Kornimate/medical-research-clean huggingface dataset:
surgery of melanoma metastases after systemic therapy

Conditions: Melanoma; Melanoma Stage IV; Metastatic Melanoma; Surgery

Summary: to evaluate if surgical removal of residual disease adds benefit in stage iv melanoma patients with partial response or stable disease after a minimum 9 months of first-line pd-1 inhibition. primary endpoint: disease-free survival (dfs) at 12 months.

a phase ii randomized controlled open-label parallel group interventional multicenter trial. patients with metastatic melanoma, stratified for stage m1a or m1b/m1c, that have received first-line treatment with pd-1 inhibitors for a minimum of 9 months resulting in either partial response or stable disease according to recist 1.1 will be eligible. patients will be screened for operability based on ct-scans examined by a multidisciplinary team, with the criteria that complete (r0) resection of all metastases should be possible. if the multidisciplinary team find that this would be possible, patients will be included and randomized 1:1 to either surgery with continued pd1-inhibition or current standard of care with continued pd1-inhibition only. at progression, treatment will be according to the treating medical oncologist. active follow-up will be performed for 12 months.

Eligibility criteria:
inclusion criteria: * age above 18 years * signed and dated written informed consent before the start of specific protocol procedures * biopsy or cytology proven metastatic melanoma stage m1a, m1b or m1c * have received a minimum of 9 months of immunotherapy (pd1-inhibitor alone or in combination) resulting in stable disease or partial response according to recist 1.1 * metastases judged to be radically resectable by surgery at a multidisciplinary conference * ecog performance status 0-2 exclusion criteria: * brain metastasis (m1d) * previous treatment with braf/mek inhibitors * inability to understand given information or undergo study procedures according to protocol

Keywords: immunotherapy metastatic surgery surgical oncology
an investigational drug study with suberoylanilide hydroxamic acid in relapsed diffuse large b-cell lymphoma (0683-013)

Conditions: B-cell Lymphoma

Summary: a study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug in the treatment of relapsed diffuse large b-cell lymphoma.


Eligibility criteria:
inclusion criteria: * patient must be 18 years or older with relapsed diffuse large b-cell lymphoma (dlbcl). * stable disease or better for at least 3 months on most recent treatment * have not received any chemotherapy, radiation therapy, major surgery, or any other investigational therapy for at least 4 weeks prior to entry in this study * adequate blood testing, liver, and kidney function as required by the study. * eligible subjects will allow tissue samples to be examined and stored. exclusion criteria: * patient has been treated with other investigational agents with a similar anti-tumor mechanism. * patient should not have failed more than 3 prior treatment regimens.

Keywords: relapsed diffuse large b-cell lymphoma
early initiation of low dose tirofiban for ppci in stemi patients.

Conditions: ST Elevation Myocardial Infarction

Summary: anti-platelet therapy is a key point of acute myocardial infarction (ami) treatment. nowadays, dual anti-platelet therapy based on aspirin and adp-p2y12 receptor inhibitor is the preferred treatment before primary percutaneous coronary intervention (ppci). restricted by pharmacokinetic and pharmacodynamic characteristics, adp-p2y12 receptor inhibitors cannot take effect immediately after oral administration. however, platelet glycoprotein ⅱb / ⅲa inhibitors take effect faster. previous clinical trials indicated that combination of full dose of glycoprotein ⅱb / ⅲa inhibitor and dual anti-platelet therapy reduced ami related ischemia events but increased bleeding events significantly. the high dose of glycoprotein ⅱb / ⅲa inhibitor may be the key factor contributing to the increased bleeding events. therefore, this study aims to evaluate the effectiveness and security of triple anti-platelet therapy based on a small dose of glycoprotein ⅱb / ⅲa inhibitor, aspirin and adp-p2y12 receptor inhibitor in ami patients receiving ppci.


