Kornimate/medical-research-clean huggingface dataset:
study to compare zoladex™ 10.8 mg with zoladex 3.6 mg in pre-menopausal women with breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with estrogen receptor positive advanced breast cancer who were randomised in a 1:1 ratio to either of the two treatment groups; the zd9393 3.6 mg depot group or zd9393 10.8 mg depot group, both given in combination with tamoxifen tablets.


Eligibility criteria:
inclusion criteria: * female ≥20 years and pre-menopausal.pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2) e2 ≥10 pg/ml and fsh ≤ 30 miu/ml within 4 weeks of randomisation. * hormone sensitivity (er positive) of primary or secondary tumour tissue. * histological/cytological confirmation of breast cancer and are candidates to receive hormonal therapy as therapy for advanced breast cancer. exclusion criteria: * patients who have received tamoxifen or other hormonal therapies as adjuvant therapy for breast cancer within 24 weeks before randomisation and/or who have received prior treatment with hormonal therapies for advanced breast cancer * patients who have received lhrha as adjuvant therapy for breast cancer within 48 weeks before randomisation * patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after completion of adjuvant hormonal therapy and/or

Keywords: zoladex pre-menopausal oestrogen receptor advanced breast cancer progression free survival
observational biologic or prosthetic mesh

Conditions: Ventral Incisional Hernia

Summary: the purpose of this study is to assess the incidence of hernia recurrence with the use of biologic and prosthetic mesh in ventral hernia repair.

incisional hernias are very common, leading to over 380,000 operative repairs done annually. despite the commonality of this problem, there has been no single operative repair that has become the standard. this is due to the high recurrence rates with all types of repairs, especially primary suture repair. because of this, most repairs are done with some type of mesh, either made out of a prosthetic material or biologic material. mesh repairs, however, have their own problems, namely surgical site infections and potential bowel erosion. potential complications associated with prosthetic mesh for hernia repairs include: adverse reactions to the mesh, mesh erosion, stricture formation, adhesions resulting in bowel obstruction, enterocutaneous fistulas, injuries to nearby organs, nerves or blood vessels, infection, chronic pain and hernia recurrence. potential complications associated with biological mesh include: adverse inflammatory response, laxity, eventration, and recurrent herniation. to address these mesh related complications, the separation of components technique was developed to reduce tension on the midline repair and the underlay technique was developed to place the mesh in the retrorectus space. nevertheless, this technique still has a significant recurrence rate. therefore, the purpose of this study is to evaluate the effectiveness of biological or prosthetic mesh in incisional hernia repair, by assessing the associated rates of hernia recurrence and complications.

Eligibility criteria:
inclusion criteria: * male and female patients \> 21 years old. * able to provide informed consent in english or spanish. * stated willingness to comply with all study procedures and availability for the duration of the study. exclusion criteria: * pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable. * allergy or hypersensitivity to materials in porcine-based study products, prosthetic or biological meshes, or personal preference. * male and female patients ≤ 21 years old * history of drug addiction (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up. * serious or active medical or psychiatric condition which, in the opinion of the investigator, may interfere with treatment, assessment, or compliance with the protocol.

Keywords: biologic prosthetic mesh
vaginal progesterone versus placebo in multiple pregnancy

Conditions: Preterm Birth

Summary: the purpose of this study is to see if daily use of vaginal progesterone will prevent preterm birth in women carrying 2 or more babies.

women who are pregnant with twins or any higher order multiple will be approached to take part. women will be randomized to get either vaginal progesterone gel or a placebo gel daily from study entry until 35 6/7 weeks. women can enter the study between 16 - 20 6/7 weeks. two hundred women will be recruited to take part. data will be collected on the women and their infants to see if the active medication prolongs pregnancy.

Eligibility criteria:
inclusion criteria: * confirmed multiple pregnancy * ultrasound confirmed minimum of 2 live fetuses * gestational age 16-20 6/7 weeks exclusion criteria: * placenta previa * pre-existing hypertension * major fetal anomaly * monoamniotic, monozygotic multiples * maternal seizure disorder * history of, or active, thromboembolic disease * maternal live disease * breast malignancy or pathology * progesterone dependent neoplasia * plans to move to another city during pregnancy * sensitivity to progesterone * participation in other clinical trials during the pregnancy

Keywords: preterm birth multiple pregnancy vaginal progesterone preterm birth in multiple pregnancy
familiy medicine perspective to maternal-infant bonding

Conditions: Maternal-Fetal Relations; Depression; Anxiety

Summary: maternal bonding was described as a qualitative change in the relationship of a mother with her infant. by this study, the investigators aimed to investigate the mother-infant bonding and the factors affecting it, from the point of the family practice, which is responsible for the healthcare of all family members from the fetus to the eldest individual in a family.

