Kornimate/medical-research-clean huggingface dataset:
renin-angiotensin and fibrinolysis in humans: effect of long-term pde5 inhibition on glucose homeostasis

Conditions: Impaired Glucose Tolerance

Summary: the purpose of this study is to determine the effect of chronic pde5 inhibitor therapy on glucose metabolism in persons with prediabetes.


Eligibility criteria:
inclusion criteria: age \> 18 years and bmi \> 25 kg/m2 (\> 23 kg/m2 among asian americans) elevated fasting plasma glucose (100-125 mg/dl) igt (2 hour plasma glucose 140-199 mg/dl) or metabolic syndrome and/or hemoglobin a1c 5.7-6.4% exclusion criteria: * diabetes type 1 or type 2, as defined by a fasting glucose of 126 mg/dl or greater, a two hour plasma glucose of 200 mg/dl or greater, or the use of anti-diabetic medication. * the use of nitrates or any disease that might require the use of nitrates. * the use of any potent cyp3a4 inhibitor. * subjects who have participated in a weight-reduction program during the last 6 month or whose weight has increased or decreased more than 2 kg over the preceding 6 months. * pregnancy. women of child-bearing potential will be required to have undergone tubal ligation or to be using barrier methods of birth control. * breast-feeding. * cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (lv hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy. * treatment with anticoagulants. * treatment with metformin. * history of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack. * history or presence of immunological or hematological disorders. * diagnosis of asthma. * clinically significant gastrointestinal impairment that could interfere with drug absorption. * impaired hepatic function (aspartate amino transaminase \[ast\] and/or alanine amino. transaminase \[alt\] \>1.5 x upper limit of normal range) * impaired renal function (serum creatinine \>1.5 mg/dl). * hematocrit \<35%. * any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult. * treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month). * treatment with lithium salts. * history of alcohol or drug abuse. * treatment with any investigational drug in the 1 month preceding the study. * mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study. * inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

Keywords: bmi greater than 25 elevated fasting blood sugar (100-125mg/dl)
digital acoustic surveillance for early detection of respiratory disease outbreaks

Conditions: Covid19; Cough

Summary: an observational study to evaluate the accuracy of a digital cough monitoring tool to reflect the incidence of covid-19 and other respiratory infections at the community level in the city of pamplona, spain.

this is a single-center prospective observational study that pretends to evaluate the accuracy of an acoustic surveillance mobile app to detect individual episodes of cough among a monitored population, as well as the barriers and facilitators that might affect uptake of similar platforms at a population level. the app in question, hyfe cough tracker, runs in the background of smartphones, and records short snippets (\<0.5 seconds) of explosive, putative cough sounds. these are then classified as cough or non-cough, using a convolutional neural network (cnn) model, and matched to gps and time data collected by the smartphone. the night-time cough of participants will be monitored for a 30-day period, and their clinical records will be reviewed regularly, specifically looking for diagnoses of cough-producing diseases, and with special emphasis on covid-19. cough data will be used to create a heatmap of cough density and geographic distribution. aggregated cough registries will be used to calculate the coughs per person-hour registered in the cohort. these data will be used to carry out an arima analysis on three parallel time series at the community level: the incidence of respiratory disease in the monitored cohort, in the entire study area (including the universidad de navarra, and the neighbouring cendea de cizur), and the cough frequency per monitored hours. changes in cough frequency will also be compared to other environmental variables such as temperature and pollution level registered in the study area.

Eligibility criteria:
inclusion criteria: * be aged 13 or above, * own and regularly use a smartphone able to run the cough-tracking system, * be willing to install and regularly use it, * be current residents of navarra, and * have an active relationship with the university (having interest in the study, or being a student or worker, be a patient with a cough-related diagnosis at the clínica universidad de navarra, or cizur's health centre). exclusion criteria: * inability to accept the privacy policy and terms of use of the cough-tracking system. * inability to grant access to medical records.

Keywords: chronic cough covid19 acoustic surveillance
survey on the clinical assessment of the psychological status of a patient over 75 years old in oncology during the realization of the g8 score (cadepo)

Conditions: Depression

Summary: the goal of this observational study is to make a statement concerning the identification of depressive symptoms at the time of the realization of the g8 score in patients over 75 with cancer and followed in oncology. the main question it aims to answer are: * compare the medical hetero-evaluation of depressive symptoms via the g8 "neuro-psychiatric disorders" item score with a self-evaluation via the gds-15 score * evaluate the number of patients over 75 treated with antidepressants * evaluate the proportion of patients with depressive symptoms according to the predisposing factors * compare the number of patients followed in oncogeriatrics over the period from 01/01/2022 to 02/28/2022 and the period from 01/01/2023 to 02/28/2023 participants will complete a self-questionnaire (gds-15 score) as well as a socio-demographic sheet.


Eligibility criteria:
inclusion criteria: * patients aged 75 and over * patients receiving treatment at the day hospital or oncology week hospital * patients informed and having not presented any opposition to their participation exclusion criteria: * patients under the age of 75 * patients under guardianship or curatorship * patients without social security * cognitive disorders compromising the understanding of the information and the performance of the study (in particular the completion of a self-administered questionnaire), in the opinion of the oncologist
oral t-6: oral androgens in man-6

Conditions: Contraception; Hypogonadism

Summary: we propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.

this is an 2-3 month open-label, two week pharmacokinetic study of two novel formulations of oral testosterone (t), in normal men whose endogenous t production has been temporarily suppressed by the administration of the potent gnrh antagonist acyline. we will be determining the relative pharmacokinetics of six different oral formulations of t in both rapid and slow release compared to the immediate release preparation studied previously by our group.

Eligibility criteria:
inclusion criteria: * males between 18 to 50 years of age in good general health based on normal screening evaluation * must agree not to participate in another research drug study during participation * must agree to not donate blood during the study * must be willing to comply with the study protocol and procedures * must agree to use an acceptable form of contraception * agrees to not take medications other than the study drugs for the duration of the study exclusion criteria: * subject in poor health, determined by medical history physical and lab results * a known history or current use of alcohol, drug or steroid abuse and/or use of more than 3 alcohol beverages per day * participation in a long-term contraceptive study within the past two months * history of bleeding disorders or current use of anti-coagulants * history of sleep apnea and/or major psychiatric disorders

Keywords: male contraception hypogonadism testosterone
laparoscopic adrenalectomy for large adrenal tumors.

Conditions: Adrenal Tumor; Adrenal Adenoma

Summary: laparoscopic adrenalectomy is the treatment of choice for the benign tumor of less than 6 cm. however, this is an ongoing debate that exact cut-off value of tumor size for la. the aim of this study was to assess whether the size of the adrenal tumor affects preoperative and postoperative outcomes in patients undergoing laparoscopic transperitoneal adrenalectomy as well as to evaluate the learning curve.

from april 2010 to october 2018, preoperative and postoperative data of 107 patients who underwent lta with adrenal mass were recorded prospectively and analyzed retrospectively. the inclusion criteria were all hormonally active adrenal lesions, detection of increases in size in \< 4 cm adrenal tumors on serial imaging, solitary adrenal metastases without evidence of local invasion, tumors size ≥ 4 cm, patients between the age of 18 and 80, and american society of anesthesiologists score (asa) ≤ 3. the patients with adrenal masses that specified suspicion of malignancy on imaging such as local invasion, irregular tumor margins were evaluated as ineligible for lta, and excluded in this study, were addressed to open surgery. retroperitoneoscopic and laparoscopic partial adrenalectomies were also excluded from the study. totally 102 patients were included in the study. the patients were allocated according to adrenal tumor size as \<6cm (group 1:76) and ≥ 6 cm (group 2: 26). the variables such as demographics, tumor size, and laterality, operation time, blood loss, per-operative and postoperative complications, length of hospital stay, final pathology result were compared between the two groups. in order to evaluate the learning curve, the patients were also classified into three consecutive groups including group a (1-25), group b (25-50), group c (51-75) and group d (76-102) according to the chronological order of their surgery. variables including operation time, tumor size, blood loss, and hospital stay, and overall complications were used to investigate the learning curve.

Eligibility criteria:
inclusion criteria: 1. all hormonally active adrenal lesions, 2. detection of increases in size in \< 4 cm adrenal tumors on serial imaging, 3. solitary adrenal metastases without evidence of local invasion, 4. tumors size ≥ 4 cm, 5. patients between the age of 18 and 80 6. american society of anesthesiologists score (asa) ≤ 3. exclusion criteria: 1. suspicion of malignancy on imaging such as local invasion, irregular tumor margins 2. retroperitoneoscopic adrenalectomies 3. laparoscopic partial adrenalectomies

Keywords: endocrine surgery; laparoscopic adrenalectomy;
1320 nm nd:yag laser for improving the appearance of onychomycosis

Conditions: Fungal Nail Infection

Summary: the purpose of this clinical study is to improve the appearance of onychomycosis and morphology of the nail (fungal infection). the researcher can use a light based therapy to gently heat the toenail infected with fungus to improve the appearance of onychomycosis.

toenail fungus (onychomycosis) is a common fungal infection of the nail that affects roughly 10% of americans. onychomycosis may be a precursor to many complications like ulcers, or skin infections, which may rarely result in amputation. current treatment options have relatively limited long-term success and recurrence is common. the researcher can determine that the laser therapy can heat the nail and destroy and decrease the fungus infecting the nail to improving the appearance of the nail.

Eligibility criteria:
inclusion criteria: * adult male/ female has been diagnose with fungal nail infection on both great toenails. exclusion criteria: * any other toenail disease including, but not limited to psoriasis, lichen planus, pachyonychia congenita, etc. as determined by the investigator. * excessively thick or hypertrophic nails. * subjects with diabetes. * subjects that are pregnant * receipt of any topical therapy for onychomycosis (i.e. antifungal) within 2 weeks of enrollment, systemic therapy for onychomycosis (i.e. antifungal) within 3 months of enrollment, or any other procedures done on the test area within 6 months of enrollment. * subjects with impaired immune systems including, but not limited to hiv, transplant patients on immunosuppression, etc. * current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent. * history of alcohol or drug abuse that would interfere with ability to comply with the study protocol.

Keywords: fungal nail
biologic predictors of leiomyoma treatment outcomes

Conditions: Uterine Leiomyomas; Fibroids; Uterine Fibroids; Myomas

Summary: the purpose of this study is to search for the hereditary (genetic) causes of uterine fibroids. some women with uterine fibroids may have one or more genes that make them more likely to develop uterine fibroids. we are trying to identify these genes to better understand how and why uterine fibroids develop and to design better treatment options for women with uterine fibroids. this information may also help us to understand and treat other problems that may be caused by these genes.

there is little information to predict outcomes of leiomyoma therapies. it is clear that both environmental exposures and genetic predisposition influence disease manifestations. our work has identified a new area of genetic linkage for leiomyomas from a genome wide scan. we therefore propose to prospectively collect biologic samples that will allow us to analyze gene/environment interactions of women enrolled in leiomyoma clinical trials or undergoing leiomyoma clinical treatments using the same methodology used previously. specifically we will collect serum aliquots, genomic dna and information using a genetic epidemiology questionnaire. in the short term we will also be able to use prospectively obtained information on epidemiologic and anthropomorphic data to characterize women undergoing treatment.

Eligibility criteria:
inclusion criteria: 1. able and willing to give consent 2. age 18 or older 3. presence of known uterine leiomyoma exclusion criteria: 1. suspected malignancy

Keywords: uterine leiomyomas (fibroids or myomas) uterine fibroids fibroids uterine leiomyomas
haic in combination with pd-1 inhibitors and lenvatinib for intermediate and advanced hcc after the failure of systemic therapy recommended by bclc

Conditions: BCLC Stage B Hepatocellular Carcinoma; BCLC Stage C Hepatocellular Carcinoma; Hepatic Arterial Infusion Chemotherapy; Lenvatinib; PD-1; Systemic Therapy

Summary: the purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (haic) in combination with pd-1 inhibitors and lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (hcc) after failure of systemic therapy recommended by bclc.


Eligibility criteria:
inclusion criteria: 1. has a diagnosis of hcc confirmed by radiology, histology, or cytology; 2. barcelona clinic liver cancer (bclc) stage c with the presence of portal vein tumor thrombus; 3. has received previous systemic therapy recommended for hcc by bclc, and the systemic therapy failed; 4. both pd-1inhibitors and lenvatinib patients received only include marketed drugs but are not limited to hcc approval; 5. haic was performed after the first pd-1 inhibitor/ lenvatinib treatment or before treatment; 6. received at least 2 cycles of haic； 7. has repeated measurable intrahepatic lesions; 8. child-pugh class a or b. exclusion criteria: 1. the interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months; 2. with other malignant tumors; 3. unable to meet criteria of combination timeframe described above.
polish nationwide registry of diagnostics, treatment and outcome in patients with cardiogenic shock

Conditions: Cardiogenic Shock

Summary: the registry objective is to get information on current epidemiology, diagnostics, treatment and outcome in patients with cardiogenic shock in poland. obtained information will help to plan the nationwide initiative for modern cardiogenic shock treatment with established place for mechanical circulatory support. it is hypothesized that the treatment and outcome of cardiogenic shock, including mechanical circulatory support, are currently poor in poland and should be improved. unfortunately, without status quo data, efficient planning for its improvement cannot be conducted, hence the cas-pol registry initiative.

the prospective registry will be open in nature; any cardiology department in poland with access to a 24-hour hemodynamic laboratory will be eligible to participate in the study. all participants will use an electronic crf (case report form) to anonymously collect data on the incidence, etiology, diagnosis, treatment approaches, and prognosis of patients with cardiogenic shock. data will be collected by researchers from the medical documentation of participating centers. the data collection period will span six months, followed by a six-month prospective observation through visit in person, per telephone contact to the patient or his/her relatives or by retracting national health fund data in case the contact to the patient or his/her relatives is impossible. to enable comparison with global data, collected information will include, among other aspects, the latest society for cardiovascular angiography and interventions (scai) classification for cardiogenic shock, the availability and application of modern short- and long-term mechanical circulatory support techniques, and the frequency of heart transplants.

Eligibility criteria:
inclusion criteria: * cardiogenic shock patients of all etiologies in scai stage b, c, d, e. * age \> 18 years old * persistent hemodynamic failure defined as systolic blood pressure of \<90 mmhg for ≥ 30 minutes or the requirement for inotropic or vasopressor agents with evidence of hypoperfusion of the peripheral organs exclusion criteria: * patients without return of spontaneous circulation who were considered to extracorporeal cardiopulmonary resuscitation (ecpr) * primary septic, anaphylactic, hypovolemic shock * post-operative cardiogenic shock * end-stage of heart failure disqualified from mechanical circulatory support and heart transplantation

Keywords: mechanical circulatory support myocardial infarction cardiogenic shock
peritoneal ropivacaine infiltration on postoperative pain in children affected

Conditions: Testicular; Colic

Summary: the aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of ropivacaine in children undergoing laparoscopic surgery.

1. quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing. 2. data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. 3. source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources . 4. data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information . 5. standard operating procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. 6. sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. 7. plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results 8. statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan

Eligibility criteria:
inclusion criteria: 1. between 6 months and 5years. 2. laparoscopic inguinal hernia repair 3. laparoscopic testicular descent fixation exclusion criteria: 1. patient who are suffering from mental disease 2. patient who suffering from neuromuscular disease 3. local anesthetic allergy 4. patient who needs directly into icu after the operation.

Keywords: analgesia pediatric pain laparoscopy ropivacaine
a study of ln-144 in people with metastatic melanoma to the brain

Conditions: Metastatic Melanoma

Summary: this is an open label study evaluating lifileucel (ln-144) in patients with melanoma brain metastases.

lifileucel (ln-144) is an autologous tumor infiltrating lymphocytes (til) cell therapy that utilizes a 22-day centralized gmp process. lifileucel is infused as part of a treatment regimen that includes preparative nma-ld, followed by one-time autologous til infusion, and a short course of high-dose il-2.

Eligibility criteria:
inclusion criteria: 1. metastatic melanoma with asymptomatic brain metastases 2. at least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate til 3. must be ≥ 18 years of age at time of consent 4. ecog performance status of 0-1 and estimated life expectancy of ≥ 3 months 5. adequate hematologic parameters and organ function exclusion criteria: 1. received organ allograft, except kidney transplant, or prior cell transfer therapy including til and car-t therapies 2. ongoing grade 2-4 toxicity from prior immunotherapy (excluding endocrine, ocular toxicity or vitiligo) 3. history of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs 4. symptomatic brain metastases 5. chronic systemic steroid therapy of \> 10 mg/day 6. active medical illness(es) that would pose increased risk for protocol participation 7. must have negative syphilis assay and be seronegative for hiv, positive serology for hbv must have corresponding pcr assay and may be enrolled if viral load by pcr is undetectable 8. primary immunodeficiency 9. received live or attenuated vaccine within 28 days prior to beginning nma-ld 10. pregnant or breastfeeding 11. patients who cannot receive gadolinium-enhanced mri.

Keywords: ln-144 non-uveal melanoma lifileucel (ln-144) 22-322
nordic luveris study

Conditions: Infertility; In Vitro Fertilization

Summary: to study whether addition of human lh hormone (luveris) during the final days of stimulation with recombinant fsh (gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.


Eligibility criteria:
inclusion criteria: * age below 40 * infertility treatable by ivf or icsi * regular cycles exclusion criteria: * na

Keywords: infertility in vitro fertilization lh supplementation benefits