Kornimate/medical-research-clean huggingface dataset:
mix and match study of two multifocal intraocular lens with different add power

Conditions: Presbyopia

Summary: to assess postsurgical visual acuity (distant, intermediate, near), refractive errors, contrast sensitivity, visual function and patient satisfaction after implantation of multifocal iols of different add power contralaterally.

multifocal intraocular lens (miol) is considered a prevailing alternative to restore the functional vision from far to near independent of glasses. many clinical studies on diffractive miols, refractive miols, or hybrid miols in enhancing quality of vision showed promising outcomes. several studies have confirmed the satisfactory visual outcomes of tecnis miol with +4.00 d add power. the purpose of study is to assess the visual performance after cataract surgery with bilateral implantation of multifocal iol with two different add power (+2.75 d or +3.25 d) in one patient.

Eligibility criteria:
inclusion criteria: * • age-related cataract * adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye. * a patient has the visual potential of 20/25 or better in each eye after cataract removal and iol implantation. * a patient with preoperative corneal astigmatism from iol master less than 1 diopters * written informed consent to surgery and participation in the study exclusion criteria: * • pregnant woman and lactating woman * a patient with history of retinal disease * a patient with history of ocular trauma or ocular surgery (intraocular surgery, refractive surgery, ocular surface surgery) in either eye * a patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye. * a patient that has been wearing pmma lenses within 6 months, gas permeable lenses within one month, or extended -wear or daily soft contact lens within 7 days of their scheduled surgery. * those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract, or marfan syndrome * those who are not able to read and understand the informed consent (illiterate or foreigners)

Keywords: depth of focus
safety and efficacy of autologous bone marrow stem cells for lower extremity ischemia treating

Conditions: Lower Extremity Ischemia; Leg Ulcer; Peripheral Vascular Disease; Diabetic Foot; Gangrene

Summary: the purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.

critical limb ischemia (cli) is a debilitating and disabling disease. symptoms include pain at rest, loss of tissue integrity, distal amputations and have a major impact on the quality of life. despite recent advances in surgical vascular procedures, a large number of patients (approximately 40%) are not eligible for these revascularization procedures. new strategies for revascularization need to be explored. besides, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. recent evidence indicates that bone marrow-derived mononuclear cells (bm-mnc) are a potential new therapeutic target.

Eligibility criteria:
inclusion criteria: * critical lower limb ischemia, defined as ischemic pain at rest and / or the presence of minor tissue loss, with the possibility of healing. * failure of conventional medical treatment and attempts to open or percutaneous revascularization before, with an observation period of two months after the last attempt at revascularization. * patients considered at high risk for new revascularization procedure by at least two independent observers. exclusion criteria: * expected life span less than six months * large tissue loss in the ischemic limb indicating the need for limb amputation in the short term. * evidence of osteomyelitis in the ischemic extremity. * current or previous history of neoplasia. * unstable angina, recent stroke or other medical condition that contraindicate anesthesia for bone marrow aspiration. * proliferative retinopathy. * debilitating disease with a life span less than one year. * myelofibrosis, myelodysplasia or other diseases that affect the bone marrow. * use of alcohol in excess of twice-daily doses or history of illicit drug use. * need for continuous high doses of drug therapy with steroids (more than 7.5 mg/day). * positivity for hiv or syphilis

Keywords: lowe extremity ischemia bone marrow neoangiogenesis
fibrous dysplasia, mccune-albright syndrome patient registry

Conditions: Fibrous Dysplasia; McCune Albright Syndrome; Mazabraud Syndrome

Summary: the fd/mas patient registry is an irb-approved research study that that invites the patients and families to help answer some of the biggest questions about fd/mas by completing questionnaires about their lives with fd or mas. have you enrolled in the fd/mas patient registry yet? are you up-to-date on your surveys? take a trip to www.fdmasregistry.org today to learn more about the project, enroll, complete your surveys, or make sure you aren't due to provide more info! the fd/mas patient registry: your story powers research.

the fd/mas patient registry is an irb approved research project that allows patients and families to share their experiences with fibrous dysplasia/mccune-albright syndrome (fd/mas) by completing a series of surveys. the surveys were created in collaboration with patients, parents, clinicians and researchers, so that the data can be used to answer some of the most important questions about fd/mas, including: the way the disease develops over time (its "natural history"), the patient experience of the disease, and its impact on quality of life, how and when diagnoses are made, the scope of treatments in use, what surgical techniques work best, and for whom, what other medical interventions work best, and for whom, what social services and therapies are useful, the costs of care to patients and their families, issues that concern patients (such as the impact of pregnancy on fd, or children feeling different and facing stigma), and which research questions and support programs you think are important to fund. participation is free and convenient for people with fd/mas and their legal guardians. you can join today at www.fdmasregistry.org.

