cyrilzakka/clinical-trials huggingface dataset:
TERPS Trial for De Novo Oligometastic Prostate Cancer

This research is being done to see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.

This study will compare the effects, good and/or bad, of using the standard of care treatment (systemic therapy + primary prostate radiation) compared to standard of care treatment plus stereotactic ablative radiation therapy (SABR) to metastatic lesions for prostate patients. The researchers are also trying to learn if the addition of SABR will affect recurrence rates. Presence of circulating tumor cells, gut bacteria, and quality of life will be assessed for both groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are seen on imaging. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or PSMA PET-CT scan.

   1. CT or MRI scan within 6 months of enrollment
   2. Bone scan within 6 months of enrollment
   3. Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months of enrollment (PET-CT scan is reasonable for study entry imaging as an alternative to CT/MRI scan and bone scan)
2. Histologic confirmation of malignancy (primary or metastatic tumor).
3. Patient may have had prior systemic therapy and/or ADT associated with treatment within 9-months of enrollment.
4. PSA \> 0.5 but \<100.
5. Patient must be ≥ 18 years of age.
6. Patient must have a life expectancy ≥ 12 months.
7. Patient must have an ECOG performance status ≤ 2.
8. Patient must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Castration-resistant prostate cancer (CRPC).
2. Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy
3. Spinal cord compression or impending spinal cord compression.
4. Suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis).
5. Patient receiving any other investigational agents.
6. Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist .
7. Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR.
8. No radiographical evidence of cranial metastasis.
9. Refusal to sign informed consent.
Efficacy of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colorectal Resection

Studies that have investigated different bowel preparations in patients with history of colorectal surgery are surprisingly lacking.Therefore, which is the best colon preparation in this subgroup of patients is still unknown. Polyethylene glycol (PEG)-based solutions are the most popular and safest bowel preparation regimens, however the 4-Liter volume is often poorly tolerated. More recently, it has been shown that the use of a low volume preparation (2-Liter PEG solution with the adjunct of a laxative, bisacodyl) achieves comparable bowel cleanliness rates to 4-Liter PEG in general population.The primary aim will be to compare the efficacy of 2-L mixed preparation (bisacodyl plus PEG) to 4-L PEG preparation.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients
2. ≥18 yrs old,
3. Prior history of colorectal resection due to colo-rectal cancer, referred for surveillance colonoscopy

Exclusion Criteria:

1. Inpatients
2. Emergency Colonoscopy
3. Comorbidities: Congestive heart failure, history of kidney disease, history of solid organ transplant
4. Pregnant and/or lactating women
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients with Solid Tumors

VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG2025, and recommended dose of VG2025 for Phase II trials.

This is a Phase 1, open-label, dose-escalation trial using standard 3+3 dose-escalation design in patients with advanced malignant solid tumors. The trial will be conducted in multiple dosing cohorts, and evaluated for safety to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). Dose limiting toxicity (DLT) evaluation period is for 4 weeks from the start of treatment Day 1 through Day 28.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent form.
2. Age 18 to 75 years (inclusive), male or female.
3. Subject with advanced malignant solid tumors who have failed standard treatment and for whom there is no effective treatment at this stage.
4. Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment.

Exclusion Criteria:

1. Subjects who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
2. Subjects who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.
3. In the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.
4. Other active uncontrolled infection.
5. Known alcohol or drug dependence.
6. Subjects with mental disorders or poor compliance.
7. Women who are pregnant or breastfeeding.
8. Subjects in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.
The Effects of Early Enteral Nutrition on Endoscopic Therapy of Esophagogastric Varices in Liver Cirrhosis

The purpose of this study was to evaluate the safety of early enteral nutrition on endoscopic therapy of esophagogastric varices in Liver Cirrhosis ,and to assess the impact of different eating times on patients, so as to determine the best time for patients to obtain nutrition after surgery.

