Kornimate/medical-research-clean huggingface dataset:
a study of ly3209590 in participants with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the reason for this study is to see if the study drug ly3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus according to the world health organization (who) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (oam): * dipeptidyl peptidase-4 (dpp-4) inhibitors * sodium-glucose cotransporter (sglt-2) inhibitors * biguanides * alpha-glucosidase inhibitors * sulfonlyureas * hba1c value of 6.5% to 10%, inclusive * body mass index (bmi) between 20 and 45 kilograms per meter squared (kg/m2), inclusive exclusion criteria: * type 1 diabetes mellitus or latent autoimmune diabetes * any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening * any of the following cardiovascular (cv) conditions: acute myocardial infarction, new york heart association class iii or iv heart failure, or cerebrovascular accident (stroke) * acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease * estimated glomerular filtration rate (egfr) \<30 milliliters/minute/1.73 m2 * active or untreated malignancy * chronic (\>14 days) systemic glucocorticoid therapy
the effects of a 3-part skin care regimen on facial wrinkles and biophysical attributes

Conditions: Wrinkle

Summary: the purpose of this study is to analyze various cosmetic endpoints, subjective assessments, and skin parameters such as hydration, transepidermal water loss, fine lines, and wrinkles with the use of a 3-part skin care regimen.


Eligibility criteria:
inclusion criteria: * men and women between the ages of 35 years old and 65 years old. * must have facial fine lines and wrinkles. exclusion criteria: * individuals who are pregnant or breastfeeding. * prisoners * adults unable to consent * individuals who have changed any of their hormonal based contraception within 1 months prior to joining the study. * subjects using any topical retinoid, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment. * subjects with any cosmetic treatments in the past 6 months and who are unwilling to withhold facial cosmetic treatments during the study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (ipl), peels, laser treatments, acid treatments, tightening treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin. * current tobacco smoker or a tobacco smoking history of greater than 10 pack-years
embody insertional achilles tendinopathy

Conditions: Insertional Achilles Tendinopathy

Summary: the primary objective of this study is to evaluate the long-term effects on ankle/achilles tendon pain after repair of insertional achilles tendinopathy (iat) augmented with tapestry biointegrative implant.

this study is a prospective case series of patients who have had insertional achilles tendinopathy repair augmented with the tapestry biointegrative implant. the primary aim of the study is to describe patient reported pain 12 months after surgical repair with tapestry. the secondary aims are to assess the proportion of study subjects that experience treatment-related adverse events post-surgery, treatment related serious adverse events resulting in second surgical intervention, quality of life and other patient reported outcomes at all follow up timepoints post-surgery, and tissue thickness measured with mri at 6 months post-surgery.

Eligibility criteria:
inclusion criteria: * adult, 21 years and older; * insertional achilles tendonitis requiring surgery that has failed at least 2 weeks of conservative management, which consist of: 1. shoe modification; or 2. nonsteroidal anti-inflammatory drugs; or 3. physical therapy with/without modalities. * chronic achilles tendon pain lasting longer than 3 months; * mri of the ankle within 30 days prior to the study surgery; * ability and willingness to comply with prescribed post-operative rehabilitation program; * ability and willingness to comply with follow-up regimen; * able to understand the informed consent process, including regulatory requirements such as hipaa authorization, and document informed consent prior to completion of any study-related procedures; and * ability to read, understand, and complete subject-reported outcomes in english. exclusion criteria: * history of achilles tendon rupture; * previous achilles tendon surgery on the index ankle; * genetic collagen disease, hypersensitivity, or objection to using bovine-derived materials; * history of auto-immune or immunodeficiency disorders; * history of chronic inflammatory disorders; * oral steroid use in last 2 months or injectable steroid use in last 4 weeks; * history of heavy smoking (\> 1 pack per day) within last 6 months; * hypersensitivity to poly(d,l-lactide) materials; * metal implants, fillings, shrapnel, and/or screws; * females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study; * currently involved in any injury litigation or worker's compensation claims relating to the index ankle; * enrolled, or plans to enroll, in another clinical trial during this studythat would affect the outcomes of this study; or * history of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation.
switching regimen in treating cirrhotic hcv gt1b subjects

Conditions: Chronic Hepatitis C Infection

Summary: this is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from peg-interferon and ribavirin to direct-acting antiviral agents in chinese with chc genotype 1b infection, who are interferon/ribavirin-intolerant.


