cyrilzakka/clinical-trials huggingface dataset:
Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

Overall Survival (OS), Patient-reported outcome (PRO)

Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
* Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
* Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
* Patients who have adequate coagulation, liver and kidney functions

Exclusion Criteria:

* Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
* Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated \> 2 years prior to entry
* Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
* Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
* Patients with a history or presence of metastatic brain or meningeal tumors
* Patients with seizure disorder requiring medication (such as anti-epileptics)
* History of organ allograft or bone marrow transplant of stem cell rescue
* Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control
* Patients who have three or more of the following:

  * ECOG performance status greater than or equal to 2,
  * Abnormally high lactate dehydrogenase,
  * Abnormally high serum hemoglobin,
  * Abnormally high corrected serum calcium,
  * Absence of prior nephrectomy
* Excluded therapies and medications, previous and concomitant:

  * Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates
  * Significant surgery with 4 weeks of start of study
  * Investigational drug therapy during or within 30 days
  * Concomitant treatment with rifampin or St. John's Wort
  * Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
  * Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors
Effects of Cannabidiol (CBD) on the Brain

Cannabidiol (CBD) is a phytocannabinoid that is one of 113 identified cannabinoids in the cannabis plant. It is derived from the hemp plant, and may treat conditions like pain, insomnia, and anxiety. CBD is a critical component of medical marijuana and does not cause the "high" typically associated with cannabis. According to the World Health Organization, CBD has shown no evidence of abuse or dependence potential. However, to the investigator's knowledge, there have not been many acute clinical studies to characterize the effects of CBD in the brain. Despite the rapid influx in CBD readily available to the public, very little is known about such effects. Some studies have shown alterations in resting state connectivity, while others have described changes in specific regions of the brain, or in networks associated with various cognitive functions. For example, CBD has been shown to increase fronto-striatal connectivity and reduce mediotemporal-prefrontal connectivity, suggesting that CBD may affect brain regions involved in salience processing. Unfortunately, few studies have examined CBD in isolation. Additionally, several studies have suggested that CBD may have a neuroprotective effect when it comes to individuals at high risk for psychiatric conditions. In this study, the investigators propose an acute administration, double-blind, placebo-controlled study in which 100% THC-free CBD will be compared to placebo (https://foliumbiosciences.com/). To the investigator's knowledge, the acute effects of this specific product have not been tested. Specifically, the investigators will examine: 1) the neurometabolic and neurophysiological effects of CBD compared to placebo and 2) the behavioral effects of CBD on measures of working memory and response inhibition. Participants will be recruited to take encapsulated, THC-free CBD provided by Folium Biosciences, in which they will have a pre- and post-ingestion scan. Each participant will have a 72-hour washout period after which they will be asked to come back for a placebo scan (however, the order will be counterbalanced so that equal numbers of participants will receive placebo/supplement and supplement/placebo). Individuals will be randomized into the supplementation group, as well as the order.


Eligibility Criteria:
Inclusion Criteria:

1. right-handed
2. between 21-50 years of age
3. no current diagnosis of psychiatric or neurological conditions
4. no history of heart disease or stroke
5. generally healthy
6. pass a screening test for the MR environment

Exclusion Criteria:

1. contraindications to the MR environment
2. use of psychotropic or neurological medication
3. history of heart disease or stroke
4. diabetes or other metabolic conditions
5. self-reported high blood pressure
6. history of concussions
7. any diagnosed psychiatric or neurological condition
8. have consumed alcohol in the 24-hour period prior to a scan
9. consumed pain relievers in the 12-hours prior to a scan
10. consumed food or drinks (except water) and/or nicotine/caffeine an hour prior to any scanning
11. have used or take THC/CBD
12. exercised within an hour of a scan
A Retrospective Study of Immunotherapy in Conversion Therapy of Unresectable Gastric Cancer

This study was an observational, non-interventional, multicenter retrospective study to evaluate the feasibility and safety of sintilimab combined with chemotherapy (SOX or PS) in the clinical practice of unresectable locally advanced or stage IV gastric cancer/gastroesophageal junction carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Ages: 18-75 Years (concluding 18 and 75 Years)
* Pathologically confirmed gastric/gastroesophageal junction adenocarcinoma
* Unresectable, locally advanced or limited distant metastasis of IV gastric cancer(AJCC 8th)
* Meets only ≤2 of the following conditions: highly locally advanced (T4b), or extensive or bulcky lymph nodes; Para-aortic lymph node metastasis(mainly 16A2/B1 region); limited liver metastasis(H1); limited Peritoneal metastasis(CY1, P1), with or without ovarian metastasis(Kukernburg tumor);
* Untreated(e.g. radiotherapy, chemotherapy, target therapy, immunotherapy, et al.)
* At least 1 measurable lesion by RECIST v1.1 criteria
* ECOG PS: 0-2
* Received sintilimab combined with chemotherapy(SOX or PS) at least 1 cycle

