Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Inflammation

Neoplasm Metastasis

Chronic Disease

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Chronic Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Herbal and Botanical

Anesthetics

Defensins

Cola

Group of patients that are operated with laparoscopic approach

Group of patients operated with open approach

Laparoscopic colectomy. Epidural anaesthesia used

Laparoscopic colectomy

Open colectomy. Epidural anaesthesia used

Open colectomy

This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery

Inflammatory Response in Laparoscopic and Open Colectomy

Contribution to the Study of Inflammatory Response in Laparoscopic vs Open Colon Cancer Surgery

University of Ioannina

G. Hatzikosta General Hospital

Konstantinos E. Tsimogiannis, MD

Crohn Disease

Necrosis

Inflammatory Bowel Diseases

Gastroenteritis

Dermatologic Agents

Gastrointestinal Agents

Antibodies

Ustekinumab

Vedolizumab

Immunoglobulins

Patients presenting an active crohn's disease (HBI score ≥ 4) with an indication of treatment by ustekinumab because of failure or unacceptable side effects of previous treatments, and who have already been treated by at least one anti TNF The patients must be 18 years old or older.

The clinical response is defined as a decrease in the Crohn's Disease Activity Index (CDAI) score ≥ 100 points or a decrease in the HBI score ≥ 3 points.

Evaluation of biological predictive factors of clinical response to ustekinumab

Ustekinumab is a fully human Immune Globulin Gk (IgGk) monoclonal antibody against the common p40 subunit of interleukin-12 and interleukin-23, which are implicated in the pathogenesis of inflammatory bowel disease. Its efficiency to induce and maintain clinical response in patients with anti TNF resistant Crohn's disease has been proved in several clinical trials, and the profile of safety of this treatment was good, but the investigators have few data about biological characteristics of patients treated by Ustekinumab, particularly about ustekinumab through levels and rate of patients developing anti ustekinumab antibodies during the induction and maintenance stages, and no predictive factors of clinical response have been identified yet.

The aim of this study will be to assess the evolution of biological markers of inflammation and ustekinumab trough levels and antibodies, in responders and non responders patients treated by ustekinumab, in order to identify predictive factors of clinical response.

The investigators will perform a prospective observational study, including the patients followed in the University hospital center of Lyon and treated by ustekinumab for a moderate to severe Crohn's disease (with a HBI score≥4 ). All the patients included will have been previously treated by at least one anti TNF and/or Vedolizumab, with specified criteria for a primary non response, a secondary loss of response or unacceptable side effects.

Then, clinical and biological data will be collected for each patient at the inclusion, and then at weeks 4, 8, 16, 24: HBI score, sides effects, extra intestinal manifestations, steroids withdraw, CRP, calprotectin, ustekinumab trough levels and ustekinumab antibodies.

The investigators will compare responding and non responding patients at week 16 (end of the induction period) according to these data.

The hypothesis the investigators state is that an early and significant decrease of the inflammation markers in blood and stools associated with a high ustekinumab through level in blood is associated with a clinical response at week 16 in the patients treated by ustekinumab

Three blood samples of 4 ml, one stool sample of 50 mg

Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's Disease

Identification of Biological Predictive Factors of Clinical Response to Ustekinumab in Patients With Anti-Tumor Necrosis Factor (TNF) Antagonists Refractory Crohn's Disease: Interest of Dosage of C Reactive Protein (CRP), Calprotectin, Ustekinumab Through Levels and Antibodies

Dosage of ustekinumab through level and ustekinumab antibodies: one 4ml blood sample

-Inflammation markers are evaluated : Dosage of CRP and leucocytes in blood: two 4ml blood sample

-Inflammation markers are evaluated : Dosage of calprotectin in stools: one about 50 mg stools sample

Clinical evaluation is realized by a medical visit with physical examination

Clinical evaluation is realized by a medical visit with evaluation of:

