Kornimate/medical-research-clean huggingface dataset:
a (prospective/pilot) study evaluating the effect of cataract surgery on the daily activity levels of elderly patients

Conditions: Cataract; Diabetes; Hypertension; Obesity; Vision Disability

Summary: to evaluate the effect of bilateral cataract surgery with intraocular lens implantation on the daily activity levels of elderly patients.

cataract formation is a natural aging process that can be influenced by environmental factors such as exposure to ultra violet light and diet. additionally, metabolic disorders, such as diabetes can lead to an earlier development of cataracts. as cataracts develop, a patient's vision can be affected. reduced vision can limit activities of daily living and may even reduce a patient's mobility. when this occurs, cataract surgery should be considered to help restore a patient's vision. with the obesity and diabetic epidemic, proper diet and exercise is a major health initiative to control these diseases. if a patient's mobility is reduced as a result of poor vision - their ability to achieve adequate daily physical activity may also be effected. it is thought that improvement in vision may increase their activity levels and help combat these health issues. this study will investigate the activity level of patients before and after undergoing cataract surgery to determine how improved vision quality from removal of the natural lens inside the eye and replacement with an artificial intraocular lens effects their activity level.

Eligibility criteria:
inclusion criteria: * patients undergoing bilateral cataract extraction by phacoemulisficatin with intraocular lens implantation and a planned bilateral distance vision target or patients with bilateral cataracts who are not having cataract surgery * patients aged 60 years old or older * best corrected visual acuity worse than 20/20 in each eye (meaning 20/25 or worse) * non-comanged patients exclusion criteria: * greater than 0.76 d pre-operative corneal cylinder, if having cataract surgery without a planned astigmatism correction (i.e limbal relaxing incision or toric intraocular lens) * planned implantation of a multifocal intraocular lens * visual field defect which may reduce mobility * wheel chair bound patients * reduced vision from an ocular disease other than cataracts * patients with significant dementia who are not able to fully comprehend the informed consent
a phase i dose-finding trial of hyperthermic intraperitoneal paclitaxel combined with cisplatin

Conditions: Ovarian Cancer; Hyperthermic Intraperitoneal Chemotherapy; Paclitaxel

Summary: primary objective of this trial is to identify the maximum tolerated dose (mtd) of paclitaxel combined with a fixed dose of cisplatin (75 mg/m2) delivered as hyperthermic intraperitoneal chemotherapy (hipec) in patients with ovarian cancer. in this single-center phase i trial, bayesian optimal interval design (tite-boin) was used. the starting dose for paclitaxel was 175 mg/m2, with escalation in 25 mg/m2 increments until the mtd was determined or the maximum dose level of 225 mg/m2 was reached. the target dose-limiting toxicity (dlt) rate was 25%, and the total sample size was 30 patients.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years; * adequate renal function (blood creatinine: 58-96 µmol/l), bone marrow function (hemoglobin ≥ 110 g/l, white cell count ≥ 4.0 ×109/l, neutrophil count ≥ 2.0 × 109/l, platelet count ≥ 100 × 109/l) and hepatic function \[bilirubin 3.4-22.2 µmol/l, alanine aminotransferase (alt) 7-40 u/l, aspartate aminotransferase (ast) 13-35 u/l, ast/alt≤ 1.5\]. exclusion criteria: * patients who had been treated with cisplatin or paclitaxel for any reason within 3 weeks prior to hipec. * a history of hipec treatment
use of a point-of-care platelet function assay for the prediction of atherothrombotic events

Conditions: Coronary Artery Disease

Summary: 1. to evaluate the role of verifynow test as prognostic marker in routine clinical practice using drug-eluting stents. 2. to determine the add-on-effect of verifynow test beyond on conventional risk factors (clinical, lesions, or procedural factors). 3. to compare the prognostic utility of verifynow test with several biomarkers.

predictive role of a point-of-care assay (verifynow test) has not been well evaluated in large number of patients receiving drug-eluting stents as a routine practice. in addition, additional predictive effect of a point-of-care assay, as compared to conventional clinical factors or other biomarkers, might be clinically interesting and important.

