cyrilzakka/clinical-trials huggingface dataset:
Neutrophil, Lymphocyte and Platelet as a Predictor for AKI and Mortality

Cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. The authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.

Acute kidney injury (AKI) after cardiovascular surgery remains a serious complication associated with increased mortality for up to 10 years. The incidence of AKI after cardiovascular surgery is as high as 55% and the incidence of renal replacement therapy (RRT) to be up to 8 %.

Cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. The authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who underwent cardiovascular surgeries with cardiopulmonary bypass (CPB), including valve replacement and surgery on the thoracic aorta at the Seoul National University Hospital between 2007 and 2015

Exclusion Criteria:

* Missing preoperative serum creatinine (sCr) values
* Missing preoperative platelet, neutrophil and lymphocyte counts
* Patients who underwent preoperative hemodialysis
Single Dose Study With 4SC-203 in Healthy Volunteers

The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 18 to 45 years (included), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
* Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and to understand and sign the written informed consent

Exclusion Criteria:

* Evidence of current or previous clinically significant disease, medical condition or finding of the medical examination (including vital signs and ECG), that in the opinion of the investigator would compromise the safety of the subject or the quality of the data
* Current or recent history of significant renal, hepatic, haematological, immunological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the subject's participation in the trial
Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients with Bulky Tumors

This is a 3+3 dose escalation phase I study which aims to evaluate the safety and tolerability of low dose radiotherapy (LDRT) plus concurrent partial Stereotactic Ablative Radiotherapy (SBRT) and Tislelizumab in Patients with bulky tumors who have failed standard therapy. At least 9 participants will be enrolled in this study.

This is 3+3 escalation phase I study which will be conducted in West China Hospital.

3 patients per cohort (a total of 9 patients) will be enrolled to observe the dose-limiting toxicity (DLT) and recommended dose for expansion (RDE) for lung LDRT and partial SBRT.

All eligible patients will receive LDRT + partial SBRT and Tislelizumab at different dose levels (decried as below). Tislelizumab will be given at 200mg as recommended in the instruction manual every 3 weeks until disease progression, unacceptable toxicities, the patient withdraws informed consent, or Tislelizumab reaches a maximum of up to 24 months. Patients in the dose escalation will receive LDRT + partial SBRT at 3 cohorts with increasing dose levels: 6 Gy (2 Gy/f) + 24 Gy (8 Gy/f); 6 Gy (2 Gy/f) + 30 Gy (10 Gy/f); 6 Gy (2 Gy/f) + 45 Gy (15 Gy/f).

Eligibility Criteria:
Inclusion Criteria:

1. Be willing and able to provide written informed consent/assent for the trial.
2. Be ≥18 years of age on day of signing informed consent.
3. Patients with histologically or cytologically confirmed stage IV NSCLC.
4. Be willing to undergo repeat biopsy of tumor lesions according to the study protocol.
5. Patients who have failed the standard therapy, or who are unsuitable for standard treatment, or refuse chemotherapy.
6. At least one measurable lesion according to RECIST 1.1. A lesion that has previously received radiotherapy can be considered a target lesion only if this lesion is clearly progressed after radiotherapy.
7. The target lesions (irradiated lesions) are \> 5cm in in diameter
8. ECOG 0-2.
9. Life expectancy of \> 3 months.
10. Subjects should agree to use an adequate method of contraception.

Exclusion Criteria:

1. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or spinal cord compression, etc.
2. With oncologic emergencies that require immediate treatment
3. EGFR/ALK/ROS-1 mutation or mutation status unknown.
4. Has evidence of interstitial lung disease or active and/or non-infectious pneumonitis (drug-induced pneumonia, radiation-induced pneumonia, etc.) requiring steroid therapy.
5. History of pulmonary fibrosis, pulmonary hypertension, severe irreversible airway obstruction disease
6. Patients with peripheral neuropathy.
7. Significant heart disease or impairment of cardiac function
8. Fluid accumulating in the third space, such as pericardial effusion, pleural effusion and peritoneal effusion that remains uncontrolled by aspiration or other treatment
9. Known allergy to drugs or excipients, known severe allergic reaction to any of the PD-1 monoclonal antibodies
10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
Association Between the Menstrual Cycle and Weight Loss

This is a research study to look at the association between weight loss and the menstrual cycle in healthy, overweight, premenopausal women. Participants will be asked to follow a reduced-calorie diet and exercise plan for 3 months.

