cyrilzakka/clinical-trials huggingface dataset:
Radiofrequency Ablation in Treating Patients With Liver Cancer (Hepatocellular Carcinoma)

This phase II trial studies how effectively radiofrequency ablation prevents recurrence of hepatocellular carcinoma (HCC) in patients with easily removable tumors. Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven HCC or unambiguous radiologic findings consistent with HCC (\> 1 cm tumor with arterial hypervascularity and venous or delayed phase washout) in patients with underlying liver disease.
* Disease must be considered unresectable (as defined by protocol).
* Age between 18 and 69 (inclusive).
* Karnofsky performance status of ≥ 80%
* Normal organ and marrow function as defined below:
* leukocytes ≥3,000/mcL
* absolute neutrophil count ≥1,500/mcL
* platelets \>100,000/mcL
* total bilirubin \<2.0 mg/dL
* AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
* creatinine within normal institutional limits OR
* creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
* Presence of ≤ 3 tumors, all of which are ≤ 3 cm in size. This will be determined preoperatively and confirmed by intraoperative ultrasound.
* Liver function of Child-Pugh class A or B
* Tumor(s) must be more than 2 cm away from of major biliary duct or major blood vessel defined as the main portal vein and its right and left primary branches and the first 1 cm of the secondary branches of the common hepatic duct and its right and left primary branches or the first 1 cm of its secondary branches.
* Able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Hepatic tumor(s) with satellite lesions. A satellite lesion is defined as a tumor which is within 2 cm of the tumor being assessed for treatment and which has a diameter of less than 33% of the diameter of the tumor being assessed for treatment.
* Evidence of metastatic/extrahepatic disease based on abdominal and chest CT performed within 4 weeks of the procedure.
* Extrahepatic disease upon laparoscopy performed at the time of RFA. If extrahepatic disease is discovered at this laparoscopy, RFA will not be performed, and the patient will be considered ineligible for this study and will be replaced.
* Pregnancy. All women of childbearing potential must have a negative pregnancy test prior to enrollment in the study.
* Significant portal hypertension based on evidence of esophageal varices or ascites. Minimal portal hypertension or ascites will not be an exclusion criterion.
* Previous history of HCC or any other non-cutaneous malignancy.

Patients who are found to be ineligible due to intraoperative findings will be recorded as to the cause of ineligibility. They will not be counted as accrued patients.

-Inclusion of Women and Minorities Both men and women and members of all races and ethnic groups are eligible for this trial.
Early Detection of Anaemia During the Maternity

Estimate the efficiency of a strategy of premature screening of the maternal anaemia during the first quarter of pregnancy versus the usual strategy of screening of the anaemia during the sixth month.

A part of the patient will have a NFS and dosage of the cast-iron, during the results of the beginning of the pregnancy at the first quarter.

The other part of the patients will have a NFS and at the first quater of the pregnancy.

All the patient will have a NFS at the results of the sixth month of the pregnancy.

A NFS will be done during the results at the end of the pregnancy like we do now.

Then a NFS at 48 hours after the birth. A treatment with iron will be done and according to the results

Eligibility Criteria:
Inclusion Criteria:

* Every patient followed at the HME at the beginnig of the pregnancy

Exclusion Criteria:

* pregnency women who don't speak french
* pregnancy women affected by béta thalassemia
* pregnancy woman having had a périconceptionnel treatment against the anaemia
Increased Salt Intake in Healthy Men

To study the effects of an increased salt intake on metabolic, cardiovascular and immunoregulatory functions in healthy men.


Eligibility Criteria:
Inclusion Criteria:

* body mass index 18.5 - 29.9 kg/m2

Exclusion Criteria:

* clinically relevant heart, lung, liver, and kidney diseases
Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia

Phase III trial evaluating the role of autologous stem cell transplantation in previously untreated patients under 65 years with stage B and C B-cell chronic lymphocytic leukemia.

Endpoints of the trial :

* major : progression free survival at 3 years
* secondary : overall survival, tolerance, prognostic factors according to baseline clinical stage and biological characteristics (IgHv mutational status, expression of ZAP70 and CD38, cytogenetics).

