Kornimate/medical-research-clean huggingface dataset:
diagnosis of cutaneous leishmaniasis using the cl-detect rapid test in travelers and migrants in belgium

Conditions: Cutaneous Leishmaniases

Summary: cutaneous leishmaniasis (cl) is a neglected tropical disease which is increasingly seen in travelers and migrants evaluated in travel clinics of non-endemic countries. various cl species are present in different parts of the world, and these different species vary in severity, prognosis and therapeutic approaches. at itm, diagnosis of cl in suspected patients is done using a skin biopsy, analyzed by diagnostic pcr, and species typing pcr. this method is invasive, and diagnosis is often delayed for days to weeks. the new antigen-based cl detect rapid test uses dental broach sampling and has results within 30 minutes. dental broach samples left over from the cl detect rapid test may still be used for pcr including species typing. how well the cl detect rapid test performs in the varied population of a travel clinic and whether it is possible to use dental broach sampling for further pcr tests in this population needs to be evaluated the aim of this study is to study the performance of the cl detect rapid test and whether dental broach sampling can replace skin biopsy for cl at itm.


Eligibility criteria:
inclusion criteria: * skin biopsy for leishmania test requested by treating itm clinician or * externally requested skin biopsy for leishmania tested at itm with an itm consultation \<7 days of the biopsy sample * willing and able to provide consent/assent * not on cl treatment
cervical ca pros in clinical practice

Conditions: Cervical Cancer; Radiation Therapy

Summary: concurrent chemo-radiotherapy followed by intracavitary brachytherapy is standard of care for patients with locally advanced cervical cancer. although curative, this treatment is challenging and leaves a significant proportion of women with severe toxicity, negatively impacting their quality of life. although most recover over time, a proportion of women do not. therefore, evaluation of quality of life becomes increasingly more important as cancer specific outcomes improve. one such method is through patient-reported outcomes (pros), defined as "any report coming directly from the patient about a health condition and its treatment." this prospective multi-institutional study, involving the princess margaret (pm), odette regional cancer centre(orcc) and royal victoria regional health center (rvh), will assess to feasibility and acceptability of integrating a cervical cancer specific pro measurement tool into clinical practice. cervical cancer patients coming for follow-up appointments will be asked to complete the eortc qlq-cx24, a validated cervical cancer specific pro questionnaire. at the end of the study period, feedback forms will be completed by participating patients and health care providers to obtain their perspectives regarding the feasibility and acceptability of incorporating the instrument into clinical practice. future directions include designing an electronic platform and expanding its use in cervical cancer clinics provincially and nationally. the data collected should help identify disease-related symptoms, treatment-related toxicities, facilitate patient-physician communication, shared treatment planning and target intervention strategies.


Eligibility criteria:
patient inclusion criteria: 1. adult (\> 18 years) english speaking patients 2. treated with curative intent with chemo-radiotherapy 3. seen in routine clinic follow-up within 5 years post completion of treatment patient exclusion criteria: 1. patients at their anticipated last clinic visit prior to cancer center discharge 2. patients unable to complete the eortc qlq cx-24 questionnaire due to inability to read or write. 3. non-english speaking patients 4. patients of the principal investigator. the rationale for this is that patients of the principal investigator who complete the feedback form may be biased and this may be reflected in the results. oncologist inclusion criteria: 1. oncologists who treat cervix cancer 2. oncologists with at least one consenting patient enrolled in the study oncologist exclusion criteria: 1) principal investigator listed on the protocol. the rationale for this is that oncologists who are also investigators on this study may have inherent bias in the study which may be reflected in the results of the feedback form.

Keywords: cervical cancer patient reported outcomes radiation therapy eortc qlq-cx24 quality of life
the mda test to differentiate of benign and malignant pulmonary nodules

Conditions: Pulmonary Nodule, Solitary

Summary: * the purpose of the study is the identification of the efficacy of mda test to differentiate of benign and malignant pulmonary nodules. * in this study, the investigators are going to validate the efficacy of the mda test for diagnosing early lung cancer by comparing results of the pre-surgery mda test with the post-surgery pathology.

* current state-of-the-art lung cancer early screening utilizes low-dose ct scan to identify lung nodules smaller than 3 cm in diameter. however, it's still a clinical challenge to differentiate between malignant and benign nodules. * this study is being conducted to evaluate the efficacy of the mda test to detect targeted chromosomal aberrations in circulating abnormal cells by fish analysis that might be an early indicator of lung cancer. approximately 200 pre-surgery adult patients with single pulmonary nodule found by ct scan, will be enrolled in the study. the sample type of mda test is peripheral blood. this study will compare the results of the pre-surgery mda test with the post-surgery pathology to determine if the test can detect lung cancer or the lack of lung cancer . * the results of the test will not be provided to the subject, the investigator and will not be used to diagnose or treat the subject.

Eligibility criteria:
inclusion criteria: * 18 years old or above * single pulmonary nodule found by ct scan. * the diameter of the pulmonary nodule is between 5mm to 30mm. * plan to accept pneumonectomy due to the pulmonary nodule. * agree to sign informed consent exclusion criteria: * fail to understand or agree to sign informed consent. * pregnant or lactating women. * the diameter of the pulmonary nodule is more than 30mm. * there are 2 or more pulmonary nodules in one single patient.

Keywords: pulmonary nodule
randomised study comparing different dosages of rabbit atg in patients with saa

Conditions: Acquired Aplastic Anemia.

Summary: the objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (ist) using rabbit anti-thymocyte globulin (atg) (thymoglobuline, genzyme) for patients with very severe aplastic anemia (vsaa) and severe aplastic anemia (saa) as a primary therapy. the primary endpoint is the response rate (complete response (cr) + partial response (pr)) at day 180 after the start of ist. secondary endpoints include evaluation of the presence and frequency of epstein-barr virus (ebv)-reactivation and ebv-associated lymphoproliferative disorder (ebv-lpd), cytomegalovirus(cmv)-reactivation and cmv associated diseases, the response rate (cr+pr) on day 360 after the start of ist, relapse rate and overall survival.


Eligibility criteria:
inclusion criteria: * acquired aplastic anemia * age: younger than 70 years old * severity: saa, vsaa. * interval between diagnosis and registration \<6 months. * written informed consent from the caretakers and/or whenever possible consent from the patient. exclusion criteria: -
an observational study of type ii diabetics treated with dual therapy with or without sitagliptin (januvia®/xelevia®, mk-0431-201)

Conditions: Type 2 Diabetes Mellitus

Summary: this is an observational study to compare the effectiveness of dual therapy of type ii diabetes mellitus with metformin + sitagliptin versus metformin + a sulfonylurea in routine clinical practice in france.


Eligibility criteria:
inclusion criteria: * type 2 diabetes participants * de novo treatment (first prescription or dated within the past 8 weeks) with: * metformin + sitagliptin dual therapy, * metformin + sulfonylurea dual therapy, * sitagliptin as part of another treatment regimen * participants also eligible for treatment with sitagliptin (januvia®/xelevia®) or a sulfonylurea.
roasted pulse snacks, post-prandial food intake, appetite, and glycemia

Conditions: Normal Weight; Overweight; Normoglycemic

Summary: an investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety response in healthy young adults.

an acute, randomized, controlled cross-over trial examining the post-prandial glycemic and satiety response to six snacks will be conducted. the study treatments are: 1) roasted corn nuts, 2) roasted chickpeas, 3) roasted yellow peas, 4) roasted pinto beans 5) roasted soybeans, and 6) roasted almonds. they will be matched for calorie content and provided in 200 kcal servings.

Eligibility criteria:
inclusion criteria: * bmi: ≥18.5 and ≤29.9 kg/m2 * fasting serum glucose: ≤5.5 mmol/l exclusion criteria: * fasting serum glucose \> 5.5 mmol/l * smoking * thyroid problems * previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease * presence of a gastrointestinal disorder or surgeries within the past year * consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgment * known to be pregnant or lactating * known intolerance, sensitivity or allergy to any ingredients in the study products. * extreme dietary habits (i.e. atkins diet, very high protein diets, etc.) * uncontrolled hypertension (systolic blood pressure ≥140 mm hg or diastolic blood pressure ≥90 mm hg) * weight gain or loss of at least 10lbs in previous three months * excessive alcohol intake * restrained eaters (identified by eating habits questionnaire)
immunoadsorption versus plasma exchange for treatment of guillain-barré syndrome (gbs)

Conditions: GBS

Summary: this is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in guillain-barré syndrome.


Eligibility criteria:
inclusion criteria: * diagnosis of guillain-barré syndrome according to the diagnostic criteria proposed by doorn et al. (clinical features, pathogenesis, and treatment of guillain-barré syndrome, lancet neurology 2008) * age 18 years or above exclusion criteria: * clinical or laboratory (c-reactive protein 20 mg/l or above, or evidence of nitrite-positive urinary tract infection) evidence of manifest systemic infection * intake of angiotensin converting enzyme inhibitor within1 weeks before first treatment * other contraindications against immunoadsorption or plasma exchange
reducing readmission for frail elderly patients with decompensated heart failure

Conditions: Heart Failure; Acute Decompensated Heart Failure; Fragility; Emergencies

Summary: a randomized study designed to determine whether telephone based interventions can prevent return hospital visits for elderly and frail patients with acute symptoms of heart failure. specifically, the intervention will improve patients ability to monitor and address self care of heart failure at home.

acute decompensated heart failure (adhf) is a common illness in canadian emergency departments (ed). the frail subset of elderly patients with adhf is challenging to treat, use a large proportion of available resources, and are at higher risk for complications, including readmission to hospital after discharge. the investigators believe that by improving access to follow-up, optimizing self-care, and addressing the various cognitive and physical limitations of frailty, it will be possible to improve quality of life and reduce readmission rates for frail patients with adhf.

Eligibility criteria:
inclusion criteria: * patients who presented to the ed and who are being discharged with a primary or secondary diagnosis of adhf * age ≥ 65 * frailty, defined as a frail score \>=3/5 or clinical frailty scale (cfs) score \>=5/9 * informed consent provided by the patient or proxy exclusion criteria: * significant dementia or active delirium * severe frailty, defined as a cfs score \>=8/9 * prohibitive language barrier * primary address outside of quebec * patient deemed to be palliative or moribund by treating team

Keywords: acute decompensated heart failure heart failure frailty geriatrics self-care emergency medicine cardiology patient oriented research
investigation of safety and pharmacokinetics following a single oral dose of 300 mg maraviroc in healthy male japanese volunteers

Conditions: Human Immunodeficiency Virus (HIV) Infection

Summary: to confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male japanese volunteers.


Eligibility criteria:
inclusion criteria: * healthy male japanese subjects between the ages of 21 and 50 years inclusive. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * positive result for hiv, hepatitis b surface antigen (hbsag) or hcv antibody. * hypersensitivity/allergic reactions to any component of maraviroc, including soy lecithin.

Keywords: pharmacokinetics, japanese, healthy volunteer, maraviroc
intermittent preventive treatment during pregnancy in benin

Conditions: Malaria

Summary: malaria in pregnancy is one of the most important preventable causes of low birthweight worlwide and a major cause of severe maternal anaemia contributing to maternal mortality. intermittent preventive treatment (ipt) with sulfadoxine-pyrimethamine (sp) is the currently adopted government recommendation for malaria control during pregnancy in benin, but the emergence and the spread of resistance to sp justifies the evaluation of alternative anti-malarial drugs. mefloquine (mq), which has been proven effective and reasonably safe in this indication, may be an interesting alternative to sp. the aim of this trial is to compare the efficacy and safety of sulfadoxine-pyrimethamine and mefloquine for ipt. it is an equivalent study designed to test the hypothesis that mq is as efficacious as sp to prevent malaria in pregnancy, and that it could replace sp when resistance of plasmodium falciparum becomes too elevated. primary endpoint will be the proportion of infants with low birthweight. secondary endpoints will be the proportion of mothers with placental plasmodial infection, and the proportion of mothers with anaemia at delivery.

the trial will be conducted in two maternity clinics in ouidah, 40km from cotonou. a total of 1600 women will be selected and randomised to receive either sp (1500 mg sulfadoxine with 75 mg pyrimethamine) or mq (15 mg/kg) twice during pregnancy at ante-natal clinic (anc) visits. the first dose will be given between 16 and 28 weeks of gestation, the second between 30 and 36 weeks, and at least one month after the first dose. women will be visited at home within one week after the initial and subsequent anc visits to check for adverse reactions due to the study drugs. peripheral blood samples will be collected on each anc visit to assess for haemoglobin level and parasitemia. peripheral, placental, and cord blood samples will be collected at delivery for haematological determinations and parasitological examination. birthweight will be recorded and the gestational age assessed by the ballard method. the mother and her child will be assessed for general health status six weeks after birth.

Eligibility criteria:
inclusion criteria: * pregnancy between 16 and 28 weeks of gestation * residence near the maternity clinics * intention to continue the ante-natal care and deliver at the study maternity clinic * ability to take drugs by oral route * written informed consent (parents or guardian if aged \< 18 years) exclusion criteria: * pregnancy prior to 16 weeks or after 28 weeks of gestation * previous suspected reaction to sulfadoxine-pyrimethamine or mefloquine * history of neurological or psychiatric event * intake of sulfadoxine-pyrimethamine or mefloquine within 4 weeks of enrollment * current treatment with halofantrine

Keywords: malaria prevention pregnancy low birthweight anemia africa
study evaluating a 13-valent pneumococcal conjugate vaccine in preterm compared to term infants.

Conditions: 13-valent Pneumococcal Vaccine; Premature Birth; Immunization; Safety

Summary: the purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.there will be a follow-up phase to assess the persistence of the antibody response at 24 and 36 months of age.


Eligibility criteria:
inclusion criteria: * healthy infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment. exclusion criteria: * previous vaccination with pneumococcal vaccine,haemophilus influenzae type b (hib) conjugate vaccine, meningococcal type c conjugate vaccine, or diphtheria, tetanus, pertussis, or poliovirus vaccines. * previous anaphylactic reaction or allergy to any vaccine * contraindication to vaccination * known or suspected immune deficiency or immune suppression * major known congenital malformation or serious chronic disorder * significant neurological disorder * participation to another study

Keywords: 13-valent pneumococcal conjugate vaccine premature immunization safety.
description of clinical anatomical features and long term follow-up for patients with alk rearrangements

Conditions: Non-small Cell Lung Cancer; Anaplastic Lymphoma Kinase Gene Mutation

Summary: description of clinical and anatomical features and long-term follow-up for patients with alk rearrangement and treated by crizotinib

several french studies on crizotinib have been conducted in recent years. these are not only patients treated in the profile 1005 and 1007 clinical studies but also patients who have been treated with crizotinib in the named patient atu followed by the cohort atu (expended access cohort). under the atu program and according to atu regulations, a limited set of data is collected and furthermore the follow up is stopped as soon as the atu program closes. thus it is not possible to have access to long term data and post progression data. our project is to collect data from the patients from the atu program (named patient and cohort) and if possible patients treated after the marketing of crizotinib, before, during and after crizotinib therapy. centers selected for this observational study will be those of the ifct network that took part in the atu program. this will allow an accurate analysis of crizotinib therapy under "real life" conditions. it should be emphasized that this information is generally neither available from clinical trials nor from atu programs.

Eligibility criteria:
inclusion criteria: * patient must have locally advanced or metastatic nsclc (stage iiib or stage iv by ajcc 7th.) with positive alk determined by ihc and/or fish. * patient who received crizotinib on an expanded access basis (compassionate use) (atu) due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable * patient who received marketed crizotinib as a result of the standard care of metastatic nsclc (stage iiib or stage iv by ajcc 7th.) with positive alk will also be eligible. * patient was able to swallow capsules and had no surgical or anatomical condition that precluded the patient from swallowing and absorbing oral medications on an ongoing basis. * patient has taken at least 1 week of treatment exclusion criteria: * patient included in a crizotinib clinical trial * patient with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

Keywords: non-squamous non-small cell lung cancer crizotinib real-world study ifct
transdermal nicotine replacement in smokers with acute aneurysmal subarachnoid hemorrhage

Conditions: Aneurysmal Subarachnoid Hemorrhage

Summary: all patients with acute aneurysmal hemorrhage are treated in accordance with our institutional protocol. after securing of the aneurysm, some smokers with acute aneurysmal hemorrhage are randomly assigned to transdermal nicotine replacement (nrt). the short- and long-term effect of nrt will be studied comparing non-smokers, smokers without nrt and smokers with nrt.

various aspects of the study: * study cerebral circulation with transcranial doppler ultrasonography (tcd) prior to and after nrt. * study cardiac output and peripheral vessel resistance minimally invasive (lidco) prior to and after nrt in patients that already have established lidco. * monitor intracranial pressure prior to and after nrt in patients that have established an intracranial pressure sensor. * register the frequency of cerebral vasospasm and complications in non-smokers, smokers without nrt, and smokers with nrt. * register the use of opioids, opioidanesthetics, propofol og psycholeptics in non-smokers, smokers without nrt, and smokers with nrt.

Eligibility criteria:
inclusion criteria: * aneurysmal subarachnoid hemorrhage after securing of the aneurysm and surviving the first 2 weeks. exclusion criteria: * manifest cerebral vasospasm at arrival at our department (i.e. before securing of the aneurysm)

Keywords: aneurysm nicotine replacement therapy cerebral vasospasm outcome
mtbi identification and monitoring through retinal scanning

Conditions: Brain Injuries, Traumatic

Summary: rebion has developed a device, the rebion trauma tool (referred to as the head and intraocular trauma tool, or "hitt"), that detects ocular fixation and alignment using a binocular retinal scan. preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (tbi) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. this study seeks to evaluate the ability of the rebion trauma tool to assess perturbations in eye movements resulting from tbi. the study will enroll 60 tbi patients and 20 controls.


Eligibility criteria:
inclusion criteria: 1. age 18-45 years 2. presents to the facility within 2 weeks of head trauma 3. able to provide informed consent * if minor, then able to provide parental consent and minor consent 4. able to participate in the examination, including the ability to follow simple instructions 5. fluency in english or spanish exclusion criteria: 1. glasgow coma scale score equal to or less than 13 at the time of study enrollment 2. under the influence of alcohol or drugs 3. previous eye surgery 4. visual acuity known to be 20/200 or less in either eye 5. known strabismus, amblyopia (lazy eye), or double vision 6. known eye movement disorder, including nystagmus 7. known optic nerve disease, including papilledema or optic neuropathy 8. known retinal disease, including macular degeneration or retinal degeneration 9. known cataract 10. history of neurosurgery 11. history of stroke/brain hemorrhage, brain tumor, or epilepsy 12. any head trauma requiring medical attention from a physician within the last 6 months 13. diagnosed dementia or cognitive impairment requiring assistance for daily living 14. other condition(s) under the care of a neurologist 15. psychiatric hospitalization in the last 90 days 16. subject considered unsuitable for participation in this clinical trial by pi, treating clinician, or study research staff 17. any minor brain injury regardless of loss of consciousness