Kornimate/medical-research-clean huggingface dataset:
improve screening criteria for retinopathy of prematurity in two french center

Conditions: Retinopathy of Prematurity

Summary: the aim of the study is to assess whether a delay of the first examination can be safely considered in french population. secondary objectives are to describe retinopathy of prematurity (rop) in a population of premature from two french tertiary nicu and to identify co-morbidities associated with the development of severe rop.

retinopathy of prematurity (rop) is a major cause of blindness and visual impairment in children worldwide. despite a stable incidence over the last decades, improvements in neonatal care and survival of extremely premature lead to an increased screening and follow up of rop. retinal examination is painful and can result in clinical deterioration, it also generates significant health care costs. in this way, several studies suggest the need to optimize screening without ignoring severe rop requiring treatment. recently, screenrop in canada and swedrop studies in sweden contributed to a modification of the national screening guidelines with a reducing upper limit at 30 weeks of gestational age (ga) and a postponing of the first examination. because of the population studied, those recommendations cannot be applicable in other countries. recommendations in france are to screen infants \< 31 ga or 1250 g, first examination should be performed at pma 31 in infants \< 27 ga and at 4 weeks postnatal age (pna) in infants born at 27 ga or more. our main hypothesis is that a reduction of the screening criteria by decreasing the upper limit of the threshold at 30 ga and/or postponing the first examination is acceptable in a population of premature newborns from two french tertiary nicu. this simplification of the screening modalities could reduced the number of fundus examinations performed, while limiting risks for the patient as well as costs. this study could be a pilot study for a national multicenter trial, with the objective of revising national screening guidelines.

Eligibility criteria:
inclusion criteria: * infant with gestational age \< 31 weeks and/or birth weight \< 1250 g * with at least one retinal examination * holders of the parental rights informed and not objecting to the study exclusion criteria: * infants died before 28 days pna * infants with hydrocephaly. * infants with significant congenital malformations or genetic abnormalities.

Keywords: birth weight gestational age premature retina screening
influence of hypocaloric diet on urinary lithogenic factors of obese patients with kidney stones

Conditions: Obesity; Kidney Stones

Summary: the objective of this study is to evaluate the influence of low-calorie diet on serum and urinary metabolic parameters of obese adults with urinary calculi and lithogenic metabolic abnormalities.

objective: to evaluate the influence of low-calorie diet on serum and urinary metabolic parameters of obese adults with urinary calculi and lithogenic metabolic abnormalities. method: prospective study of 50 patients, aged over 18 years, with a body mass index above 30 kg/m2, urinary calculi and lithogenic metabolic abnormalities. will be excluded from the study patients with psychiatric diagnoses other than depression, patients with inability to attend to clinical follow-up, patients with nephrocalcinosis, patients with urinary tract infection, patients with cystinuria and patients subjected to previous surgeries to treat obesity. each patient will be evaluated monthly on the same day by urologist and nutritionist. on the first evaluation, will be done anamnesis, anthropometric measurements of weight, height, waist, bioimpedance and requested total serum calcium, phosphate, sodium, potassium, urea, creatinine, uric acid, and pth, ph venous blood, urine tests type i, culture of urine and urine tests of calcium, oxalate, phosphate, sodium, potassium, citrate, magnesium, creatinine, uric acid, cystine and computed tomography for evaluation of urinary calculus. in the second evaluation, 30 days after, anthropometric measures will be repeated, bioimpedance and nutritional assessment will be made with recommendation of daily ingestion of 2500 ml of water and low-calorie diet of 16 kcal/kg bw/day and requested total serum calcium, phosphate, sodium, potassium, urea, creatinine, uric acid, and pth, ph venous blood, urine tests type i, culture of urine and urine tests of calcium, oxalate, phosphate, sodium, potassium, citrate, magnesium, creatinine, uric acid, cystine. patients will be monitored monthly for 3 months with anthropometric measurements, bioimpedance and strengthening of nutritional recommendations. by the end of the third month, patients will be submitted to two series of serum and urine tests as before the diet. the results of serum and urine tests from the beginning of dietary treatment will be compared to those of the end of the treatment with student t test. p\<0.05 are considered significant.

