Kornimate/medical-research-clean huggingface dataset:
bdnf gene polymorphism and antidepressants treatment

Conditions: Depression

Summary: the main hypothesis is that the therapeutic response and pharmacological resistance to ads in depressed patients can be associated with a polymorphism for the bdnf gene. the research of allelic forms associated to lesser efficiency or inefficiency of ads could add to the body of evidence that bdnf mediates the mechanism of action of ads, and could have important practical implications. we propose to compare in a group of patients with major depression, the allelic variability of the bdnf gene between responders and non-responders after a 3-week period and a 6-week period of ssri treatment.

* the main objective is to research an association between polymorphism for the bdnf gene and the 3-week and 6-week response to a ssri treatment (escitalopram) in major depression. * a case control pilot study without any direct individual benefit (200 patients). * study period: 24 months. * scores from reliable and validated psychometric scales (montgomery and asberg depression scale, mini international neuropsychiatric interview) specifically analysing depression dimension at the time of inclusion, after three and six weeks of antidepressant treatment. * genetic analysis researching a polymorphism of the bdnf gene is done by a blood sample at the baseline.

Eligibility criteria:
inclusion criteria: * patient suffering a severe depressive episode (according to dsm-iv), evolving since at least 2 weeks before entering the study * age superior to 18 years * caucasian type * in absence of any medicinal treatment that could enhance depression: methyldopa, beta-blockers, reserpine, * in absence of hypothyroidia or anaemia * without comorbidity that could affect therapy response : e.g. food disorder, substance abuse or dependence syndrome exclusion criteria: - will be excluded from the study the patients for which a modification of the depression diagnosis (according to the dsm-iv criteria) takes place during the period of study

Keywords: antidepressants escitalopram genetic polymorphism
clinical outcomes of cryobiopsy for peripheral pulmonary lesions - a prospective pilot study

Conditions: Lung Nodule

Summary: as the former radial endobronchial ultrasound (r-ebus) guided transbronchial forcep biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique, transbronchial cryobiopsy, in patients with peripheral pulmonary nodules.

this is a prospective, single arm, open label trial to assess the diagnostic accuracy and safety of the transbronchial cryobiopsy in patients with peripheral pulmonary nodule using a 1.1mm cryoprobe, combined with bronchoscope (with/without guide sheath), r-ebus, virtual bronchoscopy navigation, and fluoroscopy.

Eligibility criteria:
inclusion criteria: * patient with peripheral lung nodule less than 30mm on ct scan referred for biopsy * age ≥ 18 * written informed consent after participant's information exclusion criteria: * central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial ebus) * pure ggo lesion * patients at increased risk of bleeding 1. cannot stop agents such as antiplatelet agent or anticoagulant therapy 2. coagulopathy: thrombocytopenia (\ 1.5) * patient with existing or risk of pulmonary and cardiovascular decompensation * intolerance to sedation * vulnerable groups such as pregnant woman, breast feeding, etc. * previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility

Keywords: cryobiopsy pulmonary nodule radial ebus
roll-over study to continue treatment with the investigational drug rogaratinib and to further test its safety

Conditions: Cancer

Summary: the purpose of this study is to enable patients, who are currently receiving rogaratinib in a bayer-sponsored clinical trial (incl. nct01976741), to continue treatment after their respective study has been closed. another aim is to learn if rogaratinib is safe and how it affects the body. rogaratinib is an investigational drug that may treat different types of cancer, incl. non-small-cell lung cancer, small-cell lung cancer, urothelial carcinoma, head, neck and breast cancer. the drug may stop the growth of cancer cells by targeting different cell proteins called fibroblast growth factor receptors (fgfr) that are needed for the survival of the cancer cells.

the primary objectives of the study are the continuation of rogaratinib treatment (as monotherapy or combination therapy) for patients after closure of their feeder studies and the further assessment of the safety of the drug. the secondary objective is to investigate the tolerability of rogaratinib.

Eligibility criteria:
inclusion criteria: * participants enrolled in any bayer-sponsored rogaratinib feeder study at the time of study closure, who are currently receiving rogaratinib (monotherapy or combination therapy) and are experiencing clinical benefit from treatment, determined by the treating physician. * participants who meet criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder study protocol. * any ongoing adverse events that required temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption. * women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study treatment and until 6 months after stopping study treatment. exclusion criteria: * ineligibility, for medical reasons, to start the next treatment cycle in the respective feeder study. * patients with a beta-human chorionic gonadotropin (hcg) test consistent with pregnancy. * participants are using one or more of the prohibited medications listed in the respective feeder study protocol * negative benefit / risk ratio as determined by the investigator * positive pregnancy test for on-treatment participants

