Kornimate/medical-research-clean huggingface dataset:
malignant pediatric pelvic tumors: a retrospective study

Conditions: Abdominal Neoplasms; Pelvic Neoplasms

Summary: the aim of the study is to retrospectively review data about malignancies that arise primarily in the pelvis and/or in the pelvic organs, in pediatric cancer patients \& categorize the spectrum of these malignancies according to experience at south egypt cancer institute which is the largest referral site in upper egypt.

background: the newborn and infant pelvis is not fully developed and the bladder, uterus, and ovaries are to a large degree intra-abdominal. the pelvis of the infant and child has different anatomic relationships than the adolescent or adult pelvis. neoplasms of the pediatric pelvis constitute a unique group requiring highly specialized management in a setting staffed by pediatric surgical and radiation oncologists. the most common neoplasms are rhabdomyosarcomas of the bladder, prostate, and vagina; sacrococcygeal teratoma; and the germ cell tumors, including teratomas, endodermal sinus tumors, and the choriocarcinomas. rapidly improving chemotherapy for all of these lesions has resulted in a changed role for the surgeon. patients \& methods: a hospital-based study, involving pediatric cancer patients, those have been diagnosed with malignant tumors that primarily arising in the pelvis and/or arising from the pelvic organs, and may have an intra-abdominal extension, in the period from 2001 january till 2015 december, and received treatment at the pediatric oncology department, their medical reports will be retrospectively reviewed for data collection. spectrum of these malignancies will be categorized and recorded as specific disease entities, based on morphology \& the primary site of occurrence, their relative incidence will be calculated, and the treatment outcomes will be verified.

Eligibility criteria:
inclusion criteria: * patients whose age less than 19 years. * patients diagnosed with a primary malignant tumor in the pelvis and/or arising from the pelvic organs. exclusion criteria: * patients whose age more than 18 years. * patients diagnosed with a malignant disease primarily arising from the bone marrow.

Keywords: childhood cancer abdominal tumors pelvic tumors pediatric oncology
lithovue elite registry

Conditions: Kidney Stone; Urolithiasis

Summary: to obtain postmarket safety and efficacy data on boston scientific lithovue™ elite system.

lithovue elite registry is a post-market, multi-center, open label, non-randomized, prospective study to document the safety and efficacy data on boston scientific lithovue™ elite system. lithovue elite system, includes the stonesmart™ connect console (reusable capital/workstation) and a single-use, disposable ureteroscope device. the lithovue elite system is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. it can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract. this is a post-market registry study. any subject who meets eligibility criteria, intends to undergo a diagnostic and/or therapeutic procedure utilizing the lithovue elite system, and is willing to provide written informed consent, will be approached and considered for enrollment in the study. data from diagnostic/therapeutic ureteroscopy procedure and standard of care post-ureteroscopy follow-up visits will be collected. these standard of care follow-up visits are expected to be scheduled within 120 days of the ureteroscopic procedure.

Eligibility criteria:
inclusion criteria: 1. subject intends to undergo diagnostic and/or therapeutic procedure in the urinary tract with boston scientific lithovue elite system 2. subject is able to accurately detect and report pain 3. subject is willing and able to complete subject questionnaire at specified time points 4. subject is willing and able to return for all follow-up visits exclusion criteria: 1. subject meets any of the contraindications per lithovue elite system instructions/directions for use (ifu/dfu) 2. subject meets any of the contraindications per any accessory devices that will be used in the ureteroscopy procedure 3. investigator deems subject not suitable for the study
clinical trial evaluating the efficacy and safety of zl-2306 (niraparib) in ovarian cancer patient

Conditions: Platinum-sensitive Relapsed Ovarian Cancer

Summary: this is a 2:1 randomized, double-blind, placebo-controlled, multi-center, phase iii clinical study evaluating the efficacy and safety of zl-2306 (niraparib) for maintenance treatment in patients with platinum-sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer (collectively referred to as relapsed ovarian cancer).the evaluation will be divided into two stages: stage i will be conducted in all patients, and if the predetermined statistically significant difference is not reached, the trial will continue to extend to stage ii during which evaluation will be performed in gbrca mutation-positive ovarian cancer patients.