Eligibility criteria:
inclusion criteria: * body mass index above 30 kg/m2 and urinary calculi on tomography and lithogenic metabolic abnormalities. exclusion criteria: * psychiatric diagnoses other than depression * inability to attend to clinical follow-up * nephrocalcinosis * urinary tract infection * cystinuria * previous surgeries to treat obesity

Keywords: obesity kidney stones diet
the development of diagnostic biomarker panels for hepatitis and liver cancer

Conditions: Hepatitis B,Chronic; Carcinoma,Hepatocellular

Summary: more recent studies have shown that the hbv-infected population has a greater risk of development of hepatocellular carcinoma. nevertheless, there are still a significant number of people chronically infected by hbv who do not develop the complication. hence, there exist biological markers that could be indicator for the disease-inducing and carcinogenic potential of the virus.


Eligibility criteria:
inclusion criteria: * patients of at least 21 years old on day of giving consent for study * patients must be able and wiling to give an informed consent * patient with chronic hbv infection * patient with active hepatocellular carcinoma and chronic hepatitis b * healthy subjects exclusion criteria: * patients who have co-infection with hiv or chronic hepatitis c * subjects with other types of cancer

Keywords: hepatocellular carcinoma microarray gene expression profiling biomarkers
a feasibility study of intensive treatment with prolonged exposure

Conditions: Post Traumatic Stress Disorder

Summary: the primary objective with this study is to investigate the feasibility and acceptability of intensive treatment with prolonged exposure (i-pe) in regular swedish psychiatric care. the secondary objective is to investigate preliminary effects of i-pe in terms of reducing symptoms of post-traumatic stress, depression and increase quality of life.

the investigators will investigate i-pe delivered as a one-week intensive treatment consisting of nine individual sessions and five group sessions followed by three individual session two, four and eight weeks afterwards in a pilot trial. the feasibility and acceptability and preliminary effects of treatment- and assessment procedures will be evaluated using a within-group design with repeated measurements and qualitative interviews. the individual sessions will consist of imaginal exposure and processing and the group sessions of psychoeducation, rationale for treatment and in vivo exposure work. recruitment is designed to be broadly inclusive with minimal exclusion criteria. patients will be recruited from a psychiatric clinic specialised in ptsd in stockholm, sweden.

Eligibility criteria:
inclusion criteria: * meet criteria for ptsd * if taking psychotropic medication, then the dose must be stable for at least 4 weeks prior to study entry * ≥ 18 years * fluent in swedish * signed informed consent exclusion criteria: * other serious comorbidity as primary concern (for example ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, high suicidal risk) * other ongoing trauma-focused psychological treatment * ongoing trauma-related threat (e.g. living with a violent spouse)

Keywords: ptsd prolonged exposure intensive treatment massed treatment
biomarkers of meats and potatoes intake

Conditions: Nutrition Disorders

Summary: this cross-over meal study is a four-way intervention with 12 volunteers randomized at the same time to four meals with fried meats (beef, pork, chicken and amino-acid matched non-meat control) and to four meals with potato products (boiled, chips, fries, and a control with boiled white rice) to search for biomarkers of intake.

in a two-dimensional, cross-over meal study, 12 healthy volunteers consumed in a randomized sequence four test meals: chicken, pork, beef, and a control made of egg white and pea. at the same time they were independently randomized to four starchy foods to be consumed together with the meats: boiled potatoes, fried potatoes, potato crisps or boiled white rice. fasting and postprandial urine samples were collected to cover 48 h after each meal and samples were profiled by untargeted lc-esi-qtof-ms metabolomics. the profiles following the meal challenges were explored by univariate and multivariate analyses and single and combined markers of intake identified chemically by ms/ms fragmentation experiments and statistically by roc curves and error rates as well as fdr statistics.

