Kornimate/medical-research-clean huggingface dataset:
anastrozole monotherapy versus maximal oestrogen blockade with anastrozole and fulvestrant combination therapy

Conditions: Breast Cancer

Summary: the purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.


Eligibility criteria:
inclusion criteria: * signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (pgr) receptor positive breast cancer, local recurrence or metastasis exclusion criteria: * previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy * premenopausal women

Keywords: hormone receptor positive breast cancer first relapse
evaluating the performance of the kodex-epd cryoballoon occlusion feature in patients with atrial fibrillation

Conditions: Atrium; Fibrillation; Ablation

Summary: prospective, multi-center, non-randomized, open label, double arm study to assess the performance of the kodex-epd pv occlusion viewer. this study includes patients with atrial fibrillation who are scheduled to undergo a cryo balloon ablation procedure for their atrial fibrillation.

the study is designed to evaluate the performance of the kodex-epd occlusion viewer using a standardized workflow in a blinded setting in a homogenous patient group. furthermore, in an effort to minimize therapy, a direct comparison between the success of the freeze when initiating therapy based on the occlusion viewer vs the assessment of occlusion assessed with fluoroscopy will be evaluated. the study design indicates a post-market interventional clinical investigation to evaluate the endpoints of the study. no follow-up is foreseen ensuring a minimal burden to the subjects participating in the study.

Eligibility criteria:
inclusion criteria: 1. subject must be aged \>18 years. 2. subject must have signed a written informed consent form to participate in the study, prior to any study related procedures. 3. subject must be willing to comply with the protocol requirements. 4. subject receives a de novo ablation procedure for treatment of atrial fibrillation. exclusion criteria: 1. pregnant women.

Keywords: atrial fibrillation af cryoballoon ablation kodex-epd
quality of life on elderly patients with low grade non-hodgkin lymphoma

Conditions: Low Grade Non-Hodgkin's Lymphoma, Adult

Summary: aims of this study are to describe the variation of qol (quality of life) during the clinical management of low-grade lymphoma in elderly subjects and to identify the most important factors at diagnosis and during treatment with an impact on qol (quality of life).

this is a prospective, multicenter, non-interventional study aiming at investigating on the changes in qol (quality of life) during the clinical management of low-grade lymphoma in elderly subjects and to possibly identify the most important factors at diagnosis and during treatment with an impact on qol (quality of life). the study plans to enroll 150 patients with a local histologically confirmed diagnosis of indolent non-hodgkin lymphoma fulfilling all the inclusion/exclusion criteria who provide written informed consent will be included in the study. any type of treatment is allowed by the study (immunotherapy, immunochemotherapy at full or reduced dose, radiotherapy). all patients must undergo comprehensive geriatric assessment (cga) before starting any protocol treatment. baseline, post-treatment and follow-up instrumental assessments and response evaluation is done as part of the routine clinical management for patients with indolent nhl (non hodgkin lymphoma) . response evaluation and all other assessments planned for the eot (end of treatment) should be planned also in case of early withdrawal, according to clinical practice. hrqol (health-related quality of life) evaluation will be done at time of informed consent form signature prior to treatment start, at the end of the treatment (ranging from 1 month to 6 months according to the duration of the treatment) and after 1 year from the start of the therapy. qol (quality of life) assessment includes all scales of the eortc-qlq-c30 (european organisation for research and treatment of cancer quality of life questionnaire-core 30) and the fact-lym-lyms (functional assessment of cancer therapy - lymphoma - lymphoma-specific symptoms questionnaire).

Eligibility criteria:
inclusion criteria: * local histological diagnosis of indolent b cell non-hodgkin lymphoma: follicular lymphoma, marginal zone lymphoma (nodal, malt (mucosa-associated lymphoid tissue), splenic), lymphoplasmacytic lymphoma/ waldenström macroglobulinemia) * age ≥ 70 years * patient candidates to receive treatment for lymphoma * patient previously untreated for lymphoma * evaluation of comprehensive geriatric assessment at baseline * ability to provide informed consent: subject understands and voluntarily signs an informed consent form approved by an iec (independent ethics committee), prior to registration into the study note: patient treated in the context of a clinical trial is admitted exclusion criteria: * none
substance abuse treatment to hiv care (sat2hiv): the implementation & sustainment facilitation experiment

Conditions: Substance Use

Summary: a cluster randomized experiment focused on testing the extent to which the organization-focused implementation \& sustainment facilitation (isf) strategy is an effective adjunct to the staff-focused addiction technology transfer center (attc) strategy.

a cluster randomized experiment with 39 aids service organizations located across the united states. the overarching goal is to test the extent to which the organization-focused implementation \& sustainment facilitation (isf) strategy is an effective adjunct to the staff-focused addiction technology transfer center (attc) strategy.

