Kornimate/medical-research-clean huggingface dataset:
endoscopic treatment of intestinal fistulas and perforations

Conditions: Gastrointestinal Fistula; Gastrointestinal Perforation

Summary: gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. the purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.

novel endoscopic devices have the potential to overcome the need for invasive surgery for the treatment of gastrointestinal fistulas or perforations. instead of a large abdominal incision or multiple incisions with the related postoperative morbidity endoscopic techniques will be used used which require no postoperative limitation of activities. using novel tissue closure devices, such as a tissue apposition system or an endoscopic suturing system, we will evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in patients having either chronic gastrointestinal fistulas or acute perforations.

Eligibility criteria:
inclusion criteria: * gastrointestinal fistula and perforation * ability to undergo general anesthesia * ability to give informed consent exclusion criteria: * contraindicated for esophagogastroduodenoscopy (egd) * contraindicated for colonoscopy * bmi ≥ 40 * presence of esophageal stricture * altered gastric anatomy * intraabdominal abscess or severe inflammation

Keywords: endoscopic tissue closure, gastro-gastric fistulas, gastrointestinal perforations
a study to evaluate efficacy in subjects with esophageal cancer treated with nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

Conditions: Various Advanced Cancer

Summary: the main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin


Eligibility criteria:
inclusion criteria: * must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus * male or female at least 18 years of age * must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out * must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work * must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study exclusion criteria * presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment * active known or suspected autoimmune disease * any serious or uncontrolled medical disorder or active infection * known history of positive test for human immunodeficiency virus (hiv) or known acquired immunodeficiency syndrome (aids) * any positive test result for hepatitis b or c indicating acute or chronic infection and/or detectable virus other protocol defined inclusion/exclusion criteria apply
information with or without numbers for optimizing reasoning about medical decisions

Conditions: Colorectal Cancer Screening

Summary: experts believe that increasing the low uptake of screening for colorectal cancer (crc) requires educating patients about all approved tests and helping them choose one that fits their preferences. as one motto puts it: "the best test is the one that gets done." screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (fit)). but it is unclear how best to educate patients about the options and the tradeoffs involved. some guidelines recommend that decision aids, a promising tool in this area, provide patients with detailed quantitative information, including baseline risk, risk reduction, and chance of negative outcomes. but this sort of "comparative effectiveness" data can confuse patients, especially those with limited mathematical ability. previous studies have not measured the effect of providing quantitative information to patients with varying levels of ability or interest or asked them whether such data is essential for their decision-making. the investigators will conduct a clinical trial to determine the impact on patients who view a decision aid (da) that includes quantitative information versus a da without such data. the investigators will also seek to determine whether numeracy moderates the effect of quantitative information.


Eligibility criteria:
inclusion criteria: 1. have not had colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years, or fecal occult blood testing (including fit) in last 1 year and 2. have a scheduled appointment or due to schedule an appointment with a healthcare practitioner at our performance sites. exclusion criteria: 1. undergoing workup for symptoms consistent with colon cancer, such as weight loss or rectal bleeding 2. have a diagnosis or medical history conferring elevated risk for crc including polypectomy or colon cancer, inflammatory bowel disease, certain inherited syndromes, or a significant family history of crc 3. are unable to speak and read english.

Keywords: decision aid cancer screening colorectal neoplasm decision making risk communication numeracy health literacy
effect of immersion, performed under the conditions of obstetrical dilatation bath, on diuresis and hemodynamic variables in young women

Conditions: Healthy

Summary: like in the full immersion, studied in the context of diving, immersion in water causes a cascade of events with hemodynamic and hormonal consequences. first, immersion leads to a relative hypervolemia by venous redistribution and then 40-60 minutes later, hypovolemia by stimulating diuresis. dilatation bath is helpful in relieving moderate pain the first stage of obstetrical labor. however, when the labor progresses, the dilatation bath is no longer sufficient and epidural analgesia remains the only effective method to control pain. used before the realization of an epidural analgesia, dilatation bath could affect blood volume and thus worsen the hemodynamic consequences of the sympathetic block that is linked to the installation of sensory block of the epidural analgesia in the parturient (severe prolonged maternal hypotension that can cause a decrease of the placental perfusion and fetal distress). before beginning a study in pregnant women, it seems essential to study the hemodynamic consequences of the dilatation bath in a comparable population of volunteers healthy young women and out of the obstetrical context.


