Kornimate/medical-research-clean huggingface dataset:
accuracy of cadx system for white light colonic polyp characterization

Conditions: Colonic Polyp; Adenoma Colon

Summary: the endoscopist performances in the optical diagnosis (od) of colonic polyps with the available technologies vary widely across centers and across endoscopists. the od process is strictly related to the operator training and expertise. most of the available studies in optical characterization have been carried out by expert endoscopist in tertiary high volume centers, and weren't replied on large unselected populations. for these reasons, at the moment the optical characterization of polypoid lesions can't replace, in the everyday clinical practice, the histopathological evaluation of resected polyps. artificial intelligence (ai)-based systems have the potential to make optical characterization process of colonic polyps easier and more reliable, thus supporting the endoscopist in the application of leave-in-situ and of resect-and-discard strategies. the implementation of such strategies would lead to a significant economic saving and a decrease of risks and complications related to unnecessary polypectomy. gi-genius system (medtronic inc, minneaopolis, usa) is a cnn-based algorithm allowing an automatic od of colonic polyps. this system does not require dedicated light setting for polyp evaluation as it works with white light high definition images, which are the actual standard in every endoscopic unit. during colonoscopy, when a polyp is framed within the screen, a green detection box surrounds the polyp and the system automatically provides (whenever possible) the optical diagnosis labeling the polyp as "adenoma or non-adenoma". when the automatic polyp charaterization is unfeasible the label "no prediction" appears. nowadays only few data about the feasibility and performances of this system in clinical practice are available. in addition published studies are mostly focused on technical rather thann clinical issues. the present prospective observational trial is primarily aimed at evaluating the diagnostic accuracy of optical characterization of colonic polyps \<= 1 cm using gi-genius system in daily clinical practice, having histopathology examination as reference standard.


Eligibility criteria:
inclusion criteria: consecutive outpatients undergoing colonoscopy for one of the following indication: * fit-based screening program * voluntary screening * post-polipectomy surveillance * gastrointestinal symptoms * family history of colorectal cancer. exclusion criteria: * urgent colonoscopy * patients in which polyps could not be resected (e.g ongoing anticoagulation therapy) * patients with past colorectal cancer or polyposis syndrome
safety and efficacy of a faah-inhibitor to treat cannabis withdrawal

Conditions: Cannabis Dependence

Summary: cannabis dependence is associated with changes in the brain's cannabinoid system. when cannabis dependent individuals try to quit using cannabis, some of them experience problems that make it difficult for them to achieve and maintain abstinence. therefore, reducing the problems related to quitting cannabis may facilitate abstinence. one way to do this is by harnessing the brain's capacity to make its own cannabis-like substances - endocannabinoids. one of the main endocannabinoids is anandamide. the study is based on the hypothesis that the problems related to quitting cannabis use will be reduced by increasing the brain levels of anandamide. furthermore, by reducing the problems related to quitting cannabis, people will be less likely to relapse. brain anandamide levels will be increased by blocking the breakdown of anandamide using a fatty acid amide hydrolase inhibitor (faah-i). the effects of a novel faah-i cannabis withdrawal and relapse in cannabis dependent subjects will be studied in a double-blind, randomized, controlled, proof-of-concept study. cannabis-dependent subjects will receive placebo or the faah-inhibitor pf-04457845 in a 2:1 randomization. the trial consists of a 1 week inpatient stay to achieve abstinence, a 3 week outpatient treatment phase. cannabis withdrawal will be measured during the inpatient phase. cannabis use and urinary thc-cooh levels will be measured during the entire study. the treatment phase will be followed by a safety follow up phase of 8 weeks.


Eligibility criteria:
inclusion criteria: 1. male 2. ages 18-55 (inclusive) 3. cannabis dependence exclusion criteria: 1. allergies or intolerance to faah-inhibitors 2. current significant medical or other comorbidities
safety and efficacy study of cbt-004 in patients with vascularized pinguecula

Conditions: Pinguecula

Summary: study design: structure: multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. duration of treatment: 4 weeks of study treatment with 4 weeks follow-up observations. control: vehicle for cbt-004 (hereafter referred to as vehicle). masking: subjects, investigators, study monitors and the independent image reading center are all masked to the study medications. dosage/dose regimen: one drop of the assigned study medication will be administered in the study eye tid for 4 weeks. the study eye is defined as the qualified eye (i.e., the eye meeting the inclusion criterion for vascularized pinguecula). if both eyes are qualified, then the eye with the more severe vascularity grade at visit 1 will be the study eye.


Eligibility criteria:
inclusion criteria: * pinguecula with a vascularity grade ≥ 3 on a 5-point (0-4) scale. * ocular bothersome questionnaire score ≥ 2 on a 5-point (0-4) scale. * ≥ 18 years of age. * able to provide written informed consent and comply with study assessments for the full duration of the study. exclusion criteria: * uncontrolled systemic disease, in the opinion of the investigator. * active ocular disease other than pinguecula that may confound the study data, including but not limited to severe dry eye disease, pterygium, uncontrolled blepharitis, anterior membrane dystrophy, salzmann's, glaucoma, or active ocular infection. * history of ocular herpes disease, iritis/uveitis, in either eye. * any ocular surgical procedure within the last 3 months or anticipated ocular surgery during the study, in either eye. * anticipated wearing of contact lenses during any portion of the study. patients, who wear soft contact lenses should discontinue wearing them at least 7 days prior to day 1 visit. patients wearing rigid gas permeable or hard contact lenses should discontinue wearing them at least 3 weeks prior to day 1 visit. * female patients who are pregnant, nursing, or planning a pregnancy during the study. * current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to entry into this study. * history of myocardial infarction or stroke. * any condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study. * known allergy or sensitivity to the study medication(s) or its components. * current or anticipated use of topical ophthalmic medications in the study eye. patients must have discontinued use of ophthalmic medications in the study eye for at least 2 weeks (4 weeks for restasis® or xiidra®) prior to day 1 visit. artificial tears are allowed in the study eye until 7 days prior to visit 1 and should not be used during the treatment phase of the study.
randomized clinical trial of an exposure-based cognitive therapy for depression

Conditions: Unipolar Depression

Summary: the purpose of this study is to investigate, if exposure-based cognitive therapy (ebct) is at least as effective as the established cognitive-behavioral therapy and more effective in its long-term efficacy. moreover the mechanisms of change of the ebct are investigated.


Eligibility criteria:
inclusion criteria: * major depressive disorder according to dsm-iv as main diagnosis * minimum standardized depression scores (bdi \>= 17; hamd \>=13) * minimum age of 18 years * informed consent to participate voluntarily in the study * sufficient german language skills exclusion criteria: * acute suicidality * depressive disorder with mood-incongruent psychotic features * chronic depressive disorder * organic cause of depression * drug-induced depression * bipolar disorder * diagnosis of schizophrenia, schizophreniform, schizoaffective disorders, and/or psychosis nos * comorbid dysthymia, psychotic disorder (acute or anamnestic), dementia, substance dependence, schizotypal/ borderline/ or antisocial personality disorder * psychopharmacological treatment other than antidepressants * antidepressant medication, if it is changed within one month prior to the beginning of psychotherapy * other simultaneous psychological treatments

Keywords: depressive episode psychotherapy cognitive therapy emotional processing rct exposure dual process model implicit association test mechanism of change
ultrasound-guided erector spinae plane block using catheter for video-assisted thoracoscopy

Conditions: Post Operative Pain; Opioid Use

Summary: different modalities ranging from patient controlled analgesia (pca) to different regional blocks have been used to control postoperative pain after thoracic surgeries. thoracic epidural analgesia and paravertebral blocks are effective modes of pain relief but have the risks of severe complications and side effects which include severe hypotension, nerve injury or spinal cord injury, vascular injury and pleural injury etc. erector spinae plane block (espb) is relatively new regional technique which was described by forero et al in 2016. several studies have demonstrated an effective role of espb in controlling pain for thoraco-abdominal surgeries which include breast surgery, thoracic surgery and upper gi laparoscopy. shim et al in their study showed that espb significantly reduced pain score in first 6 hours postoperatively in patients who underwent vats. the aim of this study is to evaluate the eﬀect of espb using catheter on postoperative 24 hours opioid consumption in video-assisted thoracoscopy (vats)

video-assisted thoracoscopic surgery (vats) is more commonly used technique nowadays in thoracic surgery. this technique is associated with lesser postoperative pain, better postoperative pulmonary function, decreased mortality and shorter hospital stay. however, patients can have severe and prolonged postoperative pain following vats. homma et al reported that 18.8 % of patients have persistent pain following vats. acute postoperative pain is considered to be one of strong predictor of persistent pain postoperatively. different modalities ranging from patient controlled analgesia (pca) to different regional blocks have been used to control postoperative pain after thoracic surgeries. thoracic epidural analgesia and paravertebral blocks are effective modes of pain relief but have the risks of severe complications and side effects which include severe hypotension, nerve injury or spinal cord injury, vascular injury and pleural injury etc. erector spinae plane block (espb) is relatively new regional technique which was described by forero et al in 2016. several studies have demonstrated an effective role of espb in controlling pain for thoraco-abdominal surgeries which include breast surgery, thoracic surgery and upper gi laparoscopy. shim et al in their study showed that espb significantly reduced pain score in first 6 hours postoperatively in patients who underwent vats. the objective of this study is to investigate the role of espb using catheter in reducing opioid requirements in first 24 hours after vats.

