Kornimate/medical-research-clean huggingface dataset:
intraoperative sedatives and postoperative deilirium

Conditions: Lower Extremity Problem; Delirium; Propofol; Dexmedetomidine

Summary: delirium occurs commonly in elderly patients. its incidence after orthopedic surgery has been reported to be 5-61%. delirium is classified into three sub-types: hypoactive, hyperactive, and mixed. although hyperactive delirium is not as common as hypoactive delirium, the abnormal behavior pattern of hyperactive delirium, such as agitation, confusion, or aggressiveness, is considered to be harmful to patients and medical personnel. thus, it is important to promptly manage such behaviors associated with hyperactive delirium. intraoperative sedation plays an important role in relieving anxiety or stress response of patients. propofol-a common sedative agent-was reported to cause delirium more frequently, compared with dexmedetomidine, in post-cardiac surgery patients or mechanically-ventilated patients in the intensive care unit (icu). in addition to the benefits of reducing opioid consumption and postoperative nausea/vomiting, dexmedetomidine is most often used for icu sedation or procedural sedation. however, there has not been any prospective randomized study investigating how intraoperative dexmedetomidine sedation during regional anesthesia affects postoperative consciousness, perception, memory, behavior, emotion, and so on. in this study, based on the hypothesis that intraoperative dexmedetomidine sedation may reduce the incidence of abnormal psycho-motor behavior compared with propofol sedation, investigators prospectively will investigate the incidence of postoperative delirium in elderly patients who undergo orthopedic surgery with regional anesthesia.


Eligibility criteria:
inclusion criteria: * patients who undergo orthopedic surgery under spinal anesthesia * patients who want to sedation during the surgery * age of 65 years or greater * american society of anesthesiologists physical status classification 1 and 2 exclusion criteria: * general anesthesia * age \< 65 years * patients who do not want to sedation during the surgery * patients who do not receive patient controlled analgesia postoperatively. * cognitive disorders * central nervous system disease, including dementia and parkinson's disease
this study will evaluate efficacy and safety of deferasirox in patients with myelodysplastic syndromes (mds), thalassemia and rare anemia types having transfusion-induced iron overload.

Conditions: Myelodysplastic Syndrome; Thalassemia

Summary: this study will evaluate the efficacy and safety of deferasirox in patients with mds, thalassemia and rare anemia patients with transfusion iron overload.


Eligibility criteria:
inclusion criteria: 1. age ≥ 2 years 2. primary diagnosis: myelodysplastic syndrome (presenting with low or intermediate-1 ipss risk), thalassemia or rare anemias patients (anemia diamond-blackfan, fanconi's anemia, sideroblastic anemia, red cell aplasia) 3. ecog performance status ≤ 2 4. transfusion overload confirmed with ferritin level \>1000 µg/l. 5. no severe concomitant uncontrolled disease (uncontrolled diabetes mellitus, heart failure, renal failure). 6. serum creatine level \> uln 7. no proteinuria 8. liver enzymes level \< 5 uln. 9. no pregnancy or lactation 10. signed informed consent by adults. in case inclusion of children under 18 years old, the informed consent should be signed by parents. exclusion criteria: 1. age \< 2 years 2. no iron overload (ferritin level \<1000 µg/l). 3. primary iron overload (hereditary hemochromatosis) 4. severe concomitant disease (uncontrolled diabetes mellitus, heart failure, renal failure) 5. elevated serum creatinine \> uln or/and proteinuria 6. liver enzymes level \>5 uln. 7. pregnancy or lactation. other protocol-defined inclusion/exclusion criteria may apply

Keywords: iron overload hemotranfusion deferasirox ferritin rare anemia transfusional iron overload
ph i ipilimumab vemurafenib combo in patients with v-raf murine sarcoma viral oncogene homolog b1 (braf)

