Kornimate/medical-research-clean huggingface dataset:
a safety, tolerability, pk and preliminary activity study of gb263t in advanced nsclc and other solid tumor

Conditions: NSCLC; Other Solid Tumors

Summary: this is a phase 1/2 study of gb263t in participants with advanced nsclc and other solid tumor. the study will consist of a dose-escalation and expansion stage to determine rp2d (phase 1), and an extension stage (phase 2) where participants will be enrolled into indication-specific cohorts.


Eligibility criteria:
inclusion criteria: 1. ≥18 years of age. 2. subjects with histologically or cytologically confirmed metastatic or unresectable advanced nsclc or other solid tumors who have progressed on prior standard therapy, have been intolerant to prior standard therapy, or have refused all other currently available therapeutic options. 3. subjects must have evaluable disease according to response evaluation criteria in solid tumors (recist) v1.1. 4. ecog ps 0-1. 5. an expected survival time is ≥3 months. 6. adequate organ function. 7. subjects in phase ii must agree to provide pre-treatment tumor tissue samples. exclusion criteria: 1. subjects who have had prior chemotherapy, targeted cancer therapy, immunotherapy, or any investigational anti-cancer treatment within 2 weeks or five half-lives of the treatment (whichever is longer), prior to the first administration of the study drug. 2. toxicity (excluding alopecia, peripheral neuropathy, and hypothyroidism) that did not return to class 0 or class 1 of nci ctcae v5.0 from prior antitumor therapy prior to the first administration of the study drug. 3. prior radical radiation therapy completed within 4 weeks prior to the first administration of the study drug. 4. subjects with untreated symptomatic brain metastases. 5. history of interstitial lung disease (ild). 6. uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. 7. received live virus vaccination within 30 days of first dose of study treatment.

Keywords: nsclc phase 1/2 gb263t egfr/cmet/cmet
further evaluation of thalidomide's ability to potentiate the immune response to hiv-infected patients

Conditions: HIV Infections

Summary: to determine if thalidomide modulates the production of hiv-suppressor factors (mip-1 alpha, mip-1 beta, rantes) and th1 type cytokines (il-12 and inf-gamma) in hiv-infected patients and alters viral load.

patients will be divided, 5 per group, into groups i, ii, iii and iv. groups i and ii will include patients who have decided not to take anti-retro viral drugs. groups iii and iv will include patients receiving the same types of antiretroviral drugs. patients in groups i and iii will receive thalidomide while patients in group ii and iv will receive placebo. the placebo capsules will be the same color as the thalidomide capsules and will contain glucose powder. patients will ingest one capsule of thalidomide at 9 pm daily on days 0, 1, 2, 3, 4, 5 and 6.

Eligibility criteria:
inclusion criteria patients must have: * hiv infection. * cd4+ cell count \>= 200/microliter or \> 14% cd4+ cells in peripheral blood. * willingness to commit to the study duration and agree to abide to the time table for entry into the study, ingestion of thalidomide and follow-up. exclusion criteria co-existing condition: patients with any of the following conditions or symptoms are excluded: * fertile females. * patients who participated in a clinical study involving a new drug or device within the last 2 months or the period of time equivalent to seven times the half life of the study drug, whichever is longer. patients with any of the following prior conditions are excluded: hiv related pre-existing peripheral neuropathy. prior medication: excluded: patients using systemic steroidal anti inflammatory drugs or pentoxifylline within 10 days of dosing with thalidomide. required: 10 of the 20 patients must be on antiretroviral therapy and the other 10 will be subjects who have decided not to be on any antiretroviral drug prior to enrollment into this study and do not plan to start such treatment during the study period.

