Kornimate/medical-research-clean huggingface dataset:
the role of endothelial function test in risk stratification for early and late complications after pulmonary embolism

Conditions: Pulmonary Disease

Summary: the aim of this study is to investigate the association between endothelial dysfunction, measured by rhi as assessed by the peripheral arterial tonometry method, and pe complications defined as re-event of pe or dvt, systemic embolism or all-cause mortality

200 patients will be identified through routine daily scanning of imaging records (ct, echocardiography) for patients diagnosed with pe. presenting signs and symptoms as well as clinical and imaging findings during the initial presentation and hospitalization will be incorporated into a computerized pre-specified electronic crf. during hospitalization, an endothelial function test will be performed 48 hours post admission. a trained technician will perform the test using the endopat device in order to assess patient rhi, a score less than 1.67 will be considerate as endothelial dysfunction. patients will then be followed for pre-specified clinical events of up to 1 year post discharge and especially the development of chronic thromboembolic pulmonary disease, post thrombotic syndrome and clinical events. rhi will be assessed during 1-year follow up visit.

Eligibility criteria:
inclusion criteria: 1. age \>18 years old 2. patient is hospitalized with the diagnosis of acute pe 3. clinically stable patients. 4. clinical diagnosis of pe based on ct scan or nuclear imaging. 5. willing and able to sign informed consent exclusion criteria: 1. previous myocardial infarction during the last 3 months. 2. planned surgery or pci. 3. inability to perform endothelial function test. 4. current participation in clinical trial. 5. substrate or drug abuse or alcohol consumption.
a pilot study to assess the effectiveness of behavioural activation group program in patients with depression: brave

Conditions: Depression

Summary: the study's primary goal is to assess the effectiveness of behavioural activation in reducing depressive symptoms and re-integrate patients with depression into their personal and professional lives thus improving quality of life and helping in attaining and maintaining remission of depression. it is aimed at helping patients re-engage with several life areas that they may have lost in the course of depressive illness. the intervention is centred on behavioural activation (ba) with complementary interventions including recreation activities, and behavioural modifications. the study question is: in patients with depressive disorder attending a specialized hospital based mood disorders clinic, does the addition of behavioural activation program delivered in a group format improve depressive symptoms and quality of life compared to treatment as usual after 18 weeks of treatment? study investigators hypothesize that behavioural activation is an effective treatment for depressive disorder in patients with depression.

this is a pilot study, a mixed-methods design including an open label pragmatic randomized trial and a qualitative grounded theory approach. participants will be randomized to behavioural activation (ba) (intervention) or support group (control) in addition to treatment as usual. the qualitative component will be used to gather participant's experiences, beliefs and opinions about two topics: 1) the experience of participating in the behavioural activation program and 2) their evolving perceptions of their individual depressive illness and quality of life. based on the analysis of qualitative data pertaining to the first topic, the behavioural activation program may be modified for the main trial, to respond to patient needs and feedback, in the spirit of delivering truly patient centered care. the qualitative study will involve multiple interviews and focus groups which will take place before, during, and after the pilot intervention period.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of major depressive disorder * must be able to provide written informed consent * must be able to attend program sessions exclusion criteria: * inability to understand written and spoken english * primary diagnosis other than depressive disorder

Keywords: depression behavioral activation
methadone dose monitoring with a remote medication monitor

Conditions: Methadone Toxicity; Methadone Overdose; Pain, Chronic; Drug Metabolism, Poor, CYP2D6-Related; Metabolism Medication Toxicity

Summary: proof of concept: pilot study a pilot, proof of concept, observational study with a long-term goal to develop a minimally invasive wearable remote medication monitor (rmm) that provides continuous, real-time data on methadone levels in interstitial fluid (isf). an rmm could be used as a medication adherence monitor and would allow for the physician, counselor, patient, or family member to remotely verify that a physician-prescribed dose has been taken.

the investigator will conduct a non-randomized, non-blinded, feasibility study at a single center in the united states. the study will include up to 20 subjects of an equal number of male and female adults (ages 18-70) who have a prescription for methadone. in aim 1, the investigators will determine if an rmm can continuously assess the status of taking a prescribed dose of methadone over time, by inserting the dermal isf sensing elements into the subjects' abdominal skin. biosample collections (i.e., isf, blood) and pharmacokinetic monitoring will occur over a 6-hour period. by completing this aim, the investigator will determine if a physician is able to recognize the pharmacokinetic profile of a taken dose of methadone. the physician will see a dosing curve display generated from dermal isf dialysis fluid sampling using an external fiberoptic sensor system that is worn continuously on the abdomen similar to continuous glucose monitors.