Eligibility criteria:
inclusion criteria any one or more of the following: * clinical diagnosis of fibrous dysplasia * clinical diagnosis of mccune-albright syndrome * clinical diagnosis of mazabraud's syndrome

Keywords: fibrous dysplasia mccune-albright syndrome mazabrauds fd/mas
bioequivalence study of doxorubicin hydrochloride liposome injection

Conditions: Ovarian Epithelial Cancer Recurrent

Summary: bioequivalence study is proposed to be carried out on patients of ovarian cancer, who are already receiving or who in the opinion of their treating physicians are candidates for doxorubicin liposomal injection therapy .

this study has sequential two stage design. bioequivalence based on encapsulated doxorubicin will be tested at the end of stage 1. power analysis will be performed for the primary pharmacokinetic parameters of free doxorubicin and liposome encapsulated doxorubicin, for all completed patients before bioequivalence evaluation. if observed power will be \>= 80% then two one-sided 90% ci will be calculated for bioequivalence assessment at stage i. if observed power will be \< 80% then bioequivalence will be evaluated at stage i. if bioequivalence met then study will be stopped and if bioequivalence not met, then required additional patients will be enrolled in stage ii. each patient will be randomized to one of the two treatment sequences ( rt or tr ) according to a randomization scheme prepared prior to the start of the trial. serial blood samples for determination of free doxorubicin and liposomal encapsulated doxorubicin plasma concentration for pk analysis will be obtained in each cycle . bioequivalence criteria : the 94.12% confidence intervals for the ratio of geometric least squares means of ln-transformed pharmacokinetic parameters cmax, auc0-t and auc0-inf should be within 80.00 to125.00% to conclude the test product is bioequivalent to the reference product.

Eligibility criteria:
inclusion criteria: * female of indian nationality , between 18-60n years of age * able to understand investigational nature of this study and give written informed consent prior to the participation in the trial. * patients with ovarian cancer requiring doxorubicin and whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy with reference listed drug * ecog performance status ≤ 2 * cardiac function ( lvef) ≥ 50% * patient with life expectancy of at least 3 months * adequate hematopoietic, renal and liver function exclusion criteria: * prior doxorubicin exposure that would result in a total lifetime exposure of 550mg/m2 or more after four cycles of treatment . * pregnant or breast-feeding female * active opportunistic infection with mycobacteria , cytomegalovirus , toxoplasma * impaired cardiac function including any of the following conditions within past 6 months : 1. unstable angina 2. qtc prolongation or other significant ecg abnormalities 3. coronary artery bypass graft surgery * history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hcl or the components of doxorubicin hydrochloride liposome injection. * known brain metastasis * hiv positive antibody or syphilis * patients with significantly impaired hepatic function * clinically significant liver and kidney disease
efficacy of acapella on spirometry measures in patients with bronchiectasis

Conditions: Bronchiectasis

Summary: 1. acapella group. will use acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program . 2. only routine physical therapy program group ( control group). will only take medications and routine chest physical therapy program.

1. acapella group.will use acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program. 2. only routine physical therapy program group( control group). will only take medications and routine chest physical therapy program spirometer measures such as forced vital capacity (fvc) and forced expiratory volume in the first second (fev1) will be measured for every patient before and after the end of 7 days.

Eligibility criteria:
inclusion criteria: 1. bronchiectasis patients. 2. age range between 40 to 55 years old of both gender. 3. cooperative patients. exclusion criteria: 1. patients with severe cardiac disorders. 2. un controlled hypertensive patients. 3. un controlled diabetic patients.
enhancing consent for alzheimer's research

Conditions: Alzheimer Disease

Summary: the purpose of this study is to evaluate the efficacy of an enhanced consent procedure for patients with mild-to-moderate alzheimer disease, and to identify factors and patient characteristics that predict the degree to which enhanced consent is more beneficial than routine consent procedures.

