Kornimate/medical-research-clean huggingface dataset:
clinical effectiveness assessment of veristrat® testing and validation of immunotherapy tests in nsclc subjects

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to collect information about how a doctor uses the results of the veristrat® blood test to guide treatment for non-small cell lung cancer (nsclc) patients. understanding how veristrat test results influence doctors' decisions and patients' outcomes may help doctors to better treat nsclc in the future. this study will also look to establish whether new investigational tests can help better predict the effectiveness of certain medications for certain patients. these new investigational tests are only for research purposes at this time.

the primary purpose of this observational study is to assess the physician's clinical practice patterns while using veristrat testing in subjects with nsclc whose tumors are epidermal growth factor receptor (egfr) wild-type (negative) or have unknown egfr mutational status. this study will also attempt to further validate that veristrat test results stratify subjects by clinical outcomes in the real world, uncontrolled clinical setting while exploring whether certain therapeutic approaches may yield opportunities for further study. predictive tests that aid physician therapeutic decision making are critical for optimizing subject outcomes while minimizing toxicity and associated treatment costs. this study will provide data for the validation of immunotherapy tests currently being developed. immunotherapy mechanisms are dependent upon the interactions between the tumor, tumor microenvironment, and the patient immune system. as such, a successful predictive test will reflect the complex interplay between tumor and host. the multivariate tests from biodesix have the advantage of being able to assess this complex biology. the information gained from this research will not only guide the adoption of the veristrat test and inform medical decision making, including treatment choice, but will allow the validation of additional mass-spectrometry-based proteomic tests.

Eligibility criteria:
inclusion criteria: 1. subject must be 18 years of age or older at time of signing informed consent form (icf). 2. a diagnosis of nsclc. 3. subject is willing to provide serum samples for veristrat testing. 4. egfr mutation status wild-type (negative) or a tested unknown. 5. for subjects with untested/unknown egfr status only: the subject must be willing to provide blood samples for genestrat testing. 6. subject is willing to provide serum samples for research, understanding that no test results will be made available either to the subject or the treating physician. 7. subject is able to read and understand the icf and agrees to comply with study procedures and requirements. exclusion criteria: 1. subject's ability to understand the requirements of the protocol or to provide informed consent is impaired or subject is unwilling to comply with the protocol requirements.
a study to evaluate effectiveness and safety of tyrosine kinase inhibitors

Conditions: Non-small Cell Lung Cancer Metastatic

Summary: this is a real-world non-interventional observational study. the study was designed to evaluate the effectiveness and safety of clinical treatments in the patients with advanced non-small cell lung cancer (nsclc) complicated with brain metastases in clinical practice.

this is a real-world non-interventional observational study that focuses to evaluate the effectiveness and safety of tyrosine kinase inhibitors (tkis) in the patients of advanced non-small cell lung cancer (nsclc) with brain metastases diagnosed by medical imaging methods. the patients with core medical health records who were enrolled in the clinics from 2014 to 2017 and were administered with tkis only or combination therapies of tkis will be included in the study. all the treatments followed real-world clinical practices and experiences of clinical physicians. the effectiveness will be measured by the treatment effects on brain metastases (objective remission rate) and overall survival/progress-free survival. the safety will be evaluated by adverse events, serious adverse events, laboratory tests, electrocardiogram, vital sign, and physical examination. the mutation status of epidermal growth factor receptor (egfr) and the type of anaplastic lymphoma kinase (alk) will be assessed. all the study procedures will be in compliance with international clinical harmonization - good clinical practice (ich-gcp), standard operation procedures (sops), and regulatory policies/regulations.

Eligibility criteria:
inclusion criteria: * the patients were treated with lung cancer and were enrolled from jan 2013 to jun 2017 * the patients with advanced (clinical stage: phase iv) non-small cell lung cancer who have complete core health medical records (hmrs); * the patients who are observed with brain metastases diagnosed by imaging methods; * the patients who have complete clinical data for diagnosis time of brain metastases, and overall survival/effectiveness; * the patients who are administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors; exclusion criteria: no exclusion criteria are included in the study given that the study is designed as non-interventional and all the treatments followed real-world clinical practice and experiences of clinical physicians.

