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NCT ID: NCT04038671 Withdrawn - Clinical trials for Surgical Wound, Healed

Activated Carbon Interphase Effect on Surgical Incisions vs.Two Common Wound Dressings

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

This randomized, prospective study evaluates incision closure, post-surgical wound complications, dressing changes, incision/scar appearance, pain associated with dressing changes, and patient satisfaction rates of an activated carbon dressing versus two commercially available wound dressings.

NCT ID: NCT04038489 Withdrawn - Breast Cancer Clinical Trials

COX Inhibition and Biomarkers During Neoadjuvant Chemoendocrine Therapy for ER+, HER2- Stage I-III Breast Cancer

Breast 51
Start date: October 18, 2019
Phase: Phase 2
Study type: Interventional

This study is designed to assess the safety and clinical activity of tamoxifen and the COX inhibitor, aspirin, given in combination with standard AC-T chemotherapy (doxorubicin, cyclophosphamide, and paclitaxel) for the treatment of high-risk estrogen receptor (ER)+, human epidermal growth factor receptor 2 (HER2)- breast cancer. If successful, the study could improve long-term outcomes for a subpopulation of women with aggressive stage I-III ER+/HER2- breast cancer.

NCT ID: NCT04038203 Withdrawn - Tissue Oxygenation Clinical Trials

Tissue Oxygen Deprivation as Detected With Raman in Association With Umbilical Artery Catheters

Start date: December 2023
Phase:
Study type: Observational

Umbilical artery catheters (UACs) are associated with significant morbidity in preterm neonates however are necessary for the management of this high risk population. UACs have been linked to serious adverse events (SAEs) including arterial thrombosis, necrotizing enterocolitis, limb ischemia, and renal failure. Resonance Raman Spectroscopy (RRS), raman for short, is a technology that utilizes vibrational spectroscopy, rather than absorbance spectroscopy, to determine the oxyhemoglobin concentration in tissues. In this prospective, observational study, daily measurements of StO2 of low birth weight neonates using raman spectroscopy will be correlated with UACs.The study team hypothesizes that raman can detect changes in peripheral tissue oxygenation in the ipsilateral extremity to the UAC and that raman is more sensitive at detecting changes in peripheral tissue oxygenation then common metrics used to monitor neonatal hemodynamics. If successful, this study would demonstrate that raman can be used as an early marker of tissue oxygen deprivation in neonates with UACs and maybe used to guide management in other clinical scenarios where StO2 is affected.

NCT ID: NCT04037072 Withdrawn - Esophageal Stenosis Clinical Trials

Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

Start date: April 3, 2020
Phase: Phase 2
Study type: Interventional

This study evaluates Mitomycin C as treatment for dysphagia in adult subjects with documented complex esophageal anastomotic strictures. Patients will be randomized in a double-blinded fashion to topical application of normal saline (NS) or Mitomycin C (MMC) at the time of time of index procedure.

NCT ID: NCT04035408 Withdrawn - Clinical trials for Breast Cancer Female

Facial Skin Health Tracking Feasibility in Breast Cancer Patients

Start date: January 24, 2020
Phase:
Study type: Observational

This feasibility study will assess if tracking objective and subjective facial skin changes over time is acceptable to pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer. There is no intervention arm and no control group. Skin health will be assessed through the instruments described below, and subjective data will be collected with self-administered questionnaires.

NCT ID: NCT04032691 Withdrawn - Healthy Volunteers Clinical Trials

PET Study of a2a Agonist Effects on the Ventricular CSF Clearance of [11C]Butanol

Start date: August 27, 2019
Phase: Early Phase 1
Study type: Interventional

This investigator initiated, pilot study will assess the feasibility of characterizing the effects of an orally administered alpha-2 adrenergic (a2a) agonist, clonidine, on the clearance rates of Carbon-11 butanol from the ventricular cerebrospinal fluid (vCSF) with positron emission tomography (PET) in healthy volunteers.

NCT ID: NCT04031521 Withdrawn - Sickle Cell Disease Clinical Trials

Near Infrared Spectroscopy in Sickle Cell Pediatric Patients

Start date: June 26, 2019
Phase:
Study type: Observational

Endothelial dysfunction contributes to vaso-occlusion and acute pain in sickle cell disease. Near infrared spectroscopy (NIRS) technology can measure tissue oxygenation and endothelial function. The main objective of this study is to study the natural history of tissue muscle oxygenation using NIRS in pediatric sickle cell subjects experiencing acute pain and pediatric sickle cell patients in steady-state.

