Kornimate/medical-research-clean huggingface dataset:
the effect of a multispecies probiotics on autism symptoms and the quality of life in children

Conditions: Autism Spectrum Disorder

Summary: in this trial, the investigators aim to evaluate the impact of a multispecies probiotic consisting of bacillus subtilis w201, bifidobacterium infantis w17, bifidobacterium lactis w51, lactobacillus acidophilus w37, lactobacillus brevis w63, lactobacillus rhamnosus w140, lactococcus lactis w19, propionibacterium freudenreichii w200, on the severity of autism symptoms and the quality of life in children with autism spectrum disorder aged 7 to 15.

this study is a randomized, double-blind, placebo-controlled clinical trial. one hundred and eight children aged 7 to 15 years diagnosed with autism spectrum didorder will be randomly assigned in a 1:1 ratio to receive either a multispecies probiotics or a placebo for 12 weeks. the probiotic mixture contains 5 x 10\^9 colony forming units per dose consisting of bacillus subtilis w201, bifidobacterium infantis w17, bifidobacterium lactis w51, lactobacillus acidophilus w37, lactobacillus brevis w63, lactobacillus rhamnosus w140, lactococcus lactis w19, propionibacterium freudenreichii w200. the two co-primary outcomes will be the assessment of core autism symptoms using the autism symptom rating scales (asrs) and quality of life measured by the quality of life in autism part a questionnaire (qola-a). the secondary outcomes will include evaluations of sleep impairments using children sleep habit questionnaire - abbreviated (cshq-a), parental stress levels using parenting stress index-iii (psi-iii), gastrointestinal symptoms using gastrointestinal symptom rating scale (gsrs), and urinary p-cresol levels. these outcomes will be assessed twice: at baseline and after 12 weeks of intervention.

Eligibility criteria:
inclusion criteria: 1. diagnosis of asd according to the diagnostic and statistical manual of mental disorders, the fifth edition (dsm-5) or international classification of diseases, tenth revision (icd-10). 2. children either not taking any medication or receiving the same medication for the last 2 months. 3. patients, or their parents/caregivers, are willing to provide written informed consent, proceed with nutritional supplements throughout the 3-month trial, refrain from starting any kind of special diet for the duration of the study, and complete the questionnaires at two time points during the study. exclusion criteria: 1. use of antibiotics in the previous 2 months before enrolling (excluding topical antibiotics). 2. use of probiotics or synbiotics within the previous 2 months. 3. history of intolerance or allergy to probiotics, synbiotics or any other study product component. 4. surgery with bowel resection or short bowel syndrome. 5. children with severe immunodeficiency.

Keywords: autism spectrum disorder probiotics
treatment of proximal humeral fractures

Conditions: Humeral Fractures, Proximal

Summary: this trial is designed to compare head-to-head conservative with operative treatment in 2 stratum. stratum 1: in 2 part fractures the comparison is between conservative treatment and operative treatment with plate fixation with philos. stratum 2: in multi-fragmented fractures (mff) meaning 3 and 4 part fractures, the comparison is between conservative treatment, operative treatment with philos plate and operative treatment with epoca prosthesis. subgroup analysis will be performed in an effort to obtain limit values for specific treatment of different age and fracture groups. a cost-effectiveness analysis and comparison between different treatment modalities will be carried out. the primary outcome measure will be the dash score and the secondary outcome measure the eq-5d value. recruitment period is 3 years and follow-up 2 years.


Eligibility criteria:
inclusion criteria: * low energy proximal humeral displaced (more than 1 cm or 45 degrees) 2 part fracture where fracture line emerges through the surgical (or anatomical) neck * low energy proximal humeral displaced (more than 1 cm or 45 degrees) 3 or 4 part fracture exclusion criteria: * refuse to participate the study * less than 60 years old * non-independent * dementia and/or institutionalized * does no understand written and spoken guidance in either finnish or swedish * pathological fracture or previous fracture in the same proximal humerus * serious intoxicant dependent, eg. in first aid breathalyzer shows more than 2‰ * other operational injury in the same upper limb * major nerve injury (eg. complete radialis- or delta palsy) * open fracture * multi-trauma or -fractured patient * fracture dislocation or head splitting fracture * undisplaced fracture * isolated tuberculum fracture * fracture has no precondition to ossify by conservative treatment (no bony contact between fracture parts or the humeral shaft is in contact with the articular surface) * treating surgeon considers patient unsuitable to attend the study on medical basis * cuff-arthropathy

Keywords: proximal humerus fracture conservative locking plate philos hemiprosthesis
the effect of various types of the renin-angiotensin-aldosterone system blockade on proteinuria

Conditions: Chronic Kidney Disease; Proteinuria

Summary: the main purpose of the study is to compare the effects of three different types of raas blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.