Conditions: Melanoma

Summary: treatment of subjects who have metastatic melanoma that expresses an activated mutant form of the braf oncogene (v600e) with a combination of the specific braf inhibitor, vemurafenib, and the cytotoxic t lymphocyte antigen 4 (ctla-4) inhibitor mab ipilimumab will be safe and feasible and will show preliminary evidence of anti-tumor efficacy and survival in comparison to historical results following treatment with either agent alone.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * metastatic melanoma with activating v600 braf mutation * measurable tumor * eastern cooperative oncology group (ecog) performance status (ps) 0-1 exclusion criteria: * autoimmune disease * active brain metastasis (must be stable after radiation for at least one month) * prior therapy with immune stimulating agents
paricalcitol effect on anemia in ckd

Conditions: Anemia; Chronic Kidney Disease

Summary: current activated vitamin d therapies are approved for treating secondary hyperparathyroidism in chronic kidney disease (ckd), and a large body of experimental data in animals confirms the effects of vitamin d that extend beyond mineral metabolism. several studies show that the benefits are greater with the newer vitamin d analog paricalcitol when compared with calcitriol. a large gap exists in our knowledge between epidemiological studies in human that demonstrate improved outcomes with vitamin d use and observations in preclinical studies demonstrating the pleiotropic effects of vitamin d. to explore the provenance of epidemiological outcomes in ckd, we conducted a pilot randomized trial to determine whether the use of paricalcitol, compared to calcitriol, leads to improvement in anemia, a marker associated with worse outcomes in chronic kidney disease, and whether this effect not only reflects the hyperparathyroidism correction, but is also dependent on the direct effects of paricalcitol on erythroid progenitor cells.

to better understand the direct effects of paricalcitol on anemia in patients with chronic kidney disease (stage 3-5), we conducted a pilot trial in 60 patients who were randomly allocated equally to 2 groups to receive or not paricalcitol orally for 6 months.

Eligibility criteria:
inclusion criteria: * age \> 18 * written informed consent * ckd stage 3-5 (egfr \<60 ml/min/1,73 m2) * pth 30-300 pg/ml * hb \ 3 consecutive months * ferritin \> 100 ng/ml * transferrin saturation (tsat) 20-40% * mean corpuscular volume (mcv) 85-95% * for patients treated with ace-inhibitors or angiotensin receptor blockers, dose stable \>3 months * for patients treated with erythropoiesis-stimulating agents (esa), dose stable \>3 months exclusion criteria: * anemia due to non renal cause * presence of malignancies, inflammatory or infectious disease \>3 months * pregnancy * bleeding \>6 months * c-reactive protein (crp) \>1 mg/dl * poorly controlled hypertension (pas \> 170 mmhg and pad \>100 mmhg) * severe malnutrition * hypercalcemia (\>10,5 mg/dl) * hyperphosphatemia (\>5,5 mg/dl) * surgical interventions \>3 months * acute myocardial infarction, unstable angina, stroke or transitory ischemic attack, deep venous or pulmonary thromboembolism, congestive heart failure \>3 months

Keywords: anemia chronic kidney disease vitamin d paricalcitol hyperparathyroidism
prime vs usual care for clinical high risk

Conditions: Clinical High Risk Syndrome for Psychosis

Summary: the purpose of this study is to determine whether specialty care is superior to usual care in the treatment of patients at clinical high risk for psychosis.

this study is a randomized clinical effectiveness trial for patients at clinical high risk for psychosis that compares two treatments: 1) specialty care delivered in a specialized clinical for patients at clinical high risk for psychosis versus 2) treatment as usual in the community.

Eligibility criteria:
inclusion criteria: * subjects must meet all of the following: 1. male or female between 12 and 30 years old. 2. understand and sign an informed consent (or assent for minors) document in english. 3. meet diagnostic criteria for prodromal syndrome as per cops criteria. exclusion criteria: * subjects must not meet any of the following: 1. diagnosis of current or lifetime axis i psychotic disorder, including mood disorder with psychotic symptoms. 2. impaired intellectual functioning (full-scale iq\ 75 on the wrat reading. 3. past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment. 4. alcohol or substance dependence in the past 6 months.

