Kornimate/medical-research-clean huggingface dataset:
coronary artery ectasia database - poland

Conditions: Coronary Artery Aneurysm; Coronary Artery Ectasia

Summary: the goal of this observational study is to comprehensively investigate the current prevalence, morphological characteristics, risk factors for the development, complications as well as long-term prognosis of coronary artery aneurysm and ectasia (caae) in the polish population. data obtained from the cared-pol registry will enable the selection of morphological risk factors for the unfavorable course of caae, including the progression and development of giant aneurysms, aneurysm clotting with vessel occlusion, and thromboembolic complications. comparing the safety and effectiveness of available caae treatment methods in individual patient subgroups will allow individualization of treatment, including anticoagulant therapy.

coronary artery aneurysm or ectasia (caae) is a rare vascular pathology diagnosed in 0.15-5.3% of patients undergoing coronary angiography. caaes are often diagnosed incidentally, while symptomatic patients experience various complications, including unstable angina, acute myocardial infarction, arrhythmias, or sudden cardiac death. the most common etiology of caae is atherosclerosis, kawasaki disease, or other vasculitis. detailed pathomechanisms and risk factors of unfavorable courses of caae have not yet been known. in addition, the data on polish patients are limited to case reports, case series, and small groups from major academic centers. cared-pol is a multicenter, observational nationwide registry of caae. patients will be included ambispectively based on the angiographic diagnosis of coronary artery aneurysm (caa) or coronary artery ectasia (cae). all participating centers will enroll patients retrospectively based on their internal databases after evaluation of coronary angiography by an experienced interventional cardiologist and prospectively for six months from the cared-pol joining. angiographic assessment will be based on quantitative coronary angiography (qca). the patient data will be collected from standardized and anonymous forms via the scientific platform of the polish society of cardiology. in accordance with initial assumptions, 2,000 patients in all participating centers will be included. patients included in the registry will undergo a minimum of 6 months of follow-up with assessment of the following endpoints: all-cause death, re-hospitalization for unstable angina, myocardial infarction, heart failure, bleeding, stroke, embolic events, and any cause for repeat coronary angiography. data will be obtained from outpatient visits, medical records, or telephone interviews. in patients who undergo repeated coronary angiography, the formation of a new aneurysm or progression of an existing one will be detected. aneurysm progression is diagnosed as an increase in size demonstrated on at least two orthogonal angiographic views.

Eligibility criteria:
inclusion criteria: * caa or cae defined as a focal dilatation with a diameter of more than or equal to 1.5 times the adjacent normal coronary segment exclusion criteria: * the lack of informed consent for prospectively enrolled patients
clinical study on the efficacy and safety of rc48-adc in the treatment of metastatic castration resistant prostate cancer (mcrpc)

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: this is a single-arm, open, single-center clinical study to evaluate the efficacy and safety of rc48-adc in patients with mcrpc who have progressed after nht. a total of 40 patients with mcrpc with immunohistochemically confirmed her2 expression who had progressed after treatment with at least one novel endocrine therapy will be included in this study.

this is a single-arm, open, single-center clinical study to evaluate the efficacy and safety of rc48-adc in patients with mcrpc who have progressed after nht. a total of 40 patients with mcrpc with immunohistochemically confirmed her2 expression who had progressed after treatment with at least one novel endocrine therapy will be included in this study. participants will receive rc48-adc intravenous injection (2.0 mg/kg, q2w) until disease progression or death. during the treatment, participants will evaluate every 4 weeks, including psa testing every 4 weeks and tumor evaluation according to pcwg3 standards every 8 weeks. if the patient develops disease progression, the treatment will be discontinued and survival follow-up will be conducted every 8 weeks.

Eligibility criteria:
inclusion criteria: * 1) prostate cancer confirmed by histology; * 2) ≥ 18 years old; * 3) the presence of metastatic lesions confirmed by bone scan and/or ct/mri and/or pet-ct; * 4) ecog score 0-2; * 5) continuously maintain adt treatment and maintain testosterone levels ≤ 50ng/dl; the progression of prostate cancer recorded within 6 months prior to screening; * 6) having received at least one nht in the past before progressing; * 7) her2 ihc 1+, 2+, or 3+; * 8) inability to or refusal docetaxel chemotherapy; * 9) voluntarily join the study; * 10) expected survival time ≥ 6 months; * 11) normal function of main organs; exclusion criteria: * 1)have a history of malignant tumors other than prostate cancer; * 2)previously received allogeneic stem cell or parenchymal organ transplantation; * 3) previously or currently suffering from congenital or acquired immunodeficiency diseases; * 4) the patient have a history of allergy to rc48 or paclitaxel, or a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergy to excipients of the study drug; * 5) other significant clinical and laboratory abnormalities that affect safety evaluation; * 6) those who are unwilling or unable to take effective contraceptive measures; * 7) subjects with active brain metastasis;

