Kornimate/medical-research-clean huggingface dataset:
role of (lmwh) in prevention of thromboembolic complication after (tace) in hepatocellular carcinoma.

Conditions: HCC

Summary: hepatocellular carcinoma (hcc) is a major health problem worldwide, and most cases are inoperable because of late presentation and underlying cirrhosis. it represents the fifth most common tumor in the world and the third most frequent cause of mortality amongst patients with cancer. due to the worldwide difficulties in finding liver for transplantation, hepatic resection (hr) represents the main stay of curative treatment for patients with hcc. transcatheter arterial chemoembolization (tace) is widely used as alternative treatments for unresectable hcc or for patients not eligible to be operated on . tace also could be an adjuvant therapy for resectable hcc patients after hepatectomy, which could prevent recurrence and improve long-term survival .

thromboembolism is a well-recognised complication of malignant disease. clinical manifestations vary from venous thromboembolism to disseminated intravascular coagulation and arterial embolism. disseminated intravascular coagulation is most commonly observed in patients with haematological malignant disorders and those with wide spread metastatic cancer, whereas arterial embolism is most commonly observed in patients undergoing chemotherapy and in those with non-bacterial thrombotic endocarditis . the goals of using antithrombotic therapy with tace in hcc are to minimize mortality and to improve survival rate without provoking excessive bleeding.

Eligibility criteria:
inclusion criteria: * hcc which was not amenable to surgical resection, liver transplantation or local ablative therapy. * the lesion had not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation. * reasonable performance status as adequate hematologic function; adequate hepatic function and adequate renal function. * child-pugh class a or b and no portal vein thrombosis. exclusion criteria: * child c patients portal vein thrombosis
tdcs for the management of chronic visceral pain in patients with chronic pancreatitis

Conditions: Chronic Pancreatitis; Pain

Summary: this study is testing whether the addition of a noninvasive form of brain stimulation called transcranial direct current stimulation (tdcs) when combined with meditation helps decrease the abdominal pain in patients with chronic pancreatitis. the device involved in this study, transcranial direct current stimulation (tdcs) is investigational. this means that the study device is still being tested in research studies and is not approved by the food and drug administration \[fda\].

this is a double-blind, pilot study with the goal of testing the effects of tdcs coupled with meditation in the management of visceral pain in patients with chronic pancreatitis. we will enroll a total of 14 subjects with chronic pancreatitis. after enrollment, subjects will be randomized to active stimulation plus mediation (7 subjects) or sham stimulation plus meditation (7 subjects). subjects will undergo 5 days of active tdcs stimulation plus meditation or sham tdcs plus meditation. sessions will last approximately 30 min - 1 hour. eeg activity will be measured in the first, last and follow-up visits. after each stimulation session, we will assess for adverse effects using the tdcs adverse effects questionnaire. we will also have the subject fill out a pain/medication diary during the 5 days of treatment. all study procedures will be completed at bidmc.

Eligibility criteria:
inclusion criteria: 1. provide informed consent to participate in the study 2. 18 years old 3. if taking pain medications, stable doses are required for at least 1 month prior to initiation of the study exclusion criteria: 1. history of alcohol or substance abuse within the last 6 months as self-reported 2. suffering from severe depression (with a score of \>30 in the beck depression inventory) 3. diagnosis of any neurological diseases (such as epilepsy) 4. episodes of seizures within the last 6 months 5. unexplained loss of consciousness 6. use of carbamazepine or neuropsychotropic drugs 7. have had no neurosurgery as self reported 8. contraindications to tdcs 1. metal in the head 2. implanted brain medical devices 9. pregnant at time of enrollment 10. previous experience with meditation

Keywords: abdominal pain pancreatitis chronic abdominal pain visceral pain meditation tdcs noninvasive brain stimulation eeg kirtan kriya
phase 2 study of ambrisentan for liver function test rescue in pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: this phase 2 study was to determine the incidence of increased serum aminotransferase concentrations (alanine aminotransferase \[alt\] and/or aspartate aminotransferase \[ast\]), as well as the overall safety and tolerability of ambrisentan, in participants with pulmonary arterial hypertension (pah), idiopathic pah (ipah), or familial pah (fpah) who had previously discontinued era therapy (bosentan or sitaxsentan) due to increased serum alt or ast concentrations.


