Kornimate/medical-research-clean huggingface dataset:
efficacy of multimodal peri- and intraarticular drug injections in total knee arthroplasty

Conditions: Osteoarthritis of the Knee

Summary: total knee arthroplasty (tka) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. the aim of this study is to: 1. compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty. 2. compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

total knee arthroplasty (tka) is increasingly common in the treatment of knee osteoarthritis. tka is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. continuous epidural analgesia is often used for controlling pain after tka. recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. this infiltrations can be combined with ketorolac and/or morphine. the aim of this study is to: 1. compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty. 2. compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Eligibility criteria:
inclusion criteria: * patients at least 18 years of age * scheduled for elective total knee arthroplasty * asa i-iii * signed written informed consent exclusion criteria: * age \< 18 * asa \> iii * moderate or severe cardiac disease, bronchial asthma * allergy against ropivacaine, ketorolac or morphine * analgetic abuse * pregnancy or nursing women * severe psychiatric disease * moderate to severe dementia

Keywords: osteoarthritis knee arthroplasty local infiltration analgesia tka epidural analgesia operation surgery
concordance between ctdna assay and foundationone

Conditions: Circulating Tumor DNA; Cancer; Neoplasms; Genomic Testing; Genomic Alterations

Summary: foundation medicine inc. (fmi) is interested in studying the concordance of genomic alterations between primary and/or metastatic surgical biopsies, and circulating tumor dna (ctdna) within different solid tumor types and has been developing an assay in order to do so.

the purpose of this study is to assess whether a new ctdna assay developed by foundation medicine is able to detect genomic alterations in peripheral blood that are consistent with the genomic alterations detected in a patient's matched primary and/or metastatic tumor biopsy sample analyzed by the foundationone® test. study sites will provide matched solid tumor and peripheral blood samples of cancer patients to fmi for the purpose of testing the concordance of the fmi ctdna assay to the foundationone® test. participation in this study is part of a broader 2000 patient study to determine which tumor types are most readily measured via ctdna profiling, and to learn of the similarity between the alterations found in a patient's tumor biopsy and the ctdna from their blood.

Eligibility criteria:
inclusion criteria: * patients who have had a solid tumor biopsy isolated for analysis by foundationone under their standard clinical care exclusion criteria: * tumor specimens where no cancer representative of the diagnosis is found in submitted tissue * tumor specimens where insufficient dna (\<50 ng) is provided to run the foundationone test. * tumor specimens with ≤20% tumor nuclei (all specimens).

Keywords: circulating tumor dna cancer neoplasms genomic testing foundationone cell free dna ctdna cfdna
cerebrolysin registry study in stroke

Conditions: Ischemic Stroke

Summary: investigation of clinical practices, safety and effectiveness of cerebrolysin in routine treatment of patients with acute ischemic stroke.

stroke is a devastating disease and one of the primary causes for death and long term morbidity imposing a heavy burden on patients, relatives and the health care system. except for fibrinolytic therapy, which is only possible in a minor fraction of patients, there is no widely approved medication for the treatment of acute stroke. cerebrolysin has been approved for the treatment of stroke in over 45 countries worldwide. since the approval of cerebrolysin, stroke therapy has evolved, namely, with improved overall care, stroke units, more targeted rehabilitation, and the increasing availability of fibrinolytic therapy (rtpa, actilyse) in specialized centers throughout the world. more recently, interventional therapies with various thrombus retrievers have emerged. in addition the cerebrolysin treatment in stroke has evolved with different time windows, dosages and lengths of therapy being given in a pragmatic way by physicians within the specification of product characteristics for cerebrolysin (spc). the main aim of this study is to capture these variables of the cerebrolysin treatment and its comedication in order to give guidance to further research. this research may consist of an extension of the current registry or targeted research in one or several subgroups of patients responding to cerebrolysin treatment. it is therefore the overall aim of this registry study to monitor the effectiveness and safety of cerebrolysin therapy against the background of the now established and evolving stroke therapies. in the concomitant control group these therapies alone or in combination will be compared to the addition of cerebrolysin in these patients. of particular interest is the treatment in stroke units, with rtpa and systematic rehabilitation. an open observational treatment design has been chosen to collect data to capture the therapies as applied in real clinical practice and to avoid the selection bias typical for controlled studies excluding the majority of patients from participation. in order to overcome the observational bias as major and inherent limitation of open trial designs, a remote and blinded assessment will be done: after three months treatment the patients' assessment of the modified rankin scale (mrs, a widely accepted primary outcome parameter) will be -after specific informed consent- video-taped and subsequently assessed by at least two independent and blinded assessors experienced in the remote assessment of the mrs.

