Kornimate/medical-research-clean huggingface dataset:
treatment monitoring of advanced colorectal cancer with 18f-fdg pet/ct

Conditions: Colorectal Cancer

Summary: measuring tumor response to treatment based on computed tomography (ct) and/or magnetic resonance imaging (mri) has been a widely debated issue (response criteria in solid tumors \[recist\] and world health organization criteria). furthermore, early identification of nonresponding patients is of great importance because the rates of response of common malignant solid tumors to chemotherapy are in the range of only 20-30%. therefore, quantitative imaging of tumor metabolism with 18f-fdg pet/ct may provide important advantages and thus reduce side effects and costs of ineffective therapy. however, the evidence to date for the use of 18f-fdg-pet/ct with this indication is limited. the purpose of the present trial is to determine the impact of 18f-fdg pet/ct in the management of advanced colorectal cancer. the aim is also to confirm whether a metabolic response can be used as a surrogate end point in monitoring treatment response in this cancer type. the study consists of 40 patients with advanced colorectal cancer patients. all patients will be studied with 18f-fdg pet/ct combined with diagnostic contrast enhanced abdominal ct before the start of chemotherapy and re-evaluated 4-5 weeks after the initiation of therapy. effect of this metabolic and anatomic change in therapy are evaluated and correlated to survival, morbidity, and treatment -related costs. histopathologic confirmation of response is evaluated whenever possible. the data will be collected between 2008 and 2012.


Eligibility criteria:
inclusion criteria: * age 40 to 80 years old * language spoken: finnish or swedish * performance status: karnofsky score 70 or better or who performance status 2 or better * earlier diagnosed (histologically confirmed) colorectal cancer with discovered metastases at operation * earlier diagnosed and treated colorectal cancer with discovered recurrence in the follow up * mental status: patients must be able to understand the meaning of the study * informed consent: the patient must sign the appropriate ethical committee (ec) approved informed consent documents in the presence of the designated staff exclusion criteria: * prior medical history: patient must have no history of serious cardiovascular, liver or kidney disease * vulnerable study subjects such as described in finnish law concerning clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included.

Keywords: colorectal cancer response to treatment fdg pet/ct
effects of short-term growth hormone in hiv-infected patients

Conditions: HIV Lipodystrophy

Summary: the purpose of this study is to examine the short-term effects of two different doses of growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's secretion of growth hormone and the body's glucose metabolism. we hypothesize that growth hormone administration will alter the body's endogenous pulsatile growth hormone secretion and that higher dose growth hormone may decrease insulin sensitivity. we hypothesize that growth hormone releasing hormone will augment endogenous gh pulsatility and be neutral to insulin sensitivity.

the primary objective of this study is to determine the differential effects of growth hormone releasing hormone (ghrh) vs. low dose physiologic growth hormone (gh) vs. higher dose gh treatment and withdrawal on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. subjects with hiv-infection will be randomized to receive one of three treatments: ghrh 2mg/day, or growth hormone 6mcg/kg/day (physiologic "low" dose), or growth hormone 2mg/day ("higher" dose) for 2 weeks. at baseline and after two weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp. subjects will then stop the treatment and will return for an identical assessment after a 2 week withdrawal period.

Eligibility criteria:
inclusion criteria: * previously diagnosed hiv infection * stable antiretroviral regimen for at least 12 weeks prior to enrollment * waist circumference \>/= 95cm and waist-to-hip ratio \>/= 0.94 for males or waist circumference \>/=94cm and whr \>/= 0.88 for females, occurring in the context of treatment for hiv disease * subjective evidence of at least one of the following changes, occurring during the treatment of hiv disease: increased abdominal girth, relative loss of fat in the extremities, or relative loss of fat in the face exclusion criteria: * use of anti-diabetic agents, megace, testosterone, or any steroid use within 6 months of the study * use of gh or growth hormone releasing factor within six months of starting the study * change in lipid lowering or antihypertensive regimen within 3 months of screening * fasting blood sugar \>126mg/dl, sgot \> 2.5 times uln, hgb \ 1.4 mg/dl, fsh \> 20 iu/l in women, or cd4 count \< 200 * carpal tunnel syndrome * severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer * for men, history of prostate cancer or evidence of prostate malignancy by psa \> 5ng/ml * prior history of hypopituitarism, head irradiation, or any other condition known to affect the gh axis * positive beta-hcg (women only) * oral contraceptives, depo provera, or combined progesterone-estrogen injections, transdermal contraceptive patches, estrogen or progestin coated iud's within 6 months of the study * weight \< 110 pounds

Keywords: hiv lipodystrophy growth hormone growth hormone releasing hormone
zainidip in renal artery stenosis

Conditions: Hypertension

Summary: to evaluate the efficacy of renal artery stent combined with standardized medical therapy as treatment for renal artery stenosis.


