Kornimate/medical-research-clean huggingface dataset:
assessing the effectiveness of communication therapy in the north west (the act now pilot study)

Conditions: Speech or Language Impairment Following Stroke

Summary: this study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke.

research question: this is the pilot phase of a two-phase study. phase 1 - what is the feasibility of conducting a randomised controlled trial of therapy for adults with post-stroke communication impairment? to be followed in 2006 by phase 2 - what are the effectiveness, costs and service user preferences, for the provision of speech and language therapy for communication difficulties experienced by people in hospital with a stroke? methodology: phase 1 - qualitative (focus groups \& individual interviews) and quantitative (pilot rct). phase 2 - qualitative (focus groups \& individual interviews) and quantitative (a pragmatic, multicentred, randomised controlled trial, stratified by diagnosis and therapist/centre, using an 'intention to treat' approach). discrete choice experiments will be used to determine cost effectiveness. outcome measures: the primary outcome will be functional communicative ability. the economic analysis will estimate the incremental cost effectiveness and net benefit of the intervention group compared to the control group from a societal perspective. the qualitative study will examine service users' and carers' perspectives on the process and effects of speech and language therapy or the control treatment. sample group: adults with dysarthria or aphasia, seen early after admission to hospital with a stroke. exclusions: subarachnoid haemorrhage, progressive dementia, expected recovery without therapy.

Eligibility criteria:
inclusion criteria: * adults with communication impairment following a new stroke exclusion criteria: * not fluent in the english language * subarachnoid haemorrhage * pre-existing, progressive dementia or learning disability * palliative care only or deceased since admission * resident outside the treatment area

Keywords: functional communicative ability cost effectiveness service user preferences
serological response to sars-cov-2 virus in personnel of the institut bergonié in the context of the covid-19 pandemic

Conditions: Sars-CoV2; Serum; Disease

Summary: the question of the immune response of the population, particularly of professional populations in contact with vulnerable populations (such as those with chronic conditions such as cancer), is an important issue. knowing the evolution of this response over time in this population can help answer outstanding questions. the pro-sero-cov study is a seroprevalence study of caregivers working in the hospital sector with a follow-up at 3 months and 12 months. the objective is to evaluate and monitor at 3 and 12 months the serological immune status to an infection by the sars-cov-2 virus in active volunteer professionals working at the institut bergonié with different types of exposure: healthcare professionals and professionals in other services.


Eligibility criteria:
inclusion criteria: 1. adult 18 years-old and older. 2. person in employment (on fixed-term or permanent contracts) since (at least) march 17th, 2020, the date of national implementation of containment measures in response to the covid-19 pandemic. 3. signed informed consent. 4. person affiliated to a french social security regimen in accordance with article 1121-11 of the french public health code). exclusion criteria: 1. report of known active sars-cov-2 infection within 10 days prior to the date of signing the consent. known active sars-cov-2 infection is defined as a positive result on a diagnostic rt-pcr test. 2. presence of known symptoms suggestive of covid-19 within 10 days prior to the date of signing consent: fever, fatigue, dry cough, shortness of breath, loss of taste and/or smell, headache, body aches, aches and pains, conjunctivitis or colds, digestive disorders (vomiting, diarrhea). 3. a person who is unable to follow and comply with research procedures due to geographical, social or psychological reasons. 4. pregnant or breastfeeding woman. 5. person deprived of their liberty, incapable or incapable of giving their consent.

Keywords: covid-19 health professionals serology sars-cov-2 antibodies anxiety elisa
anser clavicle pin for surgical management of midshaft clavicle fractures

Conditions: Clavicle Fracture

Summary: the goals of this multi-site study are to evaluate the union rate, patient satisfaction, and functional results of the section 510(k) approved anser clavicle pin in a prospective 50 patient clinical trial in a u.s. population.


Eligibility criteria:
inclusion criteria: * displaced midshaft clavicle fracture type 2b according to the robinson classification * skeletally mature * surgery performed within 4 weeks after trauma exclusion criteria: * not fit for surgery by the anesthesiologist * nonunion or previous malunion * possible noncompliant patients (eg, alcohol and drug addiction, dementia) * additional neurovascular injury * pathologic fractures

Keywords: clavicle fracture clavicle pin
comparison of atomoxetine and placebo in children with attention-deficit/hyperactivity disorder (adhd) and/or reading disorder (rd)

Conditions: Attention Deficit Hyperactivity Disorder; Reading Disorder

Summary: to test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type attention deficit/hyperactivity disorder (adhd), patients with only reading disorder, and patients with combined type adhd and reading disorder.


Eligibility criteria:
inclusion criteria: * clinical diagnosis with attention deficit hyperactivity disorder and/or reading disorder exclusion criteria: * patients with conduct disorder * patients who have a history of bipolar i or ii disorder, psychosis, or pervasive development disorder. * patients who have a current diagnosis of vocal tic disorder, obsessive compulsive disorder, major depressive disorder, post traumatic stress disorder, anxiety disorder, and certain other learning disorders.
beat aml core study

Conditions: Acute Myeloid Leukemia

Summary: in this study, dna sequencing, computational biology modeling, and ex vivo drug sensitivity assays will be utilized to define clinically relevant gene mutations and identify potential therapeutics for patients with acute myeloid leukemia (aml).

as part of normal clinical care, patients will undergo a peripheral blood draw and bone marrow aspiration \& biopsy. blood draws and bone marrow aspirations are performed at the time of diagnosis, after treatments , disease progression, and relapse. under normal clinical care, patient specimens are analyzed by cytogenetics (giemsa staining), fluorescence in situ hybridization (fish), and gene mutation profiling. clinically, treatment can begin before these molecular diagnostics are available. as part of this repository study, subjects are asked to: * allow access to banked blood and bone marrow specimens in irb approved protocol # 532-2012. * donate peripheral blood specimens whenever blood is already being drawn for clinical purposes such as at times of diagnosis, relapse, refractory disease or disease progression. additional samples may be requested at other standard of care visits in the event that initial samples are not viable for dna sequencing, phenotyping, or functional assays for patients with aml, if disease is present. * donate bone marrow aspirate specimens whenever bone marrow aspiration is already being done for clinical purposes such as at times of diagnosis, relapse, refractory disease or disease progression. if bone marrow aspirate is being collected for banking protocol #532-2012, then an aliquot of the banked specimen will be accessed rather than collect an additional bone marrow aspirate for this study. * undergo skin biopsy and donate the skin biopsy specimen for genomic profiling. * allow bone marrow, peripheral blood and skin biopsy specimens to be collected for genomic profiling and ex vivo drug sensitivity testing.

Eligibility criteria:
inclusion criteria: * individuals with newly diagnosed or relapsed/refractory acute myeloid leukemia (aml) as defined by world health organization 2016. * ≥ 18 years of age * capable of providing informed consent exclusion criteria: * 17 years of age or less * greater than 80 years of age

Keywords: leukemia myeloid genomics
the turkish version of the parental smartphone use management scale (psums)

Conditions: Addiction Psychological; Addiction; Adolescent

Summary: parental smartphone use management scale (psums) was originally developed in english language to parents to educate adolescents and communicate with them about online behavior and safety, as well as to conduct plans to manage adolescents' internet and smartphone use. the purpose of this study was to translate and cross-culturally adapt the psums.

parental smartphone use management scale (psums) was originally developed in english language to parents to educate adolescents and communicate with them about online behavior and safety, as well as to conduct plans to manage adolescents' internet and smartphone use. the purpose of this study was to translate and cross-culturally adapt the psums. the study will include adults who have been using smartphones for at least the past month and have children aged 11-18. for cross-cultural adaptation, two bi-lingual translators used the back-translation procedure. within a 5-to-7 day period after first assessment, the participants completed the turkish version of the parental smartphone use management scale (psums) to evaluate test-retest reliability. cronbach's alpha (α) was used to assess internal consistency. the correlations with the turkish version of the smart phone addiction scale-short form for adolescent and the turkish version of pedsql in adolescents 13-18 years old will determine to check the validity.

Eligibility criteria:
inclusion criteria: * working at istanbul university-cerrahpaşa faculty of health sciences * having children using smart phones for at least the last one month * having children between aged 11 and 18 years. * being a volunteer to participate exclusion criteria: * having any serious vision problems or cognitive impairment * having disabilities in understanding, speaking and reading turkish

Keywords: smartphone use parental management scale validation smartphone addiction
role of sirt1 in regulation of epithelial-to-mesenchymal transition in breast cancer lymph nodes metastasis

Conditions: Breast Cancer; Lymph Node Metastases

Summary: luminal a breast cancer is a kind of breast cancer with low rate lymph node metastasis and good survival. but in clinical practice, luminal a breast cancer can present with early, unexpected lymph node metastasis some time, indicates poor survival. silent information regulator 2 homolog 1 (sirt1) plays a different role in breast cancer with different molecular typing. previous study supports a role of sirt1 protein as tumor suppressor in luminal a breast cancer, in association with apoptosis-related proteins. the epithelial-to-mesenchymal transition(emt) process results in loss of cell-cell adhesion, increased cell mobility, and is crucial for enabling the metastasis of cancer cells. but no similar study in luminal a breast cancer. hence, this study will 1) investigate the expression pattern of sirt1 in primary tumor and lymph node metastasis; 2) investigate the different expression pattern of sirt1 in t2/t3 , lymph node negative tumor and t1, lymph node positive tumor; 3) investigate potential role of sirt1 enzyme in regulating cell migration and invasion in luminal a breast cancer cells.

the study has three parts. 1. in large specimens of human luminal a breast cancer with t1 tumor and positive axillary lymph node, study the difference expression of sirt1 and related p53, bcl-2, autophagy-related protein caspase-3, apaf-1 between primary tumor and lymph node metastases. collect 50 pairs of t1 primary tumors and corresponding metastatic lymph node specimens. using immunohistochemistry, anti-sirt1, p53, bcl-2, caspase-3 and apaf-1 antibody staining to identify the expression of above proteins in the primary tumor and lymph node metastases. 2. eighty patients with luminal type a breast cancer (t1n+) were enrolled in this study. at the same time,eighty patients were enrolled in the paraffin-embedded specimens of the patients with t2n+ and t3n+,too. and all patients were followed up. immunohistochemical staining with anti-sirt1, p53, bcl-2, caspase-3, apaf-1, e-cadherin, n-cadherin, vimentin antibodies to determine the relationship between above protein expression and routine clinicopathological and survival. 3. explore the involvement of sirt1 in hormone receptor-positive human breast cancer cells at the cellular level. the molecular mechanism of emt-related protein regulation, which affects the proliferation, invasion and metastasis of tumor cells.

Eligibility criteria:
inclusion criteria: * invasive breast cancer luminal a subtype t1 and lymph node positive or t2/t3 with negative lymph node exclusion criteria: * missing clinical pathology data

Keywords: luminal a breast cancer sirt 1 lymph node metastasis emt
correlation between various adipokines and vascular inflammation measured by positron emission tomography (pet) with 18f-fluoro-deoxyglucose (fdg) (18fdg-pet)

Conditions: Atherosclerosis

Summary: the inflammatory state and composition of atherosclerotic plaques are considered the main contributing factors responsible for acute cardiovascular events, rather than the degree of stenosis. recently, positron emission tomography (pet) with 18f-fluoro-deoxyglucose (fdg) has been suggested as a promising novel imaging technique to identify the inflammatory state of atherosclerotic plaque. recently, a few clinical studies showed that circulating a-fabp level had a close relation with the development of atherosclerosis in human. therefore, in the present study, the investigators examined the relationship between circulating a-fabp and vascular inflammation of carotid arteries measured using fdg-pet in healthy male subjects.


