Kornimate/medical-research-clean huggingface dataset:
stability of secondary intraocular lenses with no capsular support

Conditions: Cataract

Summary: assessment and differences in the centration, tilt and wobble of two secondary iols without capsular support.

acquired or congenital weakness of the zonules, either as part of a pseudoexfoliation syndrome (pex), high myopia, past ocular trauma, post vitreoretinal surgery, and recurrent uveitis are the most common reasons for implantation of a secondary intraocular lenses (iol) after cataract surgery. there are several techniques available to implant a secondary iol in eyes with inadequate capsular support. some of the most common techniques are the placement of a chamber angle-supported anterior chamber iol (aciol), an iris-fixated iol (ifiol) and several different possibilities of scleral fixation of the iol (sfiol). while those methods have all been found to show high safety and efficiency, there are certain procedure-specific limitations. one approach to sutureless implantation of a sfiol is the "double needle flanged technique" described by yamane et al. when using this technique, there is no need for extensive scleral incisions or distinct scleral manipulation, however, it may be challenging for the surgeon and may lead to complications such as "iris-optic-capture". past studies found no significant difference of postoperative best corrected visual acuity or rate of complications when comparing the three mentioned techniques, therefore, up to now choice of implantation and fixation technique lies with the surgeon's preferences and abilities. however, all three techniques have their drawbacks. hence, the aim of this study is to assess the centration, tilt, and wobble of secondary iols (comparing an ifiol and a sfiol) without capsular support.

Eligibility criteria:
inclusion criteria: * secondary iol implantation performed at the hanusch hospital * ifiol or sfiol implanted * older than 21 years * written informed consent prior to recruitment exclusion criteria: * concurrent participation in another drug or device clinical investigation * pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)

Keywords: secondary iol stability
difference of surgical site infection between using sodium picosulfate solution(picosolutionⓡ) and oral sulfate tablet(ora·fangⓡ) in colorectal cancer surgery

Conditions: Colorectal Cancer

Summary: this is a prospective randomized study to evaluate the difference in the rate of surgical site infection between the patients who used sodium picosulfate solution(picosolutionⓡ) and tablet oral sulphate solution(ora·fangⓡ) for bowel preparation before colorectal cancer surgery .

it has been reported that tablet oral sulphate solution(ora·fangⓡ) showed a successful bowel cleansing rate of 95.5%, which is similar to compared to sodium picosulfate solution(picosolutionⓡ). in terms of the rate of surgical site infection(ssi), sodium picosulfate solution(picosolutionⓡ) showed 8% of ssi rate. however there is no report for the ssi rate of tablet oral sulphate solution(ora·fangⓡ). we aimed to compare the ssi rates between these two group.

Eligibility criteria:
inclusion criteria: 1. patients who are scheduled for an elective minimally invasive surgery for colorectal cancer 2. asa score, 2 or less exclusion criteria: 1. bowel obstruction 2. fap or ibd patients 3. emergency operation 4. pregnancy 5. breast feeding 6. severe medical condition such as severe cardiac,hepatic, or renal failure (creatinine ≥ 3.0 mg/dl (normal 0.8-1.4 mg/dl)), 7. allergy to drug and refusal to participate in the study

Keywords: sodium picosulfate solution oral sulfate tablet surgical site infection
eliglustat on gaucher disease type iiib

Conditions: Gaucher Disease, Type III

Summary: evaluation of the safety in the combination usage of cerdelga and cerezyme in type iii gaucher disease patients and the efficacy on soft tissue diseases.

* this is a 3-year study and the enrollment time of this study is 24 months. * the participants have to receive the investigational agent:cerdelga.(cerdelga have 21 mg、42 mg and 84 mg capsule.) * the participants have to go back to the hospital and receive the investigational agent and take the gaucher related biomarkers test before receiving cerdelga, and 2 weeks, 1, 3, 6, 12, 18 and 24 months after receiving cerdelga. * the participants have to inform if any adverse events happened. * the investigators will follow up by phone if adverse events happened in the participants after one months start the treatment.

Eligibility criteria:
inclusion criteria: * gaucher disease patients diagnosed by low b-glucocerebrosidase deficiency and gba mutation . * the participant is at least 6 years old at time of enrollment. * under stable cerezyme dosage for at least for 3 months. * presence of lymphadenopathy. * patient (and/or their parent/legal guardian) is willing to participate and able to provide signed informed consent. exclusion criteria: * the participant is cyp2d6 ultra-rapid metabolizer. * the participant had received substrate reduction therapy for gaucher disease within 3 months of enrollment. * the participant had any clinically significant disease other than gd, including cardiovascular (especially arrhythmia), renal, liver, pulmonary, endocrinopathy, hypokalemia, or hypomagnesemia that may confound the study result. * the participant is pregnant or lactating. * the participant is known to be allergy to cerdelga. * the participant use drugs that will strongly inhibit cyp2d6 or cyp3a activity .

