Kornimate/medical-research-clean huggingface dataset:
cortisol response to moderate and deep sedation in children

Conditions: Adrenal Insufficiency

Summary: currently, it is unknown whether sedation itself induces a rise in serum cortisol levels or if cortisol levels rise under only the most invasive of procedures, regardless of the type of anesthetic agent used. animal data shows significant alterations in steroid intermediates under anesthesia regardless of the procedure performed. prior studies in children show general anesthesia and even epidural anesthesia can cause a rise in serum cortisol, but the effects of moderate and deep sedation on cortisol levels during different types of procedures are unknown. general medical practice varies considerably among providers; some provide stress dosing (extra and sometimes high doses of steroids) for sedation for both non-invasive and invasive procedures for patients with known adrenal insufficiency, but the doses given vary considerably. others provide stress dosing only for the most invasive procedures in this population of patients. currently there is no published normative data on changes in cortisol levels under moderate and deep sedation in adrenally sufficient children, so the normal response we are trying to mimic is unknown. we propose to measure salivary cortisol levels prospectively in adrenally sufficient children undergoing moderate and deep sedation to determine the normal cortisol response to the stress of sedation for both invasive and non-invasive procedures. up to 300 adrenally sufficient children will be prospectively recruited to measure salivary cortisol levels during moderate and deep sedation for non-invasive procedures (e.g. mri, echocardiogram, or other imaging studies), and invasive procedures (e.g. surgery, endoscopy) to determine what the normal cortisol response is to the stress of sedation during these procedures using various anesthetic agents. the primary outcome variable will be to determine peak salivary cortisol measurements during non-invasive and invasive procedures under different levels of sedation using various anesthetic agents, and correlate these with known norms in children to determine if the patient's hypothalamic-pituitary-adrenal axis is under stress.


Eligibility criteria:
inclusion criteria: * child presenting for routine sedation to the tamc pediatric sedation center. * age 3 months to 18 years of age. * if female age 12 or greater or menstruating, must not be pregnant. exclusion criteria: * must not have the diagnosis of adrenal insufficiency or any concerns for possible adrenal insufficiency, to include recent tapering of exogenous steroids in the last 6 months. * current treatment with oral steroids or has been on oral steroids in the last 3 months. * the use of regular inhaled corticosteroids for asthma controller treatment or intranasal steroids for allergic rhinitis is specifically not an exclusion criteria.

Keywords: moderate sedation sedation, deep
manual lymphatic drainage vs marian clark drainage in pcs

Conditions: Pelvic Congestive Syndrome

Summary: pelvic congestion syndrome is a debilitating and potentially life threatening disorder of the pelvic region there is a constant hindrance in patient's daily professional and personal life due to the chronic pain. it can provide a definite way to improve pelvic congestion and quality of life. in this way it can benefit a large percentage of community females suffering from pelvic congestion syndrome and disability. this can grow at large length in favour of patients, clinicians and overall women health.

as per researcher's knowledge there are limited researches in which efficacy of manual lymphatic drainage in pelvic congestion syndrome are analyzed furthermore my comparative intervention i.e marian clark drainage is a rarely used osteopathic technique and not much studies have been conducted on it. this study helped to in identifying the effect of manual lymphatic drainage versus marian clark drainage on pain and disability in patients with pelvic congestion syndrome.

Eligibility criteria:
inclusion criteria: * multiparous women * age ranging 20 to 50 * ovarian veins \>4mm in diameter on ultrasound chronic pelvic pain/pressure for more than 6 months. * dull, aching or "dragging" pain in the pelvis or lower back, particularly on standing and worse around the time of your menstrual period. * pelvic pain that worsens as the day goes on, particularly if much time is spent standing dyspareunia * swollen veins in pelvic region, butt, thighs, vulva and vagina. * associated irritable bladder/irritable bowel present exclusion criteria: * pelvic pain due to other organic cause like uterine fibroids, endometriosis, ovarian cyst pelvic pain due to neurological or musculoskeletal disorder * uterine prolapse * pelvic cancer
timing and typology of conduction disturbances during tavi

