Kornimate/medical-research-clean huggingface dataset:
volatile anaesthesia and perioperative outcomes related to cancer feasibility study

Conditions: Cancer, Breast; Cancer Colorectal; Cancer Prostate; Cancer, Lung; Cancer Melanoma Skin; Cancer, Other

Summary: a multicentre, prospective randomized, active-controlled feasibility trial of volatile-based anaesthesia vs. propofol-based total intravenous anaesthesia to investigate the impact of anaesthesia on long-term (i.e. 5-years) patient cancer outcomes in patients undergoing elective major cancer surgery.

this study aims to assess the feasibility of conducting a phase iv, multi-centre, single-blinded, randomized control trial (vapor-c (main)). primary aims to measure the ability to recruit eligible patients into the study. to measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol.

Eligibility criteria:
inclusion criteria: * male or female * age 18-80 years * elective surgery * major cancer surgery expecting to last two or more hours, for: * breast (mastectomy or segmentectomy plus sentinel node dissection) * colorectal * lung * prostate * melanoma (excision of melanoma plus lymph node dissection and/or skin flap construction * other major cancer surgeries (e.g. oesophagectomy, head and neck cancer, etc.) exclusion criteria * palliative surgery for end-stage disease with no curative intent * emergency surgery * extensive comorbid disease, i.e. american society of anesthesiologists (asa) score \> 4 * age \ 80 years old * refusal or inability to provide valid informed consent * risk of severe postoperative nausea and vomiting (ponv risk score \>3) * previous allergy or contraindication to either anaesthetic medication * indication for gas induction of anaesthesia * currently enrolled in another clinical trial unless agreed by the coordinating principal investigator and site principal investigator that co-enrolment can occur.

Keywords: major surgeries lasting >2 hours
the effects of spasticity on glucose metabolism in individuals with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: muscle atrophy may occur in individuals with spinal cord injury (sci) as a result of diminished physical activity and alterations in glucose metabolism and body composition may be seen. in a few studies, it has been suggested that spasticity may have a positive impact on glucose metabolism by preventing muscle atrophy and alterations in body composition in individuals with motor complete sci. investigators aimed to assess the effects of spasticity on glucose metabolism and body composition in participants with complete and incomplete sci.

investigators plan a prospective clinical trial. participants with sci were included to study if times from injury were at least one year. participants had an ais grades of a-d with spasticity. we evaluated that participants with ais a and b sci were motor complete group, ais c and d sci were motor incomplete group. spasticity was assessed with modified ashworth scale (mas) and spasms were assessed with penn spasm frequency scale (psfs). hip adductor and extensor spasticity, knee extensor and flexor spasticity and ankle plantar flexor spasticity were assessed by using mas. body composition was measured by dual-energy x-ray absorptiometry. all participants underwent a 75 gram (g) oral glucose tolerance test (ogtt). insulin sensitivity was assessed by calculating matsuda index and homa-ir. investigators assessed the effects of spasticity on glucose metabolism and body composition in participants with sci.

Eligibility criteria:
inclusion criteria: • spinal cord injury ais a,b,c,d exclusion criteria: * other central nervous system diseases * significant complications that affect spasticity * joint contracture * diabetes mellitus

Keywords: body composition glucose spasticity spinal cord injury
perioperative epidural trial (poet) pilot study

Conditions: Post Operative Pain Control

Summary: to investigate if the use of perioperative neuraxial blockade reduces post-operative mortality and cardiorespiratory events compared to intraoperative general anesthesia and postoperative iv narcotic analgesia. this is a feasibility study to determine if recruitment and execution of the protocol could be done in a timely manner in a much larger trial


Eligibility criteria:
inclusion criteria: subjects at high risk of cardio-respiratory complications post operatively. exclusion criteria: contraindication to epidural anesthesia

Keywords: analgesia anesthesia
assessing the association between multi-dimension facial characteristics and coronary artery diseases