Keywords: prodrome cognitive behavioral therapy family focused therapy
rolapitant plus olanzapine in multiday cisplatin chemotherapy

Conditions: Germ Cell Tumor

Summary: phase ii study of rolapitant plus olanzapine, palonosetron, and dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy


Eligibility criteria:
inclusion criteria: * written informed consent and hipaa authorization for release of personal health information prior to registration. note: hipaa authorization may be included in the informed consent or obtained separately. * age ≥ 15 years at the time of consent. * must be able to take oral medications (swallow pills) * ecog performance status of 0-2 within 14 days prior to registration. * histological or serological confirmation of germ cell tumor planning on receiving a standard 5 day cisplatin based chemotherapy regimen. * patients must have had no nausea or vomiting for 24 hours and no antiemetic use for 72 hours prior to starting protocol therapy. * no active central nervous system (cns) metastases. patients with neurological symptoms must undergo a head ct scan or brain mri to exclude brain metastasis. a subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off of corticosteroids for ≥ 2 weeks, and are asymptomatic. * prior cancer treatments are not allowed. patients have to be chemotherapy naïve. * absolute neutrophil count (anc) ≥ 1 k/mm3 * hemoglobin (hgb) ≥ 10 g/dl * platelets (plt) ≥ 100 k/mm3 * creatinine ≤ 2 mg/dl * bilirubin ≤ 1.5 × upper limit of normal (uln) * aspartate aminotransferase (ast) ≤ 2.5 × uln * alanine aminotransferase (alt) ≤ 2.5 × uln * no concurrent use of thioridazine or pimozide. no use of agents expected to induce the metabolism of rolapitant which include: rifampin, rifabutin, phenytoin, carbamazepine, and barbiturates. * as determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study * patients and their partners must agree to use a highly effective method of birth control from the signing of the informed consent form until 90 days following the last dose of rolapitant. exclusion criteria: * any untreated central nervous system (cns) metastases. * treatment with any investigational drug within 30 days prior to registration. * concurrent participation in a clinical trial which involves another investigational agent.
new postoperative intraretinal cystoid changes after vitrectomy with membrane peeling due to epiretinal membranes

Conditions: Epiretinal Membrane

Summary: epiretinal membranes (erm) are a macular disorder leading to metamorphopsia and a decrease in visual acuity. peeling of erm during vitrectomy is, up to date, the only possible treatment option, opening chances for improvements of visual acuity and metamorphopsia. occurrence of new intraretinal cystoid changes was described to be associated with a lower level of visual acuity after surgery, compared to patients, that never had intraretinal cystoid changes aim of our study was to analyze development of new intraretinal cystoid changes after vitrectomy with membrane peeling with respect to postsurgical treatment strategies.

epiretinal membranes (erm) are a macular disorder leading to metamorphopsia and a decrease in visual acuity. while erm are rare among young people, they have prevalence rates of up to 30% in the age groups of 70 years or older. peeling of erm during vitrectomy is, up to date, the only possible treatment option, opening chances for improvements of visual acuity and metamorphopsia. nevertheless, there is a risk for development of new intraretinal cystoid changes after peeling of erm in about 10% of patients. preoperative presence of intraretinal cystoid changes was already described as a risk factor for postsurgical presence of intraretinal cystoid changes and and occurrence of new intraretinal cystoid changes was described to be associated with a lower level of visual acuity after surgery, compared to patients, that never had intraretinal cystoid changes. biomarker in presurgical optical coherence tomography (oct) have been described to be associated with postsurgical results. using a multivariable approach of analysis, presurgical dril and higher central macular thickness (cmt) were significant negative predictors on postsurgical visual acuity three months after surgery. however, influence of preoperative oct biomarkers on development of new postsurgical intraretinal cystoid changes was not examined in theses studies. aim of our study was to analyze development of new intraretinal cystoid changes after vitrectomy with membrane peeling with respect to postsurgical treatment strategies.

