. Though an anatomical resection of tumor lead to an up to 70% 5-year overall survival, the existence of micro vascular invasion(MVI) caused early recurrence. Stereotactic body radiation therapy (SBRT) has been proved to be efficient in treating vascular tumor thrombosis. The investigators tried to implement this technique in adjuvant setting for HCC after surgery with MVI. Participants with early stage HCC whose tumor locates closely to the main intrahepatic vascular will be regarded as potentially-not-enough-surgical-margin candidates. Surgical resection will be carried out as scheduled and an additional silver clip will be put into the margin. Postoperative pathological examination will detect micro vascular invasion or daughter nodule. MVI-positive candidates will be eligible for enrollment. Eligible participants will be randomized to two groups, SBRT group and surgery-alone(SA) group with 1-to-1 ratio. Participants in SBRT group will receive a 35Gy limited resection margin parenchyma SBRT after surgery, while participants in SA group just get surgery. Radiation related adverse events (AE) or reaction will be recorded and intervened necessarily. All participants will be followed up by investigators every three months. DFS, OS, and AEs are end points in this study.

Eligibility Criteria:
Inclusion Criteria:

1. solitary nodule;
2. tumor adjacent to the main trunk of hepatic vein, cava vena, or to the major branch of portal vein (including the lobar branch at least);
3. macro-vascular negative;
4. no previous treatment before surgery;
5. no previous hepatic surgery;
6. Child-Pugh score A for hepatic function.

Exclusion Criteria:

1. spontaneous rupture;
2. pathologically proved positive resection margin;
3. severe cirrhosis with hypersplenism or esophageal and gastric varices;
4. 4-weeks postoperative examination revealed α-fetal protein(AFP) still positive or new lesion in remnant liver;
5. postoperative complications required a secondary operation or more than 3 weeks'recovery from surgery.
Hydrogen-rich Water for Molecular and Phenotypic Biomarkers of Aging

This study evaluates the effects of six-month hydrogen-rich water intake on molecular and phenotypic biomarkers of aging in men and women aged 70 years and over.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 70 years
* Free of acute disorders

Exclusion Criteria:

* History of dietary supplement use during the past 4 weeks
Study of Tumor Tissue Samples From Patients With Stage I, Stage II, or Stage III Malignant Melanoma

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor tissue samples from patients with stage I, stage II, or stage III malignant melanoma.

OBJECTIVES:

* Determine the genetic profile of primary melanomas with and without synchronous regional nodal involvement by examining for 1) activating mutations B-Raf and N-Ras associated with melanoma development, and 2) allelic imbalances across the genome.
* Compare the genetic profile of primary melanomas from patients with and without lymph node involvement.
* Determine the combinations of genetic lesions that correlate with nodal metastasis by adopting a statistical machine learning approach to build a lesion-based classifier for nodal metastasis.

OUTLINE: Laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed.

Information about the patient's demographics (e.g., TNM staging, sex, age, and tissue collection dates) will be gathered by chart review or from the Multidisciplinary Melanoma Conference at University Hospitals tumor conference report in order to match cases.

Eligibility Criteria:
Inclusion Criteria:

* Node positive Group (experimental group)

  * Primary melanoma \> 2 mm in depth
  * Metastasis must be \> 0.1 mm and detectable by IHC or hematoxylin and eosin (H\&E) to be considered node positive
  * Slides and block for primary and node must be archived in UH dermatopathology
* Node Negative Group (control group)

  * Primary melanoma \> 2 mm in depth
  * A negative sentinel lymph node must be negative by IHC and H\&E

    * No stage IV disease
    * No acral and mucosal histology
    * No history of prior invasive melanoma
    * Underwent primary excision and sentinel lymph node biopsy within 3 months of each other
    * Archived tissue available
  * Slides and block for primary tumor and node biopsy must be archived in University Hospitals Case Medical Center (UH) dermatopathology

Exclusion Criteria:

* Acral and mucosal histology
* Previous diagnosis of invasive melanoma
* previous chemotherapy or immunotherapy
* patients who are found to have stage IV disease during workup
A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer

The purpose of this study is to evaluate the overall response rate, toxicity, progression free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in recurrent or metastatic breast cancer.

