Kornimate/medical-research-clean huggingface dataset:
national retrospective study of recanalization treatments in pediatric arterial ischemic stroke

Conditions: Arterial Ischemic Stroke

Summary: the purpose of this study is to evaluate recanalization treatments use, safety and efficacy at the acute phase of arterial ischemic stroke in pediatric patients

arterial ischemic stroke outcomes benefited from the implementation of recanalization treatments (iv thrombolysis, endovascular treatments) and adapted management pathways in adult patients. nevertheless randomized trials did not enroll patients under the age of 18 years old and data concerning these treatments in children are scarce. as it is much less frequent than in adults, recognition of stroke is often delayed in children. consequently, acute phase trials are difficult to set up and perform. the phase i multicentric international prospective trial tips (thrombolysis in pediatric stroke) was prematurely stopped because of poor enrollment. published retrospective regional (paris-ile-de-france region, france) and national (switzerland) studies addressed the feasibility of such treatments but, because of small samples (less than 20 patients in each study), efficiency and prognostic factors could not be addressed. exhaustive retrospective studies in a definite geographic area but with a sufficient number of patients in a limited inclusion period would provide these crucial data and address these questions with good relevance and limited bias.

Eligibility criteria:
inclusion criteria: * patients under 18 years old * suspected or confirmed cerebral infarction * with recanalization treatment in the acute phase : intravenous thrombolysis +/- intra-arterial thrombolysis +/- thrombectomy * patients treated between the january 2015, 1st and the may 2018, 31st * collection of non-opposition from legal representatives exclusion criteria: - refusal of the patient's legal representative to participate in the study

Keywords: ischemic stroke children recanalization treatment thrombolysis thrombectomy
study of ts-1 as 2nd line treatment in patients with advanced metastatic breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to assess the effectiveness and safety profile of aiyi®(tegafur gimeracil oteracil potassium capsule, ts-1) as a second line therapy in chinese female patients with advanced metastatic breast cancer.

tegafur gimeracil oteracil potassium capsule is a novel oral derivative of the 5-fluorouracil(5-fu) prodrug tegafur combined with two modulators. recent clinical trial has reported the promising effect of tegafur gimeracil oteracil potassium capsule in metastatic breast cancer. the innovative drug, s-1, has obtained the approval of treatment of advanced breast cancer in japan, meanwhile, generic drug is only approved for the indication of gastric cancer in china mainland by chinese authority, sfda, and no chinese clinical study data of ts-1 in breast cancer so far.

Eligibility criteria:
inclusion criteria: * age: 18-75 years old female. * ecog status: 0-2. * life expectancy of ≥ 3 months. * histologic or cytologic diagnosis of breast cancer. * progression after receiving one standard prior chemotherapy regimen for recurrent or metastatic lesion except an endocrine regimen. * at least one measurable lesion of \>=2 cm (\>=1 cm on spiral ct scan)according to recist (v1.1). * adequate organ functions: * hematopoietic: hemoglobin ≥90g/l, absolute neutrophil count ≥1.5×10\^9/l, platelet count ≥80×10\^9/l. * biochemistry: tbil ≤1.5 times upper limit of normal (uln), ast and alt ≤2.5× uln(≤5x uln if due to liver metastases), creatinine ≤1.0×uln and creatinine clearance \>50 ml/min. * women with children potential must have negative pregnancy tests 7 days prior to enrollment and be willing to practice acceptable methods of birth control during the study and 8 weeks after last drug administered. * ability to take oral medication . * signed informed consent. exclusion criteria: * pregnancy or lactation or no effective contraception in fertile patients. * prior treatment with 5-fu or drugs of same class(excluding patients that relapsed more than one year after adjuvant therapy). * less than 4 weeks since prior investigational agents. * conditions impacting oral drug taking or absorption (e.g. inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction). * organ invasion with rapid progression(e.g. lesions exceeding half of liver or lung). * cns or psychiatric disorders. * allergic to 5-fu. * only with bone metastases and no measurable lesions. * clinically significant heart diseases (e.g.congestive heart failure, ventricular arrhythmia, myocardial infarction) before enrollment. * serious peptic ulcer disease or digestive disorders. * bone marrow (hemoglobin \<90g/dl, anc \<1.5×10\^9/l, platelet count \<75×10\^9/l). * renal function disorder (creatinine \>1.0×uln). * liver function disorder (tbil \>1.5×uln). * uncontrolled brain metastases. * noncompliance with the study protocol.

