Kornimate/medical-research-clean huggingface dataset:
randomized study on transoral outlet reduction and lifestyle changes for weight regain after gastric bypass

Conditions: Weight Regain; Weight Loss

Summary: the goal of this clinical trial is to evaluate weight loss with tore and intensive lifestyle modification versus intensive lifestyle modification alone in subjects who have regained weight following a roux-en-y gastric bypass. participants will randomized 2:1. those randomized to the tore arm will receive a tore procedure and intensive lifestyle modification which consists of a well-balanced calorie restrictive diet, incorporation of exercise and coaching on lifestyle discussion. participants randomized the lifestyle modification alone arm will be eligible to receive a tore procedure at 6 months post enrollment. total follow up will be 24 months.


Eligibility criteria:
inclusion criteria: * 18 years or older. * experiencing weight regain (≥ 20% weight from nadir) after achieving clinically successful weight loss. * willing to have a tore procedure for the treatment of weight regain. * bmi between 30 and 50 kg/m2, inclusive. * gja diameter ≥ 20 mm, confirmed either during a * screening egd completed ≤ 30 days from study procedure or * egd performed immediately prior to the tore procedure. * anatomically accepting of the procedure, including a pouch size that will not require reduction at the time of treatment (pouch that is shorter than 12 cm in length). * agrees not to take additional over the counter or prescribed weight loss supplements / medications (including incretins) during the first 6 months of the study. * is on a stable dose of anti-diabetic medication for three months with no anticipated changes during the first 6 months of the study. * agrees to the follow-up requirements of the study and is able to read, understand, and sign a written informed consent form to participate in the study. * meets the indications for tore procedure with overstitch™ endoscopic suturing system. exclusion criteria: * current use or use within the one month prior to the baseline visit of over the counter or prescribed weight loss supplements / medications (including incretins). * current or planned management of type 2 diabetes with incretin medications. * inability or unwillingness to comply with assigned treatment or protocol requirements related to visits. * investigator's medical judgement that the subject is not a candidate for the tore procedure. * current pregnancy confirmed by site standard of care or planned pregnancy or breastfeeding in the next two years. * vulnerable subject.

Keywords: tore overstitch
unc metastatic cancer radiation therapy registry

Conditions: Cancer; Metastatic Cancer

Summary: the purpose of this registry is to collect clinical data from participants attending unc hospitals who present with metastatic cancer and are evaluated to receive radiation therapy as part of their standard of care treatment. the goal of this study is to provide a foundation for studies designed to identify projects across the translational continuum related to metastatic cancer and radiation therapy treatment. the relevant clinical data will be linked to patient-reported outcomes (pros) thus allowing for a unique and robust dataset. ultimately, this registry will provide current and future studies with the ability to analyze the correlation of radiation therapy regimens with metastatic cancer outcomes.


Eligibility criteria:
inclusion criteria: written informed consent was obtained to participate in the study and hipaa authorization for release of personal health information. ability to understand and willingness to sign informed consent diagnosed with or is suspected to have metastatic cancer. age ≥ 18 years at the time of consent. evaluated to receive radiation therapy as part of their standard-of-care treatment plan. exclusion criteria: all participants must not meet any of the following exclusion criteria prior to enrollment to participate in this study: any serious medical or psychiatric disorder that would interfere with the participant's ability to give informed consent.

Keywords: radiation therapy
dynamic external fixation in treatment distal radius fractures - elderly patients

Conditions: Distal Radius Fracture; Multiple Trauma; Elderly Person Maltreatment

Summary: a single center, parallel group, prospective, randomized clinical trial was conducted at the department of hand surgery, abc (andre, bernardo, caetano) foundation university hospital, santo andre, brazil. two implants used for fixation in closed reduction of distal radius fractures were compared: the bridging dynamic galaxy wrist external fixator (orthofix®, verona) and the non-bridging galaxy wrist external fixator system (orthofix®, verona).

dynamic external fixator in the etc (early total care) of unstable drfs (distal radius fractures) may be a good choice of treatment. because it's fast, safe, minimally invasive and easily performed method, it could help in the inflammatory systemic response to trauma, unable earlier functional recovery and shorten the hospitalization time of these patients (elderly and polytrauma). from this, in this study to obtain relevant information about each type of treatment, avoid possible selection bias, information and confusion. choose a reproducible and effective method (external fixator), which presents a cost / benefit compatible with our reality, but that generates doubt the best way to apply this "bridging" which is already used and that will be our control group and "non-bridging", which will be the group to be tested. rather than establishing the actual value of each of these procedures, is necessary to optimize and improve the quality of life of these patients in order to return to your personal and professional activities as soon as possible.

Eligibility criteria:
inclusion criteria: * skeletally mature patients, elderly (60 y.o. or more) * all with a diagnosis of unstable distal radius fractures (ao type a or c) * associated a multiple injured ( polytrauma ). exclusion criteria: * ongoing chemo or radiotherapy, * mental illness, * alcohol abuse.
efficacy & safety study of bilateral ivt injection of gs010 in lhon subjects due to the nd4 mutation for up to 1 year

Conditions: Leber Hereditary Optic Neuropathy

Summary: the goal of this clinical trial is to assess the safety and efficacy of gs010, a gene therapy, in improving the retina functional \& structural outcomes in subjects with lhon due to the g11778a nd4 mitochondrial mutation when vision loss duration is present up to one year.

gs-lhon-clin-05 is a phase iii, global, multi-center randomized, double-masked for the primary analysis, placebo-controlled, clinical study. as lhon is a neurodegenerative disease, the goal is to administer gs010 as soon as possible upon confirmation of the lhon diagnosis and the causative mutation.

Eligibility criteria:
main selection criteria: * age 15 years or older on the date of signed informed consent. * clinically manifested vision loss due to nd4 lhon, to any extent, in at least one eye. * vision loss duration of ≤ 365 days (i.e. ≤ 1 year) in each affected eye at inclusion visit (visit 2). main non-selection criteria: * contraindication to intravitreal injection in any eye. * subjects refusing to discontinue idebenone. * previous vitrectomy in either eye. * narrow angle in any eye contra-indicating pupillary dilation. * presence of known/documented mutations, other than the g11778a nd4 lhon-causing mutation, which are known to cause pathology of the optic nerve, retina or afferent visual system. * history of recurrent uveitis (idiopathic or immune-related) or active ocular inflammation. main inclusion criteria: * vision loss duration of ≤ 365 days (i.e. ≤ 1 year) in each affected eye at inclusion visit (visit 2). * each eye of the subject must maintain at least hand motion (hm) visual acuity, as defined by the study's sop for visual acuity testing. * documented results of genotyping showing the presence of the g11778a mutation in the nd4 gene and the absence of the other primary lhon-associated mutations (nd1 or nd6) in the subject's mitochondrial dna. main exclusion criteria: * light perception (lp) or no light perception (nlp) visual acuity in any eye, as defined by the study's standard operating procedure (sop) for visual acuity testing. * presence of active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye. * presence of alcoholism, alcohol dependence, or alcohol or drug abuse (excluding nicotine).

Keywords: heredity optic atrophy leber hereditary optic atrophy leber hereditary optic neuropathy lhon eye diseases hereditary eye diseases inherited retinal dystrophies or degeneration inborn genetic disease gene therapy intravitreal injections mitochondrial disease aav2 vectors nervous system diseases neurodegenerative disease heredodegenerative disorders of the nervous system atrophy pathological conditions, anatomical anesthetics central nervous system depressants physiological effects of drugs
trial of oral versus intravenous proton pump inhibitor on intragastric ph in patients with bleeding ulcers

Conditions: Peptic Ulcer Hemorrhage

Summary: patients with bleeding ulcers identified by endoscopy will be randomly assigned to receive an acid-blocking drug (called a proton pump inhibitor \[ppi\]) either by mouth every 3 hours for 24 hours or intravenously (iv) by constant infusion for 24 hours. a ph probe in the stomach will be used to determine intragastric ph (a measure of the acid production in the stomach) at baseline and during the 24 hours of therapy. the purpose of the study is to determine if the continuous intravenous administration of the drug provides better reduction of acid in the stomach than the oral administration.


Eligibility criteria:
inclusion criteria: * patients presenting to hospital with overt upper gi bleeding and found to have an ulcer as the cause on endoscopy exclusion criteria: * previous gastric surgery * active bleeding at end of endoscopy (despite hemostatic therapy) * recent ppi or h2ra use
examination of circumferential reduction

Conditions: Overweight or Obesity

Summary: the rationale for the selection of outcome measures is the compliance with fda regulations as pertain to medical devices with a moderate level of risk of hazard leading to harm of the patient; firstly, the safety of the device in achieving the desired effect of its intended use when operated in the intended manner; and secondly, the effectiveness of the device in achieving its desired effect of its intended use in accordance with its proposed label and labeling. the rationale for the selection of the primary outcome measure is to satisfy the question of safety and effectiveness of the use of red-light exposure to reduce the circumference of overweight patients with a statistically significant routine use population size. given that the routine use data analysis is open label and therefore not blinded, there is no need for a control group nor additional cohorts for varying levels of exposure and corresponding safety and/or effectiveness.

