Kornimate/medical-research-clean huggingface dataset:
mass balance study of [14c]hrs9531 in healthy male subjects

Conditions: Type 2 Diabetes Mellitus; Weight Loss

Summary: this study was a single-center, single-dose, open-label study in healthy male subjects to investigate the absorption, metabolism and excretion of hrs9531 after a single subcutaneous injection of \[14c\]hrs9531.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content and potential adverse reactions. 2. healthy male subjects aged between 18 and 55 years (inclusive), determined at the time of signing the informed consent. 3. body weight ≥50 kg, and the body mass index (bmi) between 19 to 32.5 kg/m2. 4. from the signing of the informed consent form until 12 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan. exclusion criteria: 1. history of any clinically important disease or disorder. 2. history of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug. 3. physical examination, vital signs or other laboratory measurements, other electrocardiographic parameters, abdominal ultrasound (except mild fatty liver), and abnormalities on chest radiography as judged by the investigator to be clinically significant. 4. the subject was considered by the investigator to have any other factors that would preclude him from participating in the study or the subject withdrew from the study due to his own reasons.
long-term efficacy and safety study with oralgen grass pollen

Conditions: Allergic Rhinoconjunctivitis

Summary: this study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass pollen season.

allergy is one of the most common chronic diseases. allergies to grass, weed, and tree pollens characteristically result in seasonal rhinitis symptoms commonly termed hay fever. the risk of developing asthma has been noted to be higher in patients with rhinitis than among the general population (10% versus 3.6%), confirming the fact that rhinitis is often the first step of the natural history of asthma. although several drugs effectively manage the symptoms of allergic rhinitis, conjunctivitis or asthma, they do not represent an etiopathogenic treatment of the considered diseases, and do not prevent the reappearance of the symptoms at the end of the treatment. immunotherapy is generally considered to be appropriate for patients in whom rhinitis symptoms cannot be controlled by an optimal medication regimen and avoidance of the allergens. at present, specific immunotherapy is the only therapy available that acts on the main cause of the allergic reaction by modifying or down-regulating the immune response. allergen immunotherapy is the administration of gradually increasing quantities of an allergen vaccine (extract) to an allergic subject, to reach a maintenance dose, which is effective in reducing the symptoms associated with exposure to the causative allergen.

Eligibility criteria:
inclusion criteria: * patients who meet the in and exclusion criteria for study ab0602 and successfully finished this study. * patients who have given their written consent to participate in this study. * patients who are willing to comply with the protocol and understand the information given. * female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method. * negative urine pregnancy test if female at the end of the previous study. exclusion criteria: * pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method. * patients who were non-compliant during study ab0602. * patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of this study.

Keywords: randomised double-blind placebo-controlled long-term efficacy and safety oralgen® grass pollen allergic rhinoconjunctivitis allergy rhinoconjunctivitis immunotherapy grass pollen extract
an analysis of the symptomatic domains most relevant to charcot marie tooth neuropathy (cmt) patients

Conditions: Charcot Marie Tooth Disease (CMT); Hereditary Sensory and Motor Neuropathy; Nerve Compression Syndromes; Tooth Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Heredodegenerative Disorders, Nervous System

Summary: the purpose of this study is to identify the issues that have greatest impact on qol for patients with charcot marie tooth (cmt) disease. patients who have -registered in the inherited neuropathies consortium contact registry will be invited to participate.

the protocol consists of two anonymous surveys. the first large scale survey is designed to identify items that best reflect the issues and symptoms with high impact upon qol in cmt. a second brief survey focuses on the frequency and impact of muscle cramps on qol in adult cmt. the surveys will be distributed via an online link to all adult cmt patients self-registered with the rdcrn contact registry. those who complete the first two surveys will be requested to complete only the second brief survey on muscle cramps again 3 weeks after completing it the first time. those who complete the brief muscle cramps survey a second time will be requested to complete it again 5 weeks later to assess variability in occurrence of muscle cramps. the first large scale survey to identify items that best reflect the issues and symptoms with high impact upon qol in cmt will be sent out in a second wave. this second wave will only contain the qol survey and not the muscle cramp survey. the qol survey will be distributed via an online link to three populations: adult cmt patients self-registered with the inc (rdcrn) contact registry who had not been registered at the time of the first enrollment period, adult patients who had been registered at the time of the first enrollment period and had received the survey, but had not returned it, and patients who were registered, but were under age 18 at the time of the first enrollment period and have turned 18 by the time of the second enrollment period.