Eligibility criteria:
inclusion criteria: * consecutive patients with established coronary artery disease receiving pci with stent implantation exclusion criteria: * cardiogenic shock * patients using concomitant medication known to affect platelet function other than aspirin (i.e. nonsteroidal antiinflammatory agents, dipyramidole, upstream glycoprotein iib/iiia inhibitors) * patients with a known platelet function disorder or a whole blood platelet count of less than 150000/μl.

Keywords: coronary disease platelet reactivity drug-eluting stent
use of erythropoietin to expand regulatory t cells in autoimmune liver disease

Conditions: Autoimmune Hepatitis

Summary: this study evaluates the effect of erythropoietin on the number and function of regulatory t cells in adults with autoimmune hepatitis. participants will receive a single dose of erythropoietin, and then the investigators will collect blood at different time points for analysis of regulatory t cell number and function.

there is data from the laboratory that erythropoietin helps stimulate regulatory t cells, a type of immune cell which is thought to combat autoimmunity, but this study will look at whether it does the same thing in adults with autoimmune hepatitis.

Eligibility criteria:
inclusion criteria: * diagnosis of autoimmune liver diseases (autoimmune hepatitis, autoimmune cholangiopathy, or primary biliary cirrhosis or primary sclerosing cholangitis with hepatic autoimmune liver disease or overlap syndrome) confirmed on liver biopsy * use of immunosuppressive therapy (prednisone, azathioprine, 6-mercaptopurine, mycophenolate mofetil) for the treatment of the autoimmune liver disease * stable immunosuppression regimen at least 6 months prior to enrollment * ability to provide verbal and written informed consent exclusion criteria: * diagnosis of decompensated cirrhosis (defined by presence of ascites, varices, encephalopathy) * hemoglobin above average normal value (15.7 g/dl in men, 13.8 g/dl in women) * alanine aminotransferase greater than 2 times upper limit of normal (33 iu/l in men and 25 iu/l in women) * uncontrolled hypertension with systolic blood pressure greater than or equal to 160 or diastolic blood pressure greater than or equal to 100 * end-stage renal disease on hemodialysis * history of venous thromboembolism including deep vein thromboses or pulmonary emboli * history of stroke * history of heart failure * history of seizure disorder * history of significant cardiovascular disease including a history of myocardial infarction * active malignancy (untreated or undergoing therapy) * history of pure red cell aplasia * history of intolerance or allergy to erythropoietin * known hypersensitivity to mammalian cell-derived products * known hypersensitivity to human albumin * presence of vascular access * prior recipient of erythropoietin within 12 weeks of the study * patient unable to provide consent including infants, children, teenagers, prisoners, cognitively impaired adults * non-english speaking * pregnancy
laparoscopic clipping versus extracorporeal ligation in complicated appendicitis upper egypt overview

Conditions: Appendicitis

Summary: the investigators aim to compare between laparoscopic clipping and extracorporeal ligation in complicated appendicitis regarding safety, efficacy, operative time, postoperative outcome, hospital stay and complications.

appendectomy has become one of the most commonly performed emergency abdominal operations since it's description by mcburney in the 1890s. since laparoscopic appendectomy was first described in 1983, there is an increase in the general trend towards performing this surgery using laparoscopy instead of open technique as this approach shows better pain score, lesser use of analgesics, less operative complications, better post operative recovery, less hospital stay and rapid return to normal work. there are many methods for securing the base of the appendix, some of which are expensive others are not available or technically demanding. in this study the investigators aim to compare between extracorporeal ligation and clipping techniques regarding feasibility, safety, efficacy, operative time, postoperative outcome and complications especially in complicated appendicitis. as management of complicated appendicitis laparoscopically is possible, secure and can lead to a little occurrence of infectious complications, fewer post-operative pain, quick revival and improve cosmesis so the investigators will do a prospective clinical trial comparative study between two common techniques to determine the best one in management of complicated cases.

