Kornimate/medical-research-clean huggingface dataset:
the relationship between lipid peroxidation products from traumatic brain injury and secondary coagulation disorders

Conditions: Traumatic Brain Injury; Coagulation Disorder

Summary: the purpose of this study is to observe the relationship between the level of lipid peroxidation products in serum of patients with traumatic brain injury and secondary coagulation disorders.

uncontrolled hemorrhage after trauma is the leading cause of death. the mechanism of secondary coagulation dysfunction after trauma is special and complex, which has not been fully explained, leading to limited treatment and prevention methods. coagulation disorders caused by traumatic brain injury is a systemic manifestation of local injury, which can activate platelets and promote platelet aggregation, activate thrombin, and promote the production of fibrin, leading to the formation of thrombosis. however, in non-injured areas, pro-coagulant molecules from damaged brain tissue reach the body through the broken blood-brain barrier, and also activate platelets and thrombin, promoting the formation of blood clots. lipid peroxidation products are closely related to the occurrence of coagulation dysfunction. the effects lipid peroxidation products on platelets, thrombin and anticoagulant pathways may be a novel mechanism of secondary coagulation dysfunction in traumatic brain injury.

Eligibility criteria:
inclusion criteria: 1. the interval between injury and admission is less than 24 hours 2. age\>18yrs and age\<80yrs 3. non-head abbreviated injury score \< 3 4. did not undertake treatment before enrollment 5. informed consent to participate in the study exclusion criteria: 1. take anticoagulants or antiplatelet drugs 2. smoking history 3. hemorrhagic or ischemic cerebrovascular disease occurred within six months 4. other systemic diseases: uremia, cirrhosis, malignant tumor, etc 5. patients with severe mental illness who are unable to communicate when diagnosed 6. patients who refused follow-up

Keywords: traumatic brain injury coagulation disorder lipid peroxidation
analgesic effect of oral glucose in neonates

Conditions: Pain

Summary: background: male circumcision is one of the oldest and most common operations performed all over the world. it can be performed at different ages, using different surgical techniques, for different religious, cultural and medical reasons. it was thought that the newborn baby does not experience pain because of incompletely developed nervous system. however, it has been shown that neurological system known to be associated with pain transmission and modulation, is intact and functional. objective: our objective is to determine if a 30% glucose solution would reduce pain after circumcision compared with normal saline. study design: this is a randomized placebo-controlled double-blinded clinical trial. population: we will include full term neonates, who will be recruited from the inpatient nursery at makassed general hospital over a 1-year period. outcome measure: the primary outcome is to assess efficacy of 30% glucose on pain measured using the neonatal infant pain score. secondary outcome is to assess effect of 30% glucose oh physiologic parameters


Eligibility criteria:
inclusion criteria: * estimated gestational age: 37 weeks-42 weeks * birth weight: 2500 grams-4000 grams * apgar scores a minimum of 7 at 1 and 5 minutes respectively * heart rate between 100 and 160 per minutes * blood o2 saturation of at least 95% * no recognized congenital abnormalities exclusion criteria: * they were transferred to the neonatal intensive care unit (nicu) * they required respiratory support
remote ischemic preconditioning in head and neck cancer reconstruction - a randomized controlled trial

Conditions: Head and Neck Neoplasms

Summary: the purpose of the trial is to investigate, if remote ischemic preconditioning reduces the risk of complications in patients undergoing resection of head and neck cancer and immediate reconstruction with autologous free tissue transfer. remote ischemic preconditioning is a treatment, which is carried out by inducing brief episodes of upper arm occlusion using an inflatable tourniquet. blood samples will be taken during the operation and postoperatively to evaluate the effects of remote ischemic preconditioning. these blood samples will be analyzed for clotting properties and markers of inflammation. furthermore, effects on the blood supply of the transferred tissue flap will be measured by infrared thermography. effects on surgical complication rates will be obtained by clinical follow-up and patient chart review.


Eligibility criteria:
inclusion criteria: * histologically verified or clinically suspected malignant tumor in the oral cavity, maxillae, mandible, pharynx, larynx, and/or esophagus. * will undergo tumor resection and immediate free flap reconstruction at aarhus university hospital, denmark. * the reconstruction is planned with a single free flap. exclusion criteria: * arterial and/or venous thromboembolism within the last three months. * the reconstruction is planned with more than one free flap.

