Kornimate/medical-research-clean huggingface dataset:
a phase ii trial of exploring the predictive factors of tx and xelox regimen in the first line treatment of mgc

Conditions: Gastric Cancer

Summary: platinum, fluorouracil and taxane based regimen are all acceptable in the first line treatment of metastatic gastric cancer. the tx and xelox regimen are two common regimen used in mgc. whichever regimen is used, the average response rate is less than 50%. so a rather part of patients can't get benefit from the treatment. it is urgent to find out the predictive factors of these regimens in order to get a higher response and better survival outcome.

patients with mgc will be treated with tx or xelox regimen. before treatment, 14 days after treatment and after progression, the blood sample will be collected. primary tumor blocks will also of collected. these samples will be used to detect predictive factors of the two types first line therapy.

Eligibility criteria:
inclusion criteria: * chemo-naive patients with metastatic, unresectable, histologically confirmed gastric or gastroesophageal adenocarcinoma; patients who received adjuvant chemotherapy, the duration from the last therapy to relapse at least longer than 6 months * patient must have at least one measurable lesions (recist 1.1) * 18 years to 75 years * written informed consent obtained * eastern cooperative oncology group (ecog) performance status 0-1 * patients must have adequate organ and marrow function as defined below: * neutrophilicgranulocyte greater than/equal to 1,500/mm3; * platelets greater than/equal to 90,000/ mm3; * hemoglobin greater than/equal to 9 gm/dl (may be transfused to maintain or exceed this level); * total bilirubin less than/equal to 1.5 within institutional upper limit of normal (iuln); * aspartate transaminase (ast,sgot)/alanine transaminase (alt,sgpt) less than/equal to 2.5 times iuln * serum creatinine less than/equal to 1.5 x iuln. exclusion criteria: * active clinically serious infections (\> grade 2 nci-ctc version 3.0, national cancer institute-common terminology criteria for adverse events) * symptomatic metastatic brain or meningeal tumors * history of organ allograft * patients undergoing renal dialysis * chronic inflammatory bowel disease; ileus; genetic fructose intolerance * patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months * receive previously radiotherapy in measurable regions * pregnancy or lactating status * concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma * clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months * acute or subacute intestinal occlusion or history of the inflammatory bowel disease * any factors that influence the usage of oral administration

Keywords: predictive factor response gastric neoplasm oxaliplatin docetaxol capecitabine
post authorization safety profile of booster indovac covid-19 vaccination

Conditions: COVID-19

Summary: this study is post authorization safety study (pass) phase iv of booster indovac covid-19 vaccination

this study is post authorization safety study (pass) phase iv, to assess any local and systemic reaction after immunization with indovac using retrospective cohort study trial design to assess safety profile following indovac booster vaccine in healthy populations aged 18 years and above.

Eligibility criteria:
inclusion criteria: 1. clinically healthy subjects aged 18 years and above 2. subjects have been injected with indovac booster. 3. minimum 6-month interval from primary or booster covid-19 vaccination. 4. subjects have been informed properly regarding the study and signed the informed consent form. exclusion criteria: 1. subjects concomitantly enrolled or scheduled to be enrolled in another study when the subjects got indovac booster vaccination. 2. subject's telephone number is invalid or cannot be contacted.

Keywords: covid-19 indovac safety vaccine
effect of suctioning by bronchoscope on postoperative pulmonary complications among patients with sci in the pacu

Conditions: Spinal Cord Injuries

Summary: respiratory failure and dyspnea are common in spinal cord injury (sci), and in acute situations, any spinal cord lesion above t11 can cause abnormal respiratory function and impair the airway clearance. although surgical decompression is one of the key early neuroprotective therapies, surgery and general anesthesia disrupt many aspects of respiratory function and may cause a series of postoperative pulmonary complications. endotracheal suction is important to reduce the risk of lung consolidation and atelectasis. but for patients with respiratory insufficiency such as sci, ordinary suction is not enough to clear secretions in the deeper airways. and repeated intratracheal suction may even cause some serious complications. bronchoscopy can generally penetrate into the bronchus of grade 3-4, and fully attract the secretions in it under visual conditions. its curative effect on pneumonia and atelectasis in the icu has been affirmed, but no one has yet explored the application in the postoperative care unit .

all patients admitted to pacu with tracheal tube after operation will be recruited, and than be randomly divided into two groups during resuscitation: 1. one group receives routine ordinary sputum suction ; the other group receives routine ordinary sputum suction with bronchoscopy 2. after entering the pacu, both groups will receive two lung ultrasound examinations and record the lung ultrasound scores: when entering pacu and when leaving pacu. after returning to the ward, the doctor in charge will make medical decisions and treatments based on the condition. follow up for pulmonary complications (respiratory tract infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, pulmonary edema, pulmonary embolism, aspiration pneumonia) within 7 days after surgery. follow-up 30 days and 90 days after operation.