Eligibility criteria:
inclusion criteria: * presence of an idiopathic erm with decrease in visual acuity affecting activities of the daily life * undergone pars plana vitrectomy with membrane peeling with application of periocular triamcinolone acetonide and a prolonged application of steroidal eye drops for three months after surgery, performed by a single surgeon in the time period from 01/08/2020 to 31/05/2023. * presence of a follow-up examination at our department three months after surgery (+-1 month), including oct with accurate image quality for analyzing the presence or absence of intraretinal cystoid changes and visual acuity testing. * age of 18 years of older. exclusion criteria: * age below 18 years
device evaluation of contak renewal 2and easytrak 2 - decrease-hf

Conditions: Congestive Heart Failure

Summary: the purpose of this clinical investigation is to demonstrate the safety and effectiveness of the contak® renewal™ 2/4/4he cardiac resynchronization therapy defibrillator (crt-d) family and easytrak® 2 lead in delivering lv-crt or biv-crt with an lv offset for patients with heart failure and an indication for an icd.

this clinical investigation is a prospective, multi-center, randomized, double-blind study design enrolling 360 patients at 57 centers to demonstrate the safety and effectiveness of the therapy, the contak renewal 2/4/4he devices and the easytrak 2 lead.

Eligibility criteria:
inclusion criteria: * meet the general indications for a crt-d device * moderate or severe heart failure, defined as nyha class iii-iv despite optimal pharmacological heart failure therapy. * a 12-lead electrocardiogram (ecg) obtained no more than 90 days prior to enrollment documenting a sinus rate \> 50 bpm, qrs duration ³ 150 ms, and pr interval £ 320 ms measured from any two leads, and a p-wave duration \< 150 ms measured from lead v1 * creatinine £ 2.5 mg/dl obtained no more than 14 days prior to enrollment * left ventricular ejection fraction £ 35% \[measured by echo, multiple gated acquisition (muga) scan, cardiac catheterization, etc.\] no more than 14 days prior to enrollment * willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation * have a life expectancy of more than 180 days, per physician discretion * age 18 or above, or of legal age to give informed consent specific to state and national law exclusion criteria: * right bundle branch block morphology (per world health organization guidelines) on a 12-lead ecg obtained no more than 90 days prior to enrollment. * have had previous cardiac resynchronization therapy, a previous coronary venous lead, or meet the general indications for antibradycardia pacing * have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking * have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) within 180 days prior to enrollment * have a hypersensitivity to a 0.7 mg dose of dexamethasone acetate * have surgically uncorrected primary valvular heart disease * currently requiring dialysis * have chronic obstructive pulmonary disease (copd), defined as fev1/fvc \< 60% * have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the 30 days prior to enrollment * have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis) * have a mechanical tricuspid prosthesis * enrolled in any concurrent study, without guidant written approval, that may confound the results of this study.

Keywords: left ventricular lead cardiac resynchronization therapy congestive heart failure
study comparing bioequivalence of two new formulations of premarin/mpa with premarin/mpa reference formulation.

Conditions: Postmenopausal Osteoporosis; Postmenopause

Summary: this study will compare the bioequivalence of two new investigational combination formulations of premarin and medroxyprogesterone acetate (mpa) with a currently marketed formulation of premarin and medroxyprogesterone, prempro™. prempro is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). the purpose of this study is to determine if these new formulations of premarin and mpa provide the same levels of estrogen and mpa in the blood as prempro in healthy postmenopausal women.


Eligibility criteria:
inclusion criteria: * healthy, postmenopausal women ages 35 to 70 years, inclusive. * naturally postmenopausal women must not have had a menstrual period for at least six months, but less than 12 months, as confirmed by a blood test; or for at least 12 months with no blood hormone test confirmation. naturally postmenopausal women must not have had a menstrual period since the age of 54. surgically menopausal women must have undergone bilateral oophorectomy (removal of both ovaries) at least 5 months prior to the start of the study, and the surgical report may be requested to confirm the surgery date and that the surgery was not due to a cancerous condition. * nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. must be able to abstain from smoking during the inpatient stay.

