Kornimate/medical-research-clean huggingface dataset:
immediate lymphatic reconstruction after lymphadenectomy in melanoma patients: a parallel cohort pilot study

Conditions: Lymphatic Reconstruction; Lymphadenectomy

Summary: to learn if lbp can help to prevent lymphedema when it is performed at the time of surgery rather than after a patient has already developed the disease.

to examine if performing lymphovenous bypass (lvb) at the time of axillary lymph node dissection (alnd) or inguinal lymph node dissection (ilnd) in the melanoma participant population impacts the period prevalence of lymphedema occurrence one year from surgery. to assess wound complications rates occurring in first 30-days post operatively from the time of surgery. to estimate time to drain removal. to estimate the point prevalence of le following surgery at 3 months, 6 months, and 1 year following surgery. to estimate the cumulative incidence associated with the first appearance of le. to assess quality of life and survivorship, using lymphedema quality of life (lymqol) questionnaire over the study follow-up domain.

Eligibility criteria:
inclusion criteria: 1. participants greater than or equal to 18 years of age. 2. participants willing to participate. 3. participants able to complete informed consent. 4. participants with a diagnosis of melanoma undergoing alnd or ilnd. exclusion criteria: 1. participant staking anticoagulants within 7 days prior to surgery. 2. participants that are known to be pregnant at the time of surgery. 3. participants with bmi greater than 50.0
rehabilitation after covid19-clinical results and predictive factors

Conditions: Covid19

Summary: the aim of the study is to gain insight into the rehabilitation process and predictive factors for the outcome after rehabilitation in three patient groups: 1. sars-cov-2-positive patients in the isolation ward 2. post-covid-19 patients 3. control group; matched for gender, age and co-morbidity


Eligibility criteria:
inclusion criteria: * patients assigned to rehab * written informed consent exclusion criteria: * not able to fill in questionnaires in german

Keywords: covid19 sars-cov-2 rehabilitation outcome predictive factors
analysis of gingival crevicular fluid

Conditions: Periodontal Diseases

Summary: the purpose of this study was to investigate and compare gcf interleukin-1β (il-1β), interleukin-10 (il-10), interleukin-36γ (il-36γ) levels in patients with healthy (h), gingivitis (g) and chronic periodontitis (cp) status.

gingival crevicular fluid (gcf) is formed when fluid exudes from the vessels of the microcirculation into the inflamed periodontal tissue and into the sulcus or pocket. as the fluid traverses the inflamed tissue, it is thought to pick up enzymes and other molecules that participate in the destructive process, as well as products of cell and tissue degradation. efforts to develop diagnostic tests based on host factors have been focused almost entirely on analysis of gcf. the purpose of this study was to investigate and compare gcf interleukin-1β (il-1β), interleukin-10 (il-10), interleukin-36γ (il-36γ) levels in patients with healthy (h), gingivitis (g) and chronic periodontitis (cp) status. systemically healthy and non-smokers 80 participants (30 males and 50 females) who were selected from among admitting to dentistry faculty of selcuk university were included in this study. clinical periodontal parameters were recorded and gcf samples were obtained. samples were stored in -80 ˚c until analysis with enzyme-linked immunosorbent assay (elisa).

Eligibility criteria:
inclusion criteria: * systemically healthy * non-smokers, * presence of at least 20 teeth in the mouth exclusion criteria: * receiving periodontal therapy in the last 6 months; * receiving antibiotics or anti-inflammatory drugs in the last 6 months; * currently pregnant or breastfeeding * using a removable partial denture and removable or fixed orthodontic appliances.

Keywords: pathogenesis gingival crevicular fluid cytokine
amino acids profiles in premature infants receiving nutritional support

Conditions: Premature Infant

Summary: the aim of this study is to investigate the changes of amino acid metabolic profiles in different nutritional stages of preterm infants and determine the effects of nutritional intervention on the amino acid metabolic status of preterm infants.


Eligibility criteria:
inclusion criteria: premature infants, and admitted to hospital within 24 hours after birth; documentation of informed consent; in need of receiving parenteral nutrition after birth; exclusion criteria: premature infants with a parenteral nutrition period of less than 3 days; inborn error of metabolism; chromosomal abnormalities or multiple malformations;
a study to assess the improvement of pain and health-related quality of life in patients with chronic non-malignant pain taking tramadol hydrochloride and acetaminophen

Conditions: Chronic Pain

Summary: the purpose of this study is to evaluate the impact of extended release tramadol hydrochloride (75 mg) and acetaminophen (650 mg) tablets on improvement of pain.

this is a multi-center (study conducted at multiple sites), open label (all people know the identity of the intervention), prospective (in which the participants are first identified and then followed forward as time passes), observational study to assess the improvement of pain and health-related quality of life in patients with moderate to severe chronic non-malignant pain. the study will enroll patients who had already filled a prescription for extended release tramadol hydrochloride 75 mg and acetaminophen 650 mg (ultracet er). the study medication will be administered according to local label insert. the study medication will be taken twice daily, 1 to 2 tablets each time, for a maximum of 4 tablets. safety evaluations for adverse events will be performed throughout the study. the total duration of the study will be approximately of 12 weeks.

Eligibility criteria:
inclusion criteria: * patients with the prescription of ultracet er for the treatment of moderate to severe pain * complaining of chronic pain for more than 3 months exclusion criteria: * patient who had been treated with extended release tramadol hydrochloride (75mg) and acetaminophen (650mg) or strong opioids (eg, morphine, fentanyl, oxycodone, hydromorphone) within the past 4 weeks * patient with a severe mental disease and with a medical history of hypersensitivity to opioid analgesics * pregnant females or the females likely to become pregnant during the study period * patient who had been believed likely to complain of more pain than the real pain he or she is experiencing because of industrial disaster, car insurance, and others * patients who are contraindicated according to the warnings, precautions and prohibitions regarding extended release tramadol hydrochloride (75mg) and acetaminophen (650mg)

Keywords: chronic pain chronic non-malignant pain non-malignant pain extended release tablet tramadol hydrochloride tramadol hcl acetaminophen ultracet er
oral hyoscine butyl bromide with cervical lidocaine cream in reducing pain during hysterosalpingography

Conditions: Pain Relief

Summary: hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. the major disadvantage of hysterosalpingography is pain. in a study reported the patients complained of moderate to severe pain during the procedure. it is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.


Eligibility criteria:
inclusion criteria: • the infertile women who indicated for hsg exclusion criteria: * contraindications to hyoscine or lidocaine * known sensitivity to contrast media * abnormal uterine bleeding * genital tract infection * suspected pregnancy
an international extension study of corlux for recurrent psychotic symptoms in psychotic major depression

Conditions: Major Depressive Disorder; Psychotic Disorders

Summary: corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. people who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. if corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. the purpose of this study is to allow patients who have already participated in an earlier 8 week study of corlux versus placebo (an inactive pill) to receive additional courses of treatment with corlux periodically if a psychotic episode should reappear during a period of one year.


Eligibility criteria:
inclusion criteria: * completed participation through day 56 in corcept therapeutics protocol c-1073-09 * are 18 to 75 years of age * have a diagnosis of major depressive disorder with psychotic features (dsm-iv 296.24 or 296.34) * are able to provide written informed consent exclusion criteria: * have a major medical problem * have a history of an allergic reaction to corlux (c-1073, mifepristone)

Keywords: pmd depression psychosis psychotic major depression major depression
paricipant preferences in the treatment of inflammatory bowel disease (ibd) in europe

Conditions: Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Summary: the purpose of this survey is to describe crohn's disease (cd) participants' as well as ulcerative colitis (uc) participants' preferences towards the attributes of treatment with advanced therapies for ibd, including safety and efficacy profiles, frequency and route of administration (roa) in a real-world setting.

this is a descriptive, observational, cross-sectional survey of participants with ibd. the survey will look into the preferences of participants towards the attributes of treatment with advanced therapies for ibd based on dce (experimentally designed survey), including safety and efficacy profiles, frequency and roa in a real-world setting, in european participants living with cd or uc. the survey will involve data collection in a real-world setting via an online self-reported questionnaire hosted on the carenity platform, an international participant community. the survey will enroll approximately 600 participants. participants will be enrolled in two observational cohorts: * cd participants * uc participants this multi-center trial will be conducted in france, the united kingdom, italy, spain, belgium, switzerland, the netherlands.

Eligibility criteria:
inclusion criteria: 1. self-reported suffering from cd or uc. exclusion criteria: 1. have never been ever treated with prescription medications for cd or uc. * should be included in the study only once. * data collected from participants who subsequently withdraw their consent will not be included in or will be deleted from the database.

Keywords: drug therapy
radiomics for prediction of lung cancer biology

Conditions: Non Small Cell Lung Cancer; PET/CT; PD-L1; Gene Mutation-Related Cancer

Summary: therapeutic progress for subgroups of non small cell lung cancer can largely be attributed to the accumulation of molecular knowledge and the development of new drugs that specifically target molecular abnormalities. an understanding of the immune landscape of tumors, including immune-evasion strategies, has also led to breakthrough therapeutic advances.these new options require prior treatment tumoral sampling to identify patients who have neoplasms with specific genomic aberrations or favorable immune environment. medical imaging and radiomic approach may provides surrogate markers non invasively.the objective of the present retrospective study is to build and validate a predictive model of common molecular alterations and pd-l1 expression in nsclc using pre treatment pet/ct derived radiomics.


