Kornimate/medical-research-clean huggingface dataset:
study of diclofenac capsules to treat pain following surgery in children ages 6 to <17 years of age

Conditions: Pain, Postoperative

Summary: the purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to \<17 years experiencing mild to moderate acute postoperative pain.


Eligibility criteria:
inclusion criteria: * body weight ≥18 kilograms. * mild to moderate acute pain requiring treatment with analgesic medication. * willing to have blood samples taken for pk sampling using an indwelling catheter. * must be able to swallow capsules and can tolerate oral medication. * for females: is not of reproductive potential (defined as premenarchal) or is practicing an acceptable method of birth control exclusion criteria: * severe acute pain * chronic analgesic or glucocorticoid use for any condition within 6 months before dosing with study drug. * emergency surgery * history of allergic reaction, hypersensitivity, or clinically significant intolerance to diclofenac, aspirin, codeine, acetaminophen, or any nsaid * history of peptic ulcer disease or a gi event (eg, perforation, obstruction, or bleed) within 6 months before screening * current use of any medication that may cause a clinically significant drug interaction when co-administered with diclofenac * current use of any medication that might affect the pharmacokinetics of diclofenac * history of bleeding disorders . * developmental delay or behavioral problems that would make it difficult to assess pain. * impaired liver function * clinically significant renal or cardiovascular disease * any medical condition that compromises ability to swallow, absorb, metabolize, or excrete the study drug * previously received any investigational product or device within 30 days before screening or scheduled to receive an investigational device or another investigational drug (other than that in this study) during the course of this study. * previous participation in this clinical study or currently taking diclofenac.
neo-synalar modified 48 hour patch test

Conditions: Allergy

Summary: a 48 hour patch test performed in healthy volunteers to determine the presensitization (pre-existing allergy) of neo-synalar (neomycin sulfate 0.5%(0.35% neomycin base), fluocinolone acetonide 0.025%) cream . subjects also receive a positive control (sodium lauryl sulfate) and a negative control (saline). the primary objective of this study is to determine if any subjects exhibit an allergic reaction which may be indicative of a pre-existing sensitization.

following approximately 48 hours of continuous skin contact, the patch units and test material are removed at the testing facility. the test sites are evaluated for a significant reaction according to the ess (erythemal scoring scale). the test sites are also re-evaluated at 96 and 168 hours post-application (for late reaction) using the ess.

Eligibility criteria:
inclusion criteria: * subjects must be 18 to 79 years inclusive. * subjects must be able to understand and execute informed consent. * female subjects must produce a negative pregnancy test. * subjects must be capable of following directions. * subjects must be considered reliable . exclusion criteria: * subjects who are ill of health or taking medication that could influence the purpose, integrity, or outcome of the trial. * female subjects who are pregnant. * subjects with a history of adverse reactions to cosmetics, otc (over the counter) drugs or other personal care products. * subjects who have used topical or systemic steroids or antihistamines within 7 days prior to trial initiation or plan to use either during the duration of the trial. * subjects with known allergy to neomycin, bacitracin, gentamicin, paromomycin, spectinomycin, streptomycin or tobramycin. * subjects with known allergy to corticosteroid. * subjects with a history of auto-immune disease (e.g. lupus, psoriatic arthritis, rheumatoid arthritis).

Keywords: neo-synalar patch test sodium lauryl sulfate saline presensitization
clinical evaluation of the next science surgx antimicrobial wound gel impact on surgical site complications

Conditions: Total Hip Arthroplasty; Total Knee Arthroplasty

Summary: this is a single-site, prospective, clinical study of subjects that are scheduled to undergo either total hip or total knee arthroplasties. it is anticipated that surgical wounds treated with surgx will exhibit reduced surgical site complication rates and improved post-operative treatment outcomes by potentially decreasing site bioburden of both free-floating and biofilm-entrenched organisms.


Eligibility criteria:
inclusion criteria: 1. male or female 18 years or older 2. scheduled to undergo primary hip or knee arthroplasty 3. willing and able to comply with all study procedures and be available for the duration of the study 4. provide signed and dated informed consent exclusion criteria: 1. unable to provide signed and dated informed consent 2. unable or unwilling to comply with all study-related procedures 3. known history of allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings) 4. subject with any mental impairment or condition that would make them unable to properly consent without use of lar or additional subject protections 5. subjects from a vulnerable population, in accordance with 45 cfr 46 subparts b, c, and d
increase in temperature in children undergoing mri

