Kornimate/medical-research-clean huggingface dataset:
a single-arm study to evaluate administration of lebrikizumab by participants or caregivers in the home setting

Conditions: Asthma

Summary: this multi-center, single-arm study is designed to evaluate clinical experience of participants (or caregivers) administering lebrikizumab at home in participants with asthma. eligible participants will receive four doses of subcutaneous (sc) lebrikizumab every 4 weeks (q4w) up to week 12. primary analysis visit occurs at week 13. after study treatment, all participants will complete a 12 week safety follow up. all participants will get training for the administartion of lebrikizumab using the device.


Eligibility criteria:
inclusion criteria: * age between 18 to 75 years at week -1 * asthma diagnosis for greater than or equal to (\>=) 12 months prior to week -1 * pre-bronchodilator forced expiratory volume in 1 second (fev1) of \>=40% predicted at week -1 or week 0 (day 1; prior to entering treatment phase), based on an established spirometry reference equations * competent and willing, as determined by the investigator, to independently administer lebrikizumab at home. the investigator needs to confirm that the participant (or caregiver) will be able to follow the instructions to administer lebrikizumab * able and willing to take home the pre-filled syringes of lebrikizumab at the conclusion of week 0 (day 1) and store these according to the requirements highlighted within the instructions for use (ifu) document. exclusion criteria: * history of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection * hospitalization for any reason, including acute exacerbation event, within 4 weeks prior to week -1 or during the screening period * infection that required hopitalization, treatment with intravenous (iv) or intramuscular antibiotics within 4 weeks and oral antibiotics within 2 weeks prior to week -1 or during screening * taken part in a previous clinical trial of lebrikizumab and discontinued from the trial prematurely or discontinued study drug prematurely due to an adverse event
three-year trial on a new testosterone gel

Conditions: Hypogonadism

Summary: the objective of the study is to examine the efficacy and tolerability of a three-year-testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. the replacement therapy will be performed with a new testosterone gel examined in previous trials as testosteron gel wolff.

the objective of the study is to examine the efficacy and tolerability of a three-year-testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. the replacement therapy will be performed with a new testosterone gel examined in previous trials as testosteron gel wolff (tgw). a minimum of 100 patients will be recruited and evenly distributed to two treatment arms. 1st arm: dermal (non-scrotal) application of tgw. 2nd arm: scrotal application of tgw.

Eligibility criteria:
inclusion criteria: men with * hypergonadotropic hypogonadism * hypogonadotropic hypogonadism * late-onset hypogonadism combined with an initial testosterone serum level of \< 11 nmol/l exclusion criteria: * known or suspected carcinoma of the prostate * clinically relevant abnormalities in clinical chemistry or haematology * any severe medical conditions at the opinion of the investigator

Keywords: hypogonadism testosterone substitution
serum concentration of lidocaine after local injection during mohs micrographic surgery

Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma

Summary: the primary objective of this study is to (1) determine whether local injection of lidocaine used during mohs surgery will elevate serum lidocaine concentrations to a level that could cause systemic symptoms and (2) determine whether sustained high levels of serum lidocaine occur after intralesional anesthesia on the face and neck. this study is a cross-sectional study of 10 subjects with basal cell carcinoma or squamous cell carcinoma of the face or neck requiring mohs micrographic surgery. the study will consist of a brief questionnaire and blood draws during their moh's surgical procedure.


Eligibility criteria:
inclusion criteria * age: 18-75 * basal cell carcinoma or squamous cell carcinoma of the head or neck * subjects are in good health * subjects that have the willingness and the ability to understand and provide informed consent for the use of their blood and communicate with the investigator exclusion criteria * lidocaine sensitivity * bleeding disorder * pregnancy * medical conditions which would impair hepatic blood flow: congestive heart failure, liver dysfunction, peripheral vascular disease. * subjects who are unable to understand the protocol or to give informed consent * subjects with mental illness

Keywords: squamous cell carcinoma of the head or neck
post-operative satisfaction with glaucoma surgery trial

Conditions: Glaucoma

Summary: 1. investigate degree of postoperative satisfaction in county level hospital glaucoma patients. 2. investigate the effect of educational intervention affect the degree of satisfaction in glaucoma patients. 3. investigate the effect factors of postoperative satisfaction.

glaucoma is the leading cause irreversible blindness worldwide, but only less than 10% glaucoma patients were diagnosed in the country of asia areas. in the country of china, patients who are low educational level and less known acknowledgement and information have less known glaucoma. in the help of the government and some international non-governmental organizations(ngos), a lot of people in the country know the cataract, and the operability of cataract is increase. because vision loss usually development after operation for glaucoma. if patients did not understand this, they may be not only do not accept operation, but also affect operability of cataract. we hope the educational intervention for glaucoma can increase the degree of satisfaction in glaucoma patients.

