Kornimate/medical-research-clean huggingface dataset:
investigation of the effects of aerobic exercise, balance exercise and combined exercise practices on frailty, balance, fall risk, reaction time, cognitive functions and quality of life in dementia patients

Conditions: Dementia; Aerobic Exercise; Balance Exercise; Cognitive Function; Frailty; Reaction Time

Summary: dementia is a clinical disorder characterized by progressive and permanent loss of multiple cognitive functions, especially memory, at a level that affects activities of daily living. there is no pharmacologic treatment method that can change the prognosis in dementia. the methods used today are symptomatic and cause various side effects. for this reason, non-pharmacologic approaches are on the agenda in the treatment of dementia. among these approaches, physical activity approaches such as symptomatic treatment or exercise come to the forefront due to their prognosis-slowing effects. there are also many studies showing that dementia is directly related to physical performance and frailty. deterioration of physical performance, increased frailty, and decreased muscle strength create a vicious circle with the prognosis of dementia. in addition, patients with dementia have balance problems due to prolonged reaction time, cognitive impairment and physical problems, and the risk of falls increases. in order to prevent the risk of falls, exercise practices are of great importance. although the effects of aerobic exercise on dementia have been examined many times in the literature, there are very few studies examining the effects of balance exercises and combined exercises. in addition, physical characteristics such as frailty and muscle weakness, which are very common in patients with dementia, have not been evaluated as a whole in studies on patients with dementia. therefore, this study will be conducted to comparatively examine the effects of combined aerobic exercise and balance exercises on balance and falls, frailty, muscle strength, cognitive functions, and reaction time in patients with dementia.


Eligibility criteria:
inclusion criteria: * age over 65 years, * to be able to speak and understand turkish, * to have at least primary education, * perceive and adapt to simple commands, * scoring between 18-23 on the standardized mini mental state assessment scale (200), * to be able to provide independent mobilization, * volunteering to participate. exclusion criteria: * rapid progression of dementia (infectious, vascular, hematologic diseases), * cardiac or cerebrovascular event, endocrine disorder, fluid-electrolyte imbalance or infection during the follow-up period, * presence of malignancy, * detection of a delirium picture, * presence of severe depression, * participate in a regular exercise program for at least 6 months before the study, * having a fracture or fracture surgery in the lower extremity within the last year, * any orthopedic problem that prevents him/her from exercising.
effect of sham feeding on postoperative ileus after elective liver transplantation

Conditions: Postoperative Ileus

Summary: postoperative ileus is a common after abdominal surgery. multifactorial etiology such as surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return of normal gut function chewing gum has recently been used as a form of sham feeding to stimulate acceleration of gut function after abdominal surgery. the investigators hypothesize that sham feeding with chewing gum will accelerate return of gut function after liver transplantation.


Eligibility criteria:
inclusion criteria: * elective liver transplantation surgery * an ability to chew gum exclusion criteria: * emergency surgery * age less than 18 years, * inability to provide written informed consent * an inability to chew gum * hepaticojejunostomy * sedated patients * reintubated patients * glasgow coma scale \<13 * reoperation before gas out * previous bowel surgery

Keywords: sham feeding postoperative ileus liver transplantation
high-dose gemcitabine, busulfan, and thiotepa followed by asct in primary central nervous system lymphoma

Conditions: Primary Central Nervous System Lymphoma (PCNSL)

