Kornimate/medical-research-clean huggingface dataset:
prospective study for prognostic biomarkers of nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma.

objectives: primary: evaluation of failure-free survival after three years of patients of nasopharyngeal carcinoma. secondary: evaluation of overall survival after three years of patients of nasopharyngeal carcinoma. outline: this is a multicenter observational study. tumor tissue specimens are obtained from the sun yat-sen university cancer center and affiliated hospital of guilin medical university. the samples are analyzed for biomarkers. the biomarkers are correlated with clinical outcomes (failure-free survival, overall survival, tumor response to treatment, distant metastasis, recurrence and death). the aim of the analysis is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma. this will lead to the definition of risk groups and stratification of patients and will help to precision medicine of nasopharyngeal carcinoma.

Eligibility criteria:
inclusion criteria: * patients with newly histologically confirmed nasopharyngeal carcinoma * no evidence of distant metastasis (m0) * written informed consent exclusion criteria: * treatment with palliative intent
the implementation and impact of an allergy de-labeling program in the emergency department

Conditions: Allergy Amoxicillin; Beta-lactam Allergy Labels

Summary: beta-lactams are the most common antibiotics prescribed to children, including penicillin and amoxicillin. they are usually more effective and have fewer side effects than other ty antibiotics. some children can have reactions to these antibiotics that can be mistaken as an allergy, especially rashes that develop days to weeks later. in such cases, when children take the antibiotic again, they have no problem tolerating it; this is called "delabeling an allergy" with an "oral challenge". based on our experience with a similar program among inpatients, we are implementing and evaluating an allergy delabeling program for children in the sickkids ed, with the hope and intent to delabel most children of their "allergies" using an oral challenge.


Eligibility criteria:
inclusion criteria: * all paediatric patients aged 1 month to 18 years who present to the sickkids ed with a reported bla will be eligible for the allergy history component of the study. exclusion criteria: * parent/guardian and/or patient unable to consent or assent.

Keywords: beta-lactam allergy labels pediatrics oral challenge emergency department
cabozantinib plus pembrolizumab for recurrent, persistent and/or metastatic cervical cancer

Conditions: Cervical Cancer; Recurrent Cervical Cancer; Metastatic Cervical Cancer; Persistent Cervical Cancer

Summary: drug: cabozantinib drug: pembrolizumab

this study is a multi-center, single arm, open label trial to evaluate the efficacy and safety of cabozantinib (xl184) plus pembrolizumab in recurrent, persistent and/or metastatic cervical cancer with pd-l1 tumor positivity.

Eligibility criteria:
inclusion criteria: * recurrent or persistent cervical cancer after prior systemic chemotherapy for which there is no curative intent option * documented histologic cervical cancer (acceptable histologies: squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma) * patients must have pd-l1 tumor positivity as defined as cps\>/= 1 * age greater than 18 and ecog performance status of \<= 2 * adequate organ and marrow function exclusion criteria: * prior treatment with cabozantinib or pembrolizumab * receipt of any type of small molecule kinase inhibitor * receipt of any type of cytotoxic, biologic or other systemic anticancer therapy * radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment * known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery * anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin and factor xa inhibitors) or platelet inhibitors (eg, clopidogrel) * uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: cardiovascular disorders: congestive heart failure new york heart association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias uncontrolled hypertension despite optimal antihypertensive treatment, stroke * gastrointestinal (gi) disorders including those associated with a high risk of perforation or fistula formation * clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose * active autoimmune disease requiring systemic therapy within the past 2 years * active infection requiring systemic therapy within the past month * history of immunodeficiency

Keywords: recurrent cervical cancer cervical cancer cervical carcinoma pd l1 positivity immunotherapy squamous carcinoma adenocarcinoma adenosquamous carcinoma
dengue serostatus study in the philippines

Conditions: Dengue; Severe Dengue; Dengue Fever; Virologically-confirmed Dengue

Summary: this is an observational study for 5 years, and aims to determine the risk of developing dengue among philippine children who are eligible to receive the dengue vaccine during the doh mass dengue vaccination, by dengue serostatus at baseline.

this is a cohort study that aims to determine the relative risk of developing virologically-confirmed dengue among philippine children who are eligible to receive dengue vaccine during the doh mass dengue vaccination. additionally, it also aims to determine the relative risk of developing severe and/or hospitalized virologically-confirmed dengue among philippine children who received the dengue vaccine, describe the epidemiologic trends and characteristics of virologically-confirmed dengue among these children, and assess the performance of simpler tests such as dried blood spots and serum igg for the assessment of dengue seroprevalence at the population level. we will enroll children who are residents of selected areas in region 7, philippines. children should be eligible to participate in the department of health mass dengue vaccination. they will be prospectively venipunctured for baseline dengue serologic status. the blood samples will be stored for serologic testing using neutralization tests and commercial igg tests. children in the cohort will be followed up, and those who present with \<5 days of fever will be identified and blood drawn for dengue lamp and rt-pcr.

Eligibility criteria:
inclusion criteria: * provide signed informed consent and assent (as applicable) * be a child belonging to the specified age group and resident of the targeted communities of the doh dengue mass immunization * be eligible to receive dengue vaccine during the doh dengue mass immunization in 2017 exclusion criteria: * any subject whose parent/guardian refuse to provide informed consent and/or assent * children who do not belong to the specified age groups and not residents of the targeted communities * children \<9 years old * children with history of bleeding disorder * any subject previously enrolled in a dengue vaccine clinical trial
multi-disciplinary rehabilitation program for advanced parkinson's patients in the community

Conditions: Parkinson's Disease

Summary: the present study examines the effectiveness of the rehabilitation program in the framework of the "ezra lemarpeh" project for parkinson's patients. the ezra lemarpeh association, founded by rabbi a. e. firer, provides assistance to the sick and needy. the site features a wide range of advanced, high quality rehabilitation devices, a unique hydrotherapy pool and associated accessories that enable the staff to provide the finest quality and most professional treatment. before entering a rehabilitative program, each participant will arrive independently at the ezra lemarpeh center for evaluation tests and will undergo comprehensive evaluation tests by the center's physiotherapist, including walking tests, balance tests, filling out questionnaires to assess quality of life and disease severity. at the end of the program, the participants will be asked to repeat evaluation tests.

before entering a rehabilitation program, each participant will arrive independently at the "ezra lemarpeh" center, at 24 chida st., bnei brak. after a detailed explanation of the nature of the study, the participants will sign an informed consent form. the center's physiotherapists will test walking abilities, motor functioning and abilities in activities of daily living (adl). walking tests can include walking at a comfortable pace, walking while counting (dual tasking), walking at different speeds and more. the balance tests include standing on a small base, standing on one leg, standing with eyes closed, and more. during the tests participants will wear small, non-invasive sensors at the wrists, ankles, and lower back. these sensors include an accelerometers and a gyroscopes that can be used to quantify gait measures, such as gait velocity, step length and variability. lower back sensors will be worn continuously for up to a week for everyday activity. at the end of the program, the participants will be asked to repeat evaluation tests.

Eligibility criteria:
inclusion criteria: 1. diagnosis of idiopathic parkinson's disease, as defined in the uk brain bank criteria 2. hoehn and yahr stage i-iii 3. patients who are taking anti-parkinson's drugs. 4. participants who are in a stable medication regimen during the month preceding the study and are expected to remain in a permanent regime for the next 3 months. 5. mini mental state exam (mmse) score\> 24 6. able to walk independently for at least 5 minutes with or without support. exclusion criteria: 1. any neurological condition other than pd or orthopedic disease (eg after a stroke with neurological signs, msa, parkinsonism, psp, etc.) that may impair normal walking and balance. 2. significant cognitive impairment mmse score\<24 3. any medical, surgical, and / or psychiatric condition which, in the opinion of the investigator, prevents the patient from completing all aspects of the research.
cytal® wound matrix and micromatrix® wound study

Conditions: Wounds

Summary: this is an observational study to assess the safety and efficacy of micromatrix® alone or in combination with cytal® wound matrix on primary measures of wound healing.

a single-site, prospective, observational clinical study of cytal® wound matrix alone or in combination with micromatrix® for the management of wounds. up to 100 patients with multiple wound types including but not limited to, venous ulcers, diabetic foot ulcers, trauma wounds, and external surgical wounds will be treated either with cytal® wound matrix alone or with cytal® wound matrix and micromatrix® for wounds exceeding 3mm in depth. wound healing efficacy, effect of treatment on patient-reported quality of life, complete wound management, wound-related adverse event, and wound pathology will be measured. the protocol defined patient follow-up is 12 months.

Eligibility criteria:
inclusion criteria: 1. subject has at least one wound that the treating physician determines may be treated with cytal® with or without micromatrix®. 2. subject is at least 21 years of age. 3. subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen. 4. subject or legal representative is willing to provide informed consent. 5. for females of reproductive potential, confirmed negative urine pregnancy test at enrollment. exclusion criteria: 1. allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference. 2. subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study. 3. the subject has any condition that, in the investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study. 4. the subject's wound shows evidence of infection as determined by the principal investigator (which may be indicated by the presence of: elevated wbc, pus, moderate or greater discharge, abnormal odor, or acute osteomyelitis). 5. wound with exposed organs or hardware. 6. wound with burn etiology.

Keywords: wounds acell acell micromatrix® acell cytal® wound matrix extracellular matrix urinary bladder matrix
adherence to guidelines vaccination in type 1 diabetes mellitus patients (avadi-1).

Conditions: Type 1 Diabetes Mellitus

Summary: observational study about adherence to guidelines for influenza, pneumococcal and hepatitis b vaccination in adult patients with type 1 diabetes mellitus.

cross-sectional analysis about adherence to guidelines for influenza, pneumococcal and hepatitis b vaccination in adult patients with type 1 diabetes mellitus. all clinical variables are gathered from two emr softwares (mambrino xxi and turriano). data analysis is conducted using spss (chicago, il) statistics software. results are presented as mean ± sd values or percentages. a paired student's t-test or a wilcoxon signed-rank test were used for the analysis of differences. comparisons between proportions were analyzed using a chi-squared test. a p value \< 0.05 was considered statistically significant. the protocol was approved by the reference castilla-la mancha public health institute ethic committee. all participants provided written informed consent.

Eligibility criteria:
inclusion criteria: * ≥18 years of age. * diagnosed of type 1 diabetes mellitus. * be attended in ciudad real general university hospital. exclusion criteria: * less than 18 years old. * other types of diabetes mellitus.
comparing chemoprevention approaches for school-based malaria control

Conditions: Malaria,Falciparum; Anemia in Children

Summary: this is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies arm 1: intermittent screening and treatment (ist) - students will receive treatment if they have a positive high sensitivity rapid diagnostic test (rdt). arm 2: intermittent preventive treatment (ipt) - all students will receive treatment. arm 3: control - students will receive standard of care (no preventive treatment). outcomes include p. falciparum infection and parasite density, gametocyte carriage and gametocyte density, anemia, cognitive function and educational testing, as well as infection prevalence in student's households to assess the impact on transmission.

students will be enrolled in a single primary school in machinga district, malawi. the intervention will be conducted every 6-weeks during the two school terms which coincide with peak malaria transmission. students in the ipt are and those that test positive in the ist arm will be treatment with dihydroartemisinin-piperaquine (dp) (females less than 10 years old and all males) or chloroquine (females 10 years old or older).

Eligibility criteria:
inclusion criteria: students (enrolled in the primary intervention) * currently enrolled in the study school * plan to attend the study school for the remainder of the school year * parent/guardian available to provide written informed consent household members (enrolled in the household prevalence survey) * slept in the household for most nights in the last month * age 6 months or older * for minors, parent/guardian available to provide written informed consent exclusion criteria: students (enrolled in the primary intervention) * current evidence of severe malaria or danger signs * known adverse reaction to the study drugs * history of cardiac problems or fainting * taking medications known to prolong qt * family history of prolonged qt * girls 10 years old and older with epilepsy or psoriasis household members (enrolled in the household prevalence survey) * household with more than one school-age child enrolled in the study * current evidence of severe malaria or danger signs

Keywords: malaria school chemoprevention preventive treatment screening and treatment education cognitive function adolescent hemoglobin
cognitive effects of roflumilast in (a)mci and mild dementia patients

Conditions: Mild Cognitive Impairment; Mild Dementia; Amnestic Mild Cognitive Disorder

Summary: the aim of the current project is to validate whether chronic intake (24 weeks) roflumilast (pde4 inhibitor) can improve cognition in patients with (amnestic) mild cognitive impairment (mci) and in patients with mild dementia. the project will demonstrate whether episodic memory, but also attention, information processing or executive function improves with chronic administration of roflumilast in (a)mci and mild dementia patients.


Eligibility criteria:
inclusion criteria: * 50 to 90 years of age * willingness (including the informal caregiver) to sign an informed consent * body mass index (bmi) between 18.5 and 35 * mmse of 20 or higher * clinical (amnestic)mci or mild dementia diagnosis * memory performance on the delayed recall in the clinically relevant 15 words vlt of 1 or more sd below the average * clinical dementia rating (cdr) scale total score of 0.5 or 1 * fazekas of 2 or lower exclusion criteria: * normal pressure hydrocephalus (nph) * fazekas of 3 or higher * morbus huntington * parkinson's disease * hiv/aids * hepatitis c \& b * recent transient ischemic attack (tia) (\< 2 years) * cerebrovascular accident (cva) (\< 2 years) * tia/cva followed by cognitive decline (within 3 months) * chronic obstructive pulmonary disease (copd) gold criteria 3 or 4 and severe asthma * history of schizophrenia, bipolar disorder or psychotic symptoms not otherwise specified or previous treatment for these diseases (lifetime) * current radiotherapy * current affective disorder (i.e. anxiety or major depression) * cognitive problems due to alcohol abuse, brain tumor, epilepsy, encephalitis or lack of capacity to consent to participation. * current treatment with (or illicit use of) cannabis, opiates, benzodiazepines, mdma and cocaine * patients with moderate or major liver impairments will be excluded (e.g. child-pugh b and c). * use of medication showing strong inhibition of either cyp3a4 or cyp1a2 * patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption * patients participating in other drug studies * if patient does not have the possibility to be accompanied by the same informal caregiver during all test days

Keywords: mci, amnestic mci, mild dementia
modulating pain using transcranial alternating stimulation (tacs) in healthy human subjects

Conditions: Experimental Pain in Healthy Human Subjects

Summary: pain is a highly complex and subjective phenomenon which results from the dynamic integration of sensory and contextual (i.e. cognitive, emotional, and motivational) processes. recent evidence suggests that neural oscillations and their synchronization between different brain areas might form the basis of these integrative functions. when investigating tonic experimental pain lasting for several minutes, for example, objective stimulus intensity is inversely related to alpha (8-13 hz) and beta (13-30 hz) oscillations in early somatosensory areas, while subjective pain intensity is positively associated with gamma (30-100 hz) oscillations in prefrontal cortex. yet, with a few exemptions, reported links between oscillatory brain activity and pain have mostly been established by correlative approaches which do not allow to infer causality. the current project aims at comprehensively investigating the causal role of neural oscillations for tonic experimental pain in healthy human subjects. to this end, transcranial alternating current stimulation (tacs) will be employed to modulate oscillatory brain activity in alpha and gamma frequency bands and investigate effects of this manipulation on pain perception and pain-related autonomic responses. using an established tonic pain stimulation protocol and a double-blind, sham-controlled design, effects of tacs of somatosensory as well as prefrontal brain areas will be investigated. results promise to elucidate the neural mechanisms underlying tonic experimental pain by testing the mechanistic role of neural oscillations in different aspects of pain processing. furthermore, they might contribute to the development of urgently needed new treatment approaches for chronic pain using neuromodulatory methods.


Eligibility criteria:
inclusion criteria: * aged 18-65 years * right-handedness * written informed consent exclusion criteria: * pregnancy * neurological or psychiatric diseases (e.g. epilepsy, stroke, depression, anxiety disorders) * severe general illnesses (e.g. tumors, diabetes) * skin diseases (e.g. dermatitis, psoriasis or eczema) * current or recurrent pain * regular intake of medication * surgical procedures involving the head or spinal cord * head trauma followed by impairment of consciousness * past fainting spells or syncopes * metal (except titanium) or electronic implants * side-effects following previous electrical or magnetic stimulation * side-effects following previous thermal stimulation

Keywords: pain tacs alpha gamma neural oscillations brain