Kornimate/medical-research-clean huggingface dataset:
open-label study evaluating synera® in the treatment of patients with carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: the purpose of the study is to explore the potential usefulness of synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome.

zars pharma, inc. has developed synera® (lidocaine 70 mg and tetracaine 70 mg topical patch), a drug delivery patch that utilizes controlled heat to enhance the delivery of a local anesthetic formulation consisting of a eutectic mixture of lidocaine and tetracaine. synera was approved by the food and drug administration (fda) on june 23, 2005 and is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodesiccation, and shave biopsy of skin lesions. the purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of synera for the treatment of pain associated with mild to moderate cts.

Eligibility criteria:
inclusion criteria: * pain associated with mild to moderate carpal tunnel syndrome in a single wrist * have recent (within 3 months) electrodiagnostic evidence of carpal tunnel syndrome (cts) exclusion criteria: * have bilateral carpal tunnel syndrome * have another peripheral neuropathy in the affected limb * have had an injection into the carpal tunnel within 8 weeks * have had surgical release of the target wrist within previous 6 months * have electrodiagnostic evidence of severe cts other protocol-defined inclusion/exclusion criteria may apply

Keywords: pain mild to moderate carpal tunnel syndrome
re-induction after initial response with immune therapy with radiotherapy in lung cancer

Conditions: Non-Small Cell Carcinoma of Lung, TNM Stage 4

Summary: radiotherapy in combination with different forms of immune therapy improved consistently local tumor control and very interestingly, lead to better systemic tumor control and the induction of specific anti-cancer immunity with a memory effect. in small series, it has been shown that a new long-lasting remission can be induced by irradiating one tumor site in patients who showed cancer progression after an initial response to immune therapy. in these series, the original immune therapy was continued and the treatment was very well tolerated. in this study the progression-free survival after radiotherapy to a single lesion will be investigated in patients with stage iv non-small cell lung cancer (nsclc), who have at least achieved stable disease with immune therapy alone or concurrent immune therapy and chemotherapy.

radiation has consistently been shown to activate key elements of the immune system. radiotherapy in combination with different forms of immune therapy such as anti-pd-(l)1, anti-ctla4,immunocytokines, dendritic cell vaccination and toll-like receptor agonists improved consistently local tumor control and very interestingly, lead to better systemic tumor control (the "abscopal" effect) and the induction of specific anti-cancer immunity with a memory effect. moreover, as pd1/pd-l1 is upregulated by radiation and radiation can overcome resistance for pd-(l)1 blockage, their combination is logical. in small series, it has been shown that a new long-lasting remission can be induced by irradiating one tumor site in patients who showed cancer progression after an initial response to immune therapy. in these series, the original immune therapy was continued and the treatment was very well tolerated. in this study the progression-free survival after radiotherapy to a single lesion will be investigated in patients with stage iv non-small cell lung cancer (nsclc), who have at least achieved stable disease with immune therapy alone or concurrent immune therapy and chemotherapy.

Eligibility criteria:
inclusion criteria: * stage iv non-small cell lung cancer * initially a complete remission, partial remission or stable disease under immune therapy alone or concurrent immune therapy and chemotherapy and now progressive disease * able to continue the immune therapy exclusion criteria: * not able to continue the already initiated immune therapy * patients with any grade 3 toxocity * patients in whom radiotherapy cannot be delivered, according to the radiation oncologist at the multi-disciplinary patient discussion

Keywords: non small cell lung cancer immune therapy radiotherapy
treatment with endovascular intervention for stroke patients with existing disability

Conditions: Stroke; Stroke, Acute; Stroke, Ischemic

Summary: tested will compare the risks and benefits of endovascular thrombectomy (evt) to medical management (no evt) in ischemic stroke patients who have a blockage in one of the large blood vessels in the brain and have a moderate-to-severe disability prior to their stroke.

people with disabilities can suffer acute ischemic stroke (ais). endovascular clot removal is a breakthrough therapy for large vessel occlusion (lvo) ais. pre-stroke disabled patients were excluded from pivotal evt stroke trials, so whether evt is effective for those with pre-stroke disability is not known. as a result, two competing, widely-practiced, treatment paradigms have emerged based on individual practitioners' extrapolation of evt benefits and safety from patients without a pre-stroke disability to those with disability: 1) multimodal medical management (mmm; using intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol lowering medications, and other rehabilitative measures, as indicated) without evt, and 2) evt with the background of mmm. tested will enroll patients with lvo-ais who have a pre-existing disability, defined as pre-stroke modified rankin score (mrs) 3 and 4, at 12 geographically distinct comprehensive stroke centers serving diverse race-ethnic and socioeconomic populations. the central objective of tested is to determine the comparative effectiveness and safety of these two different practice paradigms.

