Kornimate/medical-research-clean huggingface dataset:
a study to evaluate safety, efficacy and pharmacokinetics of rituximab (mabthera/rituxan) in participants with diffuse large b cell lymphoma (dlbcl) or follicular lymphoma (fl)

Conditions: Lymphoma

Summary: this single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic (pk) of subcutaneous (sc) rituximab in previously untreated participants with cluster of differentiation 20 positive (cd20+) dlbcl or fl. in addition to standard chemotherapy, participants will receive at least 4 doses of rituximab 1400 mg sc once a month during the induction period, and at least 6 doses of rituximab 1400 mg sc once every two months during the maintenance period.


Eligibility criteria:
inclusion criteria: * histologically confirmed, cd20+ dlbcl or cd20+ follicular non-hodgkin's lymphoma (nhl) grade 1, 2 or 3a, according to the world health organization (who) classification system * currently being treated with rituximab intravenously (iv) in the induction or maintenance period, having received at least one full dose of rituximab iv, defined as standard full dose of rituximab iv 375 milligrams per square-meter (mg/m\^2) administered without interruption or early discontinuation (i.e. tolerability issues) * expectation and current ability for the participant to receive at least 4 additional cycles of treatment during the induction period or 6 additional cycles of treatment during the maintenance period (participants with follicular nhl) * an international prognostic index (ipi) score of 1-4 or ipi score of 0 with bulky disease, defined as one lesion greater than or equal to (\>=) 7.5 centimeters (cm), or follicular lymphoma international prognostic index (flipi) (low, intermediate or high risk) assessed before the first rituximab iv administration in induction period * at least one bi-dimensionally measurable lesion defined as \>=1.5 cm in its largest dimension on computed tomography (ct) scan * eastern cooperative oncology group (ecog) performance status less than or equal to (\<=) 3 exclusion criteria: * transformed lymphoma or fl iiib * primary central nervous system lymphoma, histologic evidence of transformation to a burkitt lymphoma, primary effusion lymphoma, primary mediastinal dlbcl, dlbcl of the testis, or primary cutaneous dlbcl * history of other malignancy * ongoing corticosteroid use greater than (\>) 30 milligrams per day (mg/day) of prednisone or equivalent * inadequate renal, hematologic, or hepatic function * history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products * contraindications to any of the individual components of standard chemotherapy * other serious underlying medical conditions, which, in the investigator's judgement, could impair the ability of the participant to participate in the study * recent major surgery (within 4 weeks prior to dosing, other than for diagnosis) * active hepatitis b virus (hbv), active hepatitis c virus (hcv) infection, or human immunodeficiency virus (hiv) infection
canadian oxygen trial (cot)

Conditions: Respiratory Insufficiency of Prematurity

Summary: study question: in infants who are born at gestational ages of 23 0/7 to 27 6/7 weeks, does lowering the concentration of supplemental oxygen to target an arterial oxygen saturation by pulse oximetry (spo2)of 85-89% compared with 91-95%, from the day of birth until the baby's first discharge home, increase the probability of survival without severe neurosensory disability to a corrected age of 18 months?

most extremely preterm babies require supplemental oxygen for several weeks or even months after birth. the goal of oxygen therapy is to achieve adequate oxygen delivery to the tissues without causing oxygen toxicity and oxidative stress. at present, this goal is elusive in very immature infants. although it is standard practice in modern neonatal intensive care units to monitor arterial oxygen saturations via pulse oximetry, there is insufficient evidence to guide the choice of the upper and lower alarm limits. a rigorous trial with long-term follow up is urgently needed and long overdue to determine whether oxygen exposure can be reduced safely in extremely preterm infants without increasing the risk of hypoxic death or disability.

