Kornimate/medical-research-clean huggingface dataset:
neo-tace-haic for pvtt-hcc

Conditions: Hepatocellular Carcinoma; Portal Vein Thrombosis

Summary: hepatocellular carcinoma (hcc) patients is a common disease in the east asia. during the disease course, 20%-50% patients suffered portal vein tumor thrombus (pvtt), which is characterized with poor outcome and low response for treatments. although bclc (barcelona clinical liver cancer) system recommend to palliative targeted treatment, the east asian countries recommend to resection or transartery chemoembolization (tace). recently, folfox (oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (haic) exhibited high response rate for advanced hcc. pilot study showed tace combined haic (tace-haic) had better tumor response, with low progression disease rate. whether tace-haic would improve survival for patients with pvtt is need to further to study. a randomized clinical trial compared neo-tace-haic with surgery versus surgery alone is aimed to answer this question.


Eligibility criteria:
inclusion criteria: * age 18-75 years; * patients with resectable primary hepatocellular carcinoma and portal vein tumor thrombus, which was not located in main portal vein; * child-pugh a or b (7 score) liver function; * with more than 3 months expected survival; * the volume of residual liver more than 30% exclusion criteria: * patients with primary hepatocellular carcinoma and major portal vein tumor thrombus * with extrahepatic metastasis or unresectable hcc * pregnant woman or sucking period; * with other malignant cancer; * received chemotherapy, target therapy or immunosuppressive drugs therapy before this study.
overcoming barriers and obstacles to adopting diabetes devices

Conditions: Type 1 Diabetes

Summary: this study will create a comprehensive, multicomponent behavioral intervention package (onboard; overcoming barriers \& obstacles to adopting diabetes devices). onboard will provide adults with type 1 diabetes (t1d) the skills to maximize benefit and minimize daily interference from barriers associated with continuous glucose monitoring (cgm) and increase readiness for closed loop.

the proposed research will create and refine the onboard intervention for cgm use. participants will be tracked using metrics of a1c, time in glucose target range, number of days using cgm, blood glucose (bg) downloads, diabetes problem solving, diabetes distress, and technology attitudes. the investigators will examine whether onboard leads to improved diabetes and psychosocial outcomes and sustained cgm use. at the end of this study, the investigators will have created and refined a comprehensive, multicomponent intervention package to promote increased and sustained uptake of cgm and increase readiness for closed loop adoption.

Eligibility criteria:
inclusion criteria: 1. subject is age 18-50 years at time of screening 2. subject is within first year of continuous glucose monitor use or has not been using cgm regularly in the past 6 months 3. subject has a clinical diagnosis of type 1 diabetes 4. subject comprehends spoken and written english exclusion criteria: 1. subject has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol. 2. subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol.
metabolomic analysis of lung cancer

Conditions: Carcinoma, Non-Small Cell Lung; Carcinoma, Small Cell Lung

Summary: the purpose of this study is to learn more about the metabolic properties of lung cancer cells.

it has long been known that cancer cells absorb and break down substances in the body differently than healthy, non-cancer cells. this process of absorbing and breaking down substances is known as metabolism and is increased in cancer cells. recent research suggests that this increased metabolic activity makes it easier for cancer cells to multiply. the objective of the study is to characterize the metabolism of glucose by lung tumors by serum metabolite analysis, using a variant of glucose (sugar) which makes up 1% of glucose in nature.

Eligibility criteria:
lung cancer patients (groups 1 \& 2) inclusion criteria: * patients with suspected, clinically diagnosed, or histologically diagnosed lung cancer. occasionally, other cancers (including metastatic cancers to the lung) may be resected for the study as negative controls for nsclc, as warranted by the particulars of the case. * patients must have general medical conditions to allow them to undergo surgical resection of their primary tumor exclusion criteria: * history of diabetes for the experimental group (surgery + glucose); patients with a history of diabetes are allowed in the control group (surgery/no glucose) * known hepatitis c or hiv (aids) healthy subjects (group 3) inclusion criteria: * at least 30 years of age * preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment exclusion criteria: * prior history of diagnosed lung cancer * known hepatitis c or hiv (aids)

Keywords: lung cancer non-small cell lung cancer small cell lung cancer cancer metabolism
carbon: uab cardiovascular research biobank

Conditions: Natriuretic Peptides; Cardiovascular Diseases; Hypertension; Diabetes; Obesity

Summary: the uab cardiovascular research biobank (carbon) will be a resource that contains biological materials, such as dna samples, in addition to health and personal information on a large number of people over time. it will be set up so that it can be used in the future as a resource for researchers undertaking a wide range of medical research.

