Kornimate/medical-research-clean huggingface dataset:
continuous infusion gemcitabine in treating patients with advanced metastatic cancer

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of gemcitabine given as a continuous infusion in treating patients who have advanced metastatic cancer.

objectives: * determine the maximum tolerated dose of continuous infusion gemcitabine in patients with metastatic malignancies. * determine the toxicity profile of this drug in these patients. outline: this is a dose-escalation study. patients on dose levels 1-5 receive gemcitabine iv continuously over 72 hours on week 1. patients on dose levels 6 and 7 receive gemcitabine iv continuously over 72 hours on weeks 1-3. courses repeat every 2 weeks (for patients on dose levels 1-5) and every 4 weeks (for patients on dose levels 6 and 7) in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. projected accrual: a total of 27 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of an advanced metastatic malignancy for which no curative therapy exists patient characteristics: age: * 18 and over performance status: * not specified life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 2,000/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 2.0 mg/dl renal: * creatinine no greater than 2.0 mg/dl pulmonary: * corrected dlco at least 60% expected other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy * not specified chemotherapy * prior short-infusion gemcitabine allowed endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: unspecified adult solid tumor, protocol specific
dose ranging study of the safety and efficacy of r115966 in plaque psoriasis

Conditions: Psoriasis

Summary: eligible subjects will be randomly assigned to one of three dose regimens of oral r115866 or placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. the safety and efficacy of r115866 will be evaluated during the treatment period and the 8-week post treatment follow-up period.


Eligibility criteria:
inclusion criteria: * plaque psoriasis with pasi greater than or equal to 10 * male or a female who was not of childbearing potential (i.e., post- menopausal for greater than 12 months or had a complete hysterectomy); exclusion criteria: * spontaneously improving or rapidly deteriorating plaque psoriasis * guttate, pustular, erythrodermic, or other non-plaque form of psoriasis * subject was under treatment for a heart disorder or had a history of cardiovascular disease (excluding effectively controlled hypertension) * any acute psychiatric condition, including an increased risk for suicide attempt, based on medical and psychiatric history * previous use of a psoriasis vaccine or had participated in an investigational study of a psoriasis vaccine * previous use of systemic immunomodulatory therapy known to affect psoriasis and to typically decrease immune cell populations * previous use of any systemic immunomodulatory therapy known to affect psoriasis and not typically to decrease immune cell populations * previous use of any photo-therapy (including laser), photo-chemotherapy, or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids, or cyclosporine) within the previous four weeks * pregnant or a nursing mother * significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, cancer (except non-melanoma skin cancer), a positive test for human immunodeficiency virus (hiv), a history indicating adrenal cortex dysfunction

Keywords: psoriasis
the evaluation of triple therapy with vonoprazan, amoxicillin and bismuth for eradication of helicobacter pylori

Conditions: Helicobacter Pylori Infection

Summary: the eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to antibiotics. therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. the aim of this prospective study is to investigate the efficacy of triple therapy with vonoprazan, amoxicillin, and bismuth for eradication of hp, compared with standard quadruple therapy.

in china, the first-line therapy to treat helicobacter pylori (hp) consists of a bismuth-based proton pump inhibitor (ppi) and two antibiotics for 14 days.but, eradication has become less successful due to low compliance and high resistance to antibiotics. therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. vonoprazan is a novel potassium-competitive acid blocker more effective in suppressing acid production than proton pump inhibitors (ppis). several studies previously suggested that vonoprazan containing antibiotic therapy was superior to other ppi-containing therapies for hp. most strains of helicobacter pylori are sensitive to amoxicillin. bismuth salts, a topical agent, which are available in our country, have a synergistic effect on antibiotics and decrease the bacterial load. therefore, the investigators performed a prospective, multi-center, randomized trial, to investigate the efficacy of triple therapy with vonoprazan, amoxicillin, and bismuth for eradication of hp, compared with standard quadruple therapy.

Eligibility criteria:
inclusion criteria: * helicobacter pylori infected patients comfirmed by 13c/14c ubt * age 18\~65 exclusion criteria: * prior hp eradication therapy including amoxicillin and clarithromycin * previous gastric resection * allergic to the drugs used in this study * previous use of proton pump inhibitors, bismuth, h2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study * patients who were pregnant or lactating * patients taking nsaids, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy#diabete mellitus, hypertension...) effect the evaluation of this study * can't express the complaint correctly

Keywords: vonoprazan standard quadruple therapy
early weight bearing for unstable ankle fractures undergoing operative stabilization

Conditions: Ankle Fracture

Summary: the purpose of this randomized, controlled trial is to estimate the safety of early weight bearing on post ankle surgery. patients who are indicated to have surgery for unstable ankle fractures by an attending trauma physician will be consented for participation in the study. after surgery patients will be randomized to either weight bearing as tolerated at two weeks with a cam boot or non-weight bearing with a cam boot. randomization will be performed by number allocation with odd numbers in the early weight bearing group and even numbers in the non-weight bearing group. the surgeon will be blinded to this until after the surgery. the patients will all be placed in a short leg cast post operative and made non-weight bearing for 2 weeks until sutures are removed which is current standard treatment. both groups will be asked to initiate weight bearing at two weeks post operatively by wearing a cam boot that is non weight bearing in a cam boot, the latter being standard treatment.


Eligibility criteria:
inclusion criteria: * operative unstable ankle fractures exclusion criteria: * requirement of syndesmotic fixation * pilon fractures * open fractures * patients with diabetic neuropathy * bmi\>40 * polytrauma patients * patients who are unable to comply with non-weight bearing * patients who are unable to follow up

Keywords: orthopedic post-operative weight bearing range of motion
diagnostic performance of pet/ct-psma in patients with non-prostatic psma-expressing neoplasms

Conditions: PSMA Positive Tumors or Tumor Tissues; Cancer

Summary: study to collect data from pet/ct-psma performed in patients with neoplasms expressing psma, other than prostate cancer. objectives the primary objective is to evaluate the diagnostic performance of pet/ct-psma in the staging and management of patients with non-prostatic neoplasms expressing psma. the secondary objective is to analyze the prognostic value of pet-psma in such neoplasms and the possible use in the selection of patients eligible for target therapies against neovascularization (i.e. monoclonal anti-vegf antibodies) and radiopharmaceutical treatments (i.e. 177lu-psma).

purpose of the register: this single-centre observational register is intended to collect data from pet/ct-psma performed in patients with neoplasms expressing psma, other than prostate cancer. design of the register: observational, pharmacological, non-profit, prospective, monocentric. duration of the record: the expected duration for the collection of pet/ct-psma examinations is 10 years. objectives the primary objective of the following registry is to evaluate the diagnostic performance of pet/ct-psma in the staging and management of patients with non-prostatic neoplasms expressing psma. the secondary objective is to analyze the prognostic value of pet-psma in such neoplasms and the possible use in the selection of patients eligible for target therapies against neovascularization (i.e. monoclonal anti-vegf antibodies) and radiopharmaceutical treatments (i.e. 177lu-psma).

Eligibility criteria:
inclusion criteria: * patients diagnosed with a neoplasm other than prostate carcinoma who are referred to our unit as part of the standard care pathway to undergo a psma pet/ct scan for staging, restaging, and pre- and post-treatment evaluation * signed informed consent for the collection and processing of data * minimum age 18 years old." exclusion criteria: * pregnancy

Keywords: psma pet/ct psma expressing tumors
effect of different nasotracheal tubes on tube passage

Conditions: Sialolithiasis

Summary: the purpose of the study is to find out the clinical effects that can be obtained during nasotracheal intubation when using velvet-soft pvc tube compared to conventional polyvinylchloride(=pvc) tube.

the hypothesis of this study is that the velvet-soft pvc tube can advanced from the nasal cavity to the oral cavity through the posterior wall of the pharynx more smoothly than conventional pvc tube, thus reducing blockade of tube advancement, nasal/pharyngeal mucosal bleeding, and intubation time. in addition, investigators would like to compare the technique of nasal intubation using by connecting rubber suction catheter to pvc tube tip.

Eligibility criteria:
inclusion criteria: * the patients who need to nasotracheal intubation for surgery * age: 19 years old or more exclusion criteria: * patient refusal * nasal deformity * history of previous moderate degree of epistaxis

Keywords: nasotracheal intubation
group interpersonal psychotherapy for depressed adolescents in school-based clinics

Conditions: Depression

Summary: this study will assess the effectiveness of group interpersonal psychotherapy (ipt-ag) versus treatment as usual (tau) in improving the treatment of depressed adolescents in school-based health clinics.

depression is a serious medical condition. it occurs in people of all ages, but only in the past two decades has depression in children and adolescents been taken seriously. children and adolescents with depression may exhibit such behaviors as pretending to be sick, refusing to go to school or getting in trouble at school, clinging to a parent or worrying that the parent may die, sulking, or acting in a negative or grouchy manner. a previous study demonstrated that, when administered by clinicians in school-based clinics, individual interpersonal psychotherapy is effective in reducing depressive symptoms and improving global and social functioning. this study will assess the effectiveness of group interpersonal psychotherapy (ipt-ag) versus treatment as usual (tau) in improving depressive symptoms of adolescents in school-based health clinics. participants in this 16-week single-blind study will be randomly assigned to receive either ipt-ag or tau in a school-based clinic. participants assigned to receive ipt-ag will attend two to three, 40-minute individual pre-group sessions, followed by 12, 90-minute group therapy sessions and two additional individual sessions-one midway through the group sessions and another upon completion of group therapy. tau will consist of counseling sessions as regularly conducted by the school clinic social worker and/or referral to another agency. study visits will occur at baseline and weeks 4, 8, 12, and 16, or upon early termination. at the end of 16 weeks, participants assigned to receive ipt-ag will continue in a maintenance program in which they will receive ipt-ag once a month for an additional 6 months. all participants will also be assessed 6 and 12 months post-treatment to measure depressive symptoms, global and social functioning, satisfaction with care, and utilization of other services.

Eligibility criteria:
inclusion criteria: * meets diagnostic criteria for major depression, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood * score of 24 or greater on the ces-d * score between 10 and 28 on the hrsd * score of 65 or less on the c-gas * english-speaking * parental or legal guardian consent to participate exclusion criteria: * actively suicidal * score greater than 28 on the hrsd * mentally retarded * any life threatening medical illness * meets diagnostic criteria for current substance abuse, schizophrenia, or bipolar disorder * any evidence of psychosis, conduct disorder, or active eating disorder * currently in active treatment for depression * taking antidepressant medication at the time of baseline assessment * recent death of someone close

Keywords: major depression dysthymic disorder adjustment disorder with depressed mood depressive disorder not otherwise specified adolescent psychotherapy
molecular imaging of active venous thrombus with positron emission tomography (pet)

Conditions: Venous Thromboembolism (VTE)

Summary: venous thromboembolism (vte), which includes deep vein thrombosis (dvt) and/or pulmonary embolism (pe), is a major public health issue. vte is the third most common acute cardiovascular pathology, after myocardial infarction and stroke. diagnostic accuracy is essential in the case of vte, in order to select patients for whom anticoagulant treatment is necessary, and to avoid long-term treatment of patients who will derive no benefit from it. the management of patients with suspected pe is based on diagnostic strategies that use either ventilation-perfusion planar lung scintigraphy or thoracic angioscanner imaging as the cornerstone. these 2 techniques correspond to what might be termed "negative" imaging, i.e. visualization of the vascular repercussions downstream of an obstruction, whatever its nature. a research prospect in the field of vte diagnosis is the direct marking of the various elements of the active venous thrombus, which could correspond to "positive" thrombus imaging. numerous studies have already investigated the role of molecular imaging in the diagnosis of vte, especially in the diagnosis of dvt. however, these studies used conventional scintigraphy to evaluate these tracers, a technique lacking in sensitivity and with insufficient spatial resolution. nuclear medicine and molecular imaging have undergone a technological revolution since the early 2000s, with the development of positron emission tomography (pet). the technical advantages of pet over conventional scintigraphy include greater sensitivity and higher spatial resolution (4 mm for pet vs. 12 mm for conventional scintigraphy), which may have been the limiting factor in studies already carried out. the aim of this project is to develop a new radiopharmaceutical for use in pet scans, a biomarker of active venous thrombus, with a view to improving the diagnosis of mvte and hence patient management.


Eligibility criteria:
inclusion criteria: major patient (≥18 years), voluntary blood donor, with no notable medical history altering coagulation (i.e. known thrombophilia, active cancer), no chronic pathology, no current treatment. exclusion criteria: minor patient (\<18 years); known chronic pathology; long-term treatment including anti-platelet aggregation therapy or anticoagulant treatment, refusal to participate.
platelet reactivity in stent thrombosis patients

Conditions: Coronary Artery Stent Thrombosis

Summary: recent studies have demonstrated a marked interindividual variability of clopidogrel's capacity to inhibit platelet aggregation with a substantial proportion (11-34%) of the patients considered non-responders to clopidogrel treatment. variable intestinal absorption is suggested to contribute to the inconsistencies in response to clopidogrel. however, little is known about intestinal absorption in subjects who had suffered from a stent thrombosis. the mapcat-study has been designed to investigate whether plasma pharmacokinetics (represented by cmax, tmax and the auc) after a 600 mg loading dose are significantly different between subjects who have suffered a stent thrombosis and subjects who have not suffered a stent thrombosis.

objectives: the first objective of the mapcat-study is to investigate whether plasma pharmacokinetics (cmax, tmax and auc) of an additional 600 mg loading dose are impaired in patients with a history of stent thrombosis. the second objective of the mapcat study is to investigate whether genetic polymorphisms in receptors, enzymes and ligands involved in the process of thrombosis and haemostasis as well in the conversion-process of clopidogrel into its metabolites do have influence on both the absolute magnitude of platelet inhibition and cmax, tmax and auc.

Eligibility criteria:
inclusion criteria: * patients with a history of a stent thrombosis in the period 2004-2008. exclusion criteria: * persistent acute st-segment elevation * successful revascularization during the qualifying hospitalization, prior to study entry * acute pulmonary edema, hypotension, or evidence of cardiogenic shock * clinically significant liver disease * end stage kidney disease requiring dialysis * use at study entry of drugs that are strong inhibitors of cytochrome p450 3a4 and cyp3a5 (i.e. clarithromycin, erythromycin, itraconazole, ketoconazole) * contraindications to antithrombotic/antiplatelet therapy * failed coronary intervention in the previous 2 weeks * malignancies * increased risk of bleeding (previous stroke in the past months, active bleeding or bleeding diathesis, recent trauma or major surgery in the last month, suspected aortic dissection, oral anticoagulation therapy with coumarin derivate within 7 days, recent use of gpiib/iiia inhibitors within 14 days, severe uncontrolled hypertension \>180 mmhg unresponsive to therapy) * relevant hematologic deviations (haemoglobin \ 600 x 109/l) * known allergy to clopidogrel * pregnancy (present or suspected) * uncontrolled hypertension at time of randomization

Keywords: clopidogrel pharmacokinetics platelet function tests platelet reactivity
preoperative preparation for children

Conditions: Elective Surgery; Anxiety

Summary: children scheduled for elective surgery are randomized into a control and intervention group. children in the intervention group receive a cd and booklet of relaxation and distraction stories to listen to/read during the preoperative period. preoperative anxiety is assessed by the child life specialist in the preoperative holding area. ease of induction and emergence from anesthesia are rated by the anesthesia care provider. post-hospital behaviors are reported by the parents one week after discharge. it is hypothesized that children receiving the intervention will have less anxiety, easier induction and emergence from anesthesia, and fewer changes in post-hospital behaviors than children in the control group.


Eligibility criteria:
inclusion criteria: * children between 4-12 years of age scheduled for elective surgery exclusion criteria: * children \ 12 years of age
biomarkers in patients with metastatic or recurrent head and neck cancer treated with cisplatin and cetuximab on ecog-e5397

Conditions: Head and Neck Cancer

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. purpose: this research study is studying biomarkers in patients with metastatic or recurrent head and neck cancer treated with cisplatin and cetuximab on ecog-e5397.

objectives: primary * compare cetuximab activity, as reflected in response rate (rr), in pten-deficient and pten-expressing cancers. secondary * examine rr, progression-free survival (pfs), and overall survival (os) in pten-deficient and pten-expressing cancers, by treatment arm. outline: tissue microarray slides collected earlier from ecog-e5397 are immunostained with pten antibody and analyzed with aqua.

Eligibility criteria:
disease characteristics: * treated on protocol ecog-e5397 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage iii squamous cell carcinoma of the hypopharynx stage iii squamous cell carcinoma of the larynx stage iii squamous cell carcinoma of the lip and oral cavity stage iii squamous cell carcinoma of the oropharynx stage iii squamous cell carcinoma of the paranasal sinus and nasal cavity stage iva squamous cell carcinoma of the larynx stage iva squamous cell carcinoma of the lip and oral cavity stage iva squamous cell carcinoma of the oropharynx stage iva squamous cell carcinoma of the paranasal sinus and nasal cavity stage ivb squamous cell carcinoma of the larynx stage ivb squamous cell carcinoma of the lip and oral cavity stage ivb squamous cell carcinoma of the oropharynx stage ivb squamous cell carcinoma of the paranasal sinus and nasal cavity stage ivc squamous cell carcinoma of the larynx stage ivc squamous cell carcinoma of the lip and oral cavity stage ivc squamous cell carcinoma of the oropharynx stage ivc squamous cell carcinoma of the paranasal sinus and nasal cavity untreated metastatic squamous neck cancer with occult primary