Eligibility criteria:
inclusion criteria: * age 18-70 * a prescription for methadone at a dose of 10mg or more for at least one week. * taking methadone as prescribed during the last 4 days before consent to participate in the study. exclusion criteria: * age \ 70 * a condition preventing or complicating isf collection * dermatological (skin) condition * immunodeficiency * recent blood donation * anemia * end stage renal disease * liver cirrhosis * cancer * congestive heart failure * bleeding diathesis * tuberculosis (tb) * any active severe depression * suicidal ideation * mania symptoms * pregnancy * intending to become pregnant during the course of the study * enrolled in a substance use disorder treatment program * under a conservatorship.

Keywords: pharmacokinetics
high tone therapy for chemotherapy induced neuropathy

Conditions: Chemotherapy-induced Peripheral Neuropathy; Electrical Stimulation

Summary: chemotherapy-induced peripheral neuropathy (cipn), a side effect of antineoplastic medication, was reported to occur in about 68% of the patients receiving chemotherapy. cipn does not only limit quality of life due to neuropathic symptoms but also may lead to dose reductions or premature interruption of therapy and thus to suboptimal cancer treatment. patients with neuropathy suffer from sensory disturbances as tingling, numbness, burning pain or sleep disturbances and even though numerous drugs are available, it is still difficult to sufficiently control these symptoms. high tone therapy / high tone external muscle stimulation (htems) seems to be an effective treatment for neuropathic symptoms. previous studies observed promising results in diabetics and chronic kidney disease (ckd) patients. to date, there is no investigation on htems in patients with chemotherapy induced neuropathy. therefore, this aim of this project is to test if htems would bring about a stronger decrease in neuropathic symptoms in this specific patient group, compared to a placebo treatment. the primary objective is the alleviation of paresthesias. the secondary objective focuses on detailed symptoms of neuropathiy as well as on health-related quality of life.


Eligibility criteria:
inclusion criteria: * patients with histologically verified colorectal cancer and adjuvant treatment with a platin derivate (e.g., cisplatin, oxaliplatin): this group was chosen due to relatively high risk of neuropathy due to this special therapeutic agent 1,9. * cumulative dose of at least 3 cycles * interval of 2 weeks since the last chemotherapeutic cycle in order to prevent false worsenings due to delayed neurotoxic effects * life expectancy of at least 3 months * stable medication (no changes of especially pain medication during the study) * eastern cooperative oncology group (ecog) performance status score of 0-2 (that is, the capability to walk and to spend less than 50% of waking hours sitting or lying) * ability to walk (with or without aids) * european organisation for research and treatment of cancer (eortc) common toxicity criteria (ctc) peripheral sensory neuropathy grade 1 or 2 * intensity of paresthesias of 3/10 or higher on the numeric rating scale (nrs) exclusion criteria: * prevalent neuropathy of different etiology * serious central-neurological or psychiatric disorder that would interfer with a proper order of the study, according to the judgement of the investigators * epilepsy * minors or persons unable to give informed consent * current neurotoxic medication * implanted pacemakers or defibrillators * pregnancy * wounds in the area to be treated, acute local or systemic infection * peripheral arterial occlusive disease \> grade 2
criminal justice coordinated transitional care

Conditions: HIV; Hepatitis C; Substance Use Disorders

Summary: this project aims to enroll 220 incarcerated individuals living with hiv, hepatitis c (hcv), or history of substance misuse preparing for release into a pilot implementation study to test the feasibility and acceptability of an adapted coordinated transitional care intervention in a criminal justice setting (cjc-trac). participants can expect to be on study for up to 6 months.

this protocol describes the second, implementation phase of a 5-year nih-funded research project designed to evaluate post-incarceration health care utilization and outcomes for underserved people living with hiv, hcv and substance use disorder. in the first study phase, conducted from 2020-21, the investigators analyzed wisconsin medicaid data to characterize the baseline level of outpatient care utilization for adults during their first 6 months after release from prison, and conducted formative research necessary to adapt an existing transitional care intervention, called c-trac, to support individuals leaving prison. the current project aims to enroll participants in a pilot implementation study to test the feasibility and acceptability of the adapted intervention in a criminal justice setting, which has been given the name "cjc-trac." participants will be enrolled from one of two institutions: * men from oakhill correctional institute (oci) * women from the wisconsin women's correctional system (wwcs) primary objectives: to evaluate the feasibility and acceptability of cjc-trac when implemented in a state prison system. secondary objectives: to gather preliminary evidence describing the effectiveness of cjc-trac for improving the rate of outpatient care utilization.

