Kornimate/medical-research-clean huggingface dataset:
a phase ib study of jmkx001899 in combination with other therapies in advanced nsclc harboring kras g12c mutation

Conditions: NSCLC (Advanced Non-small Cell Lung Cancer)

Summary: this is a phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of jmkx001899 in combination with in10018 or in combination with chemotherapy or in combination with in10018 and chemotherapy in subjects with locally advanced or metastatic nsclc with kras g12c mutation.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically documented stage iiib or iiic nsclc disease not amenable for surgical resection or definitive chemoradiation or stage iv nsclc disease. 2. known kras g12c mutation, and negative results for other driver genes with approved targeted therapies. 3. measurable disease according to recist 1.1. 4. an eastern cooperative group (ecog) performance status of 0 or 1. 5. adequate organ function. exclusion criteria: 1. subjects with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (cns) metastases or leptomeningeal metastases are not yet controlled. 2. prior chemotherapy, radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin c; within 2 weeks of small molecule targeted therapies, traditional medicine with anticancer indication). 3. history of prior malignancy in the past 3 years, with the exception of curatively treated malignancies. 4. gastrointestinal (gi) tract disease causing the inability to take oral medication or affect drug absorption.
efficacy and safety of antiplatelet therapy after endovascular aortic repair

Conditions: Abdominal Aortic Aneurysms (AAA); Endovascular Aneurysm Repair (EVAR)

Summary: this study was a target trial emulation using the national health claims database established by the korean national health insurance service (k-nhis). 8,325 patients were included.

among these patients, any patients who were prescribed sapt or dapt at the date of discharge from the index hospitalization for standard evar were defined as being in the sapt group (n=4,162) and the dapt group (n=4,163), respectively.

Eligibility criteria:
inclusion criteria: * all patients who underwent evar for aaa and were successfully discharged exclusion criteria: * patients who had experienced a myocardial infarction * patients who had experienced a stroke * patients who had experienced percutaneous coronary intervention * patients who had history of peripheral disease * patients who had major bleeding event within 1 year of admission * those prescribed non-vitamin k antagonist oral anticoagulant or warfarin * patients who did not prescribe any antiplatelet therapy

Keywords: abdominal aortic aneurysms (aaa) endovascular aneurysm repair (evar) single antiplatelet therapy dual antiplatelet therapy
osteosarcopenia and exercise

Conditions: Sarcopenia; Osteoporosis, Osteopenia

Summary: the purpose of this study is to assess the efficacy of combination of aerobic and resistive exercise on activities of daily living and risk of fall in osteosarcopenic patients

after being informed about the study and potential risk, all patients giving written informed consent will undergo study entry. to begin with: assessment with bioelectrical body composition analyzer and first exercise and assessment clinical scales 1th month: assessment with bioelectrical body composition analyzer and assessment clinical scales 3th month: assessment with bioelectrical body composition analyzer and assessment clinical scales

Eligibility criteria:
inclusion criteria: * over 70 years of age * clinical diagnosis of osteoporosis or osteopenia * independent mobilization * walking speed \< 0.8 m / sec * grip strength \< 20 kg for women, \< 30 kg for men exclusion criteria: * uncontrolled hypertension (systolic blood pressure\> 200 mmhg, diastolic blood pressure\> 110 mmhg) * uncontrolled diabetes mellitus * stroke, hip fracture, knee and hip arthroplasty, spinal surgery in the last 6 months * severe cardiac arrhythmia * myocardial infarction in the last 6 months * severe dementia and difficulties in cooperation * cardiac pacemaker * dialysis * acute infection * severe edema * malignancy patients * severe anemia (hgb \<8 mg / dl)

Keywords: aerobic exercise resistive exercise balance falling physical performance osteosarcopenia
continuous versus bolus infusion of terlipressin for portal hypertension related bleeding in liver cirrhosis

Conditions: Liver Cirrhosis; Portal Hypertension; Variceal Hemorrhage; Bleeding; Esophageal and Gastric Varices

Summary: terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver cirrhosis. according to the drug instructions, intravenous bolus infusion is the standard approach of terlipressin. it remains unclear about whether or not continuous infusion of terlipressin should be considered.

although intravenous bolus infusion of terlipressin is the standard approach, continuous infusion of terlipressin is preferred in clinical practice. the present study is a pilot non-randomized controlled trial to explore the feasibility and safety of continuous infusion of terlipressin for the treatment of acute variceal bleeding in liver cirrhosis.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of liver cirrhosis; 2. child-pugh b or c; 3. acute gastroesophageal variceal bleeding; 4. written informed consents. - exclusion criteria: 1. no liver cirrhosis; 2. child-pugh class a; 3. acute upper gastrointestinal bleeding unrelated to varices; 4. use of somatostatin or octreotide. -
the cancer home life intervention study. a randomised, controlled multicentre trial and a health economic evaluation

Conditions: Activities of Daily Living; Everyday Activities; Palliative Care; Cancer; Quality of Life

Summary: the purpose of this study is to examine the effectiveness and cost-effectiveness of the cancer home life intervention compared to usual care on performance of and participation in everyday activities and quality of life in people with advanced cancer living at home.

the sample size is based on the primary outcome measure: the mean activty of daily living (adl) motor ability 1.04 logits (sd 0.727) as measured by the assessment of motor and process skills (amps). a significance level of 0.05 would provide 80% power to detect a between-group difference of 0.3 logits requiring a sample size of n=184. an expected drop-out rate of 32% at 3 months follow-up means that 272 patients with advanced cancer must be included in the study from three hospitals. multiple imputation will be used to estimate a plausible value for missing data of participants that are lost to follow-up due to other reasons than death. this does not, however, apply to the primary outcome data where no estimations will be computed. for normally distributed ratio data the intervention group will be compared with the control group using multiple linear regression analysis of mean changes from baseline. logistic regression analysis will be used for ordinal data. adjustments for hospital and for baseline values will be made. a modified intention-to-treat analysis will be applied. subgroup analyses to identifiy groups that especially benefit from the intervetnion will be performed. the cost-effectiveness analysis wil be performed with adl motor ability as the clinical parameter, and the cost-utility analysis will be based on the calculation of quality adjusted life years (qaly). the incremental cost-effectiveness ratio (icer) will be calculated and the results summarised in a cost-effectiveness acceptability curve (ceac).

Eligibility criteria:
inclusion criteria: * ≥18 years old * diagnosed with cancer * evaluated incurable by responsible oncologist in respective out-patient unit * functional level 1-2 on the who performance scale * live within a radius of maximum 60 km from auh or nh or on the island of funen * live in a private home or in sheltered living * know sufficient danish to fill out questionnaires and participate in interviews. exclusion criteria: * cognitive impairment preventing the participants from participating in a structured interview * live in a nursing home or a hospice * considered incapable of complying with the trial

Keywords: occupational therapy adaptive intervention home-based assistive technology home modification clinical effectiveness cost-effectiveness cost-utility
[impedance measurement for non-erosive reflux disease

Conditions: GERD; Healthy

Summary: this study is being done to determine if people with and without gerd or trouble swallowing have increased esophageal mucosa impedance (food getting into the esophageal tissue).

in patients with gastroesophageal reflux disease (gerd) but without gross evidence of esophageal injury, confirmation of acid reflux is typically performed through testing that measures reflux at or proximal to 5 cm above the gastroesophageal junction. these tests such as ph/impedance monitoring and bravo probe placement in the esophagus have been the gold standard for diagnosing and quantitating the degree of gastroesophageal reflux. this stands in contrast to the concept that the esophagus distal to 5 cm is first and foremost exposed to gastroesophageal reflux and that most injury in the form of erosive esophagitis is seen in the 4cm segment below where this instruments measure reflux. as a result, this type of testing may not allow for full understanding of the pathophysiology of gerd. furthermore, with refluxed acid exposure limited to the distal esophagus in some patients, use of conventional ph testing could lead to inaccurate diagnosing of gerd. esophageal impedance testing measures epithelial integrity as reflected through the ability of the mucosa to conduct electric current. as dilation of intercellular spaces in biopsies from patients with gerd is considered the earliest indication of esophageal injury in response to reflux in the absence of gross endoscopic injury, the measure of increased current conduction through these dilated spaces has been shown to be an accurate means of diagnosing patients with non-erosive reflux disease. to this point, most esophageal impedance has been measured using impedance ports placed at locations similar to the ph probes in a combined intra-esophageal ambulatory catheter. as a result, the most distal point of impedance measurement is also 5 cm above the gastroesophageal junction. recently, a site specific endoscopically placed impedance probe has been developed that can measure esophageal mucosal impedance at any point of the esophagus. in this study the principal investigator would like to look at patients with and without reflux symptoms measuring impedance at 1,2,3,4 and 5 cm at the 6 o'clock position above the gastroesophageal junction.

Eligibility criteria:
inclusion criteria: * adults ages 18-90 * patients with heartburn and no hiatal hernia undergoing clinically indicated endoscopy * patients with heartburn and a hiatal hernia \> 3cm undergoing clinically indicated endoscopy * patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or gerd * patients with reflux symptoms, a normal appearing esophagus on clinically indicated endoscopy undergoing clinically indicated ambulatory ph/impedance testing. exclusion criteria: * previous gastric or esophageal surgery. * use of proton pump inhibitors 1 month prior to the study * patients on anticoagulation other than aspirin or clopidogrel * presence of erosive esophagitis or barrett's esophagus
efficacy of samsung gems-h device training in older adults

Conditions: Geriatrics

Summary: the purpose of this study is to evaluate the feasibility of using samsung robotic hip assist-based mobility intervention for older adults with frailty. the specific aims of this project are: aim 1 will investigate the feasibility of the samsung robotic hip assist-based mobility intervention on gait function, sedentary time, and fall risk. hypothesis: a 6-week robotic device-based mobility intervention will improve locomotor gait function, sedentary time, and fall risk.

twelve individuals above the age of 65 years old were recruited to participate in twelve sessions that occurred 2-3 times per week over a 4-6 week period using the gems-h. in addition to selecting individuals over the age of 65, qualifying participants also had to be able to walk with or without an assistive device for greater than ten feet. medical clearance was obtained from each participant's primary physician prior to training with the device. gait training included dynamic over-ground walking (both self-selected and fast-paced), variable conditions of multidirectional walking, and training on ramps, stairs, and obstacle negotiation. all training was done under the supervision of a trained physical therapist. the amount of assistance and resistance torque provided by the hip motors of the gems-h was personalized according to each participant's specific abilities and self-reported tolerance/comfort throughout each session. these modifications followed a training progression model of increasing resistance and decreasing assistance over the course of the twelve sessions to maximize the challenge and improve strength and endurance in each participant.

Eligibility criteria:
inclusion criteria: * they are primarily english speaking * \> 65 years of age * able to walk with or without an assistive device \>10 feet * able to obtain medical clearance from the participant's primary physician * we will not include any special populations in this study exclusion criteria: * cannot comprehend or provide inform consent * unable to fit the device within the hip frame size of310mm-380mm (approximately 12-15 inches) * other weight and length limitations that restrict the proper fit of the device * any significant neurological diagnosis impacting safe use of the device

Keywords: geriatrics gait training exoskeleton fall risk
immunostimulating interstitial laser thermotherapy in breast cancer

Conditions: Breast Neoplasms

Summary: thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. immunostimulating interstitial laser thermotherapy (imilt) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. in laboratory animals the imilt method has also been shown to induce a so called abscopal effect. this means that when one tumor is treated with imilt other, untreated, tumors also decrease in size. the immunologic response has previously been characterized in breast cancer patients after receiving imilt treatment , and presumed abscopal effects induced by imilt have also been described in a malignant melanoma patient. the purpose of this trial is to investigate the functionality and safety of the imilt treatment method in patients diagnosed with breast cancer. the treatment method has successfully been used for treatment of patients with breast cancer and malignant melanoma. treatment of breast cancer patients caused an increase of cytotoxic t lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border. regulatory t lymphocytes decreased in the regional lymph nodes. this trial is explorative, prospective, open and non-randomized. five breast cancer patients will be treated in this trial, which is estimated to be carried out during a time period of 9 months.


Eligibility criteria:
inclusion criteria: 1. have histologically confirmed breast cancer 2. hormone receptor positive or negative 3. have assessable tumour by mri or ultrasound 4. are patients deemed unfit for surgical excision of tumour under general anaesthetic. 5. have been given informed verbal and written consent for participation in the trial 6. have stable hematologic, renal and hepatic functions. exclusion criteria: 1. are known to be hiv positive 2. have active autoimmune disease 3. are on corticosteroid medication 4. have evidence of bleeding diathesis or coagulopathy.

Keywords: hyperthermia laser coagulation laser therapy induced
neoadjuvant chemoimmunotherapy in stage iiia- n2iiib non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer Stage ⅢA; Non-small Cell Lung Cancer Stage IIIB

Summary: to explore the impact of preoperative neoadjuvant immunotherapy on perioperative outcomes and long-term prognosis of locally advanced nsclc in the real world


Eligibility criteria:
inclusion criteria: * confirmed as primary lung cancer through cytology or histological examination; * ecog score of 0 or 1; ③ 18 years old or above; * received imaging examination, with a preliminary clinical staging of stage iii; * received genetic testing and tested negative for egfr mutations, alk or ros-1 fusion; ⑥ accepting preoperative neoadjuvant immunotherapy combined with chemotherapy; ⑦ receive surgical treatment after completion of neoadjuvant therapy; ⑧ the postoperative specimens were sent to the pathology department of our hospital for pathological testing, and a complete pathological report is available. exclusion criteria: * patients with combined small cell lung cancer; ② patients with severe liver/kidney dysfunction, cardiovascular disease, or systemic immune disorders; * accept other neoadjuvant treatments; ④ patients participating in any clinical trial.
long-term open-label extension trial for subjects completing the phase 3 trial of fesoterodine (sp584) for the treatment of overactive bladder syndrome

Conditions: Overactive Bladder Syndrome

Summary: this trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (spm 907) in subjects with overactive bladder syndrome. subjects completing the 12 week treatment period of sp584 had the opportunity to participate if eligibility was confirmed. they received fesoterodine 8mg with the option to reduce the dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which can be followed on an annual basis. the primary variables are long-term safety and tolerability, measured by observation and assessment of adverse events and duration on therapy. further safety variables include the assessment of laboratory parameters, changes in ecg, physical exams and measurement of residual urine. secondary efficacy variables included various parameters derived from micturition diaries and the evaluation of quality of life questionnaires


Eligibility criteria:
inclusion criteria: * overactive bladder syndrome
health behavior nudge strategies for chronic disease patients: the study of hypertension and type 2 diabetes

Conditions: Economics, Behavioral; Hypertension; Type 2 Diabetes Mellitus (T2DM); Self-management Behavior; Health Behavior

Summary: this study is conducted from the perspective of behavioral economics, where individuals often display bounded rationality in decision-making, opting for habitual choices rather than those most advantageous to themselves. nudge strategies can utilize individuals\&#39; cognitive and motivational shortcomings to influence behavior. therefore, the study first examines the decision-making biases present in patients with hypertension (hp) and type 2 diabetes mellitus (t2dm) regarding the maintenance of healthy behaviors based on individuals' bounded rationality; subsequently, it develops an intervention program to encourage healthy behaviors in hp and t2dm patients alongside nudge strategies; finally, it assesses the intervention effects of the program on blood pressure, blood glucose, and health behaviors in hp and t2dm patients.

the study was conducted in lanzhou city, gansu province, china. the research selected two communities of similar scale and level, recruiting 133 patients with hp and t2dm. a six-month quasi-experimental study was performed, where the intervention group implemented nudging strategies while the control group received standard community nursing. by measuring the patients\&#39; blood pressure and blood glucose levels, and utilizing the diabetes self-care scale, hypertension self-management behavior rang scale，patient activation measure，short-form health survey, activity of daily living scale to assess the behavioral changes in both groups, validated the intervention effect of the nudging strategy on the health behaviors of patients with hp and t2dm.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * previously diagnosed with hypertension, type 2 diabetes, or hypertension combined with type 2 diabetes * able to use mobile phones or other electronic devices * informed consent exclusion criteria: * patients who are pregnant or breastfeeding; * patients with severe diabetes, hypertension complications, or other serious illnesses; * patients with hearing or vision impairments; * patients with cognitive impairments or mental illnesses; * patients with acute complications.
effect of esomeprazole on the pharmacokinetics of oral treprostinil

Conditions: Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Summary: the purpose of this study is to evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics.

this open-label study will evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics following a single 1 mg oral dose of ut-15c sr in healthy volunteers.

Eligibility criteria:
inclusion criteria: * subject is healthy and between the ages of 18 and 55 years, inclusive, at screening. * female subjects must weigh between 45 and 100 kg, inclusive, with a bmi between 19.0-29.9 kg/m2, inclusive at screening. male subjects must weigh between 50 and 120 kg, inclusive, with a bmi between 19.0-32.0 kg/m2, inclusive at screening. * subject has a medical history, physical examination, vital signs, ecg and clinical laboratory results within normal limits or considered not clinically significant by the investigator at screening. exclusion criteria: * subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ecg, or laboratory examinations. * subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug. * subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.

Keywords: hypertension, pulmonary treprostinil pharmacokinetics treprostinil diethanolamine pulmonary arterial hypertension esomeprazole