Eligibility criteria:
inclusion criteria: * signed informed consent * clinical diagnosis of acute ischemic stroke * patient's independence prior to stroke onset (pre-morbid mrs of 0 or 1) * reasonable expectation of successful follow-up (max. 100 days) exclusion criteria: * none
a study of brigatinib as preferred first therapy for adults with non-small cell lung cancer (nsclc) entirety

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: this is a study of brigatinib in adults with non-small cell lung cancer (nsclc). the main aim of this study is to learn about the time period in which the condition does not worsen after the participant has received brigatinib. another aim is to learn about the overall rate of participants who respond to the treatment with brigatinib. participants will receive brigatinib as part of their normal clinical practice. data will be collected during regular visits to the hospital (a total of up to 12 visits is planned throughout study duration).

this is a non-interventional, prospective study of polish participants with alk positive nsclc receiving brigatinib as their first line of treatment in the scope of routine clinical practice within the frames of national drug program (ndp). this study will evaluate progression-free survival (from the time of the first dose of brigatinib). this study will enrol approximately 50 participants. participants will be enrolled in the following cohort to be observed at baseline, and every 3 months up to 33 months: • brigatinib this multi-center trial will be conducted in poland. the overall duration of the study will include approximately 18 months of enrolment and approximately 33 months of data collection and follow-up.

Eligibility criteria:
inclusion criteria 1. adult (aged ≥18) alk positive nsclc participants receiving brigatinib as a first-line treatment in the scope of ndp. 2. participants willing to participate in the study and signed icf. exclusion criteria 1. current or planned participation in an interventional clinical trial for alk positive non-small cell lung cancer (nsclc). 2. cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Keywords: drug therapy
effect of food on the pharmacokinetics of nnc0123-0000-0338 in a tablet formulation in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of nnc0123-0000-0338 in a tablet formulation in healthy subjects.


Eligibility criteria:
inclusion criteria: * age 18-64 years (both inclusive) at the time of signing informed consent * body mass index 18.5-28.0 kg/m\^2 (both inclusive) * subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator exclusion criteria: * known or suspected hypersensitivity to trial products or related products * previous participation in this trial. participation is defined as informed consent * presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator
the effect of non-nutritive sucking on pain during examination for retinopathy of prematurity

Conditions: Pain

Summary: aim: the aim of the study is to determine the effect of non-nutritive sucking on pain during examination for retinopathy of prematurity. method: the study is conducted as a randomized controlled trial. the population of the study is premature newborn who treatment in a neonatal intensive unit. the premature newborns divided into two groups as an intervention and control group according to randomization. after the randomization, non-nutritive sucking is applied to the intervention group. no method is applied to the control group.

a topical anesthetic will be applied to all premature newborns 30 seconds before eye examination. non-nutritive sucking is applied to the intervention group during the examination for retinopathy of prematurity. no method is applied to the control group during the examination for retinopathy of prematurity

Eligibility criteria:
inclusion criteria: * having an examination for retinopathy of prematurity for the first time, * age was between 28-35 weeks exclusion criteria: - having no congenital anomalies
a two arm, multi-centre clinical evaluation of the nxtag respiratory pathogen panel

Conditions: Respiratory Tract Infection; Bronchitis; Bronchiolitis; Pneumonia

Summary: xtag rpp assay is a pcr-based assay to detect the presence or absence of viral and bacterial dna / rna in clinical specimens (nasopharyngeal swabs). the objective of this study is to establish diagnostic accuracy of the xtag rpp.


Eligibility criteria:
inclusion criteria: * the specimen is a nasopharyngeal swab. * the specimen is from a pediatric or adult, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility. * the specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis and pneumonia. exclusion criteria: * the specimen is not a nasopharyngeal swab. * the specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.
the effect of visual stimuli on itch perception intensity in healthy and atopic dermatitis patients

Conditions: Atopic Dermatitis

Summary: the purpose of this research study is to assess whether seeing other people itch affects itch perception in patients with atopic dermatitis and healthy subjects.

the objectives of this study are to quantitatively assess the effect of visual stimuli on perception of itch and to assess if visual stimuli affect individuals with atopic dermatitis differently than healthy people.