Summary: the goal of this single-arm, prospective study is to learn if high dose gemcitabine, busulfan and thiotepa with autologous stem cell transplantation to treat primary or relapse central nervous system lymphomas. it will learn about the safety and efficacy of combination therapy. the main question it aims to answer is: efficacy and safety of the combination of high dose gemcitabine, busulfan and thiotepa as a bridging therapy to asct in patients with cnsl. participants will: take gemcitabine (2.5 g/m²) was administered intravenously (iv) on days -9 and -3, busulfan (3.2 mg/kg) was given iv over 3 hours on days -9 to -7, and thiotepa (5 mg/kg) was administered iv on days -5, -4, and -3. peripheral stem cells were infused on day 0. visit the clinic for checkups and tests in accordance with the international primary cns lymphoma group (ipcg). researchers will observe the patients receiving gembutt regimen as conditioning therapy in cnsl.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 70 years; 2. cns status of complete remission (cr) or partial response (pr) as assessed by magnetic resonance imaging (mri), positron emission tomography-computed tomography (pet/ct), or csf analysis (if applicable); 3. eastern cooperative oncology group (ecog) performance status of 0,1 or 2; 4. absence of systemic lymphoma in the neck, chest, abdomen, and pelvis as assessed by ct and bone marrow biopsy; 5. negative hiv and hepatitis virus infections (particularly hepatitis b or c, with hbv dna ≥ 10,000 copies/ml); 6. left ventricular ejection fraction (lvef) ≥50% and no uncontrolled arrythmias or symptomatic cardiac disease; 7. forced expiratory volume in one second (fev1) ≥70%; 8. serum creatinine clearance ≥ 50 ml/min and/or serum creatinine ≤ 1.8 mg/dl; 9. serum bilirubin ≤ 2 times the upper limit of normal, serum glutamate oxaloacetate transaminase (sgot) and/or serum glutamate pyruvate transaminase (sgpt) ≤ 3 times the upper limit of normal. exclusion criteria: 1. relapse after stem cell transplantation; 2. other uncontrolled malignancies; 3. immunodeficiency; 4. active infection requiring parenteral antibiotics; 5. pregnant or lactation; 6. severe psychiatric or psychological conditions.
effect of intraoperative virtual reality on anxiety and vital findings in patients total knee replacement surgery

Conditions: Total Knee Replacement Surgery; Virtual Reality

Summary: although total knee replacement surgery improves the quality of life of the patients, a significant reduction in knee pain and normalization of the knee joint, the awareness of the surrounding events is a major concern for the patients and negatively affects their vital signs, since most of the patients are awake during the surgery. when the literature is examined, there are no pharmacological methods to reduce anxiety. when distraction techniques are used, patients' anxiety levels are significantly reduced, vital signs are normalized, patient satisfaction is increased and pain is relieved. it has been emphasized that there is a successful method in reducing one of the distraction techniques is the application of virtual reality. this study will be carried out in a randomized controlled experimental design to determine the effect of virtual reality application during surgery on patients who will undergo total knee replacement surgery, on the anxiety level and vital signs of the patients.

the aim of this study is to determine the effect of virtual reality application on patients' anxiety level and vital signs during surgery for patients who will undergo total knee replacement surgery. it will consist of patients over the age of 18 who will have total knee replacement surgery, which will be carried out in the operating room unit. patients meeting the sample selection criteria were randomized into experimental and control groups. will be divided into two groups. virtual reality glasses will be applied to the experimental group. in the collection of data; "patient information form", "state anxiety inventory scale" and "vital signs follow-up form" will be used.

Eligibility criteria:
inclusion criteria: * voluntarily agreed to participate in the research * being 18 years or older * being able to read and write turkish * no vision and hearing problems * not using glasses * absence of any psychiatric, cognitive or neurological disease exclusion criteria: * patients with visual or hearing impairment * patients receiving general anesthesia * those who have previously had total knee replacement surgery

Keywords: intraoperative virtual reality anxiety vital findings patients total knee replacement surgery
study design of 'influence of sarpogrelate in patients with renal impairment or diabetes mellitus' study

Conditions: Coronary Artery Disease; Diabetes Mellitus; Renal Insufficiency, Chronic

Summary: the purpose of the serenade trial is to evaluate the safety and efficacy of sarpogrelate in patients with ckd or dm after des implantation.