Eligibility criteria:
inclusion criteria: * age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy exclusion criteria: * patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia

Keywords: glaucoma educational intervention post-operative satisfaction knowledges
sinusitis in children and the nasopharyngeal microbiome

Conditions: Sinusitis

Summary: the purpose of this study is to investigate the relationship between viral infections of the upper respiratory tract, perturbations of the nasopharyngeal microbiome in children, and the risk of acute bacterial sinusitis over a one year period. the investigators will determine the incidence of acute bacterial sinusitis post viral upper respiratory infection and identify the viral antecedent infections and other risk factors which predispose to infection and ultimately design strategies to reduce the burden of disease and antimicrobial resistance.


Eligibility criteria:
inclusion criteria: * children 4 to 7 years of age * healthy * english-speaking parent/guardian - exclusion criteria: * any underlying condition which would predispose them to the development of sinusitis including congenital or acquired immunodeficiencies * craniofacial abnormalities * cystic fibrosis * allergic rhinitis or a previous episode of chronic sinusitis.

Keywords: sinusitis upper respiratory infection
easy diabetes treatment study 1

Conditions: Type 2 Diabetes Mellitus

Summary: a 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic outcomes of individualized treatment support in patients with type 2 diabetes. the primary objective of the trial is to confirm the superiority of standard of care with easy dss versus standard of care without easy dss in terms of glycemic control in patients with type 2 diabetes with ongoing treatment with any antidiabetic drug(s).


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * ≥ 18 years of age at the time of signing informed consent * type 2 diabetes (diagnosed clinically) ≥ 6 months prior to screening * hba1c ≥ 7.0 \[58 mmol/mol\] by central laboratory analysis * stable daily treatment with any single antidiabetic drug or any combination of antidiabetic drugs for at least 90 days prior to screening (dose adjustment ±10% of insulin dose and temporary dose correction because of e.g. infection are allowed) exclusion criteria: * previous participation in this trial. participation is defined as informed consent. * currently participating in other clinical trials for diabetes * type 1 diabetes diagnosed clinically and/or by the presence of diabetes-associated autoantibodies * history of diabetic ketoacidosis or hyperosmolar hyperglycemic state * corticosteroid-induced or pancreatitis-induced diabetes * history of chronic or acute pancreatitis * known or suspected substance abuse * pregnancy * anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids or statins) * uncontrolled hypertension (systolic blood pressure \> 180 mmhg and/or diastolic blood pressure \> 100 mmhg) * renal failure stage 5, defined as (estimated or exact) glomerular filtration rate \< 15 ml/min/1.73m2 * recent or planned major surgery (such as gastric bypass operation) * major psychiatric disorders, mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with the trial site personnel * life-threatening disease including malignant neoplasms and medical history of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer)
non-operative management of pediatric appendicitis with an appendicoltih

Conditions: Appendicitis

Summary: to determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.

this study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.

Eligibility criteria:
inclusion criteria: * age : 7-17 years * abdominal pain \</= 48hours prior to receiving antibiotics * white blood cell count \>5 but \< 18 * us or ct confirmed early appendicitis plus: * us: \</=1.1 cm in diameter, presence of appendicolith * ct: \</= 1.1cm in diameter, presence of appendicolith exclusion criteria: * positive urine pregnancy test * pain \> 48 hours prior to first antibiotic dose * diffuse peritonitis * history of chronic intermittent abdominal pain * white blood cell count ≤ 5 or ≥ 18 * absence of appendicolith or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon

Keywords: appendicitis non-operative children appendicolith fecalith pediatrics
opioid, hiv and immune system

Conditions: Immune Defect

Summary: the purpose of this research is to evaluate blood samples from hiv infected and non-hiv infected people opioid and non opioid users to understand how opioid affect the immune responses (body defenses against infection) to the flu vaccine.


