Kornimate/medical-research-clean huggingface dataset:
edof iols vs monofocal iol

Conditions: Cataract

Summary: prospective, comparative (3 arms), randomized, multicentric clinical trial


Eligibility criteria:
inclusion criteria: * patient informed of the consequences and constraints of the clinical investigational plan and who has given his/her written informed consent; * patients of any gender, aged 50 to 80 years; * assured follow-up examinations; * clinically significant bilateral cataract; exclusion criteria: * patients unable to meet the limitations of the clinical investigational plan or likely of non-cooperation during the trial; * patients whose freedom is impaired by administrative or legal order; * current participation in another drug or device investigation; * ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logmar (corrected) or worse in either eye * any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.) * pseudoexfoliations syndrome * pathologic miosis or pharmacotherapy with miotic agent * keratoconus * chronic or recurrent uveitis * diabetic retinopathy * uncontrolled glaucoma and or iop\>24mmhg * choroidal hemorrhage, * all kind of infections (acute ocular disease, external/internal infection, systemic infection) * traumatic cataract * aniridia * microphthalmia * amblyopia * degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders) * patient expected to require retinal laser treatment before the end of the 4-6 months follow-up * previous intraocular and corneal surgery * expected postop. astigmatism greater than 1 d * any type of corneal disorder * systemic or ocular pharmacotherapy, which can impact the visual acuity, * former, current or foreseeable application of tamsulosin or silodosin (e.g. flomax, flomaxtra, rapflo) ) which potentially can cause the floppy iris syndrome, insufficient dilation, or missing of appropriate iris structures which can compromise the standard procedure according to the investigator's opinion * patients who are unable to fixate for longer time (e.g. strabismus, nystagmus) * dementia * pregnancy or lactation period for female patients
a study to evaluate the immune response to the asp7374 and its safety in healthy adult volunteers

Conditions: Healthy; Immunogenicity of ASP7374

Summary: this trial is designed as a blinded, randomized and parallel group study to investigate the clinically recommended dosage for asp7374 based on the comparison of the immunogenicity and safety among two doses of subcutaneous asp7374 and one dose of intramuscular asp7374 in healthy adults.


Eligibility criteria:
inclusion criteria: * body weight: female: ≥40.0 kg, \<70.0 kg, male: ≥50.0 kg, \<80.0 kg * bmi: ≥17.6, \<26.4 * healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained exclusion criteria: * scheduled to receive another vaccine during study participation period * received influenza vaccine within 180 days prior to the study * received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine * diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome * past history of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥ 39.0°c within 2 days after the previous vaccination (influenza vaccine and others) * female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period

Keywords: recombinant influenza hemagglutinin vaccine
antibiotherapy during therapeutic hypothermia to prevent infectious complications

Conditions: Ventilator-associated Pneumonia; Cardiac Arrests With Shockable Rhythm; Mild Therapeutic Hypothermia; Preventive Antibiotics

Summary: mild therapeutic hypothermia is currently recommended in management of cardiac arrests with shockable rhythm. in mechanically ventilated patients who were resuscitated after out-of-hospital cardiac arrests, mild therapeutic hypothermia side effects are conductive for infectious complications and especially for ventilator-associated pneumonia (vap). despite high incidence of vap and other infectious complications, it is not currently recommended to use antibiotic prophylaxis on the responsible germs. yet vap incidence could be decreased if an antibiotic therapy was systematically given to patient treated with mild therapeutic hypothermia after a cardiac arrest. several retrospective studies showed less infectious complications but also decreased morbidity and mortality related to these complications when antibiotic therapy was given early to patients treated with therapeutic hypothermia after cardiac arrest.

multicenter add-on randomized controlled double-blind trial assessing the efficacy of preventive antibiotics amoxicillin-clavulanic acid vs placebo to prevent occurrence of early vap after out-of-hospital cardiac arrest receiving mild therapeutic hypothermia, in addition to usual vap prevention measures.

