Kornimate/medical-research-clean huggingface dataset:
hybrid pet/mr in the therapy of cervical cancer

Conditions: Cervix Carcinoma; Cervical Squamous Cell Carcinoma; Cervical Adenosquamous Carcinoma

Summary: this is a two arm, single center feasibility study of 20 patients with non-metastatic cervical cancer managed with surgery and/or chemoradiation therapy at unc hospitals. subjects will undergo pet/mri scans before, during (chemoradiation group only), and after treatment.

the primary purpose of this study is to evaluate the feasibility of obtaining complete and interpretable hybrid pet/mr images for patients diagnosed with cervical cancer.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * biopsy-proven, previously untreated squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix * clinically visible lesion at least figo stage ib or ajcc 7th edition t1b * scheduled to undergo standard of care pet/ct for baseline assessment of disease * anticipated to be eligible for curative intent therapy (surgery of chemoradiation therapy) as determined by the patient's primary oncologist * if female of child-bearing potential, negative serum or urine pregnancy test ≤ 7 dats prior to first pet/mri * informed consent reviewed and signed exclusion criteria: * history of sever reaction to contrast-enhanced ct scan * inability to tolerate mri (e.g., inability to lie flat \> 1 hour) * presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes * poorly controlled diabetes mellitus * creatinine \> 1.4 mg/dl or gfr \< 30 ml/min * body mass index (bmi) \> 35 * active vaginal bleeding requiring packing and emergent radiation therapy * pregnant or lactating female * history of a prior malignancy within past 5 years, unless disease free for ≥ 3 years * substance abuse, medical, psychological, or social conditions that may interfere with study participation
low dose supplementation to improve anticoagulation control with oral vitamin k as an adjuvant to warfarin therapy

Conditions: Coagulation

Summary: the main objective of this study is to assess the effectiveness of low dose vitamin k1 (200 micrograms per day) at improving anticoagulation control in unstable patients on warfarin. this study will also aim to look at effectiveness in the context of genes known to influence warfarin metabolism, variability in the consumption of vitamin k rich foods, and patient knowledge about warfarin anticoagulation -- factors which have been associated with anticoagulation control and which can influence the effectiveness of this intervention in clinical practice.

a double-blinded placebo controlled pilot rct assessing the effectiveness of daily supplementation with low dose vitamin k1 (200 micrograms per day) against placebo at improving anticoagulation control. previous studies assessing the efficacy of this intervention have been small and further trials are required to evaluate the true effectiveness and safety profile. furthermore the impact of genetic polymorphisms, known to impact warfarin metabolism, on the effectiveness/safety of this intervention will also be assessed in this study. demographic and clinical variables as well as potential confounding variables such as variable dietary vitamin k intake, concomitant interacting medications, and anticoagulation knowledge will be assessed in this study. given that this is a pilot study we will be looking at recruitment numbers and necessary parameter estimates to determine the number of patients available at our institution for the study. power analysis will be performed to evaluate the treatment effect size between the placebo and intervention groups.

Eligibility criteria:
inclusion criteria: * \>= 18 years old * have been on warfarin anticoagulation for at least 9 months * have an inr target range of 2.0-3.0 * have "unstable" anticoagulation control, defined as in the preceding 6 months having at least 3 inrs out of range (\>= 3.2 or =\<1.8) or at least 3 warfarin dose changes * have anticoagulation managed by the ottawa hospital thrombosis clinic * able to provide written, informed consent exclusion criteria: * anticipated interruption or termination of warfarin anticoagulation in the next six months for a period of 1 week or greater * patient instability in the preceding six months suspected to be due to a) interruption of warfarin therapy for a period of 1 week or more or b) significant non-compliance (assessed from patient record) * possess a known allergy to vitamin k or lactose based placebos * unable/refusal to provide written, informed consent

Keywords: vitamin k vitamin k1 (phytonadione) unstable inr vte or thrombosis warfarin anticoagulation control patients on warfarin with unstable anticoagulation control
immuno-persistence study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer; Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection

Summary: the primary objective of this study is to evaluate the immuno-persistence (type specific igg antibody) of the tested vaccine administered in girls aged 9-17 years ,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).

this is a follow-up study which is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(unique protocol id:hpv-pro-006,identifiers: nct02562508) .we will recruit people who have participated in bridging study before and collect their serum samples to test the seroprevalence and geometric mean concentrations of anti-hpv16 and anti-hpv18 antibody on 18 and 30 months after dose 1.

