Kornimate/medical-research-clean huggingface dataset:
survivorship of the press fit condylar (p.f.c.) sigma fixed bearing knee with a cobalt chrome tibial tray

Conditions: Knee Osteoarthritis

Summary: the study will determine the survivorship of the fixed bearing p.f.c. sigma knee with a cobalt chrome tibial tray at 5 years.

the primary objective of this study is to assess the survivorship of the p.f.c. fixed bearing knee system using a cobalt chrome tibial tray and moderately cross-linked polyethylene insert at 5-years. the secondary objectives of this investigation are to evaluate additional clinical outcomes to provide further information on the performance of the p.f.c. fixed bearing knee system using a moderately cross-linked polyethylene insert and cobalt chrome tibial tray. these outcomes will include radiographic assessment, american knee society score, oxford knee score and sf-12.

Eligibility criteria:
inclusion criteria: * subjects who have given voluntary written informed consent to participate in this study * subjects for whom primary total knee replacement is indicated due to degenerative joint disease, including rheumatoid arthritis, osteoarthritis, avascular necrosis, and post traumatic arthritis, which is causing pain, deformity, or limitation of function uncontrolled by medical treatment. * subjects who, in the opinion of the investigator, are able to understand this study, co-operate with the investigational procedures and are willing to return to the hospital for all scheduled post-operative follow ups. * male or female subjects who are skeletally mature and for whom an appropriate size of device is available * the following subjects are not considered eligible and must not be recruited to the investigation exclusion criteria: * subjects scheduled for revision total knee arthroplasty, or who have had previous surgery to their knee except menisectomy, arthroscopy or synovectomy. * subjects aged over 80 years * subjects experiencing any condition that may, in the opinion of the investigator, interfere with the total knee replacements survival or outcome (e.g. pagets disease, charcots disease, severe osteoporosis etc). * subjects who have evidence of active infections, which may spread, to other areas of the body (e.g. osteomyelitis, pyrogenic infection of the knee joint, overt infection etc) * subjects who are currently participating in any other clinical investigation of a device or pharmaceutical. * subjects having non-contained defects in the tibia or femur necessitating bone graft. * subjects with psychosocial disorders that would limit rehabilitation * subjects with a known history of poor compliance to medical treatment * subjects who are known drug or alcohol abusers. * other contraindications for the use of the p.f.c. ® s fixed bearing knee system as listed in the package insert. * women who are pregnant * subjects who are currently involved in any injury litigation claims

Keywords: arthroplasty, replacement, knee, tkr, pfc sigma
effects of an acute and chronic training protocol associated to the inter-set velocity loss

Conditions: Healthy

Summary: this study evaluates different performance, physiological and neuromuscular changes after acute and chronic resistance training intervention in physically active men. the participants will train with a single exercise (full squat) and will be monitored with a linear encoder. the experiment will consist of between 3 to 6 sets between 70% to 85% of 1rm in the full squat exercise. two main groups will form the intervention: one group will perform inter-set repetitions until there will be a 20% of velocity loss compared to the first repetition, while the second group will have a 40% of velocity loss.

the main dependent variables and instruments will be: 1. tensyomiography: neuromuscular properties of the vastus lateral (vl), rectus femoris (rf) and vastus medialis (vm) from the dominant leg. 2. force platform: kinetic variables in relation to a countermovement jump. 3. near-infrared spectrography: oxygen saturation in the vl and vm. 4. termographic camera: low limbs temperatura. 5. linear encoder: mean propulsive velocity from each repetition 6. electromyography: amplitude and frequency parameters related to a knee extension maximum voluntary contraction test. 7. strain gauge: maximum isometric force.