Eligibility criteria:
inclusion criteria: 1. adult patients (≥18 years) 2. moderate-to-severe pre-stroke functional disability, defined as mrs 3-4, for at least 3 months prior to stroke onset 3. presenting to study hospital within 24 hours of last known well time 4. diagnosis of acute ischemic stroke 5. intracranial causative occlusion of the internal carotid artery or the m1 or dominant m2 segments of the middle cerebral artery visualized on the baseline ct(or mr) angiogram 6. presenting ct alberta stroke program early ct (aspect) score ≥3 or mri aspect score ≥4 7. presenting nih stroke scale score ≥6 8. informed consent from patient if competent or from legally authorized representative exclusion criteria: 1. known diagnosis of a terminal cancer or terminal illness at the time of stroke 2. assessment of pre-stroke functional status cannot be performed during the hospital stay 3. pre-stroke disability deemed temporary in the investigator's opinion (for example, recovering from a general medical illness or traumatic bodily injury)
hyperapo b and coronary heart disease

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Diabetes Mellitus; Obesity; Hypercholesterolemia, Familial

Summary: to determine the role of apolipoprotein b and apolipoprotein a1 in the etiology of coronary artery disease.

background: hyperapo b is a phenotype defined as elevated plasma level of the major apoprotein b of low density lipoproteins in the presence of a normal plasma level of low density lipoprotein cholesterol. it has been demonstrated that hyperapo b is strongly associated with coronary artery disease. in 1984 when the study began, the independence of this association with other risk factors for coronary artery disease such as cigarette smoking, hypertension, and low plasma levels of high density lipoproteins was not known. the study improved knowledge of the pathophysiology of coronary artery disease and of the genetic and biochemical defects of hyperapo b and hypoalphalipoproteinemia. design narrative: interviews were conducted and clinical data collected on each index case and spouse, as well as on first degree relatives. risk factor data included blood pressure, blood lipid levels, obesity, cigarette smoking, fasting blood sugar and diabetes, hormone use and menopause for women, physical activity, personality scores, and family history. clinical data included the indications for coronary arteriography, history of use of lipid-lowering agents and insulin, presence of corneal arcus, xanthomata, and xanthelasma, and the electrocardiogram. to determine if the apolipoprotein b gene and the apolipoprotein a1-c3-a4 gene cluster were independent predictors of premature coronary disease, the relation between dna polymeric sites within the two genes and coronary disease were investigated using cloned dna fragments as molecular probes. to determine if apolipoprotein b and apolipoprotein a levels aggregated in families and to determine if hyperapo b and hypoalphalipoproteinemia segregated as mendelian traits, genetic analysis was conducted in the 200 index cases and the 900 first degree relatives. studies were also conducted on the linkages between hyperapo b and haplotypes of the apolipoprotein b gene, on hyperapo b and the ag polymorphisms, and on hyperalphalipoproteinemia and haplotypes of the apolipoprotein a1-c3-a4 gene cluster. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
a cross-over, multi-center trial to evaluate the diagnostic efficacy and safety of [123i]nav5001 as an imaging agent to aid in the diagnosis of parkinsonian syndromes

Conditions: Parkinson's Syndrome

Summary: this is a phase 3, open-label, multiple-center, randomized cross-over study to assess the safety and efficacy of \[123i\]nav5001 spect imaging in aiding in the differentiaion of parkinsonian syndromes from non-parkinsonian tremor.


Eligibility criteria:
inclusion criteria: * subject has provided written informed consent before the initiation of any study related procedures and continues to give willing consent for participation * age ≥ 40 years * have had upper extremity tremor for \< 3 years duration, regardless of presumed diagnosis or etiology * have a updrs part iii score upon entry of ≤ 16 exclusion criteria: * any clinically significant or unstable physical or psychological illness based on medical history or physical examination at screening, as determined by the investigator * structural brain abnormality affecting the entire brain (e.g., normal pressure hydrocephalus) or the striatum (e.g., local tumor or stroke) * any clinically significant abnormal laboratory results obtained at screening and as determined by the investigator * any clinically significant abnormal electrocardiogram (ecg) results obtained at screening and as determined by the investigator * any history of drug, narcotic, or alcohol abuse within 2 years before the date of informed consent, as defined by the diagnostic and statistical manual of the american psychiatric association, fourth edition, revised (dsm-iv-tr \[american psychiatric association, 1994\]) * positive urine drug screen for opiates, cocaine, or amphetamines at screening * positive pregnancy test before imaging * participation in an investigational drug or device clinical trial within 30 days before the date of informed consent * previous scan with any dat imaging agent (e.g. \[123i\]nav5001, altropane, datscan, dopascan) * any exposure to radiopharmaceuticals within 30 days before the date of informed consent * breast-feeding * inability to lie supine for 1 hour * any thyroid disease other than adequately treated hypothyroidism * known sensitivity or allergy to iodine or iodine containing products * treatment within the 30 days before the date of imaging with amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline, paroxetine, or citalopram.

