Kornimate/medical-research-clean huggingface dataset:
economic impact of dropless therapy versus usual care for cataract surgery: a real-world study.

Conditions: Cataract Surgery

Summary: this real-life health economics and outcome research (heor) study will enable to evaluate the economic impact of dropless therapy for the prophylactic treatment of inflammation and infection after routine cataract surgery. this prospective randomized controlled crossover open-label study will estimate resource utilization and cost attributable to patients' management following a cataract surgery and until last follow-up visit and adherence, satisfaction and preference between usual care and dropless in a real-life setting. data collected will include patients' characteristics and demographics, medical information, cataract surgery information, healthcare resource utilization, patients' adherence to topical ophthalmic medications as well as patients' satisfaction to both treatment and preference between usual care and dropless. patients will fill a set of questionnaires at their recruitment in the study and at their last follow-up visit for their two cataracts surgery.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older; 2. undergoing delayed sequential bilateral cataract extraction with intraocular lens implantation; 3. delayed sequential bilateral cataract surgery performed in a day surgery setting; 4. second cataract surgery planned within 3 months following the date of the first cataract surgery; 5. ability to read and understand english or french; 6. signature of icf. exclusion criteria: 1. patients with other ophthalmic conditions such as glaucoma, corneal disease, agerelated macular degeneration, and active uveitis\* (\*in line with current clinical practice in canada, uveitis should be inactive for 3 months to be included in the study); 2. any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation; 3. participation in any investigational ophthalmic-related drug or device trial within the 30 days prior to the start date of this trial or participation in any current investigational ophthalmic-related drug or device trial; 4. patients with any history of allergy to the usual care post-operative eye drops or the components of dropless.

Keywords: sequential bilateral cataract surgery
laparoscopic complete mesocolic excision on colon cancer

Conditions: Operation Finding; Complications; Pathology; Quality of Life; Neoplasms Recurrence

Summary: laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery technique to perform a resection for colon cancer. besides, the segment of the colon containing the tumor, the resection area should include an intact mesocolon as an envelope to encase the possible route for metastasis. the routes include blood vessels, lymphatic drain and etc. such hypothesis predicts better histopathological and higher oncological results which turns into better survival rate and better quality of life.


Eligibility criteria:
inclusion criteria: * patients with pathologically confirmed colon cancer * signed consent exclusion criteria: * history of malignancy * intestinal obstruction or perforation * evidence of metastasis by preoperative examinations * deformity of spine * emergency case * bmi \> 29
safety & efficacy of icl670 vs. deferoxamine in beta-thalassemia patients with iron overload due to blood transfusions

Conditions: Beta-Thalassemia

Summary: the purpose of this study is to deterimine if the new orally active iron chelator, icl670, is as effective and as safe as deferoxamine in preventing accumulation of iron in the body while a patient is undergoing repeated blood transfusions.

patients who require repeated blood transfusions to live accumulate iron in the body as blood cells contain iron and there is no natural body mechanism to eliminate it. after a while the iron levels get high enough to be toxic to the body. the current therapy of choice is deferoxamine, which does a good job of removing excess iron, but is difficult to administer. deferoxamine requires subcutaneous (under the skin) infusions over 4 to 8 hours nightly 3 to 7 nights per week. in addition to the need to wear an infusion pump nightly, adverse reactions around the site of the injection are frequent.

