Kornimate/medical-research-clean huggingface dataset:
mouth breathing habits improvement intervention

Conditions: OSA

Summary: this study intends to investigate the improvement in patients with osa through objective measurement, including oxygen desaturation index (odi) and the percentage reduction in intermittent mouth puffing (imp) before and after the intervention. the oral appliances are placed between the tongue and the soft palate to reduce the oral ventilation space. a total of 24 participants aged between 36 and 57 years were identified with odi above 5 events/hour by measuring their blood oxygen and with an originally designed mouth puffing detector to find out those who were still mouth-puffed when their mouths were taped. a suitable appliance was chosen for the participants between the two originally designed oral appliances, tongue pressed device (tpd) and tongue elevated device (ted), and the intervention lasted for six weeks.


Eligibility criteria:
inclusion criteria: * (1) aged 20-60 years old, * (2) having symptoms of osa including snoring, daytime sleepiness, etc. * (3) ahi \& odi \>=5 events/hour, exclusion criteria: * (1) taken sleep medication within the last two months or were on long-term use, * (2) reported tobacco, alcohol, caffeine or drug addiction, * (3) cancer, cardiovascular disease, psychiatric illness, kidney disease, diabetes mellitus, or other sleep disorders.

Keywords: mouth breathing mouth puffing sleep apnea oral appliance
identifying circulating breast cancer cells in women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: studying samples of blood and pleural or peritoneal fluid from patients with metastatic breast cancer in the laboratory may help doctors identify biomarkers related to breast cancer and learn more about how breast cancer begins and spreads in the body. purpose: this research study is looking at a new way of identifying circulating breast cancer cells in blood and in pleural or peritoneal fluid in women with metastatic breast cancer.

objectives: primary * to compare identification of circulating breast cancer cells (cbccs) in blood or pleural or peritoneal fluid by a novel technique using stem cell marker retinaldehyde dehydrogenase (aldh) and surface antigen expression (cd44+, cd24-) to the standard technique using the cellsearch® system in women with metastatic breast cancer. secondary * to determine whether cbccs have the potential to grow into metastatic lesions. outline: patients undergo sample collection to help develop a new technique using stem cell marker retinaldehyde dehydrogenase (aldh) and surface antigen expression (cd44+, cd24-) in isolating circulating breast cancer cells (cbccs) from blood and pleural or peritoneal fluid. blood may also be drawn to measure the number of circulating tumor cells using the standard cellsearch® system. mononuclear cells are isolated by density centrifugation. cells are stained against surface antigens that provide specific expression patterns for cbccs (cd44, cd24). cells are analyzed on a fluorescence activated cell sorting (facs) calibur flow cytometer and sequentially gated (aldhhigh→cd44+ vs cd24-/low or cd44+ vs cd24-/low→aldhhigh) for detection of cbccs. for further confirmation of epithelial origin, aldhhighcd44+cd24-/low cells are isolated using a facsaria flow sorter, cytocentrifuged onto glass slides then stained for the expression of epithelial-specific cytokeratins 5, 8, 14, 18 and 19 by standard immunohistochemical techniques. using the phenotype that is found to most highly enrich for epithelial cells, cells are isolated by facs and assayed for clonogenic growth.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the breast * metastatic disease (stage iv) * hormone receptor status not specified patient characteristics: * female * menopausal status not specified prior concurrent therapy: * not specified

Keywords: stage iv breast cancer
spanish cohort of patients with hiv infection older than 50 years for the study of fragility and physical function

Conditions: HIV Infections; Frail Older Adults

Summary: it's a prospective observational study to assess frailty and physical function

we stimate to recruit 1120 patients older tan 50 years to assess frailty and define a simplified fragility index

Eligibility criteria:
inclusion criteria: 1. patients with confirmed hiv + infection. 2. patients aged ≥ 50 years at the time of starting the study, followed in the infectious-hiv consultations of the centers participants. this limit has been chosen because it is accepted by the scientific community for define the elderly patient in patients with hiv infection. 3. have signed the informed consent and be willing to comply with the study visits. exclusion criteria: 1. have an established disability that does not allow you to walk. 2. patients who can not comply with the visits and study procedures or who are not usually followed at the center.
naltrexone treatment for alcoholism

Conditions: Alcoholism

Summary: this study will evaluate the effectiveness of the medication naltrexone (revia) for treating alcoholism. individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. this part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. assessments will be conducted 6 and 12 months after the beginning of the study.


