Kornimate/medical-research-clean huggingface dataset:
post market clinical follow-up study venezia

Conditions: Cervical Cancer

Summary: the investigational device is the advanced gynecological applicator (aga) venezia configuration, an applicator to treat locally advanced stage cervical cancer. the goal of the study is to assess the performance and the unknown risks or complications of the aga venezia configuration during clinical use of the applicator.

this is a multi-center, prospective, post-market clinical follow-up study to assess the performance and the unknown risks or complications of the advanced gynecological applicator (aga) venezia configuration during clinical use of the applicator. the aga venezia configuration is a ce-marked, fda approved and commercially available product. the aga venezia configuration is a gynaecological applicator for intracavitary and interstitial brachytherapy. the radiation oncologist can use it for treatment of cancers in the vagina, cervix and uterus. forty (40) participants will be included in this study at 5 sites: 3 centers in europe and 2 centers in the united states.

Eligibility criteria:
inclusion criteria: * patients with locally advanced cervical cancer stage ib to iva * patients eligible for brachytherapy according to the criteria of the treating radiation oncologist and center guidelines * patients that are eligible to undergo brachytherapy with the advanced gynecological applicator venezia configuration according to the criteria of the treating radiation oncologist * patient is able to understand and has voluntarily signed and dated the ethics committee approved informed consent form prior to initiation of any screening or study-specific procedures. exclusion criteria: * patients that have been treated or will be treated for cancer other than cervical cancer. * advanced stage cervical cancer patients who have been treated with pelvic radiotherapy, incl. brachytherapy, before. * patients younger than 18 years at the time of diagnosis.

Keywords: cervix uterus vagina cancer gynecology cervical cancer external beam radiation therapy brachytherapy
jak-stat signaling pathway in pyoderma gangrenosum

Conditions: Pyoderma Gangrenosum; Hidradenitis Suppurativa; Psoriasis

Summary: the investigators hypothese that janus kinase/signal transduction and activator of transcription (jak/stat) signaling pathway play a key role in pathophysiology of pyoderma gangrenosum (pg). in this study jak/stat signaling pathway will be investigated in the skin biopsies of pg patients

cytokines are key molecules in the pathogenesis of inflammatory diseases. these molecules exert their effects through cell surface receptors and intracellular signaling pathways. janus kinase/signal transduction and activator of transcription (jak/stat) signaling pathway is implicated in the pathogenesis of several autoimmune diseases. pyoderma gangrenosum (pg) is an inflammatory skin disease characterized by progressive and recurrent skin ulceration of destructive course. treatment of pg requires aggressive immunosuppressive therapy but despite the use of several agents, including tumor necrosis factor inhibitory treatments there is still an unmet need in refractory pg. recent reports suggested activation of jak/stat pathway in pg and some case-based studies suggested the beneficial effect of jak-stat inhibitory agent in the treatment of pg. skin biopsies obtained from pg, hidradenitis suppurativa, psoriasis and healthy subjects will be studied to evaluate jak/stat pathway by using immunohistochemical methods. the following immunohistochemical stains will be used to evaluate the expression of jak/stat pathway: jak1, jak2, jak3, tyrosine kinase 2, stat1, stat2, stat3, stat3, stat4, stat5 and stat6. staining intensity will be recorded categorically (negative and positive). the positive staining will also be graded semi-quantitively as follows: mildly positive, moderately positive and strongly positive.

