Kornimate/medical-research-clean huggingface dataset:
safety study of bipolar versus monopolar transurethral resection of bladder tumors

Conditions: Neoplasm of Lateral Wall of Urinary Bladder

Summary: this is a single-center, prospective, randomized, controlled trial comparing two established transurethral electrical resection methods of urinary bladder tumors regarding their risk of stimulating the obturator nerve. one of the major safety issues with transurethral resection is bladder perforation as a consequence of obturator nerve stimulation followed by muscle contraction of. this is mostly a risk of resection of lateral bladder wall tumors near the course of the obturator nerve. it has been advocated that bipolar may be superior to monopolar resection, based on its different electrical properties. this is an important safety aspect for the patient. main study question: in patients with lateral wall urinary bladder tumors, is bipolar superior to monopolar transurethral electroresection regarding risk of stimulation of the obturator nerve without preoperative nerve block?


Eligibility criteria:
inclusion criteria: * neoplasms of the lateral wall of the urinary bladder (laterally to the corresponding ostium) * operability given based on general medical condition * informed consent exclusion criteria: * antiplatelet drugs stopped \<7days (except acetylsalicylate \<= 100mg p.o. qd) * prothrombine time \<70% * age \<18 years * patronized patients * pregnancy * severe poor medical condition

Keywords: urinary bladder neoplasm bipolar transurethral resection monopolar transurethral resection obturator nerve
leonidas caregivers study

Conditions: Dravet Syndrome; Depression; Anxiety

Summary: dravet syndrome is a rare form of severe epilepsy that begins in the first year of life and is associated with frequent and/or prolonged seizures. individuals with dravet syndrome often experience a range of comorbidities, including behavioral and developmental delays, movement and balance issues, sleep difficulties, chronic infections, and growth and nutritional issues. patients with dravet syndrome are at high risk of death due to sudep (sudden unexpected death in epilepsy), prolonged seizures, seizure-related accidents, and infections. due to the severity of this condition, parents of children with dravet syndrome are typically highly involved in their child's 24-hour care and this has a considerable impact on family life. recent studies have highlighted the profound impact that such caregiving has on physical health, mental health, social function and financial resources. in particular, caregivers report high levels of stress and anxiety, fatigue, depression and social isolation. however, there is currently a lack of effective interventions to reduce the negative impact of caregiving on caregivers. the aim of this study is to prospectively study carers of individuals with dravet syndrome to identify pharmacological and psychological factors that are associated with increased or decreased vulnerability to stress, depression and anxiety. using a naturalistic, observational design the investigators will assess a cohort of dravet syndrome carers every six months for 3 years in order to further characterise trajectories of caregiver burden and the factors that influence this, including factors related to the person with dravet syndrome (e.g. age, seizure frequency/severity, treatment/medications, comorbidities) and factors related to the carer and family environment (e.g. social engagement/isolation, fatigue, finances, relationships). the investigators will use both standardized questionnaires and a neurocognitive task (facial expression recognition task) to assess vulnerability to anxiety and depression. the study will be conducted online.


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent for participation in the study * aged 18 years or above * primary caregiver of an individual with a medical history supporting a clinical diagnosis of dravet syndrome * able to access the internet exclusion criteria: * inability to provide informed written consent * another caregiver of the same individual with dravet is already enrolled in the study
ckd-828 primary hypertension trial(dose-selection)

Conditions: Hypertension

Summary: the aim of this trial is to determine the best dose combination of s-amlodipine and telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of s-amlodipine and telmisartan, compared to their monotherapy components and placebo, in patients with stage i or ii essential hypertension(a mean seated cuff diastolic blood pressure \>=95 and \<=115 mmhg).