Keywords: head and neck neoplasms surgical flaps ischemic preconditioning hemostasis thrombosis immune system reperfusion injury
centralized pan-middle east survey on the under-treatment of hypercholesterolemia, sub-study for the gulf states

Conditions: Hypercholesterolemia

Summary: the purpose of the study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the ldl-c goals according to the ncep atp iii/updated 2004 ncep atp iii guidelines, overall and by country, to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the ldl-c goals according to the ncep atp iii/updated 2004 ncep atp iii in the following sub-populations: * primary/secondary prevention patients. * patients with metabolic syndrome (according to ncep iii definition). and to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the ldl-c goals according to the third joint european task force guidelines/national guidelines, in the survey population and in the following sub-populations: * primary/secondary prevention patients. * patients with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * race * on lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks. * subject must sign informed consent exclusion criteria: * subjects who are unwilling or unable to provide informed consent.

Keywords: hypercholesterolemia update ncep atp111 survey
instillation of gemcitabine in patients with superficial bladder cancer

Conditions: Bladder Neoplasms

Summary: a randomized, double-blind, placebo-controlled phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor.


Eligibility criteria:
inclusion criteria: * clinical evidence of superficial transitional cell carcinoma of the bladder * males or females at least 18 years of age * karnofsky performance status greater than or equal to 70% * patient compliance and geographic proximity that allow adequate follow-up * female patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device \[iud\], birth control pills, or barrier device) during the study. female patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment. * signed informed consent. exclusion criteria: * clinical evidence of muscle-invasive or locally advanced bladder cancer * clinical evidence of upper urinary tract tumor * distant metastases * other malignancies within the last 2 years, except non-melanotic skin tumors, carcinoma in situ of the cervix or organ-confined prostate cancer after curative therapy * severe concomitant psychiatric disease * febrile, active infection * other serious concomitant disorders that would compromise the safety of the patient or his/her ability to complete the study according to the protocol, at the discretion of the investigator (for example, unstable angina pectoris, uncontrolled diabetes mellitus)
bariatric surgery and pharmacokinetics of ramipril

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study we investigate the pharmacokinetic effects of bariatric surgery on ramipril.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics ramipril
radiation therapy during surgery in treating older women with stage i breast cancer

Conditions: Breast Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. giving intraoperative radiation therapy may reduce the amount of normal tissue that needs to be removed. purpose: this phase ii trial is studying how well giving radiation therapy during surgery works in treating older women with stage i breast cancer.

objectives: primary * study the feasibility and reproducibility of intraoperative radiotherapy as the only treatment after lumpectomy in older women with stage i breast cancer. secondary * study the impact of this regimen on maintaining self-care. * study the quality of life (qlq-c30) and satisfaction with care. * study regimen tolerance and cosmetic results. * evaluate the economic impact of this treatment. * study relapse-free and disease-specific survival. outline: patients undergo conservative breast surgery and axillary node dissection (sentinel node or classic resection). at this point, patients must have either negative axillary lymph nodes after removal of ≥ 6 lymph nodes, negative sentinel nodes, or have had a limited lumpectomy with negative margins ≥ 2 mm. patients undergo intraoperative radiotherapy during surgery, before closing and reconstruction of the breast. patients may begin hormonal therapy after completing study therapy. after completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Eligibility criteria:
disease characteristics: inclusion criteria: * histologically confirmed stage i breast cancer * size ≤ 20 mm (by ultrasound), n0, any quadrant * hormone receptor status not specified exclusion criteria: * distant metastases * inflammatory breast cancer * lobular in situ disease * invasive cancer or ductal carcinoma in situ * nonepithelial disease or sarcoma * multicentric disease * lymphatic embolism * margins of safety unknown or positive (in situ or invasive) * preoperative mammography showing diffuse microcalcification patient characteristics: * female * menopausal * karnofsky 70-100% * no other prior cancer except basal cell skin cancer, uterine epithelioma in situ, or other cancer in complete remission for the past 5 years * no geographic, social, or psychiatric reasons that would impede participation in study treatment prior concurrent therapy: * see disease characteristics * no prior neoadjuvant therapy * no concurrent participation in another study

Keywords: stage i breast cancer
"watch and wait" after neo-adjuvant chemoradiotherapy for primary locally advanced rectal cancer.

