Kornimate/medical-research-clean huggingface dataset:
a first-in-human study of bgb-c354 alone and in combination with tislelizumab in participants with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a first-in-human, phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of bgb-c354 alone and in combination with tislelizumab in participants with advanced solid tumors. study details include: * the study will be conducted in 2 phases: phase 1a (monotherapy dose escalation and safety expansion) and phase 1b (dose expansion). * the visit frequency will be approximately every 21 days during study treatment. * the study duration is estimated to be approximately 5 years.


Eligibility criteria:
inclusion criteria: 1. able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. eastern cooperative oncology group (ecog) performance status of 0 or 1. 3. participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent: 4. ≥ 1 measurable lesion per recist v1.1. 5. able to provide an archived tumor tissue sample. 6. adequate organ function. 7. females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s). 8. nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s). exclusion criteria: 1. prior treatment with b7h3-targeted therapy. 2. for part b and phase 1b: prior treatment with antibody drug conjugates (adcs) with topoisomerase i inhibitor payload (for phase 1b, unless otherwise specified for specific cohorts). 3. participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis 4. any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). 5. history of interstitial lung disease, ≥ grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline 6. uncontrolled diabetes, or \> grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium levels despite standard medical management ≤ 14 days before the first dose of study drug(s). 7. infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s). note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: bgb-c354 tislelizumab first-in-human advanced solid tumor anti-pd-1 monoclonal antibody b7h3 antibody drug conjugate
mmp-9 monitoring particulate cerebral embolisation

Conditions: Cerebral Embolic Damage

Summary: 1. in carotid endarterectomy(cea) surgery, the dynamic changes of plasma mmp9 concentration cross cea will be identified. 2. and the part of patients suffered particulate cerebral embolic injury, their mmp9 level will increase in the early stage after cea.


Eligibility criteria:
inclusion criteria: -all patients enrolled had at least ≥70% unilateral or bilateral stenosis of internal -carotid artery， or those who had a \<70% stenosis but obvious cerebral ischema symptoms had been existed. exclusion criteria: * exclusion criteria included poor temporal window * refused to cooperate with us * nonatheromatous such as takayasu arteritis and fibromuscular dysplasia.
effect of risperidone vs aripiprazole on oxidative stress in patients with autism spectrum disorder: a randomized controlled trial

Conditions: The Goal of This Trial is to to Compare the Effect of Risperidone vs Aripiprazole in Terms of Change in Serum Glutathione Level

Summary: the goal of this randomized controlled trial is to to compare the effect of risperidone vs aripiprazole in terms of change in serum glutathione level in patients with autism spectrum disorder over a period of 6 weeks. the main questions it aims to answer are: 1. (primary outcome) change in serum glutathione levels following 6 weeks of intervention in both the arms 2. (secondary outcomes) change in serum superoxide dismutase (sod) levels following 6 weeks of intervention. change in isaa score following 6 weeks of intervention. change in abc-c score following 6 weeks of intervention. • adverse events reported in both groups details of intervention- one arm of the study population to get risperidone 1mg/day for a total duration of 6 weeks and another arm to get aripiprazole 2mg/day for a total duration of 6 weeks. baseline assessment of serum glutathione, serum sod, isaa scale, abc-c scale will be done and same will be assesssed at 6 weeks follow up.


Eligibility criteria:
inclusion criteria: * inclusion criteria: * patients diagnosed with autism spectrum disorder (according to icd-11 dcr) under the age group of 18 years. * legally authorized representative (lar) giving voluntary written consent for participation in the study. exclusion criteria: * history of adhd * history of any major genetic disorder/ storage disorder/ any special syndromes. * history of seizure disorder or any major medical or surgical disorders * legally authorized representative (lar) not giving voluntary written consent for participation in the study.
theranostic implication of complementary medicines against interleukin receptors and gp-130 proteins

Conditions: Corona Virus Disease 2019 (COVID-19)

Summary: il-6 is an inflammatory marker, secrete by the cells in many pathological conditions like covid-19 pneumonia. interleukin 6 bind with its receptors (il-6r) on cells surface and recruited a protein for its activation known as gp-130. activated receptors send signals to nucleus through secondary messenger system and up regulate the expression of il-6/gp130 domain. total of two hundred (n=200) participants were included in the current study and divided equally in four groups. group b is given tocilizumab and group c is treated with remdesivir along with the approved standard treatment. group d is only given standard therapy and group a constituted normal healthy age and sexed matched participants. levels of gp-130 were estimated by commercially available elisa kit. to estimate the relationship of severity of disease with gp-130 and il-6 pearson's correlations was used. sensitivity and specificity for what purpose


