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NCT ID: NCT04843345 Suspended - Lung Diseases Clinical Trials

Sjogren's Lung Study

Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

Lung involvement in Sjögren's syndrome is common and causes reduced quality of life and increased mortality. Sjögren's syndrome-related lung diseases (SS-RLD) are classified and treated as the primary lung diseases they resemble. Whether this approach is optimal has not been evaluated thoroughly. A critical gap in knowledge is knowing whether SS-RLDs have a unique clinical course and response to therapy. Given the underlying immune system dysfunction in Sjögren's syndrome, the investigators hypothesize that patients with SS-RLD will be more likely to respond to immunosuppressive therapy than patients with the matching primary lung disease. To address this hypothesis, the investigators will prospectively screen for Sjogren's syndrome in patients presenting to pulmonary clinics and compare the clinical course and response to therapy in Sjogren's syndrome positive and negative patients.

NCT ID: NCT04840472 Suspended - Clinical trials for Head and Neck Cancer

Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer

Start date: March 30, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular imaging agent in patients with Head and Neck Squamous Cell Carcinoma. The secondary objective is to compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to Day of Surgery versus conventional local injection with an optical dye at the time of surgery.

NCT ID: NCT04840134 Suspended - Suicide Clinical Trials

From Hardship to Hope: A Peer-led Intervention to Reduce Financial Hardship and Suicide Risk

Start date: June 8, 2021
Phase: N/A
Study type: Interventional

Financial hardship is an important risk factor for suicide. However, to date there are no evidence-based interventions to help individuals improve their financial situation and thus reduce suicide risk. The aim of our study is to develop a 24-week, peer-led intervention to reduce financial hardship for individuals experiencing financial difficulties and suicide risk, and to test whether it is feasible, acceptable to clients and achieves its desired effect. The intervention will support participants to address their financial difficulties (e.g., debt, inability to meet basic needs) by coaching them on financial management techniques, facilitating a financial wellness plan, and connecting them with community- based financial supports (e.g., free financial counseling). The intervention will be facilitated by trained peer specialists. The intervention consists of two phases: (1) a 9-week intensive phase will consist of weekly group sessions and one-on-one coaching sessions to navigate financial resources; (2) a 15-week follow-up phase will contain biweekly check-ins to achieve financial goals. This study will obtain input from stakeholders to develop the intervention (Step 1), pilot it with a small sample of participants (n=10; Step 2), use this information to revise the intervention (Step 3), test it in a larger sample of individuals with financial hardship and suicide risk (n=50; Step 4), and prepare a final version of the intervention manual (Step 5). The main outcome of this study will be a manualized intervention to lessen financial hardship as a risk factor for suicide.

NCT ID: NCT04836429 Suspended - Clinical trials for Lung Non-Small Cell Carcinoma

Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-small Cell Lung Cancer With Pleural Disease

Start date: March 10, 2022
Phase: Phase 1
Study type: Interventional

This phase I trial evaluates the side effects of intraoperative photodynamic therapy with porfimer sodium in enhancing the response to immunotherapy with an immune checkpoint inhibitor drug in patients with non-small cell lung cancer with pleural disease. Photodynamic therapy is a technique that that works by combining a photosensitizing agent (porfimer sodium in this trial) and an intense light source to kill tumor cells. Photodynamic therapy may decrease the patients' symptoms and improve their quality of life.

NCT ID: NCT04829448 Suspended - Low Back Pain Clinical Trials

The Influence of a Protein Nutrition Beverage on Exercise-based Rehabilitation Outcomes in Individuals With Spine Pain.

Start date: March 16, 2022
Phase: N/A
Study type: Interventional

SpineZone is an innovative physical therapy program with its focus on treatment of cervical, thoracic, and lumbar conditions through the use of a multi-disciplinary, technology enabled platform. Standard physical therapy modalities including exercise-based rehabilitation as well as patient education on a healthy lifestyle (sleep, nutrition, posture) are employed as part of the standard treatment. As nutrition is a key element in modulating muscle growth and function in response to exercise, providing patients with appropriate access to nutritional supplements that meet the metabolic demands of our exercise program are potentially important to our clinical outcomes.

