Kornimate/medical-research-clean huggingface dataset:
study on ex-press implantation combined with phacoemulsification in primary angle-closure glaucoma

Conditions: Glaucoma, Angle-Closure

Summary: primary angle-closure glaucoma (pacg) is common, phacotrabeculectomy is associated with a significant risk of complications.the ex-press shunt was introduced as a modification to trabeculectomy, with the theoretical advantages of reduced complications.our purpose is to perform a prospective study to evaluate the clinical outcomes and safety of the ex-press shunt with cataract surgery for pacg patients coexisting cataract.

the ex-press is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy mainly for patients with primary open-angle glaucoma.it has been proved to be as effective as trabeculectomy in a series of researches. however the early postoperative complication of ex-press implantation is less frequent compared with trabeculectomy. ex-press was designed initially for open angle glaucoma, gradually some scholars used it in refractory postpenetrating keratoplasty glaucoma and in vitrectomized glaucoma,which showed that ex-press shunt implantation was an effective procedure too. we analyzed the clinical efficacy and safety of combined phacoemulsification and ex-press implantation for pacg patients with cataract. data was recorded before surgery and postoperatively at 1 week and 1, 3, 6, 12,18,24,30,36 months，which included intraocular pressure (iop), best corrected visual acuity (bcva), number of medications, complications, corneal endothelial cell density and anterior segment optical coherence tomography(as-oct). efficacy was assessed by iop values and success rates. complete success was determined by iop between 5 and 21mmhg without medications.

Eligibility criteria:
inclusion criteria: * the presence of pacg, angle peripheral anterior synechia (pas) more than 180 degrees. * an indication for glaucoma filtering surgery based on uncontrolled iop or progressive vision field defect despite antiglaucoma medications. * mean vision field defect greater than 15db. * the presence of a clinically significant decrease of visual acuity as a result of cataract, usually bcva less than 0.6. exclusion criteria: * patients unable to give informed consent. * ocular infection or inflammation in the study eye in the 3 months prior to enrollment. * intraocular surgery in the study eye in the 3 months prior to enrollment.

Keywords: ex-press glaucoma filtration surgery phacoemulsification
a study to gain information how well dexpanthenol dermal spray helps the face skin to recover after cosmetic lasering

Conditions: Erythema; Skin Recovery

Summary: in this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery and reduction of skin redness after a dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars, open pores and change of pigmentation. after the dermatological procedure, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such redness, irritation, softness and possible side effects. in addition, study participants will be asked about their general acceptance of dexpanthenol dermal spray.

the primary objective is to evaluate the efficacy of the test product to aid skin recovery and reduction of erythema after non-ablative lasering on the face. secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.

Eligibility criteria:
inclusion criteria: * phototypes i or ii according to the fitzpatrick scale * participants willing to perform the dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea, poikiloderma, and melasma * normal eye examination exclusion criteria: * cutaneous pathologies and/or injuries as psoriasis, sensible skin, cancer of the skin, rosacea, atopic dermatitis or other medical criteria to be considered at the moment of the evaluation; * hyperpigmentation in the test area that intervenes with the evaluation of possible reactions * active cutaneous pathologies and/or injuries (local and/or disseminated) in the evaluation area * aesthetic or dermatological treatment in the area of evaluation up to 04 weeks before the selection

Keywords: dermal spray ablative lasering skin hydration consumer satisfaction sensorial perception
drug utilization study for olodaterol

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study aims to characterise the use of single-agent olodaterol and single-agent indacaterol, the only marketed long-acting beta2-agonist (laba)s authorised for chronic obstructive pulmonary disease (copd), but not for asthma, in clinical practice.