Eligibility criteria:
inclusion criteria: * aids service organizations have to 1. serve a minimum of 100 individuals living with hiv/aids per year, 2. have at least two frontline staff who were willing and able to be trained in the motivational interviewing-based brief intervention (mibi) experiment's mibi for substance use, and 3. have at least one leadership staff (i.e., supervisor, manager, director) willing and able to help ensure case-managers were given sufficient time for project participation. exclusion criteria:

Keywords: preparation strategies implementation strategies sustainment strategies
treatment of prostate cancer with firmagon®

Conditions: Prostate Cancer

Summary: how are testosterone levels of patients with prostate cancer under treatment with firmagon® changing. former studies showed a quick fall of testosterone levels after start of therapy with firmagon® and a quick recovery when therapy is stopped. the investigators want to prove this in a normal outpatient urologist setting. furthermore data is collected to prove the adherence to the german s3-guideline for the treatment of prostate cancer.


Eligibility criteria:
inclusion criteria: * advanced hormone-dependent prostate cancer with no other previous hormone therapy for whom - irrespectively of this nis -the use of firmagon® is intended exclusion criteria: * contraindication for degarelix

Keywords: testosterone s3-adherence quality of life
intranasal midazolam for pediatric pre-procedural sedation and pre-procedural anti-anxiety using sipnose device - a randomized controlled study

Conditions: Procedural Sedation; Intra-nasal Delevery Device

Summary: a three-arm, randomized controlled trial for pediatric pre-procedural sedation and pre-procedural anti-anxiety: intranasal midazolam by sipnose versus mad versus oral administration


Eligibility criteria:
inclusion criteria: * every child \>1y who is intended for medical procedure in the emrgency room(suce as: iv insertion, blood sample collection, urinary catether insertion, laceration repair exclusion criteria: * asa\>2 * active respiratory infection * systemic illness * allergy to midazolam
the use of water jet for initial treatment for peri-implant disease

Conditions: Peri-implantitis

Summary: the aim of this study was to evaluate the effect of a dental water jet on initial peri-implant disease resolution.

peri-implant disease is becoming more frequent during the last decade. till today, there is no effective evidence-based treatment. the use of water-jet might improve those situations and reduce morbidity and implant loss.

Eligibility criteria:
inclusion criteria: * signed and dated informed consent form. * patient suffer from peri- implant disease * age eligible for study: 18 year old and older * genders eligible for study: both exclusion criteria: * patient substantially fails to comply with the study schedule, or treatment program as described in this protocol.
an evaluation of novel glucose sensing technology on hypoglycaemia in type 1 diabetes (impact)

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the impact of the abbott sensor based glucose monitoring system on hypoglycaemia compared to self monitoring blood glucose (smbg) testing using a randomised controlled study design in adults with type 1 diabetes using insulin.


Eligibility criteria:
inclusion criteria: 1. diagnosed with type 1 diabetes for ≥ 5 years 2. on their current insulin regimen for ≥ 3 months prior to study entry 3. screening hba1c result ≤ 7.5% (58 mmol/mol) 4. reports self testing of blood glucose levels on a regular basis equivalent to a minimum of 3 times daily for at least 2 months prior to study entry 5. in the investigator's opinion the subject is considered technically capable of using the abbott sensor based glucose monitoring system 6. aged 18 years or over. exclusion criteria: 1. subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes or in the investigator's opinion the subject currently experiences less than minimal warning symptoms for impending hypoglycaemia) 2. subject is currently prescribed animal insulin 3. subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study 4. has known allergy to medical grade adhesives 5. currently participating in another device or drug study that could affect glucose measurements or glucose management 6. currently using a continuous glucose monitoring (cgm) device or has used one within the previous 4 months 7. currently using sensor augmented pump therapy 8. is planning to use a cgm device at any time during the study 9. a female subject who is pregnant or planning to become pregnant within the study duration 10. a breast feeding mother 11. currently receiving dialysis treatment or planning to receive dialysis during the study 12. has a pacemaker 13. has experienced an acute myocardial infarction within previous 6 months 14. has a concomitant disease or condition that may compromise subject safety including; unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition 15. has experienced an episode of confirmed or suspected diabetic ketoacidosis (dka) in the previous 6 months 16. in the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.