Eligibility criteria:
inclusion criteria: * pyoderma gangrenosum diagnosed with skin biopsy * psoriasis diagnosed with skin biopsy * hidradenitis suppurativa diagnosed with skin biopsy * skin biopsy in healthy subjects exclusion criteria: - this is a case-based study and there is no exclusion criteria

Keywords: jak-stat pathway pyoderma gangrenosum skin biopsy
a heart rate variability (hrv) biofeedback training in functional gastrointestinal disorders (fgid)

Conditions: Functional Gastrointestinal Disorders (FGIDs)

Summary: functional gastrointestinal disorders (fgids) are conditions characterized by chronic gastrointestinal symptoms without evidence of pathology. these disorders are believed to result from alterations in gut-brain communication. the most common subtypes are irritable bowel syndrome (ibs) and functional dyspepsia (fd), often accompanied by chronic pain, anxiety, and depression. the role of stress in the manifestation of fgids is notable, with stress-related distress affecting the nerve pathways that connect gut and brain. recent interest has focused on the use of heart rate biofeedback (hrv). high levels of stress are associated with reduced hrv, which is common in patients with fgid. hrv biofeedback has been shown to be effective in improving parasympathetic tone and reducing sympathetic tone. the present study aims to evaluate the effectiveness of this approach in reducing stress and symptoms associated with fgids in college students. the project involves online screening to recruit participants, who will then be randomized to receive either the true hrv biofeedback treatment or a placebo condition. pre- and post-treatment assessments include psychological questionnaires, physiological recordings, and a three-month follow-up. the treatment is expected to improve hrv, thereby reducing anxiety and gastrointestinal symptoms.


Eligibility criteria:
inclusion criteria: * presence of clinically significant anxiety symptoms (dass-21 \> 4) * presence of symptoms related to functional gastrointestinal disorders (in english, known as functional gastrointestinal disorders (fgids)) (ibs-sss \> 75); * obtaining informed consent to participate in the study; * absence of organic gastrointestinal diseases: thus, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis); * absence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.). exclusion criteria: * absence of clinically significant anxiety symptoms (dass-21\< 4); * absence of symptoms related to functional gastrointestinal disorders (in english, known as functional gastrointestinal disorders (fgids)) (ibs-sss \< 75); * lack of obtaining informed consent to participate in the study; * presence of organic gastrointestinal diseases: therefore, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis). * presence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).
phase i study of sulfatinib(hmpl-012) in patients with advanced solid tumors

Conditions: Tumor

Summary: sulfatinib (hmpl-012) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (vegfr) 1, 2, and 3 and inhibits fgfr kinase activity has demonstrated potent inhibitory effects on multiple human tumor xenografts. this first-in-human study is conducted to assess the maximum tolerated dose (mtd) and recommended dose for phase ii ,to evaluate the pharmacokinetics , safety and preliminary anti-tumor activity of hmpl-012 at single doses and multiple doses .

this will be an open-label, phase i study. this study will evaluate the safety and pharmacokinetics of hmpl-012 after a single administration followed by a 28-day continuous course of therapy; evaluate the safety and preliminary efficacy in an open-label administration of at the mtd. all subjects of this study will be permitted to continue therapy with only safety monitoring and monthly assessments for progression, if the product is well tolerated and the subject has stable disease or better

Eligibility criteria:
inclusion criteria: •≥ 18 and ≤ 70 years of age * histological or cytological confirmed solid malignant tumor * ecog performance status of 0-2 * standard regimen failed or no standard regimen available * life expectancy of more than 12 weeks * lvef ≥ 50% exclusion criteria: * pregnant or lactating women * adequate hepatic, renal, heart, and hematologic functions (platelets \<75 × 109/l, neutrophil \<1.5 × 109/l, hemoglobin \< 90g/dl ,serum creatinine within upper limit of normal(uln), total bilirubin and serum transaminase within upper limit of normal(uln), and pt, aptt, tt, fbg normal * any factors that influence the usage of oral administration * evidence of uncontrolled cns metastasis * intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure * abuse of alcohol or drugs * less than 4 weeks from the last clinical trial * previous treatment with vegf/vegfr inhibition * disability of serious uncontrolled intercurrence infection * uncontrolled hemorrhage in gi * within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc. * within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or cabg * bone fracture or wounds that was not cured for a long time * coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy

Keywords: tumor
human liver explants for hif-1 alpha analysis/comparison (hif hcc)