Keywords: fibroblast growth factor receptors (fgfr) inhibitor fgfr 1-4 non-small-cell lung cancer small-cell lung cancer urothelial carcinoma adenoidcystic carcinoma head cancer neck cancer breast cancer
remote monitoring of chronic heart failure in veneto region

Conditions: Congestive Heart Failure

Summary: the purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. in addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.

the study is designed to evaluate the impact of telemonitoring on the management of chf compared with outpatient usual care. from a clinical point of view, the trial will allow to investigate how telemonitoring contributes to reduct the combined end point of all cause mortality and re-hospitalizations, as well as the other kinds of access to hospital facilities (bed-days, specialistic and er visits). the trial will examine whether the chf patients improve their health-related quality of life and reduct the anxiety about health conditions, thanks to the telemonitoring. a cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. the evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professional perception towards the service.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years. * discharge from hospital after acute heart failure in the previous 3 months and ef \ 40% plus bnp \> 400 (or plus nt-probnp\>1500) during hospitalization exclusion criteria: * comorbidities prevalent on chf with life expectation \< 12 months. * impossibility or inability to use the equipment and help at home not available. * myocardial infarction or percutaneous coronary intervention in the last 3 months or scheduled. * coronary artery bypass, valve substitution or correction in the last 6 months. * being on waiting list for heart transplantation. * being enrolled in other trial

Keywords: chf telemonitoring
pulse spectrum analysis in adult asthmatics: correlation with lung function, asthma control exhaled nitric oxide and metabolites in exhaled breath condensate

Conditions: Pulse Spectrum Analysis; Pulmonary Function; FeNO; Metabolites

Summary: our hypothesis is that radial arterial pulse may reflect the severity and airway function in asthmatics. the aims of this study are to investigate the pulse spectrim of the radial artery in adult asthmatics, and evaluate its correlation with airy inflammation an lung funtion in asthmatics.

the microcirculation is directly involved in the cellular matabolism and homeostasis. our hypothesis is that radial arterial pulse spectrum may reflect the airway condition in asthmatics. the aims of this study are to investigate the pulse spectrim of the radial artery in adult asthmatics, and evaluate its correlation with lung function, asthma control status,exhaled nitric oxide, and metabolites in the exhaed breath condensates.

Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria of gina guideline asthma patients exclusion criteria: * cancer or immune impaired patients; * pack-year smoking\> 5; * long-term ventilator-dependent patients * control group: 30 age matched healthy controls

Keywords: asthma pulse spectrum analysis lung function exhaled nitric oxide metabolites exhaled breath condensate
effects of involvement in a group-based creative expression program on psychotropic drug use in persons with dementia

Conditions: Dementia

Summary: this project, a small-scale pilot study, will attempt to determine if involvement in a group-based creative expression program may correlate with a reduction in use of psychotropic drugs for persons with dementia.

the study site has two skilled-nursing dementia special care units. one unit will serve as a control with residents receiving the standard care activity program. the other unit will receive the standard care activity program as well as the timeslips storytelling program (two hour-long sessions per week for six weeks). the behavioral symptoms and psychotropic drug usage for both cohorts will be studied for eight months, the first four months with no intervention and the last four months with or without the six-week timeslips intervention.

Eligibility criteria:
inclusion criteria: * residence in one of two dementia special-care skilled nursing units at the study site * clinical diagnosis of dementia

Keywords: behavioral symptoms long-term care
a comparison of three fluoroquinolone topical eyedrops in the treatment of infectious corneal ulcers.

Conditions: Corneal Ulcers

Summary: this phase ii study will evaluate the safety and efficacy of three fluoroquinolone ophthalmic agents to determine the optimal treatment in patients with infectious corneal ulcers.

this is a prospective, single masked, comparative, mono-therapeutic trial evaluating three fluoroquinolone agents that are approved and marketed for the treatment of conjunctivitis. approximately 120 patients who have corneal ulcers greater than 2 mm but less than 6 mm in size who meet all other inclusion criteria will be enrolled into this study. patients will be randomized in a 2:1:1 ratio to receive besifloxacin 0.6% ophthalmic suspension, gatifloxacin 0.5% ophthalmic solution, or moxifloxacin 0.5% ophthalmic solution.

