Neoplasms

All Conditions

Symptoms and General Pathology

Adenoma

Pain

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Cola

Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.

Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.

Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.

Water colonoscopy

Yanglin Pan, MD

Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.

Colonoscopy has been considered the gold standard procedure in screening for colorectal disease. However, 5-10% of colonoscopies are incomplete due to patient discomfort, difficult anatomy and prior abdominal or pelvic surgery. The investigators postulate that these patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in patients with immediately failed colonoscopy.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in patients with incomplete colonoscopy. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.

Water Method in Patients With Incomplete Colonoscopy

Water Method With Water Exchange Versus Air Insufflation in Patients With Incomplete Colonoscopy: a Prospective Randomized, Controlled Trial

The proportion of participants with at least one adenoma in each group

Total time of colonoscope intubation from anus to cecum

Air Force Military Medical University, China

Associated professor

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Antineoplastic Agents

Azacitidine

Decitabine

Antimetabolites

Enzyme Inhibitors

Dose escalation part: (Drug escalation dose levels)

* Dose Level (1) - 13mg/m2 (twice a week for 3 of 4 weeks)
* Dose Level (-1) - 11 mg/m2 (twice a week for 3 of 4 weeks)
* Dose Level (2) - 13mg/m2 (twice weekly x 4 weeks)
* Dose Level (3a) - 17mg/m2 (twice weekly × 4 weeks)OR
* Dose Level (3b) - 17mg/m2 (twice a week for 3 of 4 weeks)

Birinapant

5-Azacitidine

Gautam Borthakur, MD

This is a dose escalation followed by dose expansion study of TL32711 in combination with 5-Azacitidine in subjects with Myelodysplastic syndrome who are naïve, have relapsed or have failed prior 5-azacitidine therapy. Pre-clinical and mechanistic studies support that 5-Azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.

This is a Phase 1b/2a, open-label, non-randomized study in male and female subjects with MDS who are naïve, refractory or have relapsed to 5-Azacitidine therapy.

Primary Objective is to determine the maximum tolerated dose (MTD), recommended Phase 2 dose, and pharmacodynamics (PD) of birinapant (TL32711) when administered in combination with 5-azacitidine (5 AZA) in subjects with myelodysplastic syndrome (MDS) who are naïve, refractory or have relapsed to 5-AZA therapy.

Secondary Objectives are to determine the clinical activity using the International Working Group (IWG) (Cheson, 2006) Response Criteria for MDS during the Phase 1b dose escalation stage of the study and in the Phase 2a expansion cohort, to determine the pharmacokinetics (PK) of birinapant when administered with 5-AZA in plasma and to assess exploratory translational biomarkers of anti-tumor activity of birinapant in combination therapy.

Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy

A Phase 1b/2a, Open-label, Non-randomized Study of Birinapant in Combination With 5-azacitidine in Subjects With Myelodysplastic Syndrome Who Are Naïve, Refractory or Have Relapsed to 5-azacitidine Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Water Method in Patients With Incomplete Colonoscopy	NCT01546246	Failed or Diffi... Adenoma Pain	Water colonosco...	18 Years - 80 Years	Air Force Military Medical University, China
Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy	NCT01828346	Myelodysplastic...	Birinapant 5-Azacitidine	18 Years -	TetraLogic Pharmaceuticals
Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy	NCT01828346	Myelodysplastic...	Birinapant 5-Azacitidine	18 Years -	TetraLogic Pharmaceuticals
Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy	NCT01828346	Myelodysplastic...	Birinapant 5-Azacitidine	18 Years -	TetraLogic Pharmaceuticals

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Spots Global Cancer Trial Database for failed

Every month we try and update this database with for failed 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 failed 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.