the study was carried out as a single-centered descriptive research among 73 women at the postpartum period. the sociodemographic status and the histories of pregnancies of the study participants were recorded. the maternal attachment inventory (mai), which questions the biological, psychological and social factors, and the hospital anxiety and depression scale (hads) were used to collect data to determine the factors affecting the mother-infant bonding in the postpartum period. the study is a descriptive survey study, which was conducted to determine the mother-infant attachment and its affecting factors in mothers in the first 6-week of the postpartum period. in order to conduct the study, the local ethics committee approval was obtained. (approval date: 24.11.2016, number 18517). the mean score of the turkish version of the maternal attachment inventory (mai) is approximately 95+6 according to the validation study. in our study, considering that the average mai score of the participants would be approximately 97, investigators determined to include 73 patients in the study with a type i error set at a=0.05 and with the power of (1-b) 80%. the universe of the study consists of the mothers in the first 6 weeks of the postpartum period presenting to the obstetrics and gynecology clinic and the mothers of the pediatric patients presenting to the pediatric clinic of the health sciences university umraniye education and research hospital.

Eligibility criteria:
inclusion criteria: * women who gave birth in 6 weeks * women who had no mental illness history * women who had no health issue * women who accepted to join the study * women who can communicate exclusion criteria: * the women who did not have the features below the inclusion criteria

Keywords: maternal infant bonding depression anxiety
wear of vita ambria only restoration compared with ips emax onlay restoration

Conditions: Carious Tooth; Dental Wear

Summary: the 1ry objective will be to evaluate the amount of wear of onlays restorations made from vita ambria \& ips e.max press and their opposing natural teeth. 2. the 2ry objective of the clinical trial will be to evaluate the fractures, retention, contact points, food impaction and radiographic examination of the vita ambria onlays compared with ips e.max press onlays as defined by fdi criteria.

a randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. the restorations are evaluated by a blind and calibrated two examiner using the fdi world dental federation criteria. a total of 24 patients will be randomly assigned to each group for a total of 48 patients. the randomization sequence will be generated (www.randomlists.com/team-generator) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. these will be kept with an independent researcher for the moment of inclusion of the subjects. both groups will receive onlay preparation . digital impression by intra oral scanner will be taken, wax pattern for the onlay restoration will be designed and milled using cad/cam software. after that, the wax pattern will be invested and final onlay restoration will be constructed from vita ambria and ips e.max press ingots according to manufacturing instructions. primary outcome: the amount of wear will be evaluated according to fdi standard.

Eligibility criteria:
inclusion criteria: * the patient is healthy. * 18-50 years old. * normal occlusion. * good oral hygiene. * tooth with complete root apex. * tooth with moderate coronal decay. exclusion criteria: • patient incapable of self-care, mental illness, undergoing radiotherapy, diabetic patient, allergy to one of the materials used, pregnancy, smoker, parafunctional habits, poor oral hygiene, severe periodontitis, tooth need vital pulp therapy or surgical crown lengthening or marginal elevation, tooth with enamel or dentin hypoplasia or hypocalcification, mallaligned or malformed teeth and adjacent or opposing teeth are missed.
a dose-finding study of silodosin in patients with urinary calculi

Conditions: Urinary Calculus

Summary: the purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.


Eligibility criteria:
inclusion criteria: * patients who have a unilateral ureteral calculus with ≥ 5 mm and ≤ 10 mm at week 0. * patients who are able to visit the site continually as out-patient during the study exclusion criteria: * patients who have multiple urethral stones. * patients who have or have history of a ureteral stricture or other structural passage obstruction of the ureter on affected side. * patients who have been diagnosed with myasthenia gravis, myopathy, spina bifida, spinal cord injury, or fibromyalgia syndrome. * patients who have a clinically significant hepatic or renal disorder. * patients with postural hypotension or with a history of postural hypotension. * patients with a history of sever drug allergy, or patients with a history of hypersensitivity to silodosin. * patients who are pregnant, nursing, or desire pregnancy during the study period, or patients who cannot strictly comply with a physician's contraception directions.

Keywords: urinary calculus ureteral stones medical expulsive therapy
evaluating an expressive writing intervention about communicatively-restricted organizational stressors

Conditions: Stress Disorder

Summary: this project evaluates the effectiveness of an intervention sought to reduce the physical effects of stress related to those issues that individuals cannot successfully communicate with anyone about. to do this, the investigators will be implementing a writing intervention over the course of the 6-week study. the investigators will be asking all participants to complete questionnaires over the course of the study period. the investigators are also asking participants to provide a small blood sample (from a fingerstick procedure) at two times during the study as well as saliva samples during that same time. the primary research question asks if this intervention procedure is effective. the investigators are evaluating total cholesterol, high sensitivity c-reactive protein, and cortisol.


