Kornimate/medical-research-clean huggingface dataset:
levocarnitine in treating patients with vismodegib-associated muscle spasms

Conditions: Musculoskeletal Complications

Summary: this randomized clinical trial studies levocarnitine in treating patients with vismodegib-associated muscle spasms. levocarnitine may decrease muscle spasms caused by vismodegib.

primary objectives: i. to determine the effect of levocarnitine on muscle spasm frequency compared to placebo (median percentage comparison) secondary objectives: i. to assess intensity of muscle spasms after levocarnitine compared to placebo. ii. to assess responses related to activities of daily living or psychosocial function after levocarnitine compared to placebo. iii. to assess the number of body locations affected by muscle spasms after levocarnitine or placebo. iv. to assess the frequency and severity of all adverse effects on levocarnitine versus placebo. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive levocarnitine orally (po) twice daily (bid) during weeks 1-4. washout is from weeks 5-8. patients then cross-over to placebo po twice daipy for weeks 9-12. arm ii: patients receive placebo po twice daily during weeks 1-4. washout is from weeks 5-8. patients then cross-over to levocarnitine for weeks 9-12.

Eligibility criteria:
inclusion criteria: * taking vismodegib daily * subject answers item #1 of muscle spasms questionnaire as moderate or severe intensity at time of screening * at least one muscle spasm per day at time of screening * muscle spasms onset after starting vismodegib * willing and able to understand and sign consent form exclusion criteria: * presence of muscle spasms or active neurologic disease prior to start of vismodegib * use of thyroid medication at the time of screening * use of coumadin or acenocoumarol at time of screening * change in regimen of muscle relaxant medications within four weeks of enrollment * if on stable muscle relaxant medication regimen for 4 weeks prior to enrolling, not willing to maintain muscle relaxant regimen without change during course of the study * presence of significant renal disease or hemodialysis which would result in dramatic reductions of systemic levocarnitine levels * history of seizures * known deficiency in carnitine (genetic, etc.) * any uncontrolled medical condition which may place the patient at increased risk during study participation (at the discretion of the clinical investigator) * unable or unwilling to comply with study procedures * pregnant or lactating * all female patients of childbearing potential including those who are within 1 year of last menstrual period will be required to take a pregnancy test during screening, enrollment and at week 0, 4, 8 and 12 * if female of reproductive age, or male partner of female of reproductive age, unwilling to use two medically reliable forms of birth control while on vismodegib * unwilling to refrain from donation of bodily fluid (blood, platelets, etc.) within 7 months of last vismodegib dose

Keywords: basal cell carcinoma gorlin syndrome erivedge basal cell nevus syndrome
preoperative use of tocotrienol from annatto bixa orellana l. in breast cancer patients: a prospective clinical trial.

Conditions: Breast Cancer

Summary: tocotrienols have shown strong in vitro and in vivo anti-oxidant and anticancer activity, promoting apoptosis and regulating oncogenic targets in breast cancer. however their clinical use is still experimental especially in preoperative setting, where there are still no data of antioxidant and antiinflammatory beneficial roles. this study is a prospective observational clinical study enrolling 50 patients with primary breast cancer (t1-2, n0-1, m0) who received 4-weeks oral treatment of delta-t3 before surgery (200 mg/twice daily) with personalized nutritional and psychoeducational support. this study evaluates the effects of treatment on oxidant (tock fast-li starfish) and antioxidant capacity (tac track, li starfish), anti-inflammatory activity (complete profiling of adaptive and innate cell immunity, immunologic serum markers (mirna)), immunological response on tumor (gene expression profiling on preoperative tissue tumor biopsy and on surgical specimen), tnf-alpha, il-6 and vegf and proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines. this study evaluates the effects of treatment on oxidant (tock fast-li starfish) and antioxidant capacity (tac track, li starfish), on anti-inflammatory activity (complete profiling of adaptive and innate cell immunity, immunologic serum markers (mirna)), on immunological response on tumor (gene expression profiling on preoperative tissue tumor biopsy and on surgical specimen), on tnf-alpha, il-6 and vegf, on proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines.

an open-label, single center, phase 2 prospective observational clinical study

Eligibility criteria:
inclusion criteria: * histologically confirmed operable primary breast cancer (t1-t2 n0-1 m0) * absence of distant metastasis * signed informed consent. exclusion criteria: * previous malignancies other than in situ cervical carcinoma or nonmelanoma skin cancer * breast cancer recurrence * metastatic breast cancer * non-epithelial breast cancer at histological examination * in situ lobular breast cancer * participation in other randomized clinical trials that could interfere with current study * living distant from center and unable to attend for check-ups and meetings
comparative bioavailability of dronabinol oral solution in healthy volunteers

Conditions: Healthy

Summary: the primary objective of this study is to evaluate the comparative bioavailability of a test product of dronabinol oral solution administered under fed conditions to the reference listed drug (rld) administered to participants under fed and fasted conditions. the secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the rld.


