Kornimate/medical-research-clean huggingface dataset:
hae burden and crisis management

Conditions: Hereditary Angioedema (HAE)

Summary: the study has been designed as a french, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (hae). the online survey assesses various aspects of hae and in particular the burden of hae from the patients' and caregivers' perspectives.

the study has been designed as a french, multicentric survey study to obtain data to describe the burden of on-demand treatment for patients with hereditary angioedema (hae). the study will also explore the burden related to the administration of intravenous or subcutaneous on-demand treatments. the study was designed to collect data concerning the burden of hae in patients with hae (during hae attacks and between attacks) and in caregivers. the online survey will collect data to describe the characteristics of patients with hae, the disease characteristics, details concern various aspects of hae attacks, and the burden of hae in patients and their caregivers.

Eligibility criteria:
inclusion criteria: for the patient population: 1. patients with a confirmed diagnosis of hae with a deficit in the c1 inhibitor. 2. aged ≥12 years 3. having consulted for hae in the last 3 months and with a medical file. for the caregiver population: 1. a person identified by the patient as part of their support group and who provides support with the management of the patients hae (including family members, friends, spouse, etc.) exclusion criteria: for the patient population: 1. opposes to participating in the study. 2. patients is under guardianship or deprived of their liberty.

Keywords: survey on-demand treatment hereditary angioedema burden caregivers quality of life
efficacy study of cyclosporine ophthalmic emulsion in patients with dry eye disease

Conditions: Keratoconjunctivitis Sicca

Summary: this study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.


Eligibility criteria:
inclusion criteria: * diagnosis of dry eye disease * currently using artificial tears daily * male or female of legal age of consent * normal lid position and closure exclusion criteria * patients currently using cyclosporine ophthalmic emulsion 0.05% * participation in other investigational drug or device study * any current or previous topical ophthalmic or oral cyclosporine use within the last three years
transcutaneous partial oxygen and carbon dioxide pressures compared with blood gas values

Conditions: Critical Illness

Summary: partial blood oxygen and carbon dioxide pressures obtained in critical ill neonates by transcutaneous sensors will be compared to respective values obtained by medically indicated arterial and capillary blood gas analyses. the influence of blood withdrawal method, sensor operational temperature and application time, presence of cyanotic heart malformations and/or intra or extra cardiac right to left shunt, vasoactive drugs, elevated non-conjugated bilirubin, and skin and soft tissue oedema, skin colour and perfusion conditions will be elucidated as well as sensor's safety. study duration will be 48 hours with sensors applied and additional 4 hours of further surveillance for thermal injury.


Eligibility criteria:
inclusion criteria: * late premature or term birth newborn infants (34 0/7 until 43 6/7 weeks gestational age (ga)). * age between first day of life and 43 6/7 weeks postmenstrual age. * ability of care taker to understand verbal and written instructions and informed consent in german. exclusion criteria: * care taker unable or unwilling to give written informed consent in german. * care taker not understanding german and without a family member able to translate. * written informed consent cannot be obtained for any other reason.
perineorraphy versus pelvic floor exercise - a randomized trial

Conditions: Perineal Tear Resulting From Childbirth

Summary: the perineal body is commonly injured during labor. it is possible to perform a secondary repair, a perineorraphy, which aims to reduce the symptomatology after an improperly healed perineal tear. the aim of the randomized trial is to evaluate the results of such an operation compared with conservative treatment.

a randomized controlled trial which aims to evaluate objective and subjective outcomes following perineorraphy compared with pelvic floor exercise after vaginal delivery. 70 women seeking help for improperly healed perineal tear following vaginal delivery, matching our inclusion- and exclusion criteria, will be randomised into two different treatment groups, 35 to operative treatment, perineorraphy, and 35 to conservative treatment, tutored pelvic floor exercise. assessment pre-and 6 months postoperatively will include clinical evaluation and condition specific validated questionnaires. surgical characteristics and adverse events during follow-up are also registered.