Eligibility criteria:
inclusion criteria: * meets criteria for alcohol dependence. * committed to alcohol abstinence as a treatment goal. * individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status. exclusion criteria: * meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine). * meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy. * females who are pregnant, lactating, or not using a reliable method of contraception. * currently experiencing a serious medical condition that would place them at risk or interfere with study participation. * experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal. * have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone. * vocabulary below the 5th grade reading level. * abnormal mri scan. * hiv infection due to the neurological sequelae. * significant central nervous system diseases. * seizure disorder or history of closed head trauma. * neuroendocrine disorders. * treatment with opiates within the last six months.
study of nivolumab in patients with classical hodgkin's lymphoma (registrational)

Conditions: Hodgkin Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of nivolumab in previously treated (cohorts, a, b \& c) or newly diagnosed (cohort d) classical hodgkin lymphoma participants.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status 0 or 1 * must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (asct) as a part of salvage therapy for chl (cohort a, b \& c - enrollment closed) * participants may be brentuximab vedotin- naïve, or may have had prior brentuximab vedotin treatment (cohort a, b \& c - enrollment closed) * newly diagnosed and previously untreated classical hodgkin lymphoma (cohort d) exclusion criteria: * known central nervous system lymphoma * participants with nodular lymphocyte-predominant hodgkin lymphoma * prior allogeneic stem cell transplantation (sct) * chest radiation ≤ 24 weeks prior to first dose * carmustine ≥ 600 mg/m² received as part of the pre-transplant conditioning regimen
diverting loop ileostomy: with or without rod

Conditions: Ileostomy; Rectal Neoplasms

Summary: diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. currently, the application of a rod to hinder slippage of the loop is an established technique to perform a diverting loop ileostomy. however, various "rod-less" techniques have been described and are performed with similar success. the aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. secondary endpoints include stoma care, determinants of quality of life and stoma function.

background for rectal anastomoses within 6 cm of the anal verge, leakage rates are up to 15%. here liberal use of protective stomas is widely accepted. fecal diversion by loop ostomy may also be performed after extended adhesiolysis with serosal lesions and risk of intestinal perforation, in patients with obstructing rectal tumours requiring neoadjuvant radio-chemotherapy or in patients with complex anorectal injuries or fistulas. generally, diverting loop ileostomies are secured at skin level by means of a supporting device in order to prevent retraction of the loop ileostomy into the abdomen. nevertheless, due to the supporting rod, difficulties may occur in applying a stoma bag correctly and leakage of feces onto the skin may occur even with correct eversion of the afferent limb. despite easier application of stoma bags and therefore reduced risk of skin irritation, none of these alternative techniques are established. in various non-randomized studies rodless loop ileostomies were described with an overall morbidity between 3 and 39%. however definition of morbidity varies significantly in these studies and randomised controlled trials are missing so far. objective the aim of this study is to determine, whether a modification (without rod) of the current standard method of protective loop ileostomy formation (with rod) could improve ileostomy specific morbidity. secondary endpoints include stoma care, determinants of quality of life and stoma function. methods the study is designed as multi-institutional, randomized controlled, two-armed study. patients scheduled for a protective loop ileostomy and meeting the eligibility criteria will be randomized to creation of a loop ileostomy with or without sustaining rod.

Eligibility criteria:
inclusion criteria: * patients scheduled for planned protective loop ileostomy exclusion criteria * patients with long-term use of corticosteroids (\> 15 mg prednisolone equivalent) * immunosuppressive agent rapamune

Keywords: loop ileostomy quality of life morbidity rectal neoplasms
comparison between patients with or without diabetes recovery after bariatric surgery

Conditions: Diabetes; Bariatric Surgery; Obesity

Summary: bariatric surgery can lead to improvement or even resolution of type 2 diabetes in about 80% of patients submitted to roux-en-y gastric bypass (rygp). otherwise, many patients experienced no resolution of their diabetes despite massive surgical-induced weight loss. there appears to be a variable response to surgery depending on surgical and patient factors. to explore potential factors affecting diabetes outcomes after rygp, this study is proposed to make a description of effects of surgical procedures on incretin, insulin production and sensitivity and a comparison between patients with or without remission of type 2 diabetes.