Conditions: Coronary Artery Disease

Summary: the purposes of this study are 1) to explore the association between multi-dimension facial characteristics and the increased risk of coronary artery diseases (cad); 2) to evaluate the diagnostic efficacy of multi-dimension appearance factors for coronary artery diseases.

previous study demonstrated the feasibility of using deep learning to detect coronary artery disease based on facial photos. however, several limitations made the algorithm hard to be utilized in clinical practice, including low specificity and lack of external validation. adding multi-dimension facial characteristics may further increase the algorithm effect. thus, the investigators designed a single-center, cross-sectional study to explore the association between multi-dimension facial characteristics and cad and to evaluate the predictive efficacy of multi-dimension appearance factors for cad. the investigators will recruit patients undergoing coronary angiography or coronary computer tomography angiography. patients' baseline information and multi-dimension facial images will be collected. the investigators will train and validate a deep learning algorithm based on multi-dimension facial photos.

Eligibility criteria:
inclusion criteria: * undergoing coronary angiography or coronary computer tomography angiography * written informed consent exclusion criteria: * prior percutaneous coronary intervention (pci) * prior coronary artery bypass graft (cabg) * screening coronary artery disease before treating other heart diseases * without blood biochemistry outcome * with artificially facial alteration (i.e. cosmetic surgery, facial trauma or make-up) * other situations which make patients fail to be photographed

Keywords: artificial intelligence facial characteristics
trial of nanodoce intratumoral injection in renal cell carcinoma

Conditions: Renal Cell Carcinoma; Kidney Cancer; Adenocarcinoma of Kidney; Adenocarcinoma, Renal; Renal Cell Cancer

Summary: this study evaluates the use of nanodoce injected directly into tumors in the kidney of people with renal cell carcinoma.

nanodoce is very small (submicron) particles of the chemotherapy drug, docetaxel, which is administered intravenously in a number of types of cancer. these submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. in this study, the submicron particle docetaxel will be injected directly into tumors in the kidney of people with renal cell carcinoma that is localized to (has not spread beyond) the kidney. all subjects in this study will receive nanodoce and will be evaluated to see if nanodoce is safe.

Eligibility criteria:
inclusion criteria: * signed informed consent; * age ≥18 years; * localized t1a renal cell carcinoma; * maximum tumor volume of 25.0 ml; * performance status (ecog) 0-2; * life expectancy of at least 6 months; * adequate marrow, liver, and renal function; * anc ≥ 1.5 x 109/l * hemoglobin ≥ 9.5 grams/dl * platelets ≥ 75 x 109/l * total bilirubin ≤ 1.5x institutional uln * ast/ alt ≤ 2.5x institutional uln * creatinine ≤ 1.5x institutional uln * egfr \< 60 ml/min/1.73m2 * adequate method of birth control. exclusion criteria: * renal cyst; * multifocal or bilateral renal mass; * known hypersensitivity to any of the study drug or reconstitution components; * pregnant or breastfeeding female; * administration of an investigational product in a clinical trial within 3 months prior to consent; * investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent; * known drug or alcohol abuse.

Keywords: docetaxel
rems retigabine study

Conditions: Epilepsy

Summary: as part of a post-marketing commitment, gsk will conduct a survey of prescribers' and pharmacists' understanding of the risk of urinary retention with retigabine products. this is to address the effectiveness of the risk evaluation and mitigation strategy (rems) as outlined in the rems approved by the fda on 10th june 2011. the objectives of this survey are to assess prescribers' and pharmacists' understanding of the risk of urinary retention and the symptoms of acute urinary retention potentially associated with retigabine use as evaluated by a survey instrument. this is a cross-sectional study of approximately 200 physicians (e.g. neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in the last 12 months, and 200 pharmacists who have dispensed an anti-epileptic drug (aed) at least once in the last 3 months. the primary outcome of the survey is the proportion of physicians and pharmacists providing correct responses to a series of questions concerning the risk of urinary retention and the symptoms of acute urinary retention that may be associated with retigabine. the risks captured will be those described in the retigabine dear healthcare provider (dhcp) letters, specifically risks of urinary retention.

potiga is a trademark of valeant pharmaceuticals north america, used by glaxosmithkline under license.

