Kornimate/medical-research-clean huggingface dataset:
a study of the pharmacodynamic effects of anti-vascular endothelial growth factor therapy in patients with advanced malignancies

Conditions: Advanced Malignancy

Summary: the well-established role of vascular endothelial growth factor (vegf) in carcinogenesis and tumor angiogenesis has led to the development of agents that target this pathway. anti-vegf agents the vegf monoclonal antibody bevacizumab, and the small molecule vegf receptor tyrosine kinase inhibitors. angiogenic factors play a key role in the maintenance of lung integrity and normal endothelial function. endothelial dysfunction has been implicated in hypertension, proteinuria and retinopathy. one of the major issues of anti-vegf agents is its long-term toxicity especially taking into account the lack of adequate knowledge in this area and the possibility of prolonged periods of therapy in non-progressing patients. hypertension and proteinuria are commonly seen in patients treated with anti-vegf agents. in addition, the investigators have also observed in a relatively high frequency of pulmonary air-filled lesions in patients with malignancy in the lung treated with an anti-vegf agent. objectives of this exploratory study are to 1) determine the effect of anti-vascular endothelial growth factor (vegf) on endothelial function 2) determine endothelial dysfunction as a marker of early response and as an indicator for the development of hypertension and proteinuria 3) characterize the effect of anti-vegf therapy on the pulmonary function of patients with malignancy (primary or secondary) involving the lung in patients treated with anti-vegf agents. pharmacodynamic endpoints to be assessed are: blood pressure, brachial artery reactivity, retinal microvessels, microalbuminuria and proteinuria, pulmonary function, assess the effects of anti-vegf therapy by assessing brachial artery reactivity, retinal vasculature and pulmonary function in a subset of patients receiving anti-vegf therapy. the development of markers of endothelial dysfunction may result in the early identification of patients who are non-responders or develop toxicity from anti-vegf treatment.


Eligibility criteria:
inclusion criteria: * eligibility * patients who are receiving single agent anti-vegf therapy * signed written informed consent * patients with measurable pulmonary malignancy (primary or metastatic) as determined by recist will undergo assessment of pulmonary function * patients with a known allergy to intravenous contrast used in fluorescein and indocyanine green angiography will be exempt from these investigations but will undergo other study assessments exclusion criteria: * none

Keywords: anti-vascular endothelial growth factor
earlysense monitoring device evaluation on copd, chf and pneumonia patients

Conditions: COPD Patients

Summary: continuous measurement of breathing patterns, heart rate, restlessness and cough in sleep using earlysense es 16 device. predicting worsening in copd patients' condition using the above parameters.

study's participants are chf, copd and pneumonia patients or patients who are otherwise hospitalized in internal medicine department. during the study the patients' breathing patterns, heart rate, restlessness and cough in sleep will be measured by the earlysense es 16 device, which is placed in the patients' bed. patients' clinical status are followed. the patient's clinical condition is followed and analyzed in comparison to the earlysense system output in order to determine the capability of the earlysense system to predict copd, chf or pneumonia deteriorations.

Eligibility criteria:
inclusion criteria: * chf, copd and pneumonia patients or control group non respiratory patients * 18 years old and up * able to perform spirometry test or connect to ecg, respiratory belt, spo2 * willing to sign consent form * home close to tel aviv exclusion criteria: * hospitalization within the passing year

Keywords: copd respiration rate monitoring
examination of neuromotor development of cases diagnosed with scaphocephaly

Conditions: Craniosynostosis, Sagittal; Scaphocephaly; Developmental Delay

Summary: it's an observational study. purpose of the study: to evaluate the neuromotor development of scaphocephaly cases. 21 infants diagnosed with scaphocephaly aged 2-17 months were included. * is there any delay in the neuromotor development of scaphocephaly cases? * if delay is observed, in which area is it most common? denver-ii developmental screening test and alberta motor infant scale were applied to the participants.

scaphocephaly (sagittal synostosis) is the most common single-suture craniosynostosis. it occurs as a result of premature ossification of the fibrous connective tissue extending between two parietal bones (sagittal suture). phenotypically, a long and narrow head shape occurs. it occurs in 2-3 per 10,000 live births and is more common in men. premature ossification of the sagittal suture can lead to cranial deformity, potentially cranial growth restriction, and resulting increased intracranial pressure. in these cases, increased intracranial pressure and compression of the sagittal sinus cause increased venous pressure, which may cause developmental delays. these delays most commonly include cognitive impairments, language disorders, motor delays, learning disabilities, executive dysfunction, and behavioral problems. when looking at the literature, it was seen that the studies were mostly on neurocognitive development in cases with craniosynostosis. there are relatively fewer studies focusing on the neuromotor development of these cases. this study aims to evaluate the neuromotor development of scaphocephaly cases.