Eligibility criteria:
inclusion criteria: * aged 18 years or older female. * high-grade serous or dominantly high-grade serous ovarian cancer * the subject shall have received two lines of platinum-containing chemotherapy, complete response \[cr\] or partial response \[pr\] after first-line platinum-containing chemotherapy, and after received at least 4 cycles of platinum-containing (must be carboplatin or cisplatin or nedaplatin) in second-line platinum-containing chemotherapy. * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * patients who have undergone ascites drainage with the last two cycles of the last chemotherapy regimen prior to enrollment. * symptomatic brain metastases or leptomeningeal metastases that have not been controlled. * patients who have been diagnosed previously or currently with myelodysplastic syndrome (mds) or acute myeloid leukemia (aml).
a long term safety study of lersivirine for the treatment of hiv-1 infection in subjects who have completed treatment with lersivirine in studies a5271015 and a5271022

Conditions: HIV-1

Summary: this is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies a5271015 and a5271022.

the trial was terminated prematurely on january 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. the decision to terminate the trial was not based on any safety or efficacy concerns.

Eligibility criteria:
inclusion criteria: * patients must complete of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols (a5271015 or a5271022). * patients must have had a viral load less than 50 copies/ml at week 84 of the parent protocol. * for women who can have children, a negative urine pregnancy test at the day 1 visit. exclusion criteria: * patients with any grade 4 division of aids toxicity (except for lipids and asymptomatic glucose elevations will not be included in this trial. * patients being treated with another investigational product or in another clinical trial, except the lersivirine parent protocols will not be included in this trial.
electronic pill bottle monitoring to promote medication adherence for people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: people with multiple sclerosis (ms) have variable adherence to ms medications, making the full efficacy of disease modifying therapies unrealized and the assessment of true treatment failures challenging. whereas some patients forget to take medications due to active lifestyles, others may have cognitive impairments that prevent them from organizing and planning their regular dosing schedules. an electronic pill cap ("pillsy") has been developed to record pill taking, timing, and set reminders through a mobile app. data on adherence can be captured and analyzed remotely for health care provider review.

the investigators will enroll 85 adult patients, 18 years old and above, with relapsing remitting multiple sclerosis (rrms), at the massachusetts general hospital ms clinics in a pilot study of pillsy electronic pill bottles. people with rrms who are taking (1) fingolimod, (2) dimethyl fumarate, (3) terifluonomide, (4) diroximel fumarate, or (5) siponimod will be eligible. patients must possess any type of smartphone capable of downloading the pillsy application to be eligible. per the pillsy manufacturer, the pillsy application is available on iphones connected to the apple app store and smartphones running the android operating system that are connected to the google play store. participants will be asked to use the pillsy bottle for 90 days each. participants will be randomized 1:1 to two conditions: 1) active reminders and 2) passive adherence tracking. patients in the active reminders group will receive daily alerts through the pillsy bottle, the pillsy app, and their phone to remind them to take their pill. patients in the passive adherence tracking group will not receive reminders and will instead have usual adherence monitored by the electronic pill bottle.

Eligibility criteria:
inclusion criteria: * ability to provide individual written consent * ability to understand sufficient levels of english to use the pillsy app * ability to come to massachusetts general hospital for two study visits over a 90-day window or ability to access zoom for virtual study visits * possess a smartphone * willingness to follow the study protocol exclusion criteria: * presence of an ms relapse requiring acute management and/or hospitalization * daily medication provided by allied health care workers * foreign travel preventing electronic remote monitoring * expectation of discontinuation of the oral disease modifying therapy (dmt) in the upcoming 90 days for any reason

Keywords: medication adherence
peripheral artery occlusive disease (paod) in women hospitalized for type 1 myocardial infarction in intensive cardiology care

Conditions: PAOD - Peripheral Arterial Occlusive Disease

Summary: the cardiovascular risk of women has been the subject of particular interest in recent years, in the world, in particular under the impetus of cardiology companies, with more and more work focusing on the specificities of these diseases in women as well as differences in terms of management and prognosis with a literature mainly based on american data and which focuses particularly on ischemic heart disease. the expected results are to have a prevalence of paod in an alsatian cohort, most of the data we currently have from american data, with analysis of the impact of specific and non-specific risk factors in this cohort and their weight in paod.


