Kornimate/medical-research-clean huggingface dataset:
interstitial pneumonia with autoimmune features: evaluation of connective tissue disease incidence during follow-up

Conditions: Idiopathic Interstitial Pneumonia

Summary: interstitial lung diseases (ild) represent a frequent complication of connective tissue diseases (ctds), especially systemic sclerosis, idiopathic inflammatory myopathies and rheumatoid arthritis. ild can either occur during ctd course or be the first manifestation of ctds. therefore screening patients with ild for ctd is crucial. in some cases, ild are associated with clinical and/or serological autoimmune features but not classifiable for ctds. evolution of these forms to defined ctds has never been study. recently, the european respiratory society/american thoracic society experts proposed a new term, "interstitial pneumonia with autoimmune features" or ipaf, to describe these patients according to updated classification criteria. aims of this study were to compare ctd occurence during follow-up between ipaf and non-ipaf patients in a idiopathic interstitial pneumonia cohort and to identify risk factors of ctd progression in ipaf patients at diagnosis.


Eligibility criteria:
inclusion criteria: * patients with a new diagnosis of ild confirmed by two chest-hrct 3 months apart * patients with a minimal follow-up duration of 3 years after ild diagnosis exclusion criteria: * patients with a defined ctd at ild diagnosis * patients with an other ild etiology identified at diagnosis (i.e. sarcoidosis, hypersensitivity pneumonitis)

Keywords: connective tissue disease interstitial lung disease interstitial pneumonia with autoimmune features
prospective evaluation assessing u2 mb™ total knee system

Conditions: Osteoarthritis; Musculoskeletal Abnormalities

Summary: the goal of this study is to evaluate the safety and effectiveness of the united orthopaedics mobile bearing total knee system (u2 mb™ knee) in patients undergoing total knee replacement surgery due to end-stage knee osteoarthritis. the main questions it aims to answer are: 1. what is the component survivorship of the u2 mb™ knee system at 1, 3, 5, and 10 years? participants will: 1. return for follow-up assessments at year 1, year 3, year 5, and year 10 after surgery 2. undergo clinical evaluations including functional outcome scoring, radiographic imaging. this study will take place across three investigational sites and will involve 150 knee replacements using u2 mb™ components. the study's objectives include assessing early to long-term outcomes in terms of implant survivorship, clinical function, patient satisfaction, radiological findings, and overall safety of the device over a 10-year period.

non-interventional prospective follow-up study.

Eligibility criteria:
inclusion criteria: 1. all patients suitable for a cemented total knee replacement, mbc design 2. all elective pathology (including osteoarthritis, rheumatoid arthritis, post-traumatic arthritis not requiring stemmed components, avascular necrosis) 3. willing to voluntarily sign the informed consent form 4. willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit. exclusion criteria: 1. skeletally immature (less than 21 years of age) at time of implantation 2. active native knee joint infection 3. post-traumatic arthritis requiring stemmed components 4. malignancy around the knee 5. all patients who are personally unable to take part in fully informed consent (dementia, reduced amts etc) 6. patients who will not be available to return for the predetermined appointments in order to complete the 10 years follow-up 7. has inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable 8. currently enrolled in another clinical investigation which could affect the endpoints of this protocol
randomized trial of intranasal versus intravenous naloxone in level of consciousness in suspected opioid overdose

Conditions: Morphinan Opioid Overdose

Summary: the purpose of this study is to determine which route of administration is better for treatment of opioid overdosed patients

in intravenous drug abusers (idus), as a result of previous intravenous substance abuse, the predictable difficult cannulate exist and cause the delay administration of antidote therapy. additionally, idus are also at increased risk of carrying blood borne infections that could be transmitted to healthcare workers through needle stick injuries. the investigators aimed to compare intranasal administration of naloxone with intravenous route.

Eligibility criteria:
inclusion criteria: * patients with the range of 15-50 years old * who were suspicious to opioid overdoses based on history and having clinical appearance such as miotic pupils with loss of consciousness * give response to naloxone with increasing the level of consciousness exclusion criteria: * not giving response to naloxone and suspicious to have another reason for loss of consciousness

Keywords: opioid overdose naloxone intranasal
study of a candidate gene involved in goldenhar syndrome.

