Kornimate/medical-research-clean huggingface dataset:
assessment of biologic parameters in preparation for future malaria vaccine trials in don gu bougou, mali

Conditions: Malaria

Summary: there are about 300-500 million cases of malaria worldwide each year, with 2-3 million deaths. plasmodium falciparum, one of four types of malaria, is responsible for most of these deaths. because of increasing resistance of this parasite to drugs and of mosquitoes to insecticides, a vaccine would be valuable in the fight against malaria. don gu bougou, mali, is an area of seasonal malaria transmission that is being investigated as a possible suitable site for testing investigational malaria vaccines. the goal of this study is to characterize the population of this site in terms of common hematologic (blood) and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials. the study will also assess the prevalence of preexisting medical conditions that might affect assessments of vaccine safety and efficacy. also, the natural immunity to antigens in the investigational malaria vaccines will be determined. don gu bougou, mali, was chosen because of its high malaria rates. data will be collected at four time-points. at least 50 individuals will be recruited from each of the following age groups: 6 months-5 years; 6-10 years; 11-15 years; and 16-45 years. village-wide consent will be obtained and about 25 of the 111 family compounds will be randomly selected. individual consent will also be obtained. enrolled volunteers will undergo a baseline medical history and physical examination. blood will be collected for various tests, and, for women of childbearing age, urine pregnancy tests will be administered. at each of three followup visits, a brief medical history and physical exam will be conducted. blood will be drawn for tests. also, blood, urine, and/or stool tests not done at baseline will be done at one of the followup visits.

doneguebougou, mali, is an area of seasonal malaria transmission that is being investigated as a suitable site for testing investigational malaria vaccines. the overall goal of this study is to characterize the population of this site in terms of common hematologic and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials, as well as in terms of preexisting medical conditions and preexisting immunity to potential malaria vaccine antigens, both of which might impact on the assessment of vaccine safety and efficacy. the development of high quality laboratory proficiency to assess these parameters in mali will also be achieved by this study.

Eligibility criteria:
* inclusion criteria: males or females aged 6 months to 45 years. resident of doneguebougou at the start of the study, and intent to remain a resident for the duration of the study. willingness to participate in the study as evidenced by the completed informed consent document. exclusion criteria: clinical evidence of acute life-threatening illness requiring immediate medical care.

Keywords: plasmodium falciparum screening malaria
paris visual learning test: a new french task for assess visual learning and memory to multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: cognitive impairment affects up to 65% of multiple sclerosis (ms) subjects, especially memory function. rothschild foundation has developped the paris visual learning and memory test (pvlt). 165 healthy volunteers were studied for its normalization. the main objective of the present study is to assess the validity of pvlt by comparing ms patients' test results to a database including the test results of 280 healthy control subjects, following recommended international standards.


Eligibility criteria:
inclusion criteria: * multiple sclerosis * 20-89 years old exclusion criteria: * acute inflammatory stage of central nervous system (\< 1 month) * other neurological or psychiatric disease * regular drug and/or alcohol consumption * refusal to participate in the study * no health insurance coverage * patient under legal protection

Keywords: paris visual learning test visual memory criterion validity
an investigational drug for the prevention of chemotherapy-induced nausea and vomiting (mk-0869-071)

Conditions: Nausea; Vomiting; Breast Neoplasms

Summary: this protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.


Eligibility criteria:
inclusion criteria: * patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy. exclusion criteria: * patient has a central nervous system malignancy. * patient will receive radiation to the abdomen or pelvis.

Keywords: chemotherapy-induced nausea and vomiting
effect of exclusive enteral nutrition on disease process, nutritional status and gastrointestinal microbiota for chinese children with crohn's disease

Conditions: Crohn Disease; Enteral Nutrition; Gastrointestinal Microbiome

Summary: inflammatory bowel diseases (ibd) are chronic inflammatory diseases. it is believed that the inflammation results from sustained abnormal immune response towards altered or pathogenic microbiota in genetically susceptible hosts. malnutrition is common in ibd, especially in pediatric crohn's disease(cd). exclusive enteral nutrion(een) has been shown to improve nutritional status and inflammatory markers in pediatric cd. but there is limited data about the effect of een on chinese children with cd. in this study, investigators focused on disease process,nutritional status and gut microbiome of chinese children with newly-diagnosed cd after een treatment.


Eligibility criteria:
inclusion criteria: * pediatric cd patients who were newly diagnosed and being treated with een at the children's hospital of fudan university exclusion criteria: * (1) patients who were administered corticosteroids, immunosuppressive drugs, or biological agents prior to the study; (2) patients who could not finish the daily prescribed volume of formula for any reason; (3) patients who could not attend consecutive follow-up sessions; (4) patients who had received antibiotics or probiotics within 1.5 months prior to the study; and (5) patients who had been given corticosteroids, immunosuppressive drugs, biological agents, antibiotics, or probiotics during the een process.

Keywords: exclusive enteral nutrition
carvedilol for psychostimulant dependence

Conditions: Cocaine Dependence; Cocaine Withdrawal

Summary: this study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.


Eligibility criteria:
inclusion criteria: * 18-45 years old * cocaine dependence, as assessed by the substance abuse section of the structured clinical interview for dsm-iv. * at least weekly self-reported cocaine use during a preceding three month period * urine toxicology screen positive for cocaine or cocaine metabolite * women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing and not be nursing exclusion criteria: * suicide attempts within the past 12 months or suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician. * current opioid, alcohol or sedative physical dependence or amphetamine dependence. * major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, significant hypertension \[i.e., \>170 sbp or \>110 dbp\] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician. * asthma or chronic obstructive pulmonary disease. * history of schizophrenia, or bipolar type i disorder. * use of medications that would be expected to have major interaction with carvedilol (e.g., rifampin, cimetidine, digoxin, diuretics). * medical contraindication to receiving carvedilol (e.g., diabetes, severe bradycardia, bronchial asthma or other bronchospastic condition, 2nd or 3rd degree av block, sick sinus rhythm, severe hepatic impairment, documented hypersensitivity to carvedilol). * patients currently taking selective serotonin re-uptake inhibitors, antipsychotics and antidepressants (e.g., amitriptyline and imipramine). * liver function tests (i.e., liver enzymes) greater than three times normal levels. * systolic blood pressure \> 170 mmhg or \ 110 mmhg or \ 110 beats/min or \ 20mm hg systolic or 10 mm hg diastolic on standing. * participants with estimated glomerular filtration rate \< 30 ml/min. * pregnant or nursing female.

Keywords: cocaine dependence cocaine withdrawal
real-time comparison of left ventricular strokevolume measurement by four different methods

Conditions: Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously.

Summary: real-time comparison of three different bedside strokevolumemeasurements (arterial waveform analysis, eosofageal doppler and 2d transthoracal ultrasound) validated against cardiac magnetic resonance imaging (cmri)

20 healthy volounteers between age of 20-40 years, no previous medical history undergo simoultaneous left ventrikular strokevolume measurements using three different methods at rest. after datasampling and without moving, the subject then undergo cardiac magnetic resonance imaging with 2d-throughplane and cine tecnology for validation of volume measurements. the data is then analyzed using bland-altman calculation.

Eligibility criteria:
inclusion criteria:healthy volounteers age 20-40, bmi \< 30, weight \< 100 kg, no medications, sinus rythm on ecg, no contra-indications for mri, ability to give written informed consent. - exclusion criteria: * heart and/or vascular disease such as angina pectoris, arrythmias, claudicatio intermittens e g. * diseases in gastrointestinal tract or nose. * coagulopathies * pregnancy * allergys for local anaesthetics * claustrofobia

Keywords: left ventricular stroke volume arterial waveform analysis esofageal doppler ultrasound cardiac magnetic imaging limits of agreement
simplified gestational age score

Conditions: Gestational Age and Weight Conditions

Summary: a large number of mothers are uncertain of the date of their last menstrual period and where there is a high incidence of small-for-dates babies, there is a real need for a method of estimating gestational age that is both rapid and accurate for early referral and management of preterm newborns to reduce their mortality and morbidity. the national family health survey 2005-06 reports that the proportion of low birth weight babies (lbw) in india is 22%. of these lbw babies, the proportion of prematurity is not known in the survey as it is difficult to measure gestational age of the newborn due to lack of reliable and valid scores with ease of use at the primary health centers. different scores to assess maturity have been developed namely new ballard score, dubowitz score and meharban singh score. it is not known whether these scores have regional, geographical, racial or ethnic robustness. it has also been found that these scores tend to overestimate newborns \> 37 weeks and underestimate those \>32 and \< 37 weeks. the investigators conducted a cross sectional study to validate three neonatal gestational age (ga) assessment scores namely new ballard, dubowitz and meharban singh with the reference standard i.e. ga assessed by lmp using naegeles rule and validated by gestational ages also assessed by at least one ultrasound (ga-lmp), in indian newborns delivered at a tertiary hospital. the investigators derived a new "simplified gestational age score" (sgas) using the best applicable items from the three validated scores and assessed its accuracy with the reference standard (ga-lmp). this score has only 4 items (posture, skin texture, breast and genital assessment) and community health workers can be trained in implementing sgas due to its simplicity. the investigators propose a study in the gn sites to validate this simplified method of assessment of the ga using our sgas protocol.


Eligibility criteria:
inclusion criteria: * hospital delivery * live birth * correct lmp known * at least one usg of ante-natal period reporting ga available * ga by lmp and usg within one week of each other * available for examination up to 24 hours of birth * informed consent given exclusion criteria: * menstrual cycle irregular * twin babies * birth asphyxia/ baby required bag and mask ventilation * major congenital anomaly * signs of neurological depression
national survey of mental health after covid-19 outbreak

Conditions: Mental Health Impairment

Summary: the serbian national survey - acronym cov2soul.rs - has been launched to document mental health (mh) status and understand needs of the population in relation to the prolonged global public health crisis. this cross-sectional study will collect a representative national sample (18-65 years) by multi-stage probabilistic household sampling method. trained staff will conduct face-to-face diagnostic interviews (m.i.n.i.). battery of self-report instruments will be used to measure quality of life (qol), level of distress, and associated protective and harmful psychological and societal factors. the investigators aim to assess prevalence rates of mh disorders and associated qol in the nationally representative sample, to explore how mh conditions and qol vary with respect to socio-demographic variables, personality, health status and traumatic events during pandemics, and to find how these relationships depend on societal factors characterising municipalities in which they live. moreover, this study will address perception of pandemic consequences and associated distress in relation to personality and different types of possible mediators. the prevalence rates of mh disorders will be calculated as percentages of participants with a positive diagnosis. the hierarchical structure of the data will be analyzed using multilevel random coefficient modeling, cov2soul.rs will contribute to an international evidence base about prevalence rates of psychiatric conditions during different phases of the pandemic in different regions and will identify protective and harmful psychological and societal factors for mh and qol.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * speaks serbian fluently * able to give informed consent exclusion criteria: * cognitive impairment leading to a disability to understand questions * severe neurological impairment * people with impaired hearing and deaf persons

Keywords: covid-19 prevalence mental health disorders stress personality multilevel modelling national survey quality of life
bone mineral density in adults with hyperphenylalaninemia on kuvan therapy

Conditions: Hyperphenylalaninemia; Phenylketonuria

Summary: prospective study to compare the bone mineral density in adults with hpa on kuvan™ therapy to those not on therapy. the investigators hypothesize that after one year of kuvan™ therapy, there will be an improvement in their bone mineral density.

hyperphenylalaninemia (hpa) is a rare metabolic disorder caused by a deficiency of the enzyme phenylalanine hydroxylase (pah) (nih, october 16-18, 2000). elevated plasma levels of phenylalanine (phe) cause mental retardation, microcephaly, delayed speech, seizures, eczema, and behavior abnormalities. adequate control of the plasma levels of phe by a phe-restricted diet can prevent the developmental and behavioral problems. the foundation of this diet is a phe-free metabolic medical product/formula made from free amino acids. based on longitudinal studies, it has been reported that the most benefit is attained by individuals who maintain a phe-restricted diet throughout life. on december 13, 2007, kuvan™ (sapropterin dihydrochloride) was approved by the fda for the indication of reducing blood phe levels in patients with hpa due to bh4 responsive pku, in conjunction with a phe restricted diet (biomarin pharmaceutical inc., investigator's brochure march 25, 2008). studies were performed to determine a definition of response to kuvan™. in a phase 2 clinical trial in 2007, burton, et. al. defined a kuvan™ responder as having a 30% or greater improvement in blood phenylalanine levels compared to baseline after 8 days of drug therapy. kuvan™ has been shown to improve phenylalanine tolerance in some individuals with hpa. this drug enables these individuals to consume more protein from natural sources. however, there have been no research studies assessing the effects of kuvan™ along with liberalization of the diet on bone mineral density. the investigators propose a prospective study to compare the bone mineral density in adults with hpa on kuvan™ therapy to those not on therapy. the investigators hypothesize that after one year of kuvan™ therapy, there will be an improvement in their bone mineral density.

Eligibility criteria:
inclusion criteria: * diagnosis of hyperphenylalaninemia at birth * age between 18 and 50 years * participated in study hsc-ms-110-0262 exclusion criteria: * peri-menopausal and menopausal women will be excluded because this is a time of increased bone loss related to hormonal mediated factors. * patients taking bisphosphonates because it alters bone density. therefore, bone mineral density would reflect the biphosphonate intervention rather than their true status. * pregnant women due to the hazard of radiation exposure during a dxa scan. in addition women who have been pregnant or who have breastfed within one year of study enrollment will be excluded because these are periods of rapid bone loss which would not reflect the entity under study but would serve to confound the data.

Keywords: hyperphenylalaninemia phenylketonuria adults bone mineral density
icotinib as adjuvant therapy compared with standard chemotherapy in stage ii-iiia nsclc with egfr-mutation

Conditions: Non-small Cell Lung Cancer

Summary: adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. this study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage ii-iiia non-small cell lung cancer patients with egfr mutation. the primary endpoint is disease-free survival.


Eligibility criteria:
inclusion criteria: * pathologically confirmed non-small cell lung cancer after surgical resection * stage ii-iiia disease according to 7th edition of tnm staging * positive egfr gene mutation (19/21) * ecog 0-1 * at least 1-year life expectancy * adequate organ function exclusion criteria: * previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc * other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * pneumonectomy of right lung * any unresolved chronic toxicity from previous anticancer therapy * allergic to study drug
anlotinib hydrochloride versus imatinib mesylate in locally advanced, unresectable or metastatic chordoma

Conditions: Effect of Drugs; Quality of Life; Chordoma; Advanced Cancer

Summary: for local relapse not amenable to reasonable curative surgery or for those with metastatic chordoma, chemotherapy is recognised as inactive. the major study drug is the small molecular tyrosine kinase inhibitors targeted at the stem cell factor receptor (kit) and the platelet-derived growth factor receptors (pdgfra and pdgfrb), eg. imatinib. anlotinib is a novel tyrosine kinase inhibitor targeting both at vegfr-2, -3 and pdgfra and pdgfrb with high affinity, which also showed broad antitumor activity against egfr and so on. thus this multicenter, two-armed phase ii trial of pkuph-sarcoma 05 intended to investigate the efficacy and safety of anlotinib versus imatinib on advanced chordoma.


Eligibility criteria:
inclusion criteria: * 18 years and older; * histologically proven metastatic or locally advanced chordoma, reviewed by the pathology committee of peking university people's hospital; * not amenable to curative-intent surgery; * measurable with computed tomography scan or magnetic resonance imaging, per recist, version 1.1. exclusion criteria: * eastern cooperative oncology group (ecog)30 performance status more than 2 ; * life expectancy less than 12 weeks; * with severe or uncontrolled medical disorders (≥grade 2 of common terminology criteria for adverse events version 4.03 \[ctcae version 4.03\]) that could jeopardise the outcomes of the study, for example, cardiac clinical symptom or disease with lvef (left ventricular ejection fraction) \<50%, hypertension that could not be well controlled through antihypertensive drugs and so on; * weight loss of 20% or more before illness; * brain or leptomeningeal metastasis; * surgical procedure or radiotherapy within 4 weeks of enrollment; * active gastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation; * proteinuria or hematuria; * denutrition with albuminemia less than 25 g/l; * pregnant or breastfeeding status; * other malignancy, positive hbv/hcv/hiv serology; * known allergy to the experimental agents; * had ever used anti-angiogenesis tkis.

Keywords: chordoma unresectable anlotinib imatinib survival quality of life