Eligibility criteria:
inclusion criteria: * able to read, speak, and understand english. * willing to take the online survey or have the survey administered via a telephone interview, including electronically signing a confidentiality \& consent agreement and completing all study protocol-specified procedures. * prescribed retigabine within the past 12 months (prescribing physicians) * filled a prescription for at least one aed within the previous three months (pharmacists). exclusion criteria: * physicians or pharmacists meeting any of the following criteria will not be eligible to take the survey: * the physician or pharmacist is currently employed by, or is a representative of any of the following: * a pharmaceutical company or manufacturer of medicines or healthcare products. * contributor/editor to published guideline committees for epilepsy or ur. * the physician or pharmacist has a visual impairment that would prevent him or her from being able to read independently. * the physician or pharmacist participated in the pilot rems study for retigabine. * the physician or pharmacist is an employee of gsk or concentrics research.
cenobamate expanded access program (eap)

Conditions: Partial Epilepsy

Summary: this cenobamate expanded access program (eap) is designed to continue providing treatment with cenobamate (ykp3089) to patients with partial-onset epilepsy that were enrolled in the sk life science clinical trial ykp3089c013, ykp3089c017 or ykp3089c021.

this expanded access program (eap) is designed to provide access to an unlicensed drug that is approved in the united states for the treatment of a serious or life-threatening condition. this eap will be sponsored by sk life science inc. and managed by wep clinical. cenobamate is approved for the treatment of partial onset seizures in adults in united states. the attached us label (appendix 1) provides the most recent guidance for use of cenobamate. the objective of this eap is to continue providing treatment with cenobamate (ykp3089) to patients with partial-onset epilepsy that were enrolled in the sk life science clinical trial ykp3089c013, ykp3089c017 or ykp3089c021. access to cenobamate under this guideline is considered a treatment scenario and is not a clinical trial. epilepsy is a symptom of a neurological problem that causes sudden, brief seizures. it leads to an increased risk of injury from accidents, an increased rate of mortality, and has a significant impact on quality of life. epilepsy can occur as a result of a neurological injury, a structural brain lesion, as a part of many systemic medical diseases or may be generic in origin. the incidence of having epilepsy during a lifetime is between 2-5%. available medications control seizures in 50% of patients and decrease seizure incidence in 75%. the remainder continued to have unacceptable number of seizures, side effects, and psychiatric symptoms. the high treatment failure may be the result of inadequate efficacy or intolerable side effects that lead to poor compliance. cenobamate is a novel small molecule that is an antiepileptic agent for partial onset seizures. the precise mechanism by which cenobamate exerts its therapeutic effects in patients with partial-onset seizures is unknown. cenobamate has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. it is also a positive allosteric modulator of the γ-aminobutyric acid (gabaa) ion channel.

Eligibility criteria:
inclusion criteria 1. patients currently enrolled in one of the following sk life science studies: ykp3089c013, ykp3089c017 or ykp3089c021. 2. patient who is currently pregnant and enrolled in one of the following sk life science studies: ykp3089c013, ykp3089c017 or ykp3089c021 may enter the eap program. 3. written informed consent signed by the patient or legal guardian prior to entering the eap in accordance with the ich gcp guidelines. if the written informed consent is provided by the legal guardian because the patient is unable to do so, a written or verbal consent from the patient must also be obtained. exclusion criteria 1. patients that have previously discontinued for any reason from studies ykp3089c013, ykp3089c017 and ykp3089c021.

Keywords: partial onset seizures treatment resistant partial epilepsy
changes of biomarkers in response to training and antioxidant treatment

Conditions: Obesity; Type 2 Diabetes

Summary: the aim of the study is to compare the effects of an intensive 4 weeks exercise training program with or without additional treatment with antioxidants. 16 volunteers are included into the study and randomized into a treatment (n=8,vitamine e 400 iu od + vitamine c 1g twice daily) and a non-treatment (n=8, training only) group. before and after the training program, skeletal muscle biopsies will be taken to measure pgc-1alpha and ppargamma mrna expression. in addition before and after the training program individuals will have the following measurements: body weight, waist circumference, body fat content (dexa scan), euglycemic-hyperinsulinemic clamps, ergospirometer (vo2 max), routine laboratory measurements, serum malondialdehyde concentrations.


