cyrilzakka/clinical-trials huggingface dataset:
A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction. Patients will be randomized in a 1:1 ratio to receive either onartuzumab (MetMAb) or placebo in combination with mFOLFOX6. Patients may continue to receive onartuzumab (MetMAb) or placebo until disease progression, unacceptable toxicity, patient or physician decision to discontinue treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 years of age and older
* Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable for curative therapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Life expectancy \>3 months
* Presence of tissue sample for immunohistochemistry assay of Met receptor and HER2 status (if unknown)
* Radiographic evidence of disease; measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1); Patients with peritoneal disease would generally be regarded as having evaluable disease and allowed to enter the trial.
* For women who are not postmenopausal or surgically sterile; agreement to use an adequate method of contraception (e.g., hormonal implant) during the treatment period and for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
* For men: agreement to use a barrier method of contraception during the treatment period and for 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
* Adequate laboratory values

Exclusion Criteria:

* HER2-positive tumor (primary tumor or metastasis)
* Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant or neoadjuvant chemotherapy must be completed at least 6 months prior to randomization)
* Prior treatment with investigational drugs that target the hepatocyte growth factor (HGF) or Met pathway
* History of other malignancy within the previous 5 years, except for appropriately treated and presumed cured carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, and localized prostate cancer
* Receipt of an investigational drug within 28 days prior to study start
* Clinically significant gastrointestinal abnormalities, except from gastric cancer (e.g., Crohn's disease)
* Significant history of cardiac disease
* Significant vascular disease
* Infection with human immunodeficiency virus, hepatitis B, or hepatitis C
Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial

Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system.

This is an extension trial to Study NCT00376168 and NCT00712348.

This will be a multi-center, double-blind, parallel group, extension trial to assess the safety and efficacy of prGCD in patients completing NCT00376168. Patients will receive IV infusion of prGCD every two weeks at the selected medical center. The duration of the extension study will be fifteen months. There will be two treatment groups: 30 units/kg every 2 weeks or 60 units/kg every 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Successful completion of Protocol PB-06-001
* The patient signs informed consent

Exclusion Criteria:

* Currently taking another experimental drug for any condition
* Presence of severe neurological signs and symptoms, defined as complete ocular paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic Gaucher disease
* Pregnant or nursing
* Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the patient's compliance with the requirements of the study
Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury

This research is being done to study the effect of Functional Electrical Stimulation (FES) cycling on factors in blood and spinal cord in people with spinal cord injury (SCI).

FES cycling is a method of applying low level electrical currents to the leg and buttock muscles to cause the weakened or paralyzed muscles to contract and produce a cycling motion of the legs. The FES cycling in this study will be done through a device called the RT300-SL Cycle Ergometer. Although this device has been cleared by the Food and Drug Administration (FDA) for use by individuals with spinal cord injury, we are trying to find out the best way to use it in order to obtain the greatest benefits in an attempt to improve functional recovery.

Eligibility Criteria:
Inclusion Criteria:

* History of traumatic spinal cord injury sustained at least 6 months prior
* Complete spinal cord injury at any level American Spinal Injury Association (ASIA) impairment scale A
* No use of functional electrical stimulation within 3 months
* Medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
* Legally able to make own health care decisions

Exclusion Criteria:

* Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke, history of arrhythmia with hemodynamic instability
* Uncontrolled hypertension (resting systolic blood pressure (BP) \>160mmHg or diastolic BP \>100mmHg consistently)
* Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability
* Unstable long bone fractures of the lower extremities
* Subjects who are unwilling to agree to two (2) CSF examinations (lumbar punctures)
* Presence of cardiac pacemaker and/or defibrillator
* Presence of cancer
* History of epileptic seizures
* Subjects having a Stage 2 or greater sacral decubitus ulcer
* Women who are pregnant
* Active drug or alcohol use or dependence
Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cisplatin, paclitaxel, and gemcitabine in treating patients who have progressive unresectable regional or metastatic bladder cancer.

OBJECTIVES:

* Determine the efficacy and toxicity of cisplatin, paclitaxel, and gemcitabine in patients with progressive unresectable regional or metastatic transitional cell carcinoma of the bladder.
* Determine the progression free survival of these patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven progressive unresectable regional or metastatic transitional cell carcinoma of the bladder
* Measurable disease by CT or MRI scan

  * Greater than 10 mm

PATIENT CHARACTERISTICS:

Age:

* 18 to 75

Performance status:

* WHO 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 150,000/mm\^3

Hepatic:

* Not specified

Renal:

* Creatinine less than 1.36 mg/dL

Cardiovascular:

* No uncontrolled cardiac disease
* No severe cardiac arrhythmias

Other:

* Not pregnant or nursing
* No other prior malignancy except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior intravesical immunotherapy for superficial disease allowed
* No prior systemic biologic response modifier therapy for advanced disease

Chemotherapy:

* Prior intravesical chemotherapy for superficial disease allowed
* No prior systemic chemotherapy for advanced disease

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior radiotherapy allowed

Surgery:

* No prior surgery
GCF IL-17 Levels and Oxidative Status of Smoking and Non-smoking Individuals With Periodontitis

This study was performed to evaluate the effects of both periodontal treatment and smoking on the gingival crevicular fluid(GCF) levels of interleukin (IL)-17A, IL-17E, Total oxidative stress(TOS) and total antioxidant capasity(TAOC) in smoking and non-smoking patients with severe chronic periodontitis.

