Kornimate/medical-research-clean huggingface dataset:
somatostatin receptor pet imaging to guide radiotherapy dose escalation in high risk meningiomas.

Conditions: Meningioma

Summary: high-risk meningiomas always require postsurgical radiation treatment. recent evidence has shown that increased radiation therapy dose may be associated with increased intracranial control of disease. in order to better define the volume of radiation treatment, the addition of pet imaging with somatostatin receptor tracers adds additional information compared to encephalon mri with moc alone.the present study aims to investigate whether radiation treatment with higher doses than the standard and defined using pet imaging can be safe and at the same time effective in order to increase progression-free survival in high-risk meningiomas.


Eligibility criteria:
inclusion criteria: * age ≥ 16 years; * ability to express appropriate informed consent to treatment; * diagnosis of grade iii meningioma (regardless of presence of residual) or diagnosis of recurrence of grade ii meningioma (regardless of presence of residual) or first diagnosis of grade ii meningioma with presence of residual; * in case of recurrence, confirmation can be either histological or radiological; * not previous brain-level radiotherapy; * performance status: ecog=0-2. exclusion criteria: * refusal to radiation treatment (i.e., absence of signed informed consent); * other concomitant oncologic therapies * current pregnancy; * grade i meningiomas or grade ii meningiomas if operated on at first diagnosis with radical resection; * inability to perform mri with moc or pet.
tranexamic acid in patients for caesarian delivery.

Conditions: Postpartum Hemorrhage; Cesarean Section Complications; Obstetric Anesthesia Problems

Summary: this is a prospective, double-blinded, randomized placebo-controlled trial. the study will be approved by the duhs institutional review board (irb) and the trial will be registered at clinical trial registry. after receiving the trial information from the obstetricians during prenatal visits or from the anaesthetists during the systematic anaesthesia visit, or both the prospective women will be invited to participate in the trial. the intervention consists of administration of 1gm of tranexemic acid (txa) or 10-mls of placebo (normal saline) intravenously, according to the randomization groups slowly over 30-60 sec, within 3 mins of the delivery of baby, after the routine prophylactic uterotonic administration and cord clamping. administration of the prophylactic uterotonic agent (and txa or placebo) may be followed by a two-hour oxytocin infusion, in accordance with the hospital policy. all women will be followed up at 48 hours after caeserian delivery. a venous blood sample will be obtained on day-two (d2) after delivery for outcome assessment. adverse events will be assessed until hospital discharge and by telephone interview at 8 weeks after delivery.


Eligibility criteria:
inclusion criteria: the inclusion criteria will include: 1. informed consent of the participant 2. all women who are 18 years old or above 3. gestational age equal or above 34 weeks 4. women undergoing emergency or elective cd 5. complete blood count (cbc) within seven days before the cd exclusion criteria: the exclusion criteria will include: 1. women with thromboembolic or bleeding incidents in the past 2. hypersensitivity to txa 3. history of epilepsy or seizure 4. women with abnormal placenta including accreta, increta or percreta 5. any active cardiovascular, renal, or liver disorders 6. autoimmune disorders 7. sickle cell disease 8. placenta previa 9. abruptio placentae 10. eclampsia or hellp syndrome 11. women who might undergo intraoperative complications.

Keywords: caesarian delivery postpartum haemorrhage obstetrics quality of recovery tranexamic acid
cardiovascular events in parkinson's disease patients

Conditions: Cardiovascular Event; Parkinson Disease

Summary: cardiovascular (cv) disease is a common comorbidity of parkinson's disease (pd). the background incidence rate of cv events in a levodopa-treated pd population was assessed to better understand these comorbidities in the pd population. one objective of the study is to identify a population of prevalent pd patients with incident levodopa use within the years 2004-2010 on the integrated health care information services (ihcis) database. the second objective is to report the incidence of cv events overall and during intervals 0-6, 6-12 and 12-18 months after first prescription of levodopa among all new levodopa users.


Eligibility criteria:
inclusion criteria: * individuals with one or more prescriptions of levodopa between 1st july 2004 and 30th june 2010 * individuals on the database with medical and pharmacy benefit for at least 6 months prior to date of first prescription of levodopa * individuals with one or more diagnosis codes for parkinson's disease within the 6 months prior or 6 months post first prescription of levodopa exclusion criteria: * individuals less than 20 years of age on date of first prescription of levodopa * individuals previously prescribed levodopa prior to study period

Keywords: parkinson's disease cardiovascular events levodopa
combined nutritional and exercise strategies to reduce liver fat content in patients with type 2 diabetes

Conditions: Postprandial Lipids Metabolism; Type 2 Diabetes

Summary: the aim of this study will be to evaluate in patients with type 2 diabetes the effects on liver fat of an intervention with a diet relatively rich in cho/rich in fibre/low gi or a diet rich in mufa, either combined or not with a structured program of physical exercise, with emphasis on mechanisms possibly underlining these effects, namely changes in postprandial triglyceride-rich lipoproteins, body fat distribution, insulin sensitivity, oxidative stress and inflammation, adipose tissue lipolytic activities, aerobic capacity and endothelial function.