Conditions: Goldenhar Syndrome; Oculoauriculovertebral Dysplasia

Summary: the aim of this study is to identify of the first gene involved in the goldenhar syndrome in a cohort of 120 affected patients.

goldenhar syndrome belongs to the heterogeneous spectrum of oculoauriculovertebral dysplasia. several chromosomal abnormalities have been described associated with this spectrum, and furthermore mutations in different genes of development cause abnormalities of the jaw or facial asymmetries in human or mouse. to date, no gene has been identified as formally involved in the genesis of the oavs, despite evidence of familial cases, mostly with autosomal dominant inheritance. the aim of this study is to identify of the first gene involved in the goldenhar syndrome in a cohort of 120 affected patients.

Eligibility criteria:
inclusion criteria: * spectrum of oculoauriculovertebral dysplasia minimal features include unilateral microtia and hemifacial microsomia exclusion criteria: * absence of minimal spectrum of oculoauriculovertebral dysplasia features, molecular anomaly identified, other diagnosis

Keywords: array-cgh exome sequencing
the rapid covid study - application of point-of-care covid-19 testing

Conditions: Covid19

Summary: this study is being conducted to study the use and application of a point-of-care (poc) covid-19 test developed by spartan biosciences and recently approved for clinical use by health canada.

this rapid covid-19 study is a prospective, unblinded clinical trial. poc testing utilizing the spartan cube covid-19 platform will be performed on a cohort of 2200 hospitalized patients who have been tested for covid-19. this cohort will be divided into three groups: 1. patients consulted upon by icu, internal medicine, or cardiology for admission to the hospital 2. patients undergoing cardiac testing and/or procedures 3. patients awaiting surgery the results from the poc test will be compared to the results from the traditional hospital core lab test to determine sensitivity and specificity of the poc test. an additional cohort of 500 quarantined health care workers will have the poc test performed and compared with the results from the traditional hospital core lab test.

Eligibility criteria:
inclusion criteria: * participants \>/= 18 years of age * patients for whom poc testing would change their course of treatment (in opinion of treatment team) exclusion criteria: * patients in whom conventional covid-19 testing would not have otherwise been performed * patients in whom immediate covid-19 testing would not alter short-term treatment * patients who refuse consent
clinical performance evaluation of the bio-self™ covid-19 antigen home test

Conditions: COVID-19

Summary: the purpose of this study is to evaluate the performance of the bio-self covid-19 antigen home test. the study will evaluate the accuracy (sensitivity and specificity) in a simulated home use environment when compared to a high-sensitivity emergency use authorization (eua) sars-cov-2 rt-pcr assay.

the bio-self covid-19 antigen home test is immunochromatographic and uses double-antibody sandwich method to detect sars-cov-2 antigen from individuals with or without symptoms or other epidemiological reasons to suspect a covid-19 infection. the test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult collected anterior nares swab samples from individuals ages 2 to 13. the primary objective of this study is to determine the accuracy of the bio-self covid-19 antigen home test when compared to a high-sensitivity emergency use authorization (eua) sars-cov-2 rt-pcr assay.

Eligibility criteria:
inclusion criteria: 1. an institutional review board (irb) approved informed consent and assent, if applicable, is signed and dated prior to any study-related activities. 2. male and female subjects 2 years of age and older. 3. subject is willing to provide a self-collected nasal swab sample. (if under the age of 14, the sample will be collected by an adult.) 4. subject is willing to have a nasal swab collected by a healthcare professional. 5. subject agrees to complete all aspects of the study. exclusion criteria: 1. subject has a visual impairment that cannot be restored with glasses or contact lenses. 2. subject has prior medical or laboratory training. 3. subject had a positive covid-19 test in past three (3) months. 4. subject uses home diagnostics, e.g., hiv tests, glucose meters, etc.

Keywords: covid, covid 19, virus
effects of exercise modality on abdominal obesity and health risk factors in older men and women

Conditions: Abdominal Obesity

Summary: the prevalence of abdominal obesity in the elderly is increasing at alarming rates and thus, requires immediate attention. by comparison to younger adults, obesity reduction in the elderly presents a unique challenge and requires an innovative approach. we propose a novel approach to investigate the effects of different exercise types as independent treatment strategies for the reduction of obesity and related health risk factors in older men and women. we propose that exercise without caloric restriction will be associated with modest weight loss (3-5%), that in turn will be associated with significant reduction in abdominal obesity, insulin resistance, and a corresponding increase in skeletal muscle mass and function. we will determine the separate effects of resistance and aerobic exercise on these primary outcome variables, and, whether a treatment strategy that combines the two is optimal.