Exclusion Criteria:

* Known Her2 positive
* Patients with incomplete data or other factors affecting the judgment of efficacy and safety
The Prospective Study on the Effect of Ilaprazole in Non-erosive Reflux Disease Patients; Focused on Histologic Findings and Inflammatory Biomarker

Non-erosive reflux disease (NERD) patients used to be less responsive to proton pump inhibitor (PPI)s as compared with patients with erosive esophagitis. The aim of this study is to objectively evaluate the effect of a new PPI, ilaprazole in NERD for adjusting the focus of symptom score, histopathologic findings and inflammatory biomarker.

A prospective study performed at single hospital enrolled 20 patients who were diagnosed clinically as NERD. Patients underwent EGD, a 24hr-combined multichannel intraluminal impedance and pH esophageal monitoring (MII-pH) and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) will be accessed.


Eligibility Criteria:
Inclusion Criteria:

* Older than 20 years old and younger than 80 years old
* Patients with typical reflux symptoms at least 2days per week (or GERD Q score ≥ 8 )
* No erosion at GE junction through endoscopy
* Patients that can perform a 24 hr - combined multichannel intraluminal impedance and pH esophageal monitoring prior to this study.

Exclusion Criteria:

* included prior history of documented intolerance of ilaprazole or similar PPIs, or
* unsuspected alarm symptoms such as weight loss, hematemesis, hematochezia, jaundice or other significant illness like malignancy
* alcoholism or drug addiction
* uncontrolled diabetes, cerebrovascular accident or diseases needed an operation in the last 3 months before enrollment
* any previous esophageal surgery
* malignancy in gastrointestinal tract within 5years
* pregnant woman
* Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal motility abnormality, esophageal stricture, duodenal ulcer, gastric ulcer, pancreatitis, absorption disorder, severe cardiovascular disease, severe lung disease in the last 3 months before enrollment
* history of steadily taking medicine such as diazepam, quinidine, diphenylhydantoin, mephenytoin, warfarin, anticholinergic, prostaglandin analog, antineoplastic agent, salicylate, steroid, pro-motility drug, nonsteroidal anti-inflammatory drugs(NSAIDS)
* patients who were registered other exams within 28days
* patients who could not conduct sedated endoscopy
Impact of PVE on Patient's Long-term Survival, Complications and Cancer Recurrence.

For patients with colorectal liver metastasis (CLM), the prospect of long-term survival relies on liver resection. Wistfully, more than 75 % of patients with CLM are initially unresectable, due to an insufficient future liver remnant (FLR) volume

In order to increase FLR volume, most patients will first receive chemotherapy to reduce the tumor load (downsizing).

When chemotherapy is insufficient to provide an adequate postoperative FLR, portal vein embolization (PVE) can be performed. About 50-70 % of patients undergoing PVE obtain a sufficient liver hypertrophy to allow liver resection.

While PVE is recognised for its efficacy to induce liver hypertrophy, some studies expressed substantial concerns regarding the potential adverse effect of this intervention on pre-resection tumor progression, increased risk of cancer recurrence following resection and reduced overall survival following resection

Those studies suggested that the need to perform PVE should be assessed thoroughly for each patient and that chemotherapy should be maintained during the whole hypertrophy process in order to contain the potential adverse effect of PVE on tumor progression.

Other studies found no significant association between PVE and negative oncological outcomes.

As mentioned in almost every study cited above, more data is needed to provide a clearer vision regarding the impact of PVE on tumor progression and cancer recurrence following liver resection.

The aim of this study is to compare the overall and disease-free survival of PVE-requiring patients to the ones who underwent upfront surgery (NoPVE).

As a secondary objective, the impact of several covariates (related to surgery, patient's condition and disease stage) on survival and cancer recurrence will be tested.

Our hypothesis are that 1) PVE might be associated with a lower overall survival and a higher risk of cancer recurrence in univariate analysis but 2) this association will not remain significant when other covariates are included in the proportional COX hazard models.