Eligibility criteria:
inclusion criteria: * 110 pounds in weight * ability to fast for 8 hours prior to laboratory visit * staff member at santa clara university * certain level of inclusionary pretest stress measure exclusion criteria: * hepatitis * endocrine disease * kidney or liver disease * cancer (in any form) * cushing's disorder * rheumatological disorders * respiratory disorders * diabetes * high blood pressure * low blood pressure * heart or cardiovascular problems * chemotherapy * current use of alpha or beta blockers, steroids, or hormone replacements * pregnant and/or breastfeeding mothers
oscillatory versus non-oscillatory nasal continuous airway pressure neonatal respiratory support

Conditions: Neonatal Respiratory Distress Related Conditions

Summary: controlled randomized trial looking at standard nasal continuous airway pressure (cpap) respiratory support versus high frequency cpap in neonates who require respiratory support or who are being extubated and require support post extubation. patients will be evaluated for need to be reintubated and oxygen requirement and paco2 levels

this study is a randomized controlled trial comparing high frequency nasal cpap versus standard nasal cpap. the patient population includes preterm newborns who require respiratory support but do not need to be initially intubated and preterm or term infants who are being extubated and will require support for the continued lung disease. after obtaining parental consent the patient will be randomized to one of the two treatments. patients will be followed for requirement of level of oxygen and blood gases looking at acidity (ph) and paco2 and bicarbonate(hco3). a respiratory index score will be measured. attending physician will determine the need for the patient to be intubated or reintubated depending on the patient selected. additionally, frequency, duration and severity of apnea, bradycardia and desaturation events will be recorded. also safety issues to include pulmonary airleak, nasal injury, facial edema and scalp edema due to straps holding the device in place will be recorded. also gaseous distension of the stomach and intestines will be assessed and compared between treatment arms. this study is not powered to look at long term outcomes.

Eligibility criteria:
inclusion criteria: * newborn (0-28 days of age) admitted to neonatal intensive care unit (nicu) * ordered respiratory treatment of nasal continuous airway pressure (ncpap) respiratory support exclusion criteria: * major congenital defect * known or suspected chromosomal disorder

Keywords: nasal cpap high frequency ncpap
(timp-2)x(igfpb7) to predict acute kidney injury (aki) in aortic surgery

Conditions: Renal Failure; Dialysis; Aortic Surgery; Biomarker; Acute Kidney Injury

Summary: new biomarkers that predict the development of renal dysfunction in patients with aortic surgery are urgently needed. the investigators investigate whether urinary (timp-2)x(igfbp7) predicts postoperative acute kidney injury and/or need for renal replacement therapy (rrt) in patients after aortic surgery (including evar).


Eligibility criteria:
inclusion criteria: * patients in need of emergency or elective abdominal aortic surgery (infra- or suprarenal clamping or evar) are eligible for study inclusion. exclusion criteria: * patients unable to give informed consent * age \< 18 * patients not speaking german or french.

Keywords: aki
evaluation of two daily disposable contact lenses.

Conditions: Myopia

Summary: the objective of this clinical study is to evaluate the product performance of soflens daily disposable contact lenses packaged in the investigational test solution versus soflens daily disposable contact lenses packaged in control, solution as it relates to comfort when used by subjects who use technology devices (eg, personal digital assistants \[pdas\], computers, electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an average of 4 hours per day over a week's time for a minimum of 4 days each week.


Eligibility criteria:
inclusion criteria: * subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logmar) or better (distance, high contrast) in each eye. * subjects must be free of any anterior segment disorders. * subjects must be adapted soft contact lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand. * subjects must be myopic and require contact lens correction from -0.50 d to -6.00 d in each eye. * subjects must be willing and able to wear the study lenses for at least 8 hours (12 hours or more is recommended) each day throughout the duration of the study. * subjects must use a technologic device for an average of 4 hours per day over a week's time and at a minimum of 4 days per week. exclusion criteria: * subjects who have worn gas permeable (gp) contact lenses within the last 30 days or who have worn polymethylmethacrylate (pmma) lenses within the last three months. * subjects with any systemic disease currently affecting ocular health or which in the investigator's opinion may have an effect on ocular health during the course of the study. * subjects using any systemic or topical medications that will, in the investigator's opinion, affect ocular physiology or lens performance. * subjects with an active ocular disease or who are using any ocular medication. * subjects with corneal infiltrates, of any grade, are not eligible. * subjects with any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * subjects with any scar or neovascularization within the central 4 mm of the cornea. * subjects who have had any corneal surgery (eg, refractive surgery). * subjects who are allergic to any component in the study care products. * subjects may not use their habitual rewetting drops while participating in this study.

