Kornimate/medical-research-clean huggingface dataset:
safety of antibiotic intake during pregnancy

Conditions: Infections

Summary: this study will be conducted to assess the knowledge of the pregnant females regarding safety of antibiotic intake ,also their attitude toward any prescribed antibiotics during their pregnancy .

this study will be conducted on pregnant females from two arab countries to assess their knowledge and attitude toward any prescribed antibiotics while they are pregnant .also to assess any malpractice while their intake for any antibiotics . this study is a cross sectional study that will involve a questionnaire including the three mentioned domains .

Eligibility criteria:
inclusion criteria: * pregnant women at any gestational age exclusion criteria: * pregnant women who refused to participate

Keywords: antibiotics, infection
transposon-manipulated allogeneic carcik-cd19 cells in pediatric and adult patients with r/r all post hsct

Conditions: Acute Lymphoblastic Leukemia, in Relapse

Summary: this is a single arm, open-label, multi-center, phase 1-2a study to determine the maximum tolerated dose and/or the recommended phase 2 dose and the safety of carcik-cd19 in adult and pediatric patients with relapsed or refractory b-cell precursor acute lymphoblastic leukemia.


Eligibility criteria:
inclusion criteria: * children (1-17) and adults (18-75 years old); * relapsed or refractory adult and pediatric b-cell precursor all after hsct; * evidence of cd19 tumor expression in bone marrow and/or peripheral blood by flow cytometry; * bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening; * no evidence of overall agvhd \> grade i or chronic gvhd (cgvhd) greater than mild at time of enrollment and in the previous 30 days; * no longer taking immunosuppressive agents for at least 30 days prior to enrollment; exclusion criteria: * patients with gvhd grades ii-iv; * any cell therapy in the last 30 days;

Keywords: acute lymphoblastic leukemia car-t carcik transposon
effect of nitrous oxide on acute pain and opioid consumption, and chronic pain after hysterectomy

Conditions: Abdominal Hysterectomy (& Wertheim); Nitrous Oxide; General Anesthesia

Summary: the study is prospective and double blind. in the clinic, patients undergoing hysterectomy that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups.

the study is prospective and double blind. in the clinic, patients undergoing hysterectomy that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups. in the first group of patients will receive nitrous oxide and in the second group of patients will receive oxygen during the general anesthesia.

Eligibility criteria:
inclusion criteria: * 18 to 65 years old at time of the first procedure * female * american society of anesthesiologists physical status i or ii * hysterectomy undergoing the general anesthesia exclusion criteria: * neuropathic disease * chronic opioid users * contraindication for nitrous oxide receive * consent will not be obtained patient * psychiatric disorders * current or recent drug abuse (within past 6 months).
syd985 vs. physician's choice in participants with her2-positive locally advanced or metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study is to demonstrate that syd985 \[(vic-)trastuzumab duocarmazine\] is superior to physician's choice in prolonging progression free survival.

this study is designed as a randomized, active-controlled, superiority study in patients with unresectable locally advanced or metastatic her2-positive breast cancer. the patients should have had either progression during or after at least two her2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment. eligible patients will be randomly assigned (2:1) to receive syd985 or physician's choice treatment until disease progression, unacceptable toxicity or study termination by the sponsor. during treatment, patients will have to visit the clinical site to assess efficacy, quality of life (qol), and safety using standardized criteria.

Eligibility criteria:
main inclusion criteria: * female patients with histologically-confirmed, unresectable locally advanced or metastatic breast cancer; * patients should have had either progression during or after at least two her2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment for locally advanced or metastatic disease; * her2-positive tumor status; * patients must have measurable or non-measurable disease that is evaluable per recist 1.1; * eastern cooperative oncology group (ecog) performance status ≤ 2; * estimated life expectancy \> 12 weeks at randomization; * adequate organ function and blood cell counts. main exclusion criteria: * current or previous use of a prohibited medication as listed in the protocol; * history of infusion-related reactions and/or hypersensitivity to trastuzumab, (ado-)trastuzumab emtansine; * history of keratitis; * severe, uncontrolled systemic disease at screening; * left ventricular ejection fraction (lvef) \< 50%, or a history of clinically significant decrease in lvef during previous treatment with trastuzumab or (ado-)trastuzumab emtansine; * cardiac troponin value above the upper limit of normal (uln); * history of clinically significant cardiovascular disease; * untreated brain metastases, symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization; * history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest ct scan.
pharmacokinetics of emtricitabine/tenofovir/efavirenz in hiv-infected patients with tuberculosis

Conditions: Tuberculosis; HIV Infections

Summary: in this pilot study the pharmacokinetics and safety of the antiretroviral combination of co-formulated emtricitabine/tenofovir/efavirenz will be studied in hiv-positive patients with pulmonary tuberculosis (tb) who are concomitantly treated with a standard rifampin-containing tuberculostatic regimen. it is expected that this antiretroviral combination causes minimal drug interactions with the rifampin-containing anti-tuberculosis medication.

the primary objectives of this pilot study in 30 patients are: 1. to determine the effect of rifampin-containing tuberculostatic treatment on the pharmacokinetic profile of emtricitabine+tenofovir+efavirenz, when co-formulated in one tablet, in hiv-infected patients with smear-positive pulmonary tuberculosis in tanzania. 2. to determine the effect of the emtricitabine+tenofovir+efavirenz regimen on the pharmacokinetics of tuberculostatics in the same population. the secondary objectives are: 1. to determine the safety of co-administration of emtricitabine+tenofovir+efavirenz with treatment for smear-positive pulmonary tuberculosis. 2. to determine the short-term (24 weeks) virological efficacy on hiv of an emtricitabine+tenofovir+efavirenz regimen in patients with smear-positive pulmonary tuberculosis. 3. to determine the short-term bacteriological efficacy on smear-positive tuberculosis of the co-administration of a standard regimen for tuberculosis and an emtricitabine+tenofovir+efavirenz regimen.

Eligibility criteria:
inclusion criteria: * a smear-positive pulmonary tuberculosis, based on positive smear of at least two sputum samples with ziehl-neelsen (zn) staining. * hiv-infected as documented by positive hiv antibody test. * subject is at least 18 years of age at the day of the first dosing of study medication. * subject is able and willing to sign the informed consent form prior to screening evaluations. * cd4 cell count \> 50 copies/mm3. * karnofsky score \> 40. * willing and able to regularly attend the kibung'oto national tuberculosis hospital (knth) clinic. exclusion criteria: * history of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial. * previously treated for hiv infection with antiretroviral agents. * pregnant or breastfeeding. * relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. * a history of severe psychiatric disease such as psychosis, schizophrenia, etc. * inability to understand the nature and extent of the trial and the procedures required. * abnormal serum transaminases or creatinine, determined as levels being \> 5 times upper limit of normal. * active hepatobiliary or hepatic disease (non b chronic hepatitis b/c co-infection is allowed). * cd4 cell count \> 350 cells/mm3.

Keywords: tuberculosis hiv coinfection pharmacokinetics emtricitabine tenofovir rifampin efavirenz treatment naive
a study to evaluate efficacy and safety of aln-agt01 in patients with mild to-moderate hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the effect of aln-agt01 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (pd) effects and safety of aln-agt01.

participants will receive aln-agt01 or placebo for the first 6 months of the 12-month double-blind (db) treatment period. participants randomized to placebo will be re-randomized at month 6 to 1 of the 4 initial aln-agt01 regimens until the end of the 12-month db treatment period. participants randomized to aln-agt01 regimens will remain on their originally assigned regimens through remainder of the study.

Eligibility criteria:
inclusion criteria: * daytime mean sbp ≥135 mmhg and ≤160 mmhg by abpm, without antihypertensive medication exclusion criteria: * secondary hypertension, orthostatic hypotension * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>2× upper limit of normal (uln) * elevated potassium \>5 meq/l * estimated glomerular filtration rate (egfr) of ≤30 ml/min/1.73m\^2 * received an investigational agent within the last 30 days * type 1 diabetes mellitus, poorly controlled type 2 diabetes mellitus, newly diagnosed type 2 diabetes mellitus * history of any cardiovascular event within 6 months prior to randomization * history of intolerance to sc injection(s)

Keywords: high blood pressure hypertension hypertensive sirna angiotensinogen agt
optical coherence tomography (oct) data collection study

Conditions: Glaucoma

Summary: collect oct data to evaluate the range and age trend of ocular measurements.

this is a prospective, multi-center study. ocular history and examination will be conducted on consented subjects to determine further participation in the study. subjects qualified to continue will undergo imaging of both eyes using the spectralis oct.

Eligibility criteria:
inclusion criteria: * subject is not an employee of the eye clinic. * age ≥18 to 90. * able and willing to undergo the test procedures, give consent, and to follow instructions. * healthy eye without prior intraocular surgery (except cataract surgery and lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve. * caucasian decent (self-reported). * negative history of glaucoma. * intraocular pressure ≤21mmhg. * best corrected visual acuity ≥0.5. * refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters. * normal visual field with glaucoma hemifield test and mean deviation within normal limits. * clinically normal appearance of the optic disc, with normal appearing neuroretinal rim with respect to color and shape. the optic disc is examined ophthalmoscopically and by evaluation of stereo photographs. * when both eyes are eligible, both eyes enter the study for inter-eye asymmetry; one randomly selected eye will be used for all other measures. exclusion criteria: * unreliable visual field. the reliability indices should be used as guide as well as the perimetrist's notes. * unusable disc stereo photos. * inability to undergo the tests. * insufficient quality of spectralis oct images (this is not determined until after spectralis oct examination, and is an unusual circumstance). minimum requirements are: * retina completely included in image frame, * quality score ≥ 20 in the stored art mean images, and * for onh-r scan: center position error ≤ 100 μm. * note: inability of a subject to perform one of the two scan patterns or insufficient image quality in one scan pattern does not exclude the subject or eye from the study.
defining mechanisms of surgical site infection after oral cancer surgery

Conditions: Oral Cancer

Summary: the study design is an observational cohort study of patients undergoing standard of care oral cavity reconstruction. an observational study is required to prospectively evaluate microbial and antibiotic mechanisms underlying surgical site infection after oral cavity reconstruction.

this is a single institution study at the medical college of wisconsin, given the feasibility of projected sample size accrual as well as the clinical and translational expertise at this location for investigating surgical site infection after oral cavity reconstruction. biospecimens collected will include oral, nasal, pharyngoesophageal, and skin microbial swabs, blood, and discard tissue samples obtained during standard of care oral cavity reconstruction surgery and an oral swab and nasal swab obtained post-operatively.

Eligibility criteria:
inclusion criteria: 1. provide signed and dated informed consent form. subjects must have the capacity to consent for themselves. 2. willing to comply with all study procedures and be available for the duration of the study. 3. aged 21 years or older. 4. planned to undergo standard of care oral cavity reconstruction surgery with use of ampicillin/sulbactam as the prophylactic antibiotic agent administered. 5. oral cavity reconstruction surgery will be defined as any surgical procedure which includes a planned connection from the oral cavity to the neck soft tissues which is repaired with a free or regional tissue flap. 6. history of oral or oropharyngeal cancer. exclusion criteria: 1. allergy to ampicillin/sulbactam. 2. vulnerable populations including pregnant women and prisoners.

Keywords: surgical site infection oral cavity reconstruction
whole exome sequencing of familial and pediatric forms of vasculitis

Conditions: Vasculitis

Summary: the familyvasc study is a prospective observational study which will aim to identify susceptibility loci and genes for systemic vasculitis risk in patients with familial or pediatric forms of vasculitis. genetic analysis based on whole exome sequencing will be carried out through salivary dna.


Eligibility criteria:
inclusion criteria for subjects with vasculitis * children and adults * patients with vasculitis, as defined in the chapel hill international classification in its revised version of 2012 * patient information and signed informed consent * pregnant and breastfeeding women can be included in the study inclusion criteria for healthy subjects * children and adults * do not have vasculitis, as defined in the chapel hill international classification in its revised version of 2012, or relatives on the 1st; 2nd; 3rd or 4th degree of a patient with vasculitis * patient information and signed informed consent * pregnant and breastfeeding women can be included in the study exclusion criteria: * refusal of consent or inability to obtain consent * dementia or unauthorized patient, for psychiatric or intellectual failure reasons, to receive information about the protocol and to give informed consent. * uncooperative patient, or any pathology that could make the patient potentially non-compliant to the study procedures, and patients interned for regulatory or legal reasons.

Keywords: vasculitis
role of nlrp3 inflammasone and hypoxia in the severity of osteoporosis in patients with bronchiectasis

Conditions: Bronchiectasis Adult; Osteoporosis, Osteopenia

Summary: the objectives of this research grant are to determine the association of hypoxia with the severity of osteoporosis in the patients with bronchiectasis and whether the mechanism of inflammation is triggered by inflammasones, which makes it more prone to osteoporosis in patients with bronchiectasis.

80 patients with proven bronchiectasis, diagnosed by high-resolution computed tomography (hrct), will be recruited from our outpatient clinic of chang gung memorial hospital with written informed consent. inclusion criteria are: daily sputum \> 10 ml; absence of asthma or other unstable systemic diseases; and "steady-state" bronchiectasis (\< 10% alteration of 24 h sputum volume, fev1, and fvc, and in the absence of deterioration in respiratory symptoms at baseline visits). exclusion criteria include: unreliable clinic attendance; regular user of inhaled or oral corticosteroids; history of lung resection and known asthma defined according to american thoracic society guidelines. the lung function and desaturation will be assessed by six-minute walking tests and the severity of disease will be evaluated by hrct scores. peripheral blood sample (40ml/person) is performed to analyze the bone turnover markers and the level of hif in pbmc.

Eligibility criteria:
inclusion criteria: 1. willing to sign a written consent form 2. male and female subjects with bronchiectasis diagnosed by high-resolution computed tomography 3. willing to accept 6-minute exercise pulmonary function test and blood draw 4. men and women over the age of 20 5. has undergone chest computed tomography and bone density examination in the recent five years exclusion criteria: 1. pregnant women or lactating women 2. asthma, lung resection history before the screening period 3. active tuberculosis infection 4. have received oral steroid treatment within 30 days 5. current acute attack or clinical symptoms instability of bronchiectasis
safety and pharmacokinetis of tap311 in dyslipidemic patients

Conditions: Dyslipidaemia

Summary: the study will assess the safety, tolerability and pharmacokinetics of tap311 in patients with dyslipidemia.


Eligibility criteria:
inclusion criteria: * male and female patients 18 to 80 years (inclusive) of age. * patients are not treated for dyslipidemia with medications other than hmg-coa reductase inhibitors (statins) for at least 4 weeks prior to day 1. patients should be on stable doses of current medications, if any, for at least 3 months to be eligible. * patients must weigh at least 50 kg to participate in the study, and must have a body mass index (bmi) within the range of 18 - 40 kg/m2. exclusion criteria: * use of other investigational drugs at the time of enrollment * history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes * use of lipid modifying agents (e.g. fenofibrate, niacin, omega-3 fatty acids, etc.) other than statins will exclude subjects. * pregnant or nursing (lactating) women * diabetic patients whose plasma glucose is not well controlled by stable diabetic treatment for at least 3 months * heavy smokers (smoke more than 10 cigarettes a day routinely and who cannot refrain from smoking during the study). * women of child-bearing potential (wocbp) can be included but must use highly effective contraception * significant illness within two (2) weeks prior to initial dosing * history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result. * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result.

Keywords: safety tolerability pharmacokinetics
corevalve advance international post market study

Conditions: Severe Aortic Stenosis

Summary: the corevalve advance study is intended to evaluate the clinical utility of the medtronic corevalve system in a "real-world" patient population.

the corevalve advance study is intended to evaluate the clinical utility of the medtronic corevalve system for percutaneous aortic valve implantation in a "real-world" patient population with severe aortic valve stenosis. data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. in addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.

Eligibility criteria:
inclusion criteria: * patients with severe aortic valve stenosis requiring treatment * patient is an acceptable candidate for elective treatment with the medtronic corevalve system and in conformity with the local regulatory and medico economical context * patient is above the minimum age as required by local regulations to be participating in a clinical study * the patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("patient informed consent form") exclusion criteria: * currently participating in another trial * high probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * pregnancy

Keywords: advance medtronic corevalve system international interventional post market study
the impact of electroacupuncture on clinical effect,brain structural and functional changes on spinal cord injury

Conditions: Spinal Cord Injuries

Summary: spinal cord injury (sci) is a kind of severe disease with high morbidity and complications. at present, electroacupuncture has certain advantages in treating motor sensory dysfunction, neuropathologic pain, neurogenic bladder and intestinal dysfunction after spinal cord injury. however, previous clinical studies of acupuncture neglected the brain, which is closely related to the structure and function of spinal cord.so,the aim of this study is to observe and analyse the impact of the changes of gray and white matter volume on whole brain and brain functional re-establish,to reveal the neuroimaging mechanism of improving the motor sensory functions of patients with spinal cord injury, and to provide a theoretical basis for the clinical application of electroacupuncture.


Eligibility criteria:
1.aged 18-75 years no matter the gender 2.14 days to 3 months after the onset of sci 3.patients with cervical, thoracic or lumbar spinal cord injuries 4.sci classified as b, c, or d grade on the asia impairment scale(ais), that is incomplete sci (isci) 5.patients with grade 1-3 muscle strength of lower limbs 6.right-handed 7.patients who submitted written informed consent exclusion criteria: 1. contraindication to mri scanning such as metal in the body, pacemaker 2. severe structural asymmetry or lesions in the brain 3. complications that may affect neurologic examination, such as severe peripheral nerve injury, limb fractures, and heterotopic ossification around the joints 4. with complex injury such as traumatic brain injury, organ injury, unstable vital signs or disturbance of consciousness 5. with severe primary diseases such as heart, liver, kidney and hematopoietic system 6. patients with sci due to myelitis, multiple sclerosis, vascular malformation caused spinal cord hemorrhage, intraspinal tumors, etc. 7. pregnancy

Keywords: spinal cord injury electroacupuncture brain structure and function multi-mode magnetic resonance imaging
emergency peripartum hysterectomy: a prospective study in iran

Conditions: Postpartum Hemorrhage

Summary: the purpose of this study is to determine the effects of peripartum hysterectomy for maternal hemorrhage.

emergency peripartum hysterectomy is a life-saving surgical procedure which performed to control massive hemorrhage. this study was conducted to determine the factors leading to and maternal mortality and morbidity rates among the women whose underwent peripartum hysterectomy with the focus on referral or non-referral patient status.

Eligibility criteria:
inclusion criteria: * women who have nonresponse hemorrhage after delivery exclusion criteria: * women who delivered before 24 weeks

Keywords: peripartum hysterectomy placenta accreta mortality