Kornimate/medical-research-clean huggingface dataset:
efficacy of treatment sequences in patients with non-small cell lung cancer receiving lorlatinib

Conditions: Non-small Cell Lung Cancer Metastatic; ALK Gene Rearrangement Positive; ROS-1 Gene Rearrangement Positive

Summary: the study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced alk- and ros1-positive non-small cell lung cancer who received lorlatinib as part of the french expanded access program.

ifct-1803 lorlatu study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced alk- and ros1-positive non-small cell lung cancer who received lorlatinib (pf-06463922) as part of the french expanded access program. those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed locally advanced or metastatic nsclc (stage iiib or iv accordingly to american joint committee on cancer \[ajcc\] classification) at time of lorlatinib initiation * patients who received at least one week of treatment with lorlatinib as part of the french expanded access program (atu program); atu was granted due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable. exclusion criteria: * patients enrolled in a lorlatinib clinical trial

Keywords: lorlatinib non-small cell lung cancer ifct real-world study
continuous renal replacement therapy with oxiris in acute kidney injury and sepsis

Conditions: Acute Kidney Injury; Sepsis

Summary: it is an epidemiology study to explore outcomes in patients with acute kidney injury (aki) and sepsis submitted to continuous renal replacement therapy (crrt) with oxiris™. objectives: describe the experience and outcomes in patients with sepsis and aki treated receiving crrt with the adsorption membrane filter oxiris™

study background \& rationale: acute kidney injury (aki) is common in patients with sepsis, occurring in 5-50%. it happens in the context of a critical illness requiring intensive care. fifteen percent require renal replacement therapy as supportive therapy until the kidneys recover. membrane-coated filters, such as oxiris™, promote high filtration clearance of uremic toxins, but additionally removal of inflammatory mediators and bacterial liposaccharide (lps) . even though this potential mechanism should be expected to benefit septic and aki patients, results have not been uniform. the investigators´ group has been prescribing crrt for aki treatment for the last 20 years, having performed more than 20 thousand procedures. the investigators´ group experience with oxiris™ filter in crrt started in 2018. the objective of the study is to describe the clinical operational management of crrt with this kind of filter and to explore patients' outcomes.

Eligibility criteria:
inclusion criteria: * adults (\>18 years) * diagnosis of aki (kdigo stage 3) * diagnosis of sepsis of any cause exclusion criteria: * covid19 diagnosis

Keywords: acute kidney injury blood purification adsorptive membranes sepsis cytokines
multi-component hiv intervention packages for chinese men who have sex with men -test, link and care (tlc)

Conditions: HIV/AIDS

Summary: 1. the number of msm who are tested for hiv in the 4 study clinics over 12 months will increase compared with historical data from the same 4 clinics over the past 12 months prior to the intervention. 2. persons diagnosed with hiv over the duration of 12 months will have higher cd4 counts at diagnosis than persons diagnosed with hiv over the past 12 months prior to the intervention


Eligibility criteria:
inclusion criteria:• men who had sex with another man in the last 12 months based on self-reporting (sex can be defined as oral, anal, or mutual masturbation)(including transgendered women)（including transgendered women）; * aged 18 years or older; * living and/or working in the defined districts of municipal beijing; * able and willing to adequately grant informed consent. for the purposes of this activity participants must consent to questionnaire surveys, receipt of phone messages, and serological testing; * having not previously participated in hiv testing in this study. besides these criteria, additional criteria for the hiv linkage and care pilot research clinical trial are: * men who are being identified as hiv positive during the testing campaign in phase i of the study; * no plan to leave beijing in the next 12 months. * willing to comply with study procedures. * having a cell phone and willing to receive study related sms texts exclusion criteria: having previously been found to be hiv positive based on self-reporting during eligibility screening; * serious psychological disturbance or cognitive impairment interfering with the participant's ability to comply with the study visit schedule and procedures, as judged by the local study clinician; * any other medical or psychiatric condition that, in the opinion of the investigator, would make participation in the study unsafe, or otherwise interfere substantially with the study objectives or interpretation.