Eligibility criteria:
inclusion criteria: * must be able to swallow tablets * signed informed consent * no concommitant medication * male * age between 25 - 35 years exclusion criteria: * drug, tobacco or alcohol abuse * any chronic disease * any acute or chronic inflammatory disease as determined by a leucocyte count \> 7000 gpt/l, c-reactive protein (crp) \> 5.0 mg/dl or clinical signs of infection * systolic blood pressure (sbp) \> 140mmhg and diastolic blood pressure (dbp) was \> 85mmhg * cardiovascular or peripheral artery disease * thyroid dysfunction

Keywords: pgc-1alpha ppargamma oxidative stress training intervention
memory and fear study (fear of memory loss study)

Conditions: Anxiety and Fear

Summary: this study is a randomized control study to determine the impact of a tailored, web-based mindfulness program to reduce anxiety and increase the quality of life in older adults experiencing dementia-related fears, relative to a conventional meditation program.

the study will test two different types of online mindfulness programs to see if an online self-paced mindfulness program can help reduce anxiety related to memory loss. participants will be involved in the study for a total of 10 weeks. participants will log on to an online mindfulness program 4 days per week for about 10-20 minutes each. the total program will last 3 weeks. participants will also be asked to complete questionnaires before starting the program, during the program, and after they complete the program.

Eligibility criteria:
inclusion criteria: * 55 years of age or older * elevated dementia-related fear * able to read/write in english * willingness to be randomized to intervention group * willingness to complete three weeks of self-guided intervention, questionnaires, and cognitive tests. * access to a reliable internet connection exclusion criteria: * diagnosis of mild cognitive impairment, alzheimer's disease, or dementia by a healthcare provider. * impaired cognitive or neurologic function * unstable medical condition * severe depression * current treatment for anxiety or depression * current participation in another psychotherapy * current use of psychiatric medication * current substance use disorder * inadequate vision or hearing to interact with study materials

Keywords: mindfulness fear of memory loss
the application of virtual reality exposure versus relaxation training in music performance anxiety

Conditions: Music Performance Anxiety

Summary: the aim of the study is to investigate the effect of exposure treatment using virtual reality (vr) in musicians with performance anxiety compared to a relaxation technique on anxiety symptoms and corresponding cardiovascular parameters. the prospective, randomized clinical trial will include 46 musicians with musical performance anxiety (mpa). the experimental group will receive four exposure sessions in vr and the control group will receive four progressive muscle relaxation (pmr) sessions. anxiety symptoms will be measured using a german version of the performance anxiety questionnaire and a behavioral assessment test (bat) before, after the treatment, and at 6-month follow-up. the cardiovascular reactivity will be assessed measuring the heart rate variability (hrv) throughout the bat and the blood pressure before and after the bat. furthermore, blood and saliva samples will be collected before and after the bat to assess endocrine stress parameters and epigenetic markers. the following hypotheses are derived: 1) significant and lasting reduction of subjective mpa symptoms for the experimental group receiving vret at t1 (post/ shortly after treatment) and t2 (follow-up/ 6 months after treatment) compared to t0 (pre/ before treatment). 2) significant better reduction of subjective mpa symptoms for the experimental group receiving vret compared to the control group receiving pmr at t1 (post/shortly after treatment) and t2 (follow-up/ 6 months after treatment) compared to t0 (pre/ before treatment). 3) the postulated effects in hypotheses 1 and 2 go along with a significantly higher hrv representing less cardiac stress during the bat in case of a successful reduction of anxiety symptoms at t1 (post/ shortly after treatment) and t2 (follow-up/ 6 months after treatment) compared to t0 (pre/ before treatment).


Eligibility criteria:
inclusion criteria: * music performance anxiety (mpa) * reporting anxiety and/or avoidance of musical performance situations * reporting psychological distress and/or impaired functioning due to the mpa * sufficient knowledge of the german language (to understand questionnaires and the therapy manual) * compliance with the covid-19-regulations for local study appointments * written informed consent exclusion criteria: * substance use disorder * physiological contraindications for an exposure therapy (i.e. epilepsy, serious disorder of the cardiovascular system) * psychological contraindications for an exposure therapy (i.e. psychotic disorder, substance dependence, borderline personality disorder, acute suicidality) * use of sedative medication or tranquilizers (i.e. beta-blockers) for the therapy appointments * claustrophobia * blood-injection-injury type phobia * instrument not portable, too big or not playable while standing (i.e. piano, drums, harp, double bass) * not able to play the instrument blindfold * current psychotherapy because of the mpa * recent (\< 6 months ago) psychotherapy because of the mpa
a study to evaluate the effect of rifampin on the single-dose pharmacokinetics of bms-986177 in healthy subjects

Conditions: Thrombosis

Summary: this study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (pk) of bms-986177 in healthy participants with parameters like cmax, auc(inf), auc(0-t)


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ecg), and clinical laboratory tests including coagulation parameters. 3. subjects with body mass index of 18 to 30 kg/m2, inclusive and with normal kidney function. 4. women participants must have documented proof that they are not of childbearing potential. 5. men who are sexually active with wocbp must agree to follow instructions for method(s) of contraception for the duration of treatment with bms-986177 plus 5 half-lives (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days after completion of bms-986177 treatment. exclusion criteria: 1. any significant acute or chronic medical illness, including any other condition listed as a contraindication in the rifampin package insert 2. history of recurrent headaches, dizziness, chronic diarrhea, gastroesophageal reflux disease, dyspepsia, gastrointestinal ulcer disease, recurrent urinary tract infections, hypermenorrhea and recurrent candida infections, abnormal bleeding, history of hemophilia, rosenthal syndrome, fxia deficiency, or other coagulopathies. 3. recent surgery, head injury, blood transfusion, systemic lupus erythamatous, aneurysm, drug or alcohol abuse and use of tobacco or nicotine containing products in past six months. 4. evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecgs, or clinical laboratory determinations beyond what is consistent with the target population 5. history of allergy to bms-986177, fxia inhibitors , rifampin or related compounds
18f-psma pet and mri in the primary staging of prostate cancer patients

Conditions: Prostate Cancer

Summary: this prospective phase ii study assesses the accuracy of second generation prostate specific membrane antigen (psma) positron emission tomography (pet; utilizing 18f-psma-1007)) and multiparametric magnetic resonance imaging (mri) for locoregional staging of clinically significant prostate cancer in men undergoing radical prostatectomy and bilateral pelvic lymph node dissection. the design will be a multicenter validating-paired cohort study using radical prostatectomy and pelvic lymph node dissection as the gold standard comparator. each patient will undergo both 18f-psma-1007 pet and 3t mri allowing comparison of each imaging modality within each subject. furthermore, pet and mri will be compared to standard-of-care imaging techniques (ct abdomen/pelvis and 99mtc-mdp bone scan).


Eligibility criteria:
inclusion criteria: 1. patients or their legal medical decision makers will sign an informed consent prior to entering the study. 2. adult patient (≥ 18 years old) with a diagnosis of at least gleason grade group 2 prostate cancer. 3. appropriate staging investigations have been performed prior to the participation in the study (i.e. ct abdomen/pelvis and 99mtc-mdp bone scan) exclusion criteria: 1. unable to obtain consent 2. weight \>250 kg (weight limitation of scanners) 3. unable to lie flat for 30 minutes to complete the pet or mri imaging 4. severe claustrophobia precluding image acquisition 5. lack of intravenous access 6. non-mri compatible pacemaker or hardware 7. egfr \< 40 ml/min/1.73 m2 and/or a history of a severe reaction to mri contrast 8. prior androgen deprivation therapy