Symptoms and General Pathology

All Conditions

Infections

Nutritional and Metabolic Diseases

Digestive System Diseases

Inflammation

Communicable Diseases

Malnutrition

Sepsis

Ileus

Nutrition Disorders

Pharmaceutical Solutions

All Drugs and Chemicals

Herbal and Botanical

Soybean oil, phospholipid emulsion

Fat Emulsions, Intravenous

Parenteral Nutrition Solutions

Soy Bean

Olive

Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital

Patients that are randomized to receive ClinOleic as a lipid emulsion in their PN, instead of Intralipid. ClinOleic is approved by Health Canada. The amount of calories from the lipid emulsion will be equivalent in the standard of care group and in the ClinOleic group.

Intralipid

ClinOleic

Johane P Allard, MD, FRCPC

Intravenous nutrition is an important therapy for the recovery of many patients. It is indicated when the patients cannot take food by mouth or use their intestines for feeding. It is important to indicate it in the appropriate setting because it's not free of complications and is a costly treatment. Some of the complications are: elevated blood sugar or lipids, elevated liver function tests, infection of the catheter or device used to administer intravenous nutrition. Intravenous nutrition is composed by proteins, lipids, carbohydrates (sugar in the form of glucose) and vitamins. Until recently, Intralipid, a soybean oil-based lipid emulsion was the only lipid available in Canada for this kind of nutrition. Since 2010, a new lipid emulsion (ClinOleic) based on olive-oil has been approved by Health Canada for use in intravenous nutrition. There is an increasing need for hospitals to evaluate the quality of intravenous nutrition administered to hospitalized patients in terms of: assessing indications, prescription, complications, clinical results and costs. The objective of this study is to determine if intravenous nutrition prescribed in hospitalized patients is indicated following existing guidelines in terms of timing of nutrition support, prescription, monitoring and whether it is associated with complications. In addition, length of stay and mortality will be assessed. Also, we will evaluate nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion (Intralipid) compared to those of patients receiving olive oil-based lipid emulsion (ClinOleic).

Until recently, Intralipid, a soybean oil-based lipid emulsion, has been the only available lipid for intravenous use in Canada. In 2010, ClinOleic, a new, predominantly olive oil based emulsion, has been approved by Health Canada as an alternative lipid.

There is an increasing need for hospitals to do quality-assurance studies for in-patient parenteral nutrition (PN) to assess indications, PN prescription, complications, clinical outcomes and costs. The only in-patient population that is well studied is the intensive care unit (ICU) population. Several meta-analyses showed that PN was associated with higher infection rate, longer length of stay and higher mortality when compared with enteral nutrition. Results from these and other studies were the basis for the Canadian ICU Guidelines.

The aim of this study is to determine if PN prescribed in in-patients is indicated, appropriately following existing guidelines in terms of timing of nutrition support, prescription and monitoring and, whether it is associated with complications. In addition, clinical outcomes such as length of stay and mortality will be assessed. Also, we will evaluate metabolic, nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion compared to those of patients receiving olive oil-based lipid emulsion.

Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions

prealbumin is an hepatic protein that is used in the diagnosis of malnutrition. It has a short half-life so any changes in nutritional status can rapidly be represented by prealbumin levels.

Length of stay in the hospital and ICU will be recorded. We will record how many days it took,since admission to the hospital, for the patient to be discharged. This is an expected average of 4 weeks of length of stay.

We will follow the patients from the day of admission until the day of discharge and record the mortality, if applicable. The expected average of hospital stay is 4 weeks.

We will measure weight before, at day 10 and after PN to calculate the BMI at this different points. The last day of PN is whenever the patient is taken off PN. This can vary considerably from patient to patient.

we will record the infections the patients develop during PN until one week after PN

We will measure hand grip strength at baseline (day0) and at day 10 of PN. This is a test that measures the strength of the hand and forearm muscles and is often used as a general test of strength

is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support

we will record antibiotic days from the start of PN until one week after PN is discontinued

hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN

Red blood cell fatty acid composition, particularly the essential fatty acids (linoleic acid and alpha-linolenic acid) will be measured to assess presence/absence of essential fatty acid deficiency

Johane Allard

Professor of Medicine, Director-Division of Gastroenterology

Substance Related Disorders

Behaviors and Mental Disorders

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Quality of Life

Antineoplastic Agents

Oxaliplatin

Capecitabine

Antimetabolites

Randomized group of patients receiving laparoscopic colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.

