Kornimate/medical-research-clean huggingface dataset:
measuring the peripheral optical quality of the eye

Conditions: Nearsightedness

Summary: the goal of the study is to quantify wavefront aberration profiles of the eye with and without contact lens across the visual field. this will enable us to investigate the impact of the aberration on retinal image quality.

the goal of this study is to investigate the effects of monofocal and bifocal soft contact lenses in the changes of peripheral optical quality and through-focus visual performance on real eyes. the goal will be accomplished by performing optical measurements using shack-hartmann wavefront sensor with and without the use of single vision and bifocal soft contact lenses.

Eligibility criteria:
inclusion criteria a person will be included in the study if he/she: * is 18 years or older and has full legal capacity to volunteer. * has no ocular condition or pathology, which may impact visual acuity e.g. keratoconus, amblyopia, cataract, macular degeneration; * has no active ocular disease or allergic conjunctivitis; * is not using any topical ocular medications; * is willing and able to follow instructions; * has voluntarily agreed to participate in the study by signing the statement of informed consent. exclusion criteria a person will be excluded from the study if he/she: * is under the age of 18 or over the age of 60 yrs. * correctable with high contrast logmar acuity (edtrs) testing to 20/20 or better; * pregnant at the time of enrolment in the study; * unable to handle, insert, remove or care for the study lenses; * considered by the investigator to not be a suitable candidate for participation.
add vitamin d with standard of care for chronic hepatitis c patients

Conditions: Chronic Hepatitis C

Summary: standard therapy for chronic hepatitis c virus (hcv) is (peg/rbv) combination therapy obtaining sustained virologic response (svr) in 77% of naïve patients with genotype 1-3 studies rarely address the issues of improving host factors. the current study examines whether adding vitamin d with peg/rbv, a potent immunomodulator, could improve viral response(svr)compared to peg/rbv.

the working hypothesis is that adding vitamin d to conventional peg/rbv therapy for naïve, genotype 1-3 patients with chronic hcv infection significantly improves rvr, evr additionally.

Eligibility criteria:
inclusion criteria: * chronic genotype 1-3 hcv infection * treatment naive exclusion criteria: * child b and c * hcc patients * pregnancy

Keywords: chronic hepatitis c svr vit d peginterferon alfa 2a ribavirin
study of morphology and functional magnetic resonance imaging (mri) muscle patients with muscular dystrophy type fshd benefiting a physical training introduced.

Conditions: Muscular Dystrophy; Facioscapulohumeral

Summary: the safety of guided practice of physical activity in myopathies is increasingly accepted, including muscular dystrophies. in facioscapulohumeral dystrophy (fshd), one of the most common muscular dystrophy, the aerobic training showed its physiological and functional efficiency without affecting the quality of life of patients. the issue of exercise therapy extended to all neuromuscular diseases, as has been rigorously analyzed, shows that the use of a training program combining endurance exercise targeted exercises and strength is even more relevant. to complete the multidimensional assessments be managed by each team ( physiological assessments, functional tissue and quality of life) it is relevant to continue , for a descriptive study quantitative and qualitative analyzes by muscle imaging and spectroscopy (mri and nuclear resonance imaging (nmr) spectroscopy ).

these non-invasive assessments already in place at the time of the initial training (fshd1 study, nct01116570) will be repeated in the medium (12 months) and long term (30 months) in the same laboratory nmr aim - cea , institute of myology in paris (p carlier ). the data obtained from nmr repeated examinations and those obtained from biochemical analyzes and additional muscle histomorphometric (cellular aging estimation of involution fibroadipose ) on biopsies already programmed (initial, 6 months and 30 months, fshd2 study, nct01689480) will be respectively compared to initial time to follow the evolution food and energy capacity of trained muscles. the study of biopsies provide mechanistic arguments and morphometric specific cellular response to exercise, data will be advantageously complemented by nmr specialized examinations extended to all the muscles of the thigh (target of training ) and muscle quantification whole body mri.