Keywords: adjuvants, immunologic thalidomide cytokines viral load
repeated low-level red-light therapy and orthokeratology in fast-progressing myopia control

Conditions: Myopia, Progressive; Refractive Errors; Eye Diseases

Summary: the purpose of this multicenter randomized clinical trial is to evaluate the adjunctive effect of repeated low-level red-light therapy (rlrl) and orthokeratology (ortho-k) on myopia control in ortho-k non-responders who have undergone ortho-k treatment but were still experiencing fast myopia progression.

myopia constitutes a major threat to personal health globally for its increased prevalence. moreover, its dose-related association with irreversible blindness complications such as myopic macular degeneration have been demonstrated. it is crucial to look for effective ways to control myopia in children to reduce risk of myopic pathologies in later life. orthokeratology (ortho-k) is the first-line optical method in myopia control, resulting in slowing axial elongation by 43-63%. however, results after ortho-k treatment vary among individuals. methods with more accurate efficacy and wider application to slowing down myopia progression, especially for myopia with limited ortho-k response, are still urgently required. repeated low-level red-light (rlrl) therapy is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. our previous clinical study suggested rlrl could effectively retard myopia progression without clinically observable side effects. the purpose of this study is to evaluate the adjunctive effect of rlrl and ortho-k on myopia control in ortho-k non-responders using a multicenter randomized controlled trial design. ortho-k non-responders are defined as who have continuously undergone ortho-k treatment but were still experiencing fast myopia progression. the subjects will be randomly assigned to either experimental group (rlrl and ortho-k) or control group (ortho-k). their axial length will be monitored over one year. changes in axial length in the two groups will be compared.

Eligibility criteria:
inclusion criteria: 1. start to receive ortho-k treatment one year ago. 2. age at enrolment: 8-13 years. 3. ortho-k non-responders: those who have continuously undergone ortho-k treatment but were still experiencing fast myopia progression (annual axial elongation equal to or more than 0.5 mm) in the past one year in at least one eye. 4. before wearing ortho-k lenses, spherical equivalent refractions (sers) ranging from -1.00 to -5.00 dioptres (d) and astigmatism less than -1.5 d in both eyes, anisometropia less than 1.5 d, and best corrected logmar visual acuity (va) equal to or better than 0 in both eyes. 5. parents' understanding and acceptance of random allocation of grouping exclusion criteria: 1. strabismus and binocular vision abnormalities. 2. ocular or systemic abnormalities. 3. prior treatment of myopia control in the past three months, e.g. drugs, progressive addition lenses, bifocal lenses, etc. 4. other contraindications.
evaluation of mt-12 implant survival and marginal bone loss

Conditions: Jaw, Edentulous, Partially

Summary: the trial is designed as a consecutive enrollment prospective one-center study. a minimum of 30 patients will be included in the study. at implant installation, the patient will be randomized to receive one of the two types of implants (control: internal hexagon connection implants (con.int); test: morse taper connection implants (mt-12)). samples of peri-implant crevicular fluid (picf) and intrasulcular plaque will be collected at -21 (second-stage surgery), -14 (impressions), 0 (baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.


Eligibility criteria:
inclusion criteria: * patient \>18 and ≤75 years old * one missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal) exclusion criteria: * one-stage bone augmentation * uncontrolled type 1 or 2 diabetes (hga1c\>8) * known auto-immune or inflammatory disease * severe hematologic disorders, such as hemophilia or leukemia * local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology) * liver or kidney dysfunction/failure * currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy * long-term history of oral bisphosphonates use (i.e., 10 years or more) * history of intravenous bisphosphonates * long-term (\>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion * severe osseous diseases (e.g., paget disease of bone) * pregnant women or nursing mothers * not able or not willing to follow instructions related to the study procedures
role of immune responses after acute myocardial infarction

Conditions: Myocardial Fibrosis

Summary: the fascinating role of lymphocyte subtypes in the development of coronary artery disease may be a new strategic target for understanding and therapy of acute myocardial infarction. the determinants of cell viability are unknown, postulating that they arise from factors not only related to microcirculation or energy expenditure, but also to inflammatory and immune responses. furthermore, the intense mobilization of progenitor cells secondary to myocardial infarction triggers large lymphocyte proliferation that colonizes plaques in development, contributing to recurrent ischemic outcomes. this project aims to evaluate the immune and metabolic mechanisms involved in the recovery of the ischemic myocardium and coronary disease progression.

specifically, the investigators will study the innate and adaptive immunity, with emphasis on lymphocytes subtypes involved in the early and late surrogate outcomes of patients with acute myocardial infarction, their characterization (b1, b2 and t lymphocytes) in cell culture and by flow-cytometry, and immune responses (igm and igg for oxldl and specific epitopes of apob). in addition, the project will evaluate new biomarkers identified by studies of metabolomics, as well as the corresponding signaling pathways. therapeutic pharmacological strategies and changes on intestinal microbiota will be evaluated since the acute phase of myocardial infarction up to 6 months. in the study, the investigators will compared four arms of combined therapy: clopidogrel with rosuvastatin; or clopidogrel with simvastatin; or ticagrelor with rosuvastatin; or ticagrelor with simvastatin. the investigator's hypothesis is that the improvement of microcirculation with rosuvastatin and ticagrelor (synergic pleiotropic effects) may decrease the infarcted mass area, resulting in better left ventricular ejection fraction when compared to the other combined therapies. the monitoring and genotype of microbiota will be examined together the metabolomics and cardiac mris obtained at the acute phase of mi and after 1-mo and 6-mo fu.

Eligibility criteria:
inclusion criteria: 1. stable patients with st elevation myocardial infarction (stemi) treated with thrombolytics in the first 6h or the initial of symptoms of mi. exclusion criteria: 1. contraindication or known intolerance to the study drug protocol 2. those with comorbidities such as neoplasm, renal insufficiency (stage 4 or higher) patients should be randomized in the first 24 hours of ami and treated by one of the four combined therapies at least 2h prior to coronary angiogram followed by percutaneous intervention when necessary.

Keywords: mri ventricular function, left
non-invasive assessment of skeletal muscle loss in cancer patients

Conditions: Cachexia

Summary: the long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. the investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (d-3mh) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples.


Eligibility criteria:
inclusion criteria: * male * 30-75 years old * body mass index (bmi) \<27 kg/m2 exclusion criteria: * uncontrolled hypertension * glomerular filtration rate less than 60 ml/min/1.73 m2 * history of recurrent gastrointestinal bleeding * unable or unwilling to provide informed consent * ongoing anti-coagulant therapy
probiotics for clostridium difficile infection in older adults

Conditions: Clostridium Difficile

Summary: the purpose of this study is to determine whether a probiotic, when used together with standard treatment, is effective in reducing duration of symptoms and preventing recurrence of infection in older adults with a first episode of c. difficile infection.

probiotics are live microorganisms that are available over the counter, widely used as dietary supplements or nutritional foods, and represent a low-cost, well tolerated, safe, non-antibiotic based strategy that may have efficacy as adjunctive treatment of infections without the attendant risks of promoting antimicrobial resistance. certain probiotics have demonstrated inhibition of adherence of pathogenic bacteria and stimulation of systemic immune functions, possibly enhancing the body's ability to eradicate c. difficile in the gastrointestinal tract. however, limited data is available on the efficacy of probiotics for ameliorating c. difficile symptoms and reducing recurrence of c. difficile infection (cdi). the investigators propose a pilot randomized, double-blind, placebo-controlled clinical trial in older adult inpatients with a first episode of cdi to evaluate the efficacy of a probiotic combination, in conjunction with standard treatment, for reducing duration of diarrhea and recurrence of cdi.

