Clinical Trials

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In general, clinical trials are used to test the safety and effectiveness of drugs and medical procedures in a human population. This ongoing collaboration between physician investigators and study volunteers is one of the foundations of modern healthcare, because clinical trials help set the standards for patient care.

There are potential benefits, as well, for clinical trial volunteers. For instance, volunteers with existing diseases or conditions can play a more active role in their own healthcare, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Cancer Clinical Trials

Colorectal Surgery Clinical Trials

A Phase II, Double-Blind, Placebo-Controlled, Dose Finding Study to Evaluate the Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function in Patients Following Small or Large Bowel Resection with Primary Anastomosis

Trial description
Cleveland Clinic Study Number: IRB 9324
Principal Investigator: David Maron, M.D
Contact Name: Canedo, canedoj@ccf.org

A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection Versus Open Resection for Rectal Cancer

Trial description
Cleveland Clinic Study Number: IRB 9017
Principal Investigator: Steven D. Wexner, M.D.
Contact Name: Canedo, canedoj@ccf.org

Quality of Life in Patients That Undergo J Pouch or Side to End Coloanal Anastomosis for Rectal Cancer

Trial description
Cleveland Clinic Study Number: IRB 9114
Principal Investigator: Steven D. Wexner, M.D.
Contact Name: Canedo, canedoj@ccf.org

Laparoscopic Rectal Prolapse Surgery: An International Double Cohort Study to Compare Laparoscopic Ventral Rectopexy with Laparoscopic Resection Rectopexy

Trial description
Cleveland Clinic Study Number: IRB 9196
Principal Investigator: Steven D. Wexner, M.D.
Contact Name: Canedo, canedoj@ccf.org

Clinical Study to Investigate the Effectiveness of the TOPAS Sling System to Treat Fecal Incontinence (TRANSFORM)

Trial description
Cleveland Clinic Study Number: IRB 9209
Principal Investigator: Dana Sands, M.D.
Contact Name: Canedo, canedoj@ccf.org

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Intra- Anal Application of Iferanserin (10 mg) as a 0.5% Ointment in Subjects with Symptomatic Internal Hemorrhoids

Trial description
Cleveland Clinic Study Number: IRB 11-004
Principal Investigator: Giovanna DaSilva, M.D.
Contact Name: Canedo, canedoj@ccf.org

An Extended PaIn Relief Trial Utilizing the Infiltration of a Long Acting Multivesicular LiPosome FoRmulation Of BupiVacaine, EXPAREL: A Phase 3b Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal (IMPROVE – Ileostomy Reversal)

Trial description
Cleveland Clinic Study Number: IRB 11-041
Principal Investigator: Marylise Boutros, M.D.
Contact Name: Canedo, canedoj@ccf.org

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PHASE 3 STUDY TO COMPARE THE EFFICACY AND SAFETY OF INTRAVENOUS CXA-201 WITH THAT OF MEROPENEM IN COMPLICATED INTRAABDOMINAL INFECTIONS

Trial description
Cleveland Clinic Study Number: IRB 11-073
Principal Investigator: Giovanna DaSilva, M.D.
Contact Name: Canedo, canedoj@ccf.org

Gastroenterology Clinical Trials

SECURE A Non-Interventional Long-term Post-Marketing Registry of Patients Treated with Certolizumab Pegol (Cimzia®) for Crohn's Disease

Trial description
Cleveland Clinic Study Number: IRB 9285
Principal Investigator: Nicole Palekar, M.D.
Contact Name: Killingbeck, killinc@ccf.org

Prospective, Multicenter, Randomized, Double-Blind, Placebo Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who are at an Increased Risk of Recurrence (PREVENT)

Trial description
Cleveland Clinic Study Number: IRB 9291
Principal Investigator: Roger Charles, M.D.
Contact Name: Killingbeck, killinc@ccf.org

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

Trial description
Cleveland Clinic Study Number: IRB 11-039
Principal Investigator: Roger Charles, M.D.
Contact Name: Killingbeck, killinc@ccf.org

Geriatric Medicine Clinical Trials

Aspirin in Reducing Events in the Elderly (ASPREE)

Trial description
Cleveland Clinic Study Number: IRB 11-056
Principal Investigator: Jerry Ciocon, M.D.
Contact Name: Formoso, formosm@ccf.org

Gynecology Clinical Trials

A combined treatment program for the symptoms of urinary urgency and frequency with Toviaz and Premarin Vaginal Cream

Cleveland Clinic Study Number: IRB 11-074
Principal Investigator: Willy Davila, M.D.
Contact Name: Canedo, canedoj@ccf.org

Neurology Clinical Trials

The PROGENI Family Study

Trial description
Cleveland Clinic Study Number: IRB 11-023
Principal Investigator: Nestor Galvez-Jimenez, M.D.
Contact Name: Formoso, formosm@ccf.org

CFTY720D2403; Long-term, prospective, observational, multinational, parallel-cohort study monitoring safety in patients with MS newly started with fingolimod once daily or treated with another approved disease-modifying therapy

Trial description
Cleveland Clinic Study Number: IRB 11-047
Principal Investigator: Virgilio Salanga, M.D.
Contact Name: Formoso, formosm@ccf.org

A double blind, randomized, placebo controlled, study of the safety and efficacy of SYN115 as adjunctive therapy in Levodopa-treated Parkinson’s subjects with end of dose wearing off

Trial description
Cleveland Clinic Study Number: IRB 11-057
Principal Investigator: Nestor Galvez-Jimenez, M.D.
Contact Name: Formoso, formosm@ccf.org

Pulmonary Medicine Clinical Trials

A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects with non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX1)

Trial description
Cleveland Clinic Study Number: IRB 9323
Principal Investigator: Anas Hadeh M.D.
Contact Name: Barton, bartonn2@ccf.org

Long-Term Oxygen Treatment Trial (LOTT)

Trial description
Cleveland Clinic Study Number: IRB 08-498
Principal Investigator: Franck F. Rahaghi M.D.
Contact Name: Barton, bartonn2@ccf.org

A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline, in patients with Idiopathic Pulmonary Fibrosis (IPF)

Trial description
Cleveland Clinic Study Number: IRB 11-020
Principal Investigator: Franck F. Rahaghi M.D.
Contact Name: Barton, bartonn2@ccf.org

Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative (QuERI) Extension Program

Trial description
Cleveland Clinic Study Number: IRB 11-021
Principal Investigator: Franck F. Rahaghi M.D.
Contact Name: Barton, bartonn2@ccf.org

A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients

Trial description
Cleveland Clinic Study Number: IRB 9301
Principal Investigator: Franck F. Rahaghi M.D.
Contact Name: Barton, bartonn2@ccf.org

An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension

Trial description
Cleveland Clinic Study Number: IRB 9302
Principal Investigator: Franck F. Rahaghi M.D.
Contact Name: Barton, bartonn2@ccf.org

Radiology Clinical Trials

Randomized Evaluation of Patients with Stable Angina Comparing Utilization of Diagnostic Examinations: RESCUE

Trial description
Cleveland Clinic Study Number: IRB 11-006
Principal Investigator: Jacobo Kirsch, M.D.
Contact Name: Killingbeck, killinc@ccf.org