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NCT ID: NCT02381795 Terminated - Cluster Headache Clinical Trials

Pilot Study Evaluating the Use of Nasal Carbon Dioxide for the Treatment of Cluster Headache

Start date: July 2015
Phase: Phase 2
Study type: Interventional

This is an open label, investigator-sponsored, pilot study. Subjects agreeing to participate in the study and meeting the eligibility criteria assessed at the screening visit will be enrolled in the study. The length of time between screening and treatment will last between 0 days to a maximum of 12 weeks. Subjects who enter the screening phase during a cluster headache episode and meet the study eligibility criteria can immediately enter the treatment phase and may opt to treat their cluster headache episode in the clinic. Subjects who are not in a cluster headache episode, who meet initial screening eligibility criteria, can remain in the screening phase for up to 12 weeks until their next cluster episode begins. Upon initiation of a cluster headache episode, subjects will enter the treatment period. Subjects will be trained on the proper use of the hand-held dispenser containing carbon dioxide (CO2 )calibrated to deliver 0.5 standard liters per minute (SLPM). This dispenser will be provided for use in the clinic or home. Subjects will be instructed to use the nasal CO2 dispenser, 10 seconds/nostril, as needed up to 6 times to treat one attack. Each dose must be separated by 3-5 minutes. Subjects should treat only one attack in a 24-hour period. Subjects may treat up to three cluster headache attacks during the treatment phase of this study. One hour after the first dose, subjects can choose to treat with investigator-approved rescue medication. Subjects will be asked to complete an online diary after the completion of the dosing. Diary assessments will collect pain severity, nasal CO2 usage, acute medication usage, satisfaction of treatment, number of cluster attacks, and unusual symptoms. Subjects will be contacted by phone within 3 days of the first use of the nasal CO2 dispenser to assess adverse events (AEs) and medication usage. A total of 25 subjects will enter the treatment period and be instructed to treat up to 3 cluster headaches with nasal CO2. Within 7 days of treating their last cluster headache episode, subjects will return for an end of study visit.

NCT ID: NCT02381548 Terminated - Clinical trials for Acute Myeloid Leukemia

Phase I Trial of AZD1775 and Belinostat in Treating Patients With Relapsed or Refractory Myeloid Malignancies or Untreated Acute Myeloid Leukemia

Start date: August 18, 2015
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of WEE1 inhibitor AZD1775 and belinostat when given together in treating patients with myeloid malignancies that have returned after a period of improvement or have not responded to previous treatment or patients with untreated acute myeloid leukemia. WEE1 inhibitor AZD1775 and belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT02381405 Terminated - Diarrhea Clinical Trials

A Study Evaluating a Proprietary Amino Acid Mixture (Enterade®)- for Maintaining Bowel Regularity in Patients With GI Toxicity From Any Combination of Therapy Including Tyrosine Kinase Inhibitors (TKI)

Start date: February 2015
Phase: N/A
Study type: Interventional

This is an open label, randomized investigation of a proprietary blend of amino acids, called Enterade®, and its effect on irregularity (diarrhea) caused by radiation therapy and/or chemotherapy including TKI*. Subjects will be randomized to receive Enterade® or continue standard of care. Two patients will be enrolled on the treatment arm for each patient on the control arm.

NCT ID: NCT02381392 Terminated - Pediatric Disorder Clinical Trials

A Comparison of Accuvein to Standard IV Access in Children 0 to 24 Months of Age in the Pediatric ED

Start date: August 2014
Phase: N/A
Study type: Interventional

Obtaining intravenous (IV) access in children under the age of 2 years is difficult, especially in the emergency department (ED) where the children can be frightened, dehydrated and ill. Often it requires multiple needle sticks and nurses to place an IV in a difficult child. In our ED the recently acquired an Accuvein AV400 device. This infrared light, like a barcode scanner, makes the veins on a child appear like roads on a map. This ideally shows the nurse where to place and direct the needle. This device is approved by the FDA to work with children and has not been shown to have any harmful effects. However, there are no studies showing whether this device helps in the difficult less than 2 year olds seen in the emergency department. This study will be to directly compare placing an IV in a child under 2 years of age with the AV400 versus not using the device. A physician, medical student, or nurse practitioner who has been trained on how to observe nurses place IVs will enroll children who require an IV for their ED clinical care (as determined by their ED doctors). This person will consent the parents, ask the parents questions regarding the child's past medical history, and have the nurse look at the veins of the child ahead of the IV access attempt to rate the level of difficulty expected (easy, moderate, difficult). Whether the child has the IV attempt performed with or without the AV400 will be computer randomized. The nurse will attempt to place the IV, and the study staff will observe and record the number of attempts, size of the IV catheter, and location of the IV. If 2 attempts are failed, the patient will "cross over" to the other condition, that is if AV400 was being used then it will not be used, and if AV400 was not being used then it will be used. If there are 4 failed attempts at IV placement, then the child will be treated as per our department's difficult IV access protocol, which is applied to all children with difficult IV access regardless of participation in the study. After the IV placement, both the parents and the nurse will be asked several questions regarding satisfaction with use of the AV400. No patient identifiers will be collected. The investigators will be recruiting 260 children to determine if using the AV400 device improves the first time needle stick success from 40% to 60%. Nursing approval for the study was obtained prior to the study.

NCT ID: NCT02381288 Terminated - Low Testosterone Clinical Trials

Effects of TAK-448 in Middle-aged and Older Men With Low Testosterone

Start date: September 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to middle-aged and older men with low ST levels.

NCT ID: NCT02381132 Terminated - Post Operative Pain Clinical Trials

A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain

Start date: November 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to explore the clinical characteristics oral MNK155 and Norco® 7.5mg/325mg when used for the treatment of moderate to severe post operative pain.

NCT ID: NCT02381067 Terminated - Spinal Stenosis Clinical Trials

A Prospective Study of NuCel® in Cervical Spine Fusion

Start date: March 2015
Phase: N/A
Study type: Interventional

The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine.

NCT ID: NCT02380677 Terminated - Clinical trials for Advanced Solid Tumor Malignancy

Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumors

Start date: April 2015
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2a, open-label, dose-escalation study with enrollment in Phase 1 to continue until determination of the Maximum Tolerated Dose (MTD) /Recommended Phase 2a Dose (RP2D), and then enrollment into Phase 2a expansion cohorts will be initiated.

NCT ID: NCT02380209 Terminated - Breast Cancer Clinical Trials

An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer

Start date: August 2014
Phase: Phase 0
Study type: Interventional

Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.

NCT ID: NCT02379858 Terminated - Ventral Hernia Clinical Trials

Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair

Start date: July 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether Alvimopan (Entereg) in ventral hernia surgery patients is associated with accelerated gastrointestinal recovery and reduced length of hospital stay compared to placebo controls.