Eligibility criteria:
inclusion criteria: - age\>=18 spinal injury level :above t11 stable preoperative spontaneous respiration elective cervical/thoracic spine fixation american spinal injury association (asia) class: a-d exclusion criteria: - unconscious before surgery pregnant with mental disorders directly transfered to icu
effect of stevia leave powder on blood glucose and lipid profile of diabetic patients

Conditions: Diabetes

Summary: the goal of this clinical trial is to know if stevia leave powder capsule (1000 mg/day) will work to treat diabetes in participants. the main objectives it aims to answer are: does stevia decrease the blood glucose level in diabetic subjects that will use stevia powder capsule? does stevia play its role in blood lipid profile in diabetic subjects that will use stevia powder capsule? the purpose of the study to see the impact of stevia in short (7 days) and long-term treatments (60 days) in diabetic subjects and compare the results diabetic subjects will: take stevia powder capsule every day for 7 days in short term study take stevia powder capsule every day for 60 days in long term study check the biochemical assessment including blood glucose and lipid profile tests at 0 and 7th days in short term study check the biochemical assessment including blood glucose and lipid profile tests at 0 and 30 and 60th days in long term study keep a record of all the tests for comparison

the selected participants will be randomly divided into placebo and treatment groups. the initial (0-day) data on anthropometric measurements and blood analysis on glucose, lipid levels and liver function tests (lfts) will be carried out. the balance diet plan will be prepared according to pakistan dietary guidelines and given to all the study participants. treatment stevia powder capsules will be provided to the participants for 7 days and for 60 days for short and long-term study respectively, for monitoring of compliance. anthropometric measurements and biochemical assessments like blood glucose levels, lipid profile, insulin resistance and lfts for short-term study will be measured at baseline, 7th and 60th day while, measurements of blood glucose, lipid profile, insulin resistance and lfts will be carried out a baseline, 30, and 60 days for long-term study. in this research we will be analysed the effect of stevia powder capsules on diabetic patients for short and long term study.

Eligibility criteria:
inclusion criteria: inclusion criteria: individuals with the following conditions will be included as participants; * patients of type 2 diabetes mellitus with the age range between 25-35 years from both genders * diabetic patients without anti-diabetic drugs and their duration of diabetes no longer than 6 months * diabetic patients with hba1c \&gt;6% and blood sugar level \&gt;200 mg/dl exclusion criteria: individuals with the following conditions were not included as participants; * patients with nephropathy, retinopathy, diabetic foot, phenylketonuria, maple syrup urine disease * participants with acute and chronic kidney disease, kidney stone, * participants with history of acute liver injury (e.g., hepatitis) or severe cirrhosis * diabetic patients with obesity, cardiovascular diseases, pregnancy * participants taking nutritional supplements and other medicines

Keywords: diabetes stevia glucose lipid profile
a prospective trial to reduce post-operative pain in implant based breast reconstruction

Conditions: Post-operative Pain

Summary: the investigators hypothesize that in mastectomy patients with breast reconstruction, the addition of bupivacaine and botulinum toxin (bt) will result in better pain control in the acute and chronic setting, compared to traditional pain management techniques which rely almost exclusively on opioid analgesics and sedatives like diazepam (valium). this expectation is based on the fact that bupivacaine produces pre-emptive analgesia and bt will produce muscle relaxation, the combination of which will target different sites of pain generation, thus producing better analgesia. we also hypothesize that additional benefits may accrue from this regimen including decreased nausea and vomiting, sedation and constipation as a result of diminished opioid use1.


Eligibility criteria:
inclusion criteria: * women undergoing immediate unilateral or bilateral tissue expander breast reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy requiring postoperative expansions * women undergoing immediate bilateral tissue expanders breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy requiring postoperative tissue expansions. exclusion criteria: * subjects who are unable to read or speak english; * breast reconstruction using the latissimus dorsi flap combined with a tissue expander; * documented diagnosis of chronic pain, chronic migraine, upper limb spasticity, cervical dystonia, axillary hyperhidrosis, strabismus or blepharospasm; * hypersensitivity to any botulinum toxin (bt) preparation or to any of the components in the formulation; * infection at the proposed site of injection; * pre-existing neuromuscular disorders (including diagnosed myasthenia gravis, eaton-lambert syndrome, or amyotrophic lateral sclerosis); * aminoglycosides intake at the time of surgery (these antibiotics can potentiate the effect of bt); * women who are pregnant or breast feeding.