Eligibility criteria:
inclusion criteria: * patients with cmt that are 18 years or older and have joined the inc rdcrn contact registry. exclusion criteria: * does not have cmt. * does not read or speak english.

Keywords: charcot marie tooth disease cmt hmsn hmn hsn
tree branch penetrating injury

Conditions: Penetrating Injury Neck

Summary: penetrating trauma to the neck can result in severe morbidity and mortality. location of the injury dictates the appropriate clinical management. challenging traumatic injuries require resourceful treatment options

a complex traumatic case of a foreign body penetrating the neck, the parotid gland, disrupting the internal jugular vein, with the tip resting at the anterior aspect of the c1 ring is reported. in this case, the authors seek to describe the clinical management of a vascular injury that resulted from penetrating zone iii of the neck. due to the complex and dense presence of various structure in the neck, injuries can be difficult to manage. thus, an algorithm identifies management strategies that are suggested based on the location of the injury, signs of vascular injury, identified injured structures and the hemodynamic stability of the patient. balloon tamponade has been described in other organs of the body and it might be a therapeuticn option in patients were venous injuries are difficult to access. penetrating neck injuries continue to result in significant morbidity and mortality. however, with appropriate and efficient evaluation and management, better outcomes are expected as demonstrated in this case.

Eligibility criteria:
inclusion criteria: * penetrating injury to the neck exclusion criteria: * n?a
geriatric assessment for older kidney transplantation candidates

Conditions: Chronic Kidney Diseases

Summary: geriatric assessment is now widely used to decide whether older patients with chronic kidney disease should be put on the kidney transplantation waiting list. this study aims to evaluate the association between geriatric assessment and inscription on kidney transplantation.

there is a high proportion of older patients among patients with kidney failure, raising the question of the access to kidney transplantation within these patients. geriatric assessment is now widely used to decide whether older patients with chronic kidney disease should be put on the kidney transplantation waiting list. this study aims to evaluate the association between geriatric assessment and inscription on kidney transplantation. secondary objectives includes the analysis of the association between geriatric assessment and: * post-kidney transplantation outcomes * quality of life. it also includes the evolution of geriatric assessment while still on waiting list and after kidney transplantation. this study takes place in an university hospital in caen, france. this hospital is the only one performing kidney transplantation in the three french departments around. candidates for kidney transplantation older than 70 years are systematically evaluated by a trained nurse and a geriatrician to perform a comprehensive geriatric assessment, evaluating cognitive functions, risk of fall, nutrition, frailty, functional status, and depressive symptoms. these patients are followed-up each year while still on the waiting list, and once after kidney transplantation. all patients evaluated within this consultation are proposed to enter the study. patients are excluded in case of refusal or if they are unable to provide informed consent. the inclusion began in january 2019.

Eligibility criteria:
inclusion criteria: * all patients addressed for geriatric assessment before inscription on kidney transplantation waiting list in caen university hospital, france exclusion criteria: * patient refusal * patient unable to provide informed consent

Keywords: chronic kidney disease kidney transplantation comprehensive geriatric assessment
efficacy and safety of nnc 0078-0000-0007 in patients with congenital haemophilia and inhibitors

Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Summary: this trial is conducted globally. the purpose of this trial is to confirm the efficacy and safety of nnc 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

scheduled dose visit in a non-bleeding state. single dose of nnc 0078-0000-0007 (vatreptocog alfa (activated)) every 3 months.

Eligibility criteria:
inclusion criteria: * male patient with clinical diagnosis of congenital haemophilia a or b and inhibitors to coagulation factors viii or ix * minimum of five bleeds requiring haemostatic drug treatment within the previous 12 months at trial entry exclusion criteria: * previous participation in this trial defined as withdrawal after administration of trial product * patient has received an investigational medicinal product within 30 days prior to this trial * congenital or acquired coagulation disorders other than haemophilia a or b * any clinical signs or known history of arterial thrombotic events or of deep venous thrombosis or pulmonary embolism (as defined by available medical records) * platelet count of less than 50,000 platelets/mcl (at the screening visit) * alat (alanine-transaminase) of more than 3 times the upper normal limit (according to laboratory reference ranges) * factor viii/ix immune tolerance induction regimen planned to occur during the trial * ongoing bleeding prophylaxis regimens or planned bleeding prophylaxis to occur during the trial * hiv (human immunodeficiency virus) positive with current cd4+ count of less than 200/mcl (defined by medical records)
eye and growth in adolescents born moderate-to-late preterm

Conditions: Preterm Birth; Visual Impairment; Eye Abnormalities

Summary: during recent years, the interest in studying the risks of being born moderate-to-late preterm (mlp), defined as birth between gestational week 32 to 36, has increased. today the investigators know that morbidity and mortality are significantly higher in these individuals compared to individuals born full-term. however, few studies have focused on the development of the eye in mlp individuals. the purpose of the study is to evaluate eye morphology and visual function in relation to growth, metabolism, blood pressure, neuropsychiatric factors, and quality of life in adolescents born mlp. the results of the examinations will be compared to an age-matched control group. the study will evaluate the structural, functional, and metabolic aspects of the eye with the hypothesis that early eye abnormalities may detect the risk of developing metabolic and cardiovascular diseases.


Eligibility criteria:
inclusion criteria: * born moderate-to-late preterm. * born in gothenburg, sweden. * born between years 2002 and 2004. exclusion criteria: * chromosomal abnormalities. * syndromes. * severe malformations. * asphyxia. * language difficulties. * psychosocial problems at birth. * severe maternal illness.

Keywords: moderate-to-late preterm
low dose steroids in the treatment of nephrotic syndrome relapse

Conditions: Glomerular Disease

Summary: background- idiopathic nephrotic syndrome is the common glomerular disease in childhood. conventional treatment is steroid treatment and nearly 90% response to this treatment well. response to this treatment is the most important prognostic factor and this patients has a benign disease course. 60-70% among patients that response to steroid treatment,will suffer a relapse of ns.repeated steroids courses can lead to serious adverse events in children such as low bone density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side effect corelation between steroid dose and treatment duration. guidelines for steroid dose for ns relapse are not based on retrospective clinical research but only on nephrologists and experts opinion. rational- what would be the optimal low dose steroids and the shortest time of treatment in nephrotic syndrome relapse?

idiopathic nephrotic syndrome in children is the most common chronic glomerular disease. the first line of therapy is prednisone and about 90% of the patients will response to this treatment. the course of the disease is characterized of recurrent relapses and repeated prednisone therapy. while prednisone doses and therapy duration in the disease diagnosis has been based on multiple prospective studies, the dose and therapy duration in the relapses was never challenged in a prospective control study. to address this question we designed prospective 3 arm study to evaluate the effective of exception steroid regiment to treat relapses versus lower doses. the study population is children in the age 2-18 year old with steroid sensitive nephrotic syndrome. after relapse will be diagnosed based on physical exam and urine tests, the patients will randomize to receive prednisone doses that are 60/m2 or 45/ m2 or 30/ m2. a measurement of time to obtain remission, duration of remission est. will be collected. we plan to recruit 100 children in this study.

Eligibility criteria:
inclusion criteria: * patients with idiopathic nephrotic syndrome with a flair that needs steroids treatment. exclusion criteria: * steroid resistance or treatment with cyclosporin or cellcept

Keywords: idiopathic nephrotic syndrome relapse
the effect of increased physical activity on adolescents' health and academic performance: the school in motion study

Conditions: Physical Activity; Academic Achievement; Mental Health

Summary: this study evaluates the effect of 120 minutes extra of physical education (pe) or physical activity (pa) on adolescents' physical health, mental health, academic performance and learning environment. this is a cluster-randomized controlled trial with three arms, where the participants in two of the groups will have different models of increased pe/pa during the school week, whereas the participants in the third arm is the control group including current practice.

this is a school-based, three-arm cluster randomized controlled trial (rct) recruiting adolescents from secondary schools in norway. adolescents (aged 14-15 years) were the unit of analysis, and schools (clusters) were randomly assigned to one of three conditions: 1. the physical active learning group (pal-group), where the schools each week include one additional physical education (pe) lesson, 30 minutes of physical active learning, and 30 minutes of physical activity (intervention condition); 2. the don't worry - be happy group (dwbh-group), where the schools include one new activity class (60 minutes: be happy class) and one additional pe-class (60 minutes: don't worry class) per week (intervention condition);or 3. current practice (control condition). an identical set of outcome measures are taken from all participants at baseline, and approximately 12 months after the baseline measures, when the participants were at the end of year 9

Eligibility criteria:
inclusion criteria: * subjects enrolled in 9th grade exclusion criteria: * none

Keywords: adolescents physical activity physical fitness academic performance cluster rct mental health secondary school physical education physical active educational lessons accelerometer
endoscopic treatment of biliary stricture caused by chronic pancreatitis

Conditions: Biliary Stricture; Chronic Pancreatitis

Summary: benign biliary strictures can be endoscopically treated with plastic or self-expandable metal stents (sems). the purpose of the prospective randomized study is to compare the safety and feasibility of covered sems with multiple plastic stents in the treatment of benign biliary stricture caused by chronic pancreatitis.

