Kornimate/medical-research-clean huggingface dataset:
nutritional cognitive behavioral therapy feasibility study in nafld and nash

Conditions: Non-alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease; Non-alcoholic Fatty Liver

Summary: this single arm interventional cohort study is designed to explore the feasibility of using bt-ncbt-00x to improve liver fat, inflammation, and stiffness in patients diagnosed with nafld or nash over a 3 month intervention.

the treatment, bt-ncbt-00x, consists of a software as a medical device developed by the study sponsor, better therapeutics. it delivers treatment to participants with cardiometabolic disease, using behavioral therapy that targets individual behaviors related to improving dietary quality and physical activity. the study evaluates the use of this behavioral therapy and its effect on clinical measures such as percent liver fat as measured by mri-pdff, and fibroscan controlled attenuation parameter score, liver stiffness as measured by fibroscan vibration controlled transient elastography in kpa, body weight and alt. participants in this feasibility study will have access to the treatment for 3- months.

Eligibility criteria:
inclusion criteria: * diagnosis of nafld or nash * at least 2 doses of the covid-19 vaccine, per self report * possession of a smartphone capable of running the bt_ncbt-00x application * bmi \>/= 30 at the screening visit * fibroscan cap \>300 db/m collected at screening visit * completion of baseline mri-pdff * understand written and spoken english exclusion criteria: * inability to read and understand english * unstable or life-threatening medical illness * weight loss of greater than 10lbs within the last 90 days * pregnant or planning to become pregnant women * concurrent enrollment in any other interventional clinical trial * presumed or confirmed covid-19 diagnosis within 30 days prior to study enrollment * change in medication regimen of hormonal contraceptives, anti-hyperglycemic medications, mental or emotional disorder medications, corticosteroids, thyroid hormones, tamoxifen or methotrexate within 90 days
a phase 1b open label, dose escalation study of plx3397 in combination with vemurafenib in v600-mutated braf melanoma

Conditions: V600-mutated BRAF Unresectable Melanoma; V600-mutated BRAF Metastatic Melanoma; Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor

Summary: the purpose of this research study is to test the safety of an investigational new drug called plx3397 when used in combination with vemurafenib (zelboraf™) at different dose levels. vemurafenib has been approved by the united states food and drug administration (fda)/european medicines agency (ema) for the treatment of a specific category of unresectable or metastatic melanoma.


Eligibility criteria:
inclusion criteria: * male or female ≥18 years old. * patients with histologically confirmed unresectable stage iii or stage iv metastatic melanoma who have not been previously treated with a selective braf inhibitor. * presence of a braf v600 mutation in the tumor tissue using the cobas braf mutation assay or comparable standard of care methodology. * measurable disease per recist v. 1.1 criteria. * ecog performance status 0 or 1. exclusion criteria: * radiation therapy within 14 days of c1d1. * investigational drug use within 28 days of c1d1. * patients with active cns lesions are excluded (i.e., those with radiographically unstable, symptomatic lesions). however, patients treated with stereotactic therapy or surgery are eligible if they remain without evidence of disease progression in the brain for ≥3 weeks.
liver function investigation with spect

Conditions: Liver Cancer, Adult

Summary: this is a phase 1 pilot study to assess feasibility and utility of 99mtc-mebrofenin hepatobiliary scintigraphy for measurement of functional liver change due to radiotherapy.

patients with cancers of the liver who are not suitable for surgery or chemo/radio embolisation are often treated with stereotactic ablative body radiotherapy (sabr). sabr results in high local control rates but, similar to other treatment modalities, carries risk of damage to healthy surrounding liver. this study aims to use a novel nuclear medicine imaging tracer, 99mtcmebrofenin, to evaluate liver function before and after radiotherapy. patients will have a 99mtcmebrofenin scan performed \< 2 weeks before radiotherapy and 1 and 6 months after radiotherapy. at the same time points, indocyanine green (icg) and liver elasticity tests will be performed. these are global measures of liver function, whereas 99mtcmebrofenin is both global and local. from the imaging data, the investigators will be able to correlate change in local liver function in each sub volume of the liver with the radiotherapy dose it received. the investigators will be able to thus measure the effect of radiotherapy on global and local liver function.