Eligibility criteria:
inclusion criteria: * men and women between 65 and 80 years of age. * men and women are self-sufficient, sedentary, abdominally obese (bmi between 27 and 34.9 kg/m2; waist circumference greater than 88 cm in women and 102 cm in men), weight stable (± 2 kg) for 6 months prior to the beginning of the study, be non-smokers, and not diabetic. * we will study elderly women who are not taking hormone replacement therapy to create a homogeneous population in whom the effect of exercise on the principal outcome variables can be evaluated with minimal confounding. exclusion criteria: * smokers and diabetics. * women taking hormone replacement therapy.
immunogenicity and reactogenicity of a booster dose of gsk bio's dtpa-hbv-ipv/hib vaccine

Conditions: Acellular Pertussis; Diphtheria; Poliomyelitis; Haemophilus Influenzae Type b; Tetanus; Hepatitis B

Summary: the purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of dtpa-hbv-ipv/ hib vaccine (infanrix hexa tm). the study will also evaluate the immune response of these subjects to a dtpa-hbv-ipv/hib booster. this protocol posting deals with the objectives and outcome measures of the booster phase. the objectives and outcomes measures of the primary phase are presented in a separate protocol posting (nct = 00376779).

this protocol posting has been updated in order to comply with the fda aa, sep 2007.

Eligibility criteria:
inclusion criteria: * subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol * subjects must have completed the full three-dose primary vaccination course with one of the formulations of the dtpa-hbv-ipv/hib vaccine in primary study 106786. * a male or female between, and including, 16 and 20 months of age at the time of booster vaccination. * written informed consent obtained from the parent or guardian of the subject * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. * participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product. * planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose. * evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis b and/or hib booster vaccination or disease since the conclusion visit of study 106786. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * acute disease at the time of enrolment. * administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.

Keywords: hexavalent vaccine booster
a study of a glaucoma therapy to treat open-angle glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosis of open-angle glaucoma * other protocol-defined inclusion criteria may apply exclusion criteria: * under 18 * pregnant * other protocol-defined exclusion criteria may apply
a study of long-term responders on olaparib

Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Summary: this is an observational and sample collection study involving patients (alive or deceased) from several clinical trials who had received the investigational drug, olaparib in other research studies. there is no intervention given for this study. this research is being done to understand of the mechanisms involved in patients whose cancer responds well and whose cancer does not respond well to investigational drug, olaparib, to help better understand how olaparib works and to better identify patients who may benefit from this therapy.

this is study will compare biomarker research with response in patients who have received olaparib. patients who have had a durable response to olaparib for at least 2 years will be approached for the study. patients who agree to this study will then have their medical history collected and will be asked to complete a questionnaire. archival tumor tissue will also be collected for biomarker research. a waiver of consent is requested to access the medical records and archival tumor tissue of patients who are deceased. if participants are still taking olaparib, they will be asked to provide blood samples for pharmacokinetics and circulating tumor dna, and the results of ct scans taken as part of their standard of care or as a part of another research study. if participants' disease worsens while still on olaparib, they will then be asked to provide a blood sample for pharmacogenomics and brca testing (if not known). an optional tumor biopsy will also be requested. participants will continue to be followed by telephone for survival and any new treatments they are receiving.

Eligibility criteria:
inclusion criteria: * previous or current treatment with olaparib in a clinical trial/standard of care that included one of the following as a first step study for epithelial ovarian cancer (including fallopian tube or peritoneal cancer): * single agent olaparib given for relapsed disease or * single agent olaparib given as maintenance therapy after response to platinum based chemotherapy or * olaparib combined with platinum based chemotherapy and then continued as maintenance therapy or * olaparib combined with other types of therapy * had a durable response to olaparib defined as patients who have benefited from olaparib for \> 18 months. patients who discontinued olaparib due to toxicities but otherwise meet the definition of a durable response will be included or the control group is patients who had a short duration benefit with olaparib of less than 6 months in any individual clinical trial/standard of care * ability to understand and the willingness to sign a written informed consent document. * patient's willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. exclusion criteria: * any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy * pregnant or breastfeeding women
a retrospective study on the factors of drug-coated balloon restenosis

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to analyze potential factors post paclitaxel drug-coated balloon angioplasty in patients with denovo large vessels disease. it includes imaging endpoints and clinical event endpoints. over 5000 patients are expected to be enrolled.

this study is a retrospective analysis that retrospectively reviewed over approximately 5000 patients with de novo-large-vessel disease who underwent paclitaxel drug-coated balloon angioplasty. the study endpoints include cardiovascular adverse events at 1 year (cardiovascular death, cardiovascular events) and coronary angiographic outcomes (primarily late lumen loss, restenosis rate). it primarily focuses on differences in baseline characteristics, lesion features, intracavitary imaging characteristics(including oct, ivus), hemodynamic parameter，and procedural approaches among patients. over 5000 patients are expected to be enrolled.

Eligibility criteria:
inclusion criteria: * age: 18 years and older. * diagnosis: diagnosed with coronary artery disease with native large vessel lesions confirmed by coronary angiography. * treatment plan: scheduled to receive paclitaxel drug-coated balloon angioplasty. * informed consent: patients have been fully informed about the nature and purpose of the study, and have voluntarily agreed to participate, with signed informed consent. * physiological status: cardiac function classified as nyha i-iii. exclusion criteria: * allergy history: known allergies to paclitaxel or any materials used in angioplasty (e.g., contrast agents). * severe complications: uncontrolled hypertension (systolic blood pressure \>180 mmhg or diastolic blood pressure \>110 mmhg). * other medical conditions: active bleeding or clotting disorders. * other serious diseases with a life expectancy of less than 1 year (e.g., advanced cancer). * pregnancy or nursing: women who are currently pregnant or breastfeeding. * participation in other studies: currently participating in other clinical trials that might affect the results of this study. * psychological or behavioral factors: history of psychiatric or behavioral disorders that could interfere with adherence to study protocols, or communication barriers that prevent understanding of study requirements.

Keywords: dcb chd ivus oct
examining carryover effect in patients treated with spinal cord stimulation (echo)

Conditions: Neuralgia; Spinal Cord Stimulation

Summary: spinal cord stimulation is a minimally invasive surgical treatment for severe, chronic, neuropathic pain that is refractory to conventional treatment. the treatment consists of an electrode implanted in the epidural space of the spinal cord, either via a percutaneous approach (using the so-called percutaneous leads) or via a surgical (hemi-) laminectomy (using the so-called surgical leads or plate leads). it is a well-known clinical observation that when activating or deactivating scs stimulation, there is a variable interval before the patient perceives a clinical effect of the change. this variation goes by different names (carryover, echo, after effect, etc.) and might be dependent on the clinical condition and treatment duration. to our knowledge only very little research has been published on the topic of carryover effects; a recent study showed that the interval is highly variable between patients. while patients may experience immediate pain relief at the onset of scs treatment, the effect in patients with a long-term scs treatment history may have different characteristics, possibly due to ongoing changes in the nervous system. the aim of this pilot study is to lay the foundation for investigating the carryover effects in spinal cord stimulation. this will be carried out in a mixed population of patients with different indications for scs, and with different treatment durations. patients will be asked to deactivate their device via their remote control or with a magnet in a standardized fashion. they will be asked to reactivate the device when specific parameters have been met, and the time is recorded.

in the post-hoc analysis the carryover and reverse carryover effect will be analyzed and correlated to a number of parameters including, but not limited to: indication, treatment duration, symptom duration, preoperative pain score, stimulation paradigm, gender, age. data will be collected and stored using a dedicated redcap database under the auspices of aarhus university.

Eligibility criteria:
inclusion criteria: * patient age minimum 18 years * signed informed consent * implanted with full scs system for neuropathic pain * scs treatment duration minimum 6 months before inclusion * maximum pain score 7 or less on a 0-10 nrs at the area of pain treated with scs during the last 48 hours before study-related deactivation of the device exclusion criteria * any surgical scs lead revision for the last 6 months before inclusion * any changes in the programming patterns of the device (except patient-controlled changes in amplitude) for a minimum of 30 days before the study-related deactivation of the device * any other ongoing neuromodulatory treatment (pns, tens, etc.) * any other neuromodulatory treatment with lasting effect (rfa, sympathectomy, infiltration anesthesia, nerve blockade) within the last 60 days * any changes in analgetic medication within the last 30 days (pn. dosings are allowed)