Kornimate/medical-research-clean huggingface dataset:
brachial artery t-pa release in heart transplant recipients

Conditions: Heart Transplantation

Summary: bradykinin stimulates t-pa release from intact vessels, but not from endothelial cells in culture. it has been proposed that the nerves of blood vessels are the source of bradykinin stimulated t-pa release. in order tho test this hypothesis, we intend to infuse bradykinin into the brachial (arm) artery and the coronary arteries of heart transplant recipients and control subjects. this is because heart transplant recipients do not have nerves to their coronary arteries. this protocol studies the effects of bradykinin on t-pa release in the forearm of transplant recipients. the brachial artery has intact nerves. separate protocols address coronary artery infusions in healthy subjects and transplant recipients and forearm infusions in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. adults 18 years and greater who have undergone heart transplantation 2. healthy exclusion criteria: 1. pvc \< 30 2. hypertensive subjects on ace inhibitors 3. pregnant or nursing mothers 4. diabetic with hba1c \> 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy) 5. cholesterol \> 30 mg/dl above ncep accepted level based on cardiac risk. 6. triglycerides \> 200 7. previously diagnosed obstructive coronary artery disease 8. renal insufficiency (creatinine ≥ 1.5 mg/dl) 9. history of cerebrovascular disease 10. any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc) 11. uncontrolled stage 2 hypertension (160/100 mmhg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease). 12. angiotensin converting enzyme inhibitor use 13. coagulopathy (inr ≥ 1.5, ptt ≥ 150% of control) 14. peripheral vascular disease 15. other chronic medical illnesses at the discretion of the investigators

Keywords: heart transplant endothelial function fibrinolysis transplant recipients at baseline
study on pre-menopausal patients with advanced er and pr + bc treated with arimidex plus zoladex

Conditions: Breast Cancer

Summary: the purpose of this study is to determine the efficacy and tolerance of the association of two drugs already marketed and used to treat your disease: arimidex® 1 mg per day per os and zoladex® 3,6 mg in injections under cutaneous once per month in subjects with breast cancer.


Eligibility criteria:
inclusion criteria: * signed informed consent, premenopausal women 18 years or older, histologically or cytologically confirmed locally advanced or metastatic breast cancer, suitable for endocrine treatment, no curative treatment available,, one or more measurable lesions, life expectancy more than 6 months, normal biological parameters. exclusion criteria: * presence of life-threatening metastases, previous endocrine therapy or chemotherapy for advanced or metastatic disease, any previous treatment with hormone (lh-rh) severe or uncontrolled systemic disease, pituitary adenoma, high risk of medullar compression.

Keywords: premenopausal advanced breast cancer metastatic breast cancer
measuring energy expenditure in ecmo (extracorporeal membrane oxygenation) patients

Conditions: Acute Lung Injury; Respiratory Distress Syndrome, Adult

Summary: with the perception that lung protective ventilation with regard to low tidal volume ventilation and limiting airway pressures improves outcome in ards (acute respiratory distress syndrome) and that the development of new technical devices of extracorporeal lung assist systems with lower complication rates support establishment of lung protective ventilation strategies these systems are more and more frequently used. all critically ill patients with and without ecla (extracorporeal lung assist)/ecmo (extracorporeal membrane oxygenation) treatment are on high risk for muscle wasting, leading to more comorbidity and higher mortality risk. besides inflammation malnutrition is known as one of the main risk factors. over and underfeeding should be prevented. however nutritional aspects of patients on extracorporeal lung assist are hardly investigated. up to now changes in metabolic rates induced by ecla/ecmo are poorly described. factors like work of breathing, changes in cardiac output and septic state are influencing energy metabolism but until now there is no tool for measuring energy expenditure in clinical routine for patients on ecla/ecmo. indirect calorimetry is a simple device only for patients without ecla/ecmo system. oxygenation and co2 (carbon dioxide) elimination by the lung assist system can be calculated but is not implemented to clinical routine. the combination of indirect calorimetry and calculation of lung assist function at the same time would give us the chance to adapt nutrition rates to energy expenditure. this may prevent muscle wasting and weakness. this pilot study will include 40 participating patients during 8 month investigating nutritional therapy adapted to energy expenditure calculated by o2 and co2 turnover rates in patients on ecla or ecmo systems. the investigators aim is to describe a calculation to set nutrition targets in ecmo patients. second the investigators will describe level of nutritional needs under consideration of different mechanical ventilation states. third o2 consumption and co2 elimination will be used to estimate cardiac output.


Eligibility criteria:
inclusion criteria: * critically ill patients with ali * informed consent by the patients or legal proxy exclusion criteria: * age \< 18 * no informed consent by the patients or legal proxy * pregnancy * infaust prognosis

Keywords: ali, ards, ecmo, energy expenditure, mechanical ventilation, extracorporeal membrane oxygenation nutrition assessment pulmonary ventilation
internet-based exposure therapy for excessive worry

Conditions: Excessive Worry; Rumination

Summary: the purpose of this study is to examine if an internet-based exposure therapy is effective in reducing excessive worry amongst patients who suffer from this problem.

trial objectives: primary objective is to investigate whether an internet-based exposure therapy can effectively reduce the degree of excessive worry. the secondary objective is to a) investigate whether imagery based exposure is more effective than verbal exposure. b) investigate the cost-effectiveness of this treatment and c) to study if any variables could moderate/mediate the treatment outcome, such as metacognitions, degree of rumination or degree of depression. trial design: randomized controlled trial with waitlist control, who also will recieve treatment after the first group has finished. duration: ten weeks primary endpoint: change in worry symptoms from baseline to week 10. long term follow-up is also investigated (baseline to 4-months after treatment completion and baseline to 12-months after treatment completion). efficacy parameters: penn state worry questionnaire (pswq) safety parameters: adverse events is assessed weekly via the internet. description of trial subjects: patients \> 18 years old with a pswq score more than 56 points number of subjects: 140

Eligibility criteria:
inclusion criteria: * outpatients * ≥ 18 years * situated in sweden * informed consent * penn state worry questionnaire score more than 56 points exclusion criteria: * substance dependence during the last six months * post traumatic stress disorder, bipolar disorder or psychosis * symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder) * madrs-s score above 25 points * psychotropic medication changes within two months prior to treatment that could affect target symptoms. * received exposure based cognitive behavior therapy (cbt) for pathological worry the last 2 years
repeat dose nasal allergen challenge

Conditions: Allergic Rhinitis

Summary: what happens in the nose during an allergic reaction? are there changes that a new drug could treat? what is the best way to test new drugs?the response of the nose to being exposed to cat allergen in someone who is allergic to cats. symptoms, level of nasal blockage and cell and chemical changes that occur in the nose will be studied before and after being exposed to cat allergen. the investigators will also to see if giving repeated doses of allergen increases the response.allergic rhinitis is a very common illness. there are over 500 million patients worldwide. it can increase the severity of associated asthma. currently available drugs do not completely treat the symptoms. new treatments need to be found. a way of testing these drugs is very important. this study will investigate causes of the symptoms that occur in allergic rhinitis. it will also validate a proposed model to test new drugs. the study hypothesis is that a model of nasal allergen challenge shows an increased response (priming) with repeat challenges as determined by changes in nasal peak inspiratory flow.


Eligibility criteria:
inclusion criteria: 1. male and female subjects aged over 18 able to understand and sign the written consent form. 2. able to comply with study procedures and protocol. 3. positive skin prick test (wheal difference ≥ 3mm compared to negative control) to cat at or within 12 months preceding the screening visit. 4. clear history of nasal symptoms on exposure to cats. 5. otherwise healthy with no other health problems, other than mild asthma controlled by intermittent β2-agonist use, that may prevent the subject participating in the study. exclusion criteria: 1. presence of perennial rhinitis or seasonal allergic rhinitis. 2. tnss \< 2 at screening 3. viral urti within the 2 weeks prior to screening. 4. current smoker or history of smoking within the previous 3 months. 5. presence of any structural nasal abnormalities or nasal polyps on examination, a history of frequent nose bleeding, nasal surgery within the previous 3 months. 6. use of concomitant medication that could affect responses to nasal challenge (e.g. corticosteroids, decongestants, anti-histamines) or any other nasally applied medication within 2 weeks prior to screening. 7. participation in any other clinical trials within the previous 3 months. 8. use of inhaled corticosteroids within the 2 months prior to screening.

Keywords: allergic rhinitis allergen
clinical trial to evaluate short-term efficacy of palliative methylphenidate in asthenia in advanced cancer patients

Conditions: Asthenia

Summary: fatigue is the most prevalent symptom in advanced cancer patients, interfering functional capacity, social relations, wellbeing, and quality of life. methylphenidate is a central nervous system stimulant that has traditionally been used in cancer patients to manage depression, opioid-induced sedation, hypoactive delirium due to multiorgan failure, and cognitive disorder associated with brain tumors. although there is evidence from prospective studies of the efficacy of this drug in cancer-related fatigue, the only one randomised clinical trials gave non-conclusive results. in order to define the real efficacy of methylphenidate in this setting, the investigators designed a new clinical trial comparing methylphenidate and placebo in cancer-related fatigue, assessed both by the verbal numeric scale (vns) included in the edmonton symptom assessment system (esas) and the subscale for fatigue of the functional assessment of cancer therapy (fact-f). the investigators will include 122 advanced cancer patients with fatigue ≥ 5/10 (vns, from 0 to 10) and hemoglobin ≥ 9 g/dl. patients will be randomized to methylphenidate or placebo. doses will be adapted to response within a range from 10 mg at morning time and 5 at noon, to 25 mg/day. assessment of response will be performed on day 3 and day 6 with esas and fact-f. drug-induced adverse events will be checked. the vns of fatigue on day 6 will be consider the primary endpoint.


Eligibility criteria:
inclusion criteria: * advanced cancer; including metastatic, locally advanced or relapsed not amenable for curative treatment. * mini.mental status examination results within normal limits. * informed consent. * estimated life expectancy of at least one month. * hemoglobin \>= 9 g/dl. * asthenia \>= 5 (0-10; numeric verbal scale). exclusion criteria: * history of psychosis. * structured suicidal ideation. * severe anxiety. * severe renal, hepatic or cardiac (arrythmia, hypertension, ischemic heart disease) failure. * simultaneous treatment with drugs that may interact with methylphenidate as: coumarinics, anticonvulsivants (phenobarbital, phenitoin, primidone), phenylbutazone, inhibitors of mono-amine-oxidase, guanethidine. * history of glaucoma. * hyperthyroidism. * history of hypersensibility to methylphenidate. * clinical suspicion of: infection, hypercalcemia, hypothyroidism or renal failure.

Keywords: asthenia advanced cancer randomized controlled trial
gaba (gamma amino butyric acid) medication for tobacco

Conditions: Nicotine Dependence

Summary: the goal of this study is to examine the effects of a gaba (gamma amino butyric acid)-enhancing medication, pregabalin (300 mg/day), on smoking behavior, tobacco withdrawal and cigarette craving in smokers. we hypothesize that in smokers, pregabalin at 300 mg/day, will be more effective than placebo in decreasing smoking behavior and attenuating tobacco withdrawal and cigarette craving.

a total of 40 smokers will be randomly assigned to a sequence of treatment conditions: 300 mg/day pregabalin or placebo treatment. each treatment condition will last 4 days, separated by 3 to 15 days of washout period. smokers will have twice daily outpatient visits during the first 3 days and a test session on day 4. in each treatment period, smokers will abstain from smoking for 2.5 days, starting at 10 pm on day 1 until the test session on day 4. during the test sessions, measures of smoking behavior and tobacco withdrawal will be obtained. smoking is an important public health problem costing over 430,000 lives a year in this county alone. the first line-treatments, nicotine replacement treatments (nrt) or bupropion, compared to placebo, approximately double the long-term success rate for smoking cessation. given that there remains 46 million smokers in this country and over 70 percent of them interested in quitting smoking, development of new treatments for smoking cessation will have great public health implications. currently this protocol is complete with 24 completers. this study has been published. (april 2011)

Eligibility criteria:
inclusion criteria: * female and male smokers, aged 18 to 55 years * history of smoking daily for the past 12 months * at least 15 cigarettes daily * in good health as verified by medical history * screening examination * screening laboratory tests * not pregnant as determined by pregnancy screening, nor breast feeding * using acceptable birth control methods. exclusion criteria: * history of pregabalin allergy * use of psychotropic medication antidepressants, antipsychotics dsm-iv axis i diagnosis (schizophrenia, bipolar disorder, major depression * dependence or abuse of alcohol or any other illicit or prescription drugs * current use of any other tobacco products, including smokeless tobacco * history of seizures * inability to fulfill all scheduled visits and examination procedures

Keywords: smoking sensations no cravings desire to smoke
panitumumab for intravenous infusion 100 mg and 400 mg special drug use surveillance "survey on unresectable, advanced or recurrent colorectal cancer with wild-type kras gene" (all-patient surveillance)

Conditions: Advanced or Recurrent Colorectal Cancer

Summary: the efficacy and safety of panitumumab (vectibix) in the routine clinical setting will be studied. specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders.

the efficacy and safety of panitumumab (vectibix) in the routine clinical setting will be studied. participants of this surveillance will be patients with unresectable, advanced or recurrent colorectal cancer with the wild-type kras gene. the planned sample size is 2,000 patients. the usual adult dosage is 6 mg/kg of panitumumab given by intravenous drip infusion over a 60-minute period once every 2 weeks. the dosage may also be reduced as needed, depending on the patient's condition.

Eligibility criteria:
inclusion criteria: * unresectable, advanced or recurrent colorectal cancer with wild-type kras gene exclusion criteria: * patients with a medical history of severe hypersensitivity to any of the ingredients of vectibix
digital parent training for disruptive behaviors in children

Conditions: Disruptive Behavior; Aggression Childhood; Anger; Non-Compliance, Patient; Irritable Mood

Summary: this is an open pilot trial of web-based parent training for tantrums and disruptive behavior in children. parents will be asked to complete a battery of tests to assess their children' behaviors before and after the intervention. children will undergo a psychiatric evaluation as part of screening. the intervention will be delivered online via an app over a period of 6 weeks. it consists of 8 self-guided courses that take approximately 10 minutes to complete and include text and animated parent-child simulations. parents will also complete 3 one-hour videoconferencing sessions with a study clinician. during the intervention, parents will be taught various strategies for managing situations that can be anger provoking for their child. this study is conducted to examine whether a digitally-delivered version of parent-management training can be used to reduce behavioral problems including anger outbursts, irritability, aggression and noncompliance.


Eligibility criteria:
inclusion criteria: * parents have access to a mobile device and/or computer device * parents speak english as native language * families agree not to initiate new mental health treatments for the duration of this study. * child meets diagnostic criteria for one of the disruptive behavior disorders * affective reactivity index parent-report score is above 3.6, which is the mean for children with severe irritability * lives within driving distance from new haven, ct exclusion criteria: * parents have previously received parent-training by a licensed provider. * untreated medical or psychiatric disorder that requires immediate intervention * child is non-verbal or minimally verbal
gemcitabine plus oxaliplatin versus oxaliplatin plus fluorouracil/leucovorin for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to determine that gemcitabine(gem) plus oxaliplatin(oxa) (gemox) is superior to oxaliplatin plus fluorouracil/leucovorin(folfox4) in prolonging progression-free survival（pfs） in patients with advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * eligible patients were age 18 to 75 years; * the patients had histologically, cytologically,or clinically diagnosed unresectable hcc;and were ineligible for local invasive treatment. clinically diagnosed patients had to have: (1) evidence of hbv or hcv with hepatic cirrhosis; (2) a-fetoprotein levels 400g/l; and (3) morphologic evidence of hypervascular liver tumor. patients had to have at least one measurable lesion according to recist (version 1.0; ≥2 cm on computed tomography \[ct\]; 1 cm on spiral ct or magnetic resonance imaging). lesions that had undergone previous interventional or local therapy were not considered measurable lesions. * ecog score≤2; * life expectancy 3 months; * barcelona clinic liver cancer (bclc) stage b or c disease; * child-pugh stage a or b disease; * adequate organ and marrow function, with neutrophil count≥1.5x10e9/l, platelet count≥75×10e9/l, ast or alt﹤2.5×upper limit of normal (uln), total bilirubin \<1.5×uln, international normalized ratio \<1.5;normal baseline left ventricular ejection fraction_lower limit of normal for the institution. patients with ast and alt\<5 ×uln could be recruited if total bilirubin was in the normal range. * patients had to provide signed informed consent to participate. exclusion criteria: * documented allergy to platinum compounds or other study drugs; any previous oxa or gem treatment, except adjuvant treatment ﹥12 months before random assignment; * previous liver transplantation; * concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion); * cns metastasis; * other serious illness or medical condition.
mastalgia treatment: is there a role for osteopathic manipulative treatment

Conditions: Mastalgia

Summary: there are many current medical treatments for mastalgia, but few have been proven effective. our objective is to evaluate the effectiveness of osteopathic manipulative treatment as compared to a light touch protocol and standard management in the treatment of women with cyclical and non-cyclical mastalgia. we will compare duration of the pain, severity of the pain and the effect of the pain on quality of life.

our objective is to evaluate the effectiveness of osteopathic manipulative treatment (omt) as compared to a light touch protocol and standard management in the treatment of women with cyclical and non-cyclical mastalgia (breast pain). a randomized placebo controlled study will be conducted at two academic health care centers. women with breast pain will be evaluated and followed by the breast surgeon. once a pathologic cause has been ruled out, the women will be stratified and randomly divided into three study groups. group a, b, and c. group a will receive standard of care treatment. group b will receive light touch (a placebo for the omt treatment). group c will receive omt directed at treating mastalgia. the treatment will continue for three months. the subjects will fill out an initial pain questionnaire and a follow-up questionnaire each month. they will also be instructed to fill out a breast pain log daily for three months. a final questionnaire will be completed at six months. statistical analysis will be utilized to determine whether the addition of omt improves the severity or duration of the pain as well as quality of life as assessed by the patient.

Eligibility criteria:
inclusion criteria: * women over 18 years of age presenting with breast pain, both cyclical and noncyclical, who complain of pain despite a negative full work-up for pathology, reassurance, and use of an appropriate supportive bra. * a pain scale questionnaire will be completed by the subject. the pain should be present for at least 7 days each month if it is mild pain or be of moderate to severe intensity for at least 3 days each month. in addition, breast pain must have been present for a minimum of 2 consecutive months preceding the date of inclusion into the study. exclusion criteria: * women under 18 years old, women who have had recent breast surgery (\<2yrs), women who have breast implants. * women with bleeding risk such as those regularly taking aspirin, nsaids, plavix or any other anticoagulation therapy. * women who are pregnant, breastfeeding or who are planning to get pregnant are excluded. * women with known chronic pain syndromes or structural abnormality such as osteoporosis will be excluded. when necessary bone densitometry will be performed. * women who are unable to complete the questionnaire.

Keywords: mastalgia breast pain osteopathic manipulative medicine osteopathic manipulative treatment