Conditions: Liver Cancer

Summary: the purpose of the study is to compare levels of hif-1 α (hypoxia inducing factor 1-alpha) in patients who have been treated with various types of liver cancer treatments.

in the currently ongoing retrospective aspect of the study, we will obtain pathologic tumor explant specimens from the tumor explant population from 8/1/1994 to 12/31/2005. we will prepare 5-10 slides from each tumor explant block and measure hif-1α using immunohistochemical staining. we will also be performing a retrospective chart review for specific data points which we believe are needed to assist us in our analysis of the histopathologic specimens. in addition, we will be looking at data in the united network for organ sharing (unos) database: www.unos.org, which will allow us to develop a more thorough and robust analysis of the subject's experience with liver cancer. this is a public, mandatory reporting vehicle that the government mandates all transplant centers to report to. even if the subject was transplanted at northwestern, and moved, accessing unos data will allow us to see what the morbidity/mortality for that patient is. secondly, we will start enrolling subjects in a prospective fashion. those that either have been treated, those currently undergoing treatment, or those newly diagnosed. from these subjects we will obtain informed consent to; a) look at the medical records (current, future and retrospective data), b) collect blood specimens for future analysis and correlation with their explant slide data, c) allow us to follow these subjects indefinitely to obtain ongoing outcomes data, morbidity and mortality information.

Eligibility criteria:
inclusion criteria: * adults, any gender ≥ to 18 years of age * previous, or current diagnosis of hepatocellular carcinoma (clinical or biopsy proven) * resection for hepatoma and/or transplant * patients with diagnosis of hepatocellular carcinoma from 8/1/94 thru 12/31/05 (retrospective) with biopsy, explant and/or liver transplantation here at northwestern memorial hospital (nmh). * patients previously diagnosed or, recently diagnosed with liver cancer that were treated, currently are being treated our will potentially undergo treatment for the disease. exclusion criteria: * any subject outside of the above inclusion criteria
assessing dextenza insert after smile procedure

Conditions: Post Procedural Infection

Summary: this three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of dextenza when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral smile surgery. in addition, the study will evaluate physician assessment of ease of dextenza insertion

4.1 study population the study aims to enroll 20 patients undergoing bilateral smile. 4.1.1 inclusion criteria a patient's study eye must meet the following criteria to be eligible for inclusion in the study: * age 18 years and older * scheduled for bilateral smile surgery * willing and able to comply with clinic visits and study related procedures * willing and able to sign the informed consent form 4.1.2 exclusion criteria a patient who meets any of the following criteria will be excluded from the study: * patients under the age of 18. * pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * active infectious systemic disease * active infectious ocular or extraocular disease * obstructed nasolacrimal duct in the study eye(s) * hypersensitivity to dexamethasone * patients being treated with immunomodulating agents in the study eye(s) * patients being treated with immunosuppressants and/or oral steroids patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Eligibility criteria:
inclusion criteria: * age 18 years and older * scheduled for bilateral smile surgery * willing and able to comply with clinic visits and study related procedures * willing and able to sign the informed consent form exclusion criteria: * patients under the age of 18. * pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * active infectious systemic disease * active infectious ocular or extraocular disease * obstructed nasolacrimal duct in the study eye(s) * hypersensitivity to dexamethasone * patients being treated with immunomodulating agents in the study eye(s) * patients being treated with immunosuppressants and/or oral steroids patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
whole exome sequencing in coronary artery ectasia