Keywords: rc48-adc metastasis castration resistant prostate cancer her2
clinical evaluation of postoperative healing after conventional and laser assisted frenectomy operations

Conditions: Frenulum; Hypertrophy, Lip

Summary: the aim of this randomized controlled parallel-designed study was to evaluate clinical healing and patient comfort after conventional and diode laser assisted frenectomy operations in case of high papillary frenulum attachment. forty-eight patients with high papillary frenulum attachments were included in the study. patients were randomly divided into three groups; conventional frenectomy operation (group c), frenectomy operation using diode laser (group l) and diode laser asissted frenectomy with horizontal incision on the periosteum (group l+p). postoperative pain, difficulty in speaking and eating scores were assessed postoperative 3 hours and 1, 7, 14, 21 and 45 days using visual analogue scale (vas). evaluation of epithelialization of the wound surface was carried out via hydrogen peroxide to the surface using a dental injector at postoperative 7, 14, 21 and 45 days. plaque index, gingival index, bleeding on probing and probing depth were assessed at baseline and postoperative 7, 14, 21 and 45 days. all data were compared between groups and within each group.


Eligibility criteria:
inclusion criteria: * systemically healthy, nonsmoker, aged between 18 and 65, high papillary frenulum attachment diagnosed according to mirko et al (mirko et al, 1974), not received any periodontal treatment within the last 3 months, presence of at least central, lateral incisors and canines at the upper jaw, and consent to participate in the study. exclusion criteria: * any systemic disease that might interfere with the prognosis of periodontal disease (i.e., diabetes mellitus, hiv infection), smoking, antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months that might affect the outcome of the study, any physical limitations or restrictions that might preclude normal oral hygiene procedures.
bilateral ultrasound-guided transversus abdominis plane (tap) block and erector spinal plane (esp) block

Conditions: Pain, Postoperative; Cesarean Section; Erector Spinae Plane Block; Transversus Abdominis Plane Block

Summary: transversus abdominis plane block (tapb) is frequently used for the management of postoperative pain in patients undergoing cesarean section. recently, erector spinae plane block (espb) has been defined and used in several clinical scenarios. however, data regarding the espb use in the aforementioned patient group is limited.


Eligibility criteria:
inclusion criteria: * 18 - 45 years * asa2 * undergoing cesarean section under spinal anesthesia exclusion criteria: * history of chronic pain * body mass index \> 35 * urgent/emergent surgeries * major bleeding * any additional surgical procedure * contraindication for any drugs used in the protocol * the presence of any instrumentation in the procedure sites
clinical determinants of disease progression in patients with limb girdle muscular distrophy type 2e

Conditions: LGMD2E

Summary: a retrospective observational study that will enable us to collect retrospective data from the clinical records of lgmd 2e patients in order to highlight any possible correlation between: * clinical variables and patient age, * clinical variables and other clinical variables, * clinical variables and clinical outcomes. the study will help to define the natural history of this rare disease and to ameliorate the management of these patients.

retrospective observational study. retrospective data from clinical charts of patients affected by lgmd 2e will be collected after the subscription of informed consent.data considered will include any clinical variable measured, both objective and subjective. all data obtained will be anonimized before any treatment. data will be grouped according to the age of the patient, in order to have more data for each age and to gain a trustable description of the disease progression. the possible correlation of each variable to age, to other variables and to objective clinical outcomes will be studied. clinical outcomes considered will include age of loss of deambulation, age of introduction of respiratory assist, age of introduction of cardiological therapy. data collected will also be divided in two groups according to different genetic diagnosis in order to evaluate phenotipical differences of genotypical clesses. first group will count all patient with the truncating mutation c.377_384duplcagtagga in exon 3, both in heterozigosis and in homozigosis second group will include all the other patients. both on the global data collection and on data divided according to genotype, statistical analysis will be performed. those analysis will study linear regression both with the univariate, bivariate and multivariate model.

Eligibility criteria:
inclusion criteria: * gene based diagnosis of lgmd 2e * subscription of informed consent when applicable exclusion criteria: * lacking gene based diagnosis of lgmd 2e * lacking subscription of informed consent when applicable
prospective study of altis system with the tvto procedure for the management of stress urinary incontinence in women

Conditions: Genuine Stress Incontinence

Summary: prospective randomized comparison of minisling (altis) with the tvto procedure for the management of women with genuine stress urinary incontinence.

prospective randomized study double blinded. two group of patients consisting group a of 40 patients being operated with altis minisling and group b with 40 patients operated with tvto procedure. all patients will be operated with epidural anesthesia. the patients participating in the study will meet the following requirements. a. having genuine stress urinary incontinence proven by urodynamics, b. be willing to be operated and participate in the study. exclusion criteria wil be the following: a.history of previous irradiation in the lower genital tract, b. bmi more than 30kg/m2, c.previous anti-incontinence surgery, previous vaginal surgery, e. having mucp\< 20 cm h2o or valsava leak point pressure less than than 60 cm h2o. patients will be allocated in each operation by an automatic system using a computer software. primary outcome measure will be the objective cure rate at 6 months as it is assessed with cough stress test during urodynamics. secondary outcome measures will be the subjective cure rate, improvement and failure rate, the incidence of complications such as obstruction, voiding difficulties, hemorrhage etc. patients will be asked to complete preoperatively and postoperatively the iciq-fluts, patient satisfaction questionnaire and the female sexual function index.postoperatively the patients will complete the pgi-i questionnaire.

Eligibility criteria:
inclusin criteria: * having genuine stress urinary incontinence proven by urodynamics * be willing to be operated and participate in the study. exclusion criteria: * history of previous irradiation in the lower genital tract * bmi more than 30kg/m2 * previous anti-incontinence surgery, previous vaginal surgery * having mucp\< 30 cm h2o or valsava leak point pressure less than than 60 cm h2o * mixed urinary incontinence.

Keywords: stress incontinence female altis transobturator tape minisling
cibmtr research database

Conditions: Autologous Stem Cell Transplantation; Allogeneic Stem Cell Transplantation; Solid Tumors; Blood Cancers; CAR-T; Gene Therapy; Non-malignant Disease

Summary: the primary purpose of the research database is to have a comprehensive source of observational data that can be used to study hsc transplantation and cellular therapies. a secondary purpose of the research database is to have a comprehensive source of data to study marrow toxic injuries. objectives: to learn more about what makes stem cell transplants and cellular therapies work well such as: * determine how well recipients recover from their transplants or cellular therapy; * determine how recovery after a transplant or cellular therapy can be improved; * determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy; * determine how access to transplant or cellular therapy for different groups of patients can be improved; * determine how well donors recover from the collection procedures.


Eligibility criteria:
eligibility to participate in the research database recipient eligibility criteria: * any recipient of an unrelated or related donor or autologous hsc transplant in a cibmtr center is eligible to participate in the research database. this includes adults with and without decision making capacity, and children. individual with marrow toxic injury eligibility criteria: * any individual who is treated for a marrow toxic injury at a center participating in the nmdp's radiation injury transplant network (ritn) is eligible to participate in the research database. this includes adults with and without decision making capacity, and children. eligible individuals may have received supportive care only, growth factor support, hsc transplant or other appropriate medical treatment for marrow toxic injury. treatments applied are at the discretion of the care facility, and are not determined by the nmdp or cibmtr. unrelated donor eligibility criteria: * all donors registered on the nmdp registry who have been requested to donate a product for a recipient are eligible to participate in the research database. * all maternal cord blood donors are enrolled in the nmdp cord blood bank investigational new drug (ind) protocol, and sign an informed consent document specific to that protocol. data collected as part of the cord blood bank protocol are included in the research database.

