Kornimate/medical-research-clean huggingface dataset:
validation of the cheetah nicom by comparison to tee during open vascular surgery - pilot study

Conditions: Aortic Aneurysm; Peripheral Arterial Disease

Summary: the cheetah nicom is a non-invasive cardiac output monitor that has been validated in various clinical contexts but not during the occlusion of major arteries, as takes place in vascular surgery. the present study will evaluate the precision and validity of the measures taken by the device during open vascular surgery procedures. the measurements will be compared to the those calculated by transesophageal echocardiography at various key points during the surgeries. the validity of the cardiac output, stroke volume and stroke volume variation measurements will be evaluated, as well as the device's ability to track rapid changes in cardiac output.


Eligibility criteria:
inclusion criteria: * patient undergoing an elective open aortic aneurysm repair surgery or a femoral endarterectomy under general anesthesia. * asa 1-3 exclusion criteria: * refuses general anesthesia * contraindication to transesophageal echocardiography * allergy to the glue of the cheetah nicom probes * severe aortic valve regurgitation * thoracic aorta anatomy anomaly * unipolar pacemaker

Keywords: cardiac output intraoperative monitoring echocardiography, transesophageal vascular cross-clamping endarterectomy monitoring, physiologic/instrumentation cardiography, impedance
a study to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers

Conditions: Healthy

Summary: this study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.


Eligibility criteria:
inclusion criteria: * subject must have a body mass index (bmi) between 19 and 25 inclusive * medically healthy subjects with clinically normal laboratory profiles, physical exams, vital signs and ecgs. * give voluntary written informed consent to participate in the study exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic renal, hematologic, gastrointestinal (inclusive of dysphagia, swallowing disorders, severe gastrointestinal motility disorders), endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease. * in addition, history or presence of: alcoholism or drug abuse within the past year; or hypersensitivity or idiosyncratic reaction to ciclosporin or other immunosuppressive agents; or chronic infection * subjects who ere tested positive at screening for hiv, hbsag or hcv * subjects who received injectable corticosteroids in the 12 weeks preceding the first dose. * subjects who are allergic to castor oil or corn oil * subjects whose sitting blood pressure is less than 110/60 mmhg at screening or 100/55 mmhg before dosing * subjects who have used any medications or substances known to be strong inhibitors of cyp3a enzymes within 10 days prior to the first dose. * subjects who have used any medications or substances known to be strong inducers of cyp3a enzymes within 28 days prior to the first dose. * subjects who have used antibiotics within 14 days prior to the first dose. * subjects who have used other medication (including over-the-counter products) vitamins and herbal products within 7 days prior to the first dose. * subjects who have used any live attenuated vaccine within 7 days prior to the first dose or are planning to use within 14 days after the end of the study. * subjects who, prior to informed consent, would have donated in excess of: 500ml of blood in 14 days;1500ml of blood in 180 days; or 2500ml of blood in 1 year. * subjects who have participated in another clinical trial: within a period less or equal to 2 half live (t1/2) of the previous investigational product used or within 60 days prior to first dose.

Keywords: familial hypercholesterolemia
prevention and early detection of cervical cancer through self-administered screening

Conditions: Cervical Carcinoma; Human Papillomavirus-Related Carcinoma

Summary: this study examines prevention and early detection of cervical cancer through self-administration screening of patients in western uganda. the cervix is the opening of the uterus or womb, which is the organ that supports babies before they are born. there are simple tests that let doctors know whether or not patients have cells that may become cancer. some of the tests determine whether patients have an increased risk for cervical disease, but they do not actually confirm that they have it: these are called "screening" tests. this study may help researchers determine how to best deliver cervical cancer prevention services using the hpv test.

primary objectives: i. to establish the acceptance and correlates of self-collected human papillomavirus (hpv)-ribonucleic acid (rna) testing among women in the rural ugandan community as well as the incidence and determinants of successful completion of the cervical cancer screening cascade from self-collected hpv testing to receipt of results. ii. to ascertain the frequency and determinants of successful acquisition of treatment among women who have hpv detected on self-collected swabs in rural uganda. iii. to derive population-based estimates of the prevalence of high-risk hpv and cervical intraepithelial neoplasia (cin) detected through community-based screening employing self-collected hpv rna testing in rural uganda. outline: patients receive a specimen kit for collection of hpv samples. patients complete questionnaire before and after collection hpv samples. patients may also participate in an interview about general ideas in improving the screening and treatment process. patients with positive results, undergo treatment for cervical cancer.