* the efficiency of the treatment: evaluation of well being, abdominal pain, stools numbers per day, presence or not of peri anal lesion, arthralgia, fever
* the tolerance/potential side effects of the treatment: infections, headache, skin rash, nausea, allergic reaction, or any clinical manifestation that could be imputed to the treatment

Hospices Civils de Lyon

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Oculocerebral Syndrome With Hypopigmentation

Anti-Inflammatory Agents

Other Dietary Supplements

Omega 3 Fatty Acid

Omega 3 fatty acids for 6 months and then off omega 3 fatty acids for the next 6 months. In the first 6 months, you will be asked to take one capsule of Omega 3 fatty acids with breakfast and 1 with dinner/day for the first week, 2 capsules in the morning and one capsule in the evening for the second week and then 2 capsules with breakfast and 2 with dinner/day for the remaining 24 weeks. In the next 6 months (Months 7 to 12), you will have a blood test for markers of inflammation at the end of Month 7 and at Month 9 and 12 to determine if the anti-inflammatory effects of Omega 3 acids are still there after you have stopped taking it.

No Omega 3 fatty acids for the first 6 months followed by Omega 3 fatty acids for the next 6 months. You will be asked to have a blood test for markers of inflammation at Month 1, 3 and 6 for markers of inflammation to determine the natural variation of the levels of these markers without Omega 3 fatty acid supplements. In Month 7, you will be asked to take one capsule of Omega 3 with breakfast and 1 with dinner/day for the first week, 2 capsules in the morning and one capsule in the evening for the second week and then 2 capsules with breakfast and 2 with dinner/day for the remaining 24 weeks.

To evaluate the efficacy of 3.6 g omega 3 fatty acid supplements (2.4 g EPA + 1.2 g DHA)/day for 6 months versus no treatment at reducing the level of C-reactive protein (CRP) in ever smokers at high risk of lung cancer. The primary endpoint of the study is reduction of CRP.

Omega 3 fatty acid

Sukhinder Atkar-Khattra, BSc

Anne DyBuncio, BSc

Stephen Lam, MD

The study duration is 12 months. The initial enrollment visit will take approximately one hour. The Month 1, 3, 6, 7, 9 and 12 visits will take approximately 30 minutes each. The three telephone visits will take approximately 10 minutes each. The total time commitment to the study will be approximately four and a half hours.

The table below explains what will be done at each study visit:

Prior to Pre-Registration Informed Consent. Questionnaire (asking about your risks for lung cancer, diet and medications including food supplement). Blood test for CRP level

Prior to Registration/Randomization Blood test for CRP level (about 6 ml or 1 teaspoon) Pregnancy test (either blood or urine, for woman with childbearing potential only)

Registration/Randomization Medical history Physical exam (Vital signs/Body height and weight) Receive 3 month supply of Omega 3 fatty acids for treatment first group. Blood tests for Fasting Blood insulin, etc (about 15 ml or 3 teaspoons) Receive a diary to record the amount of study medication you take each day and any side effects you may experience

Week 2 telephone interview Ask about side effects you may be having Ask about other medications you may be taking Review study agent diary

Month 1 visit (you will not be able to eat anything for 10 hours before the appointment) Blood test for Fasting Blood insulin, etc (15 ml or 3 teaspoons) -( All participants)

Treatment Group:

Ask about side effects you may be having Ask about other medications you may be taking Review study medication diary

Month 2, 4, and 5 telephone interview Review diary Ask about side effects you may be having Ask about other medications you may be taking

Month 3 visit (you will not be able to eat anything for 10 hours before the appointment) Physical exam with vital signs Repeat blood tests (about 15 ml or 3 teaspoons) (All participants)

Treatment Group:

Collect unused omega 3 (for treatment group) Receive next 3 month supply of omega 3 (for treatment group) Review study medication diary Ask about side effects you may be experiencing Ask about other medications you may be taking

Month 6 or end of study visit (if left study early for any reason) Physical exam with vital signs Blood tests (about 15 ml or 3 teaspoons) - All participants

Treatment Group:

Review and collect study agent diary Ask about side effects you may be having Ask about other medications you may be taking

Month 7-12 Cross over study Treatment group will become observation group Observation group will become treatment group with the same procedures in month 1 to 6

participants are randomized into 2 study groups. Group 1 Omega 3 fatty acids for 6 months and then off omega 3 fatty acids for the next 6 months. Group 2. No Omega 3 fatty acids for the first 6 months followed by Omega 3 fatty acids for the next 6 months.