Conditions: Magnetic Field Exposure; Temperature Change, Body; Children, Only

Summary: an increasing number of children undergo magnetic resonance imaging (mri). in mri, radio waves and magnetism are used to form images of the body's interior, to diagnose and monitoring diseases in children. many children are sedated to be able to collaborate with the mri procedure. sedation and general anesthesia cause the child to some extent to lose the ability to regulate his or her own bodytemperature. mri rooms are most often cold due to the function of the magnet, leading to a risk of hypothermia in young children. conversely, the mri scanner generates radio frequencies that are absorbed by the body and converted to heat, which especially in small children due to their large surface area can potentially result in an increase in bodytemperature. in this study we therefore want to investigate changes in bodytemperature in children who are undergoing mri- scanning within the neuroanesthesiology clinic. furthermore, we want to define possible risk factors for possible temperature changes. our hypothesis: children undergoing mri scanning increase in bodytemperature.

ear temperature is measured as we are primarily interested in describing temperature changes in the individual child and because this method is less invasive than the alternatives.

Eligibility criteria:
inclusion criteria: * age from 12 weeks to 12 years * children undergoing mri scans with the help of anesthesia staff from the neuroanesthesiology clinic under general anesthesia or awake * the children are recruited via prescriptions or the anesthetist immediately before scanning and outside the mri room. all children who meet the criteria for mri scan can be included. acute mri children, children admitted to intensive care and children who came is directly from the operation if consent is obtained. exclusion criteria: * inability at present. and relatives to speak and understand danish or english. an authorized interpreter may be used for a family that does not have a danish background and only if written and oral information material is understood otherwise the patient is excluded * no consent to the study * anatomically not possible to measure ear temperature * temperature above 39 ° c

Keywords: magnetic resonance imaging paediatrics temperature
long-term follow-up study of allogeneic gamma delta (γδ) car t cells

Conditions: Lymphoma, Follicular; Lymphoma, Mantle-Cell; Marginal Zone Lymphoma; Primary Mediastinal B-cell Lymphoma; Diffuse Large B Cell Lymphoma; Lymphoma, Non-Hodgkin

Summary: the purpose of this study is to assess long-term side effects from subjects who receive an adicet bio γδ car t cell product. subjects will join this study once they complete the parent interventional study. no additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. for a period of 15 years from the first administration of adicet bio allogeneic γδ car t cell product, subjects will be assessed for long-term safety and survival through collection of data that include safety, efficacy, pharmacokinetics and immunogenicity.

this is a non-therapeutic, multi-center, long-term follow-up (ltfu) study of subjects who received an adicet bio allogeneic γδ car t cell product that has been genetically engineered to express the anti-cd20 car by transduction with a self-inactivating, replication incompetent gamma retroviral vector. the period of follow-up is 15 years after the administration of the γδ car t cell product. the study involves up to 15 years post-infusion monitoring of subjects who have been exposed to a genetically engineered car in adicet bio clinical studies. upon early termination/discontinuation or completion of the parent interventional study, subjects will enroll into this study. collection of these data will further define the risk-benefit and efficacy profile adicet allogeneic γδ car t cell investigational products. this is an observational study, and the elements of the study design are per published guidelines for gene therapy medicinal products that utilize integrating viral vectors such as gamma retrovirus and it is important to evaluate any delayed adverse events after infusion with such products.

Eligibility criteria:
inclusion criteria: * all patients who received any adicet allogeneic car t investigational product and have either completed the core treatment protocol or have discontinued early * all patients who are willing and able to adhere to the study visit schedule and other protocol requirements. * capable of giving signed informed consent which includes compliance with requirements and restrictions listed in the informed consent form (icf) and protocol exclusion criteria: * there are no specific exclusion criteria for this study

Keywords: b-cell lymphoma car-t cell therapy allogeneic cell therapy t cells gamma delta immunotherapy, adoptive antigens, cd20
clinical study, non inferiority between noex® 50µg versus busonid® 50µg in treatment of allergic rhinitis

Conditions: Rhinitis, Allergic, Perennial

Summary: this study is to evaluate non inferiority of eurofarma budesonide nasal spray x referral astrazeneca budesonide. half patients will receive eurofarma medication and half patients will receive astrazeneca medication. there is no placebo group.

budesonide is a medicine already very used and registered about 20 years. eurofarma has the intention to collect more data about safety and efficacy and present them to local authority. this study was draw to treat patients with persistent rhinitis moderate to severe in sites located locally in brazil.

