Kornimate/medical-research-clean huggingface dataset:
study to investigate the efficacy and safety of sitravatinib in combination with tislelizumab in participants with esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the study aimed to evaluate the efficacy and safety of sitravatinib in combination with tislelizumab as a second- or third-line treatment for participants with locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (escc) who experienced disease progression following prior systemic chemotherapy.


Eligibility criteria:
key inclusion criteria: 1. histologically or cytologically confirmed locally advanced unresectable or metastatic escc, not amenable to treatment with curative intent 2. at least 1 measurable lesion as defined per response evaluation criteria in solid tumors (recist) v1.1 as determined by local site investigator/radiology assessment ≤ 28 days before randomization note: lesions that had been previously irradiated were considered evaluable provided 3. eastern cooperative oncology group (ecog) score ≤ 1 4. adequate organ function as indicated by the following laboratory values as indicated by the laboratory tests performed ≤ 7 days before randomization key exclusion criteria: 1. have any contraindication for receiving treatment with both docetaxel and irinotecan 2. participants with tumor located around important vascular structures as shown by imaging or the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding (ie, radiologic evidence of tumors invading or abutting major blood vessels) 3. participants with tumor that invades into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) that has an increased risk of fistula during the study treatment period as assessed by the investigator 4. history of gastrointestinal perforation and/or fistula or aorto-esophageal fistula within 6 months before randomization 5. have received prior anticancer agents that have same mechanism of action as sitravatinib (eg, receptor tyrosine kinases (rtks) with a similar target profile or vascular endothelial growth factor (vegf)/vascular endothelial growth factor receptor-targeted (vegfr) monoclonal antibodies) note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: esophageal squamous cell carcinoma
safety, tolerability, pharmacokinetics, and immunogenicity of severe acute respiratory syndrome coronavirus 2 (sars-cov-2/covid-19) neutralizing antibody in healthy participants

Conditions: Covid19

Summary: the primary purpose of this study is to investigate the safety and tolerability of bgb-dxp593 administered intravenously as a single dose in healthy participants


Eligibility criteria:
key inclusion criteria : 1. participants are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring 2. body weight ≥ 50 kg and body mass index (bmi) within the range 18 to 32 kg/m2 (inclusive) note: bmi = weight \[kg\] / (height \[m\]) 3. negative serum igg to the sars-cov-2 4. negative for covid-19 based on the nasopharyngeal or oropharyngeal swab with the method of real-time reverse transcription-polymerase chain reaction (rrt-pcr) key exclusion criteria: 1. history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk to the participant when taking the study drug; or interfering with the interpretation of data 2. any history of a severe allergic reaction prior to enrollment that has a reasonable risk of recurrence during the study 3. have a medical history of sars infection 4. any acute fever disease or infections 5. any chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant, including but not limited to: diabetes mellitus type i, chronic hepatitis; or clinically significant forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune disease, psychiatric disorders, or heart disease note: other protocol defined inclusion/exclusion criteria may apply.
effect of chlorhexidine on bacteriuria

Conditions: Urinary Tract Infection; Nosocomial Infection; Bacteriuria

Summary: this study is conducted to determine and compare the effect of applying povidone-iodine and chlorhexidine solutions for perinea washing on bacteriuria rate and type in patients with urinary catheter in intensive care unit.

this is a double blind randomized study with control group. the population is patients in intensive care unit of shahid beheshti hospital of babol city. main include criteria are 18-55 years old, need to having urine catheter for 10 days at least and no urinary infection in catheterization time. main exclude criteria are appearing genital wound, allergic or dermatitis disorders. sample size include 105 patients dividing in three equal groups of povidone-iodine, chlorhexidine and normal saline randomly. interventions are washing perinea area and catheter first 5 centimeters by 15 ml of povidone-iodine 10%, chlorhexidine .2% or normal saline .9%, 3 times a day for 10 days. urine analysis are performed in days 1,3,5,7 and 9 after catheterization and urine cultures are performed in days 5 and 10 after catheterization for detection of bacteriuria and microorganism type.

Eligibility criteria:
inclusion criteria: * must need a urinary catheter for 10 days at least * must have 18-55 years old * men subjects must doing circumcision already * urinary catheter must be apply in a standard method by researcher or via her supervision exclusion criteria: * no more tendency of patient or his/her significant other for continuing study * malignant disease such as prostate or uterine cancer * history of recurrent urinary infection * congenital urinary system disorders * history of allergy * immunodeficiency disorders * urinary system intervention in past sixth months * urinary infection at study start * positive urine analysis or urine culture results in first 3 days of study * abdominal or pelvic surgery * women having period during study * any allergic reaction or dermatitis resulted from applying study solutions * appearing genital wounds * diabetes mellitus * wound in genital area * discharging, transferring or dying in first week of study

Keywords: chlorhexidine povidone-iodine bacteriuria urinary catheterization urinary tract infection
tolerability of pentasa sachet in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: confirmation of safety profile


Eligibility criteria:
inclusion criteria: * treatment of ulcerative colitis exclusion criteria: * hypersensitivity to mesalazine * severe liver or renal impairment
determination of circulating placental biomarkers levels to predict the pregnancy outcome of first trimester after ivf.

Conditions: Infertility, Female; First Trimester Spontaneous Abortion

Summary: this study will assess the predictive potential of circulating placental biomarkers for spontaneous miscarriage within the following month in an ivf setting. it is hypothesized that a robust algorithm including one or more of these biomarkers may allow for the accurate same-day distinction between women with a low and high risk of a spontaneous miscarriage.

spontaneous miscarriage is the most common adverse outcome in the first trimester of pregnancy. this is a particularly stressful situation for the expecting parents, since their need for a final diagnosis is frustrated for a potentially extended period on time which may span over several weeks. the emotional impact of this complication can be devastating, resulting frequently in depression and anxiety which may last for several months. in an attempt to allow for an earlier and more accurate diagnosis of first trimester miscarriage, multiple circulating placental biomarkers have been tested over last years. however, their potential usefulness in an everyday clinical setting remains unclear. the investigators propose a single-center observational prospective cohort study in an in vitro fertilization (ivf) setting. all recruited consenting patients will collect blood samples on a day of the first pregnancy test (12-14 days after embryo transfer) and at the time of the first (at 5 weeks plus 4-5 days of gestational age) and second (at 7 weeks plus 4-5 days of gestational age) ultrasound scan to determine the circulating placental biomarkers concentrations in order to predict the pregnancy outcome (spontaneous miscarriage versus evolutive pregnancy) until the first obstetrical ultrasound, performed between 11 weeks and 13 weeks plus 6 days of gestational age.

Eligibility criteria:
inclusion criteria: * age: ≥18 and \<49 years old * body mass index (bmi): ≥18.5 kg/m2 and \<30 kg/m2 * pregnancy resulting from assisted reproductive technologies (art) * single blastocyst transfer pregnancy * pregnancy confirmed by blood test * gestational age \< 6 weeks at the first us * signed and dated informed consent exclusion criteria: * spontaneous pregnancies * treatment for prevention of miscarriage (i.e. corticoids, aspirin, heparin) * those unable to provide the 11th-13th week ultrasound report * those unable to comprehend the investigational nature of the proposed study

Keywords: placental biomarkers in vitro fertilization (ivf) pregnancy outcome miscarriage early prediction intracytoplasmatic sperm injection (icsi)
superficial and deep endometriosis: role of systemic inflammation as a marker of clinical, surgical, and reproductive outcomes

Conditions: Endometriosis

Summary: primary aim of this study is to evaluate the change in systemic inflammation parameters after surgery for superficial, ovarian or deep endometriosis. secondary objectives focus on correlating these parameters to clinical outcomes, in patients with pelvic pain, and reproductive outcomes, in women desiring offspring. participants already scheduled for surgery as part of their endometriosis care will be followed regarding the abovementioned outcomes after calculation of pre and postsurgical systemic inflammation markers (neutrophil to lymphocyte ratio; platelet to lymphocyte ratio and lymphocyte to monocyte ratio)


Eligibility criteria:
inclusion criteria: * age between 18 and 45 years. * postoperative follow-up of at least 12 months; * signature of informed consent regarding laparoscopic surgical treatment. * signature of informed consent to the processing of personal data duly documented by medical records. exclusion criteria: * failure to sign informed consent for laparoscopic surgical treatment * histologic diagnosis of borderline tumor and/or ovarian carcinoma and/or mucinous cystadenoma and/or germ cell tumor or other malignancy of the genital tract * postoperative follow-up of less than 12 months; * documented history of inflammatory, rheumatologic, or immunologic disease; and * failure to provide informed consent for personal data processing.
fetal middle cerebral artery doppler in preterm births receiving magnesium sulfate for neuroprotection

Conditions: Preterm Birth

Summary: two groups of women with preterm labor will be included. one will receive magnesium sulfate for neuroprotection and the other will receive placebo. fetal middle cerebral artery doppler indices will be measured before and after intake of either magnesium sulfate or placebo to find if any significant changes occur in fetal cerebral blood flow.

the study will include women with preterm labor with gestational age less than 32 weeks. women will be randomized to receive either magnesium sulfate (loading dose 6 g over 20 minutes followed by maintenance dose of 1 g/hour for 24 hours), or placebo in the form of sodium chloride solution 0.9% over 24 hours. fetal middle cerebral artery doppler indices \[peak systolic velocity (psv), pulsatility index (pi), and resistance index (ri)\] will be recorded before and after treatment in both groups. results of doppler indices will be compared between both groups and before and after intake of magnesium sulfate to find out if middle cerebral artery doppler of the fetus can explain the mechanism behind the use of magnesium sulfate for fetal neuroprotection in preterm births.

Eligibility criteria:
inclusion criteria: * pregnant women with preterm labor * gestational age less than 32 weeks * singleton pregnancy exclusion criteria: * contraindication or hypersensitivity to magnesium * preeclampsia * multiple pregnancy * intake of magnesium sulfate in this pregnancy before
core stability as a prognostic factor of urinary incontinence in patients undergoing robot-assisted laparoscopic prostatectomy

Conditions: Prostate Cancer

Summary: the study aims at investigating the possible correlation between core stability muscles and urinary incontinence following robot-assisted laparoscopic prostatectomy. sixty-two patients who are candidates for robot-assisted laparoscopic prostatectomy will be enrolled. all participants will be asked to be evaluated in their core stability functionality 30-40 days before robot-assisted laparoscopic prostatectomy intervention. the core stability functionality result will be correlated with the urinary incontinence 45-50 days after intervention.

the study aims at investigating the correlation between core stability muscles and urinary incontinence following robot-assisted laparoscopic prostatectomy. all sixty-two participants will be asked to be evaluated in their core stability functionality 30-40 days before robot-assisted laparoscopic prostatectomy intervention. core stability functionality will be evaluated through the loumajoki battery of tests, composed of 10 simple items in which the patients have to maintain core stability. in addition a quality of life questionnaire (who quality of life-bref) will be administered. the core stability functionality result will be correlated with urinary incontinence measured by the 24h pad test 45-50 days after intervention. at this point core stability will be evaluated again as done before.

Eligibility criteria:
inclusion criteria: * patient who are candidates for robot-assisted laparoscopic prostatectomy * objectivity of core muscles recruitment through the loumajoki battery exclusion criteria: * pre-surgery incontinence * pre-intervention radiotherapy treatment * previous urogenital surgery * concomitant presence of neurological, internal medicine or musculoskeletal system pathologies that may affect functional or motor recovery * subjects with cognitive deficits and/or psychiatric disorders * lumbar stabilization or abdominal interventions * acute low back pain
errors in the use of turbuhaler and spiromax devices patients with asthma

Conditions: Asthma

Summary: the aim of the study is to evaluate the errors that may occur during inhalation of two devices in patients with asthma, as well as to study whether it relates to the degree of control of patient symptoms and the degree of compliance of medication symptoms. finally, we also want to study the degree of patient satisfaction with each of the inhalers studied


Eligibility criteria:
inclusion criteria: * diagnosis of asthma with treatment indication with ci + laba according to gina 2015 guide and in dry powder device. * over 18 years. * patient in stable phase without having had exacerbations in the 3 months previous to the inclusion in the study exclusion criteria: * presence of relevant respiratory disease other than asthma (including copd). * refusal to participate in the study and sign informed consent or inability to to give informed consent. * patients who have previously been treated with inhaled dust devices dry.

Keywords: asthma, devices
teleoperation experimental comparison with able-bodied subjects

Conditions: Amputation; Traumatic, Arm, Upper

Summary: to compare the use of the semi-autonomous control algorithm (condition 1) with the standard of care myoelectric system used with the taska prosthetic hand (condition 2). able bodied subjects will enroll in a laboratory based experimental session at the university of colorado at boulder. subjects will be fitted with a by-pass prosthesis which enables the able-bodied subject to control the prosthetic hand using the myoelectric signals on their able limb. a taska prosthetic hand will be sensorized using the point touch technology. in a randomized order, the subjects will perform functional tasks evaluating dexterity and assistance with prolonged gross motor movement using each experimental condition. then, a direct comparison can be made across subjects for the semi-autonomous control algorithm and the standard of care myoelectric system used in the taska prosthetic hand.


Eligibility criteria:
inclusion criteria: * able-bodied subject * fluent in english * age of 18 years or greater exclusion criteria: * significant cognitive deficits as determined upon clinical evaluation * significant neurological deficits as determined upon clinical evaluation * significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
axial length and central corneal thickness in benign intracranial hypertension

Conditions: Benign Intracranial Hypertension

Summary: patients in for treatment of benign intracranial hypertension will undergo two tests that are not routinely performed for these patients: central corneal thickness and axial length of the eye. the data obtained from these measurements will be assessed to see if the correlate with aspects of vision loss including visual acuity, visual field status, optical coherence tomography (oct) results, and fundus photographs.

patients with benign intracranial hypertension would be identified at diagnosis from the general ophthalmic and neurologic patient population in the ochsner health system. all would have a baseline eye examination with visual field and optical coherence tomography (oct) testing, a standard step in managing any patient with this condition. two measurements would be taken at minimal risk to the patient that they would not normally have done at the baseline exam: central corneal thickness and axial length. these procedures are routinely done on patients with glaucoma, corneal disease, and cataracts without a significant risk of injury. the theoretical risks with central corneal thickness and axial length measurements by a-scan ultrasonography are related to the small risk for transmission of infection or corneal abrasion due to a probe touching the cornea. these tests would be performed at no charge to the patient and would not significantly increase the time of the ocular examination. patients would have neuro-imaging studies and lumbar puncture to confirm the diagnosis of benign intracranial hypertension as standard parts of the work up for the condition independent of the research study. the authors will statistically analyze the standard measures of visual field function and health of the nerve fiber layer by oct to see if any or all of the proposed risk factors correlates with deterioration of visual function. data would continue to be collected at follow up visits related to visual fields and oct as would normally be performed on standard visits for this condition. the measurements of central corneal thickness and axial length would be performed solely at the time of enrollment in the study since these measurements do not change over time.

Eligibility criteria:
inclusion criteria: * patients must have benign intracranial hypertension. exclusion criteria: * none
hospital workplace nutrition study

Conditions: Overweight; Type2 Diabetes

Summary: the purpose of this study is to evaluate the effects of a plant-based diet on body weight, blood pressure, and plasma lipid concentrations, as part of a hospital workplace program.

using a randomized controlled trial design, participants will be randomly assigned to either a plant-based or a control diet for 12 weeks. t before and after each intervention period, the investigators will measure participant body weight, blood pressure, and plasma lipid concentrations.

Eligibility criteria:
inclusion criteria: 1. employee of sibley hospital 2. male or female 3. age at least 18 years 4. have a bmi \>25 kg/m2 5. ability and willingness to participate in all components of the study 6. a willingness to follow a plant-based diet for the duration of the study 7. a willingness to attend weekly classes for the duration of the study 8. a willingness to keep physical activity level consistent throughout the duration of the study exclusion criteria: 1. diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or cushing's syndrome 2. smoking during the past six months 3. alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use 4. current or unresolved past drug abuse 5. pregnancy or plans to become pregnant in the next 12 weeks 6. intention to leave hospital employment in the next 12 weeks 7. unstable medical or psychiatric status 8. evidence of an eating disorder 9. lack of english fluency 10. inability to maintain current medication regimen

Keywords: body weight blood pressure lipids nutrition
aggressive versus moderate glycemic control in diabetic coronary bypass patients

Conditions: Glycemic Control

Summary: entglycemic control has been found to improve clinical outcomes following coronary bypass surgery. this study tests the hypothesis that obtaining tighter glycemic control(80-120mg/dl) as opposed to more moderate control (120-180mg/dl) will further improve outcomes.

150 diabetic patients will be randomized to achieve aggressive glycemic control (80-120mg/dl) vs moderate control (120-180mg/dl) using intravenous insulin infusions beginning at anesthetic induction and continuing for 18 hours following surgery.

Eligibility criteria:
inclusion criteria: * all diabetic patients undergoing coronary bypass surgery exclusion criteria: * patients with hepatic and renal failure

Keywords: glucose, insulin
interest of dosage of anti-pb230, anti-pb180 and cytokines for monitoring of patients suffering from bullous pemphigoid

Conditions: Bullous Pemphigoid

Summary: bullous pemphigoid is the most common subepidermal autoimmune blistering disease of the skin in european countries, including france. immunologically, bp is characterized by the production of autoantibodies directed against two major components of the hemidesmosome, bp180 and bp230. the anti-bp180 autoantibody is detected in 79-93% of cases of bullous pemphigoid and its serum level at diagnosis have been correlated with disease activity. the anti-bp230 autoantibody is detected in 57%-63% of bullous pemphigoid cases and its score at diagnosis did not correlate with disease activity. up to now, no clinical or immunologic factors have been identified to predict outcome of patients with good or poor prognosis bullous pemphigoid as defined by long complete remission off therapy and recurrent disease requiring maintenance therapy for years. the usefulness of bp180 or bp230 elisa scores for monitoring bp patients during treatment also remains unclear.

aim of the study were : to study association between the serum level of cytokines (il-17 and il-23) and of the protease mmp-9 and the relapse of bullous pemphigoid.

Eligibility criteria:
inclusion criteria: * patients with bullous pemphigoid * patients not yet receiving treatment for bullous pemphigoid * aged \> 18 years exclusion criteria: - patients with relapse of bullous pemphigoid