Systemically healthy 15 smoker,15 non-smoker with chronic periodontitis were attended for the study. Periodontal status were determined by recording periodontal clinical measurements. GCF samples were collected at the baseline, at the end of initial periodontal treatment and 4 weeks after periodontal flap surgery. The data were tested statistically by the Student t and paired sample t tests.


Eligibility Criteria:
Inclusion Criteria:

* individuals aged ˃35 years and having ≥16 teeth diagnosed as chronic periodontitis
* not received any periodontal therapy within the previous 6 months;
* not received antibiotic/anti-inflammatory drug treatment within the previous 6 months.

Exclusion Criteria:

* receiving medical treatment for cancer, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, or any other systemic disease;
* being pregnant or being in the period of menopause or lactation;
* receiving any drug therapy that might affect the clinical characteristics of periodontitis;
* usage of systemic antimicrobials during the 6 weeks prior to data collection
Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery

The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.

The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18-90 years old
* undergoing non-emergent craniotomy or single level lumbar laminectomy
* must be able to rate pain on a 0-10 scale post-operatively

Exclusion Criteria:

* history of liver disease
* allergy to acetaminophen
* age less than 18 years
* renal failure with creatinine clearance less than 30
* pregnancy
* altered mentation with inability to report pain score
* patients who have received acetaminophen within 6 hours of surgery
* patients in which a neuraxial technique has been performed for surgery
* prisoners
A Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients

This randomized clinical trial (RCT) intends to look at the preliminary efficacy of NOVELA (intervention group) in changing anxiety and self-efficacy compared to usual hospice care (control group). In the NOVELA intervention, hospice care will be enhanced with the telenovela videos for hospice family caregivers (HFCG) education during twice weekly hospice telehealth visits to prepare caregivers for proper use of hospice support and healthcare services.

Telenovela is a television drama or soap opera that can be used to lead viewers to contemplate and discuss critical issues through video storytelling. Prior work showed informational telenovelas had a positive effect on Latino family caregivers' attitudes toward end-of-life (EOL) care services. The role of videos in hospice and palliative care shows significant promise, underscoring the videos as a mode of education for family caregivers that could potentially enhance caregiver's self-efficacy, decrease caregiver's anxiety, and reduce burnout. Despite the value of video education, many programs have failed to provide engaging material.

Based on input from HFCG, the investigators have produced a bilingual (Spanish and English version) four chapter telenovela video series (To Care/ El privilegio de cuidar) as part of NCI funded diversity supplement study. Founded upon extensive preliminary work, To Care portrays the journey of one hospice family as the family struggle with the hospice decision, pain management, decision-making, and finally the dying process. Averaging only 4:65 minutes, each chapter addresses one of these problems, validating family experiences and identifying potential solutions.

In a follow-up study, the investigators developed an interventionist-led conversation guide as a companion for the telenovela. The intervention, which includes the video series and the conversation guide, is named NOVELA (short for telenovela). The investigators preliminary single-arm trial found NOVELA feasible and acceptable in the hospice setting, with promising improvements in caregiver anxiety symptoms. Thus, storytelling and culturally tailored videos can be powerful tools to educate family caregivers of hospice patients. The overall expectation is that NOVELA will improve self-efficacy thus lowering anxiety in hospice family caregivers.

This proposal has the following aims:

* Specific Aim 1: Investigate the preliminary efficacy of delivering NOVELA to African American (AA) and Hispanic HFCGs of cancer patients.
* Specific Aim 2: Evaluate the benefits of NOVELA as perceived by hospice staff.

Eligibility Criteria:
Inclusion Criteria:

* Identified family caregiver of patients enrolled in hospice
* Caregivers must be over the age of 18
* Without cognitive impairment
* With access to wireless device and internet.

Exclusion Criteria:

* HFCG of patients that are actively dying
* Caregivers younger than 18 years
* With cognitive impairment
* Without internet access.
Investigational Multi-purpose Contact Lens Care Solution.

This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.


Eligibility Criteria:
Inclusion Criteria:

* must be an adapted contact lens wearer
* best corrected distance visual acuity must be 20/25 or better in each eye
* must be wearing their habitual lenses on a daily wear basis
* must be willing to refrain from swimming during the study

Exclusion Criteria:

* any systemic diseases that may interfere with contact lens wear
* any clinically significant ocular disease
* any ocular infection
* use of certain medications
* any grade 2 or greater slit lamp findings
* any know sensitivity to marketed contact lens care solutions
* currently pregnant or lactating
* monovision corrected
Safety/Proof of Concept Study of Oral QLT091001 in Subjects With Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) Due to Retinal Pigment Epithelial 65 Protein (RPE65) or Lecithin:Retinol Acyltransferase (LRAT) Mutations

The purpose of this study is:

* to evaluate the safety of oral QLT091001
* to evaluate whether 7-day treatment with oral QLT091001 can improve visual function in subjects with LCA or RP due to RPE65 or LRAT mutations
* to evaluate duration of visual function improvement (if observed)


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with LCA or RP (with a mutation in either RPE65 or LRAT)

  * Subjects with LCA must be 5-65 years of age
  * Subjects with RP must be 18-65 years of age
* Subjects who have a "best-corrected" visual acuity of 3 letters or better (20/800 Snellen equivalent) or viable photoreceptors on OCT/FAF.

