Kornimate/medical-research-clean huggingface dataset:
impact of lazertinib dose modification on effectiveness and safety

Conditions: Non-small Cell Lung Cancer

Summary: the primary objective is to evaluate progression free survival (pfs) of the group (160 mg group) in which dose reduction was performed for 12 weeks after the first administration of lazertinib. the secondary objectives of this study are as follows. 1. to evaluate progression-free survival (pfs) of the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of lazertinib 2. in the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of lazertinib, time-to-treatment discontinuation(ttd), objective response rate(orr), disease control rate(dcr), tumor shrinkage and overall survival(os) is evaluated. 3. in the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of lazertinib, specific reasons (adverse event name, grade, etc.) according to lazertinib dose adjustment is evaluated. 4. to evaluate the treatment profile of lazertinib including duration of treatment, dose adjustment, and reason for discontinuation of treatment. 5. to evaluate the safety of lazertinib in the 240 mg and 160 mg groups

this study is a prospective multi-center observational study, and 11 institutions will participate to enroll 200 subjects competitively. we will evaluate the efficacy and safety of lazertinib according to maintenance of the 240mg dose and reduction of the 160mg dose for 12 weeks after the first administration of lazertinib in non-small cell lung cancer patients confirmed to be t790m mutation-positive after treatment failure with first- or second-generation egfr-tkis. the study period is up to 3 years from the date of irb approval. follow-up is 2 years from the last subject enrollment, and data will be collected through periodic medical record review during lazertinib administration for enrolled subjects.

Eligibility criteria:
inclusion criteria: 1. patients who agreed in writing to participate in this study 2. adult men and women over 20 years of age 3. patients with locally advanced or metastatic, recurrent non-small cell lung cancer with egfr mutation (based on ajcc 8th edition) 4. patients with confirmed disease progression after 1st or 2nd generation egfr-tki treatment 5. patients scheduled to receive lazertinib after t790m mutation was confirmed positive in tissue or plasma exclusion criteria: 1. patients who are receiving or have already completed lazertinib 2. patients whose life expectancy is less than 12 weeks

Keywords: nsclc egfr-tki lazertinib
weight loss effects of m-health app in obesity multidisciplinary outpatient clinic

Conditions: Obesity; m-Health; NAFLD

Summary: this is a randomized, open, controlled, single-center trial to identify the weight loss effects of adding mobile health application in obesity multidisciplinary outpatient clinic.

this is a randomized, open, controlled, single-center trial to identify the weight loss effects of adding mobile health application in obesity multidisciplinary outpatient clinic. the team of obesity multidisciplinary outpatient clinic includes endocrinologists, dietitians, and exercisers. the endocrinologist assesses the patients' conditions, manages the patients, and decides on appropriate medications. dietitians participate in dietary propaganda and education, and develop personalized diet prescriptions. exercisers conduct behavior and exercise propaganda, and issue personalized exercise prescriptions. patients in the experimental group combine m-health app with routine obesity clinic management. the m-health app could help patients set weight loss targets, record body weights online, learn the calories they consumed in real time, and exercise based on the prescriptions suggested by the exercisers.

Eligibility criteria:
inclusion criteria: * between 18 and 65 years old; * 24kg/m\^2 ≤ bmi \< 37.5kg/m\^2; * proficient in using mobile applications; * agree to sign the informed consent exclusion criteria: * secondary obesity (such as hypothyroidism, cushing's syndrome, hypothalamic obesity or long-term use of obesity-causing drugs, etc.); * patients with chronic diseases that require special diet and affect exercise; * patients suffering from severe liver, kidney or heart dysfunction; * patients with a history of malignant tumor; * pregnant or lactating women; * low level of education or illiteracy; * inability, unwillingness, or refusal to comply with study requirements (including lifestyle adjustments, follow-up, and subject duties)

Keywords: obesity nafld m-health
microbial community characteristics in intestinal mucosal tissue of patients with cd

Conditions: Crohn&#39;s Disease (CD)

Summary: the characteristics of the intestinal microbiota in crohn's disease and their relationship with disease pathogenesis have not yet been fully elucidated. therefore, this study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of crohn's disease patients and fill this knowledge gap. additionally, this research holds significant importance for understanding the etiology of crohn's disease and predicting treatment outcomes.