Eligibility criteria:
inclusion criteria: * adult men and women who are between 18 and 65 years of age * diagnosis of moderate to severe atopic dermatitis including involvement of the forearm confirmed by published consensus diagnostic criteria35 (except for healthy control subjects). severity of ad will be based on an investigator's global assessment score (iga). * subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of their skin or which would increase their health risk by study participation * women of child bearing potential will be required to have a negative pregnancy test in order to enroll in the study and will be required to maintain adequate birth control throughout the study. * all subjects in groups 1 and 3 will be required to cease use of oral antihistamines for a period of one week prior to and during the study visit. * subjects in groups 1 and 3 must cease using topical agents on the forearm where experimentation is going to be performed at least 1 week prior. topical agents can be used in all other parts of the body. * baseline covas ratings of more than 9/100 after histamine iontophoresis at the screening visit exclusion criteria: * adults over age 65 * children less than 18 years of age * unable to complete the required measures * currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and subjects undergoing treatment with another investigational drug or approved therapy for investigational use within 28 days prior to study participation * consumption of more than 4 caffeinated beverages per day * current treatment with oral lipophilic beta blockers, opioids, glucocorticoids, theophylline, antihistamines or other medications known to interfere with itch perception or heart rate variability as determined by the investigators * uncontrolled asthma or copd * uncontrolled thyroid disease * poorly controlled diabetes mellitus * poorly compensated congestive heart failure * use of illicit drugs * history of chronic urticaria * history of anaphylactic shock * history of neuropathy causing disease such as diabetes and uremia * allergy to histamine * blindness * baseline covas ratings of less than 9/100 after histamine iontophoresis at the screening visit * subject participation in more than one group. * positive pregnancy test
pharm-s.a.v.e.s: suicide prevention training

Conditions: Suicide

Summary: this is a pilot randomized controlled trial (rct) in which 150 pharmacy staff members will be randomized to an experimental or control group and data on suicide prevention communication and secondary outcomes will be collected over the course of the rct.

this is a prospective pilot rct that will evaluate the impact of suicide prevention gatekeeper training (pharm-saves) on 150 pharmacy staff member communication behaviors (primary outcome). data will be collected at baseline, immediately after training is completed, and at 1-month follow up. data sources include simulated patient observations (to rate quality of communication) and survey data (for self-reports of knowledge, self-efficacy, and referral behaviors).

Eligibility criteria:
inclusion criteria: staff must: * be at least 18 years of age; * read and speak english; and * be currently employed as a pharmacist or pharmacy technician at a community pharmacy exclusion criteria: * individuals will be excluded if they hold floater status (non-staff pharmacists or technicians).

Keywords: community pharmacy communication gatekeeper training suicide prevention pharmacy
efficacy and safety evaluation of anti-caries varnish

Conditions: Dental Caries in Children

Summary: the purpose of the study is to determine the efficacy \& safety of advantage anti-caries varnish for primary prevention. the objectives are: 1) to determine if advantage anti-caries varnish (test varnish) is superior to an active control varnish (5% sodium fluoride, no povidone-iodine) in the prevention of caries lesions in the primary dentition. specifically, prevention of caries lesions in primary teeth that either are sound, have only d1 (white spots) lesions or unerupted at baseline; and 2) to document the safety of the test varnish.

this is a single center randomized, double-blind, placebo-controlled, parallel-group trial. the treatment group will be exposed at baseline and once every three to four months after baseline for a maximum period of 24 months. the control group will be exposed to the control varnish in the same manner. 254 subjects will be enrolled. half will be randomized to each arm. subjects will be 6-24 mo of age and in good health. children attending maternal and child health (mch) immunization and well child programs in pohnpei state will be enrolled. primary outcome variables: 1) surface-level dental caries lesions (d2-4mfs) at 24 months post baseline; 2) presence/absence of dental caries lesions (d2-4mfs \>0) at 12 months post baseline. secondary outcome variable: adverse events

Eligibility criteria:
inclusion criteria: 1. the subject's parent or legal guardian must provide signed and dated informed consent (parent permission form). 2. the subject's parent or legal guardian of the subject must be willing and able to comply with study requirements. 3. the subject is a 6-24 months at the time of enrollment. 4. the subject must be in good general health as evidenced by parent report. 5. the subject will have at least 1 erupted tooth that is either sound or has only a d1 (white spots) lesion. exclusion criteria: 1. previous treatment with fluoride varnish 2. known allergy to iodine 3. diagnosis of thyroid disease 4. chronic, prophylactic use of antibiotics 5. treatment with another investigational drug or intervention within 30 days preceding the baseline visit. 6. visible cavities (d2-4) 7. presence of intraoral pathology that would make assessment of post treatment soft tissue ulcerations or inflammation impossible (child could be enrolled if problem is treated and lesions cleared) 8. parent anticipates the child will move from pohnpei during the next 2 years.

