Kornimate/medical-research-clean huggingface dataset:
treatment of low blood sugar with glucagon among patients with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: background: patients with type 1 diabetes (t1d) need a lifelong supply of external insulin and are advised to aim for near-normalization of blood glucose levels through intensive insulin therapy. we propose a new approach for achieving treatment goals in t1d: the combined use of insulin and glucagon, i.e. dual-hormone treatment.only recently the prospect of treating patients with soluble glucagon has arisen and thus studies of low dose glucagon treatment of mild hypoglycemia are needed to determine whether there is clinical rationale for dual-hormone treatment of t1d. aim: the purpose of this clinical study is to investigate the glycemic response to subcutaneous glucagon administration during mild hypoglycemia in t1d patients treated with insulin pump. different glucagon doses are applied to determine the most appropriate dose for future dual-hormone treatment of t1d. methods: a clinical, randomized, single blinded, crossover study will be conducted. eight t1d patients treated with insulin pump are studied on four days. all patients are in good metabolic control (hba1c \< 7.5%), c-peptide negative and with hypoglycemia awareness. on each study day, hypoglycemia is induced with subcutaneously insulin and afterward treated with a single subcutaneous dose of glucagon. the study procedures are identical on all days except from the administered dose of glucagon (day 1: placebo, day 2: 100 ug, day 3: 200 ug, day 4: 300 ug). all patients are blinded for the glucagon dose and carry out the four days in random order. endpoints: the present study focuses primarily on the dose related plasma glucose response of glucagon; secondary on the duration of the hyperglycemic effect of glucagon and tertiary the glucagon effect on catecholamine, cortisol, growth hormone, free fatty acids and triglycerides. the study will be conducted from august 2014.


Eligibility criteria:
inclusion criteria: * males and females aged 18-65 years * diagnosed with type 1 diabetes \> 3 years * hba1c \< 58 mmol/mol * no appearance of autonome neuropathy * body mass index (bmi) between 20-25 kg/m2 * remained hypoglycemic awareness * insulin pump treatment \> 1 year exclusion criteria: * allergic to glucagon or lactose * pregnancy, breast-feeding, intention of becoming pregnant, or not using adequate contraception * any disease or condition which would interfere with the subject's safety * use of a medication that significantly impacts glucose metabolism

Keywords: glucagon insulin pump artificial pancreas closed-loop
anticoagulation preference by af patients study

Conditions: Atrial Fibrillation

Summary: the main research question of this patient survey is to assess af (atrial fibrillation) patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (vitamin k antagonists \[vka\] or new oral anticoagulants \[noacs\] and, in case of noacs, apixaban, dabigatran, edoxaban or rivaroxaban). vkas (marcoumar®, sintrom ®) will be grouped together and compared to rivaroxaban.

the objective of this study is to investigate the following research questions in a cross-sectional survey of german-speaking swiss af patients being treated either with a vka or with a noac: * which attributes of a medication to prevent stroke do af patients view as important? * do af patients have a preference regarding the attributes of the medication options vka or noac and, in case of noacs, with regards to rivaroxaban attributes? * are there subgroups of af patients whose preference for one of the medication options appears above or below average? * what is the quality of life of swiss german-speaking af patients? are there subgroups with differences in their quality of life (for example: subgroups of patients with different cha2ds2-vasc scores)? * which burden do german-speaking swiss af patients experience in association with their anticoagulation therapy? are there differences in the burden of treatment (acts) between patients treated with vka or with noacs?

Eligibility criteria:
inclusion criteria: inclusion criteria for af patients in both the noac and the vka groups: * patients with a confirmed diagnosis of nonvalvular atrial fibrillation (persistent, paroxysmal, permanent), * age of at least 18 years at time of study inclusion, * generally willingness (informed consent) and ability to fill out a survey on satisfaction with treatment and quality of life, and to conduct a structured phone interview (approx. 20 - 30 min) in german language. additional inclusion criterion for group 1 (noac): * continuous anticoagulation with either apixaban, or dabigatran or rivaroxaban for prevention of stroke \& systemic embolism for at least the previous 3 months. additional inclusion criterion for group 2 (vka): * continuous anticoagulation with a vka for prevention of stroke \& systemic embolism for at least the previous 3 months. exclusion criteria: exclusion criteria for both groups: * participation in another study (clinical intervention / observational) within the 3 months prior to enrollment, * interruption of vka/noac therapy of more than 2 weeks (bridging) within the prior 3 months or planned bridging in 4 weeks after study inclusion.

