Kornimate/medical-research-clean huggingface dataset:
a study of e2020 in patients with dementia with lewy bodies (dlb), followed by a long-term extension phase

Conditions: Dementia With Lewy Bodies (DLB)

Summary: the purpose of this study is to confirm the efficacy of e2020 in patients with dementia with lewy bodies (dlb).

this 52-week study consisted of 16-week randomized placebo-controlled (rct, including 12-week confirmatory phase) and 36-week open-label extension phases. of 142 dlb patients enrolled in the rct phase (three arms: placebo, 5 mg, and 10 mg), 110 entered the extension phase. the placebo group of the rct phase initiated active treatment at week 16, and the active groups maintained allocated treatment and dosages until week 24. after week 24, all patients received 10 mg. dose reduction to 5 mg for safety concerns was allowed.

Eligibility criteria:
inclusion criteria 1. patients diagnosed as probable dementia with lewy bodies (dlb) according to the consensus diagnostic criteria for dlb 2. patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution 3. clinical dementia rating (cdr) score ≥ 0.5 4. mini-mental state examination (mmse) score of 10 to 26 exclusion criteria 1. patients diagnosed with parkinson's disease with dementia (pdd) 2. patients who received anti-dementia drug therapy at the same institution 3. patients who received anti-dementia drug therapy within 12 weeks before start of screening 4. patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency 5. patients with severe extrapyramidal disorders (hoehn and hahr staging score ≥ iv) 6. patients whose systolic blood pressure was less than 90 mmhg or pulse rate was less than 50 bpm at screening

Keywords: dlb dementia with lewy bodies lewy body disease dementia e2020 donepezil aricept
pre-exposure prophylaxis (prep) adherence intervention for women with substance use disorders

Conditions: Substance Use

Summary: the goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing prep uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. the main question it aims to answer is: • if the integrated intervention increase prep uptake and adherence compared to standard treatment participants will * receive provision of prep information through 4 counseling sessions * prevention navigation * receive nurse practitioner prescribed prep in an addiction treatment setting researchers will compare intervention group with standard treatment to see if the integrated intervention help increase prep uptake and adherence


Eligibility criteria:
inclusion criteria: * black/african american and hispanic/latina cisgender women * diagnosed with a substance use disorder (sud) per diagnostic and statistical manual of mental illnesses (dsm)-5 criteria * hiv negative * sexually active with an opposite sex partner within the past 6 months * not using prep for hiv prevention at the time of screening * able to speak, read, and write in english; and * own or have regular access to a smart phone. exclusion criteria: * be concurrently participating in another sud behavioral treatment program * unable to provide informed consent for participation (e.g., have severe cognitive impairment that would interfere with their ability to consent, understand study procedures and/or effectively participate in therapy * have psychological distress that would prohibit them from participating in the study * be unable or unwilling to meet study requirements * be ineligible for prep based on centers for disease control and prevention (cdc)-defined criteria for prep based on substance use and sexual risk * have medical contraindications for prep (e.g., known renal impairment which can be exacerbated by prep use).

Keywords: pre-exposure prophylaxis women hiv prevention
protection of ovarian function in female patients with hodgkin lymphoma

Conditions: Hodgkins Lymphoma

Summary: this study is designed to test the the protective capacity of goserelin compared with oral contraceptive


Eligibility criteria:
inclusion criteria: * advanced stage hodgkins lymphoma (histologically proven) * normal fsh-levels * written informed consent exclusion criteria: * hodgkins lymphoma as "composite lymphoma" * primary ovarial dysfunction * age \> 40
use of co2 detectors to help provide effective breaths during resuscitation of preterm newborns

Conditions: Preterm Birth

Summary: effective ventilation is the single most vital intervention to improve outcome of resuscitation in the neonatal population. assessments of effective ventilations are based on clinical parameters, but may be difficult due to inexperienced personnel as well as observer variability. end tidal co2 detectors (etco2) have been shown to improve effective ventilation in manikin model as well as in video recordings of selective infants where obstructive breaths were recognized objectively by means of lack of colour change. this is a trial evaluating the use of a qualitative end tidal co2 monitor device during mask ventilation in the delivery room. the investigators hypothesize that using a colorimetric carbon dioxide detector during mask ventilation, it could facilitate recognition of obstructed breaths and reduce the duration of bradycardia and desaturations.


