Kornimate/medical-research-clean huggingface dataset:
combined trab+trab versus combined trab+trab with subconjunctival implantation of ologen for primary congenital glaucoma

Conditions: Congenital Glaucoma

Summary: the objective of this prospective randomised study is to compare the efficacy and safety of ologen cm (collagen matrix) as adjunct to combined trabeculotomy-trabecuectomy in congenital glaucoma cases, the efficacy being the primary objective and the safety being the secondary. the investigators hypothesize that combined trabeculotomy-trabecuectomy with ologen collagen matrix implant implantation in congenital glaucoma is a safer procedure and may yield better results than combined trabeculotomy-trabeculectomy approach.

"ologen ® cm" is a biodegradable collagen matrix. to prevent episcleral fibrosis and subconjunctival scarring thay may result in the surgical failure in filtration surgery, its sporous matrix modulates the migrations and proliferations of fibroblasts to create a vascular and long-lasting bleb without the adverse effects. results of ologen cm studies have been published at conferences and published in peer-reviewed journals; ologen cm is approved in europe as an aid for tissue repair, and by the fda in the us as an adjunct in wound management(k080868). in general, over 7,000 ologen cm have been implanted worldwide during the past two years with good results and excellent safety profile.

Eligibility criteria:
inclusion criteria: * any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmhg, including corneal edema or haab's stria with or without optic disc cupping. any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities. within the age of (0 - 12). exclusion criteria: * cases of congenital glaucoma with previous intervention. age above 12 yrs. cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma
a study based on medical records that looks at the characteristics of idiopathic pulmonary fibrosis patients grouped by the type of medication they are taking

Conditions: Idiopathic Pulmonary Fibrosis

Summary: to understand differences in characteristics of idiopathic pulmonary fibrosis (ipf) patients who are prescribed nintedanib compared to those who are prescribed pirfenidone.


Eligibility criteria:
inclusion criteria: * with ≥ 1 diagnosis for ipf (the international classification of diseases, ninth revision, clinical modification \[icd-9-cm\] codes 516.3, 516.31, 515, or icd-10-cm codes j84.112) in the emr between october 1, 2013 to april 30, 2018 * with ≥ 1 prescription for nintedanib between october 1, 2014 and april 30, 2018 (the selection window) * the date of the first prescription will be defined as the index date * with ≥ 1 record in the emr database during the 12 months prior to the index date (the pre-index period) * with ≥ 1 diagnosis of ipf during the 12 months prior to the index date * age ≥ 40 on the index date * iqvia will explore also requiring ≥ 1 chest ct scan before first ipf diagnosis during the pre-index period exclusion criteria: * with ≥ 1 diagnosis of other known causes of interstitial lung disease (ild) on the date of or after the first ipf diagnosis during the pre-index period * other known causes of ild include conditions such as systemic sclerosis, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, sjögren disease, and hypersensitivity pneumonitis (icd-9-cm codes 135, 237.7, 272.7, 277.3, 277.8, 446.21, 446.4, 495, 500-505, 506.4, 508.1, 508.8, 516.0, 516.1, 516.32-516.37, 516.2, 516.8, 516.9, 517.0, 517.2, 517.8, 518.3, 555, 710.0, 710.0-710.4, 714.0, 714.81, 720, and 759.5, or icd-10-cm equivalent codes) * with ≥ 1 prescription for nintedanib prior to the index date * with ≥ 1 prescription for pirfenidone prior to or on the index date
tocilizumab for acute chest syndrome

Conditions: Sickle Cell Disease; Acute Chest Syndrome

Summary: the investigators are evaluating the role of a low dose of tocilizumab in treating acute chest syndrome in patients with sickle cell disease. tocilizumab inhibits interleukin-6 (il-6) receptors and is used to treat rheumatoid arthritis and severe cytokine release syndrome, which can be seen with chimeric antigen receptor t-cell (car-t) therapy, and it is also authorized for treatment of covid-19. since il-6 levels are elevated in the sputum of patients with acute chest syndrome, the investigators are hopeful that this will be an effective strategy. the investigators will be looking at how a low dose of tocilizumab affects oxygen status, clinical outcomes, and laboratory markers in patients admitted to the hospital with acute chest syndrome.

in this randomized, placebo-controlled, double-blinded phase ii study, enrolled patients admitted to the university of chicago who are diagnosed with acute chest syndrome will receive one dose of tocilizumab 80 mg iv and one normal saline placebo dose. the order of these doses will be randomized at a 1:1 ratio. after collecting oxygenation data as a baseline for 8 hours, patients will then receive tocilizumab versus placebo as their early dose and then the opposite (placebo versus tocilizumab) 48 hours later. clinical, laboratory, and patient-reported outcome data will be collected during their admission and compared between arms.

