Kornimate/medical-research-clean huggingface dataset:
treatment outcomes of a novel glaucoma tube shunt implant for intraocular pressure control in eyes with refractory glaucoma

Conditions: Glaucoma; Glaucoma, Open-Angle; Surgery; Intraocular Pressure

Summary: the aim of this study is to determine the effectiveness of lowering intraocular pressure and safety profile of the paul glaucoma implant (advanced ophthalmic innovations, singapore). this is a non-comparative and single-arm observational study and all the participants were recruited between 1 dec 2017 and 1 dec 2018. patients between age 21 - 80 years with glaucoma and an iop deemed poorly controlled by the study team despite on maximal tolerated medical therapy were included in this study. the participants were recruited from 6 tertiary ophthalmology centers including national university hospital, singapore, moorfields eye hospital, united kingdom, st thomas' hospital, united kingdom, chulalongkorn university and hospital, thailand, international specialist eye centre, malaysia and chinese university of hong kong, hong kong. all the eyes were followed-up for a period of 12 months after surgery. the examination and investigations included best corrected snellen visual acuity, slit lamp examination, goldman applanation tonometry (gat), dilated fundus examination and optic nerve head imaging. the participants are reviewed before surgery, 1 day, 1 week, 1 month, three months, 6 months and 12 months after surgery. all the data were captured in a standardized data-collection form for analysis. the primary outcome measure was failure, if was prospectively defined as iop more than 21mmhg or less than a 20% reduction compared to pre-operative baseline on 2 consecutive visits after 3 months, iop less than 6 mmhg on 2 consecutive visits after 3 months, reoperation for iop-related indication, loss of light perception vision, or removal of the implant for any reason. intraocular pressure outcomes, number of iop-lowering medications and the rate of surgical complications were secondary outcome measures in this study.


Eligibility criteria:
inclusion criteria: * age 21 - 80 years with glaucoma * poorly controlled intraocular pressure exclusion criteria: * unable to give informed consent * age below 21 or above 80 years * without any suitable quadrants for tube shunt implant
a longitudinal prospective outcomes study of laparoscopic abdominal wall hernia repair using symbotex™ composite mesh

Conditions: Grade I Ventral Hernia; Grade II Ventral Hernia

Summary: this study is being done to test the efficacy of symbotex™ as an effective synthetic mesh option in the repair of grade i and ii ventral hernias.

this study is being done to validate the efficacy of symbotex™ as an effective synthetic mesh option in the repair of grade i and ii ventral hernias. it will also set the groundwork for a future clinical trial in which the efficacy of symbotex® can be compared to other synthetic mesh products on the market.

Eligibility criteria:
inclusion criteria: * age 18 or older * grade i or ii ventral hernia according to vhwg classification system * pre-operative informed consent is obtainable exclusion criteria: * not candidate for laparoscopic approach for repair of their hernia * determination in the operating room that biologic mesh is needed over permanent mesh * fascial defect less than 3 cm in greatest dimension * concurrent placement of another mesh (synthetic or biologic ) at the site where the study mesh is placed * grade iii or iv ventral hernia according to vhwg system * asa score iv or above * any disease or condition along with the surgeon's clinical judgment that contraindicates the use of study mesh. these include but are not limited to the presence of chronically infected tissues subjecting patient to risk of synthetic mesh infection, accidental bowel injury during surgery or anatomy of the patient that is not receptive to laparoscopic surgery or mesh implantation. * pregnancy * use of more than one of the same study mesh is not an exclusion criterion in and of itself, so long as the type of mesh is selected according to the randomization protocol. in other words, if the hernia defect is larger than the largest symbotex™ mesh available, two or more symbotex mesh pieces may be used to appropriately repair the hernia defect.

Keywords: hernia synthetic mesh
goal attainment and physical activity in people with hemophilia a

Conditions: Hemophilia A

Summary: this is a phase 4, multi-center, observational study conducted in patients aged 12 to 50 years with moderate or severe hemophilia a who are newly starting prophylaxis with efa in the us and japan. this study aims to enroll 35 patients.


Eligibility criteria:
inclusion criteria: * at enrollment, newly starting prophylaxis therapy with efanesoctocog alfa according to usual clinical practice, with efanesoctocog alfa initiated within 6 months after the enrollment visit * diagnosis of moderate (endogenous fviii activity between 1% to 5% of normal) or severe (endogenous fviii activity \<1% of normal) hemophilia a * aged 12 to 50 years at time of enrollment, inclusive * access to a smartphone device (android version 12.0 or higher; or ios 13 or higher) with bluetooth 4.0 (minimum) or 5.0 (recommended) capabilities for compatibility with physical activity tracker * availability of home-based access to internet for electronic patient-reported outcome (epro)/diary assessments * willingness to utilize the activity tracking device exclusion criteria: * current diagnosis of a fviii inhibitor, defined as inhibitor titer ≥ 0.60 bu/ml * use of efanesoctocog alfa for prophylaxis in the 6 months prior to enrollment note: other inclusion/exclusion criteria may apply. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
reducing maternal stress to improve obesity-related parenting practices

Conditions: Obesity, Childhood

Summary: maternal stress is associated with children's risk for obesity controlling for socioeconomic status. the association between maternal stress and child obesity is particularly strong in latinx families, whose children also have the highest rates of obesity in the united states. a mindful parenting program might reduce latina mothers' psychological stress and lead to improved parenting practices and ability to create a healthier environment. the primary objective of the proposed research is to evaluate the feasibility and acceptability of a culturally-relevant intervention that integrates mindfulness-based stress reduction and mindful parenting in latina mothers. the investigators will conduct a randomized clinical trial comparing the calma, conversa, y cría (ccc) intervention to an active control condition in 50 latina mothers of elementary-school age children. participant satisfaction rates and qualitative interviews will provide evidence of the program's acceptability. feasibility will be determined by examining recruitment rates, retention rates, and treatment fidelity. completion of this project will inform the development of a full-scale efficacy trial.


Eligibility criteria:
inclusion criteria: * over the age of 18 years * identify as female * identify as hispanic or latina * have a child between the ages of 3 and 11 years who primarily resides with them * able to understand basic instructions in either spanish or english exclusion criteria: * pregnant or planning on becoming pregnant in the near future * actively dependent on a substance * have untreated psychosis, ptsd, or social anxiety that would impair their ability to function in a group setting * child has an obesity-associated genetic syndrome * child has a pervasive developmental disorder
trial of late surfactant to prevent bpd: a pilot study in ventilated preterm neonates receiving inhaled nitric oxide

Conditions: Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction); Bronchopulmonary Dysplasia

Summary: the purpose of this study is to determine if the combination of late doses of infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.

surfactant dysfunction may contribute to the development of bronchopulmonary dysplasia (bpd) in persistently ventilated preterm infants. the investigators conducted a multi-center, randomized, blinded pilot study to assess the safety and efficacy of late administration of surfactant (calfactant - high in protein b) in combination with prolonged inhaled nitric oxide in preterm infants \< 1000 grams birthweight (bw). calfactant is one of several types of exogenous surfactant. calfactant has the highest % of surfactant protein b of the different types.

Eligibility criteria:
inclusion criteria: * less than or equal to 1000 gm. birth weight * less than or equal to 30 weeks gestational age * day 7-14 of life * intubated and mechanically ventilated at any time days 7-14 of life exclusion criteria: * serious congenital malformations * life expectancy less than 7 days from enrollment * previous treatment with ino * active pulmonary hemorrhage at time of enrollment * active air leak syndrome at time of enrollment * bilateral grade iv intracranial hemorrhage prior to enrollment * less than 48 hours from last clinical dose of early surfactant.

Keywords: nitric oxide surfactant bronchopulmonary dysplasia prematurity neonates ino infasurf lung function ventilated infants
a multidisciplinary intervention in total knee arthroplasty

Conditions: Osteoarthritis; Primary; Degenerative Joint Disease of Knee

Summary: the purpose of this study is to investigate the effectiveness of cognitive behavioral therapy delivered as an e-therapy program, combined with physical exercise delivered by physiotherapists, for patients on waiting list for total knee arthroplasty. the patients will be randomized to either 1) a non-surgical program consisting of web-based cognitive behavioral therapy combined with physiotherapy, 2) total knee arthroplasty (tka) surgery followed by web-based cognitive behavioral therapy combined with physiotherapy, or 3) a control group who undergo tka followed by standard physiotherapy.

the study is a multidisciplinary trial testing an intervention delivered by physiotherapists. up to 20% of total knee arthroplasty (tka) patients continue to experience moderate/severe pain 12 months after tka. while physical therapy (pt) and cognitive-behavior therapy (cbt) have shown promise for improving outcomes, they have not been evaluated in combination or in patients at risk for chronic pain after tka. this trial will evaluate pt+cbt combined, either as a substitute for or as a supplement to tka for patients at risk for chronic pain after tka. pilot/feasibility study: the study will include a feasibility/pilot study with 15 patients to be performed from november 2018. the intervention and study procedures may be modified based on results from the feasibility/pilot study. full scale randomized controlled trial (rct): the full-scale rct will include 282 patients scheduled for tka. patients will be randomly assigned to one of three groups: 1) non-surgical intervention (i.e., pt+cbt), 2) a combination of tka with pre- and postoperative pt+cbt, or 3) a control group receiving tka and usual care follow-up. primary outcome: the pain subscale from the koos. the intervention has the potential to improve outcomes for patients who currently obtain little benefit from standard tka. cross-sectional observational study: patients declining to participate in the rct will be offered the option to participate in a separate cross-sectional study. the inclusion and exclusion criteria will be identical to the rct. patients who agree to participate in the cross-sectional study will complete the same baseline questionnaires as in the rct and are asked about the reasons they did not want to participate in the rct.

Eligibility criteria:
inclusion criteria: 1. scheduled for tka for oa at lovisenberg, oslo; martina hansen, bærum, or coastal hospital hagevik, bergen 2. age 18 - 79 years 3. asa grade 1-3 4. kl grade 3 or 4 5. bmi\<40 6. able to read and write in norwegian exclusion criteria: * diagnosis of dementia or sero-positive rheumatic disease * previously undergone uni or patellofemoral prosthesis in the index knee * large axis deviation or instability requiring use of hinged implants * scheduled for unicompartmental arthroplasty or revision surgery

Keywords: total knee arthroplasty physiotherapy cognitive behavioral therapy e-therapy
oct angiography in wet amd

Conditions: Neovascular (Wet) Age-related Macular Degeneration (AMD)

Summary: the primary goals of this study are to use optical coherence tomography (oct) angiography (blood vessel mapping) to: 1. diagnose the presence of new blood vessels in wet age-related macular degeneration (amd) 2. evaluate patients undergoing treatment for wet amd 3. determine if reduced flow to the choroid is a risk factor for developing wet amd.


Eligibility criteria:
inclusion criteria (groups with wet amd): * adults aged 50 and older with clinical findings of treatment-naïve (never treated) neovascular amd with active new blood vessel growth confirmed by clinical testing will be considered inclusion criteria (group with healthy eyes) * no evidence of retinal disease * refractive error greater than +3.00 diopters or -7.00 diopters (glasses rx) * no recent eye surgery in the last 4 months * no significant cataract to interfere with the quality of the imaging exclusion criteria (all groups): * inability to give informed consent * significant kidney disease * blood pressure greater than 180/110 * previous macular laser treatment * inability to maintain stable fixation during oct imaging * visual acuity worse than 20/200

Keywords: amd oct angiography macular degeneration
prevention of oxaliplatin-induced nerve damage in the body's extremities

Conditions: Peripheral Neuropathy; Colorectal Cancer

Summary: the purpose of this study is to examine the effect of supplementary polyunsaturated fatty acids on nerve damage in the body's extremitites of patients treated with oxaliplatin containing chemotherapy after surgery for colorectal cancer.

the primary objective of the present study is to examine if a high dosage of n-3 pufa reduces the incidence and severity of chemotherapy-induced peripheral neuropathy (cipn) 8 months after adjuvant oxaliplatin following surgery for high-risk colorectal cancer. an additional aim is to investigate whether n-3 pufas have an effect on nutritional status, cognition and mental status. inflammatory mechanisms and biomarkers of cipn in skin biopsies and in blood will be explored.

Eligibility criteria:
inclusion criteria: * histopathologically verified adenocarcinoma of the colon or rectum and planned standard adjuvant treatment with capecitabine in combination with oxaliplatin. * ecog performance status 0-2 (measurement of a patient's function in terms of self-care, daily activity and physical ability. * written and orally informed informed consent exclusion criteria: * inability to speak, read, and understand danish. * previous treatment with neurotoxic chemotherapy. * neurological (including neuropathy) or psychiatric disorders, diabetes or other significant medical conditions. * alcohol or drug abuse. * sensory disturbances in the feet * spinal stenosis. * vascular disease (fontaine grade ii or more). * known allergy to fish, fish oil or corn oil * fertile patients not willing to use effective methods of contraception during treatment or abstinence. * daily intake of oil supplements and not willing to stop during the trial period. * lack of consent to skin biopsy
evaluation of correlations between volatile organic compounds and venous blood glucose in subjects with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the goal of this study is to evaluate correlations between vocs in the breath and venous blood glucose values in various glycaemic states in people living with type 2 diabetes. vocs are measured with a gold-standard gc-ims device and a prototype of a novel breath analyzer. participants will be exposed to different blood glucose levels at different rates of change by administering glucose solution and insulin and by a meal challenge.

the research project aims to expand the understanding of correlations between vocs in the breath and venous blood glucose levels in non-insulin-dependent people with type 2 diabetes. to better understand correlations, the subjects are exposed to hyperglycaemic, euglycaemic and hyposglcycaemic states at different rates of change by applying a hand clamp procedure, and the vocs are compared after a standardized meal and the same excursion by applying a hand clamp procedure. inter- and intraparticipant variability as well as the timing of changes in the voc spectra compared to changes in the glucose values are of interest. secondarily, the feasibility of estimating glycaemic states with a prototype of a novel breath analyzer is being investigated.

Eligibility criteria:
inclusion criteria: * signed written informed consent * t2d treated with one or more oral anti-diabetic drugs (incl glp-1 and/or gip) * 10 years since t2d diagnosis * hba1c ≤8% (hba1c based on last measurement by treating physician but not older than 120 days) * willingness to undergo study procedures * age 45 -70 years (inclusive) exclusion criteria: * pregnancy and/or lactation period * currently on chronic or occasional treatment with pulmonary drugs * insulin dependency * smoking (last cigarette within the last six months) * bmi above 30 kg/m² * lp(a) above 125 nmol/l * ldl not in the individual target range of an earlier cholesterol goal according esc guideline 2021 (ldl based on last measurement by treating physician but not older than 30 days) * irregular 12-lead ecg or increased carotid plaque burden based on a three-point sonography. both examinations are performed and evaluated according to the investigator's judgment. * history of, or manifested, cardiovascular diseases * medical history of epilepsy or other neurological disease associated with seizure events * known sensitivity to medical grade adhesives * comorbidities that are suspected to alter the voc spectra * participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation * not able to understand, write or read german

Keywords: volatile organic compounds gas chromatography - ion mobility spectrometry rates of change of glucose values breath-analysis hyperglycaemia hypoglycaemia glucose excursions
atorvastatin using as a possible prophylaxis of postoperative atrial fibrillation after cardiac surgery

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to evaluate the effectiveness of atorvastatin therapy (both during preoperative and postoperative period), as prophylaxis against postoperative atrial fibrillation after cardiac surgery, in a valve disease patient population (with or without associated coronary artery disease), with no previous history of atrial fibrillation and not receiving beta-blocking drugs.


Eligibility criteria:
inclusion criteria: 1. men and women over 18 year-old. 2. in sinus rhythm. 3. affected by valve disease, isolated or associated with coronary artery disease, satisfying requirements for heart surgery under extracorporeal circulation. 4. women of childbearing potential must use effective contraception and they must commit to maintain it throughout the study. exclusion criteria: 1. urgent surgery. 2. surgery due to endocarditis. 3. patients with previous episodes of atrial fibrillation, although they are in sinus rhythm at hospital admission. 4. treatment with beta-blockers at time of randomization 5. severe left ventricular dysfunction with ventricular ejection fraction under 30%. 6. chronic using of nsaids and / or corticosteroids at time of randomization 7. uncontrolled thyroid disease. 8. active liver disease and / or history of previous chronic liver disease. 9. alcoholism. 10. predisposing factors to statins adverse effects: * increased transaminase levels at baseline (x3 normal value). * renal failure (creatinine levels over 2 mg/dl). * previous diagnosis of myopathy of any etiology. 11. known hypersensitivity to calcium atorvastatin and / or lactose monohydrate 12. in women of childbearing age, positive pregnancy test the day of inclusion in the study. 13. not signed informed consent. 14. inability to understand objectives of the study. exclusion criteria of the study once started: * withdrawal of patient's consent. * modification in liver laboratory parameters (transaminases above three times normal value) and / or creatine-fosfokinase level suggesting adverse effects of statins.
half-normal saline in atrial flutter ablation

Conditions: Atrial Flutter

Summary: to assess the acute and long-term efficacy of half-normal saline compared to normal saline for irrigation of open-irrigated catheters during catheter ablation for the treatment of cavotricuspid isthmus dependent atrial flutter.

it is unclear whether ionic strength affects energy delivery and ablation lesion size during radiofrequency ablation for atrial flutter. given that saline contains ionic sodium and chloride in the solution, it has conductive properties that may disperse radiofrequency energy away from the tip-tissue interface, thereby reducing current density and lesion size compared to ablation with nonionic solutions. the efficacy of half-normal saline will be measured by the time taken to create bidirectional block across the cavotricuspid isthmus as well as the acute recurrence rate within 30 minutes of the initial occurrence of bidirectional block and the 1 year freedom from flutter recurrence.

Eligibility criteria:
inclusion criteria: * patients \> 18 years of age at the time of enrollment * patients presenting for right sided typical atrial flutter ablation who have a clinical indication to undergo catheter ablation * fully informed written informed consent by either the subject or subject's legal representative and ability for subject to comply with study responsibilities exclusion criteria: * the presence of thrombus within the left atrial appendage * prior catheter ablation of the cavotricuspid isthmus for right sided atrial flutter * the inability to provide consent or comply with study requirements * a predicted life expectancy of \< 12 months
microbiota as potential target for food allergy

Conditions: Cow Milk Allergy

Summary: food allergy (fa) derives from a dysregulation of oral tolerance mechanisms. studies suggest a crucial role for enteric microflora in oral tolerance development. an altered composition of intestinal microflora results in an unbalanced local and systemic immune response to food allergens. there are qualitative and quantitative differences in gut microbiota composition in children with food allergy. these findings support the concept that specific beneficial bacteria from human intestinal microflora, designated probiotics, could restore intestinal microflora homeostasis and prevent or treat fa.


Eligibility criteria:
inclusion criteria: * children with cow's milk allergy * age 6-12 months exclusion criteria: * concomitant chronic systemic diseases * congenital cardiac defects * active tuberculosis * autoimmune diseases * immunodeficiency * chronic inflammatory bowel diseases * celiac disease, cystic fibrosis * metabolic diseases * malignancy * chronic pulmonary diseases * malformations of the gastrointestinal tract * suspected eosinophilic esophagitis or eosinophilic enterocolitis * suspected food-protein-induced enterocolitis syndrome.