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NCT05241873
This is a Phase 1/2, open-label first-in-human study of the safety, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of BLU-451 monotherapy and BLU-451 in combination with platinum-based chemotherapy (carboplatin and pemetrexed). All participants will receive BLU-451 on a 21-day treatment cycle.
NCT02245867
The purpose of this study is to examine the tolerance, safety, pharmacokinetics, and possible clinical benefit of the good manufacturing practice (GMP)-grade amyloid fibril-reactive chimeric (Ch) IgG1 mAb 11-1F4 in patients with amyloid light-chain (AL) amyloidosis. The phase 1a part will involve at least 3 patients and a maximum of 18 patients. The first patient will receive the starting dose of the antibody and, if tolerated, the following patients will each receive (if tolerated) progressively higher doses of the antibody. Patients in part 1a of the trial will receive only one infusion of the drug. Patients treated in the phase 1a part receive lower dosage which might not be effective. Once the maximal tolerated dosage is established during the phase 1a part, the investigators will accrue patients to the phase 1b part of the trial. Patients will receive 4 infusions, once each week for 4 weeks. Patients who were treated in the part 1a of the trial and showed no toxicity can be also treated in the part 1b of the trial. The first patient will receive the starting dose of the antibody and, if tolerated, the following patients will each receive (if tolerated) progressively higher doses of the antibody. When the investigators reach the maximum tolerated dose without toxicity, the investigators will enroll another 4 patients to receive the same dose. If there are no toxicities, another 4 patients will be treated at the next dose level, and so forth. Patients treated in Phase 1b may receive lower dosages which might not be effective. The goal of Phase 1b is to establish the tolerance and possible beneficial effects of 11-1F4. If successful, treatment with this antibody would represent a novel approach in the care of individuals with AL amyloidosis.
NCT03611621
The rationale for the current protocol is to collect data from extended follow up in subjects that have received a kidney transplant following imlifidase dosing to provide a better understanding regarding the long-term outcome for these subjects. Data of parameters such as patient and graft survival, comorbidity, treatment of graft rejection episodes and quality of life as well as anti-drug antibody levels will be collected. This prospective, observational follow up study of subjects who have received imlifidase prior to kidney transplantation will provide important data to future prescribers and patients of the potential long-term benefits of imlifidase mediated transplantation.
NCT05184452
Part A: The purpose of this part of the study is to understand how the body's immune system responds to a new lab-made antibody against HIV. The study is looking to see if the way the antibody is given affects the immune response. The study will also look at whether the antibody is safe to give to people and does not make them too uncomfortable. Part B: The purpose of this part of the study is to understand how the body's immune system responds to lab-made antibodies against HIV when they are given in combination at different doses. The study also wants to see if the way the antibodies are given affects the immune response.
NCT06817941
The purpose of this study is to develop innovative home therapy games to train the weak arm and improve speech intelligibility (clarity) of children with hemiplegia from cerebral palsy. The investigators are exploring the effects of these therapy games and how they change the children's speech, hand movement, and brain activation. 15 children who are 8-17 years old will be recruited for this study. These children should have a diagnosis of cerebral palsy, mild to moderate speech issues but use speech as the primary mode of communication, mild to moderate movement difficulty and muscle spasticity, adequate hearing (pass a hearing screening), and be able to follow simple task-related directions. Children who have severe vision impairment that limits the child's ability to interact with the entire computer screen, have severe arm weakness so they cannot move their arm enough to interact with the computer games, have severe increase in tone in their weak arm, or have difficulty following instructions or paying attention to computer video games for at least 10 minutes cannot participate in this study. The therapy games will take 8 weeks to finish at home. Each child will play these games for 30 minutes each day, 5 days per week. In addition, children will come to the lab 4 times for speech and hand movement assessment: (1) 1st assessment takes place immediately before the child start to play the video games. (2) 2nd assessment takes place 4 weeks (midpoint) after the child starts to play the games. (3) 3rd assessment takes place immediately after the video games are finished. (4) 4th assessment takes place 6 weeks after the video games are finished. Each assessment should take about 2 hours to complete in the Rutgers movement lab or at Rutgers SLP Clinic. A total of 15 children will take part in this research study. The research will last for 2 years overall.