For patients with gastroesophageal varices in Liver Cirrhosis,, there is no clear guideline and consensus on when to start eating after endoscopic treatment. In 2015, a randomized controlled study in Taiwan of China confirmed that compared with liquid diet given 48 h after endoscopic treatment, liquid diet given 4 h and started enteral nutrition would not increase the risk of rebleeding, and could improve the nutritional status of patients. However, some patients after endoscopic treatment would suffer from post-sternal pain, abdominal pain, nausea, vomiting and other discomforts, affecting appetite and delay the diet time. Based on the above research background, we observed and evaluated the safety and effectiveness of early enteral nutrition in patients with cirrhotic esophageal and gastric varices after endoscopic treatment, and analyzed the influencing factors of enteral nutrition in patients with cirrhotic esophageal and gastric varices after endoscopic treatment, so as to further clarify the optimal time for patients to eat after endoscopic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis of gastroesophageal varices undergoing endoscopic therapy

Exclusion Criteria:

* Endoscopic treatment of uncontrollable bleeding
* Accompanied with other endoscopic treatments that need to be fasting
* With obvious hepatic encephalopathy and liver failure
* Did not sign the informed consent form and refused to participate
Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer

This study is being done to determine the safety, biodistribution, and radiation dosimetry of 18F-DCFPyL, and to detect prostate cancer by visual analysis.

To assess the hypothesis that this new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, may possess pharmacokinetic and pharmacodynamic properties that will represent an advance in imaging metastatic prostate cancer in ten patients diagnosed with metastatic prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients may be enrolled into this protocol only if all of the following inclusion criteria are met:

  1. Greater than or equal to 18 years of age
  2. Histological confirmation of prostate cancer
  3. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, 18F-Sodium Fluoride PET, or 18F-FDG PET
  4. PSA ≥ 1.0 ng/mL
  5. Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.
  6. Platelet count \> 50,000/mm3
  7. Neutrophil count \> 1,000/mm3
  8. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
  9. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

* Patients will be excluded from enrollment if any of the following apply:

  1. Karnovsky performance status of \< 60
  2. Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
  3. Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants)
  4. Administered a radioisotope within 5 physical half-lives prior to study enrollment
  5. Serum creatinine \> 3 times the upper limit of normal
  6. Total bilirubin \> 3 times the upper limit of normal
  7. Liver Transaminases \> 5times the upper limit of normal
  8. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 30 days prior to study radiotracer administration
  9. Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest).
  10. Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma.
BIBR 1048 in the Prevention of Venous Thromboembolism in Patients Undergoing Primary Elective Total Hip Replacement Surgery

* To determine the therapeutic window of BIBR 1048 in order to select doses for further studies in the development plan.
* Twice daily regimen will be tested for most dose levels and once daily administration will also be evaluated when appropriate.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo a primary elective total hip replacement
* Male of female being 18 years or older
* Patients weighing at least 40 kg
* Written informed consent for study participation

Exclusion Criteria:

* Bleeding diathesis, constitutional or acquired coagulation disorders
* Major surgery or trauma (e.g. hip fracture) within the last three months. Patients with previous hip fractures associated with plate revisions at any time will be excluded
* Cardiovascular disease including uncontrolled hypertension at time of enrolment or history of myocardial infarction within the last 6 months
* Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks
* Known history of deep venous thrombosis (DVT)
* Gastrointestinal or pulmonary bleeding within the last year
* Known liver disease Aspartate transaminase (AST) or Alanine transaminase (ALT) \> 3 x ULN)
* Known renal disease (serum creatinine \> 1.5 x ULN)
* Use of long- term anticoagulants, antiplatelet drugs, or fibrinolytics within 7 days prior to hip replacement operation (also contraindicated during the period of prophylaxis)
* Women of childbearing potential
* Known allergy to radiopaque contrast media
* Known thrombocytopenia (prior platelet count below 100,000 cells/microliter)
* Active malignant disease
* Current H2 blocker or proton pump inhibitor treatment
* Current cytostatic treatment
* Treatment with an investigational drug in the past month
* Leg amputee
* Known alcohol or drug abuse
Understanding Decentralized Trial Engagement and Clinical Impediments Through Digital Efforts (UDECIDE) Among Unrepresented Groups With Poor Cardiovascular and Cardiometabolic Health

The objective of the UDECIDE study is to demonstrate adherence to decentralized clinical trials among underrepresented groups with cardiometabolic conditions .


