Kornimate/medical-research-clean huggingface dataset:
the effect of linagliptin on inflammation, oxidative stress and insulin resistance in obese type 2 diabetes subjects

Conditions: Type 2 Diabetes

Summary: this is a single center, prospective randomized double blind, parallel and placebo controlled study to evaluate oxidative stress and inflammation before and after treatment with linagliptin for 12 weeks. we will also, testing whether linagliptin is an insulin sensitizer.

this is a single center, prospective randomized double blind, parallel and placebo-controlled study to evaluate oxidative stress and inflammation before and after treatment with linagliptin for 12 weeks. the study enrolls type 2 patients with diabetes.

Eligibility criteria:
inclusion criteria: age 20-80 years inclusive. type 2 diabetes bmi ≥30 kg/m2 subjects on statins, ace inhibitors, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the course of study. hba1c ≤ 8.0% exclusion criteria: - use of glp-1 agonists or dpp-iv therapy in the last 3 months. history of pancreatitis. risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and hypertriglyceridemia. subjects who are taking antiplatelet or anticoagulant medications will be excluded from the fat biopsy portion of the study. coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks hepatic disease (liver function tests more than 3 times the upper limit of normal) renal impairment (serum egfr \ 160/100 mm of hg) congestive heart failure class iii or iv. use of an investigational agent or therapeutic regimen within 30 days of study participation in any other concurrent clinical trial
assess the pharmacokinetics of rosuvastatin and simvastatin when administered alone or in combination with fostamatinib

Conditions: Rheumatoid Arthritis

Summary: a study to assess the pharmacokinetics of rosuvastatin and simvastatin when administered alone or in combination with fostamatinib.

an open-label, non-randomized, 2-period, fixed sequence, single-center study to assess the pharmacokinetics of rosuvastatin and simvastatin in healthy subjects when administered alone and in combination with fostamatinib 100 mg twice daily.

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent, prior to any study-specific procedures * volunteers will be males or females aged 18 to 55 years and with a weight of at least 50 kg and body mass index (bmi) between 18 and 30 kg/m2, inclusive. * male volunteers should be willing to use barrier contraception, ie, condoms, from the day of first dosing until 2 weeks after the last dosing with ip. * females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, and must be of non childbearing potential, confirmed at screening . exclusion criteria: * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study. * history or presence of gi, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of ip as judged by the investigator. * any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the investigator. * any clinically significant abnormal findings in vital signs as judged by the investigator

Keywords: fostamatinib, simvastatin, rosuvastatin, phase i, healthy subjects, pharmacokinetics
study to measure the effect of part time versus full time orthodontic appliance wear

Conditions: Class II Division 1 Malocclusion

Summary: the aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring following wear of a twin block functional appliance (removable brace which postures the lower jaw forward to improve a discrepancy between the upper and lower jaw) for differing time periods.

functional appliances are ordinarily worn full time in adolescence between 11 and 14 years with a discrepancy between their upper and lower jaws. the reason it is worn between these ages is to avail of the pre pubertal growth spurt, evidence for full time wear is merely empirical.if this appliance only had to be worn part time it would have a significant change in orthodontics in terms of patient acceptance and compliance.the investigators plan on recruiting 84 patients to the study and these subjects will be referred from hospital colleagues. the investigators will randomly allocate the subjects into 2 groups, group 1 will wear the appliance full time(24hours), group 2 will wear the appliance part time(12hours). the study will be conducted in the dental institute at the royal london hospital, this hospital setting will be the sole site. the study will last for 15 months from the time the last patient is recruited. participants will undergo an initial records appointment where a radiograph and clinical measurements will be taken followed by 12 months of functional appliance treatment where the patient will be reviewed at 6-8weekly intervals and clinical measurements taken.a final radiograph will be taken at 15months.