Keywords: sensing technology type 1 diabetes,
the use of cannabidiol in cancer patients

Conditions: Cancer

Summary: alternative and complementary medicines (mac) are commonly used by cancer patients to help them to face with anticancer treatment, reduce oncology symptoms and/or anticancer treatment adverse effects, detoxifying the body. in consistence with guidelines from the french society for oncology pharmacy (sfpo), the pharmaceutical consultation includes a discussion and collection of herbs, botanical and other natural products consumed by cancer patients. this aim to prevent and manage herb-drug interaction as well as other drug-related problems (drp). the recent french experimentation dedicated to cannabidiol for medical use could enhance interest of cancer patients in the field of mac. however, cannabidiol have shown inhibitory effect on different cytochromes with a risk of hdi as other mac. while the prevalence of mac consumption is already known in some type of cancer, the consumption of cbd is less known and should be explored. through this study we wish to know the prevalence of cannabidiol consumption in cancer patients and to establish a typical profile as well as to know the modalities of use. we also want to validate a questionnaire through a literacy scale.

* a prospective observational study * conducted in an oncology day-hospital (chu de reims) all data collected were: * clinical characteristics, * administrative data, * medication review, * biologic data collection, * oncological data, * disease data statistical analysis: * quantitative variables: described as mean ± standard deviation (sd) or median (interquartile range and minimum and maximum) * student test and fischer exact performed to compare cbd users and non-users. * analysis of variance: used to compare scores between different variables * univariate logistic and multivariate logistic regressions were performed. variables with a p-value \< 0.20 (wald test) in the univariable analyses were considered eligible for the multivariable models.

Eligibility criteria:
inclusion criteria: all the patients (\>18yo) who received anticancer treatment exclusion criteria: * patients who received anticancer drug with very short administration time (typically subcutaneous anticancer drugs as 5-azacitidine, bortezomib and some monoclonal antibodies) * patients who were not able to speak and understand french as well as who were unable to communicate clearly.

Keywords: cannabidiol cancer patient
abatacept post-marketing clinical study in japan

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to compare the clinical efficacy including joint damage progression and safety of abatacept plus methotrexate (mtx) to placebo plus mtx.


Eligibility criteria:
inclusion criteria: * mtx inadequate responder * biologic naïve * functional class i, ii or iii * ≥6 swollen and ≥6 tender joints * c-reactive protein (crp) ≥2.0mg/dl or erythrocyte sedimentation rate (esr) ≥28 mm/hr * anti-cyclic citrullinated peptide (ccp) antibody positive * have erosion exclusion criteria: * any other rheumatic disease * active angiitis on main organs excluding rheumatoid nodule
right/left discrimination training on fibromyalgia patients

Conditions: Fibromyalgia

Summary: to determine whether a targeted right/left discrimination training program can improve pain perception and functional disability in fibromyalgia patients.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia according to the 2016 american college of rheumatology criteria * adults between 35 - 55 years old * both sexes * stable medication use for at least one month prior to enrollment exclusion criteria: * history of other musculoskeletal or neurological disorders * current involvement in another pain management program or study
combined resection of colorectal metastases

Conditions: Colorectal Cancer

Summary: this is a phase ii study of combined surgical resection for patients with both intra- and extra-hepatic metastases from colorectal cancer. the primary objective is to determine the two-year disease free survival (dfs) of patients who undergo surgical resection of both intra- and extra-hepatic metastases from colorectal cancer. the secondary objectives are to determine the overall survival rate (os), patterns of treatment failure, treatment efficacy (r0 resection rate), peri-operative morbidity and mortality rates, health related quality of life, and hospital length of stay.

this phase ii clinical study will examine the outcomes of surgical therapy for patients with both intra- and extra-hepatic crc metastases. the treatment protocol includes surgical resection of metastases from colorectal cancer. multi-modality co-interventions such as chemotherapy (neo-adjuvant, or post-operative), radiofrequency ablation (rfa) and/or portal vein embolization (pve) will be permitted. the eligibility criteria include: patients with both intra-hepatic and extra-hepatic metastases from colorectal cancer, the number of extra-hepatic metastases must be three or less on pre-operative imaging, all metastatic deposits must be resectable with r0 intent, there must be no contra-indications to major surgery and an ecog performance status of 0, 1 or 2.

