Kornimate/medical-research-clean huggingface dataset:
combined capsular tension ring and iol implantation for management of cataracts

Conditions: Intraocular Lens Rotation; Capsular Tension Ring

Summary: this study included cataract patients who underwent intraocular lens (iol) implantation with or without capsular tension ring (ctr), which aimed to evaluate the contribution of the use of ctr in clinical visual outcomes and rotational stability of iol after cataract surgery.


Eligibility criteria:
inclusion criteria: -cataract exclusion criteria: * preexisting corneal pathology * small pupil * glaucoma * zonular dehiscence * a history of ocular trauma or surgery * uveitis * intraoperative complications
stop menstruation and pregnancy rates in antagonist protocol

Conditions: Infertility

Summary: the proposal of this study is to evaluate the association between the achievement of ongoing pregnancy and hormonal levels on the first day after the period had stopped in rec-fsh/gnrh- antagonist cycles.

ovarian stimulation will be achieved by rec- fsh, puregon® starting on day 2 of the cycle at a dose of 200 iu/day. the dose of rec-fsh remains unchanged during stimulation until day 10 of the cycle. if it is necessary to increase the dose of rec-fsh after 10 days of stimulation, or to decrease the dose of rec-fsh due to a risk of ohss, the patient will be dropped out of the study. to inhibit premature lh surge daily gnrh - antagonist (orgalutran 0,25mg ) is used from the morning of day 6 of stimulation. final oocyte maturation will be achieved by administration of 10.000 iu of hcg (pregnyl®) as soon as ≥ 3 follicles ≥ 17 mm are present. e2 levels should not be criteria for hcg administration. oocyte retrieval will be carried out 36 hours after hcg administration. conventional ivf or icsi will be carried out. embryo transfer will be carried out day3 or day5 after oocyte retrieval. similar luteal support for all patients with vaginal administration of 600mg natural micronised progesterone in three separate doses (utrogestan® 200mg 3xday) starting one day after oocyte retrieval will be used. hormonal assessment (e2,fsh,lh,progesterone) will be performed at initiation of stimulation, on the first day after the period had stopped and every 2 days until the day of hcg administration.

Eligibility criteria:
inclusion criteria:- age ≤ 39 years * body mass index between 18 and 29 kg/m²¬ * regular cycles between 25-34 days * presence of both ovaries * basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle * treatment with ivf/icsi * embryo transfer day 3 or day 5 (1 or 2 embryos) * patients can enter in the study only once exclusion criteria: * presence of endometriosis stage ≥3(afs) * polycystic ovarian syndrome (rotterdam criteria) * need for preimplantation genetic diagnosis (pgd) * azoospermia testicular sperm extraction (tese)

Keywords: hormonal values menstruations pregnancy antagonist
ilumya in combination with halog ointment 0.1% for plaque psoriasis.

Conditions: Psoriasis

Summary: patient with moderate-to-severe plaque psoriasis will receive ilumya with or without halog ointment.

25 adult subjects with moderate to severe plaque psoriasis will receive ilumya 100mg subcutaneously at weeks 0, 4 and 16. at week 16, patients with remaining bsa ˃3% will be given halog ointment 0.1% to apply bid for 4 weeks. patients who have ≤3% bsa at week 16 will remain on ilumya monotherapy. patients will continue to be evaluated at weeks 20 and 24.

Eligibility criteria:
inclusion criteria: 1. male or female adult ≥ 18 years of age; 2. diagnosis of moderate-to-severe chronic plaque-type psoriasis as defined by * bsa 10% * pga ≥3 * pasi ≥12 3. must be a candidate for phototherapy and/or systemic therapy 4. females of childbearing potential (fcbp) must have a negative serum pregnancy test at screening and negative urine pregnancy test at baseline. fcbp who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (iud); tubal ligation; or partner's vasectomy; male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide. exclusion criteria: 1. non-plaque forms of psoriasis 2. women of childbearing potential who are pregnant, intend to become pregnant, or are lactating 3. presence of significant uncontrolled medical condition that in the opinion of the investigator would affect patient safety during the trial. 4. active or untreated latent tuberculosis (tb)
setting up a cohort of patients with crohn's disease and a cohort of patients without chronic inflammatory bowel disease

Conditions: Crohn Disease

Summary: the objective of this study is to constitute cohorts of crohn versus non-crohn patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with crohn disease, and develop a prototype for assaying such marker(s) in blood.


