Kornimate/medical-research-clean huggingface dataset:
isatuximab in combination with regn2810 (cemiplimab) in patients with advanced malignancies

Conditions: Prostate Cancer; Non-small Cell Lung Cancer

Summary: primary objectives: * to characterize the safety and tolerability of isatuximab in combination with regn2810 in participants with metastatic, castration-resistant prostate cancer (mcrpc) who were naïve to anti-programmed cell death-1 (pd-1)/programmed cell death-ligand 1 (pd-l1)-containing therapy, or non-small cell lung cancer (nsclc) who progressed on anti-pd-1/pd-l1-containing therapy, and to confirm the recommended phase 2 dose (rp2d). * to assess the response rate of isatuximab in combination with regn2810 in participants with either mcrpc who were anti-pd-1/pd-l1 therapy naive, or nsclc who progressed on anti-pd-1/pd-l1 therapy, or of isatuximab as single agent in participants with mcrpc. secondary objectives: * to evaluate the safety of the combination of isatuximab with regn2810 or isatuximab monotherapy. * to evaluate the immunogenicity of isatuximab and regn2810. * to characterize the pharmacokinetic (pk) profile of isatuximab single agent or in combination with regn2810, and to characterize the pk of regn2810 in combination with isatuximab. * to assess overall efficacy of isatuximab in combination with regn2810 or as a single agent.

the total study duration per participant was up to 28 months including an up to 28 days screening period, an up to 24 months treatment period, and a 3 months safety follow up period.

Eligibility criteria:
inclusion criteria: * participants must had a known diagnosis of either metastatic castration-resistant prostate cancer (mcrpc) or non-small cell lung cancer (nsclc) with evidence of measurable disease. * failure of, inability to, or refusal to receive standard of care. * greater than or equal to (\>=) 18 years of age. exclusion criteria: * prior exposure to isatuximab or participation in clinical studies with isatuximab. * for participants with mcrpc, prior exposure to any agent (approved or investigational) that blocks the pd-1/pd-l1 pathway. * evidence of other immune related disease /conditions. * history of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation. * had received a live-virus vaccination within 28 days of planned treatment start. seasonal flu vaccines that do not contain live virus were permitted. * prior solid organ or hematologic transplant. * eastern cooperative oncology group performance status (ps) \>=2. * poor bone marrow reserve. * poor organ function. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: anti-cd38 monoclonal antibody
influence of different prostheses on postoperative clinical function in total knee arthroplasty

Conditions: Knee Arthropathy

Summary: exploring differences in knee function after surgery with different types of prostheses(cruciate ligament retaining(cr) vs. posterior stabilizing(ps))


Eligibility criteria:
inclusion criteria: 1. age 45-80 years, any gender, bmi \< 35 kg/m2 2. initial diagnosis of bilateral knee oa (kellgren-lawrence classification grades 3 or 4). patients who are to undergo simultaneous primary bilateral knee arthroplasty 3. inversion deformity ≤ 15° 4. posterior cruciate ligament integrity exclusion criteria: 1. history of knee surgery (ligament, osteotomy, etc.) 2. knee flexion\<90°. 3. flexion contracture of one knee \> 10° 4. comorbidity with other diseases, such as peripheral neuropathy, malignant tumors, rheumatism, etc. 5. posterior cruciate ligament injury 6. those assessed to be intolerant of surgery
the effects of transversus abdominis plane block in patients undergoing total abdominal hysterectomy

Conditions: Abdominal Hysterectomy (& Wertheim); Intraoperative Complications

Summary: the purpose of this study is to determine the effects of transversus abdominis plane block on hemodynamic variables, anaesthetic and analgesic requirement, and quality of recovery in patients undergoing total abdominal hysterectomy

pain is one of the main causes of the poor perioperative outcomes and pain management is the important part of perioperative period. neuraxial blocks could provide adequate analgesia during and after abdominal surgery. however,neuraxial blocks have a lot of contraindicated situations and neuraxial anesthesia can easily induce hemodynamic abnormalities. therefore, in most cases, the choice of anaesthetic management may be the general anesthesia. in addition to reduce the blood pressure and heart rate changes due to surgical stimulations, the large amount of opioids and anaesthetics may be required. opioid related side effects can affect perioperative complications and postoperative quality of recovery. transversus abdominis plane block is a new choice to reduce postoperative pain in abdominal surgery. although its postoperative analgesic efficacy is well known, its effects on hemodynamic variables, anaesthetic and analgesic requirement is not clear. the main objective of this study is to estimate the effect of transversus abdominis plane block on hemodynamic variables, anaesthetic and analgesic requirement and quality of recovery in patients undergoing total abdominal hysterectomy.