Eligibility criteria:
inclusion criteria: * gestational age 23 0/7 - 27 6/7 weeks * postnatal age \< 24 hours exclusion criteria: * infant not considered viable (decision made not to administer effective therapies) * dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment * known or strongly suspected cyanotic heart disease * persistent pulmonary hypertension, e.g. associated with pulmonary hypoplasia * unlikely to be available for long-term follow-up

Keywords: oxygen therapy neurodevelopmental impairment
clinical evaluation of topical coenzyme q10 in management of oral aphthous ulcer

Conditions: Oral Aphthous Ulcer

Summary: recurrent oral aphthous ulcer is the most common oral lesion in occurrence and one of cause is oxidative stress so investigators need to use antioxidant drugs like topical coenzyme q10 gel to treat the lesion and more safe for the participants.

double randomized clinical trial study using two parallel group suffer from oral aphthous ulcer one take antioxidant topical q10gel and other group take placebo carpabol gel two times per day for seven days measuring outcome at fourth and seventh day including pain; healing period and clinical parameters. sample size of study include 26 in each group.

Eligibility criteria:
inclusion criteria: * patients with free medical history and no systemic diseases16. * patients clinically diagnosed as suffering from symptomatic oral minor aphthous ulcers. * patients who agreed to take medications. exclusion criteria: * patients suffering from any systemic disease as crohn's disease, behcet's disease and others. * anemic and leukemic patients (using complete blood count investigation) * patients taking systemic drugs such as systemic steroids and other immunosuppressive therapy. * patients treated with any oral topical medications 48h before the study27. * pregnant and lactating mothers.

Keywords: oral minor aphthous ulcer topical q10 gel topical antioxidant oral recurrent aphthous ulcer oral aphthous stomatitis
seeing red: clinical assessment tools for clinical trial decision support

Conditions: Incontinence-associated Dermatitis; Moisture Associated Skin Damage; Intertrigo

Summary: this research aims to assess the utility and validate the inter-rater reliability of the new nursing documentation tools for commonly encountered moisture-associated skin damage including (incontinence-associated dermatitis (iad) and intertrigo (itd)) at valley regional hospital. this is an exploratory study to assess the utility and accuracy of a structured documentation tool for iad and itd in hospitals. current documentation involves a mostly verbal description of the location, size, and general features of the rash. without a standardized approach to documentation, it can be challenging to accurately evaluate the evolution of the rash and the response to treatment from day to day and from different nurses. the reliability of the documentation tool will be assessed by comparing the results of the bedside assessment tool with that completed by wound care experts using standardized digital live photographs. the utility documentation tool from a nursing perspective will also be assessed using a structured questionnaire. analysis of digital live photographs using a standard algorithm will be done to determine whether such an analysis can objectively and accurately track the healing of moisture-associated skin damage.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * intertrigo (itd) and or incontinence-associated dermatitis (iad) * expected length of stay of seven (7) days * life expectancy greater than one week * written informed consent by the patient or his/her representative including explicit consent to take daily photographs of the rash associated with masd. exclusion criteria: * known allergy to standard masd treatments * life expectancy less than seven days * complex skin disorders
study investigating men1 and sdhd in familial carcinoid tumors

Conditions: Carcinoid Neuroendocrine Cancer

Summary: there is a high incidence among the first degree relatives of the carcinoid patients, indicating the involvement of genetic components in its initiation and pathogenesis.

this proposed pilot study will conduct detailed interviews into the medical, environmental, and family histories and to collect blood specimen to obtain dna. the blood specimen and dna will be processed by the rutgers university cell and dna repository (rucdr) to rule out familial multiple endocrine neoplasia (men 1), and succinate dehydrogenase complex, subunit d (sdhd), gene inactivation thought to be associated with different types of carcinoid cancer.

Eligibility criteria:
inclusion criteria: 1. over the age of 18 years 2. more than one ,member of a family with a history of biopsy confirmed carcinoid tumor 3. english speaking 4. mentally and emotionally capable of answering questions 5. willing and available for study participation 6. at least one other family member with carcinoid tumor exclusion criteria: 1. if you are under the age of 18 years, 2. if you are unable to understand or unable to provide informed consent, 3. if you have a psychological condition (i.e. depression, anxiety disorder, substance abuse, etc.) which might cause you significant problems in dealing with test results.