Eligibility criteria:
inclusion criteria: * adults ≥ 12 years of age * prior diagnosis of sickle cell disease (hb ss, hb sc, hb sb+, and hb sb0) exclusion criteria: * pregnant patients or breastfeeding mothers. * prior treatment with gene therapy or a stem cell transplant. * current enrollment in a clinical trial involving an fda-regulated drug or biologic. * current neutropenia (absolute neutrophil count \&lt; 1000/mm\^3) * current thrombocytopenia (platelet count \&lt; 50,000 mm\^3) * aspartate aminotransferase (ast) or alanine transaminase (alt) \&gt; 10 times the upper limit of normal (uln) * history of tuberculosis (tb). * positive purified protein derivative (ppd) tb screening test. * on active therapy with a bruton's tyrosine kinase-targeted agent, which include the following: acalabrutinib, ibrutinib, zanubrutinib * on active therapy with a jak2-targeted agent, which include the following: baricitinib, ruxolitinib, tofacitinib, upadacitinib * any of the following biologic immunosuppressive agent (and any biosimilar versions thereof) administered in the past 6 months: abatacept, adalimumab, alemtuzumab, atezolizumab, belimumab, blinatumomab, brentuximab, certolizumab, daratumumab, durvalumab, eculizumab, elotuzumab, etanercept, gemtuzumab, golimumab, ibritumomab, infliximab, inotuzumab, ipilimumab, ixekizumab, moxetumomab, nivolumab, obinutuzumab, ocrelizumab, ofatumumab, pembrolizumab, polatuzumab, rituximab, sarilumab, secukinumab, tocilizumab, tositumumab, tremelimumab, urelumab, ustekinumab
first time in man trial for friulimicin b

Conditions: Community Acquired Pneumonia; Staphylococcal Skin Infections

Summary: the purpose of this study is to study the safety of single doses and multiple doses of friulimicin b in healthy volunteers. the level of friulimicin b will be measured in the subjects blood and urine. one part of the study will assess if friulimicin b in the plasma of subjects has activity against bacteria.

continued widespread use of antibiotics has promoted the spread of antibiotic resistance and has created an urgent need for antibacterial agents with no known cross resistance to other antibiotics available for humans. friulimicin b has been shown to be highly active against a range of bacteria including such important pathogens such as methicillin resistant staphylococcus aureus (mrsa), drug resistant streptococcus pneumoniae and glycopeptide resistant enterococcus spp. these organisms are the causative agents in serious infections such as skin and soft tissue infections, pneumonia, bacteremia and endocarditis, complicated urinary tract infections, and osteomyelitis. this study is the first use of friulimicin b in man and will examine its safety and a preliminary study will assess if friulimicin b in the plasma of subjects has activity against bacteria.

Eligibility criteria:
inclusion criteria: * male or female healthy subjects * 18-55 years of age * in good health exclusion criteria: * abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.

Keywords: friulimicin b lipopeptide antibiotic first in man
development of a prenatal test for fetal aneuploidy detection

Conditions: Fetal Complications

Summary: this is an observational study to develop and evaluate a blood based prenatal blood test. pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. all samples and clinical data will be stripped of subject identifiers prior to submission to ariosa.


Eligibility criteria:
inclusion criteria: * subject has singleton pregnancy * subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality * subject is able to provide informed consent * subject is ≥ 18 years of age exclusion criteria: * subject is pregnant with more than one fetus * subject (mother) has a known aneuploidy

Keywords: fetal aneuploidy non-invasive prenatal cell free dna
mindfulness for adolescents with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: adolescents with type 1 diabetes will be invited to the mindfulness study. they will be randomly assigned to a control or active group. the active group will learn mindfulness based stress reduction (mbsr) through an online website designed to teach the basic principles of mbsr in six week-long modules. they will be measured in three main areas: before learning the intervention, directly after learning it and 3 months after learning it to determine any changes in their mindful attention awareness, diabetes quality of life and hba1c. the control group will also take the questionnaires at the beginning of the study, 6 weeks after it begins and then 3 months from the beginning to obtain data for all three time points when they have not received access to the modules/intervention.

research design and procedures this study will utilize a between group repeated measures design to measure the effects of the learned mbsr intervention over time. mbsr will be the independent variable. dependent variables include mindfulness, diabetic quality of life and hba1c. adolescents with type 1 diabetes will be randomly assigned to an intervention group or a wait list/control group that will be taught mbsr after all data has been collected. the study will utilize a 2 (experimental versus wait-list control group) by 3 (pretest \[time 1\], posttest \[time 2\], and 3 month follow-up \[time 3\]) to examine within and between group differences overtime on two psychosocial measures including mindfulness and quality of life. the physiological measure understudy, hba1c, reflects glucose control over the previous three month period and will be measured at time 1 and time 3. mbsr training will be provided via an online website and secure data collection site called mysweetmind.org.

Eligibility criteria:
inclusion criteria: * adolescents between the ages of 12 - 19 * diagnosis of type 1 diabetes * fluent in english * no diagnosed cognitive impairments * 6th grade education completion * access to a computer * access to the internet exclusion criteria: under 12, over 19 - no access to a computer/internet -
labour analgesia; comparing a combinations of either fentanyl or bupivacaine with intrathecal morphine

Conditions: Labor Pain

Summary: this study is aimed at evaluating single short spinal technique as a form of labour analgesia in a setting where more expensive and labor intensive techniques are not feasible.the study will examine the safety and efficacy of two drug combinations (intrathecal morphine+fentanyl vs intrathecal morphine+bupivacaine) through a randomized control trial. the investigators hypothesize that a single shot of either intrathecal morphine plus fentanyl or intrathecal morphine plus bupivacaine achieve analgesia and are safe in parturients experiencing normal labour.


Eligibility criteria:
inclusion criteria: * parturients with singleton pregnancy * emancipated minors exclusion criteria: * those who declined. * parturients with any identified complication of labour like preeclampsia, severe cardiac disease or previous operative delivery. * sepsis or wound at site of spinal injection. * allergy to any of the study drugs elicited from history.

Keywords: labour analgesia intrathecal morphine bupivacaine fentanyl
myocet plus endoxan for older patients with breast cancer

Conditions: Breast Cancer

Summary: this study will evaluate the efficacy, safety and effect on quality of life of liposomal-encapsulated doxorubicin in combination with cyclophosphamide as first or second line treatment of older patients (≥ 70 years old) with metastatic breast cancer. the efficacy of the combination will be correlated with the functional status of patients according to the comprehensive geriatric assessment

elderly individuals make up a large part of the breast cancer population. when treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. anthracyclines are associated with a cumulative dose-dependent cardiomyopathy with increased rate in patients over the age of 70. liposomal-encapsulated doxorubicin improves the therapeutic index of doxorubicin by reducing significantly the cardiotoxicity and grade 4 neutropenia and provides comparable antitumor efficacy, when used in combination with cyclophosphamide as first-line therapy for metastatic breast cancer

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic breast adenocarcinoma * no more than one prior therapy regimen (other than hormonal therapy) for metastatic breast cancer is acceptable. * measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions) * performance status (who) 0-2 * adequate liver (serum bilirubin \<1.5 times the upper normal limit, ast and alt \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases) * adequate renal function (serum creatinine \<1.5 times the upper normal limit) * adequate cardiac function (lvef within normal limits) * adequate bone marrow function (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) * no radiation of measurable disease (except brain metastases) * no progressive brain metastases according to clinical or radiological criteria * no brain metastases without prior radiation therapy * written informed consent exclusion criteria: * active infection * history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * prior treatment with an anthracycline-containing regimen (as adjuvant therapy) during the previous 12 months period * other invasive malignancy except non-melanoma skin cancer * psychiatric illness or social situation that would preclude study compliance * pregnant or lactating women

Keywords: breast cancer elderly chemotherapy cardiotoxicity
treatment of multiple sclerosis and neuromyelitis optica with regulatory dendritic cell: clinical trial phase 1 b

Conditions: Multiple Sclerosis; Neuromyelitis Optica

Summary: first in human study to assess the tolerability and safety profile of treatment with dendritic cell in patients with multiple sclerosis or neuromyelitis optica.


Eligibility criteria:
inclusion criteria: * patients with multiple sclerosis or neuromyelitis optica * diagnosed more than a year before inclusion * expanded disability status scale between 3.0 and 8.5 * all subtypes of multiple sclerosis or neuromyelitis optica * multiple sclerosis patients who have previously been offered therapeutic alternatives available in indications and either decline or that after receiving treatment for at least 6 months have had an outbreak or an increase of at least 1 point on the expanded disability status scale (edss) (non-responders) or who have not tolerated treatment * patients with neuromyelitis optica (nmo) in stable immunomodulatory treatment in the past 6 months or without treatment because they are not candidates to receive it exclusion criteria: * corticosteroid treatment in the last 30 days * presence of an outbreak in the last month * inability to perform brain magnetic resonance imaging (with paramagnetic contrast) * serious systemic diseases, including hepatitis b virus, hepatitis c virus, and human immunodeficiency virus. uncontrolled hypertension, insulin-dependent diabetes mellitus, heart disease or kidney failure or severe respiratory * personal history of cancer or family history of known hereditary cancer * patient participating in other experimental study in the last 3 months * women childbearing-aged that do not use effective contraceptive methods * pregnant or breastfeeding women
pharmacokinetics of advantage arrest

Conditions: Dental Caries

Summary: the study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.

the purpose of this study is to characterize basic pk parameters (cmax, t1/2, auc, and total urinary recovery) to contribute to evidence for the safety of advantage arrest, consistent with guidance for industry--exposure--response relationships (april 2003).

Eligibility criteria:
inclusion criteria: * 18 years or older, minimum 20 teeth, healthy, not taking prescription or otc medications exclusion criteria: * pregnant, weighed less than 50 kg, had oral mucositis or ulcerative lesions, known sensitivity to silver or fluoride

Keywords: adult fluoride silver silver diamine fluoride pharmacokinetics
effects of low-speed and high-speed resistance training programs on frailty status

Conditions: Frailty

Summary: the present study refers to a three-arm randomized controlled trial that investigated the effects of two types of rt on frailty status, physical performance, cognitive function, and blood pressure of prefrail and frail older adults.


Eligibility criteria:
inclusion criteria: * a) aged 60 years or over; b) were prefrail or frail according to fried's criteria; c) performed the sit-to-stand test alone, with a mobility aid, or researcher's help; d) possessed sufficient physical and cognitive abilities to perform exercise sessions; and e) had a physician authorization to participate. exclusion criteria: * exclusion criteria included having participated in a structured physical exercise training program in the past six months, prescription of hormone replacement therapy and/or psychotropic drugs, and any unstable cardiovascular event (e.g., myocardial infarction) or complication in the past 6 months.
the application of somatosensory interactive pelvic floor muscle training for stress urinary incontinence in men underwent radical prostatectomy

Conditions: Prostate Cancer (Post Prostatectomy)

Summary: the study aims to compare the efficacy of different pelvic floor muscle training (pfmt) modes on improving urinary incontinence (ui) recovery in prostate cancer (pca) patients after radical prostatectomy (rp). the methods being compared include standard pfmt (s-pfmt) , a somatosensory interactive pfmt (si-pfmt, an enhanced pfmt) , and a standard pfmt combined with pelvic floor muscle magnetic stimulation (s-pfmt+ms). eligible participants are randomized into either of the groups to receive different modalities of post-operative pfmt. subjects in the s-pfmt group received traditional verbal instructions and paper-based educational materials. for the si-pfmt group, an interactive experiential education model was adopted. first, an educational video introduced the importance and basic information of postoperative pfmt. then, synchronized pfmt guidance through a combination of audio and video would be used. subjects assigned to the s-pfmt+ms group, on the basis of traditional verbal and paper-based education, pelvic floor magnetic stimulation therapy was applied using a pelvic floor magnetic stimulator, operated by the same experienced rehabilitation physician. self administered questionnaires and 1-hour pad test would be used to assess the treatment outcomes at 1, 3, and 6 months postoperatively.


Eligibility criteria:
inclusion criteria: * pca patients aged 18 to 85 years who had undergone laparoscopic radical prostatectomy (rp) exclusion criteria: * patients currently participating in other clinical trials and those unable to cooperate with study interventions and follow-up procedures due to specific factors

Keywords: pelvic floor muscle training post operative urinary incontinence
children's blood draws: lavender study

Conditions: Nursing Caries; Pain Management

Summary: the aim of this study is to show the effect of lavender scent used to reduce pain and fear during blood collection in children aged 7-14.

the children in the experimental group were given lavender scent before the blood collection procedure. no additional intervention was made to the children in the control group. the pain and fear scores of both groups were evaluated.

Eligibility criteria:
inclusion criteria: children between the ages of 7-14 who applied to the blood collection unit, who had no mental neurological, hearing, speech, vison disorders exclusion criteria: who were not allergic to lavender essence, who were not diagnosed with asthma, allergies, epilepsy, dermatitis who had not taken analgesics in the last 6 hours were included in the study

Keywords: pai̇n fear