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A Study of Prevalence of HER3 Expression in Non-Small Cell Lung Cancer

The purpose of this study is to use archival tissue samples and RW data to generate HER3 expression prevalence data within the NSCLC population and by patient characteristics (e.g., ethnicity, histology, smoking status, age, prior treatment, etc.).

The primary objective of the study will analyze and assess archival tissue specimens and associated RW data to:

Increase the understanding of HER3 expression in NSCLC among HCPs and the medical community
Generate evidence to support future clinical strategies in this area

Source: View full study details on ClinicalTrials.gov

March 20, 2023ClinicalTrials.govComments OffOncologyClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine

BAL0891 in Patients With Advanced Solid Tumors

Substudy 1 (monotherapy dose-escalation cohorts) This study will be initiated with enrollment into Substudy 1 and will estimate the safety, tolerability, PK, and PD of increasing doses of BAL0891 in patients with advanced solid tumors. The starting dose will be 5 mg based on the GLP (Good Laboratory Practice) toxicology studies. Dose escalation will comprise a dose range from a dose of 5 mg up to a maximum absolute dose of 480 mg, with eight nominal dose levels (DLs) of 5 / 10 / 20 / 40 / 80 / 160 / 320 / 480 mg. Intra-patient dose escalations are only allowed for patients enrolled in single-patient DL Cohorts 1.1, 1.2, and 1.3. From DL Cohort 1.4 onwards, the projected maximum dose-escalation factor will be two-fold; if the DL cohort investigates an increased dose, dosing of the patients within the cohort must be separated by at least 7 days. For cohorts in which doses are not increased (including backfill enrollment), patients may be enrolled concurrently.

BAL0891 will be administered intravenously (IV) on Day (D) 1 and D8 every 3 weeks (Q3W); for the schedule of assessments of Regimen A. Alternative 21-day or 28-day dosing regimens may be investigated; for the schedule of assessments of Regimens B-D.

Substudies 2 and 3 (dose-escalation cohorts for combination regimens) Enrollment into Substudies 2 and 3 may commence as early as first signs of expected target toxicity and/or efficacy with Regimen A (or an alternative monotherapy regimen) have been observed, or alternatively, once the MTD of BAL0891 monotherapy has been assessed. Patients enrolled into Substudies 2 and 3 will be treated with increasing doses of BAL0891 in combination with carboplatin and paclitaxel, respectively, and dose escalation of both BAL0891 and carboplatin/paclitaxel if required will use the same cumulative BLRM-EWOC model as Substudy 1. The starting dose of BAL0891 in combination with carboplatin or paclitaxel will be a safe DL determined in Substudy 1 but not higher than approximately half the MTD. Backfill enrollment of up to a total of 30 additional patients for both substudies (who may be enrolled concurrently) may be used to better estimate the RP2D for each combination if required.

Source: View full study details on ClinicalTrials.gov

March 19, 2023ClinicalTrials.govComments OffOncologyClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine

Rock Steady Boxing: A Community Based In Person Class

The purpose of this study is to evaluate the feasibility and effectiveness of a non-contact Rock Steady Boxing class delivered to participants with Parkinson’s Disease via an in-person community-based program. The study will also assess the overall feasibility of integrating an in-person community program within a neuromuscular course in a Doctor of Physical Therapy program.
Specific Aim: To examine the effects of an in-person community-based Rock Steady Boxing class on the functional mobility, functional endurance, cardiovascular capacity, visual-motor reaction times, quality of life, mood/affect and overall physical activity completion and fear of falling on individuals with Parkinson’s Disease.

Detailed Description:
Participants will be recruited directly from the the Brain Center (non-for-profit neurology clinic). Participants will be educated on the study but advised that their participation is voluntary and researchers will not coerce boxers to participate in the study. Once a participant agrees to participate, the Informed consent will be completed. During this time, participants will be told their participation is voluntary and they can quit at any time. he primary interventions being assessed in this study include the in-person Rock Steady Boxing Class offered at USAHS once per week. Prior to attending the Rock Steady Boxing classes, all participants must be provided with medical clearance from a referring medical doctor. The Rock Steady Boxing classes are 60-90 minutes in duration and include the following 4 components: (1) active warm up (2) functional mobility exercises (3) whole body strengthening exercises and (4) non-contact boxing exercises. During the classes, boxers’ vitals are assessed using health rate monitors.

Source: View full study details on ClinicalTrials.gov

Registry for Mayo Clinic Adult Congenital Heart Disease Control Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05773300

Recruitment Status : **RECRUITING NOW**
First Posted : March 17, 2023
Last Update Posted : March 17, 2023

Sponsor:

Collaborators:

Information provided by (Responsible Party):
Alexander C. Egbe, Mayo Clinic

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Brief Summary:
This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.

