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NCT ID: NCT04288570 Active, not recruiting - Rotator Cuff Tears Clinical Trials

Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain

Punch/Drill
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

To determine if different techniques used in the creation of suture anchor socket creation can influence post-op pain following rotator cuff repair.

NCT ID: NCT04288089 Active, not recruiting - Breast Neoplasms Clinical Trials

A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer

Start date: April 1, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estrogen receptor-positive (ER+) HER2- breast cancer.

NCT ID: NCT04287868 Active, not recruiting - Cervical Cancer Clinical Trials

Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies

Start date: June 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Background: More than 30,000 cases of human papillomavirus (HPV) associated cancers occur annually in the United States. When these cancers spread, they do not respond well to standard treatments and are often incurable. Researchers want to see if a mix of drugs can help. Objective: To learn if a mix of immunotherapy drugs can shrink tumors in people with HPV associated cancers. Eligibility: People ages 18 and older with locally advanced or metastatic HPV associated cancer, such as cervical cancers; cyclin-dependent kinase inhibitor 2A (P16+) oropharyngeal cancers; anal cancers; vulvar, vaginal, penile, and squamous cell rectal cancers; or other locally advanced or metastatic solid tumors (e.g., lung, esophagus) that are known HPV+ cancers Design: Participants will be screened with: - medical history - disease confirmation (or tumor biopsy) - physical exam - body scans (computed tomography (CT), magnetic resonance imaging (MRI), and/or nuclear) - blood tests - electrocardiogram (to measure the electrical activity of the heart) - urine tests. Participants will get PDS0101 injected under the skin every 4 weeks for 6 doses. Then they will get it every 3 months for 2 doses. Participants will get M7824 (MSB0011395C) by intravenous infusion every 2 weeks. For this, a needle is inserted into a vein. The drug is given over a 1-hour period. Participants will get NHS-IL12 injected under the skin every 4 weeks. Participants will get the study drugs for up to 1 year. They will visit the NIH every 2 weeks. They will repeat the screening tests during the study. About 28 days after treatment ends, participants will have a follow-up visit or telephone call. Then they will be contacted every 3 months for 1 year, and then every 6 months after that, for the rest of their life. Patients with cervical cancer with prior pelvic radiation and boost brachytherapy will be enrolled in a separate cohort to evaluate safety and preliminary evidence of efficacy...

NCT ID: NCT04287621 Active, not recruiting - Asthma Clinical Trials

Registry of Asthma Patients Initiating DUPIXENT®

RAPID
Start date: March 2, 2020
Phase:
Study type: Observational [Patient Registry]

The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life. This includes characterization of: - Patient demographics (eg, gender, age, and race) - Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height) The secondary objectives of the study are: - To characterize real-world use patterns of DUPIXENT® for asthma - To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting - To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT® - To collect long-term safety data on study participants in the real-world setting

NCT ID: NCT04286555 Active, not recruiting - Hypertension Clinical Trials

Dietary Approaches to Stop Hypertension for Diabetes

DASH4D
Start date: June 2, 2021
Phase: N/A
Study type: Interventional

The objective of the DASH4D trial is to determine the effects, alone and combined, of (a) the DASH4D diet (a DASH-style diet modified for people with diabetes) vs. comparison diet that is typical of what many Americans eat and (b) lower sodium intake vs. higher sodium intake on blood pressure (BP). The core design is a single-site, 4-period, crossover feeding study with 5-week periods. Participants are fed each of four isocaloric diets, presented in random order. The primary contrast of interest is DASH4D diet with lower sodium vs. comparison diet with higher sodium.

NCT ID: NCT04286386 Active, not recruiting - Clinical trials for Prostate Adenocarcinoma

Development and Evaluation of a Quantitative HP MRI for Clinical Prostate Cancer Exam

Start date: December 19, 2019
Phase:
Study type: Observational

This trial examines if a prostate magnetic resonance spectroscopic imaging can be performed on a 3T scanner using an investigational contrast called hyperpolarized 13-C pyruvate for the development of a clinical prostate cancer exam. 3T refers to the strength of the magnetic resonance spectroscopic imaging (MRSI) machine. MRSI is a magnetic resonance imaging (MRI) technique that can show certain chemical differences in healthy and diseased prostate tumor tissue compared to standard multiparametric MRI that may not detect the tumor. Hyperpolarized (HP) 13-C pyruvate is a contrast drug that may help the scanner see the tumor site better during imaging. Hyperpolarization of 13-C pyruvate may allow pyruvate and its metabolites to be detected upon injection, which in turn, allow the prostate cancer to be found and treated.

NCT ID: NCT04286321 Active, not recruiting - Clinical trials for Nutritional Requirements

Achieving Nutritional Adequacy Of Vitamins E and K With An Egg/Plant-Based Food Pairing - Study 2

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Malnutrition of the fat-soluble nutrients vitamin E (α-tocopherol; αT) and vitamin K (phylloquinone; PQ) is problematic. Since αT and PQ are rich in plant foods (e.g. spinach) that are mostly absent of accessible lipid, dietary patterns that can potentiate αT and PQ bioavailability by pairing vegetables with lipid-rich foods have been emphasized. The purpose of this study is to use deuterium-labeled spinach (containing stable isotopes of αT and PQ) to validate eggs as a dietary tool to improve αT and PQ bioavailability directly from a model plant food, and hence achieve nutrient adequacy. It is expected that compared with deuterium-labeled spinach alone, co-ingestion of eggs will increase plasma bioavailability of spinach-derived deuterium-labeled αT and PQ without affecting time to maximal concentrations or half-lives. Further, phospholipid-rich egg yolk lipid will enhance nutrient bioavailability compared with vegetable oil. The outcomes will serve as the foundation for easy-to-implement message of public health importance in support of whole eggs and egg whites as part of a plant-based dietary pattern.

NCT ID: NCT04285671 Active, not recruiting - Clinical trials for Stage IVA Lung Cancer AJCC v8

Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer

Start date: January 29, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ib/II trial studies the side effects and best dose of trastuzumab and necitumumab together with osimertinib, and to see how well they work for the treatment of stage IV non-small cell lung cancer that is EGFR-mutated, resistant to osimertinib, and has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as trastuzumab and necitumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and necitumumab together with osimertinib may work better than osimertinib alone in treating patients with stage IV EGFR-mutated non-small cell lung cancer.

NCT ID: NCT04285567 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia (CLL)

A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation

CRISTALLO
Start date: May 28, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale [CIRS]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).

NCT ID: NCT04285398 Active, not recruiting - Clinical trials for Retinitis Pigmentosa

Prospective Natural History Study of Retinitis Pigmentosa

PHENOROD2
Start date: February 12, 2020
Phase: N/A
Study type: Interventional

This is natural history study of rods and cones degenerations in patients with Retinitis Pigmentosa (RP) caused by pathogenic mutations in RHO, PDE6a or PDE6b gene mutations.