the uab cardiovascular research biobank (carbon) will be a resource that contains pertinent genetic, health, and biological samples such as blood derived from a large-scale population. researchers may use disease correlates and predictors identified from the genetic, health, and personal information contained in the biobank as a resource to investigate cardiovascular disease, hypertension, diabetes, and a myriad of other disorders. through these studies, researchers may identify the progression of risk factors in certain diseases and help develop novel strategies to detect, treat, or prevent such diseases. in addition, the biobank serves as a valuable tool to assess how certain treatments may respond differently to individuals as a result of genotypic differences. the investigators have demonstrated that lower natriuretic peptide (np) levels are associated with a decreased insulin sensitivity and have a causal role in the development of diabetes and have also shown that certain populations, such as african americans, have relatively low np levels, which may contribute to their underlying risk for insulin resistance. since nps play an important role in the regulation of insulin sensitivity, one can infer that relatively low np levels are an important biological contributor to the high prevalence rates of cardiometabolic disease in african americans. the biobank will contain genetic information concerning the presence of gene variants that encode nps.

Eligibility criteria:
inclusion criteria: * age more than or equal to 18 exclusion criteria: * age \<18, at screening * employees or students associated with the division of cardiovascular disease at uab will not be recruited due to their vulnerable status and susceptibility to coercion. * women who are pregnant or who can become pregnant and not practicing an acceptable method of birth control.

Keywords: natriuretic peptides cardiovascular diseases hypertension diabetes obesity
to evaluate drug-drug interactions between hec585 and pirfenidone or nintedanib in healthy volunteers

Conditions: Idiopathic Pulmonary Fibrosis

Summary: an open label study to evaluate drug-drug interactions between hec585 and pirfenidone or nintedanib in healthy volunteers


Eligibility criteria:
inclusion criteria: - subjects who are willing and are able to provide a written informed consent to participate in the study. without plann for pregnancy or pregnant within 3 months after enrollment throughout the trial. subjects aged between 18 and 45 (both inclusive) years old. healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female in the first part of the trial) and body mass index ≥19 and ≤28 kg/m2 at screening. subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, chest x-ray and 12-lead electrocardiogram. exclusion criteria: * subjects with a positive serology for hiv antibodies, hbsag, hcv antibodies and/or tp antibodies at screening. subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, reproductive system; and/or thyroid disease or previous thyroid surgery, malignant tumor, metabolic disorder or others medical conditions that are not suitable for clinical trial participation. patients with photosensitivity and/or other skin diseases. bleeding or thrombosis risk. allergic. use of any prescription or non-prescription medications within 14 days prior to initial dosing，use of any medications known to inhibit or induce cytochrome p enzyme drug metabolism within 28 days prior to initial dosing. consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. positive results from urine drug screen test. history of alcoholism or drink regularly within 3 months prior to the study. positive for urine cotinine or smoked within 1 month before administration of study drug in the first part，regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug in the second part. donate blood or lose blood 400 ml or more within 1 month prior to initial dosing. subjects who plan to receive or have had organ transplants. females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential. subjects who participated in another clinical trial and have taken other study drugs within 3 months prior to initial dosing. any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
sar3419 administered weekly in patients with relapsed/refractory cd19-positive b-cell non-hodgkin's lymphoma

Conditions: Lymphoma; Non-Hodgkin

Summary: the primary objective is to determine the maximum tolerated dose (mtd) of sar3419 according to the dose limiting toxicities (dlts) observed when administered as a single agent once weekly. secondary objectives are: * to characterize the global safety profile * to evaluate the pharmacokinetic (pk) profile of sar3419 in the proposed dosing schedule * to assess preliminary evidence of anti-lymphoma activity.


Eligibility criteria:
inclusion criteria: * diagnosis of b-cell non hodgkin's lymphoma * relapsed or refractory after standard treatments and with no curative option with conventional therapy (patients having undergone stem cell transplantation may be included) * cd19 positive disease by flow cytometry or immunohistochemistry exclusion criteria: * burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia (small lymphocytic lymphoma may be included) * evidence of cerebral or meningeal involvement by lymphoma * patients without bi-dimensionally measurable disease * ecog performance status \> 2 * life expectancy less than 3 months * chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study * previous radioimmunotherapy within 12 weeks * known anaphylaxis to infused proteins * hiv, hbv and hcv positivity * poor kidney, liver and bone marrow functions * any serious active disease or co-morbid condition, which, in the opinion of the principle investigator, will interfere with the safety or the compliance with the study * pregnant or breast-feeding women * patients with reproductive potential without effective birth control methods the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: b-cell lymphoma nhl
firazyr general drug use-results survey (japan)

Conditions: Hereditary Angioedema (HAE)

Summary: the objectives of this survey are to collect data to report the safety and efficacy of firazyr (icatibant acetate) in the post-marketing phase in participants diagnosed with hereditary angioedema (hae).


