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Headache in Pregnancy

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5161. A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic Pancreas

(e.g. impaired cognition or judgment) Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory, unable to speak and read English) Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject Pregnancy [positive urine human chorionic gonadotropin (HCG (...) )] breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception Need to go outside of the designated geographic boundaries during either arm of the study Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription) Unwilling or unable to refrain from drinking more than

2014 Clinical Trials

5162. Neurotoxin and Physical Therapy

, or with physical therapy. At Baseline, disease characteristics (as measured by the Toronto Western Spasmodic Torticollis Rating Scale, or TWSTRS, and the Clinical Global Impression of Severity, or CGIS) will be measured, along with quality of life (from the Short Health 36 Survey Form 36, or SF-36). One subscale of the TWSTRS will be videotaped to be later evaluated by blinded movement disorder specialists. A pain scale will also be completed and range of head motion will be measured using a device similar (...) using the left wrist and the right side of the head. Other Outcome Measures: Visual Analog Scale [ Time Frame: Baseline to 12 weeks ] This is a single item scale, on which participants will mark the level of pain from 0-100. Higher score represents more severe pain. Cervical Range of Motion Measurement [ Time Frame: Baseline to 12 weeks ] Participants will be asked to sit in a chair and move the head to the left, to the right, to the front, and to the back. Then, participants be asked to tilt

2014 Clinical Trials

5163. Effect of Interventions on the Progression of Knee Osteoarthritis

Details Study Description Go to Brief Summary: There has been intensive search for a substance that can have disease-modifying activity for osteoarthritis. A number of medications have been reported to be of benefit on slowing progression of knee OA. This trial will be the first head to head comparison of these medications. Patients aged between age 40 to 65 will be enrolled. Patients will be assessed clinically using two scoring systems, the WOMAC index for knee arthritis and the SF 36 for overall (...) . To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 40 Years to 65 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Patients of either sex aged between 40 to 65 years with mild to moderate osteoarthritis of the knees. Patients should have history of knee pain for at least 6

2014 Clinical Trials

5164. Pain Expectations in Subjects With Osteoarthritis

will take a verbal medical and medication history and obtain blood pressure and heart rate measurements. Verbal pain intensity report (0-10 from no pain to worst pain imaginable) will be obtained from a 5 second heat stimuli, separated by 30 seconds, delivered to a nonpainful area of skin on the arm as described in preliminary data. During pain testing, study subjects will sit in a comfortable chair in a low-ambient light room with their head positioned on a chin rest for continuous recording of pupil (...) for eligibility information Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Osteoarthritis of the knee or hip Adult (ages 18-80) Moderate pain (verbal score of ≥ 4 ≤ 7 on 0-10 scale for average pain intensity with normal activity) American Society of Anesthesiologists physical status 1-3 Healthy subjects without pain Exclusion Criteria: Pregnancy; Currently taking gabapentin Currently taking

2014 Clinical Trials

5165. Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Adults

Prefilled Syringe INJ 0.5mL by intramuscular injection Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL by intramuscular injection Outcome Measures Go to Primary Outcome Measures : Solicited local & general Adverse Event, Unsolicited Adverse Event [ Time Frame: up to Day28(+7) ] Solicited local reaction: pain, tenderness, redness, swelling Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia Percentage (...) immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or is expecting to be treated with immunoglobulin or blood-derived products during the study. Subject who had participated in another experimental study within 30 days prior to administration of the study vaccine Woman of childbearing potential at screening or woman who plans to become pregnant during the study. A woman of childbearing potential must have a negative pregnancy test, and, unless

2014 Clinical Trials

5166. T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-A*01 Positive

or equal to 65 years old Clinically significant atrial and or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or have a history of ischemic heart disease, or chest pain. Patients with CNS metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions). Patients presenting with lesions that may harbor an occult infectious source. Documented FEV1 less than or equal to 60% predicted tested (...) toxicities.) Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus. Hematology Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim WBC greater than or equal to 3000/mm^3

2014 Clinical Trials

5167. Kinetic Oscillation Stimulation (KOS) of Nasal Mucosa in Non-allergic Rhinitis: Investigation of Treatment Procedure

treated with radiation on the face, head or neck regions Female patients who are pregnant or nursing, or become pregnant at any time from first visit at ENT(Ear, Nose and Throat) - clinic until treatment day (second visit) Female patients: unwilling to use adequate contraceptive between first and last visit Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer Contacts and Locations Go to Information from the National (...) ) Experimental: Group 2 Insertion of catheter into nasal cavity carried out by health professional. Fixation of catheter during treatment with helmet. Device: PBASE system 1.1 (active treatment) Outcome Measures Go to Primary Outcome Measures : Pain score on the Visual Analogue Scale [ Time Frame: Five seconds after placement of catheter in nasal cavity ] To evaluate whether patient´s self-administration of catheter into nasal cavity is associated with a different degree of patient-reported pain on Visual

