Kornimate/medical-research-clean huggingface dataset:
multidisciplinary and personalized care of behavioral disorders in frontotemporal lobar degeneration.

Conditions: Frontotemporal Lobar Degeneration

Summary: fronto-temporal lobar degeneration (ftld) refers to 3 categories of neurodegenerative diseases generally occurring between 55 and 65 years: fronto-temporal dementia(ftd), primary progressive aphasia (ppa), semantic dementia (sd). clinical expression is substantially variable among individuals, but in most cases, behavioural disorders and personality changes are prominent. ftld is poorly known by general public including health care professionals. currently, the french health system does not meet the needs and expectations of patients and their families

patients with ftld and their caregivers need to be recognized and supported through specific and tailored made actions provided by expert teams. the main objective of our study is to evaluate the effectiveness of a 6-month personalized multidisciplinary care provided to the dyad ftld patient and caregiver on patient's behavioural disorders. the secondary objectives are to assess the impact of this program on patient's cognitive deterioration, functional autonomy and behavioral problems, as well as caregiver's depressive symptomatology and sense of competence

Eligibility criteria:
inclusion criteria: patients * fronto-temporal lobar degeneration diagnoses * men or women aged 18 and over caregiver • spouse, brother, sister, child living at patient's home and can provide the medical team of reliable information on the status of their parent. exclusion criteria : patient * patient institutionalized * pregnant or breast-feeding woman * psychotic syndrome * severe and unstable general medical condition * patient bedridden caregiver * persons under legal protection * severe and unstable general medical condition * pregnant or breast-feeding woman

Keywords: frontotemporal lobar degeneration behavioral disorders
preserve-zenith® branch endovascular graft-iliac bifurcation

Conditions: Aortoiliac Aneurysms; Iliac Aneurysms

Summary: the purpose of this extended study is to collect confirmatory safety and effectiveness data on the zenith® branch endovascular graft-iliac bifurcation in combination with the commercially available atrium icast™ covered stent in the treatment of aortoiliac and iliac aneurysms.


Eligibility criteria:
inclusion criteria: * an aortoiliac or iliac aneurysm of appropriate size * unsuitable distal sealing site for a traditional zenith® iliac leg graft within the common iliac artery exclusion criteria: * less than 18 years of age * inability or refusal to give informed consent * disease considerations that would compromise patient safety or study outcomes * unsuitable arterial anatomy

Keywords: zenith aortoiliac aneurysm iliac aneurysm branch connections endovascular graft graft-iliac bifurcation aneurysm vascular diseases cardiovascular diseases
the ahead study: monitoring anticoagulated patients who suffer head injury

Conditions: Craniocerebral Trauma; Head Injuries, Closed

Summary: existing practice in emergency departments (ed) in the united kingdom (uk) for managing patients taking warfarin after a blunt head injury is variable with little research that supports the most appropriate way to manage these patients. the investigators aimed to undertake research in order to understand the range and frequency of outcomes following head injury in this group of patients and to develop robust clinical guidance for how they should be optimally managed in the future.

this prospective observational study aims to enrol patients taking warfarin that attend participating ed's (up to 33) in england and scotland after blunt head injury. over an 18-month period from oct 2011, ed attendance data will be collected from each ed as well as information from patient questionnaires about the care the patient received and the status of their health 6-10 weeks after the injury. patients who died due to their head injury, experienced surgery due to their injury, had a change identified on a ct scan or re-attended the ed with a clear head injury complication are defined as experiencing a poor outcome. information such as the patients' conscious state (gcs), level of clotting in their blood (inr) and symptoms will be investigated as predictors of a poor outcome. a mathematical model will be used to estimate the most cost-effective strategy assuming published national institute for health and care excellence (nice) thresholds for cost per quality adjusted life year (qaly).

Eligibility criteria:
inclusion criteria: * 16 years or older * blunt head trauma above the neck within 24 hours of ed attendance * prescribed warfarin exclusion criteria: * penetrating injuries to the head, for example knife wound.

Keywords: warfarin
efficacy and safety of metformin and liraglutide in obese subjects with type 2 diabetes previously treated with an oral hypoglycemic agent

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of nnc 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (oha).


Eligibility criteria:
inclusion criteria: * type 2 diabetic * treated with oha (oral hypoglycaemic agent monotherapy for at least 3 months. prior use of metformin is allowed * body mass index (bmi) between 27.0-42.0 kg/m\^2 (inclusive) * hba1c maximum 10% based on analysis from central laboratory exclusion criteria: * cardiac problems * uncontrolled treated/untreated hypertension * proliferative retinopathy or known autonomic neuropathy * recurrent severe hypoglycemia as judged by the investigator * known or suspected allergy to trial product or related products * use of any drug (except for ohas), which in the investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). stable doses, for 3 months or greater, of thyroid hormone replacement are allowed * known or suspected abuse of alcohol or narcotics * current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness * tsh (thyroid stimulating hormone) below 0.2 or above 15 u/ml * type 1 or other specific causes of diabetes
effect of food and antacid on biib021 with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this study is designed to assess the effect of food and antacid use on the pharmacokinetic properties of biib021.

this study has 2 phases (the food phase and the antacid phase), each consisting of a 2-period, 2-sequence, 2-treatment crossover design. the food phase will assess the effect of a high fat meal on the pharmacokinetics of 100 mg biib021, and the antacid phase will assess the effect of an antacid (ranitidine) on the pharmacokinetics of 450 mg biib021 in the same subjects. ranitidine 150 mg will be taken the evening before and the morning of the antacid dosing day.

Eligibility criteria:
inclusion criteria: * subjects with histologically or cytologically confirmed solid tumors who have failed or are not candidates for standard therapies or for whom no approved therapy is available. * eastern cooperative oncology group (ecog) performance status of greater or equal to 2. * medically able to tolerate a high fat meal and to fast as per protocol. * expected survival time of at least 3 months in the opinion of the investigator. * ability to take ranitidine as per protocol. * must be able to swallow and retain oral medication. * lab values consistent with adequate renal, hepatic, and bone marrow functions. * electrocardiogram (ecg) with qtc of ≤450 msec for men or ≤470 msec for women and no clinically significant findings. exclusion criteria: * pregnant (positive pregnancy test) or nursing women. * previous treatment with an hsp90 inhibitor. * use of antacids within 7 days of study day 1. * prior antitumor therapies, including prior experimental agents or approved antitumor therapies within 28 days of the first dose of biib021. * major surgery or radiation within 28 days of the first dose of biib021. * uncontrolled, severe medical illness, which in the opinion of the investigator and/or sponsor could compromise protocol objectives. * history of gastrectomy or major surgery to small intestine. * history of exocrine pancreatic insufficiency. * chronic diarrhea (excess of 2 to 3 stools/day above normal frequency). * active bacterial or viral infection requiring concurrent treatment. * history of hepatitis b or c or human immunodeficiency virus. * history of central nervous system metastasis. * any thrombotic event occurred \<3 months prior to day 1. * conditions that may predispose subjects to seizures: history of seizure, previous significant head trauma * drug or alcohol abuse.
safety study of gsk biologicals' hpv vaccine (gsk-580299) in healthy female subjects.

Conditions: Infections, Papillomavirus

Summary: this study will collect safety data of glaxosmithkline biologicals' human papillomavirus (hpv) vaccine in healthy females of chinese origin who are unable to receive all three doses of commercially available hpv vaccine before they are 25 years, and were placebo recipients in the primary study (nct00306241).


Eligibility criteria:
inclusion criteria: * subjects enrolled in the primary study (nct00306241) who received the placebo (aluminium hydroxide \[al(oh)3\]). * a female who is unable to receive all three doses of commercially available cervarix before her 25th birthday. * written informed consent obtained from the subject (prior to enrolment). * healthy subjects as established by medical history and clinical examination before entering into the study. * subjects must have a negative urine pregnancy test. * subjects must be of non-childbearing potential or, if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using adequate contraception for 30 days prior to vaccination and continue for two months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product or device). * pregnant or breastfeeding. * planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose. * history of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine. * hypersensitivity to latex (found in syringe-tip cap and plunger). * known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. * cancer or autoimmune disease under treatment. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * previous administration of an adjuvant that used in the hpv-16/18 vaccine. * previous vaccination against hpv or planned administration of another hpv vaccine during the study. * acute disease at the time of enrolment.