Eligibility criteria:
inclusion criteria: 1. participants who participated in the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls (unique protocol id:hpv-pro-006-2, identifiers: nct02562508) and received at least one dose; 2. the legal guardian of participants under age 18 can provide identity certificate, or representative can provide authorization; 3. participants under the age 18, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18 and older agree to sign the written informed consent; 4. able to comply with the requests of the study; exclusion criteria: 1. participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician after vaccination ; 2. according to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;

Keywords: human papilloma virus 16 human papilloma virus 18 adolescent girl non-inferiority immuno-persistence
surveillance program to determine product specific rates of invasive hib disease

Conditions: Haemophilus Infections; Diphtheria; Tetanus; Polio; Pertussis

Summary: to monitor the occurrence of invasive hib disease over time and to determine product-specific rates of invasive hib disease within the monitored population.

the purpose of the study is to conduct surveillance for hib disease. prospective active population-based surveillance for invasive hib disease, conducted by the center for disease control and prevention (cdc) active bacterial core (abcs) program within geographic regions currently representing 12% of the us population, will provide hib case-occurrence (numerator) data. the abcs program and the national center for health statistics will provide annual estimates of the number of persons under surveillance, by age group, within the abcs catchment area. ongoing telephone sample surveys, conducted by m/a/r/c, a national sampling organization, will provide brand-specific vaccine exposure data by age group within the abcs program catchment area at appropriate pre-specified intervals (denominator data).

Eligibility criteria:
inclusion criteria: * residence within the geographic scope of active bacterial core surveillance (abcs) during the period of surveillance * aged 0 through 59 months (prior to 5th birthday) on the day of inclusion for hib disease surveillance and 2 through 23 months (prior to 2nd birthday) for hib vaccine brand usage survey. * 2009-2014 calendar years inclusive. * for the hib vaccine usage survey, agreement to complete the required survey. exclusion criteria: not applicable.

Keywords: diphtheria tetanus pertussis poliovirus types 1-3 haemophilus influenzae type b pentacel®
safety, tolerability, pharmacodynamics and pharmacokinetics of cdx 6114 in pku patients

Conditions: Phenylketonurias

Summary: the primary objective is of this phase 1 study is to evaluate the safety and tolerability of daily, multiple, oral doses of cdx-6114 when administered to patients with pku for 14 days. the aim is to check if administration of daily, multiple, oral doses of cdx-6114 to patients with pku for 14 days shows a clinically acceptable safety and tolerability profile.


Eligibility criteria:
inclusion criteria 1. male and female patients between the ages of 18 and 65 years, with a diagnosis of classical pku 2. patients with a blood phenylalanine concentration \> 600mol/l at screening as an indicator of sub-optimal dietary management 3. body mass index (bmi) between 18 and 35 kg/m2 at screening. 4. male patients must agree not to donate sperm starting at screening and continuing throughout the clinical study period up to 90 days after last study drug administration 5. female patients of childbearing potential and their spouse/partner 6. female patients of non-childbearing potential: 7. female patients must agree not to breastfeed. this includes the period starting at screening and continuing throughout the clinical study period up to 90 days after last study drug administration. 8. female patients must agree not to donate ova. this includes the period starting at screening and continuing throughout the clinical study period up to 90 days after last study drug administration. 9. patients must be deemed competent to understand the nature of the study and capable of giving written informed consent. patients must also be willing to attend scheduled study visits in person and to reliably communicate to study personnel on adverse events and concomitant medication use. 10. patients must agree not to participate in another interventional study while participating in the present clinical study. exclusion criteria 1. presence or history of clinically significant hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease/condition (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies and childhood asthma). 2. presence or history of gastrointestinal illness or conditions interfering with normal gastrointestinal anatomy. examples include gastrointestinal bypass surgery, cholecystectomy, partial or total gastrectomy, gastric band surgery, small bowel resection, vagotomy, malabsorption, crohn's disease, ulcerative colitis, or coeliac disease. 3. active treatment with any platelet aggregation inhibitor and/or active treatment (or within the last 4 weeks) with anticoagulant medication. 4. presence or history of specific food intolerance. examples include coeliac disease, severe lactose or dairy food intolerance. 5. positive result for serum hepatitis b surface antigen (hbsag), hepatitis a virus antibodies (hav), hepatitis c virus antibodies (hcv), or antibodies to human immunodeficiency virus type 1 (hiv-1) and/or type 2 (hiv-2) at screening.
bioequivalency study of perindopril erbumine 8 mg tablet under fed conditions

Conditions: Essential Hypertension

Summary: the objective of this study was to prove the bioequivalence of perindopril erbumine 8 mg tablet under fed conditions