Keywords: data collection cibmtr nmdp stem cell transplantation gene therapy car-t
international experience in timing and choices for ductal closure in patent ductus arteriosus:interpda trial

Conditions: Patent Ductus Arteriosus

Summary: the three options for the treatment of patent ductus arterioles (pda) in preterm infants are conservative approach, pharmacological intervention and surgical ligation. there is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants.

patent ductus arteriosus (pda), of which incidence is inversely related to gestational age and birth weight, is one of the the most common conditions among preterm infants. in recent years, the use of antenatal steroids, postnatal surfactant, noninvasive ventilation strategies and low oxygen saturation targets have affected the incidence of hemodynamically significant pda (hspda). there is not any consensus about the best approach on the clinical management of pda in preterm infants. over past years, the management of hspda shifted to aggressive medical and surgical intervention from conservative treatment, but conservative treatment approach has been mainly concerned again nowadays. today, the three options for the treatment of pda in preterm infants are conservative approach, pharmacological intervention and surgical ligation. there is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants. many countries including developed countries only give recommendations, instead of publishing guidelines, on screening, timing of treatment and treatment choices of pda, because of the differences on management of pda between the centers even within a single center. timing of pda treatment and treatment choices at preterm infants born before 28 gestation weeks' differ in our country also in many countries over the world. in this study, it is aimed to record the managements of pda detected beyond postnatal 3 days, to compare the effects of the managements at postnatal 3-7 days and after 7 days on closure, surgical ligation rates and side effects of drugs.

Eligibility criteria:
inclusion criteria: * infants born at 24 0/7-28 6/7 gestation weeks' * pda detected with ductal diameter equal or greater than 1.5 mm and la/ao equal or greater than 1.5 on echocardiography at or after postnatal 72 hours of life exclusion criteria: * infants died before 72 hours of life * infants detected pda but treated before 72 hours of life

Keywords: preterm patent ductus arterioles treatment
post marketing survey of vesicare in japan

Conditions: Overactive Bladder

Summary: this study is to evaluate the effect of vesicare on quality of life (qol) in female patients.

overactive bladder (oab) represents a constellation of symptoms that must include urinary urgency as an essential symptom for the diagnosis. it is usually accompanied by daytime frequency and nighttime frequency (urgency incontinence is not an essential symptom) and impairs the patient's activities of daily living and quality of life (qol). the objective of this survey is to confirm qol improvement in patients treated with vesicare (generic name: solifenacin succinate), with the use of oab-q (overactive bladder questionnaire), a questionnaire for assessment of oab symptoms and qol. the effect of improvement of oab symptoms by solifenacin on qol will also be confirmed. this survey will not include male oab patients since many of them have benign prostatic hyperplasia as a coexisting disease and their qol is supposed to be affected by α1-blocker treatment. to define patient's response to solifenacin in terms of qol more clearly, this survey will include only female oab patients.

Eligibility criteria:
inclusion criteria: * previously untreated oab patients * patients who meet the diagnostic criteria for oab provided in the clinical guidelines for overactive bladder (patients who have urinary urgency at least once weekly as an essential symptom and at least one of the other oab symptoms including daytime frequency, nighttime frequency, and urgency incontinence) * patients who can understand and answer oab-q (japanese version) * patients from whom data on all items concerning oabss, oab-q, and satisfaction score for urination can be obtained at baseline * patients who are expected to be treated for at least 12 weeks

Keywords: overactive bladder solifenacin overactive bladder questionnaire overactive bladder symptom score satisfaction score
efficacy and safety study of myobloc® followed by open-label multiple-treatment with myobloc® in the treatment of troublesome sialorrhea in adult subjects

Conditions: Sialorrhea

Summary: this study will evaluate the efficacy and safety of myobloc in the treatment of sialorrhea (drooling), which can be a symptom of many disease conditions. myobloc will be injected directly into the salivary glands. myobloc has been shown in previous trials to safely decrease saliva production, thereby demonstrating its potential as a safe and effective treatment for troublesome sialorrhea.


Eligibility criteria:
inclusion criteria: * seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause * investigator sites will review entire list of inclusion criteria with potential subjects exclusion criteria: * any known prior exposure to botulinum toxin type b, or known adverse reaction or sensitivity to botulinum toxin type a, or known sensitivity to any of the myobloc solution components. * prior botulinum toxin treatment to the salivary glands at any time * investigator sites will review entire list of exclusion criteria with potential subjects

Keywords: sialorrhea parkinson's disease amyotrophic lateral sclerosis (als) stroke neuroleptics
a trial in diabetic patients to assess effect of ce-326,597 on glucose control and body weight

Conditions: Weight Management; Treatment Of Obesity

Summary: study of whether the investigational drug ce-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes


Eligibility criteria:
inclusion criteria: patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications, otherwise medically stable. exclusion criteria: women of childbearing potential, people with unstable medical conditions, people with gallstones

Keywords: phase 2a, safety and efficacy trial with ce-326,597 in patients with t2dm.