Eligibility criteria:
inclusion criteria: 1. patients must be between the ages of 18-90 years of age. 2. patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements. 3. patients must have a corneal ulcer greater than 2mm but less than 6mm in size. 4. patients must have corneal ulcer present in only one eye. 5. patients must agree not to wear contact lenses while on study. exclusion criteria: 1. patients with multifocal ulcers. 2. signs of any other viral or fungal infection. 3. treatment with antibiotics within 14 days of study entry. 4. treatment with systemic or topical ocular antiviral agents or systemic or topical steroids or topical ocular nonsteroidal anti-inflammatory drugs (nsaids) during the prior 14-day period. 5. known hypersensitivity or allergy to steroids (loteprednol etabonate) or to any of the ingredients in the three study drugs (besifloxacin 0.6% or gatifloxacin 0.5% or moxifloxacin 0.5%). 6. contact lens only with no spectacles available. 7. ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study. 8. participation in any investigational study within the past 30 days. 9. pregnant women, minors, or those not able to consent for themselves.

Keywords: infectious corneal ulcers
gut-derived neuropeptides in cerebrospinal fluid of patients with parkinson's disease and healthy controls

Conditions: Parkinson's Disease

Summary: in previous work, the investigators analyzed the concentration of gut-derived peptides (ghrelin, pancreatic polypeptide \[pp\]) in serum of patients with parkinson's disease (pd). the investigators have shown that the secretion pattern differs between pd patients and controls. beside ghrelin and pancreatic polypeptide other gut-derived peptides (e.g. glucagon-like-peptide 1\[glp-1\], amylin, etc.) might be relevant for pd as well. the rational to investigate gut-derived peptides in the neurological disorder parkinson's disease (pd) is based on the following considerations: * receptors for gut-derived peptides are expressed in central nervous system (cns) structures that are affected by the neurodegenerative process underlying parkinson's disease * gut-derived peptides are involved in the modulation of higher brain functions (mood, cognition, reward-related behaviour) that are frequently altered in parkinson's disease. * the secretion of gut peptides is (co-)regulated by the vagal nerve that is dysfunctional in parkinson's disease. * certain gut-derived peptides (ghrelin, glp-1) stimulate neurogenesis and might be able to prevent cell death in neurodegenerative disorders, including parkinson's disease. objective: collection of csf and serum samples in a standardized way in order to quantitatively measure the concentration of gut-derived peptides (ghrelin, leptin, glucose-dependent insulinotropic peptide \[gip\], glp-1, amylin, pp, peptide yy \[pyy\], and insulin). scientific questions: 1. do csf (and serum) concentrations of these gut peptides differ between pd patients and controls? 2. do csf (and serum) concentrations of the investigated peptides correlate with clinical and / or epidemiological characteristics of the investigated subjects (age, gender, bmi, disease duration, severity of motor impairments, presence of non-motor symptoms, co-morbidities, medication, etc.)?


Eligibility criteria:
main inclusion criteria: * informed consent to participate * capability to understand risks of study-related procedures * for pd cohort: diagnosis of (idiopathic) parkinson's disease main exclusion criteria: * pregnancy * subjects incompetent to provide informed consent * subjects that cannot undergo a lumbar puncture for medical reasons (thrombocytopenia, anticoagulation, increased cranial pressure) * for control cohort: presence of a neurodegenerative disorder
repeated employee testing for understanding our recovery to normal

Conditions: COVID-19

Summary: the purpose of this research study is 1) to conduct a prospective longitudinal surveillance research trial, enrolling up to 200 cchmc employees as they come back to work, and then following their clinical and laboratory parameters for up to 12 months; and 2) to support the ongoing development of diagnostic techniques for covid-19. the overall goal is to investigate patterns of sars-cov-2 infection, including immunological recovery and genetic risk factors, among cchmc employees to better understand how to safely reintroduce the cchmc work force back into their normal routines.

as the global and pandemic spread of the novel coronavirus (sars-cov-2, covid-19) continues, many knowledge gaps remain with regard to the epidemiology and transmission of infection, as well as the normal immunological responses after viral exposure. cincinnati only recently (march 14, 2020) had its first confirmed case of covid-19, and through shelter-in-place and social distancing efforts, has avoided the community spread experienced by some other large metropolitan areas. as investigators contemplate the gradual reintroduction of the cincinnati children's hospital medical center (cchmc) workforce back into the hospital, it is imperative that investigators determine the current prevalence of infection among cchmc employees, measure the cumulative incidence of infection over the next 12 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. investigators have a unique but time-limited opportunity to optimally track the epidemiology and natural history of sars-cov-2 infection at cchmc, including risk factors for transmission and immunological recovery. return will investigate epidemiological and immunological features of sars-cov-2 virus infection in a limited cohort of cchmc employees, as they return from the current shelter-at-home directive toward a normal work environment. by collecting and analyzing weekly serial samples for sars-cov-2 (nasal swab for virus by pcr) and monthly serological exposure (serum antibodies by elisa), investigators will determine the prevalence and cumulative incidence of exposure to sars-cov-2; document the antibody responses over time; identify cases of apparent viral recrudescence or re-infection; and create models of transmission risk among cchmc employees.