Eligibility criteria:
inclusion criteria: * patients with both intra-hepatic and extra-hepatic metastases from colorectal cancer * number of extra-hepatic metastases must be 3 or less on pre-operative imaging * all metastatic deposits must be resectable with clear margins * no contra-indications to major surgery * ecog performance of 0, 1 or 2 * age 18 or older * pregnant women or women of childbearing potential are eligible if they agree to use 2 methods of effective contraception during treatment protocol * written informed consent can be obtained exclusion criteria: * colorectal primary in situ * four or more extra-hepatic lesions on pre-operative imaging * significant medical or psychiatric conditions that preclude major surgery or may interfere with patient compliance * patients receiving investigational drugs with unknown surgical risks * failure to meet inclusion criteria

Keywords: colorectal metastases
povidone-iodine oral rinse study

Conditions: COVID-19

Summary: this study is a two-arm, randomized, 2-phase study. phase i will be double blinded clinical trial of the safety and efficacy of an antiseptic mouthwash solution on reducing sars-cov-2 load in covid 19+ adult individuals. phase ii is designed as an open label trial, and all subjects will receive the active mouthwash.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide informed consent prior to initiation of study procedures. 2. stated willingness to comply with all study procedures and availability for the duration of the study. 3. male or female, aged 18 years and older. 4. clinical diagnosis of covid-19 infection confirmed with a positive point of care test. 5. confirmed diagnosis within 5 days of baseline visit (within 5 days of covid-19 test) and at least one clinical covid-19 symptom \[\*signs and symptoms of covid-19 present at illness onset vary, but over the course of the disease, most people will experience the following: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste of smell, sore throat, congestion or runny nose, nausea or vomiting and diarrhea.\] 6. presents with a minimum of six natural teeth. 7. ability to rinse/gargle with study products. 8. not using mouth rinse/gargling solutions at the time of enrollment. 9. not taking antimicrobial medications (antibacterial, antiviral, antibiotics, including hydroxychloroquine) at time of enrollment. 10. ability to participate in the study and come to site during phase i of the study for collection of swabs and saliva. 11. willing to use an acceptable method of birth control throughout duration of the study. acceptable methods include hormonal contraceptives, barrier methods, abstinence, or other effective methods approved by the pi. 12. if continuing to phase ii of the trial, ability to continue using study products for 1 week (+ 3 days). (participants do not have to agree to participate in phase ii in order to participate in phase i.) 13. if continuing to phase ii of the trial, agree to receive text messages/phone calls containing questionnaires regarding compliance and use of study product, and reminders, able to complete virtual follow-up study visit for collection of outcomes data. exclusion criteria: 1. individuals receiving antiviral medications 2. pregnant or breastfeeding women (for premenopausal women of childbearing potential, pregnancy status to be confirmed through a urine pregnancy test during the study visit) 3. inability to comply with study protocol 4. having an allergy to any of the study mouthwash ingredients 5. having any thyroid condition. 6. presents with a current suspicious oral lesion at the examiner's discretion, and/or currently undergoing radiation therapy for head or neck cancer, and/or has received radiation therapy to the head or neck (including radioactive iodine therapy).
a randomized control trial to assess the efficacy of tadalafil in raynaud's phenomenon in scleroderma

Conditions: Raynaud's Phenomenon; Digital Ulcers; Scleroderma

Summary: raynaud's phenomenon (rp) associated with scleroderma is a difficult problem to treat. many patients develop ischemic digital ulcers due to severe rp that causes considerable morbidity and adversely affects the quality of life. in an earlier study, we have observed marked improvement in rp attacks and rapid healing of digital ulcers following therapy with phosphodiesterase v inhibitor, tadalafil. in the present multicentric study we aim to study the efficacy of tadalafil in patients continuing to have rp attacks despite using at least one or more vasodilators.


Eligibility criteria:
inclusion criteria: male or female subjects between the ages of 18 years and 65 years will be selected for the study if they have a clinical diagnosis of raynaud's phenomenon secondary to systemic sclerosis (scleroderma) despite being on vasodilator therapy. raynaud's phenomenon is defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor. patients with a history of at least 4 attacks per week during two-week pre-trial period even with treatment with other vasodilators will be recruited. patients fulfilling the diagnostic criteria of scleroderma (as per american college of rheumatology criteria) or having presence of at least 3 of the 5 features of the crest syndrome (calcinosis, raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasias)will be invited to participate in the study. exclusion criteria: patients with: * symptomatic orthostatic hypotension, * evidence of current malignancy, * history of sympathectomy, * upper extremity deep vein thrombosis or lymphedema within 3 months, * recent surgical procedure requiring general anesthesia, * acute myocardial infarction, unstable angina, strokes and transient ischemic attacks within the past three months, * smoking, * use of any investigational drug within 30 days of the study sessions, * use of medications that might interfere with tadalafil like nitrates and alpha adrenergic blockers that have vasoactive effects, and patients taking potent inhibitors of cyp3a4 such as ritonavir, ketoconazole, and itraconazole, erythromycin, itraconazole, and grapefruit juice, * patients taking alcohol, * patients with bleeding disorders * significant active peptic ulceration, * current pregnancy, * current breast-feeding.

Keywords: raynaud's phenomenon ischemic ulcers digital ulcers digital infarcts gangrene vasodilators endothelial dysfunction scleroderma