Kornimate/medical-research-clean huggingface dataset:
activates charcoal for patients undergoing invasive procedure delayed due to direct oral anticoagulants

Conditions: Anticoagulants; Circulating, Hemorrhagic Disorder

Summary: this is a prospective, multicentric, randomized, open labeled superiority trial this study aims to evaluate the efficacy of oral activated charcoal for improving elimination of direct oral anticoagulants ( rivaroxaban, apixaban) in case of an unscheduled invasive procedure delayed to this anticoagulant treatment. the primary outcome is the anticoagulant's half life. plasma concentration will be measured by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic). a total of 140 patients will randomly be assigned to the charcoal or control group, stratified according to their anticoagulant drug.


Eligibility criteria:
inclusion criteria: * patients under direct oral anticoagulant treatment (apixaban, rivaroxaban or dabigatran) * age ≥18 years; * clinical condition needing a surgery or invasive procedure ( lumbar puncture, biopsy...), needing anticoagulant treatment interruption and intervention to be postponed * signed informed consent exclusion criteria: * urgent immediate surgery without any possibility to wait for 24 hours * contraindication for receiving oral treatment * active uncontrolled bleeding or bleeding in critical organ * hemodynamic instability, shock * known anticoagulant concentration \< 50ng/ml * drug intoxication * fructose intolerance, glucose and galactose malabsorption syndrome, sucrase-isomaltase deficit * treated epileptic disease * pregnant or breast feeding * patient under guardianship * no insurance cover * patient unable to give his consent * participation to another therapeutic trial

Keywords: activated charcoal, direct oral anticoagulant
cognitive behavioral therapy in panic disorder

Conditions: Panic Disorder

Summary: the investigators hypothesized that the group of patients receiving the medication interventions and cbt would show significant changes in their behavior, such as remission or reduction in anxiety, panic attacks, anticipatory anxiety, fear of body sensations, loss of control, and agoraphobia avoidance. and also, in the general evaluation of well-being, in the beginning and end of the treatment, in comparison to the control group (medication without cbt), during the same period.

this trial consisted in tracing the profile and evaluating their response to cognitive-behavioral techniques in a sample of 50 panic disorder patients with agoraphobia treated at the psychiatric institute of the federal university of rio de janeiro/brazil. objective: to test a specific model of cognitive-behavioral therapy through instruments applied in the beginning and end of the procedures. two groups of 25 patients were formed, the first one with medication and therapy and the second one with medication and without therapy, as the control group. methods: the cognitive-behavioral therapy sessions were held weekly and individually, with one-hour sessions. the work focused on physiological, cognitive and behavioral aspects with techniques of cognitive reorganization, exercises of induction of symptoms, "in vivo" exposure, breathing and relaxation exercises. the prescribed medication consists of tricyclic antidepressants (tca) or selective serotonin reuptake inhibitors (ssri). results: there was a significant difference between the initial and final evaluation of the group with the specific therapy, such as, reduction in panic attacks, anticipatory anxiety, agoraphobia avoidance, and fear of body sensations. in the global assessment functioning scale, global well-being increased from 60.8% to 72.5% among patients in the first group with therapy, differently from the group without therapy. we observed that 77.6% of the sample in both groups presented the respiratory subtype and 22.4% the non-respiratory subtype. conclusion: the association of specific cognitive-behavioral therapy focusing on somatic complaints associated with pharmacologic treatment in the first group was effective in this sample, in comparison to pharmacological treatment alone in panic disorder patients with agoraphobia.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * both genders with a diagnosis of panic disorder and agoraphobia without severe comorbidities. exclusion criteria: * patients showing alcohol or drug dependence * mental retardation * any other severe mental disorder.