Eligibility criteria:
inclusion criteria: * age 18 years or older * stage i or ii hypertension defined as: a mean seated cuff diastolic blood pressure \>=95 and \<=115 mmhg * ability to provide written informed consent exclusion criteria: * severe hypertension defined as: a mean seated cuff diastolic blood pressure \>=116mmhg or a mean seated cuff systolic blood pressure \>=200mmhg * known or suspected secondary hypertension(ex. aortic coarctation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma) * has severe heart disease(heart failure nyha functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months * has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months * type i diabets mellitus, type ii diabetes mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(hba1c) \> 8% * known severe or malignant retinopathy * hepatic or renal dysfunction as defined by the following laboratory parameters: ast/alt \> unl x 2, serum creatinine \> unl x 1.5 * acute or chronic inflammatory status need to treatment * need to additional antihypertensive drugs during the study * need to concomitant medications known to affect blood pressure during the study * history of angioedema related to ace inhibitors or angiotensin ii receptor blockers * known hypersensitivity related to either study drug * history of drug or alcohol dependency * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, currently active gatritis, ulcers of gastrointetinal/rectal bleeding, impaired pancreatic fuction such as pancreatitis,obstructions of the urinary tract or difficulty in voiding) * cannot swallow investigational products * administration of other study drugs within 4 weeks prior to randomization * premenopausal women(last menstration \< 1year) not using adequte contraception, pregnant or breast-feeding * history of malignancy including leukemia and lymphoma within the past 5 years * in investigator's judgment

Keywords: ckd-828 hypertension primary hypertension s-amlodipine telmisartan amlodipine factorial phase 2
effect of virtual reality on preoperative anxiety

Conditions: Preoperative Anxiety

Summary: the aim of this study was to determine the effect of virtual reality (vr) on the preoperative anxietyof patients undergoing colorectal surgery.

the sample of this study consisted of 86 patients in experimental and control groups. the experimental group received vr application in the preoperative period for 10 minutes. anxiety level was assessed with the anxiety specific to surgery questionnaire (assq) and measured with physiological responses of anxiety such as systolic blood pressure (sbp), diastolic blood pressure (dbp), heart rate (hr), respiratory rate (rr) and peripheral oxygen saturation (spo2) before and after vr application.

Eligibility criteria:
inclusion criteria:the study included * conscious, * orientated and cooperated patients who could speak and understand turkish, * who had no psychiatric diseases, * who were 18 years old and older, * who were scheduled for elective colorectal surgery for the first time, * who did not take any sedative drugs before surgery, and * who gave written and oral permission to participate in the study exclusion criteria:n the study excluded * had language problems, * underwent emergency surgery, * were over 65 years of age and * refused to participate in the study.

Keywords: colorectal surgery virtual reality nurse
observational study to assess endpoint operational feasibility & measurement properties in patients with retinal degeneration

Conditions: Retinitis Pigmentosa; Choroideremia; Stargardt Macular Dystrophy; Stargardt Disease; Geographic Atrophy from Age-related Macular Degeneration; X-lined Retinoschisis; Retinal Dystrophies

Summary: the vision research and assessment institute (vrai) was established with the purpose of serving as a testing facility for efficacy endpoints for patients with low vision. the mission of the vrai is to enable the highest quality, standardized efficacy testing of patients with visual impairment. the vrai facilitates the development and refinement of existing endpoints specifically for testing patients with low vision.

the vrai is a state-of-the-art research institute specifically for patients with low or very low vision due to diseases of the retina of the eye. the institute is staffed by highly experienced low vision specialists and provides a comfortable, familiar environment for patient testing. the study is a non-interventional prospective cohort study of up to 40 patients for each disease condition (retinitis pigmentosa, choroideremia, stargardt macular dystrophy, geographic atrophy from age-related macular degeneration, x-linked retinoschisis or other retinal dystrophies ). patients are scheduled for an initial visit where they are tested on a series of efficacy tests. thereafter, patients will be invited to attend for a further visit up to two weeks and then periodically for up to one year. the objectives of the study are to evaluate how well patients use their vision, how the tests relate to activities of daily living, establish clinical meaningfulness, assess the impact of disease progression and the precision and accuracy of each test in the context of their eye condition.

