Kornimate/medical-research-clean huggingface dataset:
colonic stent and tumor cell dissemination

Conditions: Colorectal Cancer

Summary: this study aims to examine the hypothesis of tumor cell dissemination after colonic stenting for obstructing colorectal cancer by measuring the level of plasma circulating tumor cell before and after the procedure of successful colonic stenting in patients.

1. patient recruitment: patients will be recruited from the division of colorectal surgery, department of surgery, the university of hong kong, over a 12 - 18 months period. our institution is a tertiary referral center for colorectal cancer patients in hong kong. informed consent will be obtained from the patients after the inclusion criteria are met. the study plans to recruit 25 patients in the colonic stenting group to compare with 15 patients in the control group. inclusion criteria: colonic stenting group 1. patients with obstructive colorectal cancer that requires colonic stenting as treatment 2. age \> 18 years and is able to give informed consent 3. informed consent for blood collection obtained control group 1. patients with colorectal cancer who have colonoscopy without stenting 2. age \> 18 years and is able to give informed consent 3. informed consent for blood collection obtained 2. blood collection and examination for circulating tumor cell about 10ml of edta blood will be collected for examination before the procedure (colonoscopic stenting or colonoscopy in the control group) and blood collection daily will be repeated for 3 days after procedure. blood will be sent to the laboratory for processing within 2 hours of withdrawal. circulating tumour cells, which are characterized by cd45- (to exclude hematopoietic cells), cd326+ (to mark epithelial cells), ck18+ and ck19+ (to mark intestinal cells), i.e. cells expressing cd45-cd326+ck18/19+, will be detected by fluorescence activated cell sorting (facs). for each ml of blood, 1 ml of fcm lysing solution will be added and allowed to incubate for 5 minutes to lyse the red blood cells, followed by centrifugation at 1000 rpm for 5 minutes. supernatant will then be aspirated, and the pellet resuspend in approximately 1 ml cold 1x pbs. 10 µl of the appropriate antibody will be added into the tubes, vortexed and incubated for 15 in dark and room temperature. after incubation, cells will be washed with pbs and then incubated with the second antibody. the process is repeated until all 4 antibodies have been labelled to the cells. cells will then be analysed on a facs machine (moflo, beckman coulter).

Eligibility criteria:
inclusion criteria: * colonic stenting group 1. patients with obstructive colorectal cancer that requires colonic stenting as treatment 2. age \> 18 years and is able to give informed consent 3. informed consent for blood collection obtained control group 1. patients with colorectal cancer who have colonoscopy without stenting 2. age \> 18 years and is able to give informed consent 3. informed consent for blood collection obtained exclusion criteria: * patients who refuse or who is unable to give informed consent on blood taking for the study.

Keywords: colonic stenting colorectal cancer obstruction circulating tumor cell
evaluation of saccharomyces boulardii combined with standard quadruple therapy for eradication of helicobacter pylori

Conditions: Helicobacter Pylori Infection

Summary: the eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to the antibiotics. therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. the aims of this prospective study is to investigate the efficacy of saccharomyces boulardii sachets for eradication of hp, compared with standard quadruple therap.

in china, the first-line therapy to treat helicobacter pylori (hp) consists of a bismuth-based proton pump inhibitor (ppi) and two antibiotics for 14 days. but, eradication has become less successful due to low compliance and high resistance to the antibiotics. therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. several studies previously suggested that probiotics could be effective for improving hp eradication rate or reducing adverse events with ppi-based triple therapy. but, their effect for eradication of hp is not yet conclusive. and the experiments now available about efficacy of saccharomyces boulardii were mainly combined with triple therapy. the aims of this prospective study is to investigate the efficacy of saccharomyces boulardii sachets for eradication of hp, compared with standard quadruple therapy.

Eligibility criteria:
inclusion criteria: * helicobacter pylori infected patients * 13c dob\>8 * age 22\~65 exclusion criteria: * prior hp eradication therapy including amoxicillin and clarithromycin * previous gastric resection * allergic to the drugs used in this study * previous use of proton pump inhibitors, bismuth, h2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study * patients who were pregnant or lactating * patients taking nsaids, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy，diabete mellitus, hypertension...) effect the evaluation of this study * can't express the complaint correctly

Keywords: saccharomyces boulardii standard quadruple therapy
viewing surface electrical stimulation on pelvic floor with ultrasound

Conditions: Pelvic Floor Disorders

Summary: subjects will place a surface electrode on their perineal area after a bladder-filling protocol. transabdominal ultrasound will image the base of the bladder at rest, voluntary pelvic floor contraction, with the surface electrical stimulation and with a combined pelvic floor contraction and electrical stimulation active.


