Kornimate/medical-research-clean huggingface dataset:
two approaches to routine hiv testing in a hospital emergency department

Conditions: HIV Infections

Summary: this study was initially designed to compare the effectiveness of two different approaches to providing routine hiv counseling, testing, and referral services in an urban hospital emergency department setting. the initial phase was closed in july 2008. the second phase of this trial consists of establishing the differences in acceptability of hiv testing based on the method of testing offered (rapid oral fluid vs. fingerstick).

about 25% of hiv infected people do not know that they are infected. these people lack medical care that could prolong their lives and access to counseling services that could prevent further spread of hiv. with so many people unaware of their hiv status, there is a clear need for more readily available hiv counseling, testing, and referral services throughout the united states. the centers for disease control and prevention (cdc) recommends routine hiv testing in u.s. hospitals in which hiv infected patients make up at least 1% of the total patient population for that hospital. in the original proposal, we chose oral rapid hiv testing as we felt that this technique is noninvasive, acceptable to both patients and health care workers (without body fluid risk), and would maximize rates of hiv testing. this study directly compares acceptance rates of hiv testing as a function of the test type offered (oral vs. fingerstick) in a randomized controlled fashion. participants in this study will include adults who visit brigham and women's hospital emergency department in boston, massachusetts. participants will be randomly assigned to oral vs. fingerstick hiv testing by a designated hiv counselor and to fill out a questionnaire while waiting in the emergency room. the questionnaire will be anonymous. participants will then be offered a rapid hiv test. test results will be available in about 20 minutes and will be provided to participants by the hiv counselor. participants who test positive for hiv will be offered a more definitive blood test to confirm hiv infection. the blood test results will be available 2 weeks from testing, and participants must return to the hospital to get their test results. participants who test positive for hiv will be offered counseling support and referral services by either their assigned hiv counselor or emergency department staff member. follow-up care appointments will also be initiated at this time. for participants who test positive for hiv, the study will last about 6 months. there will be no follow-up visits for participants who do not test positive for hiv during their emergency room visit.

Eligibility criteria:
inclusion criteria: * waiting to receive care in the brigham and women's hospital emergency room * english- or spanish-speaking * enters the emergency room when an hiv counselor is available exclusion criteria: * an estimated severity index score of 1 or 2 who have mechanical ventilation or are not deemed alert, awake, and oriented to person, place and time by the triage nurse * hiv infected

Keywords: hiv testing hiv seronegativity
vaspect study - an open-label trial of donepezil in vascular and mixed dementia

Conditions: Dementia, Vascular; Dementia, Mixed

Summary: to document effectiveness, safety, and tolerability of donepezil in patients with mixed ad/vad, and to further document the effectiveness, safety, and tolerability of donepezil in patients with vad. the effects of donepezil on executive functioning, behavior, general cognition, adls and global functioning will be assessed.

the trial was terminated on october 15, 2007 due to difficulties in recruiting the subjects. there were no safety or efficacy concerns regarding the study medication in the decision to terminate the trial.

Eligibility criteria:
inclusion criteria: * subjects must meet dsm-iv-tr criteria for the clinical diagnosis of vascular dementia or the clinical diagnosis of dementia due to multiple etiologies. * subjects must have a reliable caregiver or family member who agrees to accompany the subject to all scheduled visits, provide information about the subject as required. exclusion criteria: * subjects with any current primary psychiatric diagnosis other than dementia of the alzheimer's type or vascular dementia.
improving reproductive function in women with polycystic ovary syndrome by high intensity interval training

Conditions: Polycystic Ovary Syndrome

Summary: the aim is to investigate whether 16 weeks of high intensity interval training, followed by 36 weeks of home-based exercise, will improve menstrual frequency in women with polycystic ovary syndrome (pcos) compared with a non-exercising control group.


Eligibility criteria:
inclusion criteria: * polycystic ovary syndrome (pcos) according to the rotterdam criteria exclusion criteria: * regular high intensity endurance (two or more times per week of vigorous exercise). * concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion). * on-going pregnancy. * breast feeding within 24 weeks * cardiovascular disease or endocrine disorders

Keywords: exercise therapy reproductive physiological processes fertility
a study of ragweed (ambrosia artemisiifolia) allergy immunotherapy tablet in adults with ragweed allergies (p05751)

Conditions: Allergy

Summary: this study assessed the safety profile of short ragweed (ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma. the primary objective was to compare treatment-emergent adverse events (aes) for participants treated with short ragweed allergy immunotherapy tablet (ait) with those treated with placebo.


