Kornimate/medical-research-clean huggingface dataset:
safety study of cb-5945 for the treatment of opioid-induced constipation

Conditions: Opioid-Induced Constipation

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of cb-5945 for the treatment of opioid-induced constipation (oic) in adults taking opioid therapy for chronic non-cancer pain.

this is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with oic taking opioid therapy for chronic non-cancer pain. approximately 1,400 participants (approximately 700 participants per treatment group) with oic will be randomized at approximately 225 study centers to receive either 0.25 milligrams (mg) cb-5945 twice daily (bid) or a matching placebo bid for the 52-week double-blind treatment period, followed by a 4-week follow-up period. all randomized participants will be evaluated for safety, tolerability, and quality of life from the first dose of study drug through week 56.

Eligibility criteria:
inclusion criteria: * is taking a stable daily dose of opioids of ≥30-mg morphine-equivalent total daily dose (metdd) for chronic non-cancer pain * has constipation that is caused by the chronic use of opioids * is willing to use only the study-provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (for example, lubiprostone) during the study period (from screening until the last study assessment). * is able and willing to refrain from facilitating defecation via manual maneuvers (for example, digital evacuation or support of the pelvic floor) during the study period (from screening to the last study assessment) exclusion criteria: * has gastrointestinal (gi) or pelvic disorders known to affect bowel transit (for example, obstruction) or contribute to bowel dysfunction * has evidence of intestinal obstruction * has a history of rectal bleeding not due to hemorrhoids or fissures * has an active malignancy of any type (participants with a history of successfully treated malignancy \>5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled) * is taking antispasmodics (for example, dicyclomine), antidiarrheals (for example, loperamide), prokinetics (for example, metoclopramide), or locally acting chloride channel activators (for example, lubiprostone) * is taking non-opioid medications known to cause constipation (for example, iron sulfate therapy or tricyclic antidepressants)

Keywords: opioid constipation chronic pain
the impact of the covid-19 pandemic on testicular cancer

Conditions: Testicular Cancer; COVID-19

Summary: in this study, investigators aim to reveal how the covid-19 pandemic process affects testicular cancer presentations, tumor stages, the time elapsed between diagnosis and intervention, tumor recurrence and progression, which are oncological outcomes.

the rapid spread of the 2019 coronavirus disease (covid-19) caused by a novel betacoronavirus known as the severe acute respiratory syndrome coronavirus-2 (sars-cov-2) has had dramatic effects on individuals and health systems around the world. beyond those infected with sars-cov-2,the intense demand for limited health system resources has led to reduced capacity, rapid depletion of healthcare systems and hospitals becoming a source of virus transmission. urology associations and reference centers have issued recommendations to inform urology care during the covid-19 outbreak. it is essential that urologists give priority to patient safety. potential delays in the diagnosis and treatment of urological conditions and the additional burden on healthcare resources must be balanced against the risks of exposure to covid-19. while this situation aims to conserve healthcare resources, it has created the risk of delaying cancer treatment. as a result, the transformation of health services and the increasing interest of the public in avoiding exposure to the disease has led to a decrease in the number of hospital admissions. the effects of the pandemic on patients with testicular cancer due to a decrease in emergency room and urology clinic admissions are not clear. during thecovid-19 outbreak, the eau (european association of urology) panel of testicular cancer published an evidence-based guideline. according to this guideline, four priority groups were formed and a certain period of delaying treatment was defined for patients in each group according to their priorities.

Eligibility criteria:
inclusion criteria: * patients diagnosed with testicular cancer in the urology clinic. exclusion criteria: * previous history of genitourinary system tumor * previous history of radiotherapy or chemotherapy

Keywords: testicular cancer covid-19 radical orchiectomy
ethyl chloride vapocoolant as anesthesia for arterial punctures

Conditions: Anesthesia; Pain

Summary: ethyl chloride vapocoolant sprays provide transient skin anesthesia within seconds of application. the current investigation aim is to compare the effect of ethyl chloride based vapocoolant spray to placebo in reducing pain associated with arterial puncture for gasometry determinations. the investigators will conduce a double-blind randomized placebo-controlled trial at emergency department. we will enroll patients who come to emergency department who need an arterial gasometry determination. patients will be randomized to intervention-group (ethyl chloride vapocoolant sprays will be usad before arterial puncture) or to placebo-group (alcohol spray as placebo will be used before arterial puncture.) and after the puncture they will rate their pain using a 10 points visual analogue scale.

single-blind, randomized placebo-controlled trial in an emergency department of hospital de basurto in bilbao, spain. patients for whom arterial blood gas analysis had been ordered will be included. they will be randomly assigned to receive application of the experimental ethyl chloride spray or a placebo aerosol spray of a solution of alcohol in water. the assigned spray will be applied just before arterial puncture. the main outcome variable is pain intensity reported on an 11-point numeric rating scale.

