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A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and
Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo
and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia
Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis

3. STUDY OBJECTIVES3.1. Primary ObjectivesThe primary objectives are:• To determine if CAEL-101 and treatment for PCD improves overall survival in Mayo stage IIIa AL amyloidosis patients who are treatment naïve compared to treatment for PCD alone•…

An open label, multi-center roll-over study to assess long-term effect in pediatric patients treated with Tafinlar (dabrafenib) and/or Mekinist (trametinib)

This study has been transitioned to CTIS with ID 2023-509276-42-00 check the CTIS register for the current data. Primary:To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.Secondary:To assess the long-term…

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age with Chronic Migraine - the REBUILD-2

This study has been transitioned to CTIS with ID 2023-505835-11-00 check the CTIS register for the current data. PrimaryTo demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in an adolescent population (12 to 17…

Multiparameter vital signs monitoring validation of the Corsano CardioWatch 287-2

This study aims to validate the Corsano CardioWatch 287-2 for the continuous monitoring of heart rate at <= 4 bpm root mean squared error (RMSE); interbeat intervals at <= 50 ms RMSE; breathing rate at <= 2 brpm RMSE; and…

A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors (SABR-COMET 10)

To assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.

Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy

The primary objective of this study is to examine whether MIS is non-inferior to laparotomy in terms of disease free survival (DFS) in women with advanced stage EOC that received 3 to 4 cycles of NACT.

A PHASE IIIB, MULTICENTER, RANDOMIZED,
VISUAL ASSESSOR-MASKED STUDY OF THE
EFFECTIVENESS AND SAFETY OF A 36-WEEK
REFILL REGIMEN FOR THE PORT DELIVERY
SYSTEM WITH RANIBIZUMAB VS AFLIBERCEPT
TREAT & EXTEND IN SUBJECTS WITH
NEOVASCULAR AGE-RELATED MACULAR
DEGENERATION (DIAGRID)

This study will evaluate the effectiveness and safety of a 36-week refill regimen for the PDS with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per a treat-and-extend regimen (aflibercept…

Treating Leg Symptoms in Women with X-linked Adrenoleukodystrophy: A Key to Improving Sleep and Gait Performance

This study has been transitioned to CTIS with ID 2024-518989-27-00 check the CTIS register for the current data. Objective: Primary Aim (PHASE 1):To determine the prevalence of RLS in women with ALD.Secondary Aim (PHASE 2):To determine whether in a…

AN OPEN-LABEL MULTICENTER PHASE 2 CLINICAL SAFETY INVESTIGATION OF THE ENDOART® IMPLANTATION IN SUBJECTS WITH CHRONIC CORNEAL EDEMA

To evaluate the safety of EndoArt® in subjects with chronic corneal edema.

A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA

This study has been transitioned to CTIS with ID 2023-503793-20-00 check the CTIS register for the current data. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who…

Effect of dapaglifozin on serum magnesium in HNF1β patients with renal hypomagnesemia

This study has been transitioned to CTIS with ID 2024-518855-43-00 check the CTIS register for the current data. Primary objective: To evaluate the effect of SGLT2 inhibition with dapagliflozin 10 mg on serum magnesium in diabetic and non-diabetic…

A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia

Primary:- To evaluate the effect of suvratoxumab on reducing the incidence of nosocomial all-cause pneumonia.Secondary:- To evaluate the safety of a single IV dose of suvratoxumab.- To evaluate the effect of suvratoxumab on reducing the incidence of…

Effectiveness of L-serine dietary supplementation in children with a GRIN2B loss-of-function mutation: n-of-1 series

Assess the potential efficay of L-serine dietary supplementation in patients children with a GRIN2B LoS mutation.

A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis

3. STUDY OBJECTIVES3.1. Primary ObjectivesThe primary objectives are:• To determine if CAEL-101 and treatment for PCD improves overall survival in Mayo stage IIIb AL amyloidosis patients who are treatment naïve compared to treatment for PCD alone•…

Comparing the migration and inducible displacement through RSA of the cementless ATTUNETM Rotating Platform and the cementless LCS Rotating Platform Knee system; A Clinical Randomized Controlled RSA follow-up study*

The primary aim of this study is to accurately compare the mid and long-term migration of two uncemented total knee prostheses. The secondary objectives of this study are to evaluate whether inducible displacement can be used as a parameter to…

The use of direct nerve visualisation with the Evotouch/7starscope compared to the conventional fluoroscopy technique for transforaminal epidural injection.

We hypothesize that using the Evotouch/7stascope, ultrasound guided TFEI procedures are non-inferior to the golden standard with fluoroscopy, which means correct placement of the needle within the neuroforamen without intravascular positioning.

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age with Episodic Migraine - the REBUILD-1

This study has been transitioned to CTIS with ID 2023-505836-36-00 check the CTIS register for the current data. Main Objective:To demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in (at least) 1 of the…

HEalthy Living in Inflammatory Arthritis (HELIA trial): a randomized controlled trial comparing efficacy between an interactive, online lifestyle intervention program and general nutrition recommendations

Lifestyle intervention programs reduce inflammatory activity and might, therefore, be of added value in the management of patients with an inflammatory arthritis. Therefore, the aims of this randomized controlled trial are: 1. To compare the…

A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

Evaluate the antitumor activity of nemvaleukin alfa (*nemvaleukin*, ALKS 4230) in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancerSecondary Objectives:Evaluate the antitumor activity of…

A Phase 3 Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ISIS 721744 in Patients with Hereditary Angioedema (HAE)

Primary objective: The primary objective of the study is to evaluate the clinical efficacy of ISIS 721744 in patients with hereditary angioedema (HAE).Secondary objective: Evaluate the effects of ISIS 721744 on the quality and pattern of HAE attacks…