Kornimate/medical-research-clean huggingface dataset:
suicide ideation in hereditary angioedema

Conditions: Hereditary Angioedema (HAE); Suicidal Ideation; Cardiovascular Risk

Summary: this study focuses on patients with hereditary angioedema (hae) to better understand how mental health affects overall well-being. through a questionnaire, the investigators will assess the presence of suicidal thoughts, anxiety, and depression, as well as cardiovascular risk markers. by analyzing these factors together, the investigators aim to identify possible links between mental health and heart health in people with hae. this research will help improve care strategies and highlight the importance of mental well-being in managing hae.

this observational study focuses on patients with hereditary angioedema (hae) to explore the impact of mental health on overall well-being. through a questionnaire, the investigators aim to assess not only the presence but also the severity of suicidal thoughts, as well as symptoms of anxiety and depression. additionally, the investigators will evaluate how these mental health factors relate to disease variables such as hae control, disease activity, and quality of life. beyond mental health, the investigators also seek to understand its connection to cardiovascular risk factors. by measuring triglycerides, glucose levels, and body mass index (bmi), the investigators aim to explore whether patients with higher suicide risk also face increased heart health risks. this research will help improve patient care by emphasizing the importance of both mental and physical health in managing hae. after identifying patients with high risk of suicide ideation the investigators will conduct a folow-up study after patients have received mental health interventions and how evaluate how treatment can determine better hae outcomes. with these resuts the investigators expect to attract the attention of the international scientific community to increase early detection and effective solutions to prevent suicide.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of hereditary angioedema * over the age of 18 exclusion criteria: * patients with intellectual disability * refusal to participate in the study * patients with acquired c1-inh deficiency * patients with other dermatological diseases.

Keywords: hereditary angioedema suicidal ideation tyg-bmi cardiovascular risk
trying a new device for performing capsulorhexis in cataract surgery surgery

Conditions: Eye Disease; Cataract

Summary: during cataract operations a capsulorhexis is being performed. this is done in order to enable the removal of lens material while keeping the capsule intact in order to put inside the lens capsule an artificial intra ocular lens. the capsulorhexis must be round and with regular edge and no tears. while performing a cataract surgery we use phako emulsification machine that sends an ultrasonic wave that creaks the lens nucleus and at the same time irrigates the anterior chamber of the eye and sucks the fluid and the lens material of the creaked lens. the round shape and the regularity of the capsulorhexis are a must in these surgeries since the lens capsule must stay intact and stable in order to enable the phacoemulsification and the implant of the artificial lens. today capsulorhexis are done with a bent needle or with special forceps; the act of capsulorhexis is delicate, sometime un predicted and difficult to teach. the learning curve is relatively long and difficult. the proposed device enables a capsulorhexis which is round and has regular edges, done almost automatically and is predicted. the learning curve is short and easy. the capsulorhexis is done through the original operating wound with no need to widen it.

planed procedure 20 patients will be tested in this trail. consecutive patients that have senile cataract will be examined preoperatively as is done usually and the data of the examination will be collected/ a special attention will be given to the type of cataract and lens stability. systemic diseases will not be considered as exclusion criteria. patients with dens or mature cataract will be excluded. patients will be explained about the new device and those who will agree will sign a consent form. during the cataract surgery all steps will be done as usually except of the capsulorhexis which will be done by using the new device. the capsulorhexis will be photographed for further evaluation by a microscope camera. after the operation the surgeon will record his impression about the convenience of using the new device, the shape and form of the capsulorhexis and its stability and any other relevant information. post operative follow up will be done as usually, one day, one week, 3 weeks and six weeks after operation. the results of those examinations will be recorded and collected with special attention of iol stability, the shape of capsulorhexis and intra ocular post operative inflammation if will occur. the data, including the surgeons' comments, shape and form of capsulorhexis iol stability and the rest will be collected and processed. in case in which the use of the device will not perform a round and regular capsulorhexis, or instability of the capsule will occur or a un predicted intraocular inflammation will be seen the trail will be stopped immediately

Eligibility criteria:
inclusion criteria: * senile cataract exclusion criteria: * dens or mature cataract trauma congenital instability of the lens(phacodonesis,txf)

Keywords: capsulorhexis
trans canal tympanoplasty with local anesthesia using fat graft and "tachosil"

Conditions: Tympanic Membrane Perforation

Summary: eligible participants with chronic tympanic membrane perforation (\>6 month) will be given a detailed description and offered to participate in the study. the study investigates the efficacy of trans canal tympanoplasty with local anesthesia using fat pad and "tachosil". participants will be followed for 1 year after the procedure with otological examination and successive hearing evaluations.