Eligibility criteria:
inclusion criteria: * patients with crohn's disease undergoing endoscopic examination * healthy individuals with no symptoms undergoing colonoscopy without any lesions detected * patients undergoing small intestinal endoscopy due to symptoms but with negative examination results. * age between 18 and 80 years. * patients or authorized family members sign the relevant informed consent forms. exclusion criteria: * patients with concurrent digestive system diseases that may affect the study results, including tumors, infections, or other autoimmune diseases. * patients with concurrent non-digestive system diseases that may affect the study results, including tumors, infections, or autoimmune diseases. * patients who have taken probiotics or antibiotics within the past week. * patients with psychiatric disorders or other conditions that prevent them from cooperating with the study. * patients participating in other clinical trials that may interfere with the results of this study.
tanezumab and nerve function in arthritis patients

Conditions: Osteoarthritis

Summary: tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves.

this study was terminated on 16 nov 2010 following a us fda clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 june 2010 for potential safety issues.

Eligibility criteria:
inclusion criteria: * bmi less or equal to 39 kg/m2 * osteoarthritis (arthritis) of the knee or hip with pain score that qualifies * willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method. * patients must consent in writing to participate in the study. exclusion criteria: * untreated, uncontrolled diseases, * unwilling or unable to discontinue the use of prohibited medications, including other pain medications, during the screening period and during the study, * significant cardiac disease within the past 6 months * significant neurological disease (e.g. peripheral neuropathy, multiple sclerosis, stroke) or signs of neuropathy at screening * known bleeding disorder or anticoagulation therapy * planned surgery during the study period * history of alcoholism or drug abuse in the past 2 years * unable to use acetaminophen * use of a biologic (including live vaccines, with the exception of flumist) within the past 3 months * allergic reaction to a biologic or an antibody in the past * disqualifying laboratory values, including hepatitis b or c, hiv or drug test * cancer in the past 5 years. basal cell or squamous cell carcinoma are okay. * medical condition that may interfere with study endpoints or safety of the subject as determined by the investigator.
markers of bone disease in children on parenteral nutrition

Conditions: Metabolic Bone Disease

Summary: parenteral nutrition (pn) is the provision of nutrients via the intravenous route. parenteral nutrition associated metabolic bone disease (mbd) was first described in children in the 1980s. since then, there has been little to no research into the underlying relationship and as a result, little evidence on which to base clinical care. in adults, mbd is associated with increased fractures. at the hospital for sick children in toronto, an intestinal failure program has been set up since 2003. this is the only intestinal failure program in canada and receives country wide referrals. most of the patients have short bowel syndrome (sbs) and require pn for prolonged periods, or for life. about 90% of these patients have mbd, and some have had bone fractures. an understanding of the etiology of mbd would provide information to guide care, and prevent this condition. funding for this area of research however is challenging because intestinal failure requiring long term pn is a rare condition, accounting for approximately 200 - 300 children in all of canada. the goal of this study therefore is to gather pilot data on markers of mbd in children on long term pn, and to compare these markers to age and gender matched control patients who are fed by mouth or feeding tube. the information gathered from this study will help us begin to understand what is actually happening in the bones of children on long term pn and will form the basis for future studies and improved clinical care.


Eligibility criteria:
inclusion criteria: for cases on long-term pn: 1. on pn for ≥ 6 consecutive weeks 2. willingness to participate in the study for control subjects: 1. healthy as assessed by history and physical exam. 2. growing normally 3. are not on medications known to affect bone metabolism eg. corticosteroids. 4. never received pn in the past exclusion criteria: for cases on long-term pn 1. patients who are on pn for shorter than 6 weeks 2. patients on hemodialysis for control subjects 1. subjects who are not able to be matched to a case/subject on long-term pn for age and gender 2. positive history of fractures 3. subjects who are unable to participate because of fear of giving blood or unable to come to the hospital for sick children for blood draws.

Keywords: pediatric parenteral nutrition bone disease long-term pn
safety, tolerability and efficacy of a vaccine against essential hypertension

Conditions: Mild Essential Hypertension; Moderate Essential Hypertension

Summary: the study medication cyt006-angqb is a vaccine, consisting of angiotensin ii (ang ii), the naturally occurring octapeptide coupled onto the surface of virus-like particles (vlp). this form of presenting ang ii to the immune system induces a b-cell mediated immune response characterized by the generation of specific antibodies (igg and igm) against ang ii. the cyt006-angqb vaccine is administered by subcutaneous (s.c.) injection. immunization against angiotensin ii may offer a valuable alternative to conventional drugs for the treatment of hypertension.


Eligibility criteria:
inclusion criteria: * patients with mild to moderate essential hypertension (grade i and grade ii) with mean sitting office sbp =140-179 mmhg and/or mean sitting office dbp = 90 -109 mmhg on 2 consecutive visits (screening and v1). * daytime blood pressure above threshold for definition of hypertension in the baseline abpm measurement (sbp \>135 mmhg). * stable baseline blood pressure confirmed on 2 consecutive visits (screening and v1). (changes \<20mmhg for sitting office sbp and \<10mmhg for mean sitting office dpb). * patients without current antihypertensive therapy. patients on previous mono-antihypertensive therapy, who can safely stop their medication * patient is willing and able to comply with all trial requirements and procedures. exclusion criteria: * patients with "very high added risk" according to 2007 guidelines for the management of arterial hypertension (journal of hypertension, 2007, 25:1105- 1187), i.e. those with:grade iii hypertension (mean sitting office sbp * 180mmhg and/or meansitting dbp ≥110mmhg/history or presence of established cardiovascular or renal disease (ischemic stroke, cerebral hemorrhage, transient ischemic attack)/ myocardial infarction, angina pectoris, coronary re-vascularization/ clinically relevant heart failure (nyha class ii-iv)/ peripheral artery disease/ diabetic nephropathy * electrocardiographic confirmed left ventricular hypertrophy * increased plasma creatinine * diabetes mellitus type i, history, presence or new diagnosis of diabetes mellitus type ii. * postural hypotension at screening * arrhythmias that would interfere with the oscilloscopic measurement of the blood pressure. * known autoimmune disease. * severe allergy. * pregnancy or breastfeeding. * women in childbearing age that are not surgically sterilized. * patients with a history or current positive test for hiv infection, aids, or other immunosuppressive disorders; hepatitis b or c. * current diagnosis or history of malignancy.
efficacy and safety of lanreotide microparticles as palliative treatment in peritoneal carcinomatosis

Conditions: Intestinal Obstruction; Carcinoma; Peritoneal Neoplasms

Summary: the purpose of this study is to determine whether lanreotide 30mg microparticles are effective in the relief of clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.


Eligibility criteria:
inclusion criteria: * digestive obstruction located in the upper part of the gastro-intestinal tract * digestive obstruction of malignant origin * peritoneal carcinomatosis confirmed by a ct scan * at least two vomiting episodes per day or a presence of a nasogastric suction tube * inoperable patients exclusion criteria: * specific anticancer therapy within the previous 15 days * signs of bowel perforation * somatostatin or any analogue as treatment of the bowel obstruction

Keywords: carcinomatosis
ultra protective ventilation without extracorporeal circulation in severe ards patients (vt4ards)

Conditions: Acute Respiratory Distress Syndrome

Summary: despite the use of protective ventilation, neuromuscular blocking agent and prone position, ards mortality remains high (30%-50%) in observational studies, and pneumothorax rate in randomized controlled trial remains stable (10%). the driving pressure (the ratio of tidal volume over respiratory system compliance) has recently been strongly associated with ards mortality, suggesting that tidal volume reduction below 6ml/kg may offer mortality benefit. while extracorporeal co2 removal technique are currently under investigation in association with tidal volume reduction