Eligibility criteria:
inclusion criteria: general criteria: * male or female ≥ 18 years old * able to follow the instructions of the study * having signed an informed consent specific for crohn cohort: * a confirmed diagnosis of cd * colonic or ileocolic involvement * patients with cd presenting inflammatory flare and disease extent in the colon or ileocolic region with: * a clinical activity defined by an average of four or more instances of very soft or liquid stools daily or an abdominal pain score of 2 or more or a cdai (cd activity index) ≥ 220 or a harvey-bradshaw index \> 8 or a faecal calprotectin ≥ 250 µg/g and * a endoscopic activity defined by a ses-cd (simple endoscopic score for crohn disease) ≥ 6 or a cdeis (cd endoscopic index score) ≥ 7 specific for control cohort: patient with no colonic lesion(s) visible during the endoscopical examination (neither crohn's nor other colitis nor cancer) exclusion criteria: general criteria: * commercial pharmaceutical probiotic administration within the previous month * treatment with antibiotics (whatever the route of administration) within last 3 months * non-remission cancer or in remission for less than 6 months * any contraindication to colonoscopy and/or biopsy, left to pi discretion * under guardianship or judiciable protection * pregnant or breastfeeding women * currently participating or having participated in the last 3 months to a clinical study with investigational medicine or food supplement specific for crohn cohort: * crohn disease localized only in ileum * inflammatory colon pathology other than crohn's (infectious, drug-induced,...)
use of white granulated sugar on wounds

Conditions: Infected Wounds

Summary: how effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating wounds compared with standard treatment?

patients for whom all the following apply: have an exudating wound sizes 5cm2 and 40cm2 a minimum of 25% slough, infected and necrotic tissue no dry necrotic eschar present ankle brachial pressure index of greater than 0.6 are over 18 years independently and willingly consent

Eligibility criteria:
inclusion criteria: * exudating wound sizes 5cm2 and 40cm2 * a minimum of 25% slough, infected and necrotic tissue * no dry necrotic eschar * ankle brachial pressure index of greater than 0.6 * age over 18 years * able to independently and willingly consent exclusion criteria: * participants in a trial evaluating other therapies for their wound * have previously been in this trial * women who are pregnant * participants not able to tolerate daily dressing change
first-line treatment for adenocarcinoma patients with epidermal growth factor receptor (egfr) mutation

Conditions: Pulmonary Cancer

Summary: the purpose of this study is to evaluate the overall objective tumor response rate (orr) of gefitinib.


Eligibility criteria:
inclusion criteria: * patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform egfr mutational analysis * who performance status 0-2 * no prior chemotherapy, biological or immunological therapy/surgery exclusion criteria: * any evidence of clinically active interstitial lung disease * newly diagnosed cns metastases that have not yet been definitively treated with surgery /radiation * patients with previously diagnosed and treated cns metastases or spinal cord compression

Keywords: locally advanced (iiib) pulmonary adenocarcinoma with egfr mutation metastatic (iv) pulmonary adenocarcinoma with egfr mutation recurrent pulmonary adenocarcinoma with egfr mutation
effect of vicriviroc on hiv ribonucleic acid (rna) levels in cerebrospinal fluid (study p05241)

Conditions: HIV Infections

Summary: vicriviroc (vye-kri-vye-rock) is an investigational drug (not yet approved by government regulatory authorities for commercial use) that belongs to a new class of drugs, called ccr5 receptor blockers. this group of drugs blocks one of the ways hiv enters t-cells (the cells that fight infection). previous studies in hiv treatment-experienced patients have shown that vicriviroc is safe and effective. the purpose of this study is to determine the effect of vicriviroc on hiv rna levels in cerebrospinal fluid (csf).

this is a nonrandomized, open-label, multicenter study to investigate the hiv antiviral response in csf when vicriviroc is added for 2 weeks to the subject's failing antiretroviral background regimen. the primary efficacy endpoint of this study is the mean change in log10 csf hiv rna from baseline at week 2. the secondary efficacy endpoint is the proportion of subjects achieving csf hiv rna \<50 copies/ml at week 2. at week 2, the subject's background regimen will be optimized and vicriviroc continued up to week 24. after completing week 24 of the study, subjects will be offered the option to continue on open-label vcv 30 mg once daily, if appropriate, until commercially available or until the sponsor terminates the clinical development of vcv. subjects who discontinue vicriviroc for any reason will be requested to participate in long-term follow up.

Eligibility criteria:
inclusion criteria: * a subject must be at least 18 years of age at the time of study entry, of either sex, and of any race. * a subject must be infected with hiv-1 virus, as documented by a positive assay for hiv-1 rna in plasma, prior to screening. * a subject's hiv isolate must be solely ccr5-tropic at screening (ie, a subject must not have detectable cxcr4-tropic or dual/mixed ccr5/cxcr4-tropic hiv isolates). * subjects must be failing their current antiretroviral regimen with plasma hiv rna \>=1000 copies/ml at the time of screening. (note: the failing background regimen must contain a ritonavir-boosted pi, and may not include an nnrti.) * a subject must be willing to undergo study procedures including lumbar punctures, and to adhere to the chosen antiretroviral regimen. * a subject must have a pretreatment csf hiv rna of \>=200 copies/ml. exclusion criteria: * a subject must not be taking medication for seizure control or have any condition that, in the judgment of the investigator, is likely to increase the risk of seizures. * a subject must not have a prior history of malignancy (with the exception of surgically resected basal cell carcinoma with clear margins or kaposi's sarcoma without visceral or mucosal involvement that resolved without systemic anticancer treatment). * a subject must not have a contraindication to lumbar puncture (eg, bleeding diathesis or use of anticoagulants).

Keywords: hiv infections acquired immunodeficiency syndrome treatment experienced
validation of the flemish montreal cognitive assessment (moca) for persons with hearing impairment

Conditions: Dementia; Hearing Loss

Summary: the montreal cognitive assessment (moca) is a screening test for detecting cognitive impairment that assesses several cognitive domains (attention and concentration, arithmetic and orientation, memory, etc.). the instructions as well as some test items of the moca are presented auditory (spoken). consequently, performance on the moca may be co-dependent on hearing. therefore, to rule out the possible negative influence of hearing loss on performance on the moca, a moca for individuals with hearing loss was recently developed. more specifically, the original moca was modified by providing the instructions audiovisually (spoken with visual support) as well as by replacing hearing-dependent items. since replacing items may affect sensitivity and specificity, the moca for persons with hearing loss should be revalidated.


Eligibility criteria:
inclusion criteria: * individuals aged 60 years or older * individuals with normal vision (with lenses or glasses if needed) * individuals with age-related hearing loss * dutch-speaking individuals * individuals capable of giving consent to participate in the study themselves * individuals still residing in their own homes * individuals with an official diagnosis of dementia (alzheimer's, vascular, or mixed) or mild cognitive impairment. this inclusion criterion applies only to the group with cognitive impairment. exclusion criteria: for individuals without cognitive impairment, the following exclusion criteria apply: * (history of) neurological problems (brain tumor, epilepsy, history of stroke, etc.) * use of influencing medication (e.g., ritalin and antidepressants)

Keywords: cognitive screening montreal cognitive assessment
impact on quality of life of "endo-app" (elea)

Conditions: Endometriosis; Endometriosis-related Pain; Quality of Life

Summary: monocentric randomized controlled trial enrolment of endometriosis patients from certified endometriosis centers. randomization to control group (no endo app use) vs intervention group (endo app use) 12 weeks use / no use of endo app. evaluation of quality of life at onset, at 4, 8 and 12 weeks by using endometriosis health profile (ehp) 5 as a global index. statistical analysis of global index at the end minus global index at onset between control and intervention group.