Eligibility criteria:
inclusion criteria: * older than 18 years-old, intubated and mechanically ventilated after out-of-hospital resuscitated cardiac arrest secondary to shockable rhythm * hospitalized in an icu * mild therapeutic hypothermia procedure (32° to 35°c) scheduled (24 to 36 hours) * delay from rosc to randomisation \< 6 hours * consent from family members or emergency consent exclusion criteria: * pregnancy * out-of-hospital cardiac arrest secondary to non shockable rhythm and in-hospital cardiac arrest * need for cardiac support by cardiopulmonary bypass * ongoing antibiotic therapy or during the week before * ongoing or concomitant pneumonia * known chronic colonization with mrb * hypersensitivity to the active substances, to any of the penicillins or to any of the excipients. * history of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam). * history of jaundice/hepatic impairment due to amoxicillin/clavulanic acid, according to the latest version of the smpc. * previous lung disease * predictable decision of early care limitation * patient under guardianship or curatorship * moribund patient * participation to another trial within 30 days

Keywords: ventilator-associated pneumonia cardiac arrests with shockable rhythm mild therapeutic hypothermia preventive antibiotics
trabeculectomy with mmc and i stent in uveitic glaucoma and poag : outcomes and prognostic factors

Conditions: Outcomes of Trabeculectomy With MMC

Summary: 1. determine whether cataract surgery has a major effect on outcomes of trabeculectomy with mmc or not. 2. success rates of trabeculectomy with mmc in queen elizabeth hospital. 3. recurrence rate of uveitis after glaucoma surgery

1. determine different success rates of trabeculectomy with mmc undergone in qe hospital, uk. 2. determine different complications and effect of cataract surgery on the outcome of glaucoma surgery

Eligibility criteria:
inclusion criteria: * fesh trabeculectomy surgeries exclusion criteria: * recurrent surgeries
metoclopramide on gastric emptying in mechanically ventilated patients

Conditions: Gastric Emptying; Mechanically Ventilation; Randomized Controlled Trial; Metoclopramide

Summary: the aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric emptying in critically ill mechanically ventilated patients .

more than 50% of patients in icu have gastric dysmotility, which leads to slow gastric emptying(ge) and high gastric residual volume (grv) and is associated with increased mortality in these patients

Eligibility criteria:
inclusion criteria: 1. patients' age 20 - 60 years. 2. either gender. 3. mechanically ventilated head trauma patients. 4. patients receiving enteral feeding via nasogastric tube. exclusion criteria: 1. patients with contraindications to enteral feeding. 2. patients with extrapyramidal manifestations. 3. patients with known allergy to metoclopramide. 4. patients with seizures. 5. patients with renal or hepatic diseases.
trk-100stp phaseii clinical study -chronic renal failure (primary glomerular disease/nephrosclerosis)

Conditions: Renal Insufficiency, Chronic

Summary: the purpose of this study is to determine the recommended dose of the sustained-release form of bps (trk-100stp low dose or high dose) in japanese patients with crf (primary glomerular disease/nephrosclerosis).


Eligibility criteria:
inclusion criteria: * the crf patient with primary glomerular disease or nephrosclerosis as the primary disease * the patient with progressive crf exclusion criteria: * the patient with secondary glomerular disease * the patient with crf caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis

Keywords: chronic renal failure prostaglandin prostacyclin glomerular disease; nephrosclerosis
effectiveness of aripiprazole long-acting injection in recent onset and chronic schizophrenia patients

Conditions: Schizophrenia

Summary: the aim of the study is to investigate the effectiveness of aripiprazole long-acting injection in recent onset and chronic schizophrenia patients

the aim of this study is to investigate the effectiveness of aripiprazole long-acting injection in recent onset and chronic schizophrenia patients

Eligibility criteria:
inclusion criteria: * patients diagnosed with schizophrenia according to dsm-5 diagnostic standards * men and women aged 19 and under 60 * a person who is being given an atypical antipsychotic. * patients should be able to reasonably cooperate with the questionnaire to be used for the study * a person who fully understands the purpose of the study and signs the consent * stable outpatient before screening without changing the volume of antipsychotics for at least two weeks exclusion criteria: * a person who has a serious and unstable physical condition either now or in the past * a fertile woman who is currently pregnant or breastfeeding, or who is either unwilling or unable to use acceptable contraception until the clinical trial is complete. * a person suffering from severe drug allergies or complex and severe drug reactions * patients who have taken clozapine in the last 60 days * subjects showing significant risk of suicide or significant risk of violent behavior based on past history or investigator's judgment

Keywords: aripiprazole long-acting injection
safety and immunogenicity of a monovalent mrna vaccine encoding influenza hemagglutinin in adult participants 18 years of age and older

