Kornimate/medical-research-clean huggingface dataset:
optic nerve head structural response to iop elevation in patients with keratoconus

Conditions: Keratoconus; Glaucoma

Summary: the mechanism by which vision loss in glaucoma occurs is still unknown, but it is clear that increased intraocular pressure (iop) is a major risk factor. it is also thought that the lamina cribrosa (lc) is a site of primary damage during the pathogenesis of the disease. the changes caused by intraocular pressure (iop) modulation at the level of the optic nerve head and lc will be evaluated in the present study. subjects with keratoconus exhibit abnormal collagen properties that can impair their lc behavior. by evaluating their lamina biomechanical response we can advance our understanding on the role of the lamina in glaucoma pathogenesis. a better understanding of the process will ultimately lead to improved detection and management of glaucoma. it is hypothesized that subjects with keratoconus have an abnormal biomechanical response of the lamina cribrosa in response to iop modulation.


Eligibility criteria:
inclusion criteria: candidates must meet the following inclusion criteria in order to participate in the study. * ability to provide informed consent and to understand the study procedures keratoconus: * clinical diagnosis of keratoconus * central thinning of the cornea * abnormal posterior ectasia. glaucoma: * glaucomatous onh abnormality: rim thinning, notching, undermining (excavation) or diffuse or localized rnfl defects that are characteristic of glaucoma. * two consecutive abnormal sita standard perimetry tests with ght outside normal limits. exclusion criteria: candidates that meet any of the exclusion criteria at baseline will be excluded from study participation. * media opacity (e.g. lens, vitreous, cornea). * strabismus, nystagmus or a condition that would prevent fixation. * diabetes with evidence of retinopathy. * previous intraocular surgery or ocular trauma (with the exception of laser procedures and subjects that have undergone uneventful cataract surgery more than 6 months from enrollment date). * neurological and non-glaucomatous causes for visual field damage. * any intraocular non-glaucomatous ocular disorders.
neural correlates of psychiatric disorders

Conditions: Psychiatric Disorder; Memory Disorders

Summary: this clincialtrials.gov record originally corresponded to the protocol approved under irb # 202370. the study was expanded to include stimulation and recordings approved under new irb #211037. the participant data originally acquired from irb# 202370 will be included in this new record: this study seeks to better understand the neural activity underlying neuro cognitive disorders. resting state local field potential recordings will be collected from medically refractory epilepsy patients implanted with depth electrodes for seizure localization, and metrics of neural activity will be correlated with psychiatric symptoms as measured from questionnaires. subjects will also participate in neuro cognitive tasks while neural recordings are performed, and/or receive neural stimulation through implanted depth electrodes. a better understanding of disordered neural activity underlying neuropsychiatric disorders may additionally contribute to novel methods for diagnosing, treating, and preventing these diseases.


Eligibility criteria:
inclusion criteria: * undergoing seeg monitoring at vanderbilt university medical center * at least 18 years of age * english speaking exclusion criteria: * age \<18 * not able to complete questionnaires (e.g., unable to comprehend instructions or follow directions)

Keywords: depression stereo electroencephalography (seeg) anxiety obsessive compulsive disorder impulsivity memory
phase i/ii study of pro044 in duchenne muscular dystrophy (dmd)

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this study is to see whether pro044 is safe and effective to use as medication for dmd patients with a mutation around location 44 in the dna for the dystrophin protein.

to assess the effect of pro044 at different dose levels in subjects with duchenne muscular dystrophy to assess the safety and tolerability of pro044 at different dose levels in subjects with duchenne muscular dystrophy to determine the pharmacokinetics of pro044 at different dose levels after subcutaneous and intravenous administration in subjects with duchenne muscular dystrophy.

Eligibility criteria:
inclusion criteria: 1. boys aged between 5 and 16 years inclusive. 2. duchenne muscular dystrophy resulting from a mutation correctable by treatment with pro044. 3. life expectancy of at least 6 months. 4. no previous treatment with investigational medicinal treatment within 6 months prior to the start of the (pre)-screening for the study. 5. no previous treatment with idebenone within 6 months prior to the start of the (pre)-screening for the study. 6. willing and able to adhere to the study visit schedule and other protocol requirements. 7. written informed consent signed (by parent(s)/legal guardian and/or the patient, according to the local regulations). 8. glucocorticosteroids use which is stable for at least 2 months prior first drug administration. exclusion criteria: 1. aberrant rna splicing and/or aberrant response to pro044, detected by in vitro pro044 assay during pre-screening. 2. known presence of dystrophin in ≥ 5% of fibers in a pre-study diagnostic muscle biopsy. 3. severe muscle abnormalities defined as increased signal intensity in \>50% of the tibialis anterior muscle at mri. 4. fev1 and/or fvc \< 60% of predicted. 5. current or history of liver or renal disease. 6. acute illness within 4 weeks prior to treatment (day 1) which may interfere with the measurements. 7. severe mental retardation which in the opinion of the investigator prohibits participation in this study. 8. severe cardiac myopathy which in the opinion of the investigator prohibits participation in this study. 9. need for mechanical ventilation. 10. creatinine concentration above 1.5 times the upper limit of normal (age corrected). 11. serum asat and/or alat concentration(s) which suggest hepatic impairment. 12. use of anticoagulants, antithrombotics or antiplatelet agents. 13. use of idebenone. 14. use of any investigational product within 6 months prior to the start of the (pre)-screening for the study. 15. subject has donated blood less than 90 days before the start of the (pre)-screening for the study. 16. current or history of drug and/or alcohol abuse. 17. participation in another trial with an investigational product.
enhanced recovery after laparoscopic sleeve gastrectomy - a randomised controlled trial

Conditions: Morbid Obesity

Summary: the investigators wish to standardise and optimise perioperative care for consecutive patients undergoing laparoscopic sleeve gastrectomy for weight loss. the investigators will compare patients under a standardised perioperative care program to patients who undergo routine perioperative in our hospital and determine whether patients who had optimised perioperative care went home earlier and had fewer complications.


Eligibility criteria:
inclusion criteria: * patients undergoing laparascopic sleeve gastrectomy for weight loss by surgeons who have agreed to participate in the study * surgery occurs at manukau surgery centre exclusion criteria: * surgery not occuring in manukau superclinic

Keywords: perioperative care fast-track enhanced recovery after surgery eras obesity bariatric surgery laparoscopic sleeve gastrectomy
kombucha tea for improving defecation in patients with schizophrenia- a randomized controlled study

Conditions: Schizophrenia; Constipation; Kombucha Tea

Summary: patients with schizophrenia frequently have difficulties in bowel habits due to medical adverse effects and unhealthy lifestyle, and the use of various interventions to ameliorate the problems have been noted in clinical setting. probiotics including kombucha tea have been proved to modulate the human gut microbiota which may help to improve the stool passage, and have been attracting the public attention across the world. however, little is known among the patients with schizophrenia. in the present study, the research team intends to evaluate effectiveness of kombucha tea when used in the clinical settings.


Eligibility criteria:
* inclusion criteria: 1. inpatient patients diagnosed of schizophrenia according to dsm-5 criteria with the icd-10-cm codes of f20.x. and hold the cards for severe illness issued by the national health insurance administration, and 2. are currently and have been hospitalized at the psychiatric rehabilitation ward for more than 6 months, and 3. are at relatively stable psychiatric state and able to clearly express their perception or observed bowel conditions, and 4. are able to read or communicate with mandarin or taiwanese, and 5. are able to consent the agreements, and 6. subjectively experience difficulty in stool passage, such as decreased frequency, requiring medication or mechanic aids for defecating. * exclusion criteria: 1. having an allergic history to fermented food, alcohol or other food, or 2. severely impaired in cognitive performance, or 3. having medications, antibiotics, probiotic or other fermented products that may influence gut microbiota at the time or within 3 months of the study, or 4. having the illness that may affect stool passage or related with intestinal obstruction, such as severe gut disease, intestinal incarceration, tumor, inflammation, stenosis, or hemorrhoid, or 5. having received major gastro-intestinal surgeries, or 6. having the ongoing or history of medical illnesses, such as cancers, chronic obstructive pulmonary diseases, peripheral vascular diseases, autoimmune diseases, chronic kidney diseases, diseases involving abnormal metabolic function of visceral organs, or current infections, or 7. participating other ongoing interventional research that may interfere the implementation or the results of present studies, or 8. being obviously unable to comply with the execution of the study, or 10. being declared of guardianship.
omega-3 fatty acid and colorectal adenoma

Conditions: Colorectal Neoplasms; Adenoma Colon

Summary: patients aged \>40 years who underwent elective colonoscopies were recruited from ten institutions. patients with a history of colorectal cancer or long-term dietary interventions were excluded. participants completed a food frequency questionnaire (ffq) prior to endoscopy. ffq data were analyzed using energy-, age-, sex-, and body mass index-adjusted models; the dietary supplemental omega-3 intake was analyzed separately. colonoscopy outcome data, including the adenoma number, pathology, and location, were collected. participants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends using p for trend analysis.


Eligibility criteria:
inclusion criteria: * all patients aged more than 40 years of age, scheduled for elective colonoscopy. exclusion criteria: * inflammatory bowel diseases * history of colorectal neoplasms * prior gastrointestinal surgery * substance abuse including alcohol * an inability to complete the survey due to emergency endoscopy * cognitive impairments and those undergoing significant dietary modifications
venetoclax for prevention of differentiation syndrom in acute promyelocytic leukemia patients

Conditions: Acute Promyelocytic Leukemia

Summary: this study is to assess the efficacy and safety of venetoclax for prevention of ds in apl patients undergoing atra/ato induction regimen.


Eligibility criteria:
inclusion criteria: 1. patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent. 2. patients must have confirmation of apl by who criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. diffusing capacity of the lung for carbon monoxide (dlco) ≤ 65% or forced expiratory volume during the first second (fev1) ≤ 65%. creatinine clearance \&lt; 45 ml/min. moderate hepatic impairment with total bilirubin \&gt; 1.5 × uln. any other comorbidity that the physician judges to be incompatible with intensive chemotherapy. exclusion criteria: 1. patient is ineligible for treatment with intensive chemotherapy 2. patient with active infection not controlled, active bleeding from vital organs 3. patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study
a polypill for secondary prevention of ischemic heart disease

Conditions: Acute Myocardial Infarction; ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction

Summary: cardiovascular diseases (cvd) are the leading cause of mortality and morbidity worldwide. the most important aspect of cvd secondary prevention is adherence to guideline-indicated pharmacological therapy which globally remains low. in previous studies, a polypill containing fixed dose combination of essential drugs have improved patient adherence to these drugs. the effect of such a strategy on pharmacological therapy uptake, cost-effectiveness, and cvd recurrence in our setting will be assessed in this study. participants hospitalized in three referral hospitals in isfahan, iran because of an acute myocardial infarction (mi) (st elevation mi (stemi) or non-st elevation mi (nstemi)) will be randomized to either receiving polypill or usual care after mi. patient recruitment will be carried out at the time of patient discharge from the hospitals.


Eligibility criteria:
inclusion criteria: * patients hospitalized because of an acute myocardial infarction (stemi/nstemi) and alive after discharge for at least 1 month * signing informed consent * clear indication of receiving all components of polypill (aspirin, statin, ace inhibitor/arb, and beta blocker) * living in isfahan city or nearby areas so that they can attend follow-ups * no mental illness limiting their self-care ability or severe illness with an estimated lifespan of less than 3 years * no history of adverse reaction or contraindication to any component of the polypill * not having secondary hyperlipidemia, serum creatinine ≥ 2, severe heart failure * no plan for a procedure (cabg, pci, or another surgical procedures) within following 6 months exclusion criteria: * patient unlikely to complete trial * need to change or discontinue any of the four principal drugs of the polypill to achieve better control of the disease or risk factors or because of adverse drug reactions (based on physician's idea) * severe illness with an estimated lifespan of less than 3 years

Keywords: cardiovascular disease fixed dose combination therapy cost effectiveness
vertical split conjunctival autograft in double-head pterygia

Conditions: Pterygium of Conjunctiva and Cornea

Summary: 15 eyes of 15 patients with primary double-headed pterygia that underwent vertical split conjunctival autograft pterygium surgery were retrospectively reviewed. all patients had primary double-headed pterygia. recurrence was defined as fibrovascular proliferation over the limbus onto the cornea. vertical split conjunctival autograft using fibrin glue is an effective technique with good cosmetic results and low to no recurrence for primary double head pterygia treatment.

the pterygium body was dissected from the sclera. complete excision of the pterygium, subconjunctival tenon's tissue and surrounding fibrovascular tissues followed.the conjunctival edge was trimmed. the corneal surface was gently scraped with a scalpel. the same procedure was done on temporal pterygia. a free conjunctival autograft was obtained. the graft was divided vertically into two parts. the nasal part of the graft was cut from limbal attachment including limbal tissue; temporal part was left attached. the nasal part of the graft was moved to the nasal conjunctival defect and attached to the sclera with fibrin sealant (tisseel; baxter, vienna, austria). the same procedure was done with the temporal part of the graft. the orientation of graft was ensured before securing it.

Eligibility criteria:
inclusion criteria: * primary double-headed pterygia exclusion criteria: * none

Keywords: pterygium double-headed vertical
rgx-111 gene therapy in patients with mps i

Conditions: Mucopolysaccharidosis Type I (MPS I); Hurler Syndrome; Hurler-Scheie Syndrome

Summary: rgx-111 is a gene therapy which is intended to deliver a functional copy of the α-l-iduronidase (idua) gene to the central nervous system. this is a safety and dose ranging study to determine whether rgx-111 is safe and tolerated by patients with mps i.

mucopolysaccharidosis type i (mps i) is a rare recessive genetic disease caused by a deficiency of α-l-iduronidase (idua) leading to an accumulation of glycosaminoglycans (gags) in tissues of patients with mps i. while currently available therapies, enzyme replacement therapy (ert) and hematopoietic stem cell transplantation (hsct), provide clinical benefit over untreated disease progression, they still possess significant limitations. ert does not cross the blood-brain barrier and, therefore, does not treat the central nervous system (cns) effects of the disease, and hsct has clinically relevant morbidity and mortality and is not able to completely treat the cns effects. rgx-111 is designed to deliver a functioning gene enabling the production of idua in the brain. this is a phase i/ii, first-in-human, multicenter, open-label, dose escalation study of rgx-111. up to 11 subjects with mps i will be treated in 2 dose cohorts and will receive a single dose of rgx-111. safety will be the primary focus for the initial 24 weeks after treatment (primary study period) whereupon, subjects will continue to be assessed (safety and efficacy) for up to a total of 104 weeks following treatment with rgx-111.

Eligibility criteria:
inclusion criteria: 1. has documented evidence of cns involvement due to mps i or documented diagnosis of severe mps i 2. subjects who have had hsct may be enrolled in the study if the pi, medical monitor, and sponsor agree that he/she can participate in the study. exclusion criteria: 1. has contraindications for intracisternal and intracerebroventricular injection or lumbar puncture. 2. has contraindications for immunosuppressive therapy. 3. has neurocognitive deficit not attributable to mps i or diagnosis of a neuropsychiatric condition. 4. received intrathecal (it) laronidase at any time and experienced a significant ae considered related to it administration 5. has received intravenous (iv) laronidase at any time and experienced a significant ae considered related to iv administration. 6. received any investigational product within 30 days of day 1 or 5 half-lives before signing of the informed consent form (icf), whichever is longer. 7. has alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>3 × upper limit of normal (uln) or total bilirubin \>1.5 × uln at screening unless the subject has a previously known history of gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin \<35% of total bilirubin.

Keywords: mps i , gene therapy, hurler, hurler- scheie
viral kinetic study with viramidine in therapy-naive patients with chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to examine the rapid virologic response (rvr) at combination therapy (ct) week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.

this phase 2b multicenter study, which is being conducted solely in the united states, consists of a randomized, double-blind, monotherapy period, where patients will receive either viramidine or placebo for 4 weeks. after the monotherapy period, all patients will receive viramidine plus peginterferon alfa-2b combination therapy for 48 weeks in an open-label fashion and will then participate in a 24-week follow-up period after completion of combination therapy. the rvr at ct week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy will be examined. the differences in virological response during treatment and end of follow-up between african-americans and caucasians (non-hispanics), as well as a correlation between duration of viral negativity (dvn) and sustained virologic response (svr) based on race and dosing regimen, will also be assessed.

Eligibility criteria:
inclusion criteria: * treatment-naive, genotype 1 only, compensated, chronic hepatitis c infected caucasian or african-american patients * body weight greater than 61 kg and not more than 87.3 kg * hcv rna greater than 2 million copies/ml * elevated measured or historical alanine aminotransferase * hemoglobin at least 12.0 g/dl for females and at least 13.0 g/dl for males * calculated creatinine clearance greater than 70 ml/min exclusion criteria: * cirrhosis of the liver * alanine aminotransferase greater than 3 times the upper limit of normal * severe neuropsychiatric disorders * history or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease * other co-morbid chronic viral infections including hepatitis b and the human immunodeficiency virus (hiv)

Keywords: viramidine peginterferon alfa-2b valeant hepatitis c rapid virologic response hcv rna
dysregulation of glutamine activity in the pathogenesis of multiple myeloma

Conditions: Monoclonal Gammopathy of Undetermined Significance; Plasma Cell Myeloma

Summary: this clinical trial studies the utilization of glutamine by the bone marrow plasma cells from patients with monoclonal gammopathy of undetermined significance (mgus) compared to multiple myeloma (mm). results from this study may identify metabolic differences between pre-malignant and malignant clonal plasma cells in mgus and mm, respectively. it may also allow researchers better determine the transition from mgus to mm for the development of potential early diagnostic purposes of preventative strategies.

primary objective: i. compare the glutamine anaplerosis activity in bone marrow clonal plasma cells (cpcs) between patients with mgus and mm using an in vivo and an ex vivo approach. secondary objectives: i. compare the tricarboxylic acid (tca) isotopomer enrichment in the bone marrow plasma obtained from patients with mgus and mm with the in vivo approach. ii. determine the peripheral blood enrichment of 13c in the tca cycle intermediates from patients with mgus and mm with the in vivo approach. outline: patients are assigned to 1 of 2 groups. group i (ex-vivo): after an overnight fast of 6 hours, patients undergo collection of blood samples. group ii (in vivo): after an overnight fast of 6 hours, patients receive 13-carbon labeled glutamine or 13-carbon-labeled glucose intravenously (iv) over 90 minutes. patients also undergo collection of blood and bone marrow aspirate samples. after completion of study, patient are followed up for 4 weeks.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * international myeloma working group (imwg) criteria for the diagnosis of either mgus or mm exclusion criteria: * unable to provide consent * eastern cooperative oncology group (ecog) performance status (ps) \> 3 * hemoglobin \< 8 g/dl * women who are pregnant * prior history of adverse events with conscious sedation