Kornimate/medical-research-clean huggingface dataset:
study evaluating the safety and intraocular pressure (iop) lowering response of brimonidine tartrate ophthalmic solution in subjects with open angle glaucoma or ocular hypertension

Conditions: Glaucoma and Ocular Hypertension

Summary: the purpose of this study is to determine the intraocular pressure (iop) lowering response and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects with open angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age at visit 1 (screening), of either sex and any race * be willing and able to provide written informed consent prior to any study procedures being performed. * be willing and able to follow all instructions and attend all study visits. * be willing to discontinue use of disallowed medication * have a documented diagnosis of ocular hypertension, open angle glaucoma or chronic angle closure glaucoma with a patent iridotomy. exclusion criteria: * have known sensitivity or poor tolerance to brimonidine or any other component of the study medications. * have any form of glaucoma other than open-angle glaucoma, ocular hypertension or chronic angle closure glaucoma with patent iridotomy.
evaluation of the effects of simvastatin 40mg

Conditions: Hypercholesterolemia

Summary: to collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.

this is an open-label, prospective study to investigate lipid-lowering efficacy and sympathetic response of normotensive hypercholesterolemia patients after receiving simvastatin 40 mg once daily for 3 months. the total duration of the study will be approximately 13 weeks, comprising of a 1-week (or 4 weeks?) screening period and a 12-week active treatment period. 20 hypercholesterolemia patients with normal blood pressure will be enrolled into treatment group.

Eligibility criteria:
inclusion criteria: * male or female patient, \>18 years of age * patients with hypercholesterolemia who meet the following lipid criteria: 1. primary cholesterolemia: total cholesterol\>=240 mg/dl or ldl-c \>= 160 mg/dl 2. secondary cholesterolemia (patients with cad, dm): ldl-c\>=130 mg/dl * the patient is willing to follow an ncep therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study exclusion criteria: * congestive heart failure (nyha class iii or iv), uncontrolled cardiac arrhythmia, unstable angina * hypertension (based on the atp 3 guidelines) * taking potent lipid-lowering agents * unstable diabetes (hba1c \>9%) or newly diagnosed (within 3 months), or a change in anti-diabetes medications within 3 months of screening
effect of topical and intravenous tranexamic acid (txa) on thrombogenic markers in patients undergoing knee replacement

Conditions: Osteoarthritis, Knee

Summary: tranexamic acid (txa) is a drug that is being used more frequently at the hospital for special surgery to lessen the amount of blood loss after total knee replacement (tkr). it is an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. txa can be given either intravenously or topically (placed directly on the open wound) before wound closure. patients with certain medical conditions have been found to have a high risk of thrombosis after being given intravenous txa, which may lead to serious complications. however, to date, no high-risk patients have been identified for use of topical txa. this study will look at thrombogenic markers (proteins found in blood that promote clot formation) after txa is given either intravenously or topically. if the effect on these markers is similar between intravenous and topical use of txa, then the safety of topical txa should be questioned. of note, these markers have never been measured after txa has been given topically. as a result, this information would be important for the medical community.


Eligibility criteria:
inclusion criteria: * patients undergoing primary unilateral total knee replacement with a participating surgeon * patients aged 18-80 exclusion criteria: * all patients on steroid therapy regardless of dose, duration, or treatment or those requiring stress-dose steroids preoperatively * patients who will require postoperative use of coumadin, xarelto, or plavix * use of non-steroidal anti-inflammatory drugs (nsaids) within 1 week of surgery * hypersensitivity to tranexamic acid * renal dysfunction (creatinine clearance \< 40 ml/min) * hepatic dysfunction (ast or alt 2x upper limit of normal) * cardiac exclusions: coronary stent, history of myocardial infarction, positive stress test, atrial fibrillation, advanced coronary artery disease * advanced chronic obstructive pulmonary disease or advanced interstitial lung disease * history of venous thromboembolism * hypercoagulability (e.g. antiphospholipid syndrome, genetic hypercoagulability with or without prior venous thromboembolism) * history of stroke or transient ischemic attack

Keywords: tranexamic acid total knee arthroplasty total knee replacement
study regarding the incidence of anti-platelet factor 4-antibodies in patients aged 18 to 60 years with spontaneous or infection- or vaccine-associated or recurrent venous and/or arterial thrombosis

Conditions: Arterial or Venous Thrombosis

Summary: prospective investigation of the incidence of anti-platelet factor 4 antibodies in suspected immune-associated arterial and/or venous thrombosis

patients with venous and/or arterial thrombosis aged 18 to 60 years are included.thromboses should have occurred spontaneously or within 30 days after an infection or vaccination. in addition, patients with recurrent thrombosis, despite anticoagulation, are also included in the study. the primary aim of the study is to determine the incidence of anti-platelet factor 4 antibodies in relation to venous and/or arterial thrombosis. for this purpose, we will take a blood sample from the patients within 120 days of the occurrence of the thrombosis. as a secondary objective, platelet count, d-dimer and results of a thrombophilia screening as well as thrombosis localization are recorded.

Eligibility criteria:
inclusion criteria: * age between 18-60 years * written informed consent of the patient * spontaneous arterial and/or venous thrombosis * infection-associated arterial and/or venous thrombosis within 30 days of infection * vaccine-associated arterial and/or venous thrombosis within 30 days of vaccination * recurrent arterial or venous thrombosis despite anticoagulant therapy exclusion criteria: * lack of consent of the patient * risk-associated venous thromboses (e.g. following surgery, immobilization, plaster cast, fractures or sprains) * risk-associated arterial thromboses (in the presence of vascular risk factors such e.g. diabetes mellitus, hypercholesterolemia, hypertension, nicotine abuse) * thromboses more than 120 days old at the time of blood sampling

Keywords: anti-pf4 antibodies infections vaccination
increasing physical activity levels in low-income women

Conditions: Healthy

Summary: regular physical activity is important for good health. women, particularly women with low incomes, have many personal barriers to regular physical activity. the purpose of this study is to reduce environmental barriers to physical activity for women in two specific low-income neighborhoods (in louisville, ky) by providing opportunities for safe physical activity and addressing barriers such as lack of child care. two groups of women will have pretest information (cholesterol, blood sugar, blood pressure, percent body fat, height, weight, waist and hip measurements) collected and the same information 6 months later at post-test. one group will have access to multiple physical activity opportunities in their neighborhood and at the neighborhood community center. an advanced registered nurse practitioner will facilitate the activity opportunities. the groups will be compared on their pretest and post-test information to see if the group with the physical activity opportunities has increased physical activity as measured by pedometer and self-report questionnaire, and to see if there are changes in the measures tested at pre and post (measures that may be improved by regular physical activity).


Eligibility criteria:
live in one of two specific low-income neighborhoods in louisville, ky
the effect of phgg-rich enteral nutrition to on the infection in liver transplant recipients: a prospective, double-blind, randomized controlled study

Conditions: Infections

Summary: to known the effect of phgg-rich enteral nutrition to on the infection in liver transplant recipients


Eligibility criteria:
inclusion criteria: 1. liver transplant recipients 2. age from 18 to 80 years old 3. apache ii score \>12 4. there is an indication for enteral nutrition and it is expected to require oral or tube feeding for more than 7 days 5. there is no intra-abdominal infection or bloodstream infection exclusion criteria: 1. severe cardiac, kidney and lung dysfunction 2. bowel obstruction, intestinal perforation, intestinal leakage before operation 3. roux and y anastomosis during liver transplant
sleep goal-focused online access to lifestyle support

Conditions: Weight Loss; Weight, Body

Summary: the overall goal of the study is to develop a novel weight loss intervention for postpartum people by providing strategies to improve sleep, diet, and physical activity behaviors. in this study, we will recruitment and enroll 40 postpartum people and randomize them to receive the sleep goals intervention or education control to evaluate the intervention's feasibility, acceptability, and preliminary efficacy.


Eligibility criteria:
inclusion criteria: * stated willingness to comply with all study procedures and availability for the duration of the study, * primiparous, singleton pregnancy, * between 3+1 and 6+1 months postpartum, * has a body mass index \>25 kg/m2, * physically inactive, defined as self-reporting \<150 minutes/week of moderate-to-vigorous intensity physical activity, * endorse \>1 indicator of poor sleep health based on the ru_sated questionnaire, and * has smartphone and home internet access exclusion criteria: * current use of medications that affect weight, * currently pregnant or plan to become pregnant during the study period (18 weeks), and * participating in another weight loss intervention.
ultrasound evaluation of uterine healing after vaginal repair of cesarean scar defect (csd)

Conditions: Ultrasound Evaluation

Summary: cesarean scar defect is one of the complications after cesarean section (csd). csd may be further caused many long term complications, such as abnormal uterine bleeding, infertility, uterine scar pregnancy and uterine rupture. vaginal repair due to csds is a minimally invasive and effective method that maintains fertility. the main concern linked to surgery is the quality of healing of the myometrial incision. however, no diagnostic method has yet been widely accepted to assess the healing process. thus, the authors investigated uterine healing after vaginal repair with two-dimensional (2d) power doppler ultrasound (pdu) in this study.

the inclusion criteria were csd patients who had one or more cesarean deliveries, patients who had intermenstrual spotting after the cesarean section or those in which the thickness of the residual myometrium (trm) was less than 3.0 mm at the preoperative stage. patients who had a history of endocrine disorders, coagulation disorders, use of intrauterine devices, sub-mucous myoma, endometrial diseases, endometrial cysts, uterine fibroids, and adenomyosis after cesarean section were excluded from this study. after vaginal repair, all patients were followed by traditional 2d us scanning and doppler velocimetry on days: 0, 2, 30, 60 and 90. authors evaluated: scar diameter and doppler velocimetry and resistance index (ri) of the uterine arteries, at their ascending branch.

