cyrilzakka/clinical-trials huggingface dataset:
Omentectomy in Radical Gastrectomy for Gastric Cancer Trial

In patients with gastric cancer, traditionally a complete omentectomy is performed as part of a radical gastrectomy with a modified D2 lymph node dissection. The omentectomy increases operation time significantly, especially in laparoscopic procedures. Patients remain more vulnerable for peritoneal infections and intestinal adhesions following omentectomy. Furthermore one can debate whether a complete omentectomy is indicated from an oncologic viewpoint. In the present study we prospectively evaluated the presence of tumor load in the greater omentum of patients with potentially curative gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* an in potentially curative gastric cancer
* age \> 18 year

Exclusion Criteria:

* palliative resection
* age \< 18 year
Risk of Hepatocellular Carcinoma in Patient With Liver Cirrhosis

Purpose of the study is to determine transcriptomics, metabolomics and proteomics features of liver cirrhotic tissue in patients with hepatocellular carcinoma (HCC) and to find a correlation with the risk of developing HCC and survival.

Patients will be enrolled after hepatic ultrasonography control and they will be submitted to hepatic vein pressure gradient and liver biopsy.

The study have four research lines:

Task # 1: transcriptomic characterization of liver tissue. During hepatic vein pressure gradient , liver tissue will be extracted with transjugular catheter equipped with a biopsy device. Tissue will be used to extract microRNA to define molecular signature.

Task # 2: Proteomic characterization of liver tissue. Protein expression changes will be analyze with MALDI-TOF

Task # 3: Metabolomic features on serum of patient with cirrhosis. Metabolomics is defined as the quantitative measurement of the dynamic multiparametric response of living systems to pathophysiological stimulus or genetic modification. Principal objective of this activity will be identify metabolites deregulated with metabolomic approach and clarify any new pathways involved in the evolution of cirrhosis to hepatocellular carcinoma.

The metabolomic analysis will be performed on sera collected in patients with cirrhosis at baseline.

Task # 4: Transcriptomic characteristics of newly diagnosed HCC. New diagnosis of hepatocellular carcinoma will undergo an eco-assisted liver biopsy. A tissue sample will be dedicated to the extraction of 'RNA. Patients will then undergo elective treatment according to international guidelines. The course of the disease and the results of therapeutic interventions will be recorded and correlated with the molecular data. Molecular signature will be obtain.

Eligibility Criteria:
Inclusion Criteria:

* Obtaining written informed consent
* Liver cirrhosis
* Aged between 18 and 75 years
* Absence of exclusion criteria

Exclusion Criteria:

* HCC
* HIV
* Pregnancy
* Portal vein thrombosis
* Liver Transplant
* Patients' refusal to participate in clinical research
AMG 714 Expanded Access Program

Expanded access requests for AMG 714 may be considered for adult patients with biopsy proven Refractory Celiac Disease Type II who have failed all available treatment options and do not have EATL. To request access, use Responsible Party contact information provided in this record.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Alternate Dosing - Initiation of Every 2 Week Epoetin Alfa (PROCRIT) in the Treatment of Anemia.

The purpose of this study is to evaluate the hemoglobin response rate in subjects with anemia, associated with chronic kidney failure, after receiving epoetin alfa (PROCRITÂ®) every 2 weeks

This is a prospective study in non-dialysis subjects with anemia associated with chronic kidney disease. Subjects will be enrolled from multiple centers in the United States. The primary objective of the study is to evaluate hemoglobin response rate. The secondary objectives include evaluating the time to when hemoglobin responds, indicated by the results of the hemoglobin blood levels, the change in hemoglobin over time, the transfusion requirements and change in quality of life measurements. These measurements asks for the subjects views about how one feels, activity and energy level, etc. The subjects are administered study drug every 2 weeks through Study Week 27 unless dosing is held or the subject withdraws from the study. Each injection of study drug should not exceed 1 ml in volume.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic kidney disease and a glomerular filtration rate within 10-60 ml/min/1.73m2 with no expected need for dialysis during the study
* subjects with a hemoglobin less than 11 g/dL
* subjects who have not received erythropoietic agents within 6 weeks before study entry
* female subjects, with a reproductive potential, must have a negative urine pregnancy test within 7 days of the first dose of study drug.