Randomized group of patients receiving laparoscopic colectomy with Fast Track Multi-Displine（FTMD）treatment and XELOX chemotherapy.

Randomized group of patients receiving open colectomy with conventional perioperative treatment and mFolfox6 chemotherapy.

Randomized group of patients receiving open colectomy with Fast Track Multi-Displine（FTMD） treatment and XELOX chemotherapy.

Laparoscopic surgery for colorectal cancer using STORZ laparoscope

Laparoscopic Surgery for Colorectal Cancer

XELOX Chemotherapy

mFolfox6 chemotherapy

Fast track treatment during perioperation period

Fast Track Perioperative Treatment

Conventional treatment during perioperation period

Conventional Perioperative Treatment

Open surgery for colorectal cancer using conventional methods

Open Surgery for Colorectal Cancer

Ke-Feng Ding, PhD/MD

A new notion"Fast Track Multi-Discipline Treatment" for colorectal cancer is thought with several benefits such as shorter hospitalization stay and less costs. This randomized study aims to compare the differences between conventional and Fast Track Multi-Discipline Treatment for colorectal cancer in hospitalization day, complications, costs and quality of life.

Laparoscopic Surgery, Fast Track Treatment and XELOX Chemotherapy have been introduced in the treatment of colorectal cancer. All of these procedures are contributed to reduce the hospitalization stay. However, the most economical mode for combination of these procedures is still unclear. This is a randomized controlled study, a new notion"Fast Track Multi-Discipline Treatment" is proposed, which is the combination of the Laparoscopic Surgery, Fast track perioperative treatment during perioperative period and XELOX Chemotherapy. The purpose of this study is to compare the Fast Track Multi-Discipline Treatment with the conventional treatment(Open Surgery with conventional treatment during perioperative period and mFolfox6 chemotherapy) for colorectal cancer on several aspects like the average hospitalization day, complications, costs and quality of life.The focus of the study will be to investigate whether the Fast Track Multi-Discipline Treatment reduces hospital stay with similar complications compared with conventional perioperative treatment. Moreover, the trial will clarify whether laparoscopic surgery is essential for Fast Track Multi-Discipline Treatment.

Study Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer

Randomized Controlled Trial Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer

The overall hospitalization stay during treatment from the first day in hospital to leave hospital when finish adjuvant chemotherapy or surgery (for patients who don't need chemotherapy).

Surgical complications include injury of ureter, intraoperative transfusion, infection of incision and anastomotic leakage etc.

Chemotherapy related adverse event, according to NCI CTCAE Version 3.0, include nausea, vomit, diarrhea and neutropenia etc.

Quality of life will be measured by EORTC QLQ-C30 and QLQ-CR38 questionaire.

The overall hospitalization costs from the first day in hospital to day that adjuvant chemotherapy finished.

Zhejiang University

Professor of SAHZU

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Pleural Effusion, Malignant

Pleural Effusion

Pleural Diseases

Respiratory Tract Diseases

Pleural Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Gastrointestinal Agents

Naproxen

Pantoprazole

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

This study arm will encompass the administration of a placebo (physically identical to Naproxen) orally to participants. Naproxen is a painkiller with intrinsic anti-inflammatory properties, while the placebo has no pharmacological properties associated with it. Participants will also be taking Pantoprazole to negate the gastrointestinal consequences of Naproxen (or the placebo). Participants will not know which arm of the study they belong to. In addition, they will attend scheduled check-ups where their vitals will be recorded, as well as laboratory indicators of gastrointestinal complications (creatinine levels, etc) for their safety.