Keywords: enzyme replacement therapy eliglustat (cerdelga®)
a randomized controlled study to assess the effects of bisoprolol and atenolol on resting heart rate and sympathetic nervous system's activity in subjects with essential hypertension

Conditions: Hypertension

Summary: this is a phase 4, prospective, multi-centric and randomized controlled study to compare the effects of bisoprolol and atenolol on resting heart rate (rhr) and sympathetic nervous system's (sns) activity in subjects with essential hypertension.


Eligibility criteria:
inclusion criteria: * subjects aged between 25-65 years * subjects with essential hypertension (eh) * subjects with systolic blood pressure (sbp) 140-160 millimeter of mercury (mmhg) and diastolic blood pressure (dbp) 90-100 mmhg * subjects with normal sinus rhythm * subjects with resting heart rate (rhr) greater than 70 bpm * subjects who give written informed consent exclusion criteria: * subjects with atrial fibrillation (af)/sick sinus syndrome (sss)/atrioventricular block ii-iii grade (avb ii-iii) without pacemaker * subjects with bradyarrhythmia/hypotension * subjects with unstable angina pectoris (uap)/acute myocardial infarction (ami)/heart failure (hf) (new york heart association \[nyha\] class iii - iv) * subjects with uncontrolled diabetes mellitus (dm) * subjects with bronchial asthma * subjects with gastro-intestinal ulcer or skin ulcer * subjects with liver dysfunction/renal impairment * subjects treated with calcium channel blockers (except amlodipine) or other beta-blockers. * subjects with glaucoma * subjects with known allergic/intolerance to beta-blocker * pregnant or lactating women * subjects who had participated in another clinical study within the last 3 months * subjects who have legal incapacity or limited legal capacity

Keywords: hypertension bisoprolol atenolol
the effect of reflective breathing therapy compared with conventional breathing therapy in patients with chronic obstructive pulmonary disease (copd) iii-iv

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determine whether different types of breathing therapies in patients with copd iii-iv decrease dyspnea and increase activity.

in the treatment of copd-patients different kinds of breathing therapy techniques are used, but many of them are not reassessed yet. dyspnea is one of the predominant symptoms of copd patients and has negative impacts on the activity of the patients. dyspnea during exertion leads to avoiding activity and results in a deconditioning of muscles and of the cardiovascular system. thus breathing therapy techniques seem to be useful, which may lead to a decrease of dyspnea and an increase of activity. the purpose of this study is to determine whether reflective breathing therapy is more effective on decreasing dyspnea and increasing activity than conventional breathing therapy.

Eligibility criteria:
inclusion criteria: * inpatient rehabilitation * copd (gold stage iii and iv) exclusion criteria: * severe exacerbation in the last four weeks * acute infections * fever * neuritides * severe osteoporosis * skin disease * manic depression

Keywords: breathing therapy reflective breathing therapy copd chronic obstructive pulmonary disease
a clinical study to evaluate the effectiveness of a novel portable non-pneumatic active compression device vs. an advanced pneumatic compression device for treating lower extremity lymphedema

Conditions: Lymphedema; Lymphedema of Leg; Chronic Venous Insufficiency; Venous Insufficiency; Lymphedema, Lower Limb

Summary: to evaluate the koya wearable device - a novel portable non-pneumatic active compression device (npcd) in contrast to an advanced pneumatic compression device (apcd)

a multi-center randomized control single cross-over study to evaluate the safety and effectiveness of dayspring, a novel portable non-pneumatic active compression device (npcd) vs. an advanced pneumatic compression device (apcd) for treating lower extremity lymphedema. to evaluate the dayspring, a novel portable non-pneumatic active compression device (npcd) in contrast to an advanced pneumatic compression device (apcd) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.

Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years of age * capable and willing to sign the informed consent and deemed capable of following the study protocol * subjects must have a diagnosis of primary or secondary unilateral or bilateral lower extremity edema or lower extremity phlebolymphedema from chronic venous insufficiency exclusion criteria: * individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy * inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent * subjects with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.) * subjects must not have any diagnosed cognitive or physical impairment that would interfere with use of the device * individuals who present with ankle-brachial index (abi) screening score \ 1.30, indicating the possibility of peripheral arterial disease (pad) * diagnosis of lipedema * diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer) * diagnosis of acute infection (in the last four weeks) * diagnosis of acute thrombophlebitis (in last 6 months) * diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months * diagnosis of pulmonary edema * diagnosis of congestive heart failure (uncontrolled/uncompensated) * diagnosis of chronic kidney disease with acute renal failure * diagnosis of epilepsy * subjects with poorly controlled asthma * any condition where increased venous and lymphatic return is undesirable * women who are pregnant, planning a pregnancy or nursing at study entry * participation in any clinical trial of an investigational substance or device during the past 30 days
persistence of oral tolerance to peanut

Conditions: Eczema; Egg Allergy; Food Allergy; Hypersensitivity

Summary: itn049ad (leap-on) study is a continuation of the itn032ad leap study (nct00329784). peanut allergy, a recognized public health concern, is a common and potentially life-threatening food allergy for which there is no treatment. itn032ad (leap) study evaluated whether early exposure to peanut promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. itn049ad (leap-on) study will evaluate persistent tolerance to peanut by assessing the effect of twelve months of cessation of peanut consumption in leap study participants who consumed peanut and those who avoided peanut over the previous five years.

this is a two-sample comparison employing all available study participants in both arms of the leap (nct00329784) study at visit 72. after obtaining informed consent, leap participants who are evaluable for peanut allergy at age 60 months (v60) will be enrolled into this study, the leap-on (nct01366846) study. all leap-on participants will avoid peanut for an additional 12 months regardless of their previous allocation to the leap study consumption arm (group a) or the leap study avoidance arm (group b). at v72, after 12 months of this new intervention, all participants will have skin prick testing (spt), specific ige and a repeat oral challenge to peanut to determine the frequency of peanut allergy in both groups. the leap study decision table will be used to determine the presence of peanut allergy. briefly, peanut allergy will be based on the presence of a positive oral peanut challenge with objective signs of allergy. tolerance will be established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut protein in the absence of symptoms). for participants who do not have an oral challenge or an oral challenge at v72 with a determinate outcome, the following criteria will be used to determine their outcome at v72: * if the participant is tolerant and has an ige \> 0.1 and/or spt \> 0 mm at v60, the participant will be considered non-evaluable and will not be included in the analysis. * for all other participants, the v60 outcome will be applied to the v72 outcome (last observation carried forward). predictive values of peanut-specific ige and/or spt will not be used in the leap-on study because participants in the peanut consumption arm in the leap study are tolerating peanuts despite having high ige and/or spt.

Eligibility criteria:
inclusion criteria: * all leap study participants who are evaluable for peanut allergy at year 5 by leap (clinicaltrials.gov id nct00329784) study criteria. * parent or guardian willing to provide informed consent. exclusion criteria: * unable or unwilling to comply with study intervention and procedures. * participation in other food allergy intervention trials.

Keywords: peanut
the effects of the food preservative propionic acid in post-prandial metabolism

Conditions: Obesity; Insulin Resistance; Diabetes

Summary: propionic acid (pa) is used as a preservative in foods such as cheeses, baked goods, or additive for artificial fruit flavors. the u.s. environmental protection agency considers it safe and therefore, has no limitation on its use. since pa has been shown before to serve as a substrate for glucose production in the liver, the purpose of this study is to find out if pa intake causes changes in levels of glucose, insulin and other important hormones following a meal. this research study will compare pa to placebo. the placebo looks exactly like the active substance, but it does not contain any active agent (pa). placebos are used in research studies to see if the results are due to the study drug or to other reasons. the investigators plan to have 20 subjects take part in this study at the brigham and women's hospital (bwh).

-to test whether pa, added as food supplement to humans, results in altered post-prandial metabolism. the investigators propose to conduct a double-blind, randomized, placebo controlled, cross-over study in which blood levels of metabolites and hormones will be measured in healthy volunteers following a mixed meal test without or with pa. study design: this is a double-blind, randomized, placebo controlled, cross-over study. twenty volunteers who meet the inclusion/exclusion criteria will be randomized into two groups, provided with a mixed meal without or with calcium proprionate (also known as e282). a week later, participants will be provided with a mixed meal again, following cross-over of the groups. blood will be collected at baseline, and every 30 minutes for 4 hours. study subjects: 20 healthy male and female volunteers (ages 18 to 65 years) with a body mass index (bmi) of 20 to \<30 kg/m2.

