Kornimate/medical-research-clean huggingface dataset:
donor iron deficiency study - red blood cells from iron-deficient donors: recovery and storage quality

Conditions: Iron Deficiency

Summary: primary hypothesis * the 24-hour post-transfusion rbc recovery of units obtained from donors exhibiting iron-deficient erythropoiesis will not meet fda standards for clinical use. * the 24-hour post-transfusion rbc recovery of units obtained after intravenous iron repletion will improve significantly and will meet fda standards for clinical use.

iron deficiency is common among regular blood donors, but the recovery and quality of red blood cell (rbc) units from iron-deficient donors has not been rigorously examined. evidence from both animal and human studies indicate that when the iron supply for erythropoiesis is inadequate, the rbcs produced have multiple metabolic defects that impair their ability to tolerate refrigerated storage. studies in a mouse model demonstrated decreased post-transfusion recovery of refrigerator-stored rbcs obtained from iron-deficient donors. the planned studies will identify human donors at greatest risk of providing rbcs with poor post-transfusion recovery by using a combination of a decreased serum ferritin concentration and increased rbc zinc protoporphyrin, as described below. to evaluate unequivocally the role of iron deficiency in poor posttransfusion rbc recovery, intravenous iron will be used for iron repletion.

Eligibility criteria:
inclusion criteria: 1. 18-75 years old; 2. healthy (by self report); 3. body weight \>110 lbs; 4. female hematocrit \>=38%, male hematocrit \>39%; 5. frequent blood donor (men ≥2 and female ≥1 rbc unit donations in past year); 6. ferritin \<=15 ng/ml; and 7. zinc protoporphyrin \>=60 µmol/mol heme. exclusion criteria: 1. ineligible for donation based on the new york blood center donor autologous questionnaire; 2. taking iron supplementation; 3. c-reactive protein \>10 mg/l; 4. sickle cell trait; 5. systolic blood pressure \>180 or \ 100 or \<50 mm hg; 6. heart rate \ 100; 7. temperature \>99.5°f prior to donation; 8. temperature \>100.4°f or subjective feeling of illness prior to 51-chromium 24-hour rbc recovery study (to avoid the subject having a concurrent illness that may affect post-transfusion recovery); 9. positive results on standard blood donor infectious disease testing; 10. pregnancy; 11. taking, or planning to take, iron supplements; and 12. history of severe asthma requiring hospitalization, allergic eczema (atopic dermatitis), or other atopic allergy causing anaphylaxis.

Keywords: iron deficiency transfusion blood donation
the relationship between structure and visual function in myopia foveoschisis

Conditions: High Myopia

Summary: macular foveoschisis (mf) is a common complication of pathological myopia, which is characterized by choroid-retinal degeneration and vision impairment. although pars plana vitrectomy (ppv) is the primary method for mf treatment, there is still a large proportion of recurrent mf due to the extremely long global axial length and posterior staphyloma. macular buckling (mb) surgery aims at counteracting the traction exerted by the posterior staphyloma, and has been proven an effective method for treating mf. optical coherence tomography (oct) is widely used for the structural analysis of mf. multifocol electroretinogram (mferg) is an objective examination for visual evaluation. to our knowledge, there is a lack of data on the comprehensive visual function evaluations of mf patients associated with oct findings. our clinical trial aims to provide the structural and functional relationship in mf patients undergoing mb surgery, and find out potential factors to determine the visual prognosis.


Eligibility criteria:
inclusion criteria: 1. axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter; 2. macular foveoschisis that requires surgical intervention. exclusion criteria: 1. ocular trauma or surgery history; 2. glaucoma, diabetic retinopathy; 3. intraocular active hemorrhage or inflammation; 4. unable to coordinate the oct, mferg, or other ophthalmological examinations.

Keywords: high myopia myopia foveoschisis macular buckling
a multicentre trial to determine the efficacy and safety of milnacipran in the treatment of fibromyalgia syndrome

Conditions: Fibromyalgia Syndrome

Summary: investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.


Eligibility criteria:
inclusion criteria: * patient with a diagnosis of fibromyalgia according to the 1990 american college of rheumatology (acr) criteria exclusion criteria: * psychiatric illness * depression of generalised anxiety disorder * suicidal risk * substance abuse * active cardiac disease * pulmonary dysfunction * liver disease * renal impairment * autoimmune disease * chronic inflammatory rheumatoid disease * current systemic infection * epileptic * active cancer * sleep apnea * active peptic ulcer * inflammatory bowel disease * unstable endocrine disease * for men : prostatic enlargement of genito-urinary disorders * for women : pregnancy or breast feeding
clinic, pathologic and genetic characterization of patients with familial carcinoid tumors (study from the gte, groupe d'étude des tumeurs endocrines)

