Kornimate/medical-research-clean huggingface dataset:
treatment of colonic obstruction with cook evolution® colonic stent system

Conditions: Colonic Obstruction; Colonic Stricture; Large Bowel Obstruction

Summary: the objective of this registry is to compile clinical data on the use of the evolution® colonic stent system for the palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.


Eligibility criteria:
inclusion: per the ifu, * colonic strictures caused by malignant neoplasms, and * large bowel obstruction due to malignant strictures prior to colectomy. exclusion: * central ischemia, * any contraindication to gi endoscopy and any procedure to be performed in conjunction with stent placement, * suspected or impending perforation, * intra-abdominal abscess/perforation, * inability to pass wire guide or stent deployment system through the obstructed area, * patients for whom endoscopic or percutaneous procedures are contraindicated, * benign disease, and * coagulopathy.

Keywords: colonic obstruction
acute carotid sinus endovascular stimulation ii study

Conditions: Hypertension

Summary: the acute carotid sinus endovascular stimulation ii (aces ii) study is a multicenter, prospective, non-randomized study that is being conducted to evaluate the feasibility of endovascular stimulation of carotid sinus nerves via an electrophysiology (ep) catheter advanced into the internal jugular vein (ijv). the current study investigates the hypothesis that intraoperative electrical stimulation of the carotid sinus from the ijv will result in an acute and dose-dependent reduction in blood pressure and heart rate.

all study objectives are being assessed during the intraoperative baroreceptor stimulation. no subsequent testing will be performed. the follow-up visit is only intended to assess for adverse events.

Eligibility criteria:
inclusion criteria: * subject is at least 18 years old * subject is hypertensive (defined as at least one in-office systolic bp measurement ≥140 mm hg or diastolic bp ≥90 mm hg within three months prior to enrollment * subject is undergoing a cardiac catheterization involving right heart catheterization and/or ep procedures. * subject (or subject's legally authorized representative) is able and wiling to give informed consent exclusion criteria: * subject has an ejection fraction (ef) less than 35% (by most recent echocardiography in the past 6 months) and there has been no change in clinical status relative to ef * subject is a woman who is pregnant, nursing, or of child bearing potential and is not on a reliable form of birth control * subject is enrolled or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. co-enrollment in concurrent trials is only allowed with documented pre-approval from the medtronic study manager, documenting that there is not a concern that co-enrollment could confound the results of this trial. * subject is unable or unwilling to participate with study procedures
a study of bimatoprost in the treatment of primary open angle glaucoma and ocular hypertension

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (iop)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.


Eligibility criteria:
inclusion criteria: * diagnosis of open-angle glaucoma or ocular hypertension * no use of lumigan® in the past 3 months exclusion criteria: * received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months
evaluation of fenofibrate on radiation-induced skin injury

Conditions: Radiodermatitis

Summary: fenofibrate is a specific ligand for pparα, which has been used for the treatment of hypercholesterolemia, hypertriglyceridemia, diabetes and cardiovascular diseases for long time. fenofibrate reduces low-density lipoprotein (ldl), very low density lipoprotein (vldl) and triglyceride levels, while increases high-density lipoprotein (hdl) levels. pparα has also shown antioxidant and anti-inflammatory properties. fenofibrate confers cytoprotective effect against myocardial ischemia-reperfusion (i/r) injury in rats by suppressing cell apoptosis and ameliorates age-related renal injury through the activation of ampk and sirt1 signaling. however, the safety and effectiveness of fenofibrate on the progression of radiation-induced skin injury remain unknown. the purpose of this study is to determine whether topical application of fenofibrate is safe and effective for radiation-induced skin injury.

radiation-induced skin injury is a significant side effect of ionizing radiation delivered to the skin during cancer treatment as well as a result of other exposure to radiation. the skin is one of radiosensitive organ systems in human body because it is a continuously renewing organ containing rapidly proliferating and maturing cells. ionizing radiation promotes reactive nitrogen and oxygen species (rns/ros) production due to radiolysis of water and direct ionization of target molecules, which result in oxidative damage and skin injuries. it is considered that \~95 % of cancer patients receiving radiation therapy will develop some form of radiodermatitis, including erythema, dry desquamation, and moist desquamation. radiation-induced skin injury negatively affects the process of radiotherapy and the quality of patients' life. despite substantial improvements in radiation technology, radiation-induced skin toxicity is still a concerning problem. the purpose of this study is to determine whether topical application of fenofibrate is safe and effective for radiation-induced skin injury.