Eligibility criteria:
inclusion criteria: admitted diagnosed cases of covid-19 infection on real time polymerase chain reaction (rt-pcr) both male and female were included all participants were on oxygen therapy exclusion criteria: asthmatics pulmonary fibrosis chronic obstructive pulmonary disease (copd) allergic to remdesivir allergic to actemra refused to take consent

Keywords: corona virus disease 2019 (covid-19) tocilizumab remdesivir interleukin receptor-6, glycoprotein-130 receptor blocker
sensor-based just-in time adaptive interventions (jitais) targeting eating behavior

Conditions: Overweight and Obesity

Summary: the purpose of this study is to determine whether a sensor device called an automatic ingestion monitor (aim) that is worn on eyeglasses can be used with a smartphone to change eating behavior. participants will wear the device for one week of no-intervention observation. they will then test behavioral interventions focused on eating for two weeks. the researchers hypothesize that messages sent to a smartphone that are based on information from the aim can reduce the amount of food that is eaten and slow eating.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 27 and 45 kg/m-squared * weight stable within 5% in the past 6 months * self-reports basic familiarity with use of a smartphone exclusion criteria: * diagnosed diabetes (type 1 and 2) * any poorly controlled medical condition that could affect weight and/or eating behavior (e.g., hypothyroidism) * medical conditions or use of medications or diets/supplements known to affect energy regulation or appetite * difficulty chewing or swallowing * diagnosed eating disorder * night or shift work * current participation in a weight loss program * history of bariatric surgery * current pregnancy or lactation within the past 1 year, or planning a pregnancy during the study participation period * consuming a medically-prescribed or unusual diet (e.g., macrobiotic) * food allergies or sensitivities, or other conditions which result in avoidance of a wide range of foods (e.g. celiac disease, tree nut allergy) * reported recreational drug use * report of conditions that would significantly interfere with an ability to follow the protocol including terminal illness, substance abuse, or other significant uncontrolled psychiatric problem
neural compensation, visual function and visual quality after monofocal or multifocal intraocular lens implantation

Conditions: Cataract

Summary: multifocal intraocular lenses (miols) provide enhanced far and near visual acuity, but they can bring about halos and glare, which are caused by design deficiencies of the iols. compared to monofocal intraocular lens, pseudo accommodation in nonphysiological state may increase the difficulty of neural compensation reconstruction in patients with multifocal intraocular lens implantation. patients enrolled into the study will be followed for 1 year and will have study visits preoperatively, at 1 week, 3 months, 6 months, 12 months postoperatively.in this trial, we aimed to specify the time of neural compensation reconstruction in patients and to explore the changes of visual function in senile patients with monofocal or multifocal intraocular lens implantation.

cataract extraction and intraocular lens (iol) implantation are the current standard treatments for age-related cataract (arc). cataract surgery increases visual acuity but may lead to complaints after surgery. multifocal intraocular lenses (miols) provide enhanced far and near visual acuity, but they can bring about halos and glare, which are caused by design deficiencies of the iols. fortunately, most of the halos and glare diminish with time. niels et al noted that neural adaptation (na) may explain the lower incidence of glare and halos in their study. compared to monofocal intraocular lens, pseudo accommodation in nonphysiological state may increase the difficulty of neural compensation reconstruction in patients with multifocal intraocular lens implantation. in the present study, the investigators evaluated the activity of neurons in the visual cortex using fmri both preoperatively and postoperatively. in addition, the investigators evaluated postoperative changes in vf, including visual acuity (va), contrast sensitivity (cs), straylight values (svs), and pattern visual evoked potential (pvep), stereoscopic vision, wavefront aberrations at 1 week, 3 months, 6 months, 12 months postoperatively.in this trial, the investigators aimed to specify the time of neural compensation reconstruction in patients and to explore the changes of visual function in senile patients with monofocal or multifocal intraocular lens implantation.

Eligibility criteria:
inclusion criteria: * visual acuity less than 0.3 * cataracts in both eyes classified by the lens opacity classification system iii * corneal astigmatism less than 1.5 diopters (d) * capability of understanding and signing the informed consent exclusion criteria: * corneal astigmatism ≥ 1.5d. * history of neurological or psychiatric disorders; systemic disease such as severe hypertension or diabetes mellitus that might interfere with the visual outcomes. * associated ocular disease that could interfere with final results * previous anterior and posterior segment surgery and intraoperative or postoperative complications * driving at night frequently; excessive expectations for visual outcomes
institut paoli calmettes thyroid cancer database

Conditions: Thyroid Neoplasms

Summary: database of institut paoli-calmettes patients diagnosed with thyroid cancer


Eligibility criteria:
inclusion criteria: * diagnosis of thyroid cancer exclusion criteria: * non applicable
ori-c101chimeric antigen receptor (car) modified t cells for the treatment of hcc

Conditions: Hepatocellular Carcinoma

Summary: this is a phase i, open-label, multi-center study to assess the safety, pharmacokinetics, and preliminary efficacy of gpc3-directed chimeric antigen receptor modified t cells injection (ori-c101) in advanced hepatocellular carcinoma(hcc).


Eligibility criteria:
inclusion criteria: 1. confirmed pathologic or radiologic diagnosis of hcc ; 2. tumor tissue gpc3 expression positive by immunohistochemistry(ihc) at the local laboratory (tumor samples ≤1 years prior to icf signature are acceptable), if no archived tumor tissue samples, tumor biopsy is required for gpc3 expression test; 3. unresectable stage b (intermediate) or c (advanced) hcc according to the barcelona clinic liver cancer (bclc) staging. if stage b, must have progressed after, or not be eligible for, surgical or locoregional therapy; 4. received at least two prior line of systemic therapy (included but not limited to target therapy, immunotherapy or chemotherapy) with radiologic disease progression during or following systemic therapy; 5. child-pugh a or b7, no history of hepatic encephalopathy; 6. eastern cooperative oncology group (ecog) performance status 0 or 1 at the time of icf signature; 7. estimated life expectancy of minimum of 12 weeks; 8. must have at least 1 target lesion exclusion criteria: 1. central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression; 2. prior bone marrow or organ transplantation; 3. have a history of another primary malignancy within 5 years prior to starting study treatment. exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ; 4. active hepatitis b infection (if hepatitis b surface antigen \[hbsag\] or hepatitis b core antibody \[hbcab\] positive, then hbv-dna must be \< 20 iu/ml, and hbsag-positive patients should have been treated with antiviral therapies as per the local guidelines); 5. positive hepatitis c (hcv) rna, human immunodeficiency virus (hiv) antibody, cytomegalovirus(cmv) dna or syphilis serology; 6. have received prior cell-based therapies such as targeted gpc3 therapy, tcr-t therapy, car-t therapy; 7. inadequate bone marrow reserve or organ function; 8. history or current evidence of any condition or disease that could confound the results of the study or, in the opinion of investigator, is not in the best interest of the patient to participate. 9. pregnant or breast-feeding women.
mfolfiri as the second line chemotherapy for advanced esophageal carcinoma after failure of 1st line treatment of paclitaxel/ddp : a phase ii single center prospective clinical trial

Conditions: Advanced Esophageal Carcinoma

Summary: there are few studies about 2nd line treatment in advanced esophageal carcinoma(aec), some showed that irinotecan may be effective. the investigators previous study has shown the efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase ii study, the investigators would like to observe the efficacy and safety of irinotecan/5fu/leucovorin as 2nd line treatment if aec after failure to 1st treatment of ptx/ddp.


Eligibility criteria:
inclusion criteria: * having signed informed consent * age 18 to 70 years old * histologically confirmed esophageal squamous carcinoma,failed to 1st line treatment of paclitaxel/cisplatin * unresectable recurrent or metastatic disease * measurable disease according to the recist criteria(diameter of the lesion should be more than 10mm by spiral ct or mri, more than 20mm by common ct, the date of image should be less than 15 days before enrollment) * karnofsky performance status ≥70 * life expectancy of ≥3 month * no prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks * alt and ast\<2.5 times uln (≤5 times uln in patients with liver metastases)(within 7 days before enrollment) * serum akp \< 2.5 times uln (within 7 days before enrollment) * serum creatinine \<1.0 times uln (within 7 days before enrollment) * bilirubin level \< 1.0 times uln (within 7 days before enrollment) * wbc\>4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, hb\>9g/dl(within 7 days before enrollment) * no sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃； * good compliance exclusion criteria: * more than 1 previous systemic therapy for metastatic esophageal squamous carcinoma * known hypersensitivity to irinotecan * only with brain or bone metastasis * tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung * no measurable lesions, eg. pleural fluid and ascites * surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry * heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months or * pregnancy or lactation period * other previous malignancy within 5 year, except non-melanoma skin cancer * chronic diarrhea * mentally abnormal or disable cognition,including cns metastasis
comparative efficacy of different regimens of pvpi 5% eye drops instillation in reducing conjunctival bacterial flora

Conditions: Eye Infections

Summary: the present study intends to assess the efficacy of 3 drops of 5% povidone-iodine (pvpi) eyedrops in reducing the bacterial flora in a conjunctival sac fundus compared to the standard procedure consisting of the application of 1 pvpi eyedrop 2 min before any intraocular surgical procedure.

studies have demonstrated that the external bacterial flora of the patients in most cases is the actual source of infection. the objective of antisepsis is to eliminate or significantly reduce the number of microorganisms in the surgical field at the time of surgery. the eyelids and the conjunctiva are considered to be quite common sources of bacteria that can lead to endophthalmitis. thus, it is believed that by reducing the number and growth of bacteria on the ocular surface and adnexa before surgery, the risk of postoperative infection would be lower. povidone-iodine 5% eye drops has been used in preoperative cataract surgery to prevent endophthalmitis and is the standard prophylactic action in preventing postoperative endophthalmitis being widely compared with other antibiotic eye drops and their associations. the standard procedure of prophylaxis of postoperative endophthalmitis corresponds to applying a single drop of povidone-iodine 2min before any intraocular surgical procedure. however, few studies have assessed the effectiveness of povidone-iodine 5% eye drops using different dosing regimens to achieve the best bactericidal effect. the aim of this study is to investigate different dosages with respect to the use of povidone-iodine drops to optimize the effectiveness of the agent, ensuring the best exogenous endophthalmitis prophylaxis.

Eligibility criteria:
inclusion criteria: * no systemic or ocular infection; * absence of auto-imune disease or immunosuppressive therapy; * no use of systemic or topic antibiotics in the last 30 days; * no previous ocular surgery or trauma in the study eye in the last 30 days; * no history of allergy to povidone iodine; * signed informed consent. exclusion criteria: * presence of blepharitis, ectropion, entropion, trichiasis or distichiasis; * diabetes mellitus; * any systemic condition that, at the discretion of the investigators, would facilitate or contribute to infection, such as influenza; * inability to understand and sign the informed consent.

Keywords: povidone-iodine ophthalmic solutions endophthalmitis preoperative procedures
improving defibrillation pad position

Conditions: Cardiac Arrest

Summary: manufacturer's diagrams showing defibrillation pad positioning (as used on public access defibrillators) are anatomically incorrect and are likely to lead to poor position of defibrillation pads, with reduced defibrillation efficacy. we will ask untrained members of the public to observe the diagrams and place pads as indicated on the diagram. we will asses the accuracy of pad placement and repeat the study using an anatomically correct diagram to see if we can improve the accuracy of pad placement.

as above

Eligibility criteria:
inclusion criteria: - 16 yrs age and willing to participate. exclusion criteria: * previous bls training * previous aed training * clinical staff (doctor, nurse, hca, paramedic etc)
self management in urinary catheter users

Conditions: Urinary Retention; Neurogenic Bladder

Summary: learning to self-manage urine flow may help people prevent or minimize persistent complications from long-term indwelling urethral or suprapubic catheters.

urinary catheter users commonly experience adverse health effects, such as urinary tract infection (uti), blockage, dislodgement, and leakage, leading to poor quality of life indicators. catheter-related problems often require health care utilization resulting in increased health care costs. self-management of urine flow is an essential part of self-care for people with long-term urinary catheters and may lead to prevention or reduction of catheter-related problems and improved quality of life.this study tests the effectiveness of a urinary catheter self-management intervention in a randomized trial of 220 patients, with 12 months of follow-up. the experimental intervention is designed to enhance self-management of urine flow in individuals with long-term urinary catheters, with the goal of decreasing catheter related complications and enhancing quality of life.

Eligibility criteria:
inclusion criteria: * have an indwelling urethral or suprapubic catheter and expect to use it for at least one year. * live in central or western new york state (utica to buffalo regions approximately)or are cared for by the visiting nurse service of new york city. * able to complete study measurements alone or with the help of a family member or caregiver. * able to communicate with the study personnel in english. * have access to a telephone for data collection. exclusion criteria: * terminally ill * cognitively impaired * no catheter associated uti within the previous 12 months nor blockage nor dislodgement in the previous 6 months(only in people who have had the catheter for 12 months or more)

Keywords: self management chronic condition urinary catheter