NCT06810687
Stress urinary incontinence (SUI) affects at least 40% of women in the United States. Synthetic polypropylene mid-urethral slings (MUS) are the gold standard treatment for SUI. Post-operative urinary tract infections (UTI) are one of the most common complications after MUS placement. Some studies have demonstrated that MUS placement can increase the risk of UTI up to 21-34%. Post-operative UTI can lead to significant healthcare and patient burden. This additional burden further contributes to an estimated annual cost of $1.6 billion for UTI management in the United States. With increased antibiotic usage, there is simultaneous increase in bacterial resistance leading to treatment refractory UTI. The investigators prescribe post-operative antibiotics prophylactically for 3 days after MUS placement with or without concurrent pelvic reconstructive surgery based on prior literature recommending post-operative prophylaxis. There is a greater emphasis on limiting antibiotic use given the trend of development of bacterial resistance. There are studies supporting alternatives such as methenamine for recurrent UTI prophylaxis treatment, but there are limited studies evaluating methenamine for UTI prophylaxis after MUS.
NCT05853822
The objective of this study is to see whether a home-use penile constriction device, Firmtech Tech Ring, can be determined to be superior to the Giddy device through evaluation of Leikert scale scores to assess ease of use and participant comfort and satisfaction with erectile quality with these devices. The primary outcome will be the satisfaction with use of the device as assessed through the Leikert scores. The other outcomes will be secondary.
NCT06074055
The goal of this randomized clinical trial is to compare frozen embryo transfer protocols in patients undergoing a second frozen embryo transfer (FET) after a unsuccessful first programmed FET cycle as a possible treatment for people undergoing infertility treatment. The purpose of this research study is to: * Determine if there is a difference between FET protocols in patients who require a second FET cycle. * Investigate if switching the FET protocol after a failed programmed cycle is beneficial for patients undergoing a second FET cycle. * Examine pregnancy outcomes including obstetrical and neonatal outcomes (if applicable) * Obtain uterine flexibility/stiffness measurements via transvaginal ultrasound prior to the embryo transfer procedure. This is called shear wave elastography. Participants will be randomized in their second FET transfer attempt to either another programmed protocol or a modified natural protocol.
NCT01219361
Couples who have created excess embryos while undergoing IVF procedures, and who do not wish to transfer those embryos or donate them to another couple may donate the extra embryos to research. The embryos are then used to develop improved laboratory techniques and conditions as well as testing the proficiency of laboratory staff.
NCT01223092
The purpose of this this study is to use DNA screening strategies to identify genes and localize genomic regions that are differentially expressed in patients with infertility to further understand the genetic basis for reproductive competence.
NCT05229900
This study will test the safety of a drug called SGN-ALPV in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have three parts. Parts A and B of the study will find out how much SGN-ALPV should be given to participants. Part C will use the dose and schedule found in Parts A and B to find out how safe SGN-ALPV is and if it works to treat solid tumor cancers.
NCT02667873
Study SL-801-0115 is a dose-escalation study evaluating multiple doses and schedules of orally administered SL-801 in participants with advanced solid tumors.
NCT02187848
Primary Objectives: * To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W). * To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle). * To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without a loading dose at Cycle 1. Secondary Objectives: * To characterize the overall safety profile of SAR408701. * To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives. * To identify the recommended phase 2 dose (RP2D) of SAR408701. * To assess the potential immunogenicity of SAR408701.
NCT03646604
The objective of this study is to evaluate the safety, pharmacokinetics and tolerability of multiple doses of upadacitinib in pediatric participants with severe atopic dermatitis and to evaluate palatability of upadacitinib oral solution in pediatric participants.
NCT06132035
This will be a randomized, comparative, parallel, clinical study to assess initial safety and tolerability of CG-P5 peptide eye drops compared to placebo in patients diagnosed with age-related wet macular degeneration
NCT04980872
This is a study of the safety and tolerability of oral miransertib (MK-7075) administered to participants at least 2 years of age with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-related overgrowth spectrum (PROS) or Proteus Syndrome (PS). This is an extension of other miransertib studies (MK-7075-002 \[NCT03094832\] or ArQule CU/EAP \[NCT03317366\]), and may also enroll participants who are approved for MK-7075-002 but have not yet started miransertib therapy.
NCT01828112
The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.
NCT04093362
This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of participants with advanced, metastatic, or recurrent unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements
NCT05065970
Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN
NCT04927234
The multicentre randomised geko™ Foot and Ankle Trial will prospectively and systematically collect clinical data on patients randomised, on a 1:1 basis, to either standard care or standard care plus geko™ therapy to assess oedema management and patient outcomes during a follow-up period of up to three months post-surgery.