Eligibility criteria:
inclusion criteria: * having been diagnosed with scaphocephaly * being between 0-18 months exclusion criteria: * be over 18 months * having a diagnosed disease other than scaphocephaly

Keywords: scaphocephaly neuromotor development alberta infant motor scale denver ii developmental screening test pediatric rehabilitation
efficacy, safety, and immunogenicity of subcutaneous dmb-3115 versus stelara® in patients with moderate to severe chronic plaque psoriasis

Conditions: Moderate to Severe Chronic Plaque Psoriasis

Summary: this study is designed to evaluate efficacy, safety, pharmacokinetics (pk) and immunogenicity of subcutaneously administered dmb-3115 in comparison with stelara for treatment of moderate to severe chronic plaque psoriasis.


Eligibility criteria:
inclusion criteria: * patients who have a diagnosis of plaque-type psoriasis for at least 6 months. exclusion criteria: * patients with hypersensitivity to ustekinumab or any of the product excipients.
il-6 and il-8 level of blood and pleural effusion during chemotherapy in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: change of il-6 and il-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease

to assess the correlation between the disease prognosis and the level of il-6 and il-8 in blood and pleural effusion before and after chemotherapy in patients with metastatic breast cancer

Eligibility criteria:
inclusion criteria: * female between 18 and 70 years old; * patients with histologic proved metastatic breast cancer; * pleural effusion with the volume of more than 1000ml, as documented by ct, x ray or ultrasound; * there are no other diseases which cause the elevation of il-6 or il-8, such as cirrhosis of liver, anaphylactoid purpura, acute pancreatitis; * with at least one measurable disease according to recist criteria, * normal laboratory results:anc≥2.0×109/l,hb≥80g/l,plt≥100×109/l,tb\<unl (\<1.5 x unl in patients with liver mets),alt/ast\< 1.5 x unl (\<2.5x unl in patients with liver mets),akp\<5 x unl(except bone mets),cr\<unl; * normal functions with heart, liver,renal and bone marrow; * got icf before enrollment; * life expectancy more than 12 weeks. exclusion criteria: * pregnant or breast-feeding women or positive serum pregnancy test; * uncontrolled brain metastases; * no recovery from previous radiation or accepted radiation within 4 weeks before enrollment; * participation in any investigational drug study within 4 weeks preceding treatment start; * concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin; * serious uncontrolled intercurrent infections; * poor compliance.
a real-world study for the tecnis synergy™ intraocular lens

Conditions: Cataracts

Summary: this is a prospective and retrospective, single-center, single-arm, open-label clinical study of the tecnis synergy™ iol. the study will enroll up to 100 subjects from a single site in china. all implanted subjects will be followed for 12 months postoperatively.


Eligibility criteria:
inclusion criteria: 1. male or female patients at least 22 years of age 2. have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with tecnis synergy intraocular lens 3. availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits 4. voluntary participation indicated by the study informed consent form (icf) signed by the patient or legal guardian exclusion criteria: 1. concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit 2. planned monovision correction (one eye designated for near correction). 3. any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the course of the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).
modified endotracheal balloon dilator to improve patient oxygenation and allow ventilation during airway procedures

Conditions: Tracheal Stenosis

Summary: the purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator that allows gas flow (oxygenation and ventilation) through the device while inflated during dilatation.

the primary aim is to determine the incidence of, and time to, arterial desaturation (defined as peripheral plethysmography below 90%). secondary aims include quantitative and qualitative (waveform) end-tidal capnography levels throughout the procedure, quantitative assessment of dilatation, and incidence of adverse events.

Eligibility criteria:
inclusion criteria: * age \>18 years * symptoms of tracheal or laryngeal stenosis or airway narrowing * endoscopic evidence of subglottic or tracheal stenosis * able to provide informed consent exclusion criteria: * refractory stenosis not amenable to balloon dilatation * contraindication to balloon dilatation * lack of informed consent

Keywords: tracheal stenosis tracheal dilatation ventilation
this study evaluates the superiority of daily self-ph monitorization of lit-control®ph meter compared to the monitorization of reactive strips (standard of care).

Conditions: Cystinuria

Summary: this study evaluates the superiority of daily self-ph monitorization of lit-control®ph meter compared to the monitorization of reactive strips (standard of care).

cystinuria is a disease of autosomal recessive inheritance. this disease belongs to the so-called orphan diseases although its prevalence may change depending on the country. it is known that urinary ph is a risk factor for the formation of cystine crystals because their solubility is ph-dependent. in different studies it has been shown that the solubility of cystine in urine increases when alkalinizing urinary ph, thus reducing the likelihood of crystal formation. therefore, the control of urinary ph along with hygienic-dietetic measures that alkalize the urine or decrease the urinary concentration of cystine (abundant intake of water, food, etc.) are highly recommended as a preventive method to prevent the formation of cystine crystals whose retention and growth results in the formation of stones. the lit-control®ph meter is a ph meter that allows a patient to self-monitor its urinary ph in a comfortable and simple way. with this tool the patient is able to know if his urinary ph is within the recommended limits. in other medical fields it has been observed that home monitoring of clinically relevant physiological parameters is a way of empowering the patient that can positively affect their attitudes and behaviors (adherence to received treatment, quality of life) and potentially improve their medical condition. specifically, in patients with chronic diseases, the self-monitoring has been associated with a significant reduction in hospitalizations and hospital readmissions.

Eligibility criteria:
inclusion criteria: * age ≥18 years old. * cystinuric patients, with or without urinary lithiasis at the time of inclusion. * patients who accept their participation in the study and give their informed consent. exclusion criteria: * patients with pathologies that require ph control other than the one established in the study protocol to avoid the formation of kidney stones.

Keywords: cystinuria ph control
clinical quality improvement of benzodiazepine-resistant alcohol withdrawal syndrome

Conditions: Alcohol Withdrawal Syndrome

Summary: the overarching goal of this project is to improve the clinical quality of patients with benzodiazepine-resistant alcohol withdrawal syndrome.


Eligibility criteria:
inclusion criteria: either 1. a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs; 2. \> 40mg of diazepam (or diazepam equivalents) in 1 hr; or 3. an individual dose of 40 mg or greater of intravenous diazepam for control of agitation exclusion criteria: * if \< 18 years of age or had evidence of use of other illicit substances as determined by urine toxicology screen
effectiveness of the aktivplan digital intervention (active-care pilot)

Conditions: Cardiac Rehabilitation; Secondary Prevention; Cardiovascular Diseases

Summary: the goal of this clinical pilot / feasibility study is to determine the feasibility of conducting a large-scale clinical effectiveness trial of the aktivplan digital intervention in cardiac rehabilitation patients. the main questions this study aims to answer are: * is it feasible to conduct a large-scale (fully powered) effectiveness trial of the aktivplan digital intervention? * what is the usability, user experience and user acceptance of the aktivplan digital intervention? patients enrolled in a phase ii cardiac rehabilitation programme will be randomly allocated to either the intervention group (aktivplan digital intervention) ot the usual care control group and followed-up for 10 weeks after discharge from cardiac rehabilitation. patients in the intervention group will be given the aktivplan application (app) on their smartphone. a rehabilitation professional will plan a personalised heart-healthy physical activity plan together with the patient and enter it to the aktivplan app. the patient will be asked to follow their personal physical activity plan for 10 weeks, using the aktivplan app to document completed physical activity sessions. patients in the control group will receive the usual standard of care without the aktivplan digital intervention. researchers will analyse information such as the rate of recruitment, participant attrition, data completeness and technical stability of the app to determine the feasibility of conducting a large-scale clinical effectiveness trial.


Eligibility criteria:
inclusion criteria: * enrollment to a cardiac rehabilitation programme phase ii, or a rehabilitation programme phase ii due to non-cardiac indication but displaying cardiovascular risk factors * ownership and use of a smartphone compatible with the aktivplan digital intervention and with internet connection * agreement to attend the study follow-up visit * written informed consent to take part in the study exclusion criteria: * existing use of a digital intervention for regular heart-healthy physical activity * medical contraindications for incremental cycle ergometry test * medical contraindications for regular heart-healthy physical activity and sports * medical contraindications for use of a smartphone * inability to carry out cardiovascular training (e.g., due to significant musculoskeletal restrictions) * participation in another clinical study within the past 6 months * addiction or other medical conditions causing reduced decisional capacity * pregnant women in the third trimester * pregnant women in the first and second trimester with medical contraindication for physical activity and sports * breastfeeding women with medical contraindication for physical activity and sports * indication that patient is unlikely to follow study procedures (limited cooperation)

Keywords: digital health mobile health electronic health smartphone app
a real-world study of adjuvant therapy in early stage nsclc with egfr mutation-positive in china

Conditions: NSCLC, Stage I; NSCLC, Stage II; NSCLC, Stage III

Summary: this study is a prospective, national, multi-center, non-interventional study. the main purpose is to explore the initial adjuvant treatment pattern after radical resection for early-stage nsclc patients with egfr mutation-positive in the real world. the secondary purpose was to observe the postoperative follow-up treatment pattern and its subgroups (based on different egfr mutation status and different clinical stages).

about 2,000 ensclc patients who received radical resection from about 50 research centers across the country will be included in this study, and will be followed up to 2 years after enrollment according to the actual clinical situation. the analysis method of this study is mainly based on descriptive statistics. the information about the human genetic resources of the subjects to be collected includes: demography, physical examination, who fitness status, medical history, smoking history, disease characteristics, surgical information, initial and follow-up adjuvant treatment pattern, laboratory tests, survival status, and adverse events related to gefitinib/osimertinib, serious adverse events/non-severe adr, measures taken for adverse events, outcome of adverse events.