Conditions: Aortic Stenosis, Severe

Summary: the tactic-tavi registry aims to collect information about a consecutive cohort of patients undergoing transcatheter aortic valve insertion. the registry is international, multi-centre and observational. the registry is planned to continue until the calculated sample size is achieved.

all patients since february 2023 treated successfully with tavi until the study endpoint will be deemed suitable for inclusion in the registry. the registry will: 1. collect the baseline clinical features of the study population. 2. evaluate the electrocardiogram (ecg) and contrast tomography (ct) scan parameters. 3. collect procedural characteristics including type and timing of any conduction disturbance 4. collect follow-up data including post-procedural ecg, echocardiographic and clinical outcomes.

Eligibility criteria:
inclusion criteria: patients successfully undergoing transcatheter aortic valve implantation for native severe aortic stenosis. - exclusion criteria: 1. presence of previously implanted permanent cardiac pacemaker. 2. valve-in-valve procedures. 3. no pre-procedural electrocardiogram is available. 4. no pre-procedural contrast ct tavi is available. 5. enrollment in another clinical trial. 6. patients aged less than 18 years old. 7. patients who do not consent for their data to be included in the registry. 8. failed transcatheter aortic valve deployment. -

Keywords: tavi pacemaker aortic stenosis
multi-reader multi-case controlled clinical trial to assess the fujifilm ffdm and dbt reader training program

Conditions: Breast Cancer

Summary: the purpose of this pilot is to assess the adequacy of the fujifilm dbt reader study training program to ensure that readers participating in the fujifilm dbt pivotal trial are properly trained in the reading and interpretation of ffdm and dbt images.

for this reader study, radiologists review images obtained via protocol fmsu2013-004a. they review both ffdm alone and ffdm + dbt images, and provide a bi-rads and pom for each. the radiologists performance metrics for the following modalities will be evaluated: ffdm and ffdm + dbt.

Eligibility criteria:
inclusion criteria: * female subjects participating in fmsu004a protocol with known clinical status exclusion criteria: * subjects with unknown clinical status not participating in fmsu004a protocol.

Keywords: mammography
prolgolimab monotherapy or in combination with bendamustine for r/r classical hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: prolgolimab is an anti-pd-1 inhibitor that has previously been shown to be effective and safe for the treatment of patients with melanoma. given the mechanism of action, it is expected to be effective in patients with classical hodgkin lymphoma (chl). the use of pd-1 inhibitors in 2nd line treatment, as part of pet-adapted monotherapy/combination therapy, has already demonstrated a favorable toxicity profile, as well as a high efficacy, which may lead to increased survival of patients with r/r chl. it has been demonstrated that long-term disease remission can be achieved after pd-1 inhibitor therapy, even in a group of heavily pretreated patients with relapsed/refractory chl. the use of prolgolimab as part of pet-adapted therapy strategy in this study may allow to achieve a prolonged remission in patients with chl who are highly sensitive to immunotherapy while omitting the autologous stem cell transplantation.


Eligibility criteria:
inclusion criteria: * patients with a histologically verified diagnosis of chl, refractory or relapsed after the first line of therapy * age 18-70 y * ejection fraction not less than 50% * no severe concurrent illness * 0-2 ecog status * use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug. exclusion criteria: * severe organ failure: creatinine \> 2 norms; alanine aminotransferase, aspartate aminotransferase \> 5 norms; bilirubin\> 1.5 norms; * respiratory failure \> grade 1 at the time of enrollment * requirement for vasopressor support at the time of enrollment * uncontrolled bacterial or fungal infection at the time of enrollment * active or prior documented autoimmune disease requiring systemic treatment * pregnancy, breastfeeding, planning pregnancy or parenthood during the study period * hypersensitivity or allergy to study drugs * somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent * simultaneous use of drugs or medical devices studied in other clinical trials * use of pd-1 inhibitors or bendamustine in the 1st line of therapy