Keywords: advanced metastatic breast cancer
assessing the effectiveness of diabetes interactive diary (did) in diabetes management

Conditions: Type 1 Diabetes Mellitus

Summary: for people with type 1 diabetes, blood glucose control is achieved by matching insulin doses directly to the amount of carbohydrate consumed. we are looking at new ways to help our patients with type 1 diabetes manage their diabetes control more effectively. we are testing if "diabetes interactive diary" (did), a novel programme designed to be used on a mobile phone, can represent an important tool in carbohydrate counting while avoiding the use of complex calculations and in depth knowledge about the carbohydrate content of their food.

this is randomized control trial aimed to evaluate the effectiveness of a did compare to the standard education approach in order to help the patients with type 1 diabetes to estimate the carbohydrate in their food and adjust insulin doses. it involves individuals with type 1 diabetes who are not habitually using carbohydrate counting. they should be testing their blood sugar levels at least 3 times a day, using multiple daily injections of short-acting and long-acting insulin analogues, with hba1c between 7.5% and 10% and are familiar with the use of mobile phones and possess a personal sim card. patients will be randomized to the standard education programme run for 4 full days over a 4 week period or to the did programme run as three 2-hour sessions over a two-week period. the did is a novel software programme installed on the patient's mobile telephone. it facilitates the communication between the dietitian and the patient by using sms text messages, so that the dietitian can monitor glycaemic control and suggest adjustments if necessary. it can be described as a little computer, where the patient can record their blood glucose value, the amount of insulin injected and the amount of carbohydrate consumed.

Eligibility criteria:
inclusion criteria: * aged 18 or over * not habitually using carbohydrate counting and insulin dose adjustment * testing their blood sugar levels at least 3 times a day * using multiple daily injections of short-acting and long-acting insulin analogues * with hba1c between 7.5% and 10% * familiar with the use of mobile phones and possess a personal sim card. exclusion criteria: * mental conditions, depression or high anxiety rendering the subject unable to understand the nature, scope, and possible consequences of the study * eating disorders * pregnancy * any clinically significant major organ system disease or infective diseases * any disease or condition or abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator may interfere with the completion of the study * subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study procedures
testing feasibility of care coordination and motivational interviewing for women with a recent preterm birth

Conditions: Preterm Birth; Health Care Utilization; Tobacco Use; Contraceptive Usage; Depression; Weight, Birth

Summary: this study continues an adaptation of care coordination to address the needs of women after preterm birth. this is a small single arm open trial designed to test intervention implementation and refine the intervention before ongoing feasibility testing.

interventionists will be trained in care coordination strategies and motivational interviewing (mi) techniques. following training, investigators will enroll eligible women from a postpartum unit at a single hospital, or within two weeks of birth. investigators will assess feasibility, adoption, reach, and fidelity of the intervention and of study data collections strategies. the intervention protocol will be revised to reflect these assessments.

Eligibility criteria:
inclusion criteria: 1. female 2. less than 45 years old 3. history of preterm birth (\< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may include low preventive care utilization, tobacco use, obesity, depression or anxiety, or history of unmet contraceptive needs) 4. intention to seek pediatric care at one of two pediatric primary care sites 5. medicaid insurance exclusion criteria: 1. history of sterilization procedure. 2. plan to move away from the area or transfer pediatric primary care within six months of enrollment. 3. limited english proficiency

Keywords: preconception care interconception care postpartum care preventive health care care coordination motivational interviewing
study of tas-102 or placebo plus bsc in patients with metastatic gastric cancer

Conditions: Refractory Metastatic Gastric Cancer

Summary: the purpose of this trial is to compare the effects of tas-102 and best supportive care (bsc) with placebo (an inactive drug) and best supportive care on metastatic gastric cancer.

this is a multinational, double-blind, two-arm, parallel, randomized, phase 3 study evaluating the efficacy and safety of tas-102 plus bsc versus placebo plus bsc in participants with metastatic gastric cancer who have previously received at least 2 prior regimens for advanced disease. eligible participants will be centrally randomized (2:1) to tas-102 + bsc (experimental arm) or placebo + bsc (control arm).

Eligibility criteria:
inclusion criteria: 1. has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction. 2. has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy. 3. has measureable or nonmeasurable disease as defined by response evaluation criteria in solid tumors (recist) 1.1 criteria. 4. is able to take medications orally (ie, no feeding tube). 5. has an eastern cooperative oncology group performance status of 0 or 1. 6. has adequate organ function as defined by protocol defined labs. 7. women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. males must agree to adequate birth control. exclusion criteria: 1. has certain serious illnesses or medical conditions 2. has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent within the specified time frames prior to study drug administration. 3. has previously received tas-102. 4. has unresolved toxicity of greater than or equal to common terminology criteria for adverse events grade 2 attributed to any prior therapies. 5. is a pregnant or lactating female.