Eligibility criteria:
inclusion criteria: * age:18-80y * gender: female exclusion criteria: * moderate-severe stress incontinence\*: as determined by self-reported \>3 accidents in 24-hr period * currently pregnant, may be pregnant (unsure pre and peri-menopausal women should take a pregnancy test.) * active urinary tract infection (uti) * pelvic pain, painful bladder syndrome, underlying neurologic/neuromuscular disorder that may impact ability to partake in the trial * implanted cardiac device or untreated cardiac arrhythmia * obesity as defined by bmi \>= 30 (height, weight recorded) * anyone with impaired decision making, drug or alcohol dependence, or potentially suicidal. * anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent \* stress urinary incontinence: as determined by an answer of "yes" to a standard question (from king's health questionnaire): "do you lose urine with physical activities such as coughing, sneezing, running?"

Keywords: pelvic floor electrical stimulation bladder ultrasound
study to evaluate safety and tolerability of sc immunotherapy with dm-101 in adults with birch pollen allergy

Conditions: Birch Pollen Allergy

Summary: randomized, double-blind placebo-controlled phase i study to investigate the safety and tolerability of ascending doses of dm-101 in adult subjects with birch pollen allergy.

the study will be carried out in a single study site located in finland.

Eligibility criteria:
key inclusion criteria: * males or females, aged 18 to 65 years * good general health * a documented clinical history of birch pollen-induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over, at least, 2 allergy seasons. * bet v 1 specific serum ige ≥ 0.7 ku/l * positive spt to birch pollen allergen, with a wheal diameter ≥ 5 mm * body weight ≥50 kg and body mass index (bmi) within the range 18-35 kg/m2. key exclusion criteria: * history or findings on physical examination of any significant disease or disorder which, in the opinion of the investigator, may put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study. * current diagnosis of asthma (other than seasonal during the birch pollen allergy season), requiring global initiative for asthma (gina) step 2 or higher treatment, or asthma partially controlled or uncontrolled according to gina classification in the 6 months before screening. * history of asthma deterioration that resulted in emergency treatment or hospitalisation in the 12 months before screening, or a life-threatening asthma attack at any time in the past. * forced expiratory volume in one second (fev1) \< 70% of predicted, regardless of asthma status at screening or baseline assessment at the first dosing visit. * history of severe drug allergy, severe angioedema or systemic allergic reaction of grade 3 or greater, according to the world allergy organization (wao) scale, due to any cause.
autologous and allogeneic whole cell cancer vaccine for metastatic tumors

Conditions: Colorectal Cancer; Ovarian Cancer; Gastric Cancer; Breast Cancer; Lung Cancer; Kidney Cancer; Melanoma

Summary: this study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. this approach will be evaluated in patients with melanoma and colorectal, gastric, ovarian, breast, lung and kidney epithelial cancer. tumor cells grown in the laboratory will be modified to make them stimulatory to the immune system, irradiated to kill them, and injected to the patient eight times at two-week intervals. this protocol is expected to prolong survival of metastatic cancer patients.


Eligibility criteria:
inclusion criteria: * one of the following metastatic cancers: melanoma, breast, ovary, colorectal, gastric, lung or kidney * above 18 years of age * failure of at least one chemotherapy protocol * clinical performance status of ecog 0,1 * absolute neutrophil count greater than 1000/mm3 * serum alt/ast less than three times the upper limit of normal * serum creatinine less than or equal to 1.6 mg/dl. * must be able to understand and sign the informed consent document exclusion criteria: * below 18 years of age * women who are pregnant * life expectancy of less than three months
ventilator weaning practices in patients intubated for guillain-barré syndrome or myasthenia gravis

Conditions: Myasthenia Gravis; Guillain-Barre Syndrome

Summary: guillain-barré syndrome and myasthenia gravis are two neuromuscular diseases that are commonly managed in icus that may require different weaning protocols. to date, no study has compared weaning modalities from mechanical ventilation in patients with these two diseases. our objective was to assess and compare for ventilator weaning modalities between patients mechanically ventilated for guillain-barré syndrome or for myasthenia gravis in a large-scale multicenter study.