Eligibility criteria:
inclusion criteria: * histologically proven nsclcc * pre treatment 18f fdg pet/ct * available molecular biology and histology results exclusion criteria: * non available pet/ct images
impact of sex in the effect of dietary capsaicin on cardiovascular health

Conditions: Pre Hypertension; Hypertension

Summary: the investigators long-term goal is to better understand novel interventions to promote cardiovascular health in humans. the goal of the proposed research is to investigate whether there is sex-specificity in the effects of dietary capsaicin on mechanisms regulating nitric oxide (no) bioavailability, its effect on key markers of cardiovascular (cv) health, including bp, macro- and microvascular function, and arterial stiffness. this knowledge will provide critical insight into the effects of dietary capsaicin on cv health and will guide future trials.

specific aim 1: determine the sex-specific effects of dietary capsaicin on central and peripheral blood pressure and arterial stiffness. the investigators hypothesize that dietary capsaicin intervention (6 week) will improve bp and arterial stiffness, likely in a sex-dependent manner. the investigators will measure heart rate variability and excretion of capsaicin and metabolites to ascertain bioavailability, and understand the mechanistic role of the autonomic nervous system, in capsaicin's effect on bp. specific aim 2: assess whether dietary capsaicin effects on vascular function is sex-specific. the investigators hypothesize that dietary capsaicin intervention (6 week) will improve no bioavailability, through improved redox balance and lowered asymmetric dimethylarginine, thereby improving peripheral vascular function, likely in a sex-dependent manner. utilizing a double-blind, randomized, placebo-controlled, design the investigators will investigate whether there is sex-specificity in the effects of a 6-week dietary capsaicin intervention on nitric oxide (no) bioavailability, bp, vascular function, and arterial stiffness.

Eligibility criteria:
inclusion criteria: * relatively healthy (other than elevated blood pressure) non-smoking men and women over the age of 18 from the local community exclusion criteria: * women who are without a period (not due to a birth control method, intrauterine device or menopause), are pregnant, attempting to conceive, or are breastfeeding will be excluded. * uncontrolled hypertension * anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment). * any participants with excessive sensitivity to spicy foods or fiber (psyllium husk) will be excluded * participants with food allergies will be excluded * participants who have difficulty swallowing or swallowing pills may be excluded. * participants who suffer from heartburn, hiatal hernia, gastritis, or peptic ulcer disease may be excluded.

Keywords: vascular stiffness blood pressure vascular function
long-term effects of covid-19: a comparative cohort study

Conditions: Covid19

Summary: this study is a longitudinal cohort study which investigates the effect of covid-19 in ambulatory care. this study aims to assess the effect of covid-19 beyond the acute phase, i.e. on long-term symptoms, respiratory and cardiovascular health, use of health services, and quality of life.

this study is a longitudinal cohort study comparing two cohorts. one cohort tested positive for sars-cov-2 and the other tested negative for sars-cov-2 matched by the timing of testing in the past 6 months. participants will be observed for two years after their test for covid-19 with online surveys at different time intervals and face-to-face follow-up visits.

Eligibility criteria:
inclusion criteria: participants eligible for inclusion in this study for the exposed cohort with a diagnosis of covid-19 in the last 6 months must meet all of the following criteria: 1. aged 18 years or older; 2. positive result on a rapid ag test or pcr for sars-cov-2 for covid-19 compatible symptoms a maximum of 6 months before inclusion; 3. patient is community-dwelling; 4. participant or their proxy is willing and able to give informed consent for participation in this study; 5. participant is willing to comply with all study procedures. participants are sampled in the same practices as the exposed cohort and are eligible for inclusion in this study for the non-exposed without a diagnosis of covid-19 in the last 6 months when they meet all of the following criteria: 1. aged 18 years or older; 2. tested because of suggestive symptoms with a rapid ag test or pcr for sars-cov-2 at the same time (+/- 1 month) as the exposed cohort, of which the result was negative 3. patient is community-dwelling; 4. participant or their proxy is willing and able to give informed consent for participation in this study; 5. participant is willing to comply with all study procedures. exclusion criteria: participants eligible for the cohort with covid-19 in the last 6 months must not meet any of the following criteria: 1. patients in palliative care; 2. patients for whom there is already someone from the same household participating; 3. judgement of the recruiting clinician deems participant ineligible. participants eligible for the cohort without covid-19 must not meet any of the following criteria: 1. a positive test for a sars-cov-2 infection in the last 2 years; 2. patients in palliative care; 3. patients for whom there is already someone from the same household participating; 4. judgement of the recruiting clinician deems participant ineligible. prior vaccination against covid-19 is not an exclusion criterion.
safety and immunogenicity study of eastern equine encephalitis (eee) vaccine

Conditions: Eastern Equine Encephalitis

Summary: this study is designed to determine the safety and immunogenicity of eastern equine encephalitis (eee) vaccine.

this was an open-label, vaccine study of eastern equine encephalitis vaccine, inactivated dried, eee, tsi-gsd 104 in healthy, adult subjects. no concurrent control group was used. the controls used in this study to assess immunogenicity were historical prnt80 values obtained in past studies of the eee vaccine. rates of adverse events (aes) were tabulated by relationship to product administration and severity. the primary objectives are to assess the safety of eastern equine encephalitis vaccine, inactivated, dried eee, tsi gsd 104, and to assess immunogenicity of eastern equine encephalitis vaccine, inactivated, dried eee, tsi gsd 104.

Eligibility criteria:
inclusion criteria: * at least 18 years old. * eee prnt80 ≤ 1:20. * eee prnt80 ≤ 1:40 for booster series * (females) negative pregnancy test on the same day before vaccination. * not planning pregnancy for 3 months. * at risk for exposure to virulent eee virus (with up-to-date risk assessment). * up-to-date (within 1 year) physical examination/tests. * sign and date the approved informed consent. * willing to return for all follow-up visits. * agree to report adverse events (ae) up to 28 days after each vaccination. exclusion criteria: * over 65 years of age (for primary immunization). * clinically significant abnormal lab results including evidence of hepatitis c, hepatitis b carrier state, or elevated (2x normal) liver function tests. * history of immunodeficiency or current treatment with immunosuppressive medication. * (females) currently breastfeeding. * confirmed human immunodeficiency virus (hiv) titer. * any known allergies to components of the vaccine. * a medical condition that, in the judgment of the principal investigator (pi), would impact subject safety (i.e.-vaccination or exposure to another alphavirus). * administration of any ind product or live vaccine within 28 days of eee. * any unresolved aes resulting from a previous immunization.

Keywords: eee
a study to investigate the safety and efficacy of abbv-105 alone or in combination with upadacitinib (abbv-599 combination) in participants with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis (RA)

Summary: this was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (els) and abbv-599 (els plus upadacitinib \[upa\]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csdmards) for the treatment of signs and symptoms of rheumatoid arthritis (ra) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bdmard)-inadequate response (bdmard-ir) or bdmard-intolerant participants with moderately to severely active ra and to define optimal dose for further development.

this was a 12-week, randomized, double-blind, parallel-group, phase 2, dose exploratory, multicenter study. participants who met eligibility criteria were randomized in a 3:2:2:2:2:1 ratio to 1 of 6 treatment groups: abbv-599 \[upa 15 mg/els 60 mg\]); els 60 mg/upa placebo; els 20 mg/upa placebo; els 5 mg/upa placebo; upa 15 mg/els placebo; and els placebo/upa placebo. the study included a 35-day maximum screening period and a 12-week treatment period with 30-day follow-up.

Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis (ra) for ≥ 3 months based on the 2010 american college of rheumatology/european league against rheumatism (acr/eular) classification criteria for ra * participant meets the following minimum disease activity criteria: * ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at screening and baseline visits * high-sensitivity c-reactive protein (hscrp) ≥ 3 mg/l (central lab) at screening visit * participants must have been treated for ≥ 3 months with ≥ 1 biologic disease-modifying anti-rheumatic drug (bdmard) therapy but continue to exhibit active ra or had to discontinue due to intolerability or toxicity, irrespective of treatment duration * participants must have been receiving conventional synthetic disease-modifying anti-rheumatic drug (csdmard) therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug * participants must have discontinued all bdmards prior to the first dose of study drug exclusion criteria: - participant has prior exposure to any janus kinase (jak) inhibitor for greater than 2 weeks (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib). a washout period of ≥ 30 days is required for any jak inhibitor prior to the first dose of study drug.

Keywords: elsubrutinib abbv-105 upadacitinib abbv-599 rheumatoid arthritis
a comparison of seroquel vs. risperidone in schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to show equal efficacy of both quetiapine and risperidone in subjects treated with study medication for up to 8 weeks.


Eligibility criteria:
inclusion criteria * male / female, 18-65 years old * schizophrenia (as per dsm iv) exclusion criteria * concurrent use of psychotropic medication * does not fulfill moderately ill on cgi