Eligibility criteria:
inclusion criteria: for opioid (op) users/non-users: 1. op users - prescribed opioids for at least the past 90 days; or injecting opioids for at least 90 days 2. opioid never-users in the past year additional criteria for op users: 1. op use for 90 days pre-flu vaccination 2. continued op use for 4 weeks post flu vaccination for hiv positive participants: 1) hiv infection, as documented by any licensed elisa kit and confirmed by western blot at any time prior to study entry. participants on art as a result of prior hiv documented infection will not be required to provide proof of diagnosis of hiv infection. additional criteria for hiv positive participants: 1. on art for at least 1 year with plasma pending viral load (vl) \<200 copies/ml. occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment 2. cd4 count available in the prior 6 months and \>200/mm3 3. undetectable viral load (\< 200 copies/ml) for hiv negative participants: 1) documented negative hiv test, either by any licensed elisa or rapid tests within the past 6 months. for all participants: 1. individuals age 18-60 yrs . 2. no history of other immunodeficiency disorders 3. not on steroid or other immunosuppressive/immunomodulators medications. 4. no active malignancies. 5. no contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine). 6. agreeable to receive the influenza vaccination. 7. agreeable to participate in study for a complete course of study full visits. 8. able to provide informed consent. exclusion criteria: 1. contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine). 2. non-adherence to art for hiv+ 3. unable to provide informed consent. 4. other comorbid conditions such as diabetes mellitus type 2 (dmt2) 5. influenza vaccination already given during the current vaccination season.

Keywords: flu vaccine response and hiv
adolescent attention to emotion study

Conditions: Depression

Summary: rates of depression increase rapidly during adolescence, especially for girls, and, thus, research is needed to spur the development of novel interventions to prevent adolescent depression. this project seeks to determine if a novel visuocortical probe of affect-biased attention (i.e., steady-state visual evoked potentials derived from eeg) can 1) be used to prospectively predict depression using a multi-wave repeated measures design and 2) modify affect-biased attention and buffer subsequent mood reactivity using real time neurofeedback. this work could ultimately lead to improved identification of adolescents who are at high risk for depression and directly inform the development of mechanistic treatment targets to be used in personalized intervention prescriptions for high-risk youth.


Eligibility criteria:
inclusion criteria: * participants will include 90 female adolescents ages 13 years 0 months through 15 years 11 months at study entry. exclusion criteria: 1. lifetime history of any dsm 5 depressive disorder 2. lifetime history of taking antidepressants (e.g., ssris) 3. lifetime history of a dsm 5 psychotic, bipolar, or autistic spectrum disorder. 4. presence of eeg contraindications (e.g., personal lifetime history of seizures or family history of hereditary epilepsy). 5. being pre-pubertal 6. lifetime history of a neurological or serious medical condition. 7. lifetime history of head injury or congenital neurological anomalies (based on parent report). 8. iq less than 80, as assessed using the wechsler abbreviated scale of intelligence (wasi). 9. uncorrected visual disturbance 10. being acutely suicidal or at risk for harm to self or others.
impact of covid-19 pandemic on patients receiving continuation or maintenance electroconvulsive therapy

Conditions: Electroconvulsive Therapy; Major Depressive Disorder; Covid-19

Summary: electroconvulsive therapy is a safe and effective therapeutic strategy in patients with treatment resistant depression. as relapse after successful ect is significant even with adequate pharmacological strategies, continuation (up to 6 months after completion of index-ect) or maintenance ect (more than 6 months after index-ect) is often necessary to maintain remission. during the current covid-19 pandemic hospitals redirected resources and closed or significantly diminished ect services. in this study we aim to assess the impact of discontinuing maintenance electroconvulsive therapy in patients diagnosed with unipolar depressive disorder.

during the height of the covid-19 pandemic in belgium all patients receiving continuation or maintenance electroconvulsive therapy (ect) for major depressive disorder in two ect centers in belgium will be included. due to differences in covid-19 infection rates and hospital management decisions, one ect-service temporarily halted all electroconvulsive treatments, where as the other ect-service continued continuation and maintenance treatments. depressive symptomatology and relapse rates will be assessed during the diminished accessibility of electroconvulsive treatment.

Eligibility criteria:
inclusion criteria: * continuation or maintenance ect, in treatment at two specified ect-centers in belgium * unipolar depressive disorder exclusion criteria: * unable to provide informed consent * unable to comply with study requirements (telephone questionnaire)

Keywords: electroconvulsive therapy maintenance ect continuation ect major depressive disorder covid-19
ncrnas in exosomes of cholangiocarcinoma

Conditions: Cholangiocarcinoma; Benign Biliary Stricture

Summary: exosomes are part of extracellular vesicles(evs), and can be secreted into the environment by many types of cells. it has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced.exosomes contain proteins,rnas and lipid,which may transfer biological information and activities from donor cells to receptor cells. non-coding rnas are involved in many biological activities including tumor growth and metastasis. in this prospective translational study, preclinical and clinical phases have been designed. on the first step, the main goal is to characterize the ncrnas of cholangiocarcinoma derived exosomes. this exosome biomarker may provide a useful diagnostic tool. as a second step, the study will evaluate the prognostic and predictive value of cholangiocarcinoma exosomes levels in plasma in a prospectively recruited cohort of cholangiocarcinoma patients before and after surgical resection.


Eligibility criteria:
inclusion criteria: * 1.provide signed informed consent. the subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by the independent ethic committee (iec)/institutional review board (irb) prior to the initiation of any study-specific procedures. 2.men or women aged \>= 18 years. 3.histology- or imaging-confirmed bile duct stricture. 4.metastatic disease or locally advanced disease not amenable to curative surgery. 5.radiographically assessable, non-measurable disease or measurable disease as per recist criteria. 6.life expectancy of at least 8 weeks from the time of enrollment. 7.no other malignancy within the past 5 years. 8.no prior chemotherapy for advanced disease. exclusion criteria: - 1.pregnant or lactating females. 2.significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent. 3.active hepatitis b or c or history of an hiv infection. 4.active uncontrolled infection.
real life long-term adherence to ticagrelor after pci for acute coronary syndromes

Conditions: Acute Coronary Syndrome (ACS)

Summary: documentation of long-term data regarding ticagrelor use and evaluation of reasons for discontinuation of ticagrelor in patients with acs

real-tica is a retrospective non-interventional study to assess the long-term use of ticagrelor in patients with acs and to evaluate the reasons for discontinuation of ticagrelor. for this purpose, selected sites from the alkk-pci registry and the respective patients will be identified. the sites' eligibility for this study includes the frequent use of ticagrelor during the acute phase of acs. eligible patients are characterised by the diagnosis of acs and the use of ticagrelor during pci. the eligible sites will be contacted by ihf and asked to contact their eligible patients by letter to obtain informed consent of the patients for the planned 12m follow-up by ihf. a detailed questionnaire on events within the last 12 months, current symptoms, current medication and the use of ticagrelor will be added to the patients' letters. patients then are asked to return their responses on consent to participate in the study as well as the filled in questionnaire to ihf. alternatively, patients may choose to receive a telephone call by ihf to answer the detailed questionnaire in person. in case of essential information missing, ihf will contact the primary care physician of the patient directly to obtain information about clinical events and medications.

Eligibility criteria:
inclusion criteria: * age \> 18 * acs (stemi or nste-acs) with pci * ticagrelor treatment during the acute phase * written informed consent for participation in the study. exclusion criteria: * none

Keywords: acute coronary syndrome (acs), ticagrelor
circulating progenitor cells levels in periodontal disease patients

Conditions: Metabolic Disease

Summary: recently, a key role played in the ethiology of periodontitis has been highlighted by a subtype of stem cells derived from bone marrow, the circulating endothelial progenitor cells (epcs). epcs possess the ability to express surface antigens of endothelial and hematopoietic stem cells and to assist in maintaining vascular integrity and the repair mechanism of the endothelium. among the main markers for the analysis of epcs levels are cd34+, cd133+ and the kinase insert domain-containing receptor (kdr). cd34+ and cd133+ originate from hematopoietic stem cell antigens whereas kdr is a specific marker of endothelial cells. more specifically, cd34+ and cd133+/ kdr+ allows less mature and mature epcs to be evaluated.

the aim of the present study was to investigate the association between endothelial progenitor cells (epcs) levels subtype (cd133+/kdr+), in patients with periodontitis. furthermore, the objective was to determine if the periodontal status influenced cd133+/kdr+ levels.

Eligibility criteria:
inclusion criteria: * presence of at least 16 teeth * cp with a minimum of 40% of sites with a clinical attachment level (cal) ≥2mm and probing depth (pd) ≥4mm; * presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs * presence of ≥40% sites with bleeding on probing (bop) exclusion criteria: * intake of contraceptives * intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study * status of pregnancy or lactation * previous history of excessive drinking * allergy to local anaesthetic * intake of drugs that may potentially determine gingival hyperplasia such as hydantoin, nifedipine, cyclosporin a or similar drugs.