Kornimate/medical-research-clean huggingface dataset:
right ventricular septal pacing in patients with right bundle branch block and heart failure (the spark trial)

Conditions: Right Bundle-Branch Block; Heart Failure

Summary: this clinical study has been designed to test whether a new pacing therapy would lead to improvement in heart function, symptoms and quality of life in a specific group of heart failure patients. this group has a unique electrical conduction problem (right bundle branch block) that did not respond well to the current available pacing therapy.

this pilot clinical trial will be a randomized single blinded cross over trial. each subject will undergo three study stages. subject will be randomized initially to either of the two arms; experimental or placebo, and then will be followed up for 3 months for the first stage to assess outcomes. in the second stage, both arms transition to a two months, intervention free, wash out period. finally, at the third stage both arms will cross over and subject will be followed up for an additional 3 months for outcomes assessment.

Eligibility criteria:
inclusion criteria: * cardiomyopathy; ischemic or non-ischemic on optimal medical therapy per current heart failure treatment guidelines for at least 3 months. * lvef \< 35% by trans-thoracic echocardiogram assessment * prior implantation of pacemaker/defibrillator with at least an atrial and rv mid septal lead. atrial lead can be waived if rv lead has atrial sensing capabilities\* * normal sinus rhythm at enrollment * rbbb with qrs duration \>120 msec on 12 lead surface ekg. * pr interval \<250 msec on 12 lead surface ekg * subjects with biventricular pacemaker/icd will be eligible for enrollment if their lv lead pacing function has been turned off by the subject's primary cardiologist prior to study enrollment for at least 3 months (this could be due to lead malfunction or the decision to deactivate the lv pacing therapy for any reason per primary cardiologist discretion) exclusion criteria: * age younger than 18 years old * pregnancy * acute myocardial infarction within 6 months of entry into the study * inotrope dependent heart failure condition * left ventricular assist device or heart transplantation * any other known conditions other than heart failure that could limit survival to \< 6 months. * atrial fibrillation or flutter burden \>10% of the time within the last 6 months * atrioventricular node disease that requires ventricular pacemaker support \>10% of the time

Keywords: cardiac resynchronization therapy
a study in relapsed and/or refractory multiple myeloma patients treated with ixazomib plus lenalidomide and dexamethasone

Conditions: Relapsed and/or Refractory Multiple Myeloma

Summary: the purpose of this study is to investigate the real world effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone (ird) in patients with relapsed and/or refractory multiple myeloma (rrmm), under conditions of standard medical care. in addition, an exploratory study of biomarkers will be conducted.

the drug being tested in this study is called ixazomib. ixazomib is being tested to treat people who have relapsed and/or refractory multiple myeloma (rrmm) under the conditions of standard medical care. this study is a non-interventional (observational), domestic, multicenter, prospective study in patients with rrmm. this study will look at the effectiveness and safety of ixazomib in combination with lenalidomide and dexamethasone in japanese patients with rrmm as standard medical care. in addition, an exploratory study of biomarkers will be conducted in this study. the study will enroll approximately 300 patients. all participants will receive ixazomib + lenalidomide + dexamethasone (ird) therapy as standard medical care. this multi-center trial will be conducted in japan. the overall time of observational period in this study will be 36 months. for each participant, the observation period will be from the start of ird therapy until either 24 months after the enrollment date of the final patient to enroll, or until death or withdrawal of consent, whichever is earlier.

Eligibility criteria:
inclusion criteria: 1. men and women aged 20 years or older at the time of enrollment 2. patients with rrmm 3. participants who are scheduled to start ird therapy 4. participants who can provide written informed consent of their own free will before the start of study treatment 5. participants who are judged by the principal investigator or investigator(s) to have the faculty to understand and comply with the requirements of the study exclusion criteria: 1. female participants who are nursing or pregnant 2. participants who have been treated with ixazomib 3. participants with hypersensitivity to any of the components of ird therapy, their analogs or excipients 4. participants with another active malignancy, i.e. synchronous active malignancy or previous malignancy with a disease-free period of less than 5 years, except for participants with carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma judged to be cured by topical treatment 5. participants who are not registered with, or comply with, the guidelines of the lenalidomide management program 6. participants who, in the judgement of the principal investigator or investigator(s), are considered to be unsuitable for enrolment into the study
comparison of clinical outcomes of toric intraocular lens

Conditions: Astigmatism

Summary: this study is to compare the clinical outcome of precizon toric intraocular lens(iol) to that of tecnis toric iol.

in cataract surgery, after phacoemulsification, intraocular lens should be implanted for patient's better visual acuity. when patient has large amount of corneal astigmatism, toric intraocular lens are recommended to correct the preexisting astigmatism.