Eligibility criteria:
inclusion criteria: * adult (18-65years old) * american society of anesthesiologists (asa) physical status i-ii * patients scheduled for elective total abdominal hysterectomy under general anesthesia exclusion criteria: * asa physical status ≥ 3 * allergy to local anesthetics * drug abuse or addiction * bleeding tendency
contribution of salivary cortisol in the detection of infra-clinic cortisol adenoma (acic)

Conditions: Obesity

Summary: the main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test (suppression of serum cortisol \<1.8 μg/dl ) as the reference method for the detection of acic in obese subjects


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) * signed informed consent * subjects affiliated with an appropriate social security system * body mass index above 30 kg/m2 and * pathological waist circumference according to criteria of ncep atpiii (men : 94 cm and women : 80 cm) exclusion criteria: * pregnancy * sepsis * recent surgery (less than 30 days) * any recent severe acute conditions requiring hospitalisation (less than 30 days) * recent use (\< 7 days) of oral steroids, inhaled, dermal, collyrium, infiltration * long-term oral corticosteroids * nicotinic substitute or per os licorice in 2 weeks before the inclusion

Keywords: infra-clinic cortisol adenoma salivary cortisol obesity
identification of stroke patients ≤ 3 and ≤ 4.5 hours of symptom onset by fluid attenuated inversion recovery (flair) imaging and diffusion weighted imaging (dwi)

Conditions: Acute Ischemic Stroke

Summary: the aim of the study is to evaluate the use of combined fluid attenuated inversion recovery (flair) imaging and diffusion weighted imaging (dwi) as surrogate marker of lesion age within the first 6 hours of ischemic stroke in order to identify patients ≤ 3 or ≤ 4.5 hours of symptom onset in a large multicenter study hours of ischemic stroke. the investigators hypothesize that the pattern of a visible lesion on dwi together with a negative flair ("dwi-flair mismatch") will identify patients ≤ 3 hours of symptom onset with \>80% specificity and positive predictive value.


Eligibility criteria:
inclusion criteria: * acute ischemic stroke (proven by initial or follow-up mri) * well defined and known symptom onset * stroke mri including diffusion weighted imaging (dwi) and fluid attenuated inversion recovery (flair) sequences performed within 12 hours of symptom onset * informed consent exclusion criteria: * contraindications against mri

Keywords: ischemic stroke thrombolysis magnetic resonance imaging diffusion weighted imaging fluid attenuated inversion recovery time window
prospective multicenter doubleblind randomized study of nxl104/ceftazidime + metronidazole vs. meropenem in treatment of complicated intra-abdominal infections

Conditions: Complicated Intra-abdominal Infections

Summary: the purpose of this study is to determine whether nxl104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.


Eligibility criteria:
inclusion criteria: * complicated intra-abdominal infections exclusion criteria: * infections limited to hollow viscus * ischemic bowel disease without perforation * acute suppurative cholangitis * acute necrotizing pancreatitis * pts to undergo stated abdominal repair, open abdomen technique or marsupialization * apache ii \>25
a study of cs1002 in subjects with advanced solid tumors

Conditions: Solid Tumor, Adult

Summary: this is a multicenter, open-label, multiple dose, dose escalation phase i study to evaluate the clinical safety, tolerability, pk, and preliminary anti-tumor efficacy of cs1002.


Eligibility criteria:
inclusion criteria: 1. subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable. 2. ecog performance status of 0 or 1. 3. life expectancy ≥12 weeks. 4. subjects must have adequate organ function 5. use of effective contraception exclusion criteria: 1. known brain metastasis or other cns metastasis that is either symptomatic or untreated. 2. subjects with active autoimmune diseases or history of autoimmune diseases. 3. subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of cs1002. 4. has received prior therapy with an anti-ctla-4 agent. 5. subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other anti cancer systemic treatment, within 14 days prior to the first dose of cs1002 or who has not recovered from adverse events due to prior therapy. 6. receipt of major surgical procedure, wide field of radiation, local radiotherapy or radioactive agents within specified time frame prior to the first dose of cs1002. 7. receipt of live vaccine within 28 days prior to the first dose of cs1002 8. use of traditional medicinal herbal preparations within 7 days prior to the first dose of cs1002. 9. history of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies. 10. known history of hiv. 11. subjects with active hepatitis b or c infection 12. subjects with active tuberculosis infection. 13. subjects with an active infection requiring systemic therapy. 14. history of organ transplantation. 15. history of alcoholism or drugs abuse. 16. history of severe hypersensitivity reactions to other mabs. 17. subjects with major cardiovascular diseases. for more information regarding trial participation, please contact at cstonera@cstonepharma.com

Keywords: solid tumors
phage therapy for the treatment of urinary tract infection

Conditions: Recurrent Urinary Tract Infection

Summary: this is a single-patient, phase i/ii clinical trial that aims to evaluate the potential of bacteriophage therapy to treat and prevent the recurrence of a drug-resistant urinary tract infection with serious long-term effects. this study will follow a minimally invasive phage therapy approach consisting of oral, topical (opening of the urethra) and bladder installations of a 3-phage cocktail comprised of hp3, hp3.1 and es19.

this is a single-patient, phase i/ii clinical trial that aims to evaluate the potential of bacteriophage therapy to treat and prevent the recurrence of a drug-resistant urinary tract infection. this study will follow a minimally invasive phage therapy approach consisting of oral, topical and bladder installations of a 3-phage cocktail comprised of hp3, hp3.1 and es19. oral and bladder installation of bacteriophages will be administered on day 1 - and potentially day 7 depending on day 5 urine and stool lab results - and a topical preparation will be applied externally to the urethra for 30-minutes on days 1 to 3. however, if the participant is still experiencing mild symptoms on day 5, systemic antibiotics will be administered in combination with phage therapy. the primary objective is to determine the safety and tolerability of minimally invasive bacteriophage therapy for treating recurrent urinary tract infections with severe long-term effects. the secondary objective is to evaluate the 90-day clinical and microbial response to the minimally invasive administration of bacteriophages for recurrent urinary tract infections with severe long-term outcomes. the total duration of participant involvement is 2 years, while the study is estimated to be completed in 3 years.

Eligibility criteria:
inclusion criteria: * diagnosis of recurrent chronic urinary tract infections with severe long term effects * can speak and understand english * willing to follow the protocol exclusion criteria: * stage 5 chronic kidney disease * abnormal liver function tests * a urinary stent or chronic indwelling catheterization * a known allergy to phage products * fever * pregnancy * involved in another clinical trial

Keywords: phage therapy recurrent urinary tract infection
evaluation of biomarkers of traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the primary objective of this study is to evaluate the utility of the banyan uch-l1/gfap detection assay as an aid in the evaluation of suspected traumatic brain injury (glasgow coma scale score 9-15) in conjunction with other clinical information within 12 hours of injury to assist in determining the need for a ct scan of the head.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age at screening * suspected traumatically induced head injury as a result of insult to the head from external force * gcs 9-15 at time of informed consent * workup includes head ct scan as part of clinical emergency care within 3 hours of presenting and within 12 hours of injury * blood sample collected within 3 hours of presenting and within 12 hours of injury * subject or legal representative is willing to undergo informed consent exclusion criteria: * participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study acceptable) * time of injury cannot be determined * primary diagnosis of ischemic or hemorrhagic stroke * venipuncture not feasible * a condition precluding entry into the ct scanner * subject has a neurodegenerative disease or other neurological disorder including dementia, parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, and history of neurosurgery, stroke or tia within the last 30 days * administration of blood transfusion after head injury and prior to study blood draw * subject is otherwise determined by the investigator to be unsuitable for participation

Keywords: traumatic brain injury head injury
a study of plb1001 enteric capsules in the treatment of sgbm/idh mutant glioblastoma patients with the zm fusion gene (fugen).

Conditions: Glioblastoma

Summary: the goal of this clinical trial is to evaluate the safety and efficacy of plb1001 enteric capsules in the treatment of ptprz1-met fusion gene positive recurrent secondary glioblastoma. the main questions it aims to answer are: 1. to evaluate overall survival (os) in the treatment of secondary glioblasts with positive recurrence of ptprz1-met (zm) fusion gene by plb1001 enteric capsules. 2. to evaluate if it is safety and tolerant in the treatment of secondary glioblasts with positive recurrence of ptprz1-met (zm) fusion gene by plb1001 enteric capsules. participants will 1. be given plb1001 300mg bid,oral who were randomly assigned in test group. 2. be given temozolomide capsules ,oral, who were randomly assigned in control group. 3. be given ep, ivgtt, who were randomly assigned in control group.

84 sgbm or idh mutant glioblastoma patients with the zm fusion gene will be randomly divided into group a (receive vebreltinib) or group b ( receive investigator choose), and the randomize ratio will be 1:1, patients in group a will receive plb1001 300mg bid, 28days/cycle. patients in group b will receive temozolomide (100-150mg/m2/d, 7 days 1 to7 and days 15 to 22 of each 28-day cycle ) or cisplatin+etoposide(cisplatin:80-100mg/m2/3 days, 28days/cycle; etoposide:100mg/m2/d, 3days, 28 days/cycle).

Eligibility criteria:
inclusion criteria: 1. histologically confirmed secondary glioblastoma,or glioblastoma with idh mutantation 2. must have evidence of prprz1-met fusion gene positivity from the result of molecular pre-screening evaluations 3. prior treatment with temozolomide and radiotherapy 4. stable or decreasing dose of corticosteroids within 5 days prior to the first dose 5. platelet count≥75×109/l,neutrophilic granulocyte count≥1.5×109/l, hemoglobin\>90g/l,ast or alt \< 3 times the lab's upper normal limit,serum creatinine \< 1.5 times the lab's upper normal limit,inr≤2.0 6. karnofsky performance score ≥ 60% 7. pregnant or nursing women 8. written consent exclusion criteria: 1. previous or current treatment with a c-met inhibitor or hgf-targeting therapy 2. received antibody anti-tumor drug within 30 days before enrollment 3. previous treatment with camustine sustained release implant 4. the subject is unable to undergo mri scan 5. patients with active bleeding were found by brain ct or mri scan before enrollment 6. uncontrolled hypertension defined by a systolic blood pressure (sbp) 150 mm hg and/or diastolic blood pressure (dbp) ≥100 mm hg 7. major surgery within 4 weeks prior to first dose of plb1001 8. pregnant or nursing women 9. involved in other clinical trials \<30 days prior to first dose
effects of whey protein consumption by patients waiting for liver transplantation

Conditions: Liver Disease; Nutrition Disorders

Summary: malnutrition is prevalent among chronic liver disease patients. inadequate ingestion and/or metabolic alterations modify the body composition and biological functions. the purpose of this study is to determine whether whey protein comsumption, due to amino acid profile, digestibility and bioactive compounds may be beneficial for patients waiting for liver transplantation

a randomized, double-blind, intervention study in which patients are randomly assigned to receive packages of 20g of whey protein (wp) or casein (ca) to take twice a day (20g in the morning and 20g at night), as a supplement, during 15 days. they are monitored weekly by calls. regular usual diet is maintained. patients underwent muscle functionality assessment by handgrip dynamometry and 6-min. walking test and, the inflammatory response by plasmatic cytokines. all tests are performed at the beginning and the end of intervention.

Eligibility criteria:
inclusion criteria: * chronic liver disease, liver transplantation exclusion criteria: * children, illiterate, elderly, renal failure
efficacy and safety of alogliptin in participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).

diabetes is a chronic illness associated with microvascular complications such as nephropathy (kidney disease), retinopathy (eye damage) and neuropathy (nervous system damage). diabetes is also associated with macrovascular complications including cardiovascular disease (heart disease), stroke and peripheral vascular disease (narrowing or blockage of blood vessels). these complications are associated with reduced quality of life and increased morbidity and mortality. takeda is developing syr-322 (alogliptin) for improvement of glycemic control in patients with type 2 diabetes mellitus. evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the united states and japan. this study will be conducted as a multi-center clinical trial in order to validate the efficacy and safety of alogliptin on type 2 diabetes population within asia. participants who qualified for the study were stratified into 1 of the 3 therapy groups based upon their background antidiabetic therapy before being randomized 1:1 to receive either alogliptin 25 mg once daily or matching placebo once daily. * monotherapy group - patients who had been treated with diet and exercise for at least 2 months prior to screening. * add-on to metformin therapy group - patients who had been treated with metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to screening. * add-on to pioglitazone therapy group - patients who had been treated with a stable dose of pioglitazone alone or in combination with metformin at a stable dose for at least 8 weeks prior to screening.

Eligibility criteria:
inclusion criteria: * has a historical diagnosis of type 2 diabetes mellitus. * has a body mass index between acceptable range. * is experiencing inadequate glycemic control. * body weight keeps constant. * females of childbearing potential and males who are sexually active agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose. exclusion criteria: * has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization. * has a systolic blood pressure beyond the acceptable range at screening visit. * has new york heart association class iii or iv heart failure regardless of therapy. * has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study. * has a history of hypersensitivity or allergies to any dpp-4 inhibitor.

Keywords: type 2 diabetes mellitus drug therapy