Eligibility criteria:
inclusion criteria: * hereditary angioedema (hae) participants in japan who receive firazyr for first time in the real world clinical setting. exclusion criteria
arthroscopic bankart repair with and without remplissage in anterior shoulder instability

Conditions: Other Instability, Shoulder; Hill-Sachs Lesion

Summary: the purpose of this prospective, randomized, controlled trial is to compare subjective patient-reported outcomes and objective clinical results between arthroscopic bankart repair with and without arthroscopic infraspinatus remplissage in patients with anterior shoulder instability with a hill-sachs defect.

significant osseous defects of the glenohumeral joint can often lead to failure of arthroscopic shoulder stabilization procedures. the best treatment in the setting of shoulder instability with significant glenoid and/or humeral defects remains controversial. several open procedures have been suggested, but arthroscopic methods have started to garner some attention in the literature. in patients with an engaging hill-sachs lesion without significant glenoid bone loss, arthroscopic remplissage consisting of arthroscopic posterior capsulodesis and infraspinatus tenodesis to fill the hill-sachs lesion has been proposed as a novel treatment method. the authors believe it is scientifically necessary to investigate the role of addition of arthroscopic infraspinatus remplissage to the conventional arthroscopic bankart repair. as more surgeons are trained in the technique, it will be performed more frequently. increased patient awareness continues to lead to increasing demand for minimally invasive approaches. arthroscopic remplissage brings with it an increase in operative time, with a theorized risk of reduction in dislocation risk. for these reasons, the authors believe that it is scientifically and fiscally necessary to determine the difference in outcome between arthroscopic bankart repair with and without arthroscopic infraspinatus remplissage for patients with anterior shoulder instability and a hill-sachs defect in the framework of a prospective, randomized controlled study.

Eligibility criteria:
inclusion criteria: * 14 years or older * must have anterior shoulder instability and hill-sachs defect * must have anterior instability with any engaging hill sachs lesion on ct scan, mri or ultrasound and no more than 15% glenoid bone loss exclusion criteria: * glenoid defect \>15% of ap diameter of glenoid * significant shoulder comorbidities (i.e, oa, previous surgery other than previous instability) * active joint or systemic infection * significant muscle paralysis * rotator cuff or charcot's arthropathy * significant medical comorbidity that may alter effectiveness of surgical intervention * major medical illness * unable to speak french or english * psychiatric illness that precludes informed consent * unwilling to be followed for 2 years

Keywords: bankart repair remplissage hill-sachs defect shoulder instability anterior shoulder instability
fdopa-pet/mri for the pre-operative evaluation of gliomas

Conditions: Glioma; Malignant Glioma

Summary: this is a pilot study designed to evaluate the potential of using fdopa-pet/mri for improving surgical planning and providing non-invasive prognostic information in patients with gliomas that have substantial non-enhancing regions. the results will be used to develop larger adequately powered studies.


Eligibility criteria:
inclusion criteria: * known or suspected diagnosis of intracranial glioma with substantial non-enhancing regions as assessed by contrast enhanced mri. for the purposes of this study, gliomas with substantial non-enhancing regions are defined as having contrast-enhancing volumes of less than 50% of the total estimated tumor volume. gliomas that do not have any contrast-enhancing regions are eligible for this study. * standard of care surgical resection and/or stereotactic biopsy of the brain tumor planned within 2 weeks of the fdopa-pet/mri study. * at least 18 years of age. * measurable disease on mri defined as tumor measuring at least 1 cm in two perpendicular dimensions. * karnofsky performance of \> 50 corresponding to ecog categories 0, 1, or 2. patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. * creatinine clearance or radioisotope glomerular filtration rate (gfr) \> 30 ml/min/1.73 m\^2 * patient or legally authorized representative must be able to understand and willing to sign a written informed consent document. exclusion criteria: * patients undergoing pet/mri: contraindication to gadolinium contrast enhanced brain mri (i.e., allergy to gadolinium contrast, mri-incompatible implantable devices, gfr \< 30 ml/min/1.73, and severe claustrophobia). at the discretion of the responsible physician, fdopa-pet/ct may be performed if pet/mri is contraindicated or unavailable. if fdopa-pet/ct is performed, the patient must have undergone a contrast-enhanced mri for fusion with fdopa-pet no more than 4 weeks before the fdopa-pet/ct. * prior chemotherapy or radiation therapy for the brain tumor. prior biopsy or surgical resection of the glioma without additional therapy is not an exclusion criterion. * pregnant and/or breastfeeding. women of childbearing potential must have a negative urine or serum pregnancy test no more than 3 days prior to fdopa injection.
long-term assessment of the safety and performance of the nuvasive simplify disc at two levels

Conditions: Cervical Disc Disease; Degenerative Disc Disease

Summary: a prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the simplify disc at two levels in subjects who were enrolled in the ide study (nct03123549) and/or post approval study (nct04980378).