Eligibility criteria:
inclusion criteria: * age between 40 - 75 * diameter of stenosis of renal artery or main branch of renal artery ≥60％. if diameter of stenosis is 60% - 75%, pressure difference between proximal and distal end ≥20 mm hg (1mmhg=0.133kpa) or captopril renography positive; * systolic blood pressure before taking antihypertensive ≥180mmhg and/or diastolic blood pressure ≥110 mmhg; taking three antihypertensive including one diuretics with systolic blood pressure ≥140mmhg and/or ≥90 mmhg; * length of ipsilateral kidney is greater than 7.0cm. exclusion criteria: * estimated glomerular filtration rate (egfr) \<30 ml/ (min﹒1.73 m 2) \[egfr (ml/min/1.73 m2) = 186.3 \* serum creatinine (mg/dl) -1.154 \* age-0.203 \* 0.742 (female)\[11\]; * unstable condition and unable to tolerate interventional therapy; * anatomy of renal artery pathology not suitable for interventional therapy; * allergic to dihydropyridines; * iii degree atrioventricular block * contrast allergy ; * any known malignant tumor; * non-compliant, history of alcoholism or drug abuse.
role of interleukin-13 pathways on pain and itch sensitivity

Conditions: Itch

Summary: atopic dermatitis (ad) is as chronic, inflammatory skin disorder affecting 20% of the world's population. intense itch and skin pain are the main symptoms. research has shown that the proteins interleukins are involved in inflammation and itch in atopic dermatitis. the medicinal product called lebrikizumab, used for treatment of ad, has shown to block the interleukin called il-13. the purpose of this experiment is to evaluate the role of il-13 in itch in both healthy subjects and people with atopic dermatitis.

atopic dermatitis (ad) is as chronic, inflammatory skin disorder affecting 20% of the world's population. intense itch and skin pain are the main symptoms. research has shown that the interleukin-13 is involved in inflammation and itch in atopic dermatitis by increasing the neuronal sensitivity to pruritogens. however, the physiological mechanisms by which il-13 increases the itch sensitivity are unclear. the aim of this project is to use, for the first time in humans, the monoclonal antibody lebrikizumab that inhibits il-13 with high affinity as a novel experimental tool to modulate the il-13 pathway and evaluate its role in the transmission and processing of itch and pain.

Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years exclusion criteria: * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids, or other drugs * previous or current history of neurological, dermatological (e.g., ad, psoriasis, etc.), immunological, musculoskeletal, cardiac disorder, or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.) * moles, wounds, scars, or tattoos in the area to be treated or tested * current use of medications that may affect the trial such as antihistamines and pain killers (use of antihistamines should be discontinued 72 hours before the experiment and all topical agents and emollients should be discontinued 24 hours before the experiment). * use of systemic and topical corticosteroids * consumption of alcohol or painkillers 24 hours before the study days and between these * acute or chronic pain * participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials) * lack of ability to cooperate
stop-uc: de-escalation of therapy in patients with ulcerative colitis with histological remission

Conditions: Ulcerative Colitis (UC)

Summary: the goal of this study is to better understand treatment strategies for people with ulcerative colitis (uc). researchers will compare patients with uc in histologic remission (no evidence of inflammation or active disease on endoscopy and biopsies) who continue to take medical therapy to patients with uc who de-escalate (decrease or discontinue) medical therapy. both treatment strategies are considered within regular medical practice. researchers want to find out whether remission can be maintained after de-escalation of therapy. participants will be: * randomly assigned to continue medical therapy or de-escalate medical therapy * clinically managed according to regular medical care * asked to provide blood, stool (poop), and tissue samples for study purposes

this is a prospective, randomized clinical trial conducted at a tertiary academic center \[university of chicago medicine inflammatory bowel disease (ibd) center\]. patients in clinical, biochemical, and endoscopic remission with biopsies showing histologic quiescence or normalization will be identified and approached after consultation with their ibd care team. after enrollment, participants will be randomized to either de-escalation of therapy (de-escalation group) or continuation of current therapy (control group) and monitored for 24 months, both consistent with current clinical practice. after the 24-month period, participants who remain in remission will continue 5 years of longitudinal data collection from routine clinical care.

Eligibility criteria:
inclusion criteria: 1. consenting patients aged 18 to 75 years with an established diagnosis of ulcerative colitis (uc) for at least 3 years. 2. patients in deep remission, defined by the absence of endoscopic and histologic signs of active inflammation (i.e. histological normalization or histological quiescence) in all biopsies obtained during colonoscopy, within the last 12 months. 3. patients in clinical, biochemical (fecal calprotectin \<100), radiologic and endoscopic remission for at least 6 months. exclusion criteria: 1. any noted active inflammation \[clinical, sonographic, biochemical, endoscopic (in any colonic segment)\]. 2. patients with any changes in therapy after colonoscopy showing histological normalization or quiescence. 3. corticosteroid use after colonoscopy showing histologic normalization or quiescence. 4. patients with any noted history of primary sclerosing cholangitis or dysplasia (suspected or confirmed). 5. inability to follow the proposed sample collection and monitoring protocol.

Keywords: histological remission de-escalation of therapy
arthroscopic treatment with ulnar nerve release for elbow osteoarthritis

Conditions: Primary Osteoarthritis, Elbow; Ulnar Nerve Release

Summary: this study is a prospective randomized controlled study of arthroscopic release for primary osteoarthritis of the elbow with stiffness with or without ulnar nerve release. the patients with primary osteoarthritis of the elbow with stiffness, which ulnar neuropathy proven by electromyography without clinical symptoms, were randomly divided into groups before the operation. before the arthroscopic operation was began, the procedure of ulnar nerve release was performed according to the group(release group or unrelease group). in different time periods postoperatively, the quantitative and qualitative indicators including pain, functional score, muscle strength, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with ulnar nerve release.


Eligibility criteria:
inclusion criteria: 1. age \>18 years 2. primary osteoarthritis of the elbow with stiffness. osteoarthritis was confirmed on ct-arthrography, by cartilage damage, osteophytes or local or global joint impingement. 3. ulnar neuropathy proven by electromyography without clinical symptoms 4. failure at least 6 months of conservative treatment 5. availability of medical information for \>2 years of follow-up exclusion criteria: 1. severe skin contracture or wound problem that could affect the neurovascular structures or require flap surgery. 2. revision surgery 3. ulnar nerve pathology results in clinical symptom such as motion and feeling deficiency 4. other indication for elbow arthroscopy: synovial or inflammatory rheumatoid pathology, osteochondritis dissecan, acute infection, tumor or pure capsular stiffness. 5. inadequate or loss of follow-up 6. elbow instability
micro rna as prediction and/or prognostic markers of iris in tb-hiv co-infected patients

Conditions: HIV Infection; Tuberculosis Infection

Summary: the role of mirnas in hiv disease is yet to be completely defined. host mirnas target certain hiv genes, thus can affect hiv replication and participate in viral control. mirnas can also block hiv production through disruption of gag assembly on cell membranes. mirna expression can characterize hiv disease phenotype, as has been shown in hiv elite controllers who have a well-defined mirna expression profile. however, the studies of mirna in acute infection and co-infections like tuberculosis are lacking. the investigators showed that during immune reconstitution syndrome (iris) in hiv/tb coinfected patients, innate immune response play a role as through nk cell degranulation, therefore testing for this could be used as a predictive marker of iris. one of the limitations of mirna detection is the technique, which is time-consuming, and needs laboratories that are specialized and equipped for molecular biology techniques. in contrast, flow cytometry has been developed in routine labs and has well-standardized techniques. for the routine detection of mirna, flow cytometry could be the best way to perform high throughput screening for clinical applications. flow cytometry is a simple and effective way to evaluate mirnas expression. in this project the investigators propose to evaluate, using flow cytometry, whether circulating mirna pattern might be applicable as potential biomarkers in prediction and prognosis of iris in hiv/tb co-infected patients. the investigators propose to study the mirna expression profile in a cohort of patients with a hiv infection and tuberculosis and correlate it with their clinical evolution. as controls, the investigators propose to analyze expression of mirnas in healthy controls as well as tb and hiv mono-infected patients. aims of the proposal 1. identify mirna expression profile as potential novel predictive and prognostic biomarkers for iris. 2. identify the mirna expression profile in hiv patients, in tb patients and in hiv/tb co-infected patients.


Eligibility criteria:
for hiv+/tb+ participants: inclusion criteria * cf the camelia clinical trial (nct00226434) exclusion criteria: * cf the camelia clinical trial (nct00226434) for hiv+/tb- participants: inclusion criteria * age ≥ 18 years * hiv+ * cd4 cell count ≤ 200 x 106 cells/l * no evidence of tuberculosis infection. exclusion criteria: * age \<18 years * pregnancy or breastfeeding * cd4 cell count \> 200 x 106 cells/l * evidence of tuberculosis infection * non art naive at inclusion for hiv-/tb+ participants: inclusion criteria * age ≥ 18 years * hiv- * confirmed tuberculosis infection. exclusion criteria: * age \<18 years * pregnancy or breastfeeding * afb negative or mtb/rif negative for mtb, * history of tb infection * hiv+ for hiv-/tb- participants: inclusion criteria * age ≥ 18 years * hiv- * no evidence of tuberculosis infection. exclusion criteria: * age \<18 years * pregnancy or breastfeeding * evidence of tuberculosis infection * hiv+

Keywords: microrna hiv tuberculosis iris biomarkers
asymptomatic colonization with s. aureus after therapy with linezolid or clindamycin for acute skin infections

