Kornimate/medical-research-clean huggingface dataset:
a multi-center study of spherule-derived coccidioidin

Conditions: Coccidioidomycosis

Summary: adult volunteers were skin tested with 1.27 ug spherule-derived coccidioidin. the skin test antigen was evaluated in three different populations of adult volunteers to determine the safety and efficacy of the product in the assessment of delayed-type hypersensitivity to coccidioides immitis. induration greater than or equal to 5 mm after 48 hours was considered positive for exposure to c. immitis.


Eligibility criteria:
inclusion criteria: * good health (absence of active medical disease) * meets criteria specific to population groups: * coccidioidomycosis group: * history of coccidioidomycosis of at least 45 days duration confirmed by roentgenograph serologic or mycologic findings * histoplasmosis group: * history of pulmonary histoplasmosis * naive control group: * lifetime residence in the states of wa, or, id, or mt * never employed as an agricultural worker * serology negative for c.immitis antibodies exclusion criteria (all groups): * active medical disease * alcohol abuse or illicit drug use * influenza-like illness within the past 4 weeks * immunizations within the past 4 weeks * current atopic or contact dermatitis, psoriasis, erythema nodosum, urticaria * current treatment with corticosteroids, cytotoxic or immunosuppressive drugs * immunodeficiency disease * hiv infection * previous skin test with coccidioidin or sd coccidioidin * pregnant or lactating * adverse reaction to thimerosal * adverse reaction to candida or trichophyton skin test antigens coccidioidomycosis group: * current cavitary or disseminated coccidioidomycosis * history of histoplasmosis, or blastomycosis histoplasmosis group: * history of coccidioidomycosis or blastomycosis naive control group: * history of coccidioidomycosis, histoplasmosis, blastomycosis * travel for more than 30 days in designated areas of ca, az, nv, ut, nm, tx and mexico, central and south america. travel for more than 7 days in restricted areas of ca, az and tx.

Keywords: coccidioidin coccidioidin sd spherule-derived coccidioidin coccidioidomycosis valley fever coccidioides immitis
a study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of ro7058584 following 7 days of instillation of eye drops in patients with primary open angle glaucoma or ocular hypertension

Conditions: Glaucoma, Open-angle; Ocular Hypertension

Summary: this is a phase i, multi-center, randomized, adaptive, investigator/patient-masked, placebo-controlled, parallel multiple-ascending dose study (part a) with an extension including up to two selected doses from part a and latanoprost 0.005% as active comparator (part b).


Eligibility criteria:
inclusion criteria: * 18 to 90 years of age inclusive, at the time of signing the informed consent form * confirmed diagnosis of ocular hypertension (oht) or primary open-angle glaucoma (poag) in both eyes as determined by the investigator at screening * treatment-naïve participants or participants who are able to safely stop their intraocular pressure (iop)-lowering medication(s) prior to randomization according to the required minimum washout periods * at baseline visit, iop ≥ 24 millimeters of mercury (mmhg) in the morning (8:00 am ± 1h) and ≥ 22 mmhg in the afternoon (2:00 pm ± 1h) measurement in the same eye and ≤ 34 mmhg at all timepoints in both eyes * best corrected logarithm of the minimum angle of resolution (logmar) visual acuity score of 0.7 or better in each eye as measured by early treatment diabetic retinopathy study (etdrs) visual acuity test at screening * central corneal thickness (pachymetry) measurement 450 to 620 micrometers (μm) in both eyes at screening * cup-to-disc ratio ≤ 0.8 (both eyes) at screening * anterior chamber angle is open and non-occludable (both eyes) as confirmed by the investigator by gonioscopy examination at screening exclusion criteria: * advanced visual field defects * other forms of glaucoma than poag or oht * any abnormality preventing reliable applanation tonometry * any clinically significant corneal scarring, haze or opacity * uncooperativeness of the participant that restricts adequate examination of iop, ocular fundus or anterior chamber * any presence or history of uveitis or other history of any ocular inflammatory disease. * history or signs of penetrating ocular trauma * risk of visual field or visual acuity worsening in either eye as a consequence of glaucoma progression or consequence of participation in the trial or any other ocular disease, according to the investigator's best judgment * history of any glaucoma surgery * history of refractive surgery * any other intra-ocular surgery within six months of screening * any active ocular disease requiring treatment. * use of any listed prohibited medications * current enrollment or past participation within the last 30 days before the screening visit in any other clinical study involving an investigational study treatment or any other type of medical research * any participant who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol
study of antenatal model to prevent preterm delivery

Conditions: Preterm Delivery; Pregnant Women; Antenatal Care Model

Summary: the purpose of this study is to determine whether antenatal model in vaginosis are effective in preventing vaginal infection and preterm delivery

the standard antenatal care nowadays can not answer for preterm delivery problems. thus, comprehensive and proactive approach is needed for preventing preterm delivery. this antenatal model is consisted of midwife training, early detection of bacterial vaginosis, pregnant women campaign and self administered ph check

Eligibility criteria:
inclusion criteria: * 14- 18 week gestation pregnant women with or without any vaginal discharge * singleton pregnancy, without any fetal or uterine anomaly exclusion criteria: * any complication in pregnancy * any history of disease in pregnancy
electrotherapy and myofascial therapy in padel players

Conditions: Low Back Pain, Mechanical

Summary: introduction. the lumbar region is one of the locations with the highest incidence of injuries in the paddle players. the crossed hands myofascial technique is used to release the restrictions of the thoracolumbar fascia, improving its mobility. the electrotherapy technique of tens consists in the application of a low frequency current for the recovery, capitalization and oxygenation of the muscle, thus improving mobility and pain. aim. to evaluate the efficacy of an intervention by electrotherapy combined with myofascial therapy, in the lumbar region, for a mobility improvement in older paddle-tennis federated players. study design. randomized, multicenter, simple blind, clinical trial with follow-up period. methods. 30 players paddle will be assigned to the two study groups: experimental (intervention through therapy myofascial and electrotherapy) and control (intervention by electrotherapy). the intervention will have a duration of 4 weeks, with 2 sessions per week, lasting 15 minutes. there will be three evaluations: pre-intervention, post-intervention and follow-up. the variable of study is the mobility of the lumbar spine in the movements of flexion and extension (assessed by the employment of tests of schober and fingertip-to-floor). the analysis of normality be performed with the kolmogorov-smirnof, and in case of homogeneity of the groups is used in parametric tests: test t-student for paired data (difference between the different assessments) and anova of mean repeated (intra-and intersujeto). expected results. improvement of the mobility of the lumbar spine in the movements of flexion and extension.


Eligibility criteria:
inclusion criteria: * padel players * with federal sheet * male * over 18 years * currently participate in regional and / or national competitions exclusion criteria: * present a medical diagnosis of musculoskeletal pathology * not signed the informed consent document.

Keywords: paddle-tennis myofascial release electrotherapy physiotherapy low back randomized clinical trial
a randomized trial assessing adverse events and disease activity when comparing intravenously (iv) infused abbv-400 to trifluridine and tipiracil (lonsurf) oral tablets plus iv infused bevacizumab in adult participants with c-met over-expressed refractory metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: colorectal cancer (crc) is the third most common type of cancer diagnosed worldwide and in china. the purpose of this study is to assess adverse events disease activity when comparing intravenously (iv) infused abbv-400 to trifluridine and tipiracil (lonsurf) oral tablets plus iv infused bevacizumab in adult participants with c-met over-expressed refractory metastatic colorectal cancer (mcrc). abbv-400 is an investigational drug being developed for the treatment of crc. participants are put into treatment arms as part of 2 stages. each treatment arm in stage 1 receives a different dose of abbv-400. each treatment arm in stage 2 receives the optimal dose of abbv-400 or lonsurf plus bevacizumab. up to approximately 460 adult participants with c-met over-expressed (oe) refractory mcrc, will be enrolled in the study in approximately 160 sites in 15-20 countries. in stage 1, participants will receive intravenously (iv) infused abbv-400 dose a or b. in stage 2, participants will receive the optimal dose of iv infused abbv-400 or the standard of care (soc), lonsurf oral tablets plus iv infused bevacizumab. the total study duration will be approximately 4 years. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at an approved institution (hospital or clinic). the effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.


Eligibility criteria:
inclusion criteria: * life expectancy \>= 12 weeks per investigator assessment. * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 during the screening period prior to the first dose of the study drug. * measurable disease per response evaluation criteria in solid tumors (recist), version 1.1. exclusion criteria: * prior systemic regimen containing c-met targeting antibody or antibody drug conjugate (adc). * history of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil. * active infection as noted in the protocol.

Keywords: metastatic colorectal cancer abbv-400 trifluridine tipiracil lonsurf bevacizumab andrometa-crc-064
impact of hyperkalaemia on therapy with renin angiotensin aldosterone system inhibitors

Conditions: Hyperkalemia

Summary: there are limited data regarding the burden of hyperkalaemia in patients attending emergency departments (ed) or who are hospitalised (excluding those already receiving dialysis). renin-angiotensin-aldosterone system inhibitors (raasi) are of prognostic benefit in patients with heart failure with reduced ejection fraction (hfref) and post myocardial infarction (mi) left ventricular systolic dysfunction (lvsd) and as such should be continued wherever possible for these indications. these drugs may contribute to elevation in serum potassium and hyperkalaemia may lead to a reduction in dose or complete withdrawal of raasi. yet it remains unknown how common this happens in standard clinical practice. inappropriate discontinuation of raasi in such patients may lead to adverse clinical outcomes. if patients have hyperkalaemia that limits the use of raasi, they may be candidates for new potassium binders that could facilitate their continued use.

research questions: in an adult population of patients who are hospitalised or attending the emergency department (and not receiving dialysis) with hyperkalaemia: 1. how does hyperkalaemia impact on raasi therapy and does this vary according to the clinical indication for the drug(s)? 2. what are the demographics, co-morbidities and drug history for patients presenting with hyperkalaemia? 3. what is the frequency of subsequent hospitalisations and mortality rate in a cohort of patients presenting with hyperkalaemia at 12 months?

Eligibility criteria:
inclusion criteria: 1. patients in ed or inpatients with at least 1 blood test with a potassium level of ≥5.5 mmol/l 2. receiving raasi. 3. aged 18 and above. 4. able to provide informed consent or consent provided by consultee in those unable to consent for themselves. exclusion criteria: 1. patients already receiving dialysis prior to the episode of hyperkalaemia. 2. for patients considered for postal consent: known cognitive impairment, learning difficulties or brain injury or those who had transient cognitive impairment, delirium or required urgent deprivation of liberty form completion during inpatient stay or in the previous 12 months prior to hyperkalaemia episode.

Keywords: hyperkalemia due to raasi raasi hyperkalaemia
e-based technology to provide decision aid on breast reconstruction for women with breast cance

Conditions: Decision Support Technique; Breast Cancer

Summary: using decision aids has been demonstrated to support women to make treatment decision effectively. however, these studies focused on the decision of receiving breast conservative surgery or mastectomy, had short term follow-ups on decision satisfaction.the aims of this study were: evaluate the effect of e-based \& personalized breast reconstruction surgery decision aid on women's decision satisfaction and mental health.

randomized controlled trial will be used to examine the effect of e-based \& personalized breast reconstruction surgery decision aid on decision satisfaction, body image, anxiety and depression. participants will be randomly assigned into either experimental or control groups with 88 women in each group. after completing the questionnaires at baseline, participants in the experimental group will be asked to receive a e-based \& personalized breast reconstruction surgery decision aid at clinic. control group will only receive pamphlet and usual care. all participants will be followed up 1 week after consultation, and 1 month, 8 month and 12 month after surgery.

Eligibility criteria:
inclusion criteria: * age of at least 20 years or under 20 years but married * females newly diagnosed with breast cancer who are candidates for mastectomy * ability to read and speak taiwanese or mandarin exclusion criteria: * women with cancer recurrence * poor cognitive function * diagnosed with psychiatric disease

Keywords: decision aid breast reconstruction e-based technology
hypothermia with intrajugular cooling in acute ischemic stroke thrombectomy

Conditions: Acute Ischemic Stroke

Summary: hypothermia with intrajugular cooling is a neuroprotective strategy that has been proven to minimize brain damage and maximize functional preservation in animal models of stroke. the purpose of this proof-of-concept study is to determine the safety and tolerability of intrajugular cooling in patients with acute ischemic stroke who are treated with mechanical thrombectomy.


Eligibility criteria:
inclusion criteria: 1. age 18-80 years; 2. acute ischemic stroke caused by unilateral internal carotid artery terminal segment/middle cerebral artery m1 segment occlusion; 3. in line with the indications for mechanical thrombectomy without contraindications; 4. successful recanalization (mtici 2b/3) after mechanical thrombectomy that confirmed by digital subtraction angiography; 5. written informed consent provided by the patients or their legal relatives. exclusion criteria: 1. suffering from cerebral venous system diseases such as cerebral venous thrombosis/stenosis/dysplasia; 2. suffering from heart diseases such as ventricular arrhythmia/myocardial infarction/congestive heart failure; 3. imaging examination after mechanical thrombectomy shows intracranial hemorrhage/contrast extravasation; 4. difficulty in reaching the designated position of the device used for intrajugular cooling; 5. difficulty in complying with intrajugular cooling or other conditions that the investigator considered inappropriate for inclusion.

Keywords: acute ischemic stroke hypothermia thrombectomy intrajugular cooling
the use of platelet-rich-fibrin in lower third molar surgery.

Conditions: Facial Swelling; Tooth Position Anomalies; Tooth, Impacted; Tooth Extraction Status Nos; Tooth Avulsion

Summary: the present study aims to analyze the effect of prf (platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (m3m) in a split-mouth randomized controlled clinical trial.

the present study aims to analyze the effect of prf (platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (m3m) in a split-mouth randomized controlled clinical trial. facial swelling will be assessed using an innovative three-dimensional digital technique.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 32 years who required both m3m extractions were recruited * good health status * indication to surgical extraction of both m3m * complete root formation * surgical risk level classified as "conventional" or "moderate" according to daugela et al. classification exclusion criteria: * person under the age of 18 or over 32 * allergy or contraindications to administration of corticosteroids * acute infection in any of the teeth to be extracted * patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease * pregnancy or breastfeeding * history of treatment with antiresorptive drugs * chronic kidney disease

Keywords: third molar surgery facial swelling 3d facial swelling evaluation prf tooth impacted platelet rich fibrin
pharmacokinetics of td-4208 in patients with moderate hepatic impairment

Conditions: Hepatic Impairment

Summary: this multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (child-pugh class b) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (pk) of td-4208.