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Study Type :
Observational [Patient Registry]

Estimated Enrollment :
75 participants

Observational Model:
Cohort

Time Perspective:
Prospective

Target Follow-Up Duration:
6 Months

Official Title:
Control Population for the Mayo Clinic Adult Congenital Heart Disease Registry

Actual Study Start Date :
January 6, 2022

Estimated Primary Completion Date :
January 2025

Estimated Study Completion Date :
December 2025

Resource links provided by the National Library of Medicine

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Primary Outcome Measures :

Peak Oxygen Uptake [ Time Frame: 6 Months ]
Peak Oxygen Uptake (L/min) : 1.7 ± 0.1

Peak Right Ventricular – Pulmonary Coupling [ Time Frame: 6 Months ]
Peak Right Ventricular – Pulmonary Coupling: (|%|/mmHg): 0.786 ± 0.065

Biospecimen Retention: Samples Without DNA2x1ml Whole Blood, 4x1mL plasma

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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)

Sexes Eligible for Study:
All

Accepts Healthy Volunteers:
Yes

Sampling Method:
Non-Probability Sample

Subjects will be healthy individuals with no history of cardiovascular disease selected from Mayo Clinic in Rochester, Minnesota.

Inclusion Criteria:

BMI ≤ 30.
No current cardiac medications.
Systolic BP ≤ 140 mmHg.
Diastolic BP ≤ 90 mmHg.
Capacity to consent.

Exclusion Criteria:

To be assessed via EMR screening.
Patient confirmation during screening visit.
Screening tests as applicable.
History of cardiovascular disease. eGFR < 30.
Current orthopedic limitations.

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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05773300

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Mayo Clinic Minnesota

Rochester, Minnesota, United States, 55905

Contact: Halley Davison 507-293-2565 rstachdresprg@mayo.edu

Mayo Clinic
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)

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Principal Investigator:
Alexander Egbe, MBBS, MPH
Mayo Clinic

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Responsible Party:
Alexander C. Egbe, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:
NCT05773300

Other Study ID Numbers:
21-011938R01HL158517 ( U.S. NIH Grant/Contract )

First Posted:
March 17, 2023 Key Record Dates

Last Update Posted:
March 17, 2023

Last Verified:
March 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:
No

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Studies a U.S. FDA-regulated Drug Product:
No

Studies a U.S. FDA-regulated Device Product:
No

Additional relevant MeSH terms:

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Heart DiseasesHeart Defects, CongenitalCardiovascular DiseasesCardiovascular AbnormalitiesCongenital Abnormalities

Source: View full study details on ClinicalTrials.gov

Tadalafil Effect + Chemotherapy in Resectable Gastric/GEJ Cancer

Despite the availability of multimodality approaches for localized gastric cancer, the survival rates remain dismal for resectable disease. There is a large unmet need to identify new therapeutic options, to be used in combination with chemotherapy and to improve survival outcomes. Emerging data have shown the implication of myeloid derived suppressor cells (MDSCs) in the alteration of tumor microenvironment. The MDSCs are involved in tumor progression by promoting immune suppression, tumor angiogenesis, drug resistance, tumor metastasis and limiting the effects of cancer immunotherapy. In vitro and animal studies have demonstrated that phosphodiesterase 5 inhibitors (PDE5i) such as Sildenafil or Tadalafil inhibit MDSCs, augment the endogenous antitumor immunity and improve the effectiveness of chemotherapy. There have been similar reports of enhanced chemotherapeutic efficacy with PDE5i in murine models of melanoma, multiple myeloma, lung, breast, head and neck, colorectal and brain cancer. PDE5 inhibitors suppress nitric oxide synthetase (Nos)-expressing myeloid derived stem cells (MDSCs). There have been no prior clinical studies using a PDE5,6 inhibitor to enhance chemotherapeutic cell death in the upper gastrointestinal cancers. Therefore, the investigators propose this trial to study the effect of the long-acting PDE5,6i Tadalafil in combination with chemotherapy (FLOT) in resectable Gastric/GEJ cancers.

This is a single arm, phase II, window trial to assess the ability of Tadalafil to suppress MDSCs as monotherapy and in combination with neoadjuvant FLOT chemotherapy in patients with resectable gastric or gastroesophageal junction adenocarcinoma.

The study will enroll 10 patients. Patients will receive Tadalafil for 14 days followed by combination of Tadalafil + FLOT for approximately 8 weeks as a part of standard of care neoadjuvant treatment. Tumor specimens, blood, and urine will be collected at baseline, after 2 weeks of monotherapy treatment with Tadalafil, and around the time of surgical intervention to analyze the tumor microenvironment (TME) and to determine whether PDE5, 6 inhibition reduces the immune suppressive microenvironment. Saliva will also be collected at baseline.

Hypothesis: The investigators hypothesize that daily dosing of Tadalafil with chemotherapy will significantly reduce myeloid-derived suppressor cells (MDSCs) in the TME.