Eligibility criteria:
inclusion criteria: * invasive mechanical ventilation * ards (berlin definition) with pao2/fio2 ratio ≤ 150 mm hg exclusion criteria: * age below 18 year * planned duration of invasive mechanical ventilation \< 48 hours * ards criteria present for more than 24 hours * known or suspected intracranial hypertension * known or suspected copd * chronic respiratory failure under long term oxygen or non-invasive ventilation * pneumothorax or broncho-pleural fistula * morbid obesity with body weight \>1 kg/cm height * sickle cell disease * recent bone marrow transplantation, aplasia following chemotherapy * burn injury on more than 30% of body surface * severe hepatic cirrhosis (child-pugh score c) * extracorporeal circulation life support * pregnancy * advance directives to withhold or withdraw life-sustaining treatment * previous inclusion in present study * patient under an exclusion period following inclusion in another biomedical study * patient deprived of freedom, minor, subject under a legal protective measure * lack of affiliation to social security as required by french regulation * lack of written informed consent by patient or next of kin
study to evaluate the safety and effects azd0530 on prostate and breast cancer subjects with metastatic bone disease

Conditions: Breast Cancer; Prostate Cancer; Bone Neoplasms

Summary: the purpose of this study is to determine the effect of azd0530 on subjects with breast cancer or prostate cancer with metastatic bone disease in comparison to zoledronic acid.


Eligibility criteria:
inclusion criteria: * subjects 18 years or older with prostate cancer or breast cancer with metastatic bone disease have evidence of recurrence or disease progression * at least one radiographically confirmed metastatic bone lesion * no change of cancer therapy for at least 8 weeks before randomization exclusion criteria: * have had any prior exposure to bisphosphonate * have had hip fractures or bilateral hip prothesis fracture of any kind or surgery to bone within the past 12 months * inadequate renal function or low haemoglobin * inadequate liver function as demonstrated by serum bilirubin ≥2 times the upper limits of reference range (ulrr) or by alanine aminotransferase (alt), aspartate aminotransferase(ast) or alp ≥2.5 times the ulrr (≥5 times the ulrr in the presence of liver metastases). if bone metastases are present and liver function is otherwise considered adequate by the investigator then elevated alp will not exclude the patient.

Keywords: breast cancer prostate cancer metastatic bone disease subjects with breast cancer or prostate cancer with metastatic bone disease
a long-term study to evaluate safety and efficacy of pregabalin for postherpetic neuralgia

Conditions: Neuralgia, Postherpetic

Summary: to evaluate the safety of the long-term use of pregabalin.


Eligibility criteria:
inclusion criteria: * patients who completed the 13-week treatment of postherpetic neuralgia in study a0081120. * patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study. exclusion criteria: * patients who experienced serious adverse events in the preceding study (a0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication. * patients exhibiting treatment non-compliance in the preceding study (a0081120)
low dose naltrexone for the treatment of juvenile primary fibromyalgia syndrome

Conditions: Fibromyalgia

Summary: the purpose of this research is to obtain data or information on the safety and effectiveness of low dose naltrexone (ldn) for treating the symptoms of juvenile primary fibromyalgia syndrome. this is a dose finding study to find whether ldn helps the symptoms of juvenile fibromyalgia, and at what dose it does so.

in this pilot dosage-finding and efficacy study, we will experimentally test whether ldn reduces the symptoms of jpfs. we will recruit 40 children with jpfs. participants will be screened via the jpfs criteria of yunus and masi. the study will be an open-label test of various doses of ldn to determine whether ldn reduces jpfs symptoms, and the appropriate dose at which it does so. primary endpoints will be daily pain, fatigue, and sleep. the protocol is designed to take 18 weeks. there are a total of 10 study visits, taking place approximately every 2 weeks.