Keywords: pain breast cancer breast implant breast reconstruction
the effect of cpap on maternal and infant outcomes in pregnant women with osas

Conditions: Maternal Hypertension

Summary: the goal of this clinical trial is to learn about the impact of cpap on the maternal and infant outcomes of women with obstructive sleep apnea syndrome. the main questions aim to answer are: \[question 1\]explore the impact of different cpap treatment times on the maternal and infant outcomes of pregnant women with combined osas; \[question 2\]explore the effects of cpap on placental weight and birth weight/placental weight ratio in osas pregnant women. the cpap treatment group received standardized cpap treatment and routine prenatal care, while the non cpap treatment group and non osas group only received routine prenatal care.

selecting high-risk osas pregnant women who underwent sleep breathing monitoring at 24-28 weeks of pregnancy and were registered in the obstetrics and gynecology department of peking university people's hospital from january 2024 to december 2025 as the study subjects, collecting baseline data, following up on the study subjects until delivery, collecting cpap treatment time, maternal and infant outcome related indicators, and placental weight. assessing high-risk factors for osas during prenatal checkups for pregnant women: symptoms, signs, clue diseases, epworth scale; select pregnant women who meet the high-risk factors for osas at 24-28 weeks and collect their baseline data and ess scores; sleep breathing tests were performed on high-risk osas pregnant women aged 24-28 weeks, and their ahi, odi, and sao2 were recorded; set ahi ≥ 5 times/h as the osas group, with those receiving standard cpap treatment being the cpap treatment group, those refusing cpap treatment being the non cpap treatment group, and ahi\ =6.0mmol/l, be\<-12mmol/l); analyze the placental weight and birth weight/placental weight ratio in the cpap treatment group, control group, and non osas group.

Eligibility criteria:
inclusion criteria: * (1)pregnant women at 24-28 weeks of gestation * (2)apnea hypopnea index (ahi) ahi ≥ 5 times/h exclusion criteria: * (1)multiple pregnancies or fetal malformations * (2)severe mental illness * (3)severe heart and lung disease or liver and kidney disease * (4)previous diagnosis of osas * (5)other sleep disorders

Keywords: gestational hypertension
personalised prevention of microbiological homeostasis in the oral cavity during fixed orthodontic treatment

Conditions: Orthodontics

Summary: oral dysbiosis systematically develops during orthodontic treatment \[35\]\[36\]. orthodontic appliances interfere with oral hygiene procedures and cause biofilm to accumulate, creating new retention zones, even in subjects who maintain correct oral hygiene \[37\]: * a group benefiting from intensive personalised prevention * a "conventionally monitored" group, with no personalised prevention. the hypothesis is that personalised prevention prevents dysbiosis from taking hold. if this hypothesis is confirmed, the concept could be extended to all patients, beyond orthodontics. based on the "biological signature" (microbiological and immune), a "risk profile" of patients could be defined, making it possible to better personalise the prevention message, the method applied and the frequency of follow-up. the aim would be to rebalance dysbiosis through a personalised prevention approach tailored to the profile defined. it was decided to explore this hypothesis initially with orthodontic patients because they are "captive", i.e. in the course of treatment requiring regular visits. prevention is aimed first and foremost at healthy patients, with the aim of maintaining them in good health. the project focuses on young patients undergoing orthodontic treatment


Eligibility criteria:
inclusion criteria: * patients aged 12 to 20 (permanent dentition) requiring fixed orthodontic treatment. exclusion criteria: * tobacco; * overcrowded restorations, untreated caries, * lack of tooth mineralisation; * medical pathologies; * known immunodepression (congenital or acquired); * taking a treatment that may induce general immunodepression; * taking a probiotic; * taking a concomitant treatment that may interact with oral health

Keywords: oral dysbiosis orthodontics oral microbiotis
comparing analgesic regimen effectiveness and safety for surgery for kids trial

Conditions: Surgery; Pain, Post Operative

Summary: this trial is being completed to compare two commonly used options to treat pain after discharge from surgery. participants that undergo tonsil removal, gallbladder removal, and knee scope will be eligible to enroll. eligible participants will be randomized to prescription of 1 of 2 groups of medications (non-steroidal anti-inflammatory drugs (nsaids) plus acetaminophen or low dose opioids with the nsaids plus acetaminophen. the key question the study seeks to answer is which option will have the best outcomes and with the fewest side effects?