Eligibility Criteria:
Inclusion Criteria:

* History of pre-diabetes/diabetes and/or pre-hypertension/hypertension
* History of Cardiometabolic risk factors including the following: hypertension, Coronary Artery Disease (CAD), heart attack, heart failure, stroke, atherosclerosis, arrhythmias, Peripheral Artery Disease (PAD), type 2 diabetes, metabolic syndrome, obesity, dyslipidemia, insulin resistance, or elevated cholesterol.
* Identify as Black or non-White Hispanic
* Own a smart phone

Exclusion Criteria:

* Does not meet inclusion criteria
Long-term Pleiotropic Effect of Statins in Patients With Peripheral Arterial Disease

The purpose of this study is to determine the long-term effects of statins, atorvastatin, upon Nitric Oxide, as an endothelial function assessment, and C-Reactive Protein, an inflammatory marker, levels in patients with Peripheral Arterial Disease. These long-term biological pleiotropic effects of statins will offer information on the role of endothelial function and systemic inflammation in the etiopathogenesis of PAD.


Eligibility Criteria:
Inclusion Criteria:

* patients at the time of diagnosis of Fontaine grade II peripheral arterial disease (PAD), confirmed by hemodynamic evaluation (Doppler ultrasound)
* over 18 years old

Exclusion Criteria:

* patients had previously undergone revascularization
* patients were receiving treatment with statins
* patients with contraindications to statin use.
* patients with coexistence of chronic inflammatory diseases or steroidal medication
Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients

The two primary goals of it's management are preventing further disease progression(mortality,hospitalizations and deterioration of left ventricular function)and alleviating patient suffering

Heart failure (HF) is emerging as an epidemic in 3rd world countries. Despite significant therapeutic advances, patients with chronic heart failure remain at high risk for HF progression and death. The two primary goals of its management are preventing further disease progression(mortality, hospitalizations and deterioration of left ventricular function)and alleviating patient suffering.Sacubitril /valsartan (previously known as LCZ696) is a first-in-class medicine that contains a neprilysin (NEP )inhibitor(sacubitril) and an angiotensin II receptor blocker (valsartan). NEP is an endopeptidase that metabolizes different vasoactive peptides including natriuretic peptides, bradykinin and Ang -II. In consequence, its inhibition increases mainly the levels of both natriuretic peptides (promoting diuresis, natriuresis and vasodilation) and Ang- II whose effects are blocked by the angiotensin receptor blocker, valsartan (reducing vasoconstriction and aldosterone release).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with heart failure (NYHA class II-IV).
2. LV EF(less than or equal to 40%).
3. eGFR (more than 30 ml/min /1.73m2).

Exclusion Criteria:

1. Symptomatic hypotension.
2. eGFR\<30 ml/min/1.73m2 .
3. Serum potassium \>5.2mmol/L
4. Angioedema
Polyp Histology Prediction by Artificial Intelligence

We have been developing artificial intelligence based polyp histology prediction (AIPHP) method to classify Narrow Band Imaging(NBI) colonoscopy images to predict the hyperplastic or neoplastic histology of polyps.

We plan to study colonoscopy polyp samples taken by polypectomy from 1200 patients.The documented NBI still images will be analyzed by the AIPHP method and by the NICE classification parallel.Our aim is to analyze the accuracy of AIPHP and NBI classification based histology predictions and also compare the results of the two methods.

Background:

Colonoscopy with polypectomy or early colorectal neoplastic lesions (polyp) is a proven and widely accepted method of reducing colorectal cancer mortality rates.

Predicting histology prior to endoscopic colorectal polyp removal is useful especially for diminutive (1-5mm) and small (6-10mm ) polyps.

Evaluation of colorectal polyps using the narrow-band imaging (NBI) technique and the NBI International Colorectal Endoscopic (NICE) classification are useful to predict the histology during endoscopy.However, NBI and magnification based polyp histology prediction needs training and endoscopic experience. Morever , the final and objective diagnosis still requires histology.

Therefore,we have been developing arteficial intelligence-based polyp histology prediction (AIPHP) software to automatically evaluate the magnified NBI colonoscopy images aiming the histology prediction of polyps.