Keywords: contact lens
drug-eluting stenting followed by cilostazol treatment reduces serious adverse cardiac events (decrease-pci)

Conditions: Coronary Artery Disease

Summary: the decrease-pci trial is a prospective, randomized, placebo controlled, double-blind, phase 4 study to evaluate efficacy and safety of triple anti-platelet therapy compared with dual antiplatelet therapy in patients treated with des for coronary artery disease. the primary objective of this study is to compare the safety and efficacy of triple antiplatelet therapy versus dual (standard) antiplatelet therapy in patients treated with drug-eluting stent (des) implantation for the treatment of coronary artery disease.

use of drug-eluting stent (des) has reduced the incidence of restenosis rate and the need for repeat revascularization compared to using bare metal stents (bms). therefore, des implantation has been default strategy in the treatment of coronary artery disease. however, despite use of des, the restenosis, subsequent repeat revascularization, and associated cardiac events (stent thrombosis, myocardial infarction) remain significant clinical problem in routine practice, especially complex lesion subsets. 2110 patients who received successful dug eluting stent implantation will be enrolled at 21 centers in korea. patients meeting inclusion criteria without any exclusion criteria and agree to participate in this trial will be randomized 1:1 to a) triple therapy (aspirin+clopidogrel +cilostazol) or b) dual therapy group (aspirin+ clopidogrel +placebo). all patients will be blindly assigned to cilostazol 100mg (1tablet bid) or matching placebo (1tablet bid) as 1:1 ratio and are prescribed for 1 year.

Eligibility criteria:
inclusion criteria: 1. clinical 1. patients with angina and documented ischemia or patients with documented silent ischemia 2. patients who are eligible and has been successfully applied for des implantation 3. age \>18 years 4. signed written informed consent form prior to study entry 2. angiographic 1. de novo lesion or restenotic lesions 2. percent diameter stenosis ≥50% 3. reference vessel size 2.5 mm by visual estimation exclusion criteria: 1. history of bleeding diathesis or coagulopathy (e.g. current use of nsaids, upper gi bleeding during the recent 6 months) 2. pregnancy or lactation (women who have child-bearing potential) 3. known hypersensitivity or contra-indication to contrast agent, heparin, eluted-drug of stent 4. limited life-expectancy (less than 1 year) due to combined serious disease 5. characteristics of lesion 1)left main disease 2)graft vessels 6. hematological disease (neutropenia \<3000/mm3, thrombocytopenia \<100,000/mm3) 7. hepatic dysfunction, liver enzyme (alt and ast) elevation 3 times normal 8. renal dysfunction, creatinine 2.0mg/dl 9. contraindication to aspirin, clopidogrel or cilostazol 10. stroke (ischemic or hemorrhagic) or transient ischemic attack (tia) within 6 months. 11. planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy

Keywords: triple anti-platelet therapy dual antiplatelet therapy des coronary artery disease
sure 18 registry -asahi chikai black 18 in lvo stroke

Conditions: Occlusive Stroke

Summary: the objective of this study is to obtain post market data on the asahi chikai black 18 neurovascular guidewire in the treatment of intracranial large vessel occlusive stroke. this will be compared to a historical control that will include the prior 50 consecutive patients fitting the same selection criteria.

this is a prospective registry collecting information on 50 patients treated with the asahi chikai black 18 microguidewire. patients will undergo mechanical thrombectomy for acute large vessel occlusive stroke within the anterior circulation as is standard of care. additionally, this study will have a retrospective portion which will examine 50 consecutive patients who meet inclusion/exclusion criteria treated for acute anterior circulation large vessel occlusive stroke prior to the initiation of the sure -18 registry. this retrospective cohort will be 50 consecutive mechanical thrombectomy cases performed using any neurovascular microguidewire other than the device under study (asahi chikai black 18) at the same enrolling centers leading up to december 10, 2018.

Eligibility criteria:
inclusion criteria: * male or female patients presenting with acute anterior cerebral circulation large vessel occlusive stroke * aspect score 5 or better * occlusion of the ica terminus and m1 mca * favorable ct perfusion with clinical/radiologic mismatch * last known well out to 24 hours * age limit \>18 years * baseline mrs 0-3 exclusion criteria: * intracranial hemorrhage * aspects (alberta stroke program early ct score) \<5 * unfavorable ct perfusion * baseline mrs 4 or greater * large vessel occlusive stroke with tandem lesion of the cervical internal carotid artery or posterior circulation

Keywords: asahi chikai black 18 neurovascular guidewire prospective retrospective