Keywords: hodgkin lymphoma prolgolimab pd-1 inhibitors bendamustine immunotherapy relapsed/refractory autologous stem cell transplantation,
evaluation study of web-based resource for youth

Conditions: Chronic Disease; Healthy

Summary: this study will evaluate digiknowit news, a web-based resource to educate youth about pediatric clinical research. youth will be randomly assigned to one of three groups (1. intervention version a; 2) intervention version b; 3) wait-list control).

compared to the high numbers of clinical trials with adults, there are far fewer clinical trials with children and adolescents; highlighting the need for more clinical trials with pediatric populations. lacking in the area of pediatric clinical research are resources to educate children and adolescents about clinical research in fun, interactive, and developmentally appropriate ways. thus, a web-based resource, digiknowit news, was developed for youth aged 8 to 14 years to educate youth about participating in pediatric clinical trials. the web-based resource includes video spotlights, investigations, and electronic comic books. the purpose of this study is to conduct a randomized controlled trial to determine the effectiveness of the web-based resource and examine its impact on youths' knowledge about pediatric clinical trials, self-efficacy about making decisions about participation in clinical research, and positive attitudes towards participation.

Eligibility criteria:
inclusion criteria: * within the ages of 8 and 14 years of age exclusion criteria: * does not speak english fluently, does not have access to a computer or tablet with internet connection, and or has participated in a clinical trial after kindergarten.
evaluation of cerebral oxygenation and hemodynamics in patients with cerebral venous thrombosis

Conditions: Cerebral Venous Thrombosis

Summary: cerebral hypoperfusion and hypoxia are the major determinants of neurological outcomes following acute brain injury as proved in traumatic brain injury/sub arachnoid haemhorrhage literature. how the brain injury affects cerebral oxygenation in patients with cvt is not currently known. some of the factors that can affect cerebral oxygenation in patients with cvt are hemoglobin, po2, pco2, cerebral perfusion pressure (or map) and change in intracranial pressure after decompressive craniectomy. this study is designed to study how these factors affect cerebral oxygenation and impact of decompressive craniectomy on the cerebral oxygenation.


Eligibility criteria:
inclusion criteria: -patients diagnosed with cerebral venous thrombosis, undergoing decompressive craniectomy. exclusion criteria: * patients on inotropic support * systolic blood pressure \< 90 mmhg * haemoglobin oxygen saturation \<95% * refusal of consent * age \ 65 years * known history of diabetes or hypertension * pregnancy * any contraindication for application of cerebral oximetry sensors

Keywords: cerebral oximetry cerebral venous thrombosis decompressive craniectomy
immunological effects of vitamin d replacement among black/african american prostate cancer patients

Conditions: Localized Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8

Summary: this early phase i is to find out how common vitamin d insufficiency is among african american patients with a history of prostate cancer that has not spread to other parts of the body (localized) or has spread to other places in the body (metastatic) and how vitamin d insufficiency affects the immune system. this study also aims to find out if replacing vitamin d results in normalization of the immune function. information from this study may benefit prostate cancer patients by identifying vitamin d insufficiency which in several studies had been found to contribute to more aggressive prostate cancers.

primary objectives: i. determine the prevalence of vitamin d insufficiency among black / african american (aa) prostate cancer patients. ii. determine the changes in circulating immunological cell function among patients with vitamin d insufficiency and the effects of vitamin d replacement on those changes. iii. determine the acceptability of cholecalciferol (vitamin d) replacement therapy among black / aa prostate cancer patients and potential impact on health-related quality of life. iv. determine if there are differences in the peripheral blood immunological cell function in black / aa patients with metastatic or locally recurrent prostate cancer compared to those with localized prostate cancer. v. determine if vitamin d replacement is associated with improvement in progression free survival (pfs) of black/aa patients with prostate cancer with detectable changes in immune response compared to those with no detectable changes in immune response and compared to stage matched historical controls. outline: patients with low vitamin d3 levels receive cholecalciferol orally (po) daily for 8 weeks in the absence of unacceptable toxicity. patients undergo blood sample collection throughout the study.