Conditions: Influenza; Influenza Immunization

Summary: the purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (im) injection of different dose levels of messenger ribonucleic acid (mrna) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (riv4) in adults 18 years of age and older. study details include: study duration: approximately 6 months treatment duration: 1 injection of mrna vaccine encoding influenza hemagglutinin encoding influenza hemagglutinin or control. visit frequency: screening visit, day 01, day 02, day 03, day 09, day 29, day 91, day 181

approximately 6 months

Eligibility criteria:
inclusion criteria: * having given written informed consent prior to undertaking any study-related procedure. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * any subject who, in the judgment of the investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
genetic analysis of familial hypertrophic cardiomyopathy

Conditions: Cardiovascular Diseases; Heart Diseases; Myocardial Diseases; Cardiomyopathy, Hypertrophic

Summary: to map the genetic defect responsible for familial hypertrophic cardiomyopathy.

background: familial hypertrophic cardiomyopathy is a disease of heart muscle that is genetically transmitted as an autosomal dominant trait, with a high degree of penetrance. affected individuals typically have asymmetric thickening of the interventricular septum often involving the adjacent left ventricular free wall. histologically, myocardial cells are enlarged and muscle bundles are grossly disorganized, producing a whorled pattern. the physiologic consequence of this cardiomyopathy is diastolic dysfunction with impaired ventricular relaxation and elevated diastolic pressures in the heart and pulmonary vasculature. patients can experience dyspnea, angina, palpitations, and syncope. complications of the disease include atrial fibrillation, congestive heart failure, thromboembolism, and most importantly, sudden death. design narrative: the three kindreds studied included one in iceland, one in the st. lawrence region in canada, and one in the pittsburgh, pennsylvania area. pedigrees were established for the three kindreds. all family members were clinically evaluated by physical exam, electrocardiogram, and comprehensive m-mode and two-dimensional echocardiography. lymphoblastoid cell lines were derived from all members of the three pedigrees. restriction fragment length polymorphism analyses were used to identify a dna probe that was linked to familial hypertrophic cardiomyopathy. studies were conducted to determine if the familial hypertrophic cardiomyopathy locus was the same in all three kindreds and to identify the gene responsible. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
in vivo evaluation of the physiological effects of arabinoxylan-oligosaccharides (axos) in healthy subjects (adults)

Conditions: Healthy

Summary: the investigational study product used in this clinical trial is a soft drink containing an arabinoxylan-oligosaccharides (axos) preparation extracted from wheat bran (hereafter called wheat bran extract, wbe). the objective of this study is to analyze the effect of the intake of two wbe doses on various parameters of gastrointestinal health. additionally, safety was analyzed using treatment emergent adverse events (aes) and clinical blood parameters.


Eligibility criteria:
inclusion criteria: * male or female 18-90 years of age, inclusive * regular eating habits * body mass index (bmi) between 18.5 and 30 kg/m2 * consent to take in the study product according to the study protocol * subject is willing to maintain his or her habitual food and beverage intake throughout the study period (with the exception of omission of prebiotic and probiotic food products as indicated in the study protocol) * for female volunteers of childbearing potential: not planning to become pregnant during the clinical trial and willing to commit to the use of a medically approved form of contraception exclusion criteria: * low-calorie diet or other extreme dietary habits in the 6 weeks before the start of the clinical trial * recent use of antibiotics * abdominal surgery in the past * serious illness within 3 months of start of clinical trial * use of medication or dietary supplements known to influence gi tract within two weeks of start of clinical trial. examples of such medication/dietary supplements are antispasmodics, anti diarrhea medication and/or probiotic medication * complete anesthetics within 1 month of the start of the clinical trial * chronic gi conditions such as inflammatory bowel disease (ibd), inflammatory bowel syndrome (ibs), chronic constipation, history of frequent diarrhea, clinically important lactose intolerance * allergy for wheat products * celiac disease * for female volunteers: pregnant or lactating * alcohol abuse * smoking more than 5 cigarettes per day * subject has a condition the investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the subject at undue risk.

Keywords: gastrointestinal health healthy subjects
development and validation of a driving simulator for evaluating the residual effects of drugs on driving performance - sensitivity analysis using zopiclone as a positive control

Conditions: Healthy Participants

Summary: the purpose of this study is to confirm of assay sensitivity of driving simulator by positive control


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥18.5 and \<25.0 kg/m\^2 at screening inspection * no visual impairment (enable to correct the vision with eyeglasses or contact lens) * receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study * other protocol defined inclusion criteria could apply exclusion criteria: * history of drug and food allergy * hypersensitivity to zopiclone * inappropriate for enrollment in this study was judged by principal investigator or subinvestigator * other protocol defined inclusion criteria could apply
a study to evaluate the safety and efficacy of an investigational diabetes drug in poorly controlled type ii diabetics

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have type ii diabetes mellitus with very high hba1c or fpg (fasting plasma glucose) levels. the hba1c test, also called the hemoglobin a1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. fpg is a test that measures the amount of sugar in the blood after an 8 hour fast.


