Kornimate/medical-research-clean huggingface dataset:
identifying very early response to seroquel extended release (xr) augmentation for major depressive disorder

Conditions: Depressive Disorder, Major

Summary: the proposed study is for a 6 week open-label clinical trial in which seroquel xr is added to a selective serotonin reuptake inhibitor (ssri) medication for the treatment of depressive and/or anxiety symptoms. each subject will self-report changes in symptoms, functional impairment, etc. on a twice daily basis using a handheld computer (hhc) that transmits real-time symptoms reports to a central database. each subject will be assessed in-person on a weekly or biweekly basis during the course of the study.

this study is a 6-week open-label clinical trial in which seroquel xr is added to an antidepressant medication for the treatment of mdd with or without comorbid generalized anxiety disorder. patients who are currently experiencing a depressive episode that has not responded to an adequate trial of an antidepressant will be eligible to participate. during the course of augmentation treatment with seroquel xr, each subject will regularly enter information on symptom severity and functional impairment into their handheld computer, and this information will be wirelessly transmitted to a central database.

Eligibility criteria:
inclusion criteria: 1. diagnosis of major depressive disorder, currently depressed with or without a comorbid generalized anxiety disorder as determined by dsm-iv diagnostic criteria (confirmed using the mini) 2. outpatient status 3. 17-item hamilton depression rating scale (ham-d) score of ≥ 18 4. treatment with any of the following antidepressant medications for the past 4 weeks at a minimum therapeutic dose exclusion criteria: 1. diagnosis of a past or current bipolar disorder 2. current psychotic symptoms 3. substance-induced mood disorder 4. substance or alcohol dependence 5. prominent current suicidal ideation as defined by a ham-d item 3 (suicide item) score of ≥ 3 6. current treatment with more than one antidepressant medication 7. current treatment with an tricyclic (tca) antidepressant or monoamine oxidase inhibitor (maoi) 8. a patient with diabetes mellitus (dm)

Keywords: major depressive disorder seroquel xr quetiapine
blood pressure assessment in waiting room during pregnancy

Conditions: Hypertension; Pregnancy Induced Hypertension

Summary: the goal of this observational study is to compare in healthy pregnant women during the first trimester. the main question it aims to answer are: accuracy of measuring automatically blood pressure (bp) at appointment compared to 24 hour ambulatory blood pressure monitor (abpm). participants will be bp measured with homologated device every 3 minutes in waiting room for 20 minutes. researchers will compare systolic blood pressure (sbp) and diastolic blood pressure (dbp) in clinical visit to see if are comparable to abpm.

659 pregnant women will be recruitment if they in with sbp readings above 130 mmhg in office or the presence of a risk factor for eclampsia: (hypertensive disease in previous pregnancy, chronic hypertension, chronic renal disease, diabetes mellitus, or autoimmune disease) or any two moderate-risk factors (nulliparity, age ≥40 years, bmi ≥35 kg/m2, family history of pe, or interpregnancy interval \>10 years). measured of bp will be performance in waiting room for 20 minutes every 3 minutes and report by an mobile app. after 24h-abpm device will be implanted. results of sbp and dbp obtained in office will be compared with 24-h, diurnal and nocturnal sbp/dbp mean. bp will be measured automatically and repeatedly every 3 minutes in the waiting room for 20 minutes. subsequently, a spacelab abpm monitor will be implanted. the sbp and dbp results obtained in the waiting room will be compared with the abpm results. clinical data related to eclampsia and maternal and newborn pregnancy outcomes will be collected from all patients.

Eligibility criteria:
inclusion criteria: woman during the first 12 weeks of pregnancy maternal age\>35 nulliparity previous history of hypertension short and long interpregnancy interval use of assisted reproductive technologies family history of preeclampsia obesity. bmi\>30. hyperglycemia renal disease exclusion criteria: any inability to perform 24-h ambulatory bp measurement

Keywords: hypertension in pregnancy. blood pressure measurement.
long term open follow-up with h376/95 vs. warfarin

Conditions: Stroke Prevention in Patients With Atrial Fibrillation

Summary: the purpose of this study is to evaluate tolerability of long-term treatment with ximelagatran compared to standard treatment with warfarin.


Eligibility criteria:
inclusion criteria: * signed informed consent. * completion of the study sh-tpa-0002, history of chronic atrial fibrillation (i.e. rapidly beating heart), at least one risk factor for stroke (e.g. high blood pressure, age over 65, previous stroke or similar attack, diabetes or coronary heart disease) exclusion criteria: * conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency
the interaction between severe acute respiratory distress syndrome viral proteins and monocytes

Conditions: Severe Acute Respiratory Syndrome

Summary: severe acute respiratory syndrome (sars) is a new threat to public health since november, 2002. the sars is highly contagious and is believed to be transmitted by person-to-person through droplet and direct contact. the patients present with fever, chills, cough, myalgia, dyspnea, and diarrhea. the symptoms aggravate in the second week and nearly 40% of the patients develop respiratory failure that requires assisted ventilation. the mortality rate is reported as 6.5%-7%. after several months, the world scientists found the etiology to be a new coronavirus not belonging to the previous coronavirus group i, ii and iii. the new virus is called sars associated coronavirus (sars-cov). although the high morbidity and mortality of sars occurred in adults, there was rare mortality reported in the children. the report from hong kong pointed out that the symptoms of sars in younger children were milder and the clinical course was not as aggressive as in adults. therefore, the aim of the project is to design the experiment to see the differences of immunological responses to sars-cov protein in healthy younger children, teenagers, and adults. the investigators hope that the result could explain the reason for milder disease in younger children and the immunological pathogenesis of sars.


Eligibility criteria:
inclusion criteria: * healthy adults, children and cord blood

Keywords: immunology
brain swelling during dialysis

Conditions: End Stage Renal Disease

Summary: the proposed controlled, randomized study aims to compare pre-dilution hemodiafiltration (hdf) and low flux hemodialysis (hd) regarding acute changes in the brain. the study consist of two examination days placed one week apart. 12 hd patients will be recruited to the study. the patients will be randomly placed in two groups: pre-dilution hemodiafiltration during the first examination and low flux hemodialysis during the second day or vice versa. brain magnetic resonance imaging (mri) will be obtained before and after both treatments. the mri-data will later be processed to estimate brain volume changes during the two types of treatment.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * informed consent * patient with end-stage renal disease (esrd) * stabile hemodialysis treatment (kt/v ≥ 1.3) * no contraindications against mri (pacemaker or other metal implants, claustrophobia, severe adiposity) * weight \<140kg exclusion criteria: * clinical signs of new structural, thromboembolic or vascular brain disease the last 3 month before entering the study * changes in corticosteroid treatment during the last two weeks * change in diuretics during the last two weeks * non-compliant with regard to salt and fluid intake * acute disease

Keywords: renal dialysis hemodiafiltration hemodialysis mri
osteogenesis imperfecta (oi) quality of life survey pilot project 2

Conditions: Osteogenesis Imperfecta; Brittle Bone Disorders

Summary: the purpose of this study is to explore the patient perspective of disease burden in osteogenesis imperfecta (oi). participants will complete a web-based survey of questions which are usually administered within the patient-reported outcome measurement information system (promis) and provide feedback regarding the appropriateness of the questions for someone with oi.

participants will be recruited through the rdcrn bbd contact registry. an email invitation will be sent to all rdcrn bbd contact registry participants that meet the inclusion criteria to complete the online promis cat instruments. the email invitation will contain a link to the informed consent form. once participants have consented to the study, they will have access to the online instruments. follow-up emails will be sent to participants that have not completed any of the instruments. reminder emails will be sent to participants with partially completed instruments. data will be collected and stored by the rdcrn dmcc at usf. data from patients co-enrolled in the "longitudinal study of osteogenesis imperfecta" and the bbd rdcrn contact registry will be linked and compared. additional disease specific information will be collected by the survey (e.g., information on oi type and diagnosis, height, number of fractures, concurrent medication use, utilization of any mobility aid, hearing aid, or other device that they may use.

