Kornimate/medical-research-clean huggingface dataset:
development of ursodeoxycholic acid 300 mg at hospital das clinicas of the university of são paulo school of medicine

Conditions: Ursodeoxycholic Acid; Primary Biliary Cirrhosis

Summary: a manipulation and an integral part of the pharmaceutical practice, where, in addition to the supply of medicines and personalized products, they represent an alternative to the therapeutic schemes, manipulating drugs of almost all of them as therapeutic categories. one of the products and ursodeoxycholic acid, commercially known as ursacol, a bile acid physiologically present in human bile, approved by agência nacional de vigilância sanitária (anvisa), among several indications, for the treatment of the symptomatic form of primary biliary cholangitis, autoimmune etiology and predominant incidence in female. this is a prospective, cross-over, interventional and open-label study, where patients attending the inclusion and exclusion criteria are attended by the instituto central do hospital das clínicas da faculdade de medicina da universidade de são paulo (ichc-fmusp) pharmacy division in the pharmaceutical care sector. as patient information as well as the prescribed drugs, compiled by a data collection instrument from the ichc-fmusp pharmacy division and a semi-structured questionnaire.

the therapeutic efficacy of ursodeoxycholic acid 300 mg tablet and capsules was measured comparing the liver enzyme parameters: alkaline phosphatase, gamma glutamyl transferase, alanine aminotransferase, aspartate aminotransferase and total bilirubin in three times: before treatment begins, in the middle of treatment and at the end of treatment.

Eligibility criteria:
inclusion criteria: * patients with primary biliary cholangitis (pbc) was diagnosed when at least two of the following three criteria: histologically proven early stage pbc; positive anti-mitochondrial antibody (ama) (titer \>1:40) and alkaline phosphatase \>1.5 times upper limit of normal at any time since diagnosis. * patients had to be on ursodeoxycholic acid for at least 6 months. * patients should be able to understand and ready to sign the informed consent form. exclusion criteria: * patients not adherent to treatment with reference medicine. * known intolerance to the study drugs. * patients who withdrew their agreement.

Keywords: liver cirrhosis, biliary ursodeoxycholic acid
sonography outcomes assessment program for lower extremity deep venous thrombosis

Conditions: Deep Venous Thrombosis

Summary: currently, most emergency physicians have limited access to obtaining formal radiology ultrasound studies, particularly overnight. many are forced to adopt risky and expensive strategies in managing their patients with suspected deep venous thrombosis (dvt) who present during off-hours: for low risk patients, discharging without anticoagulation and arranging for outpatient studies; for moderate to high risk patients, empirically anticoagulating and admitting to the hospital to await definitive testing. if emergency physicians could reliably perform an accurate ultrasound exam for dvt, such risks could be obviated. this is a prospective, observational cohort study assessing the accuracy of emergency physician diagnosis of proximal dvt using compact ultrasound equipment and a simplified compression technique. the value of color flow doppler and augmentation will also be assessed. outcomes (sensitivity, specificity, positive likelihood ratio and negative likelihood ratio) will be assessed at 30 days. prior to enrolling patients in the study, emergency physicians will undertake a 2 hour training course on the performance of the simplified compression technique for the diagnosis of lower extremity dvt. emergency physicians will perform the dvt ultrasound exam on study subjects with suspected dvt. clinical management of the study subjects will not be altered; all subjects will proceed to receive a formal dvt ultrasound study by the radiology department which will serve as the criterion reference for the study.


Eligibility criteria:
inclusion criteria: * inclusion criteria: 1. presenting signs and symptoms sufficiently suspicious for lower extremity dvt to warrant a formal radiology study in the opinion of the treating physician and either 2a. moderate or high pre-test clinical probability of dvt (wells criteria) or 2b. low pre-test clinical probability of dvt with a positive d-dimer exclusion criteria: * exclusion criteria: 1. documented lower extremity dvt within the past 60 days 2. anatomic abnormality that, in the judgment of the investigator, would preclude imaging of both femoral and popliteal veins on the affected leg (i.e. above-knee amputation or severe scarring from intravenous drug abuse in the inguinal area) 3. patient below the age of 18 years.

Keywords: deep venous thrombosis blood clot lower extremity sonography
open-label trial to check the safety and tolerability of rtx-grt7039 injections for pain associated with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: an open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of rtx-grt7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.

this trial comprises a total observation period of up to 78 weeks.