Eligibility criteria:
inclusion criteria: 1. informed consent signed; 2. newly confirmed egfr mutation-positive nsclc confirmed by histopathology except for cytology; 3. receiving or not receiving neoadjuvant treatment before surgery; 4. patients with stage i-iii nsclc undergo confirmed radical r0 resection; exclusion criteria: 1. patients who currently or have previously participated in any other anti-tumor clinical studies; 2. patients with nsclc who have received any systemic anti-cancer therapy as the main treatment in the past. cytotoxic therapy, targeted therapy (tyrosine kinase inhibitors or monoclonal antibodies) and immunotherapy included except for the use of neoadjuvant therapy; 3. patients who have received adjuvant therapy before enrollment. 4. patients with stage i-iii nsclc whose surgical resection cannot be confirmed. 5. patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has contraindications to the use of study drugs, or has treatment-related complications high risk etc.

Keywords: egfr mutation nsclc adjuvant therapy
phenotypes of copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) has been defined by international guidelines as a common preventable and treatable disease characterized by persistent air flow limitation and respiratory symptoms caused by exposure to gases or noxious particles. copd is a major cause of morbidity and mortality worldwide. it is predicted to become the third leading cause of death and the fifth leading cause of disability by the year 2020.

although the disease has been greatly associated with tobacco smoking, non- smokers can also have copd, and the burden of copd in non-smokers is also higher than previously believed especially in developing countries. exposure to gases, environmental pollution, respiratory infection, noxious particles, passive smoking, and indoor air pollution is the main cause of copd in non smokers. copd over the years has been classified into two phenotypes; chronic bronchitis or classic emphysema.however, the global initiative for chronic obstructive lung disease (gold) guidelines over the last few years have stopped emphasizing the categorization of chronic obstructive pulmonary disease (copd) into only emphysema or chronic bronchitis clear examples of copd phenotypes in smokers have been described in different researches,such as emphysema, chronic bronchitis, frequent exacerbators and the asthma_copd overlap.,but there is alack of information about copd phenotypes in non-smokers, so, there is a continuous need for research into groups of non smoking patients. therefore, the aim of this study is to describe the phenotypes of copd, their risk factors, clinical and functional assessment and the prognosis of each copd phenotype in non-smoking patients.

Eligibility criteria:
inclusion criteria: 1. non-smoker copd patients. 2. stable copd patients (≥4 weeks without exacerbation or worsening of any relevant comorbidity). exclusion criteria: 1. patients with copd exacerbation. 2. patients with associated obstructive sleep apnea. 3. patients with associated interstitial lung disease. 4. patients with associated cardiac problems. 5. patients with associated bronchiaectasis.
effects of perioperative intravenous dexamethasone in clinical outcomes after total knee arthroplasty in a hispanic population

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to evaluate the efficacy of an intravenous (iv) perioperative dexamethasone regime in the clinical outcomes after a robotic-assisted total knee arthroplasty (tka) in a hispanic population. the study aims to propose an alternative to opioid-based pain treatment following tka. the study hopefully validates the use of a two-dose, 8mg intravenous dexamethasone regimen for improving pain and range of motion scores in patients undergoing primary, unilateral tka for osteoarthritis. one dose will be applied prior to incision and the other at post-operative day (pod) 1.


Eligibility criteria:
inclusion criteria: * patient with hispanic self-identification * primary robotic-assisted tka for treatment of primary osteoarthritis * age ≥ 21 * receiving seven days of inpatient rehabilitation after medical discharge * patient with adequate glycemic control (hba1c\<7.5%) * patients who provide written informed consent exclusion criteria: * age ≤ 21 * chronic steroid use prior to surgery * previous allergies or adverse reactions to steroid drugs * indications for surgery other than primary osteoarthritis * history of narcotics abuse such as opioids * surgeries performed without robotic-assistance * outpatient or home rehabilitation programs after medical discharge * requirement of revision surgery orthopaedic implants * patients with inadequate glycemic control (hba1c≥7.5%) * other medical conditions, such as osteoporosis, fungal infections, glaucoma, joint infections, peptic ulcer disease which could worsen with steroid administration.

Keywords: tka primary osteoarthritis