Kornimate/medical-research-clean huggingface dataset:
analysis of biopsy specimens to study responses to pd-1 or pd-l1 therapies

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to attempt to obtain an on-treatment biopsy in participants with non-small cell lung cancer who are receiving standard treatment with a drug that targets the pd-1 or pd-l1 protein.


Eligibility criteria:
inclusion criteria: * pathologically confirmed newly diagnosed or recurrent advanced non small cell lung cancer/nsclc that is pi-l1 high by immunohistochemistry (pd-l1 \>/= 50%) * intended treatment with a pd-(l)1 inhibitor * age \>/= 18 years * karnofsky performance status \>/= 70% and medically fit to undergo a biopsy procedure exclusion criteria: * any medical condition or any sites of disease that would preclude a biopsy * pregnant or breastfeeding women * cognitively impairment affecting ability to understand and provide informed consent * prior pd-(l)1 blockade treatment * chemotherapy within 6 months prior to enrollment

Keywords: pd-l1 high 19-030 memorial sloan kettering cancer center
safety and tolerability of dalfampridine in subjects with cerebral palsy

Conditions: Cerebral Palsy (CP)

Summary: a double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (cp) to evaluate the safety and tolerability and the effect of dalfampridine extended release (er) tablets on sensorimotor function


Eligibility criteria:
inclusion criteria: * a diagnosis of cp * no previous use of any dalfampridine formulation * ability to perform all the required study procedures. subjects should be capable of fully extending and flexing both hands exclusion criteria: * presence of any progressive neurological disease * severe cp defined as the requirement to use a wheelchair at all times and a care taker for constant assistance in daily activities. this definition includes spastic quadriplegia * pregnant or breastfeeding
influence of fsh/lh ratio in controlled ovarian stimulation

Conditions: Sub-Fertility

Summary: the aim of this study is to compare different fsh/lh ratios in controlled ovarian stimulation


Eligibility criteria:
inclusion criteria: * patients undergoing ivf cycles in cruces university hospital. * signed ivf and cryopreservation informed consent. * age \>35 and \<40 years. * fsh levels \<10 miu/ml. exclusion criteria: * when inclusion criteria are not fulfilled

Keywords: fsh lh ivf
study to compare furmonertinib to platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) exon 20 insertion mutations (furvent)

Conditions: Metastatic Non-Small Cell Lung Cancer; Advanced Non-Small Cell Lung Cancer; EGFR Exon 20 Mutations

Summary: global, phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib (firmonertinib) at 2 dose levels (160 mg once daily \[qd\] and 240 mg qd) compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic non-squamous non-small cell lung cancer (nsclc) with epidermal growth factor receptor (egfr) exon 20 insertion mutations. a target of approximately 375 patients will be randomized in a 1:1:1 ratio to treatment with furmonertinib 240 mg qd, furmonertinib 160 mg qd, or platinum-based chemotherapy.


Eligibility criteria:
key inclusion criteria: * histologically or cytologically documented, locally advanced or metastatic non-squamous non-small cell lung cancer (nsclc) not amenable to curative surgery or radiotherapy. * documented results of the presence of an epidermal growth factor receptor (egfr) exon 20 insertion mutation in tumor tissue or blood from local or central testing. * no prior systemic anticancer therapy regimens received for locally advanced or metastatic non-small cell lung cancer (nsclc) including prior treatment with any epidermal growth factor receptor (egfr)-targeting agents (e.g., previous (egfr) tkis, monoclonal antibodies, or bispecific antibodies). * patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding egfr-tkis) must have experienced a treatment free interval of at least 12 months. * patients with a history of treated cns metastases or new asymptomatic cns metastases are eligible.