Eligibility criteria:
inclusion criteria: * the participant has given written informed consent to participate. * the participant is 18 years of age or older at the screening visit. * the participant has a diagnosis of osteoarthritis of the knee based on american college of rheumatology criteria and functional capacity class of i to iii. * there is a documented history indicating that participant has insufficient pain relief with previous standard of care. exclusion criteria: * the participant has past joint replacement surgery of the index knee. * the participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of screening. * the participant has periarticular pain at the index knee from any cause other than osteoarthritis, including referred pain, bursitis, tendonitis. * the participant has clinical hip osteoarthritis on the side of the index knee. * the participant has a history of osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, rapidly progressing osteoarthritis (rpoa) type i or type ii,pathologic fracture, primary or metastatic tumor, or joint infection in the index knee. * the participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus \>10°, valgus \>10°) by radiograph as assessed by independent central readers at screening visit. * the participant has other conditions that could affect trial endpoint assessments of the index knee. * the participant has current clinically significant disease(s) or condition(s) that may affect safety assessments, or any other reason which may preclude the participant's participation for the full duration of the trial. * the participant has a history of hypersensitivity to resiniferatoxin (rtx) or any similar component (capsaicin, chili peppers). * the participant is currently participating or was participating in another investigational drug trial within 3 months prior to the screening visit. * the participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator. the non-index knee is not eligible for treatment in the trial, if any of the knee-related exclusion criteria applies to the non-index knee.

Keywords: knee osteoarthritis pain assessment
reduction of anterior glenohumeral dislocation in ventral decubitus versus dorsal decubitus under procedural sedation

Conditions: Reduction; Emergencies; Anterior Shoulder Dislocation

Summary: the anterior glenohumeral dislocation is frequently encountered in emergency medicine. it represents about 50% of the total dislocation and affects 1 resident for 10 000 in france. in nord franche-comte hospital, 1 to 2 patients per day present this diagnosis in the emergency department, which requires reduction by external manoeuvres. a retrospective study shows the interest of the ventral decubitus compared to dorsal decubitus reduction in the care of patients with anterior glenohumeral dislocation. none prospective study has already demonstrate the interest of the ventral decubitus compared to the dorsal decubitus in the reduction of anterior glenohumeral dislocation. the main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.


Eligibility criteria:
inclusion criteria: * patients with radiological confirmed anterior glenohumeral dislocation * patient affiliated or entitled to a social security scheme * oral informed consent form exclusion criteria: * glenohumeral fracture or vasculoneural lesion associated * dislocation for more than 12 hours * homolateral shoulder surgery antecedent * contraindication to other analgesics (morphine, sedation) * bmi \> 40 * patient \< 18 year * pregnancy or nursing woment * person under guardianship or curatorship
electromyographic activity of masseter muscle during deglutition in total laryngectomized subjects

Conditions: Head and Neck Cancer

Summary: the objective of this study is to evaluate the electromyographic activity of masseter muscle during deglutition in laryngectomized subjects.


Eligibility criteria:
inclusion criteria: * laryngectomy exclusion criteria: * neurological diseases * no oral feeding

Keywords: electromyography laryngeal neoplasms masticatory muscles
sbrt versus ablation for perivascular hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this trial is a multi-center, phase iii, randomized (1:1) clinical trial. the aim is to explore the efficacy and safety of sbrt for perivascular hepatocellular carcinoma, compared with rfa.

the primary endpoint is 1-year local recurrence rate and disease-free survival. we planned to recruit 170 patients who diagnosed as perivascular hepatocellular carcinoma. the patients will be randomized into sbrt group and rfa group as 1:1 ratio.

Eligibility criteria:
inclusion criteria: 1. primary hepatocellular carcinoma or recurrent hepatocellular carcinoma after curative treatment. 2. unifocal tumor ≤5cm 3. closed to great vessels (diameter ≥3mm) 4. ecog score 0-1 5. child-pugh grade a or b7 6. sufficient liver and kidney function exclusion criteria: 1. vascular invasion 2. extra-hepatic metastasis 3. received tace before 4. inflammation of local skin 5. dysfunction of liver, kidney or bone marrow. 6. concomitant other malignant tumor or hiv infection
development of new diagnostic tools in capsule endoscopy

Conditions: Bowel Disease; Crohn Disease; Celiac Disease; Chronic Diarrhea; Tumor

Summary: patients participating to this study will provide images and videos of capsule endoscopy to train, tune and evaluate technological bricks of artificial intelligence solutions, in order to improve diagnostic performances of the procedure, while reducing reading time by physicians.