Keywords: carcinoid family members familial tumors cancer
exploring the profiles of rms patients on ofatumumab or ocrelizumab in a real-world setting in the gulf

Conditions: Relapsing Multiple Sclerosis

Summary: this is a retrospective and prospective, observational mixed-methods (quantitative and qualitative) cohort study of patients who are treated with either ofatumumab or ocrelizumab that will be recruited and followed up for one year to collect their profiles across the gulf countries.

this study will be conducted retrospectively (for patients who had their first treatment initiated on either ofatumumab or ocrelizumab before study start and from 2019 onwards) and prospectively (for patients who are initiated on either drug during the active recruitment period which spans for one year after the start of the first data collection) using data collected in a standardized manner. index date (baseline): defined as the date of the first treatment initiated on either ofatumumab or ocrelizumab index period: the patients fulfilling the inclusion criteria will be identified during the recruitment period (01-jan-2019 to 01-april-2023 or up to 1 year after the start of the active recruitment period).

Eligibility criteria:
inclusion criteria: * males and females. * age 18 to 65 years. * confirmed rms diagnosis as per the 2017 updated mcdonald's criteria (thompson et al., 2018). * having their first dose of either drugs during the index period (2019 onwards and up to 1 year since start of the active recruitment period). * the decision to initiate either drug should be based on the patient's disease and taken by the treating physician before the decision of inviting the patient to participate in the study. * the patient agreed and provided informed consent on the use of his/her de-identified data. exclusion criteria: * patients below 18 years or above 65 years. * pregnant females. * spms and/or ppms patients. * the patient's refusal to be included in the study.

Keywords: relapsing multiple sclerosis rms nis gulf region ofatumumab ocrelizumab
combined triple therapy in diabetic retinopathy (drp)

Conditions: Macular Edema; Diabetic Retinopathy

Summary: the aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic retinopathy.

this prospective, monocenter pilot case series was conducted between may 2006 and november 2008. patients were included because of dme and signs of pre- and early proliferation because of diabetic retinopathy.73 eyes of 56 patients were included, all of which had signed an informed consent to perform a pharmacosurgical procedure consisting of a 23 gauge core pars plana vitrectomy (sutureless single stitch sclerotomy, cutter with 300 cuts/minute) with removement of 1.5ml vitreous and substitution with 1ml bss, 8mg triamcinolone, and 1.25 mg bevacizumab. at baseline and follow-up, the best corrected visual acuity (bcva; 6 m snellen), and intraocular pressure (iop; goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. in addition, the need for further treatment and adverse events were monitored.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetic retinopathy * macular edema more than 200 micron * vitreous bleeding because of angiography documented nves nvds, based on the definitions of etdrs exclusion criteria: * prior intraocular injection within 4 months * core or complete vitrectomy * history of glaucoma or ocular hypertension * presence of iris neovascularization * significant media opacity * monocularity and pregnancy

Keywords: combined therapy drp efficacy safety sustainability macular edema due to drp
feasibility of individualized, model-guided optimization of proton beam treatment planning in patients with low grade glioma

Conditions: Low Grade Glioma

Summary: low-grade glioma (lgg) represent typically slowly growing primary brain tumors with world health organization (who) grade i or ii who affect young adults around their fourth decade. radiological feature on mri is a predominantly t2 hyperintense signal, lgg show typically no contrast uptake. radiotherapy plays an important role in the treatment of lgg. however, not least because of the good prognosis with long term survivorship the timing of radiotherapy has been discussed controversially. in order to avoid long term sequelae such as neurocognitive impairment, malignant transformation or secondary neoplasms initiation was often postponed as long as possible