Eligibility criteria:
inclusion criteria: * enrollment in the rdcrn bbd contact registry english speaking age 2 to adult exclusion criteria: * inability to provide informed consent inability to complete instruments

Keywords: brittle bone osteogenesis imperfecta bbd oi congenital abnormalities congenital bone disorder lobstein syndrome
efficacy of temocillin in urinary tract infection due to esbl producing and ampc hyperproducing enterobacteriaceae

Conditions: Urinary Tract Infections

Summary: the present study aims at demonstrating the efficacy of temocillin in the treatment of uti requiring parenteral therapy due to a confirmed esbl producing or ampc hyperproducing enterobacteriaceae, resistant to quinolones and bactrim® in france. in addition, this study will describe and support the use of high dose (6g/day) of temocillin which could be of interest for the treatment urinary tract infection due to multi-resistant bacteria having high mic (up to 32 mg/l). the investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual clostridium difficile associated infection.


Eligibility criteria:
inclusion criteria: * age of at least 18 year old * patient benefits from social security * signed informed consent * a urinary tract infection due to a confirmed esbl producing strain (detected by the use of a rapid diagnostic test applied on the urine) requiring parenteral antimicrobial therapy * hospitalized patient * for women able to procreate: use of an acceptable method of birth control throughout the study. acceptable methods of birth control are: oral contraceptives, intrauterine device (iud), diaphragm with spermicide and condom. (all forms of hormonal contraception are acceptable exclusion criteria: * patient infected with a bacteria which is not an esbl-producing or ampc hyperproducing enterobacteriaceae * patients infected with a strain sensible to both fluoroquinolones and trimethoprim/sulfamethoxazole * patients infected with a strain resistant to temocillin * hospital-acquired urinary tract infection (defined as a urinary infection that occurred at least 48h post admission in the hospital) * patients has received any dose of active antimicrobial therapy (an antibiotic to which the infecting bacterium is susceptible) in the last 48h (prior to enrolment) except ≤ 2 dose of gentamicin. * patients presenting another site of infection than urinary (except onset of bacteraemia from urinary tract origin) due to gram negative bacteria. * patients needing concomitant antimicrobial therapy. * septic shock * children (up to 18 years old) * women who is pregnant, breastfeeding, or expecting to conceive at any time during the study (pregnancy test will be conducted for woman without menopause) * patients with any kind of urinary/bladder catheter (jj ureteral probe, ...) * hypersensitivity to the active substance, to penicillins or to any other type of beta-lactam agent * chronically dialyzed patients * patients having a creatinine clearance \< 30 ml/min * complete obstruction of the urinary tract * perinephretic or intrarenal abscesses * tutorship or curatorship patient * patient unable to give his consent
a randomized clinical trial

Conditions: Regional Anesthesia

Summary: acute postoperative pain is a common problem faced by the patient after surgery, most frequently occurring in first 24 hours. our primary objective was to assess pain score in first 24 hours in pecs block group undergoing mastectomies. secondary objective was to observe morphine (opioids) and antiemetic consumption in post anesthetic care unit.

design: observer blinded randomized control trial. place and duration: department of anesthesiology, shaukat khanum memorial cancer hospital lahore (skmch), from february 2017 to december 2017 methods: 120 patients more than 18 years, asa i and ii, planned for unilateral elective modified radical mastectomy under general anesthesia were randomly assigned to receive either general anesthesia plus pectoral nerve i, ii and serratus (pecs) block (n = 60) or general anesthesia alone (n = 60). pain score at fixed intervals was measured using numeric pain rating score (nprs) after surgery.

Eligibility criteria:
inclusion criteria: * female age 18 or older * (asa) i and ii * scheduled to undergo elective unilateral mastectomy or modified radical mastectomy (mrm) under general anesthesia. exclusion criteria: 1. patient's refusal 2. history of allergy to bupivacaine 3. contraindications to regional anaesthesia (coagulopathy and local infection), 4. bmi \> 40 kg/m2, 5. patient scheduled for bilateral mastectomies 6. use of chronic pain medications 7. history of illicit drugs or alcohol abuse and history of psychiatric problems.