All registered patients will be treated with 6 monthly courses of chemotherapy. First three ones will be a CHOP regimen with half dosage of adriamycin, as previously published (Effectiveness of "CHOP" regimen in advanced untreated chronic lymphocytic leukemia. French Cooperative Group on Chronic Lymphocytic Leukemia. Lancet ; 1986, i : 1346-1349), followed by three subsequent courses with IV fludarabine (25 mg/sqm d1-5). Patients in CR (NCI, 1996, including CAT scan evaluation) will be then randomized to surveillance without additional treatment or autologous stem cell transplantation using peripheral stem cells collected after the three first courses of chemotherapy, and/or after the completion of the six courses when necessary. For patients not in CR after the six courses, a rescue regimen with the DHAP association ( cisplatin, 100 mg/sqm d1, cytarabine 2 g/sqm d2, dexamethasone 40 mg/sqm d1-4) will precede an additional stem cell collection if necessary, and patient will be randomized between autologous stem cell transplantation and three additional courses of an association of fludarabine (25 mg/sqm d1-3) and cyclophosphamide (300 mg/sqm d1-3). Conditioning regimen will associate TBI (10 grays, d -3-1) and cyclophosphamide (60 mg/sqm d-5-4).

Evaluation for response wil be performed before randomisation and two months after completion of therapy in each arm.

Follow-up data will be registered and monitored every three month during the first year, and then every six month. Criteria for evaluation of response will use the NCI system (1996).

Eligibility Criteria:
Inclusion Criteria:

* patients with stage B \& C CLL, 18- 65 years.
* previously untreated
* given written informed consent

Exclusion Criteria:

* Childbearing women
* OMS Performance status \> 2
* Binet stage A
* Autoimmune hemolytic anemia
* Active or previous (\< 5 years) malignant disease, except cutaneous cell carcinoma.
* Previous CLL treatment
* HIV seropositivity
* Abnormal renal or liver function tests (creatinine \> 1,5N, transaminases \> 2N, bilirubin \> 1,5N)
* Cardiac failure (ejection fraction \< 50%)
* Lung disease or perturbed ventilation tests
Artificial Intelligence-enhanced Electrocardiogram Diagnoses and Predicts Future Regurgitant Valvular Heart Diseases

This is a retrospective study to establish models for the prediction of future valvular heart diseases with artificial intelligence-enhanced electrocardiogram (ECG).


Eligibility Criteria:
Inclusion Criteria:

* Subjects that received ECG and echocardiography tests during a date frame.

Exclusion Criteria:

* Subjects who is younger than 18 years of age.
Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer

Create a living biobank of PDOs from Stage I-III lung cancer patients.

Creation a living biobank of PDOs from Stage I-IV lung cancer patients (n=50). We selected enrollment of at least 50 patients so that they can be risk stratified based on lung tumor type, staging and we plan to store these PDOs in biobank for future experiments. For each patient, tumor specimens will be collected at time of their surgery. No specific therapeutic intervention or treatment is provided as part of this study.

1. Establishment and culture of PDOs from lung cancer tumor specimens. PDOs will be biobanked for future experiments.
2. Lung organoids and CTCs will also be cultured and used to study baseline tumor characteristics using histology, immunohistochemistry, atomic force measurements; as well as, oncogenic signaling pathways and proteomic profile of lung organoids and CTCs derived from lung cancer patients (n\>50).
3. Patient demographic information and data to be collected using a patient survey data sheet with treatment and survival history collected at pre-defined time period per the protocol schedule.