in the 1960s, the concept of using light energy for a variety of health maintenance goals and overcoming a number of dermatological conditions began in earnest to receive the attention of nasa researchers as a means of providing desired clinical outcomes to astronauts while in the confines of a space capsule over long periods of time. the research was well funded and supported by the u.s. government, and confirmed the value of light emitting diode (led) low-level light therapy (lllt), in particular red light from the 635nm frequency, for producing a variety of healthful effects within the dermis. the ability to achieve a reduction in the dimensions of exposed liposomes using red light is intended to be confirmed by analyzing the clinical data from a minimum of one hundred patients who were exposed to the 635 nm frequency for 30 minutes by use of the subject device (contour light) during routine use to confirm that the device is safe and effective for its intended application. please see the following clinical articles, appended in section 10.

Eligibility criteria:
inclusion criteria: * males and females ages 18 and above * generally good health exclusion criteria: * pregnancy * active cancer within the past year * pacemaker * diminished ability to void waste (liver and/or kidney function impairment) * photosensitivity (generally and/or from medication)
finding patterns in clinical study experiences of multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: participation in medical trials usually favors a particular demographic group. but there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. this study will admit a wide range of data on the clinical trial experience of multiple sclerosis patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. it will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future multiple sclerosis patients.


Eligibility criteria:
inclusion criteria: * participant has a diagnosis of multiple sclerosis * patient has self-identified as planning to enroll in an interventional clinical trial for multiple sclerosis * patient is at least 18 years of age exclusion criteria: * inability to perform regular electronic reporting * patient does not understand, sign, and return consent form * no diagnosis of multiple sclerosis confirmed

Keywords: multiple sclerosis sclerosis
probiotics and hospital outcome in the elderly

Conditions: Diarrhea; Constipation

Summary: probiotics have been shown to reduce the rate of diarrhea and constipation. the purpose of this study was to investigate if probiotics could improve outcome of hospitalized orthopedic elderly patients.

the patients were divided into two groups. one received probiotics for 45 days and the second received placebo. the patients had a clinical and epidemiological as well as nutritional assessment. they were followed-up as for their bowel movements, abdominal pain and nosocomial infections and for the incidence of helicobacter pylori and clostridiume difficille diarrhea.

Eligibility criteria:
inclusion criteria: * patients who were hospitalized in the department of geriatric orthopedic rehabilitation a week before their enrollment in the study and signed an informed consent. exclusion criteria: * known or suspected allergy to any probiotics * neutropenia * inability to sign an informed consent

Keywords: probiotics elderly motility diarrhea
transbronchial needle forceps for endobronchial ultrasound

Conditions: Lung Cancer; Lymph Nodes

Summary: prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes

patients with enlarged mediastinal lymph nodes must be staged. the ebus tbna technique is an established technique. unfortunately the size of the needle is limited to 21 gauge. with tne new designed needle forceps it should be possible to obtain more material and establish the diagnosis more often

Eligibility criteria:
inclusion criteria: * enlarged mediastinal lymph nodes exclusion criteria: * comorbidities

Keywords: bronchoscopy endobronchial ultrasound transbronchial needle aspiration lung cancer staging
sensitivity evaluation of serological tests for covid-19

Conditions: Covid19

Summary: the primary objective of this study is to test the diagnostic sensitivity of antibody tests for the diagnosis of sars-cov2 infection, available to clinical laboratories, within a national network of hospitals carrying out research activities. test the diagnostic specificity of antibody tests for the diagnosis of sars-cov2 infection. complete a systematic evaluation of the different approaches. perform health technology assessment (hita) of the methodologies under study, in order to verify their reliability to the immunoglobulin levels produced by each individual exposed patient.


Eligibility criteria:
inclusion criteria: all patients or individuals exposed to sars-cov2 infection. exclusion criteria: there are no criteria for excluding patients or individuals, if not the refusal to participate to project

Keywords: test sierologici
teriparatide treatment in patients with inherited osteoporosis

Conditions: Osteoporosis

Summary: the purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.


Eligibility criteria:
inclusion criteria: * inherited low-turnover osteoporosis * lumbar spine or hip bmd t-score ≤ -2.5 * a written informed consent. exclusion criteria: * age less than 18 years * generally accepted contraindications for the treatment

Keywords: osteoporosis teriparatide bone turnover new forms of inherited low-turnover osteoporosis
comparison of spencer technique and conventional treatment in adjuncts to corticosteroid injection in frozen shoulder

Conditions: Frozen Shoulder

Summary: this study will compare the effectiveness of the spencer technique combined with intra-articular injection versus conventional therapy combined with intra-articular injection in managing frozen shoulder. the research problem addresses the need for optimal therapeutic approaches to improve pain relief, range of motion, and functional recovery in patients with frozen shoulder.

utilizing a randomized controlled trial, the study will recruit 100 participants, divided into two groups: group a receiving the spencer technique with intra-articular injection and group b receiving conventional therapy with intra-articular injection. outcome measures will include pain levels, range of motion, shoulder functional status and patient satisfaction, assessed through validated tools. the significance of this study lies in its potential to provide robust comparative data to guide clinical decisions and enhance patient outcomes, particularly in populations with a high prevalence of diabetes

Eligibility criteria:
inclusion criteria: * 30 years 60 years old. * diagnosed with unilateral adhesive capsulitis presenting symptoms of pain. * restricted range of motion of frozen shoulder stage 2 and 3 exclusion criteria: * rotator cuff injury * long-term systemic corticosteroid use * previous ipsilateral shoulder csi within 12 months.
extreme capsule electrical stimulation for drug-resistant focal epilepsy

Conditions: Epilepsy, Drug Resistant

Summary: evaluation of the efficacy and safety of deep brain stimulation of the extreme capsule (ec) for the treatment of drug-resistant epilepsy

this studyto evaluate the efficacy and safety of deep brain stimulation of the ec for the treatment of drug-resistant epilepsy originating from ec structurally connected cortex cortex, this study aims to explore stimulation patterns and parameters that can suppress abnormal epileptic discharges at the seizure focus without impairing language function. this study aims to improve treatment challenges for these patients and promote clinical translation and application

Eligibility criteria:
inclusion criteria: * participants are between the ages of 14 -65 years of age * diagnosis of drug-resistant epilepsy follows the standard of resistance to regular medication treatment for at least two years. comprehensive preoperative epilepsy assessment, combined with individualized fiber tracking, is used to determine whether the epileptogenic zone is located in cortex regions structurally connected to the extreme capsule. * persistence of disabling seizures at least 3 times per month or greater, * informed consent signed. exclusion criteria: * structural alterations are present in the extreme capsule. * diagnosed with generalized or hereditary epilepsy with ion channel gene mutations; * psychogenic non-epileptic seizures within 12 months; * presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). note: vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit; * risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications; * iq \< 55 or severe cognitive dysfunction, unable to complete the study; * diagnosed with a progressive neurological disorder (including progressive rasmussen's encephalitis, etc.); * diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders; * diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function; * pregnant, or planning to pregnant within 2 years; * participation in another clinical study within 3 months; * not suitable for enrollment as assessed by the multidisciplinary team of the center.

Keywords: extreme capsule deep brain stimulation drug resistant epilepsy focal epilepsy
external validation of the 4c mortality score for hospitalised patients with covid-19 in a tunisian cohort

Conditions: COVID-19 Pandemic

Summary: risk prediction scores are important tools to support clinical decision-making for patients with coronavirus disease (covid-19). the objective of this paper was to validate the 4c mortality score, originally developed in the united kingdom, for a tunisian population, and to examine its performance over time.

coronavirus disease (covid-19) caused by the severe acute respiratory syndrome virus 2 (sars-cov-2) can progress to acute respiratory distress syndrome, multiorgan failure, and death in some cases. the clinical presentation and progression of covid-19 in patients is highly variable, which makes it difficult for clinicians to triage patients and determine their prognostic risk. a simple, validated prognostic tool using data that is available at presentation can help clinicians better prognosticate and support clinical decision-making . numerous tools to predict mortality in covid-19 patients have been developed, but many are limited due to small derivation cohort sizes and/or inadequate validation. the 4c mortality score is an accessible risk stratification score developed by the international severe acute respiratory and emerging infections consortium (isaric). it was derived and internally validated on a large, diverse cohort within the united kingdom but requires external validity to confirm its generalizability. the objective of this study was to validate the 4 c mortality risk score to predict in-hospital mortality among adults hospitalised with covid-19 in a tunisian cohort. .

Eligibility criteria:
inclusion criteria: * patients ≥18 years old * admitted to one of the participating hospitals with a confirmed case of covid-19 defined by a positive reverse transcriptase-pcr (rt-pcr) assay of a nasopharyngeal swab associated with compatible clinical manifestations exclusion criteria: * under the age of 18 * incomplete electronic records were excluded from the analysis.

Keywords: covid-19 sars-cov2 4c score validation