Eligibility criteria:
inclusion criteria: * to be healthy * without injuries or actual illnesses * more than 2 years of experience in resistance training or federative sports exclusion criteria: * to be sick or injured * to have programmed during the intervention phase a dramatic change in the lifestyle

Keywords: velocity loss tensiomiography resistance training
efficacy of nutrition education in alleviating premenstrual syndrome (pms) among chinese college students at hainan university, china

Conditions: Premenstrual Syndrome-PMS

Summary: this study aims to evaluate the efficacy of nutrition education-based intervention on pms severity, perceived stress, and lifestyle-related outcomes among the students at hainan vocational university of science and technology

premenstrual syndrome (pms), occurring during the luteal phase of the menstrual cycle and spontaneously resolving after menstruation begins, is a prevalent psychological and somatic disorder among women of reproductive age.lifestyle modifications can help alleviate pms symptoms, including dietary changes (such as reducing salt and sugar intake or increasing consumption of vegetables and fruits), engaging in regular physical activity, stress management, and avoiding smoking.this study is a parallel, unblinded, randomized controlled trial assessing the efficacy of nutrition education-based intervention on pms severity, perceived stress, and lifestyle-related outcomes in chinese college students. participants will be randomly assigned to two groups: the nutrition education-based intervention group (nei) and the control group. the nutrition education-based intervention program will span 6 weeks. the participants in the "passive" control group will receive no further intervention and will each be provided with the pms management booklet. data will be collected through online surveys at baseline, post-intervention, and at 1-month and 3-month follow-up points after the completion of the intervention. data analysis will be performed using spss 26.0.

Eligibility criteria:
inclusion criteria: 1. females students aged 18 to 30 years 2. pms scores（6-36） 3. regular menstrual cycles (defined as a menstrual cycle of 21 to 35 days) 4. not using hormonal compounds (such as contraceptive pills), drugs (such as fluoxetine and escitalopram), or non-drug treatments affecting premenstrual syndrome, such as special diets 5. no participation in interventional studies related to premenstrual syndrome in the past 6 months exclusion criteria: 1. amenorrhea 2. polycystic ovarian disease (pcod) 3. those who are unable to attend according to intervention protocol
primary prevention of cardiovascular diseases in childhood and adolescence: the role of physical activity

Conditions: Obesity; Hypercholesterolemia; High Blood Pressure; Sedentary Lifestyle

Summary: this research project is about a physical activity intervention in pediatric outpatients to try control and prevent heart diseases such as hypertension, obesity, high cholesterol.

control group: receive information about health lifestyle interventional group: receive a structured plan with exercises to do 3 times per week within 50 minutes. it is a randomized clinical trial and population are children and adolescents.

Eligibility criteria:
inclusion criteria: * 6 to 17 years * obesity * high cholesterol exclusion criteria: * congenital heart diseases * less than 6 or more than 17 years old

Keywords: obesity cholesterol cholesterol, ldl cholesterol, hdl blood glucose triglyceride c-reactive protein - hs blood pressure physical activity sedentary lifestyle
mri brain changes induced by hyperbaric oxygen therapy in brain injury patients

Conditions: Hyperbaric Oxygen Therapy; Mild Cognitive Impairment

Summary: in our institute there is ongoing treatment of brain injury patients with hyperbaric oxygen therapy. these patients undergo neuro-cognitive function tests in addition to brain imaging studies before and after treatment. the aim of this study was to evaluate the perfusion and microstructure changes seen in mri in addition to the cognitive tests before and after the treatment.