Eligibility criteria:
inclusion criteria: * individuals with chronic hcv gt1b infection; * hcv rna ≥ 10000 iu/ml at screening; * received 4 weeks pegylated interferon plus ribavirin (pr4) therapy and are intolerant to pr4; * cirrhosis determination; a liver biopsy may be required; * use of highly effective contraception methods if female of childbearing potential or sexually active male; exclusion criteria: * pregnant or nursing female or male with pregnant female partner; * hiv or hbv co-infection; * hematologic or biochemical parameters at screening outside the protocol- specified requirements; * active or recent history (≤ 1 year) of drug or alcohol abuse; * history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
proof-of-concept study evaluating the safety and efficacy of ebp921 in delta hepatitis (hdv)

Conditions: Hepatitis D

Summary: the purpose of this study is to assess the optimal dose of ebp921 by comparing the efficacy and safety of 2 dose regimens in patients with chronic hdv.

this is an open-label, phase 1b, proof-of-concept study to assess the safety and efficacy of ebp921, a prenylation inhibitor, in subjects chronically infected with delta hepatitis. subjects will be randomized to receive one of two different doses of ebp921. dosing will occur over 28-days and during that time, evidence of antiviral response will be assessed by frequent measurements of hdv-rna via pcr assay. in addition, safety lab data will also be collected along with surveillance monitoring of hbv activity.

Eligibility criteria:
inclusion criteria: 1. men and women age 18 or older with the capacity to give written informed consent 2. patients with compensated chronic hdv infection as indicated by presence of anti-hdv in serum. 3. liver biopsy should be performed within one-year of study screening and graded using the knodell scoring system. 4. presence of hdv antigen in liver tissue or hdv-rna in serum. 5. active hbv replication will not exclude patients. 6. previous therapy with standard alpha-interferon or peginterferon will not exclude patients. 7. patients who are hbv therapy-naïve or who previously received hbv antiviral therapy will be eligible. patients currently taking hbv antiviral therapy will e considered on a case basis. 8. female subjects of reproductive potential and female partners of male subjects should be on two reliable forms of contraception from the start of the study until 60 days from the end of ebp921 dosing. exclusion criteria: 1. severe neuropsychiatric disorders 2. history or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease 3. pregnant or breast-feeding patients or the inability to practice adequate contraception during the conduct of the study 4. underlying autoimmune/immune-deficiency disease (e.g., lupus, sarcoidosis, celiac disease, hiv antibody positive, aids) 5. chronic (\> 4 weeks duration) diarrhea 6. body weight \> 128 kg and \< 40 kg 7. uncompensated cirrhosis 8. absolute neutrophil count less than 1500 per cubic millimeter 9. platelet count less than 90,000 per cubic millimeter 10. evidence of concurrent hcv infection with positive serum hcvrna 11. evidence of hepatocellular carcinoma 12. active substance abuse (alcohol, inhaled or injected drugs) within the past 12 months 13. diagnosis of malignancy in the previous five years excluding superficial dermatologic malignancies 14. any experimental therapy in the previous 6 months prior to enrollment. 16. patients with a history of multiple drug resistant hbv 17. patients receiving interferon therapy for any reason.

Keywords: hepatitis d hdv hepatitis
the hemodynamic effects during sustained low-efficiency dialysis versus continuous veno-venous hemofiltration for patients with intracranial hypertension in a cross over study

Conditions: End- Stage Renal Disease Patients

Summary: hemodynamic instability occurs frequently during dialysis treatment and still remains as significant cause of patient mobility and mortality. postoperative hemodynamic optimization has been proved to reduce morbidity in high-risk patients. intracranial pressure increased can lead to further structural and functional impairment owing to its deleterious effect on the compromised microcirculation and metabolism. this study was to compare the intra-cerebral pressure (icp) and hemodynamic parameters between the sustained low-efficiency dialysis (sled) and continuous veno-venous hemofiltration (cvvh) in post- brain tramatic patients.

patients and methods this study was based on a clinical cohort study of the renal failure patients in the database of the national taiwan university surgical icu acute renal failure (nsarf) study group17-21, with the approval of the institutional review board of the national taiwan university hospital (201107015rc). study protocol the inclusion criteria were end stage renal disease (esrd) patients with increased icp status post icp monitor insertion. we started the study after the hemodynamic stable and acceptable icp less than 20mmhg22. the esrd patients with active brain hemorrhage, cardiac arrhythmia during dialysis, residual urine output, with inotropic equivalent more than 15 were excluded. all the patients were ventilated in supine position in controlled-volume mode after stable from brain hemorrhage. during data collection, supportive therapies, ventilatory settings and vasopressor therapy were kept unchanged. patients were randomized to receive cvvh or sled and the next day on the other. the icp monitor was equipped and the indwelling radial artery catheter connected to the flotrac/vigileo hemodynamic monitoring system and for whom the ultrafiltration rate was set around 1.0 kg/8hr to 1.5 kg/8hr according to fluid status. ultrafiltration rate and sodium concentration were fixed during each session. clinical assessment the biochemical parameters were measured using the toshiba tba-200fr clinical chemistry analyzer (toshiba, tochigi-ken, japan). when multiple daily measurements were performed, the data obtained closest to 8:00 am were analyzed 23. the baseline hemodynamic was defined as average of two hours prior dialysis in each dialysis sessions.