Eligibility criteria:
inclusion criteria: healthy female volunteers aged 18 to 45 years exclusion criteria: * pregnancy * menopause (confirmed for at least 12 weeks) * breastfeeding * proteinuria\> 2 cross on the dipstick * glycosuria \> 2 cross on the dipstick * subject with no empty stomach for at least 8 hours * taking medication in the week before the test affecting diuresis, production of antidiuretic hormone or on the cardiovascular system: paracetamol, nonsteroidal anti-inflammatory alcohol intake the day before the tes

Keywords: volunteers
clinical data collection of myopic patients after ptk-prk with czm mel 90 excimer laser

Conditions: Refractive Errors

Summary: the objective of the clinical investigation presented to is to verify predictions of post-operative ptk-prk refractive outcome made by the epimaster application software by comparing these to post-operative clinical data after routine ptk-prk treatments.

the objective of the clinical investigation presented to is to verify predictions of post-operative ptk-prk refractive outcome made by the epimaster application software by comparing these to post-operative clinical data after routine ptk-prk treatments. the epimaster application software is not used in this clinical investigation, consequently, it is a merely observational investigation.

Eligibility criteria:
inclusion criteria: * inclusion criteria are according to the user manual of czm mel 90 excimer laser for treatment of refractive errors * patient present with myopic or myopic and astigmatic error * patient will be able to understand the patient information and willing to sign an informed consent * patient will be willing to comply with all follow-up visits and the respective examinations exclusion criteria: * exclusion criteria are according to the user manual of czm mel 90 excimer laser for treatment of refractive errors
a study to determine the efficacy of zpl-3893787 in subjects with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this was a randomized, double blind, placebo controlled, parallel group study in approximately 90 subjects with moderate-severe ad eczema area and severity index (easi) ≥12 and ≤ 48 (0-72 scale). following a run-in subjects were randomized to receive either oral 30 mg zpl-3893787 once daily (od) or placebo od for 8 weeks (56 days).


Eligibility criteria:
inclusion criteria: males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 12 months prior to screening. chronic ad should be diagnosed by the eichenfield revised criteria of hanifin and rajka (eichenfield, 2004) eczema area and severity index (easi) of ≥12 and \<48. an investigator's global assessment (iga) score ≥ 3 at both screening and day 0. a mean pruritus score of ≥ 5 on a 0-10 scale over the 7 day run in (days -7 to -1) atopic dermatitis affecting ≥10% bsa exclusion criteria: ad of such severity (easi \>48) that the subject could not comply with the demands of the study and/or the subject is not a suitable candidate for a placebo-controlled study have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments. have an active skin infection or any other clinically apparent infections. hypersensitivity to mometasone or to any other ingredients contained by the topical corticosteroid product used as rescue medication in the study. have received phototherapy (e.g. uva, uvb), or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on ad, within 4 weeks of the start of the run in. have received systemic corticosteroids (\[cs\] e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of the start of the run in. subjects on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal cs may participate. were treated with oral antihistamines or topical calcineurin inhibitors or topical steroids within 7 days of starting run in; intranasal antihistamines for the treatment of allergic rhinitis are acceptable.
follow-up in early and locally advanced breast cancer patients

Conditions: Breast Cancer

Summary: a cross-sectional follow-up study of early and locally advanced breast cancer patients after primary treatment.

the objective of this study is to assess follow-up patterns and identify patients with increased levels of physical and/or psychosocial problems after treatment in early breast cancer and locally advanced breast cancer. 830 patients stratified by cancer sites and treatment - a minimum of 120 patients within each stratum - will be recruited. institutional data on follow-up policy, demographic and clinical data (related to treatment history and tumor characteristics) will be collected. patients will complete a set of 139 quality of life questions, at one single time point. statistical analysis includes descriptive statistic for socio-demographic and clinical data, overall and per treatment, age and risk group. patterns of follow-up will be identified and described overall, and per treatment, age, risk group and country. where available, normative data will be used to identify those qol domains where there is a clinically relevant difference with the general population. multivariable model building will be used to build predictive models on the overall population to investigate determinants for the physical, sexual and emotional needs based on the identified prom outcomes. factor analysis will be undertaken to investigate the inter-correlations between physical, sexual and emotional needs in the overall population and in the relevant subgroups of interest. the magnitude of the observed differences will be assessed by clinical important effect size rather than by statistical significance.