Two different reduced calorie diet and exercise plans will be compared. One plan changes diet and exercise prescription with the phases of the menstrual cycle, while the other is a standard reduced calorie diet and exercise plan based on MyPyramid.gov website.

Eligibility Criteria:
Inclusion Criteria:

* Healthy females between the ages of 18-40 (inclusive)
* BMI between 26.5-35.4 kg/m² (inclusive)
* Regular menstrual cycle (28 ± 3 days)
* Weight stable (within ± 3-kg) 2 months prior to study inclusion
* Must use barrier contraception (e.g. male/female condom) for the study's duration
* Must be willing to follow the prescribed diet/exercise plan for the study's duration

Exclusion Criteria:

* On hormonal contraceptives or any other daily use of medications which can make the subject unsuitable for inclusion in the study.
* Any significant health problem (history of cancer, HIV/AIDS, Diabetes, cardiovascular disease, untreated hypothyroidism, etc.)
* Restrictions against participating in cardiovascular exercise and strength training
* Any condition, which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
* Women who are pregnant, lactating, or planning to become pregnant during the study period
Improving Bowel Preparation for Colonoscopy With a Simple Educational Card

The purpose of this study is to determine whether adding a simple educational card to standard pre-procedure instructions improves the quality of bowel preparation for colonoscopy.

Despite written instructions, many patients do not understand the importance of bowel preparation as they prepare for colonoscopy. This often leads to poor compliance with preparation protocol and therefore inadequate bowel preparation. Our goal is to include a simple educational card which will hopefully improve the quality of bowel preparation by providing a visual component with the preparation instructions. This card will stress the importance of drinking the entire bowel preparation and provide representative images of a dirty and clean colon. We will specifically target patients directly booked for screening colonoscopy (those without a pre-procedure office visit). In a randomized fashion, patients in the control group will receive the standard bowel preparation instructions and patients in the intervention group will receive the educational card along with the standard bowel preparation instructions. The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale. Secondary outcomes will include the number and types of polyps found, colonoscope insertion and withdrawal time, and patient satisfaction with the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* 18 years old or older
* Referred and scheduled for an elective screening colonoscopy

Exclusion Criteria:

* Inpatients
* Prisoners
* Cognitively impaired patients
* Legally blind patients
* Patients allergic to polyethylene glycol electrolyte lavage solution
Brighter Bites & UT Physicians Produce Rx Program

The purpose of this study is to clinically evaluate the effectiveness of an at-home produce delivery prescription or grocery store vouchers prescription at improving weight status and obesity-related health outcomes of participants across the two clinics as compared to a control group and to examine the impacts of the program on child dietary behavioral outcomes (child fruit and vegetable intake, junk food consumption, and eating at any type of restaurant), and parent feeding practices (preparing foods from scratch, use of nutrition facts labels to make purchasing decisions, and eating meals with their referent child)


Eligibility Criteria:
Inclusion Criteria:

* reside within a 10-mile radius of a Brighter Bites school
* Medicaid recipients or low-income uninsured
* parents must be able to read and write in English or Spanish to complete surveys

Exclusion Criteria:

* currently participating in Brighter Bites
* with a family member/sibling currently participating in Brighter Bites
* child is currently attending a school that offers Brighter Bites
Impact of Smoking Information on Concerns About Radon

Despite a push for tailored messages, health communications are often aimed at, and viewed by, people with varying levels of risk. This project examined-in the context of radon risk messages-whether information relevant to high-risk individuals can have an unintended influence on lower-risk individuals. Specifically, the investigators assessed whether information about lung-cancer risk from smoking reduced concerns about lung-cancer risk from radon among nonsmokers. The investigators hypothesized that non-smokers who read a message that included smoking-relevant information would express less concern about the effects of radon exposure and less interest in testing their home compared to those who read a version in which smoking-relevant information was excluded. Two studies were conducted. Although the investigators did not exclude smokers, the focus was on participants self-identifying as nonsmokers (including never smokers and former smokers).

