Kornimate/medical-research-clean huggingface dataset:
the risk of cancer in users of regranex (becaplermin) and matched comparators (nonusers of regranex [becaplermin])

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to compare the risk of cancers in patients who have used regranex (becaplermin) to that of patients with similar characteristics and health issues who have not used regranex (becaplermin). regranex (becaplermin) is topical medication used to treat non-healing neuropathic foot ulcers in patients with diabetes.

this is an observational retrospective study where data will be collected from a medical claims database derived from a large national managed care organization with over five million members. members enrolled in a medicare supplement program will also be included. the objective of this study is to determine the incidence of cancer among patients who have used regranex (becaplermin) compared to patients who have not used regranex (becaplermin). regranex (becaplermin) is an fda-approved prescription medicine that contains a platelet-derived growth factor that is used for the treatment of foot ulcers in patients with diabetes. patients who were treated with regranex (becaplermin) between january 1998 and june 2003 will be identified in a health insurance claims database. another group of patients who have not been treated with regranex (becaplermin) but have similar characteristics to patients treated with regranex (becaplermin) will also be identified during the same time frame in the database. medical record abstraction and review will be conducted to verify all incident cancers identified. follow-up for study outcomes will be conducted from the date of accrual through termination of health-plan membership or december 2003 (whichever comes first). the date of accrual is the date of regranex (becaplermin) exposure for each exposed patient and his or her matched unexposed comparison patients. any incidence of death from cancer will also be identified. the primary outcome measure in the study will be the incidence rate of cancers of all kinds, grouped by organ site in patients who have used regranex (becaplermin) and patients who have not used regranex (becaplermin). a secondary objective is a similar comparison of the incidence of death from cancer. this is an observational study; no investigational drug will be administered.

Eligibility criteria:
inclusion criteria: * must have at least 6 months of continuous enrollment in health plan prior to regranex initiation exclusion criteria: * any cancer-related diagnoses identified in the claims data during baseline (the 6 month period prior to regranex (becaplermin) initiation).

Keywords: regranex (becaplermin) platelet-derived growth factor bb cancer cancer incidence cancer mortality
glulisine + lantus in type i patients

Conditions: Diabetes Mellitus, Type 1

Summary: to evaluate the efficacy (in terms of change hba1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (hmr 1964) in subjects with type i diabetes mellitus to evaluate the change in hba1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type i diabetes mellitus receiving hmr 1964 and insulin glargine.


Eligibility criteria:
inclusion criteria: * adult men and women (\>18 years) with type i diabetes mellitus (onset of diabetes under the age of 40) * an hba1c range of \>6.5 - \<11% * and on multiple injection regimen (more than 1 year of continuous insulin treatment) * body mass index \<35. exclusion criteria: * active proliferative diabetic retinopathy * diabetes other than type i diabetes mellitus * pancreatectomised subjects * subjects who have undergone pancreas and or islet cell transplantats, requiring treatment with not permited drugs during the study, previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine * hypersensitivity to insulin * major systemic diseases * impaired hepatic or renal function the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
parkinson's disease biomarker study

Conditions: Parkinson Disease, Idiopathic; REM Sleep Behavior Disorder

Summary: the primary objective of this study is to determine whether data acquired from a remote monitoring approach can reliably identify and track motor symptoms in prodromal pd and clinical pd. the study is a one-year longitudinal biomarker study recruiting idiopathic rbd patients, parkinson's disease patient and healthy controls. all participants receive a smartphone with the roche pd mobile application, complete a number of active tests daily and their movements will be remotely monitored. participants will undergo additional neurological exams and dat-spect and mri imaging in the study. a second objective of this study will be to validate an immunohistochemistry skin biopsy assay for the detection of pathological alpha-synuclein diagnostic of pd, in the peripheral nerves of the skin.


