Kornimate/medical-research-clean huggingface dataset:
utilizing novel blood rna biomarkers as a diagnostic tool in the identification of long covid-19

Conditions: Long COVID

Summary: the primary objective of this study is to determine, using unblinded samples, if it is possible to develop an algorithm for the classification of specific blood rna from patients with long covid together and separately from the apparent health normal controls and other medical conditions that share the signs and symptoms of long covid.

participants will be screened and provide two blood samples28 (+/- 2) days apart. based on the participants survey results they will be placed into one of fourteen groups that reflect the type of long covid the patient is experiencing. samples will be shipped to the sponsor who will develop an ai process to validate the type of long covid and assess its severity. the long term goal is to develop a reliable test to identify the presence of long covid and its severity.

Eligibility criteria:
inclusion criteria: * mentally capable of understanding and completing informed consent for the study. * precipitants with a lab verified diagnosis of sars-cov-2 or clinician note/record that an appropriate rapid test for sars-cov-2 was positive. * to qualify for long covid group participants will need to have new, persistent symptoms related to sars-cov-2 infection. iv. no one under the age of 18. exclusion criteria: * subject is unable to provide informed consent. * primary investigator or sub-investigator determines the participant's ongoing medical complaints that began after 1 november 2019 are not related to sars-cov-2 but another disease process.

Keywords: covid-19 long covid long haul covid long covid-19 long haul covid-19
expanded access to vedolizumab for children and teenagers with ulcerative colitis or crohn's disease in the usa

Conditions: Crohn's Disease; Ulcerative Colitis

Summary: the expanded access program (eap) allows people to gain access to an unlicensed treatment on compassionate grounds. this eap provides children and teenagers with ulcerative colitis (uc) or crohn's disease (cd) who completed the vedolizumab-2005 clinical study in the united states (us) with continued access to vedolizumab intravenous (iv) which is given as infusion into a vein (intravenously iv) until it becomes commercially available in the us. to be able to participate in this eap, children and teenagers must still benefit from the treatment with vedolizumab iv. according to the participant's treating healthcare professional (hcp): there are no comparable and satisfactory alternative treatment options in the local market, or the participant would be negatively affected without continued access to vedolizumab iv.


Eligibility criteria:
inclusion criteria: 1. the participant has uc or cd and is of age less than (\<) 18 years at the time of final treatment completion of vedolizumab-2005. 2. the participant is demonstrating continued clinical benefit from vedolizumab iv for the treatment of uc or cd that outweighs possible risks. 3. the participant, participant's legally authorized representative, or adult caregiver is informed of the nature of this expanded access program and has provided signed and dated written informed consent and/or pediatric assent. 4. the participant does not have any condition, including laboratory test result, that in the opinion of the investigator may compromise the participant's safety. 5. the participant does not have a known hypersensitivity to vedolizumab or its components. 6. according to the participant's treating healthcare professional (hcp): there are no comparable and satisfactory alternative treatment options in the local market, or the participant would be negatively affected without continued access to vedolizumab iv. 7. female participants of childbearing potential only: * the participant has agreed to be abstinent or agreed to comply with the applicable contraceptive requirements of this protocol for the duration of the expanded access program and for 18 weeks after completion of the last dose of vedolizumab. * the participant is not pregnant or breastfeeding. * the participant will not donate ova during the course of the program and for 18 weeks after the last dose of vedolizumab. 8. male participants only: * the participant has agreed to comply with the applicable contraceptive requirements of this protocol for the duration of the expanded access program and for 18 weeks after the last dose of vedolizumab. * the participant has agreed to not donate sperm during the course of the program and for 18 weeks after the last dose of vedolizumab. exclusion criteria: -no specific exclusion criteria.

Keywords: drug therapy
negative pressure wound therapy in groin dissection

Conditions: Neoplasm Metastasis; Secondary Malignant Neoplasm of Lymph Node; Non-healing Surgical Wound (Disorder); Skin Neoplasms

Summary: this study investigates the use of a negative pressure wound therapy device (pico™, smith \& nephew healthcare, uk) on clean, closed surgical wounds, in patients who are undergoing inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin.

patients may develop inguinal lymph node metastases from a variety of cutaneous neoplasms. a number of factors conspire to cause a high rate of wound breakdown and other complications in this patient group. reported rates of wound healing complications vary in the literature, but tend to affect \> 40% of patients. a new negative pressure wound therapy device is recommended for use in clean, closed surgical wounds (pico™ system, smith \& nephew healthcare, uk). patients will be randomised to receive either pico™ system for up to seven days, or conventional dressings, and then assessed for wound healing and other outcome measures.

Eligibility criteria:
inclusion criteria: * histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin exclusion criteria: * inability to give informed consent for participation

Keywords: negative pressure wound therapy lymphadenectomy wound healing
study of blood and urine samples in patients with newly diagnosed localized prostate cancer treated with hormone therapy and radiation therapy. icorg 06-15

Conditions: Prostate Cancer

Summary: rationale: studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this clinical trial is studying blood and urine samples in patients with newly diagnosed localized prostate cancer treated with hormone therapy and radiation therapy.

objectives: * detect changes in serum and urine proteomic profiles that predict outcome in patients with newly diagnosed localized prostate cancer treated with hormonal therapy and radiotherapy. * identify prognostic and biochemical markers of early disease progression in patients treated with this regimen. * identify unique protein expression and temporal alterations, in these profiles, that facilitate understanding of the factors predicting relapse or toxicity. * identify molecular signatures that allow identification of targets for therapeutic intervention. outline: this is a multicenter study. patients receive induction hormones\* (bicalutimide and releasing-hormone agonist) for approximately 4 months prior to starting radiotherapy (per standard treatment). patients then receive radiotherapy consisting of 74 gy up to a maximum of 81 gy to the prostate gland per standard treatment.note: \* patients receiving short-term hormonal treatment for 4-8 months are eligible to participate in the trial. blood and urine samples are collected at baseline, and periodically during and after induction therapy for proteomic analysis. after completion of study therapy, patients are followed up periodically for 5 years and yearly thereafter for the duration of the trial.

Eligibility criteria:
inclusion criteria: 1. age 18 years or over. 2. histologically confirmed invasive adenocarcinoma of the prostate (by turp or trus). 3. localised prostate cancer with a gleason score 7 4. short term hormonal treatment 4-8 months 5. performance status of kps ≥ 60 / who 0-2 6. absence of distant metastases exclusion criteria: 1. the patient has previously received treatment for prostate cancer other than turp/ trus 2. the patient has had a bilateral orchidectomy 3. the patient has previously received hormonal treatment for prostate cancer 4. evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial. in the opinion of the investigator, any evidence of severe or uncontrolled systematic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease 5. the patient has or had other co-existing malignancies within the past 5 years other than non- melanoma skin cancer 6. treatment with non-approved or investigational drug within 30 days before day one of the trial

Keywords: adenocarcinoma of the prostate stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer
metabolic signature of healthy lifestyle and hcc

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) is the most common form of liver cancer and its incidence is increasing including in regions where hepatitis infection rates are low. this trend may be the result of increases in 'unhealthy lifestyle' factors. the main aim of this study is to identify metabolic signatures associated with healthy lifestyle behaviours and to relate these signatures to risk of developing hcc to investigate whether the metabolites were of predictive utility for hcc beyond data procured from questionnaires. to address this question, we exploited data from a large european cohort (epic) which includes detailed questionnaire-based data as well as metabolomic data.

studies using metabolomic data have identified metabolites from several compound classes that are associated with disease-related lifestyle factors. this study identified metabolic signatures reflecting lifestyle patterns and related them to hepatocellular carcinoma (hcc) risk in the epic cohort. partial least squares (pls) analysis related seven modified healthy lifestyle index variables (diet, bmi, physical activity, lifetime alcohol, smoking, diabetes, hepatitis) to 132 targeted serum-measured metabolites, and a liver function score in a nested study of hcc with 147 case-control pairs. the association between the resulting pls scores and hcc risk was examined in multivariable conditional logistic regression models where odds ratios (or) and their 95% confidence intervals (95%ci) were computed. the pls-derived lifestyle component reflected a high propensity towards healthy behaviours. its metabolic counterpart was positively related to the following metabolites: sm(oh) c14:1, c16:1 and c22:2, and negatively to glutamate, hexoses, and pc aac32:1. the lifestyle and metabolomics components were inversely associated with hcc risk with or for a 1-sd increase in scores equal to 0.49(95%ci=0.35 to 0.68) and 0.28(0.18 to 0.43). measuring a specific metabolites panel may identify strata of the population at higher risk for hcc and can add substantial discrimination compared to questionnaire data

Eligibility criteria:
inclusion criteria: * aged 30-70 * healthy volunteers residing within defined geographical areas (where study centers are located). different settings by centre; mostly general population with some exceptions: women of a health insurance company for teachers and school workers (france), women attending breast cancer screening (utrecht-the netherlands, and florence-italy), mainly blood donors (most centers in italy and spain) and a cohort consisting predominantly of vegetarians (the 'health-conscious' group in oxford, uk)

Keywords: targeted metabolomics multivariate statistics metabolic signatures partial least squares healthy lifestyle index epic
weaning form mechanical ventilation using extracorporeal co2 removal