Eligibility criteria:
inclusion criteria: * eligible patients had to have a pathologically proven cancer with a planned course of radiotherapy. * normal haematological function (granulocyte count \> 1.5 x 109 cells per litre, platelet count \> 100 x 109 cells per litre and haemoglobin \> 100 g/l) and organ function (creatinine clearance \> 50 ml/min) and aspartate aminotransferase/alanine aminotransferase \< 2.5 of upper normal limit). exclusion criteria: * the presence of rash or unhealed wound in the radiation field, known allergy or hypersensitivity to fenofibrate, pregnancy or lactation, history of/current connective tissue disorder and prior radiation to the thorax.
cohort of patients with pelvic gynecological cancer: constitution of a collection of biological samples with radioclinical characterization

Conditions: Pelvic Neoplasms; Endometriosis

Summary: the management of pelvic gynecological cancers (pgc) is based on the determination of extension to guide treatments. the biology of the cgp is constantly evolving and personalized medicine adapted to this biology is currently in full development. for example, sequencing ovarian tumors can select patients who can benefit from anti-parp therapy. there is therefore a need for patients to have biological samples of their tumor. various studies on ovarian, endometrial and cervical cancer have sought to identify the factors predictive of recurrence of these cancers. the results obtained are very promising. this study will permit to collect biological samples and detailed clinical data that would allow to test hypotheses and develop a personalized medicine based on clinical and biological characteristics of patients.

the management of pelvic gynecological cancers (pgc) is based on the determination of the extension in order to guide the treatments. the biology of pgc is constantly evolving and personalized medicine adapted to this biology is currently in full development. for example, sequencing of ovarian tumors allows selection of patients who may benefit from anti-parp therapy. there is therefore a need for patients to have biological samples of their tumor. various studies on ovarian, endometrial and cervical cancer have sought to identify factors that predict recurrence of these cancers. the results have obtained are very promising, but if coordinator team have at our disposal fundamental and translational data related to the prognosis of pgcs, the coordinator team lack access to a biological collection of these cancers that would allow us to test our hypotheses and to develop personalized medicine related to the clinico-biological characteristics of the patients. endometriosis is the 1st cause of chronic pelvic pain (25-40% of women suffering during sexual intercourse) and represents the 1st cause of school and work absenteeism. unfortunately, it is under-diagnosed and too often inappropriately managed. it is considered that 10 to 15% of the female population of reproductive age has endometriosis. this incidence reaches 50% in women with infertility. there are many similarities between deep endometriosis and pelvic cancers, whether on a physiopathological, epidemiological or clinical level. there are therefore many similarities in the surgical management as well as in the research strategies.

Eligibility criteria:
inclusion criteria: * diagnosis of pelvic gynecological cancer posed on initial histological analysis or during recurrence; * or diagnosis of endometriosis on histology or imaging * age ≥ 18 years; * affiliation to the general social security scheme; * consent signed. exclusion criteria: * refusal of the patient; * non-affiliation to the general social security scheme.
paula method of exercises in patients with lars syndrome

Conditions: Low Anterior Resection Syndrome

Summary: sphincter sparing rectal resection surgery, either total mesorectal excision (tme) with a temporary loop ileostomy or partial mesorectal excision (pme), is the mainstay of rectal cancer treatment , however, these treatments are associated with the development of low anterior resection syndrome (lars). this syndrome is characterized by a constellation of symptoms such as fecal frequency, urgency and clustering of bowel movements and can lead to fecal and flatus incontinence. there is no gold standard therapy designed to treat the root cause of the problems associated with lars. paula method of exercises, based on the theory that the body has the natural ability to self-heal and that all sphincter muscles in the body affect one another other and thus, exercising one healthy region can positively impact another. the purpose of this study is to evaluate the feasibility of the paula method of exercises in patients post sphincter sparing rectal resection surgery with lars syndrome.


Eligibility criteria:
inclusion criteria: * over age 18 * lars syndrome (lars score of 21 or higher) up to 24 months post sphincter sparing rectal resection * able to read, understand and communicate in hebrew exclusion criteria: * pregnancy * actively undergoing chemotherapy or radiation * other causes of anal incontinence or bowel dysfunction (ex: irritable bowel syndrome) * concurrent performance of other exercise methods * unable or unwilling to perform the paula exercises

Keywords: paula method sphincter sparing rectal resection anal incontinence
breast cancer risk assessment using optical breast spectroscopy (obs)

Conditions: Breast Cancer

Summary: this study aims to evaluate if a light based technique, called optical breast spectroscopy (obs) formerly known as transillumination breast spectroscopy (tibs), can be used to detect differences in breast tissue between high- and low-risk populations and within the high-risk population between brca1 or 2 carriers and non-carriers. these differences may include differences in breast tissue composition and metabolism at time of enrollment into the study (possibly reflecting changes occurring in adolescence) and in the rate of breast tissue change over time (possibly reflecting rate of tissue transformation from normal to ultimately malignant state).

preliminary data show optical breast spectroscopy (obs)has the ability to detect tissue differences with various pathologies and age-related changes in breast tissue over a two year period. in the present study, we want to determine whether obs has the ability to detect optical differences between women who harbor a mutation in the breast cancer susceptibility gene, brca1 or brca2, and their age-matched controls (non-carriers). more specifically, possible differences in the breast tissue at time of enrollment into the study (reflecting changes potentially occurring in adolescence) and in the rate of breast tissue change over time (reflecting rate of tissue transformation from normal to ultimately malignant state). the overall goal is to develop a pre-screening technique to survey or monitor the risk of breast tissue and to advise the earliest point when imaging techniques (e.g. mri) should be initiated or when more drastic primary prevention measures are recommended.