Exclusion Criteria:

* Subjects with poorly controlled high blood pressure (hypertension) - systolic \> 150 mm Hg or diastolic \> 100 mm Hg
* known hypersensitivity to human albumin and/or mammalian cell-derived products
* subjects receiving dialysis
* subjects with a ferritin level \< 50 ng/mL, Transferrin Saturation \< 20%
* subjects receiving chemotherapy for cancer within 1 month prior to study start or expected during study participation
* Pregnancy or lactation.
Energy Expenditure and Substrate Utilization During Acute Under- and Over-feeding

This study will determine the impact of 24, 48 and 72 hours of over and underfeeding on energy expenditure as measured in the metabolic chamber at the UNC Chapel Hill Nutrition Research Institute (UNC NRI).

Subjects will complete a baseline eucaloric study day. Following this, subjects will be randomized to complete 3 days of overfeeding (150% of baseline eucaloric energy requirements) or 3 days of underfeeding (50% of baseline eucaloric energy requirements). After completing one of these study arms, subjects will cross-over and complete the second arm. All study arms will be separated by two weeks. 24-hour energy expenditure will be measured 3 times during each of 3 day periods. We hypothesize that the impact of over or underfeeding on EE will be evident after 24-hours and will be comparable to 72 hour EE.

Eligibility Criteria:
Inclusion Criteria:

* Woman
* Postmenopausal
* Aged 50-65 years
* BMI 25-35kg/m2
* Not taking blood pressure or anti-inflammatory medications or any other medications that may impact the results
* Thyroid hormone profile within the normal reference range
* No medical condition which may impact the results (e.g. diabetes)
* Accustomed to eating regular meals including breakfast

Exclusion Criteria:

* Smoker
* Heavy exerciser (defined as \>150 minutes/week for more than 3 months)
* Abuses alcohol or drugs
* Vegetarian
Skeletal Muscle Energetics and Fatiguability in Older Individuals

The investigators are studying whether metabolic abnormalities in calf (leg) muscle in older people with and others without HIV are associated with decreased abilities to exercise.

This research is being done to better understand why some older people living with HIV experience more fatigue and difficulty exercising than older people without HIV. This is important because fatigue and problems exercising are predictors of disability and hospitalization in older individuals. We will use non-invasive magnetic resonance imaging (MRI) and spectroscopy (MRS) of the leg muscle to measure muscle metabolites and fat content, as well as blood samples measures levels of inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are \>= 60 years of age
* HIV serostatus positive participants on stable antiretroviral therapy (ART) (no regimen change in last month) with undetectable HIV viral load (\<100 copies).
* HIV serostatus negative participants

Exclusion Criteria:

* Unable to understand the risks, benefits, and alternatives of participation and give meaningful consent
* Contraindications to MRI
* Significant cardiovascular, pulmonary or musculoskeletal or orthopedic disease that significantly limits exercise capacity
* Significant lower extremity peripheral vascular disease.
* Weight greater than 350 lbs
* Cognitive or speech impairments that would limit completion of questionnaires or fatigue reporting.
Perioperative Epidural Trial (POET) Pilot Study

To investigate if the use of perioperative neuraxial blockade reduces post-operative mortality and cardiorespiratory events compared to intraoperative general anesthesia AND postoperative IV narcotic analgesia. This is a feasibility study to determine if recruitment and execution of the protocol could be done in a timely manner in a much larger trial


Eligibility Criteria:
Inclusion Criteria:

Subjects at high risk of cardio-respiratory complications post operatively.

