Kornimate/medical-research-clean huggingface dataset:
study to assess darbepoetin alfa dosing for the correction of anemia in pediatric patients with chronic kidney disease

Conditions: Anemia; Chronic Kidney Disease; Kidney Disease

Summary: the primary objectives of this study are the following: 1. to test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dl at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa once a week (qw) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis, and 2. to test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dl at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa every 2 weeks (q2w) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis.


Eligibility criteria:
inclusion criteria: * current diagnosis of chronic kidney disease, either receiving or not receiving dialysis * anemic, with two consecutive screening hemoglobin values drawn at least 7 days apart \< 11.0 g/dl * transferrin saturation (tsat) greater than or equal to 20% exclusion criteria: * any erythropoiesis stimulating agent (esa) use within 12 weeks prior to randomization * other hematologic disorders * upper or lower gastrointenstinal bleeding within 6 months prior to randomization * uncontrolled hypertension * prior history (within 12 weeks prior to randomization) of acute myocardial ischemia, hospitalization for congestive heart failure, myocardial infarction, stroke or transient ischemic attack * prior history (within 6 months prior to randomization) of thromboembolism

Keywords: chronic kidney disease dialysis anemia nephrology pediatric hemodialysis peritoneal dialysis chronic renal insufficiency
miroderm™ for complex wounds in an inpatient setting (miroderm closure)

Conditions: Complex Wound

Summary: this study is being conducted to collect data on the performance of miromatrix wound matrix (miroderm) when used in the treatment of complex wounds in an inpatient setting.


Eligibility criteria:
inclusion criteria: * be at least 18 years old * have a complex study wound which will require an autograft or delayed primary closure procedure and which may or may not include tunneling and/or undermining * have a study wound with a total post-debridement surface area ≥50cm2 and ≤250cm2 with no dimension \>25cm, and a minimum depth of ≥0.5cm * have a study wound which is expected to take at least 4 weeks to reach autograft or delayed primary closure using standard care and npwt * have a study wound that will be treated with npwt regardless of study participation * be in an inpatient setting * be able and willing to sign the consent form and comply with all study visits and procedures exclusion criteria: * be pregnant or be planning to become pregnant during the study * be contraindicated for npwt (necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, exposed vasculature, exposed nerves, exposed anastomotic site, exposed organs) * be immunocompromised or at risk of immunosuppression (e.g. be hiv positive, be experiencing organ rejection, be a recent, current, or anticipated chemotherapy recipient) as determined by the investigator * be taking a tumor necrosis factor (tnf) blocker * be participating in another research study * have a sensitivity to porcine material * have a life expectancy of less than 1 year * have a study wound which is a third degree burn wound * have a study wound that is infected * have a study wound that is a pressure ulcer/wound * have a study wound with sinus tract(s) leading to other open area(s) * have a wound that is being treated or expected to be treated with either hbot or topical wound oxygen therapy * have a study wound which has been treated with a cellular and/or tissue-based product within last 30 days
covid-19 e telepsychotherapy: which variables affect therapeutic experience?

Conditions: Telepsychotherapy

Summary: covid-19 pandemic forced a widespread adoption of telemedicine, including telepsychotherapy. telepsychotherapy has been proven to be effective before covid-19 breakout (poletti et al., 2020); however, both patients and therapists were skeptical about this modality. the aim of this study is to probe the experience of telepsychotherapy in both patients and therapists, during the covid-19 lockdown. thus, when the adoption of online colloquia was mandatory and not an option. crucially, studying the experience of telepsychotherapy during the covid-19 pandemic allows i) investigating also the experience of those patients and therapists that were not favorable to this kind of intervention and ii) comparing the experience of therapy in the online and face-to-face modality, in the same patients and therapists. furthermore, we collect several psychological variables that possibly influence the experience and efficacy of telepsychotherapy (e.g., personality traits, attachment state of mind, previous traumatic experiences) to define the psychological profile behind a favorable or negative experience of telemedicine in both patients and therapists. as crucial novelty, this information is collected in both patients and their therapists, allowing the direct comparisons between the experience of the therapeutic relationship (e.g., empathy, alliance) from two different point of views. the results of the present study may help in the definition of possible subgroups of patients who may be sufficiently responsive to telepsychotherapy and those who may benefit - exclusively - of face-to-face interventions.


