Kornimate/medical-research-clean huggingface dataset:
chartis collateral ventilation measurement: conscious sedation versus general anesthesia

Conditions: Emphysema or COPD

Summary: rationale: the chartis® ( pulmonx, ca, usa) measurement system is a tool to assess interlobar collateral ventilation during bronchoscopy. assessing collateral ventilation is important when you intend to treat a patient with endobronchial valves. chartis measurement of collateral ventilation can be performed under both conscious sedation as well as general anesthesia. there is no consensus on what is the preferred method of anesthesia for chartis measurements in the literature. objective: in this project we want to investigate whether there is a difference in chartis measurement outcomes between these two methods of anesthesia: conscious sedation and general anesthesia. study design: this study will be a single center observational study study population: the study population exists of patients with severe emphysema who undergo collateral ventilation assessment before bronchoscopic lung volume reduction treatment with one-way endobronchial valves. intervention: all patients will undergo two subsequent chartis measurements. the first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia. main study parameters/endpoints: our primary outcome measure is the failure rate of the chartis collateral ventilation measurement under general anesthesia versus conscious sedation.


Eligibility criteria:
inclusion criteria: * patient is scheduled for a bronchoscopic lung volume treatment using one-way valves * patient has provided signed informed consent. exclusion criteria: for safety reasons patients that meet the following criteria will not be included in this study: 1. fev1 \<20% 2. rv/tlc\>70% 3. pco2 \>6.5 4. rvsp\>40mmhg 5. 6mwt\<200m 6. known intolerance to lidocaine 7. any other medical reason/condition that warrants a short procedure (physician judgement )

Keywords: emphysema bronchoscopic intervention chartis measurement
self-weighing instruction feasibility study

Conditions: Weight Loss; Body Weight

Summary: scant data have been reported on the effects of weight self-monitoring during weight control. the purpose of this pilot project was to consider the questions: is it possible to assign participants to engage in daily weight self-monitoring, and are there differential effects on mood of daily versus weekly weighing?

this study tested the feasibility of assigning participants to daily or weekly weighing, monitored adherence to weighing instructions, and tracked additional behavioral and psychosocial indicators over a period of six months. it was hypothesized that there would be no differences in mood or adherence between daily versus weekly weighing conditions. knowledge about the benefits of frequent self-weighing may shape public health recommendations for regular weighing as a weight reduction or obesity prevention strategy.

Eligibility criteria:
inclusion criteria: * body mass index between 25 and 35 kg/m2 exclusion criteria: * current weight loss program participation * chronic health conditions (diabetes, cancer, heart disease, psychiatric disorders requiring medication) * current or past eating disorder * current pregnancy or pregnant in past year

Keywords: self monitoring self weighing weight tracking psychosocial outcomes feasibility
bipolar research and innovation network - brain

Conditions: Bipolar Disorder

Summary: to describe the broad spectrum of bipolar disorder patients admitted to out-patient and in-patient psychiatric departments in norway. include all admitted bipolar patients both with and without co-morbid disorders.

norway is both social, genetically and culturally a homogeneous society. the health service is public and has a nearly total responsibility for psychiatric care in given catchment areas. this provides excellent opportunities to describe the frequencies and patterns of the broad spectrum of bipolar illness, including co-morbid substance use disorders, to follow the patients for several years and to do molecular genetic mapping. methods: participating centers consist of outpatient clinics and hospital departments from different parts of norway and one third-line clinic with referrals from all over norway. specifically trained clinicians in each center include bipolar patients systematically and perform the patient evaluation as part of their clinical duties. in addition, ct or mri scans and eeg are performed and blood samples are collected for clinical chemistry screening and for dna sampling.

Eligibility criteria:
inclusion criteria: * all admitted patients giving written consent to participate in the study exclusion criteria: * patients without competence for consent.

Keywords: bipolar disorder
knowledge-based dietary weight management.

Conditions: Weight Loss; Dietary Modifications; Obesity; Sustainability

Summary: this research is to develop a weight loss and weight maintenance program through dietary modifications for adults with obesity. although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.