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to perindopril or any comparable or similar product.
screening for hypercholesterolemia in children using dried blood spot

Conditions: Hypercholesterolemia

Summary: purpose: heterozygous familial hypercholesterolemia (hefh) is a common genetic disease responsible for premature atherosclerosis. therefore, early diagnosis and initiation of a treatment early as at the age of eight years old are recommended to reduce cardiovascular risk. child-parent screening based on plasma ldl-cholesterol has been proposed to identify patients with hypercholesterolemia. however, in children, venipuncture is often an obstacle for screening. this study aims to evaluate the performance and feasibility of a dried blood spot collection to screen hypercholesterolemia. method: the lipid profile of 30 healthy and 30 hypercholesterolemic patients will be determined using dried blood spot (dbs) collection and veinipuncture. the study is conducted in accordance with the principles of the declaration of helsinki. the children, their parents and patients will be informed about this study according to the french bioethics law and will be included only after their agreement hypothesis * to evaluate the performance of the determination of total and ldl-cholesterol using a dried blood spot collection to screen hypercholesterolemia * to evaluate the feasibility of a dried blood spot collection to screen hypercholesterolemia


Eligibility criteria:
inclusion criteria: * patients/kindreds in family with a documented history of hypercholesterolemia * healthy subjects for controls exclusion criteria: * refusal to participate in the study * for control patients: to have a known dyslipidemia

Keywords: hypercholesterolemia, familial pediatrics
prospective study assessing thyroidectomy using robot

Conditions: Patients With Thyroid Cancer

Summary: the robot-assisted surgery for benign and malignant thyroid tumors was widely developed in asia and begins to spread in western countries. the main advantage of the technique is to avoid a scar in the neck by placing it either in the axilla or at the hairline behind the ear to improve esthetic consequences and body image. it is not surgery minimally invasive but rather a way of remote access surgery. data from the literature including cohort studies and meta-analyzes attest the security of the procedure in comparison with classic thyroid surgery (which remains the "gold standard"). however there is few data on the effectiveness of the technique in terms of the completeness of the surgery, according to the routine standard criteria used in endocrinology and endocrine cancer, and no french medico-economic study has been performed.


Eligibility criteria:
inclusion criteria: 1. benign thyroid nodule or follicular or suspicious cytological (bethesda classifications 2, 3, 4, or 5) requiring thyroid lobectomy or total thyroidectomy therapeutic or diagnostic 2. differentiated thyroid cancers - cn0 (no suspicious lymph node in the central or lateral compartments on preoperative ultrasound - cn1a / b with lymph node metastases \<or = 10 mm in areas vi, iii and / or iv, detected on preoperative ultrasound - for which the indication of a lobectomy or total thyroidectomy, with or without dissection of the central compartment and / or lateral neck was put in multidisciplinary meeting 3. patient with no cons-indication to thyroid surgery or without dissection 4. patient general condition of who grade 0-1 5. patient age \> 18 years and able to comply with the protocol visits 6. patient agreeing to undergo robot-assisted surgery, the incision being at patient choice, depending on the wishes concerning the location of the scar (axillary or behind the ear channel) 7. patient information or his legal representative and signed consent enlightened 8. patient affiliated to a system of social security or beneficiary of such a scheme exclusion criteria: 1. a history of cervical surgery or external beam radiation therapy 2. anomaly craniocervical hinge or symptomatic cervical spondylosis 3. congenital or acquired shoulder or ipsilateral upper limb surgery (for axillary ) 4. paralysis preoperatively ( a laryngoscopic examination will be performed systematically preoperatively ) 5. tumors with obvious extra- thyroid extension or suspected during preoperative ( ct3t4 ) 6. metastatic cervical lymphadenopathy \> 10 mm during the preoperative 7. pregnant women or during lactation 8. patient already included in another clinical trial with a molecule experimental
plasma cystatin c and acute kidney injury

Conditions: Acute Kidney Injury

Summary: to evaluate the utility of plasma cystatin c(pcysc) as a predictive and diagnostic marker of acute kidney injury(aki) in patients undergone cardiopulmonary bypass surgery.

this is a prospective aki observational study in patients undergone cardiopulmonary bypass surgery. pcysc and plasma creatine will be measured at entry to icu.aki was defined as 50% increase in plasma creatine above baseline.the predictive and diagnostic performance of pcysc will be assessed from area under receiver operator characteristic curve(auc) and odds ratio(or).