Keywords: non-small cell lung cancer, chinese, brain metastases
study of efficacy and safety of valproic acid in chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to determine whether valproic acid, as a single agent is effective in the treatment of chronic lymphocytic leukemia which has relapsed or is refractory to therapy with standard drugs.

chronic lymphocytic leukemia (cll) is a disease characterized by a prolonged clinical course. though various drugs such as alkylating agents, antimetabolites such as fludarabine and targeted antibodies such as rituximab are effective against this condition, relapses are frequent and cure is rare. there exists a subset of cll patients who are refractory to many of these first line agents. though one or the other of the above mentioned class of drugs can be substituted for patients who have relapsed or have refractory disease, no therapy has been conclusively proven to have survival advantage in this condition. the costs and toxicities add to the burden of these therapies. valproic acid is a well studied drug used for the treatment of epilepsy for over 30 years. it has a well documented side effect profile, is generally well tolerated and is inexpensive. recently, it has been shown to be an inhibitor of the enzyme, histone de-acetylase(hdac). inhibition of hdac promotes apoptosis, and could lead to the death of cll cells which harbor defective apoptotic mechanisms. in vitro studies have proven the ability of therapeutic concentrations of valproic acid to achieve cell kill in cultures of cll cells. this study aims to identify whether valproic acid, used in standard doses has single agent activity against cll and to assess its tolerance in these patients.

Eligibility criteria:
inclusion criteria: * active cll (as defined by the national cancer institute working group) * patients must have received at least one prior therapy for cll and have been treated with a nucleoside analogue. * age 18 years or older. * good general condition as defined by an eastern cooperative oncology group- performance status (ecog-ps) \</=2. * absolute neutrophil count\>1500/cmm and platelet count \>30,000/cmm unless the low counts are due to the disease. * adequate liver function (bilirubin\ 30 ml/min) unless abnormalities are as a result of disease involvement. * full recovery from previous treatments. exclusion criteria: * any therapy for cll within 4 weeks before initiating treatment on this study. * pregnancy.

Keywords: chronic lymphocytic leukemia relapsed refractory valproic acid valproate
in vivo and in vitro efficacy of artemisinin combination therapy

Conditions: Malaria

Summary: this study aims to assess the degree of artemisinin resistance in adult and pediatric subjects presenting with uncomplicated falciparum malaria in western kenya. the study treatments will be artemether lumefantrine (al) and artesunate mefloquine (asmq).

data generated by this study will provide a snapshot of the current situation regarding p. falciparum sensitivity to acts in western kenya. by having subjects in one of the study arms receive artesunate and then the partner drug after completion of the artemisinin phase will enable the accurate evaluation of the artemisinin derivative without the confounding influence of the partner drug. sequential administration of the components of an act drug is recognized by the who as one of the ways in which acts can be administered. there will be close follow-up of the subjects throughout the duration of the study, and as such, subjects who fail to respond adequately will receive prompt rescue treatment. since it is largely expected that most subjects in western kenya will have satisfactory responses to acts, data from this study will provide baseline information regarding parasite characteristics when compared to data from thailand, an area that has reported resistance to acts. this, in turn, will potentially enable the identification of key markers, both in the host and the parasite, that may assist in the early detection of resistance, and also to better understand the development of resistance to acts. as such, the data generated from this study, both on its own and when compared to and pooled with data from similar studies that will be conducted in peru and thailand, will potentially inform both local and international policy regarding act use for the treatment of uncomplicated p. falciparum malaria.