Keywords: patient treatment preference non-valvular atrial fibrillation noac vka
safety study of combined systemic and intraperitoneal chemotherapy to treat stomach cancer

Conditions: Stage IV Gastric Cancer With Metastasis

Summary: a maximum of 8 cycles of chemotherapy will be administered. depending on patients' tolerability, 8 cycles of chemotherapy will be given to the patients.

single-center, open-label, prospective, single-arm, phase i-ii study about 37 patients (phase i 18, phase ii 31 (including 12 patients from phase i)

Eligibility criteria:
inclusion criteria: 1. unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology 2. peritoneal seeding proven by histology or cytology 3. completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (but, patients who received docetaxel or cisplatin as adjuvant chemotherapy should be excluded) 4. age 18 to 70 years old 5. eastern cooperative oncology group performance status \<_ 2 6. estimated life expectancy of more than 3 months 7. adequate bone marrow function (wbcs\>3,000/µl and absolute neutrophil count (anc) \>1,500/µl and platelets\>100,000/µl), 8. adequate renal function: creatinine \ 60ml/min 9. adequate hepatic function: bilirubin \< 1.5 x unl, ast/alt levels \< 2.5 x unl, alkaline phosphatase \< 5 x unl (except in case of bone metastasis without any liver disease) 10. written informed consent exclusion criteria: 1. contraindication to any drug contained in the chemotherapy regimen 2. other tumor type than adenocarcinoma 3. presence or history of cns metastasis 4. gastric outlet or bowel obstruction 5. evidence of serious gastrointestinal bleeding 6. peripheral neuropathy \> grade 2 7. history of significant neurologic or psychiatric disorders 8. history of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix 9. pregnant or lactating women, women of childbearing potential not employing adequate contraception 10. other serious illness or medical conditions

Keywords: advanced gastric cancer xeloda (capecitabine) cisplatin taxotere (docetaxel)
study of human epidermal growth factor receptor 2 (her2) expression in participants with early/metastatic breast cancer in saudi arabia

Conditions: Breast Cancer

Summary: this is a retrospective, multicenter study, consisting of chart review of saudi arabian participants diagnosed with breast cancer between 2007 and 2013 and with available human epidermal growth factor receptor 2 (her2) testing. data on survival will be collected through 2015.


Eligibility criteria:
inclusion criteria: * initially diagnosed with breast cancer * has a proven result of her2 testing by immunohistochemistry (ihc), fluorescent in situ hybridization (fish) or any other in situ hybridization (ish) method * alive or not alive exclusion criteria: - inconclusive, equivocal or unavailable result of her2/neu overexpression by ihc and fish
a 14-month study on the effects of cp-945,598 for the prevention of weight regain in obese patients

Conditions: Obesity

Summary: the purpose of this study is to determine if cp-945,598 is effective in the prevention of weight regain in obese subjects.

the cp-945,598 program was terminated on november 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the cb1 class and likely new regulatory requirements for approval. no safety issues were involved in the termination decision.

Eligibility criteria:
inclusion criteria: * subject must be overweight (bmi) \>/=30 kg/m2, for subjects without co morbidities; \>/=27 kg/m2 for subjects with co morbidities * subjects who are willing and able to comply with 8 week low calorie diet, scheduled visits, treatment plan, laboratory tests, and other trial procedures. exclusion criteria: * participation in a formal weight loss program or significant weight loss (fluctuation \>5% of total body weight) in the past 3 months. * subjects with serious medical or psychiatric conditions
carotid structure and function in mps syndromes: a multicenter study of the lysosomal disease network