Eligibility criteria:
inclusion criteria: * age 18-64 years; * body mass index (bmi) \>28 kg/m2; * not currently pregnant or lactating; * have wi-fi at home, a working email, and an iphone or android smartphone. * no self-reported severe metabolic, cardiovascular or musculoskeletal disease; * not using insulin injection; * able to attend the 22 (1 hour) diet improvement sessions. * willing to lose 20 lb. or more for 6 months and maintain a healthy weight for one year. * keep weighing their weight for one and a half years. * fluent in reading and writing english. exclusion criteria: * age \ 64 years; * body mass index of \<28 kg/m2; * currently pregnant; * currently lactating; * self-reported with the severe metabolic, cardiovascular or musculoskeletal disease; * use insulin injection; * not able to attend the 22 (1 hour) diet improvement sessions for 1 year; * failed to set up a wi-fi scale; * failed to submit a food frequency questionnaire
nutritional status and body composition in childhood inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: malnutrition and growth retardation are common in children with inflammatory bowel disease (ibd), especially in crohn's disease (cd). malnutrition is associated with disease type, anatomical location, severity of disease and age of patient. recently, it is reported that almost all children with cd and half with ulcerative colitis (uc) have reduced lean mass, however, body fat alteration are not well defined. the aim of this prospective and observational study was to evaluate nutritional and growth status and body composition of children with ibd using anthropometric measurement and bioelectrical impedance during 1 year follow-up.

patients 6 to 18 years of age at the time of enrolment who have ibd at any stage of disease activity, on any or no treatment and age- and sex-matched healthy controls will be included. all participants will be followed for 1 year. written informed consent will be obtained from the parents or guardians of the participants at the time of enrolment. prospective and retrospective data will be collected. complete family and medical history, physical examination and laboratory findings will be recorded on standard case report form. disease activity will be scored using the paediatric crohn's disease activity index for children with cd and the pediatric ulcerative colitis activity index for those with uc. endoscopic data will be reviewed and disease location will be classified according to paris classification. puberty will be assessed based on the development of secondary sexual characteristics. at the time of enrollment and after 1 year, anthropometric measurements including height, weight, triceps skin fold thickness, middle arm circumference and assessment of body composition by bioelectrical impedance will be performed for each child. anthropometric data will be standardized by generation of z-scores for height and weight based on age and gender. growth deficiency for height and weight measurements will be defined as a z-score\\-2.

Eligibility criteria:
inclusion criteria: * a male or female of 6 to 18 years of age at the time of enrolment * for children with ibd; the diagnosis of ibd are based on the combination of clinical features and serological, endoscopic, colonoscopic, and histological findings * for controls : no evidence of inflammatory or chronic disease exclusion criteria: * a male or female \ 18 years old at the enrollment * for children with ibd : presence of other chronic diseases * for healthy control: any coexisting chronic disease known to affect growth, nutritional status, dietary intake, or development

Keywords: body composition nutritional status
real world effectiveness of ustekinumab in induction and maintenance therapy for crohn´s disease

Conditions: Crohn Disease

Summary: "run-cd" is an investigator initiated "non interventional trial" on biologics in crohn´s disease (cd) patients in germany with a prospective documentation of effectiveness in induction and maintenance therapy of biologics, especially of ustekinumab, with a special interest on predictors of long-term responses and favorable disease outcome and documentation of severe side effects caused by the therapy with biologics.

the effectiveness and safety of induction and maintenance therapy of ustekinumab and other biologics will be assessed in different relevant subgroups of crohn's disease patients. to this end, different confounders have to be considered. patients followed-up for several years will likely receive changing treatments. these changes have to be taken into account. furthermore, the decision to prescribe, to stop or to continue a treatment depends on the availability of treatment options and experiences with these alternatives: 1. confounding by indication will be taken into account 2. patient characteristics which likely influence the risk of developing a particular endpoint will be taken into account 3. the possible influence of co-medication will be considered 4. changing risks over time will be considered 5. power considerations needs to be conducted prior to the comparison of incidence rates 6. appropriate statistical methods will be applied to deal with these challenges the principles described above will be followed in a similar manner for the analysis of effectiveness and safety endpoints. an appropriate power analysis will be performed before each sub-analysis.

Eligibility criteria:
inclusion criteria: cd-patients aged 18-80 years at enrollment written informed consent is given exclusion criteria: planned surgical intervention malignant disease in history lack of adequate documentation possibilities
systematic sampling of lymph nodes vs. lymphadenectomy according to intraoperative frozen pathology for pulmonary invasive adenocarcinoma with ground-glass opacity

Conditions: Lymph Node Excision

Summary: the purpose of this study is to evaluate the impact of systematic sampling of lymph nodes vs. lymphadenectomy on outcome according to intraoperative frozen pathology for pulmonary invasive adenocarcinoma with ground-glass opacity (ggo) after vats lobectomy.

on hrct screening, early lung adenocarcinoma often contains a nonsolid component called ground-glass opacity (ggo). in 2011, pulmonary adenocarcinomas were classified into atypical adenomatous hyperplasia (aah), adenocarcinoma in situ (ais), minimally invasive carcinoma (mia) and more extensively invasive adenocarcinoma (iac) \[1\]. early adenocarcinomas with ggo-dominant always mean low-grade malignancy and have an extremely favorable prognosis \[2-5\]. previous studies have shown that patients with aah, ais and mia have excellent survival rates (5-year survival rate is approximate 95%) after resection, and only 0.83% - 2.91% patients have lymph node metastasis \[6-9\]. at present, lymphadenectomy is always undergone in patients with pulmonary adenocarcinoma with ground-glass opacity. however, for mia patients (especially in t1a-b stage), the appropriate use of lymphadenectomy continues to be debated. nowadays, intraoperative frozen pathology is widely used during operation. however, whether sampling of lymph nodes or lymphadenectomy should be performed for ggo lesions according to intraoperative pathological diagnosis is unclear. the aim of this prospective study is to evaluate whether there are any trends regarding the impact of subtypes of invasive adenocarcinoma according to intraoperative frozen pathology in sampling of lymph nodes vs. lymphadenectomy.