Eligibility criteria:
summary of inclusion criteria: * males and females between 12 and 75 years of age * current diagnosis of ipah, fpah, or pah associated with collagen vascular disease, congenital systemic-to-pulmonary shunts, anorexigen use, hiv infection * must have previously discontinued bosentan or sitaxsentan therapy due to serum aminotransferase (alt and/or ast) concentrations \> 3 x uln * must have normal (\< 1 x uln) serum alt and ast concentrations at screening * six-minute walk distance of at least 150 meters at screening * if receiving sildenafil or a clinically approved prostanoid for pah, must have been on stable therapy for at least 4 weeks prior to screening * subjects with a diagnosis of hiv must have stable disease status during the screening period
comparison of an artificial intelligence-assisted rehabilitation program for shoulder musculoskeletal disorders and the clinical decision making of therapists

Conditions: Shoulder Musculoskeletal Disorders; Rehabilitation Programs; Machine Learning

Summary: people with shoulder musculoskeletal disorders among middle-aged and older adults have the highest need of rehabilitation services. the population growth and aging society subsequently increase the number of disabled people, the healthcare costs and the needs for healthcare professionals. the evidence exists to support the beneficial effect of exercises on function and quality of life. traditionally, a rehabilitation program is designed by therapists for each patient depending on their conditions. in recent years, ai is increasingly being employed in the field of physical and rehabilitation medicine, however, there is no study of applying ai in predicting rehabilitation programs for shoulder musculoskeletal disorders. the main purpose of this study is to explore the possibilities of using supervised machine learning approach to predict rehabilitation programs for shoulder musculoskeletal disorders. twenty-three features are identified based on shoulder range of motion, pain, whether or not perform surgical procedure. each exercise is considered as a label with a total of twenty-five exercises. dataset is collected by clinical therapists to develop and train the model. each patient has to receive at least two months of rehabilitation and two times of evaluation. logistic regression, support vector machine and random forest are used to build the computational model. accuracy, precision, recall, f-1 score and auc are used to evaluate the performance of the computational model in machine learning. after training, we compare the consistency of rehabilitation programs predicted by using machine learning model and the clinical decision making of therapists.


Eligibility criteria:
inclusion criteria: 1. the international classification of diseases, 10th revision (icd-10) codes were selected before the study started and included the icd-10 codes m75 (shoulder lesions), s42 (fracture of shoulder and upper arm), s43 (dislocation and sprain of joints and ligaments of shoulder girdle), and s46 (injury of muscle, fascia and tendon at shoulder and upper arm level) 2. patients who need rehabilitation after undergoing surgical procedure and are able to perform stretch, active assistive range of motion (aarom) or supervised active range of motion (arom) 3. between 20-80 years old 4. are able to follow motor commands exclusion criteria: 1. patients with central and peripheral nervous system disease, such as cerebrovascular accident (cva), parkinson's disease (pd), myasthenia gravis (mg), poliomyelitis 2. patients who had shoulder contusion, vascular injury, severe crush injury and amputation
intervention effects of intensity and delivery style for toddlers with autism

Conditions: Autism Spectrum Disorder

Summary: a multi-site randomized study of intensive treatment for toddlers with autism involving a three-site collaborative network plus a data coordinating center to evaluate the effects of intervention intensity and intervention style delivered for 12 months, on the progress of very young children with asd ages 12-30 months old and their families, and the effect of children's developmental rates and autism severity on their response to intervention.

high quality, intensive early intervention is a powerful treatment for asd, improving iq and language markedly in randomized controlled clinical trials (rcts), though little long term follow-up data exists. few core characteristics that affect child change have been tested. two potential core characteristics that invoke considerable debate among parents, professionals, and administrators are the delivery style of intervention: play-based versus discrete trial teaching, and the intensity (dosage) of intervention. this ace treatment network conducted an rcts to answer the following question: what are the effects of intensity and delivery style on developmental progress of toddlers with asd? 87 young children with asd, mean age 23.4 months who live within a specified radius near the university at each site were enrolled in one of three national sites and randomized into one of four cells varying on two dimensions: dosage - 15 or 25 hours per week of 1:1 treatment; and discrete trial teaching or naturalistic developmental-behavioral intervention. other aspects of intervention held constant were: use of the principles of applied behavior analysis, 1:1 adult:child ratios, parent coaching in the assigned treatment, and treatment location. developmental progress was measured frequently allowing for growth curve analysis to examine fine-grained differences in groups as well as interactions among major child and family initial variables and these two experimental variables.

Eligibility criteria:
inclusion criteria: * 12-30 months of age at time of assessment; * ambulatory and without impairments affecting hand use; * meets criteria for autistic spectrum disorder on the apa diagnostic and statistical manual, 5th revision criteria and on the autism diagnostic observation schedule for toddlers: * clinical consensus of asd diagnosis by 2 independent staff (including a licensed psychologist) based on observation as well as record review; * developmental quotient of \>35 on mullen scales of early learning; * normal hearing and vision screen; * caregiver agreement to comply with all project requirements, including regular videotaping at home with provided equipment. exclusion criteria: * english not a primary language spoken at home; * absence at 2 or more appointments without prior notice during the intake assessment; * more than 10 hours per week of 1:1 aba based treatment; * other health or genetic conditions (i.e. fragile x syndrome, seizures, prematurity).

