Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of acd856

Conditions: Alzheimer Disease; Cognition Disorder

Summary: the multiple ascending dose (mad) design of the study is based on the aim to study safety, tolerability, pk and pharmacodynamics of selected doses of acd856 in a limited number of healthy volunteers. acd856 will be administered orally.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent prior to any study-mandated procedure. * willing and able to comply with study requirements. * healthy male or female adults of non-childbearing potential aged ≥ 18 and ≤ 65 years at screening. * body mass index (bmi) ≥ 18.0 and ≤ 30.0 kg/m2 at screening. * only subjects of non-childbearing potential may be included in the study. male subjects with partners of childbearing potential must be willing to use condoms, be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner, as well as refrain from donating sperm from the date of dosing until 3 months after dosing with the imp. * clinically acceptable medical history, physical findings, vital signs, ecg and laboratory values at the time of screening, as judged by the investigator. exclusion criteria: * any exposure to acd856 in the past. * treatment with another investigational drug within 3 months prior to or during the study. * positive screen for drugs of abuse or a positive alcohol result at screening or admission to the clinic. * clinically relevant findings in laboratory parameters, ecg or vital signs at screening. * current smokers or subjects who use nicotine products. * history of alcohol abuse or excessive intake of alcohol. * history of, or current use of, anabolic steroids. * excessive caffeine consumption. * plasma donation or blood donation prior to screening. * any planned night shift work within the duration of the study, from 48 h prior to randomisation until follow-up. * any planned major surgery within the duration of the study. * evidence of an active infection that requires treatment with antibiotics within 2 weeks of planned dosing.

Keywords: alzheimer's disease cognition disorder
effect of erythropoiesis-stimulating agent therapy in patients receiving palliative care of chronic kidney disease

Conditions: Anemia of Chronic Kidney Disease

Summary: an observational study to evaluate the effect of erythropoiesis-stimulating agents in treating anaemia of renal disease among adult patients receive palliative care instead of dialysis.

erythropoiesis-stimulating agent (esa) has been commonly used to manage patients with end-stage renal disease receiving dialysis. the effects of esa, however, are unclear. this study compares the result of erythropoiesis-stimulating agent (esa) versus supportive care for chronic kidney disease patients receiving palliative care. the investigators design a retrospective observational study to evaluate the effect of erythropoiesis-stimulating agents in treating anaemia of renal disease among adult patients receive palliative care instead of dialysis. the primary objective is to assess whether esa can reduce the transfusion burden and hospitalization.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and older, who opted for esa treatment during palliative renal care for \> 360 days between january 1, 2014 and december 31, 2016 exclusion criteria: * patients who had dialysis or kidney transplant treatment

Keywords: erythropoiesis-stimulating agent
safety and efficacy of axicabtagene ciloleucel in combination with rituximab in participants with refractory large b-cell lymphoma

Conditions: Refractory Large B-cell Lymphoma

Summary: the primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large b-cell lymphoma.

following at least 24 months of assessments after axicabtagene ciloleucel infusion, participants will be asked to rollover to a separate long-term follow-up study (study kt-us-982-5968). participants will complete the remainder of the 15-year follow-up assessments in the kt-us-982-5968 study.

Eligibility criteria:
key inclusion criteria: * histologically confirmed large b-cell lymphoma * chemotherapy-refractory disease, defined as one or more of the following: * no response to first-line therapy (primary refractory disease) * no response to second or greater lines of therapy or * refractory after autologous stem cell transplant (asct) * at least 1 measureable lesion according to the lugano classification (cheson 2014). * individuals must have received adequate prior therapy, including at a minimum: * anti-cd20 monoclonal antibody * an anthracycline-containing chemotherapy regimen * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate renal, hepatic, pulmonary, and cardiac function key exclusion criteria: * known cd19 negative or cd20 negative tumor * history of richter's transformation of chronic lymphocytic leukemia (cll) * prior car therapy or other genetically modified t-cell therapy * prior organ transplantation including prior allogeneic stem cell transplant (sct) * prior cd19 targeted therapy * clinically significant infection or cardiopulmonary disease * presence of any in-dwelling lines or drains (dedicated central venous access catheters allowed) * history or presence of central nervous system (cns) lymphoma or nonmalignant cns disorder or cerebrospinal fluid (csf) malignant cells or brain metastases * history of autoimmune disease * history of deep vein thrombosis (dvt) or pulmonary embolism (pe) within the last 6 months note: other protocol defined inclusion/exclusion criteria may apply.
group intervention for interpersonal skills