Materials and methods:

We plan to examine 1200 colorectal polyps obtained from patients. Polyps will be removed by traditional polypectomy or with mucosectomy.Endoscopic procedures and histological examinations performed at the participation hospitals. Colonoscopy will be performed with Olympus EXERA III CFHQ190I (Olympus ,Tokyo,Japan) high reolution NBI colonoscopes providing 65x optical magnification. Colorectal polyps will be detected first by high definition colonoscopy then by NBI at the optical maximum magnification (65x). All studied polyps will be photo-documented. The stored NBI photos were anelyzed by the NICE classification and AIPHP parallel system.

Histological examination methods:

We use WHO classification of colorectal polyps. The two -class classification will considere hyperplastic or neoplastic ((SSLs,tubular or villous adenomas, and invasive adenocarcinomas).

AIPHP software systtem:

The AIPHP software is based on the categorization of the vascular pattern and color of the polyps.The main steps of AIPHP software development will be the following: 1) feature vector calculation 2) training of classifier module, and 3) AIPHP classifier testing. Five features will be used by our AIPHP software.

Eligibility Criteria:
Inclusion Criteria:

* colorectal polyps removed by polypectomy

Exclusion Criteria:

* colorectal polyps with IBD
Telehealth Pilot for Veterans with Chronic Multi-Symptom Illness.

The objective of this pilot study is to examine the feasibility, safety, and acceptability of a telehealth meditation and physical activity (MAP) intervention among Veterans with chronic multi-symptom illness.

This pilot study innovatively merges with ongoing clinical practice at the War Related Illness and Injury Study Center to explore the utility of new VA technologies and distance-bridging approaches for administering a remote intervention that promotes health behaviors (e.g., physical activity and meditation, called mental and physical training or MAP). Not only does this study intend to examine the feasibility of using these tools within the home setting and integrating these practices into the weekly lives of Veterans, but it also aims to determine the best way to administer this type of intervention by comparing a directed MAP (dMAP) intervention arm to a self-guided MAP (sgMAP) intervention arm. Understanding how much guidance to provide Veterans during their path towards recovery is important since we hope that this pilot study will offer not only evidence that these practices can be administered without supervision but also reveal that giving Veterans the right tools (exercise and meditation app on tablet), guidance (directed text message or holistic goals), and support (video-chat health coaching) can have measurable benefits on symptom severity and function.

Eligibility Criteria:
Inclusion Criteria:

* Previously deployed Veterans
* Experiencing Chronic Multisymptom Illness defined using the Fukuda criteria.
* Able to engage in physical activity
* Has a smart phone
* Co-enrolled in the WRIISC Data Repository Study

Exclusion Criteria:

* Excessive alcohol consumption (AUDIT Score \>= 4 (men); AUDIT Score \>= 3 (women))
* Current or previous drug use past 90 days.
* Current prominent suicide or homicidal ideation
* Recent exposure to trauma
* Acute or unstable illness
* Dementia or significant cognitive impairments
Radial Reload Laparoscopic LAR Case Series

To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary endpoints.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is able to understand and sign Informed Consent Form.
2. The subject is between 18-85 years of age.
3. The subject is anticipated to undergo a resection of the rectum with anastomosis below the peritoneal reflection.
4. The subject is anticipated to undergo mobilization and stapling of the rectum laparoscopically.

Exclusion Criteria:

1. Any female patient, who is pregnant, suspected pregnant, or nursing.
2. The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
3. The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.
Tolerability and Pharmacokinetics of Lacidipine With and Without the Co-administration of Telmisartan in Female and Male Healthy Subjects

The objectives of this study are to compare the steady state pharmacokinetics of lacidipine with and without the co-administration of telmisartan and to compare the steady state pharmacokinetics of telmisartan with and without the co-administration of lacidipine


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female Caucasian subjects as determined by results of screening
* Written informed consent in accordance with Good Clinical Practice and local legislation given
* Age \>= 18 and \<= 50 years
* Broca \>= -20% and \<= + 20%

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (\<= 1 month prior to administration or during the trial)
* Use of any drugs which might influence the results of the trial (\<= 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= 2 months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60g/day)
* Drug abuse
* Blood donation \> 100 ml (\<= 4 weeks prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance
* Female only:

  * no reliable contraception (reliable are: oral contraceptives, 3-month injection, Intrauterine devices (IUD), sterilization)
  * Pregnancy or breast feeding period