Kornimate/medical-research-clean huggingface dataset:
anti-ctla-4 human monoclonal antibody cp-675,206 in patients with advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Hepatitis C Virus Chronic Infection

Summary: cp-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated t lymphocytes and by enhancing their activation may produce a stimulation of the immune response against tumoral or viral antigens. in this clinical trial, the ability of tremelimumab to produce tumor responses among hepatitis c virus-infected patients with hepatocellular carcinoma not amenable to other therapies will be explored. besides, the effect on the replication of the virus will be analysed.


Eligibility criteria:
inclusion criteria: * unequivocal diagnosis of hcc * unresectable disease not amenable to locoregional treatment. * a 4-week washout period after sorafenib or any other systemic agent * a 2-month washout period after internal or external radiation * hcv chronic infection * child-pugh stage a or b * measurable disease according to recist criteria * ecog \< 2 * expected survival \> 3 months * adequate liver, renal and blood functions * ability to sign informed consent exclusion criteria: * previous treatment with an anti-ctl-4 agent * serious infections or disease compromising general health status * autoimmune disease that requires therapy * treatment with immunosuppressors * treatment with investigational agents * other neoplasms except skin and bladder superficial tumors * pregnancy or lactation * snc metastasis * hiv infection * relevant heart disease (nyha class iii or iv)
tislelizumab combined with xelox as neoadjuvant therapy for g/gej adenocarcinoma

Conditions: Locally Advanced Gastric Adenocarcinoma

Summary: the effective treatment of g/gej adenocarcinoma has always been a research hotspot in academia. in recent years, mainstream studies have shown that the treatment mode of g/gej adenocarcinoma has changed from single surgery mode in the past, to multi-disciplinary comprehensive treatment mode for now, which is based on surgery. several studies indicate that for most late-stage g/gej adenocarcinoma, the neoadjuvant treatment model can further enhance the survival rates and prognosis of patients, compared with the combination of standard radical resection and postoperative adjuvant chemotherapy. according to the chinese society of clinical oncology (csco): clinical guidelines for the diagnosis and treatment of gastric cancer (wang et al , 2021), neoadjuvant therapy and adjuvant therapy are recommended for patients with g/gej adenocarcinoma. however, there is still a lack of unified standards and norms for precise preoperative staging of gastric cancer, applicable population of neoadjuvant along with adjuvant therapy, and the selection of treatment regimens. therefore, this project is aimed to carry out a single-arm, open-label, phase ii clinical trial to administer tirelizumab plus xelox for neoadjuvant management of patients diagnosed with resectable gastroesophageal junction or stomach cancer, and further explore the safety and therapeutic effect of chemotherapy together with tirelizumab in the neoadjuvant period of g/gej adenocarcinoma, eventually, providing a new option for the neoadjuvant treatment of g/gej adenocarcinoma.


Eligibility criteria:
inclusion criteria: 1. voluntarily sign the informed consent; 2. aged 18-80 (including 18 and 80), both sexes; 3. ecog score ≤1; 4. biopsy histologically confirmed adenocarcinoma (including lauren grade); 5. ct3-4a n+ m0 g/gej adenocarcinoma confirmed by basic ultrasound gastroscopy, enhanced ct (pet/ct), mri or diagnostic laparoscopy; exclusion criteria: 1. histological histological diagnosis of squamous cell carcinoma (adenosquamous carcinoma mainly including squamous cell carcinoma), carcinoid, undifferentiated carcinoma or other unclassified carcinoma; 2. patients with her2-positive status are excluded; 3. patients with distant metastases other than primary gastric cancer (any m1 stage); 4. patients with contraindications (laparoscopic surgery, open surgery, neoadjuvant chemotherapy); 5. patients who can not undergo radical surgical resection (d2 radical resection); 6. previous antitumor therapy (including chemotherapy, radiotherapy, molecular targeted therapy and hormone therapy); 7. previously received immunological drugs such as pd-1/pd-l1, ctla-4 or other immunological or molecular targeted therapies; 8. when virological testing prior to screening showed any of the following: 1. patients with active hepatitis (hbv dna≥1\*103 copies or ≥200iu/ml); 2. anti - hcv positive; 3. hiv positive; 9. patients or their families refused to sign this informed consent form to participate in the study.
cryoablation of intercostal nerves for post-operative pain management in opioid-tolerant patients

Conditions: Pain; Pain, Postoperative

Summary: the main objective study is to compare the use of the cryosphere probe to the standard-of-care method for pain management of patients receiving robotic-assisted thoracoscopic surgery, including reductions in opioid pain medication use and the development of post-surgical morbidity.