Eligibility criteria:
inclusion criteria: * all patients aged 18-70 years, asa 1 to 3 undergoing video-assisted thoracoscopy exclusion criteria: * patient refusal, contraindication to regional anesthesia, allergy to local anesthesia, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate pca, psychiatric disorders or use of psychiatric medications, conversion to open thoracotomy

Keywords: erector spinae block video-assisted thoracoscopy
conservative intervention of femoroacetabular impingement syndrome

Conditions: Femoroacetabular Impingement

Summary: 1. purpose: 1) compare three conservative treatment approaches for subjects with femoroacetabular impingement syndrome (fai), and 2) analyze functional outcome comparatively across groups. 2. interventions will be provided based on randomized assignment. group 1 will receive treatment based on identified impairments and treated twice weekly to address said impairments with hip manual therapy and exercise, as well as a prescriptive exercise for strengthening and mobility of the hip. group 2 will receive only the prescriptive exercise program. group 3 will be a control group (supervised neglect) 3. primary outcomes data analysis will involve a mixed design (repeated measures) anova for assessment of the primary outcome measure of the hagos. secondary analyses will include chi square analyses (pass, surgery at 6 months, adverse events), ancova (ppms, and expectations measures), or other appropriate comparative measures. none of the proposed treatment is considered outside of 'standard of practice'.


Eligibility criteria:
inclusion criteria: * individuals age 18 to 60 years, * diagnosed with fai by an orthopedic surgeon and exhibiting * hip/groin symptoms for at least 3 months (symptomatic); and * signs, symptoms and imaging findings conducive to fai will be recruited from a surgical practice of an orthopedic surgeon in durham, north carolina. exclusion criteria: * subjects that have radiographic evidence of hip osteoarthritis that is more than mild in severity defined as tonnis \>grade 1 or kellgren-lawrence \>2; * have other concurrent injury/conditions that will affect their ability to participate in the rehabilitation program and/or assessment procedures; * exhibit hip dysplasia (center edge angle \<20 degrees on ap radiograph * are unable to attend a study physiotherapist or participate in the rehabilitation program if randomized to the pt group; * are unable to understand english.
modified second layer repair for distal penile hypospadias

Conditions: Hypospadias

Summary: to evaluate a modification to snodgrass technique in second layer closure of distal penile hypospadias

in our study, we applied a new modification by using an intervening layer of a de-epithelialized ventral derma-dartos flap for neourethral covering. we present our newly applied technique and its impact on the success rate.

Eligibility criteria:
inclusion criteria: * all male patient with distal penile hypospadias aged less than 18 exclusion criteria: * patients with penile rotation or hypoplastic urethral plate were excluded from the study
retroperitoneoscopic donor nephrectomy

Conditions: Transplant; Complication, Failure

Summary: to compare the results of right and left-sided retroperitoneoscopic donor nephrectomy (rdn).

this was a retrospective study evaluating demographics, intraoperative and postoperative data of 158 kidney donors who underwent rdn from january 2010 to august 2018. two groups were created according to the side of the surgery including right rdn (group 1) and left rdn (group 2). the results of the recipients' were also evaluated.

Eligibility criteria:
inclusion criteria: * adult donors * kidney donors undergoing retroperitoneoscopic donor nephrectomy * recipients of the kidneys * donors with the consent form * recipients with consent form exclusion criteria: * open donor nephrectomies * donors without the consent form * recipients without the consent form

Keywords: living donor nephrectomy kindey transplantation retroperitoneoscopic donor nephrectomy hernia
phase 2 study of rapcabtagene autoleucel in myositis

Conditions: Idiopathic Inflammatory Myopathies

Summary: a phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (iim)

this is a phase 2, two-year, randomized, assessor- blinded, active-controlled study. this study comprises two cohorts: * a lead-in cohort enrolling participants to receive rapcabtagene autoleucel * a randomized cohort with participants receiving either rapcabtagene autoleucel or a comparator option. after end of study (eos), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (ltfu) period lasting up to 15 years after rapcabtagene autoleucel infusion. this ltfu will be described in a separate study protocol.