Eligibility criteria:
inclusion criteria: 1. have one or more cesarean deliveries, 2. have intermenstrual spotting after the cesarean section or trm was less than 3.0 mm at the preoperative stage 3. underwent mri and tvs to evaluate the size of the defect and the trm before surgery 4. have vaginal repair of csd 5. write consent for operation. exclusion criteria: 1. have a history of endocrine disorders 2. have coagulation disorders 3. use of intrauterine devices 4. have sub-mucous myoma 5. have endometrial diseases 6. have endometrial cysts, uterine fibroids, and adenomyosis

Keywords: ultrasound cesarean scar defects vaginal repair resistance index
gaze modification strategies for toddlers with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: this project seeks to understand how the gaze behavior of infants and children with or at high risk for autism spectrum disorder (asd) may be manipulated in the contexts of dynamic social and non-social scenes. the study explores not only the methods which may be most effective in aligning and teaching normative patterns of scene exploration, but also seeks to establish what behavioral characteristics may be most predictive of atypical scanning and atypical learning.

this study initiates a highly novel line of research which uses adaptive, gaze-contingent, eye-tracking technology to help infants and children with or at high risk for asd learn to direct their attention to people and their actions in a more typical fashion. this study will begin with a normative collection phase, and will conclude with a gaze-shaping phase. in the normative collection phase, the investigators will examine the gaze behavior of a group of typically developing infants and children with typical development (td), in order to establish a normative gaze pattern. in the gaze-shaping phase, within the same videos shown in the normative collection phase, the investigators will highlight selectively targeted people, objects, and activities, in an attempt to shape participants' viewing patterns to match the normative gaze pattern. manual coding of live-action interaction probes will provide an additional evaluative measure, allowing the investigators to track real-world (live-action) correlates alongside video-eye-tracking behaviors. in addition, live-action probes may allow the investigators to check for generalization to live interaction with another person (as opposed to gaze behavior when watching videos). in live-action probes, one or two clinical research staff member(s) will interact with each participant (or with each other in front of the participant), in a manner analogous to the actions performed in the training videos. please note: the original estimated enrollment as specified to and funded by nih was 98 participants, but was incorrectly listed on clinicaltrials.gov as 220 participants reflecting maximal recruitment in this and other ongoing studies.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 60 months * fulfill criteria for autistic disorder or pdd-nos (pervasive developmental disorder- not otherwise specified) on the autism diagnostic observation schedule - module 1 * a diagnosis of autism or pdd-nos by experienced clinicians exclusion criteria: * gestational age below 32 weeks * suspected or diagnosed hearing loss or visual impairment * history of head trauma with loss of consciousness * non-febrile seizure disorders * diagnosed neurological abnormality significantly impacting on visual or auditory acuity.
a new breath for malignant hypertension: implementation of the hama cohort

Conditions: Malignant Hypertension

Summary: this registry aims to provide the first prospective, multicentric database of patients with malignant hypertension. it will allow to assess modern epidemiology of the disease, diversity of current management and care pathway, to deepen our pathophysiological knowledges, to modernize the definition of this form of hypertension and its diagnostic criteria. the network that will emerge will finally lead to the opportunity of setting up therapeutic trials and establishing recommendations based on solid scientific evidence.

malignant hypertension is the most severe form of high blood pressure, fatal if left untreated. it has not disappeared, with an increasing incidence. patients with the disease, mainly young (35 to 55 years of age), have an unfavorable cardiovascular prognosis (14% of cardiovascular and renal events at 4 years). despite these facts, scientific research on the subject remains limited. the definitions and diagnostic criteria have not changed since 1929, and the therapeutic recommendations remain empirical. this first prospective and multicentric registry will increase and modernize the knowledge of the disease. from these data, diagnostic and therapeutic recommendations based on solid scientific evidence could be developed. the investigators want to first recruit 500 patients and define their prognosis at 5 years. the impact of the patient's phenotype, type and number of target organs affected will be studied. a modern definition, adapted to these results, could be proposed. the epidemiology of the disease, the care pathways, the target organ disorders and the management carried out in the centers will be described in detail.

Eligibility criteria:
inclusion criteria: * malignant hypertension according to the classic definition (severe hypertension, above 180/110 associated with severe hypertensive retinopathy) * severe hypertension (above 180/110) associated with acute damage of 3 target organ due to high blood pressure exclusion criteria: * age \< 18 years old * patients who cannot freely give their consent, or patients who refuse to participate * dialysis
clinical and cost effectiveness of brief cognitive-behavioral therapy (cbt) for pediatric internalizing disorders

Conditions: Depression; Anxiety

Summary: this project assesses the clinical and cost effectiveness of brief cognitive-behavioral therapy (cbt) for depressed (ages 11-17) and anxious (ages 8-17) youths seen for services in pediatric primary care. this study is designed to compare the impact of brief cbt delivered on-site in pediatric primary care to referral to specialty mental health care (smhc), as well as obtain an estimate of the total costs of the cbt protocols for depression and anxiety and the cost-effectiveness of the protocols compared to referral to and utilization of smhc services.


Eligibility criteria:
inclusion criteria for depression: * ages 11 to 17 years * meet diagnostic criteria for major depression, dysthymia, or minor depression * live with a legal guardian inclusion criteria for anxiety: * ages 7 to 17 years * meet full or probable (missing one, non-core symptom) diagnostic criteria for separation anxiety disorder, generalized anxiety disorder, social phobia, or specific phobia * live with a legal guardian exclusion criteria: * require treatment other than brief cbt (namely, youths with bipolar disorder, psychosis, active suicidal ideation with plan, post-traumatic stress disorder, substance dependence, or mental retardation * experience of recent physical or sexual maltreatment * serious or unstable physical illness * current participation in an alternate, active intervention for the target condition of interest

Keywords: anxiety depression major depressive disorder child adolescent cbt cognitive-behavioral therapy primary care
urinary incontinence awareness of syrian women

Conditions: Urinary Incontinence

Summary: this study aimed to investigate the ui knowledge, attitudes, and awareness of syrian females under temporary protection status in turkey and compare it with turkish females. establishing societal standards surrounding urinary incontinence beliefs and attitudes can alter societal approaches to urinary incontinence. early diagnosis and treatment can reduce the financial burden when urinary incontinence ceases to be an issue that needs to be hidden. additionally, as females become more aware of urinary incontinence, urinary incontinence symptoms, urinary incontinence prevention, and treatment approaches, the number of patients receiving help for incontinence will increase.

this study explores the knowledge, attitudes, and awareness of urinary incontinence (ui) among syrian women under temporary protection in turkey, compared to turkish women. involving 327 participants (186 turkish, 141 syrian), the study assesses sociodemographic data, gynecological and incontinence-related questions, and the urinary incontinence awareness and attitude scale (urinas). the study underscores the impact of sociocultural and economic factors on gender-specific health disorders, especially among refugees, and emphasizes the need for culture-specific interventions to enhance ui awareness among immigrant women. the findings can offer valuable insights for developing health policies and awareness programs aimed at improving ui management and reducing the stigma associated with it.

Eligibility criteria:
inclusion criteria: * being over 18 years of age * volunteer for participation * be under temporary protection exclusion criteria: * illiteracy * any neurological disease that would affect cooperation
comparison of the effect of nn5401 with the effect of nn1250 and insulin aspart in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to compare the blood glucose-lowering effect of nn5401 (insulin degludec/insulin aspart, idegasp) with nn1250 (insulin degludec, ideg) and insulin aspart (iasp) in subjects with type 1 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months. * body mass index 18.0-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day). * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
remote speech analysis in hf patients undergoing haemodialysis

Conditions: Heart Failure

Summary: this is an observational, non-interventional, prospective, single-arm, open study for database establishment for r\&d purposes. the study will be conducted in 1 site in israel with up to fifty (50) patients. patients under hemodialysis supervision will be enrolled in the clinical trial. clinical information for the study will be collected at the hospital and at home. the patient will conduct recordings at home every day.


Eligibility criteria:
inclusion criteria: * patients undergoing hemodialysis every 5-10 days in order to balance their volume overload. * class c heart failure patient with reduced ef chf (ef\<40%) and nyha 2-3. * patients with dyspnea clinically related to pulmonary congestion * patient with more than 3 months hf disease duration. * the patient is willing to participate as evidenced by signing the written informed consent. * male or non-pregnant female patient exclusion criteria: * subject who, in the investigator's opinion, unable to comply with the daily use of the app due to mental disorders (e.g., depression, dementia). * patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit. * patients likely to undergo heart transplantation/ lvad within 6 months of screening visit or baseline functional capacity of nyha 4. * patients with evidence of active infection. * patient with severe alcohol or drug use. * psychological instability, inappropriate attitude or motivation. * patient with life threatening debilitating disease other than cardiac. * subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.