Eligibility criteria:
inclusion criteria: * time after onset of chest pain: ≥ 30 minutes and ≤ 24 hours; * st segment elevated ≥ 0.1mv in adjacent two or more leads; * scheduled for primary percutaneous coronary intervention without contraindications; * written informed consent is obtained. exclusion criteria: * life expectancy ≤ 1 year; * history of cerebral hemorrhage; * history of stroke in 6 months; * active hemorrhage; * severe hepatic and renal dysfunction(alt \> 3 folds of upper limit of normal, egfr \ 200 mmol/l); * known hemorrhagic diseases; * known malignant tumour diseases； * active peptic ulcer disease; * blood platelet counts \< 100×10\^9/l; * blood hemoglobin \< 90g/l; * pregnancy or lactation period； * take part in other intervention clinical trials； * investigators think not suitable to participate in this trial.

Keywords: st elevation myocardial infarction tirofiban percutaneous coronary intervention
emoticare: serious game for the adaptation to the disease of adolescents with type 1 diabetes mellitus.

Conditions: Type 1 Diabetes; Adolescent Development

Summary: the intervention program targets adolescents with chronic type 1 diabetes mellitus. given the critical developmental stage and life transitions, necessitating robust personal resources, psychological support becomes imperative. to foster socioemotional skills and overall well-being, particularly crucial for averting future emotional issues and promoting a healthier, more fulfilling life, this support is especially vital for those dealing with chronic illnesses. such conditions pose a risk for psychological problems, potentially complicating treatment and prognosis. presently, digital and technological platforms are integrating psychological interventions for patients with chronic diseases, showcasing an innovative approach to address psychological challenges. the platform integrates new technologies for assessment and intervention. ecological momentary assessment enables real-time evaluation, with data transferred to the technological platform. artificial intelligence personalizes interventions based on participants' socio-demographic characteristics and assessment results. ecological momentary intervention is employed for in-context treatments in participants' daily lives and natural environments. a serious game method, proven effective in various interventions, is used to engage adolescents and young people intrinsically. the game encompasses six main areas aligning with theoretical models, facilitating the development of socio-emotional competencies, and promoting physical and psychological health. it addresses different aspects of psychological and subjective well-being, reinforcing resources needed to navigate vital changes in these developmental stages, especially when living with a chronic illness.


Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus type 1 (6 months from diagnosis) * informed consent by parents/guardians and participants exclusion criteria: * diagnosis other than type 1 diabetes mellitus * no access to internet or new technologies * not speaking spanish

Keywords: type 1 diabetes serious game technology platform psychological intervention adolescence quality of life
isolated systolic hypertension in the elderly and very elderly

Conditions: Isolated Systolic Hypertension

Summary: to evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. the study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. the study duration is up to 32 weeks, including a 24-week treatment period. after 12 weeks hydrochlorothiazide may be added to control blood pressure. efficacy and safety measurements are carried out at up to 15 visits during the trial period.


Eligibility criteria:
inclusion criteria: * age 65 or older * mean sitting bp \>160 mmhg and mean sitting dbp\<90 mmhg exclusion criteria: * secondary hypertension * malignant hypertension * severe heart failure (nyha iii-iv) * recent history of myocardial infarction * hypersensitivity to study medications * history of drug or alcohol abuse * history or evidence of renal disease
treatment of patients with major depressive disorder with mk0869 (0869-073)

Conditions: Major Depressive Disorder

Summary: a clinical study to determine the efficacy and safety of mk0869 in the treatment of depression.

the duration of treatment is 8 weeks.

Eligibility criteria:
patients with major depressive disorder
the effect of lavender essential oil for delirium in elderly intensive care unit patients: study protocol

Conditions: Delirium in Old Age

Summary: elderly critically ill patients in the intensive care unit (icu) are at risk of delirium, which is primarily characterized by acute consciousness impairment and perceptual, cognitive, and memory impairment, resulting in excess death, care expenditures, and acquired dementia, depression and anxiety, which severely affect the prognosis of critically ill patients. however, there are currently no effective pharmacological strategies for preventing delirium. inhalation aromatherapy has been proven to benefits the sleep disorder, anxiety or depression and lavender oil is one of the most used essential oils. therefore, we hypothesized that the use of lavender would reduce the incidence rate of delirium in icu patients.