Eligibility criteria:
inclusion criteria: preterm infants 24+0/7 to 32+0/7 weeks who require mask ventilation during resuscitation exclusion criteria: 1. infants with impaired pulmonary circulation (eg. cardiac arrest, pulmonary atresia, severe pulmonary stenosis 2. infants with congenital airway anomalies

Keywords: end tidal carbon dioxide mask ventilation neonatal resuscitation
plasma citrulline: a marker for monitoring & quantifying radiation-induced small bowel toxicity

Conditions: Diarrhea; Anorexia; Dyspepsia

Summary: small bowel irradiation results in epithelial cell loss and consequently impairs function and metabolism. a metabolic end product of small bowel enterocytes is plasma citrulline. the investigators evaluate the correlation between plasma citrulline level, dose-volume histogram of small bowel, and small bowel toxicity grade by common terminology criteria for adverse events version 4.0 (ctcae ver.4.0) to investigate whether citrulline can be used as a biomarker for quantifying radiation-induced epithelial cell loss.


Eligibility criteria:
inclusion criteria: * histologically confirmed cancer patients * appropriate liver, renal, and bone marrow function for radiotherapy * willing to provide informed written consent * at least 20 years old exclusion criteria: * prior abdominopelvic radiation therapy or chemotherapy or abdominal surgery * any contraindication to radiotherapy (i.e. severe connective tissue disorder, etc.) * prior or simultaneous history of other malignancy * on medication for small bowel disease or ctcae 4.0 grade 1 or higher toxicity before radiation * any treatment delay more than 1 week during radiotherapy * no radiotherapy due to any other reason except small bowel toxicity

Keywords: radiation-induced small bowel toxicity plasma citrulline
peripheral blood single cell sequencing analysis of pod and cpsp in elderly patients after total knee arthroplasty

Conditions: Postoperative Delirium; Chronic Postsurgical Pain

Summary: single-celled sequencing for evaluating differences in gene expression patterns in different cell types of the dynamics of a means of this research as a starting point, to study the postoperative delirium and chronic pain at the cellular level changes the contents of a cell, reveal its occurrence and development of the role of gene regulation, find targets and biomarkers, and to provide new ideas for its pathogenesis, to provide theoretical basis support for its prevention, clinical diagnosis and treatment.

the aim of this study was to investigate leukocyte heterogeneity in patients undergoing total knee arthroplasty with pod, paired non-pod patients, and cognitively normal healthy subjects by single cell sequencing, and to investigate leukocyte heterogeneity in patients with chronic pain and patients with pain relief after surgery through postoperative pain follow-up. moreover, multi-omics single cell technology is used to analyze various cellular contents in a single cell simultaneously, which can capture molecular footprints with higher resolution. comprehensive analysis of multiple omics datasets reveals the relationships between cellular patterns, establishes complex regulatory networks, and provides a holistic view of cellular state. from a single cell level analysis of pod and occurred in patients with chronic pain in patients with the characteristics of the white blood cells, looking for the peripheral immune system in the pathogenesis of the pod and the potential role of chronic pain occurs, may provide pod pathogenesis and chronic pain occurred an important visual angle, may also help to provide pod biomarkers and therapeutic targets, to provide a possible solution for the prevention and treatment of postoperative delirium and postoperative chronic pain.

Eligibility criteria:
inclusion criteria: * age ≥65 years old, regardless of gender. * total knee arthroplasty for the first time. * the asa classification is i-ⅲ. exclusion criteria: * severe neurological or psychiatric disorders * drug and alcohol abuse * patients on antidepressants * failure and decompensation of vital organs * chronic pain from previous surgery or trauma
systemic consequences and comorbidities in mild/moderate chronic obstructive pulmonary disease (copd), time for action!

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this prospective case-control study is to investigate the prevalence, severity and incidence of systemic consequences in newly detected patients with mild and moderate chronic obstructive pulmonary disease (copd). special attention will be paid to skeletal muscle dysfunction and physical inactivity as these factors are, together with smoking, potentially modifiable.

three groups will be included in this study: * patients with copd (cases) * patients with smoking history but no copd (smoking controls) * patients with no smoking history and no copd (non-smoking controls) an extensive test battery will be performed at baseline and after 3 years: clinical assessment (height, weight and blood pressure)\* complete pulmonary function ((post-bronchodilator)spirometry + diffusion)\* sputum induction fasting venous blood sample (fasting glucose, cholesterol, triglycerides, inflammatory markers, creatinine, nt pro bnp, hemoglobin, testosterone, vitamin d) vascular screening (arterial stiffness - arterial stenosis - cimt) muscle force (peripheral + respiratory)\* functional exercise capacity (6 mwt)\*\* maximal exercise capacity (incremental cycle test)\*\* dexa scan (osteoporosis - body composition) spiral ct scan of the chest rx thorax - rx lumbar questionnaires (mrc, ccq, sf-36, eq5d, hads, exacerbation, catz)\*\* physical activity monitoring (sensewear armband)\* \* test will be repeated every 6 months \*\* test will be repeated every year !!!! remark (26/9/2013) based on the last data analyses, in contrast to our expectations, we concluded that the two groups with a smoking history, with or without copd change in a similar way over time. the length of the study will therefore be prolonged with 3 more years (6 years in total). after 3 years the patients with a smoking history will be evaluated yearly, unless they were hospitalized for \>5 days. in that case we will sooner contact these patients in order to pick up comorbidities in these patients.!!!

Eligibility criteria:
inclusion criteria: * age 40-80 years old cases: spirometry (post-bronchodilator) based diagnosis of copd (gold criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment. smoking controls: no copd (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment. non-smoking controls: no copd (spirometry based) + \< 1 pack year exclusion criteria: * respiratory disorder other than copd * α1-antitrypsin deficiency * known history of significant inflammatory disease other than copd * copd exacerbation within 4 weeks prior to study * lung surgery * recent diagnosis of cancer * therapy with oral corticosteroids in the last 6 weeks * significant cardiovascular comorbidity * significant orthopedic/musculoskeletal problems

Keywords: copd
bone reconstruction of the skull using a metal ceramic implant after previously failed reconstruction

Conditions: Defect of Skull Ossification; Other Specified Skull or Face Bone Anomaly; Cranial Dysostosis Nec; Hemicraniectomy

Summary: the purpose of this study is to evaluate a new ceramic metal bone graft substitute for hemi craniectomies. the frequency of infections and rupture of skin will be studied, which is a reoccurring problem with currently used bone graft substitutes in this subject population. in addition, the quality of life before and after implantation will be evaluated as well as the bone regeneration around implant.


Eligibility criteria:
inclusion criteria: * obtained informed consent. * males or females, ≥18 years of age * subject with cranial defect size \> 25 cm2. * history of previous cranial implant failure and where the latest cranial reconstruction failed within 12 months. (this means that the patient demonstrates a non-reconstructed cranial defect after removal of implant or exhibit an implant failure, e.g. local infection and/or protrusion through the skin.) * willing and able to comply with all study procedures and restrictions. * the 5 subjects participating in bone regeneration analysis (pet/ct scans) has to be 50 years or older exclusion criteria: * malignancy adjacent to the reconstruction area, including brain and calvaria, with on-going or planned surgical intervention. * pregnant or nursing women. exclusion criteria during surgery, if applicable: perioperative appearance of previously not identified tumor or infection in the reconstruction area.
seroprevalence of hepatitis e in hiv positive patients in basque country in 2016 (vihvhepb)

Conditions: HIV; Hepatitis E

Summary: study of seroprevalence of hepatitis e among hiv positive patient in basque country, france in 2016.

study of seroprevalence of hepatitis e among patient followed and treated in "centre hospitalier de la côte basque" for hiv infections. study of acquisition of hepatitis e , and determination of liver status using fibrotest in co-infected patients with hepatis c and / or b.

Eligibility criteria:
inclusion criteria: * hiv positive \> 18 exclusion criteria: * patient refusal for participation

Keywords: hiv hepatitis e
an in silico trial to evaluate prospectively the performance of a radiomics algorithm for uip compared to medical doctors

Conditions: Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease; Radiomics

Summary: the purpose of this study is to compare ai performance to doctor's performance in the evaluation of ipf/uip and ilds without uip(proven by biopsy).


Eligibility criteria:
inclusion criteria: - the availability of non-contrast-enhanced hrct exclusion criteria: * the use of contrast enhancement * images containing metal or motion artifacts * images reconstructed with a slice thickness larger than 1.5 mm
vitamin b12 supplement to prevent cognitive decline

Conditions: Cognitive Decline

Summary: background: older diabetic people are at greater risk of cognitive decline than non-diabetic people. vitamin b12 deficiency in older people is associated with cognitive impairment and alzheimer's disease. vitamin b12 deficiency may therefore contribute to cognitive decline in older diabetic people. objective: to determine whether the correction of mild vitamin b12 deficiency in cognitively normal older diabetic people reduces the incidence of cognitive decline. design: randomized, double blind, placebo controlled trial subject: cognitively normal diabetic outpatients aged 70 years or older with plasma vitamin b12 150-300 pmol/l in medical and family medicine/ general outpatient clinics. procedure: after excluding those with clinical manifestations of vitamin b12 deficiency and without family member who can reliably inform on cognitive functioning (personal contact at least once a week), eligible patients will be invited to participate in this clinical trial. after obtaining written consent, research assistant (ra) will record demographic and clinical information from the subjects and perform neuropsychological tests - 1. clinical dementia rating scale (cdr), 2. neurocognitive test battery (see below) 3. chinese mini mental state examination (mmse), 4. geriatric depression scale (gds). fasting blood will be taken for serum methylmalonic acid (mma). those with cognitive impairment and significant comorbidities will be excluded. 264 eligible subjects will be randomly assigned to take either two vitamin b12 500 microgram or two identical looking placebo tablets once daily for 27 months. all subjects or family caregivers are reviewed in the research clinic every 12 weeks in which the research assistant performs a pill count and dispenses the trial tablets. at 9 monthly intervals, the subjects will have neurocognitive test battery repeated at research clinic. cdr will be repeated at month 18 and 27. at month 9 and 27, fasting serum mma and vitamin b12 will be repeated.


Eligibility criteria:
inclusion criteria: * \>/= 70 years old * b12: 150 - 300 pmol/l * caregiver (personal contact at least once a week) exclusion criteria: * dementia * peripheral neuropathy * anaemia (hb\<10 g/dl) * renal failure (creatinine \> 150 µmol/l * stroke
a study of pegasys (peginterferon alfa-2a (40kd)) in combination with adefovir or entecavir in patients with hbeag-positive chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: this 3 arm study will assess the efficacy and safety of pegasys alone, or in combination with adefovir or entecavir in patients with hbeag positive chronic hepatitis b. patients will be randomized to receive 1)pegasys 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)pegasys 180 micrograms sc weekly for 48 weeks + adefovir from weeks -4 to 2; or 3)pegasys 180 micrograms sc weekly for 48 weeks + entecavir from weeks -4 to 2. treatment will be followed by 24 weeks of treatment-free follow-up.the anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-65 years of age; * hbeag+ve for \>=3 months; * positive serum hbv dna within 3 months prior to entry; * patients with chronic hepatitis b, either naive to hbv treatment, or not responded/relapsed to nucleoside analogues; * \>=3 months treatment-free interval from nucleotide analogues. exclusion criteria: * evidence of decompensated liver disease; * history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis; * co-infection with active hepatitis a,c or d, or hiv.
rsa rct: attune rp tka versus lcs rp tka

Conditions: Osteoarthritis Arthritis; Joint Disease; Musculoskeletal Disease

Summary: the lcs complete cementless knee by depuy synthes is a rotating platform knee replacement with a good clinical track record and good survival rates. the cementless attune cruciate sacrificing (cs) rotating platform knee by depuy synthes has been designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. it is expected that the cementless attune rotating platform knee will have regulatory approval early 2016. patient inclusion will start after regular approval has been obtained. the objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes (proms) of two tkr prostheses: the cementless attune rotating platform cruciate sacrificing knee system and the lcs complete cementless cruciate sacrificing knee system (rotating platform design), both by depuy synthes, warsaw, indiana, usa. in this single-blind, randomized non-inferiority trial, 32 patients with the attune knee system and 32 patients with lcs knee system will be included. the study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for tkr surgery at the department of orthopaedics, spaarne gasthuis, hoofddorp, the netherlands. annually 300 tka procedures are performed in this department, of which about 95% is osteo arthritis (oa). the investigator anticipates that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years. main study parameters/endpoints are: * migration, measured by means of rsa. * patient reported outcome measures by means of questionnaires.


Eligibility criteria:
inclusion criteria: * patient is diagnosed with osteoarthritis and requiring primary knee arthroplasty * all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. * patient is capable of giving informed consent and expressing a willingness to comply with this study exclusion criteria: the patient has an a-priori risk for a posterior-stabilized total knee arthroplasty. * status after patellectomy * in case flexion is less than 90 degrees * the patient is unable or unwilling to sign the informed consent specific to this study * the patient does not understand the dutch or english language good enough to participate * patients indicated for revision arthroplasty * patient is diagnosed with rheumatoid arthritis * when there are not enough markers visible in the baseline rsa photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria).

Keywords: comparative study knee prosthesis prosthesis design treatment outcome follow-up studies arthroplast, replacement, knee/methods