Kornimate/medical-research-clean huggingface dataset:
radiomics and molecular expression predictive model for esophago-gastric junction and gastric cancer trg

Conditions: Gastric Cancer; Adenocarcinoma of the Stomach

Summary: the aim of this study is to develop a ct scan-based radiomics predictive model about tumor regression grade (trg) in patients with esophago-gastric junction (egj) ang gastric cancer undergoing perioperative chemotherapy. the molecular expression of the neoplasms will be evaluated to assess its association with the trg and the radiomic features.

• to compare the radiomic features of the ct scans at the time of diagnosis (t0) and at the end of the preoperative chemotherapy (t1) in order to predict the trg with the texture analysis on the first ct scan. a non-good response (non-gr) has shown to be predictable with texture analysis on the pre-treatment ct scan. therefore, we hypothesize that texture analysis could let to identify the good response patients. • to find correlation between the molecular expression of the tumor and the radiomics features. texture analysis on the pre-chemotherapy ct scan founded that entropy and compactness were higher and uniformity lower in responders. nonetheless the association between radiomics features and molecular expression has not been investigated yet. therefore, we hypothesize to add some others radiomics signatures to the analysis and to find an association with the molecular expression. • to find correlation between the molecular expression of the tumor and the trg. msi gastric cancer has been shown to be less responsive to preoperative chemotherapy. therefore, we hypothesize to confirm this result.

Eligibility criteria:
inclusion criteria: * patients with histologically proven adenocarcinoma of the egj (siewert ii-iii) or stomach. * preoperative staging: ct2-t4a, cn0-n3, m0. * patients \>18 years old. * patients undergoing perioperative chemotherapy with docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil (flot). exclusion criteria: * siewert i egj tumor * patients undergoing preoperative radiotherapy. * absence of both pre and post-chemotherapy ct-scan. * patients with tumor progression during preoperative chemotherapy. * patients undergoing other neoadjuvant chemotherapy regimen different from flot * exploratory laparoscopy with positive cytology on the peritoneal lavage or evidence of peritoneal carcinosis

Keywords: radiomics molecular expression perioperative chemotherapy flot gastric cancer esophago-gastric junction cancer
expression of inflammasomes in hcv patients

Conditions: Hepatitis C

Summary: hepatitis c virus has been identified a quarter of a decade ago as a leading cause of chronic viral hepatitis that can lead to cirrhosis and hepatocellular carcinoma. only a minority of patients can clear the virus spontaneously during acute infection. elimination of hcv during acute infection correlates with a rapid induction of innate and a delayed induction of adaptive immune responses. the majority of patients is unable to clear the virus and develops viral persistence despite the ongoing innate and adaptive immune response. the virus usually develops several strategies to escape these immune responses.


Eligibility criteria:
inclusion criteria: * chronic hepatitis c virus patients. * patients do not start treatment protocol. exclusion criteria: * pregnant women. * hepato-cellular carcinoma patients. * autoimmune disease patients. * patients with liver cirrhosis. * patients who refuse to participate in the study
an extension study evaluating the long-term safety and tolerability of degarelix one-month depots in prostate cancer

Conditions: Prostate Cancer

Summary: this was an extension study for the study fe200486 cs12 (nct00819156). each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained. the study was terminated when all ongoing participants had been treated for at least 5 years (including one year in the main study).

participants who completed the main fe200486 cs12 study initially continued with the same dose in the fe200486 cs12a extension study. after a protocol amendment all study participants were treated with 160 mg (40 mg/ml). the data include data from the participants who participated in both the main study (fe200486 cs12; nct00819156) and the extension study fe200486 cs12a.

Eligibility criteria:
inclusion criteria: * had given written consent before any study-related activity was performed (a study-related activity was defined as any procedure that would not have been performed during the normal management of the participant) * had completed the fe200486 cs12 study exclusion criterion: * had been withdrawn from the fe200486 cs12 study

Keywords: prostate cancer androgen ablation therapy
safety of transcranial direct current stimulation in pediatric hemiparesis

Conditions: Hemiparesis

Summary: the primary objective of this proposal is to investigate the safety of use of transcranial direct current stimulation (tdcs)in children with hemiparesis. the research question, "is transcranial direct current stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses: 1. tdcs will not produce a major adverse event, including seizure activity. 2. no change in paretic or nonparetic hand function or cognitive status will occur.

completing a pilot safety study is paramount to the future goal of incorporating the tdcs pediatric safety data and combining tdcs and rehabilitation with constraint-induced movement therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can provide and enhance quality of life for these children with hemiparesis.