Recent therapeutic developments, such as the introduction of new cytotoxic agents (taxanes, platinum, liposomal anthracyclines, etc) have resulted in constant improvements in treatment efficacy and consequently in recurrent or metastatic outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival of docetaxel and oxaliplatin in patients with recurrence or metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged : 20\~70 years
2. WHO (ECOG) performance status 0-2
3. Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
4. patients had previously not received chemotherapy of recurrent or metastatic lesion.
5. Have given written informed consent and are available for prolonged follow-up

Exclusion Criteria:

1. Patients with previous chemotherapy for recurrent breast cancer
2. Breast cancer recurrence within 12 months after taxane treatment
3. Her-2/neu expression breast cancer
4. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
5. Brain metastasis
6. uncontrolled infection, medically uncontrollable heart disease
7. other serious medical illness or prior malignancies
8. Pregnant or lactating women were excluded.
Prediction of Outcome in Severe Preeclampsia

this summary studied the predictive values of factor V Leiden mutation , doppler indices , placental pathology to unfavorable fetal and maternal outcomes

leiden mutation is activated protein C resistance with hypercoagulable states and increased thrombotic risk. 99 % are heterozygous and 1 % is homozygous , very rare cases are psoudohomozygous with factor V deficiency. relation to this mutation was studied in severe preeclamptic patients. doppler indices of uterine arteries , increased pulsetility index or unilateral or bilateral uterine artery notch and placental pathology were studied.

Eligibility Criteria:
Inclusion Criteria: severe preeclampsia in 3rd trimester -

Exclusion Criteria:Twin pregnancy. Fetal congenital anomalies. Diabetic patient, impaired renal function. Any medical disorders even that HTN. Any placental pathology,Autoimmune diseases. Women with uterine activity or clinical emergencies with maternal hemodynamic instability or an indication for immediate termination of pregnancy.

-
The Influence of Personality on Two Aspects of Cognitive Performance: Processing Speed, and Accuracy.

Recently, a lot of evidence for a relation between measures of cognitive performance and personality characteristics has been collected. The use of computer based latency measures is often used to study mental processes in cognitive, as well as, in personality research On the basis of these relationships we can ask a question that relates to the practical usefulness (validity) of processing speed, accuracy of performance and personality measures in predicting impulsive behavior.


Eligibility Criteria:
Inclusion Criteria:

* Men and women at age - 20-50 years

Exclusion Criteria:

* History of psychiatric disorders, previous hospitalizations and psychopharmacological treatments
* History of alcohol and substance abuse
The Incidence and Risk Factors of Postoperative Delirium

Delirium is known to be one of the most common postoperative complications in elderly patients undergoing surgery. Because postoperative delirium can affect the length of hospital stay and prognosis significantly, it is important to identify the risk factors for postoperative delirium in advance. However, there have been few reports concerning intraoperative modifiable risk factors, such as postoperative pain, for postoperative delirium.

In this observational study, we will review the electronic medical records of elderly patients underwent spine surgery and assess the incidence and risk factors for postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent spine surgery between September 2016 and August 2018 at Seoul National University Hospital

Exclusion Criteria:

* Patients who had no information on postoperative care and managements.
Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease (PD) and severe motor fluctuations.

The study was composed of a screening period followed by 3 sequential on-treatment periods, as follows:

* Screening Period (up to 28 days): determination of eligibility and discontinuation of antiparkinsonian disease medications other than levodopa-carbidopa immediate release (LC-oral) prior to nasojejunal (NJ) tube placement.
* NJ Test Period (2 to 14 days): first hospitalization period, Baseline assessments, placement of NJ tube, and optimization of levodopa-carbidopa intestinal gel (LCIG) treatment via NJ tube and infusion pump (participant was hospitalized for NJ tube placement but hospitalization was not required for entire duration of LCIG treatment optimization).
* PEG-J Period (2 to 14 days): second hospitalization period; placement of PEG-J tube; further optimization of LCIG treatment.
* Post PEG-J Long-Term Treatment Period (Day 28 to Day 378): LCIG administration via a permanent PEG-J tube and infusion pump, with dosage adjusted according to clinical condition.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
* Levodopa-responsive with severe motor fluctuations
* Recognizable off and on state (motor fluctuations) confirmed by diary

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
* Undergone surgery for the treatment of PD
* Contraindications to levodopa (such as narrow angle glaucoma)
Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers

The purpose of this study is to determine the safety and efficacy of an investigational antiarrhythmic drug (ATI-2042) in the treatment of atrial fibrillation in patients with a dual chamber pacemaker.

