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 3B, Randomized, Double-Blind, Placebo-controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Topical Diltiazem Hydrochloride 2% Cream in subjects with Anal Fissure Principal Investigator

Trial description
Cleveland Clinic Study Number: IRB 12-132
Principal Investigator: Giovanna DaSilva, M.D
Contact Name: Canedo, canedoj@ccf.org

The PILLAR II (Perfusion In Laparoscopic Left colectomy/ Anterior Resection) Multi-Center Trial

Trial description
Cleveland Clinic Study Number: IRB 12-071
Principal Investigator: Steven Wexner, M.D
Contact Name: Canedo, canedoj@ccf.org

A Prospective, Single Arm, Multicenter, Observational Assessment of the Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)

Trial description
Cleveland Clinic Study Number: IRB 12-072
Principal Investigator: Giovanna DaSilva, M.D
Contact Name: Canedo, canedoj@ccf.org

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

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


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


Infectious Disease Trials

A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients with Clostridium Difficile Associated Diarrhea

Trial description
Cleveland Clinic Study Number: IRB 12-063
Principal Investigator: Lyssette Cardona, MD
Contact Name: Killingbeck, killinc@ccf.org


Nephrology Clinical Trials

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis

Trial description
Cleveland Clinic Study Number: IRB 12-022
Principal Investigator: Mauro Braun, M.D.
Contact Name: Formoso, formosm@ccf.org


Neurology Clinical Trials

A Phase 2, randomized, double-dummy, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-923 (dextromethorphan/quinidine) for the treatment of symptoms of agitation in patients with Alzheimer's disease

Trial description
Cleveland Clinic Study Number: IRB 12-912d
Principal Investigator: Po-Heng Tsai, M.D.
Contact Name: Formoso, formosm@ccf.org

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


Pulmonary Medicine Clinical Trials

An open-label study to explore the impact of inhaled treprostinil sodium on ventilation perfusion matching when used for treatment of group 1 pulmonary arterial hypertension in patients with concomitant chronic obstructive pulmonary disease (COPD)

Trial description
Cleveland Clinic Study Number: IRB 12-031
Principal Investigator: Frank Rahaghi, M.D.
Contact Name: Barton, bartonn2@ccf.org

Inhaled Nitric Oxide/INOPulse DS Combination Product: IK-7001-PAH-201 A Phase2, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Safety, Tolerability and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo aS Add-On Therapy in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH).

Trial description
Cleveland Clinic Study Number: IRB 12-056
Principal Investigator: Frank Rahaghi, M.D.
Contact Name: Barton, bartonn2@ccf.org

A Randomized, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension

Trial description
Cleveland Clinic Study Number: IRB 9239
Principal Investigator: Frank Rahaghi, M.D.
Contact Name: Barton, bartonn2@ccf.org

A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated with Tyvaso (treprostinil) Inhalation Solution

Trial description
Cleveland Clinic Study Number: IRB 9310
Principal Investigator: Frank Rahaghi, 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

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

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


Rheumatology Clinical Trials

DUAL-2: A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis Trial description Cleveland Clinic Study

Trial description
Cleveland Clinic Study Number: IRB 12-027
Principal Investigator: Hossam Elzawawy, M.D.
Contact Name: Barton, bartonn2@ccf.org


Urology Clinical Trials

A Multi-Center, Double-Blind Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects with Bladder Cancer

Trial description
Cleveland Clinic Study Number: IRB 12-005
Principal Investigator: Richard Macchia, M.D.
Contact Name: Killingbeck, formosm@ccf.org