Eligibility criteria:
inclusion criteria: * women in the three ugandan districts (kiboga, kyankwanzi and hoima) who access screening during the community health campaigns * age 25-49 years * resident in the study district * provision of informed consent exclusion criteria: * clinical signs and symptoms of cancer of the cervix

Keywords: cervical cancer screening human papillomavirus hpv
study of monalizumab and cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck

Conditions: Head and Neck Neoplasms

Summary: the objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of monalizumab given iv in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (scchn). cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-pd(l)1


Eligibility criteria:
main inclusion criteria: 1. age ≥ 18 years 2. histologically or cytologically-confirmed, hpv (+) or hpv (-) squamous cell carcinoma of the nasopharynx (who type 1), oropharynx, hypopharynx, larynx (supraglottis, glottis, subglottis) or oral cavity. 3. recurrent or metastatic disease, documented by imaging (ct scan, mri, x-ray) and/or physical examination with measurable disease as per response evaluation criteria in solid tumors \[recist\] 1.1 for phase ii cohorts: * cohort #1: patients who received a maximum of two prior systemic regimens for recurrent and/or metastatic disease and not amenable to further therapy with curative intent * cohort #2: patients with r/m scchn not amenable to therapy of curative intent, who have received a maximum of two prior systemic regimens in the r/m setting and who have received prior pd-(l)1 blockers * cohort #3: patients with r/m scchn who have not received prior systemic regimens in the r/m setting and who have not received prior pd-(l)1 inhibitors main exclusion criteria: 1. for phase ii cohort #1 and cohort #2: patients who received more than 2 prior systemic regimens for recurrent and/or metastatic disease (no restriction in the phase ib part of the trial). 2. for phase ii cohort #1 and cohort #2: patients who received cetuximab or another inhibitor of epidermal growth factor receptor are excluded from the phase ii of the trial, except if cetuximab was given as part of a primary treatment approach, with no progressive disease for at least 4 months following the end of prior cetuximab treatment.
thoracic endoprosthesis for treatment of aneurysm of the descending thoracic aortic

Conditions: Aneurysm

Summary: to assess the safety and efficacy of the gore conformable tag® thoracic endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (dta) \> primary hypothesis: the proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the gore tag® thoracic endoprosthesis


Eligibility criteria:
inclusion criteria:\> 1. presence of dta aneurysm deemed to warrant surgical repair \> * fusiform (≥50 mm), or \> * saccular (no diameter criteria)\> 2. subject is \> 21 years of age\> 3. proximal and distal landing zone length ≥ 2.0 cm \> * landing zones must be in native aorta\> * landing zone may include left subclavian artery, if necessary\> 4. all proximal and distal landing zone inner diameters are between 16-42 mm\> * diameter assessed by flow lumen and thrombus, if present; calcium excluded\> 5. life expectancy \> 2 years\> 6. able to tolerate thoracotomy \> 7. male or infertile female\> 8. able to comply with protocol requirements including following-up\> 9. signed informed consent\> exclusion criteria:\> 1. differing proximal and distal neck diameters (aortic taper) outside the intended aortic diameter requirements (sizing guide) for a single endoprosthesis diameter and the inability to use devices of different diameters (in adherence to the sizing guide) to compensate for the taper\> 2. tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access\> 3. aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)\> 4. mycotic aneurysm\> 5. hemodynamically unstable aneurysm rupture\> 6. aortic dissection\> 7. planned coverage of left carotid or celiac arteries with the ctag device\> 8. planned concomitant surgical procedure (other than left subclavian transposition and wireless sac pressure monitoring), or major surgery within 30 days of treatment date\> 9. known degenerative connective tissue disease, e.g. marfan or ehler-danlos syndrome\> 10. known history of drug abuse\> 11. asa risk classification = v (moribund patient not expected to live 24 hours with or without operation)\> 12. nyha class iv \> 13. participating in another investigational device or drug study within 1 year of treatment\> 14. subject has known sensitivities or allergies to the device materials\> 15. subject has a systemic infection and may be at increased risk of endovascular graft infection\>
study of pemetrexed plus cisplatin in patients with malignant pleural mesothelioma