Eligibility criteria:
inclusion criteria: * beta-thalassemia patients already treated with or suitable for treatment with deferoxamine 20 to 40 mg/kg/day * liver iron content greater than 2 mg iron/g dw as measured by liver biopsy * need for regular transfusions 8 or more times per year exclusion criteria: * non-transfusional iron overload or transfusion-dependent anemias other than beta-thalassemia. * documented toxicity to deferoxamine * elevated liver enzymes in the year preceeding enrollment * active hepatitis b or hepatitis c * hiv seropositivity * elevated serum creatinine or significant proteinuria * history of nephrotic syndrome * uncontrolled systemic hypertension * fever and other signs/symptoms of infection within 10 days prior to start of the study * presence of clinically relevant cataract or previous history of clinically relevant ocular toxicity related to iron chelation * second or third degree av block, clinically relevant q-t interval prolongation, or patients requiring digoxin or other drugs that prolong the q-t interval * diseases (cardiovascular, renal, hepatic, etc.)that would prevent the patient from undergoing any of the treatment options * psychiatric or additive disorders that would prevent the patient from giving informed consent * history of drug or alcohol abuse within the 12 months prior to the study * pregnant or breast feeding patients * patients treated with systemic investigational drugs within 4 weeks or topical investigational drugs within 7 days before the start of the study * any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug, such as gastrointestinal disease or major surgery, renal disease, difficulty voiding or urinary obstruction, or impaired pancreatic function. * non-compliant or unreliable patients. * patients unable to undergo any study procedures such as the hearing or eye tests, or the liver echocardiography. * inability to undergo a liver biopsy. * patients that would need a dose of icl670 less than 125 mg per day.

Keywords: thalassemia, iron overload, deferoxamine, hemosiderosis
safety and efficacy of autologous human schwann cell (ahsc) augmentation in severe peripheral nerve injury (pni)

Conditions: Peripheral Nerve Injury

Summary: the primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.


Eligibility criteria:
inclusion criteria: 1. persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year; 2. between the ages of 18 and 65 at last birthday exclusion criteria: 1. persons unable to safely undergo an mri; 2. persons with pre-existing conditions that would preclude satisfactory sural nerve harvest; 3. persons with severe peripheral nerve injury gap length \> 10 cm; 4. persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve; 5. pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment; 6. presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study; 7. history of active substance abuse; 8. persons allergic to gentamicin; 9. persons who test positive for hiv or hepatitis b or c virus. 10. persons unable to provide consent independently due to cognitive impairment
testing response bias on sensitive topics in self- versus enumerator-administered surveys

Conditions: Bias, Implicit

Summary: within a survey of adolescent males in medellin schools (mainly 13-year old boys) the researchers are randomizing whether survey respondents answer sensitive questions themselves or are asked the questions by an enumerator. questions are of three main varieties: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.


Eligibility criteria:
inclusion criteria: * all male students in seventh grade in a sample of public schools are eligible. the sample corresponds to a representative sample of public schools (we aim at 90 schools) exclusion criteria: * female students or students not in seventh grade
study to evaluate cort125134 in participants with cushing's syndrome

Conditions: Cushing's Syndrome

Summary: cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels of the glucocorticoid hormone cortisol. cushing's syndrome may result from elevated endogenous or exogenous sources of cortisol. endogenous cushing's syndrome resulting from cortisol overproduction by the adrenal glands is the subject of this protocol. patients with exogenous cushing's syndrome, which develops as a side effect of chronic administration of high doses of glucocorticoids, were not eligible for enrollment in this study. the purpose of this study was to evaluate the safety and efficacy of cort125134 for treatment of endogenous cushing's syndrome. the multicenter study was conducted in the united states and in europe.

this was a phase 2, open-label study with two dose groups, each with a two-step dose escalation, designed to evaluate the safety and efficacy of cort125134 for the treatment of endogenous cushing's syndrome. cort125134 was administered orally once daily for 16 weeks with dose escalations occurring every 4 weeks. pharmacokinetics (pk) profiles were generated at every dose level. a data review committee reviewed pk and safety data and recommended the final plan for dose escalation in group 2.

