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NCT ID: NCT03563274 Terminated - Clinical trials for Liver, Cancer of, Non-Resectable

QuiremSpheres Observational Study

Hope166
Start date: June 21, 2018
Phase:
Study type: Observational [Patient Registry]

The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board.

NCT ID: NCT03562871 Completed - NSCLC Clinical Trials

IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC

Start date: August 22, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine if IO102 combined with pembrolizumab with or without chemotherapy is safe tolerable and effective in the treatment of Non-small Cell Lung Carcinoma (NSCLC). The hypothesis is that IO102 will improve the objective response rate (ORR) in patients with metastatic NSCLC.

NCT ID: NCT03562572 Recruiting - Clinical trials for Coronary Artery Disease

FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease

SLIM
Start date: June 7, 2018
Phase: N/A
Study type: Interventional

To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.

NCT ID: NCT03559699 Completed - Clinical trials for Pyruvate Kinase Deficiency

A Study Evaluating the Efficacy and Safety of AG-348 in Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)

Start date: June 26, 2018
Phase: Phase 3
Study type: Interventional

Study AG348-C-007 was a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, participants with pyruvate kinase (PK) deficiency, who were regularly receiving blood transfusions. The study was composed of two parts. During Part 1, Dose Optimization Period, participants started on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1 each participant's dose of AG-348 was sequentially increased to 20 mg twice a day, followed by 50 mg twice a day depending on their tolerance. During Part 2, Fixed-Dose Period, participants received AG-348 at their optimized dose from Part 1.

NCT ID: NCT03559517 Terminated - Crohn's Disease Clinical Trials

Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305)

CARMEN CD 305
Start date: August 29, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

NCT ID: NCT03559387 Terminated - Clinical trials for Chemotherapy-induced Neutropenia

Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia

Start date: August 3, 2017
Phase: Phase 2
Study type: Interventional

Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing Chemotherapy-Induced Neutropenia

NCT ID: NCT03559257 Completed - Migraine Clinical Trials

A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine

CONQUER
Start date: July 31, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.

NCT ID: NCT03558802 Completed - Clinical trials for Pelvic Floor Disorders

Pelvic Floor Signs and Symptoms in Women and Men

Start date: May 16, 2019
Phase:
Study type: Observational

Rationale: Pelvic floor symptoms (PFS) are prevalent and often impair quality of life. They include micturition problems, defecation problems, pelvic organ prolapse, sexual problems and genito-pelvic pain. The pelvic floor is an anatomical and functional unit, and therefore different PFS may co-occur. However, literature on prevalence of clusters of PFS is scarce. Furthermore, PFS is understudied in the male population and when studies are performed in male subjects, studies do not assess the complete scope of possible PFS. Objective: To generate a cohort, which provides information on sex- and gender differences in: prevalence and incidence of (clinically relevant clusters of) PFS, risk factors and prognostic factors for PFS, factors that reveal the impact of PFS on daily life, help seeking behavior and use of health care. Study design: Prospective observational population-based cohort study with follow-up moments after 1 year and 2 years. Data of the questionnaire will be connected to medical record data from the participating general practitioners (GPs). A representative sample of female and male subjects with and without PFS will be invited for a physical examination to assess pelvic floor disorders and muscle function. Furthermore, a subsample of patients will be invited for a qualitative study consisting of semi-structured interviews on healthcare seeking behavior, including barriers and facilitators, preferences and satisfaction. Study population: female and male subjects, aged ≥16 years of age, from the general population will be included. Exclusion criteria are: terminal disease, or dementia, cognitive impairment or current psychological condition precluding informed consent, not suitable or too ill to participate based on the judgement of the GP. Main study parameters: To evaluate the sex- and gender difference in prevalence and incidence of (clinically relevant clusters of) PFS, the following primary parameters are assessed: lower urinary tract symptoms, bowel symptoms, urogenital prolapse (females only), sexual functioning, and pain. Secondary study parameters are factors associated with the development of PFS ('risk factors'), factors that predict the course of PFS ('prognostic factors'), factors that reveal the impact of PFS on daily life, help seeking behavior, and health care use (consultations for PFS and consultation frequency, diagnostic tests, diagnoses, treatment, and referrals).

NCT ID: NCT03558724 Terminated - Esophageal Cancer Clinical Trials

Fluorescence Endoscopy of Esophageal Carcinoma

ORCA
Start date: October 29, 2018
Phase: Phase 1
Study type: Interventional

For locally advanced esophageal cancer (EC), neoadjuvant chemoradiotherapy (nCRT) for 5 weeks followed by esophagectomy and lymphadenectomy, if necessary, is standard of care. It is reported that the pathological complete response (pCR) rate after nCRT ranges from 16% to 43%, with a median of 26.5%. According to current clinical guidelines, patients who achieved pCR still go for surgery even though those patients who achieved pCR may not benefit from surgery. Besides, about 50% of EC patients may have post-operative complications including pneumonia, anastomotic leakage, recurrent laryngeal nerve paralysis, which lead to low health-related quality of life (HQoL). The golden standard to test the pathological response is by pathological assessment of the surgical specimen and thus after surgery. Theoretically, if pCR after nCRT can be predicted accurately before surgery by advanced imaging techniques, patients could have a wait-and-see. The wait-and-see procedure includes regular follow-up and salvage surgery if recurrence is present. Therefore, molecular fluorescence endoscopy (FME) using near-infrared fluorescence (NIRF) tracer bevacizumab-800CW targeting vascular endothelial growth factor combined with high-definition white light (HD-WL) endoscopy is expected to be a promising technique to monitor pCR and fill the gap.

NCT ID: NCT03557957 Active, not recruiting - Hyponatremia Clinical Trials

Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia

HIT
Start date: August 20, 2018
Phase: N/A
Study type: Interventional

Hyponatremia is the most common electrolyte disorder with a prevalence of up to 30% in hospitalized patients. While treatment of acute hyponatremia with severe clinical symptoms due to cerebral edema is undisputed and straightforward, hyponatremia in general is usually considered asymptomatic or not clinically relevant. Accordingly, a recent observational study showed that appropriate laboratory tests to evaluate the etiology of hyponatremia were obtained in less than 50% of patients, leading to 75% of patients being still hyponatremic at discharge. This is problematic in the context of increasing evidence, revealing an association of chronic hyponatremia with adverse effects such as gait alterations and falls, attention deficits, bone loss and fractures as well as disease-associated morbidity leading to increased rates of readmissions and mortality. Yet, there is a complete lack of randomized clinical trials with the primary aim to investigate whether correction of plasma sodium concentration counteracts the elevated risk of rehospitalization and mortality. The aim of this trial is therefore to determine the effects on mortality and rehospitalization rate of a targeted correction of plasma sodium concentration in addition to current standard care in hospitalized hyponatremic patients.