Intervention arm involves administering 500mg Naproxen twice a day to participants and 40mg of Pantoprazole once a day in tandem. Pantoprazole will negate gastrointestinal consequences of Naproxen and reduce the likelihood of a complication occurring. Participants will take Naproxen at the above dosage from the time of surgery to four weeks following surgery. They will attend scheduled check-ups where their vitals will be recorded, as well as laboratory indicators of gastrointestinal complications (creatinine levels, etc) for their safety. This experiment is double-blinded so neither investigators nor participants will know which arm of the study they belong to.

Intervention arm involves administering 500mg Naproxen BID to participants and 40mg of Pantoprazole in tandem. Pantoprazole will negate gastrointestinal consequences of Naproxen and reduce the likelihood of a complication occurring. Participants will take Naproxen at the above dosage from the time of surgery to four weeks following surgery. They will attend scheduled check-ups where their vitals will be recorded, as well as laboratory indicators of gastrointestinal complications (creatinine levels, etc) for their safety. This experiment is double-blinded so neither investigators nor participants will know which arm of the study they belong to.

Inert, inactive placebo pill similar in appearance to naproxen allocation. To be taken twice daily for 4 weeks total along with 40mg pantoprazole.

Placebo

Yaron Shargall, MD, BSc, FRCSC

Following a lung resection procedure, patients have their pleural space drained of fluid that accumulates due to the severing of proximal vessels like lymph nodes. The volume of fluid pumped depends on the severity of the inflammation. The investigators are conduction this study to attempt to use painkillers with intrinsic anti-inflammatory action to try and reduce the degree of inflammation in patients' pleural cavity, thus ensuring patients are discharged faster, with a greater comfort level, and a hopefully lower rate of admission.

In this study the investigators will attempt to reduce the degree of inflammation (and thus polymorphonuclear leukocyte counts) in the pleural space following a lung resection procedure by administering the Non Steroid Anti-Inflammatory Drug (NSAID) Naproxen in tandem with Proton Pump Inhibitor (PPI) Pantoprazole, ideally leading towards a significantly reduced volume of transudate and exudate generated.

This will be achieved by running a placebo-controlled double blinded randomized control trial where investigators and participants will be blinded so as to eliminate experimenter bias. After screening for suitable participants using stringent inclusion and exclusion criteria, patients will be administered by allied health professionals 500mg Naproxen twice daily and 40mg Pantoprazole once daily, or an identical placebo for four weeks following resection surgery. Patients will undergo a thorough examination during their scheduled follow-up appointments to monitor general vitals as well as possible gastrointestinal complications. The primary outcome is a significant reduction (Δ100ml) of chest fluid extracted in the intervention arm of the study in comparison to that of the control arm. Secondary outcomes will include a reduction in length of stay measured in days between control and intervention arms as well as a reduction in the total number of days chest tubes are retained in-situ. Conditions such as mortality and morbidity, the onset of complications, and general re-admission rates will also be recorded.

The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection

The Effect of Perioperative Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection

The investigators are looking to measure the volume of pleural effusion collected from in-situ chest tubes in patients following a lung resection, measured in mL

The length of stay will be measured from the admitting day to the day of discharge to home.

Recorded as a binary event, adverse events related to the gastrointestinal tract may occur in participants undergoing treatment. The extent of this occurrence will determine whether or not further intervention by the Data and Safety Monitoring Committee is necessary.

Participants recently discharged following a lung resection have a chance to be re-admitted for a post-operative complication. This will be measured as a binary event and the total associated length of stay associated with the episode.

This outcome is related to the volume of pleural effusion produced and will measure the time chest tubes remain in place following surgery, measured in days.

McMaster Surgical Associates

McMaster University

Blood and Lymph Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Disease Progression

Neoplasms by Histologic Type

Hematologic Diseases

Acute Graft Versus Host Disease

Anti-Infective Agents

Cytarabine

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Vosaroxin and Cytarabine

Hamid Sayar, MD

This is a pilot efficacy assessment clinical trial of vosaroxin and cytarabine for the treatment of adults 60 years of age or older with previously untreated acute myeloid leukemia. A total of 17 evaluable patients are planned to be treated on the study.

