Kornimate/medical-research-clean huggingface dataset:
ser100 in isolated systolic hypertension

Conditions: Isolated Systolic Hypertension

Summary: isolated systolic hypertension (ish)is the dominating hypertensive disease in elderly people. much attention has recently been drawn to the strong relationship between the systolic blood pressure and cardiovascular morbidity. in previous clinical studies carried out in individuals with normal blood pressure at baseline ser100 decreased primarily the systolic blood pressure. it is hypothesized that the effect on systolic blood pressure in hypertensive patients will be larger or equal to the fall seen in normotensive patients.


Eligibility criteria:
inclusion criteria: * mean systolic blood pressure ≥ 150 mmhg and mean diastolic blood pressure \< 90 mmhg - as determined by daytime continuous ambulatory blood pressure measurement (abpm) * male or female * age 50-80 years (both inclusive) at screening * patients must be on stable doses with one or more antihypertensives * bmi \<32 kg/m2 * written informed consent exclusion criteria: * acute myocardial infarction in the last 6 months before screening * stroke in the last 6 months before screening * uncompensated heart failure (nyha class iv) * angina pectoris with an anticipated need for administration of short-acting nitrates * known, severe sleep apnoea * abnormal laboratory values (i.e. \> 2 x upper normal limit) at screening * subjects working night shifts (11 pm to 7 am) * participation in any other clinical trial with an investigational medicinal product or device within 1 month prior to randomisation. * subjects with upper arm circumference ≤24 cm or ≥ 42 cm. * any general condition, serious disease or current evidence of any mental or physical disorder or collaboration attitude (e.g. dementia, substance abuse) which, in the judgment of the investigator makes the subject unsuitable for enrollment, and/or may interfere with the study evaluations or affect subject's safety and/or may cause risk for poor protocol compliance * pregnant or lactating women. * female subjects of childbearing potential, or male subjects whose female partner (unless post-menopausal for 1 year or surgically sterile) is unwilling to use adequate contraceptive measures throughout the duration of the study
mechanisms for organ dysfunction in covid-19

Conditions: COVID-19; Organ Dysfunction Syndrome Sepsis; Organ Dysfunction Syndrome, Multiple; Septic Shock; Acute Kidney Injury; Acute Respiratory Distress Syndrome

Summary: the study aims to investigate organ dysfunction and biomarkers in patients with suspected or verified covid-19 during intensive care at uppsala university hospital.

consenting patients with suspected or verified sars-cov-2 infection, covid-19, will undergo daily blood, urine and sputum sampling during their stay in intensive care. data on organ dysfunction will be collected through the electronic patient journal and electronic patient data management system. the collected samples will be analysed for a panel of potential biomarkers that will be correlated to organ dysfunction and clinical outcome.

Eligibility criteria:
inclusion criteria: * admitted to intensive care * suspected or verified covid-19 exclusion criteria: * pregnancy or breastfeeding * under-age
a post marketing surveillance study for nutropinaq® in adults with growth hormone deficiency

Conditions: Growth Hormone Disorders

Summary: this study is a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of nutropinaq® in adults suffering from growth hormone deficiency in germany, italy, and united kingdom


Eligibility criteria:
inclusion criteria: * patients with growth hormone deficiency * patients treated with nutropinaq® * patients having completed growth (fused epiphyses) exclusion criteria: * active neoplasia * pregnancy
efficacy and safety of mydriatic microdrops compared with standard drops for retinopathy of prematurity (rop) screening: a pilot randomized clinical trial

Conditions: Retinopathy of Prematurity

Summary: the purpose is to assess whether the use of microdrop instillation of phenylephrine 1.67% and tropicamide 0.33% maintains mydriatic efficacy while presents an improved safety profile compared with standard drops of phenylephrine 1.67% and tropicamide 0.33%, which is routine care for pupil dilation during retinopathy of prematurity (rop) screening in our neonatal intensive care unit.

a pilot prospective randomized crossover clinical trial is conducted for assessing the mydriatic efficacy and safety of microdrops (6-7 μl) compared with standard drops (28-34 μl) for retinopathy of prematurity screening. a random number table was used to allocate participants into either a) receiving standard drop on their first and microdrop on their second screening examination a week later, or b) receiving microdrop first and standard drop a week later. the mydriatic agent contains phenylephrine 1.67% and tropicamide 0.33%, which derives from compounding the commercial phenylephrine 5% with the commercial tropicamide 0.5% in volume ratio 1:2.

