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About 329,800 results

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
https://clinicaltrials.gov/ct2/show/NCT03412565

Sep 9th, 2022 - The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected...

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study
https://clinicaltrials.gov/ct2/show/NCT02997228

Sep 30th, 2022 - PRIMARY OBJECTIVE: I. To determine the efficacy, based on progression-free survival (PFS), of fluorouracil, oxaliplatin, and leucovorin calcium (modified [m]FOLFOX6)/bevacizumab plus atezolizumab (combination) as compared to single agent atezolizumab. SECONDARY OBJECTIVES: I. To compare the overall survival. II. To compare the objective response rates (ORR) per Response Evaluation Criteria in S...

Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
https://clinicaltrials.gov/ct2/show/NCT04708782

Sep 30th, 2022 - Study RIN-PF-301 is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of inhaled treprostinil in subjects with IPF over a 52-week period. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo. All subjects will initiate inhaled treprostinil or placebo at a dose of 3 breaths administered 4 times daily (QID) and will...

Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment
https://clinicaltrials.gov/ct2/show/NCT04438265

Sep 30th, 2022 - The lumbar square block is an interfascial block of the posterior wall of the abdomen, initially described for the management of postoperative pain in abdominal surgery due to its suggested effect on the T7-11 roots. The analgesic efficacy of type 1 lumbar square block (QL1) in hip surgery was subsequently published. Regarding chronic pain, QL2 has been successfully performed in posttherniorrha...

MARGetuximab Or Trastuzumab (MARGOT)
https://clinicaltrials.gov/ct2/show/NCT04425018

Sep 30th, 2022 - This is a randomized open-label phase II trial comparing paclitaxel/margetuximab/pertuzumab (TMP) to paclitaxel/trastuzumab/pertuzumab (THP) in patients with anatomic stage II-III HER2 positive breast cancer. The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits. Participants wil...

Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants
https://clinicaltrials.gov/ct2/show/NCT04718181

Sep 30th, 2022 - Part 1 of the study is an exploratory comparison of the relative oral bioavailability of the two dispersible tablets versus risdiplam powder for oral solution as the reference. The effect of food on the bioavailability of the two dispersible tablets will be assessed by comparing fed and fasted states in a five-way crossover manner. It will also be assessed whether antacids (omeprazole) have an ...

Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma
https://clinicaltrials.gov/ct2/show/NCT04639843

Sep 30th, 2022 - Background: T-cell lymphomas (TCLs) are a heterogeneous group of lymphoid malignancies defined by clonal proliferation of post-thymic T lymphocytes. Patients with newly diagnosed TCLs are most commonly treated with a CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone)-like regimen, with less than 30% having durable complete responses (CRs). Of the chemotherapy agents used, doxorubi...

Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis
https://clinicaltrials.gov/ct2/show/NCT05413304

Sep 30th, 2022 - Background Diffuse midline gliomas are the most aggressive brain tumors of childhood and young adults, with documented 2 year survival rates of <10%. These tumors are infiltrative midline high-grade gliomas. Treatment failure is due in part to the presence of the blood-brain barrier (BBB), which limits permeability of varied agents. Efforts to evaluate drug delivery across the BBB in midline gl...

To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects
https://clinicaltrials.gov/ct2/show/NCT05413161

Sep 30th, 2022 - This will be a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects. The study objectives will be to compare the pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate safety and immunogenicity of the Test product Vs. US-LICENSED XOLAIR and Test product Vs. EU-APPROVED XOLAIR following single subcutaneous ...

Study of Denosumab for Prevention of Skeletal Disease Progression in Children With Fibrous Dysplasia
https://clinicaltrials.gov/ct2/show/NCT05419050

Sep 30th, 2022 - Study Description: This will be a phase 2, open label, single arm study of denosumab treatment to prevent fibrous dysplasia (FD) lesion progression in children. Objectives: Primary Objective: Evaluate the effect of denosumab on FD lesion progression in children. Secondary Objectives: Evaluate the effects of denosumab on FD lesion activity. Evaluate the effect of denosumab on strength and mobili...

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies
https://clinicaltrials.gov/ct2/show/NCT05442515

Sep 30th, 2022 - Background: Despite improvements in therapy, acute lymphoblastic leukemia (ALL) contributes to significant morbidity and mortality for children and young adults with cancer. CD19-CAR and CD22-CAR therapy have proven highly effective in inducing remission in patients with relapsed/refractory disease. Immune escape has been observed by several groups following CD19-CAR and CD22- CAR therapy for B...

Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer, PAPMET2 Trial
https://clinicaltrials.gov/ct2/show/NCT05411081

Sep 30th, 2022 - PRIMARY OBJECTIVE: I. To compare progression-free survival in participants with metastatic papillary renal cell carcinoma (mPRCC) randomized to cabozantinib S-malate (cabozantinib) with atezolizumab versus cabozantinib alone. SECONDARY OBJECTIVES: I. To compare overall survival in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone. II. To compare Resp...

Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
https://clinicaltrials.gov/ct2/show/NCT05417425

Sep 30th, 2022 - The study will have three phases: screening, treatment and healing confirmation. The screening phase is to determine eligibility of subjects and chronicity of the diabetic foot ulcer and will include off-loading. The treatment phase begins with assessment to confirm continued eligibility and if met, subjects will be treated weekly with the Omeza combination therapy and standard of care to conti...

The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Condition...
https://clinicaltrials.gov/ct2/show/NCT05436418

Sep 30th, 2022 - Background: Post-transplantation cyclophosphamide (PTCy) reduces rates of severe acute and chronic graft-versus-host disease (GVHD) after allogeneic hematopoietic cell transplantation (HCT) and safely facilitates human leukocyte antigen (HLA)-haploidentical HCT When clinically translated, the dose (50 mg/kg) and timing (days +3 and +4) of PTCy used were partly extrapolated from murine major his...

Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD
https://clinicaltrials.gov/ct2/show/NCT05439616

Sep 30th, 2022 - Autism spectrum disorder (ASD) consists of deficits in social, communication, and cognitive development, repetitive and stereotypic behaviors. Many ASD patients show notably high levels of irritability, including verbal and physical aggression, self injury, and/or property destruction. Autistic infants tend to avoid eye contact and show little interest in others. This study will assess how safe...

Intra-pemetrexed Alone or Combined With Concurrent Radiotherapy for Leptomeningeal Metastasis
https://clinicaltrials.gov/ct2/show/NCT05305885

Sep 30th, 2022 - In this randomized, open-label, multicenter clinical trial, we aim to compare the efficacy and safety of intrathecal pemetrexed combined with concomitant involved-field radiation therapy and intrathecal pemetrexed alone for leptomeningeal metastasis patients from solid tumor. Patients were randomly divided into two arms willing to receive involved-field radiation therapy combined with concurren...

Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma
https://clinicaltrials.gov/ct2/show/NCT05286827

Sep 30th, 2022 - Background: Pancreatic Acinar Cell Carcinoma (PACC) is a rare pancreatic tumor, representing 0.5-1% of all pancreatic malignancies. PACC is commonly advanced at presentation and median overall survival in this population is poor. PACC is pathologically and biochemically distinct from pancreatic adenocarcinoma. No clinical trials for PACC have ever been reported. Patients are most commonly treat...

Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer
https://clinicaltrials.gov/ct2/show/NCT05284552

Sep 30th, 2022 - This is an open randomized controlled clinical pilot trial (Phase II). The study includes women with the International Federation of Obstetrics and Gynecology (FIGO) stage III-IV EOC selected for neoadjuvant chemotherapy (NACT) and without signs of thromboembolic disease or ongoing treatment of thromboembolic disease. The women will be allocated 1:1 to treatment with tinzaparin 4500 IU/8000 IU ...

A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure
https://clinicaltrials.gov/ct2/show/NCT05285813

Sep 30th, 2022 - Primary Objectives: AML MRD cohort: To determine the MRD negativity rate after 4 cycles of vibecotamab in patients with AML with MRD MDS post-HMA cohort: To determine the response rate (defined as CR + marrow CR [mCR] + partial remission [PR] + hematologic improvement [HI]) after 4 cycles of vibecotamab in patients with MDS after HMA failure Secondary Objectives: To assess other efficacy endpoi...

Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors
https://clinicaltrials.gov/ct2/show/NCT05284214

Sep 30th, 2022 - This open label, randomized study will evaluate safety and tolerability of sargramostim when combined with an ipilimumab-containing regimen received as part of standard of care therapy. The study will evaluate 2 sargramostim administration schedules. Patients will be randomized 1:1 to the sargramostim administration schedules and stratified based on planned dose of ipilimumab (1 mg/kg, 3 mg/kg)...