Kornimate/medical-research-clean huggingface dataset:
surgical management of irreparable rc tears

Conditions: Rotator Cuff Tear

Summary: the primary goal will be to compare the early postoperative recovery outcomes and complications from a series of surgical treatments for massive or irreparable rotator cuff tears. the secondary goal will be to assess factors that impact the outcomes of these reconstructions for irreparable posterosuperior rotator cuff tears.

prospective, non-randomized cohort study the surgeons will decide which surgical reconstruction technique should be used to treat patients who have a massive (2+ tendons) or irreparable (grade 3 or higher fatty infiltration into infraspinatus tendon) rotator cuff tear in the primary or revision setting. surgical options include arthroscopic superior capsular reconstruction (scr), arthroscopic assisted latissimus dorsi transfer (aaldt), or arthroscopic assisted lower trapezius transfer (aaltt), with arthroscopic biceps tendoesis/tenotomy as a control group. each patient will receive an x-ray and mri to indicate reparable subscapularis tear, teres minor pathology, grade of muscle fatty infiltration, ahi, csa, hamada grade, and arthritis grade. patients will be assessed pre-operatively and again post-operatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months to collect patient reported outcomes and complications. assessments will include clinical and shoulder motion evaluations to gauge shoulder range of motion and pathology, as well as questionnaires that evaluate the patients shoulder mobility, ability, pain, and surgical satisfaction. any adverse events post surgery will also be recorded at the defined assessment time intervals (6 wks, 3m, 6m, 12m, 24,m) and will specifically monitor temporary or permanent nerve injuries, hematomas, superficial and deep infections, recurrent moderate/severe pain, tendon or graft rupture, and humeral head superior migration. graphical comparisons will be made of the patient's recovery for each surgical technique as well as an analysis of patient specific factors based on their demographics forms which could influence the recovery curves.

Eligibility criteria:
inclusion criteria: * massive (2+ tendons) or irreparable (see below) rotator cuff tears in the primary or revision setting. * definition of "irreparable": grade 3 or higher fatty infiltration into the infraspinatus exclusion criteria: * protected populations: prisoners, military, non-english speakers, age \<18 years
cva in patients suffering from decreased consciousness, confusion or headaches to an emergency room

Conditions: CVA

Summary: a cva occurs when there is a sudden interruption of blood supply to the brain. fast identification of cva is crucial in order to refer the patient to an appropriate medical center as well as to direct him/her to a suitable treatment upon arrival to the medical center, in order to minimize the permanent damage to the brain. in this study, we are evaluating a tool for detecting cva based on eeg (electroencephalograph) data analysis using innovative algorithm. the system is comprised of four electrodes, reference electrode and earphones for auditory stimulation. in the study, 120 patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness will be monitored for five-minute each, with eeg accompanied with auditory stimulation. the eeg analysis will be performed based on the synchronization of the front and back hemispheres. during cva, specific hemisphere is damaged, therefore desynchronization is expected. the purpose of this study is to develop a tool for identifying cva in patients who have no clear cva related signs.


Eligibility criteria:
inclusion criteria: patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness exclusion criteria: pregnant women
safety and immunogenicity of 10-valent and 13-valent pneumococcal conjugate vaccines in papua new guinean children

Conditions: Pneumonia; Meningitis; Bacteraemia; Sepsis; Otitis Media

Summary: the study aims to evaluate the safety and immunogenicity of the 10-valent and 13-valent pneumococcal conjugate vaccines when administered in an accelerated schedule in papua new guinean children, who experience early dense upper respiratory tract colonisation with a broad range of pneumococcal serotypes, and to compare antibody titres following a booster dose of polysaccharide vaccine at 9 months with those children who received no booster at the same age.

the primary aim of the study is to determine whether pcv10 and pcv13 are safe and immunogenic in png infants for the serotypes in the respective vaccines. this study is important for the following reasons: 1. there is a lack of data worldwide on immunogenicity in populations with very high early onset of dense urt carriage. 2. the epi immunisation schedule is very accelerated in png (ages 1,2 and 3 months). 3. there are not data on functional antibody to pcvs in png. 4. there are no data on nthi protein d antibody responses in png and worldwide in population with very high urt carriage rates from a young age, i.e. those most likely to benefit from a vaccine including nthi protein carrier. 5. it is important to investigate impact of vaccine on carriage density in view of our finding of limited impact of 7vpcv on urt carriage. 6. there is no data on antibody responses following 10v or 13v pcv to booster with ppv as young as 9 months of age (which would be the most appropriate within the current png epi schedule and in the many other third world countries). 7. there is no data on antibody responses (including functional assays) to 23vppv challenge at age 2 years after 23vppv booster at age 9 months in children primed with pcv. 8. the broad range of serotypes causing ipd in png necessitates continuing consideration of 23vppv as a potential booster at age 9 months. 9. serotype-specific b cell memory is an important aspect that we can now test to address immunological safety of ppv in children primed with pcv. 10. the global alliance for vaccines and immunisation (gavi) and the world health organisation (who) have committed to the introduction of pcv for infants in gavi-eligible countries (including png) using novel funding mechanism. in png, the introduction of a pcv is planned for 2013.

Eligibility criteria:
inclusion criteria: * health infants between 28 - 35 days old exclusion criteria: * infants of women not intending to remain in the are for at least two years * birth weigh \< 2000 g (2kg) * severe congenital abnormalities * mother or child known to be hiv positive

Keywords: pneumococcal vaccine papua new guinea
livewell: a mobile intervention for bipolar disorder

Conditions: Bipolar Disorder; Bipolar I Disorder

Summary: livewell is a study evaluating the use of smartphones to better understand and improve the treatment of bipolar disorder. our goal is to increase access to psychosocial interventions and improve their effectiveness in reducing symptoms and preventing mood episodes.

a single blind, randomized controlled trial (n = 200, 2:3 ratio of usual care vs usual care and intervention) will be conducted in clinical practices around chicago and minneapolis. eligible participants are adult bipolar 1 disorder patients not experiencing a current mood episode with a history of at least one acute episode in the last two years who are in treatment with a psychiatrist. the primary clinical outcome will be time to relapse, and the secondary outcomes will be percent time symptomatic, symptom severity, and quality of life. participation in the study lasts for 12 months. participants are asked to carry a smartphone with them whenever they leave home and wear a wristwatch for measuring activity all day every day. participants are also asked to complete a series of telephone assessments and may be asked to complete daily check-ins on a smartphone and work with a health coach. participants will need to attend two in-person clinic visits at 680 n lake shore drive, chicago il 60611 suite 1520 or at 3311 e old shakopee rd, bloomington, mn 55425.

Eligibility criteria:
inclusion criteria: * adults 18-65 years * bipolar disorder type i * minimum of 1 acute episode in the last 2 years exclusion criteria: * not receiving psychiatric care * current mood episode * current substance use disorder (within the last 3 months) * current severe suicidal ideation or a recent serious suicide attempt (within the last 3 months) * inability to speak and read english * visual, hearing, voice, cognitive or motor impairment that would prevent completion of study and treatment procedures participants will need to attend two in-person clinic visits at 680 n lake shore drive, chicago il 60611 suite 1520 or at 3311 e old shakopee rd, bloomington, mn 55425.

Keywords: bipolar disorder smartphone behavior therapy
effects of replacing diet beverages with water on weight maintenance of type 2 diabetic obese women: 18 months follow up

Conditions: Type 2 Diabetes; Overweight; Obese

Summary: the present study aimed to follow up our participants in order to consider the changes in weight and anthropometric measurements after the 12-month weight maintenance as well as the total of 18 months, consisting of the previously described 24 weeks active weight loss and a further 53 weeks weight maintenance. the secondary outcome was to compare the abdominal adiposity, carbohydrate, and lipid metabolism during these periods.


Eligibility criteria:
inclusion criteria: * diabetic female patient with 6.5\<h1ac\<7.2. * monotherapy with metformin. * 18-45 years of age. * body mass index (bmi) between 27-35 kg/ m². * consume dbs regularly during their habitual diet. * must be able to have moderate exercise. * must be interested to have weight loss. exclusion criteria: * participating in a research project involving weight loss or physical activity in the previous six months. * pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months. * taking medication that could affect metabolism or change body weight. * report heart problems, chest pain, and cancer within the last five years. * unwilling to change intake of beverages during the study period.

Keywords: diet beverages water diabetes weight loss insulin sensitivity
a clinical assessment of the hemacopolymer daily disposable limbal ring soft contact lens

Conditions: Myopia

Summary: this purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses.

this is a subject-masked, dispensing study designed to evaluate the clinical performance and subjective acceptance when comparing two different daily disposable limbal ring lenses. limbal ring lenses, which as well as correcting vision, have a colored ring which enhance the wearer's iris and are particularly popular in east asian countries.