Conditions: Skin Diseases, Bacterial; Abscess

Summary: in this pilot study, the objective is to determine the prevalence of asymptomatic carriage of s. aureus in patients with absssis and minor cutaneous abscesses after therapy with either linezolid or clindamycin at 40 days after the completion of therapy. secondarily, the investigators will assess the efficacy of linezolid vs. clindamycin in the empiric therapy of absssis and minor cutaneous abscesses, as well as the genotypic spectrum of s. aureus isolates causing absssis or minor cutaneous abscesses and colonization in the target patient population before and after therapy. given the results of a recent study on linezolid and vancomycin and the investigator's own experience, it is hypothesized that persistent mrsa carriage will be less common after therapy with linezolid for absssis and minor cutaneous abscesses than it is with oral clindamycin.


Eligibility criteria:
inclusion criteria: * having an absssi or a minor cutaneous abscess treated in the ed * age 18 years or older * any one or more of the following co-morbidities: * diagnosis of diabetes mellitus * obesity with a bmi \>35 * chronic kidney disease * coronary artery disease * peripheral vascular disease exclusion criteria: * known history of or current thrombocytopenia * currently taking anti-depression medication * current or recent hospitalization * known current alcohol or drug abuse * known or suspected hypersensitivity to any ingredient of the study drugs * irregular heart rate and blood pressure measurements * fevers or low body temperature * known psychiatric condition * superficial skin infection * skin infection caused from an animal bite * recent treatment with antibacterials * pregnancy other protocol related inclusion/exclusion criteria may apply.
improving preschool outcomes by addressing maternal depression in head start

Conditions: Maternal Depression

Summary: within a research network of head start centers in massachusetts, an efficacy trial of a stepped-care intervention (sci) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (mde) engage with care, will be conducted. both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.

this research study is a community-based efficacy trial (n=388) of a stepped-care model intervention to strengthen the capacity of head start to address parental depression and related adversities. head start mothers with symptoms of depressed mood or anhedonia, and their head start children, are enrolled across 12 head start centers. the research study aims to improve developmental outcomes for head start children by delivering stepped care intervention that incorporates depression prevention and linkage to formal mental health care to mothers. mothers with low baseline depressive symptoms are offered a problem-solving intervention while mothers with greater symptoms are offered engagement sessions to link them to formal mental health services. at each problem-solving session participant's symptoms are assessed and if the symptoms meet pre-specified 'step-up' criteria, they are converted to engagement sessions. over 12 months, the intervention's effect will be assessed on a series of outcome measures for mothers; mechanisms by which maternal depression is theorized to impact young children; and child outcomes.

Eligibility criteria:
inclusion criteria: * mother of a 0 to 5-year-old head start child * mother speaks english or spanish exclusion criteria: * mother with suicidal ideation * mother with cognitive limitation

Keywords: stepped care intervention problem solving education engagement session head start preschool children
evaluation the clinical value of xiyanping injection in the treatment of community-acquired pneumonia in children

Conditions: Community Acquired Pneumonia

Summary: in order to verify the clinical value and safety of xiyanping injection in children with cap, we intend to carry out this multi-center, large-sample, non-intervention clinical research through more rigorous and scientific design. considering the current status of clinical research in children in china,research use real-world research methods.

this is an real world study of efficacy and safety of intravenous injection of xiyanping injection in pediatric subjects with cap.the purpose to determine the clinical value and influencing factors of xiyanping injection in the treatment of community-acquired pneumonia in children based on real-world clinical data. the starting point for the study was the time at which the patient started treatment with xiyanping injection or using a conventional treatment regimen; the end of follow-up was the date of the last visit to the patient, and if the patient had a disease progression or transfer, the date of the occurrence was the end. at the same time, baseline demographic characteristics (gender, date of birth, type of medical insurance, etc.), therapeutic drugs during the follow-up period, dose and time of use, laboratory indicators (such as white blood cells, c-reactive protein, etc., and examination time) were collected.

Eligibility criteria:
inclusion criteria: * 2 years old \< age ≤ 14 years old children, male or female, diagnosed as community-acquired pneumonia diagnosed and need hospitalization exclusion criteria: * acute infectious diseases such as measles, whooping cough, and influenza * other concomitant diseases or conditions that the investigators believe may interfere with the study, such as severe primary disease with severe heart, liver, kidney, digestive, and hematopoietic systems * children with severe malnutrition and previous history of immunodeficiency may seriously affect the self-limiting course of the disease * children with epilepsy and other central nervous system dysfunction * congenital diseases, mental patients * those who have used systemic hormones within 2 weeks before enrollment; * those who have used qingrejiedu chinese medicine within 2 weeks before enrollment * the subject is poorly compliant (not according to the doctor's prescription or medical advice) or fails to timely feedback information