Exclusion Criteria:

Contraindication to epidural anesthesia
Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa

This multicentre, randomised, double-blind, 2-parallel group, controlled trial aims to investigate whether oral milk protein supplements led to increase in serum Insulin-like Growth Factor-I levels (IGF-I) as compared with a control group fed with an iso-caloric supplement, in women with anorexia nervosa. Subjects receive either 150g/day of tested product or control product for 4-week, followed by a 4-week follow-up.

Study centres: 4 active centres in France and 2 active centres in Switzerland

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 to 40 years (bounds included).
* Women with a serum IGF-I level below the 25th percentile of the reference value according to the age (bounds included).
* Women who had given written inform consent.
* Women with DSM-IV-confirmed anorexia nervosa lasting for at least 6 months. Women with concomitant binge eating and purging type are also included.
* Women admitted in-hospital for weight and nutritional rehabilitation. It is anticipated that the patient will stay in-hospital during the full duration of the 4-week supplementation phase, and at least 5 weeks within the study.
* Women being already regular consumers of dairy products.
* For women with childbearing potential, use of a contraceptive method.
* Discontinuation of any mineral and vitamin supplements containing calcium and vitamin D, 1 week before starting the product consumption and during the study.

Exclusion Criteria:

* Women with primary amenorrhea;
* Women with lactose intolerance;
* Women with any other metabolic disease that could affect bone metabolism: osteogenesis imperfecta, Paget's disease of bone, hyperthyroidism, primary hyperparathyroidism;
* Women with current or past neoplasm;
* Women with any other severe comorbidity;
* Pregnant or breast feeding women;
* Women with epilepsy;
* Women with any current or past use of the following treatments: bisphosphonates, calcitonin, steroids;
* Patients enrolled in another clinical study within the last 4 weeks;
* Patients having already received oral nutritional supplements or who need to receive other oral or intravenous (IV) supplements during the follow-up;
* Patients having received oral or IV nutritional supplements within two weeks before the inclusion;
* Patients having willed to participate in another clinical study during the present study phase and 4 weeks after the end of their participation in the present study.
The Influences of Dialysate Bicarbonate Concentrations on Hemodialysis Patients

Background:

Patients with decreased kidney function are in the positive acid balance due to insufficient renal acid excretion. To correct the varying degrees of metabolic acidosis in these HD patients, a high concentration of HCO3 in the dialysate is routinely used.

During every 3-to-4 hours of HD treatment, a massive surge of HCO3 would enter the circulation and typically overcorrects predialysis acidosis to alkalosis and alkalemia.

The sharp acid-base shift can cause some adverse consequences.

The investigators believe that the rapid correction (or overcorrection) from the pre-dialysis metabolic acidosis to post-dialysis metabolic alkalosis during the 3-to-4 hours HD treatment would relate to adverse effects on HD patients.

Thus the investigators conduct this study to prove the hypothesis that "prevention of post-dialysis alkalosis by using lower dialysate HCO3 concentration might cause less adverse outcomes in ESRD patients on HD."

Study design:

Prospective cross-over case-control study.

Study population:

A total of 60 patients who receive regular hemodialysis (three times per week) for more than 6 months in the regional teaching hospital.


Eligibility Criteria:
Inclusion Criteria:

* adult uremic patients who received hemodialysis thrice weekly

Exclusion Criteria:

* Hospitalized patients
* Patients newly initiated on HD (\<6 months)
* Patients with HD access problems
* Patients recently discharged from the hospital (within one month).
* Patients on chemotherapy for cancer.
* Patients with a kidney transplant.
* Patients on steroids or other immunosuppressive therapy.
* Patients with recent surgery (within one month)
* Patients with an active bacterial infection.
* Patients with decompensated cirrhosis.
Effect of Oxytocin Nasal Inhalation on Empathy Analgesia