Eligibility criteria:
key inclusion criteria: 1. men and women, aged \>18 and ≤65 years, with a diagnosis of probable or definite myositis according to american college of rheumatology/european league against rheumatism 2017 (acr/eular 2017) criteria 2. participants who had inadequate response to prior therapy 3. diagnosed with active disease 4. participant must meet criteria for severe myositis key exclusion criteria: 1. any condition during screening that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-cd19 car-t therapy and further participation in the study 2. bmi at screening of ≤18.5 or ≥35 kg/m2 3. severe muscle damage at screening 4. inadequate organ function 5. hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol 6. other inflammatory and non-inflammatory myopathies 7. any medical conditions that are not related to iim that would jeopardize the ability of the participant to tolerate cd19 car-t cell therapy other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chimeric antigen receptor t cells (car-t) rapcabtagene autoleucel idiopathic inflammatory myopathies (iim) dermatomyositis anti-synthetase syndrome immune-mediated necrotizing myopathy interstitial lung disease
evaluation of immune responses and outcomes in patients with hepatocellular carcinoma undergoing radiotherapy

Conditions: Hepatocellular Carcinoma

Summary: radiation therapy is a highly effective modality for managing localized solid tumors and has become a fundamental component of treating unresectable hepatocellular carcinoma. our previous preclinical investigation revealed that radiotherapy can initiate immunogenic cell death and facilitate the cross-presentation of tumor antigens by antigen-presenting cells, thereby augmenting systemic anti-tumor t cell responses in murine tumor models. however, this immune response subsequent to irradiation has not been comprehensively evaluated in clinical trials involving hepatocellular carcinoma patients. given that radiotherapy represents a standard therapeutic approach for unresectable hepatocellular carcinoma, our ongoing phase ii non-randomized trial aims to prospectively assess immunological responses and dose-volumetric parameters, while identifying predictors of clinical outcomes in patients undergoing definitive radiotherapy for hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: 1. participants must have diagnosis of hcc. participants may have multiple lesions. diagnosis should be confirmed by at least 1 criteria listed below: * histologically or cytologically proven diagnosis of hcc. * typical arterial enhancement and delayed washout on multiphasic ct or mri. 2. age ≥18 years at the time of signing informed consent document. 3. ecog performance status 0-2. 4. child-pugh score 5-9 liver function within 28 days of study registration. 5. documented virology status of hepatitis b virus (hbv), as confirmed by screening hbv serology test. 6. documented virology status of hepatitis c virus (hcv), as confirmed by screening hcv serology test. 7. ability to understand and the willingness to sign a written informed consent document exclusion criteria: 1. presence of distant metastases that cannot be encompassed by radiotherapy 2. pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception 3. inability to treat all sites of disease by radiotherapy 4. known hiv infection.

Keywords: photon radiotherapy proton radiotherapy hcc
study of vorinostat (mk-0683) with follicular lymphoma (fl), other indolent b-cell non-hodgkin's lymphoma (b-nhl), or mantle cell lymphoma (mcl) participants (mk-0683-103)

Conditions: Lymphoma

Summary: the purpose of this study is to evaluate the safety, tolerability, and efficacy of vorinostat (mk-0683) in participants with relapsed and/or refractory follicular lymphoma. the exploratory purpose of this study is to evaluate efficacy of mk-0683 in participants with relapsed/refractory non-fl indolent b-nhl or relapsed/refractory mcl. the primary hypothesis is that mk-0683 will show efficacy in relapsed/refractory fl patients as measured by the overall response rate.


Eligibility criteria:
inclusion criteria: * participant has an histopathologically confirmed follicular lymphoma (fl), or other indolent b-cell non-hodgkin's lymphoma (b-nhl) or mantle cell lymphoma (mcl) * only relapsed/refractory fl can be included outside japan * participant has at least one measurable lesion by computerized tomography (ct) scan which is defined by cheson's 1999 criteria * participant has received at least 1 but up to 4 prior chemotherapeutic regimens, the most recent therapy must have failed to induce a partial response, or there must be recurrence in case of the most recent therapy has shown complete response, or there must be relapse in case of the most recent therapy has shown partial response * life expectancy of \>4 months * participant must have adequate organ and marrow function * women of child bearing potential must be negative for pregnancy and agree to use effective contraceptive measures until 30 days after the last dose of mk-0683. * men must agree to use effective contraceptive measures until 6 months after the last dose of mk-0683 exclusion criteria: * participant has undergone allogenic transplant treatment or autologous stem cell transplant within 6 months * participant with other active malignancies or central neurological infiltration with lymphoma * participant with severe hepatic insufficiency * participant with history of allergic reactions attributed to any component of mk-0683 * participant is known to be human immunodeficiency virus (hiv) antibody-, hepatitis b virus antigen- or hepatitis c virus antibody-positive * participant has undergone prior/concomitant treatment with mk-0683 or other histone deacetylase (hdac) inhibitors