Eligibility criteria:
inclusion criteria: brca carriers (cases) * attending one of the three participating high-risk screening centres * confirmed brca1 or brca2 mutation status through genetic testing high-risk (cases) * attending one of the three participating high-risk screening centres * confirmed negative brca1/2 status through genetic testing brca non-carriers (controls) * attain a gail model score of \<1.1 and have \<10% risk of carrying the brca mutation determined by the penn ii model) * controls from high-risk screening centre with confirmed brca1/2 negative status through genetic testing * preference will be given to sisters or first degree cousins of brca carriers exclusion criteria: cases and controls * prior diagnosis or breast or ovarian cancer * bilateral biopsy or fine needle aspiration within 1 year of study start * bilateral mastectomy, lumpectomy or cosmetic alteration (reduction/augmentation) * previous or current chemotherapy or prevention therapy (tamoxifen) * less than 3 years post pregnancy at study start * inability to provide informed consent due to language or cognitive difficulties \*for controls only * family history of breast cancer where family member had an early diagnosis (before age 45 years) * family history or ovarian cancer

Keywords: breast cancer risk brca1 brca2 breast cancer susceptibility gene optical transillumination spectroscopy transillumination breast spectroscopy
prospective study on safety and efficacy of stenting for chronic middle cerebral artery occlusion with limb dysfunction

Conditions: Chronic Middle Cerebral Artery Occlusion; Stenting Treatment; Modified Rankin Scale; National Institutes of Health Stroke Scale

Summary: the goal of this clinical study is to evaluate the safety and efficacy of stenting for revascularization treatment of chronic middle cerebral artery (mca) occlusion in patients with chronic mca occlusion. the main questions it aims to answer are: 1. whether stenting treatment can improve blood flow restoration in chronic mca occlusion. 2. if stenting can reduce the rates of reocclusion. 3. how stenting affects the recovery of neurological functions in these patients. researchers will compare the stenting group, which received stenting revascularization in addition to aspirin treatment, to the control group, which received only aspirin treatment to see if stenting treatment provides superior outcomes in terms of neurological function improvement and safety profile. participants will: 1. undergo full cerebral angiography to identify the occlusion site. 2. all participants will be monitored for post-procedure complications and neurological function using the modified rankin scale (mrs) and national institutes of health stroke scale (nihss) before and after treatment. 3. participants will be followed up for three months post-treatment to assess the long-term efficacy and safety of the stenting procedure.


Eligibility criteria:
inclusion criteria: * age and gender: individuals aged 18 and above, regardless of gender. * diagnosis: chronic mca occlusion confirmed by imaging studies (such as magnetic resonance imaging (mri) or computed tomography (ct)) for more than 3 months. * symptoms: neurological deficits caused by mca occlusion, such as hemiplegia, speech disorders, etc. * treatment history: no stenting revascularization for mca occlusion within the past three months. exclusion criteria: * acute stroke: occurrence of an acute cerebrovascular event within the past three months. * other significant diseases: such as severe heart disease, liver or kidney dysfunction, cerebral hemorrhage, active bleeding, or coagulation disorders. * allergy to contrast agents. * severe mental illness or inability to comply with study requirements. * pregnant or breastfeeding women. * discovery of mca occlusion without any symptoms. * participation in other clinical trials within the past six months.
digital marking systems

Conditions: Cataract

Summary: comparison of the alignment axis of the alcon verion and the zeiss callisto alignment systems intraoperatively

