Kornimate/medical-research-clean huggingface dataset:
ticagrelor and absorb bioresorbable vascular scaffold implantation for recovery of vascular function after successful chronic total occlusion recanalization

Conditions: Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion)

Summary: the study is a single-centre, randomized, active controlled, open label clinical trial. the primary hypothesis is that ticagrelor will show superiority over clopidogrel immediately after cto-pci (chronic total occlusion - percutaneous coronary intervention)

the hypothesis is tested in the first randomization. both antiplatelet therapy will be used in both arms at the approved doses and for the approved duration therapy of 1-year. the secondary hypothesis will test the role of ticagrelor/clopidogrel alone and together with absorb bvs implantation in the recovery of vascular function at long-term. this hypothesis is tested in the second randomization. the angiographic follow-up will be scheduled at 1 or 3-year follow-up in order to test the secondary hypothesis either at the moment of the end of the antiplatelet therapy or at the moment of scaffold bioresorption.

Eligibility criteria:
inclusion criteria: * patients of both sexes, older than 18 years old. * written informed consent obtained. * patients with stable angina pectoris (canadian cardiovascular society (ccs) class 1, 2, 3 or 4) or patients with documented silent ischemia by stress test during the last year. * patients eligible for coronary revascularization in a coronary chronic total occlusion, which was angiographically documented in a previous coronary angiography during the last year. exclusion criteria: * women who are pregnant or women of childbearing potential who do not use adequate contraception. * known allergies to aspirin, clopidogrel bisulfate (plavix ®), ticagrelor (briliquetm) heparin, or a sensitivity to contrast media, which cannot be adequately pre-medicated. * participation in other studies. * life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult. * planned cardiac surgery or major non-cardiac surgery. * the subject has a history of bleeding diathesis or coagulopathy. * the subject suffered disabling stroke within the past year. * known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction, which, in the judgment of the investigator, may affect the patient's ability to complete the study. * history of malignancy, except in patients who have been disease-free \>5 years or whose only malignancy has been basal or squamous cell skin carcinoma. * inability to provide informed consent
treatment patterns and clinical outcomes among patients in latin america receiving first line palbociclib combinations for hr+/her2- advanced/metastatic breast cancer in real world settings.

Conditions: Breast Cancer Metastatic

Summary: to describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across latin america.


Eligibility criteria:
physician inclusion criteria: * oncologist or gynecologist. * responsible for treating ≥4-10 (depending on country) abc/mbc patients who meet the eligibility criteria. * agrees to participate in the study and complete the case report forms (crfs) within the data collection period. patient inclusion criteria: * hr+/her2- breast cancer diagnosis with confirmed metastatic or advanced disease. * received palbociclib as a first line therapy. * no prior or current enrolment in an interventional clinical trial for abc/mbc. * minimum of six months of follow up data since palbociclib initiation. physician exclusion criteria: * qualified less than 2 years ago or more than 35 years ago. * participated in observational research for abc/mbc in the last 3 months. * have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor as first line therapy.

Keywords: human epidermal growth factor receptor 2 negative (her2-) hormone receptor positive (hr+) advanced breast cancer (abc) metastatic breast cancer (mbc)
[c-11]pib pet imaging in alcohol use disorders

Conditions: Alcohol Use Disorder

Summary: to determine whether alcoholics (aud) have a greater rate of amyloid positivity (abeta+) compared to an age-matched cognitively normal control group (hc).

there is a long-established relationship between alcohol use disorders (aud), cognitive impairments, and the development of dementia. some, but not all basic data suggest that alcohol abuse can alter the expression of amyloid precursor protein, and the enzymes that process it. thus, there is a need for in vivo pet studies to further investigate the relationship between aud and ad and the mechanism through which alcohol abuse exerts its effect on this type of dementia. here, we propose to use the amyloid beta (abeta) radiotracer carbon-11 labeled pittsburgh compound-b (\[c-11\]pib) and pet (klunk et al., 2004) to determine whether aud increase the risk to be brain abeta+ in middle aged adults.