the rates of stent failure after percutaneous intervention (pci) have declined after introduction of the drug eluting stent (des). however, chronic kidney disease (ckd) or diabetes mellitus (dm) still remains a strong clinical predictor of poor prognosis with des. sarpogrelate, a selective 5-ht2a receptor antagonist, has antiproliferative effects as shown by its reduction of neointimal hyperplasia and smooth muscle cell proliferation as well as a potent antiplatelet agent inhibiting of 5-ht-induced platelet aggregation. however, the efficacy and safety data for sarpogrelate in patients with ckd or dm are limited. we aimed to test whether sarpogrelate has beneficial effects in patients with cdk or dm treated with des. the serenade trial is a multicenter, off-label, prospective, placebo-controlled randomized study to test the superiority of triple anti-platelet therapy (tat; aspirin, clopidogrel and sarpogrelate) to the conventional dual antiplatelet therapy (dat; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with ckd or dm. a total of 220 patients exhibiting coronary artery disease (cad) with dm or ckd will be randomized to tat or dat (1:1 ratio) after des implantation. primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography (qca). secondary efficacy endpoints are composites of major adverse cardiovascular events (mace) including cardiac death, nonfatal myocardial infarction (mi), and target lesion revascularization. secondary safety endpoints are major bleeding event and hepatic or renal impairments. the serenade trial will give insight whether adjunctive therapy with sarpogrelate is helpful for patients with high risk profiles such as ckd or dm after des implantation.

Eligibility criteria:
inclusion criteria: * symptomatic cad (including acute coronary syndrome) or positive stress test and a native coronary lesion (\>50% diameter stenosis by visual estimation on coronary angiogram and reference diameter \> 2.5 mm) * and ckd or dm patients exclusion criteria: * if they had contraindication to aspirin, clopidogrel or sarpogrelate.

Keywords: sarpogrelate
broad spectrum hpv vaccine tolerability, immunogenicity, and efficacy study (v502-003)

Conditions: Cervical Cancer; Condylomata Acuminata

Summary: this study is to evaluate an investigational vaccine with the following objectives: (1) to demonstrate prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by the hpv types in the study vaccine, (2) to demonstrate that the vaccine is well-tolerated in women, (3) to evaluate vaccine immune responses in women. this is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria: * female, between the ages of 16 and 26 exclusion criteria: * history of an abnormal pap test or abnormal cervical biopsy result * history of external genital/vaginal warts * history of positive hpv test * currently a user of any illegal drugs or an alcohol abuser * are pregnant * currently enrolled in another clinical trial * currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent).

Keywords: anogenital warts premalignancy hpv human papillomavirus
a study of tq05105 in patients with chronic graft versus host disease

Conditions: Chronic Graft Versus Host Disease

Summary: this study was a single arm, open label, multicenter phase ib / ii trial in subjects with glucocorticoid refractory / dependent moderate to severe cgvhd.the trial consisted of two phases: phase i for the dose exploration and phase ii for the extension study.


Eligibility criteria:
inclusion criteria: * understood and signed an informed consent form. * ≥18 years old, karnofsky performance scale of ≥60, life expectancy ≥ 6 months. * has received allogeneic hematopoietic stem cell transplantation (allosct). * clinically diagnosed moderate to severe cgvhd according to nih consensus criteria. * has received systemic or topical corticosteroids therapy and confirmed steroid-refractory/dependent cgvhd according to nih consensus criteria. * has received at least 1 lines of therapy for cgvhd. * adequate laboratory indicators. * no pregnant or breastfeeding women, and a negative pregnancy test. exclusion criteria: * has active acute gvhd. * has previously failed to respond to jak inhibitors for gvhd, or who had used jak inhibitors within 4 weeks before the first administration. * has uncontrollable active infections or infections requiring systematic treatment within 7 days before the first administration. * development of other basic diseases. * has malignant tumors within 3 years. * has multiple factors affecting oral medication. * has substance abuse or a psychotic disorder. * has severe and / or uncontrolled disease. * allergic to drugs or its constituents. * has participated in any other clinical trials within 4 weeks before first administration. * according to the judgement of the investigators, there are other factors that may lead to the termination of the study.
safety study of sorafenib following combined therapy of radiation and tace for liver cancer

