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NCT ID: NCT03487276 Completed - Clinical trials for Hidradenitis Suppurativa (HS)

Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

SHINE
Start date: February 26, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.

NCT ID: NCT03486938 Completed - Clinical trials for Mild Cognitive Impairment

Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease

HOPE4MCI
Start date: December 13, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of AGB101 on slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with mild cognitive impairment due to Alzheimer's Disease (MCI due to AD) also known as prodromal AD. Participants will be randomized to receive placebo or AGB101 (220 mg), once daily for 78 weeks. Secondary objectives are to assess the effect of AGB101 compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE) and Functional Activities Questionnaire (FAQ).

NCT ID: NCT03486886 Completed - Prostate Cancer Clinical Trials

PSMA-PET Imaging in Patients With Metastatic Prostate Cancer: Institutional Evaluation of Detection Yield Performance and Reproducibility

Start date: October 2, 2017
Phase: N/A
Study type: Interventional

A promising imaging technique involving new prostate specific membrane antigen (PSMA) positron emission tomography (PET) tracers is emerging in metastatic prostate cancer (PCa). This approach has demonstrated higher sensitivity in detecting metastases, prior to and during therapy, than current imaging standard of care (CT and bone scan). PSMA is expressed in the vast majority of PCa tissue specimens and its degree of expression correlates with a number of important metrics of PCa tumor aggressiveness. [18F]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. Studies employing second-generation PSMA PET/CT imaging in men with biochemical progression after definitive therapy suggest detection of metastases in over 60% of men imaged. In fact, PSMA-based PET has so far proven to have higher sensitivity than any other modality for localization of the site of recurrence. Applications that show promise and require further investigation include the characterization and risk stratification of primary PCa, complete staging of metastatic PCa to allow for PSMA-targeted radiotherapy and improved identification of patients with oligometastatic disease. The objective of this study is to explore the detection yield of PSMA-PET in a pilot cohort of patients at CHUM and establish the repeatability of the technique before investigating it more widely.

NCT ID: NCT03486834 Completed - Clinical trials for Cytomegalovirus (CMV) Infections

V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)

Start date: April 30, 2018
Phase: Phase 2
Study type: Interventional

This study evaluated the safety, tolerability, and efficacy of the cytomegalovirus (CMV) vaccine (V160) administered in a 2-dose or 3-dose regimen to healthy seronegative women 16 to 35 years of age. Participants received blinded V160 on Day 1, Month 2, and Month 6 (3-dose regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on Day 1, Month 2, and Month 6, and were followed to approximately Month 24. The primary hypothesis of the study was that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.

NCT ID: NCT03486392 Completed - Obesity Clinical Trials

A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants

Start date: March 26, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants.

NCT ID: NCT03485911 Completed - Clinical trials for Hereditary Angioedema

Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE

APeX-2
Start date: February 6, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.

NCT ID: NCT03485872 Completed - Clinical trials for Urinary Incontinence

Urinary Incontinence Self-Screen for Healthy Aging

Start date: March 11, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to increase awareness and timely treatment of urinary incontinence through a self-screening process. This is a 3 month study involving 2 activities; one taking place at the beginning of study and another 3 months later. Participants will be randomized into experimental and control groups. The experimental group will receive a demographic questionnaire, quality of life questionnaire, a questionnaire pertaining to urinary symptoms, information about how to self-screen for urinary incontinence and information regarding how to refer oneself to urinary incontinence resources. The control group will receive the demographic and quality of life questionnaires only. It is estimated that it will take participants 20-30 minutes to complete their package of questionnaires. After 3 months, the participants will receive a phone call inquiring into what actions they have taken regarding their urinary incontinence.

NCT ID: NCT03485287 Completed - Clinical trials for Posttraumatic Stress Disorder

Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada)

Start date: March 13, 2018
Phase: Phase 2
Study type: Interventional

This multi-site, open-label, Phase 2, lead-in study assesses the safety and effect of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants diagnosed with at least severe posttraumatic stress disorder (PTSD). Therapy teams that have been identified and trained to work on the sponsor's planned Phase 3 studies will treat at least one open-label participant in this study. A flexible dose of MDMA (100 to 125 mg), followed by a supplemental half-dose, unless contraindicated, is administered during the Treatment Period with manualized therapy in three open-label monthly Experimental Sessions. This ~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The primary outcome measure is the change in the Clinician Administered PTSD Scale for DSM 5 (CAPS-5) total severity scores from Baseline to Visit 19. The secondary outcome measure is the change in the customized version of the Sheehan Disability Scale (SDS) for PTSD for the MAPS studies total scores from Baseline to Visit 19.

NCT ID: NCT03484975 Completed - Clinical trials for Acute Coronary Syndrome

Novasight Hybrid Intravascular Ultrasound and Optical Coherence Tomography System (IVUS OCT)

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Collection of coronary images with a hybrid IVUS OCT system.

NCT ID: NCT03484923 Completed - Melanoma Clinical Trials

Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

PLATforM
Start date: September 10, 2018
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma