Kornimate/medical-research-clean huggingface dataset:
daridorexant to prevent delirium after heart surgery

Conditions: POSTOPERATIVE DELIRIUM; POSTOPERATIVE COGNITIVE DECLINE

Summary: the goal of this phase 2 clinical trial is to demonstrate the feasibility of the current study methods and obtain preliminary data for an adequately powered trial of daridorexant with the aim of preventing delirium after heart surgery. the main aims this feasibility trial aims to answer are to demonstrate: (1) the feasibility of study recruitment; (2) the ability deliver study compounds to subjects according to the proposed methods; and (3) completeness of data capture; and (4) recording of potential adverse events. participants will: (1) complete a baseline visit; (2) take the study drug--either daridorexant or placebo--each of the first 3 nights after heart surgery; and (3) be evaluated for sleep and delirium each of the first three days after heart surgery.


Eligibility criteria:
inclusion criteria: * having surgical aortic valve replacement or coronary artery bypass graft surgery at strong memorial hospital * can provide informed consent * able to speak, read, and write english * family member or close friend available for collateral exclusion criteria: * prior heart surgery * infectious endocarditis * emergency surgery * delirium at baseline * auditory/visual impairment preventing study procedures * active alcohol or substance misuse * psychotic disorder * dementia-level deficits * use of a sleep aid before surgery * use of a strong 3a4 inhibitor * intolerance to daridorexant * severe kidney or liver impairment * narcolepsy * any condition that, in the opinion of the pi, compromises patient safety or data quality if enrolled in the study

Keywords: delirium sleep cognitive decline alzheimer disease and related dementias
a multidisciplinary telerehabilitation for stroke patients

Conditions: Stroke Sequelae

Summary: objective: evaluate the feasibility of a multidisciplinary telerehabilitation for chronic stroke patients. design: chronic stroke patients eligible for multidisciplinary rehabilitation funded by the social insurance institution were enrolled between september 2017 and march 2018 in a consecutive basis to receive a mixed program of inpatient rehabilitation and telerehabilitation in their homes or a traditional inpatient rehabilitation only. intervention: a rehabilitation course with a 3-day inpatient stay followed by an 8-week telerehabilitation period completed by 2-day evaluation stay in a rehab center. the control group received conventional multidisciplinary rehabilitation for two weeks in an inpatient setting. outcome and measures: change in the finnish version of functional status questionnaire (fsqfin), the world health organization quality of life - short version (whoqol-bref), the barthel index, the beck depression inventory (bdi21), and the goal attainment scale (gas) and a patient satisfaction questionnaire.


Eligibility criteria:
inclusion criteria: * chronic stroke (6 months or more) patient living in home * eligible to receive rehabilitation funded by the social insurance institution (meets the criteria of chronic disability and need for rehabilitation) * for intervention group: capable to use a personal computer and telecommunication exclusion criteria: * no access or capability to use a personal computer * significant problems in hearing, seeing or understanding information related to the intervention

Keywords: rehabilitation stroke
functional treatment for acute ankle sprains: softcast wrap versus mokcast

Conditions: Acute Ankle Sprain; Ankle Ligament Rupture; Ankle Injuries

Summary: in this study we compare two treatment options for ankle sprains. 100 patients were randomised between a flexible cast treatment and a removable and adjustable brace made out of the same materials. follow-up was 4 months. primary outcome were functional scores. secondary outcome measures were patient satisfaction scores with treatment as well as treatment result.


Eligibility criteria:
inclusion criteria: • grade 2 and 3 acute ankle sprains exclusion criteria: * history of ankle sprains with persistent instability * grade i lateral ankle sprains * ankle fracture * bilateral ankle sprains * previous ankle ligament surgery * neuromuscular disorders of the lower extremities * rheumatoid arthritis, * alcoholism, * serious psychiatric or neurological illness

Keywords: ankle sprain ankle distortion functional treatment brace treatment
a study to evaluate the safety of adjuvant treatment with exemestane following previous treatment with tamoxifen in postmenopausal women with estrogen sensitive primary breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events.