Eligibility criteria:
inclusion criteria: * patients with cpb and admitted to icu exclusion criteria: * patients with the age \>80 or \<18 years * with preexisting renal dysfunction

Keywords: cystatin c,acute kidney injury,
evaluation of the gore tigris vascular stent

Conditions: Peripheral Arterial Disease

Summary: the primary objective of the randomized study is to evaluate the safety and effectiveness of the tigris vascular stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (sfa/ppa) of patients with symptomatic peripheral arterial disease (pad).


Eligibility criteria:
inclusion criteria: * rutherford class 2 - 4. * abnormal ankle brachial index (abi ≤0.9). * at least 21 years of age. * reasonable expectation of survival of at least 12 months after the procedure. * male, infertile female, or female practicing an effective method of preventing pregnancy. * one de novo or restenotic lesion of the sfa/ppa with a cumulative length visually estimated to be ≤24cm * arteries with reference vessel diameter of 4.0 - 6.5 mm within the sfa/ppa, estimated visually. * angiographic evidence of at least one patent tibial artery (\<50% stenosis angiographically). * guidewire has successfully traversed the lesion to be treated and is within the true lumen of the distal vessel. * lesion has been pre-dilated before stent deployment. exclusion criteria: * prior enrollment in this study. * vascular access/catheterization in the target leg within 30 days of study enrollment. * prior treatment of the sfa/ppa in the target leg with stenting or bypass. * flow-limiting aortoiliac disease. * additional ipsilateral femoropopliteal or tibial disease, outside of the lesion to be stented, requiring intervention. * arterial aneurysm in the target leg. * co-morbid conditions which would preclude compliance with study protocol. * obstructive or occlusive non-atherosclerotic disease. * creatinine greater than 2.5 mg/dl. * amputation above the metatarsals, resulting from vascular disease, in the target leg. * septicemia or uncontrolled infection. * contraindication to anticoagulation or antiplatelet therapy, including allergy to heparin, or history of heparin induced thrombocytopenia (hit), or a positive platelet factor 4 (pf4) antibody assay. * abnormal platelet levels, i.e., platelet count at baseline less than 80,000/microliter. * history of coagulopathy.

Keywords: peripheral arterial disease superficial femoral artery proximal popliteal artery pad sfa ppa stent gore bare metal stent lifestent atherosclerosis heparin claudication leg pain
comparative study of two marketed 1-day soft contact lenses

Conditions: Myopia

Summary: this study is designed to evaluate ocufilcon d lens compared to ocufilcon b lens in a 1-week crossover, daily wear regimen.

this study is designed to evaluate 2 daily disposable contact lenses that are both currently cleared for the usa market. study of the ocufilcon d lens compared to the ocufilcon b lens in a 1-week crossover, daily wear regimen. the primary objective is the comparison of fitting characteristics. the secondary objective is the comparison of comfort, end of day comfort and dryness measures.

Eligibility criteria:
inclusion criteria: * has had a self reported oculo-visual examination in the last two years. * is able to wear the study lenses for at least eight hours a day, seven days a week * aged 18-40 years and has full legal capacity as a volunteer * has a distance contact lens prescription from -0.25 and -6.00d inclusive * has spectacle astigmatism of \< 1.00d in each eye * baseline vision of 20/20 best-corrected in each eye. * is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye * has read and understood the consent form and willing to sign consent form * willing and able to follow participant instructions and attend the required study visits has worn soft contact lenses for at least two weeks prior to the study (daily wear only). exclusion criteria: * currently wears contact lenses on an extended wear basis. * not a current or past wearer of the ocufilcon b 52% 1-day lenses. * has undergone anterior ocular surgery * is aphakic * has never worn contact lenses before * has any systemic disease which clinically contraindicates contact lenses * has active ocular disease or severe insufficiency of lacrimal secretion (dry eye) * use of systemic or topical medications that will affect ocular health or visual performance * slit lamp findings with a grading of greater than 1.0 using the grading scales in appendix 3 * not possible to achieve a satisfactory fit with the lens design used in the study * has keratoconus or other corneal irregularity * participating in another eye-related clinical trial * pregnant, lactating or planning a pregnancy

Keywords: contact lenses
novofine autocover safety needle versus bd safety glide

Conditions: Diabetes; Healthcare Professionals; Delivery Systems

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to examine whether nurses prefer to use the novofine® autocover needle or the bd safety glide (tm) syringe (only) in a hospital setting. the number of needle stick injuries will also be evaluated and whether these hospital nurses prefer the safety features of the novofine® autocover needle versus those of the bd safety glide (tm) syringe. the identified hospital nurses will evaluate the two types of needles during standard administration of insulin to patients being treated for diabetes.


Eligibility criteria:
inclusion criteria: * hospital nurses with prior injection training without an infectious blood borne disease