Kornimate/medical-research-clean huggingface dataset:
mobile app and digital system for patients after myocardial infarction

Conditions: mHealth; Telemedicine

Summary: the treatment of acute myocardial infarction (mi) in poland is at the level of standardized european care. however, the first months after mi are crucial from the perspective of patient's prognosis. it is extremely important to take care of all cardiovascular risk factors. mobile application (afterami) supported by web system is a novel telemedical tool created to support patient and physician during the process of cardiac rehabilitation. the application has educational model with focus on cardiovascular risk factors and lifestyle after mi. moreover, there is a module to control vital signs like blood pressure, heart rate, weight and many others. additionally, application will send reminders for better drug adherence. 100 patients will be recruited to take part in the study. all of which will be hospitalized at the 1st department and clinic of cardiology because of the mi. the aim of the project is to study the impact of application-supported model of care with comparison to standard care. at the end of the study cardiovascular risk factors control will be analysed, as well as rehospitalizations, patient's knowledge regarding risk factors, return to work and quality of life. this will be a prospective, open-label, randomized, single-centre study. all 100 patients will be observed 6 months after discharge from the hospital. end points will be assessed during control visit 1- and 6-months after inclusion into the study. this project is an example of a telemedicine solution application into everyday practice, which is consistent with multiple international cardiac societies.


Eligibility criteria:
inclusion criteria: * signing the informed consent to participate in the study * hospitalization due to myocardial infarction * a mobile device with internet access and the android/ios operating system * age \>17 years old * positive results of the test verifying the basic skills of using mobile applications

Keywords: myocardial infarction telemedicine mobile health
efficacy and safety of gv 550 in acute adenovirus keratoconjunctivitis

Conditions: Acute Adenoviral Keratoconjunctivitis

Summary: the study objective is to evaluate the efficacy and the safety of gv 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.


Eligibility criteria:
inclusion criteria: * written informed consent * male or female aged from 18 to 80 years old * acute adenoviral keratoconjunctivitis exclusion criteria: * active ocular allergy * ocular herpès disease * history of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit

Keywords: gv550 acute adenoviral keratoconjunctivitis
study comparing simulect plus standard immunosuppression to standard immunosuppression alone for the prevention of acute rejection and bronchiolitis obliterans in lung transplant

Conditions: COPD; Emphysema; Alpha-1 Antitrypsan Deficiency

Summary: the study will evaluate the efficacy and safety of basiliximab vs placebo as induction therapy combined with standard triple immunosuppression therapy, in the prevention of acute rejection episodes and prevention of bronchiolitis obliterans syndrome.

the objective of this study is to evaluate the efficacy and safety of basiluximab for the prevention of acute allograft lung rejection when used in addition to neoral, corticosteroids and azathioprine. acute rejection episodes will be evaluated during the first 6 months post-transplant. bronchiolitis obliterans syndrome (bos) will be evaluated at the end of 1 year after transplant and at additional follow-up visits at 2 and 3 years after transplant.

Eligibility criteria:
inclusion criteria * male or female recipients of a first bilateral or single lung or lobar allograft who are suitable to receive neoral/ corticosteroids/ azathioprine/ and basiliximab (simulect). * patients greater than 18 years of age. * patients capable of understanding the purposes and risks of the study and who have given informed written consent. exclusion criteria: * patients who require immunosuppressive therapy other than the study medications. * patients participating in another (investigational) drug trial or who have participated in such a study within 30 days prior to transplantation. * pregnant mothers, nursing women. * women unwilling to use adequate contraception during and for 3 months after receiving study drug. * patients receiving or requiring other investigational drugs, except antibiotics. * patients with current or past peak panel reactive antibody levels of 25% or greater. * patients with malignancy or history of malignancy other than successfully treated non-metastatic basal cell or squamous cell carcinoma of the skin. * patients with any form of substance abuse or psychiatric disorder which, in the opinion of the investigator, might invalidate patient communication with the clinician(s). * patients who have previously received simulect.

Keywords: lung transplant rejection bos
conduction system pacing international registry (conspire)

Conditions: Bradyarrhythmia; Heart Failure

Summary: the purpose of this registry study is to collect information about routine clinical practices with device implantation to treat bradycardia and cardiac systolic dysfunction (heart rhythm disorders) across global centers of excellence in cardiac pacing. in particular, this study will examine the use of conduction system pacing (csp) in clinical practice. information collected in the registry will help researchers better characterize strengths and limitations of current technology and treatments.

during this past decade, there has been a dramatic surge in interest in new physiologic pacing strategies which engage and take advantage of the intrinsic cardiac conduction system. these approaches include his bundle pacing (hbp) as well as approaches which seek to pace the proximal left conduction system (lcs), including left bundle branch area pacing (lbbap) or pacing in the region of the left posterior fascicle. left ventricular septal pacing (lvs) has also been proposed as another means to avoid dyssynchrony with early data suggestive of comparable electrical synchronization as biventricular pacing. these approaches utilize approved pacing systems and leads which are delivered to new targets in the his-purkinje system or lv endocardial fibers. despite the growing interest in hbp, lcs, and lvs, the majority of data are from disparate cohort studies and there has been a lack of uniformity in assembling data or analyzing and interpreting outcomes. the goal of the conduction system pacing international registry (conspire) is to systematically and prospectively collect data across multiple centers of excellence on the early implementation of permanent conduction system pacing devices in order to characterize strengths and limitations of current technology. the study will evaluate patient selection, intraprocedural characteristics, and clinical outcomes among patients receiving conduction system pacing (csp) as part of their routine clinical care.

Eligibility criteria:
inclusion criteria: * meets american college of cardiology (acc)/american heart association (aha)/heart rhythm society (hrs) guidelines for bradycardia, or * meets acc/aha/hrs guidelines for cardiac resynchronization therapy (crt). exclusion criteria: * age \< 18 years * inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity * pregnancy * difficulty with follow-up

Keywords: conduction system pacing (csp) his bundle pacing (hbp) left ventricular septal pacing (lvs) left bundle branch area pacing (lbbap) proximal left conduction system pacing (lcs)
safety and tolerability of kiddi® pharmaton fizz effervescent tablets in children

Conditions: Healthy

Summary: study to evaluate the tolerability and safety of kiddi® pharmaton fizz effervescent tablets, in children of 6 to 14 years, comparing a given formula with an improved one with reduced mineral content (qualitatively equivalent to the first one) and a comparator product.


Eligibility criteria:
inclusion criteria: * children of both sexes aged between 6 and 14 years, inclusive * children, healthy or during convalescence, for which prevention or treatment of marginal vitamin deficits is indicated * willingness of the children and parents to give their written informed consent, according to good clinical practice and local regulations * pregnant children will not be excluded exclusion criteria: * has taken medications containing vitamins a or d, retinoids, or iron during the 4 weeks preceding the study enrolment * pre-treatment (less than 2 weeks prior the inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology, and may interfere with the evaluation of the safety of the test drug * participation in other clinical trials within the last 4 weeks and concurrent participation in another clinical trial * relevant allergy or kown hypersensitivity to one of the ingredients of the investigational drug * has any serious disorder that may interfere with the participation to the trial * malabsorption syndrome, liver and/or renal diseases or juvenile diabetes * increased calcium blood concentration, or an increased calcium-excretion * evident states of protein deficiency * presence of lysinemia (defect of the enzyme lysine ketoglutarate reductase)
il-11 in adults with von willebrand disease undergoing surgery

Conditions: Von Willebrand Disease

Summary: the purpose of this study is to determine the efficacy and safety of rhil-11 when given subcutaneously in adults with type 1 von willebrand disease undergoing elective surgery or major dental procedure. efficacy will be measured by estimated blood loss, and frequency and severity of bleeding and transfusion requirement during and after surgery. safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.

this study is a prospective, single-center phase ii trial of neumega (rhil-11) in adults with type 1 vwd undergoing elective surgery or major dental procedure. it is anticipated that 10 subjects who meet eligibility criteria will enroll and complete the study. the specific objectives are to determine the efficacy and safety or rhil-11 during and after elective surgery, and to determine the mechanism of the hemostatic response of rhil-11.

Eligibility criteria:
inclusion criteria: * males and females 18 years of age and older * confirmed type 1 vwd, as defined by low vwf:rcof or low vwf:ag and qualitatively normal vwf multimers * a past bleeding history * responsive to ddavp * scheduled elective major surgery or major dental surgery at muh or puh * willingness to have blood drawn exclusion criteria: * presence of other bleeding disorders, acquired von willebrand disease, primary thrombocytopenia * use of immunomodulatory or experimental drugs, or diuretics * pregnant or lactating women or those unwilling to use contraception during study * previous cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation, atrial flutter), hypertension, mi, stroke, or thrombosis * past allergic reaction to neumega or ddavp * surgery within the past 8 weeks * inability to comply with study protocol requirements * concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or nsaids * treatment with ddavp, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of fviii and/or vwf within five days of study * past allergic reaction to neumega or ddavp * surgery within the past 8 weeks * inability to comply with study protocol requirements * concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or nsaids * treatment with ddavp, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of fviii and/or vwf within five days of study

Keywords: il-11 von willebrand disease von willebrand factor vwfmrna surgery
breast fractionation study - standard versus investigational fractionation trial - nodal radiation

Conditions: Breast Cancer; Post Mastectomy

Summary: the purpose of this study is to investigate the difference in fatigue, quality of life and radiation morbidity between hypofractionated and conventional radiation to the breast, chest wall and regional lymph nodes post mastectomy or lumpectomy

breast cancer is the most commonly diagnosed cancer in australia. radiotherapy to the breast, chest wall and regional lymph nodes for breast cancer after surgery can reduce the risk of local recurrence by 50% and reduce breast cancer mortality. traditionally, radiotherapy is delivered in a large number of small doses i.e. 25 treatment sessions over 5 1/2 weeks. another approach is to give a lower number of larger doses i.e. 15 sessions over 3 1/2 weeks (hypofractionated radiotherapy). several studies in europe and asia have investigated hypofractionated radiotherapy to the chest wall, breast and regional lymph nodes following surgery for breast cancer, and found that it is equally effective to standard treatment, with similar side effects. these two approaches have not been directly compared in australia. this trial is to compare these two approaches, to determine whether hypofractionated radiotherapy is better tolerated by patients.

Eligibility criteria:
inclusion criteria: * age 18 years and older * ecog performance status 0-2 * ability to understand and willingness to sign a written informed consent document * stage pt1-3, pn0-3, m0 histologically proven breast cancer no matter the status of er/pr/her2 receptor testing * managed with either mastectomy or breast conserving surgery * suitable for radiation therapy to the breast/chest wall and regional lymph nodes * neoadjuvant and adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-her2 therapy is accepted * neoadjuvant radiotherapy (reverse sequencing) accepted * breast implants and expanders are accepted * patients with connective tissue disease are allowed if the treating radiation oncologist finds radiation therapy indicated * life expectancy minimum 10 years * patients with non-breast malignancies are accepted if the patient has been disease free for five years and/or has a low risk of recurrence as estimated by the treating radiation oncologist (to be determined at initial patient appointment) exclusion criteria: * prior radiotherapy to the ipsilateral breast or chest wall * pregnancy or lactation * radiosensitivity syndrome * permanent pacemaker/defibrillator within radiotherapy field * oncoplastic surgery where boost volume unacceptable (clinician discretion) * conditions indicating that the patient cannot go through radiation therapy or follow up, or a condition where the treating oncologist thinks the patient should not participate in the trial (for example, language barriers)

Keywords: radiotherapy hypofractionation quality of life
green light exposure in healthy volunteers exposure in normal human volunteers

Conditions: Chronic Pain

Summary: this research project is intended to understand the mechanisms of action for the pain-relieving properties of visual green light exposure. the investigators have shown previously that greenlight exposure decreased acute and chronic pain in both animals and humans. however, the investigators do not yet understand how green light exposure is capable of such function.

pain is a biological function. there are several pain centers in the brain that modulate the intensity of the pain signal perceived by the brain. part of the modulations takes place through two separate pathways. the first pathway mediates pain signals and is known as the ascending facilitator pain pathway. the main function of this pathway is to relay the pain signal to the brain to be processed. the second pathway is known as the descending inhibitory pain pathway. the main function of this pathway is to inhibit the pain signal mediated by the first pathway. normal humans typically have a balance between the activities of the ascending and descending pain pathways. the investigator animal studies suggest that green light therapy exhibits its pain-relieving effects through altering the balance between the ascending and descending pain pathway in a manner to result in an overall reduction or normalization in pain perception. to test this hypothesis, the investigators propose recruiting 30 healthy human volunteers. the participants will be equally randomized into either green light (treatment) or white light (control) exposure groups. the investigators will initially test the activities of the ascending and descending pathways using thermal and mechanical stimulations. the investigators will also test brain wave activities using a non-invasive eeg device. after establishing the baseline activities of the pain pathways and brain waves, the volunteers will be exposed to the green light or white light at low intensity (4-100 lux) for two hours in our laboratory. after two hours of light exposure, the investigators will again test the activities of the pain pathways using thermal and mechanical stimulation and measure the brain wave eeg activities.

Eligibility criteria:
inclusion criteria: 1. 18-50 years healthy men or women 2. able to speak and understand english 3. no history of chronic pain 4. no known neuropathies in areas that testing will take place, (forearms, muscle at the base of thumb on the palm of the hand and upper back/shoulder area. exclusion criteria: 1. serious mental illness defined as distortions of perception, delusions, hallucinations, and unusual behaviors resulting in loss of contact with reality. this will be assessed during the screening interview. 2. colorblindness or uncorrected cataracts. 3. tissue damage in areas that testing will take place, (forearms, muscle at the base of the thumb on the palm of the hand, and upper back/should area.
cctg 594: engagement and retention in care for hiv+