Keywords: non-small cell lung cancer (nsclc) exon 20 furmonertinib firmonertinib ast2818 furmo-004 drug-therapy
sildenafil impact on ventricular function in patients with heart failure

Conditions: Heart Failure

Summary: twenty-four patients with known heart failure will be recruited. they will undergo a cardiac magnetic resonance for ventricular analyses and after this first exam they will be randomized to placebo or sildenafil. after one hour drug intake they will undergo another cardiac magnetic resonance to evaluate the drug impact on right and left ventricular function.

twenty-four patients with known heart failure will be recruited. they will undergo a cardiac magnetic resonance for ventricular analyses and after this first exam they will be randomized to placebo or sildenafil. after one hour drug intake they will undergo another cardiac magnetic resonance to evaluate the drug impact on right and left ventricular function. the first and second exams will be performed by the same staff. all patients will be evaluated by two, three and four chambers view. left and right ventricle quantification analyses will be performed by argus software.

Eligibility criteria:
inclusion criteria: patients with heart failure in stable clinical condition compatible with new york heart association functional class i to iii. eligibility criteria is consent to participate in the study after receiving detailed information about procedures, possible clinical benefits, and risks. exclusion criteria: patients with new diagnosed lesions during the procedure, eg pulmonary mass and important claustrophobia, low blood pressure ( systolic blood pressure \<90 mmhg or diastolic blood pressure \<60 mmhg) nitrate or nebivolol use over the last 48 hours, metallic non mri compatible implantable devices.

Keywords: heart failure
evaluation of the prognostic value of t7 and t12 slices on mortality in resuscitation patients with ards caused by sars-cov2 infection

Conditions: Acute Respiratory Distress Syndrom (SARS-Cov 2)

Summary: sarcopenia is a risk factor for adverse outcome in critically ill patients. sarcopenia might be estimated from muscle surface measure on tomodensitometry. the purpose of the study is to identify if muscle surfaces measured on thoracic tomodensitometry are associated with mortality in patients with acute respiratory distress syndrome due to sars-cov-2.


Eligibility criteria:
inclusion criteria: * patients hospitalized in intensive care for sars-cov-2 infection since january 2020 * thoracic tdm within the 30 day preceding icu admission and up to 24 hours after icu admission exclusion criteria: * pregnancy * neuromuscular disease
detection of acute renal failure using hospital coding data

Conditions: Acute Renal Failure; Iatrogenic Effect; Uremic Toxin

Summary: aki is a rapid and usually reversible impairment of kidney function that is life-threatening in the short term well described by the "kidney disease: improving global outcomes - kdigo" classification of 2012. whatever etiology of acute renal failure, drug iatrogeny still has its place. hospital data from the information systems medicalization program (pmsi) can be used for epidemiological research. no study has yet been performed on these data to assess drug-related aki. however, it should be remembered that these databases were not originally designed for research purposes but for reimbursement of care. therefore, before conducting a large-scale study, it remains important to determine the validity and representativeness of the codes used for coding the studied events. the objective of this project is therefore to validate the use of hospital coding to identify aki.

acute kidney injury (aki) is a rapid and usually reversible impairment of kidney function that is life-threatening in the short term; the grades of which are defined by the kdigo classification of 2012. whatever etiology of acute renal failure, drug iatrogeny still has its place. data literature indicate that aki affects more than one in five adults worldwide while hospitalized, with an associated mortality rate above 20%. it constitutes a non-negligible part of hospitalizations when it is acquired in the community, and also causes prolongations of hospitalizations, and therefore an increase in the cost for the hospital. hospital data from the information systems medicalization program (pmsi) is a device that is part of the reform of the french health system with the aim of reducing inequalities in resources between health establishments. since 2007, it has been possible to link all discharge summaries for one patient. the diagnoses identified during hospitalization are coded according to the 10th edition of the international classification of diseases (icd-10). the data from pmsi coding can be used for epidemiological research. the majority of studies were related to patients with chronic kidney disease, especially dialysis patients. no study has yet been performed on these data to assess drug-related aki. however, it should be remembered that these databases were not originally designed for research purposes but for reimbursement of care. therefore, before conducting a large-scale study, it remains important to determine the validity and representativeness of the codes used for coding the events to be studied.