Conditions: Small Intestinal Carcinoid Tumors

Summary: small intestine carcinoid tumors are rare. small intestine familial carcinoid tumors (fct) are defined by the occurrence of at least 2 cases of this tumor type in first- or second-degree relatives. the estimated prevalence of fct is 2.6%-3.7% in patients with small intestine carcinoid tumors. because of its rarity, epidemiologic, clinic and pathologic features of fct have been scarcely described. molecular abnormalities associated with fct have been poorly explored. constitutional genetic factors predisposing to fct have not been discovered to date. only one abnormality (mutation of the ipmk gene) has been reported in one fct family only, but not found in other series. the main objective of this study is to identify the constitutional factors predisposing to small-intestine fct (and other midgut localizations: ascending colon and appendix). the secondary objectives are to describe the clinic and pathologic features associated with fct.


Eligibility criteria:
inclusion criteria : * small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically) * at least one first- or second-degree relative with a small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically) * agreement to participate to the study exclusion criteria : * subjects unable to provide consent

Keywords: neuroendocrine tumors carcinoid tumors midgut small intestine genetic predisposition hereditary
the optimal urethral coverage in hypospadias repair: dartos fascia versus tunica vaginalis flap? a randomized controlled trial

Conditions: Pediatric Disorder; Hypospadias; Congenital Hypospadia; Urologic Diseases

Summary: to explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: dartos fascia versus tunica vaginalis flap.


Eligibility criteria:
inclusion criteria: * age ≥ 6 months. * distal, mid-shaft penile hypospadias. exclusion criteria: * glanular hypospadias. * penoscrotal, scrotal \& perineal hypospadias. * recurrent cases.

Keywords: hypospadias repair tunica vaginalis flap dartos fascia fistula
ipilimumab-induced lung toxicity: observational study

Conditions: Metastatic Melanoma

Summary: serial spirometries and measurements of co-diffusion capacity (dlco) in patients with mm before and during treatment with ipilimumab are performed. a reduction from baseline of forced vital capacity (fvc) of ≥10%, or ≥15% of dlco was defined clinically meaningful, thus indicative for pulmonary toxicity.

the aim of this prospective observational study is to determine the prevalence of ipilimumab lung toxicity defined by a significant decline of the diffusing capacity of the lung for carbon monoxide (dlco) and/or forced vital capacity (fvc) in patients with mm. patients aged over 18 years with an established diagnosis of mm who are treated and followed up at the department of dermatology are asked to participate in the study after the indication for treatment with ipilimumab is given by the interdisciplinary skin tumorboard conference. after written informed consent is obtained, patients undergo a baseline evaluation (v1) including a medical history, physical examination, laboratory analyses (hemoglobin, leucocytes count, c-reactive protein, and pulmonary function tests (pfts) with spirometry and measurement of dlco. thereafter, the first dose of ipilimumab (3mg/kg) is given intravenously over a period of 90 minutes without premedication. the subsequent three doses of ipilimumab are administered three weekly with analogue dose. subsequent study visits (v2, v3, v4) including pfts are scheduled on the same day as ipilimumab is administered. thus, study visits are thoroughly adapted to the clinical visits, which is given by the administration of ipilimumab (total of four injections each separated by three weeks). in case of new respiratory symptoms during the study period, additional pfts and a high-resolution computed tomography (hr-ct) of the chest are performed. in case of early study termination during follow-up pulmonary function test values which are already obtained are used for the final analysis.

Eligibility criteria:
inclusion criteria: * established diagnosis of metastatic melanoma exclusion criteria: * acute pulmonary infection at enrolment
study of the physiology of pre-eclampsia and vascular iugr with constitution of a biological collection

Conditions: Pre-Eclampsia

Summary: preeclampsia and intrauterine growth retardation (iugr) are serious and frequent pathologies, specific to pregnancy. they represent 70 000 new cases a year, or 9% of pregnancies and cause 50,000 premature births per year in france. the consequences in terms of morbidity and perinatal morbidity and the medical and economic costs make it an issue public health. pre-eclampsia associates maternal hypertension with dysfunction kidney. there is no cure for pre-eclampsia or iugr vascular during pregnancy. these pathologies invariably evolve towards a maternal and / or fetal aggravation sometimes very fast. primary prevention and secondary education and screening for these pathologies are still insufficient. a better understanding of the pathophysiology of these placental vascular pathologies is necessary for the development of supported medical, obstetric and pediatric that will improve the state of health maternal and neonatal


Eligibility criteria:
inclusion criteria: * pregnant women * with or without vascular pathology exclusion criteria: * refusal to participate * multiple pregnancy * major fetal malformation diagnosed during pregnancy follow-up
a registry study of biomarkers in heart failure

