Kornimate/medical-research-clean huggingface dataset:
clopidogrel hyper-responsiveness: incidence and associated outcomes in patients with cerebral aneurysms

Conditions: Cerebral Aneurysm

Summary: this registry study will investigate the incidence of and outcomes associated with clopidogrel hyper-responsive patients treated at methodist dallas medical center, beginning in january 2018, who suffered cerebral aneurysms.

this registry study will investigate the incidence of and outcomes associated with clopidogrel hyper-responsive patients treated at methodist dallas medical center, beginning in january 2018, who suffered cerebral aneurysms. perioperative and short-term clinical data will be obtained from electronic medical records. all the data variables will be documented in an excel sheet (appendix b). this section will provide an overview of the data collected which will include, but are not limited to, the following: • pre-operative information: demographics (e.g., age, gender), patient characteristics (e.g., bmi, american society of anesthesiologists class), and pre-operative medical history (e.g., tobacco use; comorbidities: hypertension, cardiopulmonary disease, diabetes; etc.).

Eligibility criteria:
inclusion criteria: age 18 years or older diagnosed with cerebral aneurysms (i.e. icd-10 i67.1) pre-intervention treatment with clopidogrel exclusion criteria: * does not meet inclusion criteria specified in 3.1
phase ii randomized study of leuprolide vs oral contraceptive therapy vs leuprolide and oral contraceptive therapy for ovarian hyperandrogenism

Conditions: Hyperandrogenism

Summary: objectives: i. evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian hyperandrogenism.

protocol outline: this is a randomized study. patients are randomly assigned to a 6-month course of leuprolide versus ethinyl estradiol/norethindrone (ovcon 35) versus leuprolide plus ovcon 35. leuprolide is administered intramuscularly in depot form every 28 days.

Eligibility criteria:
protocol entry criteria: disease characteristics * ovarian hyperandrogenism with lorenzo hirsutism score 7 to 20, with or without severe acne * serum hormone levels: follicle-stimulating hormone no greater than 40 miu/ml luteinizing hormone no greater than 40 miu/ml testosterone 60 to 200 ng/dl dehydroepiandrosterone sulfate no greater than 430 micrograms/dl 17-hydroxyprogesterone no greater than 3.3 ng/ml in follicular phase prolactin no greater than 18 ng/dl * no adrenal or ovarian tumors prior/concurrent therapy * at least 6 months since exogenous steroids at least 48 hours since drugs other than acetaminophen, ibuprofen, and aspirin patient characteristics * no malignancy, including the following carcinomas: breast cervix ovary uterus no other serious illness no cigarette smokers no nursing women no pregnancy within 6 months prior to entry

Keywords: endocrine disorders hyperandrogenism rare disease
novel cervical retraction device

Conditions: Pain Due to Certain Specified Procedures

Summary: this study will test a suction-based method of engaging the cervix. bioceptive has developed a device that more gently and atraumatically attaches to the cervix with no bleeding. this novel attachment mechanism may diminish pain and discomfort. pre-clinical testing has been performed on the device including testing on synthetic uterine models, human cadavers, and human uteri immediately post-hysterectomy (utah irb # 00059096). results from these efforts have shown effective attachment to the cervix and the ability for the device to maintain suction throughout a procedure atraumatically. this study proposes to introduce this minimal risk device in a clinical setting to determine the response of women undergoing gynecologic procedures.


Eligibility criteria:
inclusion criteria: * subjects presenting for iud insertion or endometrial biopsy * able to consent for study in english or spanish exclusion criteria: * post-menopausal * current pregnancy * cervical abnormalities (cervical polyp, cervical lesion, or irregularity) * use of narcotics or benzodiazepines prior to procedure
clinical outcome after total knee arthroplasty using cr or ps inlay

Conditions: Knee Osteoarthritis

Summary: compare knee flexion after cruciate-retaining and cruciate substituting total knee arthroplasty.

the aim of this study is to compare knee flexion after cruciate-retaining (cr) and cruciate-substituting (posterior stabilized - ps) total knee arthroplasty (tka). for this purpose, flexion and extension of the knee joint are measured using a goniometer preoperatively and up to ten years after surgery in addition, the clinical outcome will be assessed and evaluated using internationally recognised and evaluated scores (knee society score, oxford knee score, eq5d, ucla activity score). patients are randomized to receive a ps or cr tka. patients are assessed before surgery, after 3 months, 1 year, 2 years, 5 years, 7 years and 10 years postoperatively.

Eligibility criteria:
inclusion criteria: * indication for tka with a non-linked, bicondylar total knee replacement * written informed consent exclusion criteria: * chronic pain patients * neuromuscular diseases * general illnesses that make mobilisation more difficult and/or prevent follow-up * known posterior cruciate ligament insufficiency * need for a higher degree of linkage * bmi over 40 kg/m² * study doctor, his family, employees or other dependent persons

Keywords: total knee arthroplasty total knee replacement outcome implant design
recognition of abnormal pediatric blood pressures in primary care

Conditions: Hypertension

Summary: this study will look at general pediatricians' effectiveness at screening children for elevated blood pressure values in the primary care setting. two new screening tools will be introduced and their effectiveness will be measured against current practice by way of medical chart review.


Eligibility criteria:
inclusion criteria: * health care supervision visit * documented measured blood pressure and height * between the ages of 3 years and 17 years exclusion criteria: * younger than 3 years of age * older than 17 years of age * no documented blood pressure measurement * not a health supervision encounter
population screening using smartphone in milpa alta

Conditions: Suicidal Ideation; Depression; Depressive Disorder; Anxiety; Alcohol Abuse; Drug Abuse

Summary: the objective of this study is to make a suicide screening in the entire population of milpa alta (approximately 150,000 inhabitants), taking into account other outcomes such as depression, anxiety, alcohol and drugs. for this, an app for smartphone (memind) or a web platform (www.memind.net) will be used in which the participants will take a self-administered questionnaire, composed of several psychometric instruments . it is expected that 70% of the population between 15 and 70 years old can do so directly with their own smartphone, although web access posts will be enabled in educational and municipal units to avoid discrimination based on age or access to technology. our main hypothesis argues that the early identification of people at risk in almost the entire community can be done with an app for smartphone, serving to depict a map of mental health and related needs of the population, serving for the planning of healthcare services of the local environment, and ultimately for the best assistance of groups and individuals with greater needs through their identification and early reference to medical assistance.


Eligibility criteria:
inclusion criteria: 1. use a smartphone as personal or computer terminals enabled by the municipality of milpa alta or educational services. 2. be able to understand the nature, purpose and methodology of the study. 3. accept participation in the study and check the corresponding box in the app to verify that the informed consent has been expressly given. exclusion criteria: 1. subject deprived of liberty (by judicial or administrative decision) 2. subject protected by law (guardianship or conservatorship)

Keywords: mass screening health surveys mental health suicidal ideation
prehabilitation and heart valve surgery

Conditions: Valvular Heart Disease

Summary: to evaluate the impact of prehabilitation on quality of recovery in heart valve surgery. to evaluate the effects of mild to moderate valvular diseases with newyork heart association (nyha) grade i and ii . previous studies were designed to target on coronary artery bypass graft surgery (cabgs) patients no specifically heart valve surgery patients was studied so this study cover this aspect as well so from the outcomes of this study we will determine the prehabilitation effects on valvular surgery patients.

a review stated that " the concept of prehabilitation has entered the forefront which encompasses multidisciplinary interventions to improve health and lessen the incidence of postoperative decline. in the previous study held in pre-operative assessment clinic between march 2016 and august 2016, evaluated that prehab programme for frail patients undergoing cabg or valve surgery may be able to improve functional ability and reduce hospital length of stay for those patients undergoing cardiac surgery. previous other studies, parental study which is prequel study recruitment started in july 2018 expect patient recruitment and 3 months of follow-up will be completed in june 2022 then their analysis will be done. to improve functional and enhance the resources and postoperative recovery, prehabilitation plays a very cardial role. in some studies, it has been noticed that preoperative improvement in physical fitness, improve functional capacity all this is the part of the model for improving post-surgery recovery, this could play a vital role.

