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NCT ID: NCT06055608 Recruiting - Kidney Transplant Clinical Trials

Advancing Transplantation Outcomes in Children

ADVANTage
Start date: May 22, 2024
Phase: Phase 2
Study type: Interventional

This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months.

NCT ID: NCT06055270 Recruiting - Parosmia Clinical Trials

Stellate Ganglion Block With Lidocaine for the Treatment of COVID-19-Induced Parosmia

Stella
Start date: February 15, 2024
Phase: Phase 3
Study type: Interventional

Chronic olfactory dysfunction, both hyposmia and parosmia, from the COVID-19 pandemic is a growing public health crisis, affecting up to 1.2 million people in the United States. Olfactory dysfunction significantly impacts one's quality of life by decreasing the enjoyment of foods, creating environmental safety concerns, and affecting one's ability to perform specific jobs. Olfactory loss is also an independent predictor of anxiety, depression, and mortality. Recent research suggests that parosmia, more so than hyposmia, can increase anxiety, depression, and even suicidal ideation. While the pandemic has advanced the scientific community's interest in combating the burgeoning health crisis, few effective treatments currently exist for olfactory dysfunction. Persistent symptoms after an acute COVID-19 infection, or "Long COVID" symptoms, have been hypothesized to result from sympathetic nervous system dysfunction. Stellate ganglion blocks have been proposed to treat this hyper-sympathetic activation by blocking the sympathetic neuronal firing and resetting the balance of the autonomic nervous system. Studies before the COVID-19 pandemic have supported a beneficial effect of stellate ganglion blocks on olfactory dysfunction, and recent news reports and a published case series have described a dramatic benefit in both olfactory function and other long COVID symptoms in patients receiving stellate ganglion blocks. A previous pilot study using stellate ganglion blocks of 20 participants with persistent COVID-19 olfactory dysfunction resulted in modest improvements in subjective olfactory function, smell identification, and olfactory-specific quality of life, but it lacked a control group. Therefore, we propose a double-blinded, placebo-controlled, randomized clinical trial assessing the efficacy of a stellate ganglion block with Lidocaine versus saline injection in up to 50 participants with persistent COVID-19-associated olfactory dysfunction.

NCT ID: NCT06055075 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Start date: December 12, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). The study consists of two phases: a dose exploration phase and a dose-expansion phase.

NCT ID: NCT06054620 Recruiting - Interventional Clinical Trials

The Effect of Exercise and Presleep Nutrition on Muscle Connective Tissue Remodelling

Start date: September 15, 2023
Phase: N/A
Study type: Interventional

The primary objective of this study will be to determine the influence of a presleep vitamin C-enriched, collagen-modelled supplement (CVC) on the metabolic fate of dietary glycine using a [2H5]glycine tracer within the intramuscular connective tissue at rest and after a bout of resistance exercise. Other outcomes will be related to regulation collagen remodelling in skeletal muscle.

NCT ID: NCT06054555 Recruiting - Melanoma Clinical Trials

A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

Start date: November 2, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

NCT ID: NCT06054477 Recruiting - Clinical trials for Head and Neck Cancer

Study of ALE.C04 in Patients With Head and Neck Cancer

Start date: October 30, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety profile of ALE.C04 monotherapy and in combination with pembrolizumab, to characterize pharmacokinetics profile of ALE.C04, recommended Phase II dose (RP2D) for ALE.C04 in combination with pembrolizumab and as monotherapy and to assess anti-tumor activity of ALE.C04 monotherapy and in combination with pembrolizumab in patients with Head and Neck Cancer.

NCT ID: NCT06053827 Active, not recruiting - Fertility Disorders Clinical Trials

Natural Frozen Embryo Transfer (FET) vs Substituted Frozen Embryo Transfer (FET)

Start date: September 19, 2023
Phase:
Study type: Observational

In frozen embryo transfer substituted cycles, patients are treated with progesterone and estrogen in an attempt to mimic the natural cycle and a transfer is planned whenever the endometrium is ready. In contrast, in frozen embryo transfer natural cycle patients are not taking any hormones, only triggered with hCG (human chorionic gonadotropin) when a dominant follicle is ready or they wait for the disappearance of the dominant follicle to plan the transfer date. Some doctors and centres shift towards using the substituted protocol in an attempt to make scheduling easier with less frequent ultrasounds. This study will aim to compare clinical and biochemical pregnancy rates in patients who underwent frozen embryo transfers in natural cycles vs substituted cycles at the centre.

NCT ID: NCT06052683 Recruiting - Prostate Cancer Clinical Trials

A Trial Evaluating Toxicity of SBRT and LDRB in Localized Prostate Cancer.

Start date: September 30, 2019
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare SBRT (Stereotactic Body RadioTherapy) to LDRB (Low-Dose Rate Brachytherapy with Iodine-125 seed implant) in patients with low and favourable intermediate-risk prostate cancer. The two main questions it aims to answer are : 1. Does SBRT (Stereotactic Body RadioTherapy) for low and intermediate risk prostate cancer patients will result in less genito-urinary (GU) and gastro-intestinal (GI) toxicities than LDRB (Low-Dose Rate Brachytherapy)? 2. Does prostate cancer patients treated by SBRT have a better quality of life than patients treated by LDRB No randomized trial has yet compared LDRB to SBRT head to head.

NCT ID: NCT06052267 Recruiting - Asthma Clinical Trials

A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

Start date: August 30, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to demonstrate the efficacy of high dose and low dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs). Secondary Objectives: To evaluate the efficacy of Fp/ABS compared to ABS and the effect on systemic corticosteroid (SCS) exposure To evaluate the safety and tolerability of Fp/A BS The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 35 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria.

NCT ID: NCT06052059 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Start date: October 25, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.