Kornimate/medical-research-clean huggingface dataset:
a comparison of medication augmentation and pst in the treatment of depression in older adults

Conditions: Major Depressive Disorder; Dysthymic Disorder; Depressive Disorder Not Otherwise Specified (NOS)

Summary: the purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. the first augmentation strategy is problem solving therapy (pst), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. the second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication.

depression is common in older adults, and antidepressant medication is only effective in about 60% of patients seeking treatment. the purpose of this study is to compare the effectiveness of two different augmentation strategies of antidepressant treatment for depressed older adults who have not responded to an adequate trial of antidepressant medication. the first augmentation strategy is problem solving therapy (pst), a 12-week psychotherapy treatment that has been shown to be effective in depressed older adults. the second augmentation strategy is medication augmentation, which will begin with six weeks of aripiprazole, an atypical antipsychotic medication that has also been shown to be effective in depressed older adults who have failed a trial of antidepressant medication. if patients have not remitted at the end of the 6 week aripiprazole trial, the aripiprazole will be stopped and they will be started on bupropion for the remaining 6 weeks of the study. both aripiprazole augmentation and bupropion augmentation in depressed older adults have been approved by the fda. no study has compared the effectiveness of pst and medication augmentation strategies for depressed older adults who are non-responders to an adequate trial of antidepressant medication in the current episode of their depression.

Eligibility criteria:
inclusion criteria: * ages 50-90, inclusive * current diagnosis of major depressive disorder or dysthymia * treatment with either citalopram 30/mg or duloxetine 60 mg/day (6 weeks total, with at least three weeks of treatment at that dose) * hamilton rating scale for depression (hrsd) \>= 14 * willing and able to complete np testing * willing and able to complete medical exam, ekg, blood tests, and urine screen * willing and able to give consent exclusion criteria: * meets criteria for psychotic depression * mmse score \<24 * bipolar disorder, psychotic disorder, or ocd * history of alcohol or drug dependence (excluding nicotine) within past six months * suicide attempt within past six months or hrsd item 2 score \> 2 * diagnosis of probable alzheimer's disease * diagnosis of probable vascular dementia * acute, severe, or unstable medical illness * patients in psychotherapy * diagnosis of parkinson's disease * blood glucose \>200 and/or total cholesterol \>250
the effect of neutrophil-to lymphocyte ratio in preeclampsia- eclampsia

Conditions: Preeclampsia; Eclampsia

Summary: neutrophil/lymphocyte ratio (nlr) is a marker of systemic inflammation and endothelial dysfunction. in recent years, it has been reported that the individual components of the differential white cell count, specifically the neutrophil and lymphocyte counts,may have clinical utility in predicting diseases. an elevated nlr has been shown to be a prognostic indicator in various malignancies. i̇n the literature, many studies have been shown that nlr have predictive value in determining the prognosis of various diseases (cardiac or noncardiac diseases ). however, little is known about the predictive values of nlr in pregnancy complications. this study aimed to evaluate the potential predictive value of nlr in preeclampsia- eclampsia.

in recent years, have been reported that the individual components of the differential white cell count, specifically the neutrophil and lymphocyte counts, may have clinical utility in predicting diseases. an elevated nlr has been shown to be a prognostic indicator in various malignancies. i̇n the literatüre have been shown that nlr have predictive value in determining the prognosis of various diseases (cardiac or noncardiac diseases.however, little is known about the predictive values of nlr and plr in gestational dm, preeclampsia and the other pregnancy complications. retrospective data were collected for patients who was diagnosed with , preeclampsia- eclampsia, the nlr was defined as the absolute neutrophil count divided by the absolute lymphocyte count.

Eligibility criteria:
inclusion criteria: pregnant women who developing preeclampsia eclampsia at pregnancy exclusion criteria: known chronically maternal disease multiple pregnancy older than 40 years old

Keywords: preeclampsia eclampsia prediction neutrophil-to lymphocyte ratio
be smart nis, moderate to servere asthma patient observation

Conditions: Asthma

Summary: screen for moderate to severe asthma patients with suboptimal asthma control (as defined by gina-guidelines). document current asthma control status. re-evaluate asthma therapy and document new therapy if applicable.


Eligibility criteria:
inclusion criteria: * moderate to severe asthma with suboptimal control exclusion criteria: * intermittent or mild asthma, patient with good asthma control

Keywords: asthma nis
prospective becker-heart-study

Conditions: Dilated Cardiomyopathy; Lef Ventricular Dysfunction; Heart Failure

Summary: the purpose of this study is to determine whether electrocardiogram, echocardiography, cardiac mri, sera biomarkers can improve early detection of myocardial involvement and clinical outcome.

a cohort of 100 patients with mutations in the dystrophin gene associated with becker muscular dystrophy and/or dilated cardiomyopathy will be included (patients with duchenne muscular dystrophy are excluded). patients with undergo at baseline the following workups: electrocardiogram, echocardiography, cardiac mri, sera biomarkers measurement. at 3 years and 5 years, patients will be investigated according to the same protocol and occurrence of cardiac adverse events in the meanwhile will be recorded. statistical analysis will assess correlations between cardiac phenotype and dmd mutations and prognostic value of cardiac investigations.

Eligibility criteria:
inclusion criteria: * mutation in the dmd gene * becker muscular dystrophy and/or dilated cardiomyopathy * age\>18 years * affiliation to the french medical insurance exclusion criteria: * duchenne muscular dystrophy * any other chronic disease that may be associated with heart disease
anxiety, depression and eating attitudes of diabetes mellitus patients during covid-19 lockdown in greece

Conditions: Diabetes Mellitus; SARS-CoV-2

Summary: the aim of this observational, cross-sectional study is to evaluate the impact of the second national covid-19 lockdown in greece, regarding the aspects of depression, anxiety and eating habits, in relation to the adjusted work and family conditions, among diabetes mellitus patients.

the national lockdown was an attempt by the governments around the world to prevent the spreading of the sars-cov-2. this pandemic turned out to be a major public health challenge. in greece two national lockdown were imposed in 2020, among other measures, in order to minimize the spread of the sars-cov-2. the national lockdown consists of the temporary closure of the sports arenas, theaters, cafeterias, restaurants, cinemas, archaeological sites, schools, churches universities and most of the businesses . the first national lockdown in greece was imposed from march 23th to may 4th and the second one took place from november 6th until now. such a lockdown that forces the majority of individuals to stay at home for a prolonged period of time, except the controlled movement of the individuals for some cases, could expectedly enough have quite an impact on the daily life of people with diabetes mellitus. changes to dietary habits, limitation of physical activity, as well as the psychological aspects like those of depression and anxiety have been detected. the aim of this study is to evaluate the impact of the second national lockdown in greece, regarding the aspects of depression, anxiety and eating habits, in relation to the adjusted work and family conditions, among diabetes mellitus patients.

Eligibility criteria:
inclusion criteria: * age ≥18 years * type 1 diabetes mellitus * type 2 diabetes mellitus * mody diabetes mellitus exclusion criteria: * age \<18 years * gestational diabetes

Keywords: diabetes mellitus anxiety depression eating attitudes
splenectomy as a treatment for patient with relapsed haemophagocytic lymphohistiocytosis of unknown etiology

Conditions: Hemophagocytic Lymphohistiocytosis

Summary: to evaluate the clinical value of splenectomy as a treatment for relapsed haemophagocytic lymphohistiocytosis (hlh) in patient with unknown etiology.


Eligibility criteria:
inclusion criteria: 1. patients were older than 14 years of age 2. diagnosed as hemophagocytic lymphohistiocytosis (hlh) according to hlh-2004. 3. patients were excluded with infection, rheumatic and immunologic diseases, malignant tumors (especially lymphoma), and primary hlh. 4. informed consent exclusion criteria: 1. pregnancy or lactating women 2. active bleeding of the internal organs 3. uncontrollable infection 4. contraindication of splenectomy 5. participate in other clinical research at the same time

Keywords: haemophagocytic lymphohistiocytosis splenectomy unknown etiology
post-therapeutic imaging evaluation of patients with horton's disease (giant cell arteritis) (evhortim)

Conditions: Giant Cell Arteritis

Summary: giant cell arteritis (gca), also known as horton's disease, is an inflammatory arteritis of the large and medium-sized arteries, with an estimated incidence of 17.8/100,000 in people over 50. the disease presents potential ophthalmological, neurological, cardiac and aortic vascular complications, making diagnosis an emergency in cases of suspected horton's disease. only corticosteroid therapy started as early as possible can prevent these complications. diagnosis has historically relied on temporal artery biopsy, but the recent acr/eular 2022 classification criteria propose alternatives to this invasive examination, in particular imaging tests such as temporal artery ultrasound and pet scans. although not included in these latest recommendations, high-definition wall mri can also provide arguments in favor of this diagnosis, and avoid the need for a temporal artery biopsy, the sensitivity of which is only 75%. the investigators recently demonstrated in a prospective cohort that wall mri, possibly coupled with temporal artery ultrasound or retinal angiography, was far superior to temporal artery biopsy in diagnostic performance. the main limitation of these imaging tests is the lack of data in the literature on the evolution of abnormalities over time, and in particular after initiation of oral corticosteroid therapy. this uncertainty makes it difficult to use these examinations to monitor disease activity, particularly in cases of suspected relapse, a frequent situation in which the clinician is regularly put at fault due to an often frustrating symptomatology and the possible absence of a frank biological inflammatory syndrome. the investigators propose to conduct a study aimed at describing the evolution of cranial vessel wall abnormalities on wall mri and ultrasound by systematically repeating these examinations at 1 month, 3 months from the initial mri performed at diagnosis, in addition to the follow-up performed as part of care at 6 and 12 months from diagnosis. in the event of a relapse in the intervening period, a new mri scan can be performed and compared with the most recent mri scan, to look for evidence of disease activity.


Eligibility criteria:
inclusion criteria: * patient aged 50 and over * having received informed consent to participate in the study * affiliated or beneficiary of a social insurance scheme * patients with giant cell arteritis according to acr/eular 2022 criteria * diagnosed with mri and ultrasound. exclusion criteria: * absolute or relative contraindication to mri (incompatible implantable device, claustrophobia, etc.) * hypersensitivity to gadobutrol * patient under legal protection * pregnant or breast-feeding women
national registry of veterans with amyotrophic lateral sclerosis and dna bank

Conditions: ALS

Summary: this study will identify living veterans with amyotrophic lateral sclerosis (als) through a national registry that is being developed. diagnosis of als will be verified by study neurologists via medical record review. registry participation includes a bi-annual telephone interview to collect functional status data.

primary objective: to identify as completely as possible all veterans with als and to collect data which will be available for approved studies examining the cause(s) of als. secondary objective: to provide a mechanism for the va to inform veterans with als about clinical trials and other studies for which they may be eligible. primary outcomes: identification of all living veterans with als. intervention: n/a study abstract: amyotrophic lateral sclerosis (als) is an adult-onset, rapidly fatal neuromuscular disease of unknown etiology. als is a disease of high priority to the va, particularly due to ongoing concerns about the health of veterans who served in the gulf war. efforts are needed to systematically identify and track veterans with als. accordingly, the department of veterans affairs (va) is developing a national registry of veterans diagnosed with als. research design: the registry will not be designed to test specific hypotheses but will focus on comprehensive identification of veterans with als who may be eligible for other studies. methodology: eligible participants will include all living veterans with a physician diagnosis of als. veterans with possible als will be identified through va medical records, the veterans benefits administration (vba), and self-referral. neurologists with expertise in als will review veterans' medical records to verify the diagnosis and determine eligibility. upon enrollment, veterans will be asked to complete a brief telephone interview. registry participants will also be contacted by telephone biannually to assess health and functional status. the va may notify registry participants about clinical trials for which they may be eligible. a scientific review committee will evaluate all studies that request use of registry data and/or access to registry participants. results: n/a impacts: the registry will provide the va with a valuable mechanism for involving veterans in clinical trials and other studies that may yield improved outcomes for als. in addition, data gathered as a part of the registry has the potential to benefit not only veterans, but also the larger community of individuals with als.

Eligibility criteria:
inclusion criteria: living veteran with als verified via medical record review. exclusion criteria: veteran whose medial records did not verify an als diagnosis.

Keywords: als
the effects of lateralized thermal sleepwear on sleep, skin temperature and skin moisture in menopausal women

Conditions: Menopause Related Conditions

Summary: a home-based, sham-controlled, double-blind, crossover study evaluating the effects of wearing sleepwear with lateralized thermal characteristics on subjective and objective sleep measures, proximal skin temperature, and sternal skin moisture in menopausal women complaining of sleep disturbance and vasomotor symptoms.

sixteen menopausal women who have given informed consent to participate will be medically screened to rule out physiological sleep disorders. sleep schedules will be regulated to the average bedtime of a two-week baseline sleep log. subjects will undergo two two-night, home-based monitoring phases, one an experimental and one a control condition, separated by a washout period of at least five nights. the order of conditions will be counterbalanced between subjects in double-blind fashion. in the experimental condition subjects will wear sleepwear constructed of two fabric types arranged bilaterally, with typical cotton spandex insulating material on one side and specialized conductive material on the other. in the control condition subjects will wear sleepwear that is similarly lateralized in terms of appearance but constructed with typical cotton spandex insulating material on both sides. ambulatory monitoring will include body position, eeg, actigraphy, skin temperature at multiple proximal sites, and sternal skin moisture. subjective scales of insomnia severity, menopausal symptoms and sleepwear rating will also be employed.

Eligibility criteria:
inclusion criteria: * at least 12 months since last menstrual period * subjective complaint of sleep disturbance, confirmed by pittsburgh sleep quality index score greater than 5 * subjective complaint of at least moderate symptoms of menopause, confirmed by modified kupperman score greater than 15 * ability to sleep in the left lateral, right lateral and supine positions exclusion criteria: * unable to taper off, with health care provider's agreement, hypnotic or sedative medications, hormone replacement therapy, clonidine, gabapentin, or isoflavones and other botanical compounds used to treat vasomotor symptoms of menopause * unable to taper to two or fewer caffeinated beverages per day * unable to taper to one or fewer alcoholic beverages per day * unable to taper off nicotine in any form * unable to taper off recreational drugs * subjective sleep, based on two-week sleep logs, averaging less than 4.0 or greater than 7.5 hours per night * clinical suspicion of obstructive sleep apnea, periodic leg movements or other significant physiological sleep disturbance * known skin allergy to silver, cotton, nylon, surgical tape and other adhesives

Keywords: skin temperature hot flashes sleep disturbance
a prospective observational study of the clinical performance of femplant in pakistan

Conditions: Contraception

Summary: this will be a non-comparative prospective observational study of women using femplant as a primary method of contraception in pakistan.

this will be a non-comparative prospective observational study of women using femplant as a primary method of contraception in pakistan. it will be conducted in close collaboration with the pakistan moh and marie stopes society, pakistan in several moh-affiliated and marie stopes society clinics that have experience with implants and sufficient expected flow of implant users per month. we will enroll a total of 600 women divided into two cohorts in this one-year prospective study: * a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrolment; and * a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrolment only if they have complications, medical problems, pregnancy, or want to remove the implant the main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with femplant services.

Eligibility criteria:
inclusion criteria: * to be eligible for inclusion, a woman must: * be aged 18-44 years, inclusive * be willing to sign an informed consent document * agree to return for follow-up visits * have decided to receive femplant as a method of contraception and met the clinic criteria for eligibility of this method of contraception

Keywords: femplant ae adverse event aids acquired immunodeficiency syndrome alt (sgpt) alanine aminotransferase art antiretroviral therapy ast (sgot) aspartate aminotransferase dcf data collection forms dmc data monitoring committee fda (u.s.) food and drug administration gcp good clinical practice guidelines hb sag hepatitis b surface antigen ich international conference of harmonisation ind investigational new drug application irb institutional review board iu international units mg milligram(s) mm3 cubic millimeter(s) pcr polymerase chain reaction sae serious adverse event µg microgram uln upper limit of the normal range wb western blot
hiv database (dbhiv)-establishment of a database of hiv patients

Conditions: HIV Infections

Summary: in italy, there are over 90,000 patients with hiv-1 infection on antiretroviral therapy (art). the availability of different classes of antiretroviral drugs (nucleoside and non-nucleoside reverse transcriptase inhibitors (nrtis, nnrtis), protease inhibitors (pis), integrase inhibitors (instis) and viral entry inhibitors (ies) that act in different phases of the hiv life cycle, together with careful patient management, has allowed us to obtain long-lasting therapeutic efficacy in the vast majority of italian patients, making this infection a chronic disease.the introduction of combination antiretroviral therapy (cart) has completely revolutionized the management of hiv-positive patients, drastically reducing hiv-associated mortality and morbidity. in fact, the course of hiv infection has transformed into a chronic disease, and the number of hiv-infected patients over 50 years of age has increased significantly and the number of elderly subjects is progressively increasing. furthermore, hiv infection seems to accelerate the aging process, causing immune system dysfunction, excess oxidative stress and increased inflammatory processes (inflammaging).


Eligibility criteria:
inclusion criteria: * age \>18 years * patients with chronic hiv infection (certified by a positive test for the detection of anti-hiv antibodies) * ability to sign the informed consent or signature of the declaration in lieu of consent in the case of deceased patients exclusion criteria: * lack of willingness to provide free and informed consent.