Eligibility criteria:
inclusion criteria: * patients awaiting heart valve surgery for repair or replacement * both gender * mild to moderate valvular diseases * nyha grade i and ii * pre-frail to moderately frail patients with a cfs of 4-6 * patients with an estimated 6-8 weeks of surgical waiting list time. * able to perform 6mwt at baseline with rpe\<13 exclusion criteria: * patients with severe left ventricular obstructive disease (severe aortic or mitral stenosis and dynamic left ventricular outflow obstruction). * patients with unstable or recently unstable cardiac syndrome * other than valve surgeries e.g. cabg * hospitalization for arrhythmias/ congestive heart failure

Keywords: prehabilitation quality of recovery heart valve surgery
cholecalciferol supplementation for anemia and mineral and bone disorder in hemodialysis patients

Conditions: Kidney Failure, Chronic; Anemia; Vitamin D Deficiency; Bone Diseases, Metabolic

Summary: the purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.

there are 4 arms in this study: (1) thrice-weekly cholecalciferol supplementation (3,000 iu), (2) monthly cholecalciferol supplementation (equivalent to 9,000/week), (3) thrice-weekly placebo, and (4) monthly placebo. the primary analyses will be done regarding 2 cholecalciferol groups and 2 placebo groups as one group each, and we will evaluate the effect of cholecalciferol regardless of the supplementation regimen. as the secondary analyses, we will examine if there is any difference between thrice-weekly and once-monthly supplementation regimen.

Eligibility criteria:
inclusion criteria: * patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis * on treatment with erythropoietin stimulating agent * with written informed consent exclusion criteria: * on treatment with epoetin beta pegol as esa * on supplementation with native vitamin d * hypercalcemia (\>=10.5 mg/dl of corrected serum calcium) * on treatment with intravenous iron agents * judged as ineligible to the randomized study by the investigators

Keywords: vitamin d cholecalciferol hepcidins renal dialysis
a study of gaboxadol in primary insomnia

Conditions: Primary Insomnia

Summary: to evaluate the safety and tolerability of gaboxadol in primary insomnia.

to obtain long-term safety and tolerability data with gaboxadol.

Eligibility criteria:
inclusion criteria: * patients with primary insomnia

Keywords: primary insomnia
effect of citrus flavonoids on obesity.

Conditions: Obesity Adult Onset; Diabetes Mellitus Type 2

Summary: the aim of this study is to evaluate whether the intake of a functional juice enriched in citrus polymethoxylated flavonoids is able to improve the glycaemic profile and insulin resistance of obese patients by reversing the associated oxidative and inflammatory stress, as well as the differential alteration of the intestinal microbiota. to achieve this, a prospective, randomised, double-blind, placebo- controlled, clinical-baseline intervention study will be conducted in obese patients (bmi=30-40 kg/m2) with type 2 diabetes (dm2) (n=40) and obese patients without alterations in carbohydrate metabolism (n=40). each of these groups will be randomly divided into 2 subgroups (n=20), one of which will receive polymethoxyflavonoid-enriched orange juice (14%: nobiletin, sinensetin, tangeretin) (200 ml/ day) and the other group will receive the corresponding placebo juice for 8 weeks. in addition, all of them will receive a hypocaloric diet. anthropometric parameters, body composition and nutritional status will be assessed, cardiovascular risk factors and comorbidities will be studied (ht, sahs, dyslipidaemia, insulin resistance), oxidative stress parameters will be compared (total and mitochondrial ros production, mitochondrial membrane potential, glutathione levels by static cytometry and mitochondrial respiration rate by seahorse flow analyser), antioxidant enzymes (sod, gpx) and molecular oxidation products (carbonyl proteins and 8-oxo-dg, ldlox) and lps by elisa techniques, inflammatory parameters (il6, tnfa, il1b, adiponectin, pai-1, il10) by luminex xmap technology in serum. metabolomic analysis will also be performed in plasma (nmr spectroscopy and pls-da), and the content and diversity of the gut microbiota (16s rrna amplicons, and direct metagenomic sequencing, with illumina miseq technology) will be assessed in faeces, before and after the dietary intervention. individualised dietary follow-up and assessment of subjects' quality of life will be carried out.


Eligibility criteria:
inclusion criteria: * patients with a bmi of 30 -40 kg/m2, between 18 and 65 years of age. * obesity of more than five years' duration * patients will maintain a stable weight (±2 kg) during the 3 months prior to the study. exclusion criteria: * patients with acute or chronic inflammatory diseases and established liver and kidney failure (based on transaminase levels ±2 sd of the mean and estimated glomerular filtration rate using the ckd-epi formula \>60), neoplastic diseases and secondary causes of obesity (hypothyroidism, cushing's syndrome), use of drugs that may influence inflammatory status or insulin sensitivity (nsaids, corticosteroids, anti-tnfα), treatment with insulin or glp1 inhibitors, type 1 diabetes, morbid obesity (bmi\>40 kg/m2), hypertriglyceridaemia (\> 400 mg/dl), fructose intolerance.

Keywords: polyphenols microbiota inflammation oxidative stress insulin resistance
cardiovascular disease risk in women with endometriosis

Conditions: Endometriosis

Summary: to test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.

our scientific premise is that in women with endometriosis, elevated cardiovascular disease risk is the result of endothelial dysfunction and chronic systemic inflammation through lectin-like oxidized low-density lipoprotein receptor-1 (lox-1) receptor activation. this cardiovascular disease risk is exacerbated by standard estrogen suppression treatments.

Eligibility criteria:
inclusion criteria: * young women between the ages of 18 and 45 years (controls); * young women between the ages of 18 and 45 years with endometriosis. exclusion criteria: * subjects who smoke * subjects who have diabetes, * subjects with sleep apnea or bp\>140/90 will be excluded. * women with endometriosis and severe acute pain requiring immediate treatment will be excluded.
impact of tracheal cuff shape on microaspiration in intensive care units

Conditions: Critical Illness; Mechanical Ventilation Complication; Ventilator Associated Pneumonia

Summary: the investigators hypothesized that pvc tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

microaspiration is the main route for entry of contaminated secretions into the lower respiratory tract of intubated critically ill patients. tracheobronchial colonization might progress to ventilator-associated pneumonia (vap) when the quantity and virulence of bacteria are high and when local and general host defenses are weak. recent in vitro and animal studies suggest that tapered-cuff tracheal tubes could be associated with reduced microaspiration of contaminated secretions and might be helpful in preventing vap.

Eligibility criteria:
inclusion criteria: * age \> or = 18 years * tracheal intubation * predictable duration of mechanical ventilation \> 48h * enteral nutrition exclusion criteria: * pregnant women * refuse to participate to the study * no informed consent * contre indication for semirecumbent position

Keywords: tracheal cuff shape microaspiration pepsin ventilator-associated pneumonia
proprioception testing in persons with sensorimotor impairment

Conditions: Spinal Cord Injury; Stroke; Acquired Brain Injury

Summary: in this study, an fda-cleared device and type of treatment called "ames," which stands for assisted movement with enhanced sensation, will be used to determine whether sensation in the upper limb of individuals with incomplete spinal cord injuries, acquired brain injury, or stroke improves along with movement through treatment. we hypothesize that measureable improvement in the sensation of the upper limb will precede improvement in functional movement.

the ames device performs tests of sensorimotor impairment as well as delivering therapy. in this study, we are testing 2 additional diagnostic tests (i.e., joint position test and "frisbee" test), both of proprioception, in order to determine which of the two is the best test of proprioception. our hypotheses are: (1) both sensation and movement recover with ames treatment, (2) sensory recovery precedes that of movement, (3) robotic delivery of the joint position test produces more reliable test results than does manual delivery of this test, and (4) the frisbee test results will parallel those of the joint position test.