Eligibility criteria:
inclusion criteria: * patient with cataract and regular corneal astigmatism(between 0.50 diopter and 2.50 diopter considering both anterior and posterior corneal surface) exclusion criteria: * amblyopia, irregular astigmatism, corneal opacity, glaucoma, retinal disease, history of ocular inflammation, previous other intraocular surgery
study of incidence of drug-induced upper gastrointestinal bleeding

Conditions: Upper Gastrointestinal Bleeding

Summary: the purpose of this study is to determine and analyse the incidence, severity, risk factors and routine management of acute drug-induced upper gastrointestinal bleeding (ugib) in the population of russian patients


Eligibility criteria:
inclusion criteria: * established diagnosis of acute upper gastrointestinal bleeding, confirmed by presence of hematemesis/ coffee ground vomiting, melena, as well as other clinical or laboratory evidence of acute blood loss from the upper gastrointestinal tract * written informed consent provided prior the start of participation in the study. exclusion criteria: * subjects who are unwilling or unable to provide informed consent.

Keywords: acute upper gastrointestinal bleeding patients with drug-induced upper gastrointestinal bleeding routine management
early start of oral sildenafil 100mg for erectile dysfunction after robotic assisted laparoscopic radical prostatectomy

Conditions: Prostate Cancer

Summary: the investigators try to investigate the benefit of early administration (immediately after urethral catheter removal) of sildenafil after nerve-sparing ralp for 3 months. the investigators will compare the potency rates up to 2 years after nerve-sparing ralp in men with on- demand sildenafil 100mg dosing from the early postoperative period (immediately after urethral catheter removal) with from the delayed postoperative period (3 months after rp).

various studies using animal models of cn neuroparaxia and clinical trials have demonstrated somewhat beneficial effect of pde-5 inhibitors on smooth muscle cells of the corpus cavernosum. pde-5 inhibitors including sildenafil have demonstrated the effectiveness in the management of postprostatectomy ed. in the animal experiments, pde-5 inhibitors lowered the severity of the fibrosis in the corpus cavernosum of rats with cn cutting. in the clinical trials, on-demand dosing or routine dosing of pde-5 inhibitors improved the potency rates in men received nsrp, and improvements of the potency rate did not appear to be statistically different among two dosing regimens. but, there are few studies on the potency rate according to the start time of the administration of pde-5 inhibitors (eg. early vs. delayed post-operative dosing). at present, it is not conclusive that whether nerve-sparing ralp provides more higher potency rate than conventional surgery in men with prostate cancers. but, with more precise dissection of cn, the robotic surgery appears to have more chances to maintain the potency in men received rp.

Eligibility criteria:
inclusion criteria: * patients with agree to participate with the study * korean male subjects aged 50 years or older with clinically localized prostate cancer * preoperative potent men (iief-5 score 17 or more than 17) * patients in a stable, heterosexual relationship with a single partner for at least the past six months * suitable for nerve sparing indication exclusion criteria: * genital anatomical deformities that would significantly impair erection * other sexual disorders (e.g. hypoactive sexual desire) that are considered to be the primary diagnosis when there is a coexisting diagnosis of erectile dysfunction. * known raised prolactin level (\>3 times the upper limit of the normal range) or low free testosterone level (confirmed to be \>20% below the lower limit of the normal range on blood collected between 09:00 and 11:00 hours). * major psychiatric disorder (including major depression or schizophrenia) that is not well controlled on treatment.

Keywords: prostate cancer prostatectomy erectile dysfunction
the molecular pathogenesis study of cataract

Conditions: Cataract; Pathogenesis

Summary: to study the molecular pathogenesis of cataract and explore possible treatments，anterior lens capsules were collected from cataract patients

anterior lens capsules were collected from the patients with dc and arc, and transparent crystals of cadaveric eyes. m6a epitranscriptomic microarray was performed to investigate the altered m6a modifications and determine the differentially expressed mrnas. the potential role of dysregulated m6a modification levels was predicted through gene ontology and kyoto encyclopedia of genes and genomes pathway enrichment analyses. real-time polymerase chain reaction was performed to identify the dysregulated expression of rna methyltransferases, demethylases, and readers.

