Kornimate/medical-research-clean huggingface dataset:
comparative study of oral eletriptan (40mg and 80mg), oral sumatriptan (25mg and 50mg) and placebo

Conditions: Migraine With or Without Aura

Summary: the objective of this study was to compare the efficacy, toleration and safety of eletriptan 40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with an acute migraine.


Eligibility criteria:
inclusion criteria: * subjects who expected to suffer at least one acute attack of migraine, with or without aura, each 6 weeks (the diagnosis of migraine was to comply with the criteria proposed by the international headache society (ihs)) * subjects capable of taking medication as outpatients, and recording the effects of such medication. exclusion criteria: * pregnant or breast-feeding women * migraine subjects who also suffered from concomitant frequent (non-migrainous) headache, defined as more than six attacks per month on average.
adaptive radiation therapy for head & neck cancer patients

Conditions: Cancer of Head and Neck

Summary: the purpose of this study is to determine the utility of kilovoltage (kv) cone beam ct imaging to track the dose delivered in head and neck cancer patients, to assess the benefit of cone beam ct to patients set-up for radiation treatment, to determine how shifts based on kv cone beam ct compare to the standard approach (orthogonal pair), and to develop remote access tools (preferably internet-based) so that the md can approve these plans in real time.

the investigators' secondary objectives for this study are to assess the possibility of using kv cone beam for treatment replanning as compared to standard the treatment planning, to determine the need and feasibility of adaptive radiation therapy, to develop concept of establishing cumulative dvh (c-dvh) with daily updates and compare it to planned dvh (p-dvh), to identify tolerance margins, to evaluate local control, locoregional control, distant metastasis, and overall survival, to assess patient quality of life,and to develop predictors of patients which may benefit from art.

Eligibility criteria:
inclusion criteria: * patients should have an ecog (eastern clinical oncology group) performance status of 0-2 * patients should meet at least one of the following criteria: 1. locally advanced cancer (t3-t4 and/or n2-n3) 2. tumors wrapping around critical structures such as the optic nerves, optic chiasm, or brainstem 3. significant expected weight loss. exclusion criteria: * previous surgical procedure more significant than a biopsy to the primary tumor or regional lymph nodes. * poor renal function (inability to undergo a ct with iv contrast) * previous radiation therapy to the head and neck. * inability to tolerate prolonged immobilization. * children and women who are pregnant or decline to use contraception.
mri contrast clearance analysis for glioma grading and genotyping

Conditions: Glioma

Summary: gliomas are the most common primary brain tumor. gliomas with different grades have different clinical behaviors that determine treatment planning and patient prognosis in clinical practice. in the 2021 world health organization (who) classification of tumors for the central nervous system, glioma genotyping was considered the most relevant information for neuroradiologists. the isocitrate dehydrogenase (idh) genotype and 1p/19q codeletion status are two essential molecular markers that divide glioma into three groups: idh wild-type, idh mutant with 1p/19q non-codeletion, and idh mutant with 1p/19q codeletion. mri contrast clearance analysis (cca) is based on t1 delayed-contrast subtraction map, blue/tumor regions in cca represent efficient clearance of contrast from the tissue (delayed signal\ early signal). however, there are not any reports on the role of mri cca in glioma grading and genotyping, thus, we hypothesized that the proportion of blue/red region and their histogram analyses, which could be acquired for predicting idh genotypes and 1p/19q codeletion in gliomas, and to assess the application of cca in glioma grading.

this is a single-center bidirectional cohort study. the subjects of this study were patients diagnosed as glioma by pathological biopsy. patients with suspicious mass will be performed extra 30 and 60 min after contrast agent application delayed t1-weighted sequences as same as before. then enter the next experimental stage. (1) image format conversion; (2) registration;(3) subtraction;(4) roi segmentation;(5) roi histogram analyses. histogram parameters of blue and red roi includes 1st、10th 、90th and 99th percentiles, mean, median, variance, skewness, and kurtosis. finally, statistical methods were used to determine whether those parameters was statistically significant for idh mutation status、1p/19q codeletion status and tumor grading.