Eligibility criteria:
inclusion criteria: * class ii div 1 malocclusion(upper front teeth lying more forward than lower front teeth with upper front teeth proclined), * overjet(horizontal difference between upper and lower front teeth) measuring minimum of 7mm, * male subjects 12--14 years at the start of treatment, * female subjects 11--13 years at start of treatment, * willingness of the patient and parent to participate in the study. exclusion criteria: * no previous orthodontic treatment * no relevant medical history or craniofacial syndrome
pilot program to improve statin adherence and lower cholesterol in older adults

Conditions: Hypercholesterolemia; Medication Adherence

Summary: the purpose of this study is to pilot test a behavioral medication adherence (ma) intervention compared to control condition in older adults with low adherence to medication for hypercholesterolemia.

this study will answer the following primary research question: 1. what is the estimated effect size of a behavioral ma intervention on ma rates in older adults who are poorly adherent to statin medications? the study will also explore the following secondary research questions: 2. what is the estimated effect size of a behavioral ma intervention on low-density lipoprotein cholesterol (ldl-c) levels in older adults? 3. what is the estimated effect size of a behavioral ma intervention on high-density lipoprotein cholesterol (hdl-c) levels in older adults? 4. what is the feasibility of successfully testing this intervention protocol in a population of older adults with low adherence to statin medications?

Eligibility criteria:
inclusion criteria: * age 60 or older at the time of study entry, * take a once-daily prescription statin medication for ≥ 6 months with no changes to statin prescription for at least 30 days prior to study entry, * a score of ≤ 9 on the short blessed test, * participants must self-administer his or her own medications without prompts from any other person or device. * baseline medication adherence rate of ≤ 90%. * participants agree to complete all study contacts and measurements, including the use of a special medication bottle with a medication event monitoring system (mems) cap for the duration of the study. * able to open and close mems caps. exclusion criteria: * participant's medications are managed by someone other than the participant * participant is unable or unwilling to use mems caps.
effect of esketamine on perioperative negative mood in patients undergoing cardiac valve surgery

Conditions: Depression, Anxiety; Cardiac Surgery; S-ketamine

Summary: a multicenter, randomized controlled, blinded prospective study to investigate the effects of esketamine on perioperative anxiety and depression in patients undergoing cardiac valve surgery.

undergoing surgery can be a traumatic and painful experience for patients, often causing negative moods such as anxiety and depression. the size and type of surgery significantly impact the occurrence of anxiety and depression in patients. approximately one-third of patients after cardiac surgery experience anxiety or depression, which increases the risk of recurrent cardiovascular events and death. ketamine is an anesthetic drug with comprehensive effects, including analgesia, sedation, and amnesia. its primary mechanism of action is blocking n-methyl-d-aspartate (nmda) receptors. esketamine, the pure dextro isomer of ketamine, has a higher affinity for glutamate nmda receptors and opioid receptors, offering stronger sedative, analgesic, and antidepressant effects. on march 4, 2019, esketamine was approved by the fda for treatment-resistant depression. given its analgesic, anesthetic, and antidepressant effects, esketamine may be an ideal drug for improving negative moods in patients undergoing cardiac surgery.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old, male or female 2. patients undergoing heart valve surgery 3. patients with asa grade 1 to 4 4. bmi between 18-30 kg/m² 5. able to participate in neuropsychological testing and receive follow-up visits 6. clearly understand and voluntarily agree to participate in the study and sign the informed consent form exclusion criteria: 1. patients with significant preoperative neuro-psychiatric disease and cognitive impairment 2. intellectual disability or a minimental state examination (mmse) score \&lt;24, or a speech disorder that may compromise their ability to undergo preoperative assessments 3. history of psychoactive drug abuse 5. preoperative combined severe hepatic insufficiency or renal insufficiency 6. any contraindications to ketamine or esketamine, such as refractory hypertension or hyperthyroidism
short-term anti-plaque effect of cymenol mouthwash analysed using dentius deep plaque software

Conditions: Healthy; Dental Plaque

Summary: the objective of this project was to investigate the short-term in situ anti-plaque effect of cymenol, using the dentius deep plaque software


Eligibility criteria:
inclusion criteria were as follows: * systemically healthy volunteers * age between 20-45 years * presence of minimum of 24 permanent teeth * no evidence of gingivitis or periodontitis (cpitn= 0) * no presence of untreated caries at the start of the study. exclusion criteria were as follows: * smoker or ex-smoker * presence of dentures or orthodontic appliances * antibiotic treatment in the last 3 months or routine use of oral antiseptics
segwaypd: the effect of sensory-augmented postural training using segway on motor and cognitive function in individuals with parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this study is to examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control in individuals with pd. this project is a proof-of-concept study to assess the effectiveness of postural training using segway, which serves a platform to provide augmented and continuous proprioceptive and visuospatial information during postural training.

