Kornimate/medical-research-clean huggingface dataset:
evolution of ocular growth in myopic children: a prospective cohort study

Conditions: Myopia

Summary: myopia and high myopia are the leading causes of visual impairment and blindness worldwide. the total number of myopic people globally was estimated to be 2.6 billion in 2020, and it could reach 4.8 billion by 2050 unless preventive interventions are implemented. strategies to slow the progression of myopia, such as contact lenses, orthokeratology, atropine, and increased time spent outdoors, have shown promising results, although evidence varies depending on the method. however, most research has been conducted in asia, and there are few studies on ocular growth in myopic children in europe. meanwhile, the prevalence of myopia is also increasing significantly in europe, particularly in france. understanding the growth of the myopic eye in european children is crucial. cohort studies of myopic children are scarce and do not always include high-quality imaging. a cohort of myopic children with prospective collection of the best retinal and corneal images, along with ophthalmological exams to detail and model the growth of the myopic eye, will provide valuable insights to enhance our understanding of ocular growth and its inter-individual variability.


Eligibility criteria:
inclusion criteria: * myopia in at least one eye, defined as a refractive error in spherical equivalent ≤ -0.50 diopters (autorefraction under cycloplegia) * affiliated or beneficiary of a social security system * explicit consent from a holder of parental authority exclusion criteria: * presence of trauma in both eyes * presence of inflammatory conditions in both eyes * history of intraocular surgery (cataract, filtering surgery, intra-vitreal surgery) in both eyes * patient benefiting from legal protection measures
angiopredict. icorg 12-16, v3

Conditions: Advanced Colorectal Cancer

Summary: primary objective: the primary objective is to validate previously identified predictive/prognostic genomic dna and expression biomarkers of response to combination bvz treatments in k-ras mutant advanced crc (a crc) or metastatic crc (mcrc). secondary objective: 1. to test the efficacy of bvz in combination with folfox in patients with newly diagnosed advanced or metastatic k-ras mutant crc and 2. to determine the progression free and overall survival of patients under first line folfox + bvz in acrc or mcrc.

study design: type of study: exploratory, translational, multicenter and multinational phase ii study. patient population:all patients from the intent-to-treat population with acrc or mcrc, (incurable with any conventional multimodality approach) and who fulfil all inclusion and exclusion criteria. number of patients: 224 sample type: serial tissue and blood samples will be collected before (week 0), during (week 6, month 3 and 6) and at the end of treatment (month 12).

Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years of age. 2. patients diagnosed with recurrent or de novo, locally advanced (unresectable) or metastatic adenocarcinoma of the colon or rectum. 3. planned combination bevacizumab (bvz) treatment with either: * leucovorin, fluorouracil and oxaliplatin (folfox) * capecitabine and oxaliplatin (xelox) * leucovorin, fluorouracil and irinotecan (folfiri) * capecitabine and irinotecan (xeliri) 4. naive for bvz 5. an evaluable site of disease 6. ecog performance status 0, 1, or 2 7. adequate renal function as shown by serum creatinine ≤ 1.5 x uln or gfr ≥ 50ml/min 8. adequate hematopoietic function \[white blood cell (wbc) count ≥ 3000/μl, absolute neutrophil count (anc) ≥1500/μl, platelets ≥100 000/μl, haemoglobin level ≥ 9.0 g/dl\] 9. adequate end organ function, defined as the following: total bilirubin \< 1.5 x uln, sgot and sgpt \< 3.0 x uln (in case of liver metastases sgot and sgpt \< 5.0 x uln) 10. ability to give signed informed consent prior to any screening procedures 11. ffpe tissue is available exclusion criteria: 1. patient has received any other investigational product within 28 days of first day of study drug dosing 2. patients having familial and/or hereditary crc 3. crc associated with ulcerative colitis 4. patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Keywords: colorectal cancer advanced colorectal cancer metastatic colorectal cancer locally advanced colorectal cancer colon cancer rectal cancer
wearables to define postpartum blood pressure trajectories and facilitate evidence-based monitoring guidelines