Keywords: sodium fluoride povidone iodine dental varnish primary dentition
immune responses after a four-site intradermal rabies booster vaccination in hiv-infected adults

Conditions: Rabies

Summary: a four-site intradermal rabies booster vaccination in hiv - infected patients who have ever received primary rabies vaccination could improve their immune response to this kind of vaccine.

a four-site intradermal rabies booster vaccination has shown higher immune response than conventional intramuscular rabies booster vaccination in healthy persons. so, the investigators hypothesized the same outcome in hiv - infected patients.

Eligibility criteria:
inclusion criteria: * hiv infected patients * age 18 - 60 years * received primary rabies immunization exclusion criteria: * have any active opportunistic infections * received blood or blood product within 3 months * allergy to vaccine or any vaccine components * received anti-malarial drugs

Keywords: rabies vaccination
pembro-k : evaluation of pembrolizumab therapeutic pharmacological monitoring benefit in nsclc

Conditions: Non Small Cell Lung Cancer

Summary: solid cancers and their therapeutic management remain a major public health problem due to their increasing prevalence and associated mortality. among solid cancers, lung cancer ranks 4th among incident cancers. the prognosis remains poor, 33,117 deaths were recorded in france in 2018. two histological forms of bronchopulmonary cancer are distinguished: non-small cell lung cancers (nsclc), which represent 85% of bronchopulmonary cancer, and small cell lung cancers. the most common forms of nsclc are adenocarcinoma, squamous cell carcinoma and large cell carcinoma. the emergence of new so-called targeted therapies has considerably modified the management and prognosis of oncology patients and in particular of patients with nsclc. these new molecules were developed following the molecular characterization of tumors on the one hand and on the other hand the characterization of the role of immunity in anti-tumor defense, particularly the programmed death receptor pathway 1 (pd-1). blocking this pathway restores the anti-tumor potential of these lymphocytes. pembrolizumab is a humanized monoclonal antibody that binds to the pd-1 receptor and blocks its interaction with the programmed death ligand-1 (pdl1) and programmed death ligand-2 (pdl2), expressed by tumor cells but also by cells in the microenvironment. tumor and by antigen-presenting cells. pembrolizumab thus potentiates t cell responses, including anti-tumor responses, by blocking the binding of pd-1 with pdl1 and pdl2. pembrolizumab currently has marketing authorization (ma) for the treatment of nsclc. despite therapeutic progress due, among other things, to the emergence of anti-pd-1 antibodies including pembrolizumab, the prognosis of nsclc remains poor and the use of pembrolizumab is sometimes limited by the occurrence of adverse effects. the pharmacokinetics of pembrolizumab was studied pre-marketing in patients with melanoma, nsclc or metastatic or unresectable carcinomas. however, there are no data relating to the pharmacokinetic (pk) / clinical response (pharmacodynamic / pd) relationship of pembrolizumab, in real life. no prospective pharmacological study has in fact been published to date, especially in patients treated as part of the management of nsclc. the absence of such studies - in real life - constitutes a pitfall given the existence of a possible association between pk data and the clinical response and/or toxicity of pembrolizumab.


Eligibility criteria:
inclusion criteria: * 18 years or more * patient with nsclc * pembrolizumab treatment (monotherapy or not) with a placed line (peripheral catheter, picc or implantable port) exclusion criteria: * objection to participate in the study * patient under judicial protection
the effects of dance for breast cancer patients undergoing surgical treatment

Conditions: Breast Cancer

Summary: the goal of this non randomized clinical trial, with pre- and post-intervention evaluation, longitudinal, with prospective data collection is to evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment.

the hypothesis is that dance will promote improvements in range of motion, strength, fatigue, functionality, pain and quality of life for breast cancer patients undergoing surgical treatment. objectives: to evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment on: shoulder range of, overall muscle strength, fatigue, respiratory muscle strength, functionality, pain and quality of life. method: this is a non-randomized randomized clinical trial, with pre- and post-intervention evaluation, prospective data collection. the following will be used for pre-intervention assessment: goniometry, dynamometry, manovacuometry, 6-minute walk test, fatigue and quality of life questionnaire, and quality of life questionnaire, as well as a pain assessment scale. after 16 weeks, the same variables will be assessed.

Eligibility criteria:
inclusion criteria: * patients diagnosed with breast cancer * undergone surgical resection * after medical referral for physiotherapy * and physiotherapeutic assessment exclusion criteria: * patients with another previous oncological diagnosis * previous neuromuscular diseases * patients who do not agree to take part in the study * or the impossibility of carrying out the muscle strength assessment and/or other assessments