Eligibility criteria:
inclusion criteria: * clinical history of physician-diagnosed ragweed-induced allergic rhinoconjunctivitis of 2 years duration or more, with or without asthma * must have a positive skin prick test response to ambrosia artemisiifolia * must have a forced expiratory volume in 1 second (fev1) of at least 70% of predicted value * clinical laboratory tests, electrocardiogram (ecg) and vital signs conducted at the screening visit must be within normal limits or clinically acceptable to the investigator/sponsor * females of child-bearing potential must agree to use medically accepted methods of contraception exclusion criteria: * unstable asthma or has experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids in previous 3 months * received an immunosuppressive treatment within 3 months * history of anaphylaxis with cardio-respiratory symptoms. * history of chronic urticaria or angioedema * current severe atopic dermatitis * female subject who is breastfeeding, pregnant, or intending to become pregnant * has received maintenance doses of immunotherapy with ragweed extract for ≥1 month within the last 5 years * history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (imps) (except for ambrosia artemisiifolia), or self-injectable epinephrine * unable to or will not comply with the use of self-injectable epinephrine * participating in any other clinical trial

Keywords: immunology
pemoline for cocaine abuse - 7

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate the treatment of pemoline for cocaine abuse.


Eligibility criteria:
please contact site for information.

Keywords: pemoline
eus-b-fna vs eus-fna for left adrenal gland analysis in lung cancer patients

Conditions: Suspected Left Adrenal Gland Metastasis in Lung Cancer

Summary: the purpose of this study is to compare eus-b-fna (using the ebus scope)with eus-fna for left adrenal gland analysis in lung cancer patients.

rationale: the adrenal glands are a predilection site for distant metastases (m1b) in patients with lung cancer. however, even in a patient with a confirmed lung cancer an enlarged adrenal lesion is still more likely to be benign than to be malignant(4). therefore tissue sampling of the left adrenal gland (lag) is obligatory to either confirm or rule out metastases. sampling is regularly performed by a transgastric endoscopic approach using a conventional gi-eus scope. the aim of this study is investigate the success rate of endoscopic ultrasound guided fine-needle aspiration using the ebus scope (eus-bfna) for left adrenal gland analysis in patients with lung cancer and an on imaging suspected left adrenal gland. hypothesis: eus-b guided transgastric fna of suspected left adrenal glands (lag) reduces the need for conventional eus- fna by half. study design: a prospective cohort design setting: international, multicenter study population: patients with (suspected) lung cancer, an indication for mediastinal nodal staging and a for malignancy suspected lag on imaging. intervention: all patients will undergo a mediastinal nodal staging procedure with the ebus scope (ebus + eusb) (routine clinical care) followed by an evaluation of the lag including lag sampling (experimental). subsequently, all patients undergo a conventional eus procedure with sampling of the lag (current standard of care) main study endpoint: the proportion of patients with a successful eus-b-fna procedure for lag analysis. successful is defined as: lag is visible, sampling is possible and adequate material for cytopathological evaluation is obtained. nature and extent of the burden and risks associated with participation, benefit and group relatedness: distant metastases of lung cancer like lag metastases have significant impact on both the prognosis and treatment. in the majority of patients with an indication for lag sampling by endosonography, there is also an indication for mediastinal nodal tissue sampling. in case both the mediastinal lymph nodes and the lag can be evaluated with the same scope, patients can be evaluated for nodal and distant metastasis with just a single instead of two separate scopes. this will be beneficial for patients (reduced investigation time) and is additionally cost -effective. so far eus-b of lag has been shown to be safe and feasible.

Eligibility criteria:
inclusion criteria: * (suspected) lung cancer * for malignancy suspected lag on imaging (enlarged based on ct and/or fdg avid based on fdg-pet); * indication for endosonographic mediastinal staging by ebus; * indication for lag sampling; exclusion criteria: * contraindication for eus; * pregnancy;

Keywords: lung cancer adrenal gland metastasis
evaluation of the predictive nature of the postoperative crp on postoperative recovery in patients undergoing colorectal resection (crp-track)

Conditions: Colorectal Postoperative Complication

Summary: colic and rectal resection represents a majority of hospitalizations in visceral surgery. the objective of this study was to evaluate the prognostic of inflammatory markers dosage (crp, procalcitonin and venous lactate) on the postoperative recovery after colorectal surgery and on the length of stay.


Eligibility criteria:
inclusion criteria: * upper age to 18 years * planned hospital stay for a colonic resection with anastomosis without permanent or temporary digestive bypass * patient with pre-operative crp lower or egal to 172 mg/l * no opposition at the participation of the study * expected patient return home after surgery (or convalescent home or not medicalized institution) exclusion criteria: * patient under guardianship * protected or private patient freedom * minor patient * colectomy surgery with digestive bypass or digestive anastomosis * complex combined surgery (significantly intestinal resection associated, another surgical procedure that can interfere with postoperative crp) * general inflammatory disease susceptive to modify dosage values * anti-inflammatory therapy (ains/ corticosteroids/ immunosuppressive) * patient unable to understand the study

Keywords: crp postoperative complication length of stay
pro-minichop-like regimen for treatment-naive elderly patients

Conditions: Diffuse Large B Cell Lymphoma

Summary: the proposed study is a prospective, single-center and open-ended study in patients over the age of 70 with treatment-naive diffuse large b-cell lymphoma (dlbcl). this study intends to explore a new treatment pattern using pro-minichop-like regimen and simultaneously evaluate its safety and efficacy for future clinical practice.

the study will start with an initial 21-days of induction therapy with combination of orelabrutinib, pomalidomide and rituximab(pro regimen) in eligible patients, following contrast computed temography(ct) to guide the next treatment. patients whose lesions have 25% or more reduction will next receive pro-minichop-like regimen for 6 cycles. patients with reduction less than 25% will receive r-minichop-like regimen also for 6 cycles. after that, maintenance therapy with pomalidomide for two years will be given to patients undergoing pro-minichop-like regimen.

Eligibility criteria:
inclusion criteria: 1. histopathologically or cytologically confirmed newly diagnosed untreated dlbcl; 2. there is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter); 3. age ≥ 70 years; 4. life expectancy \>3 months; 5. patients with proper organic function (alanine aminotransferase, bilirubin, creatinine \ 90% under non-oxygenated conditions). 6. written informed consent obtained from the subject. exclusion criteria: 1. patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal); 2. patients with organic heart disease with clinical symptoms or cardiac dysfunction (nyha grade ≥2); 3. uncontrolled active infection; 4. patients with central nervous system dlbcl; 5. a history of vascular embolism; 6. co-existence of other tumors; 7. systemic corticosteroid therapy is needed; 8. any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.

Keywords: diffuse large b-cell lymphoma orelabrutinib pomalidomide rituximab
safety and efficacy study of ceftaroline versus a comparator in pediatric subjects with complicated community acquired pneumonia (cabp)

Conditions: Infections; Pneumonia

Summary: this is a study of safety and effectiveness of ceftaroline fosamil in children with complicated community-acquired pneumonia receiving antibiotic therapy in the hospital.

to evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in pediatric subjects ages 2 months to \< 18 years who are initially hospitalized with complicated community acquired bacterial pneumonia (cabp) at high risk of infection due to methicillin-resistant staphylococcus aureus (mrsa)

Eligibility criteria:
inclusion criteria: * presence of cabp warranting 3 days of initial hospitalization * confirmed presence of indicators of complicated cabp exclusion criteria: * hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial * confirmed or suspected infection with a pathogen known to be resistant to iv study drugs or known infection at baseline with a sole atypical organism * confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pneumonia * non-infectious causes of pulmonary infiltrates

Keywords: infections pediatrics teflaro ceftriaxone cephalosporin vancomycin clindamycin amoxicillin clavulanate linezolid mrsa pneumonia
dcb compared stenting in popliteal lesions

Conditions: Popliteal Stenosis; Popliteal Artery Occlusion; Diabetes

Summary: this is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in popliteal atherosclerotic occlusive lesions.


Eligibility criteria:
inclusion criteria: * age 18 years or older * symptomatic peripheral artery disease: * moderate or severe claudication (rutherford category 2 or 3) * critical limb ischemia (rutherford category 4 or 5) * atherosclerotic popliteal artery disease (stenosis \> 50%) * patients with signed informed consent exclusion criteria: * acute critical limb ischemia * severe critical limb ischemia (rutherford category 6) * involvement of sfa disease with stenosis * continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk). * known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent * age \> 80 years * severe hepatic dysfunction (\> 3 times normal reference values) * significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis * lvef \< 40% or clinically overt congestive heart failure * pregnant women or women with potential childbearing * life expectancy \<1 year due to comorbidity * previous bypass surgery or stenting for the target popliteal artery * untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

Keywords: drug-coating balloon stent popliteal artery atherosclerotic occlusion
prolact - three prolactinoma rcts

Conditions: Prolactinoma; Prolactin-Producing Pituitary Tumor

Summary: this study aims to investigate if endoscopic trans-sphenoidal prolactinoma resection as a first line treatment, or as an equally valid second line treatment after a short (4-6 months) or long (\>2 years) period of pretreatment with a dopamine agonist is superior to standard care for several outcome parameters. the main objectives are to investigate this for quality of life and remission rate. the secondary objectives are to investigate this for biochemical disease control, recurrence rates, clinical symptom control, tumor shrinkage on mri, pituitary functioning, the occurrence of adverse reactions to treatment, disease burden, and cost-effectiveness.


Eligibility criteria:
inclusion criteria: * at least 18 years of age. * a history of signs and symptoms compatible with the diagnosis prolactinoma. * new, recent (prolact-1) or known diagnosis of hyperprolactinaemia, defined as a prolactin level 2 times the local laboratory maximum. at the time of randomization hyperprolactinaemia is still present, or was present \< 12 months before inclusion (prolact-2 and prolact-3). * no clear alternative explanation for hyperprolactinaemia, e.g. medication use. * presence of a clearly identifiable (persisting) pituitary mass on mri not invading the cavernous sinus and having an optimal chance to be completely resected (generally adenomas with a maximum diameter nog exceeding 25mm). a representative mri at the time of randomization is required, this mri should generally not be older than 12 months in prolact-3 and 2 months in prolact-1 and prolact-2. * competent and able to fill in questionnaires. * one of the following, dividing patients in to our three rcts: * prolact-1: no prior treatment for prolactinoma; * prolact-2: treatment with a dopamine agonist for 4-6 months; or * prolact-3: treatment with a dopamine agonist for at least 2 years. exclusion criteria: * contraindication for one of the treatment modalities, e.g. severe side effect of cabergoline, contraindications to surgery, or a clear indication for surgical resection. * pregnancy at the time of randomization. * clinical acromegaly. * prior pituitary gland surgery or radiotherapy to the pituitary gland area. * severe renal failure (egfr \<30 ml/min). * insufficient understanding of the dutch or english language. * other medical conditions that to the opinion of the physician are not compatible with inclusion in a trial. patients eligible for participation in one of the rcts, but do not consent to randomisation or in whom there is a clear patient or physician preference for either da treatment or surgery, are considered for participation in prolact-o.

Keywords: prolactinoma dopamine agonist endoscopic trans-sphenoidal adenoma resection remission rate health-related quality of life
targeted interdisciplinary model for evaluation and treatment of neuropsychiatric symptoms in home care services

Conditions: Dementia

Summary: continuity of care in home care services is necessary to facilitate the assessment and treatment of persons with dementia and cognitive failure. time (targeted interdisciplinary model for evaluation and treatment of neuropsychiatric symptoms) is a multi-component intervention with a biopsychosocial approach, based on the theoretical framework of cognitive behavioral therapy and person-centred care. the trial is designed to assess the effects of time on neuropsychiatric symptoms for persons (nps) with dementia in home care services.

the targeted interdisciplinary model for evaluation and treatment of neuropsychiatric symptoms (time) is a multi-component intervention with a biopsychosocial approach, based on the theoretical framework of cognitive behavioral therapy and person-centred care. time consists of a manual based multicomponent program which includes a rigorous assessment, treatment, and the evaluation of neuropsychiatrc symptoms (nps). the cluster rct will contain two parallel groups, where randomisation is performed based on clusters. one municipality is one cluster, randomized to receive either the intervention with time or a brief two hours education-only intervention about dementia and nps for the control group. totally 10 municipalities will be included. data will be collected at baseline before randomisation and at the end of the implementing phase. measurements at patient level are taken at baseline prior to randomization and after 6 months. the primary outcome measure is difference in change between the intervention group and the control group from baseline to follow up at 6 months in the cornell scale for depression in dementia (csdd). data collection will be performed by project nurses recruited outside the home care services. they will interview the staff or family members who knows the patient best. the assessors will be blinded to the randomization of the home care services. interviews will be done by telephone or face-to-face, depending on what is best for the person interviewed. after the intervention focus group interviews with staff and family members will be conducted.

Eligibility criteria:
inclusion criteria: * dementia, defined as a score of 1 or more on the clinical dementia rating scale (cdr) * a minimum of 15 minutes of home care services per day for the last 4 weeks * nps, defined as a score on the npi-nh affective subsyndrom (npi depression + npi anxiety) of 12 or more * informed consent from the participant or family or next-of-kin exclusion criteria: * terminal disease

Keywords: behavioral symptoms dementia nevropsychiatric symptoms psychological symptoms the time model