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NCT ID: NCT04093700 Terminated - Shoulder Pain Clinical Trials

MDR SureLock All-Suture Anchor

Start date: November 5, 2019
Phase:
Study type: Observational [Patient Registry]

To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor.

NCT ID: NCT04093622 Terminated - Clinical trials for Hematological Malignancy

Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy

Start date: October 4, 2019
Phase:
Study type: Observational

The purpose of the study is to assess long-term side effects from subjects who receive a Fate Therapeutics genetically modified NK cell product. Subjects who previously took part in a Fate Therapeutics study and received genetically changed NK cells will take part in this long-term follow-up study. Subjects will join this study once they complete the parent interventional study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. For a period of 15 years starting from the last administration of Fate Therapeutics genetically modified NK cell product, subjects will be assessed for long-term safety and survival through questionnaires and blood tests.

NCT ID: NCT04093414 Terminated - Bradycardia Clinical Trials

Left Bundle Area Versus Selective His Bundle Pacing

LEFTBASH
Start date: October 7, 2019
Phase: N/A
Study type: Interventional

This is a voluntary research study to find out which location in the heart a pacemaker wire is the most efficient for a patient's heart and for battery life. Patients who volunteer and are eligible for the study will be randomized to receive one of two positions for the wire to be screwed into, in addition to studying multiple positions in the heart during the pacemaker insertion. Enrolled patients will be in the study for 1 year. They will also have an Ultrasound of their heart performed to assess how the pacemaker wire is affecting their heart. Pacemakers are connected to the heart by wires that are screwed into the heart. The wires can be connected to the heart in different places, which can affect how well the heart beats over time. The typical position is at the tip of the heart. This position may cause the heart to beat inefficiently. Over time, this could lead to weakened heart muscle, irregular heart rhythm, and more hospitalizations. The heart has special muscle cells and fibers that carry electrical signals through and around the heart. An alternative spot to place the pacemaker wire is in an area where these special cells are grouped together (called the HIS bundle). The pacemaker wire can be connected to the heart at a location which may allow the heart to beat more efficiently when compared to putting the wire at traditional spots in the heart (called HIS bundle pacing). However, sometimes connecting the wire into the HIS bundle may cause the pacemaker battery to wear out faster. Physicians can also connect the pacemaker wired near the HIS bundle (called Left left Bundle bundle area pacing). The study physicians hope this will allow the heart to beat more efficiently without causing the battery to wear out faster. The study physicians would like to study how different wire positions change heart beat efficiency and how long the pacemaker battery lasts when the wires are placed in different locations. This study will connect the pacemaker wire at either the HIS Bundle or the left bundle area pacing, to see how effectively the heart pumps and how much battery is being used.

NCT ID: NCT04092816 Terminated - Clinical trials for Metastatic Breast Cancer

Fathers and Mothers Invested in Lives of Their Youth (FAMILY) Study: A Pilot Intervention

FAMILY
Start date: October 30, 2019
Phase: N/A
Study type: Interventional

This is a single-arm pilot study to evaluate the feasibility and acceptability of a novel psychosocial intervention to improve psychosocial outcomes for parents with advanced cancer and their co-parents. In this single-center study, we will recruit ten mothers with metastatic breast cancer and their co-parents as dyads (N=20) to participate in the Fathers and Mothers Invested in the Lives of their Youth (FAMILY) intervention. Patient and co-parent dyads will participate in 2-3 study visits with an intervention facilitator and a post-intervention feedback interview. Participants will also complete baseline and follow-up study surveys. The final products of this study will be the FAMILY intervention manual and training materials, and fidelity assessments.

NCT ID: NCT04091737 Terminated - Anemia, Sickle Cell Clinical Trials

CSL200 Gene Therapy in Adults With Severe Sickle Cell Disease

Start date: October 2, 2019
Phase: Phase 1
Study type: Interventional

This is a phase 1 pilot study of CSL200 in adult subjects with severe sickle cell disease. The primary objectives of this study are to evaluate the safety of the following: collection of CD34+ hematopoietic stem / progenitor cells by apheresis after mobilization with plerixafor, reduced intensity conditioning with melphalan, and administration of CSL200.

NCT ID: NCT04090866 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Cardiac Metabolic Remodeling After Pulmonary Vasodilator Therapy in Pulmonary Arterial Hypertension: A Pilot Study

Start date: November 14, 2019
Phase:
Study type: Observational

Pulmonary arterial hypertension(PAH) is associated with the development of right heart failure. In the setting of heart failure, the heart shifts to increasing dependence on glucose metabolism. In this study, the investigators will perform cardiac positron emission tomography/magnetic resonance imaging (PET/MRI) scans to measure glucose metabolism in the heart before and after initiation of pulmonary vasodilator therapy for pulmonary arterial hypertension.

NCT ID: NCT04090697 Terminated - Clinical trials for Congenital Heart Disease

Use of Oxandrolone to Promote Growth in Infants With HLHS

Start date: December 20, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The primary aim of this study is to determine if clinically relevant doses of buccally administered oxandrolone are safe and tolerable in neonates with hypoplastic left heart syndrome (HLHS) or other single right ventricular anomalies who have undergone a Norwood procedure. The secondary aim is to evaluate the efficacy of buccally administered oxandrolone in improving objective indices of growth and nutrition in neonates who have undergone a Norwood procedure.

NCT ID: NCT04090242 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes

Start date: September 6, 2019
Phase: N/A
Study type: Interventional

This is a multi-center, open-label, parallel-group, randomized controlled study in subjects with type 2 diabetes using multiple daily injection (MDI) insulin therapy. Subjects will be randomized to either receive the DC App and BD Nano 2nd Gen pen needles (intervention) or continue their standard of care using their current pen needle and diabetes management (control). The study will consist of four visits and two scheduled phone calls across a total of 10 weeks.

NCT ID: NCT04089904 Terminated - Clinical trials for Gastric Adenocarcinoma

Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma

Start date: October 11, 2019
Phase: Phase 2
Study type: Interventional

To determine the pathologic complete response (pCR) rate in patients with cT1b-T2N0 GEA treated with neoadjuvant pembrolizumab followed by surgical resection.

NCT ID: NCT04089761 Terminated - Acute Migraine Clinical Trials

Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. This is a prospective, single arm, open label, multicenter trial of the safety and efficacy of Nerivio™ for the acute treatment of migraine in adolescents The study will be conducted in three phases: Phase I - Run-in: Phase II - Treatment phase: Phase III (optional) - Free-use