Conditions: Mucopolysaccharidoses

Summary: mucopolysaccharidosis (mps) syndromes are disorders characterized by enzyme deficiencies, and they have been linked to heart health complications. however, there are currently no proven markers of heart and artery health for this population. the main purpose of this observational study is to evaluate the ease and convenience of a non-invasive measurement of artery function in mps i, mps ii and mps vi patients compared to healthy control subjects. an observational study is a research design meaning that there is no treatment in this study. the research questions are: 1. is the artery health of mps i, ii and vi patients different than healthy controls? 2. is the artery health of mps vi patients different than mps i and ii patients? it is hypothesized that mps patients will have poorer outcomes of artery health compared to healthy controls.

mucopolysaccharidosis (mps) syndromes are disorders characterized by enzyme deficiencies. as a result of the enzyme deficiency, glycosaminoglycans that are normally recycled in a healthy individual cannot be degraded in the mps patient. mps syndromes have been linked to heart health complications. complications related to coronary artery stenosis (narrowing) are recognized as potentially fatal sequelae of untreated and treated mps. presently, national guidelines are largely silent on coronary artery disease risk in this population. there are currently no validated markers of cardiovascular or coronary artery disease in the mps population. the main purpose of this observational study is to evaluate the ease and convenience of a non-invasive measurement of artery function in mps i, mps ii and mps vi patients compared to healthy control subjects. exploring the validity and usefulness of this non-invasive measurement is the first step towards developing validated markers of cardiovascular or coronary artery disease in the mps population. specific aim #1: compare carotid artery intima-media thickness and carotid stiffness in individuals with mps i, ii, and vi (treated and non-treated) vs. healthy age-and gender-matched controls. it is hypothesized that mps patients will have increased carotid artery thickness and reduced carotid compliance and distensibility compared to healthy controls. specific aim #2: compare carotid artery intima-media thickness and carotid stiffness in individuals with mps vi vs. i and ii and between mps i patients clinically treated with hsct vs. ert. it is hypothesized that mps vi will have decreased carotid thickness and increased carotid compliance and distensibility compared to mps i and ii and that mps i patients treated with ert will have increased carotid thickness and reduced carotid compliance and distensibility compared to mps i patients treated with hsct.

Eligibility criteria:
inclusion criteria: * be between the ages of 3 and 18 years old * be diagnosed with mps i, mps ii or mps vi exclusion criteria: * none

Keywords: mps i mps ii mps iiia mps vi
ocl 500 treatment of women with symptomatic uterine fibroids

Conditions: Uterine Fibroid; Myoma; Leiomyoma

Summary: this is a prospective, open-label, single-arm, safety and effectiveness study of occlusin 500 microspheres in women with symptomatic uterine fibroids.

prior to entering the study, all patients will undergo pre-study assessments including compliance with inclusion and exclusion criteria, laboratory assessments, pelvic examination, and imaging of the pelvis. following conventional catheter angiography to confirm catheter placement and the uterine vasculature, each patient will undergo transarterial embolization with occlusin 500 microspheres.

Eligibility criteria:
inclusion criteria: * premenopausal women with symptomatic uterine fibroids * willing and able to provide informed consent * fibroids visible by ultrasound or non-contrast magnetic resonance imaging * fibroids with a minimum diameter of 4cm for a single fibroid or 3cm where there are 2 or more fibroids; minimum total fibroid burden 33cc * documented ovulation by luteinizing hormone (lh) testing * follicle stimulating hormone (fsh) value \>40 iu/l within 3 months prior to procedure * pelvic examination within 6 months prior to procedure * normal pap smear exclusion criteria: * positive pregnancy test * uterine size \> 20 weeks gestation * fibroids that are more than 50% submucosal * individual fibroids \> 12cm in diameter, or total fibroid burden \> 905cc * pedunculated subserosal fibroids with an attachment to the uterus less than 50% of the greatest diameter of the fibroid * fibroids situated in the cervix * abnormally large ovarian arteries * uterine pathology other than fibroids * history of gynecologic malignancy * active pelvic infection or history of pelvic inflammatory disease * undiagnosed pelvic mass outside the uterus * history of chemotherapy or radiation to the abdomen or pelvis * intra-uterine device (iud) in position * history of, or ongoing, hemolytic anemia * severe cerebrovascular disease defined by a cerebrovascular accident within 6 months of treatment * anticoagulant therapy or known bleeding disorder * treatment with gonadotropin releasing hormone (gnrh) agonists within the previous 6 weeks * received another investigational agent within past 12 weeks * compromised hematopoietic function * compromised hepatic function * compromised renal function * bmi \> 38 * claustrophobia * contraindication to angiography * contraindication to magnetic resonance imaging (mri) or mri contrast agents * allergy to contrast agents * allergy to bovine collagen * patient desires to become pregnant, or does not agree to contraception during study
blood test to measure dna damage in blood

