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NCT ID: NCT05071209 Active, not recruiting - Clinical trials for Refractory Malignant Solid Neoplasm

Elimusertib for the Treatment of Relapsed or Refractory Solid Tumors

Start date: December 22, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial tests the safety, best dose, and whether elimusertib works in treating patients with solid tumors that have come back (relapsed) or does not respond to treatment (refractory). Elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT05070858 Recruiting - Clinical trials for Generalized Myasthenia Gravis

A Study to Examine the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients With Symptomatic Generalized Myasthenia Gravis

NIMBLE
Start date: December 14, 2021
Phase: Phase 3
Study type: Interventional

The primary objective is: To evaluate the effect of pozelimab + cemdisiran on daily functioning that is impacted by signs and symptoms in patients with symptomatic generalized myasthenia gravis (gMG) The secondary objectives of the study are: - To evaluate the effect of pozelimab + cemdisiran (ie, combination) and cemdisiran monotherapy on: - Clinician-assessed signs of myasthenia gravis (MG) and muscle strength - Daily functioning that is impacted by signs and symptoms in patients with symptomatic gMG (cemdisiran monotherapy only). - Proportion of patients with improvements in daily function that is impacted by signs and symptoms of MG - Proportion of patients that have improvements in clinician-assessed signs of MG and muscle strength - Health related quality of life - Proportion of patients with minimal MG symptoms - Patient- and clinician-reported signs and symptoms of MG - To evaluate the safety and tolerability of pozelimab + cemdisiran and cemdisiran monotherapy - To assess the concentration of total pozelimab in serum - To assess the concentrations of cemdisiran and its metabolites in plasma - To assess the immunogenicity of pozelimab - To assess the concentration of total C5 in plasma - To assess the immunogenicity of cemdisiran - To study the effect of pozelimab + cemdisiran and cemdisiran monotherapy on complement activation

NCT ID: NCT05070845 Recruiting - Clinical trials for Primary Immune Thrombocytopenia

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

Start date: February 2, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (>3 months and ≤12 months), or chronic (>12 months) ITP

NCT ID: NCT05070624 Active, not recruiting - Clinical trials for Neuromuscular Diseases

The Peer Support Study

Start date: September 15, 2022
Phase: N/A
Study type: Interventional

Competent family caregivers (FC) are essential for successful caring for individuals with NMD. However, family caregiving is known to contribute to significant FC burden and social isolation, and negatively affects FC health. Infrastructure to support FCs is paramount to ensure that individuals with NMD can safely remain at home. Individuals with NMD have complex health problems, require a lot of care and they use the healthcare system often. COVID-19 physical distancing has increased the care burden and social isolation for many FCs. Infrastructure to support FCs is paramount to ensure that individuals with NMD can safely remain at home. Peer support includes emotional and informational support by an individual that has experienced a similar health problem. It improves health-related quality of life, increases self-efficacy and empowerment, and decreases stress in various patient and caregiver populations. With our study we plan to educate and empower individuals with NMD and their caregivers and develop a comprehensive peer support program.

NCT ID: NCT05070078 Recruiting - Lumbar Discectomy Clinical Trials

The Single Assessment Numeric Evaluation (SANE) for Lumbar Discectomy

Start date: November 10, 2021
Phase:
Study type: Observational

In the last several decades, many Patient Reported Outcomes Measures (PROMs) have been developed to provide assessment of patient health across multiple domains, as they relate to various spine conditions. However, many of the available PROM surveys have many questions and require substantial time to complete and/or assess one focal domain of health requiring multiple tools to achieve an overall assessment of well-being. Thus, concerns have arisen regarding patient survey fatigue and data integrity. The Single Assessment Numeric Evaluation (SANE) is a single-question outcome measure that asks patients to rate their function, as it pertains to the area being treated, on a scale of 0 to 100. The SANE score has excellent acceptance in some orthopedic surgery research, where it has been shown responsiveness similar to more comprehensive legacy measures. The SANE thus eliminates survey fatigue and has been validated across a spectrum of orthopedic subspecialties. To our knowledge, however, the SANE has never been studied in a patient population undergoing any type of spinal surgery. Thus, we set out to compare the SANE score in patients undergoing lumbar discectomy to currently utilized PROM scores, including the Oswestry Disability Index (ODI), Zurich Claudication Scale (ZCS), and short form-36 (SF-36).

NCT ID: NCT05069558 Recruiting - Stroke Clinical Trials

Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion

OCCLUFLEX
Start date: April 30, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZERâ„¢ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE).

NCT ID: NCT05069142 Completed - Inguinal Hernia Clinical Trials

Peri-Operative Rehab Program for Inguinal Hernia Repair Surgery

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Inguinal hernia repair is one of the most common surgeries, with more than 20 million performed globally each year. It is estimated that approximately 15% of patients undergoing inguinal hernia repair will experience persistent post-surgical pain that could last months to years. Evidence from related procedures indicates that better surgical preparation through pre-operative exercise and education (i.e. Prehabilitation) followed by ongoing post-surgical rehabilitation leads to more rapid recovery, return to activities and lower likelihood of persistent post-surgical pain. The investigators will determine the feasibility of a peri-operative rehabilitation program (pre- and post-surgery) and our study protocol for patients undergoing inguinal hernia repair surgery. The investigators hypothesize that: 1) our peri-operative intervention will be feasible and safe to undertake within a clinical setting; 2) adequate numbers will be enrolled to justify a larger trial; and that 3) our outcome measurement protocol will provide meaningful information with high response rate and low attrition after 3 months.

NCT ID: NCT05068700 Completed - Nursing Clinical Trials

Integrated Pulmonary Index for Nurse-administered Procedural Sedation

Start date: April 22, 2022
Phase: N/A
Study type: Interventional

Implementing capnography into practice for respiratory monitoring during sedation is considered a high priority by leading authorities in Canada and internationally. The Canadian Anesthesiologists' Society's position statement recommends that capnography should be available wherever moderate or deep sedation is used. The Academy of Medical Royal Colleges (UK) Standard and Guidance report on Safe Sedation Practice for Healthcare Procedures noted that while capnography is not a mandated practice, providers should consider implementing capnography as a long term goal. These recommendations are in place because sedated patients who are not monitored with capnography have frequent undetected, and therefore untreated, respiratory depression. Of note, though, these guidelines do not provide specific recommendations for how capnography should be implemented for nurse-administered sedation. The aim of this study is to determine if smart alarm guided treatment of respiratory depression using the Integrated Pulmonary Index is an effective way to implement capnography during nurse-administered sedation. The primary outcome is the number of seconds in an alert condition state without an intervention being applied. The IPI is intended to reduce the cognitive burden of synthesizing multiple sources of physiological monitoring input and hence lowering the threshold for triggering intervention by clinicians to support respiration. The primary outcome directly measures this concept by quantifying the time taken for an alert to trigger an intervention. Higher values of the primary outcome will result from either a problem state that should have triggered an intervention but did not, or an 'inappropriate' alert (i.e. an alert that was not important enough to warrant immediate intervention.)

NCT ID: NCT05068531 Recruiting - Clinical trials for Colorectal Cancer Metastatic

Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients

eDetect-mCRC
Start date: September 1, 2022
Phase:
Study type: Observational

In North America, colorectal cancer patients with resectable liver-restricted metastases (mCRC-LR) are treated with approximately 6 months of preoperative systemic multi-agent chemotherapy. Actuarial data however supports that approximately 20% of mCRC-LR patients can be cured without as much systemic chemotherapy. Prospective phase II-III trials also support that awaiting recurrence to initiate further metastases-targeted or systemic treatment may provide patients with longer overall survival while avoiding toxicities in those without recurrence.

NCT ID: NCT05068284 Terminated - Crohn's Disease Clinical Trials

A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease

AIM-CD
Start date: January 31, 2022
Phase: Phase 2
Study type: Interventional

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active CD. Adverse events and change in the disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide. The study is compromised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.