ATI-2042 is being developed as an alternative to amiodarone, which is considered a first-line therapy for patients with atrial fibrillation and is known to have serious side effects. ATI-2042 was designed to have a reduced plasma half-life and a lower volume of distribution, which is expected to result in an improved safety profile. In contrast to amiodarone, ATI-2042 undergoes rapid metabolism via plasma and tissue esterases, which may reduce tissue accumulation and toxicity. The current trial will determine if ATI-2042 retains the efficacy profile of amiodarone without the side effects attributable to tissue accumulation seen with long-term dosing.

This study is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants.)

Eligibility Criteria:
Inclusion Criteria:

* Proven paroxysmal atrial fibrillation
* Pacemaker with appropriate AF diagnostics and recording capabilities

Exclusion Criteria:

* Known allergy to Amiodarone or previous treatment for severe Amiodarone toxicity
* Cardioversion within one month of screening
* Severe left ventricular dysfunction or CHF with NYHA Class III or above
Integrated Behavioral Health Innovations in Childhood Chronic Illness Care Delivery Systems

Study design: At baseline, all adolescents and young adults with IBD ages 12-21 years will be screened for anxiety and depression symptoms using the PHQ-9 and the Screen for Child Anxiety Related Disorders (SCARED) during a routine medical visit in the pediatric gastroenterology clinic. Individuals who screen positive for depression or anxiety will be assessed to confirm diagnoses using the anxiety and M.I.N.I. 6.0. Participants will also complete a psychosocial risk assessment as well as medical and socio-demographic inventories. The investigators will include youth that meet full criteria for major depressive disorder and any anxiety disorder, dysthymic disorder, and any adjustment disorder. The investigators will also include patients with subclinical symptoms that have significant psychosocial stressors in addition to their medical illness. Patients will be excluded if they have active suicidal ideation with plan requiring ER referral, bipolar disorder, psychosis, substance dependence, eating disorders, or significant intellectual disability/developmental delay. Participants meeting inclusion criteria will be randomly assigned to four sessions of IBBT administered on-site by a Fink social worker or treatment as usual (TAU), which is a facilitated community referral for mental health treatment.


Eligibility Criteria:
Inclusion Criteria:

* All adolescents and young adults with IBD ages 12-21 years will be screened for anxiety and depression symptoms and includes youth that meet full criteria for major depressive disorder and any anxiety disorder, dysthymic disorder, and any adjustment disorder. The investigators will also include patients with subclinical symptoms that have significant psychosocial stressors in addition to their medical illness.

Exclusion Criteria:

* Patients will be excluded if they have active suicidal ideation with plan requiring ER referral, bipolar disorder, psychosis, substance dependence, eating disorders, or significant intellectual disability/developmental delay.
Feasibility of Nurse-performed Gastric Ultrasound After Surgery

Gastric ultrasound is a quick and non-invasive tool to evaluate gastric content.

Emptying of gastric content can be affected after abdominal surgery leading to the inability of tolerating oral foods. Gastric content can be assessed by gastric ultrasound and nurses were recently trained to do so in healthy volunteers; however, feasibility of nurse-performed gastric ultrasound after major abdominal surgery is not investigated yet.

This study aims to investigate the feasibility of nurse-performed gastric point-of-care ultrasound after major gastro-intestinal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years)
* Underwent gastrointestinal surgery:

  * partial liver resection,
  * colorectal resection,
  * HIPEC,
  * pancreatic procedures including Whipple procedures for pancreatic cancer or pancreatic disorders,
  * other gastro- intestinal abdominal procedures such as resections of sarcomas, correction of herniation.
* Obtained written informed consent.
* Admitted for at least 3 days.

Exclusion Criteria:

* patients with open abdominal wounds or with abdominal pain hindering adequate gastric ultrasound
* patients with a Percutaneous Endoscopic Gastrostomy catheter