Eligibility criteria:
inclusion criteria: * diabetic cataract * underwent cataract surgery exclusion criteria: * combined with other eye diseases * underwent other eye surgery
nigelle 5 in prevention of influanza

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Summary: this study will be carried out by more than 30 liberal tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the nig5 product sublingually, each day. against a control group which will be followed with the same protocol as the first but which will not receive the product. randomization (even days: nigella group, odd days: control group)

this study will focus on the evaluation of the natural product nigella sativa in the fractalized form. "lactose nigelle 5" from the tunisian company fractal tun, in terms of possible contribution to the prevention of influenza-like illnesses, in particular covid-19 it will be carried out by more than 30 liberal tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the nig5 product sublingually, each day. against a control group which will be followed with the same protocol as the first but which will not receive the product. randomization (even days: nigella group, odd days: control group) the monitoring and evaluation will last for 3 weeks with taking the product nig5, followed by a week without taking the product. that is 4 weeks in all. more than 30 physicians volunteered to participate in this study without remuneration and without consultation fees for the candidates. this study will be supervised by professor riadh boukef, head of emergency services at sahloul university hospital, who will collect all the data afterwards in order to submit them to the statistical tools in force. professor boukef will be responsible for preparing the abstract and publishing it on his behalf in the scientific journals of his choice, naming the doctors who participated as well as the product in question and the company that markets it in tunisia. 27 free practice doctors participate in patient recruitment: amiche sondèss baha mohamed ben amara mohamed khalil ben arbia karima ben ayad afef ben ayed ktari fouzia bentaleb mourad besbes mohamed chtourou iteb dhouib manel djait mohamed djemal najla elfidha mongi fourati imen frih sabria frikha fahmi gharbi nadia kammoun naziha ketata mourad mhiri ikram njah jamil ouarghi sameh regaieg mourad sakka samar trabelsi hinda zouari imen zouari nassira

Eligibility criteria:
inclusion criteria: * patients with an age\> 40 years exclusion criteria: * being positive for covid or having contracted it previously * positive for covid between d1 and d5 of the study, meaning that there was infection before inclusion. * immunocompromised (hiv, other ...) * under chemotherapy * on immunosuppressants * pregnant women

Keywords: nigelle 5ch covid-19
collection of blood samples in patients with non-small cell lung cancer

Conditions: Stage III Non-Small Cell Lung Cancer AJCC v7; Stage IIIA Non-Small Cell Lung Cancer AJCC v7; Stage IIIB Non-Small Cell Lung Cancer AJCC v7; Stage IV Non-Small Cell Lung Cancer AJCC v7

Summary: this pilot research trial studies the collection of blood samples in monitoring tumor specific mutations in patients with non-small cell lung cancer that has spread to other places in the body or cannot be removed by surgery. collecting blood samples may help measure the changes in lung cancer, better learn methods to track cancer in the bloodstream, and improve cancer treatments.

primary objectives: i. to evaluate the ability of next generation sequencing (ngs) to monitor the evolution of cancer-specific mutations in patients undergoing treatment for non-small cell lung carcinoma and for whom the molecular profile of the tumor cells prior to treatment is known. ii. compare the sensitivity of digital droplet polymerase chain reaction (ddpcr) to that of ngs for detecting the appearance of egfr t790m mutations in patients treated with an egfr tyrosine kinase inhibitor. outline: patients undergo collection of blood samples at baseline and every 12 weeks for up to 6 times.

Eligibility criteria:
inclusion criteria: * a diagnosis of non-small cell lung carcinoma for which the molecular profile of the primary tumor has been obtained from a block of paraffin-embedded, formalin-fixed tissue that remains available * zubrod performance status 0 or 1 * patients must have metastatic or unresectable disease and be starting a new line of systemic treatment at the time of enrollment; there are no constraints regarding the time interval between the initial collection of samples for molecular profiling studies at the time of diagnosis prior to treatment and subsequent collections of circulating cell-free deoxyribonucleic acid (dna) or circulating tumor cells * patients must have measurable disease according to response evaluation criteria in solid tumors (recist) version (v)1.1 * ability to understand and the willingness to sign a written informed consent; note: there will be no discrimination between type of treatment or whether they are on continuous versus intermittent therapy exclusion criteria: * known severe anemia (hemoglobin \[hb\] \< 8g/dl) * patients will be excluded if trackable driver mutations are not identified in the primary tumor tissue
psychotherapy of generalized anxiety disorder

Conditions: Anxiety Disorders

Summary: the purpose of this study is to compare the effects of worry exposure with the effects of applied relaxation in patients with generalized anxiety disorder.

controlled treatment studies show that there is a lower efficacy of cognitive-behavioral treatment of generalized anxiety disorder (gad) than in other anxiety disorders. the best effect sizes are found for applied relaxation (öst), but there are only three treatment studies. another, yet previously not tested in its pure form, approach is "worry-exposure", which aims at confronting the emotionally intensive imaginative contents of worries in gad. fifty-two randomized patients with gad as a primary diagnosis will be treated with one of the two treatments and will be compared with waiting-list patients. this treatment protocol contains 15 sessions (+/-2) and a 6 month and 12 month follow-up. the comparisons in this study include: worry exposure versus applied relaxation versus a waiting control group.