Despite a push for tailored messages, health communications are often aimed at, and viewed by, people with varying levels of risk. This project examined-in the context of radon risk messages-whether information relevant to high-risk individuals can have an unintended influence on lower-risk individuals. Specifically, the investigators assessed whether information about lung-cancer risk from smoking reduced concerns about lung-cancer risk from radon among nonsmokers. The investigators hypothesized that non-smokers who read a message that included smoking-relevant information would express less concern about the effects of radon exposure and less interest in testing their home compared to those who read a version in which smoking-relevant information was excluded. Two studies were conducted. Although the investigators did not exclude smokers, the focus was on participants self-identifying as nonsmokers (including never smokers and former smokers). Participants in both studies were recruited through Amazon's Mechanical Turk (MTurk). Participants viewed radon messages that varied in the information they communicated about smoking's effect on lung cancer. In Study 1, smoking information was included or excluded from messages assembled from existing radon pamphlets. In Study 2, versions of a new radon message either excluded smoking information, described smoking as a major cause of lung cancer, or also described smoking's synergistic effect with radon on lung cancer risk. After viewing a radon health message, participants completed a variety of measures. Primary measures assessed respondents' anticipated sense of concern and related reactions if they learned that they/their home had been exposed to elevated levels of radon. Other key measures included questions about participants' interest and intention to test their home for radon.

Eligibility Criteria:
Inclusion Criteria:

* Live within the US
* Have an Amazon Mechanical Turk account (website where online study was posted)

Exclusion Criteria:

* None
A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Ascending Doses of AZD5069 in Healthy Volunteers

The purpose of this study is to explore the safety and tolerability of AZD5069 at steady-state, following twice a day oral dosing in healthy subjects.

AZD5069 is being developed by AstraZeneca and this study is being carried out on behalf of the sponsor by Quintiles Drug Research Unit at Guy's Hospital, London. This is the second time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy males and females at different dose levels over an 8-day dosing period. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body. It is planned that there will be up to 3 dose groups in the study and each group will consist of up to 12 volunteers, with 9 receiving the active drug and 3 receiving placebo. The study involves 3 visits over approximately 8 weeks, and will include 1 residential visit lasting 10 nights and a follow up.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg
* Healthy male or female (of non child bearing potential)volunteers with suitable veins for cannulation or repeated venepuncture

Exclusion Criteria:

* Subjects must not have any clinically significant disease or disorder, which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subjects ability to participate
* Subjects must not have any history of gastrointestinal, liver or kidney disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body
* Subjects must not have had any significant illness or medical/surgical procedures or injuries with 4 weeks of administration of the investigational product
Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286

This is a single arm prospective pilot trial that evaluates the ability of a novel imaging agent (68Ga-FAP-2286) to identify pathologic fibrosis in the setting of hepatic, cardiac and pulmonary fibrosis.

FAP-2286 is a peptide that potently and selectively binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on fibroblasts and has been shown to have higher expression in idiopathic pulmonary fibrosis (IPF), cirrhosis, and cardiac fibrosis.

PRIMARY OBJECTIVES:

I. All cohorts: Safety of 68Ga-FAP-2286.

II. Cohort 1: Measured uptake of radiotracer (SUVpeak) in regions of known liver fibrosis.

III. Cohort 2: Measured uptake of radiotracer (SUVpeak) in regions of known pulmonary fibrosis.

IV. Cohort 3: Measured uptake of radiotracer (SUVpeak) in regions of myocardial fibrosis.

EXPLORATORY OBJECTIVES:

I. Correlation of 68Ga-FAP-2286 uptake with FAP expression determined by immunohistochemistry.

II. Compare 68Ga-FAP-2286 scan results to archival Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET) images.

Patients will receive a single administration of 68Ga-FAP-2286 prior to PET imaging and will be followed for up to two hours after the injection of 68Ga-FAP-2286 for evaluation of adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years.
2. Confirmed pathologic fibrosis in one of the following cohorts

   1. Cohort 1: Hepatic fibrosis, based on cirrhosis on imaging or hepatic fibrosis on liver biopsy.
   2. Cohort 2: Pulmonary fibrosis, based on CT findings or biopsy of lung parenchyma.
   3. Cohort 3: High likelihood of cardiac fibrosis as indicated by known cardiac sarcoidosis or amyloidosis (shown on MRI or Fluorodeoxyglucose (FDG) PET), recent myocardial infarction within the last 30 days (as shown by an elevated troponin), known cardiotoxicity (decreased ejection fraction on systemic therapy), or other known inflammatory or infiltrative disease.
3. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
2. Known pregnancy.
BN Brachyury and Radiation in Chordoma