Keywords: panic respiration anxiety exercise cognition
cardiac and respiratory function with non-invasive ventilation

Conditions: OHS; Hypercapnic Respiratory Failure

Summary: to assess patients with hypercapnic respiratory failure using echocardiography,cardiac output measurements and markers of neural respiratory drive (emgpara) prior to, during and after non-invasive ventilation (niv) initiation, and to follow the patients for 3 months. the investigators hypothesize that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in oxygenation, quality of life and exercise capacity.

respiratory failure is characterized by the incapacity of the respiratory system to maintain the normal arterial blood gas homeostasis. specifically, the overlap of hypoxaemia and hypercapnia (paco2 \>6 kpa) is referred to as hypercapnic respiratory failure (hrf). hrf is one of the most common causes for hospital admission with high re-admission rates, therefore constitute a major burden on healthcare systems. non invasive ventilation (niv) is a well established treatment in patients with hypercapnic respiratory failure who frequently suffer with associated pulmonary hypertension (ph). niv helps to increase arterial oxygenation and reduces hypercapnia. it is used in patients with hypercapnic respiratory failure caused by obesity hypoventilation syndrome (ohs). the associated degree of ph can lead to an increased afterload of the right ventricle (rv) that causes progressive remodelling of the right heart. rv dysfunction is correlated with a reduced long term prognosis in respiratory conditions. in literature niv is shown as effective method to treat acute hypercapnic respiratory failure in ohs. it has not been described how niv impacts on cardiac function and nrd in ohs.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ohs and overlap syndrome * hypercapnic respiratory failure with the need to commence niv * expected to remain an inpatient for ≥ 24 hours * age ≥ 18 and \<80 years * bmi \>30 kg/m2 * confirmed sleep-disordered breathing * able to give informed consent to participation in the evaluation study * clinically stable without exacerbations for ≥ 6 weeks exclusion criteria: * patients established on niv * inability to tolerate niv (\< 4 hours usage at during hospital titration) * contraindication to niv * requirement for immediate invasive mechanical ventilation at admission or any other acute critical illness * acute infective exacerbation * presence of other acute pathology or critical illness (such as pulmonary embolism) * presence of acute or chronic left ventricular cardiac failure * significant kidney or liver disease * significant anaemia * history of pulmonary embolism in the previous 2 years * presence of cardiac congenital disease * presence of primary pulmonary hypertension * presence of other severe medical problem, e.g. cancer and systemic connective tissue disease and vasculitides * pregnancy * psychological and social factors that would impair compliance with the evaluation
uterine niche symptoms and us and hystroscopic findings

Conditions: Uterine Niche

Summary: correlation between clinical ,soonographic and hysteroscopic findings in patients with uterine niche


Eligibility criteria:
inclusion criteria: * patient with uterine niche previous cs exclusion criteria: abnormal uterine bleeding -
efficacy and safety of zvs101e in patients with bietti 's crystalline dystrophy

Conditions: Bietti Crystalline Corneoretinal Dystrophy; Bietti Crystalline Dystrophy

Summary: this is a multi-center, randomized and controlled phase 3 clinical trial.

subjects who have signed the written informed consent form and who were eligible for enrollment after screening will be randomly assigned to the treatment group or untreated control group. each participant in the treatment group will receive a unilateral subretinal injection of zvs101e in the study eye. participants in the control group will receive no treatment during the first 52 weeks of enrollment.

Eligibility criteria:
inclusion criteria: 1. all of the following inclusion criteria should be met for enrollment into the trial: 2. fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the informed consent form, and be able to complete all trial procedures as required by the protocol; 3. clinical diagnosis of bietti's crystalline dystrophy (bcd), age≥18 years ; 4. genetic testing confirmed biallelic cyp4v2 mutations without other ophthalmic genetic diseases; 5. best-corrected visual acuity of 5-60 etdrs letters. exclusion criteria: 1. the study eye has or has had macular lesions such as macular hole or macular neovascularization; glaucoma, diabetic retinopathy, or any other ocular disease that may preclude surgery or interfere with interpretation of the study endpoints 2. the study eye had received the following intraocular surgical treatments: retinal reattachment, vitrectomy; 3. the study eye had received any intraocular surgery, such as phacoemulsification 3 months prior to enrollment; 4. previously treatment of either eye with gene therapy or stem cell therapy for bcd and other ocular diseases, including but not limited to viral vector gene therapy, rna therapy; 5. pregnant or lactating women;