Eligibility criteria:
inclusion criteria: * chronic tympanic membrane perforation (\>6 months). * central tympanic membrane perforation. * air bone gar of 35 db or lower at the operated ear. * no active otorrhea in the operated ear in the preceding 3 month prior to the procedure. * no evidence of a retraction pocket and no suspicion for a cholesteatoma. exclusion criteria: * known ossicular chain dysfunction * the tympanic membrane perforation edges are not accessible/visualized transcanal * pregnancy * allergy to lidocaine

Keywords: tympanoplasty
observational study of a novel peri infusion regimen on the infusion associated reactions with alemtuzumab infusion in patients with multiple sclerosis in a canadian clinical setting.

Conditions: Frequency of Infusion Reactions in Novel Versus Standard Protocol in Multiple Sclerosis

Summary: to evaluate a novel infusion protocol in ms patients treated with alemtuzumab

this observational study will evaluate and anaylse primary data investigating the effects of a novel peri-infusion regimen in ms patients in a candian clinical setting infused with alemtuzumab. this observational study has been developed by a canadian neurologist with the intent to treat ms patients receiving alemtuzumab in order to mitigate infusion associated reactions (safety) by utilizing an alternative peri-infusion protocol which is a deviation from the recommendation in the canadian product monograph. all the patients' recruited for this observational study were informed and consented for this novel peri-infusion regimen and were clinically followed by the neurologist for the two alemtuzumab infusion cycles and for any subsequent alemtuzumab infusions for potential mitigation of infusion associated reactions associated with alemtuzumab.

Eligibility criteria:
inclusion criteria: patient s treated with alemtuzumab as per canadian label - exclusion criteria: contraindication to alemtuzumab -
reliability and validity of the mini international neuropsychiatric interview for children and adolescents (mini-kid)

Conditions: Major Depression; Mania; Anxiety Disorders; Psychotic Disorder; Alcohol Dependence; Drug Dependence; Eating Disorders; Suicidality; Dysthymia; ADHD; Tourettes Disorder; Conduct Disorder; Oppositional Defiant Disorder; Pervasive Developmental Disorder

Summary: the primary aims of this study are to assess: 1. the inter-rater and test-retest reliability of the mini-kid 2. the validity of the standard mini-kid interview in relation to the parent rated pencil/paper version (mini-kid-p) and th longer clinician rated "schedule for affective disorders and schizophrenia for school aged children-present and lifetime version (k-sads-pl) and "expert opinion" (when available). secondary aims will include evaluating the concordance between: the children's global assessment scale (a required part of the k-sads) with the clinician-rated sheehan disability scale (to be administered with the mini-kid) as a measure of illness severity.

the mini-kid is a short, structured diagnostic interview used to assess the presence of 24 dsm-iv child and adolescent psychiatric disorders as well as the risk of suicide. to achieve adequate representation of the major psychiatric disorders and sufficient normal controls, we propose recruiting 230 children and adolescents (ages 6 to 17 years 11 months), comprised of 200 subjects identified as having one or more psychiatric disorders and 30 normal controls in the community. these subjects will be from diverse socioeconomic, racial and ethnic backgrounds. we will assess the inter-rater and test-retest reliability of the mini-kid and examine its validity with the "gold-standard" diagnostic interview for children and adolescents as well as expert opinion.

Eligibility criteria:
inclusion criteria: * subjects will be between the ages of 6 years and 17 years, 11 months * all subjects must meet mini-kid dsm-iv criteria for a least one of the axis i child psychiatry disorders covered by the mini-kid. * both sexes are included. exclusion criteria: * subjects who suffer from mental retardation, significant developmental disorders, congenital abnormalities, delirium, dementia, a language problem, or brain damage will be excluded. * subjects with neurological disorders, chronic or life threatening diseases will be excluded.

Keywords: mini-kid structured diagnostic interview reliability and validity k-sads sheehan disability scale
26 week efficacy, safety and tolerability study of indacaterol in patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive; COPD; Lung Diseases, Obstructive

Summary: stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study stage 2. study stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with copd