Eligibility criteria:
inclusion criteria: * adult of either gender, 18 years or older with a first episode of c. difficile infection * meets the case definition of c. difficile infection-diarrhea associated with a positive stool test for c. difficile toxin(s) in the 2 days prior to enrollment treated with metronidazole or vancomycin exclusion criteria: * severe disease defined as any of the following: wbc \> 30,000 or \ 1.5 times the premorbid level, icu patient at time c. difficile infection diagnosed * has other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal disease) * has a history of chronic intestinal disease (e.g. crohn's disease, ulcerative colitis) * has a presence of toxic megacolon or ileus * has a presence of colostomy or nasogastric tube * has a history of abdominal surgery within the previous 3 months (from time of enrollment) * is enrolled in another investigational drug trial * is unavailable for follow-up visits * history of multiple c. difficile infection * willing not to take other probiotics for duration of study * is severely immunocompromised.

Keywords: clostridium difficile diarrhea infection lactobacilli bifidobacteria lactobacillus acidophilus lactobacillus paracasei bifidobacterium lactis yogurt probiotics
the effectiveness of clavipectoral fascia plane block for clavicle surgery

Conditions: Clavicle Fracture; Clavicle Injury

Summary: clavipectoral fascia plane block (cpb). cpb was defined by valdes in 2017 firstly. it may be used for postoperative analgesia after clavicle surgery. in the literature, data about cpb is so limited, however it seems a good option for pain management after clavicle fracture. the aim of this study is to evaluate the efficacy of the ultrasound-guided cpb for postoperative analgesia management and patient satisfaction in patients underwent clavicle surgery.

clavipectoral fascia plane block (cpb) was defined by valdes in 2017 firstly. it may be used for postoperative analgesia after clavicle surgery. the clavipectoral fascia covers the clavicular site of the pectoralis major muscle. it provides the potential interfascial space between the clavicle and the pectoralis major muscle. cpb provide effective analgesia after clavicle surgery. it is also easy to perform. with this advantage and its analgesic effectiveness for clavicle surgery, cpb may be an alternative to interscalene brachial plexus block. however, randomized clinical efficacy trials are needed to investigate the effectiveness of cpb for clavicle fractures. in the literature, data about cpb is so limited, however it seems a good alternative to brachial plexus block for pain management after clavicle fracture

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) classification i-ii * scheduled for clavicle surgery under general anesthesia exclusion criteria: * bleeding diathesis, * anticoagulation, * thorax wall abnormalities * study drug allergy, * infection at the block area, * pregnancy or lactation, * patients who do not accept the procedure

Keywords: clavicle surgery postoperative pain management clavipectoral fascia plane block
asunercept in patients with severe covid-19

Conditions: COVID-19 Induced Pneumonia; Covid19

Summary: this is an open-label, randomized, phase ii study with the main objective to investigate the effectiveness and safety of an investigational drug (apg101; international nonproprietary name: asunercept) in patients with severe covid-19 disease. the study aims to decrease overall and sars-cov-2 associated pneumonia mortality in patients with covid-19 as well as to decrease the percentage of patients admitted to intensive care unit (icu), decrease the need to supply oxygen to patients, reduce the number of days patients are hospitalized in icu and/or on the ward, decrease the number of days required to obtain a negative result in the pcr (polymerase chain reaction, a laboratory technique that allows the amplification of small fragments of dna to detect the presence of the virus) test for covid-19 and decrease the levels of markers that indicate pneumonia.


Eligibility criteria:
inclusion criteria: * laboratory confirmed infection with sars-cov-2 or typical radiological signs of sars-cov-2 infection * hospitalisation due to covid-19 * informed consent obtained, the patient understands and agrees to comply with the planned study procedures. if a potential patient is unconscious, the patient information sheet with the informed consent form can be signed by the legal representative, if he/she accompanies the patient. it can be signed by a concilium consisting of doctors (2), investigator and an independent witness in case the legal representative is not available. * ≥18 years of age * willingness to perform effective measures of contraception during the study. * signs of respiratory deterioration such as oxygen saturation ≤94% when breathing ambient air or \>3% drop in oxygen saturation in case of chronic obstructive lung disease or need for oxygen supplementation to achieve satisfactory blood oxygen saturation (spo2\>90% at room air) as well as the need for non-invasive ventilation, high-flow oxygen devices or mechanical ventilation or radiological or clinical signs of pneumonia. exclusion criteria: * moribund, or estimated life expectancy \<1 month (e.g., terminal cancer, etc.) * patient does not qualify for intensive care, based on local triage criteria * pregnancy or breast feeding * severe liver dysfunction (e.g. alt/ast \> 5 times upper limit of normal) * anticipated discharge from hospital within 48 hours * other potent anti-inflammatory treatment, e.g. tnf- blocking therapies * mechanical ventilation for \>48 hours * known active hiv or viral hepatitis infection * known active tuberculosis * known hereditary fructose intolerance
identifying novel aging targets for treatment of delirium