Eligibility criteria:
inclusion criteria: 1. subject was enrolled in the simplify disc ide (nct03123549) and/or pas (nct04980378) at a participating study site 2. patient understands the conditions of enrollment and is willing sign an informed consent form to participate in the study exclusion criteria: 1. subject had an ssi at the index level during the ide study (nct03123549) or the pas (nct04980378) 2. subject was withdrawn or withdrew consent to participate in the ide study (nct03123549) or pas (nct04980378)
shock wave therapy versus mechanical traction on mechanical low back pain

Conditions: Mechanical Low Back Pain

Summary: investigate the effect of shock wave therapy versus mechanical traction on mechanical low back pain.

chronic low back pain (clbp) is a common condition that causes tremendous health and socio-economic problems. clbp is a widespread problem. about 70%-80% of adults in the general population are expected to suffer at least a low back pain episode at some time in their lives1. clbp is the leading cause of absenteeism at work and creates restrictions on movements, lasting disabilities, and impaired quality of life. non-specific low back pain is described as low back discomfort, which cannot be attributed to a distinct, known etiology "(e.g., infection, tumors, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome)" 2. non-specific low back pain is a mechanical musculoskeletal pain that has a symptom that varies according to the physical activity nature 3. the practice of sitting with a healthy posture and preventing a protracted-standing position can often prevent simple low back pain. however, many kinds of low back pain are addressed with therapies as numerous as the causes of low back pain. the most important treatments are therapeutic measures, such as bed rest, assistive aids, traction therapy, heat, electrical stimulation, and manual therapy are the first choice treatments4. if these methods fails, invasive therapy procedures like nerve roots blocks and epidural injections are employed, and operations are carried out when no reaction to other treatments has been seen or if the disease status is critical. new conservative therapies, including extracorporeal shock wave therapy (eswt), have recently been embraced 5.

Eligibility criteria:
inclusion criteria: * age between (20 and 35 years) * all subjects suffered from mechanical low back pain exclusion criteria: * rheumatoid arthritis or backbone pathologies, and past lumbar vertebrae surgery or cancer were reported
pet-ct based radiotherapy in esophageal cancer patients

Conditions: Esophageal Neoplasms

Summary: the purpose of this study is to determine the locoregional control in pet/ct based radiotherapy treatment planning in the treatment of esophageal cancer patients.

the purpose of this study is to determine the locoregional control in pet/ct based radiotherapy treatment planning in the treatment of esophageal cancer patients

Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus * local curable disease able to undergo chemoradiotherapy. exclusion criteria: * metastasized disease. * previous or concurrent malignancies.

Keywords: esophageal cancer pet-ct planning
the association between restricted ankle joint dorsiflexion and dynamic knee valgus

Conditions: Knee Injuries; Ankle Injuries and Disorders; Movement, Abnormal; Adolescent Development

Summary: the purpose of this study was to analyze if a low ankle dorsiflexion range is associate with dynamic knee valgus in youth basketball players.

cross-sectional study. ankle dorsiflexion range of motion was assessed by the weight-bearing lunge test and the dynamic knee valgus by the single leg squat test. the participants were basketball players who belonged to youth basketball de-velopmental teams in the under-12 (u12), under-14 (u14), under-16 (u16) and under-17 (u17) categories. all participants were recruited by means of simple random sampling from the catalan basketball federation during the 2018-2019 season. the participants were classified according to gender and age as stipulated by the rules determined an-nually for the respective official competitions. the study was carried out in the facilities of each club. the inclusion criteria were being age \>12 and ≤17 at testing and actively competing during the study. subjects were excluded if they had sustained any type of injury in the lower limbs before screening; presented any injury (overuse or acute) at the time of testing; if they had any oncological, psychological and/or psychiatric illnesses; or if they did not attend on the day of the assessment.

Eligibility criteria:
inclusion criteria: * being age \>12 and ≤17 at testing and actively competing during the study exclusion criteria: * subjects were excluded if they had sustained any type of injury in the lower limbs before screening; presented any injury (overuse or acute) at the time of testing; if they had any oncological, psychological and/or psychiatric illnesses; or if they did not attend on the day of the assessment.

Keywords: basketball adolescent knee valgus range of motion ankle