Eligibility criteria:
inclusion criteria:1. generalized musculoskeletal aching for over 3 months duration 2. moderate-severe pain in 5 of 11 tender points 3. age 7 - 17 4. male or female exclusion criteria:1. diagnosed rheumatic or autoimmune condition contributing to pain 2. abnormal laboratory results (rf, ana, esr) 3. use of opioid analgesics in the last 6 months 4. severe depression and/or anxiety as evidenced by a diagnosis of either disorder, or by evidence based on a clinical interview with the patient and parent at the time of screening. 5. current or previous psychiatric disorder requiring hospitalization 6. inability to operate palm os® handheld device for self-reports 7. inability to understand english 8. inability to attend sessions at stanford lab every 3 weeks 9. pregnancy or planned pregnancy, or breastfeeding 10. abnormal liver functioning tests
study evaluating the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vpnc)

Conditions: Pneumococcal Infections

Summary: this study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vpnc and 23vps in older, healthy subjects who have previously received a dose of 23vps at least 5 years ago. it will also evaluate the safety, tolerability and immunogenicity to a dose of 13vpnc 1 year after the initial dose of study vaccine.


Eligibility criteria:
inclusion criteria: * male or female aged 70 years or older. * documented vaccination with 1 dose of 23vps at least 5 years previous. * healthy. exclusion criteria: * receipt of more than one dose of 23vps prior to enrollment. * history of severe adverse reaction to a vaccine. * immunodeficiency.
dendritic cell vaccination in patients with advanced colorectal cancer

Conditions: Colorectal Neoplasms

Summary: dendritic cells loaded with tumor antigens induce cytotoxic t-cells which have been proved capable of killing both melanoma and breast cancer cells. melanoma and colorectal cancer cells express some common antigens. hence it is possible to use melanoma lysate to load the dendritic cells with tumor antigens similar to the antigens expressed by the patients' colorectal cancer cells. the patient receives 10 vaccinations with 14 days between each. the parameters for effect are changes in tumor/metastasis size measured with computed tomography (ct), decrease in serum concentration of carcinoembryonic antigen (cea), performance status measured by the world health organization (who) criteria, and quality of life.


Eligibility criteria:
inclusion criteria: * verified cancer of colon or rectum * no chemo- or radiation therapy in 6 weeks * performance status 0, 1, or 2 (who criteria) * adequate function of the kidneys, liver, lungs, and heart * adequate function of the hematopoietic system and the coagulation system * negative pregnancy test and adequate birth control for fertile women exclusion criteria: * pregnancy * uncontrolled infection

Keywords: dendritic cells antigens, neoplasm
impact of regional anesthesia on blood pressure in lower limb traumatism

Conditions: Fracture, Ankle; Fracture Leg

Summary: this study aims to compare the hemodynamic impact of two anaesthetic strategies 'regional anesthesia' versus 'general anesthesia' in leg and ankle fractures surgery.

leg and/or ankle surgery is frequently performed under general anesthesia (ga). ga is frequently associated with a high risk of hypotension with significant consequences. regional anesthesia could be an interesting alternative to ga in order to limit hemodynamic consequences, especially in elderly patients. furthermore, in the current state of covid 19 crisis, regional anesthesia could provide solutions in preserving drugs for ga and exposing less medical staff on patient's airway. currently, unlike neuraxial anesthesia, few data deal with impact of peripheral ra and hemodynamic consequences. the investigators hypothesize that the use of regional anesthesia reduces the use of intraoperative vasopressor. after ethical committee approval, a retrospective cohort of patients with lower limb traumatism, in montpellier's university hospital, was analyzed from 2016 to 2020. an informational note was given to all patients participating to the study.

Eligibility criteria:
inclusion criteria * asa i - iv * ankle and/or leg fracture * operated between january 2016 and december 2020 at montpellier exclusion criteria - age \< 18 years

Keywords: surgery for ankle and/or leg fracture