We Partner 4 Research

This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.

Type: Interventional

Start Date: Apr 2024

open study

This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Type: Interventional

Start Date: Mar 2022

open study

This research will explore the effect of the Transcendental Meditation® Technique on migraine intensity and frequency. It will be a single-arm pilot study involving 30 female participants recruited from migraine treatment facilities and support groups in the US.

Type: Interventional

Start Date: Nov 2024

open study

This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with/without support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 182 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be the number of successful self-managed pessary removal events completed over the six-month time frame. Secondary outcomes will include validated surveys to assess quality of life, adverse events and satisfaction with treatment. Specific Aims Aim 1: To compare number of self-management events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 2: To assess successful fitting, number of refitting visits, and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 3: To compare satisfaction with treatment and quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.

Type: Interventional

Start Date: Nov 2024

open study

The goal of this clinical study is to learn more about the study drug, obeldesivir (ODV; GS-5245), and how safe and effective it is in treating nonhospitalized adults with acute respiratory syncytial virus (RSV) infection. The researchers want to see if obeldesivir can help participants' symptoms get better faster. The primary objectives of this study are to evaluate the efficacy of ODV in reducing the duration of symptoms and to evaluate the safety and tolerability of ODV in nonhospitalized adult participants with acute RSV infection.

Type: Interventional

Start Date: Oct 2024

open study

The goal of this clinical trial is to to inhibit the anterior insula (AI) with low intensity focused ultrasound (LIFU) to determine the causal role for the AI in pain processing, anxiety, and opiate cue-induced craving. The main question[s] it aims to answer are: - the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorder (OUD), anxiety, and chronic back pain - the effects of LIFU vs sham on measures of pain processing, anxiety symptoms, and opiate cue-induced craving Participants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham.

Type: Interventional

Start Date: Apr 2024

open study

The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.

Type: Observational

Start Date: Sep 2024

open study

This is a randomized, open-label, phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy radiotherapy.

Type: Interventional

Start Date: Sep 2024

open study

The purpose of this study is to evaluate the efficacy and safety of verekitug (UPB-101) in participants with severe asthma. The study will evaluate the incidence of asthma exacerbations, other pharmacodynamic (PD) parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo.

Type: Interventional

Start Date: Feb 2024

open study

OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of this Registry is to assess effectiveness and safety outcomes of subjects who undergo embolization with Obsidio.

Type: Observational [Patient Registry]

Start Date: Jun 2024

open study

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to approximately 51 months administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will have variable duration ranging from approximately 27 to 51 months. - The study intervention duration will vary ranging from approximately 12 to 51 months. - The number of scheduled visits will be up to 27 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.

Type: Interventional

Start Date: Dec 2023

open study

Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will compare MK-2870 sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive MK-2870 sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy.

Type: Interventional

Start Date: Dec 2023

open study

Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes. In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of type 1 diabetes. The study treatment finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is approved for doctors to prescribe to people with CKD and type 2 diabetes. In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured. Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with: - medical problems (also called treatment-emergent adverse events (TEAEs)) - serious TEAEs. An TEAE is considered 'serious' when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important - higher than normal blood levels of potassium (hyperkalaemia). Depending on the treatment group, the participants will either take finerenone or placebo, Importantly, the participants will also continue to take their regular SOC medicines. The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, they will visit the study site at least 6 times. The study team will: - collect blood and urine samples - check the participants' vital signs such as blood pressure and heart rate - do a physical examination including height and weight - check the participants' heart health by using an electrocardiogram (ECG) - do pregnancy tests in women of childbearing potential

Type: Interventional

Start Date: Feb 2024

open study

The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Type: Interventional

Start Date: Nov 2022

open study

The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end. Primary Objective: To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab. Secondary Objective: To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment. To assess the long-term safety and tolerability of ibalizumab. Other Objectives: To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll.

Type: Observational

Start Date: Mar 2022

open study

ELiPSE-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety, pharmacokinetics, and preliminary efficacy of CNTY-101 in participants with relapsed or refractory cluster of differentiation (CD)19-positive B-cell malignancies.

Type: Interventional

Start Date: Jan 2023

open study

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Type: Interventional

Start Date: Mar 2022

open study

Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.

Type: Interventional

Start Date: May 2022

open study

The objective of the ROWAN clinical study is to assess the efficacy of local tumor control in HCC patients who receive TheraSphere followed by durvalumab and tremelimumab.

Type: Interventional

Start Date: Nov 2023

open study

The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death.

Type: Interventional

Start Date: Aug 2022

open study

This phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. They work by stopping cancer cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.

Type: Interventional

Start Date: Sep 2021

open study

Assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition.

Type: Interventional

Start Date: Jul 2022

open study

The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.

Type: Interventional

Start Date: Dec 2023

open study

The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled, parallel two-arm study aimed to determine if automated exchange blood transfusion and standard of care administered to high mortality risk adult SCD patients reduces the total number of episodes of clinical worsening of SCD requiring acute health care encounters (non-elective infusion center/ER/hospital visits) or resulting in death over 12 months as compared with standard of care.

Type: Interventional

Start Date: Feb 2020

open study

This phase I/II trial studies the best dose and side effects of peposertib and to see how well it works with avelumab and hypofractionated radiation therapy in treating patients with solid tumors and hepatobiliary malignancies that have spread to other places in the body (advanced/metastatic). Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving peposertib in combination with avelumab and hypofractionated radiation therapy may work better than other standard chemotherapy, hormonal, targeted, or immunotherapy medicines available in treating patients with solid tumors and hepatobiliary malignancies.

Type: Interventional

Start Date: Apr 2020

open study