Kornimate/medical-research-clean huggingface dataset:
a study to assess the safety, tolerability, and efficacy of namilumab in participants with active cardiac sarcoidosis

Conditions: Sarcoidosis, Cardiac

Summary: a randomized, double-blind, placebo-controlled, study with an open-label cohort.

study was terminated after a single participant had received 2 doses.

Eligibility criteria:
inclusion criteria: * male or female age ≥18 years * able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form * history of documented sarcoidosis (must include histological confirmation, from any organ, in the subject's medical history or records) * meet heart rhythm society cardiac sarcoid diagnostic criteria (modified) * female subjects must agree to use an approved highly effective birth control (bc) method * male subjects must agree to, and attest that, female partners of childbearing potential are using one of the allowed highly effective methods of contraception * body mass index (bmi) \<40 kg/m2 at screening. * vaccination for covid-19 with completion of the primary series at least 2 weeks prior to randomization exclusion criteria: * hospitalized for any respiratory or cardiac illness ≤30 days prior to screening * known pulmonary hypertension requiring therapy * autoimmune disease other than sarcoidosis likely to require treatment during the subject's participation in this study * symptoms and/or signs of extracardiac sarcoidosis that are likely to warrant treatment in addition to that required for the subject's cardiac disease * estimated glomerular filtration rate (egfr) ≤30 ml/min/1.73 m2 (modification of diet in renal disease \[mdrd\] equation) or requiring renal replacement therapy * hemoglobin ≤9.5 g/dl * participation in another interventional clinical trial within 6 months prior to screening and throughout the duration of participation in this study * systolic blood pressure (sbp) \ 180 mm hg; diastolic blood pressure (dbp) \ 110 mm hg at screening * has documented laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection as determined by polymerase chain reaction (pcr) or other approved clinical testing ≤3 months prior to randomization * significant valvular heart disease known or anticipated to require surgical repair or replacement during the subjects' participation in this study * female subjects who are pregnant or breastfeeding or intend to be, during the study * history of severe allergic or anaphylactic reactions to therapeutic proteins or known sensitivity to namilumab or to its inactive components * any other acute or chronic medical condition, that in the judgment of the investigator or sponsor, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study other protocol-defined inclusion/exclusion criteria may apply.
bioequivalency study of naratriptan hydrochloride 2.5 mg under fed conditions

Conditions: Migraine

Summary: the objective of this study was to prove the bioequivalence of naratriptan hydrochloride tablet under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to naratriptan hydrochloride or any comparable or similar product.
prevalence of thyroid function abnormalities in hiv-infected patients

Conditions: Thyroid; HIV Infections

Summary: review the evolution of thyroid function in hiv-infected patients, with sufficient follow-up.

since the appearance of high-efficiency anti-retrovirals (haarts) in the treatment of human immunodeficiency virus (hiv), several studies have shown an increase in the prevalence of hypothyroidism (frank, rough or low hypothyroidism t4) in cohorts of hiv-infected adults and children. more specifically, rough hypothyroidism (increased tsh and normal thyroid peripheral hormones) have a prevalence of about 3-12% in hiv-treated patients, which is higher than the general population of about 4.3%. the etiology of frustrated hypothyroidism remains debated in the literature; effects of antiretroviral therapy (arv) such as stavudine®, the effect of dyslipidemia, the effect of hiv infection itself, in proportion to severity (expressed as low cd4 cell count) and aids stage. thyroid dysfunction does not appear to be of autoimmune origin, as anti-peroxidase antibodies are rarely present in hiv-infected patients, unlike the general population. with the increased life expectancy of hiv-infected patients and the indications of different experts to be treated earlier, the duration of exposure to arvs is also increasing. therefore, their chronic toxicity deserves particular attention, in particular on thyroid function and / or thyroid hormone metabolism, since iatrogenicity has not been completely ruled out. in addition, clinical evidence suggests that dysthyroids may be corrected or worsened over time in hiv patients (unpublished personal data). today, the natural history of frustrated hypothyroidism and its consequences are not reported in patients infected with hiv. however, it is recognized in the elderly, fructified hypothyroidism evolves over time towards frank hypothyroidism; the latter is associated with an increased prevalence of dyslipidemia, atherosclerosis, diastolic hypertension and therefore an increased risk of myocardial infarction. it therefore seems interesting to review the evolution of thyroid function in hiv-infected patients, with sufficient follow-up.