capsule endoscopy is a minimally-invasive diagnostic procedure based on the ingestion (or endoscopic delivery) of a miniaturized biocompatible, camera. capsules capture tenths of thousands images of the digestive tract. reading the captured images and reporting is long, tedious, and at risk of errors when the reader's attention is disturbed. artificial intelligence is expected to alleviate these limitations, by both improving diagnostic performances of capsule endoscopy while reducing reading time. any patient in whom a capsule endoscopy examination is performed as part of routine care will be invited to participate to the study. their de-identified images and videos will be extracted, thus allowing the creation of several databases for training, tuning and testing technological bricks of artificial intelligence. basic clinical data will be collected (age, gender, indication for capsule endoscopy, type of device, ingestion or delivery of capsule). images and videos will be characterized centrally and consensually by a panel of 3 expert readers, according to their level of relevance in relation to the type and indication of capsule endoscopy. the various, developed technological bricks will aim to automatically detect and characterize anatomical landmarks and abnormal findings, and to quote the intestine cleanliness. assessment of diagnostic performance and reading time will be performed within a few months or up to five years, for each technological brick, individually and then combined, according to their stepwise development.

Eligibility criteria:
inclusion criteria: - any patient in whom a capsule endoscopy examination is performed as part of routine care. exclusion criteria: - opposition to the use of images and videos from daily, routine care for research purposes.

Keywords: small bowel capsule endoscopy artificial intelligence
presenteeism in severe asthma treated by biotherapyasthma

Conditions: Asthma

Summary: severe asthma is a condition characterized by a lower sensitivity to high doses of inhaled corticosteroids combined with a second controller, most often a long-acting bronchodilator. it concerns approximately 5% of asthmatics. treatment failure and co-morbidities induced by systemic corticosteroid therapy can cause debilitating dyspnea, limited physical activity, and impaired quality of life. severe asthma could therefore be associated with major presenteeism, defined as the presence of an employee at work despite his health issues and which implies a limitation of the employee's productive capacity. uncontrolled asthma and co-morbidities of asthma have been shown to be associated with a decrease in work productivity that includes absenteeism and presenteeism. although there is little data, a recent study found a decline in work productivity in severe asthma. various factors associated with presenteeism could be involved, such as asthma control, frequency and severity of exacerbations, comorbidities, or treatments. biotherapies targeting the signaling pathways involved in airway inflammation improve asthma control, decrease the frequency of asthma exacerbations which are major determinants of quality of life, improve lung function, and allow oral steroid sparing. biotherapies could therefore be associated with a decrease in presenteeism. the objective of the study is to describe the evolution of presenteeism at work, evaluated by the wpai: asthma, after 6 months of treatment by biotherapy and to identify factors associated with this evolution


Eligibility criteria:
inclusion criteria: * severe asthma defined as the use of a high doses of inhaled corticosteroids combined with a second controller (gina 4) and / or oral corticosteroid therapy \> 50% of the year * eligible for biotherapy according to the investigator's decision * holders of an employment contract for at least 8 days * written non-opposition to participate in the study after information * social protection affiliation exclusion criteria: * existence of another chronic pulmonary disease (bronchiectasis, copd, diffuse interstitial lung disease, neuromuscular pathology, etc.) or cardiac (cardiac rhythm disorder, ischemic heart disease, etc.) significant according to the investigator's judgment * psychiatric disorder * pregnancy * persons under guardianship

Keywords: severe asthma presenteism asthma burden biotherapy quality of life
the effects of radium-223 dichloride therapy on radionuclide bone scan lesions.

Conditions: Bony Metastases From Castrate Refractory Prostate Cancer

Summary: to describe the changes seen on bone scan and correlate them with changes in relative chemical biomarkers, patient's functional status and level of pain.


Eligibility criteria:
inclusion criteria: * prostate cancer patients scheduled for treatment with radium-223. exclusion criteria: * patients not completing their treatment regimen for any reason
positron emission tomography (pet) imaging of cholesterol trafficking: clinical evaluation of [18f]fnp-59 in normal human subjects (group 1)

Conditions: Radiotracer; Hypertension; Cholesterol

Summary: this exploratory, first-in-man, phase 0 study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of np-59 (\[18f\]fnp-59) to image the adrenal gland in healthy normal subjects. the researchers believe that \[18f\]fnp-59 would greatly improve the imaging characteristics, by providing a pet imaging cholesterol analogue with significantly improved radiation dosimetry.

following the results of radiation dosimetry from this study then next steps will be taken for groups 2 \& 3 using hormone manipulation.

Eligibility criteria:
inclusion criteria: * participants without any known adrenal pathology as normal controls for radiation dosimetry purposes exclusion criteria: * pregnancy * unable to do imaging * body weight greater than 400 lbs (181 kg) * prisoners are not eligible * subjects unable to provide own consent are not eligible * current use of steroids, oral contraceptives (ocp), spironolactone, estrogen, androgen, progesterone, angiotensin-converting enzyme (ace inhibitors)/ angiotensin ii receptor blockers (arbs), or supplements that are hormone analogues. * known adrenal pathology
effectiveness of osteopathic manipulative treatment in pediatric asthma

Conditions: Asthma

Summary: asthma is a highly prevalent chronic disease in children. complementary and alternative medicine research on asthma showed a potential effect on pediatric patients. studies looking at the effect of osteopathic manipulative treatment seems to reveal positive results. the aim of study is to further explore the role of omt on asthma in a pediatric population.