Eligibility criteria:
inclusion criteria: * healthy male volunteers for visiting routine medical check in our clinic exclusion criteria: * history of cardiovascular disease (myocardial infarction, unstable angina,stroke, or cardiovascular revascularization) * diabetes * hypertension * malignancy * severe renal or hepatic disease * subjects taking medications that might affect inflammation such as nsiad and statin

Keywords: atherosclerosis vascular inflammation adipocyte fatty acid binding protein adiponectin leptin 18fdg-pet
psychotropic-drug-induced qt prolongation and ecg monitoring in the pediatric population

Conditions: Eating Disorders; Mood Disorders in Children and Adolescents; Psychotic Disorder; QTc Intervals Changes

Summary: electrocardiogram (ecg) q-t prolongation is a cardiac electrophysiological disorder associated with the occurrence of arrhythmias potentially fatal. several psychotropic drugs are associated with an increased risk of qt prolongation, which is why in clinical practice a baseline ecg is performed before a psychotropic drug is prescribed. however, there are no validated protocols establishing when to repeat this examination or describing clinical events when this examination should be repeated in clinical follow-up. the study aims to investigate the incidence of qtc prolongation events as a side effect of chronic psychotropic drug administration. for this purpose, ecgs will be recorded and confounding factors of patients at the beginning of psychotropic therapy and after 3, 6 and 12 months will be analyzed.


Eligibility criteria:
inclusion criteria: * admitted to psychiatry ward * starting a psychotropic drug acting on qt interval exclusion criteria: * age \>18aa * history of administration of drug acting on qt interval in the 3 months prior

Keywords: qtc interval psychotropic drugs
ultrasound-guided l5 dorsal ramus block

Conditions: Pain, Back

Summary: this study will examine the accuracy of an ultrasound-guided l5 dorsal ramus block technique.

the lumbar facet joints have been implicated as a causal factor in 15 to 40% of patients suffering from chronic low back pain. because physical examination and medical imaging have limited value in determining the source of pain, diagnostic blocks play an important role in the management of this common condition. blocks of the l5 dorsal ramus (dr) are used to diagnosed pain originating from the l5-s1 facet joint, which is one of the most commonly implicated levels in patients with low back pain. fluoroscopic guidance, which uses x-rays, is currently the standard imaging modality used to perform this block. recently, ultrasound guidance has seen increasing use because of its greater accessibility and lack of ionizing radiation. although usg has been shown to provide a high level of accuracy at other levels, the greater anatomical complexity found at the l5-s1 has hindered the development of a satisfactory l5 dr block technique. in this study the investigators will use fluoroscopic control to examine the accuracy of a novel ultrasound-guided approach to this block.

Eligibility criteria:
inclusion criteria: -any consenting patient over 18 years of age with axial low back pain who requires a diagnostic l5 dorsal ramus block. exclusion criteria: * inability to consent * iodine or lidocaine allergy, * pregnancy, * coagulopathy (as defined by an inr over 1.4, platelets under 100,000, or a documented bleeding disorder) * inability to visualize lumbosacral anatomy during an ultrasound pre- scan
impact of a video explaining epidural analgesia in obstetrics

Conditions: Difficulty Processing Information

Summary: the aim of this study was to investigate the impact of multimedia information on epidural anesthesia. pregnant women were randomly assessed to get a video information in addition to an oral and written information on epidural anesthesia. maternal satisfaction concerning the quality of the information as well their anxiety and understanding of the procedure were assessed and compared in both groups.

the information in anesthesia consultation is mandatory. few studies have investigated the impact of multimedia preoperative information in terms of satisfaction, comprehension and anxiety, with conflicting results. none have evaluated the contribution of a video explaining epidural analgesia in obstetrics. this study compared two types of information given in anesthesia consultation: an oral and written information (group p) versus oral, written and video information (group v). the main objective was maternal satisfaction, the secondary objectives were understanding and anxiety. this is a common care, prospective and randomized study, conducted between september 2015 and february 2016 in the creteil intercommunal hospital center (chic) and accepted by the ethics committee paris v. after information, not opposition of women who accepted to participated was collected. oral information on epidural analgesia was provided in consultation by the anesthesiologist, with delivery of a written information sheet. the video made at chic in 2015, was transmitted, in addition, by email to patients randomized in the group v for she could look it at their convenience. satisfaction and anxiety were evaluated by numerical scale from 0 to 10 and comprehension by multiple choice questions with a final score of 10. these three criteria were also evaluated in an emergency context in which women received oral and written information (group u). evaluation questionnaires were given during the anesthesia consultation and recovered during the hospitalization after childbirth.

Eligibility criteria:
inclusion criteria: * pregnant woman * affiliated to social security system * understanding french language * internet access * \>18 years old and not subject to a measure of legal protection exclusion criteria: * contre indications to epidural * refusal to participate in the study * not affiliated with the social security system * no understanding french * no access to internet * patient minor or under legal protection

Keywords: video information satisfaction anxiety epidural analgesia comprehension delivery
the effectiveness of cancer pain management in siriraj outpatient pain clinic

Conditions: Pain, Chronic; Cancer

Summary: -background: cancer is one of the most common cause of death. cancer pain is often cited as one of the most feared in cancer patients. although, who guidelines have been provided to improve pain outcome, the results are still unsatisfied. in order to improve cancer pain management we consider to contribute a new guideline which includes interdisciplinary approach, early doing the pain interventions, breakthrough pain, education, high quality of pain assessment and contribute the effectiveness follow-up system

* objectives:primary outcome is study the effectiveness of new approach and closed follow up system by relief pain intensity 30% at 3 month up to 80% of all new cancer pain patients in opd setting secondary outcomes are quality of life (bpi,esas), side effect of treatments and the contributing factors that impact on the outcomes * study design:a prospective observational study * sample size : 150 * data collection: general information: age, gender, body weight, height, religion, residence, care giver, occupation, income, education, medical problem clinical pain information: primary diagnosis, staging, cancer site, current medications clinical assessment: at three study time points: baseline (initial assessment) and the three subsequent follow-ups (fu1, fu2 and fu3)

Eligibility criteria:
inclusion criteria: * cancer pain patients * more than 18 years old exclusion criteria: * clinical instability * cannot read and write * do not know the diagnosis
observational study of cognitive outcomes for subjects who have had prior pet amyloid imaging with florbetapir f 18 (18f-av-45)

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Summary: the primary objective of this protocol is to determine if brain amyloid imaged with florbetapir f 18 (18f-av-45) pet scans is predictive of progressive cognitive impairment during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and alzheimer's disease. hypothesis 1: the probability a subject will experience progressive cognitive impairment within 36 months of imaging will be greater in subjects whose 18f-av-45 pet scan was rated amyloid positive compared to subjects whose pet scan was rated amyloid negative. the secondary objective is to determine the stability, over 36 months of a clinical diagnosis, of ad in patients with an amyloid positive 18f-av-45 pet. hypothesis 2: the diagnosis of ad will remain unchanged in patients whose pet scan were rated as amyloid positive.

study av-45-a11 is designed to determine if brain amyloid aggregation imaged on 18f-av-45 pet scans is predictive of progression of cognitive impairment during the subsequent 36 months. approximately 180 subjects enrolled in a prior clinical study (av-45-a05\[nct00702143\]) will be offered an opportunity to be studied under this protocol. the initial visit will occur as soon as possible following the av-45-a05(nct00702143) imaging day. subjects who qualify for the study and their caregiver/partners will be contacted approximately 6,12,18,24 and 36 months after pet imaging in study av-45-a05(nct00702143), and will undergo a standardized functional and psychometric evaluation. note: this study is a clinical follow-up of subjects previously enrolled in trial 18f-av-45-a05(nct00702143). no new patients are being enrolled in this trial.

Eligibility criteria:
inclusion criteria: * all subjects who enrolled in study av-45-a05(nct00702143), received 18f-av-45, and completed a pet scan will be eligible to enroll in this trial. exclusion criteria:

Keywords: cognitive outcome 18f-av-45 pet scan amyloid pet scan florbetapir f 18 amyloid pet scan normal cognition change in cognitive status in relation to brain amyloid on pet