Conditions: Prostate Cancer

Summary: to check the radiosensitivity level in individual patients based on their dna damage level.


Eligibility criteria:
inclusion criteria: * prostate cancer diagnosis * undergoing radiotherapy * agree to participate in study exclusion criteria: * not willing to participate * not undergoing radiotherapy

Keywords: prostate cancer gamma h2ax radiosensitivity
a prospective evaluation of the catheter science c3 "umbrella catheter."

Conditions: Urinary Retention; Urinary Bladder, Neurogenic; Intermittent Catheterization

Summary: the catheter science c3 "umbrella catheter" has been developed for management of urinary retention in patients who are either using a foley or self intermittent catheter. this device is inserted into the bladder in an extended state and once the stylet is removed the device folds into collapsed state. a thread is attached to the device and traverses thru the urethra and is attached to a bobber. with gentle traction on the thread the device engages the bladder neck and the central tube extends which allows for the flow of urine. once voiding is complete, the thread is released and the device collapses back to the folded state into the bladder. each voiding cycle is accomplished in a similar fashion. this is a novel technique in which the bladder is catheterized with the device from within the bladder into the bladder neck and urethra. the standard self catheter technique is for placement of a catheter from the outside into the urethra and into the bladder.

interventional (clinical trial): participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes. this single arm, prospective study is designed to produce valid scientific evidence regarding: 1. safety and efficacy of the catheter science c3 "umbrella catheter" in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days. 2. the reduction in catheter acquired urinary tract infection (cauti) a single arm study design was chosen because there is no alternative treatment to serve as an appropriate control. the c3 catheterizes the bladder with engagement into the bladder neck under the control of the patient or care giver. a foley catheter, a pre- amendment device, was considered for a control treatment. however, although a foley catheter is used to establish urinary drainage with close to 100% efficacy, it does not restore voiding function like the c3, and severely impairs activities of daily life. the intrinsic design flaws of a foley catheter traversing thru the urinary passage which violates the anatomical protective points which help to avoid bacterial contamination. the distal 1/3 portion of the urethra in females is commonly colonized with bacteria. standard catheter technique traverses from the outside into the entire length of the urethra to drain the bladder. the standard self catheter flow characteristics are impacted due to the placements of the "eyes" to the catheter lumen. the c3 lumen is open in line with the flow.

Eligibility criteria:
inclusion criteria: 1. patients with bladder dysfunction requiring mechanical drainage. 2. patients with actual urinary retention exclusion criteria: 1. inability to undergo bladder catheterization (e.g., urethral stricture or history of urethral stricture) 2. gross hematuria
long-term safety of renzapride in women with constipation-predominant irritable bowel syndrome (ibs-c)

Conditions: Constipation-Predominant Irritable Bowel Syndrome

Summary: the main purpose of this study is to evaluate the long-term safety and tolerability of renzapride at a dose of 4 mg taken once daily for 12 months in women with constipation-predominant irritable bowel syndrome (ibs-c).

since ibs is a chronic condition affecting patients over many years, it is anticipated that renzapride will be prescribed and used by patients on a daily basis for long periods of time. hence the need to understand its long-term safety and tolerability in the target population. this study is open label and so all subjects will take renzapride and will know that they are taking it. enrolment in to this study is restricted to subjects completing a 12-week, placebo-controlled study of the effectiveness of renzapride in providing relief from ibs-c (study no. atl1251/038/cl).