Eligibility Criteria:
Patients with the following inclusion criterias were approached:

* Diagnosis of colorectal liver metastasis (CLM).
* Scheduled for a one-stage right/extended right hepatectomy in Centre Hospitalier Universitaire de Montréal (CHUS) - Hospital Saint-Luc.

Exclusion Criterias:

* Individuals requiring a two-stage hepatectomy.
* Patient who had previous hepatectomy.
Pancreaticobiliary Reflux in Patients Without Cholelithiasis

Pancreaticobiliary reflux has been found in patients with cholelithiasis and gallbladder cancer associated with normal pancreaticobiliary union. However, the presence of pancreaticobiliary reflux has not been studied in patients without gallstones (healthy gallbladders).

The authors believe that pancreaticobiliary reflux might be a normal phenomenon in patients with and without gallstones, although in patients with cholelithiasis it might constitute a pathological condition associated with dismotility of the biliary tree and the sphincter of Oddi.

The objective of this study is to measure the levels of amylase and lipase in gallbladder bile of patients without gallstones and compare these values to the values of amylase and lipase of patients with gallstones and normal pancreaticobiliary union evidenced by intraoperative cholangiography.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 15 years of age
* Elective surgery
* Normal intraoperative cholangiography
* Normal preoperative serum amylase and lipase values

Exclusion Criteria:

* Common bile duct stones
* Anatomic anomalies at the pancreaticobiliary junction evidenced by intraoperative cholangiography
* Altered preoperative amylase and lipase levels
* Altered preoperative hepatic function tests
* Emergency surgery
Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers

This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor \[HGF\] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.

This is a Phase 2, double-blind, randomized, placebo-controlled, parallel group study. Approximately 60 male or female subjects aged 18 years or older with one shallow foot ulcer and mild/moderate ischemia due to peripheral artery disease (PAD) will be randomized in a 1:1:1 ratio to one of 3 treatment groups:

* 4.0 mg AMG0001 intramuscular (IM) (n = 20)
* 8.0 mg AMG0001 IM (n = 20)
* Placebo IM (n = 20)

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of PAD and mild/moderate foot ischemia (WIFI ischemia grades 1, 2)
* A single measurable ulcer of ≥ 1 cm2 and ≤ 10 cm2 on a lower extremity without evidence of infection or gangrene and no evidence of bone and/or tendon involvement at randomization
* Subjects will undergo protocol-defined standardized wound care during the screening period and through 12 months from the first dose of investigational product
* Subjects who have a diagnosis of diabetes must be considered stable with no changes in diabetic medication regimen anticipated during the study period. Subjects who have a diagnosis of diabetes must have a HbA1c of ≤12% at Screening

Exclusion Criteria:

* Subjects who have excessive tissue necrosis that is unlikely to benefit from medication, or those subjects who, in the opinion of the Investigator, are felt likely to require revascularization within 1 month of screening
* Subjects with severe limb ischemia
* Subjects who are considered likely to require a major amputation (at or above the ankle) within 3 months of screening
* Subjects with deep ulcerations with bone or tendon exposure, or uncontrolled infection, or with the largest ulcer that is \>10 cm2 in area
* Subjects with hemodynamically significant aorto-iliac occlusive disease
* Subjects who have had a technically successful revascularization by surgery or angioplasty within 2 months. If subjects are more than two months from revascularization and still meet the inclusion criteria, they may be considered for enrollment. Subjects who have had a technically unsuccessful attempt at revascularization may be enrolled at least one week from the procedure
* Subjects currently receiving immunosuppressive medication, systematically administered steroid therapy, chemotherapy or radiation therapy. Inhaled and topical steroid therapies are allowed
Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO16)

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
* Meeting the demographic requirements

Exclusion Criteria:

* Age below 18 or over 50
* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Carboxyhemoglobin levels over 3%
* Subjects whom the investigator consider ineligible for the study
A Multi-Component Weight Loss Intervention to Improve Outcomes of Total Knee Replacement

