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NCT ID: NCT03672799 Not yet recruiting - Clinical trials for Head and Neck Neoplasms

Rehabilitation Planning Consult Phase II Trial

RPC-II
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The study will evaluate the efficacy of the Rehabilitation Planning Consult (RPC) to achieve key rehabilitation outcomes in survivors of head and neck cancer compared to a waiting list control group. The RPC is a consultative intervention that teaches survivors to use self-management and problem solving strategies to meet and attain individualized goals. Follow-through with plans and goal attainment are facilitated by a Rehabilitation Consultant. Results from this study will be used to plan for a larger multi-site trial and subsequent real world implementation.

NCT ID: NCT03672721 Recruiting - Clinical trials for Glioblastoma Multiforme

IA Carboplatin + Radiotherapy in Relapsing GBM

Start date: July 10, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Treatment of glioblastoma involves an optimal surgery, followed by a combination of radiation and temozolomide chemotherapy. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is the norm. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which limits drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, the investigators have observed responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival 23 months. How can we improve on this? By coupling radiation with a chemotherapeutic which is also a potent radiosensitizer such as carboplatin. Study design: In this phase I/II trial, patients will be treated at recurrence; a surgery will be performed for cytoreduction and to obtain tumor sample, followed with a combination of re-irradiation and IA carboplatin chemotherapy. A careful escalation scheme from 1.5Gy/fraction up to 3.5Gy/fraction will allow the investigators to determine the optimal re-irradiation dose (10 fractions of radiation over 2 weeks). Toxicity will be assessed according to the NCIC common toxicity criteria. Combined with radiation, patients will receive 2 treatments of IA carboplatin, 400 mg/m2, 4 hours prior to the first and the sixth radiation fraction. IA treatments will then be continued on a monthly basis, up to a total of 12 months, or until progression. Outcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. The investigators will also acquire a sequence that enables the measurement of cerebral blood flow, cerebral blood volume and blood vessel permeability that are all relevant to understand the delivery of therapeutics to the CNS. Primary outcome will be OS and PFS. Secondary outcome will be QOL, neurocognition, and carboplatin delivery. In vitro intracellular carboplatin accumulation: Tumor samples from re-operation will be be analyzed for intracellular Pt concentration by ICP-MS. The amount of Pt bound to DNA will be measured. The level of apoptosis will be determined for each of the sample. Putting together these data will allow to correlate clinical and radiological response to QOL, NC (MOCA), and to delivery surrogates for the IA infusion and intracellular penetration of carboplatin.

NCT ID: NCT03672630 Not yet recruiting - Clinical trials for Mycobacterium Avium Complex

Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease

MAC2v3
Start date: February 28, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated patients frequently experience debilitating side effects, and many patients delay the start of antibiotic treatment due to these risks. Common side effects include nausea, diarrhea, and fatigue, and rare but serious toxicities include ocular toxicity, hearing loss, and hematologic toxicity. To date, most of the evidence underlying the current treatment recommendations has come from observational studies in which either a macrolide has been combined with rifampin and ethambutol, or in some cases combined with ethambutol alone. The proposed study will answer whether a third drug is necessary or whether taking two drugs can increase tolerability without a substantial loss of efficacy.

NCT ID: NCT03672565 Not yet recruiting - Clinical trials for Obsessive-Compulsive Disorder

SMART ERP for the Behavioral Treatment of Youth With Obsessive Compulsive Disorder (OCD)

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The study seeks to determine the feasibility of implementing a sequential, multiple assignment, randomized trial for the behavioral treatment of youth with OCD. The study focuses on identifying the minimum level of intensive exposure and response prevention (ERP) necessary to achieve remission for youth with OCD while, via randomization, examining the influence of treatment setting (community vs hospital) on response.

NCT ID: NCT03672552 Not yet recruiting - Dysphagia Clinical Trials

Using Plain Water With Oral Care to Increase Hydration for Long Term Care Residents With Disordered Swallowing

FFWP
Start date: September 13, 2018
Phase: N/A
Study type: Interventional

The Frazier Free Water Protocol (FFWP) using plain, thin (unmodified) water is an accepted method to increase fluid intake and hydration in older adults with disordered swallowing and dementia.This study aims to take an interdisciplinary approach to see if the FFWP with improved oral care can be introduced in a long term care (LTC) setting comparing an intervention group with a control group receiving standard oral care, to prevent respiratory infections.

NCT ID: NCT03672422 Recruiting - Clinical trials for Pancreatitis, Chronic

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis

INSPPIRE 2
Start date: June 30, 2017
Phase:
Study type: Observational [Patient Registry]

The investigators will enroll a total of 860 patients under 18 years of age with ARP or CP. Included in the total are the 502 patients in the INSPPIRE 1 database who are planned to be reenrolled under this protocol over the next 4 years. Patient questionnaires and physician surveys will be applied at the time of enrollment and annually thereafter as long as possible. At the first study visit after turning 18 years of age, the patient will sign the informed consent to continue in the study. Specifically, the investigators will define the demographics of the pediatric ARP and CP cohort, describe risk factors, presence of family history of acute and chronic pancreatitis, diabetes and pancreatic cancer and assess disease burden and sequelae.

NCT ID: NCT03672201 Not yet recruiting - Alzheimer's Disease Clinical Trials

Standardizing Care for Neuropsychiatric Symptoms and Quality of Life in Dementia

StaN
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The object of this study to evaluation an Integrated Care Pathway (ICP) to treat Aggression and Agitation in Alzheimer's disease (AD-AA). The ICP is an algorithmic approach to use psychotropic medications and non-pharmacological interventions based on standardized assessments which fosters measurement-based decision making. This study will assess the efficacy of the ICP to treat AD-AA and its impact on inappropriate use of medications in inpatient settings and Long-Term Care Facilities (LTCF). We will enroll and randomize 220 participants with AD-AA (110 inpatient and 110 LTCFs) to ICP vs. Treatment As Usual. Further, this study will also examine the impact of the ICP on caregiver burden and undertake a cost-effectiveness analysis of the ICP for patients with AD-AA.

NCT ID: NCT03672045 Not yet recruiting - Clinical trials for Postpartum Hemorrhage

Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2

Start date: October 2018
Phase: N/A
Study type: Interventional

Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Carbetocin is a uterotonic with a superior pharmacokinetic profile to oxytocin. In a study performed at Mount Sinai Hospital, we have shown that smaller doses of carbetocin (14.8 mcg) are as effective in achieving adequate uterine tone at elective cesarean section compared to the current recommended dose of 100mcg. However, this study was limited to those women with a body mass index (BMI) of <40 kg/m2. Maternal obesity has been shown to increase the risks of hemorrhage secondary to uterine atony, therefore we wish to perform a dose finding study to determine the ED90 of carbetocin at caesarean section in those women with a BMI>40.

NCT ID: NCT03671694 Recruiting - Clinical trials for Stress Urinary Incontinence

Laser Vaginal Treatment for SUI

Start date: September 19, 2018
Phase: N/A
Study type: Interventional

RCT designed to answer the question: Does the application of Erbium: YAG laser treatment to the vagina improve urine control for women with SUI?

NCT ID: NCT03671421 Recruiting - Clinical trials for Anterior Cruciate Ligament Rupture

Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon: A Prospective Cohort Study

Start date: September 11, 2018
Phase: N/A
Study type: Interventional

The main purpose of this study is to determine if there is a difference in graft re-injury/failure rates between participants that have had an ACL reconstruction with a STG, BPTB or QT autograft. Additionally, to compare quality of life, patient reported outcomes and functional performance after ACL reconstruction with STG, BPTB and QT.