Eligibility criteria:
inclusion criteria: * current full-time employees at cincinnati children's hospital * age: \>18.0 years of age, at the time of enrollment * cell phone that can be used for text messaging or web-based viewing of surveys * willing and able to provide informed consent * ability to comply with all study related evaluations and follow-up exclusion criteria: * previous proven sars-cov-2 infection (positive pcr-based molecular test) * any condition or illness that makes study participation ill-advised * currently or planning to enroll in a covid-19 vaccine or prophylaxis study
eight week clinical study to investigate reduction of extrinsic tooth stain by electric toothbrush

Conditions: Tooth Bleaching

Summary: the objective of the present study was to compare the effects of reduction of extrinsic stains between a commercially available oclean electric toothbrush and oral b manual toothbrush.


Eligibility criteria:
inclusion criteria: * aged between 18-70 years old * good general health * could attend the clinical examinations during the 4 week study period * possessing \>20 natural permanent teeth that were uncrowned or heavily filled with restorative materials, excluding third molars * having a whole-mouth mean tooth stain score of more than 1.5 according to the lobene index. exclusion criteria: * severe oral diseases, chronic disease or allergic to the trial products * advanced periodontal diseases * females who are pregnant or lactating * taking part in other clinical trials * taking part in orthodontic treatment or wearing removable denture * fluorosis or tetracycline teeth * receiving prophylaxis during the previous 3 months or tooth whitening treatment during the past 6 months.

Keywords: controlled clinical trial electric toothbrush
endometriosis and risk of obstetric complications

Conditions: Endometriosis; Pregnancy Complications

Summary: the aim of this study is to compare the rate of obstetric complications at first spontaneous pregnancy among women with endometriosis, with the rate of obstetric complications at first spontaneous pregnancy among women without endometriosis

all women followed up for a surgical or clinical/sonographic diagnosis of endometriosis in 11 italian referral centres for the treatment of endometriosis, completed a questionnaire regarding their previous pregnancies. the same questionnaire was completed by women, attending a routine gynecologic visit, in whom surgery or clinical/sonographic evaluation excluded endometriosis.

Eligibility criteria:
inclusion criteria: * 30 to 50 years old women with at least one previous spontaneous pregnancy \> 12 weeks with surgical or clinical/sonographic diagnosis of endometriosis or in whom surgical or clinical/sonographic evaluation ruled out endometriosis exclusion criteria: * pregnancy achieved by assisted reproductive techniques * pregnancy terminated before 12 gestational weeks * twin pregnancy * preexisting hypertension * lupus like anti-coagulant * non corrected uterine malformation * recurrent abortion
very long-term (>15 years) results of tricuspid valve repair.

Conditions: Tricuspid Regurgitation

Summary: interest in tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional tricuspid regurgitation (tr). earlier reports advocated for a more conservative tr management in patients undergoing left-sided heart valve surgery but more recent guidelines advised for a more aggressive tr management, as accumulating evidence demonstrates its adverse impact on long term morbidity and mortality. several papers have been published analyzing the results of surgical tricuspid valve repair but the length of the follow-up is usually limited to 10 to 12 years. with this study the investigators aim to analyze the very long-term results (\>15years) of tricuspid valve repair according to the surgical method employed for valve repair (suture vs ring annuloplasty).


Eligibility criteria:
inclusion criteria: * cardiac surgery treatment of tr, isolated or in conjunction with other procedures on the left heart * patients operated on between january 1998 and december 2004 exclusion criteria:
a study to assess the safety and effectiveness of medrol® in acute asthma in indian patients

Conditions: Asthma

Summary: the present study is designed to collect data on real world experience on use of medrol in acute asthma in indian patients.

sequential enrollment

Eligibility criteria:
inclusion criteria: * to be eligible for enrollment in this study, patients must be prescribed oral medrol® tablets (4mg and 16 mg) for acute asthma as per the locally approved prescribing information. the prescription of medrol® will be separated from the decision to include the patient in the study. * medrol® tablets, will be prescribed to the patient by the physician according to his/her usual practice. the decision to prescribe medrol® tablet will necessarily precede and will be independent of the decision to enroll patient into the study. only those patients who have been prescribed medrol® tablets will be evaluated for their potential eligibility for the study * only those patients, who are ready and willing to sign an informed consent, will be included in the study * subject can be contacted through telephone exclusion criteria: * based upon history or physical exam in the emergency department (ed) or clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as copd, chf, pneumonia, pulmonary embolism, or angioedema * any contraindication to medrol tablet use. contraindications of medrol use are systemic fungal infections and known hypersensitivity to components

Keywords: acute exacerbation of bronchial asthma acute asthma