Kornimate/medical-research-clean huggingface dataset:
mmf versus cyc in the induction therapy of pediatric active proliferative ln

Conditions: Mycophenolate Mofetil; Cyclophosphamide; Lupus Nephritis

Summary: a prospective, randomized, multicenter, open-label, parallel-arm study to compare effectiveness of mycophenolate mofetil versus cyclophosphamide in the induction therapy of pediatric patients with active proliferative lupus nephritis in chinese population

scattered research in adults showed that both mycophenolate mofetil (mmf) and cyclophosphamide (cyc) can be used in the induction therapy of lupus nephritis. however data is limited in children.therefore, the purpose of this study is to observe and compare the efficacy and safety of mmf and cyc as induction therapy for children with proliferative lupus nephritis through a multi-center open randomized controlled study.

Eligibility criteria:
inclusion criteria: only those who fully meet the following criteria can be considered for inclusion in this study: 1. age 5-17 years old; 2. sle patients who meet the updated 2019 eular/acr sle classification criteria or 2012 slicc diagnostic criteria; 3. according to the revised international society of nephrology / society of renal pathology (isn/rps) classification in 2018, it conforms to active proliferative ln type iii or iv, with or without type v; 4. glomerular filtration rate egfr ≥ 60 ml/min/1.73 m2; 5. 24-hour urinary protein quantitation ≥ 25mg/kg, or urinary protein / creatinine 1.0mg/mg; 6. blood routine wbc count ≥ 3.0\*10\^9/l, lymphocyte ≥ 0.5\*10\^9/l before enrollment; 7. no immunosuppressants such as cyclophosphamide, mycophenolate mofetil, cyclosporine a, tacrolimus, azathioprine, methotrexate, or biological agents such as rituximab, baileyoumab, and etaxel were used before enrollment. exclusion criteria: 1. a known history of primary immunodeficiency, splenectomy, or any potential disease that makes participants vulnerable to infection; 2. evidence of hepatitis c, active hepatitis b, hiv infection, tuberculosis infection, severe fungal infection, or other serious infections; 3. have any history of tumor or cancer; 4. patients with lupus encephalopathy, diffuse alveolar hemorrhage, severe hemolytic anemia, blood routine platelet count lower than 10.0\*10\^9/l, glomerular filtration rate egfr \< 60 ml/min/1.73 m2, or patients with other serious complications have unstable vital signs; 5. have severe gastrointestinal bleeding, pancreatitis, serious heart, liver, blood, endocrine system diseases; 6. patients who are known to be allergic to mycophenolate mofetil, cyclophosphamide, glucocorticoids or any of the above drugs; 7. patients who participated in other clinical trials within 3 months before enrollment; 8. the researcher judged that the patient's condition was not suitable for participants in this trial.
targeted self-management for epilepsy and serious mental illness (time)

Conditions: Epilepsy; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Depression

Summary: for this project we propose to refine the psychosocial intervention developed in phase one, based on input from key stakeholders, and to test the feasibility, acceptability and preliminary efficacy of the intervention. the proposed project addresses unmet public health needs for a historically hard-to-reach group of individuals with epilepsy and comorbid serious mental illnesses, and as the intervention is an adjunct to care that individuals with serious mental illness are already receiving, and uses staff already likely to be present in a care system, it is ideally suited for "real-world" implementation in people with epilepsy and serious mental illness (e-smi). the purpose of this study is to try and engage individuals with e-smi to actively participate in illness self-management and treatment adherence that are crucial in minimizing the morbidity and mortality associated with both chronic mental disorders and chronic neurological conditions.


Eligibility criteria:
inclusion criteria: * able to provide written consent * able to speak and understand english * age 18 and older * diagnosed with epilepsy * diagnosed with serious mental illness (dsm iv diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or chronic/recurrent depression confirmed with the mini-international neuropsychiatric interview (mini)) * receive care at a community mental health center or other publicly funded community healthcare entity exclusion criteria: * actively suicidal/homicidal individuals * individuals with dementia * unable to be rated on study rating scales * pregnant women

Keywords: epilepsy schizophrenia schizoaffective disorder bipolar disorder depression intervention treatment adherence
cognitive behavioural therapy (cbt) for improving emotional well being in spinal cord injuries (sci)

Conditions: Spinal Cord Injuries

Summary: the purpose of the study is to determine whether or not a brief psychological treatment called cognitive behaviour therapy will help people who have suffered a spinal cord injury to cope better with their current circumstances.

the goal of the current proposed research project is to investigate the potential efficacy of a group cognitive behavioural therapy (cbt) intervention aimed at improving emotional well-being, specifically mood, adjustment and quality of life (qol), after spinal cord injury(sci). the intervention will be adapted to meet the unique needs of patients suffering from an sci. the study objectives are: (1) to evaluate the impact of a brief cbt intervention aimed at decreasing emotional distress and improving quality of life; (2) to evaluate the sustainability of cbt therapeutic gains over time; (3) to conduct sub group analyses in order to better determine why some patients may improve post cbt, while others may not.

Eligibility criteria:
inclusion criteria: * between ages 18-65 * diagnosed with spinal cord injury * currently endorsing significant distress as measured * able to provide informed consent * if taking psychoactive meds, on a stable dosage * are not currently enrolled in any other psychological treatment program * speak basic english with no diagnosis of communication disorder exclusion criteria: * they endorse current suicidal ideation * have a neurodegenerative disorder such as multiple sclerosis
safety and efficacy study of sofosbuvir plus ribavirin in treatment-naive adults with genotype 1 and 3 chronic hcv infection

Conditions: Hepatitis C

Summary: this study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (gt1) or genotype 3 (gt3) hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * confirmed chronic genotype 1 or 3 hcv infection * hcv treatment-naive * individuals will have cirrhosis status assessment; liver biopsy may be required. * screening laboratory values within predefined thresholds * use of two effective contraception methods if female of childbearing potential or sexually active male exclusion criteria: * pregnant or nursing female or male with pregnant female partner * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * contraindication to ribavirin therapy * excessive alcohol ingestion as defined by protocol * history of solid organ transplantation * current or prior history of clinical hepatic decompensation * history of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
safety of cultured autologous adult adipose derived mesenchymal stem cell versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cell intrathecal injection for sci

Conditions: Spinal Cord Injuries

Summary: this trial will study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cells for the treatment of spinal cord injury

studies have shown that stem cell treatment is safe and efficacious for the treatment of spinal cord injury (sci). this patient funded trial aims to study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells (ad-mscs) versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cell for the treatment of sci. patients with sci will receive a single intrathecal injection of ad-mscs. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria:
inclusion criteria: * diagnosis of spinal cord injury * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * anticoagulation medicine use * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * previous organ transplant * hypersensitivity to sulfur * continued drug abuse * pre-menopausal women not using contraception

Keywords: spinal cord injury sci stem cell treatment
impact of no-carrageenan diet on glucose tolerance in prediabetes

Conditions: Prediabetes

Summary: participants will be randomly assigned to either regular or no-carrageenan prepared diets to determine whether the no-carrageenan leads to improvement in glucose tolerance. hemoglobin a1c is the primary outcome measure.

subjects will be randomly assigned to a diet. they will at onset have hemoglobin a1c values between 5.7% and 6.4%. baseline glucose tolerance test will be performed, as well as measures of inflammation and fecal microbiome. interim tests will be performed at six weeks. subjects will participate for 12 weeks, at which time they will be re-evaluated.

Eligibility criteria:
inclusion criteria: * per diabetes, ability to follow diet and study procedures exclusion criteria: * on any medications that affect glucose, medical conditions or allergies that affect adherence to study diet, pregnancy
initial cdk 4/6 inhibitor plus endocrine therapy versus initial chemotherapy in hr positive, her2 negative unresectable or metastatic breast cancer

Conditions: Breast Cancer

Summary: a multi-center, real world study to evaluate the clinical outcomes between initial cdk 4/6 inhibitor plus endocrine therapy and initial chemotherapy in hr positive, her2 negative unresectable or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. age \>= 18 years old; 2. patients who were diagnosed as hr positive, her2 negative recurrent unresectable (local or regional) or stage iv (m1) breast cancer between june 2020 to october 2023; 3. received cdk4/6 inhibitor plus endocrine treatment or chemotherapy as first-line therapy for at least one cycle; 4. complete medical history was available. exclusion criteria: 1. medical history was incomplete.

Keywords: chemotherapy cdk 4/6 inhibitor hr positive her2 negative
comparison of idd therapy and non-surgical treatment for low back pain caused by degenerative disc disease

Conditions: Degenerative Disc Disease

Summary: this study is looking at a new machine called the accu-spina which administers internal disc decompression by following a computer program. this non-surgical treatment (similar to traction) is being compared to a rigorous physical therapy program.

this study is a randomized trial where out of every 3 people, 2 will receive idd therapy and 1 will have standardized physical therapy. patients are given surveys to complete that ask about how their back pain is affecting their quality of life before starting treatment, 6 weeks after starting treatment, and 3, 6, and 12 months after starting treatment. if at the 6 week point, the patient and doctor do not think the current treatment is working well enough, the patient is given the option to try the other treatment.

Eligibility criteria:
inclusion criteria: * chronic low back pain for \> 3 months due to mild to moderate disc degeneration, lumbar spondylosis, and facet arthropathy without leg pain based on the physician's history and physical and imaging studies * over 18 years old * able to provide written informed consent exclusion criteria: * infection, neurological deficits, systemic disease that would affect treatment outcome such as inflammatory joint diseases; malignancies with involvement in the musculoskeletal system * evidence of severe neural compression on imaging studies, i.e. spinal stenosis or large herniated disc * uncontrolled mood disorder * history of drug or substance abuse * lumbar spine pathology requiring surgical intervention * previous spine surgery of the lumbar spine, except discectomies \>12 months * improvement with similar non-surgical treatments in the last 3 months * active litigation, workers compensation * females whom are pregnant

Keywords: low back pain ddd
imagio feasibility multi-reader, multi-case study

Conditions: Breast Cancer

Summary: controlled, blinded, multi-reader, multi-case study

the imagio feasibility reader study-01 study is intended to evaluate if a subsequent pivotal study can be implemented to test prospective hypotheses for pre-specified effectiveness endpoints with an acceptable sample size. the feasibility study will be based on itd masses from the pioneer (nct01943916) pivotal study to simultaneously reflect the distributions with and without mammograms as well as site cdu bi-rads scores within benign and malignant masses as strata. the study population will be split into 3 cohorts - cohort 1, the 120 patient itd population used to run the primary/ secondary analyses. cohort 2, 30 patients used to run exploratory analyses on false negative rate and cohort 3, 5 patients used to run exploratory analyses on specific mass types

Eligibility criteria:
inclusion criteria: - female subjects participating in the pioneer-0 study of the imagio breast imaging system with known clinical status exclusion criteria: - female subjects who did not have known clinical status in the pioneer-0 study of the imagio breast imaging system with known clinical status
safety and efficacy study of sl1904b car-t cells for relapsed or refractory b-cell acute lymphocyte leukemia

Conditions: B-ALL

Summary: this is an open, single-arm, clinical study to evaluate efficacy and safety of anti cd19 car-t cell in the treatment of recurrent or refractory b-all

the cars consist of an anti-cd19 single-chain variable fragment（scfv） that was derived from the fmc63 mouse hybridoma, a portion of the human cd137（4-1bb） molecule, and the intracellular component of the human cd3ζ molecule. prior to car-t cell infusion, the patients will be subjected to preconditioning treatment. after car-t cell infusion, the patients will be evaluated for adverse reactions and efficacy. the main research objectives: to evaluate the safety and efficacy of 1904b in patients with recurrent or refractory b-all the secondary research objectives: to investigate the cytokinetic characteristics of 1904b in patients with recurrent or refractory b-all

Eligibility criteria:
inclusion criteria: 1. sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart; 2. a definite diagnosis of b-cell lymphocyte leukemia, which meets any of the following criteria: relapsed : a) relapsed within 12 months after first remission;refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter cr for 2 or more times; c) the first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation; 3. ecog scores: 0\~2 4. cd19 positivewere detected by immunohistochemistry or flow cytometry; 5. estimated survival time\>3 months; 6. peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment. exclusion criteria: 1. serious cardiac insufficiency； 2. has a history of severe pulmonary function damaging; 3. with other tumors which is/are in advanced malignant and has/have systemic metastasis; 4. severe or persistent infection that cannot be effectively controlled； 5. merging severe autoimmune diseases or immunodeficiency disease; 6. patients with active hepatitis b or hepatitis c(\[hbvdna+\]or \[hcvrna+\]); 7. patients with hiv infection or syphilis infection; 8. has a history of serious allergies on biological products (including antibiotics); 9. being pregnant and lactating or having pregnancy within 12 months; 10. any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Keywords: b-all, cd19 car-t
small airway obstruction in asthma, copd, acos

Conditions: Asthma; COPD; Asthma-COPD Overlap Syndrome

Summary: this study was designed as retrospective chart review to test our hypothesis whether there are the differences in inflammatory and anti-inflammatory mediators between asthmatic and acos patients with small airway obstruction, and copd

the data including spirometry, lung volume, impulse oscillometry, sputum data, demographic characters within 6 months are collected for later analysis. sputum supernatants and cytospins are used to determine inflammatory and anti-inflammatory responses in those patients.

Eligibility criteria:
inclusion criteria: * physician-diagnosed asthma, aco, and copd * their spirometric, ios, lung volume, demographic data and sputum samples are available exclusion criteria: * concomitant diseases requiring immunosuppressive therapy * being on treatments with nsaids, macrolides, statins

Keywords: small airway obstruction asthma copd acos
ramosetron od tablet and postdischarge nausea and vomiting

Conditions: Day Surgery

Summary: postoperative nausea and vomiting after general anesthesia is one of the common anesthetic complications. if the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea and vomiting occurred. thus, it is necessary to prevent these symptoms beforehand. patients who underwent day-surgery will be treated with prophylactic ramosetron orally disintegrating tablets to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.


Eligibility criteria:
inclusion criteria: * patients who undergo day-surgery under general anesthesia and are discharged on the day of surgery exclusion criteria: * pregnancy or breastfeeding * patients who are taking other serotonin receptor antagonists * patients who have galactose intolerance or lapp lactase deficiency * patients who have glucose-galactose malabsorption
high-resolution esophageal manometry

Conditions: Esophageal Atresia

Summary: ea is one of the most frequent birth defects, with an incidence of 1 in 3000 live births1. until the 1950s, these patients had 100% mortality; nowadays, the survival rate is greater than 90%, and only those with associated severe malformations die1-5. type c ea (atresia of the esophageal proximal segment with tracheoesophageal fistula between the trachea and the distal segment) is the most common variant, since it is present in 85% of the cases6-8. there is evidence that the esophageal motor disorder present in these children is secondary to a congenital neuromuscular disorder and a postoperative disorder9-14. patients that survive the operation have greater risk of developing gastroesophageal reflux disease (gerd), caused by anomalies in the esophageal motility and its resulting delay in the evacuation of acid of the esophageal lumen. there was a hypothesis that suggested that motility alteration could contribute to dysphagia and to the high prevalence of gastroesophageal reflux in these patients15-18. also, there were reports of a greater incidence of severe esophagitis with requirement of fundoplication, which shows a larger failure rate17-18. esophageal dysmotility has been proved in children with ea through performance of conventional perfusion manometry. lemoine c et al described three motility alteration patterns with hrm in children with repaired ea. said study allowed a more precise knowledge of segmental esophageal motility19. currently, there are no reports exclusively made about teenagers with repaired ea that describe segmental esophageal motility with hrm.


Eligibility criteria:
inclusion criteria: teenagers of more than 12 years old, with repaired ea, orally fed during the last 6 months, with no history of esophageal blockage or dilations, who underwent a hrem exclusion criteria: * patients under 12 years old

Keywords: high-resolution manometry esophageal atresia teenagers
effect of virtual reality glasses on anxiety during cystoscopy: a randomised controlled trial

Conditions: Cystoscopy; Virtual Reality; Anxiety

Summary: the aim of this study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the research * 18 years of age or older * male gender * undergoing a rigid cystoscopy procedure for the first time * application of local anaesthesia exclusion criteria: * cognitive or physical disabilities that may prevent the use of virtual reality glasses. * premedication before the procedure
x-396 capsule in patients with alk-positive non-small cell lung cancer previously treated with crizotinib

Conditions: Non-Small Cell Lung Cancer

Summary: the main purpose of the study is to evaluate safety and efficacy of x-396(ensartinib) capsule in patients with alk-positive non-small cell lung cancer previously treated with crizotinib.while exploring the relationship between biomarkers and drug efficacy and safety.

this is a phase ii, multicenter, single-arm study in which the safety and efficacy of x-396(ensartinib) will be assessed in adult chinese patients with alk-positive(rearrangement) non-small cell lung cancer previously treated with crizotinib. approximately 144 patients with locally advanced or metastatic nsclc which carry alk -rearrangement will be enrolled in the study.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer. * evidence of positive alk. * patients must have demonstrated progression during or after crizotinib treatment. * age 18 years or older at the time of informed consent. * eastern cooperative oncology group performance status (ecog ps) of 0-2 * measurable disease by response evaluation criteria in solid tumors (recist) version 1.1 (v1.1). * asymptomatic cns metastases do not require the use of steroids or anticonvulsants. * willingness and ability to comply with the trial and follow-up procedures. * ability to understand the nature of this trial and give written informed consent. exclusion criteria: * prior use of alk tkis with the exception of crizotinib. * patients currently receiving cancer system therapy. * use of an investigational drug within 4 weeks prior to the first dose of study drug. * presence of active gastrointestinal (gi) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications. * patients with a known allergy or delayed hypersensitivity reaction to drugs.