Kornimate/medical-research-clean huggingface dataset:
increased vitamin d reduces pulmonary exacerbations in cf

Conditions: Cystic Fibrosis

Summary: the investigators study is designed to test the hypothesis that correction of vitamin d in cf patients can increase their lung function and decrease the number of their pulmonary exacerbations.

vitamin d deficiency is a known problem in cf patients. the cf foundation committee published in april 2012 new guidelines for administering vitamin d in cf patients. the investigators' study is designed to look for association between normal serum vitamin d levels and lung function. \~100 cf patients from the center of chronic diseases in hadassah medical organization will be treated according to the new guidelines, and their lung function will be tested once a month during the trial, which will be held for at least one year. in this study, the investigators' goal is to test the efficiency of the new guidelines in correcting serum vitamin d levels, and to follow other related factors such as growth indices (height, weight, bmi), bone mineral density, number of pulmonary exacerbations and number of hospital admissions.

Eligibility criteria:
inclusion criteria: * clinical and laboratory diagnosis of cystic fibrosis * complete medical and nutritional follow-up for at least one year before changing the vitamin d dosage and follow up for at least one year afterwards. exclusion criteria: * age under 4 years old (because of the inability to assess lung function in a reliable fashion)

Keywords: cystic fibrosis vitamin d lung function
rtms for aneroxia nervosa in youth

Conditions: Anorexia Nervosa

Summary: this study will examine the feasibility of off-label multilocus repetitive transcranial magnetic stimulation (rtms) for symptoms of anorexia nervosa in participants between the ages of 14-24. rtms is a non-invasive, brain-based intervention that uses magnets to deliver energy to the brain. the investigators will also see if patients receiving multilocus rtms show any improvements in their eating disorder, mood, anxiety, and obsessions and compulsions (if present). participants will receive daily intervention with off-label multilocus rtms for 20 total treatments. participants will also be asked to complete mental health and well-being surveys, physical measurements, and 2 brain imagining scans (mris) at baseline, and at study end. the investigators will also ask participants to complete surveys are 1-month and 3-months after the final rtms session. the target enrollment for this study is 45 participants.


Eligibility criteria:
inclusion criteria: 1. youth aged 14-24 with dsm-5 an-restricting (anr) or an-binge-eating-purging (anbp) type as determined by the mini-kid/mini and clinical interview; 2. ybc-eds score≥16, 3. baseline cgi-s score ≥4, 4. english speaking (as this complement of questionnaires are available in english) 5. on stable psychotropic medication (if any) for the preceding 4 weeks (i.e., ssris, atypical antipsychotics and benzodiazepines of doses \<1 mg lorazepam equivalent daily), 6. medically stable, as determined by their treating clinician, and 7. not deemed to be at high risk of imminent suicidal behavior by initial study psychiatrist assessment and referring provider/team, and no endorsement of items 4 or 5 on the severity of ideation subscale of the c-ssrs. 8. for women: not currently pregnant and on reliable birth control if sexually active (as the effects of rtms on the unborn fetus are unknown). exclusion criteria: 1. a lifetime history of psychosis, mania, or seizure disorder 2. active suicidality as determined by clinical assessment by md or phd, and endorsement of items 4 or 5 on the severity of ideation subscale of the c-ssrs. 3. unstable neurological disorder, 4. metal in head/eye, 5. inability to tolerate mri, 6. at high risk of alcohol withdrawal or substance intoxication, 7. diagnosis of pervasive development disorder, 8. medical instability as determined by primary care provider and/or referring clinician (i.e., unstable electrolytes in the setting of worsening binge-eating/purging, cardiac arrhythmias requiring holter or other intensive monitoring), 9. for women: pregnant or not using a reliable form of birth control.

Keywords: an tms
a trial of sk-pc-b70m in mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to find optimistic dose and to evaluate the efficacy and safety of sk-pc-b70m in patients with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * age range : 50 \~ 85 years * clinical diagnosis of probable alzheimer's disease (dsm-iv and nincds-adrda criteria) * mri within the last 12 months consistent with a diagnosis of ad * mmse score 10 to 26 * achei or memantine was discontinued at least 3 months prior to screening exclusion criteria: * patient in mild cognitive impairment (mci; cdr-sb \<2.5) * other central nervous disease * hypothyroidism, vitamin b12/ folic acid deficiency, hypercalcemia, neurosyphilis, aids * t.i.a or major infarction within the last 12 months * any serious disorder that could limit the ability of the patient to participate in the study * copd or asthma * any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study
a retrospective observational study on compliance in patients with rheumatoid arthritis on treatment with roactemra/actemra (tocilizumab) in clinical practice (remission ii)