Eligibility criteria:
\[a\] alcohol use disorder subjects (aud) inclusion criteria: 1. males or females between 40 and 65 years old 2. fulfill dsm-5 criteria for alcohol use disorder of at least moderate severity 3. current heavy drinking as defined in samhsa criteria (i.e., drinking 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days) exclusion criteria: 1. dsm-5 schizophrenia, schizoaffective disorder, bipolar disorder (scid-5) and prior history of developmental disorders, such as autism, down's syndrome, intellectual disability. 2. a positive urine drug screen at screening for amphetamines, cocaine, methamphetamine, opioids, barbituates and pcp 3. history of severe unstable medical or neurological illnesses that could affect neuropsychological testing 4. history of cancer (other than skin or in situ prostate cancer) within the previous 5 years 5. currently pregnant or breastfeeding 6. currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year 7. metal implants or paramagnetic objects contained within the body which may interfere with the mri scan 8. no first-degree relative with alzheimer's disease or related dementias (b) healthy control subjects (hc) inclusion criteria: (1) males or females between 40 and 65 years old exclusion criteria: 1. current or past dsm-5 psychiatric and/or addictive disorders 2. current heavy drinking as defined in samhsa criteria 3. history of severe unstable medical or neurological illnesses that could affect neuropsychological testing 4. history of cancer (other than skin or in situ prostate cancer) within the previous 5 years 5. currently pregnant or breastfeeding 6. currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year 7. metal implants or paramagnetic objects contained within the body which may interfere with the mri scan 8. no first-degree relative with alzheimer's disease or related dementias
a phase 1/2 study to assess safety and efficacy of bat2020 in hospitalized covid-19 patients

Conditions: COVID-19

Summary: this is a randomized study to assess safety, pharmacokinetics, immunogenicity, and efficacy of bat2020 in hospitalized patients infected with covid-19. this study is composed of 2 parts: a single ascending dose (part 1) and single dose(s) tested in parallel with a double-blind, placebo-controlled design (part 2). patients also will receive best available standard of care (soc) treatment. a data and safety monitoring board (dsmb) will be set up for the study.


Eligibility criteria:
1. male or nonpregnant female adult ≥18 years of age at time of enrollment. 2. patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3. agrees to the collection of nasopharyngeal swabs for virology assessment. 4. women of childbearing potential must agree to either abstinence or use at least 1 primary form of contraception at the time of screening and for 4 months after study drug dosing. 5. enrollment within 72 hours of hospital admission.
electromyographic analysis of the masticatory muscles in cleft lip and palate children with temporomandibular disorders

Conditions: Cleft Lip and Palate; Temporomandibular Disorder

Summary: the aim of this study was to assess the electrical activity of the temporal and masseter muscles in cleft lip and palate (clp) children with pain-related temporomandibular disorders (tmd) and in clp individuals with no tmd by means of surface electromyography (semg). another objective was to determine the diagnostic value of electromyography in identifying clp patients with temporomandibular disorders. the sample comprised 87 children with clp and mixed dentition. the children were assessed for the presence of tmd using of the research diagnostic criteria for tmd (rdc/tmd) by a single examiner. a dab-bluetooth instrument (zebris medical gmbh, germany) was used to take electromyographical (emg) recordings of the temporal and masseter muscles both in the mandibular rest position and during maximum voluntary contraction (mvc).


Eligibility criteria:
inclusion criteria: * presence of a cleft without a syndrome, a sequence, or karyotype abnormalities * presence of mixed dentition exclusion criteria: * the presence of systemic or rheumatologic diseases * a history of cervical spine or temporomandibular joint (tmj) surgery, trauma or malformations
rotational thromboelastometry activated transfusion in trauma trial

Conditions: Trauma

Summary: this is a randomized controlled trial to compare viscoelastic (ve) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation adverse events.

this is an open labeled study as the ve guided resuscitation will be based on the visible ve results. aim 1 will compare the number of blood products utilized in each resuscitation strategy. aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation strategy to determine if there is a difference in the mechanism of coagulopathy. aim 3 will determine if the different resuscitation strategies have an effect on post resuscitation adverse events.

Eligibility criteria:
inclusion criteria: 1. trauma patient 2. mtp activation 3. only patients ≥ 14 years old 4. alive at 31 mins after arrival in ed exclusion criteria: 1. transfer from osh 2. received cpr for more than 5 mins 3. burned 4. pregnant or prisoner 5. known dnr 6. jehovah's witness

Keywords: rotational thromboelastometry viscoelastic test coagulopathy trauma hemorrhage
factors associated with pain level experience in orthodontic treatment

Conditions: Orthodontic Pain; Pain; Orthodontic Appliance Complication

Summary: orthodontic pain has been the primary concern from all patients who requires orthodontic treatment. the design of the study will help us comprehend how patient experienced and managed pain during their orthodontic treatment, average pain level in different orthodontic appliances and factors that could affect pain level experience during treatment, including gender, age, brackets types, hygiene level and habitude.

to interpret the average pain level experience in orthodontic treatment and find correlations of different pain level within each individual from the clinical reports and questionnaires collected from each patient.