Obesity, specifically BMIs ≥35 or 40 kg/m2, are associated with an increased probability of poor outcomes of Total Knee Arthroplasty (TKA) including increased pain, risk for infection, poor joint function, and increased rates of hospital readmissions. Several orthopedic and public health organizations recommend weight loss prior to TJA for individuals with overweight/obesity. However, empirical evidence suggesting the effectiveness of pre-surgical weight loss on surgical and functional outcomes of TKA is extremely limited and is based primarily on non-randomized observational studies. Thus, to gain further insight regarding the feasibility and potential effectiveness of pre-surgical weight loss on outcomes of TKA, the proposed pilot trial will randomize 30 patients (age 50-75 yrs., BMI 35\<40 kg/m2) scheduled for TKA through The University of Kansas Health System Department of Orthopedics and Sports Medicine (KUOrtho) to a multi-component weight loss (3-mo. pre-TKA, very low-calorie diet) and maintenance intervention (3-mo. post TKA, conventional maintenance diet) or standard care control which will include no dietary or weight loss advice. The weight loss/maintenance interventions will include reduced energy intake or energy intake prescribed for weight loss maintenance, increased physical activity, and individual behavior counseling. Outcomes will be assessed 1) baseline, i.e., 3 mos. prior to surgery, 2) 3 mos. i.e., at the completion of the weight loss intervention prior to TKA, 3) within a minimum of 2 weeks post TKA, and 4) 3 mos. post-TKA, i.e., after completion of the weight maintenance intervention to assess the feasibility and effectiveness of a remotely delivered multi-component pre-TKA weight loss and a post-TKA weight maintenance intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age: 50-75 years
* BMI: 35 to ≤40 kg/m2
* Patient of KU Health System Department of Orthopedics and Sports Medicine (KUOrtho)meeting all requirements for TKA surgery.
* TKA surgical date scheduled ≥3 mos. from consent
* Own a Bluetooth enabled computer, tablet, or smart phone with the ability to join remote telehealth sessions and sync study self-monitoring devices.

Exclusion Criteria:

* Weight loss ≥10 pounds in previous 6 months
* Dairy/milk protein allergy
* Currently pregnant/breastfeeding or planning to become pregnant during the study
* Currently being treated for an eating disorder or history of an eating disorder diagnosis
* Pacemaker
* Current Cancer
* Diabetes Type 1 (insulin dependent)
* Hyperuricemia (untreated)
* Inflammatory bowel disease (active)
* Liver disease requiring protein restriction
* Myocardial infarction within last 3 months
* Abnormal ECG
* Renal insufficiency.
Weight Loss in Chronic Disease Patient Population

This study will assess the effect of in-home tele-health monitoring on health outcomes for LSUHCSD chronic disease, overweight or obese patients diagnosed with type II diabetes or hypertension.

This study will assess the effect of in-home tele-health monitoring on health outcomes for LSUHCSD chronic disease, overweight or obese patients diagnosed with type II diabetes or hypertension. Primary emphasis will be on assessing the effect of tele-health home monitoring combined with motivational telephone coaching on weight loss and waist circumference as compared to self-directed, home monitoring alone, and telephone coaching alone. Secondary outcomes such as blood pressure, Hemoglobin A1c (HbA1c), fasting blood sugar, and cholesterol will be examined as well.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 yrs old
* BMI ≥ 25 kg/m2 and waist circumference \> 40 inches (men)/ 35 inches (women)
* Weight ≤ 500lbs
* At least one of the following:
* Fasting blood sugar \> 100 mg/dL at any point and/or taking medications for diabetes And/Or
* Resting blood pressure \> 130/90 mm Hg at any point and/or taking medications for hypertension
* Not involved in regular physical activity or weight loss management programs
* Capable of being physically active
* Physically able to use in-home equipment (or presence of a household member who can assist the subject in equipment use)
* Currently-working conventional telephone line at primary residence
* Grounded electrical power supply at primary residence
* Have been in LSU HCSD system for 6 months and anticipate remaining in the LSU HCSD patient population for the next 6 months

Exclusion Criteria:

* A history of drug abuse in the last year, or excess alcohol consumption (40g/day)6
* Currently dieting or engaging in any activity with the goal of losing weight
* Significant weight loss or weight gain in the past year (\> 50 lbs) or current use of weight loss medications
* History of gastrointestinal bypass or other bariatric surgery in the last 3 years
* Diagnosis of congestive heart failure
* Under treatment for end-stage renal disease or end-stage liver disease
* History of major organ transplant
* History of cancers requiring treatment in the past 5 years with anything but excellent prognosis
* Current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders
* Pregnant or plan on becoming pregnant in the next 12 months.
* Lack support from health care provider or family members.
* Current member of household participating in study
* Factors that may limit adherence to intervention or affect conduct of the trial.
* Unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment.
* Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.