Eligibility criteria:
inclusion criteria: * patients over \> = 18 years old * patients hospitalized at the chu amiens picardie during 6 months * patients for which at least two plasma creatinine measurements were taken during the hospitalization exclusion criteria: * patients under \<18 years old * patients on dialysis for chronic renal failure * hospitalization for a kidney transplant * postpartum aki

Keywords: acute renal failure iatrogenic pharmaco epidemiology medico economy uremic toxin pmsi
neural respiratory drive of patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to investigate the relationship among the neural respiratory drive (nrd), the sensation of the dyspnea and the effect of the bronchodilator on each stage copd patients.

different stage copd subjects were recruited. administration of bronchodilators was prohibited 24 hours prior to the experiment. after the application of topical anesthesia (10% xylocaine) the subject was asked to swallow the multipair esophageal electrode catheter through the nose into their right position. at the first period, the stable signals of spontaneous breathing (about 10 minutes) were collected as the baseline data. at the second period, each subject inhaled compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, boehringer ingelheim limited, germany). a multi-pair esophageal electrode catheter with 10 coils that provided five pairs of electrodes was used to obtain the nrd signals. all nrd signals the were recorded before and after the compound ipratropium bromide solution was inhaled (about 10 minutes). the subjects scored their comfort sensation with a visual analog scale (vas) ranging from 0 (best) to 10 (worst) at each period.

Eligibility criteria:
inclusion criteria: the diagnosis of copd was made according to the global initiative for chronic obstructive lung disease (gold) guideline. - exclusion criteria: (1) malignancy （2）severe cardiovascular diseases （3）neuromuscular and chest wall deformity (4) cardiovascular instability (hypotension, arrhythmias, myocardial infarction) (5) change in mental status; uncooperative patients (6) extreme obesity （7）renal failure and severe blood electrolyte disturbances (8) asthma-

Keywords: neural respiratory drive chronic obstructive pulmonary disease
efficacy and safety of b i1356 (linagliptin) vs. placebo added to metformin background therapy in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the current study is to investigate the efficacy, safety and tolerability of bi 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control


Eligibility criteria:
inclusion criteria: 1. male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug 2. diagnosis of type 2 diabetes prior to informed consent 3. glycosylated haemoglobin a1 (hba1c)at screening: for patients undergoing wash out of previous medication: hba1c 6.5 - 9.0% for patients not undergoing wash-out of previous medication: hba1c 7.0 - 10.0% 4. glycosylated haemoglobin a1 (hba1c) 7.0 - 10.0% at the beginning of placebo run-in 5. age 18 -80 years 6. bmi (body mass index) less than 40 kg/m2 7. signed and dated written informed consent by date of visit 1a in accordance with gcp and local legislation exclusion criteria: 1. myocardial infarction, stroke or transient ischemic attack (tia) within 6 months prior to informed consent 2. impaired hepatic function 3. known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo 4. treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent 5. treatment with an injectable glp-1 analogue (e.g. exenatide) within 3 months prior to informed consent 6. treatment with insulin within 3 months prior to informed consent 7. treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent 8. alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse 9. participation in another trial with an investigational drug within 2 months prior to informed consent 10. pre-menopausal women who: * are nursing or pregnant, * or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. 11. current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. 12. renal failure or renal impairment 13. unstable or acute congestive heart failure 14. acute or chronic metabolic acidosis (present in patient history) 15. hereditary galactose intolerance
electronic nose for diagnosis of neurodegenerative diseases via breath samples

Conditions: Neurodegenerative Diseases

Summary: the diagnosis of neurodegenerative conditions and adhd still mostly relies on clinical symptoms as there are no validated, inexpensive, and simple bio- markers available yet. the purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify neurodegenerative conditions and adhd based on breath testing. alveolar breath will be collected from healthy volunteers, patients with extrapyramidal conditions, patients diagnosed with dementia and from adhd subjects. the discriminative power of a tailor-made nanoscale artificial nose (™na-nose) containing an array of six nanomaterial-based sensors will be tested. discriminant factor analysis will be applied to the na-nose signals in order to detect statistically significant differences between the sub-populations, and classification success will be estimated using leave-one-out cross-validation. the identification of na-nose patterns will be supported by analyzing the chemical composition of the breath using gas-chromatography in conjunction with mass-spectrometry (gc-ms).