Eligibility criteria:
inclusion criteria: * postmenopausal patients * patients with early breast cancer after adequate loco-regional treatment and eventual adjuvant chemotherapy, treated with tamoxifen for 2-3 years or treated with tamoxifen for 2-3 years and consecutive exemestane treatment, provided the total duration of endocrine treatment is less than 5 years * estrogen receptor positive breast cancer patients * patients who remain free from disease following treatment with tamoxifen exclusion criteria: * patients taking other drugs for the adjuvant treatment of breast cancer * patients taking hormone replacement therapy * donation of blood or blood products for transfusion during the 30 days prior to initiation of treatment with study drug, at any time during the program or 30 days after completion of treatment
brain blood vessel responses to changes in blood flow: younger cohort

Conditions: Magnetic Resonance Imaging; Cerebrovascular Circulation

Summary: brain blood flow will be measured during a simulated postural change test and while breathing increased levels of carbon dioxide using magnetic resonance imaging.

global cerebral blood flow (cbf) decreases with advancing age; however, some adults have accelerated declines in cbf, placing them at a greater risk of cognitive impairment. however, there is a lack of human studies that investigate the cause or consequence of altered blood flow regulation in the brain. this study will systematically address this gap in knowledge by examining cerebrovascular control in adults during acute physiological challenges (simulated postural change test and breathing increased carbon dioxide) that stimulate a change in cbf.

Eligibility criteria:
inclusion criteria: * between the ages of 20-40 years * have a bmi ≤34.5 kg/m2 * nonsmoker exclusion criteria: * diagnosis of mild cognitive impairment (mci) or alzheimer's disease (ad) * history or evidence of hepatic disease, hematological disease, or peripheral vascular disease; severe kidney injury requiring hemodialysis * history of cardiovascular disease including: severe congestive heart failure, coronary artery disease, ischemic heart disease (stents, coronary artery bypass grafts) and tachycardia * uncontrolled hypertension * history of clinically significant ischemic or hemorrhagic stroke, or significant cerebrovascular disease * severe untreated obstructive sleep apnea * history of diabetes with hba1c greater than 9.5% * major neurologic disorders other than dementia (e.g., ms, als, brain surgery, etc.) * current or recent (\&lt;1 year) major psychiatric condition (axis i) or addictive disorders * significant surgical history * other significant medical conditions at investigators' discretion * contraindications to mri * prescribed medications that interfere with prazosin * lactose allergy

Keywords: magnetic resonance imaging brain blood flow lower body negative pressure carbon dioxide
aspirin and thienopyridine resistance in peripheral arterial disease

Conditions: Peripheral Arterial Disease; Clopidogrel, Poor Metabolism of

Summary: this study evaluates the effects of aspirin and thienopyridine resistance in relation to clinical cardiovascular outcomes as the genetic predictors of, and outcomes associated with aspirin and thienopyridine resistance in patients with peripheral arterial disease (pad) currently remain unknown.

although anti-platelet therapy is a cornerstone of pad treatment, the investigators know very little about the prevalence, genetic determinants and clinical relevance of aspirin and thienopyridine resistance in pad patients. the investigators expect to report on the prevalence of, and impact on outcomes from aspirin and/or thienopyridine (eg. clopidogrel) resistance, in patients who undergo peripheral arterial angiography/interventions (including carotid angiography/interventions) and operations. this study will provide important information on the utility of testing for aspirin and thienopyridine resistance and improve understanding of the genetic and pathophysiologic basis of anti-platelet therapy resistance in patients with cardiovascular disease, including pad. most importantly, this study will serve as the basis for a subsequent randomized prospective trial of different treatment options in pad patients with aspirin/thienopyridine resistance.

Eligibility criteria:
inclusion criteria: * patient undergoing pad (carotid or lower extremity) angiography or intervention * greater than or equal to 18 years of age exclusion criteria: * patient unable to take aspirin and thienopyridine for any reason (not excluded if take at least one of either medication) * hematocrit less than or equal to 30% * hematocrit greater than or equal to 52%

Keywords: aspirin clopidogrel peripheral arterial disease genetics
study of safety and efficacy of antihemophilic factor/von willebrand factor complex in surgical subjects with von willebrand disease (vwd)

Conditions: Von Willebrand Disease; Blood Coagulation Disorders; Blood Platelet Disorders; Hematologic Disease

Summary: the purpose of this study is to test the safety and effectiveness of humate-p® to prevent bleeding in patients with von willebrand disease who are undergoing surgery.


Eligibility criteria:
key inclusion criteria: * subjects of any age * clinical and laboratory diagnosis of vwd that can be expected to show no hemostatic response to ddavp * require substitution with vwf/fviii complex due to a surgery key exclusion criteria: * known significant hemostatic disorder other than vwd * acquired vwd * known antibodies to fviii or vwf * known platelet type vwd * emergency surgery or any surgery with a degree of urgency not permitting completion of a pharmacokinetic assessment required by the study protocol * history of allergic reaction to humate-p® * treatment with any other investigational drug in the last four weeks before the entry into the study (with exception of trials concerning anti-hiv agents) * progressive fatal disease/life expectancy of less than 6 months * treatment with ddavp, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of fviii and/or vwf within 5 days of the pre-surgical pharmacokinetic assessment * pediatric patients of insufficient body weight to permit pk sampling * woman in the first 20 weeks of pregnancy

Keywords: von willebrand factor blood coagulation disorders factor viii
clinical effect of endoscopic surgery for delayed wound healing after achilles tendon suture

Conditions: Wound Healing

Summary: this study proposes endoscopic surgery for delayed wound healing after achilles tendon suture which is a brand new treatment，and retrospectively analyzed the clinical data of 4 cases treated with this treatment. the analysis results of the clinical efficacy of the method can serve as a reference for clinical and surgical decision-making and prognosis assessment.

background: delayed wound healing is a kind of postoperative complication of achilles tendon suture. conventional surgical approach is open surgery in order to clean the wound, which requires multiple dressing changes and involves a longer recovery period. we recently developed arthroscopic surgery for delayed wound healing after achilles tendon suture. this therapy may be an alternative approach to open surgery. purposes: in this paper we evaluate the long-term efficacy of endoscopic surgery for delayed wound healing after achilles tendon suture. patients and methods: clinical data of 4 patients with delayed wound healing after achilles tendon suture who underwent endoscopic surgery from april 2008 to october 2017 at our institute were retrospectively analyzed. there were 3 males and 1 females with age of 39-60 years, the follow-up period was 8-43 months). all the patients had unilateral tendon rupture with 3 cases on the left and 1 cases on the right. scores on visual analogue scale(vas) and the american orthopaedic foot and ankle society (aofas) ankle-hindfoot scale were used. the postoperative outcome was evaluated on the basis of victorian institute of sport assessment-achilles score and achilles tendon total rupture score (atrs).

Eligibility criteria:
inclusion criteria: * the diagnostic criteria for delayed wound healing after achilles tendon suture are met, namely the presence of skin necrosis, wound nonunion, or delayed wound healing. exclusion criteria: * the expected healing time of wounds with regular dressing changes is \<2 weeks.

Keywords: achilles tendon suture delayed wound healing endoscopy
effect of acetazolamide on cognition in patients with respiratory disease at altitude

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: randomized, placebo controlled trial evaluating the effect of acetazolamide on cognition in lowlanders with chronic obstructive pulmonary disease travelling from 760 m to 3200 m.

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on visuomotor learning performance at altitude (tuja ashu, 3200 m). randomization to acetazolamide or placebo will be carried out after baseline measurements in bishkek (760 m). visuomotor learning performance will be tested by motor task manager (mtm). the mtm requires the subjects to reach visual targets with a hand-held cursor. during progression of the test, the movement direction from the cursor on the computer screen will increasingly differ from the direction of the hand movement, forcing the unaware subject to implicitly adapt to the imposed cursor rotation. this test assesses a subjects ability to visuomotor adaption, perception and attention. furthermore, as the task will be performed in the evening and after sleep in the next morning, the investigators will be able to assess overnight improvement of implicit learned skills.

Eligibility criteria:
inclusion criteria: * male and female patients, age 18-75 yrs. * copd diagnosed according to gold, fev1 40-80% predicted, spo2 ≥92% at 750 m. * born, raised and currently living at low altitude (\<800m). * written informed consent. exclusion criteria: * copd exacerbation, very severe copd with hypoxemia at low altitude (fev1/fvc \<0.7, fev1 \<40% predicted, oxygen saturation on room air \<92% at 750 m). * comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; osa; pneumothorax in the last 2 months. * internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day) * known renal failure or allergy to acetazolamide and other sulfonamides

Keywords: cognition visuomotor learning airway disease altitude prevention acetazolamide
proof of confidence study of ccr2 antagonist (bms-741672) in insulin resistance

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to determine whether a ccr2 antagonist (bms-741672) improves glucose homeostasis in drug-naive type 2 diabetic patients


Eligibility criteria:
inclusion criteria: * drug-naive type 2 diabetics with a screening hba1c of ≥ 7.5% and ≤ 10% * screening fpg ≥ 140 mg/dl and ≤ 220 mg/dl * bmi ≤ 40 kg/m2 exclusion criteria: * active tuberculosis * symptoms of poorly controlled diabetes * history of diabetic ketoacidosis * significant cardiovascular history or gastrointestinal disorders * history of unstable or rapidly progressing renal disease * active liver disease and/or significant abnormal liver function * abnormal chest x-ray at screening indicative of tuberculosis or other infection

Keywords: diabetes nos
the efficacy of hyaluronic acid and honey in healing of multiple extraction sockets of primary teeth compared to saline

Conditions: Wound Heal

Summary: this study aims to evaluate the effect of hyaluronic acid and honey compared to saline in healing of multiple extraction sockets of primary teeth in a group of children aging from two to seven years old.

a dental extraction is one of the most unpleasant experiences in children, especially for those who have undergone traumatic experiences, and this is likely to reduce future visits to the dental clinic if the treatment is not managed properly. alveolar osteitis is one of the most common complications following dental extraction. it is considered one of the most studied complications in dentistry, and many risk factors contribute to its occurrence including being a female, young age, tobacco use, difficult or traumatic extractions, pre-existing infection, and use of vasoconstrictor in local anesthesia. alveolar osteitis occurs during the first three days following the day of extraction, so that the socket is devoid of the blood clot, resulting in the exposure of the bare alveolar bone. many medicines were and are still used in treating wounds, but they are somewhat expensive.

Eligibility criteria:
inclusion criteria: * • age: from two to seven years old age. * both genders. * children with badly decayed multiple primary teeth beyond repair. * treated under general anesthesia. exclusion criteria: * • history of systemic disease. * allergy to honey. * repeatedly used honey during the previous 6 month period.
exercise capacity in patients with fontan procedure

Conditions: Single-ventricle; Fontan Procedure

Summary: in literature, it has been reported that exercise capacity decreases in single-ventricle patients undergoing fontan procedure due to various factors related to surgery and underlying cardiac anomaly. cardiopulmonary exercise test (cpet) was generally used to evaluate exercise capacity in children and adults with fontan circulation. the fact that cpet requires a clinically expert team and equipment and is more expensive does not always make it possible to perform routine cardiopulmonary exercise testing. in some cases, field tests evaluating submaximal and maximal exercise capacity may be more practical than cardiopulmonary exercise testing. therefore, in this study, it is aimed to evaluate the exercise capacity of fontan patients with 6-minute walking test and incremental shuttle walk test and to compare vital signs during the tests.


Eligibility criteria:
fontan group inclusion criteria * be between the ages of 8-50 * having undergone fontan operation in our hospital or another center * clinical stability of the patients (preserved ventricular function), * no change in ongoing drug therapy that adversely affects clinical stability, * at least 1 year after the operation and to be followed in the pediatric cardiology polyclinic of our hospital fontan group exclusion criteria: * inability to access the patient's medical data * neurological and/or genetic musculoskeletal disease * having orthopedic and cognitive problems that prevent testing * the patient's and/or family's unwillingness to participate in the study control group inclusion criteria: * not have cardiovascular, neurological and/or genetic musculoskeletal disease * not having orthopedic and cognitive problems that prevent testing * the patient's and/or family's willingness to participate in the study

Keywords: exercise capacity six minute walk test incremental shuttle walk test fontan procedure
mode of action of topiramate in the treatment of obese patients with and without type 2 diabetes mellitus

Conditions: Obesity; Diabetes Mellitus Type 2

Summary: the purpose of this study is to explore the mode of action of topiramate in the treatment of obese and diabetic patients by testing association between genetic variations within candidate genes or chromosomes (thread like structure found in cell which carries genes) and the clinical outcomes.

this pharmacogenomics (effect of genetic variation on drug response) study will analyze genetic variations in the dna extracted from blood samples collected from patients who were randomized (assigned to treatments by chance) in 1 of 3 previous topiramate studies on obesity and diabetes. the study consist of a screening telephone contact, a single visit to the study site for a blood sample collection (10 ml of whole blood) for genetic analyses, and a 24-hour post-sample adverse event reporting period. the total duration of the study is 24 hours from the time of the blood sample collection. safety will be monitored up to 24 hours after blood sample collection. no study medication was administered.

Eligibility criteria:
inclusion criteria: * must have been randomized within the previous topiramate obesity and diabetes studies: pri/top-int-31 or pri/top-int-33 or a subset of patients with diabetes mellitus who were randomized within the pri/top-int-34 study at sites that also participated in the pri/top-int-31 study * must consent to participate and use data from previous clinical trials in connection with results from the genetic analyses exclusion criteria: * patients who received a blood transfusion within 60 days before collecting dna samples

Keywords: obesity type 2 diabetes mellitus topiramate pharmacogenomics dna polymorphism
optimal treatment of miscarriage

Conditions: Abortion, Spontaneous

Summary: the main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.


Eligibility criteria:
inclusion criteria: * nonviable intrauterine pregnancy with retained gestational sac in the uterus * the embryo if visible 5 to 35 mm without a heart beat * vaginal bleeding * circulatory stable * hemoglobin at least 80 g/l exclusion criteria: * contraindications against misoprostol

Keywords: abortion, spontaneous randomized controlled trial
study of secukinumab compared to ustekinumab in subjects with plaque psoriasis

Conditions: Plaque Psoriasis

Summary: demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * subjects must give a written, signed and dated informed consent * chronic plaque-type psoriasis present for at least 6 months before randomization * moderate to severe plaque psoriasis as defined at randomization by: * pasi score of ≥12 and * body surface area (bsa) affected by plaque-type psoriasis ≥10% and * iga mod 2011 ≥3 (based on a scale of 0-4) * candidate for systemic therapy, defined as having psoriasis inadequately controlled by: * topical treatment (including topical corticosteroids) and/or * phototherapy and/or * previous systemic therapy exclusion criteria: * forms of psoriasis other than plaque psoriasis * drug-induced psoriasis * ongoing use of prohibited treatments * previous exposure to secukinumab or any other biologic drug directly targeting il-17a or il-17ra, or ustekinumab, or any therapies targeting il-12 or il-23 * use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation * pregnant or nursing (lactating) women other protocol-defined inclusion/exclusion criteria may apply

Keywords: plaque psoriasis secukinumab ustekinumab ain457 ain457a