Keywords: hiv testing linkage care
novel preventive approach against filgrastim-induced bone pain in cancer patients

Conditions: Breast Cancer; Filgrastim Adverse Reaction

Summary: no randomized controlled trial evaluated the safety and efficacy of double blockade on g-csf induced bone pain. therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of g-csf induced bone pain.


Eligibility criteria:
inclusion criteria: 1. eligible patients were 18 years or older. 2. confirmed diagnosis of breast cancer. 3. patients completed adriamycin and cyclophosphamide (ac) regimen and are planned to receive four cycles or more of paclitaxel chemotherapy with g-csf support starting in cycle 1 and continuing throughout each of the four paclitaxel cycles. 4. eastern cooperative oncology group (ecog) performance status from 0 to 2. exclusion criteria: 1. patients with signs and symptoms of grade 2 or 3 bone pain at baseline. 2. patients receiving famotidine in the previous 72 hours. 3. patient receiving any antihistaminic in the previous 72 hours. 4. hypersensitivity to famotidine or loratadine. 5. patient receiving opioid or adjuvant analgesic.
hetrombopag for low/intermediate-1 risk mds with thrombocytopenia

Conditions: MDS

Summary: myelodysplastic syndrome (mds) is a kind of clonal myeloid tumor. the major manifestation is decrease of tri-lineages of blood due to ineffective and abnormal hematopoiesis, some of which can progress to acute myeloid leukemia. according to the international prognosis scoring system (ipss) of mds, about 10% low/intermediate risk-1 mds patients have severe thrombocytopenia (plt \< 30 × 109/ l). these patients have both decreased platelet count and platelet dysfunction, resulting in a high risk of bleeding. in the new prognostic score, such as ipss-r, the degree of thrombocytopenia is regarded as a poor prognostic factor. platelet transfusion is mainly used in the treatment of this kind of patients. the indications of transfusion include bleeding events or severe platelet count reduction (\< 10 × 109 / l). however, platelet transfusion can only lead to short-term platelet elevation, while repeated transfusion increases the possibility of infection and ineffective platelet transfusion. tpo is a newly discovered hematopoietic promoting factor, which can specifically bind to the tpo receptor on the cell and participate in the regulation of proliferation, differentiation, maturation and division of megakaryocyte to form functional platelet. the efficacy and safety of the tpo receptor agonists eltrombopag and romiplostim in the treatment of thrombocytopenia in low/intermediate risk-1 mds patients have been successfully confirmed in foreign studies. hetrombopag is a new kind of a tpo receptor agonists which is highly specific platelet stimulating factor. at present, there is no large report on the application of hetrombopag in such patients. the purpose of this study is to explore the short-term and long-term therapeutic effect and safety of hetrombopag on low/intermediate risk-1 mds patients.


Eligibility criteria:
inclusion criteria: 1. confirmed mds, ipss low / intermediate risk-1 2. in the 4 weeks before inclusion, the average value of platelets was ≤ 30 × 10e9 / l, or \< 50 × 10e9 / l with bleeding events 3. patients with epo due to anemia and g-csf due to severe neutropenia can be included, and the dosage will not change during trial 4. ecog 0-2 points 5. able to sign informed consent exclusion criteria: 1. pregnant or lactating 2. ipss intermediate risk-2 / high risk mds 3. more than 5% of myeloblasts in bone marrow 4. myelofibrosis 5. previous transplantation or atg treatment within 6 months 6. previous use of tpo or other tpo receptor agonists 7. active infection or tumor 8. thromboembolic or hemorrhagic disease 9. serious heart disease, including unstable angina, congestive heart failure, arrhythmia, 1-year history of myocardial infarction 10. baseline liver and kidney function: alt / asl over than 3 times normal upper limit, tbil over than 2 times normal upper limit, and creatinine over than 2 times normal upper limit
kinematics after total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to evaluate and compare implant kinematics of conventional mechanically aligned and anatomically aligned total knee arthroplasties (tka) at 1 year post-operatively.