Eligibility criteria:
inclusion criteria: * patient with orthodontic treatment over 2 months and less than 12 months * patient with braces or invisalign * patient who goes to orthodontic visits routinely exclusion criteria: * patient undergoing orthopaedic treatment (functional appliances, 2x4 braces placement, maxillary expansion) * patient who do not understand spanish * patient with cognitive impairment * patient who do not want to participate in the study * patient who have complete their orthodontic treatment
single immediate instillation of eo9 after turbt in patients with non-muscle-invasive bladder cancer (nmibc)

Conditions: Bladder Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage ta and g1 or g2 and who were randomized into either an eo9 or placebo group after turbt.


Eligibility criteria:
inclusion criteria: 1. patients who have provided written informed consent 2. patients who have urothelial cell carcinoma of the bladder with clinically apparent stage ta, grade g1-g2 and satisfy both of the following criteria: * the maximum number of tumors is 5. * each tumor diameter: ≤ 3.5 cm. 3. age: ≥20 years old at enrollment. 4. the functions of the major organs are adequate, and the following test value criteria are satisfied: * neutrophil count ≥1,500/μl * platelet count ≥10×10\^4/μl * hemoglobin ≥10 g/dl exclusion criteria: 1. patients with a single, primary bladder cancer of \<0.5 cm. 2. patients with cis lesions in the bladder or a history thereof. 3. patients with a history of other than stage ta, histological grade g1 or g2 disease. 4. patients experiencing recurrence within 4 months following turbt for prior nmibc (duration between the last turbt and cystoscopic confirmation of the present recurrence is within 4 months). 5. patients without at least a three-month cystoscopically confirmed recurrence-free interval between the last turbt and the time of study screening 6. patients having a bladder tumor with a histological diagnosis other than urothelial carcinoma of the bladder or a history thereof. 7. patients who had been administered eo9 in the past. 8. patients who had been administered any other investigational drug within the past 30 days. 9. patients having a medical condition that would make it unsafe for them to undergo turbt under general or spinal anesthesia.

Keywords: bladder cancer nmibc turbt apaziquone eoquin immediate instillation
intravitreal triamcinolone for acute branch retinal vein occlusion

Conditions: Branch Retinal Vein Occlusion

Summary: the purpose of this study is to determine whether intraocular injection of triamcinolone is effective in the treatment of macular edema in acute branch retinal vein occlusion.

intravitreal triamcinolone has recently been shown to have beneficial effect on chronic macular edema due to vein occlusion and preventive effect on neovascularization. hypothetically, prevention of macular derangement by reducing the amount of edema from early phase after occlusion until restoration of collaterals seems to be helpful in these eyes. to our knowledge, no prospective randomized clinical trial, considering both macular changes and preventive effect on neovascularization has been published for intravitreal triamcinolone in acute branch retinal vein occlusion.

Eligibility criteria:
inclusion criteria: * eyes suffering from branch retinal vein occlusion with less than 2 months duration. exclusion criteria: * monocularity, * previous intraocular surgery or laser therapy * glaucoma or ocular hypertension * significant media opacity * existence of traction on the macula * visual acuity ≥20/40 * signs of chronicity (such as cilioretinal and/or retinal shunt vessels)

Keywords: macular edema branch retinal vein occlusion intravitreal triamcinolone macular thickness retinal neovascularization
quality of life (qol) in subjects with acromegaly under lanreotide autogel® treatment.

Conditions: Acromegaly

Summary: the purpose of the protocol is to evaluate and describe qol, in the population of polish acromegalic patients treated with lanreotide autogel® 120 mg during the 24 months (long term observation).