boehringer ingelheim gmbh (bi) developed olodaterol, an inhaled long-acting beta2-agonist (laba), for the indication of chronic obstructive pulmonary disease (copd). because the use of labas has been associated with increased morbidity and mortality in patients with asthma, the health authorities requested the conduct of a post-approval drug utilisation study to assess potential off-label use of olodaterol in asthma and to characterise the use of olodaterol in clinical practice. the single agent indacaterol, the only other marketed laba authorised in clinical practice for copd but not for asthma, will also be assessed. study objectives include the following: (1) quantify the frequency of off-label use of olodaterol and indacaterol among new users of these medications; and (2) describe the baseline characteristics of new users of olodaterol and indacaterol. this cross-sectional study will use information among new users of olodaterol or indacaterol collected in the following healthcare databases: the pharmo database network in the netherlands, the national registers in denmark, and the ims health information solutions (ims) real-world evidence (rwe) longitudinal patient database (lpd) in france. the source population is all patients enrolled in the selected study databases at the date olodaterol became available in each database's country. the study groups are those patients from the source population who receive a first dispensing for single-agent formulations of olodaterol for the primary objective or indacaterol for the secondary objective and have at least 12 months of continuous enrolment in the study databases. the study will describe the number and proportion of new users by indication and potential off-label use and according to medical history and use of co-medications.

Eligibility criteria:
inclusion criteria: * receive a first prescription/dispensing for single-agent formulations of olodaterol or indacaterol during the study period (no prescriptions/dispensings ever before) * patients must have at least 12 consecutive months of enrolment in the database before the index date exclusion criteria: - individuals with missing or implausible values for age or sex will be excluded.
open-label study of the long term safety of pirfenidone in patients with idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this is an open-label, multi-center, extension study for patients with ipf who complete a qualifying intermune clinical trial of pirfenidone. the purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with ipf who complete a qualifying intermune clinical trial of pirfenidone.

this is an open-label, multi-center, extension study for patients with ipf who complete a qualifying intermune clinical trial of pirfenidone. eligible patients must complete the final visit for their qualifying study, have not permanently discontinued study drug in their qualifying study, and meet all of the eligibility criteria noted in this protocol. since data from the qualifying study may remain blinded during patient enrollment in pipf-012, all patients will be treated as if they were taking placebo in their qualifying study. at the start of pipf-012 participation, each patient will escalate the dose of pirfenidone. the duration of treatment for each patient will vary and will continue until pirfenidone is commercially or otherwise available in his/her geographic region or the study is terminated by the sponsor for reasons outlined in the protocol.

Eligibility criteria:
inclusion criteria: * completes the qualifying clinical study final visit * in the opinion of the principal investigator (pi), has been generally compliant with study requirements during the qualifying study, or must be considered eligible to enroll in pipf-012 by the intermune medical monitor * is able to provide informed consent and comply with the requirements of the study exclusion criteria: * is pregnant or lactating * has known hypersensitivity to any of the components of the study drug * starts participation in another interventional clinical trial between the end of participation in the qualifying intermune clinical trial and entry into pipf-012 * receives concomitant and/or excluded medications as defined in the protocol * permanently discontinues study drug during the qualifying study for any reason before study completion

Keywords: idiopathic pulmonary fibrosis
a study on the potential benefit of neoadjuvant therapy for agc patients

Conditions: Early Gastric Cancer; Tumor Organoids

Summary: early gastric cancer（agc）has no effective characteristic symptoms and signs according to clinical statistics. neoadjuvant chemotherapy (nac) significantly reduces the size of agc tumors so that it has become the recommended treatment for agc in major guidelines. however, some patients miss the best time for surgical treatment and may have irreversible chemotherapy side effects due to nac lacks the guidance of new indicators for precise treatment such as molecular biomarkers. tumor organoids are highly consistent with the clinical drug sensitivities of patients which could be used as clinical treatment prediction models thus providing guidance for individualized medicine. therefore, the project is the first to carry out the prospective study by screening the potential benefit populations of nac based on tumor organoids drug susceptibility experiment. the following hypothesis are put forward：the potential benefit population of nac screened by tumor organoid drugs susceptibility technology will have better clinical efficacy, better treatment tolerance and higher adverse reaction rate.