Eligibility criteria:
inclusion criteria: * adult/child aged between 6 months and 65 years inclusive (minimum weight 11kg), presenting with a measured temperature of ≥37.5 c, or history of fever within 24 hours prior to presentation * mono-infection with plasmodium falciparum * baseline parasitemia of 2000 - 200,000 asexual parasites/µl * ability to provide informed consent * willingness and ability to comply with the study protocol for the duration of the study * willingness to remain in the hospital for 3 days exclusion criteria: * presence of signs of severe malaria as defined by who * presence of severe anemia, defined as hemoglobin level below 6 g/dl * presence of mixed plasmodium infection, or mono-infection of non-falciparum plasmodium * inability to take oral medication * history of allergy or contraindications to the study treatments * lactating or pregnant females * any condition that the investigator feels will result in an unfavorable outcome should the potential subject participate in the study

Keywords: malaria p. falciparum mono infection early treatment failure late treatment failure
a study to compare the effectiveness of tofacitinib 11 mg once a day to tofacitinib 5 mg twice a day

Conditions: Arthritis Rheumatoid

Summary: it is hypothesized that patients prescribed tofacitinib 11 mg modified release (mr) formulation once daily (qd) will achieve similar benefit to those prescribed tofacitinib 5 mg twice a day (bid) dosage in real world use. this study will therefore seek to compare the effectiveness of the mr 11 mg qd regimen to the ir 5 mg bid regimen for the treatment of ra in a real-world registry of ra patients.


Eligibility criteria:
inclusion criteria: * all us corrona ra registry patients who initiated tofacitinib 5 mg twice a day (bid) or tofacitinib 11 mg once daily (qd) after it became available in february 2016 * patients must have a follow-up visit at 6 months (+/- 3 months) after tofacitinib initiation. these 6 month visits are part of routine practice and is not associated with this protocol. * patients must have a valid clinical disease activity index (cdai) at initiation and at 6-month follow-up visit exclusion criteria: * there are no exclusion criteria for this study.
acupuncture and laser acupoint treatment on hypertension

Conditions: Hypertension

Summary: to determine the effect of acupuncture and laser acupuncture point treatment on hypertensive subjects.

the specific aims of the study are to test the effectiveness of acupuncture and laser acupoint on hypertension. the hypothesis is: the stimulation of a pattern of acupoints with acupuncture and laser will result in significant reductions in blood pressure. the points that are going to be used for the study are: zusanli (st36), tianshu (st25), quchi (li11).

Eligibility criteria:
inclusion criteria: * male or female over 18 and under 70 years of age with hypertension (blood pressure over 140/90 mmhg). exclusion criteria: * individuals with heart, kidney, thyroid disorders, diabetes, chronic disease or illness, neurological diseases, skin or bleeding disorders, and currently taking drugs or medications will not be recruited in the study. a health history questionnaire will be used to screen the subjects.

Keywords: hypertension acupuncture laser
the prevalence and impact of depression and anxiety symptoms in patients with non-cf bronchiectasis

Conditions: Bronchiectasis

Summary: patients with chronic diseases are at great risk of depression and anxiety.it is known that depression and anxiety are one of the most common comorbidities associated with chronic lung diseases such as asthma and chronic obstructive pulmonary disease. however,to date,little is known about the rates and risk factors of depression and anxiety symptoms in non-cf bronchiectasis;and no large-scale prospective studies have been performed to investigate the effect of depression and anxiety on the healthy outcomes(such as number of exacerbations and hospitalizations over the ensuing year).our purpose is to fill these gaps.

non-cf bronchiectasis is a long-term condition which affects the lungs.it is characterized by chronic airway infection with periodic exacerbations which are associated with impaired lung function, reduced quality of life and increased healthcare costs.depression and anxiety are common and are known to be associated with poor quality of life and exacerbations of other chronic respiratory diseases such as copd.studies in copd have shown that psychological distress is increasingly elevated and common,with up to 55% of patients suffering from a clinical diagnosis of anxiety and/or depression;moreover,patients with anxiety and/or depression were at greater risk for copd-related exacerbations.unfortunately,there has been no systematic evaluation of symptoms of depression and anxiety in patients with non-cf bronchiectasis or their relationship to health outcomes.a study including 111 non-cf bronchiectasis patients,o'leary and colleagues indentified that 34% of patients had elevated scores for anxiety, depression or both.in a recent study of 93 patients(including 43 with cystic fibrosis)of bronchiectasis,20% patients had elevated depression-related scores and 38 % had elevated anxiety-related scores,both depression and anxiety symptoms predicted signiﬁcantly worse health-related quality of life. to date,the studies of depression and anxiety symptoms in patients with non-cf bronchiectasis have been limited by small samples sizes;and no prospective studies have been conducted to investigate the impact of psychological distress on the health outcomes.given the importance of identifying and treating these symptoms, and their implications for long-term health outcomes,we plan to determine the prevalence and risk factors of depression and anxiety in non-cf bronchiectasis.in addition,we investigate the effect of depression and anxiety on the risk of non-cf bronchiectasis exacerbations and hospitalizations.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. hrct diagnosed bronchiectasis 3. no fever,no worsening of respiratory symptoms,and no medication change within the 4 weeks before recruitment. 4. capable of providing written informed consent exclusion criteria: 1. cystic fibrosis 2. previous lung transplantation

Keywords: bronchiectasis depression anxiety
radiomics to identify patients at risk for developing pneumonitis, differentiate immune checkpoint inhibitor-induced pneumonitis from other lung inflammation and distinguish tumour pseudo-progression from real tumour growth

Conditions: Stage IV Non-small Cell Lung Cancer

Summary: the investigators will develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-pd1 or anti-pd-l1 (cases) and 40 patients without a pulmonary event under anti-pd1 or anti-pd-l1 (controls). on the basis of the case-control study of patients treated with anti-pd1 or anti-pd-l1, they will further optimise the model using reinforcement machine learning. the model will then be validated in 300 prospective patients.

preliminary analyses on a dataset showed a clear distinction in radiomics features for patients with and without pneumonitis from anti-pd1 or anti-pd-l1. prior experience of the investigators of training and validating radiomics signatures combined with their preliminary exploratory results presented here, will be used to develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-pd1 or anti-pd-l1 (cases) and 40 patients without a pulmonary event under anti-pd1 or anti-pd-l1 (controls). on the basis of the case-control study of patients treated with anti-pd1 or anti-pd-l1, the investigators will be able to further optimise the model using reinforcement machine learning. the model will then be validated in 300 prospective patients.

Eligibility criteria:
inclusion criteria: * patients who receive standard anti-pd1 or anti-pd-l1 treatment in routine clinical practice for first or second line stage iv non-small cell lung cancer exclusion criteria: * the opposite of the above

Keywords: anti-pd1 anti-pd-l1
infusion system for hepatic cancer

Conditions: Colorectal Cancer Metastatic to Liver; Intrahepatic Cholangiocarcinoma

Summary: this is a single-site, open-label continued access study/treatment protocol under a treatment ide. in addition to treating patients, the primary objective of this study is to assess the safety of using the medtronic synchromed ii programmable pump combined with the intera tapered catheter for hepatic artery infusion (hai) of a standard chemotherapy (fudr) drug for adults with a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma. after successful implantation, the combined pump and catheter system will be evaluated using a nuclear scan in the postoperative period, which is standard procedure to confirm that the pump is functioning prior to hai of fudr. monitoring for safety will include a record of residual pump volume when it is emptied (every 2-12 weeks depending on whether the pump is being used for chemotherapy infusion) to determine if the pump is still working and surveillance of routine cross-sectional imaging (usually every 2-6 months) for any sign of a pump or catheter problem. patients will be monitored for the safety of the pump/catheter combination for up to 5 years or pump removal/study withdrawal.