Conditions: Depressive Disorder; Anxiety Disorder

Summary: the purpose of this study is to compare an individual state-of-the-art cognitive behavioral therapy (cbt) with cbt augmented by a group intervention for improving interpersonal skills, the kiesler circle training (cbt+kct), in patients with a depressive or anxiety disorder.

this study aims to test the effectiveness and feasibility of a transdiagnostic group psychotherapy to improve interpersonal skills, the kiesler circle training (kct). for this purpose, a prospective, bicentre, randomised clinical trial (rct) blinded by evaluators and statisticians will be conducted on outpatients with diagnoses of anxiety and/or depressive disorders according to dsm-5. an individual state-of-the-art cognitive behavioral therapy (cbt) will be compared with cbt augmented by kiesler circle training (cbt + kct) in a sample of 156 patients (cbt: 78 patients, cbt + kct: 78 patients). all participants will be assessed four times, at baseline (t1, week 2), at mid-treatment (t2, week 9), at post-treatment (t3, week 14) and at 3-months follow-up (t4, week 26). outcome measurements include interpersonal problems as well as symptom change in regard to both the categorical approach (primary diagnosis) and the transdiagnostic approach. the two main hypotheses are: 1. the improvement of interpersonal problems in the experimental group (cbt + kct) will be greater than the improvement in the control group (cbt). 2. the improvement of interpersonal problems will be associated with decreasing symptom severity related to the primary diagnosis, so that patients in the conjoint cbt+kct treatment will reach higher symptom change scores than patients in the cbt only condition. furthermore, we assume that the course of interpersonal problems is moderated by childhood maltreatment and mediated by the quality and quantity of daily social contacts.

Eligibility criteria:
inclusion criteria: * sufficient knowledge of the german language (b2 level) * primary diagnosis of either depressive disorder or anxiety disorder according to dsm-5 at time of screening * interpersonal distress above average (iip-32 \> 1.81) at time of screening * ongoing individual cbt at time of screening * signed informed consent regarding the study protocol exclusion criteria: * acute suicidality at time of screening * active substance abuse at time of screening * borderline, antisocial, schizoid or schizotypic personality disorder at time of screening * inability to participate in outpatient treatment with additional weekly group appointment at time of screening * any kind of additional group treatment (including self-help groups) besides individual cbt during the entire study period

Keywords: psychotherapy depression anxiety outpatient treatment group therapy childhood maltreatment moderator mediator daily social contacts electronical momentary assessment efficacy feasibility
effects of personalized actionable connected extensible (pace) interventions among patients with chronic kidney disease

Conditions: CKD - Chronic Kidney Disease

Summary: this is a randomized controlled trial study conducted on frail patients with chronic kidney disease(ckd).

the study will be conducted on 120 frail patients with ckd, who will be divided into 2 groups: group 1, consisting of 60 frail patients, will receive pace intervention (based on mobile social network support) for 6 months. group 2, comprising 60 frail patients, will receive usual ckd education and consultation for 6 months.

Eligibility criteria:
inclusion criteria: * diagnosed with ckd stage 1 to 5 * participants with pre-frail and frail conditions. * having access to a mobile phone and is capable of using mobile social network application (line) exclusion criteria: * received renal replacement therapy * participants achieved ttm stage 5
the effect on epcs by successful cardiac occlusion device implantation

Conditions: Foramen Ovale, Patent; Heart Septal Defects, Atrial; Atrial Septal Defect

Summary: all patients awaiting to have either a left atrial appendage closure (laa) or patent foramen ovale (pfo) or atrial septal defect (asd) closure device as part of standard care will be identified and reviewed in cardiology clinics. these patients will be placed on waiting list to undergo the procedure. patient-participants will be consented on the date of admission for device closure implantation. the study will recruit 20 patients divided into; 10 patients undergoing pfo/asd closure and 10 patients undergoing laa closure. epc will be measured on the day of the device implantation, day 0 and prior to discharge on day 1. patient participants are admitted overnight after the device closure implantation. then on subsequent out patient cardiology research clinic follow appointments on days (3-4) and (7-8).

the objective of this study is to assess the effect, if any, on epc count and cardiac device implantation. all patients awaiting laa or pfo/asd occlusion will firstly be reviewed in a cardiology clinic and assessed. suitable patients will then be placed on a waiting list for occlusion device implantation and therefore identified as potential participants in the study. patient-participants will be informed of the trial and given a chance to participate, this may be by face to face and or via invitation letter. all patient-participants will be given a copy of the patient information sheet. formal consent to participate in the trial will occur on the morning of the procedure. this will avoid repeated visits by patients that may have to travel some considerable distance. the study will recruit 20 patients divided into; 10 patients undergoing pfo/asd occlusion and 10 patients undergoing laa occlusion. epc will be measured on the day of the device implantation, day 0 and prior to discharge on day 1, then on subsequent follow up appointments on days (3-4) and (7-8). blood samples of 3-5ml will be taken to allow flow cytometric analysis for epcs. standard follow up for participants may include transesophageal echocardiography (toe) at 3 months after implantation. this will give a direct assessment of device related thrombus. currently toe is not standard of care in pfo follow up. if a toe result is available for either group the investigators will use the results in our study.

Eligibility criteria:
inclusion criteria: * patients aged 18 and over and suitable for cardiac device closure exclusion criteria: * patients unable to give informed consent or attend follow up
imu-based assessment of motor control in a population of young subjects with paramorphisms and dysmorphisms

Conditions: Genu Varum; Genu Valgus; Flat Feet; Cavus Foot; Scoliosis Idiopathic; Varus; Talipes; Valgus, Talipes; Laxity of Ligament; Hyperlordosis; Hyperkyphosis; Angular Limb Deformity

Summary: while various complex pathologies of the developmental age, such as infantile cerebral palsy or neuromuscular diseases, are notoriously considered causes of alteration of locomotor development, it is scarcely known whether conditions much more frequent in the pediatric population, the so-called "paramorphisms or dysmorphisms", may be associated with more or less noticeable changes in locomotor development. on a few studies, flat feet and hyperlaxity has been correlated with a motor control delay or poorer motor performance, based on complex clinical tests or on stereophotogrammetry movement analysis. although promising, these preliminary studies, in addition to not providing information on the possible influence of other paramorphisms, such as varus and valgus of the knees, do not provide conclusive indications. the aim of this study is to investigate, through clinical tests and wearable inertial units, the motor control of a pediatric population affected by paramorphisms or dysmorphisms and to compare them with a population of healthy controls, matched by age, taken from the recently developed control data set from bisi and stagni.


Eligibility criteria:
inclusion criteria: * born at term * without known delay in motor development * finding of one or more paramorphisms or dysmorphisms of the developmental age (flat or cavus foot, valgus or varus talipes, valgus or varus knee, scoliotic attitude or scoliosis, hyperkyphosis or hyperlordosis, generalized or focused hyperlaxity, heterometry of the aaii, torsional defects aaii) exclusion criteria: * preterm birth * diagnosis of pathologies compromising motor control (infantile cerebral palsy, neuromuscular diseases, spina bifida, arthrogryposis, genetic syndromes)
interference by activated protein c resistance in the determination of protein s activity

Conditions: Resistance to Activated Protein C in the Determination of Protein S Activity

Summary: protein s is an anticoagulant protein and a cofactor of protein c. it is recommended to explore it first by a functional (chronometric) technique by assessing its cofactor activity of activated protein c. existing tests measure the prolongation of a coagulation time. these tests are all dependent on factor v, but some patients have mutations in factor v (including v leiden) that make them resistant to activated protein c activity. it is suspected that these mutations lead to underestimations of protein s activity by chronometric technique.