Eligibility criteria:
inclusion criteria: 1. has a confirmed diagnosis of endogenous cushing's syndrome. 2. requires medical treatment of hypercortisolemia. 3. meets at least one of the following criteria: 1. has type 2 diabetes mellitus. 2. has impaired glucose tolerance. 3. has hypertension. exclusion criteria: 1. has non-endogenous source of hypercortisolemia 2. has uncontrolled, clinically significant hypothyroidism or hyperthyroidism 3. has poorly controlled hypertension 4. has stage ≥ 4 renal failure

Keywords: cushing's syndrome cushing's disease cushing's hypercortisolemia cushingoid type 2 diabetes impaired glucose intolerance hypertension adrenal corticotrophic hormone (acth) adrenocortical carcinoma primary pigmented nodular adrenal disease (ppnad) moon facies dorsocervical fat pad adrenal adenoma adrenal carcinoma adrenal autonomy cortisol
predicting rotator cuff tears outcomes after physical therapy treatment

Conditions: Rotator Cuff Injuries

Summary: the aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with full-thickness rotator cuff tears, after a physical therapy treatment based on therapeutic exercise and education.

a multivariable prediction model for the improvement in shoulder pain and disability will be developed based on the following predictors: * body mass index \[kg/m2, fractional polynomials fp2\]. * smoking \[years, linear relationship\]. * employment status \[3 categories\]. * maximum education degree \[4 categories\]. * previous performance of physical exercise \[2 categories\]. * baseline disability (measured with the shoulder pain and disability index) \[fractional polynomials fp2\]. * baseline pain intensity (measured with a numeric pain rating scale) \[fractional polynomials fp2\]. * pain duration \[weeks, linear relationship\] * pain catastrophizing (measured with the pain catastrophizing scale) \[linear relationship\]. * patient's expectations (measured with the musculoskeletal outcomes data evaluation and management system) \[linear relationship\].

Eligibility criteria:
inclusion criteria: * full-thickness supraspinatus rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging. * pain during resisted abduction and/or external rotation. * pain intensity equal or greater to 3 points on a numeric pain rating scale, or a degree of disability equal or greater to 15% on the shoulder pain and disability index. * pain lasting for at least 3 months. * adequate comprehension of written and spoken spanish exclusion criteria: * loss of passive external rotation at 0º of shoulder abduction equal or greater to 50% compared to contralateral side. * suspected neck-related shoulder pain. * suspected visceral-related shoulder pain. * sings or symptoms of shoulder instability, including dislocations and/or subluxation within the last year. * humerus and/or scapular fractures within the last year. * previous rotator cuff repair surgery within the last year. * presence of cancer, fibromyalgia, neurological and/or other systemic diseases. * cognitive impairment that makes it impossible to perform therapeutic exercise.

Keywords: physical therapy rotator cuff full-thickness tear exercise education prediction model
shifting brain excitation-inhibition balance in autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: this study investigates brain response to single acute dose of cannabidiol, cannabidivarin, and placebo in healthy men with and without autism spectrum disorder

previous research suggests that cannabidiol (cbd) and cannabidivarin (cbdv) could have the potential to shift brain excitation and inhibition (e-i) in the healthy brain and in neurodevelopmental psychiatric conditions, where this balance is disrupted, such as autism spectrum disorder (asd). however, no study to date has investigated this. therefore, in this study, we invited 20 healthy men with and without asd. each participant received each drug once (600mg cbd/cbdv, or matched placebo) and magnetic resonance imaging was used to obtain measures of brain biochemistry, activity, and connectivity. we further obtained questionnaires, task data, saliva, urine and blood samples, and conducted visual tasks using eye tracking, electroencephalography, and retinal imaging.