The goal of this study is to determine if the combination of BN-Brachyury plus radiation therapy can induce objective radiographic response rate (ORR) in patients, using a Simon 2-stage optimal design. In stage 1, a minimum of threshold of activity is needed to proceed to stage 2.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed chordoma
* Patients must have measurable disease by RECIST 1.1
* Patients must be scheduled to have radiation therapy to at least 1 target lesion.
* Age ≥12 years
* Patients must have normal organ and marrow function
* Must have recovered completely from any reversible toxicity associated with recent therapy.
* There should be a minimum of 2 weeks from any chemotherapy, small molecule/targeted therapy, immunotherapy and/or radiation prior to enrolment
* Females of childbearing potential and male partners of Females of childbearing potential must agree to use effective birth control or abstinence from screening to after the last vaccination therapy

Exclusion Criteria:

* Concurrent treatment for cancer, with specific exceptions noted in the inclusion criteria
* Chronic hepatitis B or C infection.
* Any significant disease, that in the opinion of the investigator may impair the patient's tolerance of trial treatment.
* Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding, or rendering of informed consent.
* Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment. This requirement is due to the potential risks of exacerbating autoimmunity.
* Concurrent use of systemic steroids, except for physiological doses of systemic steroid replacement or local steroid use.
* Patients who are receiving any other investigational agents within 28 days before start of trial treatment.
* History of allergic reactions attributed to compounds of similar chemical or biological composition to MVA-BN/FPV-Brachyury or other agents used in trial. History of allergic reactions to aminoglycoside antibiotic or egg products.
* Serious or uncontrolled intercurrent illness, included but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with trial requirements.
* Pregnant women are excluded from this trial due to the unknown effects of the BN-Brachyury on the fetus or infant.
* HIV-positive patients are ineligible because of the potential for decreased immune response to the vaccine.
* Significant cardiovascular disease, which includes but is not limited to New York Heart Association Heart Failure Class II or greater, myocardial infarction within the previous 3 months, unstable arrhythmias, unstable angina.
Study of the Relationship Between Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease

The purpose of this research study is to understand the relationship between inflammatory bowel disease (IBD) and Glycogen storage disease (GSD)type Ia. GSD type Ib has been established to have an association with IBD with clinical and histologic features that mirror those of Crohn disease. Development of the disease seems to be related to the defect of neutrophil function in individuals with GSD type Ib and subsequent colonic inflammation. In the last decade, it has become a standard for patients with GSD type Ib and gastrointestinal symptoms to be evaluated for IBD. Patients with GSD type Ia were not recognized to have similar gastrointestinal symptoms until recently. The prevalence of IBD is greater in patients with GSD type Ia versus the general population.

The purpose of this research study is to understand the relationship between IBD and GSD type Ia. The Investigators will be attempting to develop a blood test which will be aimed at the participants diagnosis of IBD.

As a participant in this research study, a blood sample will be collected during your admission to the University of Florida. This will not affect the length of stay of your scheduled visit. There will be no scheduled clinic follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Anyone with Glycogen Storage Disease type Ia

Exclusion Criteria:

* Anyone where the amount of blood needed to complete the Prometheus test exceeds 3ml/kg.
Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir

Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug.
* Minimum body weight of 50 kg and body mass index (BMI) of 18-30 kg/m2.
* Willing to comply with the study requirements and to provide written informed consent.

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.
* Abuse of alcohol or drugs.
* Use of other investigational drugs within 28 days of dosing.
* Concomitant use of prescription medications, or systemic over-the-counter medications.
* Other clinically significant medical conditions or laboratory abnormalities.
Safety and Efficacy of APD356 in the Treatment of Obesity

This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity.

The purpose of this study is to obtain preliminary assessment of the safety and efficacy of APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.

This is a double-blind, placebo-controlled, randomized, parallel group study. Three different doses of APD356 or placebo will be administered daily for 28 days, to uncomplicated obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.

Eligibility Criteria:
* Healthy male or nonpregnant, nonlactating females aged between 18 and 65 years (inclusive)
* Body Mass Index (BMI) of 30-45 Kg/m\^2.
* Non-smoker
* No concomitant medications
* No past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency