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NCT ID: NCT05410782 Recruiting - Infertility, Male Clinical Trials

Power Prenatal Supplements for Sperm Quality

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

Male factor infertility is a leading cause of primary and secondary infertility. Poor sperm quality is defined as having an abnormal semen analysis [WHO 2020 - https://www.who.int/publications/i/item/9789240030787]. The effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated (https://pubmed.ncbi.nlm.nih.gov/30462179). Taking additional supplements to improve sperm quality represent a modifiable risk-factor that would be an easy intervention for patients struggling with male factor infertility. The life cycle of sperm production is estimated at 3 months, so any intervention would require a 3 month course to see its full effect. The investigators hypothesize that a 90 day course of the "Power Prenatal for Sperm", a male fertility supplement by Bird&Be (https://birdandbe.com/the-power-prenatal-for-sperm) will improve sperm quality based on semen analysis results prior to, and after taking the supplements.

NCT ID: NCT05409066 Recruiting - Clinical trials for Follicular Lymphoma (FL)

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

EPCORE FL-1
Start date: September 20, 2022
Phase: Phase 3
Study type: Interventional

Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. 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.

NCT ID: NCT05408754 Recruiting - Atrial Fibrillation Clinical Trials

Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation

PARALELL
Start date: October 20, 2022
Phase: N/A
Study type: Interventional

A prospective, two-arm, multi-center, randomized, open-label, pre-market, First-in-Human clinical study designed to provide safety and performance data regarding the use of the Adagio PFA and PFCA Systems in the treatment of PsAF.

NCT ID: NCT05408130 Recruiting - Clinical trials for Stroke, Acute Ischemic

Remote Ischemic Conditioning With Novel Optical Sensor Feedback Device in Acute Ischemic Stroke

Start date: July 7, 2022
Phase: N/A
Study type: Interventional

Stroke is a leading cause of physical and cognitive disabilities. The most common type of stroke is ischemic (lack of blood flow to the brain due to clot blocking a blood vessel). Many people with stroke (PwS) have changes on the brain imaging called small vessel disease (SVD). This is a condition that affects tiny blood vessels supplying the brain, leading to decreased blood flow in some parts of the brain. These brain changes may hamper the recovery process after stroke, or lead to recurrent stroke and cognitive impairment. SVD is a slow process that can be seen as multiple black spots on computed tomography or white spots on magnetic resonance imaging. Current treatments to reduce the effect of SVD on PwS are to control high blood pressure, high blood sugar, high cholesterol and increase physical activity. However, these approaches do not lead to a reduction in SVD. Remote Ischemic Conditioning is a type of treatment delivered with help of a regular blood pressure machine. This does not involve any drug. A typical treatment involves the application of a blood pressure cuff followed by brief sessions of compressions and relaxation on the arm muscles much akin to blood pressure measurement but for 5 min. It leads to a transient safe state of less blood flow in arm muscles which initiates the release of molecules and signals transmitted by blood. These signals may then go on to improve blood flow in the brain. Recent animal and human studies have suggested that the use of RIC may reduce the SVD load. A new device will be used to deliver remote ischemic conditioning therapy in a better manner. Existing devices generate the same amount of compression for all people. The pressure applied by the machine in the arm may be either more than required or less than required. The ideal compression would be one that achieves a low blood flow state in the arm at the least possible pressure. To achieve this our group is using a small light sensor to inform us. The light sensor is closely applied to the skin over the arm below the blood pressure cuff. It emits light that is absorbed by the skin and the light is then reflected. This is detected by other sensors placed together. From the reflected light the sensor can obtain information about blood flow in the skin. When the pressure increases with help of an automated machine the light sensor can detect that blood flow are reduced and this information is displayed on the computer. The information about skin blood flow will inform about the level of pressure to apply to give accurate treatment. The new device with optical feedback will deliver RIC in PwS and SVD in a safe and reliable manner. A total of 51 patients will take part in this study. Thirty-four will get remote ischemic conditioning therapy and 17 patients will get sham-control therapy. All patients will get standard post-stroke treatment according to the Canadian Stroke Best Practices Recommendation.

NCT ID: NCT05408065 Recruiting - Clinical trials for Shoulder Osteoarthritis

Comparison of the Analgesic Effect of 2 Shoulder Infiltrations

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

For patients suffering of osteoarthritis, only analgesic treatments such as anti-inflammatory drugs and cortisone infiltrations provide significant but temporary relief of their pain. The objective is to compare the analgesic effect of 2 infiltrations: Cingal (sodium hyaluronate and triamcinolone) versus cortisone (triamcinolone). It is anticipated that the Cingal infiltration will have a greater analgesic effect than a simple cortisone infiltration in patients with moderate to severe osteoarthritis of the shoulder. Method: - Randomized controlled trial - Monocentric - Randomization will be done using sealed envelopes

NCT ID: NCT05407636 Recruiting - Clinical trials for Wet Age-related Macular Degeneration

Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

ASCENT
Start date: December 28, 2021
Phase: Phase 3
Study type: Interventional

RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. RGX-314 is being developed as a potential one-time treatment for wet AMD.

NCT ID: NCT05406401 Recruiting - Clinical trials for Lymphoma, Large B-Cell, Diffuse (DLBCL)

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)

Start date: July 14, 2022
Phase: Phase 2
Study type: Interventional

This study consists of a dose escalation/confirmation phase and an efficacy expansion phase. The dose escalation/confirmation phase is to determine the safety and tolerability and establish a preliminary recommended Phase 2 dose (RP2D) of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease. The efficacy expansion phase is to determine the efficacy of the RP2D of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease.

NCT ID: NCT05405426 Recruiting - Clinical trials for Extracorporeal Membrane Oxygenation

Trial of Indication-Based Transfusion of Red Blood Cells in ECMO

TITRE
Start date: April 14, 2023
Phase: N/A
Study type: Interventional

TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a multicenter, prospective, randomized clinical trial. The overarching goal of TITRE is to determine whether restricting red blood cell (RBC) transfusion according to an indication-based strategy for those with bleeding and/or deficit of tissue oxygen delivery, compared with transfusion based on center-specific hemoglobin or hematocrit thresholds, can reduce organ dysfunction and improve later neurodevelopment in critically ill children receiving Extracorporeal Membrane Oxygenation (ECMO) support.

NCT ID: NCT05405361 Recruiting - Clinical trials for Multifocal Motor Neuropathy (MMN)

A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy

ARDA+
Start date: January 18, 2023
Phase: Phase 2
Study type: Interventional

This trial is an extension of the antecedent trial ARGX-117-2002. It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ARGX-117 Intravenously (IV) in adults with Multifocal Motor Neuropathy (MMN). The trial will include a double-blinded rollover treatment period (DTP), an open-label treatment period (OTP), and a safety follow-up period.

NCT ID: NCT05405114 Recruiting - Sickle Cell Disease Clinical Trials

Research Study Investigating How Well NDec Works in People With Sickle Cell Disease

ASCENT1
Start date: July 7, 2022
Phase: Phase 2
Study type: Interventional

This study examines how well a new, potential medicine called NDec works and is tolerated in people with sickle cell disease. NDec is a combination of two medicines (decitabine-tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease. Participants who are not taking Hydroxyurea (HU) will get NDec, NDec and placebo, or placebo. Participants who are on HU treatment before joining the study will get NDec, NDec and placebo, or continue on HU. Which treatment participants get is decided by chance. Participants getting NDec and/or Placebo will get capsules to take twice weekly. The study will last for about a year.