in most patients undergoing cataract surgery, emmetropia can be achieved by implantation of a monofocal intraocular lens (iol). however, several studies have shown that approximately 20% to 30% of patients who undergo cataract surgery have a preexisting corneal astigmatism of 1.25 diopters (d) while the prevalence of corneal astigmatism \>2.00 d is 8% and over \>3.00 d 2.6%. this astigmatism, if not corrected during surgery, leads to postoperative spectacle dependence. in patients without contraindications and a desire to achieve postoperative freedom from spectacles for distance vision, correction of astigmatism can be achieved at the time of surgery by using toric iols. a number of factors relating to corneal astigmatism are critical to lens selection and positioning.the most important factors are the preoperative corneal measurements and the correct alignment of the toric lens itself. each degree of deviation results in a 3% reduction in astigmatism correction. the introduction of digital marking systems is intended to minimize the disadvantages of manual marking, such as tilting of the head during marking, incorrect and smudged marking. in addition to several different manual marking methods, there is also a range of digital markers which have been proven to be equal or even better than manual marking. these include among others the callisto eye with z-align and the alcon verion digital marker. the principle of these digital marking systems is based on a preoperative photo which is recorded in the course of biometry where the keratometry values are obtained. in the further course, the steep axis is determined on the basis of this image and the target axis is projected on to the eye intraoperatively. beside the ideal implantation axis for the t-iol, the size of the capsulorhexis and position, as well as incision placement can be displayed. in the course of this study, we will investigate the alignment axis of the two most used digital guidance systems from alcon and zeiss. a head to head comparison has already been carried out by hura et al. in 2017. 15 eyes of 15 patients will be included into this study. there will only be one preoperative study visit, on the day of surgery, where reference pictures with a slitlamp camera and the biometers will be taken.

Eligibility criteria:
inclusion criteria: * age-related cataract and scheduled for cataract surgery * age 21 or older * written informed consent prior to surgery exclusion criteria: * dense cataract or corneal pathology that would significantly influence the measurements * previous ocular surgery, ocular inflammation, or ocular trauma * nystagmus or pathologies that might affect patient's fixation * pregnancy * corneal astigmatism \> 1.5 dpt. or need for a toric iol

Keywords: astigmatism digital marking systems
high dose of erythropoietin analogue after cardiac arrest

Conditions: Comatose Survivors of Cardiac Arrest

Summary: the investigators hypothesised that the neuroprotective effects of erythropoietin and its analogues could lead to an improve outcome after cardiac arrest. to test this hypotheses, the investigators designed a randomized, multicentre, simple blind trial in which all participating patients will be receive usual treatments and 50% of them will also receive a high dose of epoetin alpha (an analogue of erythropoietin) in an "add on" fashion. the main end point will be the proportion of patients in each arm who will reach at day 60 the best level of recovery, using a 5 level score.

rationale: a recent pilot study showed encouraging results regarding the potentially beneficial effects of high dose epoetin alpha (an analogue of erythropoietin) when administered early after cardiac arrest. in this open label and non randomized trial, a high proportion of patients survived without significant cerebral disability and without experiencing severe adverse events (cariou et al. resuscitation 2008). efficiency of this treatment should now be evaluated in a randomized trial. hypotheses: an early administration of a high dose of epoetin alpha (epo) after cardiac arrest resuscitation could improve the neurological outcome of these patients by comparison with standard treatment. the proportion of patients reaching the level 1 of the pittsburgh cpc scale (i.e., no or minor cerebral disability) at day 60 could attain 45% in the interventional group versus 30% as expected in the control group. design: multicentre, randomised, controlled, simple blind trial ("add on study"). main goal: to test the efficiency of a high dose of epo administered at the early stage of the post-cardiac arrest period regarding its ability to improve the neurological outcome of these patients, when compared with standard care (including hypothermia when indicated).

Eligibility criteria:
inclusion criteria: * age between 18 and 80 * witnessed out-of-hospital cardiac arrest, presumed of cardiac origin (non asphyxic) * time from cardiac arrest and recovery of circulatory activity less than 60 minutes * persistent coma after rosc (coma glasgow scale \< 7) exclusion criteria: * out-of-hospital cardiac arrest with evidence of extra-cardiac cause (trauma, sepsis, acute respiratory insufficiency, asphyxia) * previous or chronic treatment with erythropoietin or analogues * pregnancy * rapidly fatal underlying disease (expected life duration \< 6 months) * no social security

Keywords: cardiac arrest erythropoietin post-anoxic encephalopathy neuroprotective drugs
bilateral brain stimulation in trauma therapy

Conditions: Intervention Study; Handling (Psychology)

Summary: comparatively studied the effects of eye movement desensitization and reprocessing (emdr) bilateral brain stimulation in trauma therapy. a randomized, parallel, before-after, blind study was performed.

comparatively studied the effects of eye movement desensitization and reprocessing (emdr) bilateral brain stimulation in trauma therapy. a randomized, parallel, before-after, blind study was performed. thirty nine subjects were randomly distributed to two groups: one session of emdr psychotherapy standard and other with emdr standard protocol without its typical brain bilateral stimulation. the results of the beck scales for anxiety, depression and hopelessness and the impact of events test were compared between groups.

Eligibility criteria:
inclusion criteria: * inclusion criteria for the study were to be a university student, over 18 years old, to have a complaint associated to a traumatic life event and to have accepted to participate of the study. exclusion criteria: * exclusion criteria were the existence of untreated psychiatric disorders and the hypothesis of worsening of the subject's status as the number of sessions in this study was restricted to once.

Keywords: traumatic memories comparative study single session emdr beck inventory