Eligibility criteria:
inclusion criteria: * meets protocol-specified criteria for qualification * fully comprehends and signs the informed consent form, understands all study procedures, and can communicate satisfactorily with the investigator and study coordinator exclusion criteria: * history or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters * signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding) 3. the analysis of results

Keywords: comparative bioavailability
sputum studies of anti-citrullinated protein antibodies (acpa) and rheumatoid arthritis (ra) origins

Conditions: Rheumatoid Arthritis

Summary: the study is designed to learn more about the causes of rheumatoid arthritis (ra). people who get ra have elevated protein markers called autoantibodies in their blood years before initial symptoms of arthritis. the goal of this study is to learn more about how autoantibodies in ra might be related to inflammation in the lungs.

the specific aims of this study are as follows: 1. identify whether sputum anti-ccp predicts incident ra 2. determine the effect of inflammatory cytokines on the induction of netosis in sputum neutrophils 3. determine the role of sputum macrophage phagocytosis in net clearance \ the knowledge gained from this study will improve the overall understanding of the development of ra. it is anticipated that these findings will improve the field's understanding of how best to screen for ra risk and target ra prevention. this study could support future lung-targeted prevention strategies for ra that could avoid the administration of systemic toxic therapies. such potential prevention interventions could be implemented in subjects at risk for ra in order to prevent the irreversible joint damage that can occur in the later stages of clinically-apparent ra.

Eligibility criteria:
inclusion criteria: * adults between 18 and 100 years; * at-risk for ra, ra diagnosed, and healthy control subjects will be included in the study until recruitment goals are met for each group. at-risk: 1. no evidence of inflammatory arthritis on clinical examination and 2. at elevated risk for ra based on familial or serologic risk * familial risk includes having a first degree relatives (fdrs) with ra * serologic risk includes asymptomatic serum acpa positivity healthy controls : 1. no history of ra 2. no fdrs with ra 3. no systemic use of immunosuppressants for autoimmune disease ra diagnosis: 1. classified ra by 1987 acr and/or 2010 acr/eular ra classification criteria (confirmed by medical chart review) or 2. diagnosed with ra by a board-certified rheumatologist (confirmed by medical chart review) exclusion criteria: 1. currently pregnant or planning to become pregnant during the sample collection period of the study 2. exacerbation of underlying obstructive lung disease within the past 1 month 3. known fev1 \<1 liter 4. oxygen requirement \>2 liters at rest 5. participants with health acuity or behavioral health concerns leaving them unable to participate in the current research note: if a subject temporarily does not meet inclusion criteria but is interested in participating, he/she may participate once inclusion criteria have been met. if interested, please take a few minutes to complete the screening questionnaire for this study opportunity. you may open the survey in your web browser by clicking the link below: https://is.gd/sparoscreen if the link above does not work, try copying the link below into your web browser: https://redcap.ucdenver.edu/surveys/?s=3wm8wh3wkk
prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome

aremis (antiplatelet and recurrent myocardial infarction study) to compare the relative risk of new myocardial infarction (recurrent myocardial infarction or 'rmi') in patients with a history of acute coronary syndrome ('acs': unstable angina or myocardial infarction), using ticagrelor, clopidogrel or prasugrel (if applicable) or none of these treatments, where aspirin is considered a covariate.

Eligibility criteria:
inclusion criteria: patients aged 18 years or more, both genders, with an acute coronary syndrome (acs), agreed to participate and able to respond to an interview in french and/or providing the details of an alternative replier (proxy) if necessary. no exclusion criteria.

Keywords: effectiveness study acute coronary syndrome real-life france
serum carotenoids and risk of gastrointestinal tract cancer: meta-analysis of ten studies

Conditions: Gastrointestinal Tract Cancer

Summary: previous studies have suggested that serum carotenoids may be associated with risk of gastrointestinal tract cancer (git cancer), but the results were inconsistent. thus, the investigators conducted a meta-analysis to evaluate the associations between serum carotenoids and risk of git cancer.