this trial was designed to be a randomized, single-center, double-blind, placebo-controlled trial. a total of 68 elderly patients from two icus will be randomly allocated at a 1:1 ratio to the intervention group or the control group. both groups will receive the abcdef (a2f) bundle strategy recommended by guidelines, a multicomponent approach including pain and delirium management, breathing trial practice, analgesic and sedation usage control, family engagement and so on, to prevent delirium. the intervention group will additionally receive aromatherapy lasting for five days. the primary outcome is the prevalence of delirium. secondary outcomes include the severity and duration of delirium, the length of icu stay, the duration of physical restraint, the duration of analgesic and sedative medication and the 28-day mortality rate. we will use the cam-icu and cam-s to measure the prevalence and severity of delirium, and analyses of variance (anovas) or repeated-measures anovas and wilcoxon rank-sum tests to analyze the observation results.

Eligibility criteria:
inclusion criteria: * critically ill patients aged between 60 and 90 years old * had an expected total icu length of stay (los) of 72 hours or more * admitted to the icu within 48 hours before screening * signed the informed consent form. exclusion criteria: * incapacitation preventing the assessment of delirium (i.e., coma, sedation, or active seizures) * history of psychiatric disorders, dementia, parkinson's disease, use of antipsychotic drugs, or alcohol dependence * history of traumatic brain injury or brain infection * diagnosis of delirium prior to intervention initiation * allergies to medications used in the protocol or current participation in other drug studies * inability to communicate in chinese or english * expected to be discharged or deceased within 72 hours of admission.
walking adaptability post-spinal cord injury

Conditions: Incomplete Spinal Cord Injury; Brown Sequard Syndrome

Summary: the purpose of this study is: (1) to establish assessment techniques (in our laboratory) to identify the functional integrity of long spinal tracts associated with adaptive walking recovery post-spinal cord injury and (2) to preliminary investigate locomotor outcomes associated with an adaptive locomotor training approach post-spinal cord injury.

eligible individuals without spinal cord injury that are enrolled in the study will participate for 1-2 days. these individuals may undergo a variety of non-invasive neurophysiological tests which evaluate spinal reflexes and integrity of specific spinal pathways. in addition, their movement may be assessed during walking on a treadmill and overground in a variety of different conditions (e.g. with mirrors, without mirrors, with obstacles, without obstacles). eligible individuals with spinal cord injury that are enrolled in the study will undergo the same testing as described above for the healthy controls. in addition, a small subset of these individuals may receive locomotor training (3 weeks of basic locomotor training followed by 3 weeks of adaptive locomotor training, separated by a 3 week washout period). for the individuals receiving locomotor training, they will be tested before and after each 3 week training session.

Eligibility criteria:
inclusion criteria: * 18 years or older * no neurologic injury (for individuals without sci) * \>12 mos post-incomplete sci (isci), discharged from in- and out-patient rehabilitation, with diagnosis of first time motor isci (ais c or d with upper motor neuron lesions at cervical or thoracic levels) (for individuals with sci) * medically stable condition with no changes in anti-spasticity meds * ability to walk in the home and/or ambulate in the community using a single cane or crutch, bilateral canes or crutches, or no device * walking speeds \> 0.3 m/sec, with deficit performance on the dynamic gait index * medically approved for participation exclusion criteria: * current participation in another rehabilitation program/research protocol * history of congenital sci or other degenerative spinal disorders * inappropriate or unsafe fit of the harness and/or joint contractures or severe spasticity that would prohibit the safe provision of training * receipt of a therapeutic intervention or medication within the last 6 mos that would alter the nervous system's ability to respond to treatment (e.g. botox injections) * unable to safely receive transcranial magnetic stimulation due to positive history which prohibits its use

Keywords: locomotor training walking recovery neuroplasticity
falls: a marker of preclinical ad

Conditions: Fall; Alzheimer Disease

Summary: this longitudinal cohort study investigates cognitively normal participants with and without preclinical alzheimer disease (ad) in order to examine: (1) the relationship between falls and functional mobility in preclinical stages of ad; and (2) a hypothesized model of central and peripheral mechanism(s) underlying falls and functional mobility in preclinical stages of ad.