2014 Clinical Trials

5168. Phase 1 Safety and PK Study of OLT1177 Capsules

-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 14 days prior to administration of investigational drug, except for topical products without systemic absorption Use of NSAIDs or other prescription pain medication, more than once or twice a week, especially if taken for chronic or frequently recurring headache Active infection within 3 days of the Baseline visit History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies (...) potential who: Are or intend to become pregnant (including use of fertility drugs) during the study Are nursing Are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic [injectable or patch] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based

2014 Clinical Trials

5169. Impact of Persistent Conductances on Motor Unit Firing in SCI

active range of motion medically stable have medical clearance from their primary internists or physiatrists to participate in experiments involving drug administration. Control Subjects: healthy with no history of neurological injury or disease. have medical clearance from their primary internists or physiatrists to participate in experiments involving drug administration. Exclusion Criteria: Under age 18yrs (children) Pregnancy or breastfeeding (women who are pregnant or nursing will be excluded (...) ) Spinal cord injury below T10 due to potential peripheral nerve damage/cauda equina injury concurrent medical illnesses, infections, upper extremity pain, inflammation or recent injury significant cardiovascular disease (including arrhythmias that require pacemakers, hypertension or hypotension) history of cardiovascular or pulmonary complications (including significant obstruction and/or restrictive lung diseases) metabolic (endocrine, hepatic) or renal dysfuction traumatic head injury orthopedic

2014 Clinical Trials

5170. Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol

will be asked to rate how they felt, and if present, how they perceived their headache during scanning. Patients will also be asked how they felt and how severe was their headache when comparing the rest W10 and W30 and the stress W10 and W30. Feasibility of W10 by written documentation. [ Time Frame: Day 1 of testing ] By documenting any technical or clinical difficulties during the W10 procedure Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study (...) race /ethnicity Patient has undergone or is being scheduled for a clinically indicated CardiacCath with or without angioplasty Patient may have suffered myocardial infarction more than 3 days before T99m-MPI Patient may have undergone percutaneous transluminal coronary angioplasty (PTCA) or coronary stent placement more than 3 days prior to T99m-Myocardial Perfusion Imaging (MPI) Interval between T99m-MPI and CardiacCath is within 30 days Females cannot be pregnant or lactating Women of no child

2014 Clinical Trials

5171. Positive Emotional Processing: Exploring Novel Treatment Targets in Social Phobia

/bio-stimulators (TENS unit), persons who have ever been a metal worker/welder, history of eye surgery/eyes washed out because of metal, women who are or may be pregnant (determined by a positive pregnancy test), women using an intrauterine device, vision problems uncorrectable with lenses, claustrophobia, inability to lie still on one's back for 60 minutes; prior neurosurgery; older tattoos with metal dyes; unwillingness to remove nose, ear, tongue, or face rings. Contacts and Locations Go (...) but not limited to: unstable hypertension, unstable angina, unstable diabetes mellitus, unstable cardiac arrhythmias, transient ischemic attacks, severe coronary artery disease, severe peripheral vascular disease, severe hepato-gastro-intestinal disease, severe infectious disease (e.g. HIV), recurrent severe headache or migraine, fainting spells, seizures, and history of traumatic brain injury with loss of consciousness >30 minutes Current use of the following medications: antidepressants, benzodiazepines

2014 Clinical Trials

5172. A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Frequency [ Time Frame: 5 days ] Stool frequency is the average of the daily number of stools recorded during the treatment period Percentage of Days With no Flatulence [ Time Frame: 5 days ] The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Percentage of Days With no Abdominal Pain [ Time Frame: 5 days ] The percentage of days with no abdominal pain is calculated from the diary (...) during the treatment period: 100*(number of days with no abdominal pain/ number of days recorded in diary). Percentage of Days With Formed/Normal Stools [ Time Frame: 5 days ] The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/ number of days recorded in diary). Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal

2014 Clinical Trials

5173. Low Intensity Ultrasound Therapy for Upper Back Pain Relief

number of males and females in each group. The research coordinator will be blinded to the assignment of devices to each group. The daily pain scores reported by patients who receive active devices will be compared to those who receive placebo devices. Background: Approximately 50 to 80 million people in the United States suffer from some form of chronic pain. Back pain is the most common neurological disorder in the United States after headaches and costs consumers nearly $50 billion annually (...) of the device Exclusion Criteria: Subjects with known neuropathy will be excluded from the study Women who are pregnant may not participate. Prisoners Smokers Subjects with Type I or Type II Diabetes Subjects who have had surgery in the target area within the last 6 months will be excluded from the study. Subjects who are non-ambulatory (i.e. who cannot walk) will be excluded from the study. Subjects who refuse to agree to not increase current use or initiate new use of pain medication during the course