Conditions: Coronary Ectasia; Coronary Aneurysm

Summary: the goal of this observational study is to assess the role of the whole exome sequencing (wes) application in patients with giant coronary artery ectasia (cae) with a high-risk of genetic background. the main question it aims to answer are: * the assessment of role of wes in cae * the detection of novel pathogenic mutations associated with cae development

coronary artery aneurysm and ectasia (caae) is defined as a dilation of the coronary artery by at least 1.5 times compared to the adjacent segment. the incidence of caae is reported in 0.3-5.3% of patients undergoing coronary angiography. giant caae is a rare phenomenon characterized by a dilation of a coronary artery exceeding 2 to 4 centimeters and it was found only in 0.02% of patients undergoing coronary angiography. the most common etiology of caae is atherosclerosis, followed by kawasaki disease, infectious septic emboli, connective tissue disease and arteritis. iatrogenic causes are less common. there are few genetic reports on potential loci associated with caae. meta-analysis of genome wide association studies performed in european and japanese population of children with kawasaki disease has identified itpkc, fcgr2a, casp3 and fam167a genomic regions to be associated with susceptibility to develop caae. furthermore, 9p21 variant has been linked with coexistence of coronary artery disease, cerebral artery aneurysms and aortic aneurysms, mainly due to suspected potential adverse vascular remodeling. nevertheless, the direct association of specific genetic variants with caae formation, especially with those giants, has not been proven. therefore, the investigators aim to assess the role of the whole exome sequencing (wes) application in patients with giant coronary artery ectasia (cae) with a high-risk of genetic background.

Eligibility criteria:
inclusion criteria: * diagnosed giant coronary artery aneurysm and ectasia (caae) * high risk of genetic background exclusion criteria: * the lack of informed consent for whole exome sequencing (wes) analysis

Keywords: coronary ectasia coronary aneurysm whole exome sequencing mutations
change in permeability of the small intestine after treatment with gluten

Conditions: Gastrointestinal Disorders

Summary: the overall hypothesis of this research study is that gluten intake alters intestinal barrier function in patients with irritable bowel syndrome (ibs) diarrhea who also exhibit non-celiac gluten sensitivity (ncgs).

the specific aim of this hypothesis-generating, pilot study is to randomize (like the flip of a coin) patients who have non celiac gluten sensitivity to a 4-week gluten-containing diet (gcd) or to a gluten free diet (gfd). the study will evaluate small bowel (sb) permeability functionally (2-sugar differential excretion), morphologically, using probe-based confocal laser to evaluate the small intestinal, as well as molecularly, using tight junction (tj) messenger rna (mrna) expression in small bowel mucosa in response to the different diets.

Eligibility criteria:
inclusion criteria: 1. non celiac gluten sensitive patients with a functional bowel disorder 2. age 18 to 70 years. exclusion criteria: 1. positive serum tissue transglutaminase (ttg) immunoglobulin a (iga) positive or medical record of small bowel biopsy suggestive of celiac disease. 2. use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability). 3. abdominal surgeries (except appendectomy, cholecystectomy and vaginal hysterectomy or tubal ligation) 4. use of nonsteroidal anti-inflammatory drugs(nsaids) or aspirin within the past week (since nonsteroidal anti-inflammatory drugs (nsaids) affect intestinal permeability). 5. use of oral corticosteroids within the previous 6 weeks. 6. ingestion of artificial sweeteners such as sucralose, nutrasweet ™ (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g., foods to be avoided are sugarless gums or mints and diet soda. 7. bleeding disorders or medications that increase risk of bleeding from mucosal biopsies. 8. high anxiety or depression score (\>11 on each subscale) on the hospital anxiety depression score questionnaire. 9. known allergy to fluorescein.

Keywords: ibs-diarrhea
feasibility of parathyroidectomy with exploration of 4 parathyroid glands in outpatients