the purpose of this study is to examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control in individuals with pd (parkinson's disease). this project is a proof-of-concept study to assess the effectiveness of postural training using segway, which serves a platform to provide augmented and continuous proprioceptive and visuospatial information during postural training. specifically, we will measure postural sway during quiet standing, single and dual-task walking performances, and brain activation during single and dual-task walking from the regions involved in planning and execution of locomotion; these include dorsolateral prefrontal cortex, premotor cortex and primary motor cortex. the changes in visuospatial function and proprioception after training will also be assessed. individuals with moderate disease stage of pd exhibiting postural instability will be recruited. the participants will receive 1-week training and be assessed at 3 time points: 1-week before, before, and after the training.

Eligibility criteria:
inclusion criteria: * a clinical diagnosis of idiopathic pd with moderate disease stage presenting balance alterations (hoehn and yahr stage iii) * being stable on medication for at least 1 month * the ability to stand and walk unsupported for 5 min both on and off medication * age between 50 and 85 exclusion criteria: * neurological disorders other than pd * major unstable medical illnesses * sensory or musculoskeletal disorders (e.g., diabetes, uncorrected visual problems, arthritis, severe hearing impairments) that will prohibit the ability to perform the assessment tests and receive training
assessment of quality of life after low anterior resection during cytoreductive surgery for advanced ovarian cancer

Conditions: Ovarian Cancer; Low Anterior Resection Syndrome; Quality of Life

Summary: this study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

in advanced ovarian cancer, 24-64% of patients require removal of tumors located in the rectum and sigmoid colon. in order to remove the tumor located in the rectum and sigmoid colon, low anterior resection (lar) is performed to excise the rectum and sigmoid colon. all patients who underwent low anterior resection are at risk of developing low anterior resection syndrome, which presents symptoms such as frequent bowel movements, frequent defecation, and impaired stool control. therefore, this study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

Eligibility criteria:
inclusion criteria: * those with newly diagnosed ovarian cancer, fallopian tube cancer and primary peritoneal carcinomatosis who plan to undergo cytoreductive surgery and secondary cytoreductive surgery after neoadjuvant chemotherapy. * patients with pcds or rectal and sigmoid coloni tumor invasion suspected on the preoperative image and need resection of the tumor and clinical figo stage iiib or higher * ecog performance status : 0-2 * age over 18 exclusion criteria: * patient who underwent low anterior resection in the past * past history of gastrointestinal malignant tumor except to ovarian cancer * patient who have colostomy * patient who underwent radiation therapy to abdominal or pelvic cavity * ecog performance status over 3 * patient taking opioid analgesics * patient who have intellectual disability or dementia
comfort associated with the use of eyelid cleansing products available for the management of demodex folliculorum

Conditions: Dry Eye

Summary: this aim of this study to quantify the subjective ocular awareness of different eyelid cleansing wipes available for the management of demodex folliculorum.


Eligibility criteria:
inclusion criteria: 1. is between the ages of 18 to 60 and has the full legal capacity to volunteer; 2. has read and signed an informed consent letter; 3. agrees to refrain from the use of ocular lubricants during the study period; 4. agrees to not to use eye-related cosmetics for upcoming study visits 5. is willing to use the study products 6. is willing and able to follow instructions regarding study procedures and maintain the appointment schedule; 7. has corneal sensitivity within physiological limits. exclusion criteria: 1. is participating in any concurrent clinical or research study; 2. is a contact lens wearer (due to reduced corneal sensitivity); 3. has any known active\* ocular disease and/or infection; including moderate and severe dry eye (osdi ≥ 23); 4. has a systemic (such as diabetes, thyroid disease, rheumatoid arthritis) or ocular condition (such as glaucoma) that in the opinion of the investigator may affect a study outcome variable; 5. is using any systemic or topical medications (such as glaucoma drops, antibiotics, anti-inflammatory) that in the opinion of the investigator may affect a study outcome variable; 6. has known sensitivity to the diagnostic pharmaceuticals to be used in the study (such as fluorescein dye to highlight structures of the eye and used regularly in optometric practice) and study products in this study; 7. is pregnant, lactating or planning a pregnancy at the time of enrolment; (due to the possibility of fluctuating vision as a consequence of variation in hormone levels);8 8. has undergone refractive error surgery (e.g. lasik, prk); 9. is a smoker (as smoking reduces tear film stability) \* for the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye (ocular surface disease index, osdi\<23/100) are not considered active ocular disease. neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
a post market clinical follow-up study with the anexys cup

Conditions: Arthroplasty, Replacement, Hip

Summary: the purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the anexys cup. the data will be used for an ongoing evaluation of the product safety and performance.

prospective observational multicenter case series providing short-term migration results and long-term post-market clinical data on the safety and performance of the anexys cup. the study includes patients undergoing primary total hip arthroplasty. in total 100 patients in 3 clinics will be included. in each clinic 10-57 consecutive patients shall be included. in addition, to meet the regulatory requirements, a total of minimum 20 cases with screw fixation shall be included in the study. clinical and radiological follow-up (fu) is planned after 6-12 weeks, 6 months, 1, 2, 5, 7 and 10 years. an additional fu at 3 years is planned to apply for an odep (orthopaedic data evaluation panel) rating.

Eligibility criteria:
inclusion criteria: * informed consent form (signed by participant and investigator) * primary implantation * suffer from primary or secondary osteoarthritis of the hip, femoral head and neck fractures or necrosis of the femoral head. in all cases a stable anchoring of the implant has to be possible. * age at inclusion: between 18 and 75 years old * willing to participate in the follow-up examinations * complete recovery is expected exclusion criteria: * missing informed consent form (signed by participant and investigator) * known or suspected non-compliance (e.g. drug or alcohol abuse) * enrolment of the investigator, his/her family, employees and other dependent persons * patients younger 18 years old * revision surgery * presence of sepsis or malignant tumours * asa (american society of anesthesiologists) classification \>3 * pregnancy

Keywords: primary osteoarthritis secondary osteoarthritis femoral head fracture necrosis
long-term immunogenicity of a live herpes zoster vaccine in systemic lupus erythematosus (sle) patients

Conditions: Lupus Erythematosus

Summary: a recent randomized controlled trial (rct) from our group has demonstrated safety and immune response (both humoral and cell-mediated) of the live-attenuated herpes zoster (hz) vaccine (zostavax) in stable systemic lupus erythematosus (sle) patients with a previous history of hz or varicella infection. an important research question is whether the immunogenicity of the hz vaccine in sle patients is long-lasting. there is no information in the literature regarding the long-term immunogenicity and safety of zostavax in sle patients. this prompts the current extension study which is planned to evaluate the long-term immunogenicity and efficacy of zostavax in our original patient cohort.

a recent rct from our group has demonstrated safety and immune response (both humoral and cell-mediated) of the live-attenuated zostavax in stable sle patients with a previous history of hz or varicella infection. an important research question is whether the immunogenicity of the hz vaccine in sle patients is long-lasting. there is no information in the literature regarding the long-term immunogenicity and safety of the hz vaccine, zostavax, in sle patients. patients who had completed the original rct and had been followed for 5 years since hz vaccination or placebo injection were invited to participate in this extension study. blood samples will be taken for a repeat assessment of the humoral and cell-mediated response to vzv at 5 years. outcomes of interest primary outcome difference between the two groups in the proportion of patients who have a persistent and 50% increase in igg to vzv (humoral response to zostavax) at 5 years compared to baseline secondary outcomes 1. difference between the two groups in the cell-mediated response to zostavax at 4 years as compared to baseline 2. vaccine efficacy - difference in the rate of clinical hz reactivation between two groups of patients at 5 years 3. vaccine safety - difference between the two groups in terms of sle flares and new autoimmune phenomena at 5 years

Eligibility criteria:
inclusion criteria: 1. sle patients who fulfill ≥4 of the 1997 acr or the 2012 slicc/acr criteria for sle or healthy controls who had participated in the original rct 2. age ≥18 years 3. having completed the original rct of hz vaccine vs placebo 4. having been followed for 5 years since hz vaccination or placebo injection 5. willing to comply with all study procedures exclusion criteria: 1. patients who refuse to participate in this long-term extension study 2. patients in the placebo group who have subsequently received hz vaccination 3. patients who cannot give a written consent (mentally incapable or illiterate)

Keywords: herpes zoster vaccine lupus