Kornimate/medical-research-clean huggingface dataset:
comparison of antipsychotics for metabolic problems in schizophrenia or schizoaffective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the study will compare the effectiveness of antipsychotic medications for patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease.

metabolic abnormalities associated with cardiovascular morbidity and premature mortality are more common in patients with schizophrenia than in matched controls. although there is some evidence that patients with schizophrenia have intrinsic abnormalities in lipid and carbohydrate metabolism, some antipsychotics (i.e., clozapine, olanzapine, quetiapine, and risperidone) are associated with increased rates of metabolic abnormalities that predispose patients to cardiovascular disease. this is an investigator-initiated clinical trial that will be conducted at 30 research sites that are a part of the nimh schizophrenia trials network. the aims of the study are to (1) determine the relative effects of switching to aripiprazole, versus continued treatment with olanzapine, quetiapine, or risperidone, on metabolic parameters associated with cardiovascular disease, and (2) to determine the effects of switching to aripiprazole versus continued treatment with olanzapine, quetiapine, or risperidone on the clinical stability of schizophrenic illness. this study design is a multi-site, single-blind (rater) randomized controlled trial of 300 patients with schizophrenia or schizoaffective disorder comparing treatment with the following medications: olanzapine, quetiapine, risperidone, and aripiprazole. the study will enroll patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease in spite of adequate control of symptoms on their current antipsychotic medication. patients who are taking olanzapine, quetiapine, or risperidone and who have a body-mass index (bmi) greater than or equal to 27 and non-hdl cholesterol greater than or equal to 130 mg/dl will be eligible (if non-hdl is between 130-139mg/dl, ldl cholesterol must be greater than 100mg/dl). all treatments will be open label. raters will be blinded to treatment assignment. patients will be followed for up to 6 months.

Eligibility criteria:
inclusion criteria: * diagnosed with schizophrenia or schizoaffective disorder * currently treated with olanzapine, quetiapine or risperidone * bmi greater than or equal to 27 * non-hdl cholesterol greater than or equal to 130 mg/dl (if non-hdl cholesterol is between 130 - 139 mg/dl, then ldl cholesterol must be greater than 100 mg/dl). exclusion criteria: * diabetes (fbs greater than or equal to 126) or treatment with oral hypoglycemic drug or insulin * non-hdl cholesterol greater than 300 mg/dl * serum triglycerides greater than 500 mg/dl * patients in the first episode of schizophrenia or schizoaffective disorder * known hypersensitivity to aripiprazole * on weight loss medications
comparison of the efficacy and safety of sirolimus versus everolimus versus mycophenolate in kidney transplantation

Conditions: Kidney Transplant Infection

Summary: this study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus versus everolimus and tacrolimus versus mycophenolate and tacrolimus. the primary outcome is the incidence of cytomegalovirus infection / disease, a relevant medical need in the absence of pharmacological prophylaxis.


Eligibility criteria:
inclusion criteria: 1. recipients, adults of the first living or deceased donor kidney transplant; 2. patients who agreed to participate in the study and signed the informed consent form exclusion criteria: 1. receptors with a medical history of nephrotic syndrome or focal and segmental glomerulosclerosis confirmed as the etiology of end-stage renal disease; 2. receptors with poor understanding about chronic kidney disease and its treatment alternatives; 3. receptors with early history of non compliance to treatment with immunosuppressive drugs; 4. retransplantation; 5. multi-organ recipients; 6. recipients with bmi\> 30 kg / m2; 7. kdpi\> 80%; 8. cold ischemia time greater than 24 hours; 9. receptors with a percentage of anti-hla antibodies above 50%, either class i or class ii; 10. women of childbearing potential who do not undertake contraceptive methods (condoms or oral contraceptives). 11. patients receiving immunosuppressive therapy prior to transplantation, except low dose of prednisone; 12. patients with severe uncontrolled dyslipidemia; 13. patients who have a known contraindication for administration of any of the immunosuppressive drugs provided for in this study;
value of physical capacity tests in lung cancer

Conditions: Non Small Cell Lung Cancer; Small Cell Lung Cancer

Summary: the study examines the physical capacity of lung cancer patients assessed with the six minute walk test and handgrip strength. demographic and selfreported exercise behavior is registered to explore correlations to functional and physical capacity. assessments are made before first chemotherapy cycle and after fourth chemotherapy cycle, an expected average of 12 weeks between first and second assessment.


Eligibility criteria:
inclusion criteria: * non small cell lung cancer stage i-iv * small cell lung cancer * patients \>18 years * who performance status 0-2 * undergoing chemotherapy exclusion criteria: * unstable angina during the previous month * myocardial infarction diagnosed within the last month * not approval for physical activity by primary oncologist * inability to provide informed consent.
atrial fibrillation monitoring on patients with lymphoma after chemotherapy

Conditions: Atrial Fibrillation

Summary: this prospective cohort study is to investigate the incidence of atrial fibrillation after chemotherapy by aplying wearable ecg recoder and the risk factors on patients with newly diagonsed lymphoma

this prospective, single-centre, observational cohort study is disigned to enroll 100 newly diagnosed lymphoma patients who met the inclusion and exclusion criteria to monitor the onset of atrial fibrillation and other arrhythmias during chemotherapy by using wearable ecg recorder, and to evaluate the incidence of atrial fibrillation and related risk factors.

Eligibility criteria:
inclusion criteria: 1. at least 18 years old; 2. concurrent chemotherapy on patients with new-onset lymphoma: chemotherapy regimens containing anthracyclines; 3. the subject voluntarily signed the informed consent. exclusion criteria: 1. with heart failure, acute stroke or acute coronary syndrome within 3 months before admission 2. with atrial fibrillation on admission 3. patient after pacemaker surgery 4. with mental illness or mentally disabled 5. patients that the investigator considers as unsuitable for this test

Keywords: lymphoma chemotherapy atrial fibrillation
constitution of cerebrospinal fluid and blood database/specimen in acute stage of subarachnoid hemorrhage (asah) patients

Conditions: Subarachnoid Hemorrhage

Summary: neuropeptide y (npy) may play a major role in the pathophysiology of aneurysmal subarachnoid hemorrhage (asah). to investigate the correlation of npy in cerebrospinal fluid (csf) and blood (serum) and the neurological outcome in the acute stage of asah.

evaluation of neuropeptides in csf and serum in sah patients

Eligibility criteria:
inclusion criteria: * spontaneous or aneurysmal subarachnoid hemorrhage exclusion criteria: * age younger than 18 years or older than 70 years * inflammatory disease * history of former sah * no ventricular drainage

Keywords: subarachnoid hemorrhage cerebral vasospasm neuropeptide y spontaneous aneurysmal
fructosamines and gestational diabetes (fructo)

Conditions: Pregnancy; Gestational Diabetes

Summary: the prevalence of gestational diabetes is estimated at between 2 and 6%, but can be much higher in specific populations. the specific treatment of gestational diabetes (diet, control weight gain, self monitoring glucose , insulin therapy) reduces complications severe perinatal, fetal macrosomia, and preeclampsia compared with abstention therapy, without additional risk of caesarean section. several early studies have shown that the determination of fructosamine is a very bad way of diagnosis for gestational diabetes. however, few studies have investigated the relationship between the determination of serum fructosamine and put under insulin in case of gestational diabetes. the purpose of this study is to determine if serum fructosamines rate can be a predictive marker of the starting insulin at the patients suffering from gestational diabetes


Eligibility criteria:
inclusion criteria: * age ≥18 years * ongoing pregnancy with a start date of pregnancy known and confirmed by an ultrasound of the 1st quarter performed between 10 and 14 weeks with measurement of the crown-rump length * hospitalization for a gd's discovery whatever the term of pregnancy (gd is defined with nationals recommendations of cngof) * not opposed to participate in the study exclusion criteria: * pregnancy uncertain term (absence of early ultrasound) * previous diabetes to the pregnancy (type 1 or 2) * multiple pregnancy * no affiliation to a social security scheme * woman with a measure of legal protection

Keywords: gestational diabetes fructosamines insulin treatment
effect of alum stone containing mucosal adhesive patches on healing of recurrent aphthous stomatitis

Conditions: Aphthous Stomatitis, Recurrent; Aphthous Stomatitis; Aphthous Ulcer

Summary: the evaluation of recurrent aphthous stomatitis (ras) was performed by an oral medicine specialist, who relied on the clinical manifestations of the condition. the experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo patches without any active medication. size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. statistical analysis was performed with repeated measures anova using r software.

the study's results indicated that the utilization of alum stone in mucosal adhesive patches yielded significant reductions in size of aphthous lesions and degree of pain.

Eligibility criteria:
inclusion criteria: individuals who had a history of ras, with oral ulceration occurring at least once a month and persistent oral ulceration being present in the majority of patients. additionally, individuals with mild aphthous ulcer, characterized by ulcer development lasting fewer than three days, were also included. - exclusion criteria: exclusion criteria encompassed the following: pregnancy or lactation, systemic disorders linked to aphthous ulcers, such as crohn's disease, reiter's syndrome, and people who smoke or use cigarettes. participants who were getting pharmacological therapy for fungal or viral infections, as well as those who were taking non-steroidal anti-inflammatory drugs, subjects with recent oral surgery, and those with fixed orthodontic appliances or retainers near the ulcer were not recruited for the study -

Keywords: alum stone aphthous ulcer mucosal adhesive patches
emotional dysregulation in adult adhd.

Conditions: Adult ADHD

Summary: attention deficit disorder in adults with or without hyperactivity (adhd) is a common disorder, affecting around 3% of the population. adhd increases the risk of psychiatric disorders (mood disorders, sleep disorders, personality disorders, addictive behavior), risky behaviors, and vocational difficulties. emotional dysregulation (ed) constitute a major hindrance in the daily life of subjects, with a great impact on the general functioning and the quality of life of the patients. the investigators want to determine the characteristics of patients with each type of ed (impulsivity, exacerbated emotional intensity, cyclothymia, borderline personality traits), and study the stability of these traits over time. since circadian rhythms influence mood and circadian rhythms frequently occur in patients with adhd, the investigators want to determine if there is a link between ed and instability in circadian rhythms. finally, they would like to observe whether the ed evolves and according to whether or not treatment is taken


Eligibility criteria:
inclusion criteria: * male or female aged ≥ 18 years * diagnosis of adult adhd prior to inclusion * affiliated to a social health insurance * subject having dated and signed informed consent * subject having been informed of the results of the prior medical examination exclusion criteria: * mobility project preventing follow-up for 1 year (planned move) * impossibility to give the subject information enlightened (subject in emergency situation, difficulties in understanding the subject, mental retardation, illiteracy or insufficient command of the french language ...) * subject under the protection of justice * subject under guardianship or curatorship * pregnancy * breastfeeding

Keywords: cohort study emotion dysregulation questionnaires actimetry neuropsychology
evaluation of the lung microbiome in ntm bronchiectasis

Conditions: Nontuberculous Mycobacteria; Bronchiectasis

Summary: a biomarker cohort study design is proposed to study whether specific airway microbiota alterations are associated with pulmonary non-tuberculous mycobacteria (ntm) disease. in a cohort of 200 subjects suspected of having pulmonary ntm disease, the investigators will evaluate the airway microbiome using an aliquot of the induced sputum and upper airway samples. since induced sputum may reflect different regions of the upper/lower airways, the investigators will evaluate the upper and lower airway microbiome in a subgroup (case-control group) of patients using samples obtained through upper airway sampling and bronchoscopy, respectively.


Eligibility criteria:
inclusion criteria: * history of pulmonary symptoms: cough, fatigue, malaise, fever, weight loss, dyspnea, hemoptysis, or chest discomfort * imaging abnormalities (within 2 years): defined as nodular or cavitary opacities on chest radiograph, or a computed tomography scan that shows bronchiectasis or bronchial wall thickening with associated multiple small nodules. definition of ntm case: * subjects that meet inclusion criteria and have culture positivity for ntm: at least two separate expectorated induced sputum samples or from one bronchoalveolar lavage (bal) or lung biopsy definition of ntm control: * subjects that meet inclusion criteria and have less than two separate expectorated induced sputum samples culture negative or culture negative bronchoalveolar lavage (bal) or lung biopsy. exclusion criteria for cohort study (aim 1-2): * recent (\ 1 month prior) * recent smoking history exclusion criteria for bronchoscopic study (aims 3-4): * forced expiratory volume at one second (fev1) \< 70%of predicted. * significant cardiovascular disease defined as abnormal ekg, known or suspected coronary artery disease or congestive heart failure. * diabetes mellitus * significant liver or renal disease * severe coagulopathy (inr \> 1.4, partial thromboplastin time (ptt) \> 40 seconds and platelet count \< 150x103 cells). * pregnancy * ethanol (etoh) use of more than \>6 beers or \>4 mixed drinks daily * lack of capacity to provide informed consent.

Keywords: chronic obstructive pulmonary disease (copd) cavitary nodular bronchiectatic disease ntm
cardiac resynchronization and iodine meta-iodobenzylguanidine (mibg) imaging

Conditions: Congestive Heart Failure

Summary: subjects were recruited if their healthcare provider decided that they needed treatment with a special internal cardiac defibrillator (icd) called a biventricular icd. the investigators did this study to see if part of the nerve organ, called the sympathetic nervous system, may be responsible for the improvement seen in patients that receive biventricular pacing. the investigators had three ways to measure sympathetic nervous activity: 1) by using a special blood sample, 2) by monitoring heart rhythm, and 3) by performing a special heart scan.

the specific aim #1 of this study is to assess, with 123iodine metaiodobenzylguanidine (123i-mibg imaging), whether cardiac resynchronization therapy (crt) rebalances and improves the integrity and function of sympathetic nerve terminals in the failing myocardium. the study will test the hypothesis that resynchronization of biventricular contractility attenuates excessive sympathetic drive, and improves autonomic function and cardiac performance. the specific aim #2 of this study is to determine the relationship between 123i-mibg labeling of sympathetic activity and physiological measures of cardiopulmonary and autonomic function. this aim is to test the hypothesis that impaired cardiac sympathetic activity, determined by 123i-mibg imaging will be associated with poorer submaximal exercise gas exchange (higher ventilation - carbon dioxide (co2) slopes, low end tidal co2, reduced oxygen pulse and a more rapid frequency response) as well as reduced heart rate power spectral frequencies, a blunted response to positional changes and a delayed heart rate recovery.

Eligibility criteria:
inclusion criteria: indications for biv-icd implantation 1. chronic moderate to severe congestive heart failure (chf) (nyha class ii or iv) 2. left ventricular ejection fraction (lvef) of 35% or less 3. q wave, r wave and s wave (qrs complex) qrs duration of 120 ms or more 4. on optimized anti-heart failure medical regimen 5. meet one of the following indications for icd * survivors of cardiac arrest due to ventricular fibrillation (vf) or ventricular tachycardia (vt) or spontaneous sustained vt * nonsustained vt with coronary disease, prior myocardial infarction, lvef 35% or less, and inducible vf or sustained vt at electrophysiologic study * lvef of 30% or less with severe coronary artery disease exclusion criteria: 1. patient condition is unstable 2. patient is unable to give informed consent 3. not feasible for patient to be followed at mayo clinic 4. female in pregnancy and breast feeding

Keywords: cardiac resynchronization therapy
study on the predictive value of the natural calcium isotope ratio in urine and serum for the diagnosis of osteoporosis

Conditions: Osteoporosis

Summary: the study aims at investigating whether the natural calcium isotope ratio (δ44/40ca) in urine and serum differs between postmenopausal women aged 50 to 75 years suffering from osteoporosis and a healthy control group and whether δ44/40ca in urine and serum can be used for the diagnosis of osteoporosis or whether further parameters have to be included.

according to the operational definition of who in the year 1994 osteoporosis is present if bone mineral content as assessed by dxa densitometry of the lumbar spine and/or proximal femur (total area or femoral neck) deviates from the mean of a 20 to 29 years old women by at least -2.5 standard deviations (dxa t-score ≤ -2.5). this definition of osteoporosis is only valid after exclusion of other disorders, which may be associated with a reduction of bone mineral content and exclusion of osteomalacia. by an individual screening 100 women will be included in the study who are characterized concerning existing or non-existing osteoporosis according to the guidelines of dvo 2014 and iscd 2015, respectively. according to the epos study results the prevalence of osteoporosis in germany in postmenopausal women aged 50 to 60 years is about 15% and at the age of more than 70 years about 45%. in case of risk factors, such as hip fracture of father and/or mother, smoking, lactose intolerance, vegan nutrition, underweight (bmi \< 20), diabetes, intake of loop diuretics, glucocorticoids, aromatase inhibitors and proton pump inhibitors a higher prevalence can be assumed. thus by electing women with at least one risk factor of osteoporosis a higher proportion may meet the criteria of osteoporosis. since some women are expected to present with low vitamin d levels and so far are expected to present with osteomalacia, and since other exclusion criteria may occur, n = 100 women will be investigated, in order to obtain data from n = 80 women who may meet the criteria of the target group (about n = 40 with osteoporosis and about n = 40 without osteoporosis (normal control).

Eligibility criteria:
inclusion criteria: * postmenopausal women * age 50 - 75 years * fullfilling the criteria for diagnostic examination for osteoporosis incl. dxa according to dvo/zäs list 2015 * written informed consent exclusion criteria: * known fracture within the last 3 months * dxa within the last 12 month before inclusion * substitution with sex hormones * substitution with non-identified calcium supplements * vitamin d deficiency (post-hoc stratifying and exclusion from primary analysis, respectively) * hyperparathyreoidism (by history and based on calcium, phosphate and chloride in serum * known renal failure * known cancer disease * current enrollement in a clinical intervention trial * enrollement in a clinical intervention trial within the last 4 weeks * severe cognitive or psychiatric disorder * scheduled hospitalisation before the radiological examination (dxa) * legal incapacity

Keywords: risk factors calcium isotopes calcium turnover dxa
human papillomavirus (hpv) oral transmission study in partners over time

Conditions: Oropharyngeal Cancer; Human Papillomavirus

Summary: this research is being done to understand more about a sexually transmitted virus called human papillomavirus (hpv) in people with oropharyngeal cancer and their partners.

this study evaluates oral hpv infection and risk factors in people with head and neck cancer and their partners or spouses. the study focuses on oropharyngeal cancer patients and includes patients with hpv-associated and hpv-unassociated disease. a comparison group of people without cancer (controls) are also being enrolled. couples are followed longitudinally and there is a repository of study samples. it is hoped that this research will help us understand risk factors for oral hpv infection, persistence and transmission as well as researching biomarkers for hpv-associated oral cancer and survival. the study is led by dr amber d'souza (johns hopkins) and laboratory testing for the study is performed in the laboratory of study co-investigator dr maura gillison (ohio university). the study biorepository is led by dr karen anderson (arizona state). participants are being enrolled at four sites across the united states including: mt sinai (site pi dr marshall posner), johns hopkins (site pi dr sara pai), dana farber cancer institute (site pi dr robert haddad) and oregon health and science university (site pi dr neil gross).

Eligibility criteria:
inclusion criteria: * 18 years or older and incident oropharyngeal cancer exclusion criteria: * presence of medical or psychiatric condition affecting ability to give voluntary, informed consent * cancer patients with a history of organ transplant, autoimmune disorder treated with steroids or immunosuppressive drug, lymphoma, leukemia or bone marrow transplant are also ineligible (partners with these conditions are eligible)

Keywords: hpv hnscc