This study recruited healthy volunteers and randomly divided them into four groups. They inhaled oxytocin or saline, and watched a pain test video with photos of acquaintances or strangers, respectively, to test whether their feelings of the same thermal pain stimulus had changed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* During pregnancy;
* Have participated in any research related to pain;
* Sleep disorders;
* Used alcohol, caffeine, nicotine, or other psychoactive substances within 24 hours before the test;
* Experienced intense pain requiring medical analgesia within three months prior to the trial;
* Taking any medication, including over the counter medication;
* Addiction to alcohol, tobacco, or drugs;
* A history of any respiratory, circulatory, neurological, musculoskeletal, and/or mental illness;
* Current symptoms of depression and/or anxiety. (See quantitative sensor testing for specific standards)
A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)

The purpose of this study is to investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, nonsmoking, male and/or female subjects of non-childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* An ALT or AST measurement \>2 times the ULN.
* 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec at Screening.
* Subjects at increased risk if dosed with moxifloxacin, according to the product label for moxifloxacin.
* History of risk factors of QT prolongation or torsades de pointes, congenital deafness and family history of sudden death.
Establishing a Tumor Registry for Patients With Neuroendocrine Carcinoma of the Cervix

This study collects information and data on patients with neuroendocrine cervical cancer. Information from this study may be used to better understand the correlation between clinical data, such as patient characteristics, treatment, and disease outcomes, and overall patient outcomes.

PRIMARY OBJECTIVES:

I. To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for patients with neuroendocrine carcinoma of the uterine cervix.

II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.

III. To have a single data repository kept on a secure platform that will integrate clinical information and research findings and serve as an archive for future research.

OUTLINE:

Patients' medical records are reviewed retrospectively and prospectively. On a case by case basis for up to 10 years to check status of disease and any further treatment received.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a personal history of cervical cancer with any portion of neuroendocrine component (including mixed tumors) of the following histologic subtypes:

  * Small cell neuroendocrine carcinoma
  * Large cell neuroendocrine carcinoma
  * Undifferentiated high-grade neuroendocrine carcinoma
* Patients may be in any stage of treatment, surveillance or recurrence at the time of initial participation in the study
* Patients with all stages of disease are considered eligible
* Patients who do not speak English can be eligible if accompanied by an institutional interpreter
* Patients who are receiving or have received treatment at any facility, including but not limited to M. D. Anderson Cancer Center are eligible
* Patient may be residents of any country and be of any ethnic background
* Patients who request to participate in the study, regardless of the method by which they learned of it, are eligible to participate, including, but not limited to patients who seek participation via the website
* Next of kin or legal authorized representatives of patients who are deceased but had a history of neuroendocrine carcinoma (NEC) of the cervix are eligible to participate
* Next of kin or legal authorized representatives of patients must read and speak English

Exclusion Criteria:

* Patients with other histologic subtypes of NEC of the cervix including typical and atypical carcinoid tumors
A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients

This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115 will be tested versus placebo and active comparators. The safety and tolerability of AZD2115 including investigations of clinically relevant systemically mediated effects will also be investigated.

A randomised, double-blind, placebo and active controlled, multi-centre, 6 way cross-over, single-dose Phase IIa study to investigate the local and systemic effects of 3 different doses of inhaled AZD2115 in patients with chronic obstructive pulmonary disease (COPD)

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Male or female of non-childbearing potential (post-menopausal or surgically sterilised), age ≥40 years at Visit 1
* Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD guidelines
* Post-bronchodilator FEV1 ≥ 40 to \< 80% of the predicted normal value and post-bronchodilator FEV1/FVC \< 70%
* Reversible airway obstruction

Exclusion Criteria:

* Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.
* An exacerbation of COPD within 6 weeks prior to Visit 1
* Treatment with systemic glucocorticosteroids with 6 weeks of Visit 2.
* Recent or ongoing respiratory tract infection during enrolment period.
* Need for long-term oxygen therapy and/or saturation O2 \< 92%.
Study of Transplant Related Anemia Treated With Aranesp® (STRATA)

The purpose of this study was to evaluate Aranesp® administered subcutaneously (SC) to maintain hemoglobin (Hb) levels in renal transplant recipients.