pharmacological blockade of the renin-angiotensin-aldosterone system (raas) is the main target of therapy to reduces both proteinuria and the rate of decline of the glomerular filtration rate in non-diabetic chronic renal diseases. despite recent progress, however, there is still no optimal therapy that can stop the progression of these nephropathies. therefore, it is necessary to optimize such treatment for further improving renal outcome. the aim of the present study was to compare the effects of three different types of raas blockade: (1) mineralocorticoid receptor blocker (mrb) + angiotensin receptor antagonist (ara); (2) direct renin inhibitor (dri) + ara and (3) double maximal dose of ara on 24 hours proteinuria in patients with non-diabetic chronic kidney disease

Eligibility criteria:
inclusion criteria: * age 18-65 years * chronic non-diabetic proteinuric nephropathy * chronic kidney disease stage 1-3 * stable proteinuria above 500 mg/24 hours * blood pressure above 125/75 mmhg and below 150/95 mmhg * no steroids or other immunosuppressive treatment for a minimum of six months before the study exclusion criteria: * unstable coronary heart disease * decompensated congestive heart failure in the previous 6 months * episode of malignant hypertension or stroke in the history * diabetes * creatinine clearance below 30 ml/min * pregnancy

Keywords: aliskiren eplerenon telmisartan direct renin inhibitor ace inhibitor mineralocorticoid inhibitor proteinuria chronic kidney diseases renin-angiotensin-aldosterone system
intra-operative radiation registry

Conditions: Breast Cancer

Summary: this registry trial is designed to track the local control rates and side effects of iort, which will be implemented for women who are suitable pbi per the latest astro guidelines.

eligible patients will be referred for radiation oncology consultation by the operating surgeon. patients will be presented with all radiation options and if they choose iort, they will be offered enrollment onto the registry trial and consented accordingly. the registry will collect treatment data from the operation, radiation and pathology notes post iort for each patient enrolled. sources of research material, i.e. resected breast tissue and lymph nodes, will be obtained as part of routine clinical care. no additional tissue will be collected from patients due to enrollment on this registry trial. no additional studies will be performed outside of the routine standard of care. post treatment, the registry will collect data based on the standard of care follow up schedule. follow-up visits will be scheduled 2-3 weeks post-operatively, as per standard of care, to review the final pathology and for the initial toxicity assessment. patients found to have positive margins and/or lymph node involvement may require further surgery and/or additional external beam radiation. additional follow-up visits with radiation oncology will be scheduled at 6 months and 1, 2, 3, 4, and 5 years following iort. toxicity will be scored using ctcae v4.03. local control will be evaluated using clinical exam and semi-annual to annual mammograms. all such information will be tracked and recorded into the registry database.

Eligibility criteria:
inclusion criteria: * female gender * age ≥ 45 * ct1-2n0, \<3.5cm invasive breast cancer, estrogen-receptor positive or dcis of breast, grade 1-2, mammographically detected, \< 2.5 cm, estrogen-receptor positive * suitable for breast conserving surgery * no contraindication to radiation * mammogram within 6 months of planned procedure * fitness for lumpectomy under general anesthesia * planned to receive iort exclusion criteria * known axillary lymph node positive breast cancer (negative biopsy not required) * multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound, mri or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy. * patients known to have brca 1/2 (breast cancer 1, breast cancer 2) gene * patients undergoing neoadjuvant chemotherapy

Keywords: intraoperative radiation therapy partial breast irradiation
prevalence of self reported lymphedema in patients with endometrial cancer

Conditions: Endometrial Cancer; Lymphedema

Summary: the investigators are interested in understanding how the patient has been doing since their surgery for endometrial cancer and if they are experiencing any symptoms related to lymphedema (swelling) in the your lower body. the investigators hope that information from the patient and others will help them improve care for women treated for endometrial cancer.


Eligibility criteria:
inclusion criteria: * presented to msk with newly diagnosed endometrial carcinoma of any histologic profile clinically confined to the uterus and/or uterine cervix * underwent primary surgery at our institution, to include at least a total hysterectomy via laparotomy, laparoscopy, or robotic approach, between january 2006 and december 2013 * alive at the time of study activation exclusion criteria: * had documented macroscopic evidence of extrauterine disease at the time of initial diagnosis

Keywords: lower-extremity lymphedema 16-1001
validation of the rhinitis control scoring system (rcss)

Conditions: Asthma; Rhinitis

Summary: many patients suffering from allergic rhinitis do not recognize or perceive their symptoms. instruments have been developed to assess quality of life in rhinitis, asthma or both, but there is a need to develop validated tools or methods to assess rhinitis control among rhinitis and/or asthmatic patients. the aim of this study is to assess the discriminative and evaluative properties of the rcss in asthmatic patients with allergic rhinitis.

allergic asthmatic subjects showing seasonal rhinitis symptoms will be recruited. the discriminative (internal consistency, cross sectional construct validity and reliability) and evaluative (responsiveness and longitudinal construct validity) properties of the rcss will be evaluated as well as the relationship between rhinitis control and asthma control. rcss will be completed at various time points during the seasonal allergic period.

Eligibility criteria:
inclusion criteria: * asthma * seasonal allergic rhinitis exclusion criteria: * smoking * nasal polyposis

Keywords: control symptoms
phase iiib study to evaluate the effectiveness and safety of atazanavir/ritonavir as single enhanced protease inhibitor therapy in human immunodeficiency virus (hiv)-infected subjects evidencing virologic suppression

Conditions: Human Immunodeficiency Virus (HIV) Infections

Summary: the main purpose is to explore whether atazanavir/ritonavir (atv/rtv) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.


Eligibility criteria:
inclusion criteria: * on continued antiretroviral (arv) treatment, with no discontinuation periods, for the previous 6 months (24 weeks). * absence of evidence or suspected virologic failure on antiretroviral therapy * absence of known primary mutations in the protease gene * only 1 highly active antiretroviral therapy (haart) prior to current one * hiv rna \< 50 copies/ml in the last 6 months (single blip below 200 c/ml allowed) * on atv/rtv +2 nucleoside reverse transcriptase inhibitors (nrtis) (or 1 nrti + tenofovir \[tdf\]) for at least 8 weeks before study entry, without treatment-limiting adverse effects exclusion criteria: * presence of a newly diagnosed hiv-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment. * active disease condition (e.g. moderate to severe hepatic impairment/active renal disease/history of clinically significant heart conduction disease) * patients with chronic hepatitis b receiving lamivudine (3tc), tenofovir disoproxil fumarate (tdf) or emtricitabine (ftc). * cd4 \< 100 cells/mm3 * grade iv laboratory values: hemoglobin \< 6.5 g/dl or white blood cells (wbc) \<800/mmm3 or absolute neutrophil count \< 500/mm3, or platelets \< 20,000/mm3 or diffuse petechiae.

Keywords: hiv-infected patients evidencing virologic suppression
the effect of an mbsr course on medical trainee and medical academic faculty stress and burnout

Conditions: Burnout

Summary: the study team is seeking to evaluate the efficacy of the mindfulness based stress reduction (mbsr) course at reducing stress and burnout. this will be done through the collection of brief anonymous online surveys (the perceived stress scale and the mini z) before the mbsr course and at 2 weeks, 6 months, and 12 months following the end of the course. participation is completely voluntary and will not affect anyone's ability to take this course, and the course instructors will have no knowledge of who has or has not participated in the study.

the study is a pre- and post- survey design with the 8-week mbsr course as the intervention. mbsr is an evidence-based curriculum with a greater than 40-year history, that has been taught at mount sinai since 2018. study participants will be those who have voluntarily signed up to take the course in response to an email describing the course that was sent by the office of the mount sinai graduate medical education (gme). the study participants will be separated into two groups: faculty and trainees, and the study will span approximately two weeks prior to the start of the course (9/13/2023) (the "pre-" period) and six months after the completion of the course 5/31/2024) (the "post-" period). the course will be delivered by zoom, but the participants will be joining from all mount sinai locations. the mbsr course itself involves didactics (i.e., stress physiology, review of mindfulness research, mindful communication practices), group discussions based on individual experiences with the mindful practices taught in the course, and the teaching of meditation practices including sitting and moving meditation practices. home practices are offered as guidance each week but are not required. there is no planned control group at this time.

Eligibility criteria:
inclusion criteria: - a physician in the mount sinai hospital system exclusion criteria: - none

Keywords: burnout mbsr mindfulness physician well-being
a study of an automated insulin delivery system in adult participants with type 1 diabetes mellitus during meal challenges

Conditions: Type 1 Diabetes Mellitus

Summary: the automated insulin delivery (aid) system is an investigational insulin delivery device being developed for use for participants with diabetes. the purpose of this study is to assess the safety of the aid system during meal challenges.


Eligibility criteria:
inclusion criteria: * participants with t1dm for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months * have a body mass index of 18.5 to 37 kilogram per meter squared * have a hemoglobin a1c level ≥6.0% and ≤9.0% exclusion criteria: * have known allergies or history of hypersensitivity to insulin lispro * have had an episode of severe hypoglycemia within the past 6 months * have had more than 1 episode of diabetic ketoacidosis in the past 6 months
a safety and efficacy study of one-time sar402663 in adults with neovascular age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: this is a phase 1/phase 2 multicenter study to evaluate the safety and efficacy of a one-time single-eye intravitreal dose of sar402663 in participants with neovascular age-related macular degeneration. participants will be enrolled in one of 2 parts: * in part i (dose escalation), multiple dose levels of sar402663 will be evaluated in successive cohorts of participants * in part ii (dose expansion), participants will be randomized to receive one of two dose levels selected based on data from part i. participants and investigators will be masked to dose. after receiving one-time dose of sar402663, participants will undergo regular assessments over 12 months. following this, participants will enter an extended follow-up (efu) phase for the assessment of safety and durability of clinical activity of sar402663 through year 5.


Eligibility criteria:
inclusion criteria: * between 50 and 90 years of age * participants with diagnosis of macular neovascularization secondary to age-related macular degeneration (namd) * study eye with best corrected visual acuity (bcva) etdrs snellen equivalent for dose escalation (part i) between 20/32 and 20/400 and for expansion (part ii) between 20/25 and 20/200 * currently receiving anti-vegf treatment in the study eye * demonstrated a response to aflibercept in the pre-treatment period exclusion criteria: * any condition in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments * history of active ocular infection in the study eye in 6 months prior to screening * active uncontrolled glaucoma in the study eye * history of uveitis in either eye * use of ocular corticosteroids in the 3 months prior to screening * previous gene therapy * any significant poorly controlled illness that would preclude study compliance and follow up the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
clinical evaluation of full contour zirconia chairside cad/cam crowns

Conditions: Dental Disorders Hard Tissues of Teeth; Dental Diseases

Summary: this investigation will be a randomized, prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, zirconia material with shade, translucency and material graduation for chairside cad/cam crowns. the restorations will be luted either with a self-adhesive luting material or a conventional cement. the crowns will be evaluated for a period of two years.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * at least one carious lesion, defective restoration, or fractured portion of the tooth to be restored on a maxillary or mandibular premolar or molar tooth - each lesion, fracture, or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration. * tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact * no more than ten teeth that are endodontically treated may be included in the study, equally divided between the two groups of crowns. all remaining teeth in the study will test vital and be asymptomatic at the beginning of treatment. * no more than two restorations will be placed per patient exclusion criteria: * sensitive teeth * teeth with a history of direct or indirect pulp capping procedures * patients with significant untreated dental disease to include periodontitis and/or rampant caries * women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times * patients with a self-reported history of allergies to the materials to be used in the study including composite resin cements or zirconia restorative materials * patients unable to return for the recall appointments

Keywords: dental caries, caries
evolving azimuth in musa context

Conditions: Heart Failure; Blood Pressure; Weight Change; Telemonitoring

Summary: non-pharmacological, randomized, nonprofit medical device intervention. the study aims to identify the positive impacts (co-creation), and negative impacts (co-destruction), resulting from the use of telemedicine, and, in particular, the telemonitoring service for patients with heart failure

the patient diagnosed with heart failure is randomized to either the experimental or control arm. the patient in the experimental arm downloads a telemonitoring application where they enter their pressure and body weight data, which is revised by the hospital team via a platform. patients from both arms complete a questionnaire during enrollment and during two follow-ups (3 months and 6 months) to examine various dimensions.

Eligibility criteria:
inclusion criteria: * have been diagnosed with chronic cs according to the esc guidelines; * over 18 years of age; * patients admitted to hospital or with access to first aid within the last year; * smartphome that meets the digital requirements (ie android or ios able to download and use the application); * wi-fi or 3g coverage at home; * ability to give written informed consent. exclusion criteria: * severe psychiatric disorder * inability to use portable technologies * patients unable to use the equipment provided * patients who deny consent to study participation
benefit of complex fractionated atrial electrograms elimination in atrial fibrillation ablation

Conditions: Atrial Fibrillation; Catheter Ablation

Summary: the aim of this study is to evaluate whether performing complex fractionated atrial electrograms ablation improves outcomes in persistent or atrial fibrillation ablation.


Eligibility criteria:
inclusion criteria: * patients with persistent (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion) * presence of atrial fibrillation at the beginning of the procedure exclusion criteria: * hypo or hyperthyroidism * persistent long-lasting or non-defined duration atrial fibrillation * hypertrophic myocardiopathy * implantable defibrillation or pacemaker implanted * moderate or severe mitral valve disease or mitral prosthetic valve * ejection fraction less than 30% * left atrial anteroposterior diameter more than 50 mm. * previous atrial fibrillation ablation * contraindication to anticoagulation * left atrium thrombus * current infective disease or sepsis * pregnant women * current unstable angor * acute myocardial infarction in last 3 months * atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease * reduced expectancy of life (less than 12 months) * patient participating in another clinical study that investigates a drug or device * psychologically unstable patient or denies to give informed consent * any cause that contraindicate ablation procedure or antiarrhythmic drug

Keywords: atrial fibrillation complex fractionated electrograms cfae