Kornimate/medical-research-clean huggingface dataset:
pembrolizumab, lenvatinib and chemotherapy after tkis in nsclc

Conditions: Nsclc; EGFR Activating Mutation; EGF-R Positive Non-Small Cell Lung Cancer; ALK Gene Rearrangement Positive; ROS1 Gene Rearrangement; ROS1 Positive NSCLC - Reactive Oxygen Species 1 Positive Non-Small Cell Lung Cancer

Summary: adding chemotherapy or anti-vegf to immunotherapy is an emerging strategy to enhance the efficacy of immunotherapy in many cancers. this phase 2 study aims to explore the preliminary efficacy of combination pembrolizumab with lenvatinib and chemotherapy in nsclc patients with sensitizing egfr, alk, or ros1 genetic aberration refractory to standard targeted therapy.


Eligibility criteria:
main inclusion criteria: * histologically proven nsclc * unresectable or metastatic nsclc, including squamous cell carcinoma, harboring sensitizing egfr, alk, or ros1 genetic aberrations who have received standard of care targeted therapy and have progressed on treatment. patients with known t790m mutation should have received osimertinib and failed. * measurable disease per recist 1.1 * ecog performance status ≤ 1 * adequate organ function * adequately controlled blood pressure main exclusion criteria: * prior exposure to immunotherapy or chemotherapy * active untreated brain metastasis and/or carcinomatous meningitis * active, known or suspected autoimmune disease * history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease * condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications * baseline proteinuria ≥ 1 g/24 hrs * electrolyte abnormalities that have not been corrected * significant cardiovascular impairment * gastrointestinal pathology that might affect the absorption of lenvatinib * preexisting grade ≥ 3 gastrointestinal or non gastrointestinal fistula * bleeding or thrombotic disorders or subjects at risk for severe hemorrhage * radiographic evidence of intratumoral caviations, encasement, or invasion of a major blood vessel * known history of tuberculosis * active, acute, or chronic clinically significant infections requiring therapy, including hepatitis b, hepatitis c, and hiv * ecg with long qtc interval ≥ 470 ms
high dose vitamin d replacement in patients undergoing hematopoietic stem cell transplantation

Conditions: Vitamin D Deficiency

Summary: the purpose of this study is to test the efficacy and safety of high dose vitamin d therapy among hsct patients in a tiered, step-wise manner (step one/two) in order to define treatment doses capable of providing vitamin d sufficiency.

vitamin d deficiency is common in childhood and has been associated with increased incidence of graft versus host disease (gvhd) and decreased survival in patients undergoing hematopoietic stem cell transplantation (hsct). recently, quality improvement efforts to correct serum vitamin d levels among inpatients at cchmc who have already received hsct and who were vitamin d deficient suggest that current recommended doses of vitamin d are inadequate to treat vitamin d deficiency. possible hindrances to vitamin d treatment in the hsct population include malabsorption related to gut gvhd, mucositis, increased requirement for calcium and/or vitamin d, kidney disease, liver disease, and infection. single, high dose vitamin d treatment (stoss-therapy) has been utilized effectively to treat rickets and other chronic illnesses such as cystic fibrosis in children. the investigators hypothesize that stoss-therapy provided orally prior to transplantation will result in rapid and sustained correction of vitamin d deficiency in children who require hsct. the investigators propose to test the efficacy and safety of high dose vitamin d therapy among hsct patients in a tiered, step-wise manner (step one/two) in order to define treatment doses capable of providing vitamin d sufficiency.