Eligibility criteria:
inclusion criteria: * major patients. * infected with hiv, regardless of stage of disease and treatment, diagnosed between january 2001 and december 2012 * follow-up at the university hospital of amiens. exclusion criteria: * patients in the thivy1 study lost to follow-up since 2001, having moved or undergoing therapeutic break-up * deceased patients * major protected persons (under guardianship or guardianship) * pregnant women * refusal of participation
bleeding events and maintenance dose of prasugrel

Conditions: Adverse Reaction to Antiplatelet Agent; Acute Coronary Syndrome

Summary: aim: to verify if after the acute phase of acs acute coronary syndrome (1-months), from 1 to 12 months the reduction of maintenance dose of prasugrel from 10 mg to 5 mg/day may reduce the bleeding events (5 mg vs 10 mg). all patients will be treated with 325 mg of aspirin followed by a maintenance dosage of 100 mg of aspirin for at least 1 year. at baseline (after 60 mg loading dose of prasugrel) and after 1 month (7 days after the randomization at 10 or 5 mg of prasugrel) all patients will undergo light transmittance aggregometry (lta) test to evaluate residual platelet reactivity (pharmacodynamic effects).


Eligibility criteria:
inclusion criteria: * all acs patients treated with pci (percutaneous coronary intervention) and dual antiplatelet therapy (dapt: aspirin plus prasugrel). * informed written consent exclusion criteria: * age \< 18 years * active bleeding; bleeding diathesis; coagulopathy * history of gastrointestinal or genitourinary bleeding \<2 months * major surgery in the last 6 weeks * history of intracranial bleeding or structural abnormalities * suspected aortic dissection * any previous tia (transient ischemic attack)/stroke * administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux . * known relevant hematological deviations: hb \<10 g/dl, thrombocytopenia. \<100x10\^9/l * use of coumadin derivatives within the last 7 days * chronic therapy with prasugrel or ticagrelor * known malignancies or other comorbid conditions with life expectancy \<1 year * known severe liver disease, severe renal failure * known allergy to the study medications * pregnancy

Keywords: prasugrel antiplatelet acute coronary syndrome
dna methylation testing for the screening of uterine cervical lesion

Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia; DNA Methylation; High-risk Human Papillomavirus; Cytology

Summary: in our published work, host dna methylation testing has been proved to be sensitive and specific to cervical intraepithelial neoplasia (cin) 2 or more severe lesions (cin2+). its screening effects are independent of high-risk human papillomavirus (hrhpv) status. based on the results of training and validation sets of our previous work, we perform this multicenter, prospective cohort study in unselected participants asking for cervical cancer screening in a hospital-based community. all eligible participants accept dna methylation testing, with cytology and/or hrhpv assay. the primary endpoint is the diagnostic accuracy of dna methylation compared with cytology and/or hrhpv status based on histology results. the accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.


Eligibility criteria:
inclusion criteria: * aged 21 years or older * signed an approved informed consents * feasible to be followed up * available residual cytology samples for methylation analysis exclusion criteria: * without history of cervical disease, including cervical intraepithelial neoplasia (cin) 2 or more severe lesions (cin2+) * no requirement of cervical cancer screening of cytology or high-risk human papillomavirus
home apnea testing in children trial

Conditions: Sleep Apnea, Obstructive; Sleep Disorder; Sleep Apnea Syndromes; Sleep Disturbance

Summary: this clinical trial will compare home sleep apnea testing with the gold standard in-lab polysomnography in terms of 1) accuracy, 2) therapeutic decision-making, and 3) parent/child acceptability in children referred for evaluation of obstructive sleep apnea.

in-lab attended polysomnography (psg) is recommended for the diagnosis of obstructive sleep apnea (osa) in children, but testing is limited by high cost and limited facilities. 90% of children who undergo adenotonsillectomy to treat osa never have the diagnosis made by psg. home sleep apnea testing (hsat) is an accepted means of evaluating adults for osa. however, in children there is insufficient evidence comparing hsat to psg, so it is not currently recommended in the pediatric population. this single-center comparative effectiveness trial will compare the diagnostic accuracy of hsat with psg and will assess the agreement in therapeutic decision-making between the two tests and parent- and child-reported acceptability of hsat and preference of test. participants will be randomized to the initial test (hsat or psg) and then complete the alternate test within one week. off-site investigators who are pediatric sleep medicine physicians will provide a therapeutic decision based on clinical data and either hsat or psg data, and families will complete questionnaires assessing acceptability of hsat and preference between the two tests.

