Kornimate/medical-research-clean huggingface dataset:
comparison of congenital pneumonia and transient tachypnea of the newborn

Conditions: Congenital Pneumonia; Transient Tachypnea of the Newborn

Summary: accurate and timely differentiation between transient tachypnea of the newborn (ttn) and congenital pneumonia is essential in neonatal care, as it facilitates prompt initiation of appropriate treatment, reduces the risk of complications, and minimizes inappropriate antibiotic use. this study aims to assess the clinical utility of inflammatory markers, including the systemic immune-inflammation index (sii) and the systemic immune-response index (siri), in distinguishing ttn from congenital pneumonia in neonates. in scenarios where conventional diagnostic methods prove insufficient, these indices may offer clinicians a reliable and objective diagnostic approach, thereby optimizing antibiotic stewardship and reducing the duration of hospitalization.

patients admitted to the neonatal intensive care unit of dr. behçet uz children's hospital for respiratory distress will be analyzed. the following data will be recorded in the "case report form" for each patient: age, gender,score for neonatal acute physiology- perinatal extension-ii (snappe-ii), birth weight (sga/lga), mode of delivery (elective/emergency c-section and vaginal delivery), gravidity, parity, maternal age, maternal comorbidities (gdm, preeclampsia/eclampsia, hypothyroidism, chorioamnionitis, urinary tract infection, asthma, obesity, epilepsy), presence of premature rupture of membranes or fever, sibling history, low apgar score (\<7), leukocyte count, neutrophil count, lymphocyte count, platelet count, monocyte count, aspartate transferase (ast), c-reactive protein (crp), blood smear test, blood culture, tracheal aspirate culture, antibiotics used and their duration, chest x-ray findings, length of hospital stay, onset and duration of oxygen therapy and method of administration, need for mechanical ventilation, and morbidity and mortality status.

Eligibility criteria:
inclusion criteria: * neonates born at ≥37 weeks of gestation, admitted within the first 24 hours after birth with respiratory distress and a preliminary diagnosis of ttn exclusion criteria: * congenital anomalies genetic syndromes diagnosis of sepsis patients without informed consent

Keywords: biomarker newborn inflammation
a study of atezolizumab compared with gemcitabine plus (+) cisplatin or carboplatin for pd-l1-selected participants with stage iv squamous non-small cell lung cancer (nsclc) (impower111)

Conditions: Non-Small Cell Lung Cancer

Summary: this randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in pd-l1 selected participants with chemotherapy-naive, stage iv squamous nsclc. the study was closed due to low patient enrollment and the sponsor's decision to include patients with squamous nsclc into the go29431 study, nct02409342. therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iv squamous nsclc * tumor programmed death-ligand 1 (pd-l1) expression, as determined by immunohistochemistry (ihc) assay of archival tumor tissue or tissue obtained at screening * no prior treatment for stage iv squamous nsclc * measurable disease as defined by recist v1.1 * eastern cooperative oncology group (ecog) performance status 0 or 1 * adequate hematologic and end-organ function exclusion criteria: * active or untreated central nervous system (cns) metastases * untreated or inadequately treated spinal cord compression * leptomeningeal disease * uncontrolled pleural effusion, pericardial effusion, or ascites * uncontrolled tumor-related pain * uncontrolled hypercalcemia * any other malignancies within 5 years except those with negligible risk of metastasis or death * pregnant or lactating women * known hypersensitivity to any component of atezolizumab formulation or other study medication * history of autoimmune disease except controlled, treated hypothyroidism or type i diabetes * prior allogeneic bone marrow or solid organ transplantation * positive human immunodeficiency virus (hiv) test * active hepatitis b or c * active tuberculosis * significant cardiovascular disease * severe infection or major surgery within 4 weeks prior to randomization * use of any approved anti-cancer therapy within 3 weeks prior to treatment * use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization * exposure to oral or iv antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization * prior treatment with cluster of differentiation (cd) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-pd-1), and anti-pd-l1 therapeutic antibodies * treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization
study of the microbiota, metabolome, and environmental toxins in relation to reproductive health in rwandan women

Conditions: Vulvovaginal Candidiasis; Bacterial Vaginosis

Summary: the overall objective of this clinical pilot study is to determine at a random sampling time, the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects could alter pregnancy and conception outcomes. it is hypothesized that infection and toxins will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and infertility in rwandan women. in a sub-group of subjects, a preliminary assessment of the ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a healthy state and lower environmental toxins will be completed.


Eligibility criteria:
inclusion criteria: * pregnant women between the ages of 18 and 55. exclusion criteria: * \*current infection of gonorrhoea, \*chlamydia, genital warts, \*active genital herpes lesions, \*active syphilis; \*urinary tract infection including pyelonephritis (an ascending urinary tract infection); \*receiving drug therapy that may affect the vaginal flora; \*had unprotected sexual intercourse (vaginal or oral) within the past 48 hours; \*have used a vaginal douche, genital deodorant, or genital wipe products in the past 48 hours; \*have taken any 'acidophilus' 'bifidobacteria' or probiotic health food supplements in the past 48 hours; \*are menstruating at time of clinical visit.
a study to assess the efficacy and safety of induction therapy with ro7790121 in participants with moderately to severely active ulcerative colitis

Conditions: Moderately to Severely Active Ulcerative Colitis

Summary: this phase iii, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with ro7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of uc * moderately to severely active uc assessed by mms * bodyweight \>= 40 kilogram (kg) * up to date with colorectal cancer (crc) screening performed according to local standards * demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced uc therapy * males and females of childbearing potential must meet protocol criteria for contraception requirements exclusion criteria: * currently known complications of uc (e.g. fulminant colitis, toxic megacolon) * current diagnosis of crohn's disease (cd) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis * presence of an ostomy or ileoanal pouch * current diagnosis or suspicion of primary sclerosing cholangitis * pregnancy or breastfeeding, or intention of becoming pregnant during the study * past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed * history of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer * evidence of infection with clostridioides difficile (c. difficile; formerly known as clostridium difficile), cytomegalovirus (cmv), human immunodeficiency virus (hiv), hepatitis b (hbv), hepatitis c (hcv) * has evidence of active tuberculosis (tb), latent tb not successfully treated (per local guidance) or inadequately treated tb * has received protocol-specified prohibited medicines, including known exposure to any type of anti-tl1a therapy
serum vascular endothelial growth factor in infants with intravitreal ranibizumab

Conditions: Infant, Premature, Diseases

Summary: to determine the serum concentrations of ranibizumab and vascular endothelial growth factor (vegf) in infants with retinopathy of prematurity (rop) who received intravitreal ranibizumab

infants with rop are studied. they received 0.25 mg or 0.5 mg of intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases) with vascularly active rop. serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab. the serum concentrations of ranibizumab and vegf are measured by enzyme-linked immunosorbent assay, and the changes of the serum vegf levels are determined.

Eligibility criteria:
inclusion criteria: * infants with vascularly active rop * intravitreal ranibizumab exclusion criteria: * already accepted laser therapy

Keywords: retinopathy of prematurity ranibizumab vascular endothelial growth factor
watchful waiting of incisional hernias

Conditions: Incisional Hernia; Ventral Hernia; Umbilical Hernia

Summary: this study is being conducted to gain a better understanding of the quality of life for patients with a diagnosis of primary and recurrent incisional hernias and 1) who decline to have surgery to repair the hernia or 2) patients who cannot have surgery because their health will not allow them or 3o if surgery to repair the hernia is completed. a comparison will be made between those who receive surgery and those who do not.

this study is being conducted to gain a better understanding of the quality of life for patients with a diagnosis of primary and recurrent incisional hernias and 1) who decline to have surgery to repair the hernia or 2) patients who cannot have surgery because their health will not allow them or 3o if surgery to repair the hernia is completed. a comparison will be made between those who receive surgery and those who do not. subjects will fill out three survey forms on quality of life and pain at baseline and again at six and 12 months. measurements of change in hernia size will be made, life-style changes such as smoking cessation, weight-loss, tighter control of diabetes will be initiated for outcome comparison with controls.

Eligibility criteria:
inclusion criteria: 1. abdominal hernia greater than 3 cm2 2. 18 years of age 3. able to give informed consent exclusion criteria: 1. abdominal hernia less than 3 cm2 or greater than 127 cm2 2. unable to return to clinic for follow-up visits

Keywords: hernia incisional hernia ventral hernia umbilical hernia
safety and efficacy of intravenous natalizumab in acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the primary objective of the study is to assess the clinical effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of functional independence and activities of daily living. the secondary objective of the study is to explore dose and exposure response and the clinical treatment effects of natalizumab versus placebo in acute ischemic stroke on the following: measures of independence, activities of daily living, neurologic function, quality of life, cognition, and safety and tolerability


Eligibility criteria:
key inclusion criteria: * clinical diagnosis of supratentorial acute ischemic stroke defined by lkn ≤24 hours prior to study treatment initiation. * score of 5 to 23 points, inclusive, on the nihss at screening for subjects initiating treatment ≤9 hours from lkn. note: nihss eligibility must be confirmed within 60 minutes prior to randomization. * score of 5 to 15 points, inclusive, on the nihss at screening for subjects initiating treatment \>9 to ≤24 hours from lkn. note: nihss eligibility must be confirmed within 60 minutes prior to randomization. * prior to index stroke, patient was able to perform basic activities of daily living without assistance: dressing, eating, walking, bathing, and using the toilet. * for those subjects who underwent a cranial mri, there is at least 1 acute infarct with a diameter of ≥2 cm on baseline brain diffusion-weighted imaging. key exclusion criteria: * lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care. * presence of acute intracranial hemorrhage on acute brain ct or mri. however, petechial hemorrhages of ≤1 cm are not exclusionary. * severe stroke defined by imaging criteria based on either one of the following: * alberta stroke program early ct (aspect) score of 0 to 4 based on head ct or * acute infarct volume on mri diffusion weighed imaging greater than or equal to 70 ml * seizure at the onset of stroke. * known history of prior treatment with natalizumab. * known history of active viral hepatitis b or c. * signs and symptoms of active or acute infection. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: stroke
pharmacokinetics and tolerability of subcutaneous administration of pf 04236921 in healthy volunteers

Conditions: Healthy

Summary: this study will evaluate the safety, tolerability, and pharmacokinetics of pf-04236921 administered as a single subcutaneous dose in healthy volunteers.

tolerability and pharmacokinetics of subcutaneously administered dose of pf-04236921 in healthy volunteers

Eligibility criteria:
inclusion criteria: * healthy males between 18-55 years, inclusive. * healthy females of non-childbearing potential between 18 and 55 years, inclusive. exclusion criteria: * evidence or history of clinically significant disease. * females of childbearing potential.

Keywords: safety and tolerability pharmacokinetics pf-04236921 rheumatoid arthritis
the effect of progressive muscle relaxation exercises on premenstrual syndrome, anxiety, and tendency to violence in young women

Conditions: Premenstrual Disorder

Summary: this study results will provide evidence on the effectiveness of progressive muscle relaxation exercises (pmre) as a complementary method in improving premenstrual syndrome (pms), an important women's health issue. additionally, it will contribute to the literature by shedding light on irritability and anxiety, which are common side effects of pms.


Eligibility criteria:
inclusion criteria: * female students studying at istanbul aydın university, faculty of health sciences, those who score 111 or above on the premenstrual syndrome scale (pmss), female students aged 18-24 will be included in the study. exclusion criteria: * non-turkish speakers, individuals who cannot communicate normally, students who are unable to comply with the exercise program will be excluded from the study.

Keywords: premenstrual syndrome progressive relaxation exercise
feasability study of removing the ovaries and fallopian tubes

Conditions: Ovarian Diseases

Summary: the main reason for this trial is to show the feasibility of removing the ovarien and fallopian tubes through the gaster (transgastric adnexectomy). the background for it is to look for more indications of scarless surgery and we will show that the transgastric adnexectomy can be performed in an easy way. it is necessary that there is an indication for removing the ovaries and fallopian tubes and if the patient agree we will do it instead of through the belly through the gaster and maybe with an additional inzision in the vagina. all patients with indication for adnexectomy are potential candidates.

we will show the feasibility for transgastric adnexectomy in 10 patients. patients for participating in the study suffer of benign adnexal deseases and there is an indication for removing them for diagnostic, prophylactic or therapeutic reasons. a flexible gastric scope is put transgastric into the abdomen, developing an pneumoperitoneum and removing the adnexes with a monopolar knife. the adnexes then are put out of the abdomen either transvaginally after colpotomy or even transgastric. we already performed an appendectomy in 24 patients and were able to show the feasibility in acute infectios situations.

Eligibility criteria:
inclusion criteria: * indication for adnexectomy, agreement to take part in the study exclusion criteria: * no agreement in the trial; patients younger than 18 years of age

Keywords: transgastric notes gastrotomy brca 1/2
bupivacaine and epinephrine injection study

Conditions: Sinus Disease; Anesthesia; Bleeding

Summary: endoscopic sinus surgery (ess) is a common otolaryngologic procedure that aims to remove the partitions that separate the sinus cavities, remove inflamed tissue, and optimize the sinuses for topical medication use. in this procedure, the surgeon will inject a combination of drugs, local anesthetics, and vasoconstrictors, to reduce bleeding and improve visualization. however, previous studies have shown similar results when injected with only saline. in this study, investigators want to determine if the injection of local anesthesic+vasoconstrictor compared to no injection at all makes any difference in improving the surgeon's visualization during an ess.


Eligibility criteria:
inclusion criteria: * age 19 years or older * scheduled for primary ess (including septoplasty) exclusion criteria: * cystic fibrosis * systemic vasculitis or any bleeding disorders * known or suspected hypersensitivity to bupivacaine or epinephrine * previous sinus surgery * inhaled drug use (i.e., cocaine) in the preceding 6 months * nasal tumors * patients on antiarrhythmics. * patients with history of severe liver illness. * patients identified as high-risk for complications during preoperative assessment with the anesthesiologist (e.g. untreated hypertension, ischemic heart disease, cerebral vascular insufficiency, heart block, peripheral vascular disorder, uncontrolled hyperthyroidism and diabetes)

Keywords: endoscopic sinus surgery bupivacaine epinephrine
comparison of fenofibrate and niacin in patients with hypertriglyceridemia and low high-density lipoprotein (hdl)-cholesterol

Conditions: Hypertriglyceridemia With Low HDL-cholesterol

Summary: the purpose of the study is to compare the efficacy and tolerability of fenofibrate 160 mg and niacin 1500 mg in patients with hypertriglyceridemia and low hdl-cholesterol. the primary end point is the percent change of apob/a1 and the secondary end points are other lipid parameters and biomarkers.


Eligibility criteria:
inclusion criteria: * triglyceride 150-500 mg/dl and hdl-cholesterol \< 45 mg/dl after 8 week dietary run in period * 20-79 years old exclusion criteria: * low-density lipoprotein (ldl)-cholesterol ≥ 130 mg/dl without any lipid-modifying drug * history of cerebrovascular or cardiovascular diseases * creatinine \> 2.0 mg/dl * transaminase \> 2x upper limit of normal * gall bladder disease * cancer * pregnant or breast feeding women * history of adverse events associated with test drugs
study of bendamustine combined with bortezomib for patients with relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the primary objective of this study is to assess the safety and tolerability of bendamustine as combination therapy with bortezomib for patients with relapsed/refractory multiple myeloma (mm).


Eligibility criteria:
inclusion criteria: the patient: * has a diagnosis of multiple myeloma. * currently has multiple myeloma with measurable disease. * must have received at least 1 previous treatment regimen and shows signs of progressive disease at the time of study entry. * if a woman of child bearing potential (not surgically sterile or at least 12 months naturally postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. * if a man, must agree to use an acceptable method of contraception throughout the study and for 90 days after last dose study drug. * must have an eastern cooperative oncology group (ecog) performance status not greater than 2. * must have a life-expectancy of greater than 3 months. * must meet specific protocol-related hematological and laboratory criteria within 14 days of enrollment. exclusion criteria: the patient has: * had a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix). * plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (m-protein) and skin changes (poems) syndrome. * plasma cell leukemia. * non-measurable multiple myeloma. * common terminology criteria for adverse events (ctcae) grade 2 (or greater) peripheral neuropathy within 14 days before enrollment. * previously participated in a cephalon-sponsored clinical study with bendamustine. * impaired cardiac function or clinically significant cardiac diseases. * undergone major surgery within 4 weeks prior to screening or has not recovered from side effects of such therapy. * severe hypercalcemia. * other concurrent severe and/or uncontrolled medical or psychiatric conditions. * known positivity for human immunodeficiency virus (hiv) or hepatitis b or c. * a history of allergic reaction attributable to compounds of similar chemical or biological composition to bendamustine, bortezomib, boron, or mannitol. * received chemotherapy within 3 weeks before enrollment, with the exception of nitrosoureas, which should be discontinued at least 6 weeks before enrollment. * received corticosteroids (greater than 10 mg/day prednisone or equivalent) within 3 weeks before enrollment. * received immunotherapy, antibody, or radiation therapy within 4 weeks before enrollment. * a status as a pregnant or lactating woman. any women becoming pregnant during the study will be withdrawn from the study. * a status as a male whose sexual partner is a woman of childbearing potential not using effective birth control. * used an investigational drug within 1 month before the screening visit.