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NCT ID: NCT04607421 Recruiting - Neoplasms Clinical Trials

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

Start date: December 21, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: - has spread to other parts of the body (metastatic); - has a certain type of abnormal gene called "BRAF"; and - has not received prior treatment. Participants in this study will receive one of the following study treatments: - Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. - Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. - Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone. The study team will monitor how each participant responds to the study treatment for up to about 3 years.

NCT ID: NCT04605159 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

A Phase III Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers

GRACE
Start date: November 20, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study will also evaluate the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants will continue to be monitored as part of the study.

NCT ID: NCT04603001 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations

Start date: December 1, 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent isocitrate dehydrogenase (IDH) inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who may have received standard therapy

NCT ID: NCT04599920 Active, not recruiting - Colorectal Cancer Clinical Trials

Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life)

Start date: September 25, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of partial replacement of red meat with legume-based foods on gut metabolism and markers for colorectal cancer as well as markers for cardiovascular diseases and type 2 diabetes in healthy working age men. The study participants will be stratified into two groups with different amounts of red meat in diet: 1) a diet containing 760 g of cooked and boneless red meat, supplying 25% of daily protein intake and 2) a diet supplying 20% of protein intake with legume-based foods and 5% of protein intake with red meat. The participants will get all meat and and legume-based foods from the research center; otherwise they will be asked to follow their habitual diet. Blood, urine, and stool samples will be collected at the baseline and at the end of the 6 week intervention, as well as BMI, blood pressure and body composition. Nutrient intake and food consumption will be analyzed from 4-day food records at the baseline and at the end of the intervention period.

NCT ID: NCT04597125 Active, not recruiting - Clinical trials for Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH

Start date: November 9, 2020
Phase: Phase 4
Study type: Interventional

Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer. Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.

NCT ID: NCT04593251 Completed - Celiac Disease Clinical Trials

Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis

Start date: September 28, 2020
Phase: Phase 1
Study type: Interventional

This is a single and multiple ascending study to characterize the safety, PK, PD and clinical effect in healthy volunteers and participants with Celiac Disease and Eosinophilic Esophagitis.

NCT ID: NCT04590651 Enrolling by invitation - Cataract Clinical Trials

Cataract Surgery in Patients With Pseudoexfoliation and Pseudoexfoliation Glaucoma

PHACOPXG
Start date: September 11, 2020
Phase: N/A
Study type: Interventional

The study aims to document the effect cataract surgery has on the pseudoexfoliation and pseudoexfoliation glaucoma eye. Details such has patient history, history of possible glaucoma, intraocular pressure, status of the eye, operation parameters and postoperative effect will be documented. The study is prospective and randomised . Patients will be divided in to two groups: in one standard phacoemulsification cataract surgery will be preformed. In the second group the anterior chamber angel will be aspirated an extra minute at the end of the case with the IA probe. The aim is to determine weather this extra aspiration will have an effect on postoperative intraocular pressure and other parameters.

NCT ID: NCT04590313 Active, not recruiting - Hallux Rigidus Clinical Trials

Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus

HARD
Start date: September 22, 2021
Phase: N/A
Study type: Interventional

A randomised, controlled trial will be performed by allocating 40 years or older patients with symptomatic hallux rigidus to arthrodesis or watchful waiting group in a ratio of 1:1. Our primary outcome will be pain during walking, assessed by the 0-10 Numeric Rating Scale (NRS) at one year after randomisation. Our secondary outcomes will be pain in rest (NRS), physical function (MOXFQ), patient satisfaction in terms of Patient-accepted Symptom State (PASS), health-related quality of life (EQ-5D-5L), activity level (The Foot and Ankle Ability Measure Sports subscale), use of analgesics or orthoses and rate of complications. Our null hypothesis is that there will be no difference between arthrodesis and watchful waiting in treatment of hallux rigidus. Our primary analysis will be done using intention-to-treat principle.

NCT ID: NCT04588311 Recruiting - Clinical trials for Traumatic Brain Injury

ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients

EPO-TRAUMA
Start date: November 9, 2020
Phase: Phase 3
Study type: Interventional

The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients. 2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.

NCT ID: NCT04587414 Active, not recruiting - Type2 Diabetes Clinical Trials

eHealth Intervention on Physical Activity for Type 2 Diabetics - Frustrated by COVID-19

MySteps-CoV
Start date: March 6, 2019
Phase: N/A
Study type: Interventional

This pragmatic 3-arm randomized controlled trial is conducted within the primary health care setting. The trial evaluates the effectiveness of a personalized eHealth intervention based on a hip-worn accelerometer, smartphone application and cloud service (www.exced.com) with or without face-to-face and telephone counselling contacts on physical activity (PA) compared to usual care in increasing daily PA and reducing sedentary behavior (SB) among type 2 diabetes (T2D) patients.The duration of the intervention period is 6 months, after which there is a 6 month follow-up for evaluating the maintenance of anticipated intervention effects. The primary goal of the intervention is that the T2D patients increase their daily number of steps by replacing SB with low intensity PA. The secondary goal is to increase short bouts of moderate-to-vigorous PA according to personal goals. It is expected that the eHealth intervention complemented by individual counselling is the most effective in reaching the goals, and the eHealth intervention is more effective than usual care. Measurements are done at baseline, after the 6-month intervention, and after the 6-month follow-up. Participants' one-week PA and SB are measured with a hip-worn triaxial accelerometer and analyzed with validated algorithms. Cardiorespiratory fitness is assessed with a validated 6-minute walk test. Diabetes-related metabolic biomarkers (HbA1C, LDL-c, HDL-c, oxidized LDL and HDL lipids) and cardiovascular risk factors (blood pressure, BMI, waist circumference) are measured with standard laboratory methods. Quality of life is assessed by RAND-36 method. The interventions are evaluated with RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) method. Besides effectiveness, RE-AIM methods evaluates the target group reach and adherence; provider adoption; intervention fidelity; maintenance of the changes in PA and SB behavior, biomarkers and CVD risk factors; intervention transferability to clinical practice; adverse events; and patient and provider satisfaction. Unexpectedly, the COVID-19 pandemic in spring 2020 led to substantial restrictions in outdoors mobility of T2D patients and their access access to health care in Finland, facts that frustrated the planned implementation of the original intervention, related measurements and their scheduling. This means that not all planned measurements could be done at all or at the scheduled time point. Irrespective of the time of recruitment, all follow-up measurements are done from June to September 2020. Notwithstanding the COVID-19 pandemic annulled the original intervention, the collected data yet provides unique insights into measured physical activity, fitness and metabolic biomarkers of T2D patients before and during the COVID-19 pandemic and consequent restrictions.In addition, the data allows to evaluate the implementation of eHealth approach and face-to-face and telephone PA counselling contacts within the primary health care setting.