alzheimer disease (ad) is a slowly progressive neurodegenerative disease. conversion to symptomatic ad occurs slowly over years through a series of preclinical stages marked by changes in molecular biomarkers. it is unknown whether functional mobility and falls are preclinical markers of ad. this longitudinal clinical study evaluates a cohort of cognitively normal individuals who are currently undergoing comprehensive clinical, neuropsychological, and biomarker evaluations at the knight alzheimer's disease research center (knight adrc). they receive an annual in-home evaluation of fall risks and functional mobility and prospective ascertainment of falls. comparisons of assessments of functional mobility will be performed with regard to measures of brain pathology (i.e., amyloidosis, tau, and neurodegeneration) to allow researchers to characterize when changes in falls and functional mobility occur during preclinical stages of ad. this study also examines the central and peripheral system mechanism(s) underlying falls and functional mobility in preclinical ad using structural equation modeling.

Eligibility criteria:
inclusion criteria: 1. 65 years of age or older 2. cognitively normal (clinical dementia rating \[cdr\] score of 0) * a pilot sub-study collecting stool will also enroll a few individuals with cdr\>0 for comparison. 3. have biomarkers (csf), and/or neuroimaging (positron emission tomography \[pet\] and/or magnetic resonance imaging \[mri\]) within 2 years of enrolling in this study. exclusion criteria: * history of parkinson's disease.

Keywords: preclinical alzheimer disease falls functional mobility older adults
granisetron effect on hemodynamic changes in laparoscopic cholecystectomy

Conditions: Cholelithiasis

Summary: propofol is one of the most commonly used anesthetic agents because of its ability to induce rapid and reliable collection. however, hypotension and injection pain in the induction are the most common complications. after induction of propofol; the cardiovascular system depresses, resulting in a drop in blood pressure due to decreased cardiac output and systemic vascular resistance. this may also contribute to the reduction of sympathetic tone activity in the central way, and slight reduction in the number of pulses that develop as a result of increasing vagal activity. i̇n order to attenuate these hemodynamic undesired effects caused by propofol, various agents were tried such as atropine, ephedrine, volume replacement ringer lactate, ketamine. ondansetron and granisetron, which are used for postoperative nausea and vomiting prophylaxis, have been used as such. therefore, ondansetron and granisetron were preventing hypotension induced by post-spinal and general anesthesia induction. the investigator also tried to demonstrate the effect of granisetron, another serotonin type 3 (5-ht3) receptor antagonist for postoperative nausea and vomiting prophylaxis, on induction hypotension and intubation quality after propofol induction in this study

150 participants with american society of anesthesiologists (asa) physical score i-ii who underwent elective laparoscopic cholecystectomy between the ages of 18-70 will be enrolled. participants will be divided into two groups using granisetron and control. all participants will be premedicated with 0.05 mg kg-1 midazolam 30 minutes before the operation. asa, age, sex, weight demographic data of the participants who were taken to the operating room will record. peripheral oxygen saturation (spo2), noninvasive blood pressure and electrocardiography (ecg) will monitored. a venous cannula will place on the back of the hand. participants will randomly divide into 2 groups by closed envelope method. five minutes before the induction of group g, 1 ml (1 mg / ml) iv granisetron, group k will receive 1 ml saline. propofol at induction will be administered at a dose of 0.6 mg / kg of rocuronium at a dose of 2 mg / kg. pre-induction, post-intubation and every five minutes spo2, diastolic arterial pressure (dap), mean arterial pressure (map), systolic arterial pressure(sap) and heart rate (hr) will record. intubation quality will be evaluated by evans score. systolic blood pressure \<control + 15 0 \<control + 30 1 1 * control + 30 2 heart rate pressure \<control + 15 0 \<control + 30 1 * control + 30 2 sweating no 0 moist leather 1 visible sweating 2 tears no 0 yes 1 overflowing 2