Eligibility criteria:
inclusion criteria: * patients with brain space -occupying lesions, have not yet undergone antitumor therapy; * mri with t1-contract delayed sequence was performed less than 2 weeks before surgery; * definite histopathologic diagnosis of glioma. exclusion criteria: * who 1 gliomas and other non-glioma brain tumors; * poor image quality and heavy artifact affect the subsequent image processing.

Keywords: glioma
safety and efficacy of bfh772 in psoriasis patients

Conditions: Psoriasis; Arthritis

Summary: this study will determine the efficacy of topical bfh772 in psoriasis patients and the safety after multiple dosing.


Eligibility criteria:
inclusion criteria: * stable mild to moderate plaque psoriasis (bsa involvement \< 10% or pasi \< 10 * category "mild to moderate" on pga as according to the emea (chmp 2004) (guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis), with or without arthritis * diagnosed or history of psoriasis for at least 6 months prior to screening exclusion criteria: * nonplaque forms of psoriasis * drug-induced psoriasis * current use of beta blockers * congestive heart failure (nyha \>iii), qt interval \>450msec or poorly controlled diabetes mellitus other protocol-defined inclusion/exclusion criteria may apply

Keywords: stable plaque psoriasis inflammatory skin with or without arthritis
efficacy and safety of insulin aspart vs. human insulin during pregnancy by women with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial was conducted in europe, middle east, north america and south america. the aim of this trial was to compare the use of an intensified insulin treatment with insulin aspart (novorapid®) versus human insulin (actrapid®) in pregnancy.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * treated with insulin for at least 12 months * either plan to become pregnant in the immediate future, willing to undertake pre pregnancy counselling, and has a screening hba1c lesser than or equal to 12.0%, or * pregnant with normal singleton pregnancy, gestational age for at least 10 weeks at the time of randomisation, confirmed by ultrasound scan. exclusion criteria: * previous birth of child with a major congenital malformation * more than 2 previous multiple miscarriages or stillbirths * severe hyperemesis gravidarum, requiring hospitalisation, according to investigator judgement * subjects being treated for infertility * proliferative retinopathy or maculopathy requiring acute treatment * drug or alcohol abuse * impaired renal, hepatic or cardiac function
application of circulating tumor dna test in the diagnosis and treatment of patients with advanced rectal cancer

Conditions: Rectal Neoplasms; Neoadjuvant Therapy; Circulating Tumor DNA

Summary: application of circulating tumor dna detection in diagnosis and treatment of locally advanced rectal cancer. first, to explore the feasibility of ctdna as a detection index for rectal cancer. second, evaluate the accuracy of ctdna detection in rectal cancer. third, to explore whether ctdna can be used in the evaluation of preoperative concurrent chemoradiotherapy, so as to provide guidance for subsequent treatment. fourth, to explore the guidance value for the decision of postoperative adjuvant therapy and the frequency of reexamination. fifth, search for possible recurrence related mutations.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed primary rectal cancer； * first treatment； * 18 years of age or older, male or female； * according to the indications of operation, surgical treatment can be carried out； * according to the indications of radiotherapy, radiotherapy can be carried out； * the physical status score of ecog was 0\~1； * organ function is appropriate; * expected survival time more than 3 months； * during the treatment period and 6 months after treatment, contraception was not in lactation； * the patient volunteered and signed the informed consent. exclusion criteria: * poor compliance and failure to receive medication or follow up according to plan； * there are other serious violations of the programme; * at present, it has been included in other clinical trials, or at the same time, it has been included in other medical research which is judged to be incompatible with this research； * it has a history of other cancers. unless the cancer is completely relieved, the disease is not treated for more than 3 years.
efficacy of repyflec cognitive remediation group training in schizophrenia

