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NCT ID: NCT04605302 Completed - Clinical trials for Upper Gastrointestinal Symptoms

Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms

Start date: February 10, 2021
Phase: N/A
Study type: Interventional

A prospective single blinded, tandem study, comparing a magnetically controlled capsule with or without a tether (MCC or MCC-T) with conventional upper endoscopy for the diagnosis of patients with upper abdominal symptoms.

NCT ID: NCT04605211 Completed - Clinical trials for Chronic Myeloid Leukemia

A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs or CML on Tyrosine Kinase Inhibitors

Start date: September 18, 2020
Phase: N/A
Study type: Interventional

This trial looks at how well a distress reduction intervention, called "Being Present", works to improve the quality of life of patients with BCR-ABL-negative myeloproliferative neoplasms (MPNs) or chronic phase chronic myeloid leukemia (CP-CML) who are taking tyrosine kinase inhibitors (TKIs) and their caregivers. Mindfulness meditation is the practice of repeatedly bringing attention back to the immediate experience and may help people cope with various types of illness, stress, and worry. This may help patients and caregivers to gradually learn to disconnect from reacting to and dwelling on the past and future and instead fully experiencing the present moment.

NCT ID: NCT04605198 Completed - Depressive Symptoms Clinical Trials

Mindfulness-based Intervention to Address PTSD in Trauma-exposed, Homeless Women

Start date: October 6, 2020
Phase: N/A
Study type: Interventional

Posttraumatic stress disorder (PTSD) is a major public health concern that disproportionately effects minorities and those with low-socioeconomic status, such as homeless women, creating a critical health disparity. PTSD has been linked with dysregulated hypothalamic-pituitary-adrenal (HPA) functioning and increased inflammation, which can lead to long-term physical-health problems and PTSD-symptom maintenance, exacerbating disparities. Mindfulness-based interventions, including Mindfulness-based Stress Reduction (MBSR), have shown promise as a complementary tool for addressing PTSD in veterans and with low-income, minority populations, but homeless women have not been examined adequately. MBSR may improve PTSD symptomatology and help modulate the dysregulated stress response common in individuals with PTSD, improving physical and mental health concurrently. This project is an open-label, parallel, modified-cross over clinical trial of a modified-MBSR intervention to reduce PTSD symptoms in homeless women and to explore physiological correlates of treatment-response. Hypotheses: 1. Participation in an MBSR-based intervention will be associated with clinically significant reduction in PTSD (primary outcome), lower depression symptoms and greater drug and alcohol abstinence (secondary outcomes) compared to participation in an attention control. 2. Compared to an attention control, participants in an MBSR-based intervention group will demonstrate improvements in cortisol reactivity and lower inflammation. At baseline, women will complete psychosocial assessments (e.g., depression, substance use, trauma history) and participate in a brief stress task, providing salivary samples before and after the task (which will be assayed for cortisol and C-reactive protein, a marker of inflammation). Women will then participate in 1) a 9-session MBSR-based program that was modified based on an initial qualitative component that involved a Community Advisory Board and focus groups with women from the community (N=4 focus groups; 28 women total) or 2) a nine-session health-promotion course (i.e., attention-control condition). Follow-up assessments that include psychosocial and biological data will occur immediately after final intervention session and again 6-months later. Clinically-meaningful improvements in PTSD (primary outcome) and secondary outcomes (e.g., depression, substance use, inflammation, cortisol reactivity) will be examined.

NCT ID: NCT04604925 Completed - Hypertension Clinical Trials

A Pilot Study of Hypertension Management Using Remote Patient Monitoring

Start date: November 19, 2020
Phase:
Study type: Observational

The investigators will conduct a pragmatic pilot test of a remote patient monitoring system (RPM) for blood pressure measurement for Medicare patients with hypertension. The primary objective is to better understand how patients' remote monitoring of blood pressure and the direct transmission of this data to a healthcare system's EHR can be used by the patient and the care team to support optimal hypertension care. This pilot study which we will conduct in two Northwestern Medical Group (NMG) primary care practices will: evaluate the integration of Omron's remote monitoring system into Northwestern Medicine's electronic health record (so that clinical data can flow directly from the patient's monitor to the EHR), evaluate the use of billing work flows for covered Medicare services, build and deploy clinical decision support to aid with patient identification and ordering of the remote patient monitoring system, and evaluate the uptake and clinical effects of this system in the pilot practices compared to matched patients selected from non-pilot control practices. The investigators will conduct a pragmatic non-blinded, non-randomized pilot study with contemporaneous controls among NMG outpatient clinics that provide adult primary care. They will make comparisons of data obtained through the course of routine care delivery from pilot and non-pilot practices.

NCT ID: NCT04604899 Completed - Clinical trials for Retinitis Pigmentosa

Safety of Repeat Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa

Start date: December 1, 2020
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to assess the safety of repeat injection of human retinal progenitor cells (jCell) in adult subjects with RP that have previously been treated with jCell.

NCT ID: NCT04604860 Completed - Cirrhosis, Liver Clinical Trials

Use of EL-FIT App to Promote Physical Activity

EL-FIT
Start date: September 23, 2020
Phase: N/A
Study type: Interventional

Transplant-eligible patients with cirrhosis and ESLD, age 40-70, MELD >/= 10 referred to transplant physical therapy will be invited to participate. The investigators will exclude those who lack a smartphone or the understanding of its functionality, lack home wireless internet, or have recurrent/persistent overt hepatic encephalopathy. Following signing of informed consent, each participant will be given a Fitbit Charge 3 and have EL-FIT and Fitbit apps downloaded to their smartphone. After a brief session with a member of the research team explaining the basic components and functionality of EL-FIT and Fitbit, patients will be provided with general physical activity recommendations (as per our current standard of care) and asked to explore all features of EL-FIT and Fitbit apps, up until their 12-week follow-up visit. Phone calls to incentivize physical activity and exercise will be performed by members of the research team.

NCT ID: NCT04604704 Completed - Covid19 Clinical Trials

Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome

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

Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with post-COVID-19 syndrome.

NCT ID: NCT04604652 Completed - Clinical trials for Primary Biliary Cirrhosis

Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis

PRONTO-PBC
Start date: May 27, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy. Inadequate response is defined as persistently elevated serum alkaline phosphatase at greater than or equal to1.5 times the upper limits of normal for the testing lab in spite of having been on adequate doses of standard therapy with UDCA (ursodeoxycholic acid) at 13-15 mg/kg for at least 6 months.

NCT ID: NCT04604561 Completed - Breast Cancer Clinical Trials

Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

Start date: October 27, 2020
Phase:
Study type: Observational

This is a pilot study to estimate the success of the SmartClip device for accurate placement and reproducibility of intraoperative identification of in-breast lesions and for excision utilizing surgical navigation indicators.

NCT ID: NCT04604496 Completed - Healthy Volunteers Clinical Trials

STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT

Start date: December 30, 2020
Phase: Phase 1
Study type: Interventional

The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961