Eligibility criteria:
inclusion criteria: * for hepatic impairment group: subject has moderate hepatic impairment (child pugh b) * for normal hepatic function group: subject is in good health exclusion criteria: * women who are pregnant, lactating, breastfeeding, or planning to become pregnant during the study. * subject has received an investigational drug (or medical device) within 30 days * subject who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition that would confound or interfere with the evaluation of the safety, tolerability, or pk of the investigational drug; or is unable to comply with the study protocol.

Keywords: hepatic impairment hepatitis liver cirrhosis
long-term safety and tolerability of ezetimibe (sch 58235, mk-0653) with atovastatin (p02154, mk-0653-017)

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to examine the long-term safety and tolerability of ezetimibe (sch 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.

this study is a long-term extension study of the protocol p00692 parent study.

Eligibility criteria:
inclusion criteria: * has successfully completed the 12-week double-blind, efficacy and safety parent study (p00692). * if female, has a negative pregnancy test prior to study entry and, if of childbearing potential, agrees to practice an effective barrier method of birth control for the duration of the study and for 30 days after the last statin dose. * if postmenopausal female receiving hormone therapy, a stable estrogen (ert), estrogen/progestin (hrt) or raloxifene regimen must be maintained during the study period. * is willing to continue to follow their prescribed national cholesterol education program (ncep) step 1 diet for the duration of the study. exclusion criteria: * has discontinued from the parent study (p00692) prior to study completion. * is in a situation, or has any condition which, in the opinion of the investigator may interfere with optimal participation. * is a pregnant or lactating female. * is human immunodeficiency virus (hiv) positive.
acute withdrawal from smoked cocaine - 9

Conditions: Cocaine-Related Disorders; Substance Withdrawal Syndrome; Substance-Related Disorders

Summary: the purpose of this study is to develop an experimental paradigm to examine acute withdrawal symptoms from cocaine.

although there are clearly identifiable withdrawal syndromes following cessation of a number of abused drugs such as alcohol and heroin, it is unclear whether a withdrawal syndrome follows the cessation of crack cocaine. a laboratory model of withdrawal from smoked (crack) cocaine would provide a safe and systematic method of testing the efficacy of behavioral or pharmacological treatments for withdrawal symptoms following cocaine smoking cessation. therefore, this study investigated acute behavioral, subjective, and physiological withdrawal symptomatology for 6 hrs following 7 deliveries of 2 dose sized (0.07 vs. 0.4 mg/kg) of smoked cocaine. the behavioral measure was performance on a computerized reaction time task, subjective measures included participant and observer ratings of mood and withdrawal symptomatology, and physiological measures comprised heart rate and blood pressure. it was hypothesized that signs and symptoms of withdrawal from smoked cocaine would be greater following the 0.4 mg/kg dose size, compared to the 0.07 mg/kg dose size.

Eligibility criteria:
inclusion criteria: m/f ages 21-45 with a history of smoked cocaine use at least twice a week for the past six months, including 0.5 g of cocaine in a 24hr period on at least one occasion. in good health as evidenced by physical exam and complete blood count, chest x-ray and electrolyte and liver function tests, with a normal resting 12-lead electrocardiograph (ecg) and blood pressure of less than 140/90 mmhg. using an acceptable method of birth control. having a urine toxicology screen positive for cocaine metabolites. exclusion criteria: any dsm-iv axis i disorder other than cocaine abuse or dependence, or dependence or daily use of psychoactive drugs other than nicotine or caffeine. a history of violence and/or currently on probation, parole or awaiting trial. pregnant as determined by serum pregnancy screen, lactating or having delivered a child in the past 12 months. seropositive tests for the human immunodeficiency virus (hiv) or hepatitis b. history of seizure disorder.
prevalence of hypertension using telemedical home blood pressure measurements

Conditions: Hypertension

Summary: the purpose of this study is to determine the prevalence of hypertension among citizens of holstebro, denmark aged 55-64 years, including both the well treated, the untreated and the insufficiently treated, and to estimate the prevalence of white coat and masked hypertension using home blood pressure measurements with telemedical data transmission.


Eligibility criteria:
inclusion criteria: * age 55 to 64 years * registered address in the municipality of holstebro * enrolment at a practice of one of the gps who had agreed to participate in the study. exclusion criteria: * unwillingness to participate * incapability to do home blood pressure measurements