Eligibility criteria:
inclusion criteria: * acute complicated appendicitis. * perforated appendicitis (diagnosed intraoperatively) * patients who will undergo laparoscopic appendectomy. exclusion criteria: * patients with straight forward appendectomy. * patients who are not fit for laparoscopic appendectomy.
apitox, honeybee venom treatment for osteoarthritis pain and inflammation

Conditions: Osteoarthritis of the Knee

Summary: the study will evaluate apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * osteoarthritis of one or both knees * on stable nsaid or none due to intolerance * women either post menopausal or on stable birth control * no clinically significant disease or or abnormal laboratory values * signed informed consent, communicate effectively, understand and comply with all study requirements exclusion criteria: * serious or unstable medical or psychological condition * known sensitivity to honeybee venom, histamine or lidocaine * history of asthma * any clinically significant ecg abnormalities * any clinically significant laboratory values oor * history of drug or alcohol abuse * history of joint injury and forms of inflammatory arthritis

Keywords: honeybee venom osteoarthritis pain knees
a study of pegasys (peginterferon alfa-2a) administered alone or in combination with copegus (ribavirin) in patients with chronic hepatitis c who have participated in previous pegasys trials

Conditions: Hepatitis C, Chronic

Summary: this open-label, non-randomized, single arm study will provide treatment or re-treatment with pegasys (peginterferon alfa-2a) as monotherapy or in combination with copegus (ribavirin) to patients with chronic hepatitis c infection. patients who have received prior pegasys monotherapy or combination therapy or who were considered eligible for treatment with pegasys in previous donor protocols will be eligible to participate in this study. treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 years of age. * chronic hepatitis c. * compensated liver disease (child-pugh class a). * previous participation in a donor protocol in which treatment or re-treatment with pegasys alone or in combination with copegus was recommended or deemed appropriate after study completion. * have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation. * have not received any other anti-hepatitis c virus treatment after the completion of the donor protocol. * for females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug. * fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for copegus. exclusion criteria: * pregnant or breastfeeding women. * male partners of women who are pregnant. * patients with hemoglobinopathies. * hepatic decompensation (child-pugh class b or c) before or during treatment. * non-responder patients (defined as patients previously treated with pegasys and copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load). * liver disease other than chronic hepatitis c, including hepatic carcinoma.
use of a smartphone application on the detection of complications related to smoking

Conditions: Tabagism; Lung Cancer; Chronic Obstructive Pulmonary Disease

Summary: smokers do not know the symptoms of cancer and wait on average 5 months with symptoms before consulting. 80% of lung cancers are diagnosed at too late and incurable stage. systematic ct screening of smokers is under evaluation and currently not supported because expensive and little used in real life (in the us 1.8% of smokers after 7 years of establishment in the usa). an english study showed an increase in the number of operable stage cancers of 3% among smokers by calling them on a trailing cough by a simple poster campaign ("you smoke, you cough for more than 3 weeks, consult"). regarding copd, it is linked to tobacco in 85% of cases, affects 3.5 million french and is in 2013 the 4th leading cause of death in france. the evolution of copd is marked by exacerbations, period of acute aggravation of symptoms, responsible for the deterioration of the quality of life or even hospitalization or death. copd remains a silent killer responsible, according to this same summary review, of 16,500 deaths per year in france. dr denis has developed a web application that has shown a 7-month survival benefit by early detection of lung cancer relapses based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 randomized trial. the applitabac app takes this concept of symptom self-assessment by patients. by multiplying the number of symptoms analyzed compared to the english study, applitabac should be able to increase the sensitivity of this early detection of copd and increase the number of operable bronchial cancers and increase the chances of survival of patients.