Conditions: Patient Adherence; HIV Positive

Summary: cctg 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based hiv alert specialist on improving endpoints of retention in care and maintenance of art as compared to the current standard of care (soc) in hiv primary care clinics.

design: cctg 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based hiv alert specialist on improving endpoints of retention in care and maintenance of art as compared to the current standard of care (soc) in hiv primary care clinics. duration: each subject will receive follow-up of at least 48 weeks. sample size: a total of 300 subjects will be randomized, 150 per arm. study population: eligible subjects will include 1) newly diagnosed hiv-infected individuals entering primary hiv care at one of the cctg clinics, or 2) previously diagnosed hiv-infected individuals who are "out of care" defined as having no visit with a prescribing hiv provider in the last 180 days and not on a stable arv regimen. stratification: subjects will be stratified based on study site and if they are newly diagnosed or returning to care.

Eligibility criteria:
inclusion criteria: * hiv-1 infection, as documented by any licensed screening antibody test, such as elisa, and confirmed by a second antibody test, such as western blot, or detectable plasma hiv-1 rna at any time prior to study entry. if an elisa or western blot is not available, hiv infection may be documented by two hiv rna values ≥2000 copies/ml, drawn at least 24 hours apart. the rna assays must have been run at a clia-approved laboratory or equivalent. * 18 years of age or older. * able to give written informed consent. * new patient to the clinic (defined as someone who has never engaged in hiv care) or a patient returning to care (defined as a patient previously seen at least once by a prescribing hiv provider who has not seen a prescribing hiv provider in the last 180 days and is not on a stable arv regimen). * english or spanish speaking. * registered to receive hiv primary care services at one of the identified cctg-affiliated clinic, i.e. the owen clinic at uc san diego health system, harbor-ucla medical center clinic or rand schrader clinic at usc. exclusion criteria: * unstable neurologic, psychiatric, or physical condition which, in the opinion of the investigator, would limit participation with study procedures for the duration of the study. * a level of drug or alcohol use that, in the opinion of the investigator, would preclude safe participation in the study. * resident of nursing home or skilled facility. * pregnant or breastfeeding. * patient's first primary care visit (for new patients) or return to care visit (for patients returning to care) occurred \> 60 days ago.

Keywords: retention care engagement
study of the links between suicidal intentionality and acute alcoholism

Conditions: Suicide, Attempted

Summary: there is a strong link between the alcohol consumption and the suicidal risk. indeed there is an increase of the risk of suicide in case of chronic or acute alcohol consumption. however why the alcohol consumption increase the suicidal risk is unknown. the hypothesis of this study is that the alcohol consumption induced disinhibition and facilitates the suicide attempt without premeditation

people hospitalized after a suicide attempt will answer to two questionnaires about the suicide intentionality and the acute alcohol consumption. there is 2 arms: people doing suicide attempt and with positive level of alcohol (up to 0.1g.l) people doing suicide attempt and with negative level of alcohol 110 patients will be included in this study so 55 in each arm.

Eligibility criteria:
inclusion criteria: * patient hospitalized in emergency department for a suicide attempt by voluntary drug intoxication * speaking and understanding french exclusion criteria: * patient who has used other psychoactive substances (attested by toxicological analyzes and / or interrogation) * known neurodegenerative pathology

Keywords: acute alcoholism
a comparative study of sage-217 plus an antidepressant (adt) versus placebo plus an adt in adults with major depressive disorder

Conditions: Depressive Disorder, Major

Summary: the primary purpose of this study is to evaluate the efficacy of sage-217 plus an adt in the treatment of major depressive disorder (mdd) compared to placebo plus an adt.

this study was previously posted by sage therapeutics. in november 2023, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: * diagnosis of mdd as diagnosed by structured clinical interview for diagnostic and statistical manual of mental disorders, fifth edition clinical trials version (scid-5-ct), with symptoms that have been present for at least a 4-week period * 17-item hamilton rating scale for depression (ham-d-17) total score of ≥24 at screening and day 1 * participant in good physical health and has no clinically significant findings, as determined by the investigator, on physical examination, 12-lead electrocardiogram (ecg), or clinical laboratory tests * participant is willing, able, and eligible to take at least 1 of the 5 adts specified in the protocol (an eligible adt is an adt that has not been taken during the current depressive episode and for which the participant has no contraindications; further, a participant is not eligible for citalopram if escitalopram has been taken during the current depressive episode, and vice versa) exclusion criteria: * has attempted suicide associated with the current episode of mdd * participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period * participant has treatment-resistant depression * history of bipolar disorder, schizophrenia, and/or schizoaffective disorder * known allergy to sage-217, allopregnanolone, or related compounds * has taken antidepressants within 30 days prior to day 1, and/or has taken fluoxetine within 60 days prior to day 1

Keywords: major depressive disorder mdd sage-217