Kornimate/medical-research-clean huggingface dataset:
efficacy of nat-fm treatment for fibromyalgia

Conditions: Fibromyalgia

Summary: the main objective of this study is to analyse the efficacy of the nat-fm multicomponent treatment program as coadjuvant of treatment-as-usual (tau) compared to tau alone. in this randomized controlled trial (rct), in addition to evaluating the clinical effects of nat-fm treatment in the short- and long-term, the research team will seek to identify relevant moderators and mediators of clinical change.

* this is a two-arm rct focused on the safety and potential efficacy of the multicomponent program nat-fm as coadjuvant of treatment-as-usual (tau) vs. tau alone. * nat-fm combines classical structural assessment (csa) and ecological momentary assessment (ema) to obtain more reliable information about the dynamics of the variables to be evaluated, to record the affective and cognitive impact of each activity, and to explore its potential delivery in real-world clinical practice. * the main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as self-efficacy and pain catastrophizing.

Eligibility criteria:
inclusion criteria: * adults from 18 to 75 years-old. * 1990 american college of rheumatology (acr) classification criteria + the 2011 modified acr diagnostic criteria for fibromyalgia * able to understand spanish and accept to participate in the study. exclusion criteria: * participating in concurrent or past rcts (previous year). * comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. alzheimer) that that would limit the ability of the patient to participate in the rct.

Keywords: multicomponent treatment nature therapy mindfulness physical therapy pain neuroscience education (pne)
neuroinflammation and bispectral index after subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage

Summary: subarachnoid hemorrhage (sah) is associated with a high mortality and frequently leads to severe disability in survivors caused by cerebral vasospasm and infarction. this study aims to elucidate the role of neuroinflammation (endocannabinoids and cortisol levels in cerebrospinal fluid) in the pathophysiology of cerebral vasospasm and the value of the bilateral bispectral index (bis) for the early diagnosis of cerebral vasospasm.

subarachnoid hemorrhage (sah) or bleeding in the brain is a form of stroke. sah mostly results from ruptured aneurysms. this severe disease often results in death or severe physical or cognitive disabilities and reduced quality of life. one frequent complication after sah is cerebral vasospasm, a spasm of the big arteries accompanied by infarction of healthy brain tissue. the pathophysiologic processes which drive vasospasm remain unclear. this study aims to examine the role of endocannabinoids and cortisol in cerebrospinal fluid during the development of cerebral vasospasm. additionally, this study examines whether side difference in the processed electroencephalogram (bilateral bispectral index) may be useful for early detection of cerebral vasospasm.

Eligibility criteria:
inclusion criteria: * admission to neurosurgical icu klinikum der universität münchen * sah * external csf drainage exclusion criteria: - age \< 18

Keywords: subarachnoid hemorrhage cerebral vasospasm neuroinflammation bilateral bispectral index
microstructural and sodium 7 tesla brain mri in idiopathic rem sleep behaviour disorder

Conditions: REM Sleep Behaviour Disorder

Summary: by 2030 the number of patients with parkinson's disease (pd) would increase by 56% affecting 1 out of 120 people older than 45 years-old. it is known that 10-15 years before the onset motor symptoms such as tremor, rigidity and akinesia, patients often experience a specific sleep trouble called rem sleep behaviour disorder (rbd). follow-up of those subjects showed there was a conversion rate to pd and related disorders (called synucleinopathies) over 80%. the pathophysiology of rbd is poorly understood. the development of cutting-edge technologies such as 7 tesla mri and the optimisation of image processing methods made it possible to non-invasively explore in vivo small brain structures involved in sleep and movement disorders. the investigators hypothesize that brain and brainstem microstructure, composition, sodium homeostasis and connectivity may change in 15 isolated rbd (irbd) subjects compared with 15 healthy controls and that these changes may be correlated with clinical scores. this study would help fill the gap in early diagnosis of synucleinopathies, by contributing to better targeting patients who could be included in therapeutic trials with a neuroprotective effect. besides, the exploration of original pathophysiological pathways such as sodium homeostatis could provide the necessary arguments for the development of new target therapeutics.


Eligibility criteria:
inclusion criteria for patients with rem sleep behaviour disorder : * patient aged between 40 and 80 years old * patient fulfilling the diagnostic criteria for rbd (international classification of sleep disorders version 3, american academy of sleep medicine, 2014) with polysomnographic confirmation (which will be carried out as part of the routine work-up); * updrs part iii score under or equal to 5 * the patient is enrolled in the french social security system * the patient understood and signed the consent to participate in the study. inclusion criteria for control group : * patient aged between 40 and 80 years old * score under or equal 4 for the rbd screening questionnaire * updrs part iii score under or equal 5 * the patient is enrolled in the french social security system * the patient understood and signed the consent to participate in the study. exclusion criteria : * patient / subject with a history of central nervous system disease (e.g. pd, alzheimer's disease, stroke, brain tumour, multiple sclerosis, amyotrophic lateral sclerosis, etc.). if a doubt exist, this criterion will be left to the judgement of the principal investigator, who is a neurologist. * contraindications to 7t mri: presence of a metal in the body or in the eye, patient with a pacemaker or neurostimulator, cochlear implants or any implanted electronic medical equipment in general, metallic heart valve, aneurysm clips. * claustrophobia. * montreal cognitive assessment test (moca) \< 25/30 * pregnant or breast-feeding woman or protected person (under guardianship, curatorship, deprived of liberty).

Keywords: 7t mri parkinson's disease synucleinopathies
telerehabilitation vs. in presence rehabilitation of reading disorders using the rhythmic reading training (rrt)

Conditions: Developmental Dyslexia

Summary: the aim of the study is to compare the effectiveness of telerehabilitation vs. in presence rehabilitation of reading disorders, using a rhythm-based intervention for reading (i.e., rhythmic reading training)


Eligibility criteria:
inclusion criteria: * having been diagnosed with dd (icd-10 code: f81.0) on the basis of standard inclusion and exclusion criteria (icd-10: world health organization, 1992) and of the diagnosis procedure followed in the italian practice exclusion criteria: * presence of comorbidity with other neuropsychiatric or psychopathological conditions * having been involved in previous reading intervention programs in the previous 3 months
development of a minimally invasive seizure gauge

Conditions: Epilepsy

Summary: the researchers are trying to assess changes in physiological signals before and during seizures.

subjects that are undergoing video eeg monitoring in their home for their epilepsy at seer medical will be consented to participate in this study for a minimum of two days and/or the duration of their monitoring period for their clinical care. subjects will be asked to wear up to 4 different commercially available seizure detection devices and complete surveys. when the subjects clinical eeg monitoring is completed data scientists will analyze the data to identify patterns.

Eligibility criteria:
inclusion criteria: * patients with epilepsy undergoing scalp eeg for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures * patients of age 18 or above exclusion criteria: * cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.
brief title: a clinical study to assess gingivitis

Conditions: Gingival Diseases

Summary: the objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent prior to participation and be given a signed copy of the informed consent form; * be in general good health as determined by the investigator based on a review of the health history/update for participation in the trial; * have at least 20 gradable teeth; * have established gingivitis with 10-70 % bleeding sites; * agree to return for scheduled visits and follow the study procedures; * agree to refrain from use of any non-study oral hygiene products for the duration of the study; * agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study. exclusion criteria: * having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the baseline visit; * having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease; * having known hypersensitivity to the test products; * having removable oral appliances; * having fixed facial or lingual orthodontic appliances; * self-reported pregnancy or lactation; * having any diseases or condition that might interfere with the safe participation in the study; * having an inability to undergo study procedures.
prep and consumptions

Conditions: Psychoactive Substance Use; Mood Disorders

Summary: hiv pre-exposure prophylaxis (prep) with truvada®, a combination of two antiretrovirals (tenofovir \& emtricitabine) is a prevention strategy for hiv-negative people at high risk of acquiring hiv. prep has thus been integrated as a new tool to significantly reduce the risk of hiv infection, especially among men who have sex with men (msm). since its introduction, an increase in sexually transmitted infections (stis) has been observed, particularly in relation to the use of psychoactive substances in a sexual context (chemsex). in this context, the description and evaluation of these practices seem necessary, as well as the impact on the risk of addiction and mental health.

interventional, multi-center pilot study, including all subjects aged 18 years or older presenting in consultation for a prep renewal. the newsletter and a self-questionnaire will be systematically given in the waiting room to any prep consultant to evaluate the consumption of psychoactive substances (assist questionnaire) and to identify anxio-depressive disorders (had questionnaire - hospital anxiety and depression). scale). after consent, the answers will be discussed with the doctor during the consultation for appropriate care, including a referral to a psychiatrist and / or addictologist if necessary. the duration of the inclusions will be 6 months and the number of patients to include is 250.

Eligibility criteria:
inclusion criteria: * subject aged over 18, * subject seen in consultation in one of the centers of the study for a renewal of the prep * subject having agreed to participate in the study exclusion criteria: * subject not speaking french / illiterate

Keywords: hiv pre-exposure prophylaxis recreational drugs chemsex mental disorders
long-term follow up of patients with longstanding hip and groin pain

Conditions: Hip Pain Chronic

Summary: in this longitudinal cohort study including young to middle aged people with longstanding hip and groin pain (lhgp) referred to tertiary care, we will collect data of patient reported symptoms, function and quality of life three and seven years after the initial contact with orthopedic surgeon.