Eligibility criteria:
inclusion criteria: * step 1: patients who are preparing for hsct, 25ohd level (\<50 ng/ml), and no prior history of hsct. * step 2: patients who are preparing for hsct 25ohd level (\<50 ng/ml). exclusion criteria (both step 1 and step 2): * patients with history of pathologic fractures, * uncorrected hypocalcemia or hypophosphatemia, * known history of nephrocalcinosis or nephrolithiasis, * current granulomatous disease, * those currently in icu.
real world use of tocilizumab biosimilar study

Conditions: Rheumatoid Arthritis

Summary: the goal of this non interventional study is to evaluate the use of tyenne, a tocilizumab biosimilar, in a real world setting in rheumatoid arthritis (ra) patients over a period of 12 months. the main questions it aims to answer are: * what is the patients' persistence on tyenne (patient's ability to continue the treatment for the prescribed duration), 6 months after treatment start? * what is the patients' persistence on tyenne (patient's ability to continue the treatment for the prescribed duration), 12 months after treatment start? the decision of prescribing tyenne will be done by the physician independently, prior to patient enrolment in the study. enrolled patients will be followed for 12 months following tyenne treatment start, or until they permanently discontinue tyenne. there will be one baseline visit and three follow-up visits at approximately 3, 6 and 12 months after tyenne treatment initiation. all follow-up visits will be conducted according to the physician current clinical practice and are not imposed due to this protocol.


Eligibility criteria:
inclusion criteria: * patients initially diagnosed with moderate to severe rheumatoid arthritis (ra) according to acr/eular 2010 rheumatoid arthritis classification criteria * patients for whom the decision to prescribe tyenne, a tocilizumab biosimilar has been made by the investigator prior to the inclusion, in accordance with the summary of product characteristics (smpc), local label and physician' current clinical practice * patients able to understand and complete the study questionnaires in local language during the study visits * patients are willing to enter the study (signed informed consent) exclusion criteria: * patients participating or expected to participate in any interventional clinical trial during their treatment with tyenne, a tocilizumab biosimilar

Keywords: tocilizumab rheumatoid arthritis persistence real world use biosimilar biosimilar switch tyenne
a better way to decrease knee swelling in patients with knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: in this study, we compared the effects of intermittent pneumatic compression along with conventional treatment and cold-pack treatment along with conventional treatment on clinical outcomes in patients with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: patients diagnosed with knee oa according to the criteria of the american college of rheumatology (acr), and were considered as stage 2 and 3 according to kellgren-lawrence criteria. exclusion criteria: exclusion criteria were previous knee surgery, malignancy, circulation disorder, and conditions preventing exercise or causing muscle weakness, pregnancy, diagnosis of mental disorder, scar tissue, or metal implants.
intensification with enfuvirtide in naive hiv-infected patients (anrs130)

Conditions: HIV Infections; AIDS

Summary: hiv infection is diagnosed late in a substantial proportion of patients having an increased risk of clinical progression (aids, new aids-defining event or death). the currently recommended antiretroviral therapy has suboptimal activity in this setting and potent quadruple-drug therapy has not been sufficiently evaluated. enfuvirtide may be an appropriate candidate as the fourth antiretroviral agent, regarding its activity, its parenteral administration avoiding gastrointestinal symptoms that often lead to interruption of treatment, the lack of pharmacokinetic interactions and the absence of systemic toxicity. the aim of this study is to investigate, in a comparative intensification trial, the immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral therapy in hiv-1 infected and severely immunosuppressed patients, naïve of any antiretroviral treatment. we postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting in emtricitabine/tenofovir combined with either efavirenz or lopinavir/r may improve immunological restoration, measured as the proportion of patients with more than 200 cd4 cells per mm3 after 24 weeks of antiretroviral therapy.

the purpose of this randomized, open-label study is to evaluate the immunological efficacy of two first-line strategies of antiretroviral therapy: 1. emtricitabine/tenofovir disoproxil fumarate coformulated plus efavirenz (or lopinavir/r) intensified by enfuvirtide during the first 24 weeks of therapy. 2. emtricitabine/tenofovir disoproxil fumarate coformulated plus efavirenz (or lopinavir/r) patients with lymphocytes t cd4+ cell (cd4)count below 100 per mm3, or cd4 cell count below 200 per mm3 and past history or presence of aids defining event and naïve of any antiretroviral therapy will be eligible. this multicenter study will enroll 220 patients (n=110 in each arm). the planned duration of the study is 48 weeks from the enrolment of the last subject. the primary endpoint will be immunological success defined as cd4 cell count above 200 cells per mm3 after 24 weeks of initial treatment. the durability of this response will be evaluated and patients will be followed for 48 weeks.

Eligibility criteria:
inclusion criteria: * antiretroviral naïve hiv-1 infected patients * cd4 cell count below 100 per mm3, or cd4 cell count below 200/mm3 and past history or presence of b or c(aids defining)event * signed informed consent exclusion criteria: * pregnancy; breast feeding * coinfection with hiv-2 or infection with hiv-1 subtype o * antiretroviral pretreated patients * neoplasia disease currently treated with chemotherapy or radiotherapy * severe liver failure * treatment with cytokines or hiv vaccine trial * one or more of the following biological abnormalities: hemoglobin below 10 g/dl, neutrophils below 750 per mm3, thrombocytopenia below 50000 per mm3, creatinine clearance below 60 ml per min, liver function tests over 3 upper limit of normal

Keywords: hiv infections fuzeon truvada aids treatment naive
ft596 as a monotherapy and in combination with anti-cd20 monoclonal antibodies

Conditions: Lymphoma, B-Cell; Chronic Lymphocytic Leukemia

Summary: this is a phase i dose-finding study of ft596 as monotherapy and in combination with rituximab or obinutuzumab in subjects with relapsed/refractory b-cell lymphoma or chronic lymphocytic leukemia. the study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.


Eligibility criteria:
key inclusion criteria: diagnosis of b-cell lymphoma or cll as described below: b-cell lymphoma: * histologically documented lymphomas expected to express cd19 and cd20 * relapsed/refractory disease following prior systemic immunochemotherapy regimen chronic lymphocytic leukemia (cll): * diagnosis of cll per iwcll guidelines * relapsed/refractory disease following at least two prior systemic treatment regimens all subjects: * capable of giving signed informed consent * age ≥ 18 years old * stated willingness to comply with study procedures and duration * contraceptive use for women and men as defined in the protocol key exclusion criteria: all subjects: * females who are pregnant or breastfeeding * eastern cooperative oncology group (ecog) performance status ≥2 * body weight \<50 kg * evidence of insufficient organ function * receipt therapy within 2 weeks prior to day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to day 1 * currently receiving or likely to require systemic immunosuppressive therapy * prior allogeneic hematopoietic stem cell transplant (hsct) or allogeneic car-t within 6 months of day 1, or ongoing requirement for systemic gvhd therapy * receipt of an allograft organ transplant * known active central nervous system (cns) involvement by malignancy * non-malignant cns disease such as stroke, epilepsy, cns vasculitis, or neurodegenerative disease * clinically significant cardiovascular disease * known hiv infection * known active hepatitis b (hbv) or hepatitis c (hcv) infection * live vaccine \<6 weeks prior to start of lympho-conditioning * known allergy to albumin (human) or dmso

Keywords: lymphoma leukemia
prediction of lymphatic metastasis in esophageal cancer by ct radiomics

Conditions: Esophagus Cancer

Summary: this study proposes to establish a ct radiomics-based prediction model for identifying metastasis lymph nodes in esophageal cancer.

this study proposes to establish an image feature extraction and selection method for identifying lymph node metastasis of esophageal cancer.the study will consider the relationship between the main lesion and the suspected lymph node, extract association characteristics in order to improve the sensitivity and specificity of the ct radiomics-based prediction model for identifying metastasis lymph nodes. the study includes the construction of ct radiomics-based prediction model and the validation of the prediction model.

Eligibility criteria:
inclusion criteria: * pathologically proven esophageal cancer * scheduled to preoperative enhanced chest ct and undergo surgery * sign the patient informed consent exclusion criteria: * failed to receive preoperative enhanced chest ct or undergo surgery * inavailable pathological results for local lymph node status * inquality of ct images for feature extraction * patient quit

Keywords: esophagus cancer; radiomics; computed tomograpy
tracking response to antidepressants in advance of investigational trials, relapse study

Conditions: Major Depressive Disorder

Summary: trait-rs is an observational study to evaluate ongoing treatment response stability to standard of care antidepressant treatments (adts) among individuals who met criteria for major depressive disorder (mdd) and completed the tracking response to antidepressants in advance of investigational trials (trait) study (nct04748276).


Eligibility criteria:
inclusion criteria: * participant has completed the trait study and, in the opinion of the investigator, would benefit from ongoing depression monitoring and/or adt treatment. * participant has signed an icf prior to any study-specific procedures being performed. * participant is male or female of age ≥ 18 years. * participant is in good physical health and, in the opinion of the investigator, is a suitable candidate for treatment with an adt. exclusion criteria: * participant is pregnant, breast-feeding, or planning to become pregnant. * a history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality, which, in the opinion of the investigator, may impact participant safety or study results. * participant has a history of any psychiatric condition other than mdd, which, in the opinion of the investigator, is primary or any other psychiatric or neurologic disorder or symptom that could pose undue risk to the participant or compromise the study. * any participant who represents an acute suicidal risk in the opinion of the investigator. * moderate or severe substance use disorder within 90 days prior to screen according to dsm-5 criteria that, in the opinion of the investigator, could pose undue risk to the participant or compromise the study. * any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.
sustaining remission from ptsd using tuned vibroacoustic stimulation (tvs) following mdma-assisted psychotherapy

Conditions: Stress Disorders, Post-Traumatic

Summary: the purpose of this research is to examine a wearable device called apollo that emits gentle vibrations found to benefit mood, energy, and focus. we want to understand how it affects outcomes related to mdma-assisted psychotherapy for ptsd including depression, anxiety and emotion regulation. this study will test whether regular use of the apollo wearable improves rates of sustained symptom remission in ptsd following mdma-assisted psychotherapy over the course of two years

the study examines the effect of the apollo wearable on its users after undergoing mdma-assisted psychotherapy. there will be no study specific modification to the mdma-assisted psychotherapy that participants receive. all study participants will have previously consented to maps mdma-assisted psychotherapy for ptsd clinical trial before enrolling in this protocol. once they have been identified as people who have been consented to the maps trial regardless of this research, they will be approached about the study, and screened/consented/enrolled accordingly. participants will receive the apollo wearable device via mail upon consenting to participate in this study. they will be provided an instruction manual with guidelines on how to best use the device and will be asked to continue to use the apollo device in their everyday life following mdma-assisted psychotherapy. participants in the study will be asked to complete monthly online questionnaires for the duration of the two year study. please note: this study is not affiliated with the maps organization who is running the mdma-assisted psychotherapy research study.

Eligibility criteria:
inclusion criteria: * age 18 or over * completion of the maps mdma-assisted psychotherapy for ptsd clinical trial (treatment cohort) * completion of the maps mdma-assisted psychotherapy for ptsd clinical trial (placebo cohort) * enrolled in the maps mdma-assisted psychotherapy for ptsd clinical trial, but dropped out exclusion criteria: * unable to give adequate informed consent * have any current problem which, in the opinion of the investigator might interfere with participation * are unable to complete questionnaires written in english

Keywords: remission ptsd psychotherapy mdma
evaluation of oral and maxillofacial swellings by ultrasonographic features

Conditions: Swelling Lips & Face

Summary: fifty patients were randomly selected with oral and/or maxillofacial swelling, thorough case history and clinical examination were done, then ultrasound examinations were done for all of them and they were classified into five groups (i. inflammatory/space infection and abscess swellings), (ii. cystic swellings), (iii. lymph node swellings), (iv. benign swellings) and (v. malignant neoplastic swellings) according to their ultrasound features. the patients were subjected to histopathologic evaluation.