Eligibility criteria:
inclusion criteria: 1. congenital hemiparesis confirmed by most recent mri or ct radiologic report. 2. hemispheric stroke or periventricular leukomalacia 3. ages 8-17 years old 4. ≥ 10 degrees of active motion at the metacarpophalangeal joint 5. adequate receptive language function to follow two-step commands as evidenced by performance on token test of intelligence 6. no evidence of seizure activity within the last 2 years. 7. subject is able to give informed assent and providing a signature, along with the informed consent signature of the legal guardian as evidenced by signature. exclusion criteria: 1. metabolic disorders 2. neoplasm 3. epilepsy 4. disorders of cellular migration and proliferation 5. acquired traumatic brain injury 6. expressive aphasia 7. pregnancy 8. indwelling metal or incompatible medical devices 9. evidence of skin disease or skin abnormalities 10. botulinum toxin or phenol intramuscular block within the one-month preceding tdcs
the scottish aortic stenosis longitudinal imaging and biomarker (saltire) programme

Conditions: Aortic Stenosis

Summary: the goal of this observational study is to understand the processes of what causes and accelerates the disease progress in aortic stenosis and following aortic valve replacement. participants will undergo transthoracic echocardiography every 6 months, with annual visits for state-of-the-art scanning techniques including positron-emission tomography combined with computed tomography or magnetic resonance imaging with radiotracers designed to look at disease processes including fibrosis, calcification, inflammation and thrombosis activity.

this will be an observational cohort study using existing and prospectively recruited cohorts for both cross-sectional and longitudinal comparison across the spectrum of aortic stenosis severity. for existing cohorts of patients who have previously undergone research assessments, we will invite them for repeated assessments. participants will be reviewed every 6 months in the clinical research facility (crf) over a 4-year period. they will undergo clinical assessment, blood sampling, transthoracic echocardiography and advanced imaging annually including ct angiography, magnetic resonance and positron emission tomography (pet).

Eligibility criteria:
inclusion criteria: * male or female aged \>50 years * provision of informed consent prior to any study specific procedures * patients with bioprosthetic aortic valve replacements, including both surgically and transcatheter implanted valves * patients with severe aortic stenosis (peak velocity \>4.0 m/s; previously recruited patients) * patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s; new prospectively recruited patients) * patients with mild aortic stenosis (peak velocity 2.5-2.9 m/s; new prospectively recruited patients) * patients with aortic sclerosis (tri-leaflet thickened aortic valve with no obstruction of ventricular outflow) * age and sex-matched healthy volunteers exclusion criteria: * inability or unwilling to give informed consent. * those with an allergy to iodinated contrast * patients with impaired renal function (egfr of \<30 ml/min/1.73m2) * women who are pregnant or breastfeeding. * patients with known rheumatic heart disease * patients with known ochronosis * patients with known familial homozygous hypercholesterolaemia

Keywords: aortic stenosis
bilateral erector spinae plane block as an opioid sparing technique for selective dorsal rhizotomy in pediatric patients with spastic cerebral palsy

Conditions: Erector Spinae Plane Block; Opioid; Sparing; Selective Dorsal Rhizotomy; Pediatric; Spastic Cerebral Palsy

Summary: this study aims to evaluate the efficacy of bilateral erector spinae plane block as an opioid-sparing technique for selective dorsal rhizotomy in pediatric patients with spastic cerebral palsy.

cerebral palsy (cp) is the most common physical disability affecting children. selective dorsal rhizotomy (sdr) is a neurosurgical procedure that permanently reduces lower limb spasticity in children with cp by selectively targeting and removing sensory rootlets with aberrant activity. postoperative pain is often distressing for patients and their families and can result in complications, delayed participation in therapy, and poor functional recovery. erector spinae plane block (espb) is a newly described interfascial plane block. espb is effective on both visceral and somatic pain.

