Kornimate/medical-research-clean huggingface dataset:
effects of transcranial magnetic stimulation associated to sensory therapy for treatment of motor function of upper limb of stroke patients

Conditions: Stroke

Summary: the aim of this research will be to investigate in stroke patients whether upper limb motor function can be maximized in response to sensory stimulation by comparing protocols for the application of transcranial magnetic stimulation (rtms) in the cortical region of s1 and sensory therapy in the upper limb paretic. patients will be randomly and randomly allocated into four groups, group 1 (g1) composed of individuals who will receive the protocol for the application of rtms in the ipsilateral s1 cortex and fictitious sensory therapy in the paretic upper limb; group 2 (g2) subjects will receive protocol of sensory therapy in the upper limb ethical and application of fictitious rtms in the ipsilesional s1 cortex; group 3 (g3): application of the protocol of application of rtms in the ipsilateral s1 cortex associated with sensory therapy in the upper limb paretic and, g4 (gsham) control group in which fictitious rtms will be performed and fictitious sensory therapy in the paretic upper limb).


Eligibility criteria:
inclusion criteria: * diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging, * absence of cognitive deficits (evaluated by mini mental state examination, score ≥ 20 - folstein 1975); * partially preserved motor functions (evaluated by the fugl-meyer scale, score between 14 and 60, due to the necessary movements to be performed during the intervention); * partially preserved sensorial (evaluated by the fugl-meyer scale, score between 2 and 10 in the sensorial item , indicating subjects with sensorial alterations but without extinction of the sensation) (maki, quagliato, cacho, et al., 2006); * patients who, through exposure to electric current by tens, perceive the electrical stimulation in the palm, back of the hand and ventral forearm will be included. exclusion criteria: * clinical evidence of multiple brain lesions or other associated neurological diseases; * peripheral neuropathies; * leprosy; * fibromyalgia; * rheumatoid arthritis; * other upper and lower motor neuron pathologies; * sensitizing skin diseases; * history of psychiatric illnesses including drug and alcohol abuse; * traumato-orthopedic deformities installed in upper limbs; * those who are performing some rehabilitation treatment during the collection (physiotherapy and / or occupational therapy) will not participate in the research. in addition, for the application of rtms: * patients with intracranial metal implants will be excluded; * pregnancy; * history of seizures and / or epilepsy; * use of medication that interferes with cortical excitability.
results of an interferon-gamma release assay after treatment for tuberculosis

Conditions: Tuberculosis

Summary: new blood tests have become available to detect either latent or active tuberculosis. these tests - which according to the cdc can replace the tuberculin skin test - measure the production of gamma-interferon (a cytokine) by peripheral lymphocytes (white cells) when exposed to antigens which are highly specific of mycobacterium tuberculosis (the bacteria responsible for tuberculosis). our hypothesis was that the production of gamma-interferon would be much higher at the beginning of treatment than at the end, and that decline in gamma-interferon secretion could be an indicator of clinical response to treatment.

patients either treated for active culture proven tuberculosis (tb) or having completed treatment during the preceding 6 months were recruited. exclusion criteria were : hiv infection and previous tb. interferon gamma release assay (t-spot.tb, oxford immunotec) was sampled during the 2 first weeks of treatment, at the end of treatment and 6 months later. t-spot.tb was analysed qualitatively (pos/neg) and quantitatively (spot forming units: sfu) to determine if there was a higher rate of negative tests at the end of treatment and 6 months after treatment than initially. paired samples were analysed to compare sfu counts between beginning of treatment and end of treatment, and sfu counts between end of treatment and 6 months later. clinical response to treatment was recorded, as well as treatment failures and relapses.

Eligibility criteria:
inclusion criteria: * culture proven tuberculosis exclusion criteria: * age \< 18 * prior tuberculosis * hiv infection

Keywords: tuberculosis interferon gamma release assays treatment
clinical equivalency validation protocol clinical equivalency eyenez retina camera v200 and optomed smartscope m5 ey3

Conditions: Diabetes

Summary: this prospective equivalency study compares the performance of two ophthalmic cameras, the eyenez retina ophthalmic camera v200 (oc) and the optomed smartscope m5 ey3 (op). trained technicians will take pictures of the same patients' retinas and the quality of the photos will be evaluated. the study includes healthy patients and patients with a spectrum of retinal diseases. the study requires that technicians take pictures of the retinas of adult patients between 18 and 80 years of age using both the oc and op. the pictures will be reviewed and compared by a central reader/ophthalmologist, who will determine if the oc is equivalent to the op, based on the quality of the images

subjects (patients) will be recruited via word of mouth. the study duration will be approximately 1-2 weeks, assuming a recruitment rate of 15 subjects per week. the images will be recorded within 15 minutes and will involve minimal disruption to the clinical workflow. in the study environment setting (foothill medical offices), the user interface will be evaluated by comparing retinal pictures taken with subject device oc and predicate device op. patient subjects will be given an information and consent form to complete prior to the study the technicians employed by foothill eye clinic will operate the device on patient participants by taking a retinal picture using oc. the technicians will use the predicate device op to take retinal pictures. the ophthalmologist will compare the results with the pictures taken by oc and op. the ophthalmologist will be blinded to what picture was taken by which camera and record his assessment of the quality for each picture. patient subjects will receive a standard of care exam with or without dilation.

Eligibility criteria:
healthy subjects inclusion criteria: * written informed consent * male or female * age ≥ 18 years and ≤80 years * normal retina healthy subjects exclusion criteria: * glaucoma * limited ability for agreement * spectrum of retinal diseases * subjects that may have been exposed to retinal photography in the past 24 hours prior to the study visit or plan to have retinal photography in the 24 hours after the study visit diseased subjects inclusion criteria: * written informed consent * male or female * age ≥ 18 years and ≤80 years * spectrum of retinal diseases diseased subjects exclusion criteria: * normal retina * limited ability for agreement * subjects that may have been exposed to retinal photography in the past 24 hours prior to the study visit or plan to have retinal photography in the 24 hours after the study visit
study of pro 140 by subcutaneous administration in adult subjects with hiv -1 infection

Conditions: HIV -1 Infection; HIV Infections

Summary: the purpose of this study is: 1. to assess the antiviral activity of pro 140 2. to assess the safety and tolerability of pro 140 3. to generate additional pk, pd and safety data of pro 140


Eligibility criteria:
inclusion criteria: 1. males \& females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities) 2. screening plasma hiv-1 rna ≥ 5,000 copies/ml 3. cd4+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count \< or = 250 cells/mm3 4. has not taken any antiretroviral therapy (art) w/in 12 wks of early screening visit 5. exclusive ccr5-tropic virus as determined by trofile™ assay at early screening visit 6. clinically normal or "not clinically significant (ncs)" resting electrocardiogram 7. women of reproductive potential must have a negative serum pregnancy test at late screening visit \& a negative urine pregnancy test w/in 72 hrs prior to first dose of study medication, \& be non-lactating. male \& female subjects must agree not to participate in a conception process from early screening visit through day 59. exclusion criteria: 1. cxcr4 tropic virus or dual/mixed tropic (r5x4) virus determined by the trofile™ assay. 2. females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study. 3. history of active hepatitis within the previous 24 wks 4. prior use of any entry, attachment, ccr5 co-receptor or fusion inhibitor, including pro 140, experimental or approved. 5. any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.

Keywords: hiv treatment naïve
effect of low-intensity pulsed ultrasound on functional treatment of class ii malocclusion

Conditions: Malocclusion, Angle Class II

Summary: this experimental study will evaluate the effect of combined treatment with low-intensity pulsed ultrasound (lipus) and functional appliances (twin-block) on the correction of class ii malocclusion, compared with the control group treated with functional appliances (twin-block) only. the study sample will consist of 40 patients with class ii malocclusion. the sample will be allocated randomly into two groups: control group and experimental group. the functional appliance (twin-block) will be applied for all patients, while the low-intensity pulsed ultrasound (lipus) will be applied for the experimental group only. the skeleto-dental changes occurring after functional treatment will be assessed using cephalometric radiographs; pre and post- treatment changes for each group will be evaluated individually, and the two groups will be compared.

studies of the etiologic factors of class ii malocclusions recognize that most class ii malocclusions are a result of mandibular deficiency and not of maxillary excess. for many patients, especially adults, optimal overall results are best obtained using a combined orthodontic-surgical approach. however, treating such cases early while the patient is still growing, using mandibular propulsive functional appliances, can produce satisfactory improvement in the facial esthetics, and minimizes the need for surgical intervention in many cases. ultrasound (us), a form of mechanical energy that is transmitted through and into biological tissues as an acoustic pressure wave at frequencies above the limit of human hearing, is used widely in medicine as a therapeutic, operative and diagnostic tool. therapeutic us, and some operative us. previous studies on animals have found that therapeutic ultrasound (us) can stimulate and enhance mandibular growth when applied during the active growth period. this study will evaluate the effect of low-intensity pulsed ultrasound (lipus) on the growth of mandible and the duration of functional treatment. twin-block will be applied to the two groups. while the control group will receive the twin-block only, the experimental group will receive the twin-block combined with low-intensity pulsed ultrasound (lipus) on temporomandibular joint (tmj) region. cephalometric radiographs will be obtained before and after functional treatment to evaluate the dento-skeletal changes.

Eligibility criteria:
inclusion criteria: * angle class ii malocclusion because of mandibular retrognathia * o.j \> 5 , snb \< 78 * patient during growth spurt exclusion criteria: * tmj disorders * poor oral hygiene * previous orthodontic treatment. * patients with syndromes, clefts, or craniofacial abnormalities. * reason of contraindication of functional treatment

Keywords: low-intensity pulsed ultrasound twin-block functional treatment
the powerspiral antegrade investigational device exemption (ide) study

Conditions: Small Bowel Disease

Summary: to evaluate safety and efficacy

the purpose of this study is to evaluate the safety and efficacy of the powerspiral™ enteroscopy system, when used in subjects undergoing antegrade (per-oral) enteroscopy of the small bowel.

Eligibility criteria:
inclusion criteria: * patient is ≥ 22 years of age * medical indication for antegrade enteroscopy * willing and able to provide informed consent exclusion criteria: * any medical contraindication to standard enteroscopy * any test that is done as part of the standard of care that would prevent the enteroscopy from being performed for safety reasons * unable or unwilling to provide informed consent * female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period * presence of any intra-luminal or extra-luminal foreign body in the abdominal cavity * any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable) * known or suspected bowel obstruction, or history of bowel obstruction * taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days * known coagulation disorder * known or suspected esophageal stricture or schatzki ring * known gastric or esophageal varices * suspected perforation of the gastrointestinal (gi) tract * previous abdominal radiation * inability to tolerate general anesthesia for any reason * inability to tolerate endotracheal intubation * known need for endoscopic retrograde cholangiopancreatography (ercp) during enteroscopy * american society of anesthesiologists (asa) classification 4 or greater
small macular holes treated with air

Conditions: Macular Holes

Summary: non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.


Eligibility criteria:
inclusion criteria: * primary mh ≤250 μm * mh duration ≤12 months * no previous vitreoretinal surgery in study eye * ability to sign informed consent * signed informed consent * age ˃18 years exclusion criteria: * previous vitreoretinal surgery in study eye * secondary mh caused by other conditions than vitreomacular traction * myopic mh, i.e., excessive myopia (more than -6 dioptres) * traumatic mh * mh secondary to retinal detachment or other retinal diseases * previously participation in this study
biologics in severe nasal polyposis survey.: a french registry

Conditions: Rhinosinusitis Chronic; Nasal Polyps

Summary: with a prevalence of 2-4% in western countries, chronic rhinosinusitis with nasal polyps (crswnp) is of major concern regarding its substantial impact on the social and physical quality of life. so far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed. during the last 15 years, several studies have shown that crswnp is associated with a t helper 2 (t2) immune response leading to b cell release of ige, mucosal recruitment of eosinophils from bone marrow via interleukin (il)-5, il-4 and il-13 mediated chemoattractant production. new biologic agents capable of blocking t2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with crswnp. in the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies. herein the investigators propose a prospective study monitoring medical records of crswnp patients who undergo biologic treatments. the objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, nsaid, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).


Eligibility criteria:
inclusion criteria: * patients of over 18-year old requiring a biologic treatment for crswnp in accordance with its marketing approval. * the patients already treated according to this criteria since august 2021 will be followed and their previous clinical and biological data retrospectively collected exclusion criteria: * oral corticotherapy in the previous month; * biologic treatment with anti-ige (omalizumab), anti-il-5/il-5r (mepolizumab, benralizumab) or anti-il-4/il-13r (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months of initiation of treatment apart from ongoing biotherapies for severe asthma or crswnp; * hypersensitivity to humanized antibodies ; * documented sars-cov2 infection in the last 3 months with persistent olfactory disorders related to covid; * pregnant or breast-feeding women; * patient without social coverage.

Keywords: nasal polyp chronic rhinosinusitis eosinophil endotype
trial on impact of healthpromise mobile app on inflammatory bowel disease care and quality of life

Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Summary: healthpromise is a mobile application (app) for patients that allows regular tracking of symptoms by patients and communicates them to physicians. the purpose of this randomized controlled trial is to determine the impact of the healthpromise application on improving patient outcomes. the trial will look at how much patients use the application, whether physicians change treatment in response to new information from patients, and how the patients quality of life change over the span of the study. the investigators hypothesize that healthpromise will enhance physician-patient communication and improve clinical outcomes.

this study will prospectively enroll about 300 patients with crohn's disease or ulcerative colitis presenting at the mount sinai health system. eligible participants who complete the informed consent will fill a tablet or web-based questionnaire at the end of which they will be given a pin and offered to download the healthpromise app or an education app. patients who download healthpromise app will then be requested to provide updates on quality metrics, a quality of life questionnaire, and emergency visits and hospitalizations. data will be collected continuously throughout the study using the mobile health app. study endpoints will primarily be assessed using "intention to treat" analysis. additionally, per protocol analysis of data will be performed for patients who have logged into the application at least 4 times in 12 months. the total study duration will be 2 years (104 weeks). at 1 year (52 weeks), an interim analysis will be done to determine if study needs to be continued for full 104 weeks. furthermore, patients in either arm who login using pin but not completing week 52 (or week 104) exit survey will be considered as "lost to follow up".

Eligibility criteria:
inclusion criteria: * age \>18 years, * internet or smartphone access * ability to complete a tablet or web-based questionnaire in english language. exclusion criteria: * presence of short bowel syndrome, stoma or pouch. * presence of a condition or disease that, in the opinion of the investigators, may make it exceedingly difficult for the patient to use healthpromise app, including, but not limited to, advanced dementia.

Keywords: inflammatory bowel disease crohn's disease ulcerative colitis colitis pro patient-centric healthpromise
dose reduction and discontinuation with anti-fibrotic medications

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.


Eligibility criteria:
inclusion criteria: * presence of at least one pirfenidone or nintedanib prescription during the identification period (0/01/2014 to 09/30/2021; the date of first prescription for pirfenidone/nintedanib is the index date) * evidence of ipf: patient with at least one inpatient or two outpatient claims (\>14 days apart) with a diagnosis code for ipf during the study period (10/01/2013 to 09/30/2022) * at least 18 years old at the index date * have at least 12 months of continuous enrollment in the health plan during pre-index period, and at least 6 months of continuous enrollment in post-index period exclusion criteria: * any history of lung transplant during the 12-months pre-index/baseline period * any claims for a skilled nursing facility, a long-term care facility or hospice care during the 12-month pre-index period * evidence of non-ipf chronic fibrosis interstitial lung disease (ild) or connective tissue diseases during the 12-months pre-index period. the following conditions will be excluded: autoimmune, or connective tissue diseases (i.e., rheumatoid arthritis (ra), systemic lupus erythematosus (sle), dermatopolymyositis, systemic sclerosis, sjogren's syndrome, and mixed connective tissue disease (ctd), sarcoidosis, and hypersensitivity pneumonitis). * missing demographic information (i.e., age or sex)
seasonal variations in serum 25-hydroxy vitamin-d levels in a swedish cohort

Conditions: Vitamin-D Insufficiency

Summary: the purpose of this study was to study seasonal inter-individual and intra-individual variations in s-25(oh)d and to explore parameters associated with s-25-ohd in healthy swedish adults.

serum was collected during 12 months and analysed for 25(oh)d in 540 healthy blood donors. the blood donors answered questionnaires concerning vitamin d supplements, smoking, physical activity, sunbed use and holidays in sunny locations. repeated serum samples were also collected from thrombocyte donors to study the intra-individual variations in s-25(oh)d.

Eligibility criteria:
inclusion criteria: * healthy at the time of donating blood exclusion criteria: * unhealthy

Keywords: vitamin d vitamin d deficiency parathyroid hormone