Eligibility criteria:
inclusion criteria: * men * pass diagnostic threshold for asd on the adi-r (if informant is available) * currently symptomatic on ados * age 18-50 years * can give informed consent * iq\>70 (on a standard instrument such as wasi) * medication-free in the month preceding participation (but regular medication with drug, which does not affect glutamate or gaba directly may be permitted) * willing to provide urine samples to screen for use of illicit substances prior to each scan exclusion criteria: * iq\<70 * history of psychosis, co-morbid major mental illness, significant physical illness (heart disease, high blood pressure, seizures) * habitual substance misuse (including alcohol) * known allergy to cannabis * asd caused by a known genetic syndrome e.g. fragile x or 22q11 deletion syndrome, * past/present treatment for epilepsy * women will be excluded from this pilot study to reduce heterogeneity in a small sample; avoid the issues around exposing women of reproductive age to a drug; and because pregnancy is a routine exclusion criteria for research mri. lastly, asd is more common in men.

Keywords: cannabidiol cannabidivarin e-i balance pharmacological imaging
endovascular management of direct carotid-cavernous fistula

Conditions: Carotid-Cavernous Sinus Fistula

Summary: carotid-cavernous fistula (ccf) refers to an aberrant arteriovenous communication between the carotid arterial system and the venous compartments of the cavernous sinus (cs) direct ccfs are when there is a direct fistulous connection between the cavernous sinus and cavernous segment of the internal carotid artery (ica), it is called direct or type-a ccf and occur secondary to a traumatic tear in the artery from a skull base fracture, from the acceleration-deceleration force of a traumatic injury, or from an iatrogenic injury following an endovascular intervention or a trans-sphenoidal procedure. they can also occur spontaneously following an ica aneurysm rupture or weakening of the arteries from a genetic condition with subsequent development of chemosis, proptosis, bruit, headache, and/or gradual decrease in vision either unilaterally or bilaterally. high incidence of motor car accidents in egypt carries a relative high incidence of carotid cavernous fistula. since direct (type a) ccfs are high flow fistulas with acute/ subacute presentation and may cause serious complications, such as permanent vision loss or intracranial hemorrhage, they have to be treated early. ct orbit and mri often help to confirm the initial diagnosis of ccf demonstrating extraoccularmuscleenlargement,dilatationofoneorbothsuperiorophthalmic veins and enlargement of the affected cavernous sinus.because of its high spatial and temporal resolution ; the gold standard for evaluation of ccf is digital subtraction angiography; but currently ct angiography is the non invasive modality of choice for its evaluation .previously surgical intervention included suturing or clipping the fistula, packing the cavernous sinus or ligating the internal carotid artery procedures .currently endovascular management is the main stay of treatment for patients that fail or not suitable for conservative management and compression therapy. significant advances in stent and catheter design now make it possible in many instances to deploy covered stents , detachable balloons, detachable coils, both detachable balloons and coils , both detachable and push coils , parent arterial occlusion and using of embolizing materials depending on availability, patient's affordability, type of fistula, and ease of use.trans femoral catheterization is the main approach. however, trans-radial approach will be considered in patients with advanced iliofemoral diseases


Eligibility criteria:
inclusion criteria: * patients with direct type of carotid cavernous fistula exclusion criteria: * end stage renal disease * haemodynamically unstable patients. * patients with impaired coagulation profile.
prevention of contrast nephropathy during diagnostic coronary angiogram or pci with hydratation based on levdp

Conditions: Radiographic Contrast Agent Nephropathy; Renal Failure; Coronary Heart Disease

Summary: the goal is to determine if prehydration based on levdp is superior to a standard hydratation with nacl 0.9% or nahco3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to pci.

the goal is to determine if prehydration based on levdp is superior to a standard hydratation, independant of volemic status, with nacl 0.9% or nahco3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to pci.

Eligibility criteria:
inclusion criteria: * minimum 18 years old * chronic renal insufficiency with a calculated creatinine clearance below 60 cc /min. (estimated with the mdrd formula) * hemodynamically stable exclusion criteria: * acute renal failure or in recuperation of acute renal failure * urgent coronary angiogram * moderate to severe valvulopathy or presence of a valvular prosthesis * diagnostic of multiple myeloma * dialysis before test * having had a test with contrast product in the 2 weeks preceding * receiving a nephrotoxic in the last month.