Eligibility criteria:
inclusion criteria: all patients mechanically ventilated for at least 48 hours for guillain-barré syndrome or myasthenia gravis - exclusion criteria: patients mechanically ventilated less than 48h or intubated for another reason than the neuromuscular disease. -

Keywords: myasthenia gravis guillain-barre syndrome ventilator weaning airway extubation intensive care unit
multi-centre, retrospective, open label study, to validate ml-predicare by patients with melanoma under 1st and 2nd lines of immunotherapy

Conditions: Melanoma

Summary: this is a retrospective, open label study to establish and validate a prediction technology for advanced melanoma patients under the 1st, 2nd and later treatment lines, with the immunotherapeutic drugs ipilimumab, pembrolizumab \& nivolumab, in order to predict response rate and disease progression

the aim of this project is to develop a technology application (termed ml-predicare), which is meant to be a predictive stand-alone software device, to support clinicians' decision-making, by predicting the individual patient's response to immunotherapy treatments, e.g., in terms of time-to-progression (ttp). in stage i of the study, data will be collected for establishing a training set and assess the predictive potential of the modelling technology for the response of melanoma patients to immunotherapy. in stage ii of the study, data will be collected in order to establish a validation set and test the predictive power of the modelling technology in an independent set of patients diagnosed with melanoma.

Eligibility criteria:
inclusion criteria: patients who meet all of the following criteria are eligible for this study: 1. gender: female, male. 2. age: eighteen years and older at the start of treatment. 3. histologically confirmed unresectable stage iii or stage iv melanoma, as per ajcc staging system. 4. prior radiotherapy must have been completed at least 2 weeks prior to drug administration. 5. measurable disease by ct, or pet-ct, or mri per recist 1.1 6. patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) before treatment. 7. patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) during or after the treatment. 8. patient has at least one recorded visit to the treating oncologist before treatment. 9. patient has at least one recorded visit to the treating oncologist during or after the treatment. 10. treatment as per soc for melanoma. exclusion criteria: patients meeting one or more of the following criteria are ineligible for this study: 1. history of another malignancy within the previous 2 years except for: • adequately treated stage i or ii cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years 2. ocular melanoma 3. active brain metastases or leptomeningeal metastases.
evaluation of subjective ratings of appetite and glucoregulation of a low calorie diet supplemented with a high viscosity polysaccharide (polyglycoplex - pgx)

Conditions: Appetite and Hunger, Suppression; Blood Glucose, Postprandial

Summary: the objective of the study is to compare subjective appetite ratings and after-meal and 24 hour blood glucose levels within overweight and obese female subjects consuming either a standardized 3 day low calorie diet supplemented with a viscous fibre known as pgx (treatment) or a rice flour (placebo control). each treatment phase will be 3 days in length and separated by 3 week washout phase, so subjects will also be acting as their own control. subjects will be randomized to either start with the low calorie diet with pgx or the low calorie diet supplemented with rice flour. we hypothesize that the 3 day lcd with pgx will elicit an improved appetite score compared to the 3 day lcd supplemented with the rice flour placebo control.


Eligibility criteria:
inclusion criteria: - bmi 25-35 kg/m2 exclusion criteria: * known diabetes * medications or natural health products that affect appetite * contraindications to lcd * any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.

Keywords: viscous fibre polysaccharide blood glucose postprandial appetite hunger satiety
interventions to prevent adolescents with type 1 diabetes from long-term complications

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to evaluate the effectiveness of diabetes management training combined with the method of motivational interviewing with elements of cognitive behaviour therapy and e-mail support in the treatment of type 1 diabetes in adolescents (age range 13-20 years) compared to a control group. the investigators assess motivational changes and effects on metabolic control.

diabetes mellitus type1 requires lifelong insulin substitution, aiming at near normal glycaemia. insufficient metabolic control (hba1c \> 8 %) leads to micro and macro- vascular complications. especially in adolescence a lack of compliance leads to deteriorated metabolic control. motivational factors play a pivotal role in this age-group, however they have neither been studied so far nor considered in interventions with diabetes patients. therefore, the aim of this study is to evaluate in a multi-centred randomized controlled trial the effectiveness of diabetes management training with the method of motivational interviewing with elements of cognitive behaviour therapy and e-mail support. sixty adolescents within the age group of 13-20 years and hba1c levels \> 8 % will - after a refresher course in diabetes education - be involved to 2-weekly individual interventions sessions including motivational interviewing and cbt-modules with a psychologist and weekly e-mail support for a period of six month in order to improve hba1c levels, self- efficacy in diabetes management and general quality of life. as control group sixty adolescents within the age group of 13-20 years and hba1c levels \> 8 will - after a refresher course in diabetes education - get treatment as usual, including routine medical support visits, unspecific psychological consultations and unspecific e-mail support to match with the intervention group for time bonus. we assess motivational changes and effects on metabolic control (hba1c) and define the predictors of positive effects on glycaemic control.