NCT ID: NCT04030052 Withdrawn - Hemophilia A Clinical Trials

Emicizumab PUPs and Nuwiq ITI Study

Start date: February 17, 2022
Phase: Phase 3
Study type: Interventional

This study prospectively investigates the safety, FVIII immunogenicity, and hemostatic efficacy of prophylactic HEMLIBRA® given with a concomitant low dose recombinant factor VIII (rFVIII) known as NUWIQ®, in HA infants and children <3 years old who have had little to no previous exposure to FVIII. In addition, the study investigates the safety and efficacy of a novel FVIII ITI regimen in children <21 with existing low and high titer inhibitors (LTI and HTI).

NCT ID: NCT04030000 Withdrawn - Uterine Carcinoma Clinical Trials

Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation

Start date: May 20, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Uterine serous carcinoma (USC) is an uncommon, but aggressive variant of endometrial carcinoma that has poor response to standard therapy. After staging and surgery, radiation therapy and/or chemotherapy is recommended to treat patients at high risk for recurrence. In advanced stage and recurrent setting, high risk uterine cancer mirrors ovarian cancer with it spread patterns and response to therapy. Based on these findings and the similarities as well as the clinical success of paclitaxel with IP platinum therapy in patients with ovarian serous carcinoma, investigators propose to prospectively assess IV/IP therapy in patients with advanced stage and recurrent USC. During Week 1-18, subjects will be placed on open-label IP Carboplatin/IV Paclitaxel on Day 1, then administered IP Paclitaxel on Day 8. This will be repeated every 3 weeks for 6 cycles. A CT imaging scan will be performed after six cycles of chemotherapy, prior to radiation. Also, in Week 19-23, subjects will receive Pelvic radiation therapy (IMRT) if deemed necessary. Additionally, from Week 24-26, High Dose Radiation or IMRT will be used where appropriate. Patients will be monitored for toxicity and feasibility of the regimen. Secondary outcomes will include assessing the frequency and the reasons for early discontinuation of the study treatments as well as describing patient-reported quality of life parameters at specified time points during the study using validated questionnaires: EORTC QLQ-C30 and QLQ-OV28.

NCT ID: NCT04029298 Withdrawn - PreDiabetes Clinical Trials

Home-based Prediabetes Care in Acoma Pueblo - Study 1

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The prevalence of overweight, obesity and T2D among American Indians (AIs) in the Albuquerque service area of Indian Health Services (IHS) serving all pueblos in New Mexico including Pueblo of Acoma is disproportionately elevated. Specifically, among AI, adults age 18 and over in the IHS Albuquerque Service Area, 51% have a BMI > 30, which significantly exceeds the rate of obesity observed nationally (35.3%) and the Healthy People 2020 target of 30.5%. Likewise, the rate of T2D (22.8%) among the adult AI population in our Albuquerque service area is almost double the rate of the U.S. adult population (12.2%), and the age-adjusted diabetes mortality rate for AIs was 104.7 per 100,000 compared to 23.1 per 100,000 among non-Hispanic Whites in the region. At the same time, the median age of diagnosis of T2D among AI adults was much younger (42.2 years) than the national average (53.8 years). Our major goal of implementing educational interventions to slow the current rate of increase in diabetes in Native communities is aligned with NIH's (NIGMS) and NM INBRE's vision in reducing health disparity using innovative interventions. The investigators propose following aims: Aim 1: Recruit and Screen 300 community members in Acoma Pueblo, NM to identify incident cases of pre-diabetes for the proposed study of Home Based Diabetes Care (HBDC); Aim 2: Enroll 150 Acoma Natives aged 21-70 years, at risk for T2D (i.e., overweight, obese, and/or with at least one affected first degree relative or a history of gestational DM) and conduct HBDC for a 16-week lifestyle intervention in a longitudinal cohort study. Randomize household in a 1:1 allocation to enter either the intervention arm immediately or after a 12-month waiting list in control arm. Control participants will be treated with usual care. Participants randomized to the waiting list will enter the intervention group 12 months after entering the study. Both intervention groups will be followed longitudinally for total of 12 months. Compared with people who will receive "usual care (control group)", prediabetic participants receiving 4 months of the HBDC will exhibit improved risk factor profiles for diabetes, obesity and heart disease, improved Patient Activation Measures, improved adherence with medical treatment, and improved Quality of Life scores.