Eligibility criteria:
inclusion criteria: * men and postmenopausal women * age 35-65 years * bmi 27- 34 kg/m2 * hba1c \<8% * fasting plasma cholesterol \<250 mg/dl * fasting plasma triglycerides \<300 mg/dl exclusion criteria: * hypolipidemic drugs * plasma creatinine \>1.7 mg/dl transaminases \> 2 norma values * ischemic heart disease or positive treadmill stress test * high intensity regular physical activity * any disease or chronic or/and acute condition contraindicating physical activity(anaemia, and infectious, neoplastic, neurological and osteoarticular diseases).

Keywords: liver fat postprandial lipids metabolism diet exercise type 2 diabetes
impact of v release on dysphagia in patients with traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the goal of this clinical trial is to explore clinical effect of myofascial release therapy in dysphagic traumatic brain injured survivors. the main question it aims to answer is: • can myofascial release therapy improve swallowing function in traumatic brain injured survivors? patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given myofascial release therapy. the study lasts 21 days for each patient. researchers will compare the functional oral intake scale, penetration-aspiration scale, swallowing quality of life to see if the myofascial release therapy can help improve the situation.

myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. it involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. the goal of this clinical trial is to explore clinical effect of myofascial release therapy in dysphagic traumatic brain injured survivors. the main question it aims to answer is: • can myofascial release therapy improve swallowing function in traumatic brain injured survivors? patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given myofascial release therapy. the study lasts 21 days for each patient. researchers will compare the functional oral intake scale, penetration-aspiration scale, swallowing quality of life to see if the myofascial release therapy can help improve the situation.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, meeting the diagnosis of severe traumatic brain injury. * presence of no contraindication for enteral nutrition; * with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications; exclusion criteria: * complicated with other neurological diseases; * damaged mucosa or incomplete structure in nasopharynx; * tracheostomy tube plugged; * unfeasible to myofascial release; * simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
comparison between main branch and side branch vessels

Conditions: Coronary Artery Disease

Summary: the purpose of this trial is 1. to compare the clinical significance of the main vessel and the side branch vessel using ekg, pain score and coronary wedge pressure 2. to develop a new scoring system to predict the clinical significance of a side branch

1. clinical significance ekg change, pain score during 1 min balloon occlusion 2. different characteristics between st segment elevation vs non-elevation side branches 3. comparison of coronary wedge pressure 4. establishing a new scoring system to predict the st elevation during 1min balloon occlusion

Eligibility criteria:
inclusion criteria: * age ≥ 18 * able to verbally confirm understandings of risks, benefits of receiving percutaneous coronary intervention (pci) for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure * significant stenosis at bifurcation lesion (\>50% by visual estimate) which always includes stenosis of side branch (true bifurcation) * target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. target side branch lesion(s) in a native coronary artery with diameter of ≥ 2.25 mm * target lesion(s) amenable for pci with final kissing balloon angioplasty for the side branch exclusion criteria: * non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment) * patients refuse to give informed consent * patients with left main coronary artery stenosis * patients with total occlusion of the bifurcation lesion * patients with infarct-related artery at the lesion of interest * patients with left ventricular ejection fraction\<40% * patients with primary cardiomyopathy * patients with chronic kidney disease defined as serum cr\>2.0 * patients who have severe side effects or contraindication to adenosine

Keywords: coronary artery disease bifurcation myocardial infarction myocardial ischemia collateral
a 48-week, open label, study to evaluate the efficacy and safety of amondys 45, exondys 51, vyondys 53 in subjects with duchennemuscular dystrophy carrying eligible dmd duplications.

Conditions: Duchenne Muscular Dystrophy

Summary: this is an 48-week open-label study to determine the efficacy and safety of amondys 45, exondys 51, vyondys 53 for the treatment of boys with duchenne muscular dystrophy who have a single exon duplication of either exon 45, 51 or 53, respectively. there will be weekly infusions and two muscle biopsies at baseline and at month 12.

dmd is a rare, serious, debilitating, and ultimately fatal, disease for which there is an urgent need to develop safe and effective therapies. in order to efficiently meet this urgency and the needs of the subject community, the study evaluates the efficacy and safety of amondys 45, exondys 51, vyondys 53 administration over approximately 1 year in dmd subjects with duplication mutations amenable to treatment by exon 45, 51 or exon 53 skipping. skipping of a single copy of the duplicated exon is expected to result in a wild-type (wt) dmd transcript allowing the expression of a wt, full length dystrophin protein. successful skipping of a single copy of the duplicated exon in in vitro and in vivo models has been reported in the literature. amondys 45, exondys 51, vyondys 53 have the potential to be disease-modifying treatments for boys with dmd mutations amenable to exon 45, 51 and exon 53 skipping, respectively. the totality of the non-clinical data with these pmos as well as avi-4225 (targeting exon 23) and exondys 51 suggests that pmos are well tolerated in the non-clinical setting. moreover, treatment with exondys 51(at 30 mg/kg and 50 mg/kg) has been well-tolerated by boys with dmd deletion mutations amenable to skipping exon 51. the relatively low expected risk for subjects exposed to amondys 45, exondys 51, vyondys 53 and the urgent medical need for a treatment for this subject population support the conclusion that the potential benefits of exposing subjects to amondys 45, exondys 51, vyondys 53 outweigh the potential risks.

Eligibility criteria:
inclusion criteria: * is a male with dmd and has an out-of-frame duplication of either exon 45, 51, or 53, with a normal copy number of all other dmd exons. * is above age 6 months of age. * has sufficient muscle mass in a pair of bilateral muscles that will allow for pre- and post-treatment muscle biopsies per pi discretion. * if the subject is ambulant and 4 years old or greater and has been on a stable dose or dose equivalent of oral corticosteroids for at least 12 weeks prior to week 1 the dose is expected to remain constant (except for modifications to accommodate changes in weight) throughout the study. exclusion criteria: * any additional missing exon for dmd that cannot be treated with study drugs. other inclusion/exclusion criteria apply

Keywords: dmd exon skipping
cmr imaging of autoimmune diseases

Conditions: Myocarditis; Autoimmune Rheumatologic Disease

Summary: myocarditis is an important clinical problem which can can occur as a result of viral infections and autoimmune rheumatic diseases. cardiac mri is an important non-invasive means of making a diagnosis. however, current mri techniques have significant limitations. firstly, in order to create high-quality pictures, patients are required to hold their breath several times for multiple lengths of time. they often struggle with this due to underlying heart/lung problems. this can adversely affect the overall quality and image interpretation. secondly, current techniques create 2d images that are potentially underestimating the presence and severity of any tissue inflammation/ injury. this may result in inappropriate treatment, particularly for patients with underlying autoimmune systemic disease who require immunosuppression. diagnosis by mri rests on detecting tissue injury through t2 and t1-weighted sequences which detect tissue inflammation and tissue injury. the purpose of this study is to evaluate the diagnostic accuracy of novel 3d free-breathing sequences for t2-weighted and fibrosis/ lge imaging. patients with suspected isolated myocarditis (viral/idiopathic) or myocarditis as part of an autoimmune systemic disease will be recruited to ensure that the novel techniques are tested in a broad spectrum of patients with inflammatory heart muscle disease.


Eligibility criteria:
inclusion criteria: * all patients referred for cmr for clinically suspected myocarditis either idiopathic or in the context of autoimmune rheumatic disease. * patients who are able to give informed consent. exclusion criteria: * patients in atrial fibrillation. * patients who are unable to give informed consent. * patients whose physical or mental condition indicates that the additional time in the cmr scanner should be minimised. * patients who cannot have cmr due to either contraindications to cmr (e.g., non-conditional intracardiac devices) or contraindications to contrast (e.g., history of allergy to gadolinium).

Keywords: cardiovascular magnetic resonance imaging inflammation
effect of piroxicam on ovulation

Conditions: Contraception, Postcoital

Summary: in this study the effect of piroxicam on the ovulation will be evaluated. therefore piroxicam will be administered as a single-dose after onset of lh surge (luteinizing hormone, hormone which triggers ovulation). additionally blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. in addition the concentration of piroxicam in blood will be determined in regular intervals. with regards to the tolerability of the study drug subjects will be asked regularly how they feel.