Eligibility criteria:
inclusion criteria: * male and female children age 5-12 years old inclusive * referred for diagnostic psg at the children's hospital of philadelphia (chop) sleep laboratory for evaluation of osa as part of clinical care * parental/guardian permission (informed consent) and if appropriate, child assent. exclusion criteria: * children without down syndrome who have had a psg within 3 years of enrollment * children with down syndrome who have had a psg within 1 year of enrollment. * children with a history of hypoventilation or hypoxemia or who require supplemental oxygen or positive airway pressure during sleep * children with a tracheostomy or tracheocutaneous fistula * children who live in a facility without their parent

Keywords: obstructive sleep apnea home sleep apnea testing
reducing rural colon cancer disparities

Conditions: Colon Cancer

Summary: the investigators will conduct pre-implementations assessments of primary care clinics within a rural health system to determine current practices and capacities regarding colorectal cancer (crc) screening and follow-up, preferred evidence-based interventions (ebis) to improve follow-up, and factors that could influence successful implementation and eventual impact of a multi-level intervention to increase timely and complete follow-up after positive fecal occult blood test (fobt) in rural patients.


Eligibility criteria:
inclusion criteria for primary care provider/staff participants -eligible providers and staff include physicians, nurse practitioners, nurses, case managers, medical assistants, administrative staff, or other employees of the clinic involved in the cancer screening and follow-up process. inclusion criteria for patient participants (interview) -positive fobt or colonoscopy inclusion criteria for patient participants (survey) * 50 years of age or older * had a colonoscopy at one of southern illinois healthcare's facilities within the last 24 months inclusion criteria for colonoscopy provider/staff participants -provider and a staff or mid-level provider in each office (5 colonoscopy providers in the southern illinois healthcare region) exclusion criteria for primary care provider/staff participants -none exclusion criteria for patient participants (interview) * negative fobt or colonoscopy * exclusion criteria for patient participants (survey) * younger than 50 years of age exclusion criteria for colonoscopy provider/staff participants none
childhood uveitis initial management and one-year outcomes

Conditions: Uveitis

Summary: the investigators wish to establish a robust estimate of the incidence of inflammation inside the eye (uveitis) in children age 0-16 years in the uk, which hospitals children present to, where they are referred to, which treatment they receive during the first year after diagnosis, and how well they can see at the end of the first year.

the investigators therefore propose to run a high quality surveillance study, together with the british ophthalmological surveillance unit (bosu) at the royal college of ophthalmologists and with the scottish ophthalmological surveillance unit (sosu). bosu and sosu operate a monthly reporting card scheme. all uk consultant ophthalmologists and associate specialists receive a monthly 'report card' with a list of conditions being surveyed. reporting clinicians will tick a box if they have seen a case of childhood uveitis in the preceding month, and return the card to bosu/sosu, who will inform us, the study investigators. following reporting of a new case, the investigators will directly contact reporting clinicians and send them a clinical proforma to collect clinical details about the case. at 12 months, a follow up questionnaire will be sent. the investigators will use only information available from patient case notes, with no direct patient contact. the investigators principal aim is to determine incidence of childhood uveitis in the uk. secondary aims are to identify presentation patterns, referral pathways, associated medical conditions, management, and outcomes.

Eligibility criteria:
inclusion criteria: * any child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis. exclusion criteria: * in england/wales/northern ireland, children who are known to have pre existing juvenile idiopathic arthritis (joint inflammation) will be excluded. no exclusions will apply to the scotland cohort.
study evaluating safety & efficacy of subcutaneous methylnaltrexone on opioid-induced constipation in cancer subjects

Conditions: Opioid-Induced Constipation

Summary: this purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. the length of participation will be up to 7 weeks.


Eligibility criteria:
inclusion criteria: * is a man or woman aged 18 years or older. * has a body weight \>= 38 kg. * has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer). * has a life expectancy of \>= 6 months. * has a performance status of 0, 1, or 2 based on the eastern cooperative oncology group (ecog) scale. * is taking opioids for cancer-related pain, and not just as-needed doses. * has a diagnosis of oic as determined by the investigator. * is willing to follow the protocol instructions on laxative use during the study. exclusion criteria: * has a history of chronic constipation before starting opioids. * has renal disease receiving dialysis. * has an ostomy for stools. * is a pregnant or breastfeeding woman.

Keywords: opioid induced constipation cancer patients methylnaltrexone
impact of dna fragmentation in sperm on pregnancy outcome after intra-uterine insemination in a spontaneous cycle

Conditions: Infertility Unexplained; Infertility, Male; DNA Damage

Summary: infertility affects about 10% of all couples and is defined by a failure to achieve a clinical pregnancy within a year of regular unprotected sexual intercourse. up to one third of these couples will not have an identifiable cause after routine investigation, id est idiopathic infertility. the current diagnosis of male infertility relies on the world health organization (who) 2010 criteria which focus on concentration, motility and morphology in comparison to cut-off values of a fertile population. alas, the relevance of the conventional semen analysis for the choice of treatment and the predictive value for an infertile couple with idiopathic or mild male infertility embarking on medically assisted reproduction (mar) remains questionable. in other words, there is a strong clinical need to distinguish fertile from infertile men through new sperm function testing and to be able to select both the patient population who will benefit from mar as well as the type of treatment. numerous studies utilizing different techniques for assessing sperm dna fragmentation support the existence of a significant association between sperm dna damage and pregnancy outcomes. in this prospective cohort study the investigators aim to study the role of sperm dna fragmentation analysis in selecting the patient who will benefit from intra-uterine insemination (iui) therapy since iui is still considered the first step in mar and is performed at a large scale in belgium and worldwide.