Eligibility criteria:
inclusion criteria: * age 18-65 years * good health as evidenced by history and physical exam * bmi: 20-29.9 kg/m2 exclusion criteria: * fasting plasma glucose \>110 mg/dl * hba1c \>6.0% * significant current illness other than treated hypothyroidism * bp \>135/85 or systolic bp \<90 mm hg * hepatic disease (transaminase \> 3 times normal) * renal impairment (creatinine clearance \<60 ml/min) * history of drug or alcohol abuse * participation in any other concurrent clinical trial * pregnant women * history of food allergies.

Keywords: propionic acid food preservatives
feasibility study of an adapted and supported water polo program to reduce fatigue related to cancer and improve psychological and social recovery in patients with breast cancer remission

Conditions: Cancer Related Fatigue; Breast Cancer

Summary: the main objective of the study is to assess the feasibility of a coached physical activity program in the form of an accompanied and adapted water polo program by evaluating the interest aroused in patients for this proposal. treatments (number of participants and sessions performed).

prospective, non-randomized, monocentric study, which aims to show that physical activity carried out within a high-level structure and coached by elite trainers contributes to psychological and social recovery and to the reduction of fatigue in patients in remission breast cancer.

Eligibility criteria:
inclusion criteria: 1. woman aged 18 to 65, with a good understanding and good practice of the french language. 2. having been diagnosed with breast cancer: any type of cancer, any type of treatment. inclusion from 3 weeks to 3 months after the end of treatment (excluding hormone therapy and immunotherapy) patients who have undergone surgery may be included from 6 weeks post-operative. 3. signed consent to participate. 4. affiliation to a social security scheme or beneficiary of such a scheme. 5. live within a maximum radius of 40 km around marseille. 6. swimming skills (basic level). exclusion criteria: 1. being undergoing chemotherapy treatment 2. unacquired healing 3. metastatic cancers 4. proven psychological pathology proven according to diagnostic criteria (dsm-v) 5. pregnant or lactating woman

Keywords: cancer related fatigue adapted physical activity
predictors and outcomes of intraoperative hypothermia in patients undergoing knee arthroplasty

Conditions: Knee Arthroplasty, Total; Hypothermia

Summary: the study is designed to retrospectively assess the risk factors associated with intra-operative hypothermia in patients undergoing total knee arthroplasty from january 2016 to december 2017 at aga khan university and also understand it's impact on post-operative outcomes.


Eligibility criteria:
inclusion criteria: * all adults greater than 18 years who underwent total knee arthroplasty. exclusion criteria: * any patient below 18 years
investigation of sex hormone levels in chinese women with invasive breast cancer

Conditions: Breast Cancer

Summary: this study is to investigate sex hormones levels of chinese patients with invasive breast cancer.the aim is to analyze biochemical monitoring results of premenopausal and postmenopausal patients to facilitate determination of menopausal status and propose clinical application.

follicle stimulating hormone (fsh), estradiol (e2) and luteinizing hormone (lh) can serve as indicators in the determination of menopausal status. nccn clinical practice guidelines for breast cancer recommend detecting the levels of fsh and e2 for amenorrhea patients less than 60 years of age. but the detection method and the corresponding reference ranges indicating postmenopausal status are not mentioned. in addition, the reference limits vary a lot among different equipments and methods when it comes to diagnosis of menopause, thus it is difficult to set universal criteria. so in this study, four widely used methods and instruments in china are used to detect plasma levels of fsh, e2 and ln of premenopausal and postmenopausal patients. instruments and methods must be one of the following four categories: microparticle chemiluminescent(beckman),acridinium ester chemiluminescence (siemens),acridinium ester chemiluminescence (abbott) and electrochemiluminescence（roche）.

Eligibility criteria:
inclusion criteria: * invasive breast cancer patients confirmed through pathology. * for postmenopausal group: patients at the age ≥ 60 years with more than one year of menopause, or patients having undergone bilateral oophorectomy. * for premenopausal group: patients with regular menses during recent 3 months and having never received luteinizing hormone-releasing hormone (lhrh) analogue therapy. * patients who meet the above criteria can be enrolled whether they have received anti-cancer treatment or not. exclusion criteria: * patients less than 60 years old who are amenorrhoeic but have not received bilateral oophorectomy or medical castration.

Keywords: breast cancer menopause estradiol follicle stimulating hormone
the effects of serum vitamin d and ivf outcome

Conditions: Vitamin D Deficiency; Vitamin D Insufficiency; Infertility

Summary: the purpose of this study is to investigate whether an association exists between serum vitamin d levels and ivf treatment outcome


Eligibility criteria:
inclusion criteria: * all patients undergoing ivf, icsi or fet treatment at birmingham womens fertility centre exclusion criteria: * none

Keywords: vitamin d infertility ivf art