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Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients

GliomaMalignant2 more

The primary objective of this study is to assess the safety and tolerability, feasibility of the NeoPep Vaccine in newly diagnosed glioblastoma (GB) patients.

Recruiting33 enrollment criteria

Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at...

Overactive Bladder

The purpose of this study is to learn about how the use of 500 mg of dried cranberry powder extract (NDS-446) changes the bacteria that normal reside in the bladder of women who don't have urinary leakage problems but do have problems with urinary urgency and frequency.

Recruiting15 enrollment criteria

Head-to-head Comparison of Single Versus Dual Antiplatelet Treatment Strategy After Percutaneous...

Left Atrial Appendage OcclusionAntiplatelet Therapy

The study will perform a randomized, head-to-head comparison between SAPT (aspirin) and DAPT (aspirin plus clopidogrel) after percutaneous LAA closure with implantation of the Amulet device (AbbottTM, Abbott Park, Illinois, US) in patients with AF. Primary outcome measure will be a net composite endpoint at 6 months including all-cause death, DRT, clinically relevant bleeding complications and ischemic events. The SAPT arm will receive aspirin alone up to 6 months, while the DAPT arm will receive DAPT for 3 months and then aspirin alone. Thus, between 3- and 6-month follow-up both groups will be given aspirin alone.

Recruiting26 enrollment criteria

Allogenic CD19-targeting CAR-γδT Cell Therapy in r/r NHL

Non Hodgkin's Lymphoma

CD19-CAR-γδT cell therapy is a cellular immunotherapy targeting CD19 to perform CAR modification on allogeneic γδT cells. In this study, a second-generation anti-CD19 CAR prototype was constructed, bearing murine FMC63 single-chain variant fragment (scFv) together with intracellular 4-1BB co-stimulatory and CD3ζ signaling domains linked by a CD8α sequence comprising the hinge and transmembrane domains. The cells were derived from the patient's relative donors or unrelated healthy donors. Human leukocyte antigen (HLA) -mismatched or partially matched or full matched are acceptable. This is a single center, prospective, open-label, single-arm, phase 1/2 study. A total of around 30 patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) will be enrolled in the study and receive allogeneic CD19-CAR-γδT cell infusion. Phase 1 (n=9 to 12) is dose escalation part, and phase 2 (n=15 to 20) is expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of allogeneic CD19-CAR-γδT cell therapy in patients with r/r B-cell NHL.

Recruiting54 enrollment criteria

Rescue Progesterone Supplementation During Frozen Embryo Transfer

Fertility IssuesEmbryo Implantation1 more

Endometrin is a progesterone supplement prescribed during in vitro fertilization (IVF) for preparation for embryo transfer. The usual dose of Endometrin is 100 mg two to three times per day in the form of an effervescent tablet to be inserted vaginally. The purpose of this research project is to evaluate the dose response of the Endometrin when determined based on the blood level of progesterone on the day of the FET. According to the literature, a predefined level of progesterone in the blood should be reached in order to have favorable conditions for pregnancy. The hypothesis being that a woman with low progesterone levels would benefit from a dose of Endometrin of 600 mg (200 mg 3x/day) to decrease the risk of miscarriage and improve the chances of pregnancy. Women with adequate progesterone levels according to the literature, would continue with the standard dose of progesterone prescribed at clinique ovo which is 300 mg (100 mg 3x/day). PIBF (Progesterone Induced Blocking Factor) levels, a protein found in the blood that could also predict pregnancy outcomes in women using IVF will also be looked at.

Recruiting21 enrollment criteria

Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment...

TuberculosisMultidrug-Resistant

Acquired drug-resistance is a major challenge for tuberculosis (TB) care programs. The 2020 WHO guidelines recommends replacing second-line injectables by bedaquiline in rifampicin-resistant TB (RR-TB) treatment regimens. However, recent reports show too high rates of acquired bedaquiline resistance. This may be explained by the delayed onset of action of bedaquiline. The investigators will study whether high-dose amikacin (a second-line injectable), administered during the first week of RR-TB treatment, is safe in 20 patients treated for RR-TB in Rwanda. If safe, further studies will assess whether adding amikacin in the first treatment week protect against acquired bedaquiline resistance. This study is embedded in an ongoing "Master study" of the ShORRT (short oral RR-TB) treatment regimen in Rwanda, a before/after study, with a retrospective cohort (before; the previously recommended second-line injectable-containing RR-TB regimen) and a prospective cohort (after: the newly recommended ShORRT regimen).

Recruiting15 enrollment criteria

Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK:...

Neurotrophic Keratopathy

The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)

Recruiting31 enrollment criteria

Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

Irritability Associated With Autism Spectrum Disorder

52-week, open-label extension study of double-blind study ACP-103-069 to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (aged 5 to 17 years). ACP-103-069 is a 6-week, randomized, double-blind, fixed-dose, placebo controlled, parallel group study of pimavanserin in children and adolescents with irritability associated with autism spectrum disorder (ASD).

Recruiting15 enrollment criteria

Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation

Critical IllnessAnticoagulation

The purpose of this study was to compare the efficacy and safety of nafamostat mesylate and unfractionated heparin during ECMO anticoagulation in critically ill patients.

Recruiting18 enrollment criteria

Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL

Anal High Grade Squamous Intraepithelial LesionAnal Precancerous Condition4 more

This is a phase II double blind, placebo-controlled, randomized study of Artesunate suppositories for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)

Recruiting19 enrollment criteria
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