81 physically active patients (18-55 years) with (lhgp) who were enrolled in a cross-sectional study (diagnosis and functional limitations in the young to middle-aged physically active population with long-standing hip/groin pain: a cross-sectional study) during the period october 2014 to january 2017 will be recruited to this longitudinal cohort study. a research coordinator will contact the patients and provide them with written and oral information about the study. patients who accept to participate will electronically complete the following questionnaires. the same questionnaires were included at baseline, i.e., in the cross-sectional study. * copenhagen hip and groin outcome score (hagos) * hsas - hip sports activity scale (hsas) * patient specific functional scale * medical outcomes study short form 36 (sf-36) * k-10 questionnaire * self-presentation in exercise questionnaire (speq) * multidimensional scale of perceived social support (mspss) additional questions about treatment, medication, patient satisfaction and perceived change in hip function will be included. for descriptive purposes, the mean difference (95% ci), or median (quartiles), between baseline and follow-up assessments will be used as appropriate. separate linear regression models will be used to evaluate the change in each variable compared to baseline values.

Eligibility criteria:
at baseline, the following inclusion and exclusion criteria were used: inclusion criteria: * unilateral or bilateral hip/groin pain \>3 months * age 18-55 years * no previous hip surgery exclusion criteria: * hip pathology (i.e., perthes' disease) * verified moderate or severe osteoarthritis (oa) (tönnis grade \>1) * palpable hernia * low-back pain with a positive lasègue test * mri-verified lower back/spine pathology (i.e., spinal stenosis, disc herniation) * other musculoskeletal co-morbidities overriding the hip-related symptoms and dysfunction * co-morbidities excluding physical activity and training * psycho-social disorders * drug abuse * not understanding the language of interest.

Keywords: longstanding hip and groin pain patient reported outcome
a post discharge intervention to improve stroke outcomes

Conditions: Cerebrovascular Accident

Summary: the purpose of this randomized controlled trial (rct) is to test the effectiveness of a comprehensive interdisciplinary post-discharge stroke care management intervention in improving the overall well-being of 190 stroke survivors as compared to 190 patients who receive usual post-discharge stroke care.

the major components of the model of post-stroke care being tested include equal emphasis on physical and psychosocial issues known to impact stroke outcomes, an advanced practice nurse care manager (apn-cm), an interdisciplinary healthcare team, evidenced-based care plans, collaboration with the patient's primary care physician (pcp), and ongoing patient monitoring. the apn-cm will work as part of an interdisciplinary post-stroke consultation team (psc-team) that will review problems identified at an in-home patient assessment. the core psc-team will include a geriatrician, a community-based general internist, a clinical nurse specialist from the acute stroke unit, the apn-cm, and a physical therapist. extended team members will be available as-needed and will include a neurologist, pharmacist, physiatrist, social worker, speech therapist, occupational therapist, and dietitian. the psc-team will develop patient care plans specific to each problem identified by the apn-cm. a copy of the care plans, evidence-based guidelines, pertinent references, and a short paragraph providing "academic detailing" specific to the patient's problems will be given to the patient's pcp by phone and in writing. the apn-cm will work collaboratively with the pcp to implement the recommendations and provide ongoing monitoring.the primary outcome of overall well-being of stroke survivors will be obtained at 6 months.

Eligibility criteria:
inclusion criteria: diagnosis of ischemic stroke. nih stroke scale score \>1. discharged to home from the acute care hospital, or discharged to home within 4 weeks from a short term skilled nursing facility (snf) or acute rehabilitation facility. live within 25 miles of the study site. english speaking. do not have an endarterectomy planned at the time of discharge to home. exclusion criteria: has other illness that would dominate post-stroke care (e.g., terminal diagnosis, dialysis patient, severe dementia/alzheimer's disease). -

Keywords: patient care management cerebrovascular accident
new approaches to cocaine abuse medications (a) - 6

Conditions: Cocaine-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to measure the effect of desipramine in cocaine abusers selected for major depression or dysthymia.

this is a randomized, 12-week, double-blind, 'placebo-controlled trial of outpatients meeting dsm-iii-r criteria for cocaine dependence and major depression or dysthymia (by scid interview). participants were treated with desipramine, up to 300 mg per day, or matching placebo. all patients received weekly individual manual-guided relapse prevention therapy. weekly outcome measures included the clinical global impression scale, self-reported cocaine use and craving, urine toxicology, and the hamilton depression scale.

Eligibility criteria:
inclusion: 1. meets dsm-iv criteria for current cocaine dependence. 2. used cocaine at least one day in the past month. 3. currently meets dsm-iv criteria for major depression or dysthymia. 4. depressive disorder is either: 1. primary (antedates earliest lifetime substance abuse or 2. persistent during 6 months of abstinence in the past or 3. at least 3 months duration in the current episode 5. age 18-60. 6. able to give informed consent and comply with study procedures. exclusion: 1. meets dsm-iv criteria for past mania (i.e. bipolar disorder), schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. 2. history of seizures. 3. history of allergic reaction to desipramine or imipramine. 4. chronic organic mental disorder. 5. significant current suicidal risk. 6. pregnancy, lactation or failure in sexually active female patients to use adequate contraceptive methods. 7. unstable physical disorders which might make participation hazardous such as hypertension, hepatitis or diabetes. 8. coronary vascular disease as indicated by history or suspected by abnormal ecg or history or cardiac symptoms. 9. cardiac conduction system disease as indicated by qrs duration \>0.11. 10. current use of other prescribed psychotropic medications within the last 2 weeks. 11. history of failure to respond to a previous adequate trial of desipramine or another tricyclic antidepressant. 12. currently meets criteria for another substance dependence disorder (dsm-iv) other than nicotine, marijuana or alcohol.

Keywords: desipramine, cocaine, depression
efficacy and safety of hzvsf-v13 in patients with covid-19 pneumonia

Conditions: COVID-19

Summary: preliminarily investigate the safety and efficacy of two doses of hzvsf-v13 + soc vs. placebo + soc for the treatment of covid-19 pneumonia.

proof of concept, multicentre, randomized, parallel-group, double-blind, placebo-controlled

Eligibility criteria:
inclusion criteria: 1. signed written informed consent from any patient capable of giving consent, or, when the patient is incapable of doing so, by his or her legal/authorized representative. note: in accordance with the european medicines agency (ema) "guidance on the management of clinical trials during the covid-19 (coronavirus) pandemic version 3 28/04/2020", if written consent by the trial participant is not possible (for example because of physical isolation due to covid-19 infection), consent may be given orally by the trial participant in the presence of an impartial witness. 2. age 18 years or older. 3. patient is currently hospitalized. 4. diagnosis of covid-19 pneumonia including a positive rt-pcr test for sars-cov-2 of any specimen and lung involvement confirmed with chest imaging (x-ray or computed tomography \[ct\] scan). 5. able to comply with the study protocol. 6. female patients must be postmenopausal (24 months of amenorrhea), surgically sterile or must agree to use an effective method of contraception throughout the study and for up to 120 days after stopping treatment. effective contraception includes an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide. exclusion criteria: 1. patients with known or suspected hypersensitivity to hzvsf-v13 or to any of its excipients. 2. active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides covid-19). 3. anti-rejection or immunomodulatory drugs within the past 3 months. 4. absolute neutrophil count (anc) \< 1000/µl at screening. 5. platelet count \< 50,000/ µl at screening. 6. alt or ast \> 5 x upper limit of normal (uln) within 24 hours at screening. 7. serum creatinine \> 2 mg/dl (\> 176.8 μmol/l) or estimated creatinine clearance \< 30 ml/min measured or calculated by cockroft gault equation. 8. pregnancy or breastfeeding. 9. treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational covid-19 antivirals and other off-label drugs recommended by local health authorities are permitted). 10. patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome \[ards\], septicaemia).
neural oscillations as genetic and functional biomarkers in normal and disease states

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Summary: the principle aim of the project is to analyze brain electrical activity and genetic information that will help identify the nature and cause of the disease schizophrenia. this effort should lay the groundwork for future treatment in schizophrenic patients.

there are several studies and hypotheses to be tested. this project includes a cross-sectional study design measuring brain waves, clinical symptoms, cognitive and functional ability, and genetic information in schizophrenic patients and normal controls. subjects are expected to do a brain wave recording (eeg/erp), role-play test designed to measure functionality and cognitive ability, and clinical symptom assessments. expected duration of subject participation will be approximately 8 hours (about 2 visits). outcome measures includes biomarkers, clinical symptoms and function, and genetic information.

Eligibility criteria:
inclusion criteria: * male and female between ages 14-62 (clinical assessment and blood draw only above 62) * ability to give written assent (subjects who are below the age of 18) * ability to give written informed consent (age 18 or above) * sufficient understanding of the study and risks (esc score 10 or above) * subjects above age 62 will not participate in brain electrical activity measurements although they may still participate in clinical assessments and blood draw. exclusion criteria: * inability to sign informed consent/assent * any major medical illness that may affect normal brain functioning. examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, cns infection or tumor, an other significant brain neurological conditions. * significant alcohol or drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence. * woman who is pregnant (child bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test). * can not refrain from using alcohol and/or marijuana 24 hours or more\& cigarette smoking half and hour or more prior to experiments.

Keywords: schizophrenia family psychosis