Conditions: Patients With Acute Hypercapnic Respiratory Failure

Summary: weaning from invasive mechanical ventilation is one of the major clinical problem especially ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania. the aim of this pilot feasibility and safety trial is to assess the possibility of shorten the duration of mechanical ventilation using a device able to remove co2 and theoretically able to allow therefore the praecox extubation

weaning from invasive mechanical ventilation is one of the major clinical problem especially ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania. up to 60% of the ventilatory time is devoted in these patients to the process of weaning. these patients very often fail several weaning attempt, when a t-piece trial method is used. in this case they are also very likely to require tracheotomy. in this study we will enroll those still hypercapnic patients fitting the criteria of readiness to be wean (i.e. clinical stability, normal sensorium and good cough reflex) and failing a t-piece trail because of a rise in paco2 (\>20% from baseline) and/or a rapid shallow breathing index (f/vt)\> 100. after the unsuccessful trial they will be reconnected to the ventilator and they will repeat hours later the same t-piece trial once the extracorporeal co2 removal device (decap) will be connected via a double lumen catheter in the femoral vein. the investigators aim to verify whether using the decap) the investigators will be able to avoid at the end of the t-piece trial the criteria of failure. if so, the patient will be extubated and decap will be continued when all of the following were achieved for at least 12 hours: respiratory rate less than 25 breaths/min; ph greater than 7.35; paco2 less than 20% of the baseline value; and absence of use of the accessory muscles or paradoxical abdominal movements.

Eligibility criteria:
inclusion criteria: * patients meeting the criteria for readiness to be weaned (i.e. clinical stability, fio2\<50%, normal sensorium, body temperature \< 38 and satisfactory cough reflex) * failing a t-piece trial after 1 hour or before for a rise in paco2\>20% from baseline and with f/vt ratio \>100 exclusion criteria: * patients not meeting the criteria for readiness to be weaned * patients succeeding a t-piece trial

Keywords: weaning from mechanical ventilation extracorporeal co2 removal post-extubation failure
escitalopram in asthma patients with frequent exacerbation

Conditions: Asthma

Summary: antidepressants, particularly selective serotonin reuptake inhibitors (ssris), such as escitalopram are widely used for mood and anxiety disorders. however, they have also been explored, with promising findings, for a variety of disorders outside of psychiatry. clinical studies of ssris in depressed people with asthma were associated with decreased asthma exacerbations and improvement in asthma control. in this study, the number of asthma exacerbations will be assessed as the primary outcome measure, in patients using escitalopram vs. placebo.

a 24-week, randomized, double-blind, placebo-controlled trial of escitalopram will be conducted in 105 people with moderate to severe persistent asthma who, despite treatment with medium to high dose inhaled corticosteroids and long-acting beta-agonist therapy, had ≥ 3 asthma exacerbations in the past year. the primary outcome measure will be the number of times systemic corticosteroids are given for an asthma exacerbation with the asthma control questionnaire as a secondary outcome measure. mood and anxiety symptoms and functioning will be assessed as will the role of psychological asthma triggers on asthma symptom exacerbation. serum il-6 and peripheral eosinophil levels as well as fractional exhaled nitric oxide (feno) will be assessed. thus, psychological/psychiatric and biological or immune mechanisms for the effect of escitalopram on asthma will be explored.

Eligibility criteria:
inclusion criteria: * moderate to severe persistent asthma * treatment with medium to high dose ics and laba therapy * three or more severe asthma exacerbations (requiring ≥ 3 days of systemic corticosteroids) in the past year * age 18-65 years old, male or female sex, english or spanish speaking * participants will be required to be clinically stable with no recent exacerbations, infections or changes in asthma controller therapy for at least 4 weeks before study entry * biologic therapy for asthma (e.g., omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) will be allowed if started at least 6 months prior to randomization exclusion criteria: * current substance use disorder and/or current tobacco use or greater than 10 pack-years lifetime use * a current mdd episode as well as bipolar disorder, schizophrenia, or schizoaffective disorder * vulnerable populations including intellectual disability or other severe cognitive impairment, inmates, pregnant or nursing women or women of childbearing age who will not use ut southwestern irb-approved methods of birth control or abstinence during the study * currently taking an antidepressant (antidepressants that are not ssris nor snris prescribed for an indication other than depression at subtherapeutic doses are acceptable) * high risk for suicide defined as \> 1 past suicide attempts or any attempt within the past 12 months * severe or life-threatening medical illness that would make completion of study unlikely or clinically significant laboratory or ecg findings at baseline

Keywords: escitalopram ssri adults
a clinical study to collect calibration & performance data of the kbs systems 1.0 non-invasive glucose monitoring device

Conditions: Diabetes

Summary: the purpose of this study is to calibrate the performance of the kbs-1 non-invasive glucose monitoring device with diabetic people when compared to that of the standard method currently used in the clinical setting for prescription point-of-care (poc) blood glucose monitoring. the secondary purpose of this study is to calibrate the performance of the rba-1 minimally invasive bodily fluid analyte analyzer device when compared to the results from a prescription poc blood glucose monitoring device and/or standard hospital laboratory blood test. the objective of this study is to collect non-invasive in vivo, and potentially in vitro, spectral measurements of interstitial fluid glucose from underneath the skin of the palm of the hand (test article #01), and potentially the blood, respectively, from diabetic adult hospital staff participants, and to collect in vitro spectral measurements of venous blood tested from adult hospital patients with or without diabetes (test article #02) and compare them to poc blood glucose monitor values and analyte measurements conducted by a hospital laboratory (control article #01 procedure), respectively. the comparison of the results obtained from the different analytical methods will be used to calibrate and refine the glucose, and other, analyte level calculation algorithms of the test article systems.


Eligibility criteria:
inclusion criteria: ideally, all enrolled participants will represent an ethnically diverse population with as close to an even ratio of males to females as possible. 1) age ≥ 21 years. 2) willingness and ability to provide informed consent. * additional inclusion criteria specific to kbs-1 (test article #01) testing: 1) diabetic hospital staff * additional inclusion criteria specific to rba-1 (test article #02) testing: 1. hospital patients with a physician prescribed hospital laboratory blood test. 2. diabetic hospital staff exclusion criteria: the following exclusion criteria apply to all prospective study participants. 1. a member of a vulnerable population (i.e. children, pregnant women, prisoners, etc.) 2. people with clotting factor disorders and/or currently taking anticoagulation medication. 3. has any other medical condition that, in the opinion of the investigator, would interfere with the person's participation in this study (i.e. double arm amputee). * additional exclusion criteria specific to kbs-1 (test article #01) testing: 1. any skin abnormalities or tattoos located on the palm(s) of the hand(s). the left palm is preferred for this study; however, the right palm can be used if the left palm is excluded. 2. parkinson's disease, dyskinesia, tremors, or similar that may make it challenging for said person to hold their hand on the device in a still and stable manner. * additional inclusion criteria specific to rba-1 (test article #02) testing: 1. patient is in isolation.
effects of omega-3 as an adjunct to non-surgical periodontal therapy on chemerin level in periodontitis patients with diabetes: a randomized clinical trial

Conditions: Diabetes Mellitus; Periodontal Diseases

Summary: patient grouping * group 1 (type 2 diabetes mellitus patients with cpd + srp and omega-3) * group 2 (type 2 diabetes mellitus patients with cpd + srp) different clinical parameters were recorded ; plaque index (pi), gingival index (gi), probing depth (pd), and clinical attachment loss (cal). 6.omega-3 poly-unsaturated fatty acids (1000mg) was given as an adjunctive treatment daily for 6 months to group 2, starting 2 weeks after phase 1 therapy.

a parallel design randomized clinical trial was performed involving thirty participants divided into two groups, 15 participants in each group selected from the outpatient clinic in oral medicine and periodontology department. diabetic control was assessed by glycosylated hemoglobin a1c (hba1c) of blood samples, patients had relatively stable glycemic control, as demonstrated by a difference not exceeding 1% in at least two hba1c assays over the previous 6 m. hba1c was assessed at baseline, 3m, and 6m. patient grouping * group 1 (type 2 diabetes mellitus patients with cpd + srp and omega-3) * group 2 (type 2 diabetes mellitus patients with cpd + srp) periodontal treatment protocol group 1 and 2 patients were treated by non-surgical approach in following steps: 1. each patient had received an initial phase of detailed instruction in self-performed plaque control measures using soft toothbrush and interdental cleansing devices. 2. full mouth srp using ultrasonic scaler and hand instruments under local anesthesia was performed to each patient in two sessions. 3. chlorehexidine chx mouthwash was prescribed for patients to be used twice daily. 4. for each patient, follow up visits every 2 weeks were done to ensure plaque control. 5. patients were re- examined after 2 weeks (baseline), 3 and 6 months

Eligibility criteria:
inclusion criteria: * patients had type 2 dm for more than 2 years (diagnosed according to the american diabetes association criteria), with no other systemic problem. •subjects had 14 or more natural teeth, of which at least five had a site with probing pocket depth (ppd) ≥ 5 mm and clinical attachment level ≥ 3 mm. from this point, according to the american academy of periodontology, subjects with moderate to severe periodontitis were included exclusion criteria: * pregnant and breastfeeding women, smokers or former smokers, patients with other autoimmune or systemic disease, those patients who took antibiotics in the last 6 months and patients weren't willing to follow our study protocol or plaque regimen