Eligibility criteria:
inclusion criteria: * patients must be greater than or equal to 18 years of age * have a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to liver or intrahepatic cholangiocarcinoma * at the time of pump placement, patients will either have unresectable, chemotherapy-responsive disease or they will be undergoing resection with planned postoperative hai * be deemed appropriate for pump chemotherapy by both a medical oncologist and a surgical oncologist * provision of signed and dated informed consent form exclusion criteria: * known active infection * is pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial
esophageal motility disorders in patients with non-cardiac chest pain at assiut university hospital

Conditions: Esophageal Motility Disorders

Summary: to determine the prevalence and distribution of esophageal motility disorders in nccp patients who presented after a negative cardiac evaluation and underwent esophageal manometry, esophageal ph monitoring

non-cardiac chest pain (nccp) is defined as recurrent anginalike pain without evidence of cardiac disease \[1\]. nccp is a common disorder and accounts for 14-33% of patient visits to gastroenterologists \[2\]. these patients frequently undergo testing for reflux and esophageal motility as gastroesophageal reflux disease (gerd) is seen in 50-60% and esophageal motility disorders in 15-18% of the patients \[3,4\]. nutcracker esophagus was thought to be the classic manometric finding in nccp \[5\] but other studies have reported ineffective esophageal motility (iem) as the most common motility disorder in nccp \[6,7\]. furthermore, up to one-third of patients do not have any gerd or motility disorders and are labeled as functional chest pain \[8\]. suggested causes in these patients include esophageal hypersensitivity \[9\], abnormal cerebral pain processing and psychological comorbidity \[10\]. the clinical predictors of abnormal esophageal function tests in nccp have not been identified. identifying these factors would lead to limited use of testing in those with risk factors and faster institution of pain modulator therapy in patients who are most likely to have functional chest pain.

Eligibility criteria:
inclusion criteria: 1. age above 18 years 2. patients presented with non-cardiac chest pain exclusion criteria: * 1- age below 18. 2- cardiac chest pain patients
thal-dex incorporated into double pbsc autotransplantation for untreated multiple myeloma (mm)

Conditions: Multiple Myeloma

Summary: the marked activity of thalidomide (thal) and dexamethasone (dex) in relapsed and refractory multiple myeloma (mm) provided the basis for this phase 2 clinical study aimed at investigating the efficacy and toxicity of thal-dex incorporated into melphalan-based double autologous stem cell transplantation (asct)for patients less than 65 years old with newly diagnosed symptomatic mm. thal-dex was given as primary induction therapy and was then continued throughout the subsequent treatment phases until the day before the second autotransplantation. primary study endpoints,as evaluated on an intention to treat basis, are response rates to the different treatment phases (induction, first and second asct), best response whenever achieved, duration of response (dor), time to progression (ttp), progression free survival (pfs)and toxicity profile of thal-dex. secondary endpoints, as evaluated on an intention to treat basis, are overall survival (os) and clinical outcomes (dor, ttp, pfs and os)according to prognostic factors, including cytogenetic abnormalities and imaging features, as detected by 18f-fdg pet/ct.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of symptomatic mm based on standard criteria. * no prior or current systemic therapy for mm, with exception of steroids. * at least 18 years and less than 65 years of age. * presence of quantifiable m protein in serum or urine. * durie \& salmon stage ii-iii or i with disease progression. * adequate organ function (heart, lung). * no previous deep vein thrombosis and/or recurring thrombophlebitis and/or pulmonary embolisms, confirmed by doppler ultrasound or computed tomography scan. * willing and able to comply with the protocol requirements. exclusion criteria: * diagnosis of smouldering or asymptomatic mm, plasmacell leukemia, solitary plasmocytoma of the bone o extramedullary plasmocytoma. * diagnosis of non-secretory mm. * prior or current systemic therapy for mm, with exception of steroids. * more than 65 years of age. * female subjects pregnant. * non adequate organ function (heart, lung). * patient has a prior history of thrombosis or venous thromboembolism or pulmonary embolism.

Keywords: autologous stem cell transplantation thalidomide induction therapy