Kornimate/medical-research-clean huggingface dataset:
long-term efficacy and safety of asenapine using haloperidol as a positive control (41513)(completed)(p05785)

Conditions: Schizophrenia

Summary: schizophrenia is a brain disease. the primary features of schizophrenia are characterized by positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. the symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. the clinical development of asenapine, as described in the 2007 idb appears to have antipsychotic activity with superior symptomatic control compared to placebo and an improved safety profile compared to currently available neuroleptics. its fast dissolving formulation may further add to treatment compliance. while various titration schedules have been used in previous studies, dose increases at 5 mg bid (twice daily) up to 10 mg bid have been well tolerated. therefore, further exploration in a larger group of subjects with acute exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg bid) will mimic actual clinical practice in a long-term 52-week extension trial.


Eligibility criteria:
inclusion criteria: * completed the short-term 041023 trial (nct00156104) * continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial * sign a written informed consent for the 041513 trial. * demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator exclusion criteria: * cgi-s (clinical global impressions of severity of illness) score of greater than or equal to 6 (severely psychotic) * occurrence(s) of aes (adverse events) or other clinically significant findings that would prohibit their continuation * met any of exclusion criteria regarding medical/psychiatric status listed in the 041023 short-term trial * met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.
bioequivalency study of losartan potassium/hydrochlorothiazide 100 mg /25 mg tablet under fed conditions

Conditions: Hypertension

Summary: the objective of this study was to prove the bioequivalence of losartan potassium/hydrochlorothiazide 100/25 mg tablet under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to losartan potassium hydrochlorothiazide or any comparable or similar product.
uexplorer total-body pet/ct in nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: uexplorer total-body pet/ct in nasopharyngeal carcinoma

a 194-cm-long total-body positron emission tomography/computed tomography (pet/ct) scanner (uexplorer), has been constructed to offer a transformative platform for human radiotracer imaging in clinical research and healthcare. the objective of this study is to determine its specific effect in newly diagnosed nasopharyngeal carcinoma compared with conventional pet/ct and the quantitative kinetic parameters including glucose metabolic rate (ki), glucose transport rate of flow-in (k1) and flow-out (k2) between tissue and blood, and glucosamine-6-phosphatization rate in tissue (k3). all the neck lymph nodes suspected for metastatic in pet/ct were biopsied under the guidance of ultrasound for a pathological diagnosis.

Eligibility criteria:
inclusion criteria: * patients must be informed of the investigational nature of this study and given written informed consent. * aged between 18-65, male/female. * histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, who ii and iii).. * fertile women should practice contraception during the study period. * hgb ≥90g/l ,wbc ≥4\*109/l , plt ≥100\*109/l, * with normal liver function test (alt and ast ≤2.5\*uln, tbil ≤2.0\*uln) * with normal renal function test (serum creatinine ≤1.5\*uln) exclusion criteria: * women in pregnancy or lactation * patients with diabetes * prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ. * any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×uln), and emotional disturbance. * already involved in other clinical trial. * mental disorder, civil disability, limited capacity for civil conduct.

Keywords: ultrasensitive pet ct
tube feeding tolerance after switch to peptide based formula in children with developmental delay

Conditions: Developmental Disabilities; Feeding Disorder

Summary: a retrospective chart review to assess feeding tolerance in children who had been switched from an intact protein formula to a peptide based formula due to feeding intolerance in a pediatric facility for the developmentally delayed.

medical records of pediatric patients with enteral feeding intolerance on standard polymeric formulas that were switched to a peptide based formula will be retrospectively analyzed. data will be collected on caloric intake, ability to meet enteral nutrition goals, incidence of intolerance, and the use of medications to control gastrointestinal symptoms.

Eligibility criteria:
inclusion criteria: * 13 months to \< 18 years of age on admission to facility * required enteral nutrition to meet 90% or more of their energy needs prior to switch to a peptide based formula * received enteral nutrition with an intact protein formula for a minimum of two weeks prior to a switch to a peptide based formula * have documentation of intolerance to an intact protein formula, followed by a switch in formula received to a peptide based formula * have documentation of an assessment of feeding tolerance following the switch to a peptide based formula * formulas received must be indicated for use in children or adults (not infant formulas). exclusion criteria: * recent abdominal surgery, change in tube position/placement (within past 30 days) * cow's milk protein allergy * any current infections including upper respiratory, viral, gastroenteritis, wound infection.
effects of the application of a reflex locomotion program in the neurological hand

Conditions: Neurological Disorder

Summary: the recovery of the function of the hand is one of the most important aspects for patients who have suffered the consequences of neurological damage. currently there are numerous therapeutic procedures aimed at rehabilitation that have scientific evidence such as restrictive therapy. however, dysfunction of the upper limb has an impact on the whole body that is not always taken into consideration.

the intervention of the stimulation of the reflex locomotion is carried out in this study in a sitting position in a conventional chair, an unorthodox posture in the usual treatment of vojta therapy. description of the sitting posture: the back in axial extension with the shoulders located in front of the hips. the elbows must be supported with the medial epicondyl in contact on a table, whose height is at the level of the end of the patient's sternum. the forearms are placed prone with the palms facing the surface. in this position we place a rubber sphere 3 centimeters in diameter under the pisiform of one of the patient's wrists. the reflex stimulation is performed by the passive pressure exerted by the weight of the wrist (pisiform) on the rubber sphere. simultaneously the patient has to exert a slight pressure with the heel towards the ground with his foot. this foot will be the opposite of the wrist that has the sphere under the pisiform. it is a cross-stimulation, that is, pisiform in one hand together with the load in the heel of the opposite side. alternating each diagonal 4 times, 5 minutes each. total session 20 minutes, 2 times per day, every day according to degree of affectation the duration of the study will depend on the degree of involvement: mild 2 weeks, moderate 3 months.

Eligibility criteria:
inclusion criteria: * sequelae in the upper limb after neurological damage. * understanding and oral expression preserved. * more than a year after the episode. * possibility of walking exclusion criteria: * aphasia. * concomitant diseases: diabetes and arthritis of the hand.

Keywords: stroke physical therapy neurological hand vojta therapy
autonomic response during cystodistension in patients suspected of having interstitial cystitis

Conditions: Interstitial Cystitis

Summary: the aim of this study is to check whether patients with cystoscopic findings supporting the diagnosis of interstitial cystitis (ic) have a higher autonomic response (change in blood pressure / pulse)than patients without cystoscopic findings.

checking the changes in blood pressure and pulse rate during the initiation of the anesthesia and at the completion of the cystodistension in patient with cystoscopic finding supporting ic

Eligibility criteria:
inclusion criteria: * all patients having cystodistension suspected of painful bladder syndrome * symptoms lasting for at least six months * symptoms suspect of the syndrome: super pubic pain, urinary urgency and frequency * lack of urinary infection or any other pathology of the urinary tract exclusion criteria: * refusal of the patient to participate

Keywords: autonomic response
locus-coeruleus function in normal elderly and ad risk

Conditions: Alzheimer Disease

Summary: growing evidence suggests that alzheimer's disease (ad) pathological changes begin decades before clinical symptoms and tau abnormalities in the locus coeruleus (lc) can be observed since midlife. we have previously demonstrated functional vulnerability of the lc to aging and stress, as well as an association between higher csf tau and impaired sleep phenomena influenced by the lc. we now aim to test whether lc dysfunction can be measured in preclinical ad stages by lc targeted imaging, and whether it objectively affects sleep architecture and attention. we will test this hypothesis in 30 cognitively normal older adults by performing a full clinical evaluation, one night of polysomnography, a lumbar puncture to obtain cerebrospinal fluid, \[11c\]mrb pet-mr, and attention testing. this study has the potential to identify a new mechanism by which tau pathology contributes to sleep and attention dysfunction and may provide a new therapeutic target for ad prevention.

the purpose of this study is three-fold: to test whether lower net availability in the lc is associated with: first, csf tau levels typical of preclinical stages of ad (aim 1); second, reduced rem and spindle density (aim 2); and third, impaired performance on attention tasks (aim 3). the goal is to test the overarching hypothesis that lc dysfunction occurs in preclinical ad stages, can be measured with mrb-pet, and translates into impairment of sleep architecture (lc tonic dysfunction) and attention (lc phasic dysfunction).

Eligibility criteria:
inclusion criteria: * male and female subjects with normal cognition and 55-75 years of age will be enrolled. * subjects will be within normal limits on neurological and psychiatric examinations. * all subjects enrolled will have a cdr of 0. this will be evaluated through a clinical interview administered by a study physician (informant interview will not be required). * all subjects will have had a minimum of 12 years of education. exclusion criteria: * history of brain tumor, mri evidence of brain damage or brain disease including significant trauma, hydrocephalus, seizures, stroke, mental retardation or other serious neurological disorder (e.g. parkinson's disease or other movement disorders). * significant history of alcoholism or drug abuse. * significant history of psychiatric illness (e.g., schizophrenia, bipolar, ptsd, or life-long history of major depression). * geriatric depression scale (short form)\>6. * insulin dependent diabetes. * evidence of clinically relevant cardiac, pulmonary, endocrine or hematological conditions. * physical impairment of such severity as to adversely affect the validity of psychological testing. * any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for mri imaging. * history of a first-degree family member with early onset (age \<60 years) dementia. * irregular sleep-wake rhythms (based on the actigraphy recordings) or significant osa (ahi4%≥15). * taking coumadin/warfarin and/or medications affecting cognition or sleep. * failure to complete all study visit within 4 months
effect of lumbar surgery on complexity during a walking task in chronic low back pain

Conditions: Low Back Pain

Summary: lumbar surgery is the most common treatment for chronic disabling low back pain with degenerative disc disease. there are few elements to objectively evaluate the improvement of the motor control after surgery and the motor adaptation capacities of the patients. the impact of lumbar surgery on complexity in this painful context has never been studied. theoretically, the restriction of mobility imposed by lumbar surgery should limit the subject's adaptive capacities (of one or more lumbar segments) and thus reduce complexity. nevertheless, improvement in pain intensity levels could allow the patient to find better motor adaptation capacities, necessary for a positive evolution in the long-term. the aim of this study was to investigate the evolution of gait complexity in chronic low back pain patients pre- and post-surgery. if surgery improves the adaptability of walking through an antalgic benefit exceeding the induced stiffness, the complexity of walking should be superior after surgery. this is a proof-of-concept study in which the study investigators hypothesize that measuring complexity by fractal analysis during a walking task will show the increase in gait complexity induced by lumbar surgery at 3 and 6 months after surgery.


Eligibility criteria:
inclusion criteria: * patients with chronic low back pain requiring prosthesis or arthrodesis surgery on one or two levels * subject affiliated or beneficiary of a health insurance plan. * the patient must have given their free and informed consent exclusion criteria: * patients with organic low back pain (infection, tumor, inflammatory rheumatism) * patient with a neurological deficit (cauda equina syndrome or motor testing mrc \< 3 on a muscle group of the lower limbs) * patient who has already undergone lumbar surgery (except single discectomy) * patient with serious concomitant pathologies * patients participating in a therapeutic study prohibiting participation in another study * patient in an exclusion period from a different study * it is impossible to give the subject informed information * patient is unable to express consent * the patient is under safeguard of justice or state guardianship * patient is pregnant, parturient or breastfeeding
group telehealth behavioral cough suppression therapy

Conditions: Refractory Chronic Cough

Summary: the purpose of this study is to investigate the effectiveness of behavioral cough suppression therapy (bcst) in managing refractory chronic cough (rcc) within a group telehealth setting. rcc is a cough that has lasted at least 8 weeks and has not resolved with standard medical treatment. bcst is a research-based treatment provided by specialty-trained speech-language pathologists (slps) for patients with rcc. although the treatment works very well for a large proportion of patients in a standard one-on-one format, there are a limited number of slps available to provide this treatment and patients living in rural areas do not typically have access to an slp trained in bcst. if bcst can effectively be delivered in a group telehealth model, it would significantly improve accessibility to the treatment.


Eligibility criteria:
inclusion criteria: * at least 18 years old * predominantly dry cough for at least 8 weeks * evaluated and treated by at least one physician for cough * obtained a chest x-ray or chest ct scan specifically related to the cough with unremarkable results * access to a computer or tablet that includes a camera and able to use the device independently * reliable internet access * willing to agree to maintain confidentiality of personal information (including names) related to others in the study exclusion criteria: * under age 18 * coughing up blood * current smoker of any substance * history of smoking or 10 or more years * diagnosed with a chronic lung condition (e.g., copd, emphysema, lung cancer, idiopathic pulmonary fibrosis, chronic bronchitis, asthma)? (note: if a patient has been told their cough may be (or is likely) due to asthma but they have not had any formal lung testing and asthma treatments have not helped your cough, we don't consider this a formal asthma diagnosis and will not exclude them from the study.) * diagnosed currently or in the past with head and neck cancer (i.e., cancer of the mouth, nose, or throat). * complaints of swallowing difficulty * taking any of the following medications, which have a known side effect of cough: benzapril (lotensin), captopril (capoten), enalapril/enalaprilat (vasotec oral and injectable), fosinopril (monopril), lisinopril (zestril and prinivil), moexipril (univasc), perindopril (aceon), quinapril (accupril), ramipril (altace), and trandolapril (mavik) * prior bcst treatment with an slp or respiratory therapist
study evaluating the safety and efficacy of neffy or intramuscular adrenalin in patients with allergic reactions after oral food challenge or allergen immunotherapy

Conditions: Allergic Reactions

Summary: the study is to assess the safety of neffy or im adrenalin in patients who are experiencing allergic reactions after an ofc, allergen immunotherapy (ait), or other allergy challenge that may require epinephrine intervention.