Conditions: Malignant Pleural Mesotherioma

Summary: to investigate efficacy and safety of pemetrexed combined with cisplatin for chemo-naive patients with malignant pleural mesothelioma.


Eligibility criteria:
inclusion criteria: * inapplicable for radical operation * not received prior systemic chemotherapy * performance status: 0-1 exclusion criteria: * having a history of sensitivity to platinum agent, folic acid or vitamin b12
management of children with moderate acute malnutrition in mali

Conditions: Moderate Acute Malnutrition (MAM)

Summary: the objectives of the study are to assess the impact of different dietary strategies for the management of children with mam on: the children's continued participation in the nutritional rehabilitation program and their physical growth, recovery from mam, and change in micronutrient status and body composition. the specific dietary regimens that will be compared are: 1) a ready-to-use, lipid-based supplementary food (plumpy'sup, nutriset, inc.), providing \~500 kcal/d for 12 weeks; 2) specially formulated csb for malnourished children, providing \~ 500 kcal/d for 12 weeks; 3) misola, a locally produced, micronutrient-fortified, cereal-legume blend, providing \~500 kcal/d for 12 weeks; or 4) packaged, home available foods (millet and cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder ("mix me") for 12 weeks, as is currently recommended by the national cmam protocol when special foods are not available.


Eligibility criteria:
inclusion criteria: * age from 6 to 35 months, * muac \ 11.0 cm, and weight-for-length (wlz) z-score \> -3.0 (who standard, 2006); or wlz \ -3.0 and muac \>11.0 cm * absence of bi-pedal edema * absence of current diseases requiring inpatient care * expected availability during the period of the study * residency within the study communities * acceptance of home visitors, and * written consent of a parent or guardian exclusion criteria: * age \ 36 months * muac \>12.5 cm and wlz \>-2.0; or muac \<11.0 cm; or wlz \<-3.0 * presence of bi-pedal edema, * severe anemia (defined as hemoglobin \<50 g/l), * other acute illnesses requiring inpatient treatment, * congenital abnormalities or underlying chronic diseases, including known hiv . infection, that may affect growth or risk of infection * history of allergy towards peanuts or previous serious allergic reaction to . any substance, requiring emergency medical care * concurrent participation in any other clinical trial
the use of rectal balloons in radical pelvic radiotherapy - a feasibility study

Conditions: Prostate Cancer

Summary: this study aims to test the hypothesis that insertion of an endorectal balloon into a patient receiving radical prostate radiotherapy by treatment radiographers is feasible without the patient experiencing undue discomfort. in addition this study will test the hypotheses that insertion of the rectal balloon prior to radiotherapy delivery stabilises rectal volume during radiotherapy treatment and minimises organ motion within the pelvis.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * ecog performance status 0-2 (patients with ps-2 as a result of comorbidity will be excluded). * patients with histologically confirmed diagnosis of prostate adenocarcinoma * patients who are going to undergo treatment with radical radiotherapy for prostate cancer. * patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent * patients must be able to comply with trial requirements. exclusion criteria: * patients must not have a history of previous bowel surgery involving the rectum or anus. * evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial, as well as any other serious uncontrolled medical condition. * any patient with a medical or psychiatric condition that impairs their ability to give informed consent * pre-existing anorectal disease, e.g. haemorrhoids, active bleeding, anal irritation, inflammatory bowel disease. * patients who are unable to give consent. * patients in clinical trials of new investigational medicinal products or treatment regimens unless there is written, prior agreement that the patient can also consent to this study, and that clinical data can also be used for this study. * prior pelvic radiotherapy
effect of bathing on physiological parameters, skin, bilirubin and comfort levels in infants receiving phototherapy

Conditions: Phototherapy Skin Rash

Summary: the aim of this study is to determine the effect of bathing on physiological parameters (heart rate, body temperature and oxygen saturation), skin, bilirubin and comfort level in infants receiving phototherapy.

neonatal jaundice (hyperbilirubinemia) causes a yellowish discolouration of the sclera and skin due to increased levels of bilirubin in the blood. jaundice develops in 60% of term babies and 80% of premature babies in the first week of life. currently, the appropriate treatment option for neonatal jaundice is phototherapy. phototherapy treatment reduces bilirubin concentrations through various photochemical reactions that allow bilirubin to be excreted more easily. however, phototherapy treatment is associated with short-term side effects including transient skin rashes, diarrhoea, hyperthermia and dehydration. physiological reasons such as the weak connection between the epidermis and dermis layer in the skin of the newborn, the ph value of the skin being close to neutral or alkaline, and the low melanosome production increase the susceptibility of the newborn to infection and skin damage. invasive interventions, use of antiseptics, phototherapy and various instruments may disrupt the skin integrity of the newborn. therefore, all newborns receiving treatment and care in the neonatal intensive care unit are at risk in terms of skin integrity. in the majority of newborn infants; jaundice develops, which can affect the newborn neurologically, motor and hearing if left untreated,. phototherapy devices are widely used today for the treatment of jaundice. phototherapy devices used in the treatment of jaundice have side effects such as skin rashes, diarrhea, dehydration and hyperthermia. in the literature reviewed, results were found that bathing the newborn reduces phototherapy rashes, lowers the bilirubin level and increases the comfort of the newborn. also in the literature; there are studies showing that one of the most suitable bathing methods for a newborn is bathtub bathing and that bathing with baby shampoo is not harmful to the newborn.

Eligibility criteria:
inclusion criteria: * born at 35-41 gestational weeks * indirect hyperbilirubinaemia diagnosed at 24 hours of birth or more, * no health problems, * indication for phototherapy treatment * stable vital signs * whose parents agreed to participate in the study exclusion criteria: * newborns with abo and rh incompatibility, * direct diagnosis of hyperbilirubinaemia, * congenital anomaly, * with skin lesions

Keywords: phototherapy newborn bilirubin bath comfort skin
safety and efficacy of chlorthalidone + amiloride to elderly patients treatment with arterial hypertension

Conditions: Arterial Hypertension

Summary: the purpose of this study is to assess the efficacy and safety of chlorthalidone 25 mg + amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial hypertension.

to assess the efficacy and safety of the association of chlorthalidone 25 mg + amiloride hydrochloride 5 mg (diupress® eurofarma) in the treatment of elderly patients with arterial hypertension, compared to chlorthalidone 25mg (higroton® laboratório novartis) in same presentation form. some eligibility criteria: perform blood and urine tests; ecg (electrocardiogram); abpm (ambulatory blood pressure monitoring; echocardiogram;doppler echocardiogram

Eligibility criteria:
inclusion criteria: * systolic blood pressure between 140 mmhg - 159 mmhg * diastolic blood pressure between 90 mmhg - 99 mmhg * subject aged ≥ 60 years old * be able to comply with instructions, attend study follow-up visits and be willing to participate in the research project. * diagnosis of stage 1 arterial hypertension with no prior treatment more than 120 days or uncontrolled during antihypertensive agent administration. exclusion criteria: * any serious or severe clinically significant medical condition. * psychiatric or neurological diseases * a condition that, as per principal investigator's opinion, may interfere with the optimal participation in the study, or that may result in special risk to the patient. * participation in any other investigational study within 12 months prior to visit 1. * known medical history of allergy, hypersensitivity or intolerance to any of the formulation compounds to be used in this study * routine prior use of diuretics * oral anticoagulant use * fast glycemia \> 150 mg/dl * medical treatment, not related to study, scheduled for the clinical trial duration; except non-serious, controlled comorbidities in current medical follow-up. * expected onset of additional antihypertensive drug after the study onset * acute myocardial infarction within last 6 months * prior decompensated coronary artery disease * known thyroid, renal or liver dysfunction, at investigator's discretion * obesity - body mass index (bmi) \> 33 kg/m2

Keywords: chlortalidone amiloride arterial hypertension
comparison of complication rates between initial and re-operative anterior lumbar interbody fusion surgery: is there a difference?

Conditions: Lumbar Spondylolisthesis; Lumbar Spine Degeneration

Summary: to identify the current mortality rate for initial alif procedures. establish/prove mortality rates for this operation have dropped in the past decade.

establish the mortality rate for "re-do" alif procedures \[i.e., is it different than that of initial alif procedures and - if so - postulate that there are interventions that can be done in the pre-operative period to ameliorate that risk. this study is not designed to "prove" the latter hypothesis.\] this is a single sample study where medical records will be searched by cpt codes for alif codes (e.g. 22558, 22585, 22845, etc.) by trained researcher(s) at participating methodist facilities going back 5-10 years to see if 1500-3500 cases can be identified within that time period.

Eligibility criteria:
inclusion criteria: * patients \> 17 years of age, patients having had alif procedures as defined by cpt codes at participating methodist facilities during 2010-2020 targeted. exclusion criteria: * pediatric patients (as defined by age \<18 years old), pregnant women and incarcerated individuals. we do not anticipate any of these in an elective spine surgery group of patients. if they have emergency spine surgery it is normally not an alif.
relative bioavailability of folic acid and l-5-methlytetrahydrofolate

Conditions: Vitamin B12 Deficiency

Summary: folic acid, a form of the vitamin folate, is added to grain products in canada to help reduce birth defects. folic acid is the synthetic form of folate and is very stable (doesn't break down) when added to foods. there are emerging health concerns about chronic folic acid consumption. recently another more natural form of folate, l-5-methyltetrahydrofolate (l-mthf) has become available. the investigators plan to conduct a randomized trial in women to determine if supplements containing l-mthf consumed over three months raises blood folate levels as much as supplements containing folic acid. the investigators hypothesize that l-mthf will increase red cell folate over 12 weeks to same extent as equimolar folic acid.

the proposed study is a twelve week, cross-sectional, double blind, randomized controlled trial. the sample population will consist of one-hundred fifty healthy adult volunteers. all participants will be malaysian women between eighteen and forty-two years of age. study participants will be recruited by word of mouth and through advertisements placed in hospitals and universities starting in january 2011. study participants will be randomly assigned to 1 of 3 treatment groups: 1) 1000ug l-mthf 2) 1000ug folic acid 3) placebo (methyl cellulose). all treatments will be given in capsule form. blood samples will be collected at baseline, 6 and 12 weeks. the primary outcome measure is red cell folate. a sample size of 45 subjects per group will allow us to detect a minimum difference of 100 nmol/l red cell folate assuming an alpha 0.05, a beta of 0.8 a sd of 183 nmol/l. accounting for a 10% attrition rate we will enroll 50 women per group. the study will be analyzed as intent to treat. baseline characteristics and compliance between treatment groups will be compared using a one-way anova for continuous variables and chi-square analyses for categorical variables. the difference in measurements between the treatment groups at week 12 will be determined by regression analysis, controlling for baseline values.

Eligibility criteria:
inclusion criteria: * malaysian nationality exclusion criteria: * pregnancy * vitamin supplement users * chronic disease * prior neural tube defect affected pregnancy