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NCT ID: NCT04731623 Completed - Healthy Volunteers Clinical Trials

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION904

Start date: February 26, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of ION904.

NCT ID: NCT04731298 Terminated - Graft Failure Clinical Trials

Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After HSCT.

Start date: May 25, 2021
Phase: Phase 2
Study type: Interventional

This study is designed as an open-label, single arm, proof of concept study in order to determine the appropriate emapalumab dosing regimen neutralizing IFNγ in patients at risk of GF. Patients presenting CXCL9 levels above a defined threshold and other clinical criteria will be eligible to receive emapalumab. Both children and adults, with malignant and non-malignant underlying diseases, receiving allo-HSCT who are at high risk of GF as defined in the inclusion criteria will be included in the study. The main objective of the study is to determine the appropriate emapalumab dose regimen neutralizing interferon gamma (IFNγ) activity to pre-empt graft failure post allo-HSCT in a population with various underlying diseases and at high risk of graft failure (GF). Maximum 3 cohorts are foreseen to determine the appropriate dose regimen to pre-emptively treat patients at risk of primary GF. Emapalumab will be administered by IV infusion and treatment will last up to 56 days (15 infusions) or until evidence of engraftment. The study is expected to last approximately 3 years from screening to the last follow-up phone call for each patient.

NCT ID: NCT04730570 Completed - Maternal Distress Clinical Trials

Essential Coaching for Every Mother, a Postpartum Text Message Program for Canadian Mothers

ECEM
Start date: January 5, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a text message-based program called Essential Coaching for Every Mother which sends daily text messages during the immediate six-week postnatal period. Essential Coaching for Every Mother consists of standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health.

NCT ID: NCT04730310 Completed - Clinical trials for Regional Anesthesia, Vascular Grafting, Vascular Patency

Anesthesia Technique and Lower Limb Revascularization Patency

Start date: February 1, 2021
Phase:
Study type: Observational

The role of regional anesthesia in lower extremity revascularization procedures on reducing graft failure and need for reoperation remains unclear. In this study, we will analyze data from the multicenter National Surgical Quality Improvement Program (ACS NSQIP®) to assess the association between regional anesthesia (RA) and graft outcomes, as compared to general anesthesia (GA). Our primary objective is to determine for patients undergoing elective open lower limb revascularization, whether RA (spinal, epidural, and peripheral nerve block), compared to GA or general anesthesia with regional anesthesia (GA+RA), is associated with higher rates of patent graft within 30 days postoperatively (primary outcome).

NCT ID: NCT04730258 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML

TWT-202
Start date: April 16, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.

NCT ID: NCT04729907 Enrolling by invitation - Clinical trials for Muscular Atrophy, Spinal

Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With Nusinersen

ONWARD
Start date: April 19, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA) who previously participated in study 232SM203 (NCT04089566). The secondary objective of this study is to evaluate the long-term efficacy of nusinersen administered intrathecally at higher doses to participants with SMA who previously participated in study 232SM203 (NCT04089566).

NCT ID: NCT04729608 Terminated - Clinical trials for Platinum-resistant Ovarian Cancer

Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer

AXLerate-OC
Start date: April 22, 2021
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB-S6-500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer.

NCT ID: NCT04729387 Active, not recruiting - Ovarian Cancer Clinical Trials

Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

Start date: July 2, 2021
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of the combination of alpelisib and olaparib compared with single agent cytotoxic chemotherapy in patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected.

NCT ID: NCT04728893 Recruiting - Clinical trials for Hematologic Malignancies

Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

Start date: April 5, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).

NCT ID: NCT04728711 Completed - Atopic Asthma Clinical Trials

A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of Subjects With Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)

Start date: January 9, 2021
Phase: Phase 2
Study type: Interventional

A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of ADX-629 in Subjects with Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)