Kornimate/medical-research-clean huggingface dataset:
mrl in the upper extremity

Conditions: Lymphedema of Upper Limb

Summary: objective: the aim of this study is to examine the feasibility and applicability of the mrl protocol for the upper extremity in maastricht university medical center, and to examine the differences of the lymphatic system between lymphedema patients and healthy volunteers. study design: an explorative study of an mrl protocol for the upper extremity in maastricht university medical center+. study population: there are two study groups. the first group (n=10) consists of patients with secondary lymphedema in the upper extremity. the second group (n=10) consists of healthy volunteers. intervention (if applicable): all participants will undergo an mrl examination with the same protocol, developed in a previous 'proof of principle' study, in the maastricht university medical center+. after localizer scans, a t2-weighted sequence is used. then a t1-weighted sequence will be made before the injection of contrast. after the injection of the contrast agent a t1-weighted sequences of the upper and lower arm are performed alternately. main study parameters/endpoints: the primary outcome is to determine the feasibility and applicability of the mrl protocol by evaluating the images of the upper extremity in patients with secondary lymphedema and healthy subjects. the secondary outcome is to assess the value of mrl in staging lymphedema.


Eligibility criteria:
inclusion criteria: * 18 years or older * informed consent * bmi \< 30 kg/m2 group a: - secondary lymphedema in the upper extremity group b: - healthy volunteers exclusion criteria: * active skin infection/erysipelas in the arm. * known allergy for a contrast agent * history of surgical intervention in the arm. * contraindications for mri with contrast; pregnancy, metals, prostheses, renal insufficiency, claustrophobia * active cancer * distant metastases
impact of adjuvant statin therapy in patients who underwent radical prostatectomy for locally advanced prostate cancer

Conditions: Prostatic Neoplasms

Summary: biochemical recurrence develops in approximately 30-40% of men with locally advanced prostate cancer who undergo radical prostatectomy. to date, the effect of statins on prostate cancer recurrence has been investigated in several retrospective studies with inconsistent results. the purpose of this study is to determine the impact of statin on biochemical recurrence after radical prostatectomy for locally advanced prostate cancer.

estimated enrollment: 354 study start date: october 2012 estimated study completion date: october 2015 statin group: treatment with atorvastatin 20mg daily after radical prostatectomy during 1 year. control group: treatment with placebo daily after radical prostatectomy during 1 year. follow up: every 3 months for the first year. check psa, total/ldl-cholesterol and triglyceride. primary end point rate of biochemical recurrence secondary end point clinical progression of prostate cancer change of total/ldl- cholesterol and triglycerides 5 year-biochemical recurrence free survival

Eligibility criteria:
inclusion criteria: 1. patients must have correspond to one of the following three pathologic criteria. a. gleason scores 8 or greater b. positive resection margin c. pt3-t4 2. patients must have pathologically adenocarcinoma 3. patients must be enrolled within 60 days after radical prostatectomy 4. patients must be able to provide written informed consent exclusion criteria: 1. patients who have received neoadjuvant androgen deprivation therapy 2. patients who have the participation of other clinical trial within the past 3 months 3. patients who have treated with statin 4. patients who have lymph node metastasis or distant metastasis 5. patients who have 10 year risk of cardiovascular disease over 10% based on ncep atp iii guideline.

Keywords: prostatectomy statins
accelerate study - a study of pegasys (peginterferon alfa-2a (40kd)) in combination with copegus (ribavirin) in interferon-naive patients with chronic hepatitis c (chc) infection.

Conditions: Hepatitis C, Chronic

Summary: this study will evaluate the efficacy and safety of different durations of treatment with pegasys combined with ribavirin in patients with chc genotype 2 or 3 infection who have never previously received interferon (ifn) therapy. the anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * patients \>=18 years of age; * chc infection (genotype 2 or 3); * liver biopsy (in \<24 calendar months of first dose), with results consistent with chc infection; * use of 2 forms of contraception during study and 6 months after the study in both men and women. exclusion criteria: * women who are pregnant or breastfeeding; * male partners of women who are pregnant; * conditions associated with decompensated liver disease; * other forms of liver disease, including liver cancer; * human immunodeficiency virus infection; * previous treatment with an ifn, pegylated ifn, ribavirin, viramidine, levovirin, or amantadine.
liposomal doxorubicin in treating patients with advanced stomach cancer

Conditions: Esophageal Cancer; Gastric Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of liposomal doxorubicin in treating patients who have advanced stomach cancer.