Source: View full study details on ClinicalTrials.gov

March 18, 2023ClinicalTrials.govComments OffGastroenterologyClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine

Mechanisms of Prediabetic States in Sleep Apnea

The purpose of this study is to better understand how sleep apnea contributes to the development of diabetes.
Detailed Description:
Substantial evidence indicates that obstructive sleep apnea (OSA) is associated with impaired glucose metabolism, however, metabolic mechanisms underlying this association remain unclear. This mechanistic study will determine systemic and cellular metabolic pathways that contribute to impaired glucose metabolism in obstructive sleep apnea (OSA). Understanding of how obstructive sleep apnea (OSA) affects glucose metabolism may help identify novel targets for risk prediction and/or treatment of metabolic impairments beyond continuous positive airway pressure (CPAP). Obstructive sleep apnea (OSA) patients with prediabetes will be studied under three in-laboratory conditions in a randomized cross-over design: untreated condition (obstructive sleep apnea), treated condition (continuous positive airway pressure), untreated but pharmacologically suppressed lipolysis condition (Niacin). The investigator will perform whole body and cellular assessments under each study condition.

Source: View full study details on ClinicalTrials.gov

March 18, 2023ClinicalTrials.govComments OffEndocrinologyClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine

MV-NIS Infected Mesenchymal Stem Cells in Treating Patients With Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer

PRIMARY OBJECTIVES:
I. To determine the maximally tolerated dose (MTD) of intraperitoneal administration of an Edmonston’s strain measles virus genetically engineered to produce sodium iodine symporter (NIS) (measles virus [MV]-NIS) in patients with recurrent ovarian cancer, delivered by adipose tissue derived mesenchymal stem cells (MSC). (Phase I) II. To assess the 12 month overall survival of patients treated with this regimen. (Phase II)
SECONDARY OBJECTIVES:
I. To assess the tolerability of this regimen. (Phase II) II. To assess the 4 month progression free survival of patients treated with this regimen. (Phase II) III. To assess the response rate, progression-free survival, and overall survival of patients treated with this regimen. (Phase II)
TRANSLATIONAL OBJECTIVES:
I. To assess the time course of viral gene expression and virus elimination and biodistribution of virally infected cells at various time points after infection with MV-NIS versus MSC delivered MV-NIS using single-photon emission computed tomography (SPECT)/computed tomography (CT) imaging. (Phase II) II. To assess viremia, viral replication, and measles virus shedding/persistence following intraperitoneal administration. (Phase II) III. To assess humoral and cellular immune response to the injected virus. (Phase II) IV. To assess in a preliminary fashion the development of antitumor immune response. (Phase II)
OUTLINE: This is a phase I, dose-escalation study followed by phase II study.
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter intraperitoneally (IP) over 30 minutes on day 1 of cycle 1 and MV-NIS infected mesenchymal stem cells (MSC) (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Source: View full study details on ClinicalTrials.gov

March 18, 2023ClinicalTrials.govComments OffEndocrinologyClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

PRIMARY OBJECTIVE:
I. To provide a blinded reference set of cancer versus (vs.) non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection.
SECONDARY OBJECTIVES:
I. Evaluate test performance at the time of initial cancer diagnosis by tumor type.
II. Evaluate test performance at the time of initial cancer diagnosis by clinical stage.
OUTLINE:
Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration.
After completion of study, participants are followed up at 1 year.

Source: View full study details on ClinicalTrials.gov

March 18, 2023ClinicalTrials.govComments OffEndocrinologyClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine

Exploratory PK and Imaging Study of PSMA-Targeted Trillium Compounds and PTI-122 in Metastatic Prostate Cancer

Exploratory study in adult males with metastatic prostate cancer intended to characterize the pharmacokinetics and biodistribution of PSMA-Targeted [In-111]-Labeled Trillium Compounds with and without the cytoprotective agent PTI-122. Up to 36 eligible subjects will be enrolled. Additional subjects may be enrolled if there is insufficient data for evaluation, for example if the original study subjects do not complete required imaging studies for reasons unrelated to adverse events.

Up to four PSMA-Targeted [In-111]-Labeled Trillium Compounds will be evaluated. Each compound will be evaluated first without the cytoprotective agent, PTI-122, then the [In-111]-labeled Trillium Compound may be co-administered with PTI-122.

Source: View full study details on ClinicalTrials.gov

March 18, 2023ClinicalTrials.govComments OffOncologyClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Experimental: Substudy 1

MEDI5752 Plus XELOX/FOLFOX

Drug: MEDI5752

a PD-1 and CTLA-4 bispecific antibody; IV infusion

Drug: FOLFOX

5-fluorouracil 400 mg/m^2 IV, oxaliplatin 85 mg/m^2, leucovorin 400 mg/m^2 (or levoleucovorin 200 mg/m^2 when locally preferred and available), day 1, 5-fluorouracil 1200 mg/m^2 IV 24 h day 1-2

Drug: XELOX

capecitabine 1000 mg/m^2 BID, days 1 to 14, oxaliplatin 130 mg/m^2, day 1

Source: View full study details on ClinicalTrials.gov

March 17, 2023ClinicalTrials.govComments OffGastroenterologyClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine

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