Kornimate/medical-research-clean huggingface dataset:
comparison of modafinil and methylphenidate in treatment of excessive daytime sleepiness in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: this is an open-label cross-over randomized control study comparing the effect of modafinil and methylphenidate in patients with parkinson's disease with excessive daytime sleepiness.

sleep disorders are common in parkinson's disease (pd) and a significant cause of impairment of function in already disabled individuals. almost all patients with pd report disturbed sleep, including excessive daytime sleepiness (eds), disorders of initiating and maintaining sleep (dims) or parasomnias.1 the underlying pathology associated with pd and medication effects have both been implicated in the sleep disorders affecting these patients. eds has become the focus of attention because of its effect on quality of life and impairment in driving and predisposition to traffic accidents. its prevalence has been estimated between 15-50%. treatment of eds has become an important factor in the management of the pd patient, and the recent introduction of modafinil, a wakefulness promoting agent approved for narcolepsy, has led to increasing off-label use of this agent. prior to modafinil, amphetamine and methylphenidate, two classical psychostimulants, were the agents of choice in treating eds. however, these agents also have a direct effect on the dopaminergic system. they increase both sleep and rem latency, while reducing total sleep time and rem sleep. by comparison, the mechanism of action of modafinil is unknown, yet distinct from that of the psychostimulants. a direct comparison of the effect on eds of modafinil with classical psychostimulants is lacking. the overall goals of this research proposal are to determine which agent is most effective in treating eds in pd patients by using an open-label randomized control study comparing efficacy, onset of action and tolerability.

Eligibility criteria:
inclusion criteria: * veteran at study site exclusion criteria: * patients unable to give consent * diagnosis of eds prior to diagnosis of pd * brain injury due to trauma, cva, tumor or anoxia

Keywords: excessive sleepiness hypersomnolence parkinson's disease
phantom-s: the pre-hospital acute neurological therapy and optimization of medical care in stroke patients - study

Conditions: Acute Stroke

Summary: the purpose of this prospective study in acute ischemic stroke patients is to compare alarm-to-needle time during randomly allocated periods with and without availability of a specially staffed ambulance equipped with computed tomography (ct) and point-of care diagnostics. the investigators hypothesize that compared to regular care the investigators will reduce alarm-to-needle time by a minimum of 20 minutes by implementation of the stroke emergency mobile unit.

time from symptom onset is crucial for the effectiveness of intravenous thrombolysis in acute ischemic stroke patients. many patients receive tissue plasminogen activator (tpa) with considerable delay. the investigators developed an ambulance equipped with a ct-scanner, point-of-care laboratory, teleradiological support and an emergency trained neurologist on board. in the pre-hospital acute neurological therapy and optimization of medical care in stroke patients (phantom-s)-study the investigators aim at a reduction of the current alarm-to-needle time by pre-hospital use of tissue plasminogen activator in an ambulance. the investigators hypothesize that compared to regular care we will reduce alarm-to-needle time by a minimum of 20 minutes by implementation of the stroke emergency mobile unit (stemo). this is a prospective study comparing randomly allocated periods with and without stemo availability.

Eligibility criteria:
inclusion criteria: * patients whose emergency call prompted the suspicion of stroke within 4 hours of symptom onset or with undetermined time of onset in the dispatch center * informed consent for documentation and follow-up provided by patients or legal representatives exclusion criteria: * age \< 18 years * pregnancy

Keywords: acute ischemic stroke thrombolysis prehospital emergency medicine suspected acute stroke telemedicine
effectiveness of the chess ehealth cancer support intervention in population-based care

Conditions: Primary Breast Cancer

Summary: the study's aim is to provide information about the clinical and business cases for comprehensive interactive cancer communication systems (iccs) in the context of real world use for cancer care. this study will be conducted within the kaiser permanente northwest (kpnw) healthcare system. outcomes for this study include amount of iccs use and women's ratings of cancer information competence, perceived social support, and emotional well being. secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits.


Eligibility criteria:
inclusion criteria: * all subjects must be within 2 months of their primary breast cancer diagnosis, * all subjects must be at least 18 years of age exclusion criteria: * illiterate * homeless
pocket colposcopy using care algorithm

Conditions: Cervical Cancer; HPV Infection

Summary: the pocket colposcope has 510k fda clearance and has been successfully used in \~2500 unique patients globally in duke and non-duke protocols to date. 1054 women who are hpv(+) and planned to undergo treatment at 4-6 ministry of health-supported outpatient clinics in kisumu county will be recruited to the study. after providing informed consent, participants will be proceed with colposcopy using the pocket colposcope.

women undergo pocket-assisted via (pa-via) and green light imaging using the pocket colposcope. women will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. the locations of the biopsies will be based on provider impression. after their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure. once we have obtained enough images to develop the care algorithm, it will also be used to assist the provider in diagnosis. this record reflects phase 1 of aim 3 of the grant. phase 2 of aim 3 will be added once approved. phase 1 of aim 3 was previously included within nct04998318.

Eligibility criteria:
inclusion criteria: 1. age \> 25 years old and \< 65 years old 2. sex: female 3. positive hpv test within past 6 months exclusion criteria: 1. pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated) 2. women with a negative hpv test 3. patients incapable of giving informed consent 4. women with a history of cervical cancer 5. pelvic exam concerning for cervical cancer or cervical infection

Keywords: hpv testing colposcopy cervical cancer screening
a bioequivalence study of vinorelbine tartrate injectable emulsion in patients with advanced cancer.

Conditions: Breast Cancer; Non-small Cell Lung Cancer; Non-Hodgkins Lymphoma

Summary: this study was a randomized, single dose crossover comparison of the investigational product with a reference product (vinorelbine tartrate injection, navelbine®). the primary objective was to demonstrate the equivalence of anx-530 and the reference product, navelbine.

anx-530 (vinorelbine tartrate injectable emulsion), an investigational drug, is an oil-in-water emulsion of vinorelbine tartrate composed of an oil phase and emulsifier dispersed in an aqueous solution. adventrx pharmaceuticals, inc. of san diego, california, developed anx-530 as a vinorelbine tartrate formulation to be used in clinical settings where vinorelbine tartrate injection (navelbine) is indicated. nonclinical toxicology studies suggest either equivalent or less toxicity of anx-530 compared to reference product. in particular, anx-530 caused less vein toxicity in a rabbit vein irritation model, suggesting anx-530 could potentially cause less venous irritation than navelbine in a clinical setting. adventrx is investigating whether anx-530 could substitute for navelbine in these settings.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * advanced cancer potentially sensitive to vinorelbine: * breast cancer. * stage 3 or 4 non-small cell lung cancer. * non-hodgkins lymphoma. * cancer of other histologic type, sensitive to vinca alkaloids. * rare tumor type with no standard treatment, for which single agent vinorelbine is appropriate therapy. * failure of standard treatment(s) of the tumor. * life expectancy of at least three months. * ecog performance level 0-2 or karnofsky score 100-70. * hematological and serum chemistry results with defined ranges. * willingness and ability to provide written informed consent. exclusion criteria: * pregnancy or lactation. in a woman of childbearing potential, a positive pregnancy test result, no pregnancy test result, or no use of reliable contraception, at baseline. a postmenopausal woman will be considered to be of childbearing potential until there has been amenorrhea for at least 12 consecutive months. * previous treatment with vinorelbine or mitomycin. * any history suggesting or demonstrating resistance to, lack of response to, or intolerance of any prior vinca alkaloid treatment. * active infection. * prior anticancer therapy completed within four weeks prior to the first day of study treatment. * failure to have recovered from any toxicity of previous cancer treatment (patients with alopecia will not be excluded). * participation in another experimental drug study within four weeks prior to the first day of study treatment. * requirement for any concomitant chemotherapeutic agent other than the study medication. * any investigator judgment that the individual would not be an appropriate study subject.
association of host genetics with vaccine efficacy and study of immune correlates of risk from a tetravalent dengue vaccine

Conditions: Dengue Fever; Dengue Haemorrhagic Fever

Summary: primary objectives: * to assess how dengue vaccine efficacy varies across participant subgroups regarding polymorphism in human leukocyte antigen (hla) alleles of interest. * to assess the association between hla alleles and, serotype-specific neutralization antibody titers and summary neutralization measure in the vaccine and placebo groups. * to assess the association between the polymorphism in hla alleles of interest and susceptibility to dengue fever and dengue haemorrhagic fever. secondary objectives: * to assess whether dengue serotype-specific neutralizing antibody titers and associated summary neutralization measure at 28 days post-dose 3 are related to the rate of occurrence of symptomatic virologically-confirmed dengue infection after post-dose 3 * to evaluate whether the dengue serotype-specific neutralizing antibody and associated summary neutralization measure at 28 days post-dose 3 are related to the level of vaccine efficacy against dengue viruses after post-dose 3.

the enrolled population will include both, virologically-confirmed (vc) dengue cases and subjects not having experienced a vc dengue infection (control subjects) from the first proof of concept efficacy study conducted in thailand analyses for correlates will be performed on samples collected in the context of the first proof of concept efficacy study. sequencing of dengue viruses will also be done on samples collected within the same context. immunogenetic testing will be performed on saliva samples collected at the study enrollment visit. no intervention or vaccine will be provided or administered as part of this study.

Eligibility criteria:
inclusion criteria: * subject currently enrolled in, or having recently finished, cyd57 (nct01983553; long-term safety follow-up study of the first poc efficacy study), included in the subjects list provided by the sponsor, with or without past experience of virologically confirmed dengue. * for children 7 to \< 18 years. assent form (af) has been signed and dated by the subject, and informed consent form (icf) has been signed and dated by the parents or another legally acceptable representative and by independent witness, as per local ethics committee (ec) requirement. for subjects ≥ 18 years. icf has been signed and dated by the subject and by independent witness, as per local ec requirement. * subject (and parent(s) / legally acceptable representative for subject \< 18 years) are able to attend the scheduled visit and can comply with all study procedures. exclusion criteria: * any illness that, in the opinion of the investigator, might interfere with study procedures.

Keywords: dengue fever dengue haemorrhagic fever tetravalent dengue vaccine
home semen testing in men beginning attempts to conceive

Conditions: Male Infertility

Summary: the overall objective of the proposed study is to enhance early detection of male factor infertility and reduce cost and morbidity associated with delayed diagnosis through development of a universal screening model based on home semen testing. the advent of inexpensive and accurate home semen testing has enabled a potential paradigm shift in the approach to male fertility evaluation. the investigator's central hypothesis is that universal home semen testing prior to attempts to conceive is easy for participants and can lead to reduced fertility-related anxiety and early detection of male factor infertility, thereby expediting evaluation and treatment for the couple while minimizing unnecessary cost and morbidity. this study is specifically designed to assess the feasibility and utility of home semen testing for couples who are beginning attempts to conceive. first, the investigator will assess participants' ability to complete the home semen testing, ease of use, and obstacles encountered in doing so. second, the investigator will examine the impact of home semen testing in fertility-related quality of life among couples beginning attempts to conceive, as well as ability of home semen testing to increase the diagnosis and treatment of male infertility in these couples.


Eligibility criteria:
inclusion criteria: * natal males over the age of 18 with no prior children who are interested in future fertility * current female partner * not attempting to conceive for more than 3 months * willing to sign the informed consent form * able to read, understand, and complete patient questionnaires, pain texts, and medication diary. * ownership or accessibility of a smart phone or electronic device that is compatible with the yosperm® device exclusion criteria * prior semen testing * history of male infertility, klinefelter syndrome, undescended testis, or chemotherapy * female partner with history of infertility * female partner with irregular menstrual periods
vaccine therapy in treating patients who have received first-line therapy for hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: vaccines made from a tumor antigen may help the body build an effective immune response to kill tumor cells. purpose: this phase i/ii trial is studying the side effects and how well vaccine therapy works in treating patients who have received first-line therapy for hodgkin's lymphoma.

objectives: * determine immunologic responses in patients who have completed first-line therapy for hodgkin's lymphoma treated with hodgkin's antigens-gm-csf-expressing cell vaccine. * determine the durability of these immunologic responses in these patients. * determine the utility of an epstein-barr virus reporter system for monitoring cellular vaccine responses. * determine the safety and tolerability of this vaccine in these patients. outline: beginning 4-6 months after last chemotherapy, patients receive hodgkin's antigens-gm-csf-expressing cell vaccine on day 1. treatment repeats every 3 weeks for up to 4 courses. immunologic responses are serially monitored along with disease status. projected accrual: a total of 35 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of classic hodgkin's lymphoma * must have completed first-line therapy without evidence of disease progression patient characteristics: * hiv negative prior concurrent therapy: * see disease characteristics * no more than 6 months since prior chemotherapy or radiotherapy

Keywords: stage i adult hodgkin lymphoma stage ii adult hodgkin lymphoma stage iii adult hodgkin lymphoma stage iv adult hodgkin lymphoma
hypothyroidism, metabolism and food intake

Conditions: Hypothyroidism

Summary: this project has the following primary aims: to measure changes in appetite and food intake in newly diagnosed hypothyroid patients during the first six months after starting levothyroxine (l-t4) substitution therapy secondary aims are: to delineate the effect of l-t4 substitution therapy on thyroid status, body weight, body mass index (bmi), body composition, physical activity, glycaemic control, postprandial gut and pancreatic hormone responses, gastric and gall bladder emptying, resting energy expenditure (ree), quality of life (qol) and cognitive function

18 newly diagnosed hypothyroid female patients and 18 healthy controls age between 20 and 75 years will be recruited from the out-patients clinic in herlev and gentofte hospital and the general practitioners before start of substitution therapy. the study is devided in to three identical experimental days of approx. 6 hours. first experimental day placed before t4 treatment is initiated. second day as soon as thyroid stimulating hormone (tsh) is below 4 milli unit pr liter (mu/l). the third experimental day after 6 months of t4 therapy. for 5-7 days before each experimental day, the participants' physical activity energy expenditure (paee) will be monitored by an actiheart® pedometer attached to the skin of the chest. the last two days before each experimental day, the participants will follow a standardised diet following world health organization guidelines on energy requirements and nutrient composition according to gender, age and body weight shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting. visual analog score on satiety and thirst will be filled out continuously. ree will be measured by a ccm-express calorimeter, * dual energy x-ray absorptiometry (dexa)-scan * blood samples will be taken continuously during the experimental day. gall bladder size will be examined at 6 times during the experimental day using ultra sound. at the end of the day, patients´ satiety will be examined with an ad libitum meal. blood will be analysed for gastric inhibitory polypeptide (gip), glucagon-like peptide 1 (glp-1), glucagon-like peptide 2 (glp-2), glucagon, peptide tyrosine tyrosine (pyy), gastrin, cholesystokinin (cck), insulin, c-peptide, blood sugar, cholesterol, free fatty acids and paracetamol.

Eligibility criteria:
inclusion criteria: * tsh \> 10 * female exclusion criteria: * competing serious disease * male * not able to understand written and spoken danish * pregnancy * thyroidectomized patients * amiodarone treatment.

Keywords: food intake resting energy expenditure gall bladder emptying insulin response body composition
modulation of immune response by oral zinc supplementation in chemotherapy for colon cancer

Conditions: Adjuvant Chemotherapy; Colon Cancer; Immunity

Summary: in leukocytes of patients undergoing adjuvant chemotherapy for colon cancer treatment: a)identify genes modulated by oral supplementation of zinc; b) evaluate the effects of oral zinc supplementation on humoral immunity and neutrophil function. the study will be conducted on 30 adult patients aged grater than 18 years, of both genders who have undergone surgical resection of colonic neoplastic lesions without metastatic lesion. patients will be randomized into two groups, with the first (group qt zn, n = 15) receive 70 mg/d of zinc for 16 weeks and the second will receive placebo (qt placebo group, n = 15). the study will also include 30 healthy volunteers who receive supplementation of 70 mg/d of zn (c zn group, n = 15) or placebo (group c placebo, n = 15). zinc supplementation or placebo for all study groups will start two days before the volunteers received the pneumococcal vaccine, polyvalent 23. fifteen days after vaccination, patients begin chemotherapy as pre-established criteria by the oncology service. will be monitored the parameters of nutritional status (anthropometry, bioelectrical impedance, food intake, and laboratory tests) adverse effects, according to rules of the ctcae. in the evaluation of humoral immunity, antibodies opsonization and in the pneumococcal polysaccharide will be measured. will be evaluated the function of neutrophils by measuring dna nets and quantified calprotectin and elastase released in the culture supernatants of activated neutrophils. rt-qpcr will be done of genes differentially expressed(degs) on activated leukocytes. in six volunteers from each group will be analyzed global gene expression from rna extracted from leukocytes by microarray; will be detected and correlated the molecular pathways modulated by zinc by metacore software (genego). the degs will be validated by rt-qpcr.


Eligibility criteria:
inclusion criteria: * age greater than 18 years * diagnostic histopathology of colon cancer stage iii (dukes' stage c) * performance scale karnofsky greater or equal to 70% * have been subjected to resection of the primary neoplastic lesion in more than 8 weeks before start of chemotherapy * patient in the first cycle of chemotherapy in adjuvant xelox regimen. exclusion criteria: * patients with a history of autoimmune or inflammatory disease, active infectious disease, liver disease, renal failure or diabetes mellitus * patients with metastatic disease * have previously received radiotherapy or chemotherapy * use of gcsf-granulokine ® (growth-stimulating factor granulocyte) * use of immunosuppressive drugs, diuretics and supplements of zinc or copper.

Keywords: humoral immunity neutrophil function gene expression
ibuprofen lozenge in acute sore throat pain

Conditions: Acute Sore Throat Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.


Eligibility criteria:
inclusion criteria: * male or female aged at least 18 years old * patient with an acute sore throat exclusion criteria: * severe respiratory tract infection (pneumonia, bronchitis or laryngitis) * oro-pharyngeal paresthesia or mycosis * severely traumatised and/or very severe oromucosal inflammation * tonsillopharyngectomy * peritonsillar abscess * hypersensitivity to ibuprofen or other nonsteroidal anti-inflammatory drugs (nsaids) (including bronchospasm) or to excipients * long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of antiinflammatory drugs- any long-acting or slow release analgesic intake including nonsteroidal anti-inflammatory drugs (nsaids)within 24 hours before randomisation (e.g. piroxicam or naproxen) * any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation * any paracetamol intake within 6 hours before randomisation * any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation * any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation * heavy smokers (\>20 cigarettes/day)

Keywords: sore throat pain tonsillopharyngitis upper respiratory tract infection