Eligibility criteria:
inclusion criteria: * children with asthma age between 5 and 14 exclusion criteria: * associated co-morbities surgical patients

Keywords: pediatrics asthma osteopathic manipulative treatment
implementation and evaluation of bright futures curriculum within cornet continuity practice

Conditions: Dental Health; Iron Deficiency

Summary: the purpose of "bright futures" is to promote and improve infant, child, and adolescent health within the context of family and community. cornet (continuity research network of the ambulatory pediatric association) is a national practice-based research network of resident continuity practices, whose mission is to establish a self-sustaining collaborative research network among pediatric continuing clinic clinicians who will produce quality research in primary care, health care delivery, and education.

"bright futures" offers a child and family-centered approach to health promotion in incorporating partnership and communication skills of providers. two areas of importance are promotion of oral health and prevention of iron deficiency. residents will be randomized to one of these two groups and will receive web-based education about that particular topic. residents randomized to group 1 will receive training consisting of 7 modules: 3 on the bright futures concepts and 4 on oral health promotion. they will be trained in performing an oral health assessment, identifying caries, and encouraged to establish a dental home for patients. they must communicate with at least one dental practice in the community to determine barriers to care, issues regarding insurance, potential solutions to improve referral, and access to dental care. residents in group 2 will complete a single educational module on the identification and prevention of iron deficiency. they will be trained to identify iron deficiency and iron deficiency anemia, understand risk prevention strategies, improved methods of identification, and treatment. each resident will recruit 3 patients, children between the ages of 12-35 months, for whom he/she is the primary care provider. each parent-child dyad will participate in one well-child care visit. each visit will be observed by a faculty preceptor. this study design was chosen to compare a more sophisticated and time-intensive curriculum to a more modest one. by having a curriculum with minimal overlap between the two groups, the investigators hope to examine the knowledge obtained by the residents, which health promotion aspects they address during their encounters, and to compare the establishment of a dental home in the two groups of patients.

Eligibility criteria:
inclusion criteria: * children ages 12-35 months exclusion criteria: * none
safety, tolerability, pharmacokinetics, and pharmacodynamics of ionis-maptrx in patients with mild alzheimer's disease

Conditions: Mild Alzheimer's Disease

Summary: the purpose of this study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ionis-maptrx in patients with mild alzheimer's disease.

this was a randomized, double-blind, placebo-controlled study in 46 participants, followed by an open-label extension. this study consisted of two parts: part 1: a randomized, double-blind, placebo-controlled multiple ascending dose period in participants with mild alzheimer's disease, followed by part 2: the open-label, long-term extension period.

Eligibility criteria:
inclusion criteria for part 1: * males or females aged 50-74 years, inclusive, at the time of informed consent * diagnosed with mild alzheimers disease, including csf biomarkers consistent with this diagnosis * body mass index bmi ≥ 18 and ≤ 35 kg/m2 and total body weight \> 50 kg (110 lbs) * able and willing to meet all study requirements, including toleration for mri scans, blood draws and lumbar punctures, travel to study center and participation in all procedures and measurements at study visits * have a trial partner who is reliable, competent and at least 18 years of age, is willing to accompany the patient to select trial visits and to be available to the study center by phone if needed * reside within 4 hours travel of the study center exclusion criteria for part 1: * treatment with another study drug, biological agent, or device within one-month of screening or 5 half-lives of investigational agent, whichever is longer * clinically significant medical condition which would make the patient unsuitable for inclusion or could interfere with the patient participating in or completing the study * use of a disallowed cns-active or antipsychotic medication within 4 weeks prior to screening punctures inclusion criteria for part 2: * must have completed the treatment evaluation and post-treatment periods in part 1 exclusion criteria for part 2 (only applicable to participants in cohorts a and b, as participants from cohorts c and d will seamlessly transition to part 2): * treatment with another study drug, biological agent, or device within one-month of screening or 5 half-lives of investigational agent, whichever is longer * clinically significant medical condition which would make the patient unsuitable for inclusion or could interfere with the patient participating in or completing the study * use of a disallowed cns-active or antipsychotic medication within 4 weeks prior to screening punctures

Keywords: mild alzheimer's disease isis 814907 memory loss alzheimers mapt tau