Eligibility criteria:
inclusion criteria: * age: 18-85 years old. * arterial gasometry determination needed * iii, iv or v level classification on manchester triage. exclusion criteria: * refusal to participate, * inability to provide informed consent (non-spanish speaking, dementia or altered mental state), * skin disease associated with cold intolerance (raynaud's phenomenon), * known allergy to spray contents, * glasgow coma scale \<15, * pregnancy, * under effects of alcohol or drugs, * allen test +.
a proof-of-concept study of faricimab (ro6867461) in participants with choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd)

Conditions: Choroidal Neovascularization

Summary: this multiple-center, multiple-dose and regimen, randomized, double-masked active comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of faricimab (ro6867461) in participants with choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd). the study was designed to allow the evaluation of ro6867461 in a treatment-naive population (comparison of arms a, b, c, and d) and an anti-vegf-incomplete responder population that met a predefined criterion at week 12 (comparison between arms a and e). only one eye per participant was chosen as the study eye.


Eligibility criteria:
inclusion criteria: * treatment-naive with cnv secondary to amd, with subfoveal cnv or juxtafoveal cnv with a subfoveal component related to the cnv activity by ffa or sd-oct * active cnv exclusion criteria: * cnv due to causes other than amd * subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than 50% of the total lesion area * cataract surgery within 3 months of baseline, or any other previous intraocular surgery * major illness or surgery within 1 month prior to screening * glycosylated hemoglobin (hba1c) above 7.5% * uncontrolled blood pressure
role of elastin metabolites in aortic remodelling in as

Conditions: Aortic Stenosis

Summary: around 1-2% of people are born with a 'bicuspid' aortic valve, with only two cusps instead of the common 'tri-leaflet' valve. people with this valve develop dysfunction of the valve (narrowing or leakage) at a much earlier age. it is also more common for them to develop enlargement of the main blood vessel coming out of the heart, the aorta, and some studies suggest that they are also at higher risk of life-threatening tears in the aortic wall. current guidelines recommend surgical replacement of the aorta at an earlier stage in these patients. the exact mechanism for the dilatation is not clear, and some studies have suggested greater 'stiffness' in the wall of the aorta. in this study, the investigators propose to 1.) study aortic size, stiffness and flow patterns using mri in patients with bicuspid and tricuspid valves with a narrowing (aortic stenosis, 2.) measure markers in patients' blood that may be important in the process of expansion, 3.) compare the change in mri and blood markers at before and 12 months after surgery, in patients who are due to have aortic valve replacement surgery.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * age 18 years or above. * planned surgical avr (+/- cabg or aortic root surgery) for severe as. * ability to understand the written information in english. exclusion criteria: the participant may not enter the study if any of the following apply: * contraindication to mri (e.g., non-compatible pacemaker or other device). * severe claustrophobia (unable to have mri scan). * egfr\<30ml/min (contra-indication to have contrast agent during mri). * contraindication to adenosine (severe asthma). * significant arrhythmia. * other valve disease \> moderate in severity. * female participants who are pregnant or lactating. * previous aortic valve or aorta surgery, previous cabg or other surgery involving aortic cross clamping. * participant in an interventional cardiovascular clinical trial.

Keywords: magnetic resonance imaging elastin metabolites aorta stiffness bicuspid aortic valve
norursodeoxycholic acid vs. placebo in nash

Conditions: Nonalcoholic Steatohepatitis

Summary: this is a double-blind, randomised, multi-centre, placebo-controlled, comparative, phase iib trial. the trial will be conducted with three treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d or 1000 mg/d norudca tablets vs. placebo tablets for the treatment of nash.