Keywords: pectoral nerves i & ii block, serratus plane block, general anesthesia, opioid analgesia, breast cancer and modified radical mastectomy
retrospective observational study to update 5-year survival of subjects who participated in axitinib trial a4061012

Conditions: Carcinoma, Renal Cell

Summary: the primary objective of this observational study is to retrospectively collect current survival data for patients originally included in axitinib a4061012 \[nct00076011\] study to estimate the 5-year survival rate in subjects with metastatic renal cancer cell treated with axitinib.

subjects participating in this observational study originally participated in study a4061012 \[nct00076011\], and may have also have participated in study a4061008 \[nct00828919\]. subjects participating in this observational study originally participated in study a4061012 \[nct00076011\], and may have also have participated in study a4061008 \[nct00828919\]. 5-year survival information to be updated.

Eligibility criteria:
inclusion criteria: * subjects participating in this observational study originally participated in study a4061012 \[nct00076011\] and may have also participated in study a4061008 \[nct00828919\] exclusion criteria: * subjects who withdrew from the original study a4061012 \[nct00076011\] or the continuing access study a4061008 \[nct00828919\]

Keywords: retrospective trial 5-year survival metastatic renal cancer cell
effect of equal ratio ventilation on blood loss during posterior lumbar interbody fusion surgery

Conditions: Blood Loss, Surgical

Summary: ventilator mode change was associated with decrease in blood loss during posterior lumbar interbody fusion (plif) due to decrease in the peak inspiratory pressure (pip). the purpose of this study was to determine the effect of equal ratio ventilation (erv), which sets the i:e ratio of the ventilator to 1:1 during volume controlled ventilaiton, on surgical blood loss during plif. investigators hypothesized that erv would decrease surgical blood loss due to decrease in the pip.

after anesthesia, patients will receive ventilator settings according to theri group. the cvp will be measured before and after the prone position to ensure the proper positioning. airway pressures including peak inspiratory pressure, mean/plateau airway pressure, arterial blood gas analysis data, hct, lactate, body temperature, mean arterial pressure, cardiac index. recodings will be done 5min afte the induction, 5 min after the prone positioning, sikin suture, and 5min after supine position. amount of bleeding, coagulation profile and hct will be recorded 72 hrs after the surgery.

Eligibility criteria:
inclusion criteria: * 1) age : 20\~75 yr-old 2) surgery : posterior lumbar interbody fusion(plif) 2\~3 levels exclusion criteria: * 1) urgent or emergency case 2) previous lnstrumentation of lumbar spine (exclusion : discectomy, partial hemilaminiectomy, etc) 3) concurrent other operation 4) patients who cannot understand informed consent (ex. illiterate, foreigner) 5) obesity (bim\>30kg/m2) 6) recent myocardial infarction (within 3 months) 7) reduced left and right ventricular function (ejection fraction\<40%) or congestive heart failure 8) preoperative dysrhythmia 9) aspirin or plavix during perioperative periods 10) lung disease 11) chronic kidney disease or dialysis 12) severe hepatic disease

Keywords: equal ratio ventilation(erv) peak inspiratory pressure(pip) blood loss posterior lumbar interbody fusion(plif) prone position
visual performance with clareon® vivity® intraocular lenses (iols)

Conditions: Astigmatism

Summary: the purpose of this study is to generate clinical data to quantify the impact of residual astigmatism on the overall visual performance during distance, intermediate, and near viewing in patients implanted with clareon vivity iols.

this single visit study is designed to help understand how vision is affected if the eye still has astigmatism after cataract surgery. participants will be individuals who have already undergone cataract surgery and received a clareon vivity iol in both eyes at least 4 months prior to study enrollment. during the study visit, trial lenses (glass lenses that are used during an eye exam) will be used to temporarily create the effect of astigmatism on the eye.

Eligibility criteria:
inclusion criteria: * able to understand and sign an institution review board-approved informed consent form; * willing and able to attend all scheduled study visits as required by the protocol; * implanted with study iols in both eyes at least 4 months prior to study participation; * bcdva of 0 logmar or better in each eye. exclusion criteria: * residual astigmatism greater than or equal to 1.00 d; * clinically significant ocular conditions as specified in the protocol; * history of ocular surgeries other than limbal relaxing incisions * other protocol-specified exclusion criteria may apply.