Eligibility criteria:
inclusion criteria: * african american males, age \>= 18 years * patients with a previous history of localized or metastatic or locally recurrent prostate cancer * patients with vitamin d levels below 30 ng/ml exclusion criteria: * known hypersensitivity to vitamin d * end stage renal failure on dialysis * liver cirrhosis * currently taking a vitamin d or multivitamin supplement, that has more than 400 iu/10mcg of vitamin d daily for the past month * legal inability or restricted legal ability. medical or psychological conditions not allowing proper study completion or informed consent signature * chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection * history of hypercalcemia
evaluation of hysterectomy after chemoradiation therapy for stage ib2/ii cervical cancer

Conditions: Stage IB2 Cervical Cancer; Stage II Cervical Cancer; Adenocarcinoma; Squamous Cell Carcinoma; Adenosquamous Carcinoma

Summary: gyneco 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional relapse, especially in patient with a reduced metastatic risk and who received a local chemoradiation therapy with an increase of radiotherapy doses (45 grays).


Eligibility criteria:
inclusion criteria: * operable stage ib2/ii cervical cancer * adenocarcinoma, squamous cell or adenosquamous carcinoma * patient between 18 and 70 years old * no lombo-aortic lymph node invasion at baseline * previous 45 grays external pelvic radiation with concomitant chemotherapy (cisplatin 40 mg/m2/week corresponding to 5 cycles) * followed by a 15 grays utero-vaginal brachytherapy, eventually combined with a 6th cycle of chemotherapy (cisplatin 40 mg/m2) * with a pelvic boost if lymph node or parametrial invasion * no macroscopic residual tumor after 6 to 8 weeks after brachytherapy. exclusion criteria: * other tumor histology (neuro-endocrine) * stage \> ii (figo 1995) at baseline * patient with remaining cervical cancer (after sub-total hysterectomy)
acupuncture for post covid-19 condition (long covid) neuropsychiatric symptoms

Conditions: Long Covid19; Neuropsychiatric Symptom; Acupuncture

Summary: in this study, a 12-week pragmatic, randomized, double-blinded clinical trial will be conducted to evaluate the efficacy of acupuncture for the treatment of long covid neuropsychiatric symptoms and provide reference for clinical non-drug treatment.

this is a pragmatic, randomized, double-blinded clinical trial on acupuncture for treating neuropsychiatric symptoms in long covid patients. a total of 160 participants will be diagnosed by a registered chinese medicine practitioner and randomly assigned to the acupuncture and the control group with a 1:1 ratio. the acupuncture group will receive 24 sessions of interventions during a 12-week treatment duration (2 sessions per week) and will be followed up at week 18. the control group will only receive conventional therapy.

Eligibility criteria:
inclusion criteria: * meet the clinical diagnosis of long covid by the world health organization (who), with no neuropsychiatric symptoms 1 year before infection with covid-19, and continue to have at least one neuropsychiatric symptom for 2 months after sars-cov-2 turned negative 3 months above; * aged 12 to 80 years; * willing and able to consent, and complete all assessment and study procedures exclusion criteria: * patients with a history of chronic neuropsychiatric symptoms; * cardiovascular diseases pre-existing to the covid-19 episode such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers; * documented pre-existing history of psychiatric illness, including substance abuse; * suicidal tendencies (attempted suicide in the 12 months before the study); * any chronic or remote neurological disorder (i.e. stroke, head trauma, epilepsy, tumor); * those who participated in other clinical trials within one month; * pregnant or lactating female patients; * have surgery within two months before the study or will have a scheduled surgery during the study; * acute brain injury or acute encephalopathy from another etiology than covid-19 (e.g., sepsis, liver or renal failure, alcohol or drug withdrawal, drug toxicity); * open-heart cardiac surgery or cardiac arrest during the last 6 months; * patients who received acupuncture treatment 1 month before the start of the study; * patients who were unable to complete the assessment during screening due to severe mental, cognitive, or emotional impairment
peer partners to improve physical activity in older latino and latina adults with parkinson's disease.