Eligibility criteria:
inclusion criteria: * must be willing to participate in the study and provide written informed consent * male or female patients ≥ 18 and \< 75 years * centrally assessed histological evidence of nash and liver fibrosis * women of childbearing potential agree to use a highly effective method of birth control during the entire duration of the trial and for 4 weeks following the last dose of trial treatment exclusion criteria: * patients taking prohibited medications * presence of liver cirrhosis * type 1 diabetes or uncontrolled type 2 diabetes * history or presence of any other significant concomitant liver diseases * history of liver transplantation * bmi \>45 kg/m\^2 * any known relevant infectious disease (e.g., active tuberculosis, acquired immunodeficiency syndrome \[aids\]-defining diseases) * abnormal renal function (glomerular filtration rate estimated from cystatin c \< 30 ml/min) at screening visit * any active malignant disease (except for basal cell carcinoma) * existing or intended pregnancy or breast-feeding
study to assess demographic, pharmacologic, biomarker, clinical features and quality of life (qol) of participants with lupus nephritis

Conditions: Systemic Lupus Erythematosus

Summary: this is a multicenter prospective study to assess clinical characteristics, demographics, treatment and health-related quality of life (hrqol) of lupus nephritis (ln) participants across 5 gulf countries (united arab emirates \[uae\], qatar, bahrain, kuwait and oman).


Eligibility criteria:
inclusion criteria: * more than or equal to 18 years of age * clinician diagnosed ln participants. * at least one visit to the investigational center during 12 months prior to the baseline visit, recorded in medical documentation. * literacy in english or arabic allowing to fully comprehend the written informed consent and study-specific patient reported questionnaires. exclusion criteria: * incomplete medical records to be able to assess the disease severity or absence of any of the following renal laboratory results from the medical record within the last twelve months: a. urinary protein to creatinine ratio (upcr) or 24-hour proteinuria or urine sediment (activity). b. serum creatinine or estimated glomerular filtration rate (egfr); or measured glomerular filtration rate (gfr), if egfr is not available. * current or medical history of: a. congenital or acquired immunodeficiency. b. malignancy in active treatment phase. c. acute viral infection, such as human immunodeficiency virus (hiv) infection, requiring hospitalization.

Keywords: lunelord systemic lupus erythematosus lupus nephritis organ damage gulf countries real-world
early evaluation of the response of large b cell non hodgkin's lymphoma to chemotherapy by pet/ct

Conditions: Lymphoma, Large-Cell

Summary: patients affected with non-hodgkin's large b-cell lymphoma are treated by chemotherapy. the evaluation of the response to this treatment is made by positron emission tomography (pet/ct) in many centres where this technology is available. presently pet scans and ct scans are being performed before treatment, after 4 cycles of chemotherapy and a few months after the end of treatment. the goal of this study is to determine if it is possible to evaluate the efficiency of chemotherapy treatments after one cycle of treatment instead of waiting after 4 cycles, using a new scanner that combines pet and ct modalities. data available from studies on these combined exams suggest that pet/ct helps to rapidly evaluate the response of the chemotherapy treatment. we also want to verify if some pathological characteristics measured from tumor cells will enable doctors to predict in advance the response to treatment.

participation in this study involves 4 pet/ct exams, which occur before the treatments start, after the first cycle of chemotherapy, after 4 cycles of chemotherapy and then 12 weeks after the end of the treatments. the only additional test performed in this study compared to the regular follow-up of patients that are not in this study is the pet/ct exam after the first cycle. your participation in this study will not affect treatment since the results of the first pet/ct test will not be communicated. all other tests results will be available in the medical record.

Eligibility criteria:
inclusion criteria: * newly diagnosed large b cells non hodgkin's lymphoma, cd20 positive * chemotherapy treatments planned (r-chop) but not started exclusion criteria: * pregnancy (determined by urinary β-hcg and blood test) * patients younger than 18 years * unable to tolerate the procedure (30 minutes laying down on the back) * no chemotherapy treatment planned secondary to the patient's health performance * previous lymphoma that has been treated with chemotherapy with the exception of stade i lymphoma treated only with radiotherapy. * all lymphoma other than large cell non hodgkin's lymphoma

Keywords: diffuse large b cells lymphoma pet/ct fdg
recording facial and vocal emotional productions in children with autism as part of the jemime project

Conditions: Autism; Pervasive Developmental Disorder

Summary: the purpose of the jemime project is to create a serious game to help children with autism and pervasive developmental disorder (pdd) develop facial and vocal emotions in context. the objective of this study is to record facial and vocal emotional productions in children with autism and pdd in order to create an algorithm for the recognition of facial emotional expressions implemented in the serious game jemime.