Keywords: gastric cancer metastatic gastric cancer
abdominal-kegel exercise and the effect of telemedicine in stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: urinary incontinence is a very common health problem that reduces the quality of life mostly in women. behavioral therapy (lifestyle changes, abdominal-kegel exercises) is recommended as the first choice in the treatment of the disease. it is known that surgical and medical treatment cannot give a definite result. the application of behavioral therapy with telemedicine has advantages such as reducing the cost and increasing the treatment rate. in this study, it is aimed to evaluate the effect of telemedicine practices on compliance with multi-module behavioral therapy in women with stress urinary incontinence.

the study is a randomized controlled study to be conducted in female patients between the ages of 20-65 who applied to the eskişehir city hospital urology outpatient clinic and diagnosed with stress urinary incontinence. when type 1 (α) error was 5%, type 2 error (1-β) was 95%, and the effect size was accepted as 0.5, it was calculated that there should be at least 47 people in the groups. stratified and block randomization will be used to recruit patients into study groups. the patients will be evaluated with the quid test, risk assessment questionnaire in patients with stress urinary incontinence, incontinence short test, bladder diary, daily urinary incontinence, a notebook to record the duration of the exercises to be performed, quality of life scale and lifestyle changes questioning form. the intervention group will be re-evaluated as a result of the intervention with measurement tools. intervention group: brochure about incontinence will be given, web-based training will be applied, sms will be sent every day according to the risks. control group: only brochure will be given. it is expected that a low-cost application to be developed after the study will reduce the complaints of the patients, increase their quality of life and have a positive effect on women's health. it is difficult for physicians to allocate sufficient time to convey lifestyle changes and exercises to patients with stress urinary incontinence during their busy work hours in the clinic. after the success to be achieved, the usage rate of the website to be prepared will be increased through various scientific platforms and associations.

Eligibility criteria:
inclusion criteria: * having symptoms of ui for at least the last 6 months, * quid stress score is ≥ 4, * diagnosed with sui as a result of the evaluation made by a specialist physician, have minimal skills in using new technologies * those who have the opportunity to access the web page to be prepared can participate in the research. exclusion criteria: * history of using medical therapy for ui, * existing urinary infection, * diabetes mellitus, * nervous system disease (such as multiple sclerosis, cerebrovascular disease), * psychiatric illness or dementia, * genitourinary malignancy, * having limited range of motion in the foot or pelvic region, * pregnant

Keywords: stress urinary incontinence kegel exercises randomization telemedicine
three doses of tas-108 to treat recurrent or recurrent inoperable breast cancer

Conditions: Breast Cancer

Summary: this study is being done to find out how safe tas-108 is and how well tas-108 works on recurrent or recurrent inoperable breast cancer.

the objective of this study is to investigate the efficacy and safety of tas-108 administered in postmenopausal patients with locally advanced or locally recurrent inoperable or progressive metastatic breast carcinoma who have previously responded to one or two standard endocrine therapies, with or without one prior chemotherapy.

Eligibility criteria:
inclusion criteria: * postmenopausal females * histologically or cytologically confirmed diagnosis of breast carcinoma * locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression * has laboratory documentation of positive estrogen receptor (er) and/or progesterone receptor (pgr) status, and has responded to the standard first or second line hormonal anti-tumor therapy given * has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies * performance status of greater than or equal to 2 on the zubrod scale * predicted life expectancy of greater than or equal to 12 weeks * must give written informed consent * measurable disease according to the response evaluation criteria in solid tumors (recist) criteria * absolute granulocyte count of greater than 1,500/meql, platelet count greater than 75,000/meql, and a hemoglobin of greater than 10 g/dl * adequate liver and renal function as defined by a bilirubin of less than 1.5 times the upper limit of normal and a creatinine of less than 1.5 times the upper limit of normal * transaminases must be less than 2.5 times the upper limit of normal except for patients with liver metastases who may have transaminases less than 5 times the upper limit of normal. * the patient has recovered from all previous anti-cancer treatment related to toxicities to at least grade 1. * all previous investigational drugs must be stopped at least four weeks before commencement of treatment with tas-108.