Eligibility criteria:
inclusion criteria: * the study had both case and control groups * serum carotenoids levels, relative risk (rr) or or and corresponding 95% ci were reported * patients in case group were diagnosed with git cancer exclusion criteria: ·animal studies

Keywords: serum carotenoids gastrointestinal tract cancer meta-analysis
phase iii efficacy and tolerability trial of the fixed dose combination of etodolac 400 mg and cyclobenzaprine 10 mg versus isolated active substances in pain control after impacted third molar extraction

Conditions: Pain, Acute

Summary: this phase iii study will compare the efficacy and tolerability of a fixed dose combination of etodolac + cyclobenzaprine versus the isolated drugs in postoperative pain control after impacted third molar extraction.


Eligibility criteria:
inclusion criteria: * healthy research participants of both sexes (male and female non-pregnant), aged 18 years or over, underwent impacted third molar extraction surgery exclusion criteria: * presence of any event and / or pathology at the site of interest that may interfere with and contraindicate the performance of the surgical procedure at the discretion of the investigator, including periodontitis, odontogenic tumors or cysts (associated or not with the third molar), trauma, presence of inflammation and / or infection; * present or past history of any cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematological event; * previous diagnosis of alcohol and drug abuse defined by dsm-v; * current or past history (for less than 12 months) of smoking; * use of illicit drugs; * history of bleeding / bleeding or coagulation disorders, gastric ulcer and / or active peptic hemorrhage; * any finding of clinical (clinical / physical), laboratory or cardiac evaluation (ecg) observation that is interpreted by the investigating physician as a risk to the participant; * use of drugs that potentially interfere with the kinetics / dynamics of acetaminophen or any other medicinal product considered clinically significant by the investigator; * known hypersensitivity to the active principles used during the study (etodolac and cyclobenzaprine); * women in gestation or breastfeeding, as well as women who present a positive pregnancy test (β - hcg) during the study screening / selection period; * professionals directly involved in the realization of the present study and their relatives; * participant of the research that has participated in clinical study protocols in the last 12 (twelve) months, unless the investigator deems that there may be direct benefit to it.
muscle quality, fall concern and lower extremity functionality in older women

Conditions: Old Age; Debility; Age-Related Sarcopenia

Summary: the aim of the study was to investigate the effects of muscle quality on fear of fall, and lower extremity functionality in older women. the differences between muscle quality, fear of falling and lower extremity functionality in the elderly male and female participating in the study were investigated. older women had worse muscle quality, higher fall concern and less lower extremity functionality than older men.

the effects of muscle quality and lower extremity functionality, and fear of falling in older women are not well-known compared to older men in the same age group. the aim of the study was to investigate the effects of muscle quality on lower extremity functionality and fear of falling in older women. 168 age-matched older adults participated in the study. the muscle quality index, fear of fall, and lower extremity functionality were evaluated. the results of older women and men were compared.

Eligibility criteria:
inclusion criteria: * being 65 years old or older * having no neurological, orthopedic, communicational, * mental disability that affects the evaluations. exclusion criteria: * incomplete data and older adults not agreeing to participate in the study.
vascular closure device in transcatheter aortic valve replacement

Conditions: Aortic Valve Stenosis

Summary: evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.


Eligibility criteria:
inclusion criteria: * patients undergoing transfemoral tavi at the karolinska university hospital exclusion criteria: * patients undergoing tavi with access other than transfemoral * use of closure device other than manta
assessment of kidney function and osteomuscular status after critical care

Conditions: Critical Illness; Kidney Injury; Muscle Loss; Bone Loss

Summary: this observational study aims to assess kidney function through direct glomerular filtration rate (gfr) using iohexol clearance, compared to estimated gfr based on creatinine and cystatin c equations. kidney function will also be evaluated through renal fibrosis biomarkers. kidney function will be correlated to body composition, muscle turnover biomarkers, and bone micro-architecture.

the investigators developed a post-icu clinic where complications of the post-intensive care syndrome are detected. muscle function is assessed by clinical testings, muscle strength measurement. body composition is measured by electrical bioimpedance. bone mass is assessed using dual-energy radiographic absorptiometry. it is well known that icu survivors experience a loss of muscle mass. this can lead to misinterpretation of estimated gfr based on creatinine equations. the aim of the present study is to assess the evolution of kidney function after a prolonged stay in icu, using gfr equations based on cystatin c, and to compare it to measured gfr using iohexol clearance. the second aim is to explore the evolution of bone and muscle health in these patients.

