Clinical Trials Logo

Filter by:
NCT ID: NCT03524092 Active, not recruiting - Ulcerative Colitis Clinical Trials

A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

LUCENT 2
Start date: October 19, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).

NCT ID: NCT03522025 Active, not recruiting - Clinical trials for Osteoarthritis, Knee

GMK-UNI Anatomical UKA: Fixation of Cemented vs Cementless Designs

Start date: February 15, 2019
Phase: N/A
Study type: Interventional

Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis over a 5-year time period.

NCT ID: NCT03518086 Active, not recruiting - Ulcerative Colitis Clinical Trials

An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Start date: June 18, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

NCT ID: NCT03516981 Active, not recruiting - Clinical trials for Advanced Non-Small Cell Lung Cancer

A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with quavonlimab (MK-1308), favezelimab (MK-4280), or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either quavonlimab, favezelimab, or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB.

NCT ID: NCT03510858 Active, not recruiting - Colorectal Cancer Clinical Trials

Randomized Controlled Trial on Colorectal Cancer Screening Among Quality Circles of Primary Care Physicians

Start date: March 14, 2018
Phase: N/A
Study type: Interventional

In Switzerland, colorectal cancer (CRC) is the third most common cause of death from cancer with 1600 persons dying from CRC each year. CRC screening can prevent most of these deaths. If screening begins at age 50, with either colonoscopy or faecal immunological test (FIT), the absolute risk of dying from CRC at age 80 can be cut in half. The choice between CRC screening methods can be seen as preference-sensitive condition. FIT can detect CRC at a similar rate as colonoscopy, but cannot detect as many polyps and advanced polyps as colonoscopies. Colonoscopy would seem the best choice for patients who want to reduce their risk of developing CRC or dying from CRC, but colonoscopy is an invasive procedure with rare but serious adverse effects. Patients who choose FIT do not need to prepare their bowels, or take a day off, but instead sample their own stool at home and mail the test to the laboratory. Offering the choice of test might also increase overall screening rates. Guidelines from the US Services Task Force (USPSTF) suggest shared decision making as a method for increasing adherence to screening and elicit patients' preferences for screening options. Family physicians are recognized as the most trusted professional to discuss CRC screening in Switzerland. However, many primary care physicians (PCPs) appear to prefer colonoscopy over FIT, and the preferred method seems to vary widely between regions. Physician preferences and local medical culture likely determine these choices more than patient preference. It may be possible to reduce the number of PCPs who prescribe only one screening method by encouraging them to diagnose their patient's preferences for screening method. In Switzerland, training PCPs with educational support and decision aids increased the number who intend to prescribe both screening modalities in equal proportions (prescription of both colonoscopy and FIT in equal proportions). To implement the intervention and determine how and if it changes PCP practice over time, the study will be conducted in quality circles (QCs) of PCPs. QCs are usually groups of 6 to 12 PCPs who meet regularly to reflect on their practice. QCs are a multifaceted, step-based intervention for quality improvement that has gained international traction because they can foster long-lasting behaviour change. In Switzerland, 80% of all PCPs attend QC regularly. Through QCs following the principles of Plan-Do-Check-Act (PDCA) quality improvement cycles, PCPs can find ways to lower structural barriers to screening, assess their screening practices, and give each other feedback. The study hypothesizes that providing PCPs with evidence summaries on CRC screening, decision aids for patients, and sample FIT tests will increase the number of patients screened for CRC, better balance the selection of screening methods (colonoscopy vs. FIT), increase the proportion of patients with whom PCPs discuss CRC testing, and increase the number of patients who make decision for or against CRC screening. The outcomes in PCPs of QCs allocated to the intervention group will be compared to those in the control group. The outcomes will be measured through anonymous structured patient data collected on 40 consecutive patients by PCPs and questionnaires filled by PCPs. To ensure that relevant outcomes important for future implementation and dissemination works are collected, the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework will be followed for structuring the data collection. The RE-AIM framework helps structure the collection of data on the characteristics of the participants invited who finally participate in the study (Reach), on the integration of the planned intervention in their work (Adoption), on the consistency of implementation of the planned intervention by study participants (Implementation), on the maintenance of the intervention effects over time (Maintenance), and finally, on the effectiveness of the intervention on the planned outcomes (Effectiveness). The RE-AIM criteria are useful for identifying the translatability and public health impact of this intervention, and for making clear to future stakeholders the internal and external validity of study results. This study will test the benefits of a multilevel training program in participatory medicine designed to help PCPs in Switzerland to better diagnose patient preferences for screening and method of screening method (colonoscopy or FIT) through. If the program is successful it will increase the proportion of patients who can decide to undergo testing or not and with which method. This should increase in number of patients who are screened or intend to be screened for CRC, and thus reduce CRC deaths in the longer term.

NCT ID: NCT03503799 Active, not recruiting - Clinical trials for Estrogen Receptor Positive Tumor

Reaching for Evidence-baSed Chemotherapy Use in Endocrine Sensitive Breast Cancer

RESCUE
Start date: July 17, 2018
Phase:
Study type: Observational [Patient Registry]

Systematic assessment of survival data of patients who have been tested with EndoPredict®; prospective proof that patients with low risk classification by EndoPredict® (EPclin) can safely forgo chemotherapy and be treated with endocrine therapy alone.

NCT ID: NCT03499236 Active, not recruiting - Heart Failure Clinical Trials

Reducing Lung CongestIon Symptoms in Advanced Heart Failure

RELIEVE-HF
Start date: September 19, 2018
Phase: N/A
Study type: Interventional

The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

NCT ID: NCT03498521 Active, not recruiting - Clinical trials for Cancer of Unknown Primary Site

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

CUPISCO
Start date: July 10, 2018
Phase: Phase 2
Study type: Interventional

This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy.

NCT ID: NCT03475134 Active, not recruiting - Metastatic Melanoma Clinical Trials

TIL-ACT After NMA Chemo With IL-2 and Nivo Rescue in Metastatic Melanoma (mMEL)

Start date: February 21, 2018
Phase: Phase 1
Study type: Interventional

This is a single center, single arm phase I trial to test the feasibility and safety of Tumor- Infiltrating Lymphocyte-Adoptive Cell Therapy (TIL-ACT) followed by nivolumab rescue in unresectable locally advanced or metastatic melanoma patients. The trial is based on lymphodepleting chemotherapy followed by ACT, utilizing ex vivo expanded TILs in combination with high dose interleukin-2 (IL-2) (optional, depending on patient's tolerance), followed by nivolumab rescue (if indicated) for a maximum duration of 2 years.

NCT ID: NCT03474107 Active, not recruiting - Bladder Cancer Clinical Trials

A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

Start date: June 27, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy. In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.