Conditions: Rheumatoid Arthritis

Summary: this multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with intravenous roactemra/actemra (tocilizumab) in daily clinical practice. data will be collected from each eligible patient over a period of 6 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe rheumatoid arthritis according to the revised 1987 acr criteria at baseline * roactemra/actemra treatment must have been initiated 6 months prior to icf signing * patient eligible according to the summary of product characteristics (spc) and routine clinical practice/european recommendations for the use of biologic dmards for the treatment of rheumatoid arthritis exclusion criteria: * rheumatic autoimmune disease other than ra * participation in interventional clinical trials during the observational period
safety study of amg 811 in subjects with discoid lupus erythematosus

Conditions: Cutaneous Lupus; Discoid Lupus; Lupus; Systemic Lupus Erythematosus

Summary: this is a multi-center, randomized, double-blind, placebo-controlled, two-period, crossover study in which approximately 20 subjects with discoid lupus erythematosus will be enrolled to receive amg 811 and placebo in one of two sequences (ie, amg 811 followed by placebo or placebo followed by amg 811).


Eligibility criteria:
inclusion criteria: * men and women, between the ages of 18 and 70 years of age, inclusive, at the time of randomization; * diagnosis of discoid lupus erythematosus (dle) with or without sle; * intolerance of anti-malarial therapy or ≥ 3 months of anti-malarial therapy with residual disease activity. the total clasi activity must be ≥ 10; * stable dose of topical steroids no stronger than medium-potency (class iii or less) for ≥ 2 weeks and/or systemic immunosuppressive therapy at stable dose for ≥ 8 weeks prior to randomization (except for leflunomide which requires ≥ 12 weeks) are permitted; * oral prednisone ≤ 20 mg/day (or equivalent) is permitted; one increase or one decrease of ≤ 5 mg/day prednisone equivalent (not to exceed 20 mg/day) will be allowed within 30 days before randomization; exclusion criteria: * any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of dle or sle) that would, by its progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures per the investigator's discretion; * history of malignancy; * signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic infection, or recent history of repeated infections; * subjects with evidence of past or active tuberculosis * positive serology for hiv antibodies, hepatitis b surface antigen or hepatitis c antibodies (confirmed by pcr or riba) during the screening period; * receipt of a live vaccine within 3 months of study randomization and during the study; * prior use of the following agents: * administration of an investigational biologic agent that primarily targets the immune system - * rituximab, lymphostat-b, or tacl-ig within 9 months prior to randomization (or comparable b cell depleting or b cell inhibiting biologics); rituximab (or other depleting cd20 targeted agents) treated patients must demonstrate a return of cd19+ b cells to \> 5/μl; * ctla4-ig within 3 months prior to randomization; * other agents within 5 half-lives prior to randomization; * administration of cyclosporine, tacrolimus, sirolimus, iv immunoglobulin, and/or plasmapheresis within 3 months of randomization; * administration of thalidomide or lenalidomide within 3 months of randomization; * administration of oral or iv cyclophosphamide (or any other alkylating agent) within 9 months of randomization;

Keywords: lupus discoid lupus cutaneous lupus
the effect of increasing dialysate magnesium on calcification propensity in subjects on haemodialysis

Conditions: Endstage Renal Disease

Summary: the purpose of this trial is to examine the effect of increasing dialyse magnesium on serum calcification propensity in subjects with end-stage renal disease treated with haemodialysis.

patients with end-stage renal disease (esrd) have a 20-fold increased risk of cardiovascular mortality compared to the general population. arterial stiffness, likely due to vascular calcification (vc), has been shown to predict cardiovascular mortality in esrd. serum calcification propensity (t50) is a novel biomarker, which is believed to reflect the propensity toward ectopic calcification (e.g. vc). increasing serum magnesium (smg) should increase t50, which might in turn reduce the formation of vc in patients with esrd. a cheap and easy way of achieving this would be to increase the concentration of mg in the dialysate (dmg) of patients with esrd treated with haemodialysis (hd). the investigators wish to conduct a randomised controlled double-blind clinical trial to examine whether increasing dmg will improve t50 in subjects with esrd treated with hd.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * treatment with maintenance haemodialysis for more than 3 months. * dialysate magnesium of 0.5 mmol/l (standard concentration). * serum magnesium \< 1.2 mmol/l on average of previous measurements within the last 3 months. * women of childbearing age must be actively using contraceptive therapy (p-pills, estrogen depots or intrauterine device) as well as have a negative pregnancy test. * written informed consent. exclusion criteria: * treatment with peritoneal dialysis. * parathyroid hormone \> 66 ρmol/l. * previous parathyroidectomy. * current treatment with magnesium containing medication or supplements. * other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial. * pregnancy or breastfeeding.