Eligibility criteria:
inclusion criteria: * end-stage kidney disease with anuria status post icp monitor insertion received exclusion criteria: * acute dialysis patients * end-stage kidney disease with uria

Keywords: sustained low-efficiency dialysis; continuous venovenous hemofiltration; hemodynamic stability, intracranial pressure
perception of physical exertion in healthy weight and obese adolescents

Conditions: Physiological Response to Exercise; Perception of Exercise Difficulty

Summary: little is known regarding the relationship between perceived and physiological exertion in adolescents. the purpose of this study is to investigate the association between physiological and perceptual markers of effort during exercise and the relationship of these markers to other health-related behaviors in healthy weight and obese adolescents.


Eligibility criteria:
inclusion criteria: * healthy weight (\>5th-85th bmi percentile) or obese (\>95th bmi percentile) * male and female adolescents, 13-18 years * approval to participate in a submaximal and maximal treadmill test received from the adolescent's pediatrician. exclusion criteria: * underweight (\<5th bmi percentile) * overweight (85 - \<95th bmi percentile) * evidence/reporting of significant cardiovascular disease, cardiac arrhythmias, liver disease, or the chronic use of medications including diuretics, steroids and adrenergic-stimulating agents. * adolescents with emotional problems such as clinical depression or other diagnosed psychological condition and currently use prescription medication for psychological conditions. * approval to participate in a submaximal and maximal treadmill test from the adolescent's pediatrician not obtained
evaluate efficacy and safety of xelox in potentially resectable liver metastasis from colorectal cancer(crc)

Conditions: Potentially Resectable Liver Metastasis From CRC; Colorectal Cancer

Summary: this is a single arm, open-label phase ii study to evaluate the efficacy and safety of capecitabine plus oxaliplatin (xelox) in the peri-operative treatment of patients with potentially resectable liver metastasis from colorectal cancer.

to investigate the progression free survival (pfs) advantage of xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer

Eligibility criteria:
inclusion criteria: * age of 18 and 65 * histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis * potentially curable by resection, as determined by a surgeon with hepatic surgery expertise * no evidence of extrahepatic disease by chest x-ray or ct scan of the chest, abdomen, and pelvis * patients with adequate hepative, renal and bone marrow function * signed written informed consent exclusion criteria: * pregnant or nursing patients (fertile patients must use effective contraception) * other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix * preexisting grade 2 or greater peripheral neuropathy * concurrent uncontrolled illness * ongoing or active infection * psychiatric illness or social situation that would preclude study compliance * less than 6 months since prior adjuvant fluorouracil-based chemotherapy * prior chemotherapy for liver metastasis * prior oxaliplatin for colorectal cancer * prior or concurrent hepatic artery infusion chemotherapy for metastatic disease * prior or concurrent radiotherapy for metastatic disease * prior or concurrent radiofrequency ablation for metastatic disease * concurrent treatment with any other anti-cancer therapy.

Keywords: xelox potentially resectable liver metastasis from crc
effects of vns on rt-induced inflammation and prognosis of patients with nsclc

Conditions: Lung Cancer, Non-small Cell

Summary: lung cancer (lc) remains a leading cause of death among cancers worldwide. though radiotherapy is one of the most frequently used treatments, it increases side-effects (pain, fatigue) and inflammation, possibly leading to further tumorigenesis of surviving cancer cells. the purpose of this study is to test the effects of transcutaneous auricular vns vagal nerve stimulation (tavns), known to reduce inflammation, on radiotherapy-induced inflammation and other side-effects in lc patients undergoing radiotherapy. in this feasibility study 12 patients with nsclc stage iii (a/b) receiving radiotherapy will be enrolled. our primary endpoint is the effect of vagus nerve stimulation (vns) on inflammatory levels (such as crp and cytokines), immunological factors (neutrophils, monocytes, lymphocytes) and the tumor marker cea. our secondary endpoint is the psychological well-being and quality of life of the patients during their radiotherapy treatment.