Eligibility criteria:
inclusion criteria: * histologically proven early breast cancer (ebc) and locally advanced breast cancer (labc) patients who have completed their primary treatment (except endocrine therapy), between 12 months and 36 months after the diagnosis. * disease-free without any evidence of relapse * age ≥ 18 years. * ability to understand and fill out questionnaires. * written informed consent. exclusion criteria: * metastatic breast cancer (defined as secondary spread to other organs, such as bones, lung, liver, mediastinal lymph nodes) or dcis. * other cancer diagnosis in the past 5 years except non-melanotic skin cancer or cervical intraepithelial neoplasia. * male breast cancer. * patients on maintenance therapy (other than endocrine therapy). * patients participating in interventional clinical studies with quality of life as primary endpoint. * any psychological (including preexisting psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
italian registry on unprotected left main

Conditions: Cardiovascular Disease; Coronary Artery Disease

Summary: the ritmo (registro italiano sul trattamento del tronco comune non protetto) observational study will appraise the prevalence, management strategy, and prognosis of unprotected left main coronary artery disease in italy.

the ritmo (registro italiano sul trattamento del tronco comune non protetto) observational study will be a prospective, multicenter, observational study aiming to appraise the prevalence, management strategy, and prognosis (up to 5 years) of unprotected left main coronary artery disease in italy. a total of 45 italian secondary and tertiary care centers will participate, and enroll patients during a period of 12 to 18 months. patients will be included provided that they complete a written informed consent form and significant unprotected left main coronary artery disease is established at diagnostic coronary angiography. the primary end-point will be the 12-month rate of major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization).

Eligibility criteria:
inclusion criteria: * angiographic evidence of significant unprotected left main disease * lack of patent bypass grafts for the left coronary system * willingness to complete written informed consent form * willingness to comply with subsequent follow-up contacts exclusion criteria: * lack of written informed consent form * inability to comply with subsequent follow-up contacts

Keywords: cardiovascular disease coronary artery bypass grafting (cabg) coronary artery disease (cad) percutaneous transluminal coronary angioplasty (pci) unprotected left main disease
visual performance of center distance daily disposable multifocal lenses

Conditions: Myopia

Summary: the purpose of this study is to compare visual performance (high and low contrast acuity, reading acuity, contrast sensitivity, stereoacuity, accommodative response, eye hand coordination, far near vision, and dynamic vision) between visioneering technologies, inc. naturalvue multifocal and coopervivion misight.


Eligibility criteria:
inclusion criteria: * participants must satisfy the following conditions for inclusion in the trial: * be between 9 and 30 years of age * sign written informed consent/assent. * spherical equivalent glasses prescription: -0.50 to -7.00 diopters (d), astigmatism: ≤ -0.75d, anisometropia: ≤ 1.00d * 20/20 vision in each eye * existing contact lens wearer * an eye exam in last 9 months, normal stereoacuity on prior chart (or test if not available) * no known ocular disease - anterior or posterior (posterior determined by history/chart) * have an acceptable or optimal fit with test lenses and be willing to wear these lenses as directed for the duration of the study. * on examination, have ocular findings considered to be within normal limits. * be willing and able to follow instructions and attend the schedule of follow-up visits. exclusion criteria: * any of the following will exclude a participant from this trial: * current hard lens wearers * using eye medication contraindicating lens wear such as daily use of artificial tears. * eye injury or surgery within twelve weeks immediately prior to enrollment for this trial. * history of corneal refractive surgery * currently enrolled in an ophthalmic clinical trial that could negatively impact corneal or conjunctival health in this trial. * evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. * allergy or sensitivity to any product used in this trial. * pre-existing ocular condition that would contraindicate lens wear. * any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye or be exaggerated by wearing contact lenses. * lazy eye (strabismus or amblyopia) * pupil size \< 3.00 mm in either eye in dim light (measured at approximately 10 cd/m2 )