Eligibility criteria:
inclusion criteria: * signed informed consent available before any study specific tests or procedures are performed * healthy female subject * age: 18 to 35 years (inclusive) at the first screening visit * body mass index (bmi ): 18-30 kg/m² (inclusive) at the first screening visit * confirmation of the subject's health insurance coverage prior to the first screening visit * willingness to use non-hormonal methods of contraception during the study * ability to understand and follow study-related instructions * adequate venous access exclusion criteria: * incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs will not be normal * hypersensitivity to the active substance or skin reactions (irrespective of severity) to piroxicam, non-steroidal anti-inflammatory drugs or other medicinal products in the past * history or presence of inflammatory diseases of the gastrointestinal tract, gastrointestinal bleeding, ulcers or perforation * regular intake of medication other than hormonal contraceptives * clinically relevant findings in the gynecological examination including transvaginal ultrasound (tvu) * clinically relevant findings in the physical examination, especially signs of bleeding diathesis or heart failure * time point "onset of lh surge" in the pre-treatment cycle not determinable * time point "ovulation" in the pre-treatment cycle not determinable * lacking suitability for frequent tvu examinations * history or presence of suffering from hay fever

Keywords: emergency contraception contraception
safety, fatigue, and continuity in the intensive care unit (icu)

Conditions: Fatigue

Summary: the purpose of this study is to describe the features of continuity and quantify fatigue in three icu resident work schedules, estimate the frequency of preventable adverse events, and inform the design and demonstrate the feasibility of a future multi-centre study.

the overall goal of our research is to describe the optimal scheduling pattern for frontline physicians working in icus. our hypothesis is that call schedule associated reductions in fatigue are counterbalanced by reductions in continuity, resulting in no change in the safety of patients. this is a prospective before-after, two-centre study using a mixed-methods design. we will apply 3 work schedules, each for a period of 2 months over a 6 month period in the adult medical-surgical icus at two university affiliated hospitals in toronto. in this mixed methods approach, quantitative and qualitative data will be collected concurrently, analysed separately, and their results compared, to produce an integrated interpretation of the impact of work schedule on the relationship between continuity and fatigue. this will evaluate healthcare continuity and fatigue, describe adverse events in icus, identify the two best resident schedules for subsequent comparison, and demonstrate the feasibility of a future multi-centre study of physician scheduling.

Eligibility criteria:
inclusion criteria: * all residents at participating icus starting a rotation in fall 2008 * staff members supervising and/or working with participating residents * patients/family members under the care of the participating residents * patients admitted to participating icus exclusion criteria: * lack of informed consent

Keywords: resident safety fatigue continuity icu
pessary in singleton gestations with short cervix without prior preterm birth

Conditions: Preterm Birth

Summary: spontaneous preterm birth (sptb) remains the number one cause of perinatal mortality in many countries, including the united states. in singleton gestations a short cervical length (cl) on transvaginal ultrasound (tvu) has been shown to be a good predictor of sptb. the cervical pessary is a silicone device that has been used to prevent sptb. the efficacy of cervical pessary has been assessed in several populations including singletons with short cl, unselected twins, twins with a short cl, and triplet pregnancies. several randomized clinical trials (rcts) have been published, and several are ongoing. however, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.


Eligibility criteria:
inclusion criteria: * 18-50 years of age * singleton pregnancy (limits the participants to female gender) * short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation exclusion criteria: * multiple gestation * prior spontaneous preterm birth 16-36 6/7 weeks * ruptured membranes * lethal fetal structural anomaly * fetal chromosomal abnormality * cerclage in place (or planned placement) * vaginal bleeding * suspicion of chorioamnionitis * ballooning of membranes outside the cervix into the vagina or cl = 0 mm on transvaginal ultrasound * painful regular uterine contractions * placenta previa
infrastructure for developing gastrointestinal cancer prognostic and predictive markers

Conditions: Gastrointestinal Cancer

Summary: the proposal seeks to establish: * a comprehensive compilation (database) of clinical information comprising clinical, histopathological, treatment and follow-up characteristics of past and future gastrointestinal cancer (gic) cases in singapore that can be shared by investigators. the characteristics will include clinical (eg age, sex, stage), histopathological (eg. grade, type), treatment (eg. treatment status, regimens) and outcome data (eg. survival, toxicity) from medical records. * a collection (bank) of corresponding frozen and fixed tissue, blood and processed samples (enriched blood mononuclear cells, protein, rna, dna, tissue arrays) in singapore that can be shared by the investigators. * a gastrointestinal cancer co-operative group (gccg) of clinicians and scientists researching prognostic and predictive markers in gic, which will benefit from the multi-disciplinary knowledge, information and samples of its members. * to characterise genetic polymorphisms related to gastrointestinal cancer chemotherapy treatment in controls (healthy volunteers)


Eligibility criteria:
inclusion criteria: * patients with cancers of the gastrointestinal tract (eg. colorectal, gastric, pancreatic, esophageal) exclusion criteria: * none