Eligibility criteria:
inclusion criteria: * male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure * co-operative outpatients with a diagnosis of copd (moderate to severe as classified by the global initiative for chronic obstructive pulmonary disease (gold) guidelines, 2005) and: * smoking history of at least 20 pack years * post-bronchodilator fev1 \< 80% and ≥ 30% of the predicted normal value. * post-bronchodilator fev1/fvc \< 70% (post refers to within 30 min of inhalation of 400 µg of salbutamol) exclusion criteria: * pregnant or lactating females * patients who have been hospitalized for a copd exacerbation in the 6 weeks prior to visit 1 or during the run-in period * patients requiring long term oxygen therapy (\> 15 h a day) * patients who have had a respiratory tract infection 6 weeks prior to v1 (with further criteria) * patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis * patients with a history of asthma (with further criteria) * patients with type i or uncontrolled type ii diabetes * patients with contraindications for tiotropium * patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality * any patient with active cancer or a history of cancer with less than 5 years disease free survival time * patients with a history of long qt syndrome or whose qtc interval is prolonged * patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures * patients who have had treatment with the investigational drug (with further criteria) * patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period * patients with known history of non compliance to medication * patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements other protocol-defined inclusion/exclusion criteria may apply

Keywords: indacaterol long acting beta-2 agonist
the potential role of microrna-155 and telomerase reverse transcriptase in diagnosis of non-muscle invasive bladder cancer and their pathological correlation

Conditions: Bladder Cancer; Bladder Disease; Bladder Neoplasm; Micro-RNA

Summary: we try to assess the potential role of telomerase reverse transcriptase and microrna (mir-155) in diagnosis of non-muscle-invasive bladder cancer and their correlation with stage and grade of the tumor.


Eligibility criteria:
inclusion criteria: * men and women 18 years or older. * patient with hematuria suspected to be of bladder origin clinically. * willing to be participate in the study. exclusion criteria: * patient having another malignancy. * hematuria of other causes as trauma and stones
creation of a normal database for fluorodeoxyglucose-positron emission tomography (fdg-pet) neurological examinations

Conditions: Lymphoma

Summary: the purpose of this study is to define a reference population for fdg-pet neurological examinations starting from patients having fdg-pet to supervise a non-complicated lymphoma (tumor in remission, low disabling chronic tumor).

this study will also check normality of cerebral functions in this population and analyse the influence of various variation factors, such as age, sex ratio, education level, professional activity and neuropsychological test results on normal data. this database could be later used as comparison to patient images defining the gravity and localization of their cerebral functional disorders.

Eligibility criteria:
inclusion criteria: * patient with tumor in remission or low disabling chronic tumor * no parenteral chemotherapy for at least 1 month * no glucocorticoid treatment * no general health modification (asthenia, anorexia, weight reduction) exclusion criteria: * patient having a known neurodegenerative disorder, a general disease or physical problems that can interfere with cognitive function * patient with cerebral pathology history (epilepsy, vascular event, cerebral vascular malformation, tumor, severe cranial trauma, meningitis or infectious or inflammatory encephalitis, hydrocephalus, mental retardation...) * patient not having at least 4 years of education * patient having an anxiolytic or anti-depressive treatment * patient refusing to participate to the study * patient incapable to give informed consent (guardianship)
study of combined oral contraceptive effects in female subjects

Conditions: Infection, Human Immunodeficiency Virus

Summary: the purpose of this study is to assess the effect of bms-955176 on the pharmacokinetics of coadministered oral contraceptives.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent a) the signed informed consent form 2. target population * a) healthy female subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, vital sign measurements, 12-lead ecg measurements, physical measurements, and clinical laboratory test results * b) body mass index (bmi) of 18.0 to 32.0 kg/m2, inclusive, at screening and day -1. bmi = weight (kg)/\[height (m)\]2 * c) weight greater than or equal to 45 kg * d) subject reenrollment: this study permits the reenrollment of a subject that has discontinued study as a pretreatment failure (ie, has not been treated). if reenrolled, the subject must be reconsented 3. age and reproductive status * a) women, 18 to 40 years of age, inclusive * b) women of childbearing potential (wocbp) with intact ovarian function as determined by medical history and history of regular menstrual cycles, and who have been on a stable regimen of ortho cyclen for at least 2 consecutive months without evidence of breakthrough bleeding or spotting, or subjects who have been using a stable regimen of another combination oral contraceptive containing ee for at least two months prior to dosing on day 1 of cycle 1 and willing to switch to ortho cyclen for the total duration of the study (approximately 78 days) * c) women must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of human chorionic gonadotropin) within 24 hours prior to dosing on day 1 of cycle 1 * d) women must not be breastfeeding exclusion criteria: medical history and concurrent diseases * a) any significant acute or chronic medical illness * b) history of biliary disorders, including gilbert's disease or dubin-johnson disease * c) current or recent (within 3 months of dosing on day 1 of cycle 1) gastrointestinal disease * d) any major surgery within 4 weeks of dosing on day 1 of cycle 1 * e) any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug * f) donation of \> 400 ml to a blood bank or in a clinical study (except a screening visit) within 8 weeks of dosing on day 1 of cycle 1 * g) blood transfusion within 4 weeks of dosing on day 1 of cycle 1 * h) inability to tolerate oral medication * i) inability to be venipunctured and/or tolerate venous access * j) smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on day 1 of cycle 1) * k) recent (within 6 months of dosing on day 1 of cycle 1) drug or alcohol abuse as defined in diagnostic and statistical manual of mental disorders, fourth edition (dsm iv), diagnostic criteria for drug and alcohol abuse * l) any other sound medical, psychiatric, and/or social reason as determined by the investigator
primary renal lymphoma on a 48 year old woman

Conditions: Renal Lymphoma

Summary: a 48-year-old female presented to our hospital with the following medical conditions: systemic arterial hypertension in treatment. she denies any allergies or surgical history. she reports a history of asthenia and adynamia for 3 months, accompanied by intermittent pain in the left flank. she denies hematuria, fever or weight loss. she underwent an enhanced ct examination at the local hospital, and a mass (10 x 9 cm in diameter) was noted in the left kidney.

she underwent radical nephrectomy and lymph node dissection. with the following surgical findings: (figure 3) kidney measuring 7 x 6 x 5 cm, with a tumor located in the upper pole of approximately 12 cm, with abundant newly formed vessels, loose and firm adhesions tumor-spleen and tail of pancreas, 1 artery, 1 vein, 1 ureter. postoperative pathology and inmunohistochemistry indicated dlbcl wich only localized in the kidney. bone marrow biopsy and ct of the chest region dod not show any evidence of linmphoma invasion. according to the findings, she was diagnosed with prl. after operation the patient received the r-chop regimen.

Eligibility criteria:
inclusion criteria: * patient with renal lymphoma exclusion criteria: * patient without renal lymphoma

Keywords: neoplasms, renal, primary
post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: pilot study in england

Conditions: Influenza, Human

Summary: this pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (aeis) after flu vaccination.

this is the third pilot study following, epi-flu-045 vs uk \[nct02567721\] and epi-flu-046 vs uk \[nct02893878\] studies, carried out in the 2 previous influenza seasons (2015/2016 and 2016/2017). this study will collect data about vaccination status and adverse events following influenza immunisation (aefi) on a weekly basis, from 01 september 2017 onwards, using a customized adverse drug reaction (adr) cards and data from electronic health records system for a period of approximately 13 weeks.

Eligibility criteria:
inclusion criteria: * all individuals who receive influenza vaccination among the 10 participating gp practices between 1 september and 30 november 2017 are eligible for inclusion in the analysis. exclusion criteria: * registered patients who have explicitly opted out of data sharing will be excluded from the analysis.

Keywords: england adverse event of interest seasonal influenza vaccines pilot study prospective passive enhanced safety surveillance
oral vitamin b12 supplementation and cognitive performance in elderly people

Conditions: Cognitive Decline; Cognitive Symptoms

Summary: the purpose of this trial is to study the effects of oral vitamin b12 supplementation and vitamin b12 combined with folic acid supplementation on cognitive performance for 24 weeks in elderly people with mild vitamin b12 deficiency.

mild vitamin b12 deficiency is highly prevalent in old age. reasons for this high prevalence are not fully understood, but include atrophic gastritis and bacterial overgrowth which affect the absorption (active) of food-bound vitamin b12. in contrast, the ability to absorb crystalline vitamin b12 (e.g. the form found in fortified foods or vitamin pills) remains intact in old age. in both healthy and cognitively impaired elderly people, associations between vitamin b12 status and cognitive performance have been observed, and the follow-up of geriatric patients suggests effects of parenteral treatment in early cognitive impairment. we investigated whether daily oral supplementation with 1,000 μg vitamin b12 or 1,000 μg vitamin b12 combined with 400 μg folate for 24 weeks improves cognitive performance in people over 70 years with vitamin b12 deficiency.

Eligibility criteria:
inclusion criteria: * mild vitamin b12 deficiency: * low plasma vitamin b12 concentration (100 \< b12 \< 300 pmol/l) * elevated methylmalonic acid (mma) concentration (\> 0.32 umol/l) * creatinine concentration \< 120 umol/l exclusion criteria: * severe cognitive impairment * anemia * gastrointestinal surgery or diseases * use of vitamin b12 injections or supplements containing \> 25 ug vitamin b12 and/or 200 ug folic acid * \< 90% compliance during a 2 week placebo run in period * no written informed consent * participation in other research studies

Keywords: vitamin b12 cognitive function oral supplementation elderly