Keywords: vaginal atrophy postmenopausal osteoporosis menopause hot flashes
intensive care therapy of covid-19 disease in germany

Conditions: COVID; ARDS

Summary: multi-center retrospective and prospective observational study of covid-19 patients with severe or critical illness treated on a german icu


Eligibility criteria:
inclusion criteria: * age above 18 years * covid-19 disease (positive sars-cov-2 pcr) exclusion criteria: -none
a randomised single centre study to compare the long-term performance of 4 designs of the depuy ultima lx stem in primary total hip replacement

Conditions: Osteoarthritis; Post-traumatic Arthritis; Collagen Disorder; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

Summary: the purpose of this study is to compare the performance of 4 designs of the depuy ultima lx hip stem in the treatment of patients with hip joint disease requiring a total hip replacement. patients who enter the study will be randomly allocated to one of the 4 designs of the depuy ultima lx hip stem and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility criteria:
inclusion criteria: current indications for primary total hip arthroplasty utilising a cemented femoral component. these include pain, deformity and loss of function which are not responsive to medical treatment exclusion criteria: i) revision total hip arthroplasty ii) rheumatoid arthritis iii) age greater than 80 years at time of surgery iv) age less than 60 years at time of surgery v) previous hip joint sepsis vi) obesity vii) patient likely to remain housebound once rehabilitation is complete

Keywords: hip cemented
the relation between serum ascorbic acid concentration and preterm premature rupture of membranes

Conditions: Preterm Premature Rupture of Membranes

Summary: to study the association between maternal serum vitamin c concentration in women with preterm premature rupture of membranes (pprom) and women without pprom.

the micronutrient vitamin c is an effective water soluble antioxidant that scavenges several reactive oxygen species, thus reducing oxidative stress, it also acts as an enzymatic cofactor to the enzymes lysyl hydroxylase and prolyl hydroxylase, which is required for synthesis of hydroxyproline and hydroxylysine, collagen requires hydroxyproline bridges across the triple helix to provide stability to it, ascorbic acid also causes down regulation of the metalloproteinase-2 and biosynthesis of collagen where it is required for the formation of triple helical structure of collagen. thus, ascorbic acid participates in the equilibrium between synthesis and degradation of collagen and this may be critical in reducing the occurrence of preterm prom.

Eligibility criteria:
inclusion criteria: * singleton pregnancies * gestational age between 28-37 weeks * rupture of membranes will be diagnosed by history, sterile speculum examination to confirm fluid leakage from the cervical canal exclusion criteria: * patients with multiple pregnancies * smoker * polyhydramnios * maternal diseases such as: anemia, diabetes, uti, rti and vaginal infection * history of pprom in previous pregnancies * evidence of chorioamnionitis in current pregnancy

Keywords: vitamin c preterm premature rupture of membranes
evaluation of a stage-based tailored, nutrition education package for childhood obesity (st-nepco) (7-12 years old)

Conditions: Educational Materials (ST-NEPCO) During Nutrition Counselling for Obese Children

Summary: a randomized controlled trial will be used to determine the effectiveness of st-nepco. the study will involve obese children aged 7 to 11 years old. participants will be assigned randomly to either the intervention or control group. the intervention group will receive counselling from the researcher based on st-nepco, meanwhile the control group will receive counseling from dietitians based on the routine care for the management of childhood obesity. the study will be conducted for duration of 24 weeks. the individual counseling session will be held once a month for each participant during the weekend.


Eligibility criteria:
inclusion criteria: * children aged 7 to 11 years old * children classified as obese (\>+2sd) based on bmi-for-age for 5 to 19 years old (who, 2007). exclusion criteria: * children diagnosed with chronic asthma, diabetes mellitus, psychiatric disorders (e.g. schizophrenia, severe autism or mental retardation, or psychosis), or other serious medical conditions. * children receiving medications that can potentially promote weight gain or weight loss. * children participating in any weight management program