Kornimate/medical-research-clean huggingface dataset:
effect of anticoagulant drug intervention on postoperative male and mace in patients with pad

Conditions: Anticoagulant Drugs; Antiplatelet Drug; Peripheral Arterial Disease

Summary: patients with pad were grouped according to the combination of different anticoagulant and antiplate drugs. the type, dosage and duration of anticoagulant and antiplatelet drugs were recorded after operation. major adverse cardiovascular events and major adverse limb events were followed up at 1 month, 6 months and 12 months, respectively.


Eligibility criteria:
inclusion criteria: 1. age ≥50 years old 2. patients with symptomatic pad 3. moderate intermittent claudication, or severe limb ischemia 4. radiographically confirmed occlusion 5. received a successful revascularization exclusion criteria: 1. acute limb ischemia occurred within 2 weeks before revascularization; 2. large tissue defect of any lower limb (defined as obvious ulceration/gangrene near phalangeal head); 3. after revascularization, there are clinical conditions requiring systemic anticoagulation
placebo controlled efficacy evaluation of the hydrolyzed collagen peptide in adult females

Conditions: Skin; Skin Manifestations; Wrinkle

Summary: the aim of this study is to evaluate the contribution of hydrolized collagen products to elasticity, hydration and roughness of the skin of female volunteers. safety and tolerability of the product is the other objective of this placebo-controlled, randomized study.


Eligibility criteria:
inclusion criteria: * female volunteers aged between 35 and 60 years, * volunteers who have normal physical examination at screening visit, * volunteers who have ability to communicate adequately with the investigator and in agreement to comply with the study requirements, * volunteers who have normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: sbp within 100 to 140 mmhg, dbp within 60 to 90 mmhg and hr within 50 to 100 bpm at least after 5 minutes of rest, * volunteers who have understanding of the study and agreement to give a written informed consent. exclusion criteria: * who have atopic constitution or asthma and/or known allergy for biosynthetic collagen products and/or other any of the excipients of the product. * who have hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption. * who have the use of oral retinoids or oral steroids in the 6 months prior to initiation of the study. * who have the use of topical retinoids, anti-wrinkle cosmetic products including retinol and/or aha, or moisture-rich cosmetic products within the 3 months prior to initiation of the study. * who use skincare therapy using lasers or peeling within the 3 months prior to initiation of the study. * who have current participation in another clinical study, or participation in any type of dermatology study within 3 months. * who have any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphiria. * who have the presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy. * who had undergone, or planned to undergo, pregnancy or breastfeeding. * who have current intake of contraceptives, female hormones, obesity drugs, absorption inhibitors, antidepressants, or appetite suppressants. * who are suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgment. * who have history of drug abuse. * who have relationship to the investigator. * who are not suitable to any of inclusion criteria. * who have history of difficulty of swallowing. * who are on a special diet due to any reason, or, have gained or lost 5% of baseline weight.
soybean based diets and cvd risk factors

Conditions: Hypercholesterolemia

Summary: to evaluate the impact of soybean processing as well as the effect of soy relative to animal protein, independent of alterations in the fatty acid profile of the diet on cvd risk factors in hypercholesterolemic subjects.

recent data suggests that the magnitude of the effect of soy protein on lipid and lipoprotein levels is variable and less dramatic than originally reported. this discordance might be attributable to the forms of soy protein used, as well as subtle unrecognized shifts in the fatty acid, cholesterol and fiber content of the diets.the aim of the present investigation is to assess the effects of different forms of soybeans (whole bean and products made thereof), products derived from soy flour (textured soy protein) and products made from a soybean extract (i.e. tofu, yogurt) relative to animal protein, independent of alterations in the fatty acid profile of the diet on cvd risk factors in hypercholesterolemic subjects. the intent is to isolate any potential impact of processing on the plasma lipid lowering efficacy of the soy product or soy protein relative to animal protein.

Eligibility criteria:
inclusion criteria: plasma ldl-c \>120mg/dl, free from chronic illness, not taking medications known to affect lipid metabolism (lipid lowering drugs, beta-blockers, fish-oil capsules, cis-retinoic acid, ascorbic acid, vitamin e, diuretics or hormones), post-menopausal women. exclusion criteria: soy allergy, smokers, consuming \>2 alcoholic drinks per day, pre-menopausal women.

Keywords: soy protein lipids lipoproteins apolipoproteins cholesterol endothelial function
efficacy and safety study of bendamustine with or without rituximab in chronic lymphoproliferative disorders

Conditions: Chronic Lymphocytic Leukaemia

Summary: the purpose of this study is collect and evaluate the clinical experience reached in italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.

all patients who meet the criteria for inclusion will be included in the study. a specific database will be created to collect the following information: personal data, medical history, histology related to the underlying disease, comorbidities, laboratory data, initial staging, data on the dosage and the number of cycles administered, the recorded toxicity data, the clinical response and the main events (relapse, progression, death, and cause of death). these data will then be retrospectively examined in order to obtain information about the life-saving treatment.

Eligibility criteria:
inclusion criteria: * patients with relapsed or refractory chronic lymphoproliferative disorders * salvage treatment with bendamustine +/- rituximab * age ≥ 18 years exclusion criteria: * previous treatment with bendamustine
the effect of watching cartoons during treatment on children's anxiety and fear levels

Conditions: Nursing Caries; Anxiety; Fear

Summary: objective: the study was carried out in a randomized controlled manner to determine the effect of the watching cartoons on the fear and anxiety levels of children during treatment. method: the population of the study consisted of children aged 5-10 years who were brought to a state hospital in a southeastern province for blood collection. a total of 92 children, 43 of whom were in the cartoon group and 49 of which were in the control group, were included in the study. research findings; data form was obtained by using child anxiety scale and child fear scale. the children in the cartoon group were shown the cartoons they wanted during the treatment. anxiety and fear levels before and during the blood collection were evaluated in the cartoon and control groups. the anxiety level of the children was evaluated according to their own expressions, and the level of fear was evaluated independently according to both the children's own statements and the observers' statements.


Eligibility criteria:
inclusion criteria: * being healthy * ability to express himself/herself verbally * having no visual or auditory problems exclusion criteria: * mental disease * neurological disease

Keywords: anxiety fear nursing
first in human study to evaluate the safety and tolerability of eyp-1901 in patients with wet age related macular degeneration (wamd)

Conditions: Wet Age-related Macular Degeneration

Summary: phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single dose injections of eyp-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg in subjects with wet age related macular degeneration (wamd)


Eligibility criteria:
inclusion criteria: * subjects diagnosed with wet age-related macular degeneration (wamd), in the study eye. * subject must have received ≥3 prior injections with the same anti-vegf product: bevacizumab, ranibizumab, or aflibercept) in the 6 months prior to the screening visit, in the study eye. * demonstrated response to the intravitreal anti-vascular endothelial growth factor (vegf) treatment in the study eye. * best-corrected visual acuity (bcva) using etdrs charts of 25 letters (20/320 snellen equivalent) to 85 letters (20/20 snellen equivalent). exclusion criteria: * history of vitrectomy surgery, submacular surgery, or other surgical intervention for amd in the study eye. * subfoveal fibrosis or scarring \>50% of the total lesion, or atrophy in the study eye, confirmed by central reading center. * choroidal neovascularization (cnv) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia that would compromise vision in the study eye, confirmed by central reading center. * any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma) that, in the opinion of the investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of the study results. * active intraocular inflammation (grade trace or above) in the study eye. * history of rhegmatogenous retinal detachment or treatment for retinal detachment or macular hole (stage 3 or 4) in the study eye. * history of idiopathic or autoimmune-associated uveitis in either eye. * active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye. * history of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye.

Keywords: wamd eyp-1901 eyepoint davio
safety and efficacy of study drug versus placebo for negative symptoms of schizophrenia

Conditions: Schizophrenia

Summary: this study is to determine the efficacy (how well the drug works), safety, and side effects of the study medication compared to placebo in the treatment of the negative symptoms of schizophrenia in adults.


Eligibility criteria:
inclusion: * adults aged 18-60 * current diagnosis of schizophrenia * significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression. * female subjects of childbearing potential must test negative for pregnancy at the time of enrollment. * subjects must be able to provide consent * must be healthy based on medical exam, laboratory tests and electrocardiogram exclusion: * female subjects who are either pregnant or nursing. * acute or unstable medical conditions * diseases of the central nervous system * subjects who are judged clinically to be at serious risk for suicide or violence * subjects with delusional disorder, psychotic disorder nos, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence

Keywords: schizophrenia with negative symptoms
expanded access protocol to provide brincidofovir for the treatment of serious adenovirus infection or disease

Conditions: Adenovirus

Summary: provide patients with serious adv infection or disease access to treatment with bcv.


Eligibility criteria:
inclusion criteria: * confirmed serious adv infection based on clinical symptoms and laboratory testing showing adv in the blood or other bodily fluids * able to swallow medication, either tablet or liquid exclusion criteria: * previous dosing with brincidofovir * if female, not pregnant or trying to become pregnant

Keywords: adenovirus brincidofovir
ym598 in patients with rising psa after initial therapy for localized prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine the optimal dosage of ym598 for slowing down disease progression in patients with rising psa after initial therapy for localized prostate cancer.


Eligibility criteria:
a clinical trial to explore safety and efficacy of different doses of pegaptanib sodium, compared to sham, in patients with wet amd.

Conditions: Age-Related Macular Degeneration

Summary: the purpose of this study is to compare the ability of different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or impriving vision in patients with wet amd when compared to placebo injections.


Eligibility criteria:
inclusion criteria: subjects of either gender, aged 50 years or greater. subfoveal choroidal neovascularization (cnv) due to amd. best corrected visual acuity in the study eye between 20/40 and 20/320. exclusion criteria: any prior subfoveal thermal laser therapy.

Keywords: amd age-related macular degeneration macular degeneration macugen pegaptanib sodium
the efficacy of adductor-canal-blockade on morphine consumption, pain and mobilisation after total knee arthroplasty

Conditions: Total Knee Arthroplasty

Summary: the purpose of this study is to determine whether adductor-canal-blockade is effective at reducing morphine consumption and pain, and at the same time improving mobilisation after total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * total knee arthroplasty in spinal anaesthesia * asa 1-3 * bmi 18-40 * written informed consent exclusion criteria: * can not cooperate to the exam * do not speak or understand danish * drug allergy * alcohol or drug abuse * daily consumption of strong opioids * unable to complete the timed up and go test preoperatively

Keywords: adductor-canal-blockade postoperative pain us-guided nerve block total knee arthroplasty
feasibility study assessing the treatment of fibroadenomata with a circumferential sonication treatment with hifu

Conditions: Breast Fibroadenoma

Summary: the purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with hifu..

primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.

Eligibility criteria:
inclusion criteria: * patients \>18 years of age * fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients \ 25 (graded b2 or less) * visible on ultrasound (graded u2/u3) * definitive diagnosis of fibroadenomata confirmed by the breast multi-disciplinary team meeting (mdt). exclusion criteria: * lesion with atypia or suspicion of phyllodes (graded b3 or greater) * pregnant or lactating women * history of laser or radiation therapy to the targeted breast
the relation between triglyceride- glucose index, procalcitonin and cardiac affection in septic shock.

Conditions: Septic Shock

Summary: the study is carried out to demonstrate the relation between triglyceride -glucose index and cardiac affection in the patients admitted to the icu with septic shock.

sepsis, a condition characterized by a dysregulated immune response to infection, is a prominent contributor to global mortality(1). insulin resistance (ir) is typified by reduced insulin sensitivity in peripheral tissues and is linked to various pathological conditions ( 2) the triglyceride-glucose (tyg) index, recognized as a surrogate marker of insulin resistance, has recently gained attention as a potential prognostic tool for various metabolic and cardiovascular diseases . ( 3) preliminary investigations have revealed a correlation between metabolic disorders characterized by dysregulated lipid and glucose metabolism and the severity of sepsis. notably, a high tyg index has been associated with increased in-hospital mortality in sepsis patients (4) studies only focused on the initial tyg value within the first 24 h of icu admission and did not consider the dynamic changes in this marker over time. as insulin sensitivity in critically ill patients can change over time, (5) ,(6) it is possible that the tyg variability ratio (tygvr) during hospital stay may be a better marker for adverse long-term prognosis and could be used for early risk stratification in critically ill patients, procalcitonin (pct) is produced during bacterial infections, sepsis, cardiogenic shock, major surgery, burns, multiple trauma, and after cardiac surgery( 7.8) in this study we will discuss the relation between dynamic changes in both tyg index, procalcitonin and cardiac affection in the icu patients admitted with septic shock.

Eligibility criteria:
inclusion criteria: * 1- adult patients (≥18 years) 2-patients admitted to the icu with septic shock. exclusion criteria: * 1-patients who have mixed aetiology of shock. 2-known previous cardiac disease ( cardiovascular disease, heart failure, arrhythmia )
comparative study of oral atogepant versus oral topiramate to assess adverse events in adult participants with migraine

Conditions: Migraine

Summary: a migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. the main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. topiramate is an approved medication for migraine prevention. this study is conducted in 2 periods. in period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. in period 2, eligible participants will receive atogepant. approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in period 1. both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. after 24 weeks, all eligible participants will receive atogepant for 52 weeks in period 2. participants are monitored for safety for 4 weeks after their last study treatment. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.


Eligibility criteria:
inclusion criteria: * documented history of migraine (with or without aura) for \>= 12 months prior to screening (visit 1). * history of \>= 4 migraine days per month who require preventive treatment of migraine and are eligible for conventional migraine prophylaxis. exclusion criteria: * have used topiramate or atogepant in the past. * have clinically significant cardiovascular, cerebrovascular, hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Keywords: migraine episodic migraine chronic migraine atogepant topiramine qulipta migraine prophylaxis
telephone support during overseas deployment for military spouses

Conditions: Military Personnel; Family Members; Resilience, Psychological; Deployment

Summary: deployment impacts both service member and family, and the cost can be high. spouses' reactions to deployment may include emotional distress, loneliness, anticipatory fear or grief, somatic complaints, and depression. the goal is to help spouses learn ways to manage stress and solve problems related to deployment and reintegration, communication, managing long distance relationships, and other common problems. the study will compare telephone support groups to online education sessions. the study will enroll 160 spouses. in the telephone support groups, a group leader and participants will meet 12 times over six months to focus on education, skills building and support. education only online sessions will provide the same education content, without skills building or support. content includes strategies to reduce or eliminate communication difficulties during deployment, how to find help; practical concerns during deployment; fostering resilience and decreasing stress; fostering relationships while apart, negotiating roles and relationships; changes during deployment; strategies to support the spouse and the service member; and cues to alert spouses when to seek mental health services for the family or themselves. outcomes will include resilience, depression, anxiety and coping behaviors. telephone data collection will be conducted at baseline, six and twelve months.


Eligibility criteria:
inclusion criteria: * spouse or significant other (living as married for at least one year before deployment) of an overseas deployed military service member * deployed at least six months exclusion criteria: * living as married for at least one year before deployment

Keywords: telephone support groups social support depression
observational study of patients with diabetes using levemir® flexpen®

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. this study is a prospective, open, uncontrolled, observational surveillance study with levemir® flexpen® conducted in korea. the aim of this observational study is to evaluate the short term and the long term safety and efficacy of levemir® flexpen®. the study is planned and conducted as per requirement from korea food and drug administration (kfda).


Eligibility criteria:
inclusion criteria: * diabetes mellitus exclusion criteria: * contra-indication based on local label