Eligibility criteria:
inclusion criteria: 1. a peripheral nodular lesion; 2. the maximum diameters of whole ggo lesions and solid components on lung windows were no more than 3 cm (t1 stage); 3. vats lobectomy 4. 25%≦consolidation/tumor ratio ≦50% 5. ecog performance status 0-2; 6. without distant metastasis; 7. intraoperative frozen pathology confirmed invasive or minimally invasive adenocarcinoma. 8. no operation contraindication 9. cardiovascular: cardiac function normal 10. renal: creatinine clearance greater than 60 ml/min 11. the expected survival after surgery ≥ 6 months 12. must be able to sign written informed consent form exclusion criteria: 1. age less than 18 years old 2. known hereditary bleeding disorder with history of post-operative hemorrhage 3. patients maintained on chronic anticoagulation (eg coumadin therapy) 4. known hematogenous disorder 5. known primary or secondary malignancy 6. pregnant or breast-feeding women; 7. clinically significant heart disease; 8. patients who are unwilling or unable to comply with study procedures; 9. receiving immunosuppressive therapy; 10. hiv/aids. 11. multiple lesions in lung
the need for fiber addition in symptomatic heart failure

Conditions: Heart Failure

Summary: feast-hf is a single-centre clinical trial in ambulatory patients with chronic hf to evaluate whether dietary supplementation with acacia gum reduces hf-related biomarkers nt-probnp and st2 and how the gut microbiome responds to dietary supplementation with acacia gum. the hypotheses of this study are 1) that changes in the gut microbiome will be correlated with a reduction in nt-probnp and st2 in patients with hf after treatment with acacia gum, and 2) gut microbiome configurations (composition, diversity), stability and function (gene content) will be significantly altered in patients with hf in response to acacia gum.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * willing and able to provide informed consent * patients with established heart failure (as per their treating physician) including those with both reduced and preserved ejection fraction exclusion criteria: * patients requiring a special diet that would prohibit the intervention (e.g. celiac disease, irritable bowel disease) * patients who do not control their own meals (e.g. meals-on-wheels, long-term care) * patients with conditions that would interfere with the analysis of the microbiome (e.g. chronic diarrhea, recent antibiotics within the past month)

Keywords: heart disease cardiovascular disease diet fiber microbiome
platelet derived growth factor stimulates bone fill and rate of attachment level gain

Conditions: Periodontitis

Summary: the aim of the study was to evaluate the safety and effectiveness of platelet derived growth factor (pdgf) mixed with b tricalcium phosphate (btcp) for the treatment of advanced periodontal osseous defects at 6 months of healing.

this triple blind, prospective and parallel arm trial was conducted in subjects requiring surgical treatment of a periodontal osseous defect.

Eligibility criteria:
inclusion criteria: * probing depth of 7mm or greater at baseline * following debridement, 4mm or greater vertical bone defect depth with at least one intact bony wall * sufficient keratinized tissue to allow complete tissue coverage of the defect * a radiographic base of the defect at least 3mm coronal to the apex of the tooth * no evidence of localized aggressive periodontitis * smoke less than 1 pack of cigarettes per day exclusion criteria: * failure to maintain adequate oral hygiene * pregnant women or women intending to become pregnant * history of oral cancer within last 6 months or hiv * history within last year of periodontal surgery on study tooth * study tooth mobility greater than 2 * study tooth exhibiting a class 3 furcation defect * signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cementoenamel junction (cej) projections not easily removed, untreated carious lesions at the cej or on the root surface, subgingival restorations or restorations with open margins at or below cej * history within 6 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking, or more than 20 cigarettes a day * allergy to yeast derived products * investigational therapy within 30 days of surgery

Keywords: periodontitis
iron absorption from fortified extruded rice using different extruding temperatures.

Conditions: Iron-deficiency

Summary: food fortification is regarded as a safe and cost-effective approach to counteract and prevent iron deficiency. rice is a staple food for millions of people living in regions where iron-deficiency anaemia is a significant public health problem. therefore, rice may be a promising fortification vehicle. hot and cold extrusion, have been identified as the major methods for rice fortification. extruded rice has the advantage of incorporating vitamins and minerals into the food matrix. cold, warm and hot extrusion differ in the processing temperature and the physical structure of fortified rice kernel matrix. a recent human study in young women showed fractional iron absorption was higher in cold extruded rice compared to hot extruded rice and this was associated with changes in the starch microstructure. these changes cannot be detected in warm extruded rice, thus, our aim is to test the iron bioavailability in difference extrusion methods; hot and warm and cold with and without the solubilizing agent ca/tsc. this will provide information on optimized rice formulations for optimal iron delivery.


Eligibility criteria:
inclusion criteria: * female, 18 to 40 years old * normal body mass index (18.5 - 25 kg/m2) * body weight ≤ 65 kg * signed informed consent exclusion criteria: * pregnancy (assessed by self-declaration) * lactating up to 6 weeks before study initiation * anaemia (hb \< 12.0 g/dl) * elevate crp (\>5.0 mg/l) * any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) * continuous/long-term use of medication during the whole study (except for contraceptives) * consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration * blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months * earlier participation in a study using fe stable isotopes or participation in any clinical study within the last 30 days * participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments) * smokers (\> 1 cigarette per week) * difficulties with blood sampling * male gender * do not understand english

Keywords: iron deficiency iron fortified rice extruded rice
safety and efficacy of stsp-0601 in adult patients with hemophilia a or b without inhibitor

Conditions: Hemophilia

Summary: this study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of stsp-0601 at two dose levels for the treatment of bleeding episodes in hemophilia a or b patients without inhibitor.


Eligibility criteria:
inclusion criteria: * 18 ≤age≤70 years of age,male; * hemophilia a or b patients; * a bleeding event requiring treatment occurred (only applicable to the on-demand treatment stage); * factor viii or ix level \<2%, inhibitor titer \< 0.6 bu; * there were at least 2 bleeding events that requiring treatment occurred in the past 6 months before screening (only the second stage is applicable); * establish proper venous access; * agree to use adequate contraception to avoid pregnancy; * provide signed informed consent. exclusion criteria: * have any coagulation disorder other than hemophilia; * plan to receive prophylactic treatment of coagulation factor during the trail; * 4 weeks before screening, receive prophylactic treatment of amesetuzumab or plan to receive prophylactic treatment of amesetuzumab during the trial; * patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial; * patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment; * have a history of arterial and/or venous thrombotic events; * platelet \<100×109/l; * hemoglobin\<90g/l; * severe liver or kidney disease; * severe bleeding event occurred within 4 weeks before enrollment; * accepted major operation or blood transfusion within 4 weeks before enrollment; * hiv positive; * have a known allergy to stsp-0601; * participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, fvii, fviia, fviii, fix trails); * patients not suitable for the trail according to the judgment of the investigators.
probiotics use in the chronic peritoneal dialysis patients

Conditions: Peritonitis; Malnutrition

Summary: the purpose of this study is to determine whether probiotics can improve the nutrition status and prevent peritonitis in the chronic peritoneal dialysis patients.

peritoneal dialysis was one of therapies for uremia patient. however, peritoneal dialysis related peritonitis was a major complication for these patients. severe and prolong peritonitis may led to membrane failure and drop out of peritoneal dialysis. among the pathogens, g(+) bacteria came from skin surface and g(-) bacteria came from gastrointestinal tract. the later might be related to the pathogens in the gastrointestinal tract, and led to peritonitis if constipation or diarrhea developed. in addition, intestinal pathogens may be related to chronic inflammation in uremia patients. there was a mia syndrome (malnutrition, inflammation and atherosclerosis) noted before, and chronic inflammation may be related to malnutrition. today, we know that nutrition status and inflammation marker (crp) may be associated with patients' outcome. many gastrointestinal syndromes such as constipation suffer our patients. the dialysate in the abdominal cavity may further exacerbate the appetite. the probiotics was though to improve the pathogens in intestinal tract, improve gastrointestinal function. we want to decrease the incidence of peritonitis by using the probiotics. in addition, the improvement in gastrointestinal function can increase the nutrition status.

Eligibility criteria:
inclusion criteria: * 1. uremia patient under chronic peritoneal dialysis ≧ 3 months * 2. age between 16 and 75 years exclusion criteria: * 1. uremia patient with advanced malignance disease * 2. uremia patient had more than 2 episode of g(+) peritonitis within the last one year * 3. uremia patient with expected life ≦ 1 years * 4. uremia patient with the history of drug or alcohol abuse * 5. uremia patient with poor drug compliance * 6. uremia patient with active infection disease * 7. uremia patient with uncontrolled autoimmune disease such as sle

Keywords: probiotic peritoneal dialysis peritonitis nutrition status