Keywords: autism autism spectrum disorder intensive intervention early intervention early start denver model
burnout preventions, professionalism heightening, and enhancing resiliency (bupher)

Conditions: Professional-Patient Relations; Burnout, Professional

Summary: due to their difficult and stressful work surgeons are under continuous physical and mental stress exposing them to increased risk for burnout and lack of professionalism. the present intervention focuses on providing time and a safe space to debrief and explore personal and group experiences and dilemmas, as well as acquire coping skills related to burnout, communication and professionalism.


Eligibility criteria:
inclusion criteria: * all physicians (residents and experts) of the surgical division at tel aviv sourasky medical center. * all medical students studying at the sackler faculty of medicine, tel aviv university, and attending a surgery round at the surgical division at tel aviv sourasky medical center. * patients (and/or family members) in the surgical division at tel aviv sourasky medical center following their surgery. exclusion criteria: * the research will not include children and/or judgment-impaired patients; * population not met by inclusion criteria; * non-hebrew speaking patients; * ventilated patients; * patients in surgical intensive care; * patients medically defined as suffering from clouding of conscious or delirium; * subjects who decided to stop their participation in the study.

Keywords: professionalism burnout prevention resiliency student education
effect of intra-operative glove-changing during cesarean section on post-op complications: a randomized controlled trial

Conditions: Wound Complications

Summary: a randomized controlled trial to determine whether changing of gloves by the surgical team during cesarean section may decrease post-operative infectious morbidity and wound complications

this was a randomized, single-blind controlled trial of women who underwent cesarean section at healthpartners regions hospital. potential participants were identified during routine obstetrical care of singleton pregnancies at regions hospital, at the time that cesarean section was decided as the route of delivery by patient and provider. patients were excluded if the cesarean section was performed emergently. randomization occurred in the operating room during preparation for cesarean section; nursing staff drew a computer generated allocation card from a stack placed within an envelope in the room. patients assigned to the control group underwent cesarean section with standard surgical technique at the discretion of the attending surgeon. patients assigned to the glove change group underwent cesarean section in which the surgical team - surgeon, assistant, and scrub nurse - replaced their outer surgical gloves with a new sterile pair of gloves prior to abdominal closure. abdominal closure was considered to begin with closure of the peritoneum, if performed, otherwise with closure of the abdominal fascia.

Eligibility criteria:
inclusion criteria: * pregnant woman with singleton pregnancy and shared decision making with provider resulting in plan for cesarean section exclusion criteria: * severe immunocompromise (aids) or emergent nature of cesarean section
open label trial on the safety and efficacy of sym001 in the treatment of immune thrombocytopenic purpura (itp)

Conditions: Immune Thrombocytopenic Purpura

Summary: this trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label trial evaluating the safety and efficacy of sym001 in 4-9 consecutive cohorts. subjects will receive a single iv dose of sym001.


Eligibility criteria:
inclusion criteria: * confirmed presence of thrombocytopenia with platelet count \< 30,000/mm3 at the pre-dose visit. * history of isolated itp * rhd-positive serology. * previous treatment and response to first line therapy for itp exclusion criteria: * known clinical picture suggestive of other causes of thrombocytopenia, especially systematic lupus erythematosus,antiphospholipid syndrome, evans syndrome, immunodeficiency states, lymphoproliferative disorders, liver disease,ingestion of drugs such as quinidine/quinine, heparin and sulfonamides and hereditary thrombocytopenia confirmed by relevant laboratory findings. * suspected infection with hiv, hepatitis c, h. pylori. * clinical splenomegaly * history of abnormal bone marrow examination. * ongoing haemorrhage corresponding to a grade 3 or 4 on the who bleeding scale. * underlying haemolytic condition * history of splenectomy. * subject is pregnant, breast feeding or intends to become pregnant.

Keywords: idiopathic itp
safety and efficacy of empagliflozin for patients with diabetes mellitus and planned percutaneous coronary interventions

Conditions: Coronary Artery Disease; Diabetes Mellitus; Percutaneous Coronary Intervention

Summary: aim: to study the effectiveness and safety of empagliflozin as a preoperative preparation tool, as well as to improve the long-term prognosis of planned percutaneous coronary interventions in patients with type 2 diabetes

patients with type 2 diabetes will be randomized into 2 groups using the envelope method. one group will receive empagliflozin 10 mg 1 month before planned percutaneous coronary interventions and for 12 months thereafter in addition to previously taken hypoglycemic therapy. patients of the second group will continue to take previously prescribed hypoglycemic therapy. thus, the safety and effectiveness of empagliflozin for preoperative preparation of patients with type 2 diabetes before planned percutaneous coronary interventions will be evaluated, as well as the impact on the immediate and long-term outcomes of percutaneous coronary interventions in comparison with patients on standard hypoglycemic therapy