alzheimer disease can impair the capacity of patients to give informed consent for research participation. studies of informed consent involving other patient populations suggest better understanding of consent-relevant information may be achieved through modifications in the consent delivery process, including incorporation of multimedia learning tools into the consent discussion. in the present study, participants with alzheimer disease and age-comparable healthy participants will be randomly assigned to review a hypothetical research protocol via routine or enhanced consent procedures. participants will also complete standard cognitive and other rating scales so that we can characterize the sample, as well as evaluate the degree to which specific characteristics may be associated with need for enhanced consent procedures. advances in the methods to optimize the informed consent process should enable future research participants to make more fully informed decisions.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mild to moderate possible or probable ad or demographically comparable healthy comparison subjects * fluency in english * 50 yrs and older * informed written consent (or written assent with consent from legally authorized representative) exclusion criteria: * diagnosis of lewy body dementia or mild cognitive impairment * mmse less than 15 * physical or medical conditions that preclude participants from completing tasks * healthy comparison volunteers if they have a known neurologic or psychiatric condition that could impair neurocognitive functioning

Keywords: computer assisted instruction decision making educational resource design /development executive function
food-specific igg4-guided elimination diets improve allergy symptoms in children

Conditions: Rhinitis, Allergic; Asthma, Allergic; Conjunctivitis, Allergic; Atopic Dermatitis; Chronic Urticaria

Summary: allergic diseases in children are major public health concerns due to their widespread and rising prevalence. the most classic pathway to trigger allergy is type i allergy mediated by immunoglobulin e(ige), but the role of immunoglobulin g4(igg4) in allergic diseases is still worth exploring.we have collected the data of allergic patients aged 0-14 years for retrospective cross-sectional analysis to evaluate the positive rates of total ige, hdm ige, fs-ige and fs-igg4. meanwhile, investigators screened out patients who were treated with fs-igg4-guided elimination diets with/without probiotics for more than 3 months to clarify the role of fs-igg4 in childhood allergic diseases by assessing the improvement of clinical symptoms before and after treatment.

allergic diseases in children are major public health concerns due to their widespread and rising prevalence. and management of allergic diseases beyond medication, such as food management is also very important. the most classic pathway to trigger allergy is type i allergy mediated by immunoglobulin e(ige), but the role of immunoglobulin g4(igg4) in allergic diseases is still worth exploring.in present study, investigators have collected the data of allergic patients aged 0-14 years for retrospective cross-sectional analysis to evaluate the positive rates of total ige, house dust mite (hdm) ige, fs-ige and fs-igg4. meanwhile, investigators screened out patients who were treated with fs-igg4-guided diet elimination with/without probiotics for more than 3 months to clarify the role of fs-igg4 in childhood allergic diseases by assessing the improvement of clinical symptoms before and after treatment. this retrospective study was conducted to clarify the clinical relevance of food-specific igg4 in allergic diseases and the effect of dietary avoidance on clinical symptoms, thus making a breakthrough in the diagnosis and treatment of childhood allergies.

Eligibility criteria:
inclusion criteria: clinical diagnosis of allergic rhinitis. * clinical diagnosis of asthma. * clinical diagnosis of conjunctivitis. * clinical diagnosis of urticaria. * clinical diagnosis of atopic dermatitis. * total ige,fs-ige, hdm-ige and fs-igg4 must be tested. exclusion criteria: · autoimmune diseases.

Keywords: immunoglobulin e immunoglobulin g elimination diets chlid
safety and immunogenicity of gsk biological's candidate tuberculosis vaccine mtb72f/as02a in healthy ppd-positive adults

Conditions: Tuberculosis (TB)

Summary: this study will evaluate the safety, reactogenicity and immunogenicity of mtb72f/as02a in healthy european volunteers who are ppd-positive either via previous vaccination with bcg and/or conversion to ppd positivity through exposure to mycobacterium tuberculosis.

the bcg vaccine has been widely available for several decades. it is easy and cheap to produce, and when given to neonates or young children it is effective in preventing severe manifestations of disease such as meningeal tuberculosis and miliary tuberculosis. however, in terms of the capacity of the vaccine to protect adult humans it shows a wide range of efficacy, including zero levels of protection. due to the general realization that bcg is losing its protective effect, particularly in terms of preventing adult-onset tuberculosis, a major effort has been made to try to develop new alternative vaccines. one such candidate, mtb72f/as02a, is a polyprotein derived from two known m. tuberculosis antigens adjuvanted with as02a. mtb72f/as02a is a candidate tb vaccine under development for two indications: prevention of primary tb infection in young children in highly endemic areas and as an adjunct to treatment for tb in adolescents and adults.