Conditions: Hepatocellular Carcinoma

Summary: patients with liver cancer will receive interventional therapy plus radiotherapy. maintenance sorafenib will be taken after the completion of radiotherapy. hypothesis of the current study is that sorafenib as a maintenance therapy is safe and superior to radiotherapy combined with interventional therapy in terms of survival in comparison to historical data.

patients with solitary lesion (bigger than 5 cm in diameter) histologically or cytologically confirmed hcc receive tace (1-3 cycles) plus 3dcrt/imrt 4-6 weeks later. maintenance sorafenib will be administered only for the patients with non-progression disease 4 to 6 weeks after the completion of radiotherapy. the dose will be 400 mg, p.o., twice a day. sorafenib will be continuously given for 12 months unless intolerable toxicities and/or tumor progression. hypothesis of the current study is that sorafenib as a maintenance therapy after combined therapy of 3dcrt/imrt and tace is safe and superior to radiotherapy combined with tace alone in terms of time to progression (ttp), progression-free survival (pfs) and overall survival (os) in comparison to historical data.

Eligibility criteria:
inclusion criteria: 1. age of equal or older than 18 years and not over 75 years with a life expectancy of at least 12 weeks; 2. karnofsky performance status (kps) of ≥70; 3. histologically or cytologically confirmed hcc; 4. bclc stage b, solitary lesion (bigger than 5 cm in diameter) with tumor burden less than 50% of total liver volume; 5. liver function of child-pugh a; 6. technically unresectable, medically inoperable, or surgery declined by the patient; 7. normal renal function and adequate bone marrow reservation; 8. signed informed consent must be obtained prior to any study specific procedure. exclusion criteria: 1. presence of intrahepatic and/or extrahepatic metastases 2. previous received systemic therapy for liver cancer; 3. history of radiotherapy to the liver; 4. indistinct tumor boundary on ct/mri images; 5. previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix or superficial bladder tumors \[ta, tis and t1\]; 6. history of cardiac disease: congestive heart failure \> nyha class 2, active cad, cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension within the last 12 months; 7. concurrent uncontrolled medical conditions; 8. pregnancy or breast feeding; 9. investigational drug therapy outside of this trial during or within 4 weeks of study entry; 10. psychiatric or medical unstable conditions that compromise the patient's ability to give informed consent.

Keywords: sorafenib three-dimensional conformal radiation therapy intensity-modulated radiation therapy transcatheter arterial chemoembolization
bioequivalence study of fixed dose combination of 2.5 mg saxagliptin/850 mg metformin tablet relative to 2.5 mg onglyza and 850 mg glucophage tablets co-administered

Conditions: Type 2 Diabetes Mellitus

Summary: to demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination (fdc) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (glucophage marketed by merck-serono) tablet co-administered to healthy subjects in the fasted and fed condition.


Eligibility criteria:
inclusion criteria: * men and women ages 18 to 55 inclusive * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ecgs), and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m\^2, inclusive. bmi = weight (kg)/ \[height (m)\]\^2 exclusion criteria: * any significant acute or chronic medical illness * current or recent (within 3 months) gastrointestinal disease * any major surgery within 4 weeks of study drug administration * history of allergy to a dipeptidyl peptidase-iv (dpp4) inhibitor or related compound * history of allergy or intolerance to metformin or other similar acting agents * prior exposure to saxagliptin * prior exposure to metformin within 3 months of study drug administration * estimated creatinine clearance (clcr) of \< 80 ml/min using the cockcroft gault formula
evoked fields after median and ulnar stimulation

Conditions: Complex Regional Pain Syndromes

Summary: in order to be able to study the effects of evoked fields with magnetoencephalography (meg) in two groups of patients, comparison is made with a group of healthy volunteers.