Eligibility criteria:
inclusion criteria: * aged 18 or older * has provided written informed consent for participation in this trial and is willing to comply with the study * patients undergoing external beam radiotherapy at northern sydney cancer centre * histologically proven hepatocellular carcinoma or oligometastatic liver metastases (3 or less). histological diagnosis will be obtained if clinically indicated. * ecog performance status 0-2 exclusion criteria: * previous high-dose radiotherapy to the liver * previous sirt * women who are pregnant or lactating * unwilling or unable to give informed consent * no venous access * inability to lie supine and still for 30 minutes * history of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of iodide or seafood allergy (excluded from icg testing only) * pacemaker (excluded from fibroscan elasticity test only)

Keywords: radiotherapy mebrofenin liver cancer spect
dose-dependent effects of erythritol on endothelial function in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this study is an open-label pilot designed to examine the dose-dependent effects of erythritol, a zero calorie sweetener, on endothelial function. twenty-four subjects with type 2 diabetes mellitus will make three study visits. at each visit, the will consume an orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams). endothelial function will be assessed before and two hours after beverage consumption. endothelial function will be measured as the change in pulse amplitude in response to reactive hyperemia measured in the fingertip by peripheral arterial tonometry. the results will be used to plan a randomized, placebo-controlled study.


Eligibility criteria:
inclusion criteria: * male and female subjects * otherwise healthy patients with type 2 diabetes mellitus as defined by fasting blood glucose \>125 mg/dl or with ongoing treatment for type 2 diabetes mellitus with the exception of insulin. exclusion criteria: * women with a positive urine pregnancy test * body mass index \>35 kg/m2 * current daily long-acting insulin therapy (short acting, insulin as needed is not an exclusion). * clinical history of other major illness including cancer, renal failure, hepatic failure, or other conditions that in the judgment of the principal investigator make a clinical study inappropriate. * treatment with an investigational drug within the last twelve weeks * history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study. * treatment with vitamin e, vitamin c, and beta carotene, lipoic acid, and other food or herbal supplements within 1 month of enrollment. subjects taking multivitamins or other forms of vitamin e and c in doses that do not exceed two times the recommended daily allowance will not be excluded. * recent change in diet or level of physical activity that in the judgment of the investigators would be likely to affect endothelial function (to be evaluated on a case by case basis). * ongoing illicit drug use or alcohol abuse. * sensitivity/intolerance to dietary polyols.

Keywords: erythritol endothelial function
bioavailability and pharmacokinetic measures of h. procumbens extract

Conditions: Osteoarthritis, Knee

Summary: study will define the bioavailability and short term pharmacokinetics of the principal secondary metabolites of a aqueous-ethanolic extract of h. procumbens in non-enteric and enteric capsules.

the study(n = 12) will use a one-dose design to measure bioavailability and pharmacokinetic properties of an aqueous extract of h. procumbens containing 100mg harpagoside. plasma levels of harpagoside, harpagide, verbascoside, and 8-p-coumarylharpagide will be measured for 24 hours with blood collections taken at timed intervals.