Eligibility criteria:
inclusion criteria: * traumatic incomplete sci, stroke or acquired brain injured abi subjects. * able to tolerate sitting upright at for at least 1 hour. * significant, but not complete, motor deficit in the hand and wrist, as determined by the study physician performing the screening. * significant, but not complete somatosensory deficit in the hand and wrist as determined by the study physician performing the screening. * cognitively and behaviorally capable of complying with the regimen. exclusion criteria: * fracture of the treated limb resulting in loss of range of motion. * progressive neurodegenerative disorder. * dvt of the treated extremity. * uncontrolled seizure disorder. * uncontrolled high blood pressure/angina. * osteo- or rheumatoid arthritis limiting range of motion * contractures equal to or greater than 50% of the normal rom. * chronic itb therapy. * peripheral nerve injury of the treated extremity. * pain in affected limb or exercise intolerance. * participation in another therapy or activity-based program. * skin condition not tolerant of device.

Keywords: spinal cord injury robotic therapy rehabilitation sensation movement proprioception stroke acquired brain injury
life-saving treatment with dry-plasma for massive bleeding in an pre-hospital setting

Conditions: Bleeding; Aortic Rupture; Gastrointestinal Hemorrhage; Obstetric Bleeding; Blunt Injury; Penetrating Injury

Summary: the overall goal of this clinical trial is to study how prehospital transfused dry plasma affect outcomes in terms of mortality as well as complications and coagulation status of patients in or about to develop bleeding shock. researchers will compare dry plasma to standard care to see if dry plasma improves survival compared to crystalloid fluid in prehospital patients with heavy bleeding.

major haemorrhage remains one of the leading causes of preventable early death after injury, and the window for effective intervention often closes in the pre-hospital phase. contemporary european guidelines therefore advocate damage-control resuscitation: permissive hypotension, minimal crystalloid use and early infusion of blood components to avoid dilutional coagulopathy, acidosis and hypothermia. several reports support that early resuscitation with blood products may save lives. freeze- or spray dried plasma containing coagulation factors having up to two years storage time and the possibility of storing ambient temperature, may be an alternative to crystalloids. the results regarding the beneficial results of treatment with plasma are ambiguous. in a previous randomized study using fresh plasma versus crystalloids, 9,8% reduced mortality was shown with resuscitation with plasma. lower inr and lactate were also seen among the patients treated with plasma. in some studies no effect on mortality could be shown, but in other studies it is suggested that plasma may be beneficial in long transport time. acute traumatic coagulopathy can be seen in at least 25 % of severely injured patients who are admitted to a trauma centre. dilution is often considered as a likely cause although the exact mechanisms and level of aggravation is unknown. most studies of prehospital bleeding refer to trauma, but also other causes of bleeding can be severe and even fatal, especially in countries with long distances, e.g. obstetric bleeding, gastrointestinal bleeding and vascular catastrophes. hypothesis. the hypothesis of this study is that prehospital treatment with dry plasma to bleeding patients improves the outcome compared to patients receiving standard treatment in terms of lower mortality, lower degree of coagulopathy and less need for blood products when in hospital. study aim. the aim of this study is to report outcome for patients receiving standard treatment for major prehospital bleeding compared to patients receiving standard care and to report clinical data for both groups.

Eligibility criteria:
inclusion criteria: * patients with clinical signs of bleeding. the bleeding is estimated by the ambulance personnel as being \> 500ml. exclusion criteria: * patients \< 18 years of age. * patients who lack clinical signs of major bleeding.