Kornimate/medical-research-clean huggingface dataset:
hu007 in patients with dry eye syndrome

Conditions: Dry Eye Disease

Summary: a multicenter, randomized, double blind, restasis®-controlled non-inferiority, moisview® eye drops controlled superiority, phase iii study to evaluate the efficacy and safety of hu007 eye drops in patients with dry eye syndrome


Eligibility criteria:
inclusion criteria * age over 19 * corneal staining score(oxford grading) ≥ 2 and schirmer test ≤ 10mm/5min (if schirmer test = 0mm/5min, nasal stimulation schirmer test ≥ 3mm/5min) and tbut test ≤10 in at least one of both eyes * patients who have had more than one symptom of dry eye disease for at least 3 month before screening visit * best corrected visual acuity of 0.2 or higher in both eyes * those who voluntarily decided to participate and agreed in writing to comply with the precautions exclusion criteria: * patients with clinically significant ocular disorders affected the test result * current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status * sbp ≥140mmhg or dbp ≥ 90mmhg or hba1c \> 9% * wearing contact lenses within 72 hr prior to screening visit or during clinical trial * pregnancy or breastfeeding * patient with a history of glaucoma, or intraocular pressure of 25mmhg or higher at least one eyes * patient with autoimmune disease (e.g. sjogren's syndrome) * patients with a history of corneal transplant or neurotrophic keratitis
cardiac biomarkers in early detection of cardiotoxicity in patients receiving sunitinib or sorafenib chemotherapy

Conditions: Malignant Neoplasm

Summary: this trial studies how well cardiac biomarkers work in the early detection of cardiotoxicity in patients receiving sunitinib malate or sorafenib chemotherapy. some chemotherapies are known to cause damage to heart muscle cells, resulting in heart failure. often, the damage is not detected until heart failure has already occurred. testing for cardiac biomarkers, such as troponin i and/or t and b-type natriuretic peptide (bnp), may be useful in detecting heart damage earlier than other tests currently performed (such as echocardiogram and electrocardiogram).

primary objectives: i. to determine if specific biomarkers (troponin i and b-type natriuretic peptide \[bnp\]) detect cardiotoxicity earlier than standard clinical means in patients receiving sunitinib malate (su11248) or sorafenib chemotherapy. secondary objectives: i. to prospectively evaluate the incidence and severity of cardiac toxicity related to sunitinib or sorafenib during chemotherapy. outline: patients receive sunitinib malate or sorafenib chemotherapy then undergo blood collection 2 weeks later, and then every 4-6 weeks for up to 6 months to test for troponin i and bnp.

Eligibility criteria:
inclusion criteria: * patient age 18-85 years * starting a new course of chemotherapy at md anderson cancer center that includes sunitinib or sorafenib * has a life expectancy of greater than 6 months exclusion criteria: * unstable angina within the last 3 months * myocardial infarction within the last 3 months * left ventricular ejection fraction (lvef) less than 40% * decompensated heart failure (hf) in the last 3 months
mitochondrial genetics of presbycusis

Conditions: Presbycusis; Age Related Hearing Loss

Summary: the main goal of this study is to identify mitochondrial mutations associated with presbycusis. patients affected by severe presbycusis and normal hearing controls (according to iso7029 norm) will be enrolled if satisfying inclusion criteria (aged from 40 to 80 years old) in existing biocollections in the university hospital of angers. after dna extraction, the mitochondrial genome will be sequenced and data in silico analysed.

the study will be proposed to patients consulting in the ent department of the university hospital of angers. after clinical examination and audiometry recording, the eligibility criteria will be checked and inclusion in biocollections proposed. presbycusis affected subjects will be enrolled in "mitochondrial disease biocollection" and normal hearing controls in "healthy volunteer biocollection". these biocollections have been approved by the board comitee "centre de protection des personnes". after dna extraction and mitochondrial sequencing, candidate variants will be selected by in silico analysis. the presence of mitochondrial variants in both groups (presbycusis and control) will be compared in multivariate analysis if needed. the nuclear dna may be sequenced in order to complete the previous analysis and look for any candidate variant .