Conditions: Indication for Modification of Patient Cognitive Status

Summary: the purpose of this study was to develop an integrative intervention for schizophrenia taking into account previous efficacious therapies. thus, our aim was to evaluate the efficacy of our cognitive remediation group training: problem solving and cognitive flexibility training (repyflec), focused to improve neurocognition and functioning in schizophrenia patients. we hypothesized that training executive function and metacognition would allow us to achieve improvements in neurocognition, functioning and psychiatric symptoms of patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder * more than 2 years illness duration * literate * mini mental status examination score over 24 * global assessment of functioning scores between 40 and 70 exclusion criteria: * current acute illness exacerbation * mental retardation * neurological disorder which impairs cognition * currently participating in social skills training or cognitive remediation * change of antipsychotic medication one month before the trial or during the 40 study weeks * diagnosis of alcohol or drug dependence within 6 months of trial commencement.

Keywords: schizophrenia cognitive remediation group training executive function social functioning
creatine supplementation and bone mass

Conditions: Osteopenia; Osteoporosis

Summary: resistance training as well as creatine supplementation may increase bone mass. therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on bone mass in elderly women with osteopenia and osteoporosis.


Eligibility criteria:
inclusion criteria: * osteopenia and osteoporosis * women older than 60 years old exclusion criteria: * cardiovascular diseases or muscular disturbances precluding exercise training * drugs affecting bone metabolism

Keywords: creatine supplementation resistance training osteopenia osteoporosis bone mineral density
functional change in endothelium after cardiac catheterization, with and without music therapy

Conditions: Coronary Artery Disease; Endothelial Dysfunction

Summary: the purpose of this study is to determine the effect of music therapy before, during, and after cardiac catheterization is associated on (a) change in reactive hyperemia index measured before and after catheterization using peripheral arterial tonometry and (b) patient stress and discomfort measured by a questionnaire, as compared to the standard of care (no music during cardiac catheterization). the hypothesis of the study is that music therapy during cardiac catheterization will be associated with more favorable change in reactive hyperemia and higher patient satisfaction compared to no music playback.


Eligibility criteria:
inclusion criteria: 1. age \>18 years 2. referred for clinically-indicated cardiac catheterization exclusion criteria: 1. refusal or inability to provide signed informed consent 2. significant hearing loss

Keywords: music cardiac catheterization endothelial function
pioglitazone tablets specified drug-use survey

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this survey is to evaluate the effects on glycemic control and to evaluate the safety of long-term use of pioglitazone tablets (actos tablets) in type 2 diabetic patients with inadequate glycemic control and a prior history of cerebral infarction.

this survey was designed to evaluate the effects on glycemic control and to evaluate the safety of long-term use of pioglitazone tablets (actos tablets) in type 2 diabetic patients with inadequate glycemic control and a prior history of cerebral infarction. for adults, 15-30 mg of pioglitazone is usually administered orally once daily before or after breakfast. the dose should be adjusted depending on sex, age, and symptoms; however, the maximum daily dose should not exceed 45 mg.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients with a prior history of cerebral infarction who meet all the following conditions, \[1\] to \[3\], at the time of enrollment in the survey: 1. first onset of cerebral infarction was at least 24 weeks prior to enrollment 2. hba1c values ≥ 6.5% within 12 weeks prior to the start of treatment with pioglitazone tablets 3. no prior history of treatment with pioglitazone tablets since the first onset of cerebral infarction exclusion criteria: * patients who meet any of the following conditions, \[1\] to \[5\], shall be excluded from the survey: 1. contraindication for actos tablets 2. prior history of recurrence of cerebral infarction 3. prior history of cerebral hemorrhage or subarachnoid hemorrhage 4. complications or prior history of myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease, atrial fibrillation, atrial flutter, or valvular disease 5. reduced cardiac function (defined as an ejection fraction \[ef\] ≤ 40%)

Keywords: pharmacological therapy
risk factors for postoperative nausea/vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: general anesthetic technique plays a key role in most surgical procedures. this technique has some complications especially postoperative nausea/vomiting (ponv). this complication can lead to serious problems. department of anesthesiology has developed and implemented a ponv prophylaxis guideline for high risk ponv patients but ponv still remains.

objective: to identify risk factors for ponv after implementation of ponv prophylaxis guideline. methods: this will be a retrospective analytic study. relevant clinical data from medical records of adult patients undergoing general anesthesia in srinagarind hospital from november 2014 to february 2015 will be used to identify relevant risk factors.

Eligibility criteria:
inclusion criteria: * asa classification i-iii exclusion criteria: * incomplete or illegible medical records * patients who underwent cardio-thoracic surgery * patient who had chronic treatment with antiemetic drugs
intrapleural dnase and tissue plasminogen activator in pediatric empyema (dtpa trial)

Conditions: Pleural Empyema

Summary: bacterial pneumonia can be complicated by the development of excess fluid and pus (pleural empyema) around the lungs in children. the incidence of pleural empyema in children has increased significantly in the last 10 years. short term morbidity for this condition is substantial, but unlike in adults, the long term outcome of this condition for children in developed countries is favourable. inserting a chest drain and then adding a medicine (tissue plasminogen activator - tpa) to break down organized pus has been shown to be an effective therapy for reducing the duration of illness. however, this treatment is still suboptimal and prolonged hospitalization is common. recent data from adults suggests that adding an additional medicine (dnase) to decrease the viscosity (thickness) of the fluid improves drainage and leads to better patient outcomes; however, there are no published studies on children. this is a multi-centre randomized controlled trial comparing the time to discharge from hospital after chest drain insertion in previously well children who present with pleural empyema, treated with intrapleural dnase and tissue plasminogen activator (tpa) by chest drain for three doses over 48 hours compared with three doses over 48 hours of tpa alone. other outcomes related to effectiveness, safety and cost will be assessed as well.


Eligibility criteria:
inclusion criteria: 1. age 6 months to 18 years 2. hospitalized with diagnosis of pleural empyema requiring chest tube drainage with fibrinolytics as judged by the attending physician with the following criteria: 1. pneumonia with pleural effusion as documented on ultrasound of the chest; and 2. need for further intervention in addition to antibiotics based on clinical criteria \[persistent fever despite on antibiotics for at least 48 hours or significant respiratory distress tachypnea, hypoxia) as a result of the pleural fluid collection\] exclusion criteria: 1. empyema as a result of tuberculosis, fungus or non-infectious causes (e.g. malignancy) 2. known coagulation impairment 3. suspected or proven allergy to tpa or dnase 4. chronic lung disease or other chronic illnesses (e.g. immunodeficiency or neurologic impairment) 5. child has already undergone a drainage procedure (e.g. chest drain or vats). 6. recent administration of an investigational drug (within previous 30 days) 7. pregnancy 8. breastfeeding

Keywords: randomized controlled trial pleural empyema tpa dnase
a trial to assess efficacy and safety of octreotide subcutaneous depot in patients with gep-net

Conditions: Gastro-enteropancreatic Neuroendocrine Tumor

Summary: the purpose of this study is to compare the effectiveness and safety of cam2029 to octreotide lar or lanreotide atg in patients with advanced, well-differentiated gep-net. patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with cam2029.


Eligibility criteria:
inclusion criteria: * male or female patient ≥18 years old * histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated net of gep or presumed gep origin * at least 1 measurable, somatostatin receptor-positive lesion according to recist 1.1 determined by multiphasic ct or mri (performed within 28 days before randomization) * ecog performance status of 0 to 2 exclusion criteria: * documented evidence of disease progression while on treatment (including ssas) for locally advanced unresectable or metastatic disease * known central nervous system metastases * consecutive treatment with long-acting ssas for more than 6 months before randomization * carcinoid symptoms that are refractory to treatment (according to the investigator's judgement) with conventional doses of octreotide lar or lanreotide atg and/or to treatment with daily doses of ≤600 µg of octreotide ir * previous treatment with more than 1 cycle of targeted therapies such as mtor inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of chemotherapy or interferon for gep-net * treatment of gep-net with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening * previously received radioligand therapy (prrt) at any time