Eligibility criteria:
inclusion criteria: * no significant analgesic medication use before surgery as defined in the protocol * undergo one the following: elective tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), and knee scope (arthroscopy). exclusion criteria: * anticipated other surgery within 12 months * anticipated life expectancy of \<12 months * those that have legal guardians (due to special permission to enroll in trials) * participants with complex chronic conditions per the pediatric medical complexity algorithm (e.g., trisomy 21) * patients with contraindications to non-steroidal anti-inflammatory drug (nsaid) drugs in the nsaid arm, opioid drugs in the opioid arm, or acetaminophen will be excluded. * liver disease * acute psychiatric instability (defined as current uncontrolled severe depression, severe post-traumatic stress disorder (ptsd), or suicidal ideation), substance use disorder not in remission or treatment, and history of diversion of controlled substances (opioids)

Keywords: medications after surgery nsaids acetaminophen opioids analgesics, non-narcotic tonsil removal gallbladder removal knee scope analgesics, opioid
edoxaban for tia and acute minor stroke

Conditions: Ischemia; Stroke; Cerebral Infarction

Summary: transient ischemic attack (tia) or minor ischemic stroke has a high risk of early recurrent stroke. as the golden standard, aspirin effect modestly on acute ischemic stroke, and slightly increase the risk of intracerebral hemorrhage. recently, edoxaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying significantly less risk of intracranial hemorrhage. this trial is a randomized, double-blind, multicenter, controlled clinical trial in china. the investigators will assess the hypothesis that a 30-days edoxaban regimen is superior to aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event.


Eligibility criteria:
inclusion criteria: * adult subjects (male or female ≥18 years old) * acute nondisabling ischemic stroke (nihss ≤3 at the time of randomization) that can be treated with study drug within 24 hours of symptoms onset. symptom onset is defined by the "last see normal" principle * tia (neurologic deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with investigational medication within 24 hours of symptoms onset. symptom onset is defined by the "last see normal" principle * informed consent signed exclusion criteria: * diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major nonischemic brain disease, on baseline head ct or mri scan * mrs score \>2 at randomization (premorbid historical assessment) * nihss ≥4 at randomization * clear indication for anticoagulation (atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism or known hypercoagulable state) * contraindication to investigational medications * thrombolysis for ischemic stroke within preceding 7 days * history of intracranial hemorrhage * current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anticoagulation * gastrointestinal bleed or major surgery within 3 months * planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months * tia or minor stroke induced by angiography or surgery * severe noncardiovascular comorbidity with life expectancy \<3 months * women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test result * severe renal failure, defined as glomerular filtration rate (gfr) \<30 ml/min -severe hepatic insufficiency (child-pugh score b to c)

Keywords: edoxaban aspirin new oral anticoagulant tia acute minor ischemic stroke
efficacy of treatment intensification with maraviroc on hiv-1 viral latency in recently infected hiv-1 naïve patients starting raltegravir plus tenofovir/emtricitabine

Conditions: HIV Infections

Summary: the intensification with maraviroc in recently hiv-1-infected patients of a preferred gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could accelerate the decay of the hiv-1 reservoir in latently infected cells established early in hiv-1 infection. this could provide further insight into this area, decrease the size of latent reservoir, and translate into clinical benefits for patients.

a reservoir of latently infected cells established early in infection may be involved in the maintenance of viral persistence despite continuous highly active antiretroviral therapy (haart). this is likely to represent the major barrier to virus eradication in patients on successful combination antiretroviral therapy. the majority of the viruses in the latent reservoir use ccr5 receptor during entry. more recently, clear evidences for decay of this hiv-1 reservoir in patients who initiated antiretroviral therapy early in infection have been demonstrated. the treatment of acute infection may set the stage for subsequent attempts at eradication. to achieve this, more potent antiretroviral therapy and/or more potent antilatency therapies may be needed. in contrast to previous antiretroviral drugs, maraviroc does not need to cross the cell membrane, nor does not require intracellular processing in order to exert its activity. in addition, there is no cross-resistance between entry inhibitors and agents that act on intracellular targets. maraviroc has demonstrated potent antiviral activity against all ccr5-tropic hiv-1 viruses tested. maraviroc could thus fulfil the requirements for an optimal candidate for treatment intensification in hiv-1 infected patients with a recent hiv-1 infection.

Eligibility criteria:
inclusion criteria: 1. hiv-1 infected adults (\>=18 years old). 2. no previous antiretroviral therapy for more than 2 weeks. 3. hiv-1 infection documented in the past 6 months by a previous negative elisa test, or a documented clinical acute seroconversion in the past 6 months. 4. ccr5-tropism confirmed at screening. 5. voluntary written informed consent. exclusion criteria: 1. pregnancy or fertile women willing to be pregnant. 2. active substance abuse or major psychiatric disease. 3. presence of nrti mutations in the screening genotype.

Keywords: maraviroc ccr5 antagonists primary hiv infection hiv-1 reservoir eradication treatment naive