Eligibility criteria:
inclusion criteria: * licensed and currently practicing psychotherapists * individuals currently undergoing a psychotherapy exclusion criteria: * not applicable
the sam project: science against malnutrition project

Conditions: Malnutrition

Summary: the latest data from the world health organization (who) shows that malnutrition in all its forms affects over 2.5 billion people globally. this condition is constantly increasing and affects the entire population, from childhood to the elderly. malnutrition in all its forms negatively impacts the quality of life of patients affected and increases the risk of morbidity and mortality, as well as healthcare costs. considering the complexity and multifactorial nature of malnutrition, the integration of multi-omics data obtained from analyzes with high-throughput technologies such as epigenomics, metagenomics, metabolomics, could benefit the prediction and evaluation of prognosis and/or response to specific treatments; this could pave the way for personalized precision medicine interventions for patients suffering from malnutrition. the sam study aims to characterize malnutrition through the identification of specific biomarkers of the condition with the aim of developing innovative prevention and treatment programs.


Eligibility criteria:
inclusion criteria: * caucasian ethnicity; * both sexes; * age between 0 and 85 years; * affected by malnutrition due to deficiency or excess in association with other patology and sex- and age-matched healthy controls not affected by malnutrition due to deficiency or excess and any pathology * written informed consent exclusion criteria: * non-caucasian ethnicity; * age \> 85 years.
a multicenter, randomized, open label study to evaluate the lipid lowering efficacy and safety of vytorin® 10/20 vs. atorvastatin 10mg in hypercholesterolemia patients with metabolic syndrome in korea (0653a-129)(completed)

Conditions: Hypercholesterolemia

Summary: prevalence of metabolic syndrome in korea is increasing. there is no clinical trial targeting on such increasing populations like metabolic syndrome patients with vytorin® in korea. therefore this trial will help evaluate the lipid lowering effect of vytorin® in asian population with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * diagnosis of the metabolic syndrome according to 2005 american heart association/national heart, lung and blood institute (aha/nhlbi) scientific statement * no history of diabetes and 100 \<=ldl-c \<=250 mg/dl exclusion criteria: * myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months * congestive heart failure defined by new york heart association (nyha) class iii or iv * uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins * uncontrolled hypertension * unstable angina

Keywords: metabolic disorder
extended access program to assess long-term safety of bardoxolone methyl in patients with pulmonary hypertension ranger

Conditions: Pulmonary Hypertension

Summary: this extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (ph) who previously participated in controlled clinical studies with bardoxolone methyl.

this extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (ph) who previously participated in controlled clinical studies with bardoxolone methyl. qualified patients will receive 10 mg of bardoxolone methyl once daily until the drug is available through commercial channels or until patient withdrawal, whichever is sooner. dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.

Eligibility criteria:
inclusion criteria: * treatment-compliant patients who are participating in qualifying ongoing studies and have completed required end-of-treatment and/or follow-up visits in a prior clinical study with bardoxolone methyl exclusion criteria: * participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication; * patients who have an ongoing sae from a clinical study that is assessed by the investigator as related to bardoxolone methyl; * unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while taking study drug; * women who are pregnant or breastfeeding; * patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason; * known hypersensitivity to any component of the study drug

Keywords: pulmonary arterial hypertension pulmonary hypertension ph pah bardoxolone methyl 6-minute walk distance cddo-me rta 402 lariat catalyst ranger
safety and efficacy of olanzapine in the long-term treatment for bipolar i disorder, depressed

Conditions: Bipolar I Disorder

Summary: to assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar i disorder, depressed.

this is an open-label, multi-center, long-term treatment study conducted only in japanese sites. the subjects are patients who fulfill the diagnostic criteria for bipolar i disorder, most recent episode depressed, as defined in the diagnostic and statistical manual of mental disorders fourth edition, text revision (dsm-iv-tr) (296.50=unspecified, 296.52=moderate severity, 296.53=severe without psychotic features, 296.54=severe with psychotic features), who have completed study hgmp (nct#00510146) and patients who did not participate in study hgmp who have been recruited to participate in study hgms.

Eligibility criteria:
inclusion criteria: 1. patients must be aged 18 to less than 75 years. 2. each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent. 3. all female patients must test negative for pregnancy. 4. females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug. 5. male patients who are not surgically sterilized must agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug. 6. patients must fulfill the diagnostic criteria for bipolar i disorder, most recent episode depressed, as defined in the diagnostic and statistical manual of mental disorders fourth edition, text revision (dsm-iv-tr). 7. patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode, as defined in the dsm-iv-tr. 8. patients must have a current young mania rating scale (ymrs) total score =\<8. exclusion criteria: 1. is investigator site personnel directly affiliated with this study or their immediate families. 2. is a lilly employee. 3. has previously completed or withdrawn from this study or any other study investigating olanzapine. 4. is pregnant or nursing. 5. has a serious, unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months.

Keywords: bipolar
test the phototoxicity of sunscreen products

Conditions: Sunscreen Agents

Summary: the primary objective of this study was to evaluate the potential for phototoxicity of the sun care products spf 50 y65 110, spf 50 y51 002, and spf 15 v27 104 compared to that of a negative control (0.9% sodium chloride \[nacl\]) after a single 24 h application of test materials followed by irradiation with ultraviolet a (uva) and ultraviolet b (uvb). the secondary objective of this study was to evaluate the safety of the sun care products spf 50 y65 110, spf 50 y51 002, and spf 15 v27 104 combined with uva/b irradiation by monitoring adverse events (aes) throughout the study.


Eligibility criteria:
inclusion criteria: * male or female subjects, aged 18 to 65 years * good general health, as assessed by medical history and brief visual examination of the skin * fitzpatrick skin type i iv, determined by interview at screening * willing and able to practice an acceptable measure of contraception during the study, if female of childbearing potential * willing to follow study rules, which include: no sun exposure; avoidance of activities that would cause excessive sweating; and no use of lotions, creams, or oils on the back area * must be willing not to change current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, and body spritzes while participating in the study
open label study of duloxetine for the treatment of phantom limb pain

Conditions: Chronic Phantom Limb Pain

Summary: this is a study to assess the possible benefit of duloxetine in the treatment of chronic phantom limb pain.


Eligibility criteria:
inclusion criteria: 1. chronic plp \> 6 months 2. short-form mcgill pain questionnaire sensory pain rating index raw score ≥ 16 3. age ≥ 18 years old 4. inpatient or outpatient 5. able to come to all appointments, in the opinion of the investigator 6. able to give informed consent, in opinion of investigator exclusion criteria: 1. current major depressive disorder, anxiety disorder, or psychotic disorder assessed by the mini international neuropsychiatric interview (mini) 2. substance abuse or dependence within the last six months, as assessed by the mini 3. known diabetes mellitus to exclude diabetic peripheral neuropathy 4. history of coronary artery disease, hepatic disease, renal disease 5. other pain syndromes 6. any unstable medical conditions in the opinion of the investigator 7. other psychotropic medications excluding hypnotics
nutritional support for patients operated for malignant tumors in hpd zone

Conditions: Nutritional Support; Hepato-Biliary Neoplasm; Postoperative

Summary: a comprehensive comparative analysis of the effectiveness of isolated enteral, isolated parenteral and mixed type of nutritional support in the early postoperative period in patients after operations performed on the malignant neoplasms of hepatico-pancreatico-duodenal zone.

a prospective, longitudinal, parallel study and retrospective analysis of the results of treatment of 91 patients with malignant tumors of the hepatico-pancreato-duodenal zone who underwent the following operations: 1. resection of various segments of the liver; 2. hemihepatectomy; 3. transhepatic drainage of the right and left hepatic duct; 4. bypass gastroenteroanastomosis or cholecystenteroanastomosis with interintestinal enteroenteroanastomosis according to brown; 5. gastro-pancreato-duodenal resection; 6. corpore-caudal resection of the pancreas with splenectomy. the first group (n=31) included patients who received enteral nutrition (en) after surgery. the second group (n=30) included patients who received parenteral nutrition (pn) and the third group (n=30) who received mixed nutrition (mn), as a variation of the partial parenteral nutrition technique, in the early postoperative period. some nutritional status indicators available for determination at the oncology clinic were assessed - body mass index (weight measurements were carried out before surgery, on the 5th, 10th and 15th days), basal metabolic rate (calculated using the harris-benedict equation, based on anthropometric data of the patient (gender, age, weight and height).), laboratory parameters: blood hemoglobin, lymphocytes, total protein, serum albumin, serum transferrin, total bilirubin and direct, alanine aminotransferase (alt), aspartate aminotransferase (ast), which are related to the traditional method for assessing nutritional status

Eligibility criteria:
inclusion criteria: female and male patients in age of 20-75 with malignant tumors of the hepato-pancreato-duodenal zone who have undergone any of the following operations: 1. resection of various segments of the liver; 2. hemihepatectomy; 3. transhepatic drainage of the right and left hepatic duct; 4. bypass gastroenteroanastomosis or cholecystoenteroanastomosis with interintestinal enteroenteroanastomosis according to brown; 5. gastro-pancreatoduodenal resection; 6. corporecaudal resection of the pancreas with splenectomy. exclusion criteria: * patients in age of up to 20 and older than 75 * pregnant and breastfeeding women

Keywords: nutritional support hepato-biliary neoplasm postoperative curation
when to apply to which patient in msc?

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Summary: mesenchymal stem cell (msc) therapy is among the promising treatments for acute respiratory distress syndrome (ards). our study aimed to investigate the clinical efficacy of msc treatment in covid-19 patients, to determine when this treatment can be applied to which patient, and to evaluate its contribution to prognosis.

the study was conducted retrospectively in patients diagnosis of covid-19 in the intensive care units. patients with severe ards \[partial pressure of arterial blood oxygen and inhaled oxygen fraction (pao2: fio2) ratio of 100 or less\] were included in the study. demographic data of the patients (gender, age), comorbidities (hypertension, coronary heart disease, diabetes, cerebrovascular diseases, hepatitis b infection, cancer, chronic kidney disease, and immunodeficiency), charlson comorbidity index (cmi), date of diagnosis, date of admission to the hospital, date of admission to the icu, acute physiology and chronic health evaluation (apache) ii score, presence of high flow nasal oxygen (hfno) or mechanical ventilator (mv) support, laboratory findings (blood cell count, blood biochemistry, hepatorenal function, coagulation function, d-dimer, c-reactive protein (crp), procalcitonin, ferritin, arterial blood gas analysis) before (day 0) and after msc application, on 3rd and 7th days, partial oxygen/fractionated oxygen (pa/fi) ratio, discharge or death information, and attributed causes of death were recorded on the study form. pa/fi ratio was calculated with the formula (oxygen dissolved in arterial blood gas / oxygen liter given to the patient).

Eligibility criteria:
inclusion criteria: * patients who were followed up and treated after being admitted to the intensive care unit after march 2020 * patients with covid pcr + * typical or suspected cases of thorax bt covid * cases over the age of 18. exclusion criteria: * those with a contraindicated condition (cancer disease, allergy) for msc application * those who are endotracheal intubated during the application and are connected to a respirator * those who died in the first 24 hours after the application * cases that are not positive or suspicious for covid. * cases under the age of 18. * cases where patient data could not be reached.

Keywords: covid-19 sars-cov-2 mesenchymal stem cell intensive care units
efficacy and safety of biomatrixtm stent and 5mg-maintenance dose of prasugrel in patients with acute coronary syndrome

Conditions: Cardiac Death; Hemorrhage; Cerebrovascular Accident; Myocardial Infarction

Summary: the purpose of this study is to evaluate the efficacy and safety of 5mg maintenance dose (md) of prasugrel in patients with acute myocardial infarction (ami) who underwent percutaneous coronary intervention (pci) with biomatrixtm stent.

about 1400 patients derived from korean patients with acute coronary syndrome (acs) receiving percutaneous coronary intervention (pci) with bes(biolimus-eluting stent, biomatrixtm) in a routine manner will be enrolled in the investigators trial. these patients will be randomized 1:1 to either prasugrel 5mg once daily md or clopidogrel 75mg once daily md after successful pci with bes . the investigators excluded the patients with age ≥75 years, body weight \<60 kg, or history of tia (transient ischemic attack) or stroke. follow-up data will be collected until 1-year after index procedure. primary efficacy end-point defined as the composite of cardiac death, non-fatal mi, stent thrombosis and ischemic driven target vessel revascularization and safety end-points as barc (the bleeding academic research consortium) type ≥ 2 bleeding.

Eligibility criteria:
inclusion criteria: * patients who can undergo percutaneous coronary intervention with biomatrix stent with no history of tia or stroke, * 75 years old or younger, * body weight of 60 kg or more and diagnosed with acute coronary syndrome exclusion criteria: * patients with history of tia or stroke, * 75 years old or older, * body weight of 60 kg or under, * hypersensitivity to or contraindicated for heparin, aspirin, clopidogrel, prasugrel or contrast media
clinical and health-related outcome of rfviiifc prophylaxis

Conditions: Hemophilia A

Summary: current standard therapy for patients with haemophilia (pwh) in the prevention of bleeding episodes is a prophylactic intravenous treatment with recombinant coagulation factor (f) viii (haemophilia a) or rather fix (haemophilia b) two to three times weekly. with the development of recombinant factor viii fc fusion protein (rfviiifc) the conventional routine prophylaxis regime is complemented by an extended half-life (ehl) factor replacement prophylaxis with the potential of improved bleed prevention and reduced injection frequency at similar factor consumption. aim of this longitudinal multicentre study is to evaluate the influence of an ehl factor replacement regime with rfviiifc on haemophilic specific parameters (annual bleeding rate, bleeding localisation), joint status, pain, functional parameters, treatment adherence and health-related quality of life in pwh a.


Eligibility criteria:
inclusion criteria: * patients suffering from moderate to severe haemophilia a * age ≥ 18-years * treatment with fviii prophylaxis * submitted written informed consent exclusion criteria: patients suffering from other bleeding diseases * patients with inhibitors * patients without written informed consent * age \< 18-year-old * any surgeries up to 6 months before the examination date * suffering from different rheumatologic diseases like m. bechterew, psoriasis or other local or generalized joint infections (borreliosis, septic arthritis)