Eligibility criteria:
inclusion criteria: * diagnosis of bilateral retinitis pigmentosa, choroideremia, stargardt macular dystrophy, geographic atrophy from age-related macular degeneration, x-linked retinoschisis or other retinal dystrophies confirmed from previous eye examination records * best-corrected visual acuity between 20/70 and hm in at least one eye as tested with clinic-based visual acuity method * reasonably fluent in english exclusion criteria: * cognitive impairment, memory loss or dementia sufficient in severity to preclude informed consent or in the opinion of the investigator would prevent satisfactory completion of some or all of the testing. * any circumstance that in the opinion of the investigator, would interfere with participation in, or compliance with the study protocol * current pregnancy as reported by patient
safety study of tivanisiran to treat dry eye

Conditions: Dry Eye Disease

Summary: this study will examine the safety of tivanisiran sodium eye drops versus vehicle when dosed once daily for 1 year in subjects with signs and symptoms of dry eye disease (ded).


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * have given their written consent to participate in the study * use of artificial tears (at), autologous serum or specific dry eye medications during the last 6 months prior to the selection exclusion criteria: * pregnant or breast feeding females with a postitive pregnancy test * women of childbearing potential not willing to use a medically acceptable contraceptive method * currently participating or has participated in another clinical trial within the 2 months prior to inclusion * current, previous chronic or recurrent medical condition that, according to the investigator, might impact on the study * any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications that could interfere in the trial

Keywords: sirna oligonucleotide keratoconjunctivitis sicca syl1001
high-flow oxygen therapy vs non-invasive ventilation: comparison of alveolar recruitment in acute respiratory failure

Conditions: Acute Respiratory Failure With Hypoxia

Summary: this physiological study showed an increase in regional ventilation with niv but no difference in alveolar recruitment as compared to hfnc in patients with hypoxemic arf. although niv provided better oxygenation than hfnc, the effect on lung volumes could explain the potentially deleterious effect of niv in hypoxemic arf, reinforcing the recently developed concept of patient self-inflicted lung injury.

background: high-flow nasal cannula (hfnc) oxygen therapy has recently shown clinical benefits in hypoxemic acute respiratory failure (arf) patients, while the interest of non-invasive ventilation (niv) remains debated. the primary endpoint was to compare alveolar recruitment using global end-expiratory electrical lung impedance (eeli) between hfnc and niv. secondary endpoints compared regional eeli, lung volumes (global and regional tidal volume variation (tv)), respiratory parameters, hemodynamic tolerance, dyspnea and patient comfort between hfnc and niv, relative to face mask (fm).

Eligibility criteria:
inclusion criteria: * adult patients referred in icu * with hypoxemic acute respiratory failure due to a community acquired pneumonia confirmed by chest x ray, * with pao2 \< 60mmhg in ambient air, without hypercapnia (paco2 \< 45 mmhg), * requiring more than 6l/min of o2 on admission with high concentration fm, and justifying hfnc or niv for the attending icu physician exclusion criteria: * cardiogenic pulmonary oedema, * moderate to severe underlying respiratory disease including copd (chronic obstructive pulmonary disease) * contraindication to or failure of previous niv or hfnc with the need for immediate invasive ventilation * pregnant or breast-feeding women * carrier of an implantable defibrillator or pacemaker * body mass index (bmi)\>50 kg/m2 * with cutaneous lesion next to the positioning zone of the pulmovista® (dräger, lübeck, germany) belt

Keywords: alveolar recruitment electrical impedance tomography non-invasive ventilation high-flow nasal cannula oxygen therapy hypoxemic acute respiratory failure
increasing equity in lung cancer screening

Conditions: Lung Cancer

Summary: the overall objective of this mixed methods study is to: 1) refine the emergency department lung cancer screening (ed-lcs) intervention using qualitative interviews among key stakeholders; 2) pilot test the ed-lcs intervention evaluating the intervention efficacy, acceptability, and feasibility; and 3) provide an in-depth description of stakeholders' experiences with the ed-lcs intervention for future refinement.