Eligibility criteria:
inclusion criteria: * included in the fshd1 and fshd2 studies * social security regimen affiliated * consent form signed exclusion criteria: * severe cardiac or respiratory insufficiency * cardiac pacemaker * morbid obesity (bmi upper to 35) * anti platelet therapy

Keywords: muscular dystrophy facioscapulohumeral physical training magnetic resonance imaging muscle biopsy
procalcitonin in diagnosis of bacterial infections in young infants

Conditions: Sepsis

Summary: a diagnostic accuracy study investigating the accuracy of procalcitonin in diagnosing invasive bacterial infections in your infants.

the primary aim of this study was to report on the diagnostic accuracy of procalcitonin in the diagnosis of bacterial infections in young infants. this included invasive bacterial infections; defined as the isolation of a bacterial pathogen in blood or cerebrospinal fluid culture. we conducted a prospective observational diagnostic accuracy study. young infants less than 90 days of age presenting to the royal belfast hospital for sick children with signs of possible bacterial infection were eligible for inclusion. eligible infants underwent procalcitonin testing using 0.5ml of whole blood with a brahms assay on the samsung labgeo ib10® analyser.

Eligibility criteria:
inclusion criteria: * suspected bacterial infection exclusion criteria: * none
impact of additional resistance training during rehabilitation therapy in patients with heart failure

Conditions: Heart Failure

Summary: the impact of moderate- or low-intensity resistance training will be investigated additional to endurance training in heart failure patients following rehabilitation. the aim is to optimize intensity of resistance training in this patient population.


Eligibility criteria:
inclusion criteria: * diagnosis of heart failure and participation in cardiac rehabilitation exclusion criteria: * orthopedic disorders, neurological disorders affecting muscle strength, cognitive disorders, heart or arterial surgery (percutaneous coronary intervention, bypass, heart valve surgery) in the last year, acute myocardial infarction in the last 6 months, participation in another intervention

Keywords: heart failure resistance training rehabilitation therapy
oxygen extraction-guided transfusion in critically ill patients

Conditions: Anemia; Critical Illness

Summary: anemia is common in intensive care unit (icu) patients and often appears early in the icu course. the optimal management red blood cells rbc transfusion in critically ill patients remains controversial and clinical studies in this field have usually been based on transfusion thresholds. in the "tricc" trial, patients assigned to a restrictive transfusion strategy (transfusion if hb\<7 g/dl) had similar mortality to patients transfused if hb\<10 g/dl. notably, none of the large rct tried to focus on a personalize rbc transfusion protocol, i.e. a transfusion protocol which address the individual need for transfusion basing on physiological approach. we therefore hypothesized that patients with high extraction of oxygen could benefit more of rbcs transfusion regardless their hemoglobin levels.


Eligibility criteria:
inclusion criteria: * hemoglobin level \<10 g/dl during the first 72 hours of icu exclusion criteria: * acute bleeding * hemoglobin level less than 7 g/dl

Keywords: transfusion intensive care medicine 90-day mortality
use of direct-acting antiviral to treat hcv recurrence after liver transplantation (anrsco23cupilt) infection

Conditions: HCV Recurrence; Liver Transplantation; Direct-acting Antiviral Agents

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of direct-acting antivirals therapy in liver transplanted patients who experienced hcv recurrence. this cohort is multicentric with constitution of biobank (plasma, serum) and the prospective collect of biological and clinical data's in the liver transplanted patients with recurrent hcv infection and treated with direct-acting anti-hcv agents.