Eligibility criteria:
inclusion criteria: * patients \>18 years old * patients with non-small cell lung cancer stage iii (a or b) * patients receiving radiotherapy or chemoradiotherapy * patients with an hrv \< 70 msec exclusion criteria: * patients with an active implantable medical device, such as a pacemaker, hearing aid implant or any other implanted electronic device * patients with an implanted or wearable defibrillator. * patients with myocardial disease * patients with arrhythmias * patients with an implanted metallic or electronic device in their head. * pregnant or breastfeeding women
probiotics in the treatment of irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: some evidences have shown that probiotics are effective in the treatment of irritable bowel syndrome. because few evidences are available in our population, we investigated if probiotics are effective in our patients as well. we hypothesize that the probiotic lactol which contains lactobacillus sporogenes reduces the symptoms of irritable bowel syndrome.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 * diagnosis of ibs based on the rome iii criteria * willingness to participate exclusion criteria: * receiving other probiotics compound during the study * receiving antibiotics during the study

Keywords: irritable bowel syndrome functional gastrointestinal disorders gut flora probiotics
advanced eeg technology in childhood epilepsy

Conditions: Epilepsy in Children; Sleep Disorder

Summary: a lot of effort has already been put into the development of smaller, wearable and more user-friendly devices to monitor seizures in patients with epilepsy. the investigators hypothesize that a wearable eeg ( in combination with additional non-eeg biosignals (motion, ecg, emg, respiration, temperature,...) derived from byteflies sensor dot and new medical patches (plug 'n patch system), will be able to objectively detect epileptic seizures and monitor sleep in the hospital and home environment for specific types of childhood epilepsy. the accuracy of seizure detection and sleep monitoring by the wearable miniature eeg device in combination with other (autonomic) biosignals (full pnp system) will be compared with the golden standard video-eeg and seizure and sleep diaries filled-out by the participants.

the objective of the study will be the following: 1. multimodal seizure detection evaluation of data quality and seizure annotation accuracy. comparison of data derived from the multimodal wearable device (sensor dot in combination with plug and patch system) versus video eeg and seizure diary in childhood epilepsy syndromes with * tonic seizures * atonic seizures * myoclonic seizures during wakefulness and during sleep 2. sleep monitoring assessment of sleep data quality, latency, sleep fragmentation and time spent in different sleep stages in different childhood epilepsy syndromes. investigation of the influence of occuring seizures on sleep architecture. comparison of data wearable device (byteflies sensor dot in combination with plug and patch system) versus video-eeg and sleep diary in childhood epilepsy syndromes.

Eligibility criteria:
inclusion criteria: * childhood epilepsy with tonic, atonic or myoclonic seizures * parental informed consent and assent of the child if applicable * parent or caregiver can keep a seizure and sleep diary reliably. exclusion criteria * inability to provide written informed consent by parent or caregiver. * known allergy to electrodes or medical adhesives used as part of the study protocol. * having an implanted device, such as (but not limited to) a pacemaker, icd, vns because sensor dot contains magnets that could interfere with the operation of these devices. * any other condition or finding that would compromise the safety of the participant or the quality of the study data, or otherwise interfere with achieving the study objectives, as determined by the investigator or research coordinator.
knee replacement outcome predicted by physiotherapists

Conditions: Total Knee Replacement; Osteoarthritis

Summary: the aim is to assess if physiotherapists attending inpatients at elective orthopaedic wards can predict the future course (post hospitalisation) of recovery of patients undergoing ka. the prediction is made at hospital discharge using a 1-10 numerical rating scale (1=poor prognosis; 10=best prognosis). to identify candidate prognostic factors, the therapist are asked to qualify their prognosis narratively, by listing at least 3-5 factors that they consider important for their projected prognosis score. there will be no maximum number of factors the physiotherapist can list.


Eligibility criteria:
inclusion criteria: 1. received primary knee replacement surgery for knee oa 2. age ≥ 18 years 3. reads and speaks danish 4. has an email address 5. signed informed consent exclusion criteria: 1. cognitive impairments that preclude reliable answers to online questionnaires (e.g. dementia) 2. revision surgery
methotrexate-inadequate response study

Conditions: Rheumatoid Arthritis (RA)

Summary: the purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects who are considered methotrexate inadequate responders * 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count) exclusion criteria: * subjects who failed one or multiple anti-tumor necrosis factor (tnf) therapies * subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous) * subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules) * subjects with severe chronic or recurrent bacterial infections * subjects who have received treatment with rituximab an anti-tnf failure sub-study was initiated (recruited separately from main study) using the same treatment as the main study in order to assess the immunogenicity and safety in the anti-tnf failure population. the sub-study terminated due to low recruitment and participants were permitted to roll into the lt open label period.