Eligibility criteria:
inclusion criteria: * able to understand and speak in english * plans to reside in wisconsin after release * eligible for wisconsin medicaid and willing to enroll prior to release * has a history of one or more of the following: current hiv infection, current or past hcv infection, identified need for substance use related services based on correctional offender management profiling for alternative sanctions (compas) assessment * anticipated release date (must be within 6 months of review) exclusion criteria: * unable to provide informed consent form or impaired ability to make decisions * planned discharge to another correctional facility or other carceral setting (e.g. release to jail or immigration detention center)

Keywords: incarcerated transition release
effectiveness of the arth-e application on adherence to physical exercises in patients suffering from koa: rct

Conditions: Knee Osteoarthritis

Summary: the aim of this study is to investigate the effectiveness of a smartphone-based e-health application (intervention group) compared with standard care (control group) in terms of changes in adherence in patients with knee osteoarthritis using the ears questionnaire. in addition, other questionnaires presented in the appendix (koos, tsk, epap, eq-5d-3l, pain) will be given to all patients in order to meet the secondary evaluation criteria.

knee osteoarthritis is the most common joint disease affecting the joint itself as well as the peri-articular structures in a global and progressive manner. it can affect all the joints of the body, with a predominance for those which undergo strong mechanical constraints such as the rachis, the hip or the knee. it is a chronic pathology correlated with age, since nearly one adult in two is affected by osteoarthritis. today, connected objects have taken a predominant place in the daily life of the majority of the population, including seniors. it is an object of communication and socialization as well as a major information tool. e-health applications are more and more numerous in the stores and are a tool for assistance, information and support already used in many fields. in the context of therapeutic education, it is a motivational tool that can accompany patients by adapting to their needs and progress compared to traditional self-exercise methods. studies of the obstacles and levers for the use of smartphone applications in chronic pathologies such as low back pain support the development of this tool.

Eligibility criteria:
inclusion criteria: * patients aged between 40 and 85 years with uni or bilateral knee osteoarthritis according to eular (european league against rheumatism) criteria, symptomatic and diagnosed prior to inclusion by a specialist or not. * having an involvement of at least one knee. * own a smartphone or tablet running at least android 5 or ios 11. * able to give written consent to participate in the study. * beneficiary of a social security plan. exclusion criteria: * pregnant or breast-feeding women patients under legal protection measures (guardianship, curatorship or protection of the court) * patients who have undergone knee surgery (total or partial prosthesis, tibial transposition surgery, arthrodesis) * patients with inflammatory rheumatism * patients with neurological sequelae * contraindications to physical activity for medical reasons * patients with difficulties in understanding the french language * refusal to participate * patients who have already participated in the arth-e 2 study or who are already included in a research protocol that could influence the current protocol

Keywords: knee osteoarthritis e-health app effectiveness
metabolic evaluation of nutrition in rett syndrome

Conditions: Rett Syndrome

Summary: rett syndrome (rtt) is an x-linked severe neurodevelopmental disorder. despite their good appetite, many females with rtt meet the criteria for moderate to severe malnutrition. the pathological mechanism is barely understood. although feeding difficulties may play a part in this, other constitutional factors as altered metabolic processes are suspected. irregular breathing is a common clinical feature, reflecting the immaturity of the brainstem in rtt. the primary pathophysiology is a defective control mechanism of carbon dioxide exhalation that leads to chronic respiratory alkalosis or acidosis. we assume that chronic respiratory acidosis or alkalosis causes derangement of the metabolic equilibrium in rtt females with important nutritional consequences. the aims of this pilot study are to describe the nutritional status of the rtt girls and to examine the consequences of a chronic respiratory acidosis or alkalosis on metabolic processes as a possible cause of impaired nutritional status.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of rtt (meeting consensus diagnostic criteria (hagberg et al, 2002)); * mecp2-mutation; * complete neurophysiological work-up. exclusion criteria: * male gender.

Keywords: rett syndrome. nutritional status. metabolic alterations.
transfemoral transcatheter aortic valve implantation with or without predilation of the aortic valve (ease-it tf)

Conditions: Aortic Stenosis

Summary: prior to the deployment of transcatheter heart valves (thv), balloon aortic valvuloplasty (bav) is often performed under rapid right ventricular pacing (burst \>180 bpm) with the induction of a functional cardiac arrest for up to 30 seconds. aortic valve predilation aims at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. however, bav has been shown to have a number of potentially detrimental effects. there is limited experience for the balloon expandable edwards thv on the need for predilation (bav). experience so far has only been documented from smaller, uncontrolled case series. the investigators aim to document the incidence of several kinds of complications in a large, multicenter registry / prospective controlled cohort study to identify associations between patient related variables and outcomes.