Eligibility Criteria:
Inclusion Criteria: - Subjects who are greater than 6 months post-renal transplant (living or cadaveric) - Using adequate contraceptive precaution, if of childbearing potential - Available for follow-up assessments and dosing visits - Hb concentration less than 11.0 g/dL within 3 months of screening and a hemoglobin concentration less than 11.0 during the screening period Exclusion Criteria: - Expected to initiate dialysis or transplantation or be scheduled for a kidney transplant within 6 months of study start, or have less than 1 year life expectancy - Systemic hematologic disease, myeloma, hemolytic anemia, or malignancy (excluding basal cell carcinoma) - Active systemic or chronic infection - Uncontrolled hypertension defined as diastolic blood pressure greater than 110 mm Hg on 2 separate occasions during the 2 weeks prior to screening - Known hypersensitivity to Aranesp® or any of the product's excipients - Disorders that compromise the ability of the subject to give written informed consent and/or to comply with study procedures - Use of any erythropoietic protein or androgen therapy within the 12 weeks prior to screening - Females who are pregnant or breast-feeding - Currently enrolled in or received treatment in an investigational drug/device trial within the past 30 days - Have previously been enrolled in this study - Recent history (within 12 weeks prior to screening) of severe cardiovascular events, grand mal seizure, dialysis or major surgery - Have received a red blood cell transfusion(s) within 8 weeks prior to screening, or currently have active bleeding
Potential Value of Immunohistochemical Expression of SOX17 and E-Cadherin in Variable Endometrial Lesions

Endometrial carcinoma (EC) is the 6th most commonly occurring cancer in women and the 15th most common cancer overall According to facts derived from Globocan for the year 2020.The overall incidence was 417,367 and 97,370 died due to it. There were more than 417,000 new cases of endometrial cancer in 2020 .EC incidence is predicted to continue to rise in the coming decades, in particular among low and middle-income countries.

SOX17 protein (SRY-box 17) is a member of the SRY-related HMG-box (SOX) family of transcription factors that controls the first step of gene expression and regulates cellular growth and differentiation in the endoderm, during hematopoiesis, and in the cardiovascular system E-Cadherin is a calcium-dependent cell adhesion protein (predicted molecular weight of 97 kDa) that plays a vital role in cell migration and proliferation. The E-cadherin epithelial cell adhesion protein is a tumor suppressor that has an important role in tumor metastasis The loss of expression of E-Cadherin during the epithelial mesenchymal transition (EMT) is often thought to promote metastasis by allowing the dissociation and invasion of cancer cells

The aim of this study is:

1. To evaluate accuracy of SOX17 expression in neoplastic and hyperplastic endometrial lesions.
2. To correlate SOX17 expression with some clinical and pathological parameters of endometrial carcinoma.
3. To evaluate E-Cadhrin expression and its relation to SOX17 in neoplastic and hyperplastic lesions


Eligibility Criteria:
Inclusion Criteria:

* 1. Specimens of total abdominal hysterectomy and bilateral salpingio-oopherectomy of endometrial carcinoma patients 2. D\&C of endometrial tissue suspected of hyperplastic or neoplastic lesions

Exclusion Criteria:

* • Specimens with insufficient clinical data.

  * Specimens with extensive necrosis
Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation

Prospective case-control study comparing pulsed field ablation for atrial fibrillation under mild conscious sedation vs standard of care (general anaesthesia).

This study will prospectively assess 40 patients (20 per arm). Those in the general anaesthesia arm will undergo routine clinical practice. Those in the mild conscious sedation arm will undergo pulsed field ablation with intravenous sedation but without general anaesthesia, though conversion to general anaesthesia is allowed if the patient does not tolerate the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients clinically referred for and undergoing catheter ablation of atrial fibrillation using pulsed field ablation

Exclusion Criteria:

* Inability to provide informed consent