Eligibility criteria:
inclusion criteria: * patient of legal age (≥ 18 years) * patient for whom a sample has been sent to the hus hematology laboratory for measurement of protein s activity between 28/12/2009 and 29/12/2020 * patient who does not object to the reuse of his/her medical data for scientific research purposes. exclusion criteria: * minor patient * patient with incomplete data

Keywords: protein c protein s activated protein c
patient outcomes of clinic transition from face to face encounter to telemedicine in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: adult patients with cystic fibrosis who are seen at the specialty cf clinic at university of virginia will be given an option to utilize telemedicine instead of in-person visits for standard clinic visits. health information from standard of care visits including fev1, exacerbations, leading to oral or intravenous antibiotics, laboratory results, hospitalization records, and responses to health questionnaires will be recorded for research purposes. data collected for the research study will be compared to baseline and previous years to determine if there are any deleterious effects for those who transition to telemedicine clinic visits.


Eligibility criteria:
inclusion criteria: * adult patients (18-year-old and older) with cf seen in the uva adult cf clinic who agree to participate in the study. exclusion criteria: * patients who cannot consent to the research study. in addition, prisoners will not be included.
idiopathic dilated cardiomyopathy

Conditions: Heart Diseases; Cardiomyopathy, Congestive

Summary: to determine the familial occurrence and pathogenesis of idiopathic dilated cardiomyopathy.

background: in 1987 idiopathic dilated cardiomyopathy was a disorder of unknown cause that directly affected one or both cardiac ventricles in a diffuse or multifactorial fashion, and that produced heart failure, at least in some patients. although a viral etiology had been proposed, dilated cardiomyopathy could be associated with numerous genetic and non-genetic diseases. however in 1987, the role of genetic factors was not known in humans. although the condition was usually dismissed as sporadic, numerous families with multiple affected members have been observed. the role of atrial natriuretic peptide levels in the pathogenesis or progression of idiopathic dilated cardiomyopathy was just beginning to be explored in 1987. although syrian hamster studies did not suggest a genetic deficiency as the primary cause of dilated cardiomyopathy in that model, it was thought possible that anp production or levels were somehow involved in how the myocardium responds in idiopathic dilated cardiomyopathy patients. design narrative: eligible patients were interviewed and asked whether any first-degree relatives were willing to participate. if family members participated, a three generation pedigree was constructed and first-degree relatives contacted. the relatives were interviewed for a medical history and medical records from other institutions were reviewed. each family member had a brief cardiovascular examination, a 12-lead electrocardiogram and 2-dimensional, m-mode, and doppler echocardiogram. blood was drawn for determination of atrial natriuretic peptide (anp) levels. the contributions of variability in age, sex, drug use, smoking, and other concomitants to variability in anp and echocardiographic data were estimated. after removing these sources of variability, the strength of similarity among family members was assessed. the relative contributions of genes and shared environments to the similarity among family members were estimated. heterogeneity in the mean levels of echocardiographic indices and anp levels, familial aggregation and etiology of aggregation were assessed between families with familial idiopathic dilated cardiomyopathy and families with non-familial idiopathic dilated cardiomyopathy. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
reducing problematic substance use in youth with chronic medical conditions

Conditions: Alcohol Abuse; Drug Abuse

Summary: the investigators goal is to pilot a substance use-related brief intervention (bi) for youth with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability and impacts of the approach for reducing substance use among this group.