Keywords: magnesium ectopic calcification chronic kidney disease - mineral and bone disorder serum calcification propensity
a mobile app for medication adherence in persons with hypertension: a pilot study

Conditions: Hypertension

Summary: a development and pilot test of an app targeting persons with hypertension. content in the app was based on persons with hypertensions experiences and a literature review. the participants experience of using the app as well as testing a instrument for medication adherence.


Eligibility criteria:
inclusion criteria: * 40-70 years of age, * have hypertension (i.e., icd 10 codes i10-i15 in the person's medical history) for ≥1 year * have been prescribed medications to treat said hypertension * speak and understand swedish * have a smartphone exclusion criteria: * having received medication with unit-dose packages (apodos) * previous stroke * previous myocardial infarction * psychological disorder or cognitive impairment (i.e. icd 10 codes f01-f99) * pregnancy-induced hypertension´ * insulin treatment * kidney disease, defined as glomerulus filtration rate (gfr) \<60 ml/min.

Keywords: artificial intelligence focus group adherence, medication pilot study
study of dc-cik combined with chemotherapy for advanced solid tumor

Conditions: Solid Tumor

Summary: combinations of dendritic cell-activated cytokine-induced killer cell (dc-cik) with chemotherapy treatment may enhance the immune response and stop cancer cells from growing.

patients in group a will receive 4 cycles of dc-cik treatments within 8 months. patients in group b will have no immunotherapy. chemotherapy are available in both groups.the investigators want to evaluate the efficacy of combination of dc-cik with chemotherapy in patients with treatment-refractory solid tumors.

Eligibility criteria:
inclusion criteria: 1. patients with treatment-refractory advanced solid cancer can not accept operation; 2. age 10 to 90 years; 3. eastern cooperative oncology group (ecog) score ≤ 2 points; 4. estimate survival \> 3 months; 5. blood white blood cell(wbc)≥ 4×109/l, hb ≥ 100g/l, platelet count (plt)≥ 80×109/l; alanine amino transferase (alt) and aspartate amino transferase (ast)≤ 2 times of normal upper value; serum cr ≤ 2 normal upper value; 6. without any other malignant disease; 7. with more than one scalable lesions; 8. patients voluntary attempt, and informed consent; 9. women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus. exclusion criteria: 1. patients who do not conform to the inclusion criteria; 2. patients with uncontrolled infection; underlying disease that was severe or life-threatening (such as uncontrolled brain metastasis ); 3. patients who were pregnant or lactating; 4. ecog perform status ≥ 2;4. 5. other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)
feasibility of an augmented two-day step test and causal modeling for post-exertional symptom exacerbation in post covid-19 syndrome

Conditions: Long COVID

Summary: this study aims to evaluate exercise capacity and identify causes of post-exertional symptom exacerbation (pese) in individuals with long covid. the investigators will compare the effectiveness of the two-day 6-minute incremental step test (6mist) and the cardiopulmonary exercise test (cpet) in detecting pese. additionally, the investigators will assess metabolism, mitochondrial function, autonomic symptoms, psychological factors, and physical activity. participants will complete both the two-day 6mist and the two-day cpet, with a one-month gap between them. each test is performed on two consecutive days to assess the delayed symptom response. the subjective symptoms of pese will also be measured through questionnaires. to explore potential causes of pese, the investigators will measure metabolism using indirect calorimetry, bioelectrical impedance analysis and food diaries, mitochondrial dysfunction with nirs technology, autonomic symptoms using the compass-31 questionnaire, psychological factors with questionnaires and physical activity levels using an activity tracker. this study will determine if the two-day step test (6mist) is a feasible alternative to the two-day cpet for measuring pese and will help uncover underlying mechanisms contributing to symptom exacerbation.


Eligibility criteria:
inclusion criteria: * ≥18 years old * long covid patients following the world health organization (who) criteria: "the continuation or development of new symptoms 3 months after the initial sars-cov-2 infection, with these symptoms lasting for at least 2 months with no other explanation" * previously active as described in the who recommendations for physical activity (minimal 150 minutes/week of moderate intensity aerobic physical activity or minimal 75 minutes of vigorous intensity activity/week or an equivalent combination of moderate- and vigorous-intensity activity throughout the week) * patient suffers from pese as defined by the depaul symptom questionnaire pem (post-exertional malaise) subscale * able to understand and sign written informed consent in dutch, french or english exclusion criteria: * any pre-existing conditions or new medical diagnosis that can alternatively explain the current symptoms * being unable to perform a cycle ergometer test as decided upon by the medical study team members * suffering from chronic obstructive pulmonary disease (copd) gold classification category 2,3 or 4 (by the global initiative for chronic obstructive lung disease) * allergies to medical adhesive bandages * skin conditions aggravated by sunlight including porphyria * participation in other interventional trials * mitochondrial diseases * pregnancy * lactation