Eligibility criteria:
inclusion criteria: * signed consent form, male or female over age 40, ability to follow protocol, additional group-specific inclusion criteria exclusion criteria: * participation in interventional clinical study within 3 months of screening, moderate to severe depression in judgement of the investigator, any concomitant disease, condition or treatment which may interfer with the conduct of study (determined by investigator), additional group-specific exclusion criteria
long-term experience and health effects of covid-19

Conditions: Covid19; Corona Virus Infection; Quality of Life; Risk Reduction

Summary: the purpose of this study is to gain on-going covid-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. data will be deidentified and consolidated to create a large national longitudinal database.

ths is a longitudinal, observational, descriptive study to gather data needed to support a better understanding of covid-19 from the perspective of a diverse national population. this multi-phase study will use an action research approach to identify specific ways that physician groups, federally qualified health centers (fqhcs), public health departments, and other health and social services systems in the united states can address healthcare needs and mitigate the transmission of covid-19. email surveys will be used to assess the historical and current status of participants by medical condition, geography, and demographic characteristics, as well as their history of symptoms (e.g. recent cough, fever, loss of sense of taste or smell, etc.) and their current psychosocial needs. the study will provide the structure for an iterative exploration of trends over time (up to 24 months). the opt-in survey will be posted and available to individuals 18 and older who choose to participate. survey frequency will be every two weeks. to analyze broader trends, all survey responses will be de-identified and aggregated. overall general findings will not be linked to individuals or physician groups when reporting and publishing study results.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * any gender specification * has consented to proceed with survey * is able to complete the survey via email on a regular basis exclusion criteria: * none

Keywords: covid-19 corona virus covid19 coronavirus sars-cov-2 infection household transmission vaccine clinical trials online altura outpatient telemedicine
sophie: online-intervention for prevention and treatment of social anxiety in adolescents

Conditions: Social Anxiety; Social Anxiety Disorder

Summary: this study's aim is to investigate the efficacy of the online-intervention sophie. sophie is an online-intervention for adolescents with social anxiety. in switzerland, germany, austria and liechtenstein, about one in 15 adolescents suffers from social anxiety. the sophie intervention aims to help these adolescents to better understand and cope with their social anxiety symptoms and to feel more comfortable in social situations. the investigators intend to include 248 adolescents in the study. stratified by subclinical and clinical level of social anxiety, participants will be randomly assigned to the sophie group or the control group receiving care-as-usual. both groups will complete online questionnaires and will be interviewed via telephone several times during the study. this allows to compare the two groups regarding their efficacy of the sophie programme in terms of changes in social anxiety over time.


Eligibility criteria:
inclusion criteria: * age between 11;00 (11 years and 0 months) and 17;11 (17 years and 11 months) * good written and spoken german language skills * access to an internet connection and a device to use the intervention (tablet, smartphone, pc) and to collect the ema data (smartphone) * subclinical values on the spin (value: 16-23; loscalzo et al., 2018) or criteria for social anxiety disorder according to kinder-dips (schneider et al., 2017) * written consent of the adolescent (if at least 14 years old) or the parents or guardian (if adolescent under 14 years old) and assent of adolescent under 14 years old exclusion criteria: * known diagnosis of autism spectrum disorder * current suicidal ideation (collected via phq-a item 9) * lack of knowledge of the german language in spoken and written form * past diagnosis of social anxiety according to the dsm-5 criteria assessed by the kinder-dips (schneider et al., 2017) in participants with current subclinical anxiety

Keywords: prevention intervention adolescents youths online-intervention internet-intervention
sensory workshops and anorexia nervosa

Conditions: Anorexia

Summary: in the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. the investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. the team propose a prospective study over a period of 12 months in which we use the body mass index (bmi) as the primary endpoint of the state of anorexia nervosa patients.

as part of the unit that specializes in eating disorders in adolescents, we see patients decreased taste and smell sensory abilities. since 2006, we have implemented various sensory workshops: olfactory, tactile-kinesthetic and auditory. the establishment of this therapeutic practice that is centered on oral sphere and all respect, it was observed a decrease of 30% of the length of hospitalization. all the data we currently have in the field, suggests a rehabituation food odors and facilitate the recall of memories related to food in anorexic patients. however in the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. the investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. the team propose a prospective study over a period of 12 months in which we use the body mass index (bmi) as the primary endpoint of the state of anorexia nervosa patients.

Eligibility criteria:
inclusion criteria: * diagnosis of anorexia nervosa according to dms iv-tr (diagnostic and statistical manual of mental disorders) criteria. * follow outpatient care or hospitalization * able to respond to the clinical evaluation questionnaires * affiliated to the social security system * consentement informed of the legal representative and the patient exclusion criteria: * somatic comorbidity associated diabetes, celiac disease, brain tumor. * intolerance odors, predisposition to develop asthma and / or respiratory allergies. * pathologie chronic of nose and sinus. * hyposmic or anosmic.