Eligibility criteria:
inclusion criteria: * patients surviving an icu stay of at least 7 days * patients who experienced acute kidney injury (kdigo criteria) during icu stay exclusion criteria: * chronic kidney injury with dedicated follow-up before icu admission * chronic extrarenal epuration * kidney transplant * allergy to iohexol * iodinated contrast allergy * refusal
feasibility study of vessel analysis for noninvasive diagnosis of malignancy in breast tumors

Conditions: Breast Cancer

Summary: this is a pilot study designed to explore the feasibility of non-invasively diagnosing the presence of cancer in the breast using non-invasive magnetic resonance imaging (mri) methods and an analysis of vessel shape defined from these magnetic resonance images.


Eligibility criteria:
inclusion criteria: * adult women (age \>= 18), * with histologically documented newly diagnosed stage ii-iv invasive breast cancer appropriate for neoadjuvant (preoperative) systemic therapy. * ecog performance status of 0, 1, or 2 at the initiation of the study. exclusion criteria: * pregnant women * women with contralateral mastectomies * known bilateral tumors * subjects prone to claustrophobia * contraindicated to have mri * mentally impaired * not fluent in english
impact of telemonitoring on metabolic variables in severe obesity

Conditions: Severe Obesity

Summary: the goal of this clinical trial is to compare, in a population of severely obese patients, two different kinds of follow-up after discharge from in-hospital rehabilitation programme. the main questions addressed are: * primary outcome: comparing the dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up. * secondary outcome: comparing the amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits. participants are given a set of instruments (scale, activity tracker, automatic blood pressure monitor, oxymeter, and glucometer) and asked to measure vital parameters following a predetermined schedule for one year. subjects are asked to engage in regular physical activity and follow the nutritional guidelines received at the moment of discharge from hospital.


Eligibility criteria:
inclusion criteria: * bmi 38-60 kg/m2, * age between 18 and 65 years, * patient residing in piedmont, lombardy * recent admission to san giuseppe hospital in piancavallo for a period of residential rehabilitation. * patient with wi-fi and/or mobile data connection at home. exclusion criteria: * illiteracy * inability to engage in physical activity * psychiatric illnesses capable of impairing the proper use of the devices provided by telemonitoring * cognitive impairment, mental retardation * predictability of long periods of stay abroad * anticipation or planning of pregnancy during the year following discharge * legal protection
long term safety and tolerability of qva149 versus tiotropium in japanese patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily qva149 (indacaterol and nva237 (\[glycopyrronium bromide\]) using tiotropium as an active control in japanese patients with moderate to severe chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * patients with moderate to severe stable copd (stage ii or stage iii) according to the global initiative for chronic obstructive lung disease (gold) guidelines 2008. * current or ex-smokers who have a smoking history of at least 10 pack years. (ten pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.) * patients with post-bronchodilator forced expiratory volume in one second (fev1) ≥30% and \< 80% of the predicted normal, and post-bronchodilator fev1/forced vital capacity (fvc) \< 0.7 at visit 2. exclusion criteria: * pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception * patients requiring long term oxygen therapy * patients who have had a lower respiratory tract infection within 4 weeks prior to visit 1 * patients with concomitant pulmonary disease * patients with a history of asthma * any patient with history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years * patients with a history of certain cardiovascular comorbid conditions * patients with a known history and diagnosis of alpha-1 antitrypsin deficiency * patients in the active phase of a supervised pulmonary rehabilitation program * patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd qva149 nva237 indacaterol combination bronchodilator
tong-xie-yao-fang granules for diarrhea-predominant irritable bowel syndrome

Conditions: Diarrhea-predominant Irritable Bowel Syndrome

Summary: the purpose of this study is to test the efficacy and safety of a traditional chinese medication tong-xie-yao-fang for patients with diarrhea-predominant irritable bowel syndrome (ibs-d).

participants: the sample size of this trial is 118, to test an odds ratio of 3.5 at a significance of 0.05 and power of 0.8. intervention: tong-xie-yao-fang versus placebo data collection: standard operation procedure will be developed for how to interviewing the participants, how to use the ibs diary, how to enter the data into the electronic case report forms.

Eligibility criteria:
inclusion criteria: * being diagnosed as ibs according to the rome iii criteria; * diarrhea was present for at least 75% of the time; * with a tcm differentiation as "liver stagnation and spleen defficiency" * had a colonoscopy within a year to rule out other bowel diseases. exclusion criteria: * organic gastrointestinal disease, such as colorectal cancer, inflammatory bowel disease, advanced colonic polyp; * had gastrointestinal surgery within a year; * used durgs that affect gastrointestinal motility; * had psychological disorder; * serious disease in other system, which may bias the outcome measures.