randomized controlled trial enrolment of patients with diagnosed endometriosis 300 patients in total, 150 patients per group, randomization to control group (no endo app use) vs intervention group (12 weeks endo app use). the endo app is a german language certified medical device which can be used to monitor the disease and gives support by providing complementary, multimodal interventions to standard therapy and is commercially available. purpose of this study is the evaluation of quality of life at onset and then at 4, 8 and 12 weeks by using endometriosis health profile (ehp) 5 as a global index. the secondary endpoints of this study to evaluate are fatigue symptoms (fsssurvey), pain- specific self-efficacy (fess), difficulty in everyday life due to pain (pdi) and emotional wellbeing (dass- 21)

Eligibility criteria:
inclusion criteria: legal capacity * living in germany * adequate german language skills * female biological gender * ages eligible for study ≥ 18 years * medical diagnosis of endometriosis diagnosis verification by following documents: 1. operation report 2. histological finding 3. mri finding 4. other medical examination documents with endometriosis diagnosis (for example sonography, colonoscopy, cystoscopy) owning a smartphone and having an internet access willingness and capability of using the smartphone device and the endo app motivation to regularly fill out the questionnaries owning an e-mail address for app registration absence of exlusion criteria exclusion criteria: * absence of inclusion criteria * pregnancy existing at survey period * ongoing hormonal fertility treatment or planned treatment within the next 12 weeks (artificial insemination as part of in vitro fertilization, such as ivf or icsi, hormone injections for fertility treatment) * ongoing or within the next 12 weeks planned rehabilitation or multimodal pain therapy * planned change in hormone therapy (change of active substance, new start or discontinuation of therapy) in the next 12 weeks or change in hormone therapy within the last 8 weeks before the start of the study * endometriosis surgery planned in the next 12 weeks or endometriosis surgery performed within the last 8 weeks prior to study start * previous or existing access to endo app or current prescription

Keywords: endometriosis quality of life endo-app ehp-5 endometriosis health profile digital therapeutics
prostate delineation: high quality volume ct

Conditions: Prostate Cancer

Summary: this study will look at how feasible it is to use a certain type of computed tomography (ct) to scan prostate cancer, called a high quality volume ct scan. it is hoped that this technique will help doctors provide a higher-quality image of the prostate cancer, making it easier to plan the area that will be treated. using this type of ct scan will also lessen the amount of time patients spend in the scanner. this study will not offer patients a different treatment for their prostate cancer. patients will receive the most appropriate standard treatment whether or not they are in this study.


Eligibility criteria:
inclusion criteria: 1. at least 18 years old 2. subjects undergoing radical external beam radiotherapy for prostate cancer 3. ability to provide written informed consent exclusion criteria: 1. age ≤ 18 years 2. subjects not suitable for mri scanning 3. 3 usable image sets not obtained during treatment planning scans.

Keywords: prostate cancer mri scan external beam radiotherapy
evaluation glizigen® and ocoxin®-viusid® in high-grade cervical intraepithelial lesions

Conditions: Carcinoma; Neoplasia; Intraepithelial, Cervix; Glandular Neoplasms; Epithelial Neoplasm; Neoplasms

Summary: phase ii clinical trial, monocentric, not controlled, in patients with high grade cervical intraepithelial lesions. a total of 62 patients with a diagnosis of cin ii, iii or carcinoma in situ will be included. it is expected that with the combination of natural products glizigen® and ocoxin®-viusid® at least 60% of patients with treated intraepithelial lesions (iel) have a global response (complete or partial), with elimination of the human papillomavirus and the viral load.

main objective: to evaluate the effect of the combination of glizigen® and ocoxin®-viusid® in the treatment of high-grade cervical intraepithelial lesions. specific objectives: 1. to evaluate the overall response (colposcopic, histological and virological) in patients treated with the combination of the natural products glizigen® and ocoxin®-viusid® in the treatment of high-grade cervical intraepithelial lesions. 2. evaluate the colposcopic response in patients treated with the combination of natural products. 3. evaluate the histological response in patients treated with the combination of natural products after conization. 4. evaluate the virological response in patients treated with the combination of natural products. 5.describe adverse events during treatment.

