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NCT ID: NCT05327790 Recruiting - Ulcerative Colitis Clinical Trials

LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

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

To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.

NCT ID: NCT05327647 Recruiting - Clinical trials for Non-Muscle Invasive Bladder Cancer

A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer

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

This is a phase II randomized controlled clinical trial comparing standard induction BCG versus bicalutamide and standard induction BCG among patients with non-muscle invasive bladder cancer.

NCT ID: NCT05327530 Recruiting - Clinical trials for Locally Advanced or Metastatic Urothelial Carcinoma

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

Start date: August 17, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.

NCT ID: NCT05327127 Recruiting - NASH Clinical Trials

Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis

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

A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).

NCT ID: NCT05326334 Recruiting - Clinical trials for Glioblastoma, IDH-wildtype

THERApeutic Outcomes Related to Gut microBIOME in Glioblastoma (GBM) Patients Receiving Chemo-radiation (THERABIOME-GBM)

THERABIOME-GBM
Start date: March 2, 2023
Phase:
Study type: Observational

This is a pilot or feasibility study to test the study plan and to find out whether enough participants will join a larger study and accept the study procedures. Eligible participants (adults with newly diagnosed glioblastoma multiforme [GBM] and had a good tumour resection [>= 70% of initial tumour volume] and plan to receive 6 weeks of chemoradiation followed by up to 6 months of chemotherapy) are asked to donate their own stool samples at 4 different time points during their treatment course. Participants will also complete a 7-day diet diary and two questionnaires about their health-related quality of life. Glioblastoma multiforme (GBM) is the most common and aggressive form of primary brain cancer in adults. The current best evidence-proven treatment for GBM includes maximum safe tumour resection, brain radiation over a 6-week period given with chemotherapy pills called temozolomide (Brand name: Temodal or Temodar), followed by approximately 6 months / cycles of temozolomide. Despite these treatments, the average life expectancy is generally less than 2 years. Researchers are recognizing that the immune system has an important role in directing the effectiveness of chemotherapy, radiation, and newer therapies such as immunotherapies. Some immunotherapies have been quite successful in improving cancer control and survival in other cancers like melanoma (an aggressive skin cancer), but when these drugs were given to patients with GBM, there appeared to only be a small effect. Therefore, finding ways to make existing and new treatments work better should be a priority. Recent scientific studies have shown that the bacteria that make up our stool, often referred to as the gut microbiome, play a major role in regulating the immune system. For example, researchers were able to make patients with melanoma who previously did not respond to immunotherapy become responsive to the treatment after receiving a stool transplant from responders to immunotherapy. This provides proof of concept that we could modify the body's immune environment to favour cancer killing by changing a person's gut bacteria environment. The role of the gut bacteria in patients with brain cancer is poorly understood as very few studies have been published about it in this population. We believe that understanding the composition of the gut microbiome and how it relates to the effectiveness and side effects of treatments in GBM patients will be an important first step to understanding how we can modify the gut microbiome to improve outcomes for patients living with GBM.

NCT ID: NCT05325866 Recruiting - Solid Tumors Clinical Trials

A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

FORTITUDE-301
Start date: September 23, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.

NCT ID: NCT05325177 Recruiting - Clinical trials for Patent Ductus Arteriosus After Premature Birth

PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.

Start date: June 1, 2022
Phase: Phase 4
Study type: Interventional

Babies who are born very prematurely are often born with murmurs in the heart. In preterm babies, one of the most common causes of murmur is the presence of a PDA. This is the persistence of a connection that normally exists in the baby before it is born, connecting between the major blood vessels that leave the heart. In term babies, this channel closes shortly after birth when normal adult circulation is achieved. However, in preterm babies, the PDA can remain open, which can lead to multiple problems in the baby. Our current standard of treatment in the Neonatal Intensive Care Unit (NICU) is to perform cardiac ultrasound (echocardiogram) in all babies less than 29 weeks gestation to diagnose the presence of hsPDA. We also use an echocardiogram to follow the PDA until complete closure. If present, the standard treatment in the NICU is to give medication, usually Ibuprofen, a non-steroidal anti-inflammatory drugs (NSAID), to close the PDA. Near-infrared spectroscopy (NIRS) is a new type of device to detect oxygenated blood supply to the brain, kidney, and abdominal regions. This device is used to assess the effects of Ibuprofen on oxygen supply to these three regions.

NCT ID: NCT05324826 Recruiting - Clinical trials for Temporomandibular Joint Disorders

Effectiveness of Handheld Ultrasound for Diagnosing Patients With TMD

Start date: May 16, 2022
Phase:
Study type: Observational

The aim of this research is to add to the limited body of knowledge comparing the effectiveness of ultrasound (US) to MRI diagnoses in patients with TMJ disorders. More specifically, we will review the efficacy of handheld US devices, which has not yet been done to the author's knowledge.

NCT ID: NCT05323253 Recruiting - Clinical trials for Recurrent Squamous Cell Carcinoma

A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma

Start date: September 21, 2022
Phase: N/A
Study type: Interventional

This is a multi-center clinical study enrolling up to 86 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy, as well as to assess the Duration of Response (DOR) 6 months from initial response. Secondary objectives are to assess the safety of DaRT, and to assess the progression free survival (PFS), overall survival (OS), Overall Duration of Response (O-DOR), local control and quality of life (QOL) for patients treated with DaRT.

NCT ID: NCT05320224 Recruiting - Critical Illness Clinical Trials

Feasibility & Acceptability of a Patient-Oriented Music Intervention to Reduce Pain in the Intensive Care: A Pilot Trial

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

Introduction Many patients experience pain in the intensive care unit (ICU) despite receiving pain medication. Research has shown that music can help manage pain. Music interventions that have been studied so far have not been based on patient preferences, recommended tempo and duration, nor used music streaming. It is important that a music intervention take into consideration the expertise of ICU patients, family members and nurses/orderlies. Study objectives This study aims to evaluate the feasibility and acceptability of a new patient-oriented music intervention (POMI) to reduce pain in ICU patients. In addition, the aim is to evaluate the feasibility of conducting a crossover randomized controlled trial (RCT) to test the interventions in the adult ICU. A secondary objective will be to examine the preliminary efficacy of the POMI. Methodology/Study Design A single-blind 2x2 crossover pilot RCT will be used to evaluate the feasibility, acceptability, and preliminary efficacy of the POMI. Patients will undergo a sequence of two intervention periods: the POMI and the Active Control intervention (ACI; headphones/pillow without music). Patients will be randomly assigned to Sequence 1 or Sequence 2, where patients in Sequence 1 receive the POMI during the first intervention period, followed by the ACI in the second intervention period; and patients in Sequence 2 receive the ACI first, followed be the POMI (with a 4-hour washout period). Before the turning procedure, music will be stopped, and the headphones will be removed. For patients able to self-report, the music (or control period without music) will be delivered either via headphones or a music pillow, depending on their individual preference. For patients unable to self-report, music (or control period without music) will be delivered via the music pillow. Twenty-four patients (12 patients able to self-report their pain and 12 patients unable to self-report) will be recruited. The 12 patients able to self-report will be asked about their music preferences and to complete an acceptability questionnaire (AQ). For the 12 patients unable to self-report, 12 family members will be recruited to answer questions on the patient's music preferences and to complete an AQ. In addition, 12 nurses/orderlies (involved in the turning procedure for a patient participant) will be recruited and asked to complete an AQ.