Keywords: contact lens multifocal
hdr focal: feasibility study

Conditions: Prostate Cancer

Summary: brachytherapy as a monotherapy treatment is highly effective for localized prostate cancer, traditionally being delivered to the whole prostate gland. lately, low dose rate (ldr) brachytherapy has been increasingly replaced by high dose rate (hdr) brachytherapy treatment schemes. while brachytherapy's oncologic outcomes are excellent, it is not without incidence adverse effects including urinary, rectal, and sexual toxicities that affect the patient's quality of life. this study will incorporate hdr monotherapy treatment option for early stages and favourable risk prostate cancer. additionally, we aim to evaluate the role of focal hdr brachytherapy for well-defined disease based on multiparametric mri (mpmri). this approach may offer an option of reducing the treatment toxicities while maintaining oncologic outcomes when compared with whole-gland therapy. advantages in quality of life could be exhibited in the form of reduced urinary discomfort and incontinence, rectal symptoms, and improved erectile and prostatic gland function. this study would be particularly relevant in the current era of earlier localized prostate cancer detection, where newer imaging modalities (e.g. mpmri) become a routine component of patient care.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * ecog performance status 0 - 2 * histological evidence of prostate adenocarcinoma * low- and favorable intermediate-risk prostate cancer * informed consent: all patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed * no contraindications to mri: * absent or unifocal intraprostatic disease (\<2 separate/distinct lesions), on multiparametric mri * prostate gland size \<80cc * baseline ipss \<18 * no trup within the past 6 months, nor large turp defect * absence of radiological evidence of regional or distant metastases (optional evaluation, at physician discretion) * no previous pelvic and/or prostate ebrt and/or brachytherapy * no contraindications to general anesthesia, or spinal/epidural anesthesia * absence of bleeding diathesis and/or anti-coagulative therapy that cannot be temporarily ceased during brachytherapy * no contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or colorectal surgery * negative past medical history of ulcerative colitis, crohn's disease, ataxia telangiectasia, or sle * absence of latex allergy * no other medical conditions deemed by the pi to make patient ineligible for prostate hdr brachytherapy

Keywords: high dose-rate brachytherapy
omega-3 and quality of life in recurrent aphthous stomatitis patients

Conditions: Recurrent Mouth Ulcers

Summary: the study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers

in this study, we tested the hypothesis that the administration of omega 3 improve the quality of life in patients suffering recurrent oral ulceration and improve associated symptoms of pain in addition to reduction of ulcers episode.

Eligibility criteria:
inclusion criteria: 1. male and female patients older than 13 years of age 2. presenting with 1 to 3 aphthous ulcers (less than 48 hours' duration) with a size no greater than 5mm in diameter. 3. history of recurrent minor aphthous ulcer for at least one year with a frequency of at least one outbreak every one month. 4. normal sense of pain, without anesthesia or paresthesia. 5. willingness to participate and sign the informed consent. exclusion criteria: * 1- concurrent clinical conditions that could pose a health risk to the subjects including serious heart, liver, or kidney dysfunctions. 2- pregnancy and lactation. 3- ulcers as a manifestation of systemic disorders such as ulcerative colitis, crohn's disease, behçet's syndrome or serious anemia. 4- treatment with systemic steroids, immunomodulatory agents, antibiotics, non-steroidal anti-inflammatory drugs (except occasional use for headaches) one month prior to the study entry. 5- treatment of the current ulcer with any topical or systemic medication. 6- attendance of any other clinical trials prior to 3 months of study entry.

Keywords: omega-3 recurrent aphthous stomatitis quality of life
high (100mg) versus standard (60mg) loading dose of prasugrel in patients with st-elevation myocardial infarction (stemi), undergoing primary percutaneous coronary intervention (pci)

Conditions: Platelet Reactivity

Summary: this is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups of p2y12 inhibitor-naive consecutive stemi patients undergoing primary pci. following aspirin 325 mg ld, patients will receive 60 mg or 100 mg of prasugrel, respectively. platelet reactivity (pr)will be assessed at hour 0 (before prasugrel's administration immediately prior to pci) and at hours 0.5, 1, 2, 4 thereafter. platelet function testing (in pru) will be performed with the verifynow (accumetrics inc., san diego, ca, usa) p2y12 function assay.


Eligibility criteria:
inclusion criteria: * st elevation myocardial infarction * pain onset \<12 hours * age \>18 and \<75 years * written informed consent exclusion criteria: * history of stroke/transient ischemic attack * oral anticoagulation * hemodynamic instability * platelet count \<100000/μl * hematocrit \<30% * creatinine clearance \<30 ml/min * severe hepatic dysfunction * active bleeding * weight \<60 kg * periprocedural iib/iiia inhibitor administration

Keywords: prasugrel st elevation myocardial infarction