diabetes reversion is observed after bariatric surgeries even before significant weight loss could explain it, mainly in predominantly malabsorptive procedures (98,9% for biliopancreatic diversion or duodenal switch), followed by those combining malabsorption and gastric restriction (83,7% for roux-en-y gastric bypass). changes in the hormonal communication between the digestive system and the pancreas would explain the antidiabetogenic role of the surgery, so this effect could be obtained in nonobese, diabetic individuals. to explore potential factors affecting diabetes outcomes after rygp, this study is proposed to make a description of effects of surgical procedures on incretin, insulin production and sensitivity and a comparison between patients with or without remission of type 2 diabetes.

Eligibility criteria:
inclusion criteria: * capacity to understand the procedures of the study. * to agree voluntarily to participate of the study, signing an informed consent. * weight variance less than 5% in the last 3 months. * operative group with at least 2 year follow-up. exclusion criteria: * history of hepatic disease like cirrhosis or chronic active hepatitis. * kidney dysfunction (creatinine \> 1,4 mg/dl in women and \> 1,5 mg/dl in men). * hepatic dysfunction: alt and/or ast 3x above upper normal limit). * recent history of neoplasia (\< 5 years). * use of oral or injectable for more than consecutive 14 days in the last three months.

Keywords: diabetes mellitus, type 2 insulin resistance bariatric surgery glucagon-like peptide 1 gastric inhibitory polypeptide insulin glucagon ghrelin adiponectin cytokines gastric bypass obesity
exploiting pathogenic tp53 mutation for early diagnosis of ovarian cancer by mean of papanicolau test

Conditions: Ovarian Cancer

Summary: the aim of the project is to corroborate them on a large retrospective cohort of hgs-eoc and confirm the possibility of identify tp53 mutations in high grade endometrioid tumors. this will consequently allow to confirm the previous results and define with a greater precision the temporal windows in which it will be possible to detect, through the tp53 analysis, tumor material by vaginal swab sampling. the results of the study will be the first step of a multiphase prospective validation program for the development of a novel approach for early diagnosis of eoc.

all participating women will be identified through the ovarian cancer audit implemented by the "oncological network of piedmont and valle d'aosta" and the clinical epidemiology unit of cpo piemonte between 2015 and 2020. women with eoc, and the center where they have been treated for the tumor, will be identified by linking the databases of the "oncological network of piedmont and valle d'aosta" with those of the "prevenzione serena" project. a few clinical information from eoc patients will be collected by clinical investigators at each center using an electronic case report form (e-crf) developed at the mario negri institute. these information will include age, date of diagnosis, histological subtype and grading, tumor stage according to figo 2014 classification2,3, previous gynecologic conditions and surgical operations, date of pap test collection, and pap test cytological reports. participants' data will be identified by a unique patient code.

Eligibility criteria:
inclusion criteria: age ≥18 years; * confirmed histologic diagnosis of hgs-eoc or high grade endometrioid tumor; * presence of one ffpe primary tumor biopsy with at least 40% of tumor cells based on hematoxylin and eosin staining, in the archive of the pathology departments of the hospital centers where they have been treated; * presence of one or more pap tests sampled up to eight years before eoc diagnosis during routine cervical cancer screening; * negative history for other gynecologic malignancies; exclusion criteria: * pap test not available in patients with ovarian cancer

Keywords: ovarian cancer pap-test
response of intracardiac thrombus to anticoagulants in patients with non-valvular atrial fibrillation (lysis)

Conditions: Atrial Fibrillation; Intracardiac Thrombus

Summary: this study aims to analyze changes in the immune status, metabolic status, and host microbiome community structure in non-valvular atrial fibrillation patients with intracardiac thrombus. additionally, the study aims to analyze factors that influence the responsiveness and occurrence of adverse events related to anticoagulant therapy.

the researcher-initiated clinical cohort study is a national multicenter, retrospective-prospective study of non-valvular atrial fibrillation patients with intracardiac thrombus, based on molecular biology and multi-omics analysis. the study aims to analyze the changes in the body's immune status, metabolic status, and host microbiome community structure, as well as to analyze the factors that influence the responsiveness of intracardiac thrombus to anticoagulant therapy. the study also evaluates the occurrence of adverse events related to anticoagulation in these patients.