Eligibility criteria:
inclusion criteria: * patients diagnosed with neurodegenerative conditions * healthy subjects * subjects diagnosed with adhd

Keywords: detecting volatile biomarkers using breath sample
clinical trial of novel implantation promoting medium (embryoglue) to improve ivf success rates

Conditions: Embryo Implantation; Infertility

Summary: hypothesis: a special solution for improving human embryo implantation, when added to the solution during embryo transfer, will improve implantation rates in embryo transfers using previously frozen embryos.

embryoglue (tm) is added to embryo transfer solutions immediately prior to the transfer of frozen-thawed human embryos before placement of embryos into the patient uterus.

Eligibility criteria:
inclusion criteria: * frozen embryo transfer patients, men over the age of 18 and women between the ages of 18 and 42 completed years (if using their own eggs and with embryos frozen before 39 completed years) or 18 to 50 completed years if using donated eggs. exclusion criteria: * prior participation in this study, blastocyst transfers, single embryo transfer for medical reasons, prior embryo transfer with large amount of blood on the outside of the catheter, \> or = 3 consecutive failed embryo transfers at mayo clinic (fresh or frozen-thawed cycles).
influenza vaccination in hemodialysis patients and renal transplant recipients

Conditions: Hemodialysis; Renal Transplantation

Summary: disturbances of acquired immunity are considered to be responsible, at least partly, for the high infection rate and inadequate response to vaccinations observed in hemodialysis (hd) patients and renal transplant recipient (rtr). the present prospective trial aims at (a) evaluating the immunogenicity of a standard influenza vaccine in hd and rtr patients and (b) at identifying determinants of the immune response.


Eligibility criteria:
inclusion criteria: * maintenance hemodialysis patients or * renal transplant recipients (beyond month 3 after transplantation) exclusion criteria: * patients with known allergy to chicken proteins
study of efficacy and safety of inc424 in regularly transfused patients with thalassemia.

Conditions: Thalassemia Major

Summary: patients with severe thalassemia (thalassemia major) present with severe anemia that required life-long transfusion therapy, spleen enlargement that led to increased transfusion requirement, and other serious complications as early death, growth retardation, bone deformations and iron overload due to blood transfusions. splenectomy can significantly reduce transfusion requirement in thalassemia patients, but it is associated with an increased risk of serious complications such as sepsis and thrombosis. preliminary preclinical and clinical data suggested that jak2 inhibition, by reducing spleen size, could improve hemoglobin levels, thereby eliminating the need for splenectomy and reducing transfusion requirement and related iron overload.


Eligibility criteria:
inclusion criteria: * patients with thalassemia on a regular and stable transfusion regimen (at least 2 rbc units within every 4-week interval for 24 weeks prior to screening) and anticipated to receive the same transfusion regimen during the study. * patients with spleen enlargement at screening, defined as spleen palpable below the costal margin and spleen volume of ≥ 450 cm3 as confirmed by mri (or ct scan in applicable patients). * patients need to be on iron chelation treatment (deferoxamine or deferasirox) for at least four weeks prior to screening exclusion criteria: * splenectomy prior to or planned during the study * active serious bacterial, mycobacterial, fungal, parasitic or viral infection which requires therapy (e.g., pneumonia, tuberculosis, systemic mycosis, herpes zoster) * hemoglobin \<65 g/l (\<4.0 mmol/l) at screening * platelet count \<75×109/l, absolute neutrophils count \< 1.5×109/l at screening. * estimated mdrd \< 30 ml/min/1.73 m2 at screening. * alt (sgpt) levels \>5 times uln at screening. * hepatocellular disease such as hepatitis b (presence of hbs antigen), hepatitis c (presence of hcv rna), liver cirrhosis. * hiv positivity