Eligibility criteria:
inclusion criteria: subjects will only be eligible for the study if: * they are 18 years of age and above. * they understand their rights as a research subject and are willing and able to sign a statement of informed consent. * they are willing and able to follow the protocol. * they agree not to participate in other clinical research for the duration of this study. * they can attain at least 6/9 in each eye with the study lenses within the available power range. * they can be fitted with study lenses within the available power range. * the currently use soft contact lenses, or have done so within the last six months. exclusion criteria: subjects will not be able to take part in the study if: * they have an ocular disorder which would normally contraindicate contact lens wear. * they have a systemic disorder which would normally contraindicate contact lens wear. * they are using any topical medication such as eye drops or ointment. * they have had cataract surgery. * they have had corneal refractive surgery. * they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. * they are pregnant or lactating. * they have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. * they have any infectious disease which would normally contraindicate contact lens wear, or may, in the opinion of the investigator, pose a risk to study personnel; or any immunosuppressive disease (e.g. hiv), or a history of anaphylaxis or severe allergic reactions. * they have taken part in any other clinical trial or research, within two weeks prior to starting this study.
infliximab for kawasaki disease patients resistant to ivig : a multicentre, prospective, randomised trial

Conditions: Kawasaki Disease

Summary: the objective of this study is to investigate the effect of infliximab to the children who don't respond to the first dose of intravenous immunoglobulin (ivig) (2g/kg) in kawasaki disease.

kawasaki disease(kd), the most common cause of acquired heart disease in developed countries, is a self-limited vasculitis that is treated with high doses of intravenous immunoglobulin. resistance to intravenous immunoglobulin in kawasaki disease which is defined as a temperature of 38.0°c or higher at 36 hours to 7 days after completion of the infusion of intravenous immunoglobulin increases the risk of coronary artery lesions. we will conduct a multicenter, randomized, prospective trial to determine whether the use of infliximab to the children who don't respond to the first dose of ivig(2g/kg) reduces the risk of coronary artery diseases. the ivig-resistant children will be randomly assigned to either the infliximab or ivig group in a 1:1 ratio and receive either infliximab (5 mg/kg at 1 mg/ml intravenously over 2 h) or ivig (2g/kg). the level of leukocyte (wbc)counts, c-reactive protein, alanine transaminase,interleukin- 1( il-1), interleukin- 6(il-6), tumor necrosis factor-a(tnf-a), soluble tumor necrosis factor receptor-1(stnfr-i), soluble tumor necrosis factor receptor-2(stnfr-2), the fever days,and the cost of hospital stay will be analyzed between these two groups.the final outcome is the incidence of coronary artery lesions.

Eligibility criteria:
inclusion criteria: * (1)individual patient's medical file data confirmed the diagnosis of kd using the 5th revised edition of diagnostic criteria for kd, issued by the japan kawasaki disease research committee at the 7th international kawasaki disease symposium in 2002.(2) resistance to intravenous immunoglobulin in kawasaki disease is defined as a temperature of 38.0°c or higher at 36 hours to 7 days after completion of the routine primary treatment .(3) the patients aged from 2 months to 12 years old. (4) all included patients required to sign an informed consent form exclusion criteria: . exclusion criteria: (1) the patients with severe infections; (2) the patients with a history of tuberculosis or recent close contact with tuberculosis; (3) the patient vaccinated with live vaccine in 6 months; (4)the patients with the application of hormone or other immunosuppressive agents; (5) the patients didn"t want to signed informed consent.

Keywords: kawasaki disease coronary artery lesion, ivig- resistant, infliximab
study in participants with early stage coronavirus disease 2019 (covid-19) to evaluate the safety, efficacy, and pharmacokinetics of remdesivir administered by inhalation

Conditions: COVID-19

Summary: the primary objective of this study is to characterize the impact of inhaled remdesivir (rdv) on severe acute respiratory syndrome coronavirus 2 (sars-cov-2) viral load in participants with early stage coronavirus disease 2019 (covid-19).

this study will have multiple parts: part a, part b, and part c. part b will be conducted if supported by evaluation in healthy volunteers in another phase 1a gilead study (gs-us-553-9018). participants in part c will be enrolled after review of preliminary safety and available efficacy data from parts a and b through at least day 7. gs-us-553-9018 is a phase 1a randomized, blinded, placebo-controlled, single- and multiple-dose study in healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics of remdesivir administered by inhalation.

Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent, or with a legal representative who can provide informed consent * sars-cov-2 infection first confirmed by polymerase chain reaction (pcr) (parts a and b) or by nucleic acid testing or direct antigen testing (part c) with sample collected ≤ 4 days prior to randomization * covid-19 symptom onset ≤ 7 days prior to randomization * oxygen saturation as measured by pulse oximetry (spo2) \> 94% on room air key exclusion criteria: * ongoing or prior participation in any other clinical trial of an experimental vaccine or treatment for covid-19 * prior or current hospitalization for covid-19 or need for hospitalization * treatment of covid-19 with other agents with actual or possible direct antiviral activity against sars-cov-2 including intravenous (iv) rdv or administration of any sars-cov-2 (or covid-19) vaccine * participants chronically administered chloroquine or hydroxychloroquine for any reason are to be excluded * requiring oxygen supplementation * positive pregnancy test * breastfeeding female * known hypersensitivity to the study treatment, its metabolites, or formulation excipient * pre-existing pulmonary conditions such as chronic obstructive pulmonary disease or asthma (parts a and b only) note: other protocol defined inclusion/exclusion criteria may apply.
detecting pnes with single-channel semg

Conditions: Epilepsy, Motor Partial; Psychogenic Seizures

Summary: this is a prospective, comparative, multicenter study of subjects being admitted for standard of care therapy in epilepsy monitoring units in the veteran's affair (va) medical centers.


Eligibility criteria:
inclusion criteria: 1. subject has a history of suspected epileptic seizures with upper extremity motor involvement, or pnes with upper extremity motor involvement. 2. is being admitted to a hospital for routine veeg monitoring related to seizures. 3. male or female between the ages 22 to 99. 4. if female and of childbearing potential, has a negative pregnancy test and must not be nursing. 5. can understand and sign written informed consent, or will have a parent or a legally authorized representative (lar) who can do so, prior to the performance of any study assessments. 6. subject and/or primary caregiver must be competent to follow all study procedures. 7. subject/lar consents to the use of veeg files, including video/audio recordings, for purposes of this research study. exclusion criteria: * intracranial eeg electrodes are being used.
screening for genes in patients with congenital neutropenia

Conditions: Congenital Neutropenia

Summary: syndromic congenital neutropenia (scn) includes a heterogeneous group of diseases characterized by congenital neutropenia associated with the involvement of other organs. most patients have syndromic congenital neutropenia, which does not correspond, either clinically or genetically, to any other previously described form. a large number of genes still have to be identified in these syndromic forms. the aim of this study is to identify the molecular bases of congenital neutropenias that have not yet been classified, by taking advantage of high-throughput exome sequencing.


Eligibility criteria:
inclusion criteria: * persons who have provided written consent * patients with congenital neutropenia and mental retardation and/or a development anomaly (malformation, facial dysmorphism) * patients who accept a clinical evaluation, and to give at least one blood sample * screening for chromosomal microrearrangements by normal array-cgh exclusion criteria: * persons without national health insurance cover * patients who do not meet the clinical and/or biological criteria * refusal to give written consent to take part in the study * refusal to give a blood sample * blood samples from parents not available
effectiveness of imt/pep therapy in group e copd and comparison of gold vs star classifications

Conditions: COPD; Inspiratory Muscle Training

Summary: this prospective study aims to evaluate the effects of inspiratory muscle training (imt) combined with positive expiratory pressure (pep) therapy on respiratory function, muscle strength, and symptom burden in patients with group e chronic obstructive pulmonary disease (copd). the primary objective is to compare the predictive value of the gold and star classification systems in identifying patients who respond better to imt/pep therapy. a total of 61 patients will receive standard copd treatment along with imt/pep twice daily for 12 weeks. pulmonary function tests, dyspnea scores, and 6-minute walk test results will be assessed at baseline, at 1 month, and at 3 months. regression analysis will be used to determine the independent predictors of treatment response.


Eligibility criteria:
inclusion criteria: age ≥ 40 years diagnosis of group e copd according to gold 2023 criteria post-bronchodilator fev₁/fvc \< 0.70 and fev₁ \< 50% predicted mmrc score ≥ 2 or cat score ≥ 10 history of ≥2 exacerbations or ≥1 hospitalization in the past year stable clinical condition (no exacerbation in the past 2 weeks) ability and willingness to perform imt/pep therapy provided written informed consent exclusion criteria: acute exacerbation of copd at time of enrollment contraindications to pulmonary function testing or 6-minute walk test (e.g., recent myocardial infarction, unstable angina) inability to perform inspiratory or expiratory maneuvers reliably (e.g., due to cognitive or neuromuscular disorders) significant orofacial muscle weakness unresponsive to modified mouthpiece participation in another interventional study within the past 3 months nonadherence to copd treatment plan any condition deemed by investigators to interfere with study participation

Keywords: copd inspiratory muscle training pulmonary rehabilitation gold star
staphylococcus aureus bacteremia: impact of an intervention program in improving the clinical management and review of the clinical and molecular epidemiology

Conditions: Staphylococcus Aureus Bacteremia

Summary: staphylococcus aureus bacteremia: impact of an intervention program in improving the clinical management and review of the clinical and molecular epidemiology.


Eligibility criteria:
inclusion criteria: * patients over 14 * clinical significant bacteremia by s. aureus * patient hospitalized exclusion criteria: * non clinical significant bacteremia * ambulatory patient * end-of-life patients

Keywords: multiresistant bacteremia bacteremia management blood culture