Eligibility criteria:
inclusion criteria: * age from 6 to 18 years. * both sexes. * american society of anesthesiology (asa) physical status ii, iii. * patients with spastic cerebral palsy undergoing selective dorsal rhizotomy. exclusion criteria: * allergy to local anesthetics. * severe fixed joint deformity. * previous orthopedic surgery. * patient with abnormal liver/kidney function. * patient with skin damage or infection at the proposed puncture site.
a comparison study of pain relief from dysmenorrhea between the vipon tampon and ibuprofen

Conditions: Dysmenorrhea

Summary: the purpose of this study is to compare the vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea. subjects completed a total of 4 treatment intervals; each subject was randomized to use the vipon as their treatment for two intervals and ibuprofen as their treatment for two intervals.

pain caused by dysmenorrhea can range from mild to severe. at least 50% of all menstruating women experience appreciable pain at some time during their menstruation. an estimated 600 million work hours are lost annually to this affliction with an average loss of time of two or more workdays per year per female employee. treatment of dysmenorrhea may include either non-pharmacological or pharmacological measures. pharmacological treatments include oral contraceptives to treat hormonal imbalances, over-the-counter analgesics or non-steroidal anti-inflammatory drugs. the vipon is a tampon with a small motor unit within, which produces vibratory stimulation. this study aims to provide information on the safety and efficacy of the vipon in a randomized controlled clinical trial.

Eligibility criteria:
inclusion criteria: * females ages \>= 18 years * 4 consecutive monthly menstrual cycles * self-assessment of dysmenorrhea * non-pregnant status * agrees to use adequate birth control during the trial * consents to use tampons through the test of cure assessment * provides informed consent for participating in the trial exclusion criteria: * prohibited use of pain medication 4 hours prior to treatment and during the first 2 hours after treatment with study medication * positive pregnancy test * unwilling or unable to comply with protocol * allergic to ibuprofen

Keywords: dysmenorrhea
peer-supported diabetes self-management support

Conditions: Diabetes

Summary: the objective is to evaluate the efficacy of a web-trained workforce of hispanic and african american diabetes peer mentors delivering diabetes self-management support (dsms) to patients with poorly-controlled diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c\>9% * african american or hispanic ethnicity

Keywords: peer mentor peer supporter peer coach peer-to-peer mentoring
global electrical heterogeneity and clinical outcomes

Conditions: Heart Failure; Implantable Defibrillator User; Ventricular Arrythmia

Summary: this retrospective multicenter cohort will validate an independent association of electrocardiographic (ecg) global electrical heterogeneity (geh) measures with sustained ventricular tachyarrhythmias and appropriate icd therapies in systolic heart failure patients with primary prevention icd, and will validate and re-calibrate geh ecg risk score for prediction of sustained ventricular tachyarrhythmias and appropriate icd therapies in systolic heart failure patients with primary prevention icd.


Eligibility criteria:
inclusion criteria: * records of systolic heart failure patients with primary prevention icds/crt-ds implanted for routine clinical indications exclusion criteria: * absent baseline pre-implant digital ecg; * missing data on clinical predictors and covariates; * missing icd programming data (including number of intervals to detect \[nid\] or time to detect, number of detection zones, heart rate for each detection zone, and anti-tachycardia pacing \[atp\] programming); * missing outcomes data. * records of patients with inherited channelopathies (e.g. long qt syndrome, brugada syndrome), inherited cardiomyopathies (e.g. hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy), and congenital heart disease.
food-effect bioavailability study of fdc(gemigliptin/metformin hcl sustained release) 50/1000mg(25/500mg x 2tablets)

Conditions: Type 2 Diabetes

Summary: this study is designed to investigate the food-effects on fdc(gemigliptin/metformin hcl sustained release) 50/1000mg(25/500mg x 2tablets)


Eligibility criteria:
inclusion criteria: * age between 20 to 45, healthy male subjects(at screening) * bmi between 19.0 - 27.0 * fpg 70-125mg/dl glucose level(at screening) * subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress. exclusion criteria: * subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.) * subject who had gi tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included) * subject who had drug hypersensitivity reaction.(aspirin, antibiotics) * subject who already participated in other trials in 90 days * subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently. * smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
efficacy study of the vaginal gel carraguard to prevent hiv transmission

Conditions: HIV Infections; AIDS; Sexually Transmitted Diseases; HIV Seroconversion

Summary: the purposes of this study are to determine whether carraguard® gel can prevent the transmission of hiv when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.

this study is designed to show if carraguard® can protect women against hiv if it is used before sex, and is safe for long-term use.