Eligibility Criteria:
Inclusion Criteria:

* Read, consented to and signed the IRB-approved informed consent form prior to any study related procedure.
* Diagnosis of lung cancer or lung mass or lymphadenopathy that will either systemic treatment or tumor resection as part of standard of care
* Any clinical stage of lung cancer
* Adult patients ≥18 years of age
* Able and willing to complete a questionnaire on their environmental/occupational exposures and smoking/alcohol history

Exclusion Criteria:

* At the discretion of the treating physician, patient will not be able to fulfill the requirements of the study.
Sugar Sweetened Beverage Intake and Biomarkers of Cardiometabolic Risk in US Women

This study is a secondary analysis of data collected in the Nurses' Health Study (NHS) that will evaluat the association between intake of sugar sweetened beverages (SSB), juice and artificially sweetened beverages in relation to biomarkers of hepatic function, lipid metabolism, inflammation and glycemic control.

The investigators will analyze cross-sectional data from 8,492 participants in the Nurses' Health Study who were free of diabetes and cardiovascular disease to evaluate the association between intake of sugar sweetened beverages (SSB), juice and artificially sweetened beverages (ASB) and biomarkers of hepatic function, lipid metabolism, inflammation and glycemic control. Biomarkers were measured from blood samples that were collected in 2 cycles, approximately 10 years apart.

Specifically, multivariate linear regression will be used to assess the associations of SSB, ASB, and fruit juice intake with concentrations of fetuin-A, alanine transaminase, gamma-glutamyl transferase, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol, C-reactive protein (CRP), intracellular adhesion molecule 1 (ICAM-1), vascular cell adhesion protein 1 (VCAM-1), adiponectin, insulin, and hemoglobin A1c as well as total cholesterol/HDL-C ratio.

Eligibility Criteria:
Inclusion Criteria:

For the current study, we included participants who provided a blood sample and were previously selected as controls for nested case-control analyses of type 2 diabetes, coronary heart disease, stroke, colon cancer, colon polyps, pancreatic cancer, and breast cancer in the Nurse's Health Study.

Exclusion Criteria:

Participants with self-reported prevalent diabetes or cardiovascular disease (CVD) at blood draw were excluded. After exclusions, a total of 8,492 individuals (6,961 from cycle 1 and 1,531 from cycle 2) with valid beverage intake data were included in the current analysis.
Surgical and Refractive Outcomes of Combined Glaucoma Surgery

The aim of the study is to examine surgical and refractive outcomes of glaucoma combined surgery in six months period of follow up

Trabeculectomy and implantation of the Ex-Press device belong to the same group of anti-glaucoma procedures improving subconjunctival outflow. The most frequently performed glaucoma surgery of choice is still trabeculectomy, although the less invasive implantation of the Ex-Press device is also an effective alternative. Despite the wide application of these two techniques, their impact on postoperative refraction is not entirely known. Quite often, in the early postoperative period there is a decrease in visual function, which is short-term, although there are reports that it can last up to a year after surgery. It can be caused by a reduction in IOP, as well as the direct effect of trabeculectomy on corneal topography, and thus on postoperative astigmatism and refractive error. The occurrence of astigmatism after trabeculectomy has been widely documented Combined operations of implanting the ExPress implant with cataract phacoemulsification differ from phacotrabeculectomy in that, they do not require cutting of the sclera, cutting the limbus and using a punch.

The purpose of our research was to compare the phacotrabeculectomy and phacoemulsification combined with Express device implantation in terms of incidence of postoperative astigmatism in a prospective randomized study, and to attempt to determine what factors determine its size.

Eligibility Criteria:
Inclusion Criteria:

* Glaucoma with coexisting cataract graded Nuclear-Cortical 1 (NC1) and Nuclear-Cortical 2 (NC2), according to the The Lens Opacities Classification System III (LOCS III scale), was an indication for surgery.
* Patients with primary open-angle glaucoma (POAG), pseudoexfoliation glaucoma (PXG) and pigmentary glaucoma (PG), in which satisfactory intraocular pressure (IOP \>21 mmHg) was not achieved despite maximally-tolerated topical and systemic medication, were qualified for treatment.
* Additional inclusion criteria were as follows: well documented progression of visual field defects, significant diurnal variations in the IOP, poor patient compliance, and allergy to topical drugs.