this study is directed at the (central and / or peripheral) mechanisms of pain and the cortical changes (plasticity) due to chronic non-malignant pain in two groups of patients and one healthy volunteer group. the aim of the study is further to evaluate cortical processes by meg (and fmri, if feasible) to quantify and qualify the responses, localise the generators and study the effects of a pain therapy. to search for patterns that may result in diagnostic criteria and have an indicative value for the treatment and the monitoring of the effects. finally the study not only intends to support clinical diagnosis but also to provide tools to monitor treatment and support the choice (algorithm) between scs and san. an algorithm, facilitating decision making between these two treatments, will be promoted. it should also provide a clinical decision tool for the use of san

Eligibility criteria:
inclusion criteria: crps i: * (absolute) functio laesa, secondary pain and cold sensations * (relative) abnormal skin colour, allodynia, hyperalgesia, hyperpathia, hyperhydrosis,oedema, increased nail growth, increased hair growth. (at least 4 need to be present). crps ii: * all the previous but evidence of traumatic peripheral nerve injury. exclusion criteria: * general condition * pregnancy * technical implants (pacemaker, scs: disturbs meg)

Keywords: pain magnetoencephalography median ulnar causalgia complex regional pain syndrome evoked fields nerve injury neuropathic pain
paracetamol and metamizole with spi-guided anaesthesia for vrs

Conditions: Vitreoretinal Surgeries; Postoperative Nausea and Vomiting; Postoperative Pain

Summary: the aim of this randomized trial is to assess the efficacy of preemptive analgesia using paracetamol or metamizole or both of them under spi-guided anaesthesia for vitreoretinal surgery (vrs), presence of ponv (postoperative nausea and vomiting) and oculocardiac reflex (ocr) and compare numerical rating scale (nrs) with surgical pleth index (spi) for monitoring pain perception postoperatively. patients will receive general anaesthesia combined with either preemptive analgesia using preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous infusion of 1,0 g of acetaminophen or both of them together.

monitoring depth of anaesthesia using spectral entropy (se) and quality of neuromuscular block are routine in modern anaesthesia, whereas monitoring of analgesia still requires further studies. recently, the surgical pleth index (spi) was added as a surrogate variable showing the nociception-antinociception balance into abovementioned parameters constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (aoa) or tailor-made anaesthesia. different options of preemptive analgesia are used to decrease the postoperative pain perception as well as diminish the rate of ponv by deceasing intraoperative consumption of intravenous narcotic analgesics

Eligibility criteria:
inclusion criteria: * written consent to participate in the study * written consent to undergo general anaesthesia alone or combined with different techniques of pre-emptive analgesia and vitreoretinal surgery exclusion criteria: * history of allergy to local paracetamol or metamizole * necessity of administration of vasoactive drugs influencing spi monitoring * pregnancy

Keywords: surgical pleth index (spi) general anaesthesia (ga), numerical rating scale (nrs) adequacy of anaesthesia (aoa) oculocardiac reflex (ocr) paracetamol metamizole
hypnosis mask: a new approach to management of pain in medical imaging

Conditions: Prostatic Diseases

Summary: the prostatic biopsies echo-guided are a painful and stressful. the purpose is to test a new medical device created recently, " hypnos-pro ", wich uses connected technologies. this connected device is a mask with diodes coupled with an audio headset and a touch pad. this connected mask is an another option to induce an hypnotic state for our patients. the objective is to value hypnotic mask effectiveness, to reduce the level pain and anxiety for the patients who benefit a prostatic biopsies echo-guided with local anesthesia.


Eligibility criteria:
inclusion criteria: * patient eligible for prostate biopsies * having accepted and signed the consent, for performing a prostate biopsy ultrasound examination * no contraindication to the gesture * supporting the left lateral decubitus exclusion criteria: * patient isolation contact / droplets * patient with hearing and / or epilepticus and / or dementia and / or having a history of stroke and / or allergic to lidocaine * person unable to consent, or benefiting from a system of legal protection (tutelage / curatorship). * patients with epileptic seizures. * patients with known allergies to plastics and other resins that may develop allergic contact dermatitis. * patients who are hypersensitive to radio frequency. * patients with rocephin administration before the gesture

Keywords: prostatic biopsies echo-guided pain measurement anxiety assessment