Eligibility criteria:
inclusion criteria: * laboratory result for hba1c \>11% or fpg \>270mg/dl * clinical diagnosis of type ii diabetes * prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin. exclusion criteria: * women who are pregnant

Keywords: hyperglycemia hba1c hemoglobin a1c type 2 diabetes mellitus
phase ii study of dose-dense doxurubicin and cyclophosphamide (ac) followed by paclitaxel with trastuzumab in her2/ neu-amplified breast cancer: feasibility

Conditions: Breast Cancer

Summary: her-2/neu (+) breast cancer is a more aggressive form of breast cancer. her-2/neu is a protein that is overproduced by your tumor. it makes your cancer more aggressive. standard treatments for this type of cancer will help some people, but there is a moderate to high chance that your cancer may come back. the purpose of this study is to see if a new regimen will be effective in preventing cancer from coming back. this is a phase ii trial. in this trial, patient get a drug regimen that has been tested in small groups of people to see what dose is safe. researchers now wish to see how effective the drug is for her-2/neu (+) breast cancer. the objective includes looking at short-term side effects and risks of the drug. all of the drugs on this regimen can affect the heart which can be a serious side effect. the drugs affect on heart function is a primary focus.


Eligibility criteria:
inclusion criteria: * adenocarcinoma breast cancer * ecog performance status of 0 or 1 * peripheral neuropathy less than or equal to 1 * discontinued hormonal therapy as a chemoprevention while onstudy * lvef by muga \> 55%? * absolute neutrophil count (anc)\> 1000/µl) * platelet count \> 100,000/µl) * sgot or sgpt \< 92.5 units/l exclusion criteria: * stage iv breast cancer * any chemotherapy, radiation therapy, immunotherapy, or biotherapy for a current breast cancer * pregnant or lactating patients * active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer * previous allergy/hypersensitivity to doxorubicin, cyclophosphamide, paclitaxel, or other drugs formulated in cremophor el? * unstable angina, congestive heart failure, current use of digitalis, beta-blockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or a history of a myocardial infarction within 12 months * psychiatric illness that prevents her from understanding the nature of this study and complying with protocol requirements? * active, unresolved infections * sensitivity to e. coli derived proteins * prior chemotherapy with an anthracycline * prior herceptin therapy

Keywords: breast cancer adenocarcinoma of the breast cardiac safety breast cancer patients seen at the memorial sloan-kettering cancer center
using nanotechnology structured water to control blood glucose in type 2 diabetic patients.

Conditions: Type2 Diabetes

Summary: type 2 dm is due to insulin resistance or low insulin secretion or sometimes a combination of both. nanotechnology structured water is a type of water that is produced using energy field modulators to change the biological, chemical, and physical properties of water molecules and improve the bioavailability of this nano-water. objective: to find out the effect of drinking nanotechnology structured water (magnalife®) on the blood glucose levels in patients with type 2 diabetes mellitus.

this is a blind randomized control trial, according to consort guidelines for randomization, "participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups.", that included 387 patients with type 2 diabetes mellitus in diabetes care center, sulaymaniyah, kurdistan region from july 2016 till february 2018. a total of 387 patients with type 2 diabetes who were patients in this center and agreed to participate in this clinical trial were included in this study. in group a, patients were given nanotechnology structured water magnalife® and in group b they were given ordinary bottled drinking water as a control . the bottles were unlabeled so that the patients did not know which water they were drinking. then they were asked to eat their usual food and to drink their usual drinks, also they could drink water ad libitum after drinking the daily doses, and to have the same physical activities that they used to do in their usual daily life. they were instructed to take their medications as usual, and were told to come to test their blood sugar level at the end of the third month to get the hba1c tested at the end of the three months of drinking the water.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients exclusion criteria: * malignancy * steroids * immunotherapy * chemotherapy * radiotherapy * chronic infections * drugs that antagonize or synergies insulin effects

Keywords: nanotechnology water hba1c type 2 diabetes mellitus