retrospective analysis of patients suffering from chronic neuro-cognitive damage due to tbi treated at sagol center for hyperbaric medicine and research, assaf harofeh medical center, israel patients included if they had at least two perfusion mris + dti and two neurocognitive tests, before and after hyperbaric oxygen therapy (hbot). the study was approved by the institutional review board of the hospital. patients are treated with 50-70 daily hyperbaric sessions, 5 days per week. each session consists of 60 minutes exposure to 100% oxygen at 1.5 ata. all patients that underwent mri before and after hbot. the mri protocol included dsc, dce, dti, flair, t2 and swi. mri scans sequences parameters: \* dsc: 50 t2\*-weighted gradient-echo echo planar imaging (epi) volumes were acquired, 2 repetitions before a bolus injection of gadolinium-dtpa (gd-dtpa), 48 repetitions after injection of gd-dtpa. sequence parameters: tr=2,300 ms, te= 40ms, flip angle = 30°, voxel size = 1.8 x1.8, matrix = 128x128, no. of slices = 25, slice thickness = 3.9 mm. * dce: three t1 weighted fast low angle shot (flash) volumes were acquired with different flip angles (2, 7 and 15 degrees) followed by 70 dynamic t1 weighted flash volumes with flip angle of 15 degrees after bolus injection of gd-dtpa. sequence parameters: before injection: tr=4.09, after injection - tr=4.86 ms, te= 1.76 ms, voxel size = 1.5x1.5, matrix = 192x192, no. of slices = 26, slice thickness = 3.5mm. * dti: 30 diffusion weighted images were scanned with different gradient directions (b=1000) and one volume without diffusion weighting, with the following parameters: tr=10,300 ms, te=89 ms, voxel size = 1.8x1.8, matrix = 128 x 128, no. of slices = 63, slice thickness = 2.2mm

Eligibility criteria:
inclusion criteria: * patients included if they had at least two perfusion mris + dti and two neurocognitive tests, before and after hyperbaric oxygen therapy (hbot). exclusion criteria: * did no complete treatment or did not complete examinations.

Keywords: hyperbaric oxygen therapy brain trauma cognitive impairment
use of otoscope as a non-invasive tool for diagnosis of pilomatricoma

Conditions: Pilomatrixoma

Summary: stanford university dermatology clinics and lucile packard children's hospital are evaluating the use of the otoscope for the diagnosis of skin lesions. we are particularly looking for children and/or adults with nodules, cysts, tumors, or pilomatricomas. the study will take 15-30 minutes and we will use light to examine and take a picture of your skin lesion. there is no monetary compensation for participating in the study.

pilomatricoma is a benign tumor that presents as a 3-30mm firm, solitary, deep dermal or subcutaneous tumor on the head, neck, or upper extremities. the clinical diagnosis is often made by the firm, sometimes rock hard texture of the skin. the diagnosis can be confirmed by a skin biopsy and/or excision of the lesion. we have recently noted that pilomatricomas appear as a black mass in the skin when the lesion is transilluminated by placing the light of a fiberoptic otoscope adjacent to the skin lesion. we would like to confirm our impression by a prospective study using transillumination to examine subcutaneous tumors in the skin. pilomatricoma is also known as a benign calcifying or calcified epithelioma, pilomatrixoma, or a calcifying epithelioma of malherbe.

Eligibility criteria:
inclusion criteria:- potential participants will be any patient that is seen at stanford dermatology or lpch that has a cyst, nodule, vesicle, tumor, or possible pilomatricoma exclusion criteria:- inability of subject or subject's guardian to understand informed consent form.
clinical study of chimeric antigen receptor t lymphocytes (car-t) in the treatment of myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: researchers plan to enroll a total of 100 patients with relapsed, refractory acute myeloid leukemia (aml) to receive a single dose of autologous car t cells.the safety of car t therapy was evaluated by observing adverse events after cell therapy;the efficacy of car-t therapy was evaluated against the outcome of patients' own past standard treatment regimens or historical data.blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of car t cells, and to evaluate the pharmacokinetics (pk) of car t cells.