Eligibility criteria:
inclusion criteria: * age ≥18 years old, age ≤80 years old * patients with atrial fibrillation detected by routine surface 12-lead electrocardiography or holter * transesophageal echocardiography confirmed the presence of cardiac thrombus, and the patient had not received any anticoagulant therapy exclusion criteria: * echocardiography confirmed valvular heart disease * contraindications to anticoagulants * patients with the previous history of hemorrhagic stroke * low platelet count or functional platelet defects * congenital or acquired coagulation or bleeding disorders * abnormal liver function (liver enzymes \>2 times the upper limit) * renal failure (endogenous creatinine clearance \<30ml/min) * surgery was planned within the intended study time or had been operated within 30 days before the study * other comorbidities that can cause bleeding, such as tumors * patients with autoimmune diseases or immunodeficiency, or patients who are currently using immunosuppressants and immunomodulators * patients are currently participating in other clinical studies

Keywords: atrial fibrillation intracardiac thrombus anticoagulation therapy major adverse cardiovascular and cerebrovascular events
db-3q bmmsc-evs in patients with perianal fistulizing crohn's disease

Conditions: Perianal Fistula Due to Crohn's Disease

Summary: this is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of db-3q for the treatment of perianal fistulizing crohn's disease.


Eligibility criteria:
inclusion criteria: 1. written informed consent from participant 2. men and women 18-75 years of age with a diagnosis of crohn's disease for at least six months duration prior to day 1 3. single and/or multi-tract perianal fistula(s) with 2 or fewer openings, that are actively draining 4. failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-mp, methotrexate, azathioprine), monoclonal antibodies (adalimumab, certolizumab, golimumab, guselkumab, infliximab, risankizumab, ustekinumab, vedolizumab), or small molecule inhibitors (tofacitinib, upadacitinib) 5. previous failed surgical intervention, including seton placement at least two weeks prior to screening, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula 6. medical therapy for cd stable for at least 2 months prior to day 1 (changes in dosing or dosing intervals related to serum drug levels are not permitted) exclusion criteria: 1. lack of informed consent 2. pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding 3. a participant who is unwilling to use medically acceptable contraception methods during participation in study 4. active perianal abscess or infection at screening or day 1 5. clinically significant medical conditions within six months before day 1 that would, in the opinion of the investigator, compromise the safety of the participant 6. confirmed hiv, hepatitis b, or hepatitis c infections 7. history of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening 8. history of colorectal cancer within 2 years of screening 9. use of investigational therapy or treatment within 30 days prior to day 1
a pharmacogenomics study of simvastatin-induced adverse drug reaction

Conditions: Simvastatin Adverse Reaction; Pharmacogenomics; Accurate Medication

Summary: adverse reactions of simvastatin are mostly slight and transient, however, the incidence of simvastatin-induced hepatic impairment and myopathy are obviously higher in chinese population than other racial groups. there is still lack of research data in chinese. in this study, we will investigate whether there are specific genotypes which may predict the incidence of simvastatin-induced hepatic impairment and myopathy in chinese so as to provide a basis for developing guidelines on precise medication in simvastatin therapy apply to chinese population.


Eligibility criteria:
inclusion criteria: * patients taking simvastatin therapy * signed informed consent. exclusion criteria: * patients not taking simvastatin therapy * intolerance or unwillingness to blood sample collection.
effectiveness and reliability of vectselect™ feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (crt) patients

Conditions: Heart Failure

Summary: it's the aim of this study to analyse efficacy and reliability of vectselect feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (crt) patients.


Eligibility criteria:
inclusion criteria: * indication for crt-d implantation / upgrade * written informed consent exclusion criteria: * pregnancy * age \< 18 years * patients, who cannot visit the routine follow ups (within first 3.5months) * participants to other studies with active treatment arm

Keywords: phrenic nerve stimulation lv pacing configuration crt cardiac resynchronisation therapy heart failure