Eligibility criteria:
inclusion criteria * written informed consent * healthy ppd-positive volunteers aged 18 to 50 years * no active pulmonary disease as confirmed by chest x-ray * no history of extrapulmonary tb * seronegative for hiv 1 and 2, hbsag, and hcv * clinically normal laboratory values for creatinine, alanine aminotransferase (alt), aspartate aminotransferase (ast), total bilirubin, complete blood count (cbc) and differential, haemoglobin, platelet count and urinalysis. * females : non pregnant, must use adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. exclusion criteria * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. * history of prior vaccination with experimental mycobacterium tuberculosis vaccines or experimental products containing mpl or qs21. * any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency. * history of hypersensitivity to vaccines or vaccine components * history of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
evaluation of the brada and abilhand questionnaires

Conditions: Rheumatoid Arthritis

Summary: this protocol is designed to evaluate the brada and abilhand questionnaires in rheumatoid arthritis (ra) patients that will be treated with an effective therapy. patients with moderate to severe ra treated with tocilizumab will be asked to complete the brada and abilhand questionnaires at screening, baseline, after 12 weeks and after 24 weeks of treatment. all other assessments and questionnaires from daily clinical practice (such as the global assessment of disease activity by the patient, the health assessment questionnaire (haq), the sf36 questionnaire, measurement of esr and crp and the das 28 calculation), will also be used to evaluate these questionnaires.


Eligibility criteria:
inclusion criteria: * patients with moderate to severe ra. * inadequate response on earlier optimal use of a minimum of two dmards (disease modifying anti-rheumatic drugs such as goldsalts, salazopyrine, leflunomide, methotrexate (mtx)) as far as one of the two used dmards is mtx that at the exception of a documented intolerance despite the association with folic acid, should have been administered im or oral during a minimum of 3 months and at a minimal dose of 15mg/week. * das 28 score ≥ 5.1 * for whom a drug that is registered for the treatment of moderate to severe ra is commercially available but does not constitute a satisfactory treatment for this patient.

Keywords: patients with moderate to severe ra
safety, tolerability and pk study of single doses of abt-450 with and without ritonavir to treat hepatitis c virus (hcv) genotype 1

Conditions: HCV Infection

Summary: the purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental hcv protease inhibitor with and without ritonavir in healthy volunteers.


Eligibility criteria:
inclusion criteria: * overall healthy subjects * non-childbearing potential females included exclusion criteria: * history of significant sensitivity to any drug * positive test for hav igm, hbsag, anti-hcv ab or anti-hiv ab * history of gastrointestinal issues or procedures * history of seizures, diabetes or cancer (except basal cell carcinoma) * clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder * use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration * donation or loss of 550 ml or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration * abnormal screening laboratory results that are considered clinically significant by the investigator * current enrollment in another clinical study * previous enrollment in this study * recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol * pregnant or breastfeeding female * requirement for any otc and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Keywords: fih sad
mucopexy versus laser hemorrhoidoplasty for the treatment of hemorrhoidal disease

Conditions: Hemorrhoids

Summary: hemorrhoidal disease is a frequent anorectal disorder and the main reason for a visit to a coloproctologist. hemorrhoids are present in healthy individuals. however, they can become pathologic, manifesting with pain, prolapse, itching, bleeding or soiling. initially, they can be managed conservatively. when this failed to cure the symptoms, surgical therapy is indicated. for grade ii (hemorrhoids prolapsing during straining but reducing spontaneously) or grade iii (hemorrhoids prolapsing during straining but requiring manual reduction), laser hemorrhoidoplasty or mucopexy are safe and efficient procedures to treat hemorrhoids. however, the optimal treatment is still under debate. recently, a randomized controlled trial reported lower recurrence and faster return to work associated with laser therapy. we aimed to compare both therapies, to assess the benefits of laser therapy for the treatment of hemorrhoidal disease symptoms, using a validated score.


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * hemorrhoidal disease grade ii to iii unresponsive to medical therapy * age ≥18 exclusion criteria: * inability to follow the procedures of the study, * enrollment of the investigator, his/her family members, employees and other dependent persons, * anesthesiology contraindications to surgery, * emergency situation, * hemorrhoids associated with pregnancy, * oher surgical intervention performed at the same time of the hemorrhoids treatment, * concomitant anorectal disorders (fissure, fistula), thrombosed hemorrhoid, * previous pelvic radiotherapy, previous proctologic intervention during the last three months.