Eligibility criteria:
inclusion criteria: 1. age: 18-75 years old; 2. qualitative diagnosis: gastroscopic biopsy confirmed adenocarcinoma; 3. localization diagnosis: the tumor is located in the stomach or gastroesophageal junction; 4. the clinical staging is stage iii: a. assess tumor stage: t3-4n1-2; b. excluding distant organ metastasis (m0); 5. physical condition (ecog) score ≤ 1 point; 6. those with effective preoperative neoadjuvant therapy and successful surgery agreed to receive 5 cycles of standard sox chemotherapy after surgery; 7. sign the informed consent form and be willing to participate in this project. exclusion criteria: 1. simultaneous or metachronous multiple primary malignant tumors; 2. preoperative imaging examination results showed that there was distant metastasis; 3. preoperative imaging findings: a. the tumor involving surrounding organs requires combined organ resection; b. distant organ metastases; c. those who cannot perform r0 resection; 4. past history of malignant tumor; 5. abnormal heart, lung, liver, kidney, hematopoietic function and bone marrow reserve function, unable to tolerate surgical treatment and chemotherapy; 6. mental illness or other serious cardiovascular disease; 7. pregnant or lactating women.
validation of home sleep testing (wp) compared to an overnight sleep testing in the sleep laboratory

Conditions: Sleep Disorders

Summary: obstructive sleep apnea syndrome (osas) is considered to be a major public health problem. the prevalence of osas is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. the prevalence of snoring in children is high - 5% in the age group of 6 and less and about 1.5% above. the in-lab sleep study using full polysomnography (psg) and the manual scoring criteria set by the american academy of sleep medicine was considered the gold standard for osas diagnosis. the high cost of in-lab full night psg, together with long waiting lists for sleep studies, have led to the commonly used procedure of "split-night" for osas patients, as well as to the development of a variety of ambulatory sleep study systems. the primary study objective is to compare the efficacy of the watchpat (wp), as an ambulatory device for aiding in the diagnosis of sleep disorders for subjects from age 5 to 90, to the manual scoring of the psg that serves as a "gold standard".


Eligibility criteria:
inclusion criteria: 1. age between 5-90 2. subjects that are able to read understand and sign the informed consent form to undergo an overnight sleep study in the clinical sleep laboratory exclusion criteria: 1. permanent pacemaker. 2. severe lung disease. 3. peripheral neuropathy. 4. finger deformity that precludes adequate sensor appliance. 5. using one of the following medications: short/long acting nitrates (less than 3 hours before the sleep study) or alpha-adrenergic receptor blockers (less than 24 hours before the sleep study).

Keywords: sleep disorders sleep apnea ambulatory device polysomnography watchpat
the application of ticagrelor combined with low molecular weight heparin during pci

Conditions: LOVASTATIN/TICAGRELOR [VA Drug Interaction]

Summary: the purpose of this study is to determine ticagrelor combining with low molecular weight heparin is effective and safe during pci or not.

ticagrelor is a new drug compared with clopidogrel. it has a stronger antiplatelet capacity. after pci，whether using low molecular weight heparin can make patients better prognosis or not, what's more，full amount or half amount low molecular weight heparin?, also investigators want to explore that whether it may lead to more bleeding events.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old and ≤75 years ; 2. unstable angina, non-st segment elevation acute myocardial infarction, old myocardial infarction, or confirm the presence of myocardial ischemia; 3. voluntary participation in clinical trials, and informed consent; exclusion criteria: 1. acute st segment elevation myocardial infarction, stable angina pectoris; 2. aspirin allergy or resistance; 3. consolidated stroke, chronic obstructive pulmonary disease and other ticagrelor contraindications; 4. patients have coagulopathy; 5. can not be continued for one year with aspirin and treatment of dual antiplatelet ticagrelor; 6. can not complete revascularization; 7. nyha ≥ⅲ level or left ventricular ejection fraction \<40%; 8. severe liver and kidney dysfunction (alt and ast were more than three times the upper limit of normal, creatinine clearance less than 30ml / min-1.1.72m-2);
treatment of social phobia and panic disorder in adults

Conditions: Social Phobia; Panic Disorder

Summary: the purpose of this study is to compare a stepped care model for the treatment of social phobia and panic disorder with standard psychological treatment. the stepped care model comprises three steps: short psycho-education, a 10 weeks internet-based self-help program, 12 weeks individual cognitive-behavioural therapy. patients are assessed at each step and taken out of the study if they show significant clinical improvement and follow for 12 months. patients are randomized to either the stepped care model or standard psychological treatment, i.e. individual cognitive-behavioural therapy. all treatment components are manualized.


Eligibility criteria:
inclusion criteria: * clinical diagnoses of panic disorder or social phobia * informed consent exclusion criteria: * alcohol/drug dependency * major depressive disorder * psychosis * unstable medication

Keywords: cognitive therapy stepped care self-help internet anxiety
development of indices predicting response to pre-operative chemotherapy in osteosarcoma patients

Conditions: Osteosarcoma

Summary: the purpose of this study is to develop indices predicting response to pre-operative chemotherapy in osteosarcoma patients. histologic response to pre-operative chemotherapy is very important for the ultimate outcome of osteosarcoma patients. conventional methods such as ct or mri evaluating tumor response to chemotherapy is not so efficient in tumors like osteosarcoma. instead, the investigators will test whether blood tgf-b1 levels, pet/ct findings, mrs findings as well as the level of nf-kb expression in tumor tissues can predict chemotherapy response in osteosarcoma.

we will conduct a prospective trial to verify the validity of indices utilizing tgf-b1, nf-kb, pet/ct, and mrs for predicting response to neoadjuvant chemotherapy in osteosarcoma patients. we assume that changes in plasma tgf-b1 levels, pet/ct and magnetic resonance spectroscopy (mrs) findings during the period of neoadjuvant chemotherapy as well as the initial nuclear nf-kb expression status of tumor biopsy specimen either alone or in combination may predict a chemotherapeutic response determined by histopathologic necrosis fractions of tumors removed. to test this, we will obtain tgf-b1 levels, pet/ct and mrs findings at diagnosis and at follow-up (after first and second/third chemotherapy cycle). tumor will then be removed. chemotherapy regimen comprised of various combination of cisplatin, adriamycin, and high-dose methotrexate, ifosfamide, and etoposide. indices derived from tgf-b1, pet/ct, mrs predicting greater than 90% necrosis fractions will be sought utilizing statistical methods.

Eligibility criteria:
inclusion criteria: * karnofsky (over 15 years) or lansky (less than 15 years) score equal or greater than 50 * adequate organ functions: * gfr\>60ml/min/1.73m2 * ef\>50% or sf\>28% on echocardiogram * anc\>1.5 x 10\^9/l * platelet\>100 x 10\^9/l * obtainment of informed consents from parents/legal guardians and/or patients exclusion criteria: * pregnant or lactating women * cardiovascular dysfunction * history of previous chemotherapy

Keywords: osteosarcoma transforming growth factor-beta 1 nuclear factor-kappa b positron emission tomography/computed tomography magnetic resonance spectroscopy predicting response to neoadjuvant chemotherapy
the effect of heart rate on cardiac index in patients with left ventricular hypertrophy

Conditions: Left Ventricular Hypertrophy; Diastolic Dysfunction; Heart Failure; Heart Rate

Summary: the purpose of this study is to compare the effect of heart rate on cardiac index in patients with or without left ventricular hypertrophy. the study will be conducted in postoperative heart surgery patients with a pacemaker.


Eligibility criteria:
inclusion criteria: * scheduled heart surgery including thoracotomy * ejection fraction \> 45% * duration of qrs complex \< 120 milliseconds * sinus rhythm * planned perioperative temporary pacemaker group: left ventricular hypertrophy: thickness of interventricular septum and posterior wall \>11 mm. group: no left ventricular hypertrophy: thickness of interventricular septum and posterior wall \<11 mm. exclusion criteria: * active endocarditis * severe mitral insufficiency * no patient consent

Keywords: heart failure left ventricular hypertrophy diastolic dysfunction
evaluation of [18f]flt pet/ct as an early predictor of outcome in pediatric solid tumors

Conditions: Solid Tumor

Summary: the experimental \[18f\]flt-pet/ct will be completed before initiation of chemotherapy at either diagnosis or initiation of salvage chemotherapy at relapse and prior to the third cycle (or month) of chemotherapy. laboratory analysis and correlative radiology, as directed per clinical care based on the primary diagnosis, are required within 30 days of the baseline \[18f\]flt pet/ct. follow-up will comprise 24 months of standard practice treatment and follow up.

primary objective is to assess if percentage change in \[18f\]flt pet/ct quantitative parameters (suv max, or suv peak or proliferative tumor volume) after 2 cycles of chemotherapy can predict progression free survival at 1 and 2 years in pediatric patients with newly diagnosed or relapsed solid tumors. secondary objectives are: (1) to assess if percentage change in \[18f\]flt pet/ct quantitative parameters (suv max, or suv peak or proliferative tumor volume) after 2 cycles of chemotherapy can predict overall survival at 2 years in pediatric patients with newly diagnosed or relapsed solid tumors; and (2) for enrolled patients that undergo tumor resection as part of their therapy regimen within one month of the flt imaging, mitotic index of the tumor will be assessed as compared to initial biopsy specimen and correlate with flt activity.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed solid tumor malignancies with residual tumors present that require standard of care chemotherapy for a minimum number of cycles. all anatomical sites and all tumor histologies are eligible including central nervous system tumors. both newly diagnosed and/or newly relapsed patients are eligible. * patients ages 8 - 25 years * in the opinion of the investigator, patients must be thought to be able to lie still for imaging without sedation for 20 - 30 minutes. * patients must have a performance status of \> 50% (lansky or karnofsky). * patients of childbearing potential must have a negative urine or serum pregnancy test as per institution's standard of care within 7 days prior to \[18f\]flt pet/ct imaging. * ability to understand and the willingness to sign a written informed consent/assent. exclusion criteria: * patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to \[18f\]flt * newly diagnosed subjects who had prior chemotherapy or radiotherapy before enrollment in the study. relapsed patients are eligible prior to starting their relapsed chemotherapy regimen if they meet the other eligibility criteria. * subjects for whom chemotherapy is not a standard of care primary therapy option. * patients who are pregnant or breast-feeding. * patients with no residual tumor (i.e. complete resection at diagnosis or relapse).
inflammatory bowel disease(ibd)database

Conditions: Inflammatory Bowel Disease

Summary: this will be a comprehensive epidemiological, clinical, endoscopic and histological database for inflammatory bowel diseases patients in our medical center that will further provide clinical and basic investigations.

inflammatory bowel diseases (ibd), which include crohn's disease (cd), ulcerative colitis (uc), undefined ibd and pouchitis (in patients who required ipaa for their colitis) affects about two million people in the world. at this time there is no definitive cure and current treatment is aimed at managing the symptoms and inflammation that accompany these diseases. these diseases are predominantly chronic, and patients may experience various gastrointestinal symptoms depending on the location, nature, and extent of their disease. both genetic and environmental factors play etiological roles. the overall goal of our research is to understand the etiology and course of these diseases in order to prevent and to manage cases more effectively. in order to do so we are aiming at building a comprehensive database that will include detailed clinical data conjoined with dedicated research information and collection of biological specimens that will target the gut epithelium immune system, the microbiota and specific genetic risk factors.

Eligibility criteria:
inclusion criteria: diagnosis of ibd regular treatment and follow up in tel aviv sourasky medical center fap (familial polyposis)patients after a large bowel resection, as controls family members of ibd patients as controls patients with irritable bowel syndrome (ibs), as controls - exclusion criteria: pregnancy age\<18 years -