Eligibility criteria:
inclusion criteria: * • eligible for lcs (50-80 years old, smoked in past 15 years, and smoked at least 20 pack years) exclusion criteria: * • non-english/spanish speaking * decompensated psychiatric illness (suicidal, homicidal, psychosis). will confirm with attending physicians at time of enrollment * intoxicated with alcohol or drugs * cannot provide reliable follow up contact information (cell phone) * presenting to the ed with a life-threatening condition * have received chest ct scan in past 12 months * already enrolled in lcs * hospice enrolled
tele-dermatology of skin cancer in a cohort of local health authority employees in the province of bergamo

Conditions: Erysipelas; Impetigo; Herpes Zoster; Molluscum Contagiosum; Warts; Tinea; Melanoma; Actinic Keratosis; Basal Cell Carcinoma; Squamous Cell Carcinoma

Summary: the purpose of this study is to demonstrate the validity and utility of a tele-dermatology system in the midterm periodic screening of non-widespread skin lesions of recent onset or for which a specialized early classification is deemed to change the prognosis - including precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to control visits at fixed follow-up.


Eligibility criteria:
inclusion criteria: * subjects currently working at the local health authority of the province of bergamo exclusion criteria: * subjects who are not able to use the tele-dermatology system or who have no access to the website or the specific app.

Keywords: melanoma non-melanoma skin cancer mole app cliccailneo
safety and efficacy study of oral xigo tablets to treat the common cold

Conditions: Common Cold

Summary: the purpose of the study will be to assess the efficacy and safety of xigo administered orally, three times a day, compared with placebo in patients with the common cold.

the common cold is one of the most frequent human illnesses and has been shown to result in significant morbidity and economic loss. at the present time no truly effective therapy is available. therapeutic interventions with compounds such as zinc have been found to be helpful however well reported side-effects have prevented its extensive use. based on several years of anecdotal clinical evidence which has shown that xigo is effective in alleviating the symptoms of the common cold-the findings of which are supported by competent and reliable evidence from in vivo and in vitro and clinical trials studies on each of the individual active ingredients of the formulation, it has been proposed that xigo, when administered orally, has a direct stimulatory effect on multiple components of the immune system. it is proposed that this stimulation increases both the immune cell population as well as its functionality and this will be observed in cells and molecules from both the innate and adaptive responses.

Eligibility criteria:
inclusion criteria: * must be in good health in the clinical judgment of the investigator, other than cold symptoms * must have a cumulative score of 2 or higher, but not larger than 6, with symptom severity rated as 0=absent, 1=mild, 2= moderate, or 3=severe for each of the eight symptoms: sneezing, nasal discharge, nasal obstruction, sore throat, cough, headache, malaise and chillness. at least one of the first four "cold specific" symptoms must be present, and none of these symptoms can have been present for more than 12 hours. * must enter trial within 12 hours of symptoms onset. * aged 18-50 years, (inclusive), at visit 1. * subjects must understand and sign and date an informed consent form prior to any study related procedures being performed. * subjects must be capable of understanding and following directions. exclusion criteria: * subjects taking medications, other than birth control, which, in the opinion of the investigator, could influence the purpose, integrity or outcome of the trial. * pre-menopausal women (last menstruation \<=1 year prior to icf) who are nursing or pregnant or are of child-bearing potential and, in the opinion of the investigator, are not practicing an acceptable method of birth control, or do not plan to continue using method throughout the study. * a history of adverse reactions to otc drugs or other personal care products. * subjects who have used systemic steroids for at least 6 weeks prior to trial initiation or during the trial. * a medical history of autoimmune disease, including type 1 or type 2 diabetes or hiv. * treatment with immunosuppressive drugs with the exception of cyclosporine for keratitis sicca.

Keywords: common cold cold virus feeling sick influenza
hfnc vs nppv after early extubation for patients with copd

Conditions: COPD; Hypercapnic Respiratory Failure

Summary: high-flow nasal cannula oxygen therapy(hfnc) has proved no significant difference compared with noninvasive positive pressure ventilation (nppv) in preventing postextubation respiratory failure and reintubation in patients with acute hypoxemic respiratory failure.however, the efficacy of early postextubation sequential hfnc in copd patients with hypercapnic respiratory failure is inconclusive.

the investigators conducted this prospective randomized controlled trial to explore the efficacy, safety of hfnc versus nppv after early extubation in copd patients with hypercapnic respiratory failure.the investigators hypothesized that the efficacy of hfnc after early extubation is non-inferior to that of nppv.

Eligibility criteria:
inclusion criteria: * 1. copd patients with bronchopulmonary infection 2. patients with hypercapnia respiratory failure treated with invasive mechanical 3.14 days ≥ invasive mechanical ventilation ≥ 48 hours; 4.reached the pulmonary infection control (pic) window; 5.have self-care ability with oxygen supply during stable phrase exclusion criteria: * severe organ dysfunction;myopathy or myasthenia gravis;upper airway obstruction;a large amount of secretions and inability to drain;

Keywords: nppv hfnc weaning copd pic
broad spectrum hpv vaccine dose ranging study (v502-001)

Conditions: HPV; Cervical Cancer; Premalignancy Anogenital Warts

Summary: this dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) to demonstrate that the vaccine is well-tolerated in women (2) to evaluate immune responses in women who are between 16 and 23 years of age at enrollment.


Eligibility criteria:
inclusion criteria: * lifetime history of 0-4 sexual partners exclusion criteria: * history of abnormal pap test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive hpv test
the evaluation of an interface for the treatment of obstructive sleep apnea (osa)

Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea

Summary: this investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.

a minimum of 40 osa participants who currently use cpap will be recruited for the trial. participant will be in the trial for three weeks- first week will be a collection of positive airway pressure baseline data on participant's usual interface. the participant will then use the trial interface in-home for 2 weeks. there is also an option of a six month extension if the participant wish to continue on the trial interface.

Eligibility criteria:
inclusion criteria: * adult (18+ years of age) * able to give written consent * ahi ≥ 5 on diagnostic night * either prescribed apap, cpap or bi-level pap for osa exclusion criteria: * inability to give written consent * anatomical or physiological conditions making pap therapy inappropriate * commercial drivers who are investigated by new zealand transport agency (nzta) * current diagnosis of respiratory disease or co2 retention * pregnant or may think they are pregnant.
assessing the clinical utility of adding pentoxifylline to neoadjuvant chemotherapy protocols in breast cancer patients"

Conditions: Breast Cancer Female

Summary: breast cancer, a leading cause of cancer-related mortality in women worldwide, has spurred the investigation of novel therapeutic approaches. pentoxifylline (ptx), a synthetic methylxanthine derivative, has shown promise in preclinical studies when combined with conventional anticancer drugs. this study aims to assess ptx's impact when added to neoadjuvant chemotherapy protocols in breast cancer patients, with the goal of improving treatment outcomes and reducing associated toxicities.


Eligibility criteria:
inclusion criteria: * adult female patients \>18 years old with histologic confirmation of invasive breast cancer * planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/ cyclophosphamide followed by paclitaxel (ac/t) * adequate hepatic, renal, and bone marrow functions exclusion criteria: * patients on treatment regimen of phosphodiesterase inhibitors * patients who are taking antiplatelet or anticoagulant treatment * patients who are allergic to phosphodiesterase inhibitors * history of recent hemorrhagic events * active peptic ulcer

Keywords: neoadjuvant chemotherapy doxorubicin cyclophosphamide paclitaxel efficacy toxicity