Eligibility criteria:
inclusion criteria:- adult (at least 18 years of age); * diagnosed with knee osteoarthritis (oa) ; * body mass index (bmi) of less than 40; * willing to use only the study product, and tramadol or tylenol as a rescue pain medication over the course of their participation in the study; * willing and able to monitor blood glucose levels if diabetic; * willing to abstain from caffeine-containing drinks and food before coming into a study visit; * able to read and understand english and have the cognitive capacity to give consent; * willing to abstain from use of the following during participation in the study: prescription and over-the-counter non-steroidal anti-inflammatory medications, (e.g., aspirin, ibuprofen, advil, motrin, nuprin, naproxen, etc.); any dietary supplements (st. john's wort, etc.); and, grapefruit and/or products containing it. exclusion criteria:- cardiovascular disease, previous myocardial infarction, stent, coronary artery bypass graft (cabg), arrhythmia, high or low blood pressure; * recurrent stomach upset, or gastric or duodenal ulcers; * gallstones or gall bladder disease (cholelithiasis); * liver or kidney disease; * alcohol use of more than two drinks per day on a regular basis; * coumadin or anti-platelet drug use; * at risk for respiratory depression, history of seizures, or taking drugs that reduce the seizure threshold or may increase the risk for development of serotonin syndrome; * pregnant or breast feeding, or intention to become pregnant during the study; * pronounced allergies, or known allergy to study product or corn starch (placebo); * have had an injection to treat oa within the past three months; * currently taking nsaids, unless they are willing to stop for a 1-week wash-out period; * currently on a selective serotonin reuptake inhibitor (ssri) but are poorly stabilized, or have evidence of suicidal ideation and/or suicide attempts in the past year; and, * reported use during the 7 days prior to study drug administration of: prescription and over-the-counter medications (e.g., nsaids), and any dietary supplements; grapefruit and/or its products; and, st. john's wort.
inhaled no in prevention of chronic lung disease

Conditions: Bronchopulmonary Dysplasia; Lung Diseases

Summary: to test the hypothesis that low-dose inhaled nitric oxide administered to preterm infants who continue to require mechanical ventilation at 14 days of age will reduce the incidence of chronic lung disease.

background: respiratory morbidity, particularly chronic lung disease (cld), remains a major cause of long-term morbidity and mortality for preterm infants. although surfactant replacement has decreased acute respiratory morbidity and mortality, it has not reduced the incidence of cld. a number of other approaches, including antenatal thyrotropin releasing hormone in conjunction with corticosteroids, postnatal steroid administration, as well as administration of vitamin e, diuretics, and bronchodilators, have not resulted in clinically important decreases in cld. infants with the most severe cld go on to develop findings suggestive of pulmonary hypertension with cor pulmonale. there is preliminary evidence in the preterm infant with severe chronic lung disease that low-dose inhaled nitric oxide may significantly attenuate the disease and decrease mortality. design narrative: the multi-center, controlled and blinded trial investigates the hypothesis that low-dose inhaled nitric oxide administered to preterm infants between 500 and 1250 grams birth weight who continue to require mechanical ventilation at 10 days of age will increase survival without chronic lung disease (cld) at 36 weeks post menstrual age. secondary outcomes are duration of ventilation, oxygen requirement and duration of hospitalization. in addition, that there will be expected improvement in infant respiratory status (ventilatory support, airway resistance and compliance) associated with inhaled nitric oxide treatment. indicators of inflammation and oxidant stress will be assessed by measurements of specific cytokines and protein modifications in tracheal aspirate and plasma samples, respectively. the safety of this therapy will be evaluated by assessing toxicity as measured by clinical bleeding, including intraventricular hemorrhage as well as the incidence of other morbidities of the preterm infant (necrotizing enterocolitis, retinopathy of prematurity and infection) and assessing neurodevelopmental outcome through two years of age. a total of 480 infants were randomized to either inhaled no or placebo. in summary, this clinical trial will assess the efficacy and safety of inhaled nitric oxide for amelioration of a major disease of premature infants.

Eligibility criteria:
preterm infants who are 500-1250 grams at birth and who require mechanical ventilation at 10 to 21 days of age. exclusions include congenital heart disease or pulmonary abnormalities, including a patent ductus arteriosus, ventilation solely for apnea, small-for-gestational age, or clinical bleeding.
safety and efficacy of everolimus in metastatic renal cell carcinoma after failure of first line therapy with sunitinib or pazopanib

Conditions: Metastatic Renal Cell Carcinoma (mRCC)

Summary: patients with metastatic renal cell carcinoma (mrcc) who failed first-line therapy with sunitinib or pazopanib was treated with everolimus. efficacy and safety of everolimus was evaluated in these patients.