patients who take more opioid medications after surgery tend to have longer hospital stays, and they are at risk of developing pneumonia and other postoperative morbidities. opioid-tolerant patients are at a higher risk of developing these morbidities because they often require higher doses of opioid medications to manage their post-operative pain. reducing post-operative pain in these patients through non-opioid means helps reduce their risk of developing morbidities, and is potentially a more effective form of pain management, particularly in this patient population. this is a single-center, prospective cohort registry with a historical control, and an estimated duration of 2 years. this study's primary objective is to evaluate the cryosphere probe for ablation in pain control after surgery (measured using opioid medication). the secondary objectives are the evaluation of morbidities, length of stay, cost, and incidence of neuroma formation. we plan to recruit 75 patients who will receive the cryosphere probe and compare them to 75 patients who did not receive the cryosphere probe. the experimental group will receive cryosphere ablation of intercostal nerves and liposomal bupivacaine. the historical control group will have had robotic-assisted thoracoscopic surgery and an intercostal nerve block with liposomal bupivacaine and no cyrosphere probe.

Eligibility criteria:
inclusion criteria: * male and female patients 18-90 years of age * diagnosis requiring robotic-assisted thoracoscopic surgery * daily opioid use for at least 30 days consecutively at any point during the last 12 months prior to surgery or using opioids at the time of study enrollment * experimental group only: agreement and consent to comply with all aspects of the study protocol and data collection, including follow-up contact. exclusion criteria: * previous major surgery at the operative site (thoracotomy) * allergy to aluminum * allergy to plastics * allergy to bupivacaine * shingles disease * demyelinating illnesses * involvement with other interventional studies

Keywords: pain management pulmonary surgical procedures robotic surgical procedures pneumonectomy nerve block neuroma analgesics, opioid bupivacaine length of stay drug tolerance
a study to compare sb12 (proposed eculizumab biosimilar) to soliris in subjects with paroxysmal nocturnal haemoglobinuria

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: this is a randomised phase iii, double-blind, multicentre, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between sb12 and soliris® in subjects with pnh.

subjects will be randomised in a 1:1 ratio to either treatment sequence. subjects randomly assigned to treatment with sb12 or soliris® will receive 600 mg of eculizumab iv every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks until week 52. subjects who are randomised to initially receive sb12 will be switched to receive soliris® and subjects who are randomised to initially receive soliris® will be switched to receive sb12 at week 26.

Eligibility criteria:
inclusion criteria: * male or female aged 18 or older * eculizumab-naïve patients with pnh * presence of the pnh white blood cell (wbc) clone ≥ 10% * documented ldh level ≥ 1.5 x uln at screening * history of transfusion for anaemia within 12 months prior to screening or having pnh-related symptoms at screening * subjects must be vaccinated against neisseria meningitides exclusion criteria: * previous treatment with any complement pathway inhibitors * anc ≤ 500/mm3 or platelet count \< 70,000/mm3 * history of meningococcal disease * history of bone marrow transplantation * known or suspected active bacterial/viral/fungal infection within 30 days * stable use of erythropoietic, corticosteroids, heparin, warfarin before randomisation
relapse prevention to reduce hiv among women prisoners

Conditions: Opioid Dependence; HIV

Summary: this study is a feasibility and acceptability study assessing whether providing buprenorphine for women under criminal justice supervision leaving a controlled environment and returning to the community would prevent opioid relapse and reduce hiv risk behaviors.

this study sought to enroll opioid dependent women under supervision in the criminal justice system and in a controlled environment (substance abuse treatment)but at at high risk for opioid relapse and engaging in hiv risk behaviors when returning to the community. initially, 9 women were enrolled and received buprenorphine medication. after the first 9 participants, women were randomized to either buprenorphine or placebo. women received the buprenorphine medication for 12 weeks in the community and at the end of the 12 weeks were transitioned either to another buprenorphine provider, methadone provider, or tapered off buprenorphine based on the participant's preferences. one additional follow-up at 3 months after treatment was conducted. the primary outcome was opioid positive urines at all time points.

Eligibility criteria:
inclusion criteria: * female, * history of opioid dependence, * released back to the community from a controlled environment, * criminal justice involvement. exclusion criteria: * under age 19, * medical contraindications, * major psychiatric problems.

Keywords: opiates hiv
development of camera based gait quality measure for persons with multiple sclerosis

Conditions: Multiple Sclerosis; Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis Relapse; Multiple Sclerosis, Relapsing-Remitting

Summary: the purpose of this study is to develop a measurement of walking quality, called gait deviation index (gdi) for people with multiple sclerosis (ms).

in rehabilitation in general, in order to track patients' progress and provide next steps, there is a need for easily obtainable, understandable, and objective measures of ability. currently, there is no measure that clinicians can utilize to determine walking quality. while gait deviation index has been validated and can reliably be used in adults who experienced a spinal cord injury, it has not yet been validated in people with ms. after the ms-specific gdi is developed from this study, therapists and clinicians will be able use it as a reliable progress measure. which may lead to the delivery of more effective therapy for patients with ms. here we plan to measure body position with camera based tracking during your gait cycle.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsing form of ms (including relapsing-remitting ms and secondary progressive ms) * able to ambulate overground * relapse free for at least 1 month * age ≥18 and ≤ 75 years * participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening exclusion criteria: - orthopedic injuries, fractures, surgeries or other conditions affecting locomotor function or weight bearing
efficacy and safety of sr58611 compared to placebo and paroxetine

Conditions: Major Depressive Disorders

Summary: primary objective : * to demonstrate the antidepressant efficacy on the hamilton depression rating scale of sr58611a 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode. secondary objectives: * to assess the safety profile of sr58611a 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.


Eligibility criteria:
inclusion criteria: * patients suffering from a recurrent major depressive episode of at least moderate intensity (dsm-iv) * patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months. * the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration

Keywords: depression
the factors cause vasospasm after aneurysmal subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage; Vasospasm, Intracranial

Summary: extensive research has shown that the big event that leads to the initiation of vasospasm is the release of oxyhemoglobin (blood breakdown product).depletion of no synthase (19,20,21) was also noted after sah.csf is produced from choroid plexus in the ventricle. if the sah is too dense, the blood in the subarachnoid space will not easy to be washed out.

cerebral vasospasm remains a significant source of morbidity and mortality in patients with subarachnoid hemorrhage (sah) after an aneurysmal rupture. despite being a significant source of morbidity and mortality, death and disability from vasospasm have declined from approximately 35% in the early 1970's, to between 15% and 20% in the 1980's to \<10% in the 1990's(1,2,3,4).extensive research has shown that the big event that leads to the initiation of vasospasm is the release of oxyhemoglobin (blood breakdown product)(1,12,13). this mechanism appears to be a multifactorial process that involves the generation of free radicals, lipid peroxidation and activation of protein kinase c as well as phospholipase c and a2 with resultant accumulation of diacylglycerol and the release of endothelin-1(14,15,16,17,18). on the other hand, depletion of no synthase (19,20,21) was also noted after sah. previous reports showed that shunting of csf through a lumbar drain after an sah markedly reduces the risk of clinically evident vasospasm and its sequelae, shortens hospital stay, and improves outcome. its beneficial effects are probably mediated through the removal of spasmogens that exist in the csf(22). in our preliminary data, we have demonstrated a case with severe vasospasm, csf was collected both from evd and lumbar drain. the adma level and amount of nitrate was well correlate with vasospasm and the level was much higher in lumbar drain then evd. so, we will compared the csf from evd and lumbar puncture to see which factor is correlate with vasospasm.

Eligibility criteria:
inclusion criteria: * aneurysmal rupture with sah exclusion criteria: * bleeding tendency, * large ich with impending herniation

Keywords: sah, vasospasm, adma
renal impairment study of empagliflozin (bi10773) in japanese patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of bi10773 following oral administration of high dose bi10773 as a single dose in japanese patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * type 2 diabetes patients * glycosylated haemoglobin\>= 6.1% (japan diabetes society) * estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of \>= 15 ml/min/1.73m2 exclusion criteria: * any evidence of significant disease (other than renal impairment) * moderate and severe concurrent liver function impairment * gastrointestinal tract surgery, that might affect absorption and elimination of drugs * diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders * chronic or relevant acute infections * participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial
comparing refractive and visual outcomes of migs and traditional surgeries

Conditions: Glaucoma; Ocular Hypertension

Summary: the primary goal of this study is to evaluate refractive and visual outcomes in glaucoma patients who will be having either traditional glaucoma surgery or minimally invasive glaucoma surgery, also known as migs.

there is an increasing number of surgical options to lower intraocular pressure (iop) in patients with glaucoma and ocular hypertension performed with or without concurrent cataract surgery. today, patients undergoing glaucoma surgery have increasingly higher expectations for their postoperative visual outcomes. therefore, it is important to understand the influence of various glaucoma surgical procedures on refractive outcomes. this information would aid in patient and surgical procedure selection, pre-operative counseling to set appropriate expectations and may help surgeons adjust their plans and techniques to improve visual outcomes. the advent of minimally invasive glaucoma surgery (migs) procedures further highlights the importance of studying refractive outcomes as many of these surgeries are being performed earlier in the glaucoma severity spectrum where central visual potential is still preserved. furthermore, this class of surgeries is often performed in combination with cataract surgery. there remains a lack of data regarding refractive outcomes in patients who have had phaco-istent, phaco-cypass, as well as goniotomy (kahook dual blade (kdb) gonioscopy assisted transluminal trabeculotomy), and xen gel stent implantation with or without cataract surgery. this information would help during pre-operative patient discussions and lens selection in the context of a combined procedure.

Eligibility criteria:
inclusion criteria: diagnosis of glaucoma or ocular hypertension in the study eye(s) and are consented to receive any of the following procedures: * ab interno goniotomy surgery: gonioscopy-assisted transluminal trabeculotomy (gatt) surgery to decrease intraocular pressure. * gelatin stent surgery: subconjunctival stent (xen) surgery to decrease intraocular pressure. * suprachoroidal stent and cataract surgery: suprachoroidal stent (cypass) to decrease intraocular pressure in combination with cataract surgery. * trabeculectomy surgery: glaucoma filtering surgery to decrease intraocular pressure. * cataract surgery: cataract surgery with no glaucoma procedure. exclusion criteria: patients with previous corneal ectasia or history of refractive procedures; patients who cannot fixate well due to poor vision (worse than 20/200)

Keywords: glaucoma surgery migs, minimally invasive glaucoma surgery refractive outcomes visual outcomes
dynamic treatment regimes for opioid use disorder

Conditions: Opioid Use Disorder

Summary: this study aims to develop and evaluate dynamic treatment regimes (dtrs) to improve personalized care for individuals with opioid use disorder (oud). using machine learning methods and longitudinal data from a national behavioral health provider, we will identify optimal treatment sequences that minimize overdose risk and improve recovery outcomes. a pilot hybrid factorial smart trial will be conducted to assess the feasibility and acceptability of implementing these personalized treatment decision rules in real-world clinical settings.

this project supports the development and testing of dynamic treatment regimes (dtrs) for individuals with opioid use disorder (oud), leveraging clinical and behavioral data from discovery behavioral health and linked administrative records. in the first phase, multiple machine learning approaches (e.g., q-learning, causal forests) will be used to estimate and validate dtrs that recommend tailored sequences of care based on patient characteristics and treatment response. the dtrs will be evaluated based on their ability to reduce fatal and non-fatal opioid overdose risk and hospital-based service use. in the second phase, we will conduct a pilot hybrid factorial sequential multiple assignment randomized trial (smart) to test the feasibility and acceptability of implementing the highest-performing dtr in a clinical setting. this pilot study will assess recruitment and retention, adherence to assigned treatment paths, and the practicality of integrating the dtr into routine care. findings will inform a future full-scale trial aimed at improving personalized oud care and outcomes.

Eligibility criteria:
inclusion criteria: * age 18 or older * diagnosed with opioid use disorder (oud) * receiving care at a participating discovery behavioral health site * able to provide informed consent exclusion criteria: * significant cognitive impairment or psychiatric instability that would prevent participation * current incarceration or involuntary commitment

Keywords: opioid use disorder
tcb self-monitoring in healthy term and near-term neonates

Conditions: Hyperbilirubinemia, Neonatal

Summary: the goal of this observational study is to monitor the transcutaneous bilirubin (tcb) level in healthy near-term and full-term neonates from birth to 30 days of age across china. the main question it aims to answer is: development of tcb nomogram to identify neonatal hyperbilirubinemia in term and late-preterm infants compare the changing trend of tcb among different areas in china compare the changing trend of tcb among different gestational groups in china


Eligibility criteria:
inclusion criteria: gestational age \>=35wk; did not admitted to hospital for any reason less than 30 days of age exclusion criteria: accept phototherapy within 60h of age

Keywords: hyperbilirubinemia transcutaneous bilirubin neonate
efficacy of fluvastatin and fenofibrate in comparison to simvastatin and ezetimibe in patients with metabolic syndrome

Conditions: Dyslipidemia

Summary: this study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.


Eligibility criteria:
inclusion criteria: * written informed consent to participate in the study prior to any study procedures. * male or female subjects, age between 18-75 years inclusive. * all women of child bearing potential must have a negative pregnancy test * metabolic syndrome according to the international diabetes federation definition: * low plasma hdl-c (men \< 40 mg/dl ; women \< 50 mg/dl ). * elevated waist circumference (men ≥ 94 cm, women ≥ 80cm) * and one or more of the following criteria: * triglycerides ≥ 150 mg/d.l * raised blood pressure (dbp ≥ 85 mmhg and/or sbp ≥ 130mmhg ) or treated hypertension. * fasting plasma glucose≥ 100mg/dl. * previously diagnosed type 2 diabetes. exclusion criteria: * dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease. * type 1 diabetes. * hba1c \> 9.5%. * unexplained serum creatine phosphokinase \> 2 x upper limit of normal. * history of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris. * known or suspected contraindications and warnings according to the country specific label for the investigational drugs. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: dyslipidemia metabolic syndrome fluvastatin fenofibrate simvastatin ezetimibe