Eligibility criteria:
inclusion criteria: * is a patient 4 years old or greater, inclusive, who are scheduled to undergo ofc, ait, or other relevant allergy challenge. * has body weight 15 kg or greater at the time of allergy challenge. * is willing and able to provide written informed consent prior to participating in the study. in the case of minors (\<18 years old), assent can be obtained from his/her legal representative, and as much possible from the patient himself/herself. * patient experiences an allergic reaction that, in the opinion of the investigator, requires treatment with epinephrine via neffy or im adrenalin. exclusion criteria: - has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the investigator.
research on a new intelligent mobile screening and diagnosis pattern for ocular diseases

Conditions: Ophthalmic Diseases (Specific Types Not Restricted); Cataract; Refraction Error; Diabetic Retinopathy (DR); Age Related Macular Degeneration (ARMD)

Summary: the global distribution of primary ophthalmic medical resources is uneven, and the traditional eye disease screening model has problems such as low efficiency, high cost and limited coverage. with the development of artificial intelligence and other technologies, it provides technical support for the construction of intelligent mobile screening model for eye diseases. the investigator's team has developed the 5g intelligent ophthalmic vehicle and served tens of thousands of people in 108 cities nationwide, initially verifying the feasibility of the new intelligent mobile screening model. however, the application effect, acceptance and influencing factors of this model in different regions are not clear, and there is a lack of economic benefit analysis based on real-world data. in this study, the investigators will conduct a cross-sectional study of large-scale population screening for blinding eye diseases in grassroots areas through the smart mobile screening model, focusing on the screening effectiveness and cost-effectiveness of the smart mobile screening model, integrating real-world multimodal eye health data, developing multiple smart screening analysis models, and exploring its adaptability and direction of improvement in grassroots areas.


Eligibility criteria:
inclusion criteria: * age ≥ 7 years * voluntary informed consent exclusion criteria: -inability to complete the required examinations with the help of others due to old age, infirmity, poor general condition, etc.
impact of a clinical pathway for pelvic fragility fractures

Conditions: Pelvic Bone Injury; Sacral Fracture; Pelvic Fracture; Fragility Fracture

Summary: patients with pelvic fragility fractures suffer from high morbidity and mortality rates. despite the high incidence of these injuries, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practice. new insights in treatment strategies, such as early diagnosis and minimal invasive operative treatment of these fragile patient population, has led to the development of several clinical pathways in recent literature. the aim of this study is to implement an evidence and experience-based treatment clinical pathway to improve the outcomes in this fragile patient population that currently has multifactorial risks for poor outcome.


Eligibility criteria:
inclusion criteria: * pelvic fragility fracture caused by low energetic trauma * patients presented at the emergency room or out-patient clinic of a participating hospital exclusion criteria: * patients with high suspicion of a pelvic fracture due to a malignant tumor * patients who are unable to follow instructions due to severe cognitive decline (for example due to dementia or alzheimer's disease) * patients who pre-trauma received palliative or terminal care * patients who pre-trauma were wheelchair bound or bedridden * patients who suffer from complications from previous pelvic ring fixation * patients with insufficient comprehension of the dutch language to be able to carry out the physiotherapy instructions for early mobilization
prospective cohort of patients with systemic sclerosis at brest university hospital with biobanking

Conditions: Systemic Sclerosis

Summary: this study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis. it will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood samples, as well as stool sample and skin swab for microbiota analysis.


Eligibility criteria:
inclusion criteria: * major patient with systemic sclerosis defined according to the eular 2013 criteria (see appendix 1) * patient evaluated within the framework of the reference center for rare autoimmune diseases of the chu of brest. * patient affiliated to the social security system * patient having signed a written informed consent. exclusion criteria: * minor * patient under legal protection (guardianship, curatorship) * refusal to participate * patient unable to consent * pregnant or breastfeeding woman * hemoglobin (hb) level \< 7g/dl

Keywords: systemic sclerosis patient library