Exclusion Criteria:

* Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of Day 0.
* Subjects with any clinically important abnormal physical finding at Screening.
* Subjects who have taken any prescription or investigational oral retinoid medication (e.g., Accutane,® Soriatane®) within 6 months of Day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure.
* Subjects with a history of diabetes or chronic hyperlipidemia, hepatitis, pancreatitis, or cirrhosis.
* Subjects who have taken any supplements containing ≥10,000 IU vitamin A within 60 days of screening
Music Therapy/Physical Therapy Intervention to Enhance Well-being and Functional Recovery Post-stroke

The purpose of this study is to see if group Music Therapy and Physical Therapy will help in the recovery from stroke. It is hoped that music and physical therapy in a group setting will help physical, mental, and social well-being.

The purpose of the study is to investigate the feasibility and efficacy of an "enriched," combined music therapy/physical therapy (MT/PT) rehabilitation intervention that addresses physical, psychological, and social well-being simultaneously in a group setting to enhance post-stroke recovery. The intervention will be implemented through collaboration between the Nordoff-Robbins Center for Music Therapy at NYU Steinhardt and the Motor Recovery Laboratory at the Rusk Institute of Rehabilitation Medicine, NYU Medical Center.

Eligibility Criteria:
Inclusion Criteria:

1. Able to read and write in English
2. Unilateral stroke at least 6 months prior
3. Independent community ambulation with or without assistive devices
4. Presence of at least 5 degrees of active motion in proximal and distal upper extremity joints, suggesting presence of a neural substrate for recovery

Exclusion Criteria:

1. Neurological or psychiatric disease such as clinical depression
2. Hearing deficits
3. History of surgery or other significant injury that could preclude task performance
4. Complicating medical problems such as uncontrolled hypertension, diabetes with signs of neuropathy, and previous neurological illness such as head trauma, prior stroke, epilepsy or demyelinating disease
5. Any factors that may put the subject at significant risk or confound study results
Renal Denervation in Diabetes.

Renal denervation (the use of radio waves to oblate the renal artery) has been shown to be an effective treatment for high blood pressure. It is currently being tested in heart failure patients and we would now like to look it its effects on diabetes.

We therefore plan to enrol 20 participants with type II diabetes into this study. Half will undergo renal denervation in addition to their standard care and the other half will act as controls and only receive standard care. Treatment allocation will be randomly assigned.

All participants will undergo screening (including a physical exam, blood tests, ultrasounds and a muscle biopsy). All patients will have follow up tests (including physical exams and blood tests) 1, 3 and 6 months later.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Able and willing to provide informed consent
* Patients with established type II diabetes mellitus (HbA1C\>7%, diet or oral hypoglycaemic agents)
* Clinical stable as demonstrated by no change in background anti-diabetic medication in the last 30 days.
* Anticipated that patients are able to maintain a stable dose of medication for the duration of the study

Exclusion Criteria:

* Renal arterial anatomy ineligible for RDN: main renal arteries \<4 mm in diameter or \<20 mm in treatable length; multiple renal arteries where main renal artery is estimated to supply \<75% of the kidney; haemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the investigator's opinion, would interfere with safe cannulation of the renal artery or require surgical repair or interventional dilation
* History of prior renal artery intervention including balloon angioplasty, stenting or previous renal denervation.
* Single functioning kidney
* Need for insulin (interferes with euglycemic clamp testing) or GLP-I analogues
* eGFR \<30 ml/min (MDRD formula)
* Any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial
Study of Immunotherapy to Treat Advanced Prostate Cancer

The purpose of the study is to determine if advanced prostate cancer patients that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Advanced prostate cancer
* At least 1 bone metastasis
* Testosterone \< 50 ng/dl
* Prior treatment with docetaxel

Exclusion Criteria:

* Brain metastasis
* Autoimmune disease
* Known HIV, Hep B, or Hep C infection
* More than 2 prior systemic anticancer regimens for prostate cancer
* Prior treatment on BMS CA180227 for prostate cancer
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Inoperable extrahepatic biliary obstruction by any malignant process
* Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

* Participation in another invesitgational study within 90 days prior to date of patient consent.
* Strictures that cannot be dialated enough to pass the delivery system
* Perforation of any duct within the biliary tree
* Presence of any esophageal or duodenal stent
* Patients for whom endoscopic procedures are contraindicated
* Patients with known senesitivity to any components of the stent or delivery system
* Patients with active hepatitis