Eligibility criteria:
inclusion criteria: * women with 2nd or 3rd degree laceration during vaginal delivery seeking for help because of troublesome symptoms from the pelvic floor * height of perineum 2 cm or less. * a least 6 months post partum * stopped "exclusive breastfeeding" * no indication for other gynecological surgical procedure exclusion criteria: * history of 4th degree laceration * connective tissue disorder (systemic lupus erythematosus, sjögrens syndrome, polymyalgia rheumatica, marfans syndrome, ehlers-danlos syndrome) * current use of systemic corticosteroids * diabetes mellitus * suspect occult sphincter tear on ultrasound * history of previous urogynecological operation

Keywords: perineum. perineorraphy. pelvic floor exercise.
study to evaluate sotagliflozin in subjects with varying degrees of renal function

Conditions: Renal Impairment; Healthy

Summary: the purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (esrd) requiring hemodialysis (hd), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function.


Eligibility criteria:
inclusion criteria: * adult male and female subjects ≥18 to ≤75 years of age * body mass index ≥18.0 to ≤36.0 kg/m2, at screening * subjects with mild, moderate, or severe renal impairment, or esrd requiring hd * control group of matched healthy subjects * willing and able to provide written informed consent exclusion criteria: * presence of clinically significant physical, laboratory, or ecg findings that may interfere with any aspect of study conduct or interpretation of results * existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin * history of any major surgery within 6 months * history of hepatic disease, or significantly abnormal liver function test * women who are breastfeeding or are planning to become pregnant during the study
conjunctival rebound after scleral lens wear

Conditions: Conjunctival Diseases

Summary: scleral lenses, customized rigid contact lenses that land on the soft and spongy conjunctival tissue overlying the sclera, will be fitted on 15 subjects with normal ocular surfaces. the purpose of the study is to determine the amount of conjunctival compression caused by the devices and the length of time required for the shape to recover from compression.

the purpose of this study is to determine the interval required for the conjunctival tissue to return to its natural shape after scleral lens wear. all study visits will take place at the university of houston college of optometry (uhco). subjects will be recruited and fitted with scleral lenses to wear during the experimental days. once the proper fit has been achieved, subjects will wear the scleral lens for 4 days total, returning after the 1st and 4th day of lens wear for approximately 2 hours of testing. the subjects will then return every 24-hours for measurements until their conjunctival shape has returned to the original shape. the testing will be done using the smap scleral topographer, which measures the elevation of the conjunctiva. testing is non-invasive although it requires instillation of fluress eye drops, a sodium fluorescein dye with anesthetic that allows for imaging. the total number of visits is 9-14 and the length of visit ranges from 10 minutes to 2.5 hours.

Eligibility criteria:
inclusion criteria: * normal ocular surface without conjunctival or scleral disease * male or female * 18 years of age and older prior to the initial visit * a non-scleral lens wearer. exclusion criteria: * individuals with anterior segment ocular pathology that may affect intraocular pressure and/or scleral/conjunctival health. * individuals with known adverse response to fluress® ophthalmic drops * individuals with a history of habitual scleral lens wear * if a usable baseline image is unable to be obtained at the initial visit due to small ocular surface area or eyelid anatomy * individuals currently taking any ocular medications that could affect intraocular pressure and/or scleral/conjunctival health * individuals who have any other conditions or situations which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study

Keywords: scleral lenses
vitamin d supplementation reduces renin-angiotensin system activity in obesity

Conditions: Obesity; Vitamin D Deficiency; Hypertension

Summary: hypothesis: vitamin d supplementation lower renin-angiotensin system activity in obesity. specific aim: to investigate whether vitamin d supplementation in obesity improves the vascular sensitivity to angiotensin ii.

vitamin d deficiency and obesity are international epidemics that have both been associated with increased activity of the renin-angiotensin system (ras). because increased ras activity is associated with cardiovascular disease, interventions to lower ras will have favorable public health impacts. this study aims to evaluate whether the supplementation of vitamin d in obese subjects will lower local tissue ras activity. ras activity will be evaluated by cross-sectional measurement of ras components and by quantifying the vascular response to an infusion of angiotensin ii. subjects will be studied while vitamin d deficient, and will return for repeat study following vitamin d supplementation, for comparison.

Eligibility criteria:
inclusion criteria: * age \< 65, * cr \< 1.6, * 25-hydroxyvitamin d \< 25 ng/ml, * bmi \> 30 kg/m2, * stage i hypertension. exclusion criteria: * diabetes, * coronary heart disease, * heart failure, * renal failure, * liver failure, * hyperparathyroidism, * granulomatous disease.

Keywords: obesity renin angiotensin system vitamin d deficiency hypertension
chemoimmunotherapy plus residual lesion irradiation for the treatment of extensive stage small-cell lung cancer

Conditions: Small-cell Lung Cancer; Residual Tumor; Radiation

Summary: this is a phase ii trial studies the effect of chemoimmunotherapy sequential residual tumor irradiation in treating patients with extensive stage small cell lung cancer. even though small cell lung cancer is initially highly responsive to first-line chemotherapy plus pd-l1 inhibitors, treatment resistance inevitably happens. residual tumor irradiation my prolong drug resistance, and may help prevent the growth and spread of the tumor cells to other parts of the body.

primary objective: i. to evaluate the progression-free survival (pfs) and overall survival of chemoimmunotherapy sequential residual tumor irradiation in patients with extensive stage small cell lung cancer (sclc). secondary objectives: ii. to assess the overall response rate (orr) and toxicity in extensive stage sclc patients treated with chemoimmunotherapy squential residual tumor irradiation

Eligibility criteria:
inclusion criteria: \>= 18 years of age have an eastern cooperative oncology group (ecog) performance status of =\ = 1.5 x 10\^9/l platelets \>= 100 x 10\^9/l hemoglobin \>= 9 g/dl serum creatinine =\< 1.5 x institution upper limit of normal (uln) and calculated creatinine clearance of at least 15 ml/min. alanine aminotransferase (alt) and aspartate aminotransferase (ast) =\< 3 x upper limit of normal (uln) (alt and ast =\< 5 x uln is acceptable if liver metastases are present) total serum bilirubin =\< 1.5 x uln. for patients with well documented gilbert's syndrome, total bilirubin =\< 3 x uln with direct bilirubin within normal range. participant must understand the investigational nature of this study and sign an approved written informed consent form prior to receiving any study related procedure. exclusion criteria: * ad major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery positive for immunosuppressive disease, acquired immunodeficiency syndrome (aids) or other immune depressing diseases. for human immunodeficiency virus (hiv), hvc and hbc-mandatory testing is required prior to enrollment patient has known hypersensitivity to the components of the study drugs or any analogs history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, including, but not limited to: myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, new york heart association (nyha) class iii or iv disease. history of documented congestive heart failure (new york heart association functional classification iii or iv) within 6 months prior to baseline. poorly controlled arrhythmias
primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction

Conditions: Cholangiocarcinoma Non-resectable; Gall Bladder Cancer; Liver Metastasis; Malignant Hilar Stricture

Summary: the goal of this clinical randomized controlled trial is to perform primary percutaneous stenting (pps) in patients with malignant hilar biliary obstruction (mhbo). the main question it aims to answer is: to compare the efficacy of pps above the ampulla to standard endoscopic biliary drainage (ebd) in patients with a mhbo who are ineligible for surgical resection. researchers will compare pps with ebd to see if major complications within 90 days after randomisation occur. participants will undergo either primary percutaneous stenting or endoscopic biliary drainage, depending on randomization.


Eligibility criteria:
inclusion criteria: * written informed consent must be given according to ich/gcp and national/local regulations. * mhbo on imaging with histopathological confirmation or high clinical suspicion. * ineligible for surgical resection. * hyperbilirubinemia (a combination of a total bilirubin level \>50 mmol/l. exclusion criteria: * fluctuation or spontaneous decrease of a total bilirubin level before start of any treatment suggesting a potential non-malignant diagnosis. * patients who underwent previous biliary drainage procedures endoscopically or percutaneously. patients who underwent an attempted but failed ercp are eligible only when no papillotomy or cannulation was performed. * clinical signs of cholangitis. cholangitis is defined as the presence of both fever (i.e. body temperature \>38.5°c) and leucocytosis (i.e. ≥10 \*109/l) without clinical or radiological evidence of acute cholecystitis (22). * uncorrectable coagulation disorder. * uncorrectable contrast allergy.
demonstration of reverse remodeling effects of entresto. using echocardiography endocardial surface analysis

Conditions: Heart Failure

Summary: this study intends to measure the effects of valsartan/sacubitril compared to baseline standard medical heart failure therapy on reverse remodeling using echocardiographic endocardial surface analysis techniques to assess changes in ventricular volume, function, and shape.

this study intends to measure the effects of valsartan/sacubitril compared to baseline standard medical heart failure therapy on reverse remodeling using echocardiographic endocardial surface analysis techniques to assess changes in ventricular volume, function, and shape. furthermore, metaiodobenzylguanidine (mibg) scintigraphy and the heart to mediastinum ratio will be used to assess left ventricle (lv) volume regression and risk reduction. the investigators also intend to measure the effects of valsartan/sacubitril on exercise capacity as assessed by the 6 minute walk test and peak volume of oxygen (v02) on cardiopulmonary exercise testing. additionally, the investigators will examine the impact of valsartan/sacubitril on functional status and quality of life using the kansas city cardiomyopathy questionnaire (kccq) and qualia health (a novel iphone application that incorporates fitbit technology to provide a "real time" daily 6 minute step count and assesses quality of life using a series of short targeted questions. the investigators will also measure brain natriuretic peptide (bnp), n-terminal of the prohormone brain natriuretic peptide (nt-probnp), and rho-kinase (a biomarker associated with heart failure) levels at multiple time-points throughout the study period.

Eligibility criteria:
inclusion criteria: 1. males and females aged ≥18 years 2. congestive heart failure (chf) new york heart association (nyha) class ii-iv with 25%≤ left ventricular ejection fraction (lvef) ≤40% (echo within last 6 months) * nt-probnp ≥ 600 pg/ml or * nt-probnp ≥ 400 pg/ml and a hospitalization for heart failure within the last 12 months 3. stable and optimized on an angiotensin-converting-enzyme inhibitor (acei) equivalent to enalapril ≥ 10 twice a day (bid) for at least 4 weeks 4. stable and optimized on a beta-blocker for at least 4 weeks 5. optimized dosing of aldosterone antagonist at stable dose for at least 4 weeks exclusion criteria: 1. history of angioedema 2. estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m2 at screening 3. serum potassium \> 5.2 mmol/l at screening 4. symptomatic hypotension as defined by investigator, systolic blood pressure (sbp) \< 100 mmhg at screening 5. current acute decompensated heart failure 6. history of severe pulmonary disease 7. active malignancy 8. requirement for treatment with both angiotensin-converting-enzyme inhibitor (acei) and angiotensin receptor blockers (arb)
ngs panel of incomplete forms of ocular albinism

Conditions: Albinism, Ocular

Summary: implementation of a next-generation sequencing panel of genes to identify deleterious variants in patients with incomplete forms of albinism.

scientific context : albinism is clinically characterised by cutaneous hypopigmentation and ophthalmologic features. these features common to all forms of albinism are foveal hypoplasia, misrouting of the optic nerves at the chiasm, retinal hypopigmentation, translucent irides and nystagmus. the molecular genetic lab at bordeaux university hospital is the national reference for the study of this disease. more than 1400 patients have been analyzed with a strategy including next-generation sequencing of the 19 known genes of albinism and array-cgh. despite this thorough analysis, 25% of patients remain without molecular diagnosis. our experience tells us that these patients often show an incomplete form of albinism with the presence of only few ophthalmologic signs. the molecular diagnosis is very challenging as the phenotype often overlaps with other ophthalmologic disorders.

Eligibility criteria:
inclusion criteria: * minor and adult patient. * patient presenting a clinical diagnosis of incomplete form of albinism with presence of at least 2 signs of ocular albinism among which nystagmus, low vision, foveal hypoplasia, retinal hypopigmentation, translucent irides, misrouting of the optic nerves at the chiasm. * registered for the social security system. * informed consent signed by patient or parent of a minor patient. exclusion criteria: * refusal to participate in research protocol.

Keywords: next generation sequencing albinism
clarithromycin prophylaxis in preterm infants colonisation with ureaplasma urealyticum and mycoplasma hominis

Conditions: Bronchopulmonary Dysplasia

Summary: the purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.

the investigators planned that clarithromycin treatment in preterm babies who are under 1250 grams birth weight. the investigators aimed with this treatment, the bronchopulmonary dysplasia rate of preterm babies may decrease.

Eligibility criteria:
inclusion criteria: * all infant must be under 1250 gram birth weight exclusion criteria: * major congenital anomaly, * cardiac abnormality, * without inform consent

Keywords: bronchopulmonary dysplasia clarithromycin preterm babies
rct of post-suicide attempt case management (action-j)

Conditions: Suicide Attempt

Summary: this study will determine the effectiveness of continuous follow-up care by case manager in preventing further suicide attempts

it is well known that many subjects who survived a suicide attempt will make further suicide attempts, even after the medical treatment at critical emergency unit. to examine the effectiveness of continuous follow-up care by case manager after the suicide attempt, a randomized, controlled, multicenter trial by j-misp (japanese multimodal intervention trials).this research project is one of the strategic research projects funded by the japanese ministry of health, labor and welfare. in this study, j-misp will implement the intervention for suicide attempters, a considerably high-risk group of further suicide attempts, who are transported by emergency services.

Eligibility criteria:
inclusion criteria: 1. over 20 years old 2. suffering from axis i disorder 3. had intent for suicide (confirmed more than 2 times) 4. able to understand this study and provide informed consent 5. able to have interview before trial registry and psycho education at hospital 6. able to have interview for assessment at continuous follow-up care by case manager at the hospital exclusion criteria: 1. not suffering from axis i disorder as a primary diagnosis

Keywords: suicide attempt
comparative study between platelet rich plasma and steroid injection in trigger finger treatment

Conditions: Trigger Finger Disorder

Summary: the goal of this clinical trial is to learn if platelet rich plasma works to treat early stage trigger finger in adults. it will also learn about the safety platelet rich plasma. the main questions it aims to answer are: does platelet rich plasma lower the pain associated with trigger finger of participants? does it improve the hand grip strength and q dash score of participants? researchers will compare platelet rich plasma to depo-medrol steroid (a known standard of care for early stage trigger finger) to see if platelet rich plasma works to treat early trigger finger. participants will: take platelet rich plasma or a depo-medrol steroid intralesional injection at recruitment into the intervention visit the clinic once every 4 weeks for checkups and parameter measurements. investigator will will keep a record of participants progress in symptom remission


Eligibility criteria:
inclusion criteria: * patients who are 18year and above with mild or moderate trigger finger, who are willing to have intra-lesional administration of blood product. no previous treatment for the affected finger. exclusion criteria: * previous steroid injection * previous surgery to that finger * thrombocytopenic patients * hand and finger contracture * rheumatoid arthritis of the finger