Keywords: thalassemia thalassemia major spleen enlargement inc424 ruxolitinib
lifestyle online re-intervention on blood pressure, bmi, and physical activity on obese hypertensive patients

Conditions: Hypertension; Overweight and Obesity

Summary: this research will constitute a 3 years follow-up which includes a re-assessment and re-intervention of obese or overweight adults with hypertension, recruited from a hypertension unit of a public hospital, that already participated in a similar program 3 years ago. at the same time, the aim of the study is to analyze the effects of the current program, which will take 3 months and promotes lifestyle changes focusing on healthy eating and increased physical activity in their 9 modules, comparing the results obtained in 2018. these patients will be allocated into one experimental group. assessment will include: blood pressure, body mass index, physical activity levels, and adherence to the mediterranean diet.

hypertension incidence and overweight or obesity related, constitute a worrying public health problem nowadays. in this sense, healthy eating and regular physical activity have demonstrated a relevant role maintaining health while ageing. information and communication technologies (icts) have been shown as a useful way to promote health, improving motivation and overcoming difficulties to maintain a healthy lifestyle. icts also reach a wider audience at a lower cost, due to their good cost-benefit relationship and the possibility of increasing the efficiency of interventions. this research will constitute a 3 years follow-up which includes a re-assessment and re-intervention of obese or overweight adults with hypertension, recruited from a hypertension unit of a public hospital, that already participated in a similar program 3 years ago. at the same time, the aim of the study is to analyze the effects of the current program, which will take 3 months and promotes lifestyle changes focusing on healthy eating and increased physical activity in their 9 modules, comparing the results obtained in 2018. these patients will be allocated into one experimental group. assessment will include: blood pressure, body mass index, physical activity levels, and adherence to the mediterranean diet.

Eligibility criteria:
inclusion criteria: * hypertension * overweight or obesity (25 ≤ bmi ≤ 35 kg/m2) * aged between 18-65 years * have participated in the same program 3 years ago exclusion criteria: * not having access to the internet or lack of information about it. * treatment with more than 3 antihypertensive drugs. * meet the criteria of the dsm-iv-tr of a food disorder. * presenting some type of severe psychiatric disorder. * disability that prevents or hinders physical exercise. * receiving some treatment for weight loss.

Keywords: hypertension obesity internet exercise nutrition reintervention
a study of tq-a3334 combined with entecavir in the treatment of chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this is a randomized, double-blinded, placebo-controlled, phase iia study to evaluate safety and efficacy of tq-a3334 combined with entecavir in the untreated or hbv dna negative subjects with chronic hepatitis b.


Eligibility criteria:
inclusion criteria: * 1. 18 and 65 years old ; 2. hbsag positive at least for 6 months ; 3. hbeag positive chronic hepatitis b, hbv dna \> 10\^5 copies/ml; 4. fibroscan ≤ 12.4 kpa，2×uln ≤ alt ≤ uln; 5. new diagnosed chronic hepatitis b subjects; exclusion criteria: * 1.combined with other virus infection ; 2.has cirrhosis or hepatocellular carcinoma; 3.has autoimmune diseases; 4.has thyroid disease; 5.has eye diseases; 6.has clinically significant abnormalities/diseases ≥ grade 2; 7.has history of chronic kidney disease, renal insufficiency, renal anemia; 8.peripheral blood index is low; 9.has a history of allergy to experimental drugs or their excipients; 10.has participated in other clinical trials within 3 months; 11.breastfeeding or pregnant women.; men unwilling to use adequate contraceptive measures during the study; 12.according to the judgement of the researchers, there are other factors that subjects are not suitable for the study.; 13.has history of drug abuse in the past five years;