Kornimate/medical-research-clean huggingface dataset:
transcranial current stimulation as a treatment for auditory hallucinations in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder; Auditory Hallucinations

Summary: investigating the effect of non-invasive transcranial current stimulation on auditory hallucinations in patients with schizophrenia. normal neuronal activity is perturbed in schizophrenia, so selective targeting of this abnormal activity could serve as a treatment for schizophrenia and alleviate symptoms caused by abnormal neuronal activity, such as auditory hallucinations.

aim 1: to evaluate the effect of transcranial direct current stimulation (tdcs) (2ma for 20min on five consecutive days) on auditory hallucinations in schizophrenia patients using the change in ratings on the auditory hallucination rating scale (ahrs) by patients before and after stimulation. we hypothesize that tdcs will modulate the abnormal neuronal activity found in schizophrenic patients and thereby decrease their auditory hallucinations when measured after stimulation. aim 2: to evaluate the long term effects of tdcs by having patients give a rating on the ahrs after one month has passed since stimulation and comparing this value to their baseline score and their score immediately after stimulation. we hypothesize that there will remain a significant reduction in auditory hallucination score in participants who received tdcs at one month.

Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual iv (dsm-iv) diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. duration of illness \>1 year. * 18-99 years old. * clinically stable for at least 12 weeks, i.e. not requiring hospitalization or a change in level of care . * on current antipsychotic doses for approximately 4 weeks or more. * capacity to understand all relevant risks and potential benefits of the study (informed consent) or has a legal guardian who can complete consent forms on the patients behalf * right handed exclusion criteria: * subjects with a dsm-iv diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a dsm-iv diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months. * history of significant head injury/trauma, as defined by loss of consciousness for more than 1 hour, or recurring seizures, or requiring later cognitive rehabilitation or causing cognitive sequelae. * prior brain surgery. * any brain devices/implants, including cochlear implants and aneurysm clips. * co-morbid neurological condition (i.e. seizure disorder, brain tumor). * medical or neurological illness (unstable cardiac disease aids, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation. * non english speakers. * pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation

Keywords: schizophrenia auditory hallucinations transcranial stimulation tdcs tacs
hba1c as an early serologic marker for the hemodynamic progression of stage a heart failure

Conditions: Heart Failure, Diastolic

Summary: in a retrospective community based cohort study from pueblo county colorado which has a higher population proportion of metabolic syndrome and diabetes mellitus, we hope to clarify and quantify an association of the age hba1c elevation with the early subclinical hemodynamic changes of diabetic cardiomyopathy as measured by lav, lvm, e/a ratio, e/e' ratio and bnp in patients with stage a heart failure.

the classic association of glycemic control, as represented by hba1c, with progression or improvement of microvascular and macrovascular clinical complications has been well documented. additionally, while the association of hba1c elevation with a syndrome described as diabetic cardiomyopathy has also been well documented, the use of the advanced glycation end product axis (age/srage/esrage which includes hba1c) as markers for the early subclinical hemodynamic changes of diabetic cardiomyopathy has been suggested but less well characterized or utilized. stage a heart failure is defined as persons with normal cardiac structure and function who have predisposing subclinical risks for cardiovascular disease. estimates suggest that stage a heart failure may comprise up to 56% of any community's patient population and are patients most commonly seen in non-specialty primary care clinics. in light of newer cardiometabolic agents which show promise in cardiovascular disease primary prevention, these patients may be an important target for preventative cardiometabolic care. in a retrospective community based cohort study from pueblo county colorado which has a higher population proportion of metabolic syndrome and diabetes mellitus, we hope to clarify and quantify an association of the age hba1c elevation with the early subclinical hemodynamic changes of diabetic cardiomyopathy as measured by lav, lvm, e/a ratio, e/e' ratio and bnp in patients with stage a heart failure. methods: retrospective cohort analysis by chart review of patients presenting to parkview medical center's inpatient service and outpatient clinics who obtained a full resting echo characterized by normal cardiac structure and function in conjunction with hba1c and bnp levels within a 3 month time window. using multiple regression analysis of the dependent variables lav, lvm, e/a ratio, e/e' ratio and bnp, powered to detect a 5% change in lav in conjunction with rising hba1c levels characterized as normal (\ 6.4) after controlling for the presence of hypertension and coronary artery disease.