Keywords: hong kong human papillomavirus safety
evoked potential response to full-endoscopic cervical foraminotomy

Conditions: Cervical Foraminal Stenosis

Summary: cervical foraminotomy is used to treat recalcitrant foraminal stenosis in the cervical region. this foraminotomy can be performed under endoscopy. the irrigation pressure used to allow adequate visualization of the anatomical structures is usually between 40 and 50 mmhg. this pressure has no adverse effect intraoperatively on motor evoked potentials but its effect on somesthetic evoked potentials has not yet been studied. the purpose of this study is to validate the absence of disruption of somatosensory evoked potentials by endoscopic cervical foraminotomy


Eligibility criteria:
inclusion criteria: 1. cervical radiculopathy due to foraminal stenosis 2. age \> 18 years 3. radicular arm pain that were refractory to optimal medical therapy for a minimum of 3 months. 4. persistent pain despite 3 types of pharmacological treatments (paracetamol, non-steroidal anti-inflammatory drugs, opioids, antidepressant medications, and anticonvulsant medications, etc.). 5. intact llemniscal pathways must remain at least partially intact exclusion criteria: 1. history of coagulation disorders; lupus erythematosus; diabetic neuropathy; rheumatoid arthritis; morbus bechterew; active malignancy; immune deficiency 2. presence of myelopathy 3. addiction to drugs, alcohol (5 units/day) and/or medications

Keywords: evoked potential endoscopy irrigation pressure dorsal columns
the cranio-cervical flexion test using the nod device

Conditions: Muscle Strength; Neck Muscle Issue; Bruxism; EMG

Summary: to measure strength of the deep anterior neck muscles with a new measurement protocol and by using the nod device, a dynamometer, in subjects with and without bruxism, and compared to emg on the superficial muscles of the anterior neck and the masseter muscle.


Eligibility criteria:
inclusion criteria: * with or without bruxism * german fluent * informend consent exclusion criteria: * primary headache * cranio-mandibulary disorders (cmd) in \>3 months within the last 12 months * current neck pain intensity \> 2 out of 10 on numeric rating scale * known: * neurological pathologies * mental impairments or diseases * pregnancy * rheumatic disorders
veliparib and topotecan for relapsed ovarian cancer with negative or unknown brca status

Conditions: Ovarian Cancer

Summary: the purpose of this study is to investigate the effect of combined topotecan and veliparib (abt888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown brca mutation status.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. 2. verified progression by either recist criteria and/or gcig ca125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment. 3. platinum resistance or partially platinum sensitive disease * relapsed within six months of prior first line/later lines of platinum-based therapy or * relapsed within six-twelve months of prior first line/later lines of platinum-based therapy 4. age ≥ 18 years. 5. performance status 0-2. 6. measurable disease by recist 1.1 or ca125 gcig criteria 7. adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to enrollment): * wbc ≥ 3.0 x 10\^9/l or neutrophils (anc) ≥ 1.5 x 10\^9/l * platelet count ≥ 100 x 109/l * hemoglobin ≥ 9.7 g/dl (6 mmol/l) * serum bilirubin ≤ 1.5 x uln * serum transaminases ≤ 2.5 x uln * serum creatinine ≤ 1.5 x uln 8. written informed consent. 9. tissue available for brcaness analysis/brca mutation analysis. exclusion criteria: 1. prior treatment with a parp inhibitor. 2. patients with brca1/2 germline mutation. 3. platinum-refractory disease (disease that progressed or was stable during prior platinum therapy) 4. patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days prior to entering this trial. 5. pregnant or breast-feeding. for fertile women a negative pregnancy test at screening is mandatory. 6. fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment 7. other present or previous malignancy except curatively treated cervical cancer stage i, non-melanotic skin cancer or other cancer with minimal risk of relapse. previous breast cancer is allowed, if disease free follow-up at least five years prior to enrollment. 8. cns metastasis. 9. history of any chronic medical or psychiatric condition or laboratory abnormality, which is not medically controlled or in the opinion of the investigator may increase the risks associated with study drug administration (e.g. diabetes, cardiac diseases, hypertension, renal or liver disease). 10. allergy to the ingredients of the study medication.

Keywords: epithelial ovarian cancer brca mutation platinum resistant platinum sensitive relapsed ovarian cancer
epidemiology of hepatitis c virus infection among opioid substituted patients

Conditions: Hepatitis C

Summary: the aim of the present study is to estimate the national annual prevalence and incidence of current hepatitis c virus (hcv) infections among opioid dependent individuals in opioid substitution treatment (ost) based on a representative sample of approximately 2,500 outpatients in 100 substitution facilities across germany. furthermore, the study aims to describe factors influencing hcv therapy initiation and seroconversion during ost.

in this non-interventional, observational, longitudinal study, data is collected at two time points. the primary outcome measures hcv prevalence and incidence will be based on documentation from routine patient care at baseline and 12-month follow-up. secondary outcome measures will be investigated by means of surveys of opioid substituted patients and their clinicians (completed at baseline), as well as data from routine patient care. the sample size calculation is based on the primary outcome variable of hcv incidence among ost patients. the literature reports an hcv incidence of about 4/100 person-years +/- 2 new infections per 100 person-years in this target group. for a partial sample size of (at least) 32 patients with hcv seroconversion and an observation period of 1 year, 800 hcv antibody-negative patients are needed as an initial group for observation. assuming an hcv antibody prevalence of 68% among ost patients, 2500 patients are needed in total (32% corresponds to n = 800). recruitment of clinicians is conducted via the national substitution registry in which all clinicians in germany, who hold a qualification to prescribe substitution medication, are registered. to ensure that all substituting clinicians in germany are considered in the present study, the investigators sent study invitations to all 3,356 addresses in the substitution registry as of 31.12.2013. of the clinicians eligible for participation, a representative sample of clinician is drawn according to two criteria: 'german federal state' (gfs) and 'number of patients per clinician' (ppc). using the spss complex samples procedure, clinicians are stratified by gfs and ppc, such that each gfs is represented at least once, and such that the same proportions of clinicians per gfs and per ppc category are achieved (to the best of our ability) as in the total sample of clinicians registered in the substitution registry.

Eligibility criteria:
inclusion criteria: * minimum age 18 * diagnosed opioid dependence according to the icd-10 * currently in opioid substitution treatment exclusion criteria: * severe mental impairment * insufficient german reading and writing skills

Keywords: hepatitis c virus opioid substitution treatment
non-invasive modulation of spinal cord nociceptive reflexes

Conditions: Pain

Summary: the aims of this study are threefold. first, to investigate whether spinal nociceptive processing - represented here by the nociceptive flexion reflex (nfr) - is influenced by thoracic transcutaneous spinal direct current stimulation (tsdcs) in a spatially selective manner, i.e., whether effects are only observed for lower limb nfrs, but not for upper limb nfrs. second, to investigate - in a double-blind, sham-controlled, within-participant design - whether anodal and cathodal tsdcs do affect the nfr in a polarity-dependent manner. third, to investigate whether tsdcs effects observed on a spinal measure (nfr) are also observed in responses that are mediated supra-spinally, namely autonomic parameters and pain intensity ratings.


Eligibility criteria:
inclusion criteria: 1. healthy volunteers between the ages of 18 and 40 years 2. having participated in the mri medical assessment session and consented to taking part in 3t mri measurements in written form 3. having participated in the magnetic/electric neurostimulation medical assessment session and consented to taking part in magnetic/electric neurostimulation experiments in written form 4. voluntary participation and signing of the study-specific consent form exclusion criteria: 1. existence of any contraindications for mri measurements and magnetic/electric neurostimulation experiments 2. pregnancy or breastfeeding 3. very dry or sensitive skin (e.g., intolerance to creams/shampoos) 4. chronic skin diseases - such as eczema or neurodermatitis - in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg) 5. scar tissue in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg) 6. acute sunburn in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg) 7. current or recurring pain 8. injuries to the nervous system 9. history of or current neurological or psychiatric disorders 10. chronic diseases that require permanent medication (e.g., asthma, diabetes mellitus, etc.) 11. persons not capable of giving consent (e.g., in case of dementia) 12. lack of consent with regards to report of incidental findings
study of cerebral mri anomalies in mutated transthyretin amyloidosis patients

Conditions: Transthyretin Amyloidosis

Summary: transthyretin amyloidosis (attr) initially described as a rare disease, became the most serious hereditary polyneuropathy of adult onset and family screening has made it possible to identify and follow up many asymptomatic patients and carriers of the mutation in the ttr gene. considered as a systemic disease with involvement of target organs (the heart, the eye, the kidney and peripheral nervous system), it seems to be more complex for neurologists according to recent publications raising the issue of central nervous system involvement. indeed, ttr amyloid deposits seem to be correlated with the duration of the disease. these deposits can cause cortical damage by different mechanisms: direct ttr toxicity or as a result of pathology related to cerebral amyloid angiopathy (intraparenchymal or subarachnoid hematomas, small infarcts, hemosiderin). a small number of mutations in the ttr gene cause a rare phenotype of systemic amyloidosis, the oculoleptomeningeal form, characterized by clinical neurological symptoms: progressive dementia, epilepsy, ataxia, spastic paraparesis, stroke-like episodes. hypothesis of the work: the central nervous system involvement is probably underestimated on the radiological description in patients with ttr mutation.


Eligibility criteria:
inclusion criteria: * patients followed at the university hospital of nîmes between 2017 and 2021 for a ttr neuropathy with proven mutation, having benefited from a brain mri. exclusion criteria: * patients without ttr neuropathy with proven mutation, or who did not have a brain mri.