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NCT ID: NCT05347095 Recruiting - Clinical trials for Perianal Crohns Disease

A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

FUZION CD
Start date: September 27, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.

NCT ID: NCT05346887 Active, not recruiting - Cerebral Palsy Clinical Trials

Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture

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

The purpose of the study is to assess implementation and effectiveness of a caregiver-delivered rehabilitation intervention for infants and toddlers with cerebral palsy.

NCT ID: NCT05346354 Recruiting - Clinical trials for Neuromyelitis Optica Spectrum Disorder

Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD

Start date: June 23, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder (NMOSD).

NCT ID: NCT05345561 Recruiting - Clinical trials for Fetal and Neonatal Alloimmune Thrombocytopenia

Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia

Start date: March 14, 2022
Phase:
Study type: Observational

A prospective, non-interventional, natural history study to assess the occurrence of higher FNAIT risk across a broad population of different racial and ethnic characteristics and the occurrence of HPA-1a alloimmunization in these women.

NCT ID: NCT05345470 Completed - Nutrition, Healthy Clinical Trials

Dose Response Effect of Chia Seeds on Subjective Appetite and Glycemic Response

Start date: March 17, 2022
Phase: N/A
Study type: Interventional

To compare subjective appetite, satiety and glycemic responses for 3 h after consumption of investigational products containing 0, 3, 5 and 7 grams of chia seeds, controlling for energy intake. The primary objective is to compare total area under the curves (tAUC) of hunger and fullness ratings. The hypothesis is that chia seeds have a significant effect on hunger and/or fullness.

NCT ID: NCT05345171 Recruiting - OTC Deficiency Clinical Trials

Clinical Study of DTX301 AAV- Mediated Gene Transfer for Ornithine Transcarbamylase(OTC) Deficiency

Start date: October 18, 2022
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the efficacy of DTX301 on the improvement of ornithine transcarbamylase (OTC) function by maintaining safe plasma ammonia levels with removal of dietary protein restriction and alternative pathway medication.

NCT ID: NCT05345158 Recruiting - Clinical trials for Stage II Testicular Seminoma

R-RPLND as First-line Treatment for Clinical Stage IIA/B Testicular Seminoma

Start date: February 23, 2022
Phase: N/A
Study type: Interventional

This study will investigate the safety and efficacy of using robotic retroperitoneal lymph node dissection (R-RPLND), a minimally invasive surgical approach, as the first-line of treatment for stage IIA/B (or equivalent) seminoma patients. R-RPLND will be trialed as an alternative to chemotherapy, radiation therapy (for seminoma patients) and open RPLND in this study.

NCT ID: NCT05344521 Not yet recruiting - Burns Clinical Trials

A Phase I, Single-blind, Randomized Study of the Safety and Efficacy of Cellularized Integra® Using Autologous Burn-derived Stem Cells

Integra®-SC
Start date: February 2024
Phase: Phase 1
Study type: Interventional

Burn injuries are one of the most severe skin injuries and lead to a complex wound healing response. When the skin is wounded, stem cells in the skin must respond fast to help repair the injured tissue. The damaged skin of burn patients contains cells that are still alive and have typical stem cell characteristics. Because stem cells are so important for wound healing, the investigators have combined them with an existing skin substitute, Integra®, to examine the potential wound healing benefits of these stem cells. This is an investigational treatment and a first in-human trial. The purpose of this study is to test the safety of using a patient's own stem cells combined with Integra®, which the investigators call Integra®-Stem Cells (Integra®-SC). The investigators hypothesize that Integra®-SC will result in improved wound healing, better scar quality, and decreased scar formation at one-year post-injury.

NCT ID: NCT05343650 Not yet recruiting - Epistaxis Clinical Trials

NOVAPAK Nasal Packing in Shellfish Allergic Patients

Start date: March 15, 2024
Phase: Phase 4
Study type: Interventional

NOVAPAK is a sponge-like material made from materials found in shellfish. It is commonly used after nasal surgery or in nasal bleeding, as it promotes healing, decreases bleeding, and has antibacterial properties. Although NOVOPAK does not contain proteins or compounds known to be responsible for allergic reactions in people with a known allergy to shellfish, out of an abundance of caution, the manufacturer (Medtronic) has recommended avoidance in those with known shellfish allergy. There have been no reported allergic reactions in patients with shellfish allergy who were given chitosan bandages in emergencies (e.g. military applications). The study aims to investigate the safety of its use in patients with known shellfish allergy to improve healthcare quality and patient care support.

NCT ID: NCT05342402 Completed - Vestibulodynia Clinical Trials

Feasibility Study for Provoked Vestibulodynia

Start date: May 16, 2022
Phase: N/A
Study type: Interventional

The feasibility and acceptability of a somatosensory rehabilitation program and an educational pain management program will be investigated in women with provoked vestibulodynia. Forty-four women will be randomized into the two groups. The secondary objective is to explore the effects of the somatosensory rehabilitation program compared to the pain management program. Each participant will receive 12 weekly sessions with a physiotherapist. The somatosensory rehabilitation program includes minimizing contact with the painful zone of the vulva and uses repeated tactile stimulation at a tolerated distance, proximal to the vulva. The pain management program includes teaching participants about vulvar hygiene, chronic pain mechanisms, relaxation techniques, and approaches to reduce skin irritations in painful regions. Participants in both groups will also receive advice on sexual function and steps toward resuming sexual activities with vaginal penetration. Feasibility and acceptability outcomes will be assessed and analyzed using descriptive statistics for the adherence rates to treatment sessions and home exercises, the recruitment rate, retention rate, satisfaction, and adverse effects. The results will be compared to predetermined thresholds to determine the feasibility and acceptability of a future clinical trial. Secondary measures will be assessed at baseline, two weeks after the treatment, and at three months follow-up. These outcomes will be assessed using validated questionnaires (pain, sexual function, global impression of change, psychological variables, quality of life) as well as evaluations of tactile and pressure sensitivity in vulvar regions using monofilaments, a 2-point aesthesiometer and an algometer. Linear mixed models for repeated measurements (2 groups, 3 measurement times) will be used to explore the treatment effects and will contribute to determining the feasibility of a future clinical trial. Hypothesis and expected results: It is expected that both programs will meet the pre-determined criteria for acceptability and feasibility in women with provoked vestibulodynia. This study will provide guidance for a future randomized clinical trial.