objectives: i. determine overall survival, time to disease progression, objective reponse rate, safety profile, and quality of life in patients with inoperable gastric adenocarcinoma when treated with doxorubicin hcl liposome. outline: patients receive doxorubicin hcl liposome iv over 1 hour every 4 weeks. treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression. patients with responding disease may continue therapy past the 6 courses until documented disease progression. quality of life is assessed prior to every treatment course. all patients are followed at 1 month. patients with stable or responding disease are then followed every 3 months until death. projected accrual: a total of 30 patients will be accrued for this study within 24 months.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed advanced gastric adenocarcinoma, including adenocarcinoma of the esophagogastric junction evaluable disease no cns involvement patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: at least 12 weeks hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hemoglobin at least 9 g/dl hepatic: bilirubin normal ast or alt less than 3 times upper limit of normal (uln) (5 times uln if documented liver metastases) renal: creatinine less than 1.5 times uln cardiovascular: lvef normal no history of new york heart association class ii-iv heart disease with congestive heart failure no unstable cardiovascular disease other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no other prior primary cancer within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix no hypersensitivity to anthracycline therapy no history of severe hypersensitivity reactions to products containing chremophor el (e.g., cyclosporine or teniposide for injection concentrate) no other significant medical disorder (e.g., active uncontrolled infection) that would preclude study treatment prior concurrent therapy: biologic therapy: no concurrent immunotherapy chemotherapy: no prior chemotherapy for metastatic disease no other concurrent chemotherapy endocrine therapy: not specified radiotherapy: at least 4 weeks since prior radiotherapy to less than 1/3 of hematopoietic sites and recovered surgery: not specified other: at least 30 days since other prior investigational agents

Keywords: stage iii gastric cancer stage iv gastric cancer recurrent gastric cancer stage iii esophageal cancer stage iv esophageal cancer recurrent esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus
total ige (immunoglobulin e) and der p 1 (d1) specific ige in induced sputum in patients with allergic and non-allergic asthma

Conditions: Asthma

Summary: asthma is a heterogeneous disease, and specifically the phenotype of non-allergic asthma is not yet well defined. several studies describe this group of patients as having severe asthma, persistent eosinophilia and poor therapeutic response. among the theories being considered is the role of local ige. objectives: 1) to perform a pilot test to validate the measurement technique and standardize the levels of total ige and ige specific to dermatophagoides pteronyssinus (d1) in the induced sputum of asthmatic patients and healthy volunteers. 2) correlate local total ige and specific ige levels to d1 (sputum and peripheral blood) in patients with allergic and non-allergic asthma. 3) describe the clinical and inflammatory characteristics of patients with allergic and non-allergic asthma.

comparative cross-sectional study. it will include 32 allergic and non-allergic asthma patients and 10 healthy volunteers. all patients will have an induced sputum, pulmonary function studies, feno (exhaled fraction of nitric oxide), total and specific ige measurement at d1 (the most common perennial pneumoallergen) in blood and induced sputum, as well as a prick skin test with standardized allergen extracts. measurement of total ige and ige for d1 in induced sputum will be performed in the supernatant and by the immunocap (phadia thermofisher scientific) immunofluoroassay technique.

Eligibility criteria:
inclusion criteria: * age 18-70 * asthma according to gema (spanish asthma guideline) exclusion criteria: * pregnancy * active smoking * moderate alcohol consumption * atopic dermatitis * other respiratory disease different than asthma (copd, bronchiectasis, cystic fibrosis, pleural disease, interstitial disease) * treatment with steroids or inmunodepressants * active malignancy.

Keywords: asthma allergy specific ige
portable oxygen concentrator signal capture study

Conditions: Hypoxia

Summary: the main purpose of this study is to learn how patients breathe on portable oxygen concentrators (pocs), and to get feedback from patients using pocs.

this study aims to examine patient oxygenation levels and markers of exertion (e.g. breath rate, heart rate and breath pattern) while using a portable oxygen concentrator, with the aim to understand exercise desaturation in hypoxemic subjects.

Eligibility criteria:
inclusion criteria: * patient is willing to give written informed consent * patient can read and comprehend english * patient is ≥ 18 years of age * patient has moderate to severe hypoxaemia (spo2 ≤ 92%) at rest * patient reports shortness of breath on exertion exclusion criteria: * patient has musculoskeletal impairment, or other impairment that may be the limiting factor in 6mwt * patient has a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study * patient has acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency * patient shows signs of acute exacerbation of underlying lung condition * patient is deemed to be unsuitable for inclusion in the opinion of the researcher, including for the following reasons: * they do not comprehend english * they are unable to provide written informed consent * they are physically unable to comply with the protocol
family based treatment for weight loss with breakfast prescription