Eligibility criteria:
inclusion criteria: preterm infants undergoing screening for rop, i.e. * with gestational age (ga) \< 32 weeks and/or birth weight (bw) \< 1501 grams * infants of greater ga and bw with increased comorbidity, e.g. sepsis, prolonged need for oxygen supplementation etc. exclusion criteria: * unstable clinical condition * suspicion of cardiovascular disease * severe congenital anomalies * clinical syndromes * traumatic apoptosis of the corneal epithelium * corneal ulcer * anatomical variations of the anterior segment

Keywords: microdrops mydriasis dilating drops retinopathy of prematurity rop screening
use of rm technology in pediatric bai recipients

Conditions: Hearing Loss, Unilateral

Summary: the purpose of this research study is to learn about the hearing outcomes of children with conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology.

the purpose of this research study is to learn about the hearing outcomes of children with unilateral conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology. it has been shown that the use of intervention (hearing aids, cochlear implants, bone conduction devices) alone does not alleviate the difficulties children with hearing loss encounter in noisy environments such as a classroom or restaurant. one of the most common methods to help children hear better in these types of environments is the use of a personal remote microphone (rm) system. this study will evaluate how much benefit children are getting from their bone conduction device alone compared to the bone conduction device with a personal rm system.

Eligibility criteria:
inclusion criteria: * english speaking * unilateral conductive hearing loss with a minimum of a 30 db air-bone gap and their parent/guardian exclusion criteria: * do not meet inclusion criteria
enb for the diagnosis of ppns:a real world study

Conditions: Peripheral Pulmonary Nodules

Summary: the study is designed as a multi-center prospective trial of enb for the diagnosis of peripheral pulmonary nodules in the real world. the purpose of the study is to identify the optimal method of using enb.

the study will be conducted at no less than 5 clinical centers. patients with peripheral pulmonary nodules suspicious for malignancy will be enrolled in the study. enb will be performed with/without other guided bronchoscopy techniques and/or rose. different biopsy methods will be recorded as well. the primary endpoint is the diagnostic yield of enb. the secondary endpoints include factors affecting diagnostic yield, operation time, complications, safety and so on.

Eligibility criteria:
inclusion criteria: 1. patients who are older than 18 year-old. 2. chest ct shows peripheral pulmonary nodule (8mm\<longest diameter≤30mm) suspicious for malignant that needs to be confirmed by pathology. the nodule is surrounded by lung parenchyma and invisible with standard bronchoscopy. 3. patients who agree to undergo bronchoscopy without any contraindications. 4. patients who have good compliance and sign informed consent. exclusion criteria: 1. presence of concomitant endobronchial lesion during the brochoscopy procerdure. 2. severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

Keywords: electromagnetic navigation bronchoscopy(enb) peripheral pulmonary nodules diagnostic yield
c-brace prospective registry

Conditions: Pareses; Lower Extremity

Summary: to gather prospective safety and effectiveness data for the c-brace system following the standard of care.

the purpose of the c-brace prospective registry is to gather prospective baseline and follow-up data to characterize the safety and effectiveness of the c brace. patients casted for c-brace fitting and willing to provide informed consent at participating clinics will be enrolled in the registry. all patients will be followed in accordance with the standard of care for a c-brace, which will include, at a minimum, baseline evaluation, fitting, patient training/therapy sessions, follow-up at 6 months, 12 months, 24 months and 36 months after the definitive fitting of the c-brace.

Eligibility criteria:
inclusion criteria: * patient has been evaluated and successfully tested with the trial tool, and has been casted for a c-brace. * patient is able to communicate, provide feedback, understand and follow instructions during the course of the registry. * patient is willing to provide informed consent. exclusion criteria: * patient is geographically inaccessible to comply and participate in the registry. * patient has not been casted for a c-brace fitting.
study to assess the safety and efficacy of tacrolimus (prograf capsule/injection) and methotrexate (mtx) combination therapy for prevention of graft versus host disease (gvhd) in patients who received peripheral hematopoietic stem cell transplantation from a sibling donor

Conditions: Graft Versus Host Disease

Summary: the objective of this study is to assess the safety and efficacy of tacrolimus (prograf capsule, prograf injection) and methotrexate combination therapy for gvhd prophylaxis in patients who received peripheral hematopoietic stem cell transplantation from a sibling donor, and to compare with data from a historical control group that administered a conventional cyclosporine formulation.