Keywords: gene replacement therapy zvs101e aav8-hcyp4v2 phase 3 bietti crystalline corneoretinal dystrophy
a study in healthy subjects to investigate whether administration of clazosentan can affect normal heart function

Conditions: Healthy Subjects

Summary: the study will investigate whether administration of clazosentan can affect normal heart function in healthy subjects


Eligibility criteria:
inclusion criteria: general criteria * signed informed consent prior to any study-mandated procedure * body mass index of 18.0-30.0 kg/m2 (inclusive) at screening * systolic blood pressure 100-145 mmhg, diastolic blood pressure 50-90 mmhg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at screening and on day -1 of the first period * 12-lead ecg: qt interval corrected using fridericia's formula (qtcf) \<450 ms for male subjects and \< 470 ms for female subjects, qrs interval \< 110 ms, pr interval ≤ 200 ms, and heart rate (hr) ≤ 90 bpm without clinically relevant abnormalities using a 12-lead ecg measured after 5 min in the supine position at screening and on day -1 of the first period study-specific criteria * women of non-childbearing potential * male subjects must accept to use a condom and not to procreate for the duration of the study and for 3 months thereafter exclusion criteria: general criteria * previous exposure to clazosentan or to moxifloxacin within 3 months prior to screening * known hypersensitivity to any of clazosentan excipients or to moxifloxacin or any of its excipients * any contraindication to moxifloxacin treatment * acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study * previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions if considered clinically significant by the investigator * veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access, or puncture, veins with a tendency to rupture during or after puncture) * participation in a clinical study involving study treatment administration within 3 months prior to screening or in more than 4 clinical studies within 1 year prior to screening * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol study-specific criteria • history or presence of rhythm disorders (e.g., sinoatrial heart block, sick-sinus syndrome, second- or third-degree atrioventricular block, long qt syndrome, symptomatic bradycardia, atrial flutter, or atrial fibrillation)
phase 1, multiple dose study of mpc-6827 in subjects with refractory solid tumors

Conditions: Refractory Solid Tumors

Summary: phase 1, multiple dose study of mpc-6827 in subjects with refractory solid tumors.


Eligibility criteria:
inclusion criteria: 1. advanced or metastatic cancer 2. measurable / evaluable disease 3. karnofsky score greater than or equal to 70% 4. adequate hematology / organ function 5. no baseline peripheral or central neuropathy above grade 1 exclusion criteria: 1. hypersensitivity to cremophor el 2. pregnant or lactating 3. spinal cord compression 4. pre-existing dementia / cognitive disfunction 5. require neupogen or neulasta to maintain neutrophil count 6. have primary brain cancer 7. have history of ischemic heart disease 8. have diabetes

Keywords: solid tumors refractory brain
extension of phase ii therapeutic trial with a humanized non-mitogenic cd3 (chagly cd3) monoclonal antibody in recently diagnosed type 1 diabetic patients

Conditions: Diabetes Mellitus, Type 1

Summary: compared to placebo, treatment with chagly cd3 has a beneficial effect on preservation of beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical onset of disease that persists until 48 months after administration. the investigators also hypothesize that in type 1 diabetic patients with recent clinical onset of disease compared to placebo, chagly cd3 will be safe and well tolerated between 18 and 48 months after administration, based on assessment of clinical and laboratory adverse events.


Eligibility criteria:
inclusion criteria: * subjects with type 1 diabetes mellitus included in the phase ii therapeutic trial with a humanized non-mitogenic cd3 monoclonal antibody (chagly cd3) at time of clinical diagnosis and who agree and are likely to comply with the investigator's instructions exclusion criteria: * any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient * use of illicit drugs or over consumption of alcohol (\> 3 beers/day) * being legally incapacitated, having significant emotional problems at the time of the study

Keywords: diabetes mellitus, type 1 chagly cd3
clinical trial of low intensity shockwaves therapy for erectile dysfunction post-radical prostatectomy

Conditions: Erectile Dysfunction

Summary: research study designed to learn about and compare shockwave therapy (swt) vs placebo (no shockwaves) treatment in men with moderate to severe erectile dysfunction (ed) after radical prostatectomy


Eligibility criteria:
inclusion criteria: 1. be willing and able to provide informed consent. 2. be male 3. be ≥ 40 and ≤ 75 years of age (inclusive). 4. undergo radical prostatectomy for prostate cancer (nerve sparing or non-nerve sparing without neoadjuvant chemotherapy or radiation therapy.) 5. be at least six weeks post radical prostatectomy. 6. be in a stable sexual relationship for over 3 months prior to enrollment. 7. have testosterone level of 300-1000 ng/dl within 1 month prior to enrollment. 8. have an hba1c level ≤ 7% within 3 months prior to enrollment. 9. have undetectable psa value at the time of enrollment exclusion criteria: 1. be currently participating in a clinical trial or have recently received an investigational therapy within the past 30 days that may interfere with the results of this study. 2. be under judicial protection (prison or custody). 3. be an adult under guardianship. 4. refuse to sign the informed consent. 5. have evidence of venous leak prior to surgery or use of pde5i prior to surgery 6. have past radiation therapy of the pelvic region or hormonal therapy with androgen deprivation within 12 months prior to enrollment. 7. be recovering from any cancer within 12 months prior to enrollment (other than prostate cancer) 8. have neurological disease such as alzheimer's or parkinson's disease which affects erectile function (at the discretion of the investigator). 9. have a psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications (at the discretion of the investigator). 10. have an anatomical malformation of the penis, including peyronie's disease. 11. have testosterone level \ 1000 ng/dl within 1 month prior to enrollment. 12. be using blood thinners with international normalized ratio (inr) to be \> 3. 13. have received shockwave therapy for at least 6 months before enrollment. 14. have detectable psa value after the radical prostatectomy. 15. require radiation therapy after radical prostatectomy. 16. require hormonal therapy after radical prostatectomy.
thalidomide in mucosa associated lymphoid tissue (malt) lymphoma patients

Conditions: MALT Lymphoma

Summary: the purpose of this study is to evaluate thalidomide for treatment of disseminated malt lymphoma or at relapse following helicobacter pylori (hp) - eradication or chemotherapy or radiation.

the objectives of this study are to evaluate the effectivity and the safety of thalidomide in patients with disseminated malt lymphoma or at relapse following hp-eradication, or chemotherapy or radiation. it is a phase ii prospective single arm study with a target sample size of 16 patients. thalidomide is given orally at an initial dose of 100 mg for a maximum duration of 6 months.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed malt lymphoma with measurable disease (stage i-iv) * with first or greater relapse after hp-eradication, radiation or chemotherapy * age \> 18 * must be able to tolerate therapy and have adequate cardiac, renal and hepatic function * ecog status _\< 2 * must be capable of understanding the purpose of the study and have given written informed consent

Keywords: malt lymphoma thalidomide disseminated malt lymphoma or at relapse following hp-eradication or chemotherapy or radiation
evaluation of the bard® true™ flow valvuloplasty perfusion catheter for aortic valve dilatation

Conditions: Aortic Valve Stenosis

Summary: the primary objective of this study is to collect data to confirm the performance and safety of the true™ flow valvuloplasty perfusion catheter during dilatation of the aortic valve in the preparation for transcatheter aortic valve implantation (tavi).

the bard® true™ flow valvuloplasty perfusion catheter study is a prospective, single-center, non-randomized, single-arm observational study intended to collect data to confirm the performance and safety of the bard® true™ flow valvuloplasty perfusion catheter (true™ flow catheter) when used for dilatation of the aortic valve in preparation for transcatheter aortic valve implantation (tavi). this study will be conducted in conformance with the declaration of helsinki, applicable national privacy laws, and european, national regulations and international organization for standardization (iso) requirements (iso 14155:2011 (e)).

Eligibility criteria:
inclusion criteria: * the subject voluntarily provides written informed consent prior to the collection of study-specific data or performance of study-specific procedures using an informed consent form (icf) that is reviewed and approved by the ethics committee (ec) for the site. * the subject is a male or non-pregnant female ≥ 18 years old. * the subject is undergoing tavi for treatment of aortic stenosis. * the subject has an annulus diameter that can be treated with the available size device, in accordance with the instructions for use (ifu). exclusion criteria: * the patient is unable or unwilling to provide written informed consent. * the patient has a known allergy or sensitivity to contrast media that cannot be adequately pre-medicated. * the patient has had previous aortic valve replacement. * the patient has a known congenital aortic valve abnormality (e.g., bicuspid aortic valve). * the patient has echocardiographic evidence of intracardiac mass, or thrombus. * the patient has vascular conditions that make insertion and endovascular access to the aortic valve impossible. * the patient has another medical condition, which, in the opinion of the investigator, may cause him/her to confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures. * the subject is currently participating in an investigational drug, biologic, or another device study that has not completed the study treatment or that clinically interferes with the objectives of the study.
diagnostic accuracy of rapid antigen test based on anterior nasal swab compared with rt-pcr for sars-cov-2 detection.

Conditions: Covid19

Summary: the aim of this study was to determine the accuracy of anterior nasal swab in rapid antigen (ag)-tests in a low sars-cov-2 prevalence and massive screened community.


Eligibility criteria:
inclusion criteria: * citizens, above 18 years of age, who had self-booked an appointment for covid-19 test at testcenter taastrup, copenhagen, denmark, in the period of 2nd of march to 22nd of march were offered to participate in the project exclusion criteria: * patients referred to covid-19 testing by a doctor with symptoms of covid-19 were tested in a separate section of the test centers and are not included in this study

Keywords: rapid antigen test
prevalence of influenza related invasive aspergillosis

Conditions: Invasive Pulmonary Aspergillosis; Influenza, Human

Summary: this is a multicenter study with the aim to determine the prevalence of influenza-related invasive pulmonary aspergillosis in swedish intensive care units and to assess the clinical impact of and risk factors for influenza-related invasive pulmonary aspergillosis

this is a multicenter prospective observational study conducted at 12 intensive care units (icu) in sweden. all patients \>18 years of age with a polymerase chain reaction (pcr)-verified influenza a or b diagnosed up to 7 days before admission to the icu or during icu care, will be included in the study. a new clinical routine has been implemented at the study centers: during the icu stay screening with beta-d-glucan and galactomannan in blood/serum will be performed twice weekly and a respiratory sample will be retrieved for fungal culture and microscopy once weekly. all results from collected samples will be available to the patient's attending physicians. clinical and microbiological data will be collected, and the diagnosis of invasive aspergillosis will be made using predefined diagnostic criteria. objectives: 1. to determine the prevalence of influenza-related invasive pulmonary aspergillosis in swedish intensive care units 2. to assess the clinical impact of and risk factors for influenza-related invasive pulmonary aspergillosis

Eligibility criteria:
inclusion criteria: * confirmed influenza a or b diagnosed up to 7 days before icu admission, or during icu care * admitted to the icu exclusion criteria: - under 18 years of age
altaire gel forming solution versus refresh tears for the treatment of dry eye signs and symptoms

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to evaluate and compare the effects of altaire gel forming solution and refresh tears in mild-moderate dry eye patients.


Eligibility criteria:
inclusion criteria: * patients 18 years or older. * males or females. * patient reported dry eye symptoms (episodic, annoying, activity limiting). * physician assessment of mild-moderate dry eye. * patient willing to instill drops tid and complete entire length of protocol. * tbut _\< 10 seconds. * at least grade 6 corneal staining. exclusion criteria: * current topical cyclosporine use (restasis) * current refresh use. * refractive surgery within the last 6 months. * oral or topical corticosteroid use. * severe dry eye patients by physician assessment. * current active blepharitis. * oral doxycycline use. * oral antihistamine use.

Keywords: dry eye signs and symptoms