Eligibility criteria:
inclusion criteria: * signed inform concent * stable coronary artery disease * planned percutaneous coronary intervention * diabetes mellitus exclusion criteria: * previously performed coronary revascularization * glomerular filtration rate less than 45 ml/min * intolerance to empagliflozin * serum potassium more than 5/5 mmol/l * heart failure (nyha iii-iv) * congenital heart disease * acute coronary syndrome less than 3 months before enrollment

Keywords: stable coronary artery disease empagliflozin
phase i/ii follow-up study of sar422459 in patients with stargardt's macular degeneration

Conditions: Stargardt's Disease

Summary: primary objective: to evaluate the long-term safety and tolerability of sar422459 in patients with stargardt's macular degeneration. secondary objective: to assess: * safety * biological activity

patients will be followed for 15 years after completion/early termination from the previous tdu13583 study (nct01367444). as the initial tdu13583 study is terminated - recruitment to this lts13588 study is over with 27 patients enrolled.

Eligibility criteria:
inclusion criteria: patients must meet all of the following criteria: 1. provide signed and dated written informed consent and any locally required authorization (e.g., health insurance portability and accountability act \[hipaa\]) 2. must have been enrolled in protocol tdu13583 (sg1/001/10) 3. must have received a subretinal injection of sar422459 4. must have completed protocol tdu13583 to week 48 or undergone an early discontinuation visit. exclusion criteria: the following would exclude patients from participation in the study: 1. did not receive sar422459 as part of the tdu13583 protocol.
improving the appearance of skin and hair in patients undergoing valley fever treatment

Conditions: Valley Fever; Coccidioidomycosis

Summary: this will be a multi-visit study that will take approximately 3 hours in total. up to 200 subjects from the bumc valley fever and bumc dermatology clinics will be enrolled in this study and assigned to one of three cohorts according to timeline of oral anti-fungal therapy. subjects in cohort 1 will be randomized to apply topical cholesterol-containing moisturizers to the skin, hair and lips on either the right or left side of the body daily. measurements of skin barrier function, appearance of skin and hair, and hair samples will be obtained at baseline and at 4 week follow-up visits. cohorts 2 and 3 will be observational groups at differing points in oral antifungal treatment regimen. subjects will be randomized to have measurements of skin barrier function and hair and skin characteristics obtained from either the right or left side of the body at baseline and at monthly follow-up visits.

coccidioidomycosis, also known as valley fever, is a fungal condition most commonly seen in arizona and can affect multiple organs, including the skin, lung, bone, joints, and central nervous system. oral antifungal therapy such as fluconazole is the first-line medication to treat coccidioidomycosis. through the investigator's clinical observations at the valley fever center for excellence, nearly all patients who have been placed on systemic azole treatment show some extent of cosmetic changes in their skin and hair, such as dry skin, chapped lips, hair loss, and change in hair characteristics. the goals of the study are to 1) understand the cosmetic changes in the skin and hair in patients initiating and discontinuing long-term oral antifungals, and 2) to examine whether cholesterol-based commercially-available moisturizers for the skin and for the hair can improve the cosmetic appearance better than a vehicle without these cholesterol ingredients.

Eligibility criteria:
inclusion criteria: * men and women, age 18 or older * patients who have been diagnosed with coccidioidomycosis (valley fever) requiring oral anti-fungal medications such as but not limited to fluconazoles * able to comprehend and read the english language exclusion criteria: * subject does not fit inclusion criteria * children younger than 18 years of age * pregnant women * prisoners or those that are cognitively impaired * those with known allergies or intolerance to ingredients in the topical formulations * subject is unwilling or unable to comply with study procedures * unable to read or comprehend english

Keywords: valley fever coccidioidomycosis
efficacy, safety and tolerability of two fixed dose combinations of aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo for 28-weeks treatment in patients with moderate to severe, stable chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this phase iii study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe chronic obstructive pulmonary disease (copd). long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. this extension study will include a 28 week treatment period, followed by a four week follow up visit. all patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.


Eligibility criteria:
inclusion criteria: * completion of the treatment phase of the lead-in study, lac-md-31 * written informed consent obtained from the patient before the initiation of any study specific procedures * no medical contraindication as judged by the pi * compliance with lac-md-31 study procedures and ip dosing. exclusion criteria: * no specific exclusion criteria

Keywords: copd chronic obstructive pulmonary disease chronic bronchitis emphysema airflow obstruction, chronic chronic airflow obstruction chronic obstructive airway disease chronic obstructive lung disease