Kornimate/medical-research-clean huggingface dataset:
efficacy & safety study of lorlatinib in alk/ros1 metastatic nsclc patients with compassionate use treatment

Conditions: Metastatic Non Small Cell Lung Cancer

Summary: this is an observational, non-interventional, retrospective, multicentre and nationwide study. the information will be obtained retrospectively, in most cases when the treatment has already ended. the primary objective of this study is determine the activity of lorlatinib (percentage of responses, duration of response, progression-free survival and time to treatment failure) of patients included in the compassionate use program in spain.

this is an observational, non-interventional, retrospective, multicentre and nationwide study. the information will be obtained retrospectively, in most cases when the treatment has already ended. in cases where the patient continues on the treatment, the researcher will not modify the clinical management of the patient by participating in the study. patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in spain between november 2016 and february 2019 for those with an alk alteration, and between november 2016 to march 2021 for those with ros1 alteration. according to the records of the spanish centres participating in this program, approximately 145 patients have been included. the primary objective of this study is determine the activity of lorlatinib (percentage of responses, duration of response, progression-free survival and time to treatment failure) of patients included in the compassionate use program in spain.

Eligibility criteria:
inclusion criteria: * patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in spain between november 2016 and february 2019 for those with an alk alteration, and between november 2016 to march 2021 for those with ros1 alteration. * patients must have been treated with at least one cycle of lorlatinib within the compassionate use program. * alive patients must have signed, dated the ethics committee approved written informed consent form in accordance with regulatory and institutional guidelines. this must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. exclusion criteria: * alive patients who refuse to sign and date an ethics committee approved written informed consent form. * patients who were accepted in the compassionate use program , but did not receive treatment.

Keywords: lung diseases non small cell lung cancer metastatic disease lorlatinib alk alteration ros1 alteration
the efficacy and safety of dwp16001 in combination with metformin in patients with type 2 diabetes.

Conditions: T2DM (Type 2 Diabetes Mellitus)

Summary: therapeutic confirmatory study to evaluate the efficacy and safety of dwp16001 in combination with metformin in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone.

a multi-center, randomized, double-blind, active-controlled, phase 3, therapeutic confirmatory study to evaluate the efficacy and safety of dwp16001 in combination with metformin in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone.

Eligibility criteria:
inclusion criteria: 1. subjects with t2dm aged 19 to 80 years 2. subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ hba1c ≤ 10.5% 3. subjects with bmi of 20-45 kg/m2 4. subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study exclusion criteria: 1. subjects with current or history of hypersensitivity to the ip of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or sglt2 inhibitors) 2. diabetic ketoacidosis, diabetic coma or precoma within the past year 3. urinary tract infections or genital infections within 4. uncontrolled hypertension (sbp \> 180 mmhg or dbp \> 110 mmhg) 5. egfr \< 60 ml/min/1.73 m2 6. severe heart failure (nyha class iii/iv)
prevalence of hrr-related genes mutations and prognosis in metastatic castration resistant prostate cancer (mcrpc) patients in real world setting

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to investigate the prevalence of tissue homologous recombination repair (hrr)-related gene mutations (positive/negative/variant of uncertain significance (vus)), clinical outcome such as prostate-specific antigen-progression free survival (psa-pfs), overall survivals (os) and treatment pattern in mcrpc patients. \ study design: multi-center, prospective cohort study data source(s): in this study, 155 patients (expected recruitment patients: maximum 205 patients) will be enrolled from approximately 20\~30 sites in japan. study population: mcrpc patients who diagnosed between 2014 and 2018. exposure(s): n.a outcome(s): prevalence of tissue hrr-related gene mutations, clinical outcomes such as over survival and psa-pfs, treatment pattern sample size estimations: the target population is 155 patients based on the prevalence of hrr-related genes (brca1, brca2 and atm) which is reported in previous global study (profound study). statistical analysis: this study is not intended to verify specific hypotheses, and the results are evaluated descriptively. there is no plan of interim analyses before the final analysis.


Eligibility criteria:
inclusion criteria: * age \> 20, japanese men at the time of informed consent. * patients who provided informed consent. if the patient has died, opt-out will be applicable. * patients who are diagnosed as mcrpc between january 1st in 2014 and december 31st in 2018. * patients who have a ffpe tumor sample (primary or metastatic) with formalin neutral buffer solution. * patients which the investigator judges to secure the enough amount of tumor samples for future laboratory test. exclusion criteria: * patients who have failed hrr-related gene mutation testing with the mychoice hrd plus in screening period. * patients who have an only ffpe primary tumor sample (primary or metastatic) with unbuffered formalin including acidic formalin. * patients who have taken an investigational medical product for prostate cancer from jan 1st , 2014 to dec 31st 2020.

Keywords: metastatic castration resistant prostate cancer, brca1, brca2, atm, homologous recombination repair
comparative study of gemcitabine,cisplatin and radiation versus cisplatin and radiation in cancer of the cervix

Conditions: Cancer of Cervix

Summary: the purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. half the patients will receive gemcitabine plus cisplatin while undergoing radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will receive cisplatin along with radiation therapy without adjuvant therapy.


Eligibility criteria:
inclusion criteria: * diagnosed with cancer of cervix * tumor that can be measured * no previous treatment with chemotherapy or radiation for this cancer * karnofsky performance status score \>=70 * able to give written consent * willing and able to participate in the study, both during the active treatment and the follow-up period. exclusion criteria: * impairment such as hearing loss from prior cisplatin therapy * damage to nerves such as being unable to distinguish hot and cold to touch * used other experimental medication in past 30 days * lab test results are not within the limits required for this study * pregnancy or breast-feeding or possibility of becoming pregnant during this study and not using an approved method of birth control.
the problem of colorectal anastomosis safety

Conditions: Colorectal Cancer; Colorectal Carcinoma; Colorectal Neoplasms; Colorectal Adenocarcinoma

Summary: this is a prospective cohort pilot study. the investigators are planning to develop an original, standardized colorectal anastomosis inspection method, which will systemically inspect the anastomosis vascularity using the indocyanine green fluorescent angiography intraluminally and intraperitoneally, the air leak test, the methylene blue test, the tension in the anastomosis inspection, patients' risk factors scale sum. the summarized evaluation will determine the final anastomotic leak risk.


Eligibility criteria:
inclusion criteria: * patients over 18 year * signed written consent * a colorectal anastomosis lower 15 cm from anal verge * elective surgery exclusion criteria: * allergy to indocyanine green dye * pregnancy
study of the natural variation in strokevolume

Conditions: Stroke Volume Variation

Summary: we would like to investigate the natural variation in the strokevolume of the heart. at the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in strokevolume, after a fluid bolus of 200ml voluven, when using esophageal doppler.

we would like to investigate the natural variation in the strokevolume(sv) of the heart. at the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in sv, after a fluid bolus of 200ml voluven, when using esophageal doppler. also we will compare the variation in sv both before and after the patients have been fluid optimized, using an algorithm of 10% increase in sv in order to receive another fluid bolus. the equipment used, will be the cardioq from deltex medical.

Eligibility criteria:
inclusion criteria: * planned abdominal surgery exclusion criteria: * oesophageal pathology, * age \>90 yr or \<18 yr, * alcohol abuse, * aneurism in thoracic aorta

Keywords: stroke volume sv variation esophagus doppler goal directed therapy
predicting episodes of intracranial hypertension in neuro-injured patients: development of a decision algorithm using artificial intelligence (predict-ce)

Conditions: Creation of a Warehouse of Clinical Data and Physiological Signals at the Patient's Bedside

Summary: the investigators wish to build up a database of clinical data and physiological signals with a view to developing a predictive algorithm based on continuous analysis of the intracranial pressure waveform and other parameters commonly used in intensive care to predict the occurrence of an episode of intracranial hypertension (htic). this algorithm will be designed using supervised learning statistical methods based on innovative statistical analysis methods (artificial intelligence). these methods are classically used to exploit massive data such as sensor data.


Eligibility criteria:
inclusion criteria: * more than 18 years * admission to intensive care for less than 3 days for a neurological lesion * sensor placement for intracranial pressure monitoring exclusion criteria: * patient under judicial protection * refusal to participate * patients under 18 years of age
comparison of patient outcomes using different delivery models of anticoagulation care

Conditions: Anticoagulation; Thromboembolism

Summary: hypothesis: does the time spent within the target inr range differ when patients are managed by amd or it models of anticoagulation care? experimental design: the 36-month trial enrolled 192 eligible patients currently receiving chronic warfarin therapy at the william s. middleton memorial va hospital. consenting patients are enrolled and randomized to 1 of 2 groups: usual clinic care with face-to-face visits every 4 weeks (ams model) or clinic visits every 3 months with interim laboratory visits and telephone follow-up every 4 weeks (it model). at study conclusion, the amount of time the inr is within target range will be compared between the two groups. thromboembolic and bleeding event rates, patient knowledge, quality of life and healthcare utilization will also be analyzed.


Eligibility criteria:
inclusion criteria: * completion of \>3 months of warfarin * indefinite warfarin therapy exclusion criteria: * patients who currently receive \>25% of inr determinations per year from local labs * extended absences from va
indocyanine green fluorescence in evaluation of pancreatic remnant perfusion.

Conditions: Pancreatic Fistula

Summary: main goal of this study is to evaluate the blood flow in a post resection pancreatic remnant after pancreaticoduodenectomy with use of indocyanine green fluorescence. if the hypothesis will be proven, evaluation of perfusion of the pancreatic remnant with indocyanine green could be used to estimate the increased risk of the development of pancreatic fistula.

pancreatoduodenectomy is associated with nearly 25% incidence of postoperative complications. one of the most severe complications is a postoperative pancreatic fistula. the exact cause of postoperative fistula development is still unknown, but it appears to be multifactorial. proper perfusion of pancreatic remnant is essential for the healing of pancreaticojejunostomy. to date, there is no method to reliably evaluate the vascular supply of the remnant. one of the methods for assessment of organ perfusion is the indocyanine green fluorescence. this study aims to determine if indocyanine green fluorescence is a reliable method to measure the perfusion of the post-resection pancreatic remnant. secondary outcome is to determine, if perioperative evaluation of the vascular supply of the postresection remnant may predict the increased risk of the postoperative pancreatic fistula development. this study is designed as a prospective experimental study. all consecutive patients undergoing open pancreaticoduodenectomy at our department in the 1.5.2024-31.12.2026 period will be enrolled. exclusion criteria are allergy to indocyanine green and refusal by the patient.the adequacy of the vascular supply of the post-resection pancreatic remnant will be perioperatively evaluated using fluorescence detector. patients will be divided into two groups. those with hazardous and non-hazardous vascular supply. the incidence of pancreatic fistula in both groups is to be compared. postoperative data including morbidity, mortality, hospital stay, intensive care unit stay and postoperative fistula development will be collected. if a perioperative assessment of the perfusion of post-resection pancreatic remnant using indocyanine green is proven to be a suitable method to estimate the increased risk of the pancreatic fistula, the list of the existing known risk factors could be expanded. in the most high-risk patients the modification of the surgical procedure could be considered.

Eligibility criteria:
inclusion criteria: * all consecutive patients undergoing open pancreaticoduodenectomy at our department in the selected period exclusion criteria: * allergy to indocyanine green * refusal by the patient * mini-invasive procedure.

Keywords: pancreatic surgery icg minimal invasive surgery, pancreatic cancer pancreatic perfusion
microbiome in pulmonary tuberculosis, non-tuberculous mycobacterial pulmonary diseases, lung cancer and hemoptysis

Conditions: Tuberculosis, Pulmonary; Non-Tuberculous Mycobacterial Pneumonia; Lung Cancer; Hemoptysis

Summary: microbiome in lower respiratory diseases is not sufficiently known yet. the objective of this study is to investigate microbiome in patients who present with hemoptysis, and those with pulmonary tuberculosis, non-tuberculous mycobacterial pulmonary disease (ntm-pd), and lung cancer, analyzing respiratory specimen acquired by bronchoscopic approach.

subjects who were going to undergo bronchoscopy for hemoptysis or suspected lower respiratory diseases including endobronchial tuberculosis (tb), ntm-pd, or endobronchial lung cancer (lc) were enrolled after informed consents. subjects who were supposed to receive bronchoscopy to rule out endobronchial lesions were also enrolled as control group (ctrl) after informed consents. in those control group, endobronchial tuberculosis, malignancy or other certain respiratory diseases was not clearly suspected. before acquiring respiratory specimens, bronchoscopic channels were washed to acquire negative control in all cases of groups. in tb group and lc group, specimens of normal bronchial mucosa near suspicious endobronchial lesion were obtained with protected brush (pb), then specimens of abnormal bronchial mucosa in suspicious endobronchial lesion with pb. after acquiring respiratory specimens of pb, bronchial washing was done in suspicious endobronchial lesion. in ntm-pd group, specimens of bronchial mucosa in bronchus of suspicious ntm-pd with pb. after acquiring respiratory specimens of pb, bronchial washing was done in bronchus of suspicious ntm-pd. in hemoptysis group, bronchial washing was done in bronchus of ongoing bleeding. in control group, specimens of bronchial mucosa in predetermined random bronchus (not bronchus with suspicious endobronchial lesion) with pb. after acquiring respiratory specimens of pb, bronchial washing was done in the same bronchus. microbiome in lower respiratory species was analyzed using 16s rrna sequencing.