Keywords: parkinson's disease
access anti-hav and access anti-hav igm assays eu clinical trial protocol (hav-eu-11-23)

Conditions: HAV

Summary: the purpose of this study is to evaluate the clinical performance supporting that intended purpose of the access anti-hav as an aid in the laboratory diagnosis of hav infection and for detection of anti-hav after vaccination and of the access anti-hav igm assay as an aid in the laboratory diagnosis of acute or recent hav infection, on the dxi 9000 access immunoassay analyzer. this study will be used to obtain ce mark for both access anti-hav and anti- hav igm assays.

the objective of this study is to determine the diagnostic accuracy of access anti-hav and access anti-hav igm assays on the dxi 9000 access immunoassay analyzer, measured as clinical sensitivity and specificity. the testing will be performed using banked, de-identified, prospective and retrospective us leftover clinical samples, and fully-anonymized retrospective known anti-hav igm positive patient samples procured from sample vendors.

Eligibility criteria:
inclusion criteria: subject inclusion criteria for the signs and symptoms (s/s), at risk (a/r), hav test ordered, and acute hav infection cohorts: * subjects ≥ 2 years of age * subject or legal guardian has signed the informed consent form (icf) (a minor may need to sign an assent form (af) if required by irb) * subjects who are willing to donate the required amount of blood * subjects qualified for one (1) or more of the following four (4) cohorts: * signs and symptoms (s/s); * at risk (a/r); * presumed s/s or a/r (hav test ordered) and * acute hav infection (known anti-hav igm positive samples) - these samples are not subject to the individual informed consent and volume criteria. subject inclusion criteria for the vaccination cohort * subjects 2 years of age or older * subjects able to understand and willing to sign the icf at both pre and post vaccination time points. subject or legal guardian has signed the informed consent form (a minor may need to sign an assent form if required by irb) * subjects who are willing to donate the required amount of blood: 30 ml * subjects with no signs or symptoms of hepatitis as determined by a medical provider, no history of known exposure to hav * subjects previously unvaccinated for hav exclusion criteria: * subjects who previously participated in the study * subjects who have received experimental or investigational drugs or treatments within four weeks of phlebotomy note for vaccination study: subjects were screened for anti-hav prior to vaccination, if positive they were excluded from the study.

Keywords: hepatitis a virus (hav) igm antibody to hepatitis a virus (hav igm) antibody to hepatitis a virus
the effect of gemcabene on insulin sensitivity in nondiabetic subjects

Conditions: Insulin Sensitivity

Summary: the purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.


Eligibility criteria:
inclusion criteria: * good health, as determined by medical history, physical examination, ekg and clinical laboratory assessments * males; and females of non-reproductive potential * obesity * non-diabetic exclusion criteria: * use of any medication considered unacceptable by the clinical investigators during the 14-day period before the start of day 1. hormone replacement therapy is acceptable. * use of a lipid-lowering agent (niacin, fibrates, statin) during the 8 weeks before screening * use of any anti-diabetic medications * use of any steroid medications * donation of any blood or plasma product or participation in another study in the 30 days prior to day 1 * if female, pregnant, lactating or of childbearing potential; and * history of significant reaction to any fibrate lipid-lowering agent

Keywords: insulin resistance lipid regulator
evaluating the feasibility of disseminating a novel mobile platform to treat depression

Conditions: Depression

Summary: the goal of this project is to conduct a pilot study to test the utility of a natural language processing (nlp) clinical messaging tool to improve the reach and the quality (fidelity and competency) of coaches providing behavioral activation (ba) strategies through a mobile mental health app called personalized real-time intervention for motivational enhancement (prime). this study will improve the reach of clinicians by using a nlp-powered messaging tool, which will ensure fidelity to the ba model and clinicians will have access to real-time clinical information about their patients to guide more targeted treatment (competence). if successful, prime could operate as a cost effective tool for clinicians to extend their reach and an accessible treatment for the population of those struggling with depression.