Eligibility criteria:
inclusion criteria: 1. age ≥ 12 2. history of allergic persistent rhinitis moderate to severe at least 2 years 3. proved allergic using prick or rast test 4. nasal symptoms (nis) \> 3 and nasal obstruction \>1 5. indication of nasal corticosteroids use 6. washout of nasal corticosteroids for 14 days 7. icf exclusion criteria: 1. other types of rhinitis 2. asthma non controlled 3. use of oral/injectable corticoids 30 days before screening 4. patients not eligible to complete diaries 5. patients with allergy to any substance of medicines 6. non controlled disease
dna analysis of blood and tissue from patients with lung cancer

Conditions: Lung Cancer

Summary: rationale: studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help the study of cancer in the future. purpose: this clinical trial is analyzing the dna in blood and tissue samples from patients with lung cancer.

objectives: * assess the role of genetic polymorphisms in lung-cancer risk in patients with lung cancer. * assess the role of germline polymorphisms in dna repair genes, p53 pathway genes, and a matrix metalloproteinase gene (tumor invasion factor) in lung-cancer risk, after adjusting for potential confounders. * assess the roles of gender and age in the genetic susceptibility of lung cancer. * assess the role of genetic polymorphisms in modifying the diet-lung cancer risk association (gene-diet and exploratory gene-gender-diet and gene-gene-diet interactions). * assess the role of polymorphisms on the risk of developing specific histologic subtypes of lung cancer in case-only analyses. * determine whether continued exposures to mainstream and/or second-hand tobacco smoking is associated with poorer clinical prognosis in patients treated for lung cancer. outline: this began as a case-control study, but is currently case only. blood samples are collected from patients and controls. samples are analyzed by polymerase chain reaction for gene polymorphisms. genes to be studied include gstp1, gstm1, gstt1, ercc2, xrcc1, ephx, nat-2, p53 gene, cyp1a1, nqo1, mnsod, and gpx1. tissue samples collected from patients undergoing surgery and blood samples are archived for future studies. patients and controls complete questionnaires about diet, medical history, and occupational/environmental history. projected accrual: a total of 3,400 patients and 3,400 controls will be accrued for early phases of this study. total enrollment to reach 15,000.

Eligibility criteria:
disease characteristics: * patient: * newly diagnosed primary lung cancer * patient at massachusetts general hospital (mgh) or boston medical center cancer center patient characteristics: * not specified prior concurrent therapy: * not specified exclusions: vulnerable populations are excluded. patients with metastasis from another site to lung or mesothelioma are excluded.

Keywords: non-small cell lung cancer small cell lung cancer pulmonary carcinoid tumor
interventions for adolescent obesity

Conditions: Adolescent Obesity

Summary: this study will evaluate whether the short-term use of activity tracking devices improves short-term weight loss in adolescents. the investigators will evaluate whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. in addition, the investigators will report outcomes after the implementation of activity tracking devices in conjunction with an intense adolescent weight loss program.

this study will evaluate the short-term use of activity tracking devices and their effects on short- and long-term weight loss in adolescents. the investigators plan to establish whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. each participant with an activity tracking device will have the goal of reaching 10,000 steps per day, in addition to their individual fitness plan.

Eligibility criteria:
inclusion criteria: ages 12-18 years bmi ≥ 95th percentile for age and sex group participant able to read and understand english willingness to be randomized to any condition exclusion criteria: inability to obtain informed parental consent and/or child assent inability to participate in the program due to pre-existing conditions (e.g., paralysis, heart failure, severe autism or mental retardation, psychosis) pregnancy clinical judgment concerning safety inability of the participant to speak english

Keywords: obesity adolescent tracking device fitbit
99mtc labelled affibody spect/ct imaging for breast cancer her2 characterization

Conditions: Breast Cancer

Summary: this is an open-label single photon emission tomography/computed tomography (spect/ct) study to investigate the diagnostic performance and evaluation efficacy of 99mtc-abh2 in breast cancer patients. a single dose of 370±54 mega-becquerel (mbq)99mtc-abh2 will be injected intravenously. visual and semiquantitative method will be used to assess the spect/ct images.

99mtc-abh2 is an affibody probe targeting her2. the investigators will determine the use of 99mtc-abh2 spect/ct in the detection of her2-positive breast cancer, and to compare its diagnostic value with routine immunohistochemistry (ihc) pathological staining. her2 imaging, specifically to her2 receptor expressed on malignant breast cancer cell surface, might help for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer. the investigator will determine the use of 99mtc-abh2 spect/ct in stratifying breast cancer.

