Kornimate/medical-research-clean huggingface dataset:
carboplatin plus docetaxel with day 2 pegylated g-csf (neulasta®) in patients with advanced stage ovarian carcinoma

Conditions: Ovarian Cancer

Summary: in this study the investigators will be using an auc of 6 based on creatinine clearance using the carboplatin dosing formula used for gynecologic oncology group protocols. given that myelosuppression was significant using the docetaxel dose of 75 mg/m\*2 in the scotroc trial, the prophylactic use of pegylated g-csf in this phase ii trial is warranted. the expectation would be that patients will be able to receive their cycles in a more timely fashion, with less delays, thereby allowing for improved outcomes and decreased hospitalizations due to myelosuppression.


Eligibility criteria:
inclusion criteria: * histologically confirmed newly diagnosed stage iii/iv epithelial ovarian or primary peritoneal carcinoma at time of initial diagnosis * treatment must start within 8 weeks of surgery * subjects may be measurable per recist criteria or evaluable for disease response by ca125. evaluable ca 125 levels are defined as an elevated ca125 pre operatively which either remains elevated post-operatively or normalizes after surgery * no prior chemotherapy or radiation therapy * age ≥ 18 * performance status must be ≤ 2 (ecog) * peripheral neuropathy: must be ≤ grade 1 * hematologic (minimal values) * absolute neutrophil count ≥ 1,500/mm3 * hemoglobin ≥ 8.0 g/dl * platelet count ≥ 100,000/mm3 * hepatic \*total bilirubin ≤ uln * ast and alt and alkaline phosphatase must be within the range allowing for eligibility. * if alkaline phosphatase is ≤ uln and ast or alt is \>5x uln then the patient is not eligible * if alkaline phosphatase is \>1x but ≤2.5 x the uln and the ast or alt is \>1.5x the uln then the patient is not eligible * if alkaline phosphatase is \>2.5x but ≤5x the uln and the ast or alt is \>1x the uln then the patient is not eligible * if alkaline phosphatase is \>5x the uln then the patient is not eligible * renal: creatinine (serum) less than or equal to 1.5 uln, ctc grade 1. * women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. pt/ptt ≤ 1.5 x's uln exclusion criteria: * patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. * women who are pregnant or breast-feeding. * patients who have signs of infection or who have not recovered from the effects of recent surgery * patients with a performance status of 3 or 4 * patients with a second malignancy within past 5 years other than non-melanoma skin carcinoma. * patients who have received prior myelosuppressive chemotherapy or xrt.
infection and adverse pregnancy outcome

Conditions: Preterm Birth

Summary: miscarriage (spontaneous abortion, stillbirth, and preterm birth) is the most common adverse out-come of pregnancy and a significant proportion is caused by infection. the investigators aim to study vaginal specimens from 1200 pregnant women recruited before 14 weeks of gestation with follow-up at mid-term (week 19) as well as 300 women aborting spontaneously. adverse pregnancy outcome will be correlated to the presence of bacterial vaginosis (bv) subclasses, to vaginal fluid inflammation markers, and to the presence of novel chlamydia-like bacteria, in particular waddlia chondrophila. species specific quantitative pcr assays for bv-related bacteria as well as next-generation-sequencing will be applied on selected specimens with the aim to identify markers allowing for a personalised treatment approach.


Eligibility criteria:
inclusion criteria: * pregnancy exclusion criteria: * none
efficacy of artificial intelligence for gatekeeping in referrals to specialized care

Conditions: Primary Care; Primary Care Patients With Chronic Conditions

Summary: in rio grande do sul, brazil, the demand for specialty care referrals has increased sharply with the adoption of the electronic regulatory system, especially in rural areas. in 2023 alone, over 79,000 referrals were submitted monthly, totaling 1.7 million annual gatekeeping decisions. due to workforce limitations, nearly 70% of referrals are authorized automatically, often without clinical validation. this leads to delays for high-risk patients, unnecessary specialist visits, and a growing backlog, currently over 172,000 pending referrals. to address this, an ai algorithm was developed to triage referrals based on urgency and appropriateness. we propose a prospective controlled study with randomized implementation of the ai tool across selected specialty queues in the electronic referral system. the population will consist of referrals from specialties waitlists from municipalties in rio grande do sul. specialties to be included will be selected by the state health department prospectivelly according to gatekeeping needs. the intervention will be an ai-based triage algorithm. the control will be a standard gatekeeping process. the primary outcome is the proportion of referrals with a final decision (authorized or redirected to primary care) within six months; secondary outcomes include time to decision and appointment, system-level performance metrics. referrals will be randomly assigned to algorithmic or human gatekeeping with a 1:1 ratio. the algorithm classifies referrals into two groups: not authorized (pending more data or teleconsultation), authorized. authorization cases are further divided into routine and high-risk referrals to help managing the demand. for every ai prediction, the response is a probability from 0 to 1 of authorization (or deferring). for implementation this threshold is set at 0.8; cases below this level will be classified as low confidence for decision and will not be included. according to the state health department's decisions, several referral lines are expected to be selected for the intervention. a sample size 934 (467 per arm) for each included specialty was calculated to detect a 1.2 relative risk for the primary outcome with 90% power and 5% significance.


Eligibility criteria:
inclusion criteria: * all referrals from a given specialty (waitlist) will be eligible. * specialties will be selected following rio grande do sul health department priorities. exclusion criteria: * referrals that the ai algorithm can not evaluate. these include referrals with attachments (further information in image or pdf files) and referrals with previous rounds of discussion. * referrals in which the algorithm has low confidence in the decision (i.e., informed data lead to a decision with a probability below 80%) will not be included in the study.
diet, physical activity and related candidate biomarkers in relation to prostate cancer risk (biocappe)

Conditions: Epidemiology; Prostate Cancer

Summary: the risk of prostate cancer is associated with lifestyle habits, such as diet and physical activity. indeed, results of numerous studies suggest links between obesity, diabetes, inflammation and androgen and estrogen metabolism in the pathogenesis of prostate cancer. the goal of biocappe study (biomarkers and prostate cancer/ prevention and environment) is to identify biomarkers of prostate cancer risk that are potentially modifiable by environmental exposures (e.g. diet and physical activity). a selection of few of the most promising biological markers will be evaluated in a cohort of more than 2000 men at high-risk of prostate cancer. such biomarkers would provide a practical approach to identify men at high risk of prostate cancer who could benefit from interventions aiming at reducing their risk. the biomarkers would also be useful to monitor the efficacy of the interventions on patient's lifestyle.

the main objective of the proposed research project is to assess the association between five candidate biological markers potentially modifiable by environmental exposures (diet and physical activity) and the two-year risk of prostate cancer in a newly recruited cohort of men at high-risk of prostate cancer showing no evidence of cancer. four hospitals in the province of quebec (canada) participate to the recruitment of 2,055 men at high-risk for prostate cancer, i.e. men who had a first negative prostate biopsy or whose prostatic specific antigen (psa) level is between 2.5 and 10 ng/ml without previous prostate biopsy. the candidate biomarkers that will be tested are: 1. the ratio of ω-3/ ω-6 fatty acid content of red blood cell membranes, 2. oxidized low density lipoprotein cholesterol 3. adiponectin 4. insulin growth factor-1 5. the ratio of dihydrotestosterone glucuronide derivatives over estradiol a biobank, composed of biological material (whole blood, plasma, serum, lymphocyte layer and excess tissue collected from prostate biopsy or prostate surgery) and clinical data is being created. questionnaires are used to compile information on socio-demographic aspects, family and personal medical history, quality of life, lifestyle like food and sexual habits.

Eligibility criteria:
inclusion criteria: * group 1: a first negative prostate biopsy within 6 months * group 2: serum-psa level between 2.5-10 ng/ml and no prior prostate biopsy exclusion criteria: * prostate cancer * positive result for transurethral prostatic resection

Keywords: prostate cancer risk environmental risk factors biomarkers inflammation and prostate cancer
evaluation of the ifuse bedrock technique in association with posterior lumbosacral fusion with iliac fixation.

Conditions: Sacroiliitis; Sacroiliac; Fusion; Lumbosacral; Fusion; Spine Deformity

Summary: the purpose of this study is to describe the impact of the ifuse bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.

this study is a multicentric, post-marked clinical investigation to assess the efficacy of the ifuse bedrock technique to avoid post-operative pains in patients who underwent open posterior multilevel lumbosacral fusion. subjects will be monitored for lumbar pains (oswestry score, vas, sf-12 questionnaire) and sacroiliac joint pains (provocative tests) up to 12 months after initial procedure. a single ct-scan acquisition will be performed at 12 months to detect any ifuse system-related abnormality (implants loosening or breakages).

Eligibility criteria:
inclusion criteria: * subject scheduled for open posterior lumbosacral arthrodesis (including at least the following three vertebrae: l4, l5 and s1) associated with a sacroiliac fusion procedure and iliac fixation (thoracolumbar fusion procedures extended to sacrum are eligible in the study); * insertion of at least 1 ifuse-3d implant according to the ifuse bedrock technique (uni- and bilateral insertion are eligible); * subject who preoperatively responded positively to pain provocation tests for sij dysfunction with or without a positive sij infiltration test; * patient with a degenerative sacroiliac joint disease requested a fusion procedure; exclusion criteria: * major osteoporosis (dexa scan \> 3); * any previous history of sacroiliac joint fusion or any surgical procedure involving a s2-iliac fusion; * subjects requested a sij fusion without the ifuse-3d device or ifuse-3d not inserted according to the manufacturer instruction (bedrock technique); * subjects with a medical or surgical contraindication preventing the intervention from being performed or potentially interfering in the interpretation of the data collected (neurologic condition, local or systemic infection, any known allergy to surgical implants, psychiatric diseases, ...); * currently pregnant or planning pregnancy; * prisoner or a ward of the state; * subject no willing to participate in the study; * subject not affiliated to a social security insurance.

Keywords: sacroiliac joint pain sacroiliac joint fusion bedrock technique open posterior lumbosacral fusion spine deformties
the electronic medical records and genomics (emerge) network genomic risk assessment

Conditions: Genetic Disease

Summary: the emerge network embraces the opportunity to use new methods in genomic medicine, information science, and research participant engagement to identify people at very high risk for specific diseases and recommend individualized approaches to prevention and care. the investigators will conduct a prospective study, with diverse and underserved participants, across ten emerge study sites to evaluate clinical implementation of a genome informed risk assessment (gira) tool that combines genetic, family history, and clinical risk information from participants.

the purpose of the study is to determine if providing a genome informed risk assessment (gira) will impact clinical actions taken by providers and patients to manage disease risk and the propensity of participants to develop a disease reported in the gira. new tools in genomic medicine - polygenic risk scores, monogenic genetic screening tests, platforms to capture family history, and advanced electronic phenotyping - offer the prospect of early identification of people at especially high risk of common diseases. the investigators developed methods to generate integrated genomic risk assessments for ten conditions; a plan to engage, recruit, and retain \~25,000 subjects to receive these assessments; and methods to study outcomes in those designated high risk and those designated non-high risk. by enhancing understanding of new methods to create and deliver integrated genomic risk assessments, this project will enable prevention and early treatment of people at high risk for common diseases.

Eligibility criteria:
inclusion criteria: * adults 18-75 * children 3 to \< 18 * able to read or understand english or spanish * able to provide a healthcare provider or clinician to receive results * willing to accept gira report exclusion criteria: * inability to provide consent * transplant (solid organ or bone marrow) or transfusion within 8 weeks * research staff and investigators in emerge * not a patient at parent institution

Keywords: genomic risk genomic medicine gira genome informed risk assessment risk report
safety, tolerability, and pharmacokinetic study of isis apoc-iii rx in hypertriglyceridemia

Conditions: Hypertriglyceridemia

Summary: the purpose of this study is to evaluate the dose/response pharmacodynamic effects of isis apoc-iii rx vs. placebo on fasting total apoc-iii levels.


Eligibility criteria:
inclusion criteria: * severe hypertriglyceridemia exclusion criteria: * hba1c \>/=9.0%, type 1 diabetes, or history of outpatient insulin use for more than 2 weeks in the last year * body mass index (bmi) \>40 kg/m2 * history of bariatric surgery or currently on weight loss drugs * use of oral contraceptives or hormone replacement therapy or statins unless stable for 3 months prior to dosing * group 1 and 2 patients: use of systemic corticosteroids, fibrates, niacin, fish oil or other products containing omega-3 fatty acids within 6 weeks of dosing. group 3 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing ; use of niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period. group 4 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing; use of fibrates niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period. * use of topical corticosteroids, anticoagulants, or drugs or dietary supplements with potential lipid-altering effects unless dose is stable and well controlled for 30 days prior to dosing * any screening laboratory values that are out of allowed reference ranges * inability to comply with protocol or study procedures * any other significant illness or condition that may adversely affect the subjects participation in the study

Keywords: hypertriglyceridemia
nebulized hypertonic saline for bronchiolitis

Conditions: Bronchiolitis

Summary: in randomized controlled trials, the use of nebulized hypertonic saline in acute bronchiolitis has been reported to improve respiratory distress scores, to reduce length of hospital stay and to show a trend towards lower hospitalization rates. the investigators aim to verify by an observational study if the rate of hospital admission and the length of hospital stay of infants presenting to the emergency department (ed) with bronchiolitis decreases after the inclusion of 5.85% nebulized hypertonic saline in the treatment strategy of the ed and hospitalization wards. the investigators will assess the evolution of hospital admission rates and the length of hospital stay in two hospitals that use 5.85% nebulized hypertonic saline for the treatment of bronchiolitis and in two hospital that do not use these nebulizations. if nebulized hypertonic saline is effective in this setting, then the hospitalization rates and length of stay should be lower during the year of hypertonic saline use compared to two previous years when this therapy was not used. these parameters would not be modified in centers that do not use hypertonic saline.

this is a before-after observational study designed to compare the results in terms of hospitalization rate and length of hospital stay between a period when nebulized hypertonic saline was included in the treatment of bronchiolitis in infants versus the two previous years when this therapy was not used in two hospitals. there will not be any randomization. physicians have been instructed on the use of hypertonic saline for moderate and severe bronchiolitis in infants but its totally up to them whether to use this nebulization for each particular patient. two other hospital where nebulized hypertonic saline has never been used and will not be used during the next bronchiolitis epidemics will be the control centers. the study comprises two periods, one prospective starting on november 2011 and ending in march 2012 and one retrospective including the two previous bronchiolitis epidemics, november 2009-march 2012 and november 2010-march 2011. during the prospective period a standardized assessment of the respiratory status of each infant will be carried out before and after each hypertonic saline nebulization.

Eligibility criteria:
inclusion criteria: * all infants up to 1 year of age presenting to the ed for bronchiolitis during the study periods. exclusion criteria: * bronchiolitis in infants older than 1 year

Keywords: bronchiolitis saline nebulization hypertonic
the ovarian reserve and laparoscopic ovarian drilling

Conditions: Polycystic Ovary Syndrome

Summary: long term assessment of ovarian reserve after more than two years of laparoscopic ovarian drilling in polycystic ovary syndrome

inclusion criteria: goup "a": patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years. goup "b": patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to rotterdam criteria and didn't undergo laparoscopic ovarian drilling anti-mullerian hormone (as an indicator for ovarian reserve) will be measured for the two groups and data collected will be compared

Eligibility criteria:
inclusion criteria: * goup "a": patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years. goup "b": patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to rotterdam criteria and didn't undergo laparoscopic ovarian drilling exclusion criteria: 1. age \ 35 years. 2. bmi \ 35 3. patients refusing to participate in the study. 4. previous ovarian cystectomy.
cpap for infantile pompe disease

Conditions: Pompe Disease

Summary: patients with infantile onset pompe disease will be trained with continuous positive airway pressure to see if hypernasality can be improved.


Eligibility criteria:
inclusion criteria: 1. confirm as pompe disease 2. age 4 and can speak 2-words sentence by order 3. mild to severe hypernasality 4. have regular speech therapy for 8 weeks or longer exclusion criteria: (1）hearing loss （2）congenital pharyngeal or laryngeal structure anomalies including cleft palate （3）cerebral palsy （4）recent otitis media effusion （5）very severe hypernasality （6）use non-invasive ventilator
electrostimulation in patients with leg ulcers

Conditions: Venous Leg Ulcer

Summary: abstract evaluate the effect of transcutaneous electrical nerve stimulation on proinflammatory cytokines, angiogenic and growth factors in subjects with venous ulcers of the lower extremities. material and methods a randomized, double-blind, placebo-controlled, parallel-groups clinical trial was carried out in 32 adults (18-75 years of age) with venous ulcers of the lower extremities according to ceap classification with duple doppler ultrasound. after random allocation of intervention 16 patients received continuous and intermittent transcutaneous electrical nerve stimulation or placebo during 30 minutes three times per week for 60 days. proinflammatory cytokines, angiogenic and growth factors were measured before and after intervention. mann-whitney u test and wilcoxon's rank-sum test were performed to statistical analyses.


Eligibility criteria:
inclusion criteria: * venous ulcers c6,es, as/ap,pr according to ceap classification by spanish society of angiology and vascular surgery or demonstrated with duplex doppler ultrasound * who did not respond to conventional treatment. * evolution of no less than 12 weeks * ulcers with a size \> 2 and \< 12 cm in any of its dimensions did not affect the dermis and epidermis, but should not spread to the tendon or bone, without formation of ischemia and infection. exclusion criteria: * patients with active superficial or deep thrombus phlebitis, chronic arterial insufficiency (figures less than 0.8 in iptb), neoplasms. * treated with chemotherapy or radiation therapy * clinically infected ulcers at the time of study evaluation, signs of cellulitis. * osteomyelitis or ulcer with a necrotic background individuals with a surgical history of venous insufficiency at least 12 months prior to undergoing the protocol. * participants with diseases such as rheumatoid arthritis, lupus erythematosus, or disseminated, mental diseases, electrical implants (bypass), pregnancy and breastfeeding, diabetes mellitus, lung cancer, a history of stroke, or undergoing anticoagulant treatment. * patients receiving corticosteroids or some other immunosuppressive, non-steroidal anti-inflammatory, histamine antagonists, or antibiotics on a regular basis within 4 weeks prior to the study.

Keywords: leg venous ulcers tens electrical stimulation