Eligibility criteria:
inclusion criteria: * age \> 18 years-old * liver transplanted patient * hepatitis c virus infection before transplantation * hcv recurrence with a detectable hcv rna before enrollment in cohort * use of at least one direct-acting antiviral agents with or without association with peginterferon and with or without association with ribavirin * treated by direct-acting antiviral agents or has been yet completed the treatment but still on follow up * affiliated to health insurance * written signed consent form exclusion criteria: * pregnant or breast-feeding female
efficacy and safety of oral roflumilast taken with low dose inhaled corticosteroids in patients with asthma (12 to 70 y) (by217/m2-013)

Conditions: Asthma

Summary: bronchial asthma is among the world's most prevalent diseases. roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma. the aim of the study is to investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function. roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily. the study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24 weeks). the study will provide further data on safety, tolerability, and effectiveness of roflumilast.


Eligibility criteria:
main inclusion criteria: * written informed consent * diagnosis of persistent chronic bronchial asthma, according to global initiative for asthma (gina) guidelines * the patient has been receiving bdp - cfc ≤1000 mcg per day or equivalent for the previous four weeks * fev1 between 60 and 90% predicted at visit 1 * no change in asthma treatment within 4 weeks prior to visit 1 main exclusion criteria: * patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1 * patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period * a history of lower airway infection in the four weeks prior to visit 1 * a diagnosis of chronic obstructive pulmonary disease (copd) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis) * heavy smoker currently smoking \>20 cigarettes per day and/or \>10 pack years or the patient is an ex-smoker who has smoked \>10 pack years * patients using \>8 puffs/day relief medication regularly prior to visit 1 * clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation * a diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1 * patients with chronic heart failure class iii or iv (new york heart association) * suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, bdp, or salbutamol) * a history of alcoholism or substance abuse within the 12 months prior to visit 1 * pregnancy or women of childbearing potential who are not using a reliable method of contraception

Keywords: asthma roflumilast corticosteroids
rechallenge of prior regimen in third or later-line chemotherapy in metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer; Chemotherapy Effect

Summary: this is a single-arm, open-label, single-center prospective phase ii study to evaluate the efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in patients with advanced colorectal cancer. the primary end point is progression free survival (pfs). a total of 42 patients who failed with oxaliplatin, irinotecan and fluorouracil in previous treatment and could not receive the target therapy presently are planned for recruitment. for patients with metastatic colorectal cancer who met admission criteria, oxaliplatin- or irinotecan-based chemo regimen could be used and evaluation was repeated every 6 weeks. the treatment continues until the disease progression or the untolerable adverse reaction.

the treatment for reintroduction was oxaliplatin- or irinotecan-based chemo-regimen. optional chemotherapy regimen included xelox,folfox,folfiri,irinotecan single-agent

Eligibility criteria:
inclusion criteria 1. patients age between 18 and 80 years 2. histologically confirmed metastatic colorectal cancer (mcrc) 3. an eastern cooperative oncology group (ecog) performance status of 0 to 2 4. treatment failure to at least two lines of chemotherapy (regimens should include oxaliplatin, fluorouracil and irinotecan); progression free survival (pfs) of prior oxaliplatin or irinotecan-based chemotherapy should be at least four months without any unrecoverable toxicity. prior target therapy was acceptable 5. for those who received other anti-tumor treatment, the toxicity should have been restored, with the time interval from last dose of cytotoxic drugs, radiation or surgery (the wound should be healed completely) ≥3 weeks 6. life expectancy≥12 weeks 7. at least one measurable lesion as defined by recist 1.1 8. acceptable hematologic, hepatic, and renal function within 7 days from screening: the blood anc count≥1.5\*10\^9/l; hemoglobin≥9.0 g/dl, the blood platelet count≥80 x 10\^9/l, total bilirubin\ 50ml/min 9. targeted drugs are currently not suitable or affordable exclusion criteria 1. receiving other systemic anti-cancer treatment within 3 weeks 2. prior radiation therapy of target measurable lesion 3. presence of grade iii or iv chemo-related toxicity in previous treatment without recovery to grade ii or less 4. with other malignant tumor in 5 years; except for cured cervical carcinoma in situ or basal cell carcinoma 5. symptomatic intracranial or meningeal metastasis 6. history of uncontrolled seizures, central nervous system dysfunction or mental disorder 7. uncontrolled pleural or peritoneal effusion 8. severe life-threatening concomitant disease that might impair the safety of patients or affect the completion of treatment, according to the researcher's judgment
cabergoline before or after oocyte collection for follicular resolution

Conditions: Infertility, Female

Summary: randomized trial comparing the efficacy of two different times of administration of cabergoline in patients undergoing controlled ovarian stimulation and oocyte collection.