Eligibility criteria:
inclusion criteria: * age related hearing loss more severe than the predicted hearing thresholds according to the norm iso7029, for the presbycusis population; * normal hearing according to norm iso7029 for the control population exclusion criteria: * deafness diagnosed before 40 years old * exclusion criteria of one of the biocollection
colchicine after electrocardioversion for atrial fibrillation

Conditions: Atrial Fibrillation; Cardiac Arrhythmia

Summary: the purpose of this study is to investigate whether a 3 month treatment course of low-dose colchicine decreases the recurrence of atrial fibrillation (af) after electrocardioversion (ecv) in patients with af.

atrial fibrillation is the most common cardiac arrhythmia worldwide and is associated with an increased risk of heart failure, stroke and death. over the next 40 years the investigators expect another increase in the prevalence of atrial fibrillation with a risk of 1:3 in people over 65 years to develop atrial fibrillation. electroconversion can occur in patients with atrial fibrillation reestablish sinus rhythm acutely with a controlled electrical shock. unfortunately it is known however, that there is a short-term recurrence of atrial fibrillation in about 60%. this underlines that our current treatment options are inadequate. there is increasing evidence that inflammation is integral to initiation and maintenance of atrial fibrillation. therefore, the researchers see inflammation as a possible therapeutic target to reduce the recurrence rate of atrial fibrillation after electroconversion. to test this hypothesis and to help patients, the investigators want to conduct the colectro-af study.

Eligibility criteria:
inclusion criteria: * age \&gt;18 years * ecg-documented af prior to ecv * successful ecv with conversion of af to sinus rhythm with persistent sinus rhythm ≥30 minutes after ecv * ability to give written informed consent exclusion criteria: * af persistence after cardioversion or early af recurrence within 30 minutes after ecv * any other rhythm than af before cardioversion * pulmonary vein isolation within 3 months prior to ecv or pulmonary vein isolation planned within 3 months after ecv * known intolerance or hypersensitivity to colchicine * any other absolute indication for colchicine intake * intake of a strong inhibitor of cyp3a4 or p-glycoprotein (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole) * serious gastrointestinal disease (severe gastritis or diarrhea) * clinically overt hepatic disease * severe renal disease (egfr\&lt; 30ml/min/1.73m2) * clinically significant blood dyscrasia (e.g., myelodysplasia) * significant immunosuppression (e.g. due to transplantation or rheumatic disease) * pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control * life expectancy \&lt;1 year

Keywords: electrocardioversion colchicine
rct :thoracic sympathetic block for the treatment of complex regional pain syndrome i of the upper limb

Conditions: Complex Regional Pain Syndrome I of Upper Limb

Summary: this is a double-blind randomized controlled trial to evaluate the efficacy of the sympathetic block via thoracic vertebra t3 for the treatment of crps i upper limb. patients with crps i refractory to medical treatment will be subjected to four physical therapy sessions and then the randomized for experimental or control block and then more four physiotherapy sessions. patients will be evaluated after one month of the blockade (primary outcome) and then up to 12 months. will be evaluated by analgesic scale (mcgill, brief pain inventory, dn4 questionnaire, npsi, vas), functional (adm) and quality of life (had and whoqol-brief).


Eligibility criteria:
inclusion criteria: * complex regional pain syndrome (iasp, 1994) involving an upper limb; * pain scores in excess of five visual analog scale (vas); * poor outcome to treatment (less than 50% reduction in vas scores) - exclusion criteria: * history of severe brain injury, epilepsy and stroke * patients who had undergone sympathetic ganglion block for treatment of the affected limb, by any technique * severe systemic disease * addictive behavior, severe psychiatric disorders, psychiatric diseases untreated * refusal to participate or not initial adherence to orientations * refusal to be randomized in a treatment group or with contraindications to any of them pregnancy.

Keywords: crps i
bioavailability of bms-626529 in healthy subjects from prototype low dose extended release formulations (part 1) and prototype extended release multi-particulate formulations (part 2) of bms-663068 relative to 600 mg extended release tablet

Conditions: Infection, Human Immunodeficiency Virus

Summary: this 2-part study will determine the bioavailability of bms-626529 in healthy subjects from prototype low dose extended release formulations (part 1) of bms-663068 and prototype extended release multi-particulate formulations (part 2) of bms-663068 relative to 600 mg extended release tablet of bms-663068.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * males and females, 18 to 50 years of age, inclusive * healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, pe findings, vital sign measurements, 12-lead ecg measurements, physical measurements, and clinical laboratory test results * women of childbearing potential (wocbp) must have a negative urine pregnancy test (performed for all females; minimum sensitivity 25 iu/l or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug exclusion criteria: * any significant acute or chronic medical illness * evidence of organ dysfunction or any clinically significant deviation from normal in pe, vital signs, ecg, or clinical laboratory determinations beyond what is consistent with the target population * any of the following on 12-lead ecg prior to study drug administration, confirmed by repeat: i) pr ≥ 210 msec ii) qrs ≥ 120 msec iii) qt ≥ 500 msec and iv) qtcf ≥ 450 msec * exposure to any investigational drug or placebo within 12 weeks of study drug administration * positive blood screen for hepatitis c antibody (hcv ab), hepatitis b surface antigen (hbsag), or hiv-1 and hiv-2 antibody
conservative versus operative management in adhesive intestinal obstruction