Conditions: Parkinson Disease

Summary: the goal of this interventional study is to culturally adapt and determine feasibility of the peer partner training program and the peer-supported mobile health physical activity intervention in older latin/hispanic people with parkinson's disease. the main question\[s\] it aims to answer are: * what is the feasibility of the peer partner training program? * what is the feasibility of the peer-supported mobile health physical activity intervention? * what are the effects of the peer-supported mobile health physical activity intervention on physical activity, motivation, depression, apathy and self-efficacy? participants will be asked to: * wear a research-grade activity monitor, actigraph gt9x device for 10 days at the beginning and end of the study. * watch 11 educational videos about parkinson´s disease and exercise and attend two virtual educational sessions. * connect with another person with parkinson´s disease one time a week on a virtual meeting platform for 8 weeks. * use fitbit activity monitors and connect with other participants through the fitbit application for 8 weeks. * attend a weekly online exercise class for 8 weeks with other people with parkinon´s disease.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson disease, * able to walk without the assistance of another person for 10 minutes -≥ 29 on telephone interview for cognitive status (tics) * to have a close friend/family member over the age of 18 that would support the participant during the intervention -≥ 50 years of age * hispanic * to be willing to use an activity monitor and use a fitbit and fitbit application * to be on a stable course of pd medications without any plans for change over the next 3 months * to be able to speak, read and write in spanish or english exclusion criteria: * unstable cardiopulmonary, orthopedic, psychological or metabolic condition * atypical parkinsonism disorders * a fall in the last 6 months (that was unrelated to an external force) * currently engaging in 150 minutes of mod-vigorous physical activity/week

Keywords: exercise peer support hispanic parkinson´s disease
placebo controlled trial of a titanium dioxide semiconductor toothbrush on mild-to-moderate gum disease

Conditions: Periodontal Diseases

Summary: the effects on indices of gingivitis/periodontitis will differ between study arms in which the titanium dioxide semiconductor toothbrush is used, compared to an otherwise identical toothbrush with an inert resin core in place of the titanium dioxide semiconductor.

organic acid producing anaerobic bacteria are implicated in the development and progression of gingivitis and periodontal disease (brill, 1962; kleinberg, 1974). the disease process manifests as periodontal inflammation and tissue destruction (oliver et al, 1969). although relatively crude methods are used for routine clinical diagnosis and monitoring of periodontal disease (eg, probing for gingival pocket depth and bleeding), sensitive and reproducible measures of periodontal disease have been validated (oliver et al, 1969; löe et al, 1965; egelberg, 1964; golub et al, 1976; borden et al, 1977). by the lewis definition, an acid is an electron pair acceptor. in the presence of light \&/or electrical induction, valence electrons from a wetted titanium dioxide (tio2) semiconductor will donate electron pairs to neutralize organic acids. whereas a tooth surface is negatively charged, plaque has a net positive charge, and in part, ionic attraction contributes to the adherence of plaque to the tooth surface. donating electrons to the plaque will alter polarity and diminish the ionic attraction between the plaque and the tooth surface (iontophoretic effect). thus, in addition to the established mechanical benefits of brushing, the flow of electron pairs for disrupting ionic bonding of plaque to the tooth surface and neutralizing bacterial organic acids, may confer an advantage over a conventional toothbrush (hoover et al, 1992; niwa et al, 1989; kusunoki et al, 1986). there is some evidence that the electrons may also interact with bacterial coenzyme-a to have an antibacterial effect (morioka et al, 1988; onoda et al, 1996).

Eligibility criteria:
inclusion criteria: * 30 to 70 yrs of age * mild-to-moderate periodontal disease * dentulous exclusion criteria: * any unstable medical condition * pocket depth \> 5 mm

Keywords: periodontal disease toothbrush titanium dioxide semiconductor mild-to-moderate periodontal disease adult patients 18 to 70 years of age