Conditions: Hypertension, Pregnancy-Induced; Hypertension; Postpartum Preeclampsia; Postpartum Complication; Postpartum Pre-Eclampsia; Cardiovascular Diseases; Cardiovascular Morbidity; Morbidity;Perinatal

Summary: to better understand postpartum blood pressure changes, we are proposing a study to monitor blood pressure after delivery in 100 patients who we expect to have normal blood pressure (i.e. low-risk group), 100 patients who we expect to be at risk of new-onset high blood pressure postpartum (i.e. intermediate-risk group), and 100 patients who had high blood pressure prior to pregnancy (or very early, before 20 weeks in pregnancy) who we know are at high risk of blood-pressure related complications postpartum (i.e. high-risk group). patients will be given a non-invasive wearable device that monitors blood pressure continuously for 6 weeks postpartum. we expect that the daily changes in blood pressure will be different between these groups, which may allow us to better predict who is at risk, how much monitoring is needed, and when to intervene before the blood pressure abnormalities cause complications. the blood pressure device that will be given to patients is the yhe® bp doctor med blood pressure smartwatch. this is a highly-accurate medical grade device that has not received fda clearance. as such, the device is not being used to make blood pressure management and treatment decisions, but rather to gather data on postpartum cardiovascular physiology. safety stops are built into the protocol such that elevated readings detected by the watch will trigger clinical referrals and validation by standard blood pressure cuffs prior to determine need for treatment.


Eligibility criteria:
inclusion criteria: * postpartum birthing person 18 years of age or older * at least 20 weeks gestation at time of delivery * meeting criteria for 1 of 3 risk categories for pp htn and hypertensive morbidity * planned postpartum care at ucsd exclusion criteria: * inability to give informed consent * institutionalization for psychiatric disorder, mental deficiency or incarcerated * initiation of antihypertensive therapy prior to discharge from delivery hospitalization.
aquatic therapy and autism spectrum disorders

Conditions: Autism Spectrum Disorder

Summary: to compare the efficacy of one-on-one versus group-based aquatic therapy on the social interactions, behaviors and physical activities of children with autism spectrum disorders (asds).


Eligibility criteria:
eligibility criteria: * dsm-v diagnosis of autism spectrum disorder or dsm-iv diagnosis of asperger's syndrome or high functioning atypical autism or pervasive development disorder - not otherwise specified or else the typical clinical findings and suspicion of an asd * treatment naïve to prior aquatic therapy exclusion criteria: * not willing to undergo an investigational treatment * unable to cooperate well enough to safely participate in aquatic therapy under the protocol guidelines * known allergies to pool chemicals * other significant co-morbidities which may include (but is not limited to): severe cerebral palsy with low motor function, advanced pulmonary disease, home oxygen requirement, spina bifida with low motor function, permanent feeding tubes, poorly controlled seizure disorder, chronic indwelling urinary catheters or any condition causing severe cognitive impairment

Keywords: aquatic therapy, hydrotherapy
fresh corneal lenticule implantation in hyperopic patients with high astigmatism

Conditions: Hyperopia; High Astigmatism

Summary: the refractive combination of high hyperopia with high astigmatism is difficult to treat surgically. in addition, there are not many suitable options to offer such patients presenting with this condition. the method used at the eye hospital pristina using fresh lenticule implantation by relex-smile is safe and effective method. fresh corneal implantation is a safe treatment for hyperopia with high astigmatism comparing with refractive iol implantation (loss of accommodation, endophthalmitis). its primary objective is to increase visual acuity, accommodation process, patient satisfaction which makes patient to enjoy a happier life. we believe this study will be the future of refractive surgery for treating high hyperopia.

this study is to investigate the effect of fresh corneal lenticule implantation as allogenic implant that will be taken from myopic patients to implant in hyperopic patients with high astigmatism using visumax femtosecond laser - smile module surgery with primary objective to assess (increase) visual acuity (far, intermediate, near vision) and secondary objective to stabilize (decrease) high astigmatism by reducing k-values.

Eligibility criteria:
inclusion criteria: * patients with high spherical hyperopia over + 4.5 d * astigmatism over + 3 cyl. * corneal thickness minimum 450 µm and maximum 550 µm. exclusion criteria: * corneal thickness over 550 µm * history of glaucoma * retinal detachment * cataract * history of ocular inflammation.
effect of folic acid in levodopa treated parkinson's disease patients

Conditions: Parkinson Disease

Summary: this is a prospective single center, randomized, double-blind, 2 arm placebo-controlled study in subjects with parkinson's disease receiving levodopa .the patients will be randomized to receive tablet folic acid 10 mg per day or placebo for 8 weeks. the safety and efficacy outcome measures will be assessed at baseline and 8 weeks.

parkinson's disease is a progressive neurodegenerative disorder that is caused by degeneration of dopaminergic neuron in the substantia nigra. most commonly used drug, levodopa can improve the dopamine level in brain but levodapa causes hyperhomocysteinmia as a result increse neurotoxicity,oxidative stress and motor fluctuations and dyskinesia in many patients. folic acid has been reduced homocystein level in levodopa treated parkinson's disease on animal model and also reduced levodopa induced dyskinesia without compromising the motor benefits of levodopa. therefore, the present study is to attempt to improve the sign symptoms of parkinson's disease by giving folic acid along with levodopa. this study is a randomized, double-blind, placebo-controlled trial and conducting at department of pharmacology, bsmmu in collaboration with department of neurology, bsmmu. a total of 60 patients suffering from parkinson's disease is selected according to inclusion and exclusion criteria. the diagnosis of the patients suffering from parkinson's disease will be performed by a neurologist at movement disorder clinic of department of neurology, bsmmu. patients will undergo mds-unified parkinson's disease rating scale (mds-updrs) to assess the severity of the disease. the patients will be randomly allocated into two arms: control and intervention. patients in intervention arm consisted of 30 patients who will receive levodopa plus folic acid orally for 8 weeks. on the other hand, control arm consisted of 30 patients who will receive levodopa plus placebo for 8 weeks. the severity of parkinson's disease will be assessed 8 weeks follow up.

Eligibility criteria:
inclusion criteria: * diagnosed pd patients taking levodopa for at least 6months. * mild to moderate parkinson's disease patient according to hoehn and yahr staging, stage -i, ii, iii * homocysteine level ≥ 13 µmol/l exclusion criteria: * secondary causes of parkinsonism * prior stereotactic surgery for pd * suffering from active malignancy * known hypersensitivity to folic acid * multivitamin supplementation within 30 days of enrollment * patients taking anticonvulsant, oral contraceptive pill, disease modifying anti-rheumatic drugs * pregnancy or lactating mother * has any clinically significant medical condition that could interfere with the subject's ability to safely participate in the study or to be followed
lung transplant hcv, pilot study

Conditions: Lung Transplant Infection; Hepatitis C

Summary: in this study hcv negative recipients will be transplanted with hcv positive lungs. investigators will attempt to decrease infectivity rates by performing normothermic ex vivo lung perfusion (evlp), which is an approved method of donor lung preservation, assessment and treatment, and could be an excellent platform to reduce/eliminate hepatitis c virus. patients will be treated by the standard approved direct-acting antivirals (daas) if infection occurs. it is planned to enroll 20 patients from the lung transplant wait list in this study. patients will be actively followed for 6 months including hcv pcr tests and then for up for 5 years to look for evidence of hcv infection and any liver or extra-hepatic complications, as well as standard post-transplant complications. this will be a single center pilot study.

the success of lung transplantation (ltx) is significantly hindered by the lack of sufficient number of available donors. many potential donor lungs cannot be utilized in clinical transplantation because donors have chronic viral infections such as hepatitis c (hcv) infection. this study will test the possibility of safely transplanting lungs from hcv positive donors. donor lungs will be subjected to normothermic ex vivo lung perfusion (evlp) for 6 hours for organ assessment and reduction of viral load prior to transplantation. after transplantation, recipients will be carefully monitored for hcv infection and if infection occurs, they will be promptly treated with highly effective antiviral therapy using newly approved daas. the aim of the study is to show that transplantation of lungs from hcv positive donors is safe in the era of daas. the hypothesis is that the rate of hcv transmission to recipients will be lower than previously described due to evlp pre-treatment and any hcv transmission that does occur will be readily treatable and curable. if successful, the knowledge from this study can have a large impact to patients with end stage organ diseases by providing a large novel source of donors for lung and potentially other organ transplantations.

Eligibility criteria:
inclusion criteria: * recipients listed for single or bilateral lung transplant * hcv nucleic acid amplification testing (nat) negative * ability to provide written informed consent exclusion criteria: * participation in another interventional clinical trial

Keywords: lung transplant hepatitis c daas epclusa
reconstruction of the anterior cruciate ligament of the knee joint, by the method of stabilization of the screw with a bioabsorbable method, with or without the use of autogenous spongiform bone grafts.

Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Knee Injuries; Knee Ligament Injury

Summary: clinical and comparative evaluation of the results of autograft healing of the tendon of the semitendinus muscle in the tibial canal, after reconstruction of the anterior cruciate ligament of the knee joint, by the method of stabilization of the screw with a bioabsorbable method, with or without the use of autogenous spongiform bone grafts.

assessment of the results of autograft healing of the tendon of the semitendinus muscle in the tibial canal, after the reconstruction of the anterior cruciate ligament (acl) of the knee joint using the arthroscopic technique, with the method of tibial stabilization with a bioabsorbable screw (arthrex) with the use of autogenous transplantation of spongy bone, drilling of the tibial canal inserted into the tibial canal prior to insertion of the screw. the detailed objectives are: comparison of the treatment results - healing and reconstruction of the autograft of the semitendinus tendon in the tibial canal of the knee joint, obtained in the study groups using two methods: a- stabilization of the tibial attachment with a bioabsorbable screw (arthrex) with simultaneous application to the tibial canal of autogenous cancellous bone grafts taken during the drilling of this canal and b- stabilization of the tibial insertion with a bioabsorbable screw (arthrex) without simultaneous application of autogenous cancellous bone grafts to the tibial canal.

Eligibility criteria:
inclusion criteria: * age 18-65 years; * surgery for acl damage to the knee joint; * arthroscopic surgery; * no prior knee surgical interventions; * no additional pathologies in this anatomical area; * informed consent of the patient to participate in the study. exclusion criteria: * age under 18 or over 65; * previous surgical interventions in the examined anatomical area; * additional pathologies in this area identified as part of preoperative diagnostics; * damage to the second knee joint; * failure to comply with the rigor of the same rehabilitation treatment protocol.

Keywords: injury rupture damage reconstruction techniques
mxa and crp-guided use of antimicrobial agents for aecopd

Conditions: Acute Exacerbation Chronic Obstructive Pulmonary Disease

Summary: this randomized controlled trial will investigate the clinical impact of myxovirus resistance a (mxa) and c-reactive protein (crp)-guided antimicrobial treatment compared to usual care in outpatients with acute exacerbations of chronic obstructive pulmonary disease (aecopd).

respiratory viral infections are a leading cause of acute exacerbations of chronic obstructive pulmonary disease (aecopd). however, there is currently a lack of rapid diagnostic methods to differentiate the cause of aecopd, resulting in insufficient attention to viral-induced exacerbations, with antibiotic treatment remaining the primary treatment. myxovirus resistance protein a (mxa) has been identified as a potential biomarker to distinguish respiratory viral infections, while c-reactive protein (crp) has been confirmed as a useful guide for antibiotic therapy in aecopd. this randomized controlled trial aims to investigate the clinical value of mxa and crp-guided antimicrobial treatment in outpatients with aecopd, with the goal of reducing antibiotic overuse and improving patient outcomes.

Eligibility criteria:
inclusion criteria: * ≥40 years old； * current or former smoker with a minimum smoking history of 10 pack years, clinical diagnosed with mild-to-severe copd; * presenting with an acute exacerbation of copd * the severity of aecopd is mild to moderate. exclusion criteria: * required urgent hospitalization * received interferon therapy within 30 days before screening * had an active systemic inflammatory condition within 30 days prior to screening, such as cerebral infarction, myocardial infarction, or surgery * received vaccine in the past 30 days * active tuberculosis * immunocompromised * presenting with current respiratory failure * clinical suspicion of pneumonia or pulmonary edema. * coexisting bronchiectasis, cystic fibrosis, or asthma * had a concurrent infection at another site, such as urinary tract infections or sinusitis; * contraindications to antibiotics and/or antivirals * known etiology of the present exacerbation * pre-treatment with corticosteroids (cumulative dose of methylprednisolone ≥ 80 mg or equivalent dose) for the present exacerbation.
probiotics therapy of mood disorders

Conditions: Depression

Summary: the evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.

the aim: the evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group. the study hypothesis: by using periodic probiotics therapy it is possible to positively influence the mood of women with depressive syndromes. these efforts focus on the improvement of the functioning of the gut barrier and gut-brain axis. in practice, such activities should lead to the reduction in the dysfunction of the barrier, the reduction of endotoxemia and the concentration of neurotoxic metabolites of tryptophan (in blood) with the simultaneous increase in the content of butyric acid that has a neuroprotective effect. the of the trial: intervention, cohort, randomized, double-blind, using placebo. a multi-strain probiotic will also be provided ( bifidobacterium bifidum w23, bifidobacterium lactis w52, lactobacillus acidophilus w37, lactobacillus brevis w63, lactobacillus casei w56, lactobacillus salivarius w24, lactococcus lactis w19 and lactococcus lactis w58 or maize starch, maltodextrins and vegetable protein/placebo). the applied method of study: 1. a controlled dietary intervention that includes probiotics therapy; the verification of the past nutritional pattern (the food frequency questionnaire); anthropometric measurements; 2. psychiatric studies: the evaluation of sleep disorders (the athens insomnia scale) and mood (the beck scale), and the worsening of depression (the hamilton scale); 3. biochemical studies: the content of short chain fatty acids (in the stool); 4. cytometric studies (b-type lymphocytes' panel, t-type lymphocytes' panel, regulatory t cells' panel); 5. genetic (the microbiome of bacteria in the stool, pyrosequencing); 6. chromatographic (the derivatives of tryptophan e.g., kynurenine, anthranilic acid, kynureic acid, 3-hydroxykynurenine, 5-hydroxytryptophan, serotonin). currently, there is an urgent problem to develop recommendations regarding the nutrition and probiotics therapy that could complement the therapy of women with mood disorders. if the achieved results confirm the study hypothesis, it will be possible to: 1. better understand the pathomechanism of mood disorders in the perimenopausal period; 2. develop a holistic strategy for depressive disorders in women in the menopause period.

Eligibility criteria:
inclusion criteria: * must presence of mood disorders confirmed by beck scale (more than 10 points) * must be able to swallow tablets exclusion criteria: * individuals that had prescribed antibiotics, proton pump inhibitors, or probiotics in the 6 months preceding the study (eg. inflammatory bowel syndrome) * circulatory disorders patients * diagnosed coagulopathies, * diagnosed respiratory disease * inflammatory bowel disease patients * addicted to alcohol * addicted to psychoactive substances,

Keywords: probiotics mood depressive therapy
effects of total parenteral nutrition on skeletal muscle genomics.

Conditions: Wasting;Muscle(S)

Summary: the study investigates effects related to muscle protein metabolism at provision of total parenteral nutrition.

randomized study investigating alterations in muscle protein metabolism at provision of parenteral nutrition. the study uses a genomic/transcriptomic/proteomic approach to evaluate factors related to activation of skeletal muscle protein synthesis. patients scheduled for major gastrointestinal surgery are included. muscle specimens are collected during surgery.

Eligibility criteria:
inclusion criteria: * major gastrointestinal surgery * assumed need of post-operative artificial nutrition. exclusion criteria: * insulin dependent diabetes * steroid medication