Eligibility criteria:
inclusion criteria: * healthy exclusion criteria: * non-pregnant, no abuse of alcohol or drugs, no chronic medication except p-pills

Keywords: biomarkers of food intake
patient-reported outcome follow-up based on the northern shanghai community chronic disease management system

Conditions: Atrial Fibrillation

Summary: influence of patient-reported outcome follow-up based on the northern shanghai community chronic disease management system on the follow-up compliance and satisfaction of patients with atrial fibrillation after cryoablation.

influence of patient-reported outcome follow-up based on the northern shanghai community chronic disease management system on the follow-up compliance and satisfaction of patients with atrial fibrillation after cryoablation.among patients with left atrial fibrillation after cryoablation at several sites, 240 consecutive eligible patients were randomly assigned to routine follow-up (control) and pro (test) for 12 months. follow-up, comparison of postoperative follow-up compliance, satisfaction, etc.

Eligibility criteria:
inclusion criteria: * 18-85 years old;symptomatic, paroxysmal atrial fibrillation with cryoablation；ability to understand and sign informed consent； exclusion criteria: * none

Keywords: atrial fibrillation; follow up；patient-reported outcomes；
a phase iii study assessing the efficacy and safety of de-117 ophthalmic solution compared with timolol maleate ophthalmic solution 0.5% in subjects with glaucoma or ocular hypertension - spectrum 4 study

Conditions: Glaucoma and Ocular Hypertension

Summary: this is a phase iii, randomized, double-masked, active-controlled, parallel-group, multi-center study. subjects diagnosed with glaucoma or oht who meet eligibility criteria at visit 1 (screening) will washout of their current topical iop-lowering medication(s), if any. after completing the required washout period, subjects will return for visit 2 (baseline, day 1). subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months. approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or oht who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either: * de-117 ophthalmic solution once daily and vehicle once daily, or * timolol maleate ophthalmic solution 0.5% twice daily. the study will evaluate the efficacy and safety of de-117 ophthalmic solution compared with timolol maleate ophthalmic solution 0.5% in subjects with glaucoma or oht through month 3.


Eligibility criteria:
inclusion criteria: • glaucoma or ocular hypertension exclusion criteria: * females who are pregnant, nursing, or planning a pregnancy * any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements
the effect of lung recruitment maneuver on postoperative atelectasis in children

Conditions: Atelectasis

Summary: the investigators compare the degree of atelectasis in recovery room between conventional recruitment maneuver and ultrasonography-guided lung recruitment during surgery.


Eligibility criteria:
inclusion criteria: * patients who undergo surgery for more than 1 hour under general anesthesia * children under 6 years old * american society of anesthesiologist physical status i or ii exclusion criteria: * history of lung surgery * abnormal findings in chest x-ray * laparoscopic surgery * abdominal surgery
safety and tolerability of repeat courses of im alefacept

Conditions: Chronic Plaque Psoriasis

Summary: the purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.


Eligibility criteria:
inclusion criteria: * written informed consent. * at least 16 years of age. * diagnosed with chronic plaque psoriasis and require systemic therapy. * cd4+ lymphocyte counts at or above the lower limit of normal for covance central laboratory services, inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3). exclusion criteria: * unstable erthrodermic or pustular psoriasis. * diagnosis of guttate psoriasis. * serious local infection or systemic infection within 3 months prior to first dose of alefacept. * positive for hiv antibody. * known invasive malignancy within 5 years of enrollment. patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded. * evidence of active tuberculosis. * current treatment for active tuberculosis or tuberculosis prophylaxis. * female patients unwilling to practice effective contraception as defined by the investigator. * female patients who are pregnant or breast-feeding. * current enrollment in any other investigational drug study. * previous participation in this study or previous alefacept studies.
illness related distress in women with clinically localized cutaneous melanoma

Conditions: Melanoma

Summary: the purpose of this study is to examine the experiences and quality of life of women who have been treated for melanoma. by quality of life, we mean how they are feeling about different aspects of their life. in this study, we are especially interested in their feelings about survival, physical appearance and any family concerns. we will administer a series of qol questionnaires, data sheets with many questions, to get their response to measure their feelings about these issues.