NCT ID: NCT04827810 Suspended - Lymphoma Clinical Trials

A Phase I Safety and Pharmacokinetic Study of Gamitrinib Administered Intravenously to Patients With Advanced Cancer

Start date: November 5, 2021
Phase: Phase 1
Study type: Interventional

This is a first-in-human, phase I, open-label, non-randomized dose-escalation and dose-expansion study with the primary objective to determine the safety profile of small molecule, mitochondrial-targeted Hsp90 inhibitor, gamitrinib, including identification of dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) in patients with advanced cancers. A secondary objective of the study is to determine the recommended dose and regimen(s) for a phase II study. This study is based on preclinical data demonstrating the anticancer activity, unique mechanism of action and preliminary safety of gamitrinib. In the dose-finding portion of this study, gamitrinib formulated in Lipoid S100®-based formulation will be administered as a 1-hour IV infusion once weekly for four weeks as 28-day treatment cycles. Up to 36 patients will be enrolled in the dose-escalation component of the study based on anticipated cohorts. The starting dose will be 10 mg, corresponding to allometric scaling) from the most sensitive species (rats) in the 29-day GLP toxicology and toxicokinetic studies with 14-day recovery period of gamitrinib. Dose-escalation will follow a 3+3 design. Six patients will be enrolled in the dose-expansion component of the study at MTD for the purpose of exploring pharmacodynamic effects via tumor pre and on-therapy biopsies.

NCT ID: NCT04826341 Suspended - Clinical trials for Advanced Solid Tumors

A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors

Start date: September 20, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Small cell lung cancer and PARP inhibitor resistant tumors are aggressive cancers. Current treatments for people with these tumors yield little benefit. Researchers want to see if a combination of drugs can help. Objective: To find a safe combination of sacituzumab govitecan and berzosertib and to see if this will cause small cell lung cancer and PARP inhibitor resistant tumors to shrink. Eligibility: People ages 18 and older with a solid tumor, small cell lung cancer, or a homologous recombination-deficient cancer that is resistant to PARP inhibitors Design: Participants will be screened with: Standard clinical exams and tests EKG to test the heart Medical documentation to confirm cancer diagnosis Participants will get sacituzumab govitecan by vein on days 1 and 8 of each 21-day cycle. They will get berzosertib by vein on days 2 and 9. Treatment will continue as long as they can tolerate the drugs and their tumors are either stable or getting better. Before treatment and at least once per cycle, participants will have a physical exam and blood tests. Before treatment and every 2 or 3 cycles, they will have a CT scan. They will have a contrast agent injected into a vein for the scan. Participants will give blood and hair samples and tumor biopsies for research. Biopsies will be taken with a small needle under imaging guidance. After they stop treatment, participants will have a visit 1 month later. They will then be contacted by phone or email every 3 months for the rest of their lives.

NCT ID: NCT04815369 Suspended - Clinical trials for Urinary Tract Infections

Evaluating UTI Diagnosis in Nursing Homes

Start date: June 7, 2021
Phase:
Study type: Observational

This prospective, multicenter, comparative cohort observational study is to determine whether the use of Guidance® UTI Clinical Pathway, a standardized infrastructure for specimen collection and result delivery, compared with current traditional pathways for urine testing reduces the proportion of UTI patients with poor outcomes.

NCT ID: NCT04814108 Suspended - Clinical trials for Uterine Serous Carcinoma

A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma

Start date: July 28, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study to evaluate the clinical activity and safety of ZN-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (USC).

NCT ID: NCT04810624 Suspended - Anorexia Nervosa Clinical Trials

Relapse Prevention and Changing Habits in Anorexia Nervosa

REACH+
Start date: June 21, 2021
Phase: N/A
Study type: Interventional

This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the Preparation Phase, we examined accessibility and feasibility of the treatment package. In the current Optimization Phase, we will identify which components of treatment contribute to positive outcomes after acute hospitalization. We will carefully evaluate maintenance of remission, measured by rate of weight loss and end-of-trial status.