Conditions: Obesity; Overweight; Overeating; Weight; Childhood Obesity

Summary: the purpose of this study is to evaluate whether a behavioral weight loss group in conjunction with a prescribed breakfast can help children between 8 and 12 years of age change their behaviors to help them lose weight and become healthier.

the purpose of this application is to evaluate the acceptability and initial efficacy of consumption of an egg breakfast, compared to a cereal breakfast, in the context of family-based behavioral treatment (fbt) with overweight and obese children and their parents. investigators will randomize 66 parents and their overweight and obese child (85-99.9%bmi) to fbt+egg or fbt+cereal groups. families will eat their assigned breakfast (eggs or cereal) 5 out of 7 days during the 4 month fbt treatment. however, all other aspects of fbt will be the same in the two groups. children and parents will complete assessments at three time points; baseline, post-treatment and 4-months post-treatment.

Eligibility criteria:
inclusion criteria: 1. children between the ages of 8 and 12 years old; 2. bmi ≥85th% and \<100% overweight 3. children with parents who are willing to attend 16 weekly group sessions and be randomized to either treatment arm; 4. have at least one parent who is overweight or obese (bmi≥25); 5. children and parent who endorse liking of both eggs and cereal 6. parents who speak english at a 5th grade level. exclusion criteria: 1. children with serious medical conditions that affect their weight; 2. children taking medication that affect appetite or weight; 3. children with severe developmental delay or disability that would affect participation; 4. children or parents with psychological illness that would limit treatment participation; 5. families who plan to move out of the area within the time frame of the study.

Keywords: overweight children overweight parents eating in the absence of hunger families with overweight child bmi body mass index treatment behavioral treatment family based treatment experiments intervention psychophysiological response to food cues
craniosacral therapy to treat chronic low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to determine whether a craniosacral therapy program are effective on disability, quality of life, autonomic nervous system and oxidative stress indicators in patients with chronic low back pain.

design: randomized clinical trial. objective: to determine the effectiveness of a craniosacral therapy program on disability, quality of life, autonomic nervous system, body mass, hormonal indicators, spinal projection, and oxidative stress indicators in patients with chronic low back pain. participants: seventy patients with chronic non-specific low back pain will be randomly assigned to an experimental and control group. intervention: for 10-week, the experimental group will undergo treatment comprising 10 sessions (1/week) of a craniosacral therapy program with ten techniques, and the control group will receive only one craniosacral technique. main outcome measures: disability, quality of life, biochemical estimation interstitial fluid, body mass indicators, hormonal indicators, indicators of autonomic nervous system,and indicators of oxidative stress will be collected in both groups at baseline, 10 weeks and 15 weeks after the last intervention in the experimental and control groups, by an assessor blinded to the treatment allocation of the patients. baseline demographic and clinical variables will be examined between both groups with an independent student t-test for continuous data. separate 2x3 model anova with time (baseline, 10 weeks and 15 weeks) as the within-subjects factor, group (experimental, control) will be to determine the effects of the treatment.

Eligibility criteria:
inclusion criteria: * low back pain for \> 3 months * score \> 4 on the roland morris disability questionnaire * no undergoing another physical therapy treatment exclusion criteria: * clinical signs of radiculopathy * presence of lumbar stenosis * fibromyalgia * spondylolisthesis * history of spinal surgery * treatment with corticosteroids in the past two weeks * disease of the central or peripheral nervous system

Keywords: low back pain manual therapy randomized controlled trial quality of life
daa therapy in pediatric patients with chronic hepatitis c

Conditions: Chronic Hepatitis c

Summary: the mukh-mantri punjab hepatitis c relief fund (mmphcrf) is a public health initiative for prevention and control of hepatitis c in the punjab state, india. the efficacy of decentralised public health services and safety of 12- or 24-weeks of sofosbuvir (sof) + ledipasvir (ldv) or sof + daclatasvir (dcv) with or without ribavirin (rbv) in the treatment of pediatric chronic hepatitis c will be assessed

consecutive chronic hepatitis c (hcv) infected children \[age: ≥12 to \<18 years; both treatment-naïve (tn) and treatment-experienced, (te)\] are being enrolled. genotyping is not recommended for non-cirrhotic or tn patients and are treated with sof+dcv for 12-weeks, while genotyping is recommended for patients with cirrhosis and te patients. patients with liver cirrhosis or te and genotype (gt)-3 are being treated with sof+dcv for 24 weeks, while non-gt-3 patients are being treated with sof+ldv for 24-weeks. patients \< 35 kg are being given half doses of medications and patients ≥35 kg are being given adult dosages of sof (400 mg), ldv (90 mg) and dcv (60 mg) per day.