Eligibility criteria:
inclusion criteria: 1. the diagnosis of myeloid leukemia was clear;refractory treatment was defined as: (1) 2 patients who did not achieve partial remission after treatment with standard induced remission regimens.② the patients who relapsed within 6 months after the first remission were also called early recurrence.③ the failure relapsed 6 months after the initial response, but was retreated with the original induced response regimen.(4) multiple relapse.relapse is defined as: patients who achieve complete remission after treatment, more than 5% of leukemia cells in the bone marrow, also known as intramedullary recurrence;or the presence of leukaemia outside the bone marrow, also known as extramedullary relapse (usually in the central nervous system, testicular leukemia is the most common); 2. diseased cells were confirmed to express cd123, cll1 and other targets; 3. kps \> 60 points; 4. expected survival of more than 3 months; 5. no gender limitation, age 2-75; 6. patients clinically diagnosed as high-risk type, refractory type of recurrence or not eligible for standard treatment; 7. no serious mental disorders; 8. sufficient heart, liver and renal function (a. liver function: alt/ast \< 3 times upper limit of normal value (uln) and bilirubin ≤34.2μmol/l;b. renal function: creatinine \< 220μmol/l;c. lung function: indoor oxygen saturation ≥95%;d. cardiac function: left ventricular ejection fraction (lvef) ≥40%;); 9. no other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation) that are in conflict with this program; 10. can cooperate with trial management and follow-up; 11. patients voluntarily participated in the study and signed the informed consent exclusion criteria: 1. history of other malignant tumors; 2. uncontrolled active infection; 3. patients with underlying diseases requiring systemic use of glucocorticoids; 4. acute or chronic gvhd; 5. t-cell inhibitor therapy; 6. pregnant and lactating women; 7. patients with active hepatitis b; 8. other conditions considered by the investigator to be inappropriate for the study (hiv infection, intravenous drug addiction, etc.), or other conditions that may affect the analysis of the results of the clinical study.
combined anesthesia for labor and maternal temperature

Conditions: Pyrexia; Abdominal Delivery

Summary: maternal intra-partum fever commonly complicates the process of labour. its occurrence is often regarded as being synonymous with the presence of chorioamnionitis. this inevitably results in the administration of antibiotics to the affected mother. review of the literature however suggests that this approach is not always appropriate. non-infective causes of this condition that are often overlooked include the use of epidural analgesia for pain relief, normal thermal physiological changes in women not using any form of analgesia and delivery in an overheated room. women with certain risk factors such as nulliparity and a long latent phase of labour are also more prone to developing maternal intra-partum fever. irrespective of its aetiology, maternal intra-partum fever carries risks both for the mother and her unborn child. putting more thought into the care of these patients will go a long way in reducing the maternal and neonatal morbidity associated with this complication.the combined spinal-epidural (cse) technique has been introduced in an attempt to reduce these adverse effects. cse is believed to during labour provide more rapid onset of analgesia than epidural analgesia, the incidence of fever is significantly lower with cse technique.

the objective this study is determine the fever maternal incidence with cse technique for labor analgesia. methods: a randomized open clinical trial will be conducted involving seventy healthy, term, nulliparous women in spontaneous labor were assigned to either cse technique or non pharmacologic analgesia for labor.these patients will be randomly assigned to receive or not cse technique for labor analgesia. outcomes analysis wiil include maternal fever, pain intensity measured by visual analog scale, labor duration, c-section and instrumental delivery. statical analysis will performed using mann-whitney and fisher" exact test 5% level of significance.

Eligibility criteria:
inclusion criteria: * singleton pregnancies * babies were presenting head first * were expecting a vaginal delivery single fetal * gestational age up to 37 weeks * cervix length between 3-6 cm exclusion criteria: * maternal fever before randomization * antibiotics before randomization * haemostatic disorders during pregnancy * severe preeclâmpsia-eclampsia

Keywords: fever anesthesia labor
consumption of 4d dietary supplement on perceptual-cognitive and visual-motor performance

Conditions: Dietary Supplementation

Summary: the purpose of this investigation is to determine if supplementation with the 4d dietary supplement impacts perceptual-cognitive and visual-motor skills in healthy individuals.

multi-ingredient supplements (mis) have been reported to positively impact various aspects of performance. while caffeine alone has been shown to improve aerobic performance, resistance training (such as bench press), reaction time and sprint performance, it has also been suggested that it lacks the ability to improve cognition. therefore, the purpose of this investigation is to examine the effects of a caffeine containing mis on measures of cognition and reaction time, with the intent of providing additional benefits to athletic performance. this study will utilize a randomized, double-blind, placebo-controlled design. following two familiarization trials, participants will complete two testing visits. during these visits, they will complete baseline assessments, consume either the 4d dietary supplement or a taste matched placebo, and rest for 45 minutes. reaction time, cognition assessments (visual tracking speed), and reactive agility performance will be assessed following the rest period.