Conditions: Rectal Cancer

Summary: among patients treated for locally advanced rectal cancer with neo-adjuvant radio-chemotherapy, about 15% will have complete clinical response in terms of no visible tumor or ulcerations on the site of the primary tumor, or whitening of the rectal wall or telangiectasia. in this norwegian national multicenter observational study, patients with complete clinical response (ccr) after neo-adjuvant treatment for rectal cancer as defined by national guidelines, will be invited to a watch\&wait program with a specially designed follow-up in order to see if the tumor has disappeared permanently, or if there is regrowth of the tumor. primary endpoint is the true regrowth rate in an unselected national cohort of patients.


Eligibility criteria:
inclusion criteria: * histologically verified adenocarcinoma of the rectum within 15 cm from the anal verge measured by rigid proctoscopy * patients who have completed neoadjuvant treatment according to national guidelines for rectal cancer, i.e., radiotherapy or chemo-radiotherapy (at least 40 gy) or short-course radiotherapy combined with chemotherapy * patients aged ≥18 years of age are eligible for inclusion. however, patients aged ≤40 years are recommended to undergo surgery on the theoretical base of a possibly more aggressive tumour disease in this age group, and will be asked to participate in the study by consenting to recording of data. those patients who insist on w\&w approach after careful consideration and well-documented informed consent are eligible for entering the w\&w protocol. * given informed consent * stage i-iii rectal cancer; however, patients with limited liver metastases who undergo primary liver surgery as part of a "liver first" treatment approach may be included exclusion criteria: * patients without ccr * patients unable to give informed consent * patients with short course radiotherapy (5x5 gy) without additional chemotherapy, or patients receiving less than 40 gy in long course crt * patients with ccr but with increasing tumour growth on mri after preoperative treatment * patients with metastatic disease at the time of diagnosis with the exception of those who are eligible for "liver first" treatment approach as part of an intention to cure approach. * patients previously diagnosed and treated for malignant disease in the pelvic region with radio- or chemoradiotherapy * other circumstances that may interfere with successful participation in the w\&w protocol

Keywords: locally advanced, neo-adjuvant treatment, watch & wait
health coaching for glaucoma patients

Conditions: Glaucoma

Summary: the study will be conducted to examine the feasibility of using a health coach for improving the ophthalmic care of glaucoma patients. patients taking glaucoma medications will have a coaching intervention and adherence to glaucoma drops will be monitored using a dose-recording device. the dosing data will be analyzed to examine the effect on adherence and qualitative interviews at the conclusion of the study will be used to examine which elements of the coaching experience were most helpful in the glaucoma patient population.

glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage.

Eligibility criteria:
inclusion criteria: * adult whose age is \>18 years * diagnosed with glaucoma * patient of duke glaucoma service * prescribed or using topical glaucoma eye medication for at least 6 months * primarily self-administering his or her eye drops * english speaking * patient should be able to use the telephone for the coaching intervention, * patient should be available by phone to complete the coaching intervention * patient should be willing and able to use the mems (medication event monitoring system) device for recording medication use * patient must be willing and able to come to the eye center for an exit interview and to return the mems device * patient must be able to give consent exclusion criteria: * patient should be excluded if he or she may need glaucoma surgery or laser during the 6 months of the study period
treatment of depression following multiple brain tests

Conditions: Major Depression; Dysthymia

Summary: the main purpose of this study is to correlate brain testing with treatment outcome.

40 medication-free depressed patients will receive a battery of neuropsychologic tests, standard dichotic listening tests, eeg, erp and an f-mri while performing a neuropsychologic test, the simon. once testing is completed, patients will be treated in an open treatment trial of ssri. non-responders will then receive bupropion followed by tricyclic antidepressant if still depressed. while our main purpose is to correlate imaging testing with other measures of brain functioning, we also intend to see whether f-mri findings demonstrate specific brain areas which differ between responders and non-responders. at the end of ssri treatment, patients will have a second f-mri scan to investigate any changes treatment and/or response may have caused.

Eligibility criteria:
inclusion criteria: * dsm-iv major depression or dysthymia * age 18-65 * physically healthy * normal hearing * drug-free (two weeks for most antidepressants, four weeks for fluoxetine) exclusion criteria: * hearing deficit in one or both ears * body metal (e.g., wire stitches, screws in bones, stainless steel hips) * history of psychosis or epilepsy * current (past six months) substance use disorder (illicit drugs and/or alcohol) * unstable medical problem * insufficient english for neuropsychological and dichotic testing * bipolar i * need for wash-out from effective treatment in order to participate * pregnant * high suicide risk * currently taking (within 2 weeks; 4 weeks for fluoxetine) antidepressants

Keywords: major depression dysthymia f-mri escitalopram bupropion imipramine neuropsychologic test dichotic listening eeg erp
ppar-gamma agonists, rheumatoid arthritis and cardiovascular disease

Conditions: Rheumatoid Arthritis

Summary: patients with rheumatoid arthritis have a significantly higher risk to develop heart attacks and other complications of their blood vessels. new therapies are needed to prevent this complication. the purpose of this study is to establish the role of the medication pioglitazone in improving the function of the blood vessels and heart and decreasing the risk of future atherosclerosis development in individuals with rheumatoid arthritis. as a secondary aim-point, we will evaluate the efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation.

this study will establish the role of pioglitazone in improvement of endothelial function, arterial compliance and disease activity in patients with rheumatoid arthritis. this will be a placebo-controlled, double blind, cross-over trial. two of the measures which were initially listed as separate outcome measures: (decrease in inflammation) and efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation are now shown as a combined score (das-28-crp). the risks or side effects as an outcome measure would be duplicative of the tables in the adverse event section and therefore were deleted as an outcome measure.

Eligibility criteria:
inclusion criteria: * women on adequate contraception if they are of child-bearing age. * meet revised acr criteria for ra. * stable doses of dmards,biologic agents and or corticosteroids for at least 3 months. exclusion criteria: * pregnant or lactating women. * current smokers or individuals who smoked in the last 6 months. * diagnosis of diabetes, heart failure, or infection. * current diagnosis of malignant disease except for basal cell or squamous cell carcinoma of the skin. * no active liver disease. * no cholesterol-lowering medications or oral hypoglycemic agents.
itraconazole pharmacokinetic with and without efavirenz using the capsule formulation as part of talaromycosis treatment in hiv-infected adults

Conditions: Pharmacokinetics; Efavirenz; Penicilliosis

Summary: talaromycosis continues to be a common opportunistic fungal infection among people living with hiv/aids (plwha) in southeast asia and remains a leading cause of death among this population. itraconazole (itz) is an important component of talaromycosis treatment. in thailand, the capsule formulation of itz is primarily used to treat talaromycosis but it is known to have lower bioavailability than the more expensive solution formulation. limited data on the drug exposure of itz with the capsule formulation are available in adults plwha in thailand. moreover, the effect of efavirenz (efv), which has been recommended as the first line antiretroviral therapy in thailand, to itz level is not well understood. thus, our aim is to assess itz pharmacokinetics with and without efv in adult plwha receiving talaromycosis treatment with the capsule formulation. an understanding of the relationship between itz drug exposure and its active metabolite (hydroxyl-itraconazole) and treatment response is also planned to help optimize therapy.


Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. available documentation of hiv infection 3. itz capsule therapy is indicated for talaromycosis infection with the anticipation to start on efv-based art 4. willing to consent and compliance to the study protocol exclusion criteria: 1. history of itz allergy 2. pregnancy or lactation 3. use concurrent medication that could interfere with itz level 4. creatinine clearance less than 30 ml/min 5. alanine aminotransferase (alt) or aspartate aminotransferase (ast) value is more than 5 times of upper normal limit and total bilirubin is more than 3 times above upper normal limit 6. hemoglobin less than 7 mg/dl 7. history of itz exposure within 35 days (only applicable to intense pk group)

Keywords: pharmacokinetics efavirenz penicilliosis