aortic valve predilation aims at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. however, bav has been shown to have a number of potentially detrimental effects, such as: * functional cardiac arrest induced by rapid pacing leads to transient coronary, cerebral, and renal ischemia. * in patients with a reduced left ventricular ejection fraction (lvef), prolonged cardiac depression after rapid pacing is observed and may result in hemodynamic failure and systemic inflammatory response syndrome (sirs). both are associated with a high periprocedural mortality. * bav has been identified as a major source of thrombotic and valvular material, thus increasing the risk for coronary obstruction with subsequent myocardial infarction and/or stroke. * the local trauma in the left-ventricular outflow tract caused by bav may potentially contribute to aortic root rupture. the investigators aim to document the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a large, multicenter registry / prospective controlled cohort study to identify associations between patient related variables and outcomes.

Eligibility criteria:
inclusion criteria: * signed informed consent * males or females * at least 18 years of age exclusion criteria: * logistic euroscore i \>40% * mitral or tricuspid valvular insufficiency (\> grade ii) * previous aortic valve replacement * uncontrolled atrial fibrillation * left ventricular or atrial thrombus by echocardiography * high probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * patients with mobile structures on the leaflets * need for a cerebral protection device

Keywords: thv (trans-catheter heart valve) severe aortic stenosis pre-dilation rapid pacing bav (balloon artery valvuloplasty
a study of genetic based chemotherapy dosing for breast cancer patients

Conditions: Breast Neoplasms

Summary: epirubicin is a common chemotherapy medication used in the treatment of breast cancer. however, chemotherapy dosing is calculated based on people's height and weight, which may not be the most accurate way. the purpose of this study is to see if epirubicin dosing based on people's genetic profiles is better than the usual methods.


Eligibility criteria:
inclusion criteria: 1. female patients with histologically confirmed non-metastatic invasive breast cancer who are scheduled to receive at least three cycles of fec100 in the adjuvant or neoadjuvant setting 2. documented pathological evaluation of the breast cancer for hormone receptor (estrogen receptor \[er\], progesterone receptor \[pr\] and her-2 status 3. eastern cooperative oncology (ecog) performance status of ≤ 2 4. a left ventricular ejection fraction (lvef) ≥ 50%. exclusion criteria: 1. uncontrolled congestive heart failure (chf) or angina, history of myocardial infarction within 2 months before study enrollment, or cardiac functional capacity class iii or iv as defined by the new york heart association classification. 2. psychiatric disorder(s) that would interfere with consent, study participation, or follow up.

Keywords: breast cancer non-metastatic carcinoma of the breast chemotherapy adjuvant therapy neoadjuvant
clinical study of a fixed combination of timolol-brimonidine-dorzolamide

Conditions: Primary Open Angle Glaucoma; Ocular Hypertension

Summary: to compare intraocular pressure lowering effectiveness of a new fixed combination drug.

this is a multicentric, double blind and prospective clinical study. we will include patients with confirmed diagnosis of primary open-angle glaucoma and/or ocular hypertension, with intraocular pressure (iop) ranging between 21 and 31 mm hg. patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (krytantek ofteno®, laboratorios sophia, mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (cosopt®, msd laboratories, usa). patients will receive 1 drop twice a day of either formulations and were examined at days 2, 7, 15, 30, 60, and 90 after initiation of treatment. the primary objective is to compare the efficacy of both formulations, estimated as a decrease in iop. a goldmann applanation tonometer will be used for iop determination.

Eligibility criteria:
inclusion criteria: * adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; * visual acuity of 20/40 to 20/80 or better (snellen equivalent). exclusion criteria: * clinically relevant ophthalmic or systemic conditions may be excluded.

Keywords: open-angle glaucoma ocular hypertension poag treatment
antimicrobial barrier dressing versus closed-incision negative pressure therapy in the obese primary total joint arthroplasty

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine whether an occlusive antimicrobial barrier dressing or portable negative pressure wound dressing is superior in preventing wound complications and infection rates in obese patients undergoing total joint arthroplasty (tja). approximately 240 subjects (120 for total knee arthroplasty and 120 for total hip arthroplasty) will be enrolled to evaluate the outcomes associated with silver impregnated dressings and negative pressure wound therapy (npwt) in treating this subset of patients and analyze the cost benefit of each.


Eligibility criteria:
inclusion criteria: * those identified at pre-operative testing to have an elevated bmi (\> 35) exclusion criteria: * active infection * previous scar or wound healing complication * post traumatic degenerative joint disease (djd) with hardware * revision surgery * inflammatory arthritis * anticoagulation outside of the standard of care.