A computer will be used to select participants for each of the study groups.

Efficacy and Safety of Omega 3 Fatty Acid Supplements on Heavy Smokers

A Phase II Randomized Cross-over Study of the Efficacy and Safety of Omega 3 Fatty Acid Supplements on Lung Cancer-Promoting Inflammatory Markers in Heavy Smokers

Individual participant data will not be shared with other researchers

Blood will be collected over the duration of the study

Lotte & John Hecht Memorial Foundation

British Columbia Cancer Agency

Nutritional and Metabolic Diseases

Heart and Blood Diseases

Syndrome

Metabolic Syndrome

Microvascular Angina

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Abdominal Obesity Metabolic Syndrome

Antirheumatic Agents

Analgesics

Etanercept

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Immunosuppressive Agents

Immunologic Factors

Placebo

Steven K Grinspoon, MD

Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.

Screening visit 1:

Fifty six patients will be randomized to receive etanercept or identical placebo. During the screening visit, after informed consent is obtained, subjects will undergo a medical history and physical exam, which will include vital signs, weight, abdominal girth measurements and an evaluation for signs of underlying infection. A purified protein derivative (PPD) of 5 tuberculin units (TU) (0.1 milliliter of 5 TU/0.1 ml solution) will be intradermally placed to test for the presence of tuberculosis (TB). Fasting blood work will include a complete blood count (CBC), glucose, insulin, a cholesterol panel, and urine pregnancy test. Subjects will be shown what a subcutaneous injection entails using placebo. Patients will be selected based on their laboratory results, abdominal girth measurements and PPD negativity 48 hrs after placement.

Screening visit 2:

Subjects will return 48 hours after their first screening visit for evaluation of their PPD test. In the event of a positive PPD, subjects will be excluded from the study, and their primary care physicians will be notified of their test result.

Day 1 visit:

Subjects will report to Massachusetts General Hospital (MGH) or Massachusetts Institute of Technology (MIT) Clinical Research Center (GCRC) after an overnight fast. Fasting blood work will be obtained to test for CRP, adiponectin, IL-6, TNF-alpha, TNF-alpha receptor 1, TNF-alpha receptor 2, free fatty acids, glucose, insulin and a cholesterol panel, and CBC. A urine pregnancy test will be done. Patients will be asked to recall the food they consumed over the past 24 hours. A bionutritionist will measure height, weight, waist, hip, chest, arm, neck and thigh circumference. Subjects will be instructed to practice adequate birth control throughout the study. Serum will be stored for etanercept antibody testing.

Subjects will then undergo an insulin modified frequently sampled intravenous (IV) glucose tolerance test (FSIGT) as initially developed by Bergman et al.

Dual energy x-ray absorptiometry (DEXA) (Hologic QDR 4500) will be used to determine whole body and regional fat. The technique has a precision error (1 SD) of 3% for whole body fat and 1.5% for lean mass. Subjects will also undergo a single thin-slice CT scan of the abdomen at L4 vertebral body to determine visceral and subcutaneous fat area.

Indirect calorimetry for the measurement of resting energy expenditure indirect calorimetry using the Deltatrac instrument (Sensormedics, Anaheim, CA) will be carried out.

Drug administration:

Patients will be given a total of either etanercept 50 mg subcutaneously or placebo subcutaneously at the GCRC at the end of their visit. They will receive this in two injections of 25 mg each, one given immediately following the other, at different body sites. Etanercept will be supplied as a sterile, white, preservative-free, lyophilized powder. The pharmacy will reconstitute it with 1 mL of the supplied sterile bacteriostatic water for injection (BWFI), United States Pharmacopeia (USP) (containing 0.9% benzyl alcohol). Each vial of etanercept contains 25 mg etanercept, 40 mg mannitol, 10 mg sucrose, and 1.2 mg tromethamine. Subjects will receive the 50 mg dose of etanercept or placebo once a week, given as two 25 mg injections, one immediately following the other, at different body sites, at each of their ensuing three visits to the GCRC, on Visit Day 8, Visit Day 15 and Visit Day 22. Subjects will be monitored for 30 minutes after the injection of study drug at each visit. The skin injection site will be observed and their vital signs will be taken. If a subject has a significant exposure to varicella virus during the study, transient termination of the study will be considered.

Day 8 visit, Day 15 visit, Day 22 visit:

Subjects will report to MGH or MIT Clinical Research Center after an overnight fast. Each subject will undergo a history and physical exam to assess for safety and compliance. Fasting blood work will be obtained. A bionutritionist will measure subjects' height, weight, hip and waist circumference and calculate a waist to hip ratio. They will receive 50 mg of either etanercept or placebo, given as two 25 mg doses subcutaneously, at different body sites.

Day 25 visit:

Subjects will report to MGH or MIT Clinical Research Center after an overnight fast. Each subject will undergo a history and physical exam to assess for safety and compliance. Blood work, a urine pregnancy test and 24 hour food recall will be collected, identical to that on Day 1 visit. Anthropomorphic measurements will be the same as the Day 1 visit. Subjects will undergo an intravenous glucose tolerance test (IVGTT) identical to that on the Day 1 visit. Subjects will undergo a DEXA, bioelectric impedance analysis (BIA), and CT, and indirect calorimetry identical to those on the Day 1 visit. No study drug will be administered at this visit.

Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome

Massachusetts General Hospital

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Skin and Connective Tissue Diseases

Breast Neoplasms

Obesity

Breast Diseases

Skin Diseases

Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group.

The control group will receive basic information on physical activity but not be instructed.

Exercise Regimen

Breanne Eddington

Karen Milligan, MD

The proposed study compares the outcomes of a physical activity intervention begun at diagnosis, continuing through active cancer treatment and into six months of survivorship compared to the outcomes of a control group receiving limited information on activity.

Patients (with stage 0 to stage III breast cancer)receiving chemotherapy, radiation or both chemotherapy and radiation will be included in the study.Randomization will be stratified by disease stage at diagnosis, treatment modalities planned, and hormonal status. Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group. The control group will receive basic information on physical activity but not be instructed. Any physical activity in this group will be self-reported. Change in C-reactive protein will be the primary endpoint. Changes in other laboratory values, DEXA measurements, and quality of life measurements will be secondary endpoints.

Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory

Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory

The primary endpoint for this study change in C-reactive protein.

Compare changes in:

* Glucose
* Insulin
* Estradiol
* Testosterone

Body composition parameters and bone density will be assessed using Dual Energy X-ray Absorptiometry (DEXA) and compared between the two groups.

Quality of Life will be measured and compared between the groups

Comparing overall survival and progression free survival between groups.

Vons

Nevada Cancer Institute

Antipyretics

Fibrinolytic Agents

Platelet Aggregation Inhibitors

Aspirin

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Smoking cessation through the administration of Cytisine (in standard and prolonged administration) + reduction of inflammatory status through the administration of Acetylsalicylic acid, diet modification and physical activity increase + standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test

Smoking cessation through the administration of Cytisine (in standard and prolonged administration) + standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test

reduction of inflammatory status through the administration of Acetylsalicylic acid, diet modification and physical activity increase + standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test

standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test

Cytisine administration will be randomized 1:1 in standard (40 days)and prolonged treatment (84 days).

Subjects will be educated on how to take the product and informed about possible adverse effects.