Eligibility criteria:
inclusion criteria: * adult patients with acromegaly treated for at least three months and no longer than three years with lanreotide autogel® 120 mg just before inclusion. * patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form. exclusion criteria: * active participation in any interventional or any other non-interventional acromegaly clinical study. (previous participation in any interventional or any observational / post marketing study (pms) of other somatostatin analogue should not be an exclusion criteria). * any medical or psychological condition, according to investigator judgement, that might compromise the ability to give informed consent.
a study to evaluate immune biomarker modulation in response to vtx-2337 in combination with an anti- pd-1 inhibitor in head and neck cancer

Conditions: Carcinoma, Squamous Cell

Summary: this is an open label, phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous (iv) anti-pd-1 inhibitor, nivolumab, given along with toll-like receptor 8 (tlr 8) agonist motolimod delivered either subcutaneously (sc) or by intratumoral injection (it) in subjects with squamous cell carcinoma of the head and neck (scchn). subjects with previously untreated, resectable scchn, will be recruited onto this trial and will initially undergo pre-treatment diagnostic imaging and biological sample collection. these subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to a scheduled surgical resection.


Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age at the time of signing the informed consent form (icf). * subject has eastern cooperative oncology group (ecog) ps of 0 or 1. * subject has a new clinical or pathologic diagnosis of resectable hpv+ or hpv- scchn of the oral cavity, pharynx, or larynx * macroscopic complete resection of the primary tumor must be planned and subjects should have no medical contraindication to surgery. * subject consents to and has tumor accessible for tumor biopsy pre-treatment. * subjects must have acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests. exclusion criteria: * subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study * subject has unresectable or inoperable tumors * subject has primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors * subject has evidence of distant metastasis * subject is a pregnant or nursing female. * subject has active or uncontrolled infection including known hiv infection or known chronic hepatitis b or c. * subject has active autoimmune disease. * subject has clinically significant ophthalmologic disease.

Keywords: motolimod nivolumab head and neck cancer squamous cell carcinoma checkpoint inhibitor anti-pd1 inhibitor tlr 8 agonist
effectiveness of peer navigation to link released hiv+ jail inmates to hiv care

Conditions: HIV-infection/Aids

Summary: this study will implement a peer navigation intervention to improve linkage to and retention in hiv care for inmates released from l.a. county jail into the community.

the proposed study has two primary specific aims: 1. to examine individual-level and structural-level barriers to hiv care after release from jail, using formative semi-structured interviews with ex-inmates, case managers, and hiv care providers; and to use the information we obtain to inform the adaptation and tailoring of an intervention designed to improve linkage with and retention to hiv care for hiv+ ex-inmates (complete); 2. using a two-group experimental rct design, to test the adapted peer navigation intervention condition for hiv+ inmates upon release from jail compared to a usual care condition, and to evaluate the intervention's effectiveness at improving linkage with and retention in hiv care, self-reported art adherence, and hiv rna viral load suppression; the intervention is hypothesized to result in greater linkage to care, a greater proportion completing at least three hiv care visits per year, increased self-reported art adherence, and decreased levels of hiv rna viral load compared to the usual care control group. secondary aims of the study include assessing the potential moderating effects of substance abuse, the potential mediating effects of substance abuse treatment, and the program's effects on recidivism, and costs. active substance abuse is hypothesized to moderate the effect of the intervention, such that the intervention will be less effective among participants who report substance use.

Eligibility criteria:
inclusion criteria: * age 18 or older * men or tgw diagnosed hiv-positive * english or bilingual spanish speaking * selected for the tcm program (control condition) prior to link la enrollment * residing in la county upon release * eligible for art or incarcerated on art. exclusion criteria: * inability to give informed consent * parole hold or planned transfer to prison * stay in jail \<5 days.

Keywords: hiv aids peer navigation viral load corrections
physician survey on monitoring of patients treated with quetiapine

Conditions: Schizophrenia; Bipolar Disorder; Major Depressive Disorder

Summary: a physician survey to document receipt of metabolic educational materials and assess behavior of physicians in following messages communicated through the educational materials

assessment of physician behavior regarding metabolic monitoring of patients treated with seroquel® (quetiapine fumarate) tablets and seroquel® (quetiapine fumarate) extended release tablets in selected countries in the eu

Eligibility criteria:
inclusion criteria: * physicians targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe seroquel® or seroquel® xr. exclusion criteria: * physicians who have participated in a survey involving seroquel® / seroquel® xr in the past six months are not eligible to participate in this survey.

Keywords: effectiveness of risk minimization metabolic monitoring seroquel® seroquel® xr/quetiapine fumarate