Eligibility criteria:
inclusion criteria: * primary diagnosis of generalized anxiety disorder (according to impairment) * 18-70 years of age * informed consent exclusion criteria: * not able to understand and speak the german language * acute, unstable and severe somatic disease (dsm-iv, axis iii) * history of schizophrenia or bipolar disorder * other mental disorders requiring treatment * substance dependence within the past 12 months preceding treatment * personality disorders that interfere with treatment compliance * participation in any other psychotherapeutic interventions * use of anxiolytics (e.g. tranquilizer, hypnotics, neuroleptics; does not include stabile use of antidepressants)

Keywords: psychotherapy generalized anxiety disorder randomized-controlled trial worry exposure applied relaxation
adverse drug reactions of different brands of ceftazidime injection

Conditions: Infection

Summary: the purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.

ceftazidime is a third generation cephalosporins that should be reserved for severe bacterial infections. substitution of the brand ceftazidime with a generic ceftazidime raised some concerns. the purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.

Eligibility criteria:
inclusion criteria: * patients in surgical intensive care unit who require ceftazidime treatment exclusion criteria: * less than 1 year old

Keywords: ceftazidime safety infection
a clinical comparison of two multifocal toric soft contact lenses

Conditions: Astigmatism; Presbyopia

Summary: this study aims to compare the short-term clinical performance of the two study contact lenses.

the aim of this study is to evaluate the short-term clinical performance of two multifocal toric soft contact lenses after 15 minutes of daily wear each.

Eligibility criteria:
inclusion criteria: 1. they are aged 35 years or over and have capacity to volunteer. 2. they understand their rights as a subject and are willing to sign a statement of informed consent. 3. they are willing and able to follow the protocol. 4. they agree not to participate in other clinical research for the duration of this study. 5. they are currently wearing soft contact lenses or have done so within the past 12 months. 6. they have a spherical prescription between +10.00 and -10.00ds inclusive, (based on the ocular refraction). 7. they have astigmatism of between -0.75 and -5.75dc (based on the ocular refraction) in each eye. 8. they have a reading addition component to their spectacle refraction of between +0.75 and +2.50ds. 9. they can be satisfactorily fitted with the study lenses. 10. they own a wearable pair of spectacles. exclusion criteria: 1. they have an ocular disorder which would normally contraindicate contact lens wear. 2. they have a systemic disorder which would normally contra-indicate contact lens wear. 3. they are using any topical medications such as eye drops or ointment. 4. they have had cataract surgery. 5. they have had corneal refractive surgery. 6. they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. they have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 8. they have eye or health conditions including immunosuppressive or infectious diseases which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction. 9. they have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
the effectiveness of topical latanoprost compared with topical brimonidine in the treatment of the primary open angle glaucoma

Conditions: To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma Patients

Summary: outpatient department of cmch, ceitc,cimch poag patients enrolled for the study.


Eligibility criteria:
inclusion criteria: * iop 22_34mmof hg,newly diagnosed case, bilateral poag patients patients. exclusion criteria: * pregnant and lactating women, infection, any eye surgery.
effect of two different dosages of ethinyl-estradiol in association with drospirenone in women with polycystic ovary syndrome.

Conditions: Polycystic Ovary Syndrome; Estro-progestin Drugs

Summary: the estrogenic component of estro-progestin (ep) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (pcos). the objective of this study is to compare the effects of a long term administration of two ep combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (ee) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in normal weight pcos women. the investigators enrolled 30 patients, randomly allocated to group a (20 µg ee - 3 mg drsp) and 15 to group b (30 µg ee - 3 mg drsp). hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy.


Eligibility criteria:
inclusion criteria: * normal weight women with polycystic ovary syndrome, diagnosed in accordance with rotterdam consensus conference criteria 2003. exclusion criteria: * pregnancy * past history of cardiovascular disease, diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), hypertension * significant liver or renal impairment * other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs) * neoplasms * unstable mental illness

Keywords: pcos drospirenone ethinylestradiol androgens metabolism