Conditions: Delirium; Dementia Alzheimers; Respiratory Failure

Summary: the long-term goal of this research program is to improve understanding of the mechanistic link between alzheimer's disease (ad) neuropathology, acute delirium, and cognitive impairment following acute respiratory failure. in this pilot study, the study team will establish a prospective cohort of older patients with acute respiratory failure and obtain data on delirium duration, ad imaging and csf biomarkers, and cognitive outcomes following critical illness.

the study team will recruit patients with no known history of dementia for enrollment into the cohort during their hospital stay for acute respiratory failure. the cohort will undergo testing including cognitive testing, mri imaging, lumbar puncture for cerebrospinal fluid (csf) analysis at 3 months following hospital discharge. the study will examine the association of delirium duration during the hospital stay and cognitive impairment at 3 month follow-up with csf levels of amyloid- β42, tau, and phospho-tau. measures of delirium will also be related with structural/functional mri dependent measures. the goal is to design a larger prospective cohort study to evaluate the relationship between ad imaging and csf biomarkers with delirium and post-icu cognitive impairment. the results of this pilot study with provide important information with regard to future study design including: (1) ratio of eligible to recruited patients (2) retention rate; (3) safety and feasibility of protocol; and (4) preliminary effect size estimates.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 55 years * anticipated icu stay of at least 48 hours * delirium during icu stay defined as cam-icu positive on at least two occasions at least 12 hours apart within 72 hours. exclusion criteria: * diagnosis of dementia in electronic medical record at time of icu admission * blindness, deafness, or inability to understand english as this prevents icu delirium assessment * cognitive impairment prior to hospitalization (inability to follow instructions/comply with study/sign consent) * score of \> 3.30 on informant questionnaire of cognitive -decline in the elderly (iqcode)\[34\]. questionnaire will be given to family member or legally authorized representative. * pregnancy/lactating/breastfeeding * legally incapacitated: prisoner/ward of state * history of prior large vessel cerebrovascular accident (cva) * history of neurologic disorder prior to icu admission including multiple sclerosis, parkinson disease, epilepsy, amyotrophic lateral sclerosis (als), guillain-barre syndrome (gbs) * psychiatric illness including schizophrenia, bipolar disorder, depression with psychotic features * not expected to survive 24 hours * judgment of investigator that subject participation could jeopardize subject health/safety or integrity of study * active malignancy requiring treatment in the prior 6 months * inability to return for study procedures * inability to obtain consent
choroidal thickness in glaucoma patients and healthy controls

Conditions: Glaucoma Patients and Healthy Controls

Summary: with the new software tool (edi, enhanced depth imaging) of the spectralis® spectral-domain optical coherence tomography (sd-oct) it is possible to visualize and measure the choroidal thickness. in glaucoma a vascular component is known. therefore a difference of choroidal thickness in glaucoma patients and healthy controls is proposed. * trial with medical device


Eligibility criteria:
inclusion criteria: for both groups (glaucoma study group and control group): men and women of at least 50 years of age for the glaucoma study group: diagnosis of primary open angle glaucoma (poag) exclusion criteria: for both groups (glaucoma study group and control group): * less then 50 years of age * any pathology of the central retina * any optic nerve disorder other then glaucoma * retinal vascular disorder for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma for the control group: any diagnosis of glaucoma