Eligibility criteria:
inclusion criteria: 1. adult female at least 18 years of age intending to undergo ovarian stimulation for a cycle of ivf. 2. ability read and understand english sufficiently to obtain informed consent and complete a study diary. 3. pre-implantation genetic screening (pgs) is allowed. 4. egg donors are allowed. 5. patients using a gestational carrier are allowed. 6. patients with prior ivf cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study. exclusion criteria: 1. egg banking, donor egg banking, or any cycle type that would preclude immediate culture to blastocyst stage. 2. patients that would be unavailable for the follow-up ultrasound 5 days post-retrieval, such as patients that live far from the clinic (e.g. out of state). 3. uncontrolled hypertension. 4. ergot alkaloid hypersensitivity or allergy. 5. history of pulmonary, pericardial, retroperitoneal fibrotic disorders. 6. history of bipolar disorder, schizophrenia, or psychotic illness. 7. breast feeding. 8. history of eclampsia or pre-eclampsia. 9. severe hepatic dysfunction. 10. current use of any dopamine receptor agonist or antagonist for any purpose, including, but not limited to, cabergoline (dostinex), aripiprazole (abilify), bromocriptine (parlodel), methylphenidate (ritalin), buproprion (wellbutrin, zyban), lisdexamfetamine (vyvanse). 11. any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
a study to evaluate efficacy and safety of adc3680 in subjects with inadequately-controlled asthma

Conditions: Asthma

Summary: this randomised, double-blind, placebo-controlled study will evaluate the efficacy and safety of adc3680 administered once daily as an add-on therapy to inhaled corticosteroids and when co-administered with montelukast in patients with inadequately-controlled asthma. patients will be randomised to 3 arms to receive adc3680, placebo or montelukast.

this is a multi-centre, randomised, placebo-controlled, double blind, parallel group 3-arm study (including montelukast as an active comparator) designed to compare the efficacy and safety of a once daily dose of adc3680 with placebo in subjects with inadequately-controlled asthma despite receiving a low to moderate dose of an ics controller therapy, over a 10 week treatment period. at the end of the 10 week treatment period open label montelukast (10 mg) will be added to adc3680 and placebo arms for a two week extension period to assess whether efficacy of adc3680 is enhanced by the addition of montelukast compared with montelukast alone. the montelukast arm will continue with 10 mg montelukast alone.

Eligibility criteria:
inclusion criteria: * men and women aged 18 years to 50 years (inclusive) * diagnosis of asthma (gina 2011) including a demonstration of reversible airway obstruction * pre-bronchodilator fev1 value ≥ 40% and ≤ 85% of the predicted normal value at baseline * a score of 1.5 or greater on the asthma control questionnaire at baseline * daily use of low to moderate dose of ics (equivalent to budesonide ≤ 800 µg per day) * prescribed a short-acting inhaled bronchodilator as reliever therapy for relief of symptoms * a peripheral blood eosinophil count ≥ 0.25 x 109/l * non-smoker or former smoker who has not smoked in the last six months * body mass index (bmi) ≥ 17 and ≤ 35 kg/m2 * able to comply with the protocol requirements, instructions and restrictions * able to provide signed and dated written informed consent exclusion criteria: * subjects with severe asthma exacerbation in the 4 weeks prior to consent * subjects with respiratory tract infection in the 4 weeks prior to consent * subjects with copd or other relevant lung diseases * subjects with clinically significant condition which may compromise subject safety or interfere with study evaluation other protocol-defined inclusion/exclusion criteria may apply.
orthoptic rehabilitation for low vision people with innovative mechanisms (eye tracker and tactile device)