Conditions: Primary Hyperparathyroidism

Summary: the development of outpatient surgery has become a national priority, with the objective of an ambulatory surgery rate of around 50% in 2016, whereas this rate reached only 37.7% in 2010. in the context of the management of primary hyperparathyroidism, there are two possible approaches. the first, which is commonly performed on an outpatient basis, consists in approaching only the pathological gland, if it was first identified by scintigraphy and ultrasound (which is the case in one patient in two), without exploring the others parathyroid glands. the reference technique consists in exploring the 4 parathyroid sites by transverse cervicotomy. although more invasive, it minimizes the risk of failure due to the lack of knowledge of multi-glandular forms of the disease (15 to 20%), whose preoperative diagnosis is difficult. this reference technique is poorly performed on an outpatient basis while it lends itself to this type of management because of the superficial character of the operative site, a short operating time, moderate postoperative pain, rapid return oral nutrition and exceptional and early serious complications (delay \<24 h for cervical hematoma, \<24 h for hypocalcemia and immediate diagnosis of recurrent palsy). in this study, the investigators hypothesize that parathyroidectomy with 4-gland parathyroid exploration is feasible by ensuring patient safety. the investigators also believe that outpatient management will not lead to any difference after 3-month surgery, but will reduce hospitalization costs while increasing patient satisfaction with conventional care. to do so, the investigators carried out an observational cohort study of patients with an indication of parathyroidectomy wo will undergo outpatient management or conventional management (stay overnight in hospital) to inform all of these data.


Eligibility criteria:
inclusion criteria: * patients \> 18 years old * diagnosis of primary hyperparathyroidism (inappropriate parathyroid hormone secretion compared with calcemia) * surgical indication of parathyroidectomy with possible management outpatient or conventional hospitalization (choice of mode of care by the surgeon, after consultation with the patient) exclusion criteria: * non-eligibility for outpatient surgery for general medical reasons (asa score), determined during the consultation of preoperative anesthesia * preoperative hypercalcemia\> 3 mmol / l (due to the high risk of postoperative hypocalcemia) * history of cervicotomy for thyroidectomy or failure of parathyroid surgery * treatment of primary hyperparathyroidism with elective surgical approach * person under guardianship and curatorship

Keywords: primary hyperparathyroidism parathyroidectomy outpatient management
hormonal predictors of oncologic surgery

Conditions: Hypogonadism

Summary: an observational trial to determine whether preoperative hormonal status predicts outcomes of oncologic surgery.


Eligibility criteria:
inclusion criteria: * undergoing above surgery for cancer exclusion criteria: * started hormonal replacement in past two months
multi-center clinical trial of shenling baizhu granules for preventing low-risk colorectal adenoma recurrence

Conditions: Low-risk Colorectal Adenoma

Summary: the goal of this clinical trial is to learn if shenling baizhu granules can prevent colorectal adenoma from coming back in people who had low-risk colorectal adenomas removed. the main questions it aims to answer are: * can shenling baizhu granules lower the rate of colorectal adenoma returning after removal? * how safe is shenling baizhu granules when used long-term for preventing adenoma? * which patients are most likely to benefit from this treatment? researchers will compare shenling baizhu granules to no treatment to see if the medicine works to prevent adenomas from returning. participants will: * take shenling baizhu granules (6 grams, 3 times daily) or receive no treatment for 6 months each year for 2 years * have regular check-ups and provide blood, stool, saliva, and tissue samples * get a colonoscopy after 3 years to check if any adenomas have returned * fill out questionnaires about their symptoms and overall health throughout the study this study will include 624 adults aged 18-70 who recently had low-risk colorectal adenomas removed at participating hospitals. the total study duration is 4 years.


Eligibility criteria:
inclusion criteria: * diagnosed with low-risk colorectal adenoma * complete colonoscopy examination (adequate bowel preparation, cecal intubation, withdrawal time \>6 minutes), with endoscopic resection performed including snare polypectomy, emr, epmr, esd * within 1 month after adenoma resection * age 18-70 years * willing to provide written informed consent exclusion criteria: * incomplete adenoma resection * long-term use of aspirin, folic acid, calcium, or vitamin d supplements * familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (lynch syndrome), or other hereditary polyposis syndromes * severe inflammatory bowel disease * history of malignancy within past 5 years (excluding basal cell carcinoma of the skin and/or cervical intraepithelial neoplasia after surgery) * pregnant or lactating women * severe cardiovascular disease, cerebrovascular disease, liver or kidney dysfunction, or diabetes * severe mental illness that prevents compliance with colonoscopy examination