Eligibility criteria:
inclusion criteria: * diagnosis of autism and pervasive developmental disorder according to diagnostic and statistical manual of mental disorders iv (dsm iv) criteria using scales (autism diagnostic interview adi and / or autism diagnostic observation schedule ados). * intelligence quotient (iq) = /\> 70 (wechsler intelligence scale for children wisc iv) * subjects and holders of parental authority who have given their informed and written consent * subjects affiliated to social security system. exclusion criteria: * subjects non affiliated to social security system.

Keywords: autism pervasive developmental disorder
a pilot study to evaluate alternative viral load tests during start of antiretroviral therapy

Conditions: HIV-1-infection

Summary: a pilot study of alternative viral load testing with samples collected in the clinic and at home compared to traditional viral load monitoring in participants engaged in hiv care. approximately 15 participants starting art, or working to suppress a detectable viral load, will monitor viral loads during regular clinic appointments and in intermediate time-points during their participation in this pilot study.

a pilot study of alternative viral load testing with samples collected in the clinic and at home compared to traditional viral load monitoring in participants engaged in hiv care. approximately 15 participants starting art, or working to suppress a detectable viral load, will monitor viral loads during regular clinic appointments and in intermediate time-points during their participation in this pilot study. there are three planned research viral load evaluations in the trial, which may include but are not limited to the evaluations listed below: 1. clinical care viral load - this will take place at the clinic during the regular clinical follow-up to confirm effective viral suppression.. during these visits an hiv viral load sample will be collected using traditional venipuncture methods and analyzed using a qualified commercial test. these plasma values may be used as a comparator with other viral load test results. 2. clinic tasso collection - participants will collect one or more tasso device specimen(s) during in-clinic study visits. the main objective of these measurements is to evaluate hiv viral load monitoring using novel collection approaches with the supervision of trained study staff to minimize user error potential. 3. home tasso collection - participants will be provided with tasso devices to use at home in between regular parent study visits. these devices will be shipped in real-time to wistar institute for archiving before hiv viral loads will be measured. the main objective of these measurements is to evaluate the feasibility hiv viral load monitoring using novel collection approaches at home.

Eligibility criteria:
inclusion criteria: * persons living with hiv starting an art regimen or working to suppress a previously detectable viral load ≥ 5,000 copies/ml exclusion criteria: * persons living with hiv suppressed on art regimen.
establishing clinical utility evidence for chronic disease management testing

Conditions: Cardiometabolic Syndrome

Summary: this is a national-level research study of primary care physicians. the purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.

the results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. the data from this study will be submitted to a national journal for publication. the study plans to enroll up to 300 physicians. upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as clinical performance and value vignettes (cpv®). cpvs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. in each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis and 5) treatment and follow-up. each case takes approximately 15-20 minutes to complete and we estimate the time commitment for each round of cpv administration to be approximately 45 - 60 minutes. all responses to the cases will be completed online and will be kept confidential. over 2 cpv administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours. if physicians are randomized to an intervention group in this study, they will receive education materials on a diagnostic test currently available for use in the market after the first round of cpv administration. they are asked to review these materials before moving to the next cpv administration round. time to review education materials is estimated to be approximately 15 minutes. depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll into a follow-on study. if they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.

Eligibility criteria:
inclusion criteria: * subjects must meet the following criteria to be enrolled in the study: 1. board-certified physician currently practicing in the following areas: 1. internal medicine 2. family medicine 2. have practiced as a board-certified physician in internal or family medicine or greater than 2 but less than 30 years 3. community / non-academic based practice setting 4. ≥ 40 patients under care weekly 5. commonly treats patients with atrial fibrillation, coronary artery disease, congestive heart failure, diabetes, hypertension, and hyperlipidemia 6. practicing in the u.s. 7. english-speaking 8. access to the internet 9. informed and voluntarily consented to be in the study exclusion criteria: 1. non-english speaking 2. practicing in an academic setting 3. unable to access the internet 4. not practicing in the u.s. 5. do not voluntarily consent to be in the study