Keywords: mental anorexia sensory workshops bmi
a study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of asc50 tables in healthy participants and participants with plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this is a phase i, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of asc50 tablets in healthy adult participants and adult participants with mild to moderate plaque psoriasis.


Eligibility criteria:
inclusion criteria: 1. male and female participants between 18 to 65 years of age inclusive, at the time of screening. 2. willing and able to give informed consent prior to any study specific procedures being performed. 3. have venous access sufficient to allow for blood sampling exclusion criteria: 1. female participants who are pregnant, breastfeeding or plan to be pregnant during the study period and 3 months after last dose. 2. history or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the investigator. 3. have received systemic immunosuppressive therapy (mtx, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug. 4. have any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.

Keywords: asc50 plaque psoriasis
multitract percutaneous nephrolithotomy(pcnl) in large renal stones.

Conditions: Staghorn Calculi

Summary: investigator aimed to analyze the clinical efficacy and safety of multiple tracts pcnl as one step therapy to treat the staghorn stones or multiple calyceal calculi which are inaccessible by single tract

staghorn calculi are branched stones either partial or complete occupying the pelvis and one or more of the renal caliceal system that is detected by non contrast computrized tomography (ncct) and plain on kidney, ureter, urinary bladder (kub). an untreated staghorn calculus over time can damage the kidney and deteriorate its function and /or cause life threatening sepsis. total stone clearance is an important goal to eradicate any infective focus, relieve obstruction and preserve the kidney function. based on american urological association (aua) guideline, pcnl is the most effective, safest and minimally invasive treatment option compared to open surgery

Eligibility criteria:
inclusion criteria: 1. adult patients more than 18 years old. 2. patients with staghorn stone (partial, complete). 3. patients with multiple calyceal calculi which are inaccessible by single tract. exclusion criteria: 1. patients under 18 years old. 2. patients with renal anomalies. 3. patients with only function kidney. 4. patients with distal ureteric obstruction. 5. patients with radiolucent stone. 6. patients with febrile urinary tract infection. 7. patients with abnormal coagulopathy state. 8. patients refused to participate in this study. 9. pregnancy. 10. musculoskeletal deformity.

Keywords: pcnl
hyperbilirubinemia after cardiac surgery

Conditions: Cardiovascular Diseases

Summary: this study aims to evaluate the incidence and risk factors of hyperbilirubinemia following major cardiac or thoracic aorta surgery, and to determine the clinical impacts of the hyperbilirubinemia on postoperative mortality and morbidity.

patients receiving elective cardiac or thoracic aorta surgery will be monitored for the development of postoperative hyperbilirubinemia. collection of data will include patient baseline demographic characteristics, laboratory and echocardiographic findings, procedural factors of the surgery, and early postoperative variables. serial postoperative liver function testings will be done during the hospitalization. postoperative hyperbilirubinemia is defined as serum bilirubin level of 3mg/dl.

Eligibility criteria:
inclusion criteria: patients aged over 18 years who are scheduled to undergo elective major cardiac or thoracic aorta surgery. major cardiac surgery includes coronary artery bypass grafting, pericardiectomy and corrections of cardiac diseases using cardiopulmonary bypassing (valve surgery, tumor excision, arrhythmia surgery, heart transplantation, ventricular reconstruction, pulmonary thromboembolectomy, and atrial or ventricular septal defects closure). exclusion criteria: 1. univentricular or one-and-half ventricle repairs 2. presence of known liver cirrhosis or hepatic cancer 3. history of liver transplantation 4. genetic diseases that affects bilirubin metabolism (i.e. gilbert syndrome) 5. preoperative bilirubin level of 3mg/dl or more.