Eligibility criteria:
inclusion criteria: * 14-18 years old * currently being treated for diabetes, rheumatologic disorders, asthma, or ulcerative colitis (uc) at boston children's hospital with a duration of chronic illness of at least one year * previous participation in the screening validation study * evidence of problems related to substance use exclusion criteria: * medically or emotionally unstable or otherwise unable to provide assent/consent * unable to speak/read english * unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire

Keywords: alcohol abuse drug abuse diabetes mellitus persistent asthma juvenile arthritis ulcerative colitis
lactobacillus rhamnosus and pcos treatment

Conditions: Insulin Resistance; Polycystic Ovary Syndrome; Hyperandrogenism; Obesity

Summary: the effect of lactobacillus rhamnosus supplementation on body weight, hyperandrogenism and insulin resistance in overweight and obesity women with polycystic ovary syndrome will be analysed.


Eligibility criteria:
inclusion criteria: * patients diagnosed with pcos, * bmi\> 28 kg/m2 (overweight or obesity), * patients not participating in other similar research programs at the same time, * no previous operations on ovaries such as: laparoscopy, ovarian cautery etc., * written agreement to take part in the research. exlusion criteria: * the use of antibiotics or probiotics within 6 months before the start of the experiment, * the use of pharmacological agents or hormones that may affect the course of the menstrual cycle or metabolic rate within 3 months, * the use of medicament that may affect on carbohydrate metabolism within 4 weeks, * failure to comply with dietary recommendations established during the nutritional intervention, * the use of weight loss supplements during the study, * clinical diagnosis of digestive disease (for example: irritable bowel syndrome, ulcerative colitis, crohn's disease, celiac disease), * pregnancy and breast feeding.

Keywords: lactobacillus rhamnosus polycystic ovary syndrome insulin resistance nutrition intervention probiotic
cerebral oximetry in newborns - comparing invos 5100c and oxyprem vs. 1.2

Conditions: Near-infrared Spectroscopy, Transition, Caesarean Section

Summary: regional tissue oxygenation (csto2) can be monitored by near infrared spectroscopy. the commercial device invos 5100 (covidien, mansfield, ma, usa) and the prototype oxyprem vs. 1.2 (biomedical optics research laboratory, zurich, switzerland) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective caesarean section. reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. the adult somasensor (invos) will be used together with the oxyprem sensor.


Eligibility criteria:
inclusion criteria: * term infants * elective caesarean section exclusion criteria: * thick hair that makes good measurements difficult/impossible * obvious malformations or syndromes * complications in relation to caesarean section * depression after birth (apgar \< 8 after 1 minute)

Keywords: near-infrared spectroscopy, cerebral oxygenation, term newborn, reproducibility,
effects of tissue sealers on minor laparoscopic procedures between obstetrics and gynecology residents

Conditions: Benign Gynecologic Neoplasm

Summary: the kind of equipment used during laparoscopic surgery may have an effect on how quickly resident surgeons improve their skills. the effects of these technologies on various general and specialized procedures have been the subject of numerous research, all of which have produced comparable results in terms of efficacy and safety. although a minimally invasive laparoscopy represents the gold standard method in over 70% of procedures for uterine and adnexal benign diseases, there is a paucity of evidence regarding the potential advantages or disadvantages of such kinds of devices in gynecologic laparoscopy. based on this, the purpose of this study was to determine whether using a hemostatic surgical device affects how quickly gynecology residents learn to execute simple laparoscopic procedures and how well they perform surgically.


Eligibility criteria:
inclusion criteria: * senior gynecological surgeons * at least 4 years of residency in gynecology exclusion criteria: * junior residents, fellows, consultants * operative procedures due to malignancy * women who were not suitable for or denied a laparoscopic approach * declined the procedure * did not sign a written informed consent form * suffering from a gynecologic malignant disease or severe systemic illnesses * laparotomic conversion