Eligibility criteria:
inclusion criteria: * stage a heart failure on basis of metabolic criteria exclusion criteria: * lv dysfunction, valvular heart disease, hypertension and cad
clinical efficacy of the drug ster® compared with predfort® in control of postoperative inflammation in cataract surgery

Conditions: Inflammation; Cataract Surgery

Summary: is the primary objective of this investigation to compare the clinical efficacy of the drug test - ster ® (prednisolone 1% ophthalmic suspension - union chemicals) in the comparator - fort ® pred (prednisolone 1% ophthalmic suspension - allergan) in the control of postoperative inflammation in cataract surgery by phacoemulsification through periodic measurement of efficiency scores (number of cells in the anterior chamber, the presence of fibrin in the anterior chamber, conjunctival hyperemia, corneal edema and descemet folds).

the secondary objective is to compare the safety data observed during the study period, ie will be assessed the frequency and intensity of adverse reactions and compared statistically between groups.

Eligibility criteria:
inclusion criteria: * patients who agree with all study procedures and sign, by his own free will, ic; * adult patients, regardless of gender, ethnicity or social status, with good mental health; * patients who present at screening visit, a clinical diagnosis of cataract with an indication for corrective surgery with phacoemulsification technique. exclusion criteria: * patients with a history or clinical diagnosis of other eye diseases such as glaucoma, corneal ulcers, scarring, and uveitis; * patients with known hypersensitivity to any component of the drug under investigation; * patients who have made use of systemic corticosteroids within 15 days before surgery; * patients who have made use of topical corticosteroids in the 7 days before surgery; * patients who have made use of systemic antibiotics in the 15 days preceding surgery; * patients who have made use of topical antibiotics in the 7 days before surgery; * patients presenting abnormality, at the discretion of the principal investigator in the following ophthalmic examinations preoperative slit-lamp examination, measurement of intraocular pressure (applanation tonometry) and examination of background, other than the underlying disease (cataract); * pregnant or lactating women.

Keywords: preuni0710 cataract
prevention of post-extubation laryngeal edema with intravenous corticosteroids

Conditions: Post-Extubation Laryngeal Edema

Summary: tracheal intubation is a frequent procedure in intensive care units (icu). post-extubation laryngeal edema is a frequent complication with potential morbidity and mortality, and may lead to urgent tracheal re-intubation. corticosteroids have been proposed to reduce the incidence of post-extubation laryngeal edema. a few clinical studies have been conducted in adult icu patients and have led to discrepant results. these discrepancies may be related to the time lag separating the administration of the corticosteroids and the planned extubation. accordingly, we tested the hypothesis that pretreatment with corticosteroids initiated 12 hours before a planned extubation may efficiently prevent the occurrence of postextubation laryngeal edema in critically-ill adults who have been mechanically ventilated for more than 36 hours in the icu.

we conducted a prospective, double-blind, placebo-controlled, multicenter trial of 12-hour-pretreatment by methylprednisolone before a planned extubation in adult patients ventilated for more than 36 hours in the icu. methylprednisolone (20 mg) or placebo was first administered intravenously 12 hours before extubation and continued every 4 hours until tube removal. primary endpoint was the occurrence of laryngeal edema within 24 hours of extubation. laryngeal edema was clinically diagnosed and considered as major when requiring tracheal reintubation.

Eligibility criteria:
inclusion criteria: * adult ≥ 18 years * intubated for ≥ 36 hours * scheduled extubation * informed written consent exclusion criteria: * pregnancy * history of postextubation laryngeal dyspnea * laryngeal disease * tracheotomy * patient receiving corticotherapy prior to admission * traumatic intubation * participation to this study or to another trial

Keywords: corticosteroids laryngotracheal injury intubation-extubation
safety and patient satisfaction with glash vista™ (bimatoprost 0.03%) in the treatment of eyelash hypotrichosis in japan

Conditions: Eyelash Hypotrichosis

Summary: this is a post-marketing surveillance study in japan that will evaluate the safety and patient satisfaction with glash vista™ (bimatoprost cutaneous solution 0.03%) in the treatment of hypotrichosis of the eyelashes.


Eligibility criteria:
inclusion criteria: -patients who have been prescribed glash vista™ in clinical settings and filled at least one prescription for glash vista™. exclusion criteria: -none.
the merit wrapsody central feasibility study

Conditions: Venous Stenosis; Venous Occlusion

Summary: the purpose of the study is to demonstrate the safety and efficacy of the merit wrapsody endovascular stent graft for treatment of stenosis or occlusion within the dialysis access outflow circuit in the thoracic central veins


Eligibility criteria:
inclusion criteria: * subject provides written informed consent * subject is male or female, with an age ≥ 18 years at date of enrollment. * subject is willing to undergo all follow-up assessments. * subject has a life expectancy ≥ 12 months. * subject is undergoing chronic hemodialysis. * subject has either a mature avf or avg in the arm. * target lesion(s) involves a non-stented restenotic lesion. * target lesion has ≥50% stenosis. * target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm exclusion criteria: * subject is unable or is unwilling to comply with the procedural requirements of the study protocol. * subject has a comorbidity that in the investigator's opinion would limit life expectancy to less than 12 months. * subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia. * subject has a stroke diagnosis within 3 months prior to enrollment. * subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment. * subject is pregnant, breastfeeding, or intending to become pregnant within the next year. * target lesion is located within a stent / stent graft.
characteristics of sexual dysfunction in patients with lung cancer

Conditions: Lung Cancer; Sexual Dysfunction

Summary: the general objective of this observational study is identify and describe the type, frequency, and severity of sexual dysfunction in patients with lung cancer and generate strategies for clinical management and oncological follow-up directed and based on the specific findings in this population. the recruitment will be carried out from july 2023 and will be carried out until december 2023, the analysis of the information will be carried out from january to march 2024.

it is planned to develop a study with a larger number of patients with lung cancer, including the population of spain and latin american countries to obtain a sample of more diverse and heterogeneous characteristics, with clinical, cultural, and sociodemographic differences. this will make it possible to obtain better and greater data and therefore define the clinical and treatment factors significantly associated with ds in these individuals and obtain a more complete vision of the reality of the problem. the results of this research will make it possible to carry out interventions specifically directed at this population and to modify the oncological follow-up guidelines currently in force. likewise, the information collected will serve as the basis for generating new protocols for a multidisciplinary approach, including the participation of psychology and specialists in urology, gynecology, and psychiatry. the general objective of this observational study is identify and describe the type, frequency, and severity of sexual dysfunction in patients with lung cancer and generate strategies for clinical management and oncological follow-up directed and based on the specific findings in this population. the recruitment will be carried out from july 2023 and will be carried out until december 2023, the analysis of the information will be carried out from january to march 2024.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years and less than or equal to 70 years. * diagnosis of lung cancer stages ib to iv. * having received systemic oncological treatment for at least 3 months or being in oncological follow-up after having received systemic treatment for a minimum of 3 months with stable tumor disease or partial or complete response in images. * ecog ≤ 2 exclusion criteria: * patients with comorbidities (renal failure, cardiovascular diseases or similar) not controlled with corresponding medical management. * individuals with physical disability or cognitive impairment that prevents them from completing the electronic data collection form.

Keywords: lung cancer sexual dysfunction
effect of intravenous iron versus placebo on muscle oxidative capacity and physical performance in premenopausal women

Conditions: Non Anemic Patients With Iron Deficiency (Low Ferritin Value)

Summary: effect of intravenous iron substitution (iron carboxymaltose (ferinject®), total dose 15 mg/ kg (maximal dose: 1000mg) in 250 ml 0.9 % nacl; intravenous infusion in 20 min)in non-anemic premenopausal women with iron deficiency on primary objective: - mitochondrial capacity (phosphocreatine recovery rate assessed by 31p-mr-spectroscopy of the lower leg muscle) secondary objectives: * maximal oxygen uptake during a graded cycling exercise test and time to exhaustion at submaximal power during a constant-load cycling exercise test * plantarflexor muscle fatiguability as assessed by isokinetic dynamometry * trial with medicinal product


Eligibility criteria:
inclusion criteria: inclusion criteria * healthy female subjects, age \> 18 years, premenopausal, regularly menstruating * bmi 18-25 kg/m2. * serum ferritin level \< 15ug/ml * recreationally active with = 1.5 h/w structured activity * adequate contraception during the study period * informed consent exclusion criteria: exclusion criteria * anemia with hb level \< 120 g/l * known hypersensitivity to iron carboxymaltose, iron sucrose or iron sulfate * intake of iron preparations (also multivitamins containing iron) during the last 8 weeks before the start of the trial protocol * pregnancy or lactation * any cardiovascular or pulmonary disease * any orthopaedic or rheumatologic disease which affects exercise performance * presence of muscle disease * acute or chronic infection/inflammation or malignancy * known mental disorders (e.g. depression) * intake of concurrent medication, except oral contraceptives * crp \> 10 mg/l * tsh out of normal range * elevated ck (\> 167 u/l) * any concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients. * participation in any other therapeutic trial within the previous month
a dose-finding study of the second mitochondrial activator of caspases (smac) mimetic debio 1143 when given in combination with avelumab to participants with advanced solid malignancies and to participants with advanced or metastatic non-small cell lung cancer (nsclc) after platinum-based therapy

Conditions: Carcinoma, Non-Small-Cell Lung; Neoplasms

Summary: the study is primarily designed to assess the safety and tolerability of escalating oral doses of debio 1143 and preliminary anti-tumour activity when combined with the standard dose of avelumab in participants with advanced solid malignancies.


Eligibility criteria:
inclusion criteria: part a • with advanced solid malignancies who are not eligible for standard therapy or for whom standard therapy has failed part b • with histologically or cytologically confirmed nsclc of stage iiib or iv (per 7th international association for the study of lung cancer classification) that has progressed after one line of platinum containing doublet chemotherapy part a and b * willingness and feasibility to provide a tumor biopsy sample both at screening and during treatment (if archived tumor material not older than 1 year is available, then the screening biopsy will not be performed). * participants with prior radiation therapy must have measurable disease in non-irradiated sites or documented evidence of progression within the radiation field. * with known central nervous system (cns) must have completed primary brain therapy (such as whole brain radiotherapy, stereotactic radiosurgery, or complete surgical resection) and must have remained clinically stable, asymptomatic, and without steroid treatment for at least 21 days. exclusion criteria: * not recovered (i.e. toxicity grade \>1) from prior investigational drug and/or anti-cancer therapy (chemo- or palliative radiotherapy). * symptomatic and/or progressive brain metastasis or carcinomatous meningitis. * immunosuppressive agents (such as steroids) for any reason should be tapered off before initiation of study treatment (except low-dose prednisone at a total dose of up to 10 mg/day). part b only * tumor activating epidermal growth factor receptor (egfr) mutation(s) or anaplastic lymphoma kinase (alk)/ros1 translocation/rearrangement (testing required in non-squamous participants if status is unknown). * more than one prior line of chemotherapy and one line of anti-pd1/pdl1 therapy.
safety, tolerability, pharmacodynamics and pharmacokinetics of bea 2180 br in healthy male subjects

Conditions: Healthy

Summary: main study: to investigate safety, tolerability, pharmacodynamics (pd) and pharmacokinetics (pk) of bea 2180 br sub-study; to investigate whether treatment with 36 μg tiotropium bromide is able to protect of methacholine-induced bronchoconstriction compared to baseline (methacholine challenge at screening).


Eligibility criteria:
inclusion criteria: * healthy male volunteers based upon a complete medical history, including the physical examination, vital signs (bp, pr), 12-lead ecg, clinical laboratory test * no finding deviating from normal and of clinical relevance * no evidence of a clinically relevant concomitant disease * age ≥ 30 and age ≤ 55 years * body mass index (bmi) ≥ 18.5 and bmi \< 30 kg/m2 * signed and dated written informed consent prior to admission to the study in accordance with good clinical practice and the local legislation exclusion criteria: * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * history of relevant orthostatic hypotension, fainting spells or blackouts * chronic or relevant acute infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator (or his deputy) * intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial * use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial * participation in another trial with an investigational drug within two months prior to administration or during the trial * alcohol abuse (more than 60 g/day) * drug abuse * blood donation (more than 100 ml within four weeks prior to administration or during the trial) * excessive physical activities (within one week prior to administration or during the trial) * any laboratory value outside the reference range of clinical relevance exclusion criteria specific for this study: * bronchial hyperreactivity as demonstrated by a 45% change of sgaw at or below a cumulative methacholine concentration of 10 mg/ml = 1% * asthma or bronchial hyperreactivity * allergic rhinitis (hay fever) * glaucoma * urinary tract obstruction * epilepsy * history of cardiovascular disease * history of peptic ulcer disease * history of thyroid disease
quantitative computed tomography for mortality risk stratification in ards

Conditions: Acute Respiratory Distress Syndrome

Summary: acute respiratory distress syndrome remains a deadly disease with hospital mortality remaining between 40 to 50%. ards mortality risk factors have been identified from patient history, common clinical and biological variables in the lung safe study. part of ards mortality is attributable to ventilator-induced lung injury (vili), in relation with inappropriate settings on the ventilator. tidal hyperinflation and recruitment/derecruitment during lung inflation are 2 identified mechanisms leading to vili, that may be identified on computed tomography while poorly identified with variables collected at the bedside. the aim of this study is to identify whether tidal hyperinflation identified on computed tomography is a risk factor for ards mortality, independently from know bio-clinical risk factors.


Eligibility criteria:
inclusion criteria: * patient aged 15 or older with ards according to the berlin definition * invasive mechanical ventilation with pao2/fio2 ≤ 300 mm hg * with computed tomography acquired at both end-expiration and end-inspiration, or at both peep 5 and 15 cm h2o at end-expiration * peep setting according to a peep/fio2 table, with secondary adjustment according to hemodynamic tolerance * tidal volume 6 ml/kg of predicted body weight or less exclusion criteria: * use of contrast agent during computed tomography acquisition * ards criteria onset since more than 72 hours or ecmo onset since more than 72 hours * proven copd * pneumothorax or bronchopleural fistula * patient with spontaneous breathing preventing realization of end-expiratory and end-inspiratory pauses * previous inclusion in current study * patient under a legal protective measure

Keywords: ards computed tomography alveolar recruitment peep tidal hyperinflation