Cytisine

The treatment will consist of Acetylsalicylic acid at 100mg once a day

Acetylsalicylic acid

It will be proposed:

1. an optimal diet with the aim of favoring control of weight, abdominal fat and adequate nutritional status without increasing the levels of IGF-I and inflammatory factors or glycemic peaks, with periodic verification of the results
2. a regular and sustainable physical activity program with periodic verification of the results.

Diet Modification and Physical Activity Increase

standard treatment for early lung cancer detection with ultra low dose CT

early lung cancer detection

spirometry with CO test

anthropometic data collection

blood test to assess the metabolic and inflammatory profile

blood test

Ugo Pastorino, MD

This prospective randomized pilot trial will evaluate a multiple intervention program of prevention in lifelong smokers aiming at reduction of chronic inflammation status through treatment with low-dose acetylsalicylic acid (ASA), smoking cessation with cytisine, targeted modification of diet and physical activity, in addition to early diagnosis with annual ultra low-dose spiral computed tomography (LDCT).

The most recent population-based studies carried out in Europe and the US on hundreds of thousands of individuals have unequivocally identified three principal causes of mortality, morbidity and chronic disability: tobacco smoke, inadequate diet, and reduced physical activity. These risk factors are in large part reversible, because in heavy smokers, even after 60 years of age, cessation is associated with a clear reduction in all-cause mortality. The finding that lifestyle and eating habits are associated with the development of cancer has been confirmed in many studies: smoking, a sedentary lifestyle, excess red meat, processed foods and sugars are associated with increased risk, while an active lifestyle, non-exposure to smoke (both active and passive), consumption of whole grains, legumes and vegetables are associated with protection or a reduced incidence in at-risk subjects.

What is clear, and confirmed by many studies, is that cancer occurs more often in overweight individuals, and that cancer patients who are overweight have more difficulty treating their disease. Elevated plasma levels of C-reactive protein (CRP), even when still within normal limits, are the reflection of a chronic state of inflammation and are associated with poor prognosis in several tobacco-related diseases. CRP measurement is besides a simple test to predict the risk of heart attack and stroke as well as mortality from all causes and from cardiovascular disease. In a systematic review on adult solid tumors, elevated CRP levels were associated with higher mortality and recurrence rates, and this observation was confirmed in early-stage lung cancer by a recent meta-analysis. In patients with chronic obstructive pulmonary disease (COPD), high CRP is a strong and independent predictor of future morbidity and mortality, and an increase in CRP concurrent with a reduction of the forced expiratory volume in 1 second (FEV1) shows an even stronger effect on patient's outcome.

High levels of CRP are associated with poor prognosis in cancers of the upper aerodigestive tract, rhinopharynx, lung and urinary tract. From a dietary point of view, consumption of saturated fats has been directly associated with an increase in inflammatory status as measured by high levels of CRP, just like consumption of meat, while an inverse correlation with consumption of vegetables has been observed. For example, low levels of inflammatory factors have been found in individuals adhering to a Mediterranean diet. Another recurrent finding, at least for cancer, is the importance of daily physical activity, such as brisk walking for 30 minutes. Moreover, regular physical activity is associated with better prognosis and increased survival in patients with a cancer diagnosis.

The number of heavy smokers that will participate in early-diagnosis programs using spiral CT will undoubtedly increase in the future as a result of awareness campaigns, and the participating volunteers represent an excellent opportunity to evaluate the efficacy of targeted primary prevention programs.

The present program will combine several interventions according to the randomization arm, proposed in combination or in single treatment, including treatment with cytisine, reduction of chronic inflammation by treatment with low-dose aspirin (ASA), targeted modification of diet and physical activity, in addition to early diagnosis with annual ultra low-dose spiral computed tomography (LDCT).