Eligibility criteria:
inclusion criteria: * laparoscopic cholecystectomy (lap) surgery exclusion criteria: * acute pancreatitis disease * cardiorespiratory disease * hypertension * anti hypertension treatments
skin cancer in swiss transplant cohort study

Conditions: Skin Cancer

Summary: it's known that organ transplant recipients with long-term drug-induced immunosuppression have a increase of the life-time incidence of squamous cell carcinoma. this study will analyze the incidence and type of skin cancer in the swiss transplant cohort study and the association with exposure to immunosuppressive and antiinfective drugs and other parameters like age or gender of organ transplant recipients.

organ transplant recipients with long-term drug-induced immunosuppression have an increase of the life-time incidence of squamous cell carcinoma and are also affected at an earlier age than the general population. in organ transplant recipients prognosis of squamous cell carcinoma differs due to more rapid growth, less differentiation and higher risk for metastases in comparison to the general population. epidemiological data indicate that the risk of skin neoplasms in organ transplant recipients is related to the cumulative exposure to immunosuppressive drugs over time. it remains unclear wether this risk differs between drug classes. this study is a prospective observational cohort study of kidney, heart, lung, liver, pancreas and small bowel transplant recipients enrolled into the swiss transplant cohort study (stcs). since 2008 almost all organ transplant recipients in switzerland are enrolled to the stcs. the stcs collects * baseline patient and case data: date of transplantation, age, gender, type of transplanted organ, past immunosuppression * follow-up patient and case data: organ rejection with type and date of rejection, type of immunosuppression in response to organ rejection, graft loss with date of graft loss, immunosuppressive drug treatment, other drug treatment, death, drop out, occurrence of cancer and infections) * drug exposure data (with start and stop dates): induction immunosuppressive drugs (basiliximab, rituximab, thymoglobulin, atg, atgam, ig iv, plasmapheresis), maintenance immunosuppressive drugs (cyclosporine a, glucocorticoids, tacrolimus, mycophenolate mofetil, everolimus, azathioprine, sirolimus, ec-mpa), infectious disease prophylaxis (e.g. tm-sulfamethoxazole, valaciclovir, fluconazole, atovaquone, voriconazole, quinolone), other drugs (e.g. statins, beta-blockers, oral antidiabetics). the investigators will statistically illustrate the incidence, prevalence and type of skin neoplasms in the stcs. the investigators will show the association of the incidence of skin neoplasms and the exposure to different immunosuppressive drugs, other drugs and other parameters in the stcs (e.g. age, gender).

Eligibility criteria:
inclusion criteria: * solid organ transplant recipients within the stcs * patients with multiple organ transplantations will be included as well * patients within the stcs, who gave the informed consent to use their data * patients with graft loss will remain in the study, since they remain at risk of skin cancer development exclusion criteria: * organ transplant recipients of non-solid organs (e.g. hematopoetic stem cell transplantation) within the stcs
neurophysiology of locomotor adaptation and freezing of gait in parkinson's disease

Conditions: Parkinson Disease

Summary: locomotor adaptation will be studied using an established split-belt treadmill paradigm, consisting of baseline (1:1 speed ratio), split-belt adaptation (2:1) and post-adaptation (1:1) walking. split-belt walking will be performed under dbs on and dbs off conditions, while off-medication.

we will test the hypotheses that dbs can facilitate split-belt walking adaptation with dbs on compared with dbs off.

Eligibility criteria:
inclusion criteria: * consensus diagnosis of idiopathic pd by fellowship trained movement disorders neurologists at the normal fixel institute of neurological diseases; * chronically stable dbs, defined as having had dbs for at least 6 months in duration with optimized dbs settings; * age between 18 - 80 years old per the fda data sheet for pd dbs; * no dementia according to the clinical diagnostic criteria for pd dementia; * ambulatory without the use of walking aids, or another person's assistance. exclusion criteria: * other previous neurological surgery; * suspicion of other neurologic diagnoses such as atypical parkinsonism, or alzheimer's disease.

Keywords: freezing of gait deep brain stimulation