fifty patients with swellings in the oral and/or maxillofacial region were randomly selected. any other swellings that were caused by trauma and/or fracture, extended below the neck or patient reluctant to undergo us were excluded from the study. this study was approved by the (research ethics committee) (rec), faculty of dentistry, minia university before starting the research and all the entire patients had signed a standardized informed consent laid down by rec. a comprehensive questionnaire was used to assess history and through extra-oral \& intra-oral examinations were carried out and recorded on the basis of criteria reported by das.11 the ultrasonographic investigations were carried using an ultrasound diagnostic modality (logiq- p5) (ge medical system, korea) with color doppler function by using a linear array transducer, operating at a frequency of (7.5-12 mhz). all the examinations were performed over the swellings and also compared to the contra-lateral/normal side whenever needed. (fig. 1) all sonographic images were interpreted by an expert sonologist (15 years experience) and us features were recorded to extract ultrasonographic guided (usg) diagnosis and patient's swellings were categorized into five groups: inflammatory/infection/abscess swellings (group i), cystic swellings (group ii), lymph node swellings (group iii), benign swellings (group iv) and malignant neoplastic swellings (group v).12 finally, the included patients were subjected to either fine needle aspiration cytology (fnac) or surgical intervention for histopathological examination to extract the histopathological diagnosis

Eligibility criteria:
inclusion criteria: * all with oral and/or maxillofacial swelling, exclusion criteria: * any other swellings that were caused by trauma and/or fracture, extended below the neck or patient reluctant to undergo us were excluded from the study.
contrast-enhanced bowel ultrasound in making a diagnosis and follow-up of patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: the purpose of this study is to determine the efficacy of sonovue® in participants with crohn's disease and ulcerative colitis to various aspects including type of inflammatory bowel disease, disease activity, the need for surgical treatment.

each patient is subjected to clinical, laboratory and endoscopic evaluation, each eligible patient is assigned to one of the arms: arm 1: patients with ulcerative colitis (50 patients) arm 2: patients with crohn's disease (50 patients) in each arm, patients are classified according to clinical an endoscopic activity of the disease. each patient is subjected to ultrasound examination of the bowel using a philips iu 22 machine according to a standardized protocol: * 12h fasting period * exploratory scanning with the use of convex c5-1 probe * detailed scanning with the use of linear l 12-5 probe with power doppler * choosing a bowel segment with the most prominent changes * contrast-enhanced ultrasound (ceus) ceus is performed according to the following protocol: * administration of drotaverine hydrochloride (no-spa ®) to reduse excessive peristaltic movement * visualization of the previously chosen affected bowel segment with the use of dce-us (dynamic contrast-enhanced ultrasound) technology * administration of 2.4 ml sonovue® intravenously with a bolus injection through a peripheric venous line (left antecubital vein), followed by a 10ml 0.9% natrium chloride bolus * the video-loop is acquired during contrast agent administration and wash-out (preferable loop duration - 3 min) * the original dicom loop is sent to a work station philips qlab platform is used to acquire a fitted local density random walk wash-in wash-out algorithm (ldrwiwo algorhithm) time-intensity curve of contrast agent wash-in and wash-out. qualitative and quantitative (time to peak, rise time, mean transit time, wash-in slope, peak intensity, area under curve, time from peak to one half) parameters are calculated for each region of interest (roi).

Eligibility criteria:
inclusion criteria: * patient with verified uc/cd aged from 18 to 60y * signed informed consent form for the study exclusion criteria: * pregnancy * known allergy or history of adverse reaction to sulfur hexafluoride preparations * marked pulmonary hypertension * uncontrolled hypertension

Keywords: contrast-enhanced ultrasound inflammatory bowel disease cd uc sonovue endoscopic activity