Kornimate/medical-research-clean huggingface dataset:
evolution of a novel optical coherence tomography based index in diagnosing keratoconus

Conditions: Scansys, Pentacam, Keratoconus, Subclinical Keratoconus

Summary: comparison of corneal topography based on oct oct principle (casia2) with pentacam and scheimpflug-based biomechanical devices (corvis st) in screening and diagnosing keratoconus; and evaluation of the consistency with pentacam in measuring corneal parameters (such as curvature and thickness).


Eligibility criteria:
inclusion criteria: 1. best corrected visual acuity (bcva) ≥ 20/20; 2. no other eye diseases except myopia and astigmatism; 3. the cornea was transparent, and there was no cloud or pannus; exclusion criteria: 1. the presence of ocular diseases other than myopia and keratoconus; 2. ocular trauma; 3. previous ocular surgery; 4 patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination; 6. pregnant and lactating women;

Keywords: scansys, pentacam, keratoconus, subclinical keratoconus
evaluation and risk factors of post-traumatic endophthalmitis

Conditions: Endophthalmitis

Summary: 1. identify the incidence of post-traumatic endophthalmitis and the related risk factors influencing its development. 2. study the clinical- microbiological profile and evaluate the functional and anatomical outcomes of post-traumatic endophthalmitis (ppte).


Eligibility criteria:
inclusion criteria: * patients exposed to eye trauma and developed post-traumatic endophthalmitis exclusion criteria: * patients who refuse to sign informed consent in this study
ocrelizumab access by socio-economic status

Conditions: Multiple Sclerosis

Summary: the primary aim of this project is to determine whether there are differences in access to, efficacy and tolerability of ocrelizumab in men and women of different racial and ethnic origins and socio-economic backgrounds with rrms and ppms in two large academic ms centers with a high volume of patients on ocrelizumab. the study is a retrospective analysis of multiple sclerosis patients cared for at brigham and women's hospital and boston medical center who were treated with ocrelizumab during the 4 year study period.

this study will be a two-center retrospective/observational analysis with data collected from the research patient data registry (rpdr), brigham multiple sclerosis center patient database (oracle), and boston medical center ms clinic database (bmc-ms). using the oracle database, bmc-ms database and electronic medical records (epic), the investigators will capture all ms patients who satisfy inclusion criteria. this study will collect age, sex, race, socio-economic status by residence zip code, disease duration, previous treatment, current treatment status, the reason for discontinuing or switching to another treatment, expanded disability status scale (edss), and functional systems scores (fss) where available. additionally, the investigators will collect the date, dose, and interval between each ocrelizumab infusion, as well as any pertinent laboratory values and mri scan results.

Eligibility criteria:
inclusion criteria: * all ms patients at the brigham ms center and boston medical center ms clinic who have been diagnosed with rrms or ppms, ages 18 or older, on ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord mri, and who have received ocrelizumab infusions at these institutions for the duration of the study period. exclusion criteria: * simultaneous use of high dose monthly iv steroids, * secondary progressive ms (spms) disease category, * additional serious medical or neurologic co-morbid diseases, * additional concomitant immunosuppressive therapy of any kind, * additional concomitant ms-specific therapy (dmt) of any kind, * change of infusion or care site and absence of neurologic or imaging follow-up.
ultra structure of peritoneum at electronic microscopy in control subjects and patients with gastric cancer

Conditions: Stomach Neoplasm

Summary: peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. objectives: to study ultra-structure of peritoneal surface by electronic microscopy in control subjects and in patients with early or locally advanced gastric cancer looking for spontaneous changes in peritoneal surface not related with surgical injury.

18 out of 32 cases were eligible for analysis. four patients operated on for benign diseases served as control and 14 patients with operable local gastric adenocarcinoma (4 mucosa/submucosa/muscular y 10 serosa lesions) were studied. at the beginning of surgery, a 2 x 2 cm. sample from macroscopically normal visceral peritoneum at mesenterium root was carefully obtained, washed with saline and fixed in glutaraldehyde solution. besides a sample of peritoneal washing fluid was studied to exclude patients with free cancer cells. peritoneal tissue was fixed during 24 hours and then all samples were evaluated by electronic microscope.