2014 Clinical Trials

5174. Optimizing Management of the 2nd Stage of Labor: Multicenter Randomized Trial

, etc. No neuraxial anesthesia: epidural or combined epidural-spinal anesthesia (subjects without adequate pain control tend to push involuntarily and cannot delay pushing) Pregnancy complications requiring expedited delivery: severe preeclampsia, placental abruption, maternal cardiac disease Fetal head visible at the introitus at complete cervical dilation Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact (...) of neonatal composite morbidity (Secondary Aim #1), and 3) Determine the impact of immediate versus delayed pushing on objective and subjective measures of maternal pelvic floor morbidity (Secondary Aim #2). They estimate that randomizing a total of 3184 women will provide adequate statistical power to detect meaningful differences in the primary and secondary outcomes. Condition or disease Intervention/treatment Phase Pregnancy Procedure: Immediate pushing Procedure: Delayed pushing Not Applicable Study

2014 Clinical Trials

5175. The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System)

to the Standard of Care. Condition or disease Intervention/treatment Phase Meniscectomy Osteoarthritis Device: NUsurface® Meniscus Implant Drug: NSAID's and Non-surgical Treatment Options Drug: Intra-Articular Injections with Corticosteroids Drug: Intra-Articular Injections with Hyaluronic Acid (HA) Not Applicable Detailed Description: The NUsurface® Meniscus Implant is intended for use in patients with medial compartment pain that have had a previous partial medial meniscectomy. Patients who meet (...) the inclusion/exclusion criteria will be assigned by balanced randomization into one of two groups: the Meniscus Implants versus non-surgical standard of care. The KOOS (Knee injury and Osteoarthritis Outcome Score) and IKDC (International Knee Documentation Committee) forms will be used to provide a comprehensive evaluation of the patients' pre-intervention and post-intervention condition including activity levels, pain, swelling, locking, stability, support, sports activity, and quality of life assessment

2014 Clinical Trials

5176. Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy

radiation treatment?? Radiation can cause inflammation in your esophagus which can feel like a chest pain, either at rest or during swallowing Able to swallow the study medication Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 Negative pregnancy test done =< 28 days prior to registration, for women of childbearing potential only Ability to complete questionnaire(s) by themselves or with assistance Provide informed written consent Willingness to complete evaluation (...) Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy - Full Text View - Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail

2014 Clinical Trials

5177. Women With Migraine With Aura Neuroimaging Study

pregnancy subjects that wished not to be informed about abnormal findings on MRI chronic tension-type headache, medication overuse headache, or cluster headache (diagnosed through physician interview) frequent tension-type headache (control group only, self-reported or diagnosed through physician interview) Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information (...) Responsible Party: David Gaist, professor, consultant, Odense University Hospital Identifier: Other Study ID Numbers: S-20100126 First Posted: January 28, 2014 Last Update Posted: April 4, 2017 Last Verified: April 2017 Keywords provided by David Gaist, Odense University Hospital: migraine with aura migraine case-control study magnetic resonance imaging brain diseases Additional relevant MeSH terms: Layout table for MeSH terms Migraine Disorders Migraine with Aura Headache Disorders

2014 Clinical Trials

5178. Duration of Benefit for OnabotulinumtoxinA in Treatment of Chronic Migraine

pregnant during the study period, breast feeding, or is of childbearing potential and not practicing a reliable form of birth control headache disorders outside ICHD-3 defined chronic migraine that cannot be easily distinguished from CM (Appendix I) evidence of underlying pathology contributing to their headaches any medical condition that may increase their risk with exposure to BTX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant (...) Completion Date : September 2015 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment onabotulinumtoxinA At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated

2014 Clinical Trials

5179. ExAblate Transcranial MR Guided Focused Ultrasound in the Treatment of Essential Tremor

transducer) positioned above the subject head. The ExAblate transcranial system also includes means to immobilize the subject head, cool the interface water, and software for CT analysis and phase correction computation. The ExAblate transcranial system is an experimental device and is being investigated in this study. Condition or disease Intervention/treatment Phase Essential Tremor Device: ExAblate Transcranial MRgFUS System Phase 1 Study Design Go to Layout table for study information Study Type (...) of intracranial hemorrhage Cerebrovascular disease (multiple CVA or CVA within 6 months) Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.) Symptoms and signs of increased intracranial pressue (e.g. headache, nausea, vomiting, lethargy, and papilledema) Are participating or have participated in another clinical trial in the last 30 days Patients unable to communicate with the investigator and staff

2014 Clinical Trials

5180. Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor

stability. It ripens the cervix by inducing regular uterine contractions. However, it is associated with several adverse effects especially uterine hyperstimulation, which is painful and may result in fetal compromise. Testing the efficacy and safety of titrated oral misoprostol versus vaginal dinoprostone may develop a new safe and effective method for labor induction. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 200 (...) by either misoprostol or Syntocinon (oxytocin) to active phase of labor [ Time Frame: 12 hours ] Duration of 1st,2nd and 3rd stages of labor [ Time Frame: 24 hours ] Maternal complications [ Time Frame: 24 hours ] uterine hyperstimulation, postpartum hemorrhage, uterine rupture, sepsis, shivering, headache, nausea, vomiting, and retained placenta. Mode of delivery [ Time Frame: 24 hours ] Vaginal , instrumental or Cesarean section Neonatal outcome [ Time Frame: 24 hours ] Apgar score at 1 and 5 minutes

2014 Clinical Trials

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