Eligibility criteria:
inclusion criteria: * adult woman (≥18 years old) * patient hospitalized in an intensive cardiology unit (icu) at the hus for a type 1 myocardial infarction confirmed according to the criteria of the fourth universal definition of the esc between 01/01/2021 to 30/06/2021 inclusive * patient who did not express her opposition to the reuse of her data for scientific research purposes. exclusion criteria: * patient who expressed her opposition to participating in the study * impossibility of providing the subject with enlightened information (difficulties in understanding the subject, mms \<20/30...) * non-type 1 or unconfirmed myocardial infarction * unstable or refractory shock state at the time of the echodoppler examination * complication of the coronary angiography approach, in the case of femoral approach only, requiring surgical management. * patient under curatorship, guardianship or judicial safeguard.

Keywords: peripheral arterial occlusive disease paod cardiovascular risk factors myocardial infarction
l-carnitine for fatigue in copd

Conditions: Copd; Fatigue

Summary: supplementation with l-carnitine that is available both as an fda-approved therapy for primary carnitine deficiency, as well as widely available as an over-the-counter ergogenic aid will improve wellbeing and function measured by questionnaires in patient with chronic obstructive pulmonary disease (copd). based on our review of literature that addition of health coaching (hc) to l-carnitine will yield greater gains.


Eligibility criteria:
inclusion criteria: - copd patients with a positive screen for fatigue exclusion criteria: * vulnerable population - pregnant women, prisoners, unable to provide consent * pre-menopausal/breastfeeding women (pregnancy category b) * thyroid disease * anticoagulation therapy * decompensated cardiac disease * chronic kidney disease (ckd4 or above) * known seizure disorder * active malignancy * exacerbation of underlying pulmonary disease or acute illness in the 6 weeks before screening * enrollment in the past 6 weeks or currently in a cardiac or pulmonary rehab program or other physical fitness class(es). * difficulty with swallowing pills
clomiphene citrate versus tamoxifen for ovulation induction in pcos

Conditions: PCOS

Summary: comparison between clomiphene citrate and tamoxifen for induction of ovulation in women with pcos.

participants fulfilling inclusion and exclusion criteria will be divided into two groups, each group containing 300 participants; group (a): 300 participants will receive clomiphene citrate oral tablets and placebo of tamoxifen oral tablets. group (b): 300 participants will receive tamoxifen oral tablets and placebo of clomiphene oral tablets. participants with abnormal menstrual history will receive two tablets of norethisterone 5mg tab (steronate nor ®, hi pharm/egypt) every12 hours for 5 days to withdraw period before starting the procedure. then; group (a): women will receive one tablet of clomiphene citrate oral tablets 50 mg (clomid®, aventis/egypt) twice daily 12 hours apart (total dose 100 mg daily), and one tablet of placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses for 5 days, for only one menstrual cycle. group (b): women will receive one tablet of tamoxifen oral tablets 10 mg (tamoxifen®, amriya/egypt) twice daily 12 hours apart (total dose 20 mg daily), and one tablet of placebo of clomiphene citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one menstrual cycle.

Eligibility criteria:
inclusion criteria: * primary infertility. * body mass index (bmi) between 25 and 30 kg/m 2. * polycystic ovary syndrome (using eshre/asrm criteria). exclusion criteria: * secondary infertility. * patients with bmi under 25 or over 30 kg/m 2. * hyper or hypothyroidism, or hyperprolactinemia. * current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs. * intention to start a diet or a specific program of physical activity. * organic pelvic diseases. * tubal or male factor infertility. * interval of earlier treatment with any of the fertility drugs of less than 6 months. * contraindication to either: * clomiphene citrate. * tamoxifen. * hcg injection.

Keywords: pcos induction of ovulation clomiphene citrate tamoxifen
host-pathogen interaction in otitis media

Conditions: Otitis Media

Summary: otitis media (om) is one of the most frequent diseases in childhood and the primary reason for children to visit a physician. in many countries it is the most common reason to prescribe antibiotics leading to increased drug-resistance of the causative agents, or to undergo surgery. costs for general health care are expanding, and are estimated to be 3-5 billion dollar annually in the united states. prevention is suspected to be an important solution to this problem. although om management has no universal standard yet, it may imply watchful waiting, antibiotic treatment, adenoidectomy, insertion of tympanostomy tubes and (future) vaccination. approximately 80% of the acute otitis media (aom) cases is self-limiting within 2-14 days and also otitis media with effusion (ome) resolves spontaneously: 60% of newly detected ome resolves within 3 months. however, in a significant part of the om population persistent or recurrent episodes of om are responsible for a significant morbidity for both children and parents, despite variable treatment options. through the set up of a new prospective cohort in a clinical setting, relevant patient characteristics, the role of bacterial and viral pathogens, the role of recurrent infection in relation to biofilm formation, and the host response at protein level will be studied in detail. this project is expected to increase the understanding of the underlying mechanisms of om disease, which will support future treatment and prevention strategies. better understanding in om pathogenesis is warranted in order to develop these novel preventive strategies.


Eligibility criteria:
inclusion criteria: * children up to 5 years of age * suffering from raom, come or csom * waiting for tympanostomy tube insertion * informed consent exclusion criteria: * no informed consent * the child has a malignancy, or organ transplantation, or immune deficiency in the medical history * the child had recent elective ear surgery (i.e. mastoidectomy, implants \<2 weeks ago) * the child suffers from systemic infectious diseases (i.e. hepatitis, chickenpox)

Keywords: otitis media demography streptococcus pneumoniae haemophilus influenzae moraxella catarrhalis rhinovirus children, 0-5 years of age diagnosed raom, come or csom by an otorhinolaryngologist primary and secondary hospital nijmegen, the netherlands
study to compare efficacy and safety of lubt010 and lucentis® in patients with neovascular amd

Conditions: Neovascular Age-related Macular Degeneration

Summary: this study is designed to compare the efficacy, safety and immunogenicity of lubt010 with lucentis® given as once monthly intravitreal injection in patients with neovascular age-related macular degeneration (amd).

this is a global, phase iii, double blind, randomized controlled study to compare the efficacy, safety \& immunogenicity of lubt010 with lucentis® in patients with neovascular age-related macular degeneration. eligible patients will be randomly assigned in 1:1 ratio to receive once monthly intravitreal injection of lubt010 or lucentis® for 12 months.

Eligibility criteria:
inclusion criteria: 1. ambulatory male or female participants with age ≥ 50 years at the time of screening 2. capable of understanding and giving written informed consent 3. primary or recurrent (anti-vegf naïve) active cnv lesions involving the foveal center secondary to amd 4. bcva between 20/40 and 20/200 (snellen equivalent) in the study eye, using etdrs testing 5. willingness and ability to undertake all scheduled visits and assessments exclusion criteria: 1. known hypersensitivity to ranibizumab or any of the components of study medication 2. known history of allergy to fluorescein dye 3. scar, fibrosis, or atrophy involving the center of the fovea in the study eye 4. subretinal hemorrhage in the study eye that involves the center of the fovea 5. uncontrolled glaucoma 6. use of prohibited treatments other in-/exclusion criteria may apply

Keywords: neovascular age-related macular degeneration, ranibizumab
study of orl-1g (d-galactose) in patients with glycogen storage disease type 14

Conditions: Glycogen Storage Disease, Type 14

Summary: study of orl-1g in patients with glycogen storage disease type 14


Eligibility criteria:
inclusion criteria: * diagnosis of glycogen storage disease type 14. * less than 18 years old. exclusion criteria: * diagnosis of any other disease that is not a manifestation of glycogen storage disease type 14.

Keywords: cdg it; cdgit phosphoglucomutase 1 deficiency pgm1 deficiency glycogen storage disease xiv; gsd14 gsd xiv
a clinical study of va-cag as induction therapy in newly diagnosed aml patients

Conditions: Acute Myeloid Leukemia

Summary: this study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and cag(va-cag) as induction regimen in newly diagnosed young patients with acute myeloid leukemia(aml).

this is an open-label, multicenter, phase ii clinical trial to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine (va) and cag (g-csf priming, low dose cytarabine, and aclarubicin) as induction regimen in newly diagnosed patients with acute myeloid leukemia (aml). the combination of venetoclax and azacitidine is the standard therapy for elderly (\> 60 year old) patients with newly diagnosed aml who are not eligible for intensive chemotherapy. previous studies have shown that venetoclax plus intense chemotherapy represent promising efficacy in de novo aml patients with high complete remission rates and good tolerance. the preliminary results suggest that venetoclax in combination with azacitidine and cag are well tolerated and effective for newly diagnosed young patients with aml. thus, this phase ii clinical trial is going to further explore its efficacy and safety. it is expected that about 100 patients will take part in this trial.

Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years old and ≤ 65 years old 2. newly diagnosed as aml patients according to 2016 world health organization (who) classification; 3. patients without receiving prior therapy for aml; 4. eastern cooperative oncology group (ecog) performance status score less than 3; 5. liver function: total bilirubin ≦2 upper limit of normal (uln); aspartate aminotransferase (ast) ≦3 uln; alanine aminotransferase (alt)≦3 uln 6. renal function：ccr（creatinine clearance rate） ≧30 ml/min; scr (serum creatinine) ≦2 uln 7. heart function: left ventricular ejection fraction ≧45% 8. patients must participate in this clinical trial voluntarily and sign an informed consent form. exclusion criteria: 1. acute promyeloid leukemia； 2. aml with central nervous system (cns) infiltration； 3. patients have received prior hypomethylating agents (hma) therapy for myelodysplastic syndrome (mds) and progressed to aml； 4. patients with a life expectancy \<3 months 5. patients with uncontrolled active infection; 6. hiv infection; 7. evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) chronic hepatitis b virus (hbv) or hepatitis c (hcv) requiring treatment; b) an active second cancer that requires treatment within 6 months of study entry. 8. female who are pregnant, breast feeding or childbearing potential. 9. patients deemed unsuitable for enrollment by the investigator.

Keywords: venetoclax azacitidine granulocyte colony-stimulating factor(g-csf) cytarabine aclarubicin
target volume in noninvasive positive pressure ventilation

Conditions: Obesity Hypoventilation Syndrome

Summary: patients with ohs are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (nippv). several nippv devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined "ideal tidal volume" or "ideal ventilation". however algorithms used to achieve these ideal targets are different among different commercialized devices and the relative efficacy from an algorithm compared to another remains unknown. the main objective is this study is to compare two commercialized nippv that have this option

resmed stellar-150 (ivaps mode)versus philips-respironics a30 (avaps-mode).

Eligibility criteria:
inclusion criteria: * patient with obesity hypoventilation syndrome (bmi≥ 30 kg/m2 and diurnal paco2 ≥ 45mmhg at diagnosis after exclusion of others causes of hypoventilation) * 18 to 75 years old * in stable state but treated by nocturnal nippv for more than 3 months and adherent to nippv (above 4h/night). exclusion criteria: * patient treated with additional long term oxygen therapy * patient previously treated by avaps mode or ivaps mode

Keywords: noninvasive ventilation obesity hypoventilation syndrome