Eligibility criteria:
inclusion criteria: patients with breast cancer before surgery conventional imaging within 1 month signed written consent age above 29 years female exclusion criteria: pregnancy breastfeeding renal function: serum creatinine \> 3.0 mg/dl known allergy against affibody any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance

Keywords: spect/ct her2 imaging
epithelioid sarcoma natural history study

Conditions: Epithelioid Sarcoma

Summary: this study is a multi-center, non-interventional retrospective medical records review. the study will involve identification of medical records of patients with confirmed locally advanced unresectable or metastatic es, who initiated systemic therapy between january 1, 2000 and december 31, 2017. data for the chart review will be extracted retrospectively from eligible subjects' charts (electronic or paper). information on prior surgical treatment and neoadjuvant/adjuvant therapies for es will also be collected for ineligible subjects with a locally advanced or metastatic es diagnosis who did not initiated systemic therapy. data collected will be anonymized by the investigators and will not be traceable back to individual subjects by the sponsor (i.e., no protected health information \[phi\] will be collected).

the sampling period will span from january 1, 2000 to december 31, 2017. as the chart abstraction dates may be different across institutions due to contracting and other logistical issues, to avoid seeing biased outcomes that may be related to this type of heterogeneity, a consistent study end date will be imposed for all patients when conducting the analysis. information before this study end date will be analyzed and used to conduct the analysis.

Eligibility criteria:
inclusion criteria: * diagnosed with histologically confirmed, locally advanced unresectable or metastatic epithelioid sarcoma (es) requiring systemic therapy during between january 1, 2000 and december 31, 2017. the date of the confirmed locally advanced unresectable or metastatic es diagnosis is designated as the index date. * patients may have a date of es diagnosis at an earlier stage prior to 2000 and still be eligible for the study * initiation of treatment with any systemic anti-cancer therapy for the treatment of their locally advanced unresectable or metastatic es between january 1, 2000 and december 31, 2017 * at least 10 years of age at the index date
a study of avastin (bevacizumab) in combination with docetaxel and cisplatin in patients with metastatic or locally advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this study assessed the efficacy and safety of avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. patients received avastin 15 mg/kg intravenously (iv), docetaxel 75 mg/m\^2, and cisplatin 75 mg/m\^2 on day 1 of each 3-week cycle for a maximum of 6 cycles.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 years of age. * stage iiib or iv non-small cell lung cancer. * chemotherapy-naive. exclusion criteria: * previous treatment for non-small cell lung cancer. * previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer. * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study. * recent or current chronic treatment with aspirin (\> 325 mg/day).
long term clinical and radiographical outcomes of different anterior cruciate ligament reconstruction techniques

Conditions: Anterior Cruciate Ligament Tear; Osteoarthritis, Knee

Summary: the purpose of this study is to evaluate the long-term results of various anterior cruciate ligament reconstruction techniques. this assessment is necessary for the current context of anterior cruciate ligament research as several techniques and grafts are used in clinical practice, however, the various studies existing in the literature focus mainly only on the direct comparison of two techniques and usually with short-to-medium term follow-up. since gonarthrosis is one of the most debated consequences of cruciate ligament reconstruction, a comparison of different long-term procedures would be desirable to have a clearer picture of the risks and benefits associated with different types of intervention.

in the beginning, the database of our institute is consulted, all the patients that underwent acl reconstruction at least 15 years ago are selected. the original group will be divided into subgroups based on the surgical technique adopted, of the different techniques we took into consideration only these three: anatomical acl reconstruction with patellar tendon, anatomical acl reconstruction with hamstrings, non-anatomical acl reconstruction "over-the-top plus lateral plasty". the patients will be contacted to ask if they are interested to take part in the study; at least 25 patients for each group will be recruited. all the patients recruited will sign an informed consent about the study and the personal data treatment. after consent acquisition, patients will undergo a clinical examination and a questionnaire about pain and knee status will be administered; moreover, a radiographical examination of the operated knee will be performed to assess the osteoarthritis progression. patients that reported graft rupture will be registered as failures.

Eligibility criteria:
inclusion criteria: 1. patients who underwent acl reconstruction with single-bundle anatomical technique (patellar tendon, semitendinous and gracile tendons) or "over-the-top plus lateral plastic" technique and any associated procedures with at least 15 years of follow up; 2. patients aged between 15 and 50 at the time of surgery; 3. patients with isolated acl tear; 4. patients with healthy contralateral knee at the time of surgery. exclusion criteria: 1. patients with grade iii-iv chondral lesions according to outerbridge scale at surgery; 2. patients no longer available; 3. women of childbearing age who cannot exclude pregnancy; 4. patients unable to give informed consent or patients unwilling to sign informed consent.

Keywords: anterior cruciate ligament knee osteoarthritis hamstrings patellar tendon lateral extra articular tenodesis