Conditions: Adhesive Intestinal Obstruction

Summary: this study aims to evaluate the role of conservative management in patients with adhesive intestinal obstruction regarding the selection criteria of the patients, duration of conservative route, success rate, and recurrence of adhesions and avoiding the surgical route complications.

adhesive intestinal obstruction is very common and represents a serious life threatening condition, which can be caused by congenital band, following abdominal surgeries and other medical conditions like tuberculosis. the management options for adhesive intestinal obstruction (aio) could be operative treatment (open-laparoscopy) or non-operative (conservative management) according to many reasons. some reports indicate that the operative management for adhesive intestinal obstruction lead to further adhesions in the future in addition to other possible complications (anaesthetic - iatrogenic injury during adhesolysis - wound site infections - illius-long hospital stay). the conservative route is recommended in all patients except those with signs of peritonitis, strangulation, or bowel ischemia which would have been diagnosed during physical examination and imaging. a few studies compared the advantages, safety, and less complications of conservative versus operative management. therefore, this study will be conducted on patients with adhesive intestinal obstruction to compare the effectiveness of conservative versus operative management regarding the selection criteria for the patients, the duration of the conservative route, things to be done and what need to be observed during the conversation time.

Eligibility criteria:
inclusion criteria: * age 6-70 years. * both sexes. * complete \\ partial adhesive intestinal obstruction, with ct abdomen and pelvis with oral and iv contrast. exclusion criteria: * patients with signs of strangulation * patients with signs of peritonitis. * patients with signs of bowel ischemia * failure of conservative management for more than 72 hours. * vitally unstable patients * patients with comorbidities which need rapid interventions.
lume-columbus: nintedanib plus docetaxel in advanced non-small cell lung cancer with translational research

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage iiib/iv or recurrent nsclc of adenocarcinoma histology after failure of first-line platinum-based chemotherapy.


Eligibility criteria:
inclusion criteria: * male or female patients of at least 18 years of age * histologically confirmed, adenocarcinoma of the lung, after failure of first line platinum-based chemotherapy. exclusion criteria: * more than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for advanced and/or metastatic (stage iii b or iv nsclc) or recurrent disease. * patients known to be positive for activating epidermal growth factor receptor (egfr) mutation or anaplastic lymphoma kinase (alk) translocation * previous therapy with other vascular endothelial growth factor (vegf) or vegfr inhibitors (other than bevacizumab) or docetaxel for the treatment of nsclc at any time * prior monotherapy with an egfr inhibitor except as maintenance therapy
exploratory study on the effectiveness of myopia control lenses in slowing myopia progression in young children

Conditions: Myopia

Summary: this study will be a mono-center, single-arm, unmasked study evaluating the effectiveness of test lens in slowing myopia progression in children aged 6 to 8 years. the study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lens over a 1-year period. a total of 25 children will be recruited.

as myopia has become a global epidemic and public health concern, it is crucial to gain deeper insight to the possible treatments in slowing myopia progression. in a previous clinical trial, spectacle lenses with higher lenlets asphericity demonstrated effectiveness in reducing myopia progression and axial length elongation in children. this clinical trial will assess the effectiveness of a test lens in slowing myopia progression in younger children over 1 year. without compromising vision, the test lens is designed to modify the area and the amount of myopia defocus on the retina. the study population includes 25 children subjects in singapore, aged 6 to 8 years during the commencement of the treatment. the axial length and spherical equivalent refraction will be the primary and secondary measures for myopia progression.

Eligibility criteria:
inclusion criteria: * volunteer subject and guardian, fluent english spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form. * equal to or greater than 6 years and less than 9 years at time of informed consent and assent. * spherical equivalent refractive error (ser) by manifest refraction between -0.75 and -4.75 d in each eye. * astigmatism, if present, of not more than 1.50 d. * difference in ser between the two eyes (anisometropia) by manifest refraction not more than 1.00 d. * best corrected visual acuity in each eye equal to or better than +0.10 logmar (≥ 20/25 as snellen) * be in good general health based on his/her and parent's/guardian's knowledge. absence of ocular disease with full ophthalmic examination. without any ocular or systemic condition known to affect refractive status. * absence of strabismus by cover test at near or distance wearing correction. * absence of amblyopia * without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state. exclusion criteria: * vulnerability of subject * history of myopia control intervention * participation in any clinical study within 30 days of the baseline visit.