Conditions: Cardiovascular Diseases

Summary: the registry study aims to discover the prognostic value of bio-markers in heart failure

the purpose of this study is to investigate the prognostic value of biomarkers in heart failure.patients with confirmed diagnosis of heart failure are enrolled.the primary outcome is all-cause mortality based on the death certificates. the secondary outcome is readmission for heart failure and all-cause mortality/readmission for heart failure according to the patients' medical records.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years at the time of admission to the hospital * with symptoms of new-onset or worsening heart failure * received or is eligible to receive a principal hospital discharge diagnosis of hf * with signs and syndromes as follows: dyspnea at rest or with minimal exertion (dyspnea, orthopnea, or edema)；rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography. * patients who received packed red blood cells, whole blood, or platelets less than 10 days before the blood sample was taken; exclusion criteria: * have objective evidence of cardiac dysfunction documented either by plasma concentrations of bnp and/or n-terminal pro-brain natriuretic peptide (nt-probnp) \<35 pg/ml or \<125 pg/ml, respectively * current known inability to follow instructions or comply with follow-up procedures. * eligible patients without informed consent form

Keywords: heart failure
laparoscopic-assisted total gastrectomy versus open total gastrectomy with splenic hilum lymph nodes dissection

Conditions: Gastric Cancer; Splenic Hilum Lymph Nodes Dissection; Total Gastrectomy

Summary: this study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy.

for advanced proximal gastric cancer, total gastrectomy with d2 lymphadenectomy is the standard surgical therapy. apparently, lymph nodes (lns) dissection along the splenic artery (no.11) and the splenic hilum (no.10) is recommended by the japanese gastric cancer treatment guidelines. nevertheless, complete removal of the no. 10 and no. 11d lns is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. however, laparoscopic-assisted total gastrectomy (latg) with standard d2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. herein, we aim to investigate the safety and feasibility of latg with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy (otg).

Eligibility criteria:
inclusion criteria: * patient with advanced proximal gastric cancer （t2-t4a,n0-n3,m0） * informed consent * eastern cooperative oncology group (ecog): 0 ot 1 * american society of anesthesiologists （asa） score: ⅰto ⅲ exclusion criteria: * pregnancy or female in suckling period * contraindication to general anesthesia (severe cardiac and/or pulmonary disease) * severe mental disease * emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor * body mass index (bmi) \> 30 kg/m2
video-based detection of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the project focuses on the evaluation of a novel, contactless monitoring technology to measure the blood pulsatile signal based on the video recording of an individual's face. the variability of the pulse rate is computed to identify the presence of atrial fibrillation (af). we propose to enroll 315 patients with symptomatic af, paroxysmal or persistent, who go through successful radiofrequency ablation or electrical cardioversion. a computer tablet will be used by the subjects at home during 14 days after their procedure to read emails, browse the internet and watch videos. facial video recordings will be automatically acquired during these daily activities by the tablet device. the subject will be wearing an ecg patch during the follow-up period. the one-lead continuous ecg will be used as a reference to verify the presence of af rhythm during facial video recordings. the primary aim of the study is to demonstrate the validity and robustness of the video-based technology to detect the presence of af when facial videos are acquired by the patients at home.


Eligibility criteria:
inclusion criteria: * men and women older than 18 years of age, * medically-managed for symptomatic af (persistent or paroxysmal), * in sinus rhythm after their ablation procedure, * in sinus rhythm after trans-thoracic electrical cardioversion. exclusion criteria: * implanted with a device (pacemaker, crt, icd) and a ventricular pacing requirement superior or equal to 70%, * known allergic reaction to adhesives or hydrogels or with a family history of adhesive skin allergies, * unable to cooperate with the protocol due to dementia, psychological, or other related reason, * refusing to sign the consent for participation, * unable to operate the device such as blind patients. * patients with parkinson disease (or other central nervous system disorder/tremor) who cannot record a stable video signal of their face. * the subject was previously enrolled in the current study. * the subject wears clothing covering the face, or uses facial makeup that will interfere with the quality of facial recordings. * subject does not have internet access at home and lacks the technology to participate.
a study of the tolerability, safety, and pharmacokinetics of isu302 in healthy volunteers