Eligibility criteria:
inclusion criteria: * blood diseases for a standard risk group * primary remission of aml (acute myeloid leukemia) * primary remission of all (acute lymphocytic leukemia) * secondary remission of all (acute lymphocytic leukemia) * saa (severe aplastic anemia) * chronic stage cml (chronic myeloid leukemia) * mds (myelodysplastic syndrome) * myeloma (multiple myeloma) * a patient who received peripheral hematopoietic stem cell transplantation from a hla-matched sibling donor exclusion criteria: * a patient with renal impairment (serum creatinine level ≥ 1.5mg/dl or 130μmol/l, gfr≤ 30%) * a pregnant or breastfeeding woman * a woman who is unwilling or unable to practice appropriate contraception during the study * a patient who is highly likely to experience aggravation during treatment due to active tuberculosis, other hepatic disease, hypertension, heart failure, chronic obstructive respiratory disease, etc. * a patient with hypersensitivity to tacrolimus

Keywords: prograf graft versus host disease hematopoietic stem cell transplantation prophylaxis peripheral hematopoietic stem cell transplantation
efficacy and safety study of rhtsh for adjuvant radioiodine ablation therapy in patients with differentiated thyroid cancer

Conditions: Differentiated Thyroid Cancer

Summary: this study was conducted in patients with differentiated thyroid cancer who had undergone total/near-total thyroidectomy. after surgery patients were randomized to one of two methods of performing thyroid remnant ablation. one group of patients who took thyroid hormone medicine and were euthyroid \[i.e. their thyroid stimulating hormone (tsh) levels are normal\], and received injections of rhtsh (0.9 mg daily on two consecutive days) followed by oral radioiodine. the second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their tsh levels were high), and were given oral radioiodine.


Eligibility criteria:
inclusion criteria: * subjects voluntarily sign the informed consent form (icf). * age ≥ 18 years old, either male or female. * patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as pt 1-3, n 0-1or nx, and m0. * eastern cooperative oncology group (ecog) score of 0-2; * expected life expectancy is greater than 12 weeks; * patients with a total or near-total thyroidectomy within 12 months prior to randomized. * low iodine diet for two weeks prior to randomized. exclusion criteria: * patients with recent history of 131i whole body scan within 2 weeks prior to randomized. * pregnant or breast feeding women. * patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission) * subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator. * subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.
personalized feedback after alcohol health education for members of greek life (greek study)

Conditions: College Student Drinking

Summary: heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. negative consequences from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g., assault, even death). although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. online interventions are cost-effective, offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment. in a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention. a second randomized, controlled trial confirmed efficacy for students of legal drinking age for a longer timeline. although promising, the booster incorporated in the study needs further empirical refinement. the current project seeks to build on past progress by further developing and refining the booster. in particular, the current project is an extension of previous work by expanding the investigation into complete social networks (students involved in greek life). this booster contains feedback about alcohol use tailored to the recipient, and will be emailed 2, 6, 10, and 14 weeks after baseline (experimental condition), or not at all (control condition). this study will be conducted specifically with students who are members of fraternities or sororities at odu (specifically, those in the organizations that agree to participate). this population engages in heavy alcohol use so is ideal for an alcohol intervention. members of fraternities and sororities (i.e., "greek life") engage in more frequent drinking, consume more when drinking, and have higher peak drinking occasions than students not involved in greek life. we aim to administer the intervention and associated booster among complete networks of greek organizations to examine how the intervention and booster and progress through social networks.


Eligibility criteria:
inclusion criteria: * participants must be at least 18 years old so that they can legally consent to participate. * participants must be an undergraduate student at the host institution and a member of a participating fraternitiy or sorority. exclusion criteria: * under 18 years of age * not a member of a participating fraternity or sorority at the host institution.
possible epigenetic changes in offspring of women with pregestational and gestational diabetes

Conditions: Gestational Diabetes; Pregestational Diabetes; IDM (Infant of Diabetic Mothers); Neurodevelopmental Outcome; Epigenetic Changes

Summary: pregestational diabetes (pgd) during pregnancy may be associated with an increased rate of spontaneous abortions, intrauterine death and congenital anomalies among the offspring. although the prevalence of congenital anomalies among the offspring of diabetic mothers is reduced as a result of the improvement of the glycemic control in the early pregnancy, the rate of congenital anomalies is increased and there seems to be an increased rate of neurodevelopmental disorders including some fine and gross motor deficits as well as increased rate of inattention and/or hyperactivity. in gestational diabetes, that develops in the second half of pregnancy (past the period of major organogenesis), there seems to be no increase in the rate of major congenital anomalies but there are some developmental disorders in the offspring. the exposure of the developing embryo and fetus to diabetic environment (i.e. hyperglycemia, hyperketonemia ext), is known to cause increased oxidative stress and significant changes in gene expression as observed in several experimental diabetic models. we hypothesize that diabetic environment may also cause long lasting epigenetic changes. it is therefore our purpose to evaluate these possible epigenetic changes and correlate their presence with the degree and time of onset of diabetes, (i.e. whether from the beginning as in pgd or in the second half of pregnancy as in gd), the degree of oxidative stress and with the neurodevelopmental outcome of the offspring. diabetic pregnancies will be compared to a similar number of normal pregnancies in all parameters studied.