Keywords: cataract iol
is real-time cgm superior to flash glucose monitoring

Conditions: Diabetes Mellitus, Type 1

Summary: the aim of the investigator's study is to compare real-time continuous glucose monitoring and flash glucose monitoring in adult patients with type 1 diabetes during 4-day training program focused on physical activity and over 4 weeks of follow-up.


Eligibility criteria:
inclusion criteria: * patients with t1d naive to rtcgm and iscgm * type 1 diabetes for \>2 years * ≥ 18 years old * csii or mdi * gold score \< 4, no history of severe hypoglycemia within last 6 month * written informed consent prior to starting study related activity exclusion criteria: * severe noncompliance * severe diabetic retinopathy and/or macular edema * lactation, pregnancy, intending to become pregnant during study * condition likely to require mri * use of acetaminophen-containing medication * unwillingness to use the study device for \>70% of time

Keywords: continuous glucose monitoring flash glucose monitoring hypoglycemia time in range physical activity
a study of ezetimibe added on to rosuvastatin versus up titration of rosuvastatin in patients with hypercholesterolemia (mk0653-139)

Conditions: Hypercholesterolemia

Summary: a study to evaluate the low-density lipoprotein cholesterol (ldl-c) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their national cholesterol education program adult treatment panel iii (ncep atp iii) ldl-c goal


Eligibility criteria:
inclusion criteria: * participant is currently taking a stable dose of lipid lowering agent(s). (if applicable) or is statin naive * participant is currently taking a stable dose of lipid lowering agent(s). (if is at least moderate high risk for coronary heart disease (chd)) * participant is currently taking a stable dose of lipid lowering agent(s). (if is willing to maintain therapeutic lifestyle changes (tlc) / american diabetes association(ada) diet) exclusion criteria: * participant weighs less than 100 lbs (45 kg). * participant has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any components of these medications. * if female, participant is pregnant or breastfeeding. * participant consumes more than 2 alcoholic beverages per day. * participant has been in a clinical trial within the last 30 days. * participant has heart problems such as chf, unstable angina or heart attack. * participant has type 1 or 2 diabetes and has changed their medication in the last 2 months. * participant has liver disease. * participant is human immunodeficiency virus (hiv) positive. * participant has a history of drug or alcohol abuse in the last year.
alpha long study- biomatrix alphatm stent study in patients with cad

Conditions: Coronary Artery Disease

Summary: prospective, multi-center, open-label single-arm study designed to enroll 85 patients in up to 15 centers in up to 3 european countries. all patients will be followed up for 9 months. the "bmx alpha registry" study will serve as reference and historic comparator.

the objective of this study is to evaluate if pci performed using the additional sizes of the biomatrix alphatm stent results in similar safety and efficacy outcomes as the currently approved (ce marked) sizes of biomatrix alpha.

Eligibility criteria:
inclusion criteria: 1. patients must provide written informed consent 2. patient is at least 18 years old 3. patients scheduled to undergo pci of a de novo lesion(s) with reference vessel diameter and lesion length suitable for treatment with at least one study device 4. patients who agree to comply with the follow up requirements 5. patients with a life expectancy of \> 1 year at time of consent 6. patients eligible to receive for ≥6 months either dual anti-platelet therapy (dapt, i.e. 75 mg clopidogrel or another p2y12 inhibitor per choice of the investigator, and 75-100 mg aspirin) or a combination of an oral anti-coagulant (vitamin k antagonist or novel anti-coagulant) and a single anti-platelet agent 7. hemodynamically stable patients exclusion criteria: 1. inability to provide informed consent 2. currently participating in another clinical trial 3. planned surgery ≤6 months of pci unless dapt or combination anti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgical period 4. planned use of additional stents other than biomatrix alphatm during the index procedure. 5. patients with a life expectancy of \< 1 year 6. known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other p2y12 inhibitor if applicable), cobalt chromium, zinc, biolimus a9 or a sensitivity to contrast media, which cannot be adequately pre-medicated