Conditions: Gaucher Disease

Summary: the purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single dosing study with three ascending dose cohorts of isu302 in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy male volunteers, aged between ≥ 20 and ≤ 45 years old * weight ≥ 50, with calculated body mass index of 17 and 25 kg/m2 * bmi = (weight \[kg\])/(height \[m\])2 * subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written * considered ineligible through screening test (such as medical history, physical examination, ecg, safety laboratory test) performed within 35 days prior to study start (dosing of investigational products) exclusion criteria: * with symptoms indicating acute diseases within 28 days prior to start of study (dosing of investigational product) * history or presence of clinically significant and active cardiovascular, respiratory, renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric disorder, autoimmune disease, or malignant tumor * any medical history that may affect drug absorption, distribution, metabolism and excretion(e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic or renal disease) * with presence of clinically significant allergic disease (including mild allergic rhinitis or allergic dermatitis which does not need medication) * with presence of clinically significant hypersensitivity to any drugs * with hemolytic anemia, anemia due to blood loss (hb \< 14g/dl and hct \<42%) * with the results of safety laboratory test 1. ast (aspartate transaminase) or alt (alanine transaminase) \> 1.5 times of upper normal limit 2. total bilirubin \> 1.5 times of upper normal limit * subject who has immune deficiency or medication with immune suppressants * participation in other clinical study within 60 days prior to start of study (dosing of investigational products) * use of any drugs, possibly affecting drug metabolizing enzymes, within 1 month prior dosing, or any drugs, possibly affecting the results of clinical trial within 10 days or use of drug was not passes 5 x half-life of drug * donated whole blood within 60 days, or transfused within 20 days before the study * history of alcohol abuse (\> 14 units/week) and the subject could not stop drinking alcohol beverage during study period * heavy smoker (\>10 cigarettes/day) or the subject could not stop smoking during study period * unwillingness or inability to follow the procedures outlined in the protocol * positive in pregnancy test in urine and unwilling to follow contraception during study period and following 3 months (for female subjects).

Keywords: gaucher disease, imiglucerase, isu302
intranasal txa for anterior epistaxis in the emergency department

Conditions: Epistaxis

Summary: the objective of this study is to evaluate the efficacy of and patient satisfaction with the use of intranasal tranexamic acid (txa) for anterior nosebleeds in the emergency department (ed).

pledget soaked in either saline or txa will be applied to the bleeding nare of the patient presenting with anterior epistaxis. after fifteen minutes, the pledget will be removed and patient reassessed. informed consent will be obtained prior to patient enrollment. enrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1ml) txa. patients will initially be asked to gently blow their nose to remove any clots. group 1 will receive the saline soaked pledget. after fifteen minutes the pledget will be removed. if patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. group 2 will receive the txa soaked pledget and the procedure will continue like group 1. patient satisfaction will be assessed in both groups during ed stay and one week after ed stay.

Eligibility criteria:
inclusion criteria: • patients 18 years and older with anterior epistaxis exclusion criteria: * patients with inability to give consent * patients without a working telephone number * patients lacking the mental capacity to make their own decisions * patients with posterior epistaxis * epistaxis following major trauma * patients with known bleeding disorder like hemophilia and thrombocytopenia * prisoners * patients hemodynamically unstable * pregnant patients * patients with a known allergy to txa * patients with a visibly bleeding vessel * those recently post-op nasal/sinus surgery (within ten days) will also be excluded
evaluation of impulsivity on cocaine and crack addicts

Conditions: Substance Dependence

Summary: this study main objective is investigating impulsivity on cocaine or crack addicts. the investigators main hypothesis is that different measures (such as scales or behavioral tasks, for example) of impulsivity may produce distinct outcomes, and they might also differ among cocaine (sniffed) and crack users. thus, it would be of great value to compare such measures once these data are often interpreted as the same phenomenon.

drug dependence is characterized by a sum of cognitive, behavioral and physiological symptoms. among these symptoms are the lack of control over ones own behavior and substance use even in face of significant issues related to it. impulsivity (expressed as impulsive choice or fail on behavioral inhibition) is important in crucial phases of drug dependence development. both behavioral and neurobiological studies have confirmed the association between impulsivity and addictive behaviors. thus a high impulsivity level might have influence on patients' treatment. even though, several questions on this matter remain unclear for humans, such as the differences on impulsivity between users of different forms of cocaine (either sniffed or smoked). this kind of difference could establish distinct ways of treatment and then enable developing better treatments for drug users. for this study it will be recruited 60 non-treated dependent patients, among them 30 cocaine users and 30 crack users. these individuals will be selected based on dsm-iv dependence criteria. the instruments used will be scales to measure compulsion and consumption of cocaine/crack, a pharmacological screening for psychotropic drugs and a cognitive evaluation. as impulsivity measures are barratt impulsivity scale (bis 11), a reward discounting questionnaire and a computer-based behavioral test on "progref v3" software. for data analysis the impulsivity measures will be compared with the behavioral and cognitive instruments through the pearson's correlation matrix. an anova will be also performed to verify any differences between cocaine and crack dependents on the impulsivity and compulsion tests. when it is appropriate subsequent newman-keuls post-hoc test will be performed. significance level adopted is 0.05.

Eligibility criteria:
inclusion criteria: * male * 18-50 years old * cocaine/ crack dependence criteria according to dsm-iv * have at least high school education level exclusion criteria: * present dependence criteria for other drugs, except for nicotine/tabacco * have any other psychiatric conditions