At baseline each volunteer will undergo:

* questionnaires on population evaluation (e.g. socio-demographic, smoking habits, physical activity, etc)
* blood sampling for the assessment of the inflammatory and metabolic profile
* evaluation of respiratory function and measurement of carbon monoxide (CO)
* thorax ultra low-dose computed tomography (LDCT) without contrast
* anthropometric evaluation (e.g. weight, height, BMI, etc)

To reduce levels of chronic inflammation will be used:

* treatment with low-dose acetylsalicylic acid (ASA)
* dietary / nutritional intervention in order to promote an optimal diet, based on characteristic of the Mediterranean Diet, for weight maintenance, visceral fat control and an adequate nutritional status
* physical activity intervention, through the reduction of sedentary behaviour and the implementation of a moderate intensity activity of about 30 min a day

In the Smoking cessation will be used Cytisine. It is a molecule known since the early 60s for the treatment of smoking. In recent clinical trials it revealed efficacy in smoking cessation. In 2014, the NHS (National Health Service) produced a document evaluating the cost-effectiveness of drug treatment of smoking, concluding that cytisine has the most favorable profile among the drugs taken into consideration

The imaging will be performed by volumetric acquisition with a computed tomography scanner equipped with advanced technology hardware and software, including: high performance X-ray tube with low potential, high sensitivity detectors combined with dedicated reconstruction algorithms for optimisation of the signal to noise ratio within an ultra low radiation dose. The protocol for ultra-low dose computed tomography will be specifically set for lung cancer screening with semiautomated image analysis and nodule quantification, according to the international standard for image quality (Quantitative Imaging Biomarker Alliance). In particular, the ultra-low dose computed tomography protocol will be developed for the lowest radiation exposure and tested by dedicated phantom for quantitative analysis of imaging metrics.

In the control group subjects will receive an information booklet containing advice on an optimal lifestyle with particular reference to smoking, diet and physical activity according to the best international guidelines.

Screening and Multiple Intervention on Lung Epidemics

Multifactorial Intervention of Primary Prevention in High Risk Subjects: a Randomized Trial

Reduction in the percentage of subjects with CRP\>=2 mg/L

Dietary intakes are collected by a self reported food frequencies questionnaire and data are expressed as the average daily/weekly consumption of foods and food groups.

Servings size is defined as "natural unit" (e.g. 1 glass of soft drinks, 1 teaspoon of sugar) or as an average serving (e.g. 80 g of pasta or rice, 30 g of dried fruits).

The frequency of serving size is reported as continuous measure. Data will be collected as continuous measures and will be analyzed by performing statistical models to investigate a potential relationship among changes in dietary habits and anthropometric parameters (BMI, waist circumference..), socio-demographic characteristics (gender, smoking status, physical activity), biochemical parameters (CRP blood levels), drugs assumption and the risk of chronic diseases, such as lung cancer.

Increase in the physical activity measured by the validate short form IPAQ questionnaire (International Physical Activity Questionnaire) The items in the short IPAQ form were structured to provide separate scores on walking, moderate-intensity and vigorous-intensity activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of each activity.

METs are multiples of the resting metabolic rate and a MET-minute is computed by multiplying the MET score of an activity by the minutes performed:

* Walking MET-minutes/week = 3.3 \* walking minutes \* walking days
* Moderate MET-minutes/week = 4.0 \* moderate-intensity activity minutes \* moderate days
* Vigorous MET-minutes/week = 8.0 \* vigorous-intensity activity minutes \* vigorous-intensity days
* Total physical activity MET-minutes/week = sum of Walking + Moderate + Vigorous MET-minutes/week scores

Weight and height will be combined to report BMI in kg/m\^2. Reduction in BMI

Reduction in waist circumference expressed in centimeters

Enhancement in blood glucose, total cholesterol, LDL, HDL and triglycerides

Reduction in lung cancer specific and overall mortality

Istituto Di Ricerche Farmacologiche Mario Negri

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Head of Thoracic Surgery Division

Postoperative Complications

Antiemetics

Anti-Bacterial Agents

Pre-operative: Assessment, counseling and education; preoperative nutritional drink up to 4 h prior to surgery, bowel preparation, only oral intestinal cleaner，antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes). Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia keeping temperature at 36 ±0.5℃, antiemetics at end of anaesthesia. Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery).

pre-operative assessment：pre-operative fasting at least 8h, bowel preparation for traditional surgery, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade.

Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust

pre-operative assessment, counseling and FT management education

pre-operative assessment, counseling and education

Preoperative nutritional drink up to 4 h prior to surgery mechanical bowl preparation should not be used

Preoperative nutritional drink up to 4 h prior to surgery

patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool

bowel preparation

preoperative treatment with carbohydrates (patients without diabetes).

preoperative treatment with carbohydrates

fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia;

fast solid

avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.

avoiding hypothermia

Postoperative glycaemic control

postoperative nausea and vomiting (PONV) control;

early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).

early postoperative diet

pre-operative fasting at least 8h

Oral bowel preparations or mechanical bowl until liquid stool

bowel preparation for traditional surgery

6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust

began to take solid diet after anal exhaust

Ling Cui, MD

Yu Shi

Hong Liu

Dengfeng Wang

Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. It has been used successfully in non-malignant gynecological surgery, but it has been proven to be especially effective in elective colorectal surgery. However, no consensus guideline has been developed for gynecological oncology surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. NO randomised controlled trials for now.

The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. There is a existing research showed FTS in gynecological oncology provide early hospital discharge after gynaecological surgery meanwhile with high levels of patient satisfaction.

The aim of this study is to identify patients following a FTS program who have been discharged earlier than anticipated after major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery.

Methods/Design

Comparison of Fast-Track (FT) and traditional management protocols. the primary endpoints is length of hospitalization post-operation (d, mean±SD). It was calculated by the difference between date of discharge and date of surgery. The secondary endpoints are complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis and APACHE II score.

The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. NO randomised controlled trials for now. The aim of this study is to compare the LOS (Length of hospitalization post-operation) after the major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery. This trial can show whether the FTS program can achieve early hospital discharge after gynaecological surgery meanwhile with low levels of complications.

Patients were randomly divided into two groups（ FTS group/traditional group）, after that doctors and patients were aware of the grouping situation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Inflammatory Response in Laparoscopic and Open Colectomy	NCT00942461	Colorectal Canc...	Laparoscopic co... Open colectomy	-	G. Hatzikosta General Hospital
Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's Disease	NCT03351647	Crohn Disease	Evaluation of b...	18 Years - 18 Years	Hospices Civils de Lyon
Efficacy and Safety of Omega 3 Fatty Acid Supplements on Heavy Smokers	NCT03936621	Lung Cancer	Omega 3 fatty a...	55 Years - 80 Years	British Columbia Cancer Agency
Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	NCT00111956	Metabolic Syndr...	Etanercept Placebo	18 Years - 55 Years	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory	NCT01157130	Early Stage Bre...	Exercise Regime...	18 Years -	Nevada Cancer Institute
Screening and Multiple Intervention on Lung Epidemics	NCT03654105	Inflammation Smoking Cessati... Diet Modificati... Physical Activi... Lung Cancer	Cytisine Acetylsalicylic... Diet Modificati... early lung canc... spirometry with... anthropometic d... blood test	55 Years - 75 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Fast-track Surgery After Gynecological Oncology Surgery	NCT02687412	Length of Stay Postoperative C... CRP	pre-operative a... Preoperative nu... bowel preparati... preoperative tr... fast solid avoiding hypoth... Postoperative g... postoperative n... early postopera... pre-operative f... bowel preparati... began to take s...	18 Years - 70 Years	Sichuan Cancer Hospital and Research Institute
Inflammatory Response in Laparoscopic and Open Colectomy	NCT00942461	Colorectal Canc...	Laparoscopic co... Open colectomy	-	G. Hatzikosta General Hospital

Spots Global Cancer Trial Database for crp

Every month we try and update this database with for crp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for crp

Every month we try and update this database with for crp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for crp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.