Eligibility criteria:
inclusion criteria: * chronic hepatitis c, all genotypes * ages eligible for study: ≥12 to \<18 years (child) * gender eligible for study: either * treatment-naive or treatment-experienced: either exclusion criteria: * chronic liver disease of a non-hcv etiology * serum creatinine \>1.5 mg/dl * evidence of hepatocellular carcinoma or other malignancy * co-infection with hepatitis b virus, or hiv * significant cardiovascular, pulmonary, or neurological disease * evidence of a malabsorption syndrome that could interfere with absorption of orally administered medications * history of solid organ or bone marrow transplantation.

Keywords: mukh mantri punjab hepatitis c relief fund,mmphcrf direct acting antiviral agents (daa) chronic hepatitis c pediatric population adolescent chronic hepatitis c
evaluation of partial and total femoral replacement

Conditions: Survival, Prostheses

Summary: several surgical options for the reconstruction of massive bone defects have been described and include biologic methods with autografts and allografts, and the use of tumor endoprostheses (total femoral replacement, tfr). several types of modular tfr are available, but nevertheless unpredictable outcomes and high complication rates have been described from most authors. the aim of the present study was to compare complication rates after tfr performed with modular total femur prosthesis mml (fa. eska/orthodynamics) in patients with and without malignant disease.


Eligibility criteria:
inclusion criteria: * total or partial femoral replacement exclusion criteria: * failure of device
complex ocular infection, optimization of microbiological diagnosis

Conditions: Endophthalmitis; Keratitis

Summary: the purpose of this study is to evaluate the impact of different technique to optimize the microbiological diagnosis of the coi. * metagenomic for the endophtalmitis * multiplex polymerase chain reaction for corneal abscesses

microbiological diagnosis of complex ocular infection (coi) (i.e: endophtalmitis and corneal abscess) is a current challenge. indeed, endophtalmitis are often germ-free because a lack of microbiological diagnosis due to small volume to analyze and a complex site to attain. the microbiological etiologies of corneal abscesses are more frequently identified. since few years, new molecular tools are developed in infectious diseases to optimizing the microbiological diagnosis. the investigators implemented these techniques in our hospital to optimize the microbiological diagnosis of complex ocular infection (coi). thus, endophtalmitis benefit, when the volume of the ocular sample is sufficient, of molecular techniques (16s pcr and metagenomic shotgun). corneal abscesses could shortly benefit of multiplex pcr in order to reduce the time to diagnosis. the impact and accuracy of these techniques is unknown.

Eligibility criteria:
inclusion criteria: * adult patient * patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis: * corneal abscess requiring hospitalization * any suspicion of endogenous or exogenous endophthalmitis. * patient not opposed to participating in the research exclusion criteria: * patient under guardianship or curatorship * pregnant women

Keywords: endogenous endophtalmitis exogenous endophtalmitis keratitis pcr ngs
the association between different monocyte subsets and coronary collateral development

Conditions: Coronary Artery Disease; Coronary Ischemia

Summary: collateral growth and coronary angiogenesis are chronic adaptations to myocardial ischemia. collateralization helps to restore blood flow and as a result salvages myocardium in severely ischemic myocardial regions. thus, good collateral development in patients with severe coronary artery disease (cad) improves ventricular function and prognosis (1-3). however, coronary collateral development is different among patients even with similar degrees of coronary artery stenosis. several factors, such as diabetes mellitus (4) and duration of myocardial ischemic symptoms (5) have been reported to effect coronary collateral development. at the cellular level, inflammatory cells, especially monocytes have an important role in collateralization. in a series of experimental studies with animals, it has been shown that monocytes are important elements for development of collateral vessels (6-7). in a recent study, it has been demonstrated that increased circulating monocyte count is related to good collateral development in patients with stable coronary artery disease (8). monocytes in human blood are heterogeneous and can be classified into two subsets according to the presence or absence of the fcγriii receptor cd16 (9): cd14++cd16- monocytes characterized by high level expression of the cd14 cell surface receptor but no expression of cd16 receptor, and cd14+cd16+ monocytes characterized by the co-expression of cd16 receptor with either high or low level expression of the cd14 receptor. these subsets differ in function and response to several cytokines. our aim in this study was to find out any possible relationship between the levels of circulating monocyte subsets and coronary collateral development.


Eligibility criteria:
inclusion criteria: * \> 95% stenosis of at least one major coronary artery in their first coronary angiogram exclusion criteria: * previous percutaneous or surgical revascularization history * evidence of ongoing infection and inflammation * known malignancy and chronic kidney disease (serum creatinine \> 1.5 mg/dl * diabetic patients

Keywords: coronary collateral development monocyte subsets collateralization