Keywords: myopia refractive errors eye diseases
post-myocardial infarction patients in santa catarina, brazil - catarina heart study

Conditions: Myocardial Infarction

Summary: prospective cohort evaluating patients in the state of santa catarina (brazil) with the diagnosis of the first acute myocardial infarction from july 2016 until december 2020.


Eligibility criteria:
inclusion criteria: * age over 18 years; * presence of precordial pain suggestive of acute myocardial infarction associated with electrocardiogram with new st segment elevation in two contiguous leads with limits: ≥0.1 mv in all leads other than leads v2-v3 where the following limits apply : ≥0.2 mv in men ≥40 years; ≥0.25 mv in men \<40 years, or ≥ 0.15 mv in women or presence of precordial pain suggestive of acute myocardial infarction associated with elevation of troponin i or ck-mb above the 99th percentile of the upper reference limit exclusion criteria: * previous acute myocardial infarction; * disagreement with the terms of informed consent.
topical ruxolitinib evaluation in chronic hand eczema study 1

Conditions: Hand Eczema

Summary: the purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (che) and moderate to severe disease activity (investigator's global assessement (iga) of che score 3 or 4).


Eligibility criteria:
inclusion criteria: * diagnosis of chromic hand eczema (che) as defined by hand eczema (he) lasting \> 3 months or ≥ 2 flares within the previous 12 months. * screening and baseline iga-che 3 or 4. * baseline che-related itch nrs ≥ 4. * recent history (within the past 1 year of baseline) of inadequate response to treatment with topical corticosteroids (tcs), topical calcineurin inhibitors (tci), or oral alitretinoin; or intolerance or contraindication to tcs or tci or oral alitretinoin. * willingness to avoid pregnancy or fathering children based on the criteria below. exclusion criteria: * known triggers for che (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study. * participants who have an unstable course of ad (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline. * participants with concurrent conditions and history of other diseases such as other active skin disease or infection on the hands; immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with study assessments or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids; current or history of hepatitis b or c virus infection. * any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * laboratory values outside of the protocol-defined criteria. * use of protocol-defined treatments within the indicated washout period before baseline. * psoralen ultraviolet a (puva) or ultraviolet b (uvb) therapy on the hands within 4 weeks before baseline. * pregnant or lactating participants, or those considering pregnancy during the period of their study participation. * further exclusion criteria apply.

Keywords: eczema chronic hand eczema (che) dermatitis skin disease jak inhibitor
genetic basis of non syndromic congenital diaphragmatic hernia

Conditions: Isolated Non Syndromic Left CDH With Postero Lateral Diaphragmatic Defect With Good Perinatal Outcome

Summary: in isolated congenital diaphragmatic hernia (cdh), recurrent risk is low suggesting the occurrence of novo mutations (dominant or recessive). our objective is to test this hypothesis by combining the search for pathogenic genomic alteration and intragenic mutations through whole exome sequencing in a homogenous group of patients.

to elucidate the genetic basis of non syndromic congenital diaphragmatic hernia in a sub group of individuals with similar phenotype: isolated cdh presenting with postero-lateral-left diaphragmatic defect with good perinatal outcome (n=16) to establish the prevalence of the identified gene(s) in a cohort of identical patients (n=30) two complementary approaches will be used: * search for pathogenic genomic alterations using microarrays (\~2.106 markers (snp and cnv) in 16 trios (affected child and 2 parents). * sequencing of the whole exome from patient genomic dna (n=16) * selection of unknown or very rare variants according to different criteria: recessive or dominant model, prediction of their pathogenicity, filtered on genes already known in cdh or involved in diaphragmatic development and non annotated cnv or variants of new gene(s) shared by different patients. * variants will be validated by sanger sequencing (for intragenic variants) or quantitative pcr (for cnv) on cdh cases and their parents as well as their absence on 100 controls.

Eligibility criteria:
inclusion criteria: * families with one (or more) non syndromic cdh child * signed consent form exclusion criteria: * syndromic cdh or associated with a known karyotype anomaly * no signed consent form * not affiliated to french social security

Keywords: isolated non syndromic cdh