Keywords: long covid pem post-exertional malaise cpet 6mist fatigue
a study of perfusion of colorectal anastomosis using fluorescence angiography (flag-trial)

Conditions: Rectal Cancer; Sigmoid Cancer

Summary: this is a randomized, controlled, parallel study to determine the difference in post-operative anastomotic leak rate of colorectal anastomosis where colon and rectal tissue perfusion is evaluated using fluorescence angiography with indocyanine green and without this method.

the design involves random allocation of eligible patients to operation with colorectal anastomosis and intraoperative fluorescence angiography with indocyanine green and operation alone. after surgery on 7-8 pod patients are examined to two sides x-ray proctography performed by introducing 100 ml of water-soluble liquid contrast material through the anus over the anastomotic line by a foley catheter for diagnosis of anastomotic leakage.

Eligibility criteria:
inclusion criteria: * have a planned circular stapled colorectal anastomosis * have signed an approved informed consent form for the study exclusion criteria: * has known allergy or history of adverse reaction to indocianyne green, iodine or iodine dyes.

Keywords: fluorescence angiography indocyanine green anastomotic leakage
lurasidone hci - a 6-week phase 3 study of patients with bipolar i depression

Conditions: Bipolar Depression

Summary: lurasidone hci is a compound that is a candidate for the treatment of bipolar i depression. this clinical study is designed to test the hypothesis that lurasidone in combination with either lithium or divalproex is effective among patients with bipolar i depression.


Eligibility criteria:
inclusion criteria: 1. provide written informed consent and is 18 to 75 years of age inclusive. 2. meets dsm-iv-tr criteria for bipolar i disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features. 3. has a lifetime history of at least one bipolar manic or mixed manic episode. 4. currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex. 5. not pregnant or nursing and is not planning pregnancy within the projected duration of the study. 6. females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after 7. good physical health on the basis of medical history, physical examination, and laboratory screening. exclusion criteria: 1. subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. 2. any chronic organic disease of the cns (other than bipolar i disorder). 3. hospitalization for a manic or mixed episode within the past two months. 4. used investigational compound within past 6 months. 5. clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.

Keywords: bipolar i depression lurasidone latuda
collecting and analyzing tissue samples from patients undergoing surgery for non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in rna and identify biomarkers related to cancer. purpose: this research study is collecting and analyzing lung tissue samples from patients undergoing surgery for non-small cell lung cancer.

objectives: * develop statistical and computational methods for modeling the relationships between multiple variable protein and rna expression data and clinical endpoints using both supervised and unsupervised classification and pattern recognition approaches. * determine protein and rna expression fingerprints on completely resected non-small cell lung cancer without prior chemotherapy. * correlate protein and rna expression fingerprints with t-stage and nodal involvement at the time of surgery, and collect outcome data to allow correlation with recurrence (local and/or distant) and survival. outline: this is a multicenter study. any excess tissues removed from surgery and would otherwise be discarded (tissues not used for diagnosis and/or treatment decision making) are obtained for this study. tissue are analyzed for molecular features that predict biologic behavior. quantitation of rna, gene expression profiles, and protein expression patterns are assessed by matrix-assisted laser desorption/ionization time of flight mass spectroscopy and microarray analysis. medical records are reviewed to obtain information about results of tests associated with cancer diagnosis. further progress in cancer treatment and tumor behavior after surgery are followed via record review.

Eligibility criteria:
inclusion criteria * diagnosis of non-small cell lung cancer * clinical stage i and ii disease * resectable disease and complete surgical resection planned * treated on companion studies at vanderbilt university, the veterans administration hospital, st. thomas, and vanderbilt-ingram cancer center affiliate network * tumor specimen samples must be available at resection exclusion criteria * chemotherapy before surgery * radiotherapy before surgery

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer
associations between air pollutants exposures and respiratory system study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: epidemiological investigations has suggested exposure to air pollution linked with respiratory disease, especially chronic obstructive pulmonary disease. however, the potential mechanisms of adverse effects remains scare. the present study will assess the association between air pollutants and respiratory related parameters to elucidate possible mechanisms.


Eligibility criteria:
inclusion criteria: * long-term residents, aged \>23 and \<82 years exclusion criteria: * severe cardiopulmonary diseases, active inflammatory diseases, cancer

Keywords: chronic obstructive pulmonary disease