Keywords: cam2029 gep-net octreotide sorento
cfdna in hereditary and high-risk malignancies 2

Conditions: Hereditary Cancer Syndrome

Summary: the goal of this study is to understand the performance of an experimental blood test that aims to detect early tumors in patients with hereditary cancer syndromes. if this new blood test is accurate, it could be used to screen patients for cancer and allow for earlier cancer detection. the study will compare cancer detection rates between those receiving the new blood test and those receiving standard care, assess if the test leads to earlier cancer diagnosis, and evaluate its impact on patient outcomes. the study will also use questionnaires and interviews to understand how patients feel about the blood test, its incorporation into routine medical care, and perceptions of the medical value of test results. this research could lead to more effective and less invasive cancer screening for high-risk individuals.

through the charm consortium (www.charmconsortium.ca), we have shown that cell-free dna (cfdna) profiling can enable more frequent cancer surveillance from readily accessible blood collections. we are now conducting a prospective, multi-center, randomized control trial of cfdna testing of 1,000 hcs carriers from across canada to 1) compare cancer detection rates with and without cfdna testing, 2) assess cancer stage shift and clinical impact reducing mortality and morbidity cancers, and 3) assess impact of access to cfdna results on patients' quality of life and psychological distress.

Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of hereditary breast and ovarian cancer (hboc), lynch syndrome (ls), neurofibromatosis type i (nf1), li-fraumeni syndrome (lfs), palb2, and hereditary diffuse gastric cancer (hdgc), (i.e., patients with an identified pathogenic variant in the respective cancer predisposition gene, or patients with uninformative genetic testing but with a family history suggestive of the cancer predisposition syndrome). * patients must be receiving standard-of-care clinical assessment for cancer by a managing physician under a provincial screening program or cancer surveillance protocol. * all patients must have signed and dated an informed consent form for this study. exclusion criteria: * patients must not have a personal history of cancer diagnosed and treated within 3 years prior to the expected first sample collection date for this study. if a patient has a personal history of cancer, treatment must have been completed successfully at least 3 years prior to first study sample collection. * patients diagnosed more than 3 years prior to the expected first sample collection date, but never been treated for the cancer. * patients undergoing investigations for a clinical suspicion of cancer. * patients who are not able to comply with the protocol (i.e., tri-annual blood sample collection if randomized into the experimental cohort).

Keywords: cfdna cell-free dna hereditary cancer syndrome brca1 brca2 lynch syndrome hereditary breast and ovarian cancer (hboc) liquid biopsy circulating tumor dna hereditary diffuse gastric cancer (hdgc) li-fraumeni syndrome
vitamin d and omega-3 inhibit metabolic syndrome

Conditions: Type 2 Diabetes Mellitus; Hypertension; Hyperlipidemia; Obesity

Summary: the study will test the hypothesis that supplementing the diet of subjects with metabolic syndrome with 2000 iu vitamin d and 1.8 g omega-3 fatty acids (epa + dha) per day, will facilitate weight loss, improve body composition and reduce metabolic and biochemical risk factors associated with type ii diabetes and cardiovascular disease. adult men and women who meet the international diabetes federation criteria for metabolic syndrome will be enrolled and embark on a 16 week diet and exercise intervention using a low glycemic index diet with or without the supplementary vitamin d and omega-3. subjects will be counseled weekly and blood collected at weeks 0 and 16.


Eligibility criteria:
inclusion criteria: * must have metabolic syndrome as defined by international diabetes federation * must be able to swallow tablets and capsules * must be 18 years of age or older * must be physically capable of moderate intensity exercise exclusion criteria: * pregnant or lactating * vegetarian

Keywords: weight loss overweight body composition visceral obesity insulin glucose tolerance cholesterol hypertriglyceridemia