Eligibility criteria:
inclusion criteria: * hiv negative and agree to be tested for hiv and told their results at all visits during the study * aged 16 - 40 years of age * have had at least one vaginal intercourse within the last three months * willing and able to give written informed consent (or if desired, consent provided by parent or guardian with written assent from the minor participant) * provide locator information to study staff throughout the trial * comply with all aspects of the study protocol, including random assignment to the carraguard® plus condom or placebo plus condom arm, clinical valuations, specimen collection and testing, visit schedule and study drug regimen * citizen or permanent resident of south africa * resident for the past year and intends to reside in the catchment area of the site for the next two years * during the study, will not use any vaginal products except tampons or those prescribed or approved by the study clinician. exclusion criteria: * currently pregnant, or indicate a desire to become pregnant in the next two years at the time of screening * within four weeks of last pregnancy outcome at the time of enrolment * pap smear at screening is graded as carcinoma. * injected illicit drugs in the 12 months prior to screening * participating in any other clinical trial/hiv prevention study

Keywords: microbicide hiv aids stis stds efficacy hsv women south africa seroconversion condom safe-sex vaginal intercourse prevention hiv seronegativity
double-blinded trial of household-based chlorination in india

Conditions: Diarrhoea

Summary: the proposed study is a 12-month double-blinded, randomized, placebo-controlled trial to determine if the impact of treating water with chlorine at the household level is effective in preventing diarrhea among young children. for more than a century, chlorine has be used to treat water in municipal systems in developed countries. lack of infrastructure has prevented its use in lower-income settings. nadcc is a tablet form of chlorine that has been used for more than 30 years in emergencies and has recently been approved for routine treatment of drinking water by the who and us environmental protection agency. the placebo will consist of the food-grade ingredients in the effective tablet, without the chlorine. study participants will be supplied with tablets (intervention or placebo) and instructed to use the same to treat their water daily. monthly follow-up visits will assess diarrhoea morbidity and weight-for-age z scores in \<5s. chlorine residual and bacteriological quality of water stored in the home will be measured each month. the study will also assess the impact of the intervention on absenteeism from school and work and on health care expenditure for diarrhoea.


Eligibility criteria:
approximately 2000 households with children \<5 will be enrolled. inclusion criteria: * households with at least one child\< 5 * male and female head of household consent to participate * reside permanently in study area
a pilot trial of a smartphone-based self-management support program for copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: copd patients often experience multiple symptoms (e.g. dyspnea, cough, and deteriorating quality of life) and have imposed a substantial economic and social burden on health care. the current proposal is to evaluate the feasibility and acceptability of a pilot trial of a smartphone-based instant messaging self-management support program to improve the quality of life in patients with copd.

chronic obstructive pulmonary disease (copd) is the number 3 killer globally by 2020. copd patients often experience multiple symptoms (e.g. dyspnea, cough, and deteriorating quality of life) and have imposed a substantial economic and social burden on health care. current policy for the prevention and management of long-term conditions focuses on efforts to prevent the onset or slow progression of disease early in the disease trajectory. this prevention paradigm has only recently been adopted for copd. systematic reviews have shown self-management support for patients with copd is effective in improving health-related quality of life and in reducing hospital admissions, but the evidence comes largely from patients with moderate or severe disease and is predominantly recruited from secondary care. simple and systematic strategies are needed to improve out-of-hospital support and management for people living with copd. an instant messaging smartphone app, which allows texts, audio, pictures and video messages to be shared in chat groups, is already available to and is the most popular in the hong kong general public. mobile instant messaging can be conducted through a daily use device to increase access and efficacy, which has been suggested as a feasible approach to delivering an intervention with positive effects on health behaviours and outcomes. text messaging via mobile phones has been shown to be effective in helping promote lifestyle change in diabetes self-management, weight loss, physical activity, smoking cessation and medication adherence with quantitative and qualitative evidence. however, the investigator has not found messaging intervention that was applied in people with copd, except an ongoing study of using instant text message support for patients with chronic respiratory and cardiovascular diseases. hence, the current intervention program is to evaluate the feasibility and acceptability of a smartphone-based instant messaging self-management support program to improve the quality of life in patients with copd.

Eligibility criteria:
inclusion criteria * aged 18 years and above * diagnosis with copd * general condition stable * able to speak and read chinese * able to complete the self-administered questionnaire * able to use instant messages such as whatsapp or wechat * mental, cognitive and physically fit for joining the trial as determined by the clinician or responsible investigator * signed informed consent exclusion criteria * skeletal fragility * serious active infection * inability to walk * severe respiratory insufficiency

Keywords: copd self-management support smartphone-based