Eligibility criteria:
inclusion criteria: * patients with operable local gastric adenocarcinoma exclusion criteria: * previous abdominal surgery * previous open or blunt abdominal trauma * history of inflammatory bowel disease or typhoid fever, gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity. * all other gastric malignancies such as lymphomas, gist, carcinoids

Keywords: stomach neoplasms peritoneum
post-marketing surveillance study of otezla

Conditions: Psoriasis

Summary: to evaluate the safety and efficacy of otezla in actual clinical settings of use in patients with psoriasis vulgaris that is with an inadequate response to topical therapies and psoriasis arthropathica 1. planned registration period 2 years 2. planned surveillance period for 4 years from 6 months after launch


Eligibility criteria:
inclusion criteria: - patients who have received a diagnosis of either of the following diseases and have received otezla for the first time will be included in this survey. * psoriasis vulgaris that is with an inadequate response to topical therapies * psoriasis arthropathica exclusion criteria: * n/a

Keywords: psoriasis vulgaris psoriasis arthropathica serious infections gastrointestinal disorders serious hypersensitivity weight decrease vasculitis malignancies depression and suicidal ideation
open-label trial to determine the long-term safety of safinamide in parkinson's disease patients

Conditions: Parkinson's Disease

Summary: parkinson's disease (pd) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. the understanding that pd is a syndrome of dopamine (da) deficiency led to the introduction in the clinical practice of l-dopa, a precursor of da that crosses the blood brain barrier, and also to the use of selective inhibitors of mao-b, the major da metabolising enzyme in humans. safinamide is an inhibitor of mao-b. this study is to evaluate the long term safety and tolerability of safinamide in pd patients, that have already completed a previous clinical study with safinamide. the physical and neurological conditions as well as other safety parameters will get compared from baseline to subsequent visits.


Eligibility criteria:
inclusion criteria: 1. the subject has completed a previous clinical study with safinamide in pd 2. the subject successfully completed all trial requirements of the antecedent trial 3. if female, they must be either post-menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential, they must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of study medication. for the purpose of this trial women of child bearing potential are defined of all female subjects after puberty unless they are postmenopausal for at least two years, are surgically sterile or are sexually inactive 4. subjects must be willing and able to participate in the trial and provide written informed consent exclusion criteria: 1. the subject experienced a clinically significant adverse effect to attributable to investigational medicinal product (imp) during a previous trial that could put the subject at risk for further treatment with safinamide 2. if female, the subject is pregnant or lactating 3. any medical issues, which have emerged since the initial clinical trial, that in the opinion of the investigator precludes a subject's ability to participate in this open-label trial

Keywords: mao inhibitors motor fluctuations dyskinesia parkinson's disease
a dose ascending, study to examine the safety, tolerability, pharmacokinetics and pharmacodynamics of gsk233705b.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: gsk233705 is a high-affinity specific muscarinic receptor (machr) antagonist which is being developed for the treatment of chronic obstructive pulmonary disease. this is a randomised, double-blind, placebo-controlled, dose ascending, parallel group study to examine the safety, tolerability, pharmacokinetics and pharmacodynamics of twice daily inhaled doses of gsk233705b for 7 days, in copd subjects.


Eligibility criteria:
inclusion criteria: * men or women who are between 40 and 75 years of age * female subjects must be of non-childbearing * subject diagnosed with copd * body mass index 18.0 - 32.0 kg/m2 (inclusive) * subject is a smoker or an ex-smoker * subject has post-bronchodilator (200µg salbutamol) fev1 of = 40% to = 80% of predicted normal. * subject has fev1/fvc \< 0.7 post-bronchodilator (200µg salbutamol). * capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * subject is available to complete all study measurements and procedures. * subjects have a 24hour holter recording that is within normal limits and does not demonstrate any clinically important abnormality that, in the opinion of the investigator, would make the subject unsuitable for participation in the study. exclusion criteria: * subjects who have a past or present disease, which as judged by the investigator and the medical monitor, may affect the outcome of this study. * the subject has a positive pre-study alcohol screen. * the subject has a positive pre-study drug screen. * history of alcohol/drug abuse or dependence within 12 months of the study: abuse * the subject has a positive pregnancy test. * a positive pre-study hepatitis b surface antigen or positive hepatitis c antibody result within 3 months of screening * subject has tested positive for hiv * the subject has participated in a clinical trial and has received a drug or a new chemical entity within 60 days or 5 half-lives * exposure to more than three new chemical entities (nce) within 10 months prior to the first dosing day or one nce within 3 months prior to the first dosing day. * the subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study. * the subject has a known allergy or hypersensitivity to ipratropium bromide, atropine and any of its derivatives or milk protein/lactose. * history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation * subject has prostate hypertrophy or narrow angle glaucoma

Keywords: muscarinic receptor, bronchodilators chronic obstructive pulmonary disease,
polyurethane foam on the heel for prevention in children

Conditions: Flat Foot; Pressure Ulcer

Summary: the post-operative treatment of pediatric patients operated for the correction of flat foot, sees today the use of preformed leg-foot splint (walker) as an alternative to the application of plaster casts. the change of the immobilization system has led to the appearance of problems of tolerability in particular in the skin. the aim of the study is to assess whether by placing a polyurethane foam dress at the heel in the immediate postoperative period until removal of the walker, the rate of skin lesion and pain is reduced.


Eligibility criteria:
inclusion criteria: * children aged \> 3 years underwent surgery for flat foot * children with intact skin at the heel exclusion criteria: * caregivers who cannot speak italian * those who refuse to give their consent to take part in the study * patients with lower limb casts after surgery
trauma screening/referral and interpersonal violence prevention for women with substance use disorders

Conditions: Substance Use Disorders; Posttraumatic Stress Disorder; Opioid Use Disorder; Violence, Sexual; Violence, Gender-Based; Violence, Domestic

Summary: the purpose of this project is to implement a pilot study to investigate the feasibility and preliminary efficacy of a peer support specialist delivered violence prevention program for women in substance use treatment. the program entails a posttraumatic stress disorder (ptsd) screening, resource referral, and two session interpersonal violence prevention protocol for 60 participants. in this single arm trial, women are recruited from three substance use treatment facilities. participants complete baseline, post-intervention, one-month, and three-month follow-up assessments. self-report surveys assess trauma exposure, knowledge and behaviors related to interpersonal violence, and intervention engagement.

the majority of women entering substance use treatment have a trauma history, placing them at risk for revictimization and substance use relapse. the purpose of this project is to implement a pilot study to investigate the feasibility and preliminary efficacy of a peer support specialist-delivered violence prevention program for women in substance use treatment. the program entails a posttraumatic stress disorder (ptsd) screening, trauma-focused resource referral, and two session interpersonal violence prevention protocol for 60 participants. in this single arm trial, women are recruited from three substance use treatment facilities. participants complete baseline, post-intervention, one-month, and three-month follow-up assessments. self-report surveys assess demographics, trauma and sexual assault experiences, knowledge and attitudes towards sexual and intimate partner violence, protective behavioral strategies, and intervention satisfaction and engagement.

Eligibility criteria:
inclusion criteria: 1) age 18 or higher;2) female gender identity; 3) currently engaged in substance use treatment or care (behavioral, peer support, pharmacological, medical) - exclusion criteria: 1) non-english-speaking; 2) acute physical and medical conditions that interfere with participation in educational sessions (e.g., active psychosis, suicidality). -

Keywords: prevention peer support specialist substance use disorders posttraumatic stress disorder interpersonal violence intimate partner violence sexual violence
clinical study to evaluate the tolerability, safety and efficacy of enteric-coated mycophenolate sodium after equimolar conversion from mycophenolate mofetil (mmf) in patients with renal transplant

Conditions: Prevention of Acute Rejection After Kidney Transplantation

Summary: the aim of the study is to evaluate the safety and efficacy of equimolar conversion from mmf to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine.


Eligibility criteria:
inclusion criteria: * first or second (single or double) deceased or living donor kidney transplant received at least six months previously; * immunosuppressive therapy with cyclosporin and mycophenolate mofetil (mmf); * receiving an mmf dose of \<2/g/day because of any adverse event and/or altered laboratory test result attributed to mmf exclusion criteria: * • subjects expected to discontinue cyclosporin therapy; * patients with thrombocytopenia (\<75,000/mm3), an absolute neutrophil count of \<1,500/mm3 and/or leukopenia (\<2,500/mm3), or anemia (hemoglobin \<6 g/dl) at baseline; * patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia \>2.5 mg/dl) or worsening renal function in the previous two months.

Keywords: kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium.
phase ii trial of brecadd in hiv-positive patients with advanced-stage classical hodgkin lymphoma

Conditions: Hodgkin Lymphoma (Category)

Summary: participants receive chemotherapy with brecadd in standard doses and cycle length. after the first two cycles, a restaging is performed by contrast-enhanced computed tomography (cect) and pet (pet/ct) in order to guide response-adapted continuation of therapy consisting of 4 or only 2 additional cycles of brecadd in case of a pet-positive or -negative staging result, respectively. a second restaging will be performed after completion of chemotherapy. in patients with pet-positive residual disease, local irradiation followed by another restaging is recommended. art should be continued during chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed first diagnosis of chl * advanced-stage disease: stage iib with large mediastinal mass and/or extranodal lesions or stage iii or iv * no previous treatment for hl with the exception of steroid prephase * confirmed hiv infection with cd4 counts ≥ 150/μl at registration or \> 250/μl at any time within 8 months prior to hl diagnosis * continuation of antiretroviral treatment (art) / initiation of art in patients who are art-naive * age: 18-60 years exclusion criteria: * previous malignancy during last 5 years or active malignancy, prior chemotherapy or radiotherapy which precludes protocol treatment * nodular lymphocyte-predominant hodgkin lymphoma or composite lymphoma * multi-drug resistant hiv infection or concurrent aids-defining conditions * pregnancy or breastfeeding

Keywords: advanced stage hiv positive brentuximab vedotin
comparison of immunogenicity and safety of dtp-hb-hib (bio farma) with pentabio® vaccine primed with recombinant hepatitis b

Conditions: Immunogenicity; Safety

Summary: comparison of immunogenicity and safety of dtp-hb-hib (bio farma) with pentabio® vaccine primed with recombinant hepatitis b

comparison of immunogenicity and safety of dtp-hb-hib (bio farma) with pentabio® vaccine primed with recombinant hepatitis b at birth dose (using different source of hepatitis b), in indonesian infants

Eligibility criteria:
inclusion criteria: * healthy, full term, newborns infants. * infant born after 37-42 weeks of pregnancy. * infant weighing 2500 gram or more at birth. * father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. * parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial. exclusion criteria: * child concomitantly enrolled or scheduled to be enrolled in another trial. * mother with hbsag positive. * evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \>37.5c on day 0). * suspected of allergy to any component of the vaccines (e.g. formaldehyde). * suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. * newborn suspected of congenital or acquired immunodeficiency (including hiv infection). * received or plans to receive any treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)). * received other vaccination with the exception of bcg and poliomyelitis. * any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
a survey on ninlaro risk management plan (rmp) material utilization among pharmacists in japan

Conditions: Multiple Myeloma

Summary: this is a survey among pharmacists who have instructed ninlaro therapy in ixazomib, lenalidomide and dexamethasone (ird) dosing to patients with relapsed/refractory multiple myeloma (rrmm). the main aims of the study are: * to assess the frequency of pharmacists who have provided patients with the contents of the rmp material for patients. * to assess the frequency of pharmacists who have obtained the rmp material for patients. * to evaluate the depth of understanding of proper usage of ninlaro among pharmacists.

this is a prospective, non-interventional, observational web-based survey in pharmacists who have instructed the dosing of ninlaro (ixazomib) in combination with lenalidomide and dexamethasone therapy to patients with rrmm. the study will assess the effectiveness of distributed rmp material in prevention of ixazomib overdose in japanese clinical practice. the study will enroll approximately 300 pharmacists who belong to hospitals prescribing ninlaro. the data will be collected through a self-administered web-based survey with questionnaires provided in japanese. this web-based survey will be conducted in japan.

Eligibility criteria:
inclusion criteria: 1. who belong to hospitals prescribing ninlaro. 2. who have instructed the dosing of ninlaro in ird therapy to patients. exclusion criteria: none

Keywords: drug therapy
atricure minimally invasive surgical ablation for atrial fibrillation/restore iib

Conditions: Atrial Fibrillation

Summary: feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the cox-maze lesion set to the current restore sr ii ide study procedure of performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (gp) ablation, and optional left atrial appendage (laa) excision/exclusion on a beating heart for patients with permanent or persistent atrial fibrillation (af).


Eligibility criteria:
inclusion criteria: 1. patient between 18 and 80 years of age 2. patient with documented symptomatic persistent or permanent af and failure or intolerance of one or more class i or class iii antiarrhythmic drugs. * persistent af: af that is not self-terminating or is terminated electrically or pharmacologically. * longstanding af: persistent af of 12 months (or longer) duration. * permanent af: longstanding af in which electrical or pharmacological cardioversion has failed or has not been attempted. 3. patient is willing and able to provide written informed consent. 4. patient has a life expectancy of at least 2 years. 5. patient is willing and able to attend the scheduled follow-up visits. exclusion criteria: 1. prior cardiac catheter ablation for the treatment of arrhythmia within 4 months. 2. patients who refuse, but have not failed and can tolerate anti-arrhythmic medications 3. myocardial infarction within 8 weeks. 4. prior cardiac surgery. 5. patient requires cardiac surgery for treatment other than for af. 6. class iv nyha heart failure symptoms, unless due to uncontrolled af 7. cerebrovascular accident within previous 6 months 8. known carotid artery stenosis greater than 80% 9. evidence of significant active infection 10. patient unable to undergo tee 11. pregnant woman 12. patient requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia 13. presence of thrombus in the left atrium 14. co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery 15. patient is enrolled in another cardiac clinical trial 16. left ventricular ejection fraction \< 30% 17. left atrial transverse diameter \>6.0 18. patient has undergone previous thoracic targeted radiation