Keywords: locally advanced breast carcinoma locally recurrent inoperable breast carcinoma progressive metastatic breast carcinoma
study of ono-4538 in unresectable advanced or recurrent gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of study is to evaluate the efficacy and safety of ono-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.


Eligibility criteria:
inclusion criteria: * men \& women ≥20 years of age * unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) * histologically confirmed adenocarcinoma * refractory to or intolerant of standard therapy * ecog performance status score 0 or 1 * a life expectancy of at least 3 months exclusion criteria: * current or past history of severe hypersensitivity to any other antibody products * patients with multiple primary cancers * patients with any metastasis in the brain or meninx that is symptomatic or requires treatment * patients with active, known or suspected autoimmune disease
metabolomics during electroconvulsivotherapy

Conditions: Major Depressive Episode; ECT

Summary: investigators will measure the variation of blood metabolome through 1h nmr at several time points during the course of electroconvulsivetherapy in patients with a major depressive episode. patients with a major depressive disorder or a bipolar disorder and a current major depressive episode will be included in this study. investigators hypothesized that metabolome could be a source to predict response during ect and to help understanding underlying biological mechanisms.

biological signatures of blood metabolome will be measure before and after the first session of electroconvulsivetherapy, and during the course, before the 6th, 12th and the last sessions. proton nuclear magnetic resonance spectroscopy will be used to measure metabolites in blood sample. in parallel, at each time point, depression severity (madrs and bdi), perceived severity (cgi), global functioning (egf), convulsive characteristics and cognitive tolerance (moca) will be measure, at each time point. the aim of this study is to determine whether 1hnmr could help to understanding metabolic ways and predict response to ect in patients with a current major depressive episode (mde) in major depressive disorder (mdd) and in bipolar disorder (bd). to date, scientific community knows that ect is a safety and efficacy treatment in mde particularly resistant or severe, but scientific community knows little about its mechanism of action. the investigators hypothesize that 1hnmr could help to go further.

Eligibility criteria:
inclusion criteria: * major depressive episode according to dsm-5 criteria * diagnosis of major depressive disorder or bipolar disorder * madrs score \>22 * having given written, free and informed consent * without protective measures * resistance criterion defined as failure of 2 antidepressants at an effective dose for a minimum of 6 weeks * current major depressive episode according to dsm-5 criteria with indication of treatment by ect cure exclusion criteria - cannot be included in the study, people: * whose consent is not admissible or who refuse to participate in the study * deprived of liberty by judicial or administrative decision * for which there is a particular risk contraindicating the cure of ect * suffering from schizophrenia spectrum disorders or persistent delusional disorder as described by dsm-5 criterion d for major depressive disorder * suffering from neurological disorders (such as patients suffering from multiple sclerosis, epilepsy, encephalitis, etc.) and/or neurodegenerative disorders (such as parkinson's disease, alzheimer's disease or related diseases, etc.) as described by criterion c of the major depressive disorder listed in the dsm-5 * suffering from an acute or chronic systemic inflammatory disease requiring specific treatment with immunomodulators or suppressors. as well as any recurrent inflammatory disease requiring specific management, and which may lead to a differential diagnosis of the characterized depressive episode as described by criterion c listed in the dsm-5

Keywords: 1hnmr electroconvulsive therapy major depression
post-operative dental pain study comparing two different dosage of analgesic efficacy

Conditions: Post-surgical Dental Pain

Summary: glaxosmithkline will be conducting this trial to compare analgesic efficacy of paracetamol 1000 mg vs 650 mg. the post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. each subject will be enrolled in the study for up to six weeks. the duration of the entire study will be approximately 18 weeks. each subject will have to come to the clinic for three visits (screening, treatment and follow up visits).


Eligibility criteria:
inclusion criteria: * subjects aged 18 to 45 years with moderate-to-severe dental pain as assessed by verbal rating scale (vrs) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue (vas) following the surgical removal of up to two mandibular third molars. if only one mandibular third molar is removed, it must be a full bony impaction. if two mandibular third molars are removed, both may be partial bony impactions or there may be a combination of one full bony impaction with the second tooth being erupted, soft tissue impaction, or partial bony impaction. ipsilateral maxillary third molars may be removed at the surgeon's discretion, regardless of impaction level. exclusion criteria: * pregnant and lactating females * allergy/intolerance to study materials or nitrous oxide or local anaesthetic used during surgery * current or recurrent liver, kidney or cardiac disease, stomach ulcers, gastrointestinal bleeding, gastroesophageal reflux disease, bronchospasm, rhinitis, urticaria or asthma

Keywords: dental pain paracetamol post-surgical dental pain