all consecutive patients admitted for ercp and treated for benign biliary stricture caused by chronic pancreatitis are prospectively enrolled in the study. at the initial ercp, an endoscopic sphincterotomy will be performed and one 10 fr plastic stent will be inserted for the initial treatment of cholestasis in all patients.pancreatic stent will be inserted if indicated. one to three months after the initial ercp the patients will be randomized into two groups: those who receive csems and those who receive multiple plastic stents into the bile duct. for the randomization, sealed envelopes will be used. as for csemss, removable csemss with diameter of 10 mm will be placed. a dilation with a 8-10mm balloon will be performed before and after the stent placement to secure the stent expansion. as for plastic stents, minimum three simultaneous 10 fr stents will be inserted after 8-10 mm balloon dilation. after three months a further ercp will be performed. the number of plastic stents will be increased maximally to six 10 fr stents after dilation if possible. in the group with csems, the position of the stent will be controlled. once the csems or plastic stents have been in place for minimum six months, the stents will be removed at the last ercp. follow-up clinical response (adequate biliary drainage) is the primary endpoint of the study. therefore, blood liver function tests (bilirubin, alkaline phosphatase) as well as the minimum diameter of the common bile duct in the area of the stricture, the maximum diameter of the common bile duct above the stricture and the length of the stricture are measured at ercps at the time of the initial plastic stent insertion (i.e. the first ercp) and at removal of csems or multiple plastic stents (the last ercp). in addition, blood liver function tests are measured and abdominal ultrasonography performed in the follow-up six months and two years after the stent removal. morbidity and mortality are additional endpoints of the study. therefore, complications (deaths, stent occlusions, dislodgements or migrations, cholangitis, hemobilia, stone formation above the stent), management of complications, admission times, surgical interventions and any additional care needed are monitored and recorded during the follow-up time. patients are asked to contact the physician at any time if symptoms such as fever, abdominal pain or jaundice occur.

Eligibility criteria:
inclusion criteria: * benign biliary stricture caused by chronic pancreatitis exclusion criteria: * malignancy, cirrhosis acute/chronic hepatitis or abnormal hepatic imaging. first attack of acute pancreatitis.

Keywords: chronic pancreatitis biliary stricture endoscopic treatment sems
sy001 targets mesothelin in a single-arm, dose-increasing setting in subjects with advanced solid tumors

Conditions: Treatment Related Cancer; Ovarian Cancer

Summary: single-arm, dose-increasing setting study of car macrophages in mesothelin overexpressing solid tumors.

this study was a single-arm, single-center, dose-increasing design, using the "3+3" approach for dose escalation, to evaluate the safety, tolerability and initial effectiveness of sy001, and to evaluate the pharmacokinetic characteristics, cytokines and the correlation between the efficacy of sy001.

Eligibility criteria:
inclusion criteria: 1. patients with pathologically diagnosed advanced ovarian cancer/pancreatic cancer who have failed at least 1 prior lines treatment, and tumor tissue samples were positive for mesothlin ihc staining; 2. according to the recist 1.1, there is measurable tumor lesions (non-lymph node lesion 10mm in length or lymph node lesion 15mm in diameter measured by ct or mri, with scan layer thickness 5mm); 3. eastern cooperative oncology group (ecog) score of 2 and satisfactory major organ functions; 4. estimated life expectancy \>3 months; 5. female patients of childbearing age must undergo a serum pregnancy test at screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment. exclusion criteria: 1. pregnant or lactating women; 2. any uncontrollable active infection, including but not limited to active tuberculosis, hbv infection; 3. patients who have a history of other mesothelin-targeting therapy; 4. patients who have a history of autoimmune disease; 5. the investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.
normigs - a study of micro-invasive glaucoma surgery

Conditions: Glaucoma

Summary: normigs is a non-randomized clinical study of intraocular pressure lowering effect and complications after preserflo microshunt implantation versus other types of glaucoma surgery. the study is conducted in the department of ophthalmology, oslo university hospital, norway.


Eligibility criteria:
inclusion criteria: * patients must be 18 years or older at the time of signing the informed consent form. there is no upper age limit. * scheduled for implantation of preserflo microshunt, trabeculectomy or other types of migs * ability to cooperate fairly well during the examinations * willing to participate in the study and capable of providing informed consent exclusion criteria: - high intraocular pressure due to increased episcleral venous pressure, hemorrhagic glaucoma, traumatic glaucoma or uveitis glaucoma