Eligibility criteria:
inclusion criteria: * patients who underwent bronchoscopy for hemoptysis, or * patients who underwent bronchoscopy for suspicious endobronchial pulmonary tuberculosis observed on chest computed tomography, or * patients who underwent bronchoscopy for suspicious non-tuberculous mycobacterial pulmonary disease (ntm-pd) observed on chest computed tomography, or * patients who underwent bronchoscopy for suspicious endobronchial lung cancer observed on chest computed tomography, or * patients who underwent bronchoscopy to rule out endobronchial lesion which did not seem to be typical for any criteria of pulmonary diseases including tuberculosis, ntm-pd or lung cancer on chest computed tomography exclusion criteria: * other malignancy, infection or serious diseases of neural, cardiovascular, renal, hepatobiliary, gastrointestinal, hemotologic or respiratory system * use of any antibiotic within a month * vulnerable volunteer * subject's rejection
a efficacy, safety, and tolerability study of canagliflozin in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin alone or in combination with a sulphonylurea

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the safety, tolerability, and efficacy of the addition of canagliflozin relative to the addition of placebo in patients with inadequate glycemic control on metformin alone or in combination with a sulphonylurea.

this is a double-blind (neither study staff or the patient will know the identity of the treatment assigned) study of canagliflozin where chinese and other asian adult patients with type 2 diabetes mellitus (t2dm) who have inadequate glycemic control on metformin alone or in combination with a sulphonylurea (su) will be randomized (assigned to 1 of 3 treatments by chance) to receive the addition of treatment with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, or matching placebo capsules (placebo is a treatment identical in appearance to canagliflozin but does not contain active drug). all patients will take orally (by mouth) 1 single-blind placebo capsule once daily before the first meal of the day for up to 2 weeks (last dose of single-blind placebo to be taken the day before the baseline (day 1) visit. on day 1, patients will take orally, once daily 1 capsule of canagliflozin 100 mg, canagliflozin 300 mg, or placebo before the first meal of the day for up to 18 weeks.

Eligibility criteria:
inclusion criteria: * patients with t2dm with inadequate glycemic control on metformin monotherapy or on metformin in combination with an su at protocol-specified doses and having hba1c \>=7.0% and \<=10.5% at week -2 are eligible for enrollment in the study. exclusion criteria: * history of diabetic ketoacidosis, type 1 diabetes mellitus (t1dm), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy * has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (fpg) and/or fasting self-monitored blood glucose (smbg) measurements \>=270 mg/dl (15 mmol/l) during the pre-treatment phase, despite reinforcement of diet and exercise counseling * history of a severe hypoglycemic episode within 6 months before screening * history of or current illness considered to be clinically significant by the investigator

Keywords: canagliflozin placebo type 2 diabetes mellitus
intraoperative optimisation of tissue oxygenation

Conditions: Higk Risk Surgery

Summary: monitoring and optimizing tissue oxygenation (sto2) in high-risk surgery and/or high-risk surgical patients may decrease the risk of postoperative complications. tissue hypoxia occurs frequently during high-risk surgery in high-risk patients. the investigators want to see if an algorithm aimed at optimizing intraoperative tissue oxygenation reduces perioperative complications as well as length of stay in the intensive care unit (icu los), 28-day mortality, and the duration of mechanical ventilation in these patients.


Eligibility criteria:
inclusion criteria: . major elective surgery * aged over 65 years with moderate functional limitation of one or more organ systems * asa classification iii or iv, i.e. severe cardiac, vascular, respiratory or metabolic illness resulting in severe functional limitation * routine use of arterial and central venous lines * planned postoperative stay on icu or pacu exclusion criteria: * refusal of consent * acute myocardial ischemia prior to enrolment * patients receiving palliative treatment only * disseminated malignancy * patients unlikely to survive more than 6 hours * emergency surgery * transplantations * neurosurgical patients * patients undergoing extensive liver surgery requiring low cvp management

Keywords: tissue oxygenation higk risk surgery high risk patient postoperative complications