Keywords: coronary angiogram percutaneous coronary intervention
pharmacokinetic study of laf237 and its metabolites in mild renal impaired patients

Conditions: Type 2 Diabetes Mellitus

Summary: this study will evaluate the pharmacokinetics of vildagliptin (laf237) and its metabolites in patients with mild renal impairment compared to their sex, age and weigh based healthy volunteer counterparts.


Eligibility criteria:
inclusion criteria: * age from 18 to 75 years of age (inclusive). * male, non-fertile female or female of childbearing potential using a medically approved birth control method. * body mass index (bmi) ≤42 kg/m2 (inclusive) at screening. * able to provide written informed consent prior to study participation. * able to communicate well with the investigator and comply with the requirements of the study. for renal insufficient patients only * patients must have stable renal disease without evidence of renal progressive disease * if patient is diabetic, must be treated with standard anti-diabetic therapy andmust agree to continue their anti-diabetic therapy throughout the duration of the study. * if patient is diabetic, must be on a stable dose of standard anti-diabetic therapy or diet and exercise regimen over the past 4 weeks prior to screening. for healthy subjects only * no current significant medical conditions as determined by history and physical. * a serum creatinine with a calculated crcl of \>80 ml/min. * matched to renal impaired patients (group a) undergoing study by age (±5 years), sex and weight (±10% bmi). exclusion criteria: subjects meeting any of the following criteria during screening or baseline evaluations will be excluded from entry into or continuation in the study: * pregnant or lactating female. * a history of certain disorders as specified in the protocol. * subjects that have been enrolled in a laf237 (vildagliptin) study or other dpp-4 inhibitor studies six months prior to baseline. * history of renal transplant at any time in the past and on immunosuppressant therapy. * acute infections which may affect blood glucose control within 4 weeks prior to screening and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study. * certain electrocardiogram (ecg) abnormalities: * malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years. * liver disease such as cirrhosis or positive hepatitis b and c. * any alcohol related hepatic disease. * patients undergoing any method of dialysis (hemodialysis or peritoneal dialysis) * concurrent medical condition that may interfere with the interpretation of safety and tolerability data during the study. * use of certain medications as specified in the protocol. * laboratory abnormalities as defined by the protocol * history of active substance abuse (including alcohol) within the past 2 years. * smokers defined as any subject who reports heavy cigarette use (i.e., 10 or more cigarettes per day). urine cotinine will also be measured and recorded at screening and baseline. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: type-2 diabetes, dpp-4 inhibitor, vildagliptin
follow-up study of the effectiveness of virtual reality therapy in ms patients

Conditions: Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Primary Progressive

Summary: different therapies can improve clinical and motor symptoms of multiple sclerosis (ms) similarly, but studies comparing the effects of different exercise therapies on clinical and motor outcomes are scant. we compared the effects of exergaming (exe), balance (bal), cycling (cyc), proprioceptive neuromuscular facilitation (pnf), and a standard care wait-listed control group (con) on clinical and motor symptoms and quality of life (qol) in people with ms (pwms). methods: pwms (n = 68, 90% female; age, 47.0 yr; expanded disability status scale score 5-6) were randomized into five groups. before and after the interventions (five times a week for 5 wk), pwms were tested for ms-related clinical and motor symptoms (multiple sclerosis impact scale-29 (msis-29), primary outcome), qol (euroqol five dimensions questionnaire), symptoms of depression, gait and balance ability (tinetti assessment tool), static and dynamic balance and fall risk (berg balance scale), walking capacity (6-min walk test), and standing posturography on a force platform. patients were followed up for 2 years after 5 weeks of intensive care. tests are performed every six months.


Eligibility criteria:
inclusion criteria: * multiple sclerosis * instability problem exclusion criteria: • severe heart problems, severe demeanor, alcoholism, drug problems

Keywords: multiple sclerosis posture neurorehabilitation balance