Primary objective: rate of complete remission (morphologic complete remission or morphologic complete remission with incomplete blood count recovery) Secondary objectives: (1) safety of this combination in induction therapy of older patients previously unexposed to intensive chemotherapy; (2) progression-free survival; (3) length of stay in hospital for induction; (4) 30- and 60-day mortality rate.

The treatment period will include up to 4 cycles of treatment (induction 1, induction 2, consolidation 1, and consolidation 2). In each cycle, the first day of study treatment will be considered day 1.

* Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) \> 1000 cells/L.
* Up to 2 cycles of consolidation treatment may be completed by eligible patients in remission (morphologic complete remission or morphologic complete remission with incomplete blood count recovery) if safety parameters are met.

Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML

Pilot Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML

Percentage of patients who have complete remission as defined by the International Working Group for AML: morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi or CRp)

Number of unique patients who had a procedure or treatment related (possible, probable or definite) adverse events. (graded per NCI CTC v4.0)

Hamid Sayar

Assistant Professor of Clinical Medicine, Hematology/Oncology

Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) \> 1000 cells/L

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Due to the death of 2 patients which raised safety concerns, the study was closed with 2 patients enrolled.

All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit

Rate of Complete Remission

All patients enrolled and received treatment

Procedure or Procedure Related Adverse Events

Overall Study

Neoplasm Metastasis

Liver Diseases

Liver Neoplasms

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Adjuvants, Anesthesia

Central Nervous System Depressants

Antipyretics

Hematinics

Sufentanil

Anesthetics

Acetaminophen

Ropivacaine

Morphine

Liver Extracts

Ketorolac

Dsuvia

Anesthetics, Local

Analgesics, Opioid

Narcotics

Anesthetics, Intravenous

Anesthetics, General

Patients will receive spinal analgesia (morphine 0.2 mg) before general anesthesia for minor laparotomic liver resection.

Patients will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL) before general anesthesia for minor laparotomic liver resection.

Administration of morphine 0.2 mg in subarachnoid space.

Spinal analgesia

Bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL in epidural space

Epidural analgesia

Administration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally

Transversus Abdominis Plane block

Infiltration of the surgical wound with ropivacaine 0.75% 10- 20 mL

Surgical wound infiltration

Administration of 1000 mg of acetaminophen 40 minutes before ending of surgery followed by intravenous administration of 1000 mg every 8 hours

Administration of a non-steroidal antinflammatory drug (ketorolac 30 mg) as a rescue therapy

Epidural bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL

Epidural continuous epidural infusion of sufentanil 50 mcg/mL 1 mL

Administration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally to obtain the transversus abdominis plane block

Elena Bignami, M.D.

Raffaella Reineke, M.D.

Elena Bignami, MD

The purpose of this study is to evaluate the efficacy of spinal analgesia for minor laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale (VAS). The investigators expect at least the same post-operative pain control in the two groups (non inferiority of pain control with spinal analgesia compared to epidural analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease in patient's length of hospitalization according to enhanced recovery after surgery (ERAS) principles.

Liver surgery is performed under general anesthesia. Loco-regional analgesia is generally performed before general anesthesia induction to obtain the best post-operative pain control,in association with intravenous analgesic drug administration.

For minor laparotomic surgery (defined as the resection of up to three hepatic segments), if not contraindicated, in our hospital loco-regional analgesia is performed through the placement of a thoracic (T7-T8 or T8-T9) epidural catheter in which a local anesthetic (usually ropivacaine) and an opioid (usually sufentanil) are administered for the first three post-operative days. This is still considered the gold-standard for pain management in this surgery. In our institute, there is a dedicated acute pain service (APS) for pain management in the post-operative period. APS is also responsible for monitoring, registering and treating all side effects related to both the procedure and the drugs used.

In laparoscopic abdominal surgery, instead of epidural analgesia, if not contraindicated, spinal analgesia with low dose morphine before general anesthesia induction is performed. This technique is actually considered efficacy and safe in these type of surgeries.

The investigators therefore decided to test the efficacy of spinal analgesia versus epidural analgesia for minor liver surgery since anterior hepatic segments resection is less painful than major liver surgery because it requires less liver manipulation without significant involvement of the Glisson's capsule. This might imply a less incidence of procedure-related side effects such as post-dural puncture headache or site infections. Moreover, spinal analgesia may allow a earlier post-operative patients mobilization and thus a earlier hospital discharge.

In this randomized controlled trial, the investigators therefore aim to randomize 40 consecutive patients into 2 arms. The experimental group will receive spinal analgesia (morphine 0.2 mg) for post-operative pain control while the control group will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2%: 99 mL + sufentanil 50 mcg/mL: 1 mL).

Randomization will be performed with closed opaque envelopes. During surgery, patients will be monitored as usual. Intraoperative blood losses and fluids administration will be recorded.

Patients randomized into the epidural group will not receive local anesthetic administration through the epidural catheter during the hepatic resection phase to avoid hemodynamic instability. Once the hepatic resection phase is finished and euvolemic status is recovered, epidural analgesia will be administered as mentioned before.

In patients in the spinal group, transversus abdominis plane (TAP) block with ropivacaine 0.375% 20 mL bilaterally or surgical wound infiltration with ropivacaine 0.75% 10- 20 mL will also be performed before anesthesia recovery.

In both groups, post-operative pain control will be managed with intravenous acetaminophen 1000 mg 40 minutes before ending of surgery followed by intravenous administration of acetaminophen 1000 mg every 8 hours and a non-steroidal antinflammatory drug (ketorolac 30 mg) as a rescue therapy in the post-operative period if not contraindicated.

Patients will be monitored every 24 hours until the achievement of the "ready to discharge" status defined as:

* appropriate oral alimentation;
* optimal pain control with drugs administered orally;
* adequate ability in walking and personal care;
* clinical, laboratory and instrumental absence of any post-operative complication;
* intestinal function recovery;
* patient consent to discharge.

Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery

Spinal Analgesia Versus Epidural Analgesia in Minor Laparotomic Liver Surgery in an Enhanced Recovery Programme: A Randomized Controlled Trial

Visual analog scale (VAS) will be assessed and compared between the two groups.

The postoperative day in which patients reach the "ready to discharge" status will be recorded and compared between the two groups.

Ospedale San Raffaele

M.D.

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils	NCT01943409	Obstruction Cancer Ileus Malnutrition Surgery	Intralipid ClinOleic	18 Years -	University Health Network, Toronto
Study Comparing Conventional and Fast Track Multi-Discipline Treatment Interventions for Colorectal Cancer	NCT01080547	Length of Stay Complications Adverse Drug Ev... Quality of Life Hospital Costs	Laparoscopic Su... XELOX Chemother... mFolfox6 chemot... Fast Track Peri... Conventional Pe... Open Surgery fo...	18 Years -	Zhejiang University
The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection	NCT01612975	Pleural Effusio... Pleural Effusio...	Naproxen Placebo	18 Years - 100 Years	McMaster University
The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection	NCT01612975	Pleural Effusio... Pleural Effusio...	Naproxen Placebo	18 Years - 100 Years	McMaster University
The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection	NCT01612975	Pleural Effusio... Pleural Effusio...	Naproxen Placebo	18 Years - 100 Years	McMaster University
Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML	NCT02485353	Leukemia, Myelo...	Vosaroxin and C...	60 Years -	Indiana University
Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery	NCT02647047	Secondary Malig... Liver Diseases Liver Neoplasms	Spinal analgesi... Epidural analge... Transversus Abd... Surgical wound ... Acetaminophen Ketorolac Ropivacaine Sufentanil Ropivacaine Ropivacaine	18 Years -	Ospedale San Raffaele
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

Spots Global Cancer Trial Database for length of stay