Eligibility criteria:
inclusion criteria: * completed 12 weeks treatment in the preceding pivotal study atl1251/038/cl exclusion criteria: * subjects who are pregnant or breastfeeding

Keywords: constipation predominant irritable bowel syndrome
dose adjustment trial of sk-1403 in hemodialysis patients with secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism

Summary: this study is conducted to assess the efficacy and safety of sk-1403 in hemodialysis patients with secondary hyperparathyroidism. in the first treatment period, the efficacy of sk-1403 is assessed after 18 weeks of treatment with sk-1403 individually dose-adjusted . safety is also assessed during this period. patients who completed the first treatment period proceed to the second treatment period and receive the treatment with sk-1403 for 34 weeks. efficacy and safety of sk-1403 are also assessed during this period.


Eligibility criteria:
inclusion criteria: * average serum pth\>240 pg/ml during 2 weeks at the screening * serum corrected ca≧8.4 mg/dl at the screening * stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration exclusion criteria: * primary hyperparathyroidism * severe liver disease * severe cardiac disease * history or family history of long qt syndrome * malignant tumor * uncontrolled diabetes mellitus * uncontrolled hypertension * a history of severe drug allergy
a real-world study of camrelizumab alone or in combination with apatinib/chemotherapy for advanced gastric cancer

Conditions: Gastric Cancer; RWS; PD-1 Immunotherapy

Summary: the purpose of this observational study is to evaluate the safety and efficacy of camrelizumab and apatinib in patients with advanced gastric cancer under real-life conditions, particularly in various subgroups of gastric cancer patients, with a view to providing information about the treatment modalities and efficacy of the treatment in real-life gastric cancer patients and to explore the possible predictive biomarkers of prognosis.patients, who had both decided to be treated with camrelizumab or apatinib prior to enrollment, were entered into one of the following three cohorts at the discretion of the investigator, based on their disease stage and prior treatment


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old, both male and female; 2. patients with advanced gastric cancer diagnosed by pathology or histology and progressed or recurred after 6 months of adjuvant therapy can also be considered for enrollment; 3. have at least one measurable lesion on imaging (recist 1.1 criteria), the spiral ct or mr target lesion should be ≥10 mm and lymph node ≥15 mm; 4. the investigator determines that the patient is amenable to treatment with karelizumab or apatinib; 5. voluntary enrollment; good compliance and willingness to cooperate with follow-up. exclusion criteria: 1. pregnant or lactating women; 2. previous use of other immunotherapy drugs (e.g. pd-1 monoclonal antibody, pd-l1 monoclonal antibody, ctla4 monoclonal antibody, etc.); 3. prior use of other anti-angiogenic therapeutic agents (e.g., apatinib, etc.); 4. patients who, in the judgment of the investigator, are not suitable for inclusion.
acute effect of agiotensin-(1-7) in healthy and hypertensive subjects

Conditions: Hypertension

Summary: in the modern concept of renin-angiotensin system, angiotensin-(1-7) plays a key role and demonstrates promising therapeutic potential due to it is generally opposite effects to angiotensin ii. the aim is to evaluate the effect of ang-(1-7) acute administration on systolic and diastolic blood pressure (sbp and dbp) and heart rate (hr) in healthy and hypertensive subjects.


Eligibility criteria:
healthy group inclusion criteria: * arterial pressure \<140/90 mmhg * body mass index (bmi) between 18,5 and 29 kg/m2 hypertensive group inclusion criteria: * anti-hypertensive drug treatment * ambulatory blood pressure monitoring (abmp) \>130/85 mmhg * body mass index between 18,5 and 29 kg/m2 healthy group exclusion criteria: * drug treatment * recent surgeries * pregnancy * previous cardiovascular events * high performance athletes * dislipidemia * diabetes * renal injury * obesity (bmi above 30 kg/m2) * alcoholism * smoking. hypertensive group exclusion criteria: * recent surgeries * pregnancy * beta-blockers drug treatment * previous cardiovascular events * high performance athletes * dislipidemia * diabetes * renal injury * obesity (bmi above 30 kg/m2) * alcoholism * smoking

Keywords: angiotensin-(1-7) renin-angiotensin system autonomic nervous system