Eligibility criteria:
inclusion criteria: * age \>= 18 years old * applitabac user who has received a notification directing him to his doctor * smoker or former smoker (current smoking cessation or ≤ 5 years) * patient informed of the use of his data and not opposing it exclusion criteria: * presence of another evolutionary neoplasia in the past 2 years * patient who did not use the applitabac app

Keywords: screening tabagism chronic obstructive pulmonary disease cancer lung
beneficial bacteria treatment for autism

Conditions: Gastrointestinal Problems; Autism Spectrum Disorders

Summary: this is an open-label clinical trial to investigate a combination therapy for treating gastrointestinal problems in children with autism spectrum disorders. the combination therapy includes beneficial bacteria.

this is an open-label clinical trial to evaluate the safety, tolerability, and feasibility of a combination therapy to treat gastrointestinal problems in children with autism spectrum disorders. it involves a combination therapy including beneficial bacteria.

Eligibility criteria:
inclusion criteria: 1. children ages 7-17 years 2. diagnosis of autism per autism diagnostic interview-revised (adi-r) 3. moderate or severe gi problems ( on the gsrs, a single score of 4 (severe) on any item, or a score of 3 (moderate) on two items, or a score of 2 (mild) or more on any 4 items 4. no changes in medications, supplements, diet, therapies, or education in last 3 months, and no intention to change them during clinical trial 5. general good physical health aside from gastrointestinal problems 6. cognitive ability to provide informed assent exclusion criteria: 1. antibiotics in last 6 months 2. probiotics in last 3 months 3. single-gene disorder (fragile x, etc.) 4. major brain malformation 5. tube feeding 6. severe gastrointestinal problems that require immediate treatment (life-threatening) 7. ulcerative colitis, crohn's disease, diagnosed celiac disease, eosinophilic gastroenteritis, or similar conditions 8. severely underweight/malnourished 9. recent or scheduled surgeries 10. current participation in other clinical trials

Keywords: children
a prospective cohort for ex vivo cure studies with chronic hiv infected patients in the netherlands

Conditions: HIV Infections; HIV-1-infection; HIV-2 Infection

Summary: a prospective non-interventional cohort study at erasmus mc of adult chronic hiv infected patients of ≥18 years of age who initiate antiretroviral therapy in routine care.

hiv cannot be cured with the current treatment armamentarium. a reservoir of latently hiv infected long lived cd4+t-cells is present in patients with hiv that are not affected by antiretroviral therapy. the evolution of this reservoir after therapy initiation is ill understood, as are the potential strategies to eradicate this reservoir. this study aims to anticipate on future hiv cure strategies by building a cohort to study ex vivo the reservoirs of hiv patients, the obstacles to cure hiv, and new therapeutic compounds and strategies. main study parameters/endpoints: 1. change in viral reservoir size after antiretroviral treatment initiation. 2. evolution of phenotypical and functional aspects of the anti-hiv host immune responses. 3. ex vivo activity of established and novel hiv latency reversing agents. 4. variance in hiv reservoir and host immunity between hiv subtypes and clinical variables. a project from the erasmus mc hiv eradication group (eheg).

Eligibility criteria:
inclusion criteria: * age \>18 years. * confirmed hiv-1 or hiv-2 infection * judged willing to initiate and adhere to cart by the hiv physician. exclusion criteria: * inability to place venous catheters to draw blood. * major comorbidities: 1. severe symptomatic anemia or recent symptomatic cardiovascular event (un-stable angina pectoris, decompensated heart failure, myocardial infarction). 2. the inability to participate due to any other relevant social, environmental,psychological, factors or according to the hiv treating physician's judgement.

Keywords: hiv hiv cure hiv reservoir
neurostimulation in chronic and episodic migraine

Conditions: Double-blind Design; Sham-controlled; Randomized

Summary: currently, successful prevention of migraine is not sufficiently achieved by (prophylactic) drug therapy. in contrast, neurophysiologically guided treatments might provide an alternative avenue, since these can normalize brain alterations without side effects. transcranial direct current stimulation (tdcs) appears useful in the acute and prophylactic treatment of migraine, probably because of its modifying and re-balancing influence on neuronal activity. yet, to test for the efficacy of tdcs in a clinically acceptable way, it is necessary to apply not only tdcs but also a "sham" placebo, which is often neglected in tdcs stimulation studies. further, tdcs needs to be applied in a large (n \> 20) sample of well-defined migraine patients, which would be advantageous, compared to previously published work. monitoring sources of regional neuronal alterations in migraineurs prior and after tdcs is essential to investigate physiological mechanisms of tdcs. there is an increasing interest towards non-pharmacological treatment alternatives for migraine (and headache disorders) with reduced side effects to established prophylactic medications. the primary outcome of this project is to demonstrate that repetitive sessions of neurostimulation lead to a significant and permanent reduction of the primary symptom severity (i.e. migraine attacks) for patients suffering from chronic and episodic migraine. since neurostimulation tools are nowadays accepted as therapeutic tools, our study might provide evidence that tdcs can be a non-pharmacological alternative for treating migraine.


Eligibility criteria:
inclusion criteria: patients from age 18 upwards (max. 80 years) suffering from chronic or episodic migraine. medication overuse headache (moh) patients are included as well (as chronic migraine patients do often show moh). healthy volunteers (18-80 years) are included if they don't fulfil the exclusion criteria and do not suffer from migraine or other headache disorders, except infrequent episodic tension-type headache all volunteers are able to read and sign the informed consent. exclusion criteria: patients and healthy volunteers are excluded if they fulfil one of the following exclusion criteria: common mr exclusion criteria: such as metallic items in the body (i.e. eye splinter, mr incompatible implants\*), pacemaker, claustrophobia or obesity (body mass index \> 35). also pregnant participants and participants suffering from a degenerative disorder of the central nervous system, such as stroke, multiple sclerosis, parkinson's disease, alzheimer's disease and huntington's disease will be excluded. participants with major psychiatric disorders such as schizophrenia, bipolar disorder will also be excluded.

Keywords: migraine neurostimulation neuroimaging tdcs mri
cognitive oriented strategy training augmented rehabilitation (costar) treatment approach for stroke

Conditions: Stroke

Summary: stroke is the most serious disabling condition in the united states and the developed world. novel stroke rehabilitation approaches, such as task-specific training, have shown promise in improving an individual's recovery in the rehabilitation setting; however, evidence suggests that these improvements are not generalized or transferred to the home, community, or work settings. thus, these interventions usually do not impact overall health and participation outcomes. this research study seeks to improve task-specific training as a stroke rehabilitation approach by integrating it with evidence-based cognitive-oriented strategies which have shown great promise as a way to address the limitations of task-specific training. the new treatment protocol is called cognitive-oriented strategy training augmented rehabilitation, or costar. the hypothesis of this study is that costar will result in more efficient functional skill acquisition, better long-term retention of skills learned, and generalization and transfer of skills learned to home, community, and work settings.


Eligibility criteria:
inclusion criteria: 1. age 18 or older; 2. have completed all physician recommended rehabilitation and currently not receiving rehabilitation services; 3. at least one-month post-stroke; 4. have self-reported unmet functional goals; and 5. nih stroke scale (nihss) total score of 2-12. exclusion criteria: 1. have sustained a hemorrhagic stroke; 2. nih stroke scale (nihss) aphasia rating of 1 or more (impaired speech); 3. moca cognitive screen score of less than 21 (impaired general cognitive ability); 4. neurological diagnoses other than stroke; 5. major psychiatric illness (bipolar disorder, ocd, panic disorder, ptsd, and/or borderline personality disorder); 6. no major depressive symptoms (phq-9 \< 20); 7. a score of 6 or less on the cihi aphasia screen combined items 64 and 66; 8. terminal illness; 9. blindness; and 10. non-english speaking.

Keywords: stroke occupational therapy cognition