Eligibility criteria:
inclusion criteria: * patients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell renal carcinoma. * progression during or after a treatment with sunitinib or pazopanib given in a 1st line treatment situation for mrcc. * patients scheduled for treatment with everolimus. * patients with at least one measurable lesion at baseline as per recist v1.1. exclusion criteria: * patients who have received \>1 prior systemic treatment for their metastatic rcc. prior systemic treatment in an adjuvant setting is allowed. * patients who have previously received systemic mtor inhibitors (e.g. sirolimus, temsirolimus, everolimus). * patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start. * patients unwilling or unable to comply with the protocol.

Keywords: kidney cancer mrcc metastic renal cell carcinoma everolimus sunitinib pazopanib
a tissue sparing, laser assisted penile prosthesis implantation technique

Conditions: Erectile Dysfunction; Erectile Dysfunction Associated With Type 2 Diabetes Mellitus; Erectile Dysfunction Due to Arterial Disease; Erectile Dysfunction Due to Arterial Insufficiency; Erectile Dysfunction Due to Venous Disorder; Erectile Dysfunction Due to Neuropathy; Erectile Dysfunction Following Radical Prostatectomy

Summary: a surgical technique using laser assisted penile prosthesis implantation

a surgical technique using deep-red laser diode for visualization of the implantation track of the penile implant or holium laser for clearing the track whenever it is obstructed by fibrotic tissue.

Eligibility criteria:
inclusion criteria: * men with ed not responding to medical treatment exclusion criteria: * men with hba1c more than 10

Keywords: cavernosal tissue sparing laser assisted implantation
eras in colorectal surgery: benefits of late adoption

Conditions: Colorectal Cancer; Colorectal Neoplasms; Colorectal Disorders

Summary: the aim of this single-center retrospective cohort study is to explore the effect of late adaptation of an eras protocol in a high-volume colorectal surgical unit. the primary endpoint is the surgical outcome measured by early postoperative complications, defined by the comprehensive complications index. secondary endpoints include amongst others los (length of stay), cost analysis, short-term follow-up in the eras group.

at clarunis - university center for gastrointestinal and liver diseases at st. claraspital between 2019 und 2020, all colorectal patients were treated according to a standardized perioperative protocol. as of 2021 until today, an eras protocol was established and all colorectal patients who met inclusion criteria participated in this program automatically as part of a new standardized care. perioperative data was collected in a clinical information system (phoenix - cgm clinica information systeml). in this retrospective cohort study, we compare demographic, perioperative and postoperative data among the two groups "eras" and "non-eras" using a weighted propensity score analysis for patients who underwent surgery as part of the eras program and for patients without a standardized eras protocol. all patients treated at the colorectal unit from 2019 until august 2022 and who are considered for the analysis have given written general consent for the use of health-related data for research projects (attached to this document).

Eligibility criteria:
inclusion criteria: * written general informed consent * patients undergoing a colorectal procedure between 2019 and august 2022 at colorectal unit, santa clara hospital, basel exclusion criteria: * all patients undergoing an emergency procedure or a combined procedure with the colorectal procedure not being the main indication for surgical treatment (i.e. gynecological debulking, liver resection, etc.) were excluded from the analysis.
pre-surgical grading system of asherman syndrome

Conditions: Asherman Syndrome

Summary: utilising a novel pre-surgical grading system to class cases of asherman syndrome into 3 groups based on expected difficulty of surgery and potential prognostic outcomes.

using the grading system, patients are classified into mild, moderate and severe asherman syndrome. with the mild disease having the best prognostic value and a 1 step procedure, moderate cases having a mediocre prognosis and usually multi-step procedure and severe cases having a poor prognosis and counseled to other options. this observational study looks at the surgical outcomes following hysteroscopy for cases graded according to the new system to identify the accuracy of the classification in predicting the surgical success and prognostic value.