Eligibility criteria:
inclusion criteria: * 18 and older * read and speak english * phq-9 score of 5 or greater or indicate that their depressive symptoms are interfering with their daily functioning (item 10 of the phq-9 \> 2). * to be consistent with the nimh rdoc initiative, we will assess for co-morbid problems (substance abuse, anxiety, and psychosis), but will not exclude participants with psychiatric comorbidities * must own a mobile device on ios or android platforms that either wi-fi or 3g/4g ready; exclusion criteria: * under 18 * cannot read or speak in english * cannot attain suitable mobile device

Keywords: human mental disorders intervention digital health
the effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction

Conditions: Childbirth Problems; Labor Pain; Birth Disorder

Summary: it has been reported that the birth ball has benefits such as decreasing the perception of labor pain, reducing the anxiety level, shortening the duration of the first stage of labor, increasing the satisfaction of birth, and facilitating the descent of the fetal head, but the literature is quite limited. so, this randomized controlled experimental study aimed to examine the effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction.

this randomized controlled experimental study aimed to examine the effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction. the sample of the study consisted of 120 primiparous pregnant women presented to the delivery room between november 2021 and april 2022. pregnant women were randomly assigned to the intervention group (ig, n=60) or the control group (kg, n=60). after the cervical dilatation reached at 4 cm, the pregnant women in the ig performed birth ball exercises, adhering to the birth ball guide created by the researcher. no intervention was made in the control group other than standard midwifery care practices. a personal information form,a visual analog scale (vas), the childbirth comfort questionnaire (ccq), a labor and postpartum follow-up form, and the mackey childbirth satisfaction rating scale (mcsrs) were used for data collection. women in both groups underwent vas when cervical dilatation was 4 cm and 9 cm, and the ccq was applied when dilatation was 8 cm. the mcsrs was administered two hours after delivery.

Eligibility criteria:
inclusion criteria: * being 18 years or older; * being in 37-42 weeks of pregnancy; * having a singleton pregnancy; * having a cervical dilatation of 1-4 cm; * being primiparous; * not having any complications that prevent vaginal delivery; * not having any extremity problems for using the birth ball and performing activities; * being able to speak and understand turkish. exclusion criteria: * having maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature rupture of membranes, presentation anomalies, intrauterine growth retardation, fetal anomaly, intrauterine death, fetal macrosomia, fetal distress, etc.), * getting pregnant by assisted reproductive techniques, * electing cesarean section. exclusion criteria in the research process: * to receive induction (oxytocin, prostaglandins, and misoprostol); * having a cesarean delivery due to any complications; * the baby admitted to the neonatal intensive care unit for any reason; * receiving analgesics.

Keywords: birth pain labor duration birth comfort birth satisfaction birth ball
treatment-resistant depression registry

Conditions: Major Depressive Disorder

Summary: this registry will collect information about patients with treatment-resistant depression (trd) who are currently in a major depressive episode. for the purposes of this study, trd is defined as an ongoing depression lasting at least 2 years or that has recurred at least 3 times, to include the current episode, during the patient's lifetime and has not adequately responded to 4 or more adequate antidepressive treatments. the registry will follow the clinical course and outcomes for patients with trd who are treated with and without adjunctive (used along with other treatments for depression) vagus nerve stimulation (vns) therapy.

enrollment of trd patients treated with vns therapy will consist of patients originally enrolled in the registry as well as patients who have completed the d-21 dosing study and are enrolled in the registry for long-term follow-up. sites will maintain a screening log of all patients who have been screened for original trd registry patients. please note that because this is a post-approval registry, cyberonics does not cover the cost of vns therapy implantation.

Eligibility criteria:
inclusion criteria: * patient diagnosed with a current major depressive episode according to dsm-iv-tr criteria. * for d-21 patients only who have completed the d-21 dosing study without any d-21 inclusion and exclusion protocol deviation. * patient has been in the current depressive episode for 2 years or longer, or has had at least 3 lifetime episodes including the current mde. * patient has had an inadequate response to 4 or more adequate antidepressive treatments. * the patient has a cgi severity of illness score of moderately ill (score of 4) or greater. * the patient must be able to provide informed consent and complete all forms. exclusion criteria: * patient has a history of schizophrenia, schizoaffective disorder, any other psychotic disorder, or a current major depressive episode that includes psychotic features; or is currently psychotic. * patient is currently enrolled in a double blind investigational study; patients who have completed the double-blind d-21 study will be allowed to enter the registry for long term follow-up * other than those patients who were enrolled in the d-21 study, patient has previously received vns therapy. * patient has a history of rapid cycling bipolar disorder.

Keywords: major depressive disorder treatment-resistant depression