Conditions: Low Vision

Summary: this project is working on orthoptic rehabilitation for low vision people. the aim of the project is to assess the interest and integration of this rehabilitation device used at home, in low-vision private practice and at the hospital. it leads to develop and evaluate an innovative device to integrate and adjust monitoring of patients according to their need and their progress, to create new interactions with the patient, enabling the orthoptist to stay in touch with his patient at home between rehabilitation sessions and to obtain a more fine and objective analysis of the exercises done by the patient. using an eye tracker and a digital tactile screen with data uploads allows the practitioner to observe the progress objectively. it also leads the patient to a better understanding of his/her visual behavior and of the effects of rehabilitation. therefore, it will be easier to adopt better strategies.


Eligibility criteria:
inclusion criteria: * patients suffering from visual impairment, with a need for visual rehabilitation * visual acuity (≤1.3 logmar) * good knowledge of french language * informed consent of research exclusion criteria: * medical treatment that may interfere with the study * degenerative diseases or any other diseases that may interfere with the study. * mini-mental state examination score without visual item ≤ 20/25 * pregnancy and lactation.

Keywords: orthoptic rehabilitation low vision eye tracker tactile device
web-based family history tool

Conditions: Gynecologic Cancer; Breast Cancer; BRCA1 Mutation; BRCA2 Mutation

Summary: the purpose of this pilot study is to determine if a web-based tool that collects family health history is useful for patients being seen in a gynecologic oncology office setting. this research study is being done because collecting a comprehensive family health history is critical as it allows physicians to appropriately refer patients for genetic counseling and genetic testing. however, prior research indicates that the family health history collected in clinical settings is often inadequate to truly assess the risk of genetic disease. therefore we plan to explore a web-based program that guides patients through the collection of their family health history and uses this information to create clear concise pedigrees (family tree information) and risk assessment models that can be used by a physician during the office visit.

patients presenting for a new patient visit with a gynecologic oncologist will be randomized to one of three methods of collection of family health history (arm 1 - standard of care consisting of interview with the physician; arm 2 - completion of a web-based family health history tool completed in the clinic waiting room on a computer; arm 3 - completion of a web-based family health history tool completed prior to the visit and accessed by an email link). a new 4th arm was added with 200 chart reviews to retrospectively look back at how previous family health history was taken for new patients in 2019. the study will evaluate the quality of the family health history collected, the resulting referral to genetic services and patient and physician satisfaction.

Eligibility criteria:
inclusion criteria: female \> 18 years of age. scheduled for new patient visit with one of the gynecologic oncologists at weill cornell medicine (melissa frey md, kevin holcomb md, evelyn cantillo md, eloise chapman md). exclusion criteria: subjects who cannot communicate in english as the fhh collection tool and surveys are available only in english. subjects who were adopted and have no information about their family health history. subjects who do not present for the new patient visit.
supplementation of vitamin d in patients with type 2 diabetes and hypertension

Conditions: Hypertension

Summary: in patients with type 2 diabetes, the effects on blood pressure of vitamin d has been shown to be variable. thus, the goal of this proposal is to evaluate the effect of vitamin d supplementation in patients with type 2 diabetes and hypertension


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hypovitaminosis d * hypertension exclusion criteria: * pregnant or lactating * patients using vitamin d supplementation * using drugs that interfere on vitamin d metabolism (corticosteroids, anticonvulsants) * illicit drug use * diseases such as chronic renal failure (serum creatinine greater than 2.0 mg/dl) * liver cirrhosis * alcoholism * dementia * malignant disease that compromises the 5-year survival, * digestive tract (malabsorption) diseases * bmi\> 40 kg / m2

Keywords: hypertension diabetes mellitus vitamin d