Eligibility criteria:
inclusion criteria: 1. patients that meet the diagnostic criteria. 2. patients with age ≥18 years. 3. patients with residual lesion greater than 3 mm after the initial punch, measurable by video colposcopy and with major changes (criteria from rio 2011). 4. patients that have a positive test to the oncogenic virus of the human papilloma (16, 18, 31, 33, 45, 52 and 58). 5. patients who give their informed consent to participation in writing. 6. patients who consent to perform the conization according to the study schedule. 7. patients with normal laboratory parameters within the limits established in the institution (complete blood count, platelets and erythrosedimentation. in the case of male sex (vasectomy, use of condoms) while the treatment lasts. exclusion criteria: 1. patients who have received surgical, ablative, radiant, immunomodulatory or chemotherapy treatment 30 days before recruitment. 2. patients pregnant or breastfeeding. 3. patients with acute cervico-vaginal infections. 4. patients with positive serology known to hiv and/or syphilis. 5. patients with diseases that compromise the state of consciousness or their possibility of collaboration. 6. patients with a history of severe allergic history. 7. patients who are participating in another research.

Keywords: carcinoma intraepithelial cervix lesions oxidative stress ocoxin viusid glizigen spray
characteristics and prognosis of moderate or severe tricuspid regurgitation

Conditions: Tricuspid Valve Disease

Summary: the tricuspid valve : its evaluation is relatively difficult in echocardiography and the management of tricuspid valve diseases remains poorly codified.

the tricuspid valve is often called the "forgotten valve" because its evaluation is relatively difficult in echocardiography and the management of tricuspid valve diseases remains poorly codified. in developed countries, tr is mainly functional, related to a remodeling of the right cavities in response to an increase in the load conditions. this remodeling induces a dilation of the tricuspid ring and / or a "tenting" of the tricuspid leaflets. once tr is present, a vicious circle settles because tr increases right ventricle dilation. transthoracic echocardiography is the key examination allowing noninvasive, quantification and assessment of hemodynamic repercussions of tr. tr remains asymptomatic for a long time, often diagnosed with a significant delay at the stage of advanced right heart failure. at this stage, the surgical risk is important, at least more important than for left heart valve diseases and it is therefore essential to define the right time for proposing valvular surgery to patients. indeed, tr is an independent factor of mortality and only surgical treatment improves the prognosis. current guidelines remain vague given the low number of prognostic studies and of their contradictory results often influenced by the significant comorbidities of patients, the presence of pulmonary hypertension or left heart valve disease. only a minority of patients (\<1%) is referred to surgery because operative mortality is often judged unacceptable in elderly patients or in cases of advanced right ventricular dysfunction. the constitution of a prospective and retrospective cohort will improve the state of knowledge on etiologies, natural history, prognosis and management of patients with moderate or severe tr.

Eligibility criteria:
inclusion criteria: * age \>18 ans * inclusion criteria: moderate or severe tricuspid regurgitation * exclusion criteria: refusal to participate/ prior surgery of the tricuspid valve

Keywords: tricuspid regurgitation tricuspid valve surgery outcome prognosis mortality right ventricle asymptomatic
prospective randomized trial comparing urinary diversion after robot-assisted radical prostatectomy

Conditions: Prostate Cancer

Summary: the purpose of the study is to determine, whether the urinary diversion via suprapubic cystostomy compared to transurethral catheterization after robot-assisted radical prostatectomy superior the postoperative patient comfort and reduce the postoperative bacteriuria.


Eligibility criteria:
inclusion criteria: 1. minimum age of 18 years 2. voluntarily agreement to participate in this study 3. written informed-consent 4. release of medical records for regulatory or research purposes 5. clinically organ-confined prostate cancer exclusion criteria: 1. bmi \>40 2. history of catheterization 3. history of radiation 4. history of chemotherapy 5. person's participating in any other research 6. unable to provide informed consent

Keywords: urinary diversion urethral catheter suprapubic tube radical prostatectomy robotic surgery discomfort pain