Eligibility criteria:
inclusion criteria: * male or female between the ages of 18-40 years old * determined to be healthy by the mhq and par-q+ exclusion criteria: * any response of "yes" on the par-q+ * daily caffeine consumption greater than 200 mg

Keywords: multi-ingredient supplement reaction time reactive agility cognition
arc therapy to restore hemodynamic stability and trunk control in people with spinal cord injury

Conditions: Spinal Cord Injury; Orthostatic Hypotension

Summary: the goal of this interventional study is to evaluate the safety and preliminary effectiveness of the arc-im therapy to improve hemodynamic management in people with sub-acute or chronic spinal cord injury. participants will be implanted with the arc-im thoracic system which aim to deliver, at the low thoracic level, targeted epidural electrical stimulation that will support natural hemodynamic control.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * must provide and sign the informed consent prior to any study-related procedures * traumatic spinal cord injury * spinal cord injury lesion level between c3 and t6 (inclusive) * ais- a, b, c or d * sci ≥ 1month * confirmed orthostatic hypotension * stable medical, physical and psychological condition as considered by the investigators * able to understand and interact with the study team in dutch or english * agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments * in case participants need continuous support from a personal caregiver in daily life, then the presence of their caregiver during the visits to the study site is needed, including independent transport (not dependent on a cab) exclusion criteria: * diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery * diseases and conditions that would require regular mri * the inability to perform an mri due to metal, magnetic or electrical device in the body (e.g. oral implant with magnet, mtal splinter, neurostimulator, artificial heart valve, clips, stents...) as assessed by the mri form of sint maartenskliniek * the inability to withhold antiplatelet/anticoagulation agents perioperatively * history of myocardial infarction or cerebrovascular event within the past 6 months * other conditions that would make the subject unable to participate in testing in the judgement of the investigators * clinically significant mental illness in the judgement of the investigators * botulinum toxin non-vesical and vesical injections in the previous 3 months before the enrolment * presence of significant pressure ulcers * recurrent urinary tract infection refractory to antibiotics * presence of indwelling baclofen (e.g. intrathecal baclofen pump) or insulin pump * women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding * lack of safe contraception for women of childbearing capacity * intention to become pregnant during the course of the study, * other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant * participation in another study with investigational drug within the 30 days preceding and during the present study * enrolment of the investigator, his/her family members, employees, and other dependent persons
plethysmography curve variability depending on the breath cycle

Conditions: Apnea; Circulatory; Change; Respiration

Summary: the aim of the study is to analyze the variability of plethysmography curve depending on the breath cycle (respiratory rate and tidal volume).

the plethysmography curve measured by finger sensors using pulse oximetry shows the changes in blood volume at the measured site. the presence of respiratory information within the pulse oximeter signal is a well-documented phenomenon. however, previous studies have mainly focused on extracting the respiratory rate from the plethysmography curve. the aim of this study is to analyze the variability of plethysmography curve as a function of both respiratory rate and tidal volume. furthermore, the aim is to analyze the possibilities of apneic pause detection from the plethysmography curve.

Eligibility criteria:
inclusion criteria: * healthy volunteers/students from the czech technical university in prague exclusion criteria: * any acute illness * pregnancy * severe cardiovascular conditions * severe asthma or other severe respiratory conditions * diabetes * hypotension or hypertension

Keywords: pulse oximetry photoplethysmography curve breath cycle apnea