Eligibility criteria:
inclusion criteria: * asherman syndrome * intra-uterine synechiae exclusion criteria: * patients with a fundectomy or uterine reduction surgery.

Keywords: asherman syndrome hysteroscopy intra-uterine surgery intra-uterine adhesions classification
javemacs: japan avelumab maintenance and continuous treatment study

Conditions: Urothelial Carcinoma

Summary: this study is a multicenter, non-interventional, retrospective, medical chart review of locally advanced or metastatic (la/m) urothelial cancer uc participants who were prescribed avelumab as first line maintenance therapy after a platinum-based chemotherapy. this study aims to understand the index date (i.e., at the initiation of avelumab maintenance therapy) demographics and clinical characteristics of participants with locally advanced/metastatic urothelial carcinoma in japan, and to describe their treatment patterns and outcomes.


Eligibility criteria:
inclusion criteria: * participants diagnosed with locally advanced/metastatic urothelial carcinoma (la/m uc) before receiving avelumab first line maintenance therapy * participants with la/m uc (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response, or complete response) following completion of first line pbct and who has been treated with avelumab * participants who has been started avelumab first line maintenance therapy for la/m uc from 24 feb 2021 (date of approval for uc) to 6 months before the date of approval of implementation of this study at each site * participants aged \>= 18 years old at index date * other protocol defined inclusion criteria could apply exclusion criteria: * participant participated in a clinical trial in la/m uc during the study periods.

Keywords: urothelial carcinoma avelumab javemacs locally advanced uc metastatic uc
evaluation of persistent postsurgical pain after breast surgery with a pectoral nerves block (pecs) type ii

Conditions: Chronic Post-Procedural Pain; Breast Cancer

Summary: background and objectives the pectoral nerves block (pecs) type ii is a regional anesthesia technique that provides post-surgical pain relief for patients undergoing breast surgery. post-procedural pain relief is known to diminish persistent pain. in this prospective follow-up, the investigators evaluated whether the pecs ii block, compared to placebo, is effective in reducing persistent post-procedural pain after breast cancer surgery in female patients. patients and methods 140 breast cancer stage 1-3 patients undergoing mastectomy or tumorectomy with sentinel node or axillary node dissection under general anesthesia were randomized to receive a pecs block (levobupivacaine 0.25%) or placebo (saline 0.9%). patients were invited between 9 and 31 months after surgery to complete a persistent postsurgical pain survey.

breast cancer is the most common cancer in women. for breast cancer patients, surgery is the most effective therapeutic intervention. up to two thirds of female patients undergoing breast cancer surgery develop chronic post-procedural pain. this can be best understood by the fact that chronic post-procedural pain is strongly associated with acute post-procedural pain and that even minimal breast surgery can result in significant post-procedural pain. regional anesthesia techniques can improve acute and chronic post-procedural pain outcomes. in the prospective double blind placebo-controlled randomized controlled trial, the investigators found that the pectoral nerves (pecs) block type ii, as described by blanco et al., provides reliable and effective post-procedural analgesia for patients undergoing breast surgery. in this prospective follow-up, the investigators evaluate whether the pecs ii block is effective in reducing chronic post-procedural pain in female adult patients undergoing breast cancer surgery compared to placebo.

Eligibility criteria:
inclusion criteria: * participated in the large-scale prospective double-blind randomized controlled trial of pecs ii block for breast surgery (nct02544282) exclusion criteria: * patient refusal
efficacy of ultrasound in evaluating occult fractures

Conditions: Fractures, Occult

Summary: the purpose of the study is to examine the efficacy and accuracy of ultrasound in evaluating occult fractures. we want to examine it on children that suffer from suspected fractures of the foot and ankle and the results of the x-ray are either negative or inconclusive.


Eligibility criteria:
inclusion criteria: * boys and girls aged \<=15 years * suspected fracture of the wrist or ankle (no later than one week after the injury) * negative or inconclusive x-ray exclusion criteria: * unwillingness to sign informed consent

Keywords: suspected fractures in the ankle and wrist