Exclusion Criteria:

* Lack of consent to participate in the study,
* History of eye surgery or laser procedures within the eye,
* Closed or narrow angle glaucoma,
* Diabetes,
* Advanced macular degeneration
* Active inflammatory disease.
A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy

To evaluate the efficacy and safety of azithromycin given chronically for the treatment of serious nontuberculous mycobacterial infection in patients failing or intolerant of other available therapy.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Other antimicrobial drugs as long as documented on Case Report Form.

Patients must have:

* Serious nontuberculous mycobacterial infection.
* Approval of eligibility from Pfizer Clinical Monitor. Patients below the legal age of consent must have consent of parent or guardian.

NOTE:

* Pregnant women, women of childbearing potential, and children will not be specifically excluded from participation. However, patients and physicians should be aware that the safety of azithromycin during pregnancy and in long-term use in children and adults has not been established. The risks and benefits of azithromycin use in these patients will be considered in consultation with the physician and the Pfizer Clinical Monitor.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Disseminated Mycobacterium avium complex (MAC) who are eligible for treatment with azithromycin under protocol 066-162.
* Known hypersensitivity or intolerance to macrolide antibiotics.

Patients with the following prior conditions are excluded:

History of hypersensitivity or intolerance to azithromycin.
Bevacizumab (Avastin) in Unresectable/Recurrent Hemangioblastoma From Von-Hippel-Lindau Disease

Von Hippel-Lindau (VHL) disease is an inherited syndrome manifested by a variety of benign and malignant tumors. Hemangioblastomas are the most common lesion associated with VHL disease affecting 60-84% of patients with a mean age at diagnosis of 29 years. Standard treatment for this disease is by surgery or radiotherapy. No approved systemic therapy yet exists. Patients with VHL have an increased growth factor production, specifically vascular endothelial growth factor (VEGF), resulting in angiogenesis (growth of blood vessels). Studies show that Bevacizumab inhibits the growth of VEGF protein and will block the VEGF-driven angiogenesis and result in stabilization and regression of hemangioblastomas in VHL disease patients. The dose of bevacizumab will be 10 mg/kg every two weeks for up to 6 months.


Eligibility Criteria:
Inclusion Criteria:

* One or more CNS hemangioblastomas not amendable to surgical resection or recurrent post resection
* Confirmed diagnosis of von-Hippel-Lindau disease
* No prior treatment with VEGF inhibitors
* Index hemangioblastomas lesion at least 5mm on MRI
* No major bleeding event from hemangioblastoma within 90 days
* KPS \> or equal to 60%
* Age \> or equal to 18 years

Exclusion Criteria:

* Prior treatment with VEGF inhibitors
* Major bleeding event from hemangioblastoma within 90 days
* Inability to comply with study and/or follow up procedures
* Life expectancy of less than 12 weeks
* Current or recent (within 4 weeks of the first infusion of this study) participation in an experimental drug study other than a Genentech sponsored bevacizumab cancer study
* Active malignancy will be permissible if treating physician deems that concurrent administration of bevacizumab is not contraindicated and that the patient would be able to complete with the other parameters of the protocol
A Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Postmenopausal Women

The use of dietary amino acids has been explored for therapeutic and safety intervention of obesity and obesity-induced dysfunction. In particular, 3 molecules have been shown to be effective both in the animal model and in humans, in promoting the loss of fat mass, specifically visceral adipose tissue, and in maintaining free fat mass: arginine, glutamine and leucine (and its metabolite beta hydroxy methyl butyrate, HMB). The aim of this study was to evaluate the efficacy in terms of fat mass, in particular Visceral Adipose Tissue reduction, as primary end point, in obese patients following the administration of specific food for special medical purposes (FSMP) for muscle recovery, consisting of arginine, glutamine and HMB. The secondary end point is the evaluation of skin state, by a validate self-reported questionnaire survey to assess skin, after 4- weeks intake of this FSMP.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopause
* Obesity (I class) or overweight

Exclusion Criteria:

* Taking any medication
* Having liver, renal and thyroid disease
* Smoking
* Drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
The Microenvironment in Barrett's Esophagus

This study aims to elucidate the relationship between the microbiome, inflammation, and the microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the end goal of developing a non-endoscopic testing strategy based on pathogenic factors to identify patients at highest risk for EAC. To accomplish this the investigators will enroll 100 patients with known BE (50 with dysplasia or EAC) and 50 subjects without BE undergoing upper endoscopy. Prior to endoscopy each subject will undergo three minimally invasive potential screening and surveillance tests: saliva (oral microbiome), breath test (exhaled volatile organic compounds), and tethered capsule sponge sampling (methylated DNA markers). The study will evaluate these novel tests in combination with clinical and anthropometric factors to describe an optimal strategy for BE screening and monitoring.

The investigators will perform a multi-center cross-sectional study of patients with Barrett's esophagus, with and without associated dysplasia or cancer, and controls without BE. Enrollment of controls will be stratified based on use of proton pump inhibitors (PPIs). The investigators plan to enroll an approximate total of 150 subjects:

100 BE patients (with or without associated dysplasia or cancer)

* 50 subjects with non-dysplastic BE
* 50 subjects with BE and dysplasia or EAC

  50 controls
* 25 controls on PPIs (at least once daily)
* 25 controls not taking PPIs

Various tests will be performed and samples collected on the day of endoscopy. These tests include: saliva samples, electronic nose device testing, tethered capsule sponge testing, dietary questionnaires, and collection of blood and gastrointestinal biosamples. Analyses of this data and samples will then be performed to address the specific aims above.

Eligibility Criteria:
Inclusion Criteria:

(for BE patients)

* History of histologically confirmed BE, defined as endoscopically-suspected BE with intestinal metaplasia with goblet cells on esophageal biopsies
* BE length M≥2
* Taking proton pump inhibitors at least once daily for 3 months prior to enrollment
* Age ≥18

Exclusion Criteria:

* History of gastric cancer or esophageal squamous cell cancer
* History of gastric or esophageal surgery
* Use of antibiotics or systemic immunosuppressants within three months prior to the date of endoscopy (intranasal and inhaled steroids are allowed)
* Known untreated esophageal stricture or uninvestigated dysphagia
* Inability to give informed consent
* (BE patients only) History of prior endoscopic therapy for BE except a history of prior endoscopic mucosal resection (EMR) of focal lesions without subsequent ablative therapy is permitted
CREST-2 Long-term Observational Extension Study

The purpose of this Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial (C2LOE - ClinicalTrials.gov Identifier: NCT02089217) study is to study is to assess post-procedural efficacy of carotid endarterectomy and carotid stenting.

Atherosclerotic plaque in the carotid arteries is responsible for 10 to 15% of all ischemic strokes. The ongoing NINDS-funded CREST-2 multicenter randomized clinical trial is testing whether in the short term (up to 4 years after study entry) procedural revascularization improves stroke prevention above and beyond what can be achieved with intensive medical management of vascular risk factors, especially hypertension and hyperlipidemia. Our proposal is for an observational extension of the CREST-2 clinical trial to test whether revascularization improves stroke prevention in the clinically relevant long term (up to 8 to 10 years). The current application proposes to use a site-less, centralized telephone approach to extend the follow-up of CREST-2 trial participants for assessing the primary study outcome (stroke) for up to 10 years. The average follow-up will increase from between 2-3 years (clinic-based randomized trial) to 7-8 years (observational extension). Each patient will be contacted by telephone at 6-month intervals, and queried regarding all hospitalizations since the last contact. Suspected stroke events will be adjudicated by an expert clinical events committee based on medical record review.

Eligibility Criteria:
Inclusion Criteria:

* Currently active or graduated participants in the CREST-2 randomized trial
* Able to provide written informed consent by self
* Fluent in English or Spanish

Exclusion Criteria:

* Unable to provide written informed consent
* Inability to follow study procedures
Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum

The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.


Eligibility Criteria:
Inclusion Criteria:

* An established diagnosis of pyoderma gangrenosum
* Currently experiencing an inflammatory episode of pyoderma gangrenosum
* Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

* Clinical evidence of acutely infected pyoderma gangrenosum
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent or chronic systemic infections
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply