Kornimate/medical-research-clean huggingface dataset:
a phase i study of s-1 in combination with radiotherapy in locally advanced or recurrent gastric cancer

Conditions: Gastrointestinal Neoplasms; Gastric Cancer

Summary: the purpose of this study is to determine maximum tolerated dose (mtd), dose limiting toxicities (dlt) and recommend a proper dose for our phase ii study of s-1 when combined with radiation therapy for locally advanced or recurrent gastric cancer.

this is a phase i trial of s-1 given in treatment days with an oral dose from 30mg/m2/d to 80mg/m2/d, concurrently with radiation in patients with locally advanced or locally recurrent gastric cancer. patients will be treated with external beam radiation therapy in a standard manner. s-1 will be administered for 6 dose levels,30/40/50/60/70/80mg/m2/d. patients will be assessed for acute toxicities according to common toxicity criteria for adverse effects (ctcae)3.0.

Eligibility criteria:
inclusion criteria: * histologically or cytologically proven locally advanced gastric adenocarcinoma in patients undergoing r0, r1, r2 resection, or with unresectable or locoregional recurrent disease * any prior chemotherapy is allowed in this protocol. * no distant metastasis in liver,lung,,bone,central nervous system(cns),no peritoneal transplantation * no prior abdominal or pelvic radiotherapy. * karnofsky performance status(kps)≥ 70,predictive life span no less than 6 months * patients must have normal organ and marrow function as defined below: * leukocytes greater than or equal to 3,000 g/l * platelets: greater than or equal to 100,000/mm3 * hemoglobin:greater than or equal to 10g/l * total bilirubin: within normal institutional limits * ast/alt: less than or equal to 1.5 times the upper limit * creatinine within normal upper limits * informed consent * without any serious complications,such as hypertension,coronary artery disease,psychiatric history. exclusion criteria: * patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer * with any distant metastasis in liver,lung,,bone,cns,or peritoneal transplantation * history of allergic reactions attributed to similar chemical or biologic complex to s-1 * uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness * history of myocardial infarction within the past 6 months or history of ventricular arrhythmia * history of prior radiation to the abdomen * pregnant or lactating females

Keywords: combined modality gastric cancer radiation therapy s-1
real-time cancer pain assessment and intervention

Conditions: Malignancy; Pain

Summary: this study aim at the advanced malignant tumor patients who suffer from cancer pain, investigate the current status of cancer pain treatment, and study the effects in pain control and quality of life improvement using the method of real-time monitoring and treatment instruction of cancer pain. this study is a randomized, controlled, single center clinical study. after recruitment, the subjects will randomly assign to standard cancer pain treatment group and standard cancer pain treatment plus real-time dynamic monitoring and treatment intervention of cancer pain using the cloud computing concept system. and then, assess the alleviation of cancer pain and quality of live. the assumption is the system will alleviate the cancer pain efficiently.

1. cancer pain is a common symptom exists in malignant tumor patients, which bother the patients and decrease the quality of life. 2. the goal of the study is that using the real-time monitoring and intervention system will alleviate cancer pain better than the standard cancer pain treatment. 3. the cloud computing concept is developed by sun yat-sen university cancer center, and accord with clinical practice. 4. the subjects receive the real-time monitoring and intervention system will install the software and report in the contents of cancer pain in the software correspondingly to the doctors, and advices will be given by the software as well. 5. the quality of life and overall survival follow-up is also required.

Eligibility criteria:
inclusion criteria: * solid tumors confirmed by pathology or cytology * eastern cooperative oncology group performance status: 0-2 * sign the informed consent form * good compliance, willing to comply with the requirements of the study * anticipate survival time more than 3 months * pain intensity is greater than 2 points according to numerical rating scale on enrollment; have indication of opioid analgesic drugs. * can express subjective feelings of pain intensity clearly. * own a smartphone or tablet device which can install and use the application program software, and can operate the software proficiently. exclusion criteria: * poor compliance, refuse to sign the informed consent form, or difficult to comply with the requirement of the study. * slight pain or no pain, no indication of opioid analgesic drugs. * contraindication of opioid analgesic drugs * no other medical workers give instructions during the study.

Keywords: malignancy solid tumor cancer pain
ibodutant for relief of irritable bowel syndrome (iris)

Conditions: Irritable Bowel Syndrome

Summary: the purpose of the study is to evaluate the benefit of treatment with oral dose of ibodutant (code: men 15596) on ibs symptoms and the safety and tolerability of this therapy.

irritable bowel syndrome (ibs) is a functional disorder characterised by chronic or recurrent abdominal pain or discomfort associated with altered bowel habits. this trial aims to evaluate the efficacy of ibodutant in improvement of ibs symptoms through a daily oral administration, testing three dosages or placebo in ibs patients for 4-weeks. in each patient, the experimental clinical phase encompasses a screening/ 2-week run-in period (no study medication), followed by a 4-weeks treatment period and a 2-weeks treatment withdrawal period, for total study duration of 8 weeks in each patient.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged 18 - 70 years. 2. clinical diagnosis of ibs . 3. for patients older than 50 years or patients with positive family history of colorectal cancer: normal results from colonoscopy or flexible sigmoidoscopy. 4. use of appropriate contraceptive methods. 5. normal physical examination or without clinically relevant abnormalities. exclusion criteria: 1. patients with organic abnormalities of the gastro-intestinal tract including history of colonic or major abdominal surgery, current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis. 2. history of gluten enteropathy. 3. lactose intolerance as assessed by response to diet 4. diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months. 5. previous diagnosis of diabetes mellitus (either type 1 or 2) 6. unstable medical condition. 7. concomitant medication within 7 days prior to screening with drugs known to interfere with gastro-intestinal motility and sensitivity. 8. pregnancy or breastfeeding. 9. patient not able to understand or collaborate throughout the study. 10. participation in other clinical trials in the previous 4 weeks.

Keywords: irritable bowel syndrome bowel disease
extension study of asenapine [p06107 (nct01244815)] for pediatric bipolar disorder (p05898)

Conditions: Bipolar Disorder

Summary: this study will investigate the safety and tolerability of a flexible dosing regimen of asenapine for the long-term treatment of manic or mixed episodes associated with bipolar disorder i in children and adolescents who completed study p06107.


Eligibility criteria:
inclusion criteria: * completed study p06107 and demonstrated acceptable degree of compliance with medication, visits and other study requirements * must be male or a female who is not of childbearing potential and is not sexually active or is using a medically accepted method of contraception; or female who is not pregnant, or not lactating. * must have a caregiver or responsible person living with the participant who agrees to provide support to ensure compliance with treatment, visits, and protocol procedures exclusion criteria: * positive pregnancy test or intention to become pregnant during the study * at imminent risk of self-harm or harm to others * under involuntary inpatient commitment * known serological evidence of human immunodeficiency virus (hiv) antibody
evaluation of renal damage after pcnl and eswl using novel rna based biomarkers

Conditions: Acute Kidney Injury; Renal Calculi; Percutaneous Nephrolithotomy; Extracorporeal Shockwave Lithotripsy

Summary: the study evaluate the damage effect of eswl and pcnl on kidney tissue by measuring non-coding lnc-rna profile in urine before and after eswl and pcnl procedures

the study evaluate the damage effect of eswl and pcnl on kidney tissue by measuring non-coding lnc-rna profile in urine before and after eswl and pcnl procedures and assess their usefulness as diagnostic biomarkers for aki and the relationship between the selected rna based biomarker panel and clinicopathological changes of patients.

Eligibility criteria:
inclusion criteria: * inclusion criteria for patients : 1. patients undergoing treatment for a stone(s) located in the kidney less than 2 cm 2. radiopaque stone 3. able and willing to give informed consent inclusion criteria for healthy volunteers 1. no history of kidney or stone disease 2. asymptomatic 3. no indwelling ureteral stent 4. willing to provide medical history information 5. able and willing to give informed consent exclusion criteria: * exclusion criteria for patients 1. active urinary tract infection 2. bleeding disorder 3. chronic renal failure (egfr\<30) 4. ureteral stone

Keywords: lncrna, mrna, eswl,pcnl,sbf2-as1, fendrr-19, nlrp3.
pharmacokinetics, efficacy and safety of twice daily dosing regimen of hydroxycarbamide dispersible tablets in children with sickle cell disease

Conditions: Sickle Cell Disease

Summary: the purpose of this interventional, phase ii, national, multicentric, non-randomised, open-label study is to evaluate the pharmacokinetics (pk), efficacy and safety of hydroxycarbamide paediatric dispersible tablets with a twice daily dosing regimen in children with sickle celle disease between 9 months to 11 years of age. participants will: * take hydroxycarbamide twice a day every day for 12 months * visit the clinic at screening, baseline, 1, 3, 6, 9 and 12 months


Eligibility criteria:
inclusion criteria: * written informed consent, signed and dated by both parents or by the legally acceptable representative(s) of the children, and, if possible, assent from the children, * hbss or hbsβ0 scd, * aged between 9 months and 11 years old, * hydroxycarbamide naïve, * parent(s) or legally acceptable representative(s) capable of communicating with the investigator and understanding the requirements and constraints of the study protocol and willing to comply with the study requirements, * contraception criterion, if applicable: for patients who are sexually active * affiliated to a social security plan or beneficiary of a similar insurance plan, * patient must meet the following laboratory values : absolute neutrophil count ≥ 1.0x109/l, platelets ≥ 75x109/l and haemoglobin (hgb) \> 5.5 g/dl, * transcranial doppler (tcd) in the last 12 months indicating low risk for stroke is required for children over 18 months of age. exclusion criteria: * participation in any other clinical study for any other pharmaceutical product within 4 weeks preceding the inclusion visit, * patients who have had chronic blood transfusion or transfusion in the last 3 months preceding the inclusion visit, * patients treated with other scd-modifying therapies, * patient with a stage 3, 4 or 5 chronic kidney disease, * patients known to be infected with human immunodeficiency virus, hepatitis b virus, or hepatitis c virus, * known hypersensitivity or allergy to the excipients, * any surgical or medical condition or any significant illness that, in the opinion of the investigator, constitutes a risk or a contraindication to the participation of the patient to the study, or that may interfere with the objectives, conduct or evaluation of the study, * female patients who are pregnant or lactating, * any documented history of a clinical stroke or intracranial haemorrhage, or an uninvestigated neurologic finding within the past 12 months.

Keywords: hydroxycarbamide pharmacokinetic
fes implementation pediatrics

Conditions: Cerebral Palsy (CP)

Summary: physical rehabilitation interventions that promote activity-dependent neuroplasticity are desired for children with cp as this will result in improved motor skill and function. in adult neurological populations, such as stroke and spinal cord injury, fes is a recommended, evidence-based intervention that addresses motor and sensory impairments and promotes neuroplasticity. the evidence base supporting the safety, feasibility and efficacy of fes for youth with cp is rapidly growing, yet fes is not commonly used in canadian pediatric rehabilitation. through interviews with canadian pediatric physical and occupational therapists, we identified numerous barriers to fes implementation, including a lack of knowledge and training in fes, difficulty accessing fes equipment, and a perceived lack of time to deliver fes within a treatment session. to address these barriers, we have developed an implementation intervention for fes that consists of an online course and toolkit for physical and occupational therapists. as a next step, we will evaluate the effects of the implementation intervention on pediatric therapists' knowledge, confidence and use of fes.


Eligibility criteria:
inclusion criteria: 1. licensed to practice physical or occupational therapy in canada. 2. report that cp comprises ≥20% of their caseload over the past year. 3. has not previously taken a continuing education course in fes. 4. reports never (0% of treatment sessions) or rarely (1-20% of treatment sessions) using neuromuscular electrical stimulation (nmes) or fes in their clinical practice. 5. report being able to participate in a six-week online fes course from october 18 2024 - november 28 2024. 6. able to complete the course and interview in english.

Keywords: functional electrical stimulation implementation intervention physical therapist occupational therapist
corneal topographic changes after pterygium surgery

Conditions: Pterygium

Summary: the purpose of the study is to assess the corneal topographic changes after primary pterygium surgery

prospective interventional comparative study . this study will be conducted on eyes with primary pterygium before and after successful excision in department of ophthalmology, sohag university hospital to assess the corneal topographic changes using pentacam . postoperative evaluation will be scheduled for one month ,three and six months postoperative.

Eligibility criteria:
inclusion criteria: * patients with primary pterygium exclusion criteria: * patients with recurrent pterygium * patients with primary pterygium with other ocular pathologies.
atrial fibrillation and non-obstructive coronary lesions

Conditions: Fibrillation, Atrial; Coronary Artery Disease; Chronic Kidney Diseases

Summary: atrial fibrillation (af) is the most common cardiac arrhythmia associated with excessive risk of ischemic stroke and heart failure as well as reduced life expectancy. on the other hand, chronic coronary syndromes (ccs) remains the main cause of morbidity and mortality in an aging population. both disease entities share common risk factors such as hypertension, diabetes and obesity the purpose of the study is to investigate the hypothesis indicating lack of significant coronary lesions in af vs. sinus rhythm (sr) patients.

atrial fibrillation (af) and chronic coronary syndromes (ccs) share common risk factors and both disease entities frequently co-exist. additionally, af symptoms may mimic ccs. objectives: to investigate the hypothesis indicating lack of significant coronary lesions in af vs. sinus rhythm (sr) patients. the prevalence of ccs in patients with af varies from 17% to 47% whereas af in patients with ccs is much less common, ranging from 0.2% to 5.patients with af more often have concomitant ccs as compared with sinus rhythm controls. additionally, af is more frequently present in patients with either peripheral- or cerebrovascular artery disease than in non-atherosclerotic individuals we conducted a multi-center retrospective study including consecutive patients referred for elective coronary angiography.

Eligibility criteria:
inclusion criteria: * coronary angiography exclusion criteria: * we excluded patients with acute coronary syndromes (acs), tako-tsubo cardiomiopathy and history of ischemic heart disease, as well as those referred for coronary angiography before heart valve surgery. prior cardiosurgical valve replacement was also the exclusion criterion.

Keywords: fibrillation, atrial coronary artery disease chronic kidney disease
clinical study on the effect of pth on cyp3a4 activity

Conditions: Chronic Kidney Diseases

Summary: parathyroid hormone (pth) may play an important role in the down-regulation of cyp3a4 expression induced by chronic kidney diseases (ckd). in the study of molecular mechanism, the research group found that the expression of cyp3a2 metabolic enzyme in rat liver decreased in the state of ckd.and pth may down-regulate the expression of cyp3a4 metabolic enzyme by inhibiting the expression of nuclear factor- kilobuse (nf-kb) p65 subunit


Eligibility criteria:
inclusion criteria: * chinese male or female subjects with an age of 18 or older were included; * the clinical physician diagnosed ckd with hypertension; * the physician decided that nifedipine controlled release tablets should be given. * subjects agree to the study protocol, clinical and follow-up time, and sign the informed consent after the approval of the ethics committee; * subjects will be able to communicate well with the investigator and will be able to complete the study as required. exclusion criteria: * patients with ckd requiring dialysis treatment; * other clinical reasons that may be considered inappropriate for inclusion by clinicians.
gm1 prophylaxis for nab-paclitaxel-associated chemotherapy-induced peripheral neuropathy (cipn) in patients with breast cancer

Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)

Summary: this study is a randomized, double-blind, multicenter, placebo-controlled phase iii clinical trial, aiming to evaluate the efficacy and safety of gm1 in preventing chemotherapy-induced peripheral neuropathy in breast cancer patients treated with albumin-paclitaxel chemotherapy regimen.

this study was randomly divided into two groups at a ratio of 1:1, with 176 subjects in each group. all patients received gm1/ placebo treatment + chemotherapy. the main purpose of this study is to evaluate the effectiveness of gm1 in preventing peripheral neuropathy caused by albumin-paclitaxel chemotherapy. the primary endpoint was the end of gm1 treatment in cycle 4 (c4d21), and the proportion of patients whose fact/gog-ntx score changed by more than 12 points from baseline.

Eligibility criteria:
inclusion criteria: * voluntarily sign the informed consent form; * age: 18 to 75 years old; * female patients with breast cancer confirmed byhistological and/or cytological diagnostic basis for breast cancer and are intended to receive adjuvant/neoadjuvant therapy with albumin paclitaxel regimens; * ecog: 0-1 * adequate organ function level * glycated hemoglobin (hba1c) \< 7.0%; * for women of childbearing potential: use effective contraceptive measures for contraception from the date of signing the informed consent form until 30 days after the last use of the investigatory drug. * patients can accurately record or express the occurrence and severity of peripheral neuropathy through questionnaires. exclusion criteria: * grade ≥1 peripheral neuropathy (ctcae grade ≥1) or any of the first 4 items of fact/gog-ntx ≥1; * there are risk factors for peripheral neuropathy (excluding peripheral neuropathy caused by chemotherapy). * history of another malignant tumors (except breast cancer) * symptoms such as muscle pain in the limbs that interfere with the evaluate of peripheral neuropathy; * uncontrolled cardiovascular and cerebrovascular system diseases or hypertension * active infections that require systematic treatment, including bacteria, fungi or viruses, within one week before first study drug use; or infectious diarrhea occurred within 4 weeks before the first study drug use; * hereditary abnormal glycolipid metabolism, hiv infection or known acquired immune deficiency syndrome (aids); positive syphilis antibody, active hepatitis b, active hepatitis c
evaluation of long term safety and efficacy of glepaglutide in treatment of sbs

Conditions: Short Bowel Syndrome

Summary: the primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (sbs). glepaglutide is the international nonproprietary name and usan for zp1848.

a double-blind phase 3 extension trial assessing the long term safety and efficacy of glepaglutide in patients with short bowel syndrome (sbs)

Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activity * completed the lead-in trial (zp1848-17111) or completed the phase 2 trial (zp1848-15073) exclusion criteria: * withdrawal of consent from the lead-in trial * any condition or disease or circumstance that in the investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results * use of glp-1, glp-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to screening * females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods