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NCT ID: NCT03329430 Completed - Foot Clinical Trials

Custom Foot Orthoses & Venous Status

Start date: November 5, 2017
Phase: N/A
Study type: Interventional

The purpose of the research is to compare the influence of customized foot orthoses use on the venous status among healthy female and male subjects. This is a quasi-experimental study which included 20 healthy subjects. Sociodemographic and medical record data are registered. Furthermore,venous function is evaluated by plethysmography, first, without orthoses and, after 20 days, with orthoses.

NCT ID: NCT03324880 Completed - Hypoparathyroidism Clinical Trials

A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)

Start date: January 24, 2018
Phase: Phase 4
Study type: Interventional

Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve symptoms in adults with hypoparathyroidism. In this study, participants will receive 1 of 2 treatments: rhPTH(1-84) or a placebo. A placebo looks like the medicine being studied but does not have medicine in it. In this study, the placebo will be a standard treatment which is either active Vitamin D, or active Vitamin D with calcium. Active Vitamin D is a form of vitamin D that has a faster effect on the body. These treatments will be given as a daily injection just under the skin. Participants will not know which treatment they received, nor will their study doctors. This is to help make sure the results are more reliable. All participants will also take active vitamin D and calcium supplements during treatment. Participants will record their symptoms in a tool called the hypoparathyroidism symptom diary. This tool is used to assess symptoms and their impact and will give an overall score for each participant. The study doctors will also check for side effects from the study treatments. After treatment, researchers will check if there is any difference in the diary scores between the 2 treatment groups. A difference in score means there is a difference in symptoms and their impact. From this, researchers will learn if symptoms have improved for participants treated with rhPTH(1-84) compared with those treated with placebo.

NCT ID: NCT03323489 Completed - Pain Clinical Trials

Celiac Plexus Radio-Surgery for Pain Management

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

Many cancer patients, especially those with pancreatic cancer, suffer from severe lower back / upper abdominal pain. This pain is often poorly managed with standard treatments; the doses of painkiller required often induce side effects, whereas nerve block procedures (where a needle is deeply inserted into the back) are both invasive and of limited benefit. This clinical trial investigates a unique novel approach in which high-dose radiation (radiosurgery) is focused on the offending nerve bundle (the celiac plexus) in the posterior abdomen. Preliminary results from a single institution pilot trial are very promising: pain relief is substantial and side effects minimal. In this multi-center clinical trial, patients will be accrued and receive treatment at several international locations. Main aim of the study: Establish the safety and efficacy of the treatment in the multi-center setting. This trial will bring pain relief to cancer sufferers and improve current acceptable standard of care. The trial resonates with the Gateway mission of promoting new treatments that directly benefit people living with cancer, enhancing their wellbeing, and consequently decreasing the fear associated with a cancer diagnosis.

NCT ID: NCT03321981 Completed - Clinical trials for Breast Cancer Metastatic

MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.

Start date: January 15, 2018
Phase: Phase 2
Study type: Interventional

A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2. MCLA-128 (zenocutuzumab) is given in combinations in two metastatic breast cancer (MBC) populations, Human Epidermal Growth Factor Receptor (HER) 2-positive/amplified (Cohort 1) and Estrogen Receptor-positive/low HER2 expression (Cohort2). Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially zenocutuzumab is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet. The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet. In Cohort 2 zenocutuzumab is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.

NCT ID: NCT03320655 Completed - Clinical trials for Chronic Heart Failure

Effectiveness of Combined Aerobic and Strength Training in Acute and Chronic Adaptations in Patients With Heart Failure

Start date: October 9, 2017
Phase: N/A
Study type: Interventional

Patients with chronic heart failure (CHF) underwent to a hospital-based cardiac rehabilitation (CR) program in the Lisbon district Hospitals will be recruited. The participants will be randomized into one of the following exercise groups: A) combined exercise training with more aerobic training and less strength training (CAT); B) combined exercise training with more strength training and less aerobic training (CST). The investigators will test two proportions in combined training, CAT and CST. There hasn't been any data on the so called combined regimes, which include both aerobic exercise with HIIT and ST and the investigators will evaluate the effects of acute and chronic response. The research project will contribute to a better understanding in several aspects that are unexplained by scientific research.

NCT ID: NCT03320252 Recruiting - Clinical trials for AAA - Abdominal Aortic Aneurysm

Endurant CHevAr New Indication Trial: ENCHANT

ENCHANT
Start date: October 26, 2017
Phase:
Study type: Observational

The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.

NCT ID: NCT03319667 Active, not recruiting - Plasma Cell Myeloma Clinical Trials

Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant

IMROZ
Start date: December 7, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: -To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant. Secondary Objectives: - To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms: - Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria. - Minimal residual disease (MRD) negativity rate in patients with CR. - Very good partial response or better rate, as defined by the IMWG criteria. - Overall survival (OS). - To evaluate the overall response rate (ORR) as per IMWG criteria. - To evaluate the time to progression (TTP) overall and by MRD status. - To evaluate PFS by MRD status. - To evaluate the duration of response (DOR) overall and by MRD status. - To evaluate time to first response (TT1R). - To evaluate time to best response (TTBR). - To evaluate progression-free survival on next line of therapy (PFS2). - To evaluate the sustained MRD negativity >12 months rate. - To evaluate safety. - To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only). - To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (IVRd and crossover arms). - To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.

NCT ID: NCT03316833 Suspended - Clinical trials for Coronary Artery Disease

The Rolex Registry (Revascularization Of LEft Main With Resolute onyX)

Rolex
Start date: November 1, 2017
Phase:
Study type: Observational

The primary objective of this study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of unprotected left main coronary artery disease (ULMCAD), both isolated or in association with two- or three-vessel coronary artery disease.

NCT ID: NCT03315143 Terminated - Heart Failure Clinical Trials

Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

SCORED
Start date: December 19, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.

NCT ID: NCT03313180 Completed - Clinical trials for Lung Diseases, Interstitial

A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis

Start date: November 27, 2017
Phase: Phase 3
Study type: Interventional

The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).