since patients with low grade glioma are expected to become long-term survivors, the prevention of long-term sequelae is particularly important. in addition to disease progression, also treatment related side effects such as decline of neurocognitive function, endocrine impairment or sensorineural deficits can have a negative impact on patient's quality of life. owing to the biophysical properties of protons with an inverse depth dose profile compared to photons and a steep dose fall of to the normal tissue, there is a strong rationale for the use of prt in the treatment of patients with low-grade glioma. although data from large randomized trials are still missing there is increasing evidence from smaller prospective trials and retrospective analyses that the expected advantages indeed transform into clinical advantages. however, in about 20 % of all patients, late contrast-enhancing brain lesions (cebl) appear on follow-up mr images 6 - 24 months after treatment. at hit in heidelberg and at oncoray in dresden, cebls have been observed to occur at very distinct locations in the brain and relative to the treatment field. retrospective analysis has elucidated potential key factors that lead to cebl occurrence. however, avoidance of cebls is hardly feasible using conventional treatment planning strategies. model-aided risk avoidance denotes the use of model-based cebl risk calculations as an auxiliary tool for clinical treatment planning: model-based risk calculations and risk reduction via software-based optimization help the clinician to minimize risk of cebl occurrence during treatment planning.

Eligibility criteria:
inclusion criteria: * age \> 18 years * histologically proven low-grade glioma * indication for definitive or adjuvant radiotherapy * ability to understand character and personal consequences of the clinical trial * written informed consent exclusion criteria: * previous cerebral irradiation * contraindication for contrast-enhanced mri * neurofibromatosis * participation in another clinical trial with competing objectives
comparison of tear evaporation rate with dailies total1 and biotrue oneday

Conditions: Evaporative Dry Eye

Summary: the purpose of this pilot study is to compare the effect of dailies total1, a low water content silicone hydrogel lens, and biotrue oneday, a high water content hydrogel lens, on the rate of tear evaporation. the study will also serve to validate the novel, in-house developed evaporimeter.


Eligibility criteria:
inclusion criteria: 1. is at least 17 years of age and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. has worn soft contact lenses for a minimum of 6 months; 5. currently wears soft contact lenses for at least 4 days per week and 8 hours per day; 6. has an acceptable fit and comfort with both study contact lenses in the powers available; 7. has less than or equal to 1.00ds difference between eyes in their habitual contact lenses; 8. is willing to be awake for at least 2 hours before visit 2; 9. is willing to not wear eye makeup on the day of visit 2 and 3; 10. is willing to not use eye drops or artificial tears on the day of visits 1, 2, and 3; 11. has a wearable pair of spectacles. exclusion criteria: 1. is participating in any concurrent clinical or research study; 2. has any known active\* ocular disease and/or infection; 3. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. has known sensitivity to sodium fluorescein dye; 6. is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); 7. is aphakic; 8. has undergone refractive error surgery; 9. has a known sensitivity to petroleum jelly (vaseline); 10. has epilepsy and/or a sensitivity to flashing lights; 11. wears toric contact lenses; 12. has any physical impairment that would interfere with holding the evaporimeter; 13. has taken part in another research study within the last 14 days.
effect of metformin on healthy live birth in women with prediabetes

Conditions: Metformin; Prediabetes; In-Vitro Fertilization

Summary: to evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.

to evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes and to determine whether either starting metformin pretreatment before ovarian stimulation (aiming at improving the quality of oocyte/embryo) or starting before frozen embryo transfer (fet) (aiming at improving the receptivity of endometrium) could increase the chance of a healthy live birth compared with placebo.

Eligibility criteria:
inclusion criteria: 1. women who are diagnosed with prediabetes by ada criteria, including either ifg, igt, or hba1c 5.7-6.4%. 2. women aged 20-40 years. 3. women who plan to undergo a new cycle of ivf, icsi, or pgt-a. exclusion criteria: 1. women who are diagnosed with diabetes according to the ada criteria11,12, which is meeting one of the following criteria: fasting plasma glucose ≥7.0mmol/l, 2-h plasma glucose during 75-g ogtt ≥11.1mmol/l, hba1c≥6.5%, or a random plasma glucose≥11.1mmol/l. 2. women who are taking medicine that interfere with glucose metabolism, such as metformin, oral anti-diabetic agents (sulfonylureas, glinides, thiazolidinediones, α-glycosidase inhibitors, glp-1 receptor agonist, etc.), weight loss drugs (i.e.orlistat, etc.), glucocorticoids, and growth hormones within 2 months before enrollment. 3. women with un-corrected hyperthyroidism or hypothyroidism. 4. women with congenital or acquired abnormal uterine cavity including septate uterus, unicornous uterus, uterus duplex, and intrauterine adhesions. 5. women with a diagnosis of adenomyosis. 6. women with untreated hydrosalpinx. 7. women who plan to undergo pgt-sr or pgt-m. 8. women with major medical comorbidities, such as known liver disease, known renal disease, or known significant anemia.
transversus abdominis plane(tap) block versus local anesthetic infiltration

Conditions: Pain, Postoperative

Summary: there have been some studies to compared trans abdominis plane(tap) block with wound infiltration of local anesthetics in multiport laparoscopic surgery, but there have been no studies in single incision laparoscopic gastrectomy. the purpose of this study was to compare the effect of ultrasonography-guided transverse nerve block and localized anesthesia infiltration in patients with single incision laparoscopic gastrectomy.

patients were randomly divided into group n(ultrasonography-guided tap) block and group w( before surgery local anesthetic infiltration at the incision site). we compared the opioid usage, postoperative 6, 24, and 48 hours pain, presence of vomiting, and duration of hospitalization during the operation.

Eligibility criteria:
inclusion criteria: * asa class i-ii * age: \>18 exclusion criteria: * patients of severe kidney \& liver dysfunction * allergy of local anesthetics
bkm120 for patients with pi3k-activated tumors

Conditions: PI3K Pathway Activated Tumors

Summary: the purpose of this signal seeking study was is to determine whether treatment with bkm120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.


Eligibility criteria:
inclusion criteria: * patient had a confirmed diagnosis of a solid tumor or hematological malignancy with the exception of endometrial cancer, glioblastoma, nonsmall cell lung cancer, prostate cancer or breast cancer. * patient's tumor was evaluated and pre-identified to have activation of the pi3k pathway, at a clia certified laboratory * patient must have received at least one prior treatment for recurrent metastatic and /or locally advanced disease and for whom no standard therapy options was anticipated to result in a durable remission. * patient must have had progressive and measurable disease as per recist 1.1. or other appropriate hematological guidelines * patient had an eastern cooperative oncology group (ecog) performance status ≤ 1 exclusion criteria: patient had received previous treatment with bkm120 patient had symptomatic cns metastases patient had mood disorder as outlined in section 5 patient had received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-c) prior to starting study drug.

Keywords: solid tumor malignancy hematologic malignancy pi3k pathway activation p13k activated tumors bkm120 signature aml acute myelogenous leukemia cervical ovarian hepatobiliary buparlisib
evaluation of the postoperative agitation prevention and analgesic efficacy of perioperative dexmedetomidine infusion in a pediatric patient group to undergo dental treatment

Conditions: Anxiety; Postoperative Pain; Nausea

Summary: dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. the purpose of this run is to use the association between this use during surgery and the attrition of post-operative pain and discomfort. in the research, laboratory and monitoring results will be obtained before, during and after the operation. postoperative patient complaints will be evaluated at the postoperative service visit. this study is decided on a completely voluntary basis.


Eligibility criteria:
exclusion criteria: inclusion criteria: patients with asa 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included. exclusion criteria: developmental delay anxiety disorder known history of allergy to alpha-2 agonistic agents use of antipsychotic medication beta blocker use of anticonvulsant drugs chronic pain syndrome with cardiac and craniofacial anomalies

Keywords: dexmedetomidin dental treatment post operative anxiety