Eligibility criteria:
inclusion criteria: * age 18 years or older * clinically node-negative primary cutaneous melanoma. * patients participating must be female * patients must have completed surgical treatment for melanoma at least 10 days ago and less than 2 years at the time of study entry. exclusion criteria: * prior history of cancer with the exception of squamous or basal cell carcinoma of the skin.

Keywords: skin
migraine survey in gulf region

Conditions: Migraine

Summary: the objective of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction in patients newly started on erenumab over 12 weeks

this is a longitudinal prospective descriptive primary data collection using a 20 min online survey. patients will be selected by investigators (general neurologists, headache/migraine specialists) in primary care clinics and hospitals. after fulfilling the inclusion criteria, the patient will be asked to sign an online informed consent. a 5 min screener will follow after which the patient will be directed through a link to the full survey. the duration of data collection will be for 6 months since the start of survey rolling in each site across centers in the gulf region.

Eligibility criteria:
inclusion criteria: * em\& cm (with or without medication overuse headache (moh)) patients * newly started on erenumab either 70 mg or 140 mg (first dose received within 1 month prior study enrollment and baseline endpoints collection) * ability to receive 3 monthly doses of erenumab. * age more than 18 years * males and females * allowing the patients to be stable on 1 adjunctive migraine preventive medication (if present) * agreed to be included in the study and signed informed consent exclusion criteria: * less than 18 years * age at onset of migraine more than 50 years * any contraindications to the start of erenumab as per label * refusal to sign informed consent * inability to participate or restricted access to the online survey * enrolled in an interventional migraine-related study at the time of the study enrollement

Keywords: migraine survey gulf
phase ii study to evaluate modified folfirinox and stereotactic body radiation therapy in non-metastatic unresectable pancreatic adenocarcinoma

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the efficacy of modified folfirinox followed by stereotactic body radiotherapy (sbrt) in patients with borderline resectable pancreatic cancer (brpc) and locally advanced pancreatic cancer (lapc). the primary hypothesis will be to determine if modified folfirinox followed by sbrt improves progression free survival (pfs) compared to historical controls treated with gemcitabine-based chemotherapy with or without standard fractionated radiation.

the primary and secondary are listed below. primary objective: - to evaluate progression free survival after modified folfirinox and sbrt in borderline resectable and locally advanced pancreatic cancer. secondary objective: * to evaluate the radiographic response to folfirinox and sbrt by comparing iv contrast ct scans before and after therapy. * to determine rates of recurrence (local only, systemic only, and both local and systemic), and overall survival. * to determine rates of grade 3 or greater gastrointestinal toxicity, including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation.

Eligibility criteria:
inclusion criteria: * histologically confirmed pancreatic adenocarcinoma * borderline resectable pancreatic adenocarcinoma or locally advanced pancreatic adenocarcinoma * no evidence of extrapancreatic disease on diagnostic imaging * no evidence of invasion into the duodenum or stomach, as determined by egd/eus * no prior treatment (chemotherapy, biological therapy, or radiotherapy) for pancreatic cancer * no prior treatment with oxaliplatin, irinotecan, fluorouracil, or capecitabine * ecog performance status of 0-1 * no other malignancy within past five years (exceptions include basal cell carcinoma of the skin, cervical carcinoma in situ, and non-metastatic prostate cancer) * no evidence of second malignancy at the time of study entry * no interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung * no \> grade 2 sensory peripheral neuropathy * no uncontrolled seizure disorder, active neurological disease, or known cns disease * no significant cardiac disease, including the following: unstable angina, new york heart association class ii-iv congestive heart failure, myocardial infarction within six months prior to study enrollment * not pregnant and not nursing * no other medical condition or reason that, in the opinion of the investigator, would preclude study participation * laboratory parameters as follows: * absolute neutrophil count ≥1,500/ul, * platelet count ≥75,000/ul, * hemoglobin ≥9 g,/dl, * creatinine \ 30 ml/min, * bilirubin \<1.5 x uln, * ast and alt \<3 x uln, * negative pregnancy test in women of childbearing potential * able to be treated with sbrt only at the smilow new haven campus * able to have fiducials placed in the pancreas exclusion criteria: * failing to meet any of the inclusion criteria
metronomic cyclophosphamide in combination with standard chemotherapy for squamous cell lung carcinoma

Conditions: Lung Cancer; Squamous Cell Carcinoma of the Lung; Locally Advanced and Metastatic Squamous Cell Carcinoma of the Lung

Summary: treatment of locally advanced and metastatic squamous cell carcinoma of the lung involves the use of chemotherapy as the therapeutic mainstay. platinum-etoposide regimens (such as cisplatin-etoposide) are the most commonly used chemotherapeutic regimen, which is delivered intravenously in the standard three-weekly intervals. recent interest in oral metronomic chemotherapy has arisen, especially due to its beneficial effects in delaying disease progression among heavily pre-treated patients with various malignancies. this study attempts to combine the use of metronomic chemotherapy concurrently during standard intravenous chemotherapy.

adenocarinoma and squamous cell carinoma are the two major types of non-small cell lung carcinoma. while patients with adenocarcinoma of the lung have the feasibility of treatment with tyrosine kinase inhibitors, the patients with squamous cell carcinoma can only be treated with standard chemotherapy due to the ineffectiveness of tyrosine kinase inhibitors. thus, the current standard is to treat patients of squamous cell lung cancers with standard intravenous chemotherapy, which is mostly delivered once in three weeks. metronomic chemotherapy, meaning the delivery of low doses of chemotherapy, often by an oral approach, on a daily basis so as to maintain a low but definite level of the chemotherapy has received great interest in recent times due to its beneficial effects in terms of extending progression free survival among patients of various malignancies, even after failure with previous conventional therapies. metronomic chemotherapy is proposed to be active by alternate mechanisms, such as the predominant anti-angiogenic effect, in contrast to the cytotoxic and genotoxic effects of standard chemotherapy. metronomic chemotherapy with oral cyclophosphamide has been shown to extend progression free survival when used as a single agent in various malignancies. given the fact that progression after varying time spans is a rule (rather than the exception) among patients of squamous cell lung cancer being treated with conventional chemotherapy, we have intended to combine the use of oral metronomic chemotherapy given concurrently with standard intravenous cisplatin-etoposide based chemotherapy. we intend to observe a prolongation of progression free survival.

Eligibility criteria:
inclusion criteria: * histopathologically proven squamous cell carcinoma of the lung * surgically unresectable or metastatic disease exclusion criteria: * severe life limiting diabetes, hypertension or cardiac co-morbidities * co-existing tuberculosis * brain metastases at presentation * non-consenting patients * previously treated with any regimen of chemotherapy for existing or previous malignancy

Keywords: nsclc metronomic chemotherapy metronomic cyclophosphamide
tissue bank for pulmonary diseases

Conditions: Cystic Fibrosis

Summary: the aim of this research study is to collect and store the specimens that are left over after patients undergo tests ordered by their physicians. these specimens will be used at a later time by researchers in the pulmonary division to develop a better understanding of pulmonary diseases or for the development of new treatments. typical research studies that will be conducted on the stored tissue, fluid, or bacteria from the patient sample involve obtaining bacterial cultures, measurement of inflammatory markers, and examination of the characteristics of the tissue. other similar tests may be done in the future; however, these tests have not all been determined at this time. it is important to note that no genetic testing will be performed on any samples that are obtained as part of this protocol.


Eligibility criteria:
inclusion criteria: * open