Eligibility criteria:
inclusion criteria: * diabetes mellitus, type1 * hba1c\>8 * 1 year of diagnosis * access to internet available exclusion criteria: * n/a
noninvasive methods for prediction of esophageal varices in children

Conditions: Esophageal Varices

Summary: the aim of this study is to use non-invasive methods to identify patients at risk of developing gastrointestinal varices and correlation of these non-invasive methods with the degree of esophageal varices and the presence or absence of risk signs of bleeding such as cherry red spots.

portal hypertension is the underlying pathophysiological process that leads to the formation of portosystemic collaterals and heralds the onset of a severe complication: variceal hemorrhage. it is estimated that approximately 50% of pediatric patients with chronic liver disease and 90% of those with extrahepatic portal vein obstruction (ehpvo) will experience gastrointestinal bleeding. esophagogastroduodenoscopy (egd) is considered the primary modality for detection and surveillance of esophageal varices (ev) and to determine the risk of bleeding. varices were graded into four grades i, ii, iii, and iv according to the modified paquet classification. however, invasiveness of the technique and a significant risk associated with sedation on long-term neurological outcomes have limited its use. many studies have sought to determine clinical, laboratory, or other noninvasive methods that could predict the presence of ev. preliminary data suggests that laboratory tests such as platelet count, albumin and ultrasonographic parameters such as presence of splenomegaly, spleen size z score and platelet count to spleen size ratio and the clinical prediction rule (cpr; calculated from platelet count, spleen size z-score, and albumin concentration) may be useful as first-line tools for identification of adults and pediatric patients at risk of variceal development and thus reduce the number of unnecessary egds.

Eligibility criteria:
inclusion criteria: * patients aged \< 18 years with a diagnosis of chronic liver disease, extra hepatic portal vein obstruction and/ or liver cirrhosis. exclusion criteria: * patient who underwent prior variceal treatment (any type) or variceal bleeding prophylaxis (including nonselective β-blocker use, endoscopic variceal ligation or sclerotherapy, surgical portosystemic shunt or transjugular intrahepatic portosystemic shunt insertion), liver transplantation, and malignancy.
bg9924 in combination with methotrexate extension of study 104ra203 (nct 00458861)

Conditions: Rheumatoid Arthritis

Summary: this study is to observe the long-term treatment of bg9924

extension study for 104ra203 (nct 00458861)

Eligibility criteria:
inclusion criteria: * must be a participant from study 104ra203 (nct 00458861) exclusion criteria: * participants with a significant change in medical history from their previous bg9924 study 104ra203 (nct 00458861). * nursing mothers, pregnant women, or women who are planning to become pregnant while in the study. * male and female participants of child-bearing potential not willing to practice effective birth control for the duration of the study. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: rheumatoid arthritis arthritis bg9924 methotrexate
step up to pd: a community-based walking program for people with parkinson's disease

Conditions: Parkinson Disease; Parkinson Disease, Idiopathic

Summary: this study will investigate the feasibility of a 6-month community walking program for people with parkinson's disease (pd) and their care partners in greater saint louis, missouri region. the walking program will consist of weekly, organized walking groups at the missouri botanical gardens. participants in the program will use nordic walking poles during the walks. the walking group(s) will meet once per week and will be supervised by walking group leaders from saint louis university. participants will be given a smart watch to wear that will help step counts will be tracked in real-time. the program is designed to get people with parkinson's disease out of their homes, cultivate a culture of connection with others with parkinson's disease, and to be collectively accountable for a common goal toward increasing their physical and social engagement in their communities.


Eligibility criteria:
inclusion criteria: * 30-85 years old * neurologist-diagnosed parkinson's disease * able to walk independently with or without a walking aid (e.g., cane, walker) * willing to participate in study for at least 6 months exclusion criteria: * health diagnosis that would limit exercise participation (e.g., heart problems, uncontrolled blood pressure, exercise-induced asthma). * additional neurologic disease or injury beyond parkinson's disease. * evidence of significant cognitive impairment. this will be determined by completing the montreal cognitive assessment * participants with poor walking ability (determined using the timed up and go test during initial testing).

Keywords: walking physical activity social connectedness loneliness