Eligibility criteria:
inclusion criteria: couples seeking fertility treatment after at least 12 months of unprotected intercourse are eligible. all couples underwent basic fertility investigations which included semen analysis, evaluation of menstrual cycle, and tubal patency testing. exclusion criteria: double sided tubal disease, severe endometriosis (classified as revised american society for reproductive medicine stage iii or iv), premature ovarian failure, and known endocrine disorders (such as cushing's syndrome or adrenal hyperplasia), azoö- or necrozoospermia

Keywords: unexplained infertility idiopathic infertility dna damage dna fragmentation insemination
assessment and treatment of social skills deficits in individuals with social phobia

Conditions: Social Phobia

Summary: this study will determine whether people with social phobia are deficient in certain social skills.

social phobia is a debilitating condition that can cause severe social, emotional, educational, and occupational functioning problems. evidence suggests that individuals with social phobia are deficient in social skills, but the exact skills deficits have not been elucidated. this study will comprise two substudies: one will examine social skills deficits in social phobics and determine how they differ from those of people without social phobia; the other will determine if skills deficits in social phobics can be improved and whether improvements will affect overall social functioning. participants in this study will be randomly assigned to one of three groups for 16 weeks: an exposure group, a social skills training and exposure (set) group, or a wait-list control group. interviews, self-reports, and simulated role plays will be used to assess the social skills of participants.

Eligibility criteria:
inclusion criteria: * diagnosis of social phobia exclusion criteria: * axis ii diagnosis of schizoid or schizotypal personality disorder or paranoia * axis ii diagnosis of mental retardation, obsessive-compulsive disorder, and personality disorders, except for avoidant personality disorder * instability on any antidepressants * psychotic disorder

Keywords: phobic disorders
oxygen concentration during alveolar recruitment

Conditions: Atelectasis, Postoperative Pulmonary

Summary: the purpose of this study is to investigate the effect of oxygen concentration during alveolar recruitment on absorption ateletasis.


Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic obstetric or colon surgery with trendelenburg position exclusion criteria: * american society of anesthesiologists physical status iv or more * severe cardiovascular disease * severe chronic obstructive pulmonary disease, emphysema * history of pneumothorax, bullae * history of lung resection surgery * conversion to laparotomy * refusal to participate

Keywords: absorption atelectasis lung sono oxygen concentration
a study of active immunotherapy with grnvac1 in patients with acute myelogenous leukemia (aml)

Conditions: Acute Myelogenous Leukemia

Summary: this is a phase ii study to evaluate the safety, feasibility and efficacy of immunotherapy with grnvac1 in patients with aml.

this is a multicenter, open-label evaluation of feasibility, safety and immunotherapy in patients with aml in complete clinical remission. patients will undergo leukapheresis prior to or shortly after completing consolidation chemotherapy. dendritic cells will be transfected with the messenger rna encoding human telomerase reverse transcriptase (htert) and a portion of the lysosome-associated membrane protein lamp-1 (lamp), matured, aliquoted, and cryopreserved. the final autologous vaccine product is referred to as grnvac1. patients will be vaccinated with weekly for 6 weeks,will "rest" for 4 weeks, then will receive 6 boost injections, each administered every other week for 12 weeks. patients will be followed every 4 weeks until week 54, then every 3 months for 1 year, then every 6 months up to approximately 5 years from the first vaccination or until relapse/progression.

Eligibility criteria:
inclusion criteria: * aml in first complete remission (cr1) or in second complete remission (cr2) with cr1 \>/= 6 months * has completed at least one cycle of consolidation chemotherapy within past 6 months * eastern cooperative oncology group (ecog) performance status 0 or 1 * adequate hepatic/renal function exclusion criteria: * cr1 and good risk cytogenetic features \[t(15;17), t(8;21), inv(16) or t(16:16)\] * central nervous system or leptomeningeal disease * allogeneic stem cell transplant planned or expected * documented allergy to penicillin or beta-lactam antibiotics * active or ongoing autoimmune disease * clinically significant pulmonary or cardiovascular disease