Eligibility criteria:
inclusion criteria: * infants born to women suffering from pre-gestational or gestational diabetes. exclusion criteria: * non jewish population * triplets and up * premature infants under 32 weeks * infants suffering from major congenital anomalies * infants with chromosomal aberrations
anti-cll1 car t-cell therapy in cll1 positive relapsed/refractory acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia

Summary: this is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of anti-cll1 chimeric antigen receptor engineered t cell immunotherapy (cart) in the treatment of cll1 positive relapsed or refractory acute myeloid leukemia.

the patients will receive infusion of anti-cll1 car t-cells to confirm the safety and efficacy of anti-cll1 car t-cells in relapsed or refractory acute myeloid leukemia.

Eligibility criteria:
inclusion criteria: * cll1 positive relapsed/refractory acute myeloid leukemia * age 6-65 years * left ventricular ejection fractions ≥ 0.5 by echocardiography * creatinine \< 1.6 mg/dl * aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal * total bilirubin \<2.0 mg/dl * karnofsky performance status ≥ 60 * expected survival time ≥ 3 months (according to investigator's judgement) exclusion criteria: * patients are pregnant or lactating * uncontrolled active infection * class iii/iv cardiovascular disability according to the new york heart association classification * active hepatitis b or hepatitis c infection * patients with hiv infection * patients with history of seizure * active central nervous system leukemia

Keywords: cll1 cart aml
evaluate cardiac function using cardiac mri and dosimetric correlation

Conditions: Node Positive Breast Cancer

Summary: the association between radiation exposure and cardiac disease is well recognized, it is not fully understood if there exists an optimal or "safe" radiation dose-volume relationship.

identification of "safe" dose volume constraints (dvc) for the heart from breast cancer radiotherapy would permit maximal oncologic benefit from radiation, identifying which patients require more complicated and resource consumptive radiation methods such as respiratory-gating or intensity modulated radiotherapy (imrt) and establish patients who need targeted follow-up for their long term cardiac risk. two recent technical developments now make it conceivable to identify the dose-volume relationship between heart dose and subsequent cardiac event risk: 1. ct based three dimensional conformal radiation delivery methods (3dcrt) where the precise radiation dose to any given heart volume is known, and 2. cardiac mri (cmr) that is more sensitive to prior methods of cardiac evaluation (e.g. spect) for detecting and measuring cardiac injury. an mri, subject health questionnaire, clinical and dosimetric data will be included in the analysis.

Eligibility criteria:
inclusion criteria: * women with node positive breast cancer treated with surgery, anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007. exclusion criteria: * women who have not received anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.

Keywords: breast cancer
change of body composition after kidney transplantation in korea

Conditions: Kidney Transplantation

Summary: the graft survival in kidney transplantation has been improving after the introduction of new immunosuppressive agents. therefore, other complications after transplantation are concerned; one of those is obesity. several factors are attributable to obesity in kidney transplant recipients. the body composition such as fat mass and lean mass is important concept in overweight patients. some studies have been conducted on the change of body composition in kidney transplants. however, all of them are studied among caucasians or using dual energy x-ray absorptiometry (dexa). in this study, the investigators plan to study the body composition among asian kidney transplant recipients using the bioelectrical impedance analysis (bia).


Eligibility criteria:
inclusion criteria: * aged 20 years and over exclusion criteria: * history of previous transplantation * co-transplantation with other organs * neuropsychological problem with diet (such as anorexia nervosa, bulimia)

Keywords: body composition obesity kidney transplantation
haemostatic gel prophylaxis for post duodenal endoscopic resection bleeding

Conditions: Duodenal Bleeding

Summary: the purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to standard therapy.

this is a post-marketing follow-up study of a ce marked medical device, controlled, comparative, randomized, multicentre, international single-blind. the main objective is to evaluate the efficacy and safety of purastat in duodenal endoscopic mucosal resection or ampullectomy. this study will be carried out in france in 3 investigative centers. the duration of patient participation in the study is approximately 37 days depending on the time between the selection and the endoscopic intervention.

Eligibility criteria:
inclusion criteria: ampullary lesions * single ampullary lesion ≥ 10mm * resection via hot ampullectomy, injection/endoscopic mucosal resection of adjacent lateral spreading component duodenal lesions * ≤ 2 lesions * lesion ≥15mm * resection via hot endoscopic mucosal resection * morphology: 0-is, 0-iia/b/c or combination, submucosal lesions exclusion criteria: * inability to provide informed consent (including people with cognitive impairment); * pregnant or breastfeeding women; * allergy to purastat®; * "cold" mucosal endoscopic resection; * patient under guardianship or curatorship, or under a regime of deprivation of liberty; * participating patient, or in a period of exclusion from another clinical trial; * patient not benefiting from a social security scheme.