participants will be randomized to receive a primary tka using either an anatomic alignment or a conventional mechanical alignment technique. participants will undergo a kinematic analysis of a deep knee bend using single-plane fluoroscopy at 1 year post-operatively. the primary outcome will be based on the 6 degree of freedom kinematics and associated joint component proximity during the knee bend task. secondary outcomes include the knee society score, the knee injury and osteoarthritis outcome score, and the forgotten knee score.

Eligibility criteria:
inclusion criteria: * males and females * primary arthroplasty for treatment of osteoarthritis * age between 40 and 80 years old * willingness to provide written consent for study participation exclusion criteria: * revision arthroplasty * pre-operative knee flexion lower than 90 degrees * varus knee deformity greater than 15 degrees * pre-operative valgus knee deformity * presence of infections, highly communicable diseases or metastatic disease * significant neurological or musculoskeletal disorders or disease that may interfere with normal gait or weight bearing * congenital, developmental, or other bone disease or previous hip surgery that may, in the surgeon's judgment, interfere with total knee prosthesis survival or success * presence of previous prosthetic knee or hip replacement device * bmi \> 40 * pregnant women
evaluate the efficacy and safety of quetiapine fumarate (seroquel) extended release as monotherapy in the treatment of patients with bipolar depression

Conditions: Bipolar Depression

Summary: the primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(xr) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with bipolar i and bipolar ii disorder


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * male and female patients, aged 18 to 65 years, inclusive. * meets diagnostic and statistical manual of mental disorders - 4th edition (dsm-iv) criteria for bipolar disorder i or bipolar ii, most recent episode depressed (296.5x and 296.89x). * hamilton rating scale for depression (ham-d) (17-item) total score of ≥ 20 and ham-d item 1 (depressed mood) score ≥ 2 at enrolment and randomisation. * patients must be able to understand and comply with the requirements of the study,as judged by the investigator exclusion criteria: * patients with a current diagnostic and statistical manual of mental disorders - 4th edition (dsm-iv) diagnosis other than bipolar disorder * patients whose young mania rating scale (ymrs) total score \>12 at enrolment and randomisation. * patients with \>8 mood episodes during the past 12 months at enrolment. * patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment. * patients with a history of non-response to an adequate treatment (6 weeks) with more than 2 classes of antidepressants during their current episode. * alcohol or other substance dependence or abuse as defined by diagnostic and statistical manual of mental disorders - 4th edition (dsm-iv) criteria at enrolment that is not in extended full or extended partial remission (12 months or longer), except caffeine and nicotine dependence. * patients who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, have a hamilton rating scale for depression (ham-d) item 3 score ≥ 3, or have made a suicide attempt within the past 6 months.

Keywords: bipolar depression mental disease,
the effect of amantadine on post-covd-19 fatigue

Conditions: Post-COVID-19 Syndrome

Summary: this study aimed to investigate amantadine's safety and its effect on reducing post-covid-19 fatigue.

background the 2019 coronavirus disease has severely affected the health of the general public. even after recovery, this disease can cause problems, including chronic fatigue, which the patient can suffer from for years and cause permanent disability for a number of patients. despite the fact that fatigue due to covid-19 has affected many patients, not many studies have been done in the field of effective treatment for this problem. in this study, the investigators studied the effect of amantadine on the fatigue of covid-19 patients. method in this clinical trial study, 83 patients were randomly included in the study from the patients referred to the internal clinic of shohada tajrish hospital in tehran, and they were initially evaluated by vafs and fss questionnaires. 17 patients were initially excluded due to having at least one exclusion criterion. and 66 patients were randomly divided between two groups using amantadine and the control group. the amantadine group was treated with amantadine capsules 100 mg bd for 2 weeks and after 2 weeks again for both the group questionnaire was completed, and the data was analyzed by spss software version 26.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of covid-19 * clinical evidence of fatigue despite the passage of 30 to 60 days from the onset --of the symptoms of covid-19 * willingness and informed consent to participate in the study exclusion criteria: * the recurrence of covid-19 in the form of re-infection * history of psychiatric diseases * psychotic disorders (in the form of hallucinations and delusions) * anxiety disorders and major depression * substance abuse in the last four months * taking antidepressants during the last six weeks * corticosteroids consumption during the last six weeks * taking psychostimulant drugs * an unstable medical condition * cognitive disorders and confusion * withdrawal from participating in the study * history of rheumatological disease * getting cancer and malignancy * advanced chronic diseases (heart, liver, kidney, etc.) * edema of organs * hypertension (untreated) * hypogonadism (untreated) * hypothyroidism (untreated) * anemia (untreated) * pregnancy and breastfeeding * nausea and vomiting when starting to take amantadine * convulsions * dyspnea * post-covid-19 encephalopathy
fatigue in primary sjögren's syndrome

Conditions: Sjogren's Syndrome; Fatigue; Pain Syndrome; Depression; Anxiety; Fibromyalgia

Summary: fatigue is a common clinical finding in primary sjögren's syndrome (pss). in pss, there is not enough data about the conditions in which fatigue develops and which clinical conditions the disease is associated with. this study was aimed to determine the level of fatigue in primary sjögren syndrome and to investigate the factors affecting the level of fatigue.

while fatigue is seen with a prevalence of 7-8% in the normal population, it is more prevalent in primary sjögren's syndrome (pss). in the studies conducted so far, the frequency of fatigue was seen at a frequency of over 30% in primary sjögren's syndrome. although fatigue is so common in pss, there is not enough data about the conditions in which fatigue develops in pss. other common conditions in pss, apart from fatigue, are psychometric disorders such as common pain, depression and anxiety, and sleep disorders. in the studies conducted so far, each situation mentioned is common in pss and seems to be related to each other. in the literature, there is no data on how many psychometric parameters, pain level, and insomnia affect fatigue and which are independent risk factors in pss.

Eligibility criteria:
inclusion criteria: * patients diagnosed with pss according to the 2016 acr / eular criteria * healthy hospital staff exclusion criteria: * pregnant women * cancer patients * those with other connective tissue diseases other than pss * multiple sclerosis patients * chronic obstructive pulmonary disease * those with heart failure and adrenal insufficiency * those with renal failure: gfr \<60 ml/min * anemia: hemoglobin \<11 g / dl in women, hemoglobin \<12 g / dl in men * hypothyroidism: tsh \>5 mu / l * those with electrolyte disturbance
fetal tracheal occlusion in severe diaphragmatic hernia: a randomized trial

Conditions: Congenital Diaphragmatic Hernia; Congenital Abnormality

Summary: the neonatal mortality rate in cases with severe isolated congenital diaphragmatic hernia is higher than 90% due to severe pulmonary hypoplasia. many studies have suggested that fetal tracheal occlusion may increase lung volumes and therefore reducing the risk for severe pulmonary hypoplasia and by consequence the risk for neonatal death. the main objective of the present study is to evaluate if fetal tracheal occlusion improves survival rate in those cases that are followed in our hospital, by conducing a randomized trial.

fetuses will be randomly allocated in two groups: 1. for fetal tracheal occlusion at 26-28 weeks (feto group) or 2. postnatal therapy only (control) main outcome: survival rate in both groups second outcomes: postnatal diagnosis of severe pulmonary arterial hypertension, percentage of newborns in each group that will have clinical conditions for neonatal surgical repair of the diaphragmatic defect, fetal lung responses (increase of fetal lung size), maternal and obstetrical complications (prematurity, preterm rupture of the membranes, maternal hemorrhage and infection).

Eligibility criteria:
inclusion criteria: * ultrasound diagnosis of congenital diaphragmatic hernia * fetuses at gestational age between 24 and 28 weeks * absence of chromosomal and/or other structural anomalies (isolated congenital diaphragmatic hernia) * severe congenital diaphragmatic hernia defined by lung-head ratio \< 1.0 and more than 1/3 of liver herniated into fetal thorax and observed/expected fetal total lung volume \< 0.35 * patient's consent to participate in the present study exclusion criteria: * patient's refusal to participate in the study after allocation * preterm labor diagnosed before the procedure * preterm rupture of membranes before fetal intervention

Keywords: congenital diaphragmatic hernia fetal anomalies
a human experimental model for neuropathic pain using combined application of capsaicin and local anesthetics

Conditions: Ipsi- and Contralateral Hypoesthesia

Summary: main of the present study was to develop a model of concomitant c-fibre block and sensitization eliciting spontaneous pain as well applying topical capsaicin and local anesthetics (la) to examine the sensory alterations after combined c-fiber block and sensitization in both different application orders (sensitization of blocked c-fibers and block of sensitized c-fibers), compared to each of both mechanisms alone. thereby, we expect stronger sensory changes during the combined substance application than during the monoapplication. we expect also contralateral sensory alterations mirroring the changes on the intervention site after the combined capsaicin and la application, being stronger than after sensitization alone absent after c-fiber block alone.


Eligibility criteria:
inclusion criteria: * healthy subject, older than 18 years, provided written informed consent exclusion criteria: * insufficient comprehension of the german language, history of severe internal, neurological or dermatological diseases, substance abuse, manifest psychiatric diseases, chronic and acute pain, any medication intake (except contraceptives in females) regularly or on demand during the last 14 days before study inclusion and during the study period, hypersensitivity to lidocaine or other amide-type anesthetics, hereditary or acquired methemoglobinemia, pregnancy, nursing, abnormal sensory profile in the quantitative sensory testing (qst) with side-to-side differences beyond the normal range at baseline and participation in clinical trials during the last month.
effect of kb003 in subjects with asthma inadequately controlled by corticosteroids

Conditions: Moderate-to-Severe Asthma

Summary: this study will evaluate the safety, tolerability and efficacy of a single dose level of kb003 in subjects with inadequately controlled asthma.


Eligibility criteria:
key inclusion criteria: * a diagnosis of asthma established for at least 2 years * symptomatic asthma as defined by the juniper asthma control questionnaire * symptomatic asthma despite stable treatment with inhaled corticosteroids fluticasone or budesonide, or other corticosteroids, for at least 12 weeks * currently receiving inhaled long-acting beta agonist (laba) or previously documented laba intolerability or lack of responsiveness * at least 2 exacerbations (no more than 6) in the previous 12 months that required systemic corticosteroids or at least a doubling of daily oral dose key exclusion criteria: * acute asthma worsening (requiring emergency room visit, hospitalization, urgent care, physician visit, or change in asthma medications) or lower respiratory tract infection requiring the use of antibiotics, within 4 weeks prior to screening visit. * history of life-threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past 12 months * use of any immunosuppressive or immunomodulatory agents within 12 weeks or an investigational agent within 4 weeks prior to screening visit * history of any cardiovascular, neurological, hepatic, or renal condition * history of smoking within the past 12 months

Keywords: asthma gm-csf moderate-to-severe asthma
safety, tolerability and pharmacokinetic study of mt-3995 in subjects with diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: the purpose of this study is to evaluate safety, tolerability and pharmacokinetics of mt-3995 in subjects with diabetic nephropathy


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ace-i) or angiotensin ii receptor blocker (arb) * glycosylated haemoglobin (hba1c) ≤10.5% * subject with albuminuria exclusion criteria: * history of type 1 diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy. * serum potassium level \ 5.0 mmol/l * subjects who had acute kidney injury within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation * subjects with clinically significant hypotension

Keywords: diabetic nephropathy