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Headache in Pregnancy

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5121. Chordate System Prophylactic Migraine Clinical Investigation

headache days per month (i.e. headaches of any kind), confirmed during baseline Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during baseline Unable to distinguish between migraine headaches and other headache types Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visits Ongoing treatment with implanted stimulator or other implanted device in the head and/or neck region Known pronounced anterior septal (...) investigation Any change in migraine prophylaxis the previous two months Pregnant women Participation in a clinical research study within three months of enrolment or planned participation at any time during this clinical investigation Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members or any such individuals Headache or migraine episode within the 48 hours prior to the first treatment Contacts and Locations Go to Information from

2014 Clinical Trials

5122. Ibuprofen vs Acetaminophen for AMS Prevention

Headache Altitude Sickness Pain Neurologic Manifestations Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Acetaminophen Ibuprofen Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action (...) Description Go to Brief Summary: AMS (acute mountain sickness) affects those who ascend too high (>2000m) too fast. Acetazolamide is an effective drug for the prevention of AMS where proper acclimatization with gradual ascent may not be an option. AMS presents with headache and other non-specific symptoms such as nausea, tiredness, and dizziness. Because of the side effects of acetazolamide such as a tingling sensation, other drugs have been investigated to see if they will prevent AMS. Ibuprofen has

2014 Clinical Trials

5123. Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer

be enrolled. Subjects will be staged according to the 2010 American Joint Committee on Cancer (AJCC) staging system with pathologic stage T1-4, N0 being eligible; and have a primary tumor of the pancreas (either pancreatic head, neck, uncinate process, or body/tail) The tumor must be deemed as being borderline resectable. Final CT confirmation of surgical staging/ eligibility will be at the discretion of the pancreatic surgeon of the patient. Disease is confined to locoregional site as confirmed by the CT (...) > 12 weeks If female patient is of child bearing potential, she must have a negative serum pregnancy test (βhCG) documented up to 72hrs prior to administration of first study drug Patient has screening blood work performed which includes the following (should be drawn ≤ 14 days prior to randomization) absolute neutrophil count (ANC) > 1.5 x 109/L Platelet count ≥ 100000/mm3 Hemoglobin (HgB) ≥ 9g/dL aspartate aminotransferase (AST),Alanine Aminotransferase (ALT)≤ 2.5 x upper limit of normal (ULN

2014 Clinical Trials

5124. Close Kinect Chain Exercise With Kinesio Taping in the Management of Patellofemoral Pain Syndrome

minutes of physical activity at least three times per week.) Exclusion criteria: Patients with previous knee surgeries, Chronic pain with more than one year of evolution, Pregnancy or suspected pregnancy Application of intra-articular steroids in the three months prior to their evaluation Patients with meniscal injuries Ligament or intra-articular knee structures Degenerative diseases such as diabetes Rheumatoid arthritis OA of the knee, hip or ankle History of dislocation or subluxation of patella (...) Close Kinect Chain Exercise With Kinesio Taping in the Management of Patellofemoral Pain Syndrome Close Kinect Chain Exercise With Kinesio Taping in the Management of Patellofemoral Pain Syndrome - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove

2014 Clinical Trials

5125. Duration of Immune Response to Influenza Vaccination in Patients With RA

[ Time Frame: 6 months post vaccination ] proportion of patients who are diagnosed with confirmed influenza despite vaccination Occurrence of flu-like illnesses [ Time Frame: 6 months post vaccination ] proportion of patient who developed influenza-like symptoms (defined as two or more of the following: cough, myalgias, fever, arthralgias, throat pain, headache, nasal congestion). Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study (...) with RA receiving treatment with an Anti-T Cell or Anti-TNF biological agent Age 40-75 Inclusion Criteria (Healthy Controls): Age 40-75 Exclusion Criteria: Exclusion criteria (RA Patients) Known hypersensitivity/allergy influenza vaccine Chronic debilitating conditions (such as end-stage Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), liver disease, Chronic Kidney Disease (CKD) ) Active malignancy at time of vaccination Pregnancy and lactation Known HIV Active infection

2014 Clinical Trials

5126. Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery

providers and surgeons alike, as a safe mode of airway management when delivering general anesthesia. In sinonasal surgery, however, there are more concerns regarding the use of LMA's for airway management. Due to the nature of sinonasal procedures, the patient is exposed to blood and secretions that may drip/flow from the nasal cavity into the oropharynx and potentially into the upper and lower airways if not protected adequately. Additionally, often times, manipulation of the patient's head throughout (...) time, post‐op pain medication requirements, and airway complications between LMA and endotracheal intubation. Aim 3: Analyze and compare both patient comfort and surgeon satisfaction after procedure between LMA and endotracheal intubation groups. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 104 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment

2014 Clinical Trials

5127. Long-term Consequences of the Posterior Reversible Encephalopathy Syndrome in Eclampsia and Preeclampsia: A Review of the Obstetric and Nonobstetric Literature. (Abstract)

the 20th week of pregnancy. Neurological symptoms include headache; visual deficits; confusion; seizures; and, in the most severe cases, intracranial hemorrhage. Eclampsia is an acute cerebral complication of preeclampsia, defined as the occurrence of tonic-clonic seizures in pregnant or recently postpartum women. With severe preeclampsia, in conjunction with neurological symptoms, or eclampsia, neuroimaging changes consistent with PRES can be seen. Posterior reversible encephalopathy syndrome (...) is a specific clinicoradiological syndrome presenting with headaches, visual impairment, seizures, and altered mental status. Characteristic neuroimaging features are consistent with cerebral edema predominantly in the parietal and occipital lobes. In addition to preeclampsia/eclampsia, PRES has been associated with various conditions in the nonobstetric population, that is, severe hypertension, transplantation, or autoimmune disease, in combination with immunosuppressive therapy or high-dose chemotherapy

2014 Obstetrical & Gynecological Survey

5128. The Effects of Glyceryl Trinitrate Patch on the Treatment of Preterm Labor: A Single-blind Randomized Clinical Trial. Full Text available with Trip Pro

of corticosteroids and the mean prolongation of the pregnancy. However, delivery times in patients who delivered during the hospitalization were 31±4.4 and 18.3±2.2 hr (p=0.01), respectively. Headache was more severe in control group (p=0.007). The systolic and mean arterial blood pressure decrease (p<0.001) and maternal heart rate increase (p=0.01) were significant in GTN group. The changes of vital signs were not significant in placebo group.The effect of GTN in the treatment of PTL is similar to the placebo (...) The Effects of Glyceryl Trinitrate Patch on the Treatment of Preterm Labor: A Single-blind Randomized Clinical Trial. Preterm labor (PTL) is one of the main causes of neonatal mortality and morbidity. PTL leads to serious complications especially in the gestational age prior to 24-26 weeks. The aim of this study was to investigate the effect of glyceryl trinitrate (GTN) patch on the treatment and complications of PTL.In this clinical trial, 84 singleton pregnant women with gestational age of 27

2014 Journal of reproduction & infertility Controlled trial quality: uncertain

5129. GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes (DIAGNODE-1)

the last injection with study drug. Participation in other clinical trials with a new chemical entity within the previous 3 months Inability or unwillingness to comply with the provisions of this protocol A history of alcohol or drug abuse A significant illness other than diabetes within 2 weeks prior to first dosing Known human immunodeficiency virus (HIV) or hepatitis Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior (...) (Calciferol) in oral solution. Dosage and interval: 2000 IU daily for 120 days Drug: GAD-Alum Other Name: Diamyd Drug: Vitamin D Outcome Measures Go to Primary Outcome Measures : Safety of giving Diamyd directly into lymph glands in combination with an oral vitamin D regimen at Month 6 (main study period) and Month 15 and 30 (extension study period) [ Time Frame: 6 months ] Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching); Number of adverse events and number

2014 Clinical Trials

5130. Two-way Crossover, Single Dose Randomized, Two-stage Bioequivalence of Ketoprofen Lysine Salt Immediate Release vs Granules Oral Solution

program, Dompé develops a new immediate release tablets formulation of ketoprofen lysine salt 40 mg. The new immediate release tablets formulation of KLS 40 mg (corresponding to 25 mg of ketoprofen free acid) is expected to be essentially similar to the formulations of ketoprofen 25 mg for oral administration, that are already available in the European Community with the same indications: pain such as episodic tension-type headache, dental pain, neuralgia, dysmenorrhoea, postpartum pain, muscular (...) ) or substantial changes in eating habits in the 4 weeks before this study; vegetarians Pregnancy (females only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women 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 provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350296

2014 Clinical Trials

5131. Biomarkers of Injectable Extended Release Naltrexone Treatment

activity, such as anti-dopaminergic agents, anti-depressants and beta-blockers; current DSM-IV-TR Axis I psychiatric disorders other than opioid and nicotine dependence; life time history of concurrent IV cocaine and heroin (speedball) administration; pregnancy or breastfeeding; history of clinically significant head trauma; contraindications for naltrexone treatment including medical conditions requiring opioid analgesics, e.g. chronic pain or planned surgery, obesity, elevated liver enzymes (> 3

2014 Clinical Trials

5132. Cannabinoid Profile Investigation of Vapourized Cannabis in Patients With Osteoarthritis of the Knee

, Layout table for eligibility information Ages Eligible for Study: 50 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Idiopathic (primary) OA of the knee as defined by American College of Rheumatology criteria Age ≥50 years Numerical Rating Scale (NRS) Pain intensity score ≥ 4 (on a 0-10 scale) Stable medication and treatment regimen Open to Canadian Residents only Exclusion Criteria: Pregnant/nursing BMI >39kg/m2 Secondary (...) Controlled, Proof-of-concept, Crossover Clinical Trial of Vapourized Cannabis in Adults With Painful Osteoarthritis of the Knee Study Start Date : June 2015 Estimated Primary Completion Date : December 2018 Estimated Study Completion Date : June 2019 Resource links provided by the National Library of Medicine related topics: related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: CanniMed™ DPF-I Volcano® Vapourization Using the Volcano® Medic, a dose of 100 mg of finely

2014 Clinical Trials

5133. MLD10 in the Prevention of Migraine in Adults

the baseline, continue to meet entrance criteria will be eligible to enter into the treatment phase and be randomized according to the Clinvest generated randomization schedule. Approximately 142 subjects (71 subjects per arm) will be randomized and enter the treatment phase receiving MLD10 or placebo in a 1:1 design at 6 United States sites. Diary assessments will collect study medication adherence, pain severity, headache symptoms, acute medication usage, and unusual symptoms. Serum samples (...) with MLD10 versus placebo. All headaches and/or migraines will be including in this outcome analysis. Change in Self-Reported Headache Pain Severity [ Time Frame: Day 1(Screening) - Day 116 (Visit 5 End of Study) ] Change from baseline (28 day period) in the average self-reported headache pain severity at time of onset compared to each 28-day treatment period month 1, 2, & 3 in subjects treated with MLD10 versus placebo. Subjects will be asked to rate their headache pain severity using the following

2014 Clinical Trials

5134. Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury

Severe spasticity that interferes with use of the ReWalk Active pressure sores Pregnancy Severe head injury Conditions that preclude intensive exercise (such as high blood pressure) Presence of conditions contraindicated for transcranial magnetic stimulation 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 provided by the sponsor. Please refer (...) Sitting and standing balance [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of training ] While sitting/standing on a force plate, the participant will lean in 8 directions guided by a computer screen with feedback of the center of pressure. The participant will also sit/stand as still as possible with eyes closed McGill Pain Questionnaire [ Time Frame: Weekly, up to 20 weeks from beginning of training ] Paper/pencil questionnaire regarding pain experienced over the last week Structured

2014 Clinical Trials

5135. Antibiotics In Modic Changes

: Kjersti Storheim, Head of section, Oslo University Hospital ClinicalTrials.gov Identifier: Other Study ID Numbers: 2014/12701 First Posted: December 23, 2014 Last Update Posted: November 14, 2018 Last Verified: November 2018 Keywords provided by Kjersti Storheim, Oslo University Hospital: Low back pain Chronic Modic Changes MRI epigenetics antibiotics randomized placebo controlled trial Additional relevant MeSH terms: Layout table for MeSH terms Back Pain Low Back Pain Pain Neurologic Manifestations (...) Party): Kjersti Storheim, Oslo University Hospital Study Details Study Description Go to Brief Summary: Low-back pain (LBP) is the single leading cause for disability worldwide, affects all age groups and has increased from 58 million years lived with disability (YLDs) in 1990 to 83 million YLDs in 2010. The burden is accordingly substantially higher than previously assessed, causing activity limitation and work absence with subsequently enormous economic burden. Norwegian expenses reach at least

2014 Clinical Trials

5136. Phase 2 Study to Evaluate the Safety & Efficacy of Brilacidin Oral Rinse in Patients With Head and Neck Cancer

Phase 2 Study to Evaluate the Safety & Efficacy of Brilacidin Oral Rinse in Patients With Head and Neck Cancer Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number (...) of saved studies (100). Please remove one or more studies before adding more. Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer (Brilacidin) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02324335 Recruitment Status : Completed First

2014 Clinical Trials

5137. Non-Ambulatory SCI Walk Using a Robotic Exoskeleton: Effect on Bone and Muscle

the device Must have no memory and/or thinking disability (e.g. due to brain injury) Must be able to follow directions well and demonstrate learning capability Must be able to physically fit into the exoskeletal device Exclusion Criteria: A woman who is pregnant, lactating, or post-menopausal Wearing an external device that supports the spinal column or the head, neck, or trunk Have persistent orthostatic hypotension (blood pressure drop of more than 30 millimeters of Mercury in robotic system) Have had (...) the walker while wearing the exoskeleton Must have a height between 62 inches or 74 inches Must weigh less than 220 lbs,(limitation of the devices) Must have no joint tightening of any extremity that limits movement during walking with the assistive devices Must have no medical issue that precludes full weight bearing, ambulation or exercise intolerance in the exoskeleton (e.g. orthopedic injuries, pain, severe spasticity) Must have no skin issues (e.g. pressure sores) that would prevent wearing

2014 Clinical Trials

5138. A Clinical Trial of the PfSPZ Vaccine Administered by Direct Venous Inoculation in Healthy Malaria-Naïve Adults: Heterologous vs. Homologous Controlled Human Malaria Infection and Reduction in Number of Doses

the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 45 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Healthy adults (male or non-pregnant female) 18 - 45 years of age, inclusive. Able and willing to participate for the duration of the study. Able and willing to provide written (not proxy) informed consent. Women of childbearing (...) bundle branch block; or advanced (secondary or tertiary) A-V heart block. Current use of systemic immunosuppressant pharmacotherapy. Current significant medical condition (cardiovascular, hepatic, renal, or hematological) or evidence of any other serious underlying medical condition identified by medical history, physical examination, or laboratory examination. History of a splenectomy. History of neurologic disorder (including seizures) or migraine headache. History of psychiatric disorders

2014 Clinical Trials

5139. Utility of CrocsRx Clog as a Diabetic House Shoe: a Pilot Study

ulceration in the lower extremity History of or active Charcot neuroarthropathy of either foot Severe peripheral vascular disease (i.e. ischemic rest pain, 2-block claudication, or gangrene) End stage kidney disease requiring hemodialysis, stroke, or widespread malignant disease Pregnant or nursing Not willing or able to make the required follow-up visits Insufficient (corrected) vision to complete the questionnaire Unable to fit into available shoe sizes Contacts and Locations Go to Information from (...) heads or hallux Participants with and without signs of peripheral neuropathy (unable to perceive a 10 gram monofilament or vibration perception threshold (VPT > 25 Volts) Able to walk independently without the use of walking aids (cane, crutches, or walker) Able to speak and understand English Able to understand the information in the consent form and willing and able to sign the consent form Exclusion Criteria: History of lower limb amputations (excluding toe amputations) Presence of cutaneous

2014 Clinical Trials

5140. Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation

or peritoneal dialysis for renal failure (excluding ultra-filtration for fluid removal). Evidence of intrinsic hepatic disease defined as liver enzyme values (AST, ALT and LDH that are > 3 times the upper limit of normal) OR a total bilirubin > 3 mg/dl OR biopsy proven liver cirrhosis or portal hypertension. Pregnancy Active systemic infection prior to study enrollment not yet resolved by treatment. Active Systemic Infection is defined by any one of the following in spite of antibiotic, antiviral (...) or antifungal treatment: 2 or more consecutive positive cultures; elevated temperature > 37.2 (°C) and white blood cell count > 11.0 (103/ml); hypotension, tachycardia and generalized malaise. Stroke within 90 days prior to enrollment OR patient has a history of cerebral vascular disease with > 80% extra cranial stenosis documented by carotid Doppler study during transplant evaluation Modified Rankin Scale score of ≥ 2 or has any neurologic disability as confirmed by imaging (CT or MRI). Significant lower

2014 Clinical Trials

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