Keywords: hyperbilirubinemia cardiac surgery aorta prognosis
promoting smoking cessation in hospital patients

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to experimentally test methods to promote long-term smoking cessation in hospitalized patients.

background: cigarette smoking is a vitally important public health problem. it is a major contributor to cardiovascular disease and one of the leading causes of cancer and respiratory disease. research in primary care over the last two decades has indicated that smoking cessation interventions in medical settings can be effective. however, there have been few published reports of research examining the effectiveness of smoking cessation interventions in hospital settings. in-patient smoking cessation interventions can potentially reach a large number of smokers. a hospital stay can also be an effective "teachable moment" for smoking cessation advice. smoking bans in place in hospitals make it a time of enforced abstinence and therefore, an opportunity to overcome the symptoms of physical addiction. patients are removed from their usual environmental cues for smoking, making initial cessation easier, and they might be particularly receptive to preventive health messages at a time of ill-health. finally, there is increased access to health care providers whom patients see as valid and knowledgeable sources of health information. design narrative: all smokers admitted to three hospitals over a 27-month period were identified as part of the admissions process. those who met eligibility requirements were randomly assigned to one of three treatment conditions: minimal care; a low intensity intervention whose centerpiece was brief firm advice by health care providers and labelling of the smokers' charts (pa intervention); and the pa intervention plus more intensive counseling and follow-up after discharge performed by a research nurse (pa+nc intervention). intervention components included provision of smoking cessation manuals and training of health care providers (all conditions); structural reminders to health care providers to give smoking cessation advice and provision of smoking cessation advice by a variety of health care providers on several different occasions (pa and pa+nc); and in-hospital counseling tailored to patient characteristics, feedback about a biological marker of smoking, a stepped care approach, and follow-up telephone counseling after discharge (pa+nc only). all participants were followed for twelve months after discharge from the hospital to examine the relative effectiveness and cost-effectiveness of the smoking cessation programs. in addition, information about smoking cessation advice given to study patients by primary care physicians in the twelve months after discharge from hospital was gathered to assess the possible synergistic effects of advice provided in in-patient and out-patient settings.

Eligibility criteria:
no eligibility criteria
home based exercises with and without posture and ergonomics training among students during covid-19

Conditions: Musculoskeletal Pain

Summary: the aim of this study is to investigate the effect of exercises with and without postural and ergonomic training among the students returning to university after quarantine due to covid-19.

postural awareness and ergonomic trainings are approaches that can help to relive pain among patients with musculoskeletal complaints. the purpose of this study was to investigate the effects of posture and ergonomics training for students receiving distance education during the covid-19 pandemic on musculoskeletal pain and physical activity level

Eligibility criteria:
inclusion criteria: 1. participant's using gadget like computer, mobile or laptop for online education during quarantine. 2. participant's having musculoskeletal pain during covid-19 quarantine. 3. prolonged sitting and low physical activity during quarantine. 4. prolonged exposure of screen more than 6 hours per day due online classes during the quarantine. exclusion criteria: 1. participant's having musculoskeletal pain before the quarantine. 2. participant's doing any type of physical activity during quarantine. 3. participant's taking online classes or any online educational program before quarantine. 4. participant's with known congenital, inflammatory and infectious conditions of spine. 5. participant's following any ergonomic recommendations or any postural awareness during and after quarantine.

Keywords: musculoskeletal pain posture ergonomic exercise covid-19
ophthalmic compatibility during seven days of continuous wear of silicone hydrogel lenses

Conditions: Myopia

Summary: the purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.


Eligibility criteria:
inclusion criteria: * is at least 17 years of age and has full legal capacity to volunteer * is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction * has had an ocular examination in the last two years * is a current soft (hydrogel or silicone hydrogel) contact lens wearer * has clear corneas and no active ocular disease * can be successfully fit with the lenses to be used in the study * other protocol-defined inclusion/exclusion criteria may apply exclusion criteria: * is pregnant or lactating * has undergone corneal refractive surgery * currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study * other protocol-defined inclusion/exclusion criteria may apply
chemical shift encoding-based water-fat magnetic resonance imaging in spinal tumors

Conditions: Spinal Tumor; Bone Tumor

Summary: fat composition of the spinal tumors is positively correlated with classification and differential diagnosis of benign and malignant tumors.

chemical shift encoding-based water-fat magnetic resonance imaging (mri) is a non-invasive method that provides quantitative information about the biochemical water-fat composition of bone marrow and skeletal muscle in vivo.

Eligibility criteria:
inclusion criteria: * pathological biopsy of a patient with diagnosed spinal tumor lesion, and preoperative examination chemical shift encoding-based water-fat mri was performed. exclusion criteria: * recurrent neoplasms; lesion diameter \< 1 cm; poor image quality.