Kornimate/medical-research-clean huggingface dataset:
molecular imaging assessment of acl viability

Conditions: ACL Injury

Summary: the objective of this study is to answer the following questions: 1. does the appearance of the reconstructed anterior cruciate ligament (acl) vary in appearance on pet/mri depending on graft type and time after surgery? 2. what is the appearance of the native acl on positron emission tomography/magnetic resonance imaging (pet/mri)?

this phase i feasibility trial will evaluate knee injuries utilizing a standard of care non-contrast 3 tesla (t) mri. in addition, knee injuries will be assessed with a low dose (1/5 of the dose given for standard of care pet scans) fluorodeoxyglucose (fdg) pet research scan with cest sequences. patients enrolled in this study will include both those with and without a history of acl repair; however, patients receiving the standard of care mri will not be currently suspected of having an acl injury based on physical examination and history. patients with and without a history of acl reconstruction will undergo a low dose fdg pet scan in the same setting as their mri. the pet examination will be performed such that the early phase of imaging is performed prior to the mri and the delayed phase is completed immediately following the mri. this dual-phase scanning will allow for both assessment of the vascularity of the graft as well as its metabolic activity. patients will be asked to provide study personnel with authorization to their medical records regarding the outcome of the knee graft. this authorization will be provided for 10 years from date of signed consent. comparisons of the finding in normal and reconstructed ligaments as well as between graft types based on time from reconstruction will demonstrate the feasibility of this imaging technique and allow for generation of an imaging based hypothesis that will provide metabolic activity of the graft in a post-operative knee.

Eligibility criteria:
inclusion criteria: * male and female patients between 18 and 60 years of age. * patients scheduled for a standard of care mri at osu. exclusion criteria: * patients with a suspected acl injury. * patients who are pregnant or lactating. * patients who are prisoners. * patients who are unable to provide consent. * patient with significant renal insufficiency, i.e. an estimated glomerular filtration rate (egfr) less than 30 ml/min/1.73m2. * patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit sever vertigo when they are moved into the mr. * subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.). * subjects with any type of ferromagnetic bioimplant that could potentially be displaced or damaged. * subjects that have vascular or aneurysm clips, or metallic staples from a surgical procedure. * subjects with permanent tattoo eye liner (may contain metallic coloring). * subjects that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims.
observational study of patient comprehension, perception, fears and appreciation following home-monitoring implementation

Conditions: Defibrillators; Tachycardia

Summary: describe the mutual influences between trainings realized in implantation centers, medico-technical knowledges, technical implementation, perception, fears and appreciation felt by the patients during home monitoring implementation.

500 patients with an indication for icd (primary and secondary prevention) will be included in the registry during a period of 12 months. for the survey, patients must answer two questionnaires. the first one will assess the knowledges regarding home-monitoring which certainly depend on the time devoted to patient information during the implantation. this period of training is important and has a direct impact on the cardiomessenger use by the patient. although the study is multicenter, the aim is not to evaluate or compare practices of each center for the information provided to patients. the objective is to find ways to improve this phase. a second questionnaire was designed to observe the perception of home-monitoring by the patient and thus to understand how this new technology is apprehended. this part is important because we must take in consideration patient point of view and expectations to improve care and offer new products or services. a focus on patients' perception and appreciation may give a support to the elaboration of training and prevention strategies, the anticipation of the needs, and the improvement of the technology. all these improvements may eventually take part in the success of icd treatment.

Eligibility criteria:
inclusion criteria: * primo icd implantation with home-monitoring system exclusion criteria: * nyha class iv * pregnant women or women who plan to become pregnant during the trial * patient whose medical situation is not stable * presence of psychiatric illness, depression, anxiety disorders * presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea \> 70mg/dl or creatinine \>3mg/dl, liver failure, etc. * age \< 18 years * patient unable to handle the cardiomessenger correctly * the patient is not willing and able to comply with the protocol (i.e. unable to answer to the questionnaires) * change of residence expected during the study * participation in another clinical study * patient unwilling to sign patient informed consent

Keywords: remote monitoring defibrillators survey indication for icd (primary and secondary prevention)
integrated intervention post-sexual assault

Conditions: Substance Use Disorders; Posttraumatic Stress Disorder; Sexual Assault

Summary: the primary objective of the proposed stage ia/ib study is to establish feasibility of an integrated cognitive-behavioral intervention for reducing sud and ptsd symptoms among women who experienced a sexual assault within the past six weeks. the intervention will be tested in an open label trial to make final modifications to evaluate feasibility, acceptability, and preliminary efficacy of the five to six week integrated intervention with standardized repeated measures during a one-month follow-up.


Eligibility criteria:
inclusion criteria: 1. female; any race or ethnicity; age 18 to 65 years old. 2. sexual assault that occurred within the past ten weeks. 3. subjects must be able to comprehend english. 4. report a minimum of two substance use disorder symptoms 5. a minimum of one symptom of each cluster of posttraumatic stress disorder 6. subjects may also meet criteria for a mood disorder or other anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder). the inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with substance use disorder and posttraumatic stress disorder 7. must consent to complete all treatment and follow-up visits. exclusion criteria: 1. lack of any memory of the sexual assault 2. women who are menopausal 3. subjects with a history of or current psychotic, manic, dissociative identify disorder, or a current eating disorder, as the study protocol may be therapeutically insufficient. 4. subjects experiencing significant withdrawal symptoms, as evidence by a score of 10 or more on the clinical institute withdrawal assessment for alcohol (ciwa)99 or a positive score of on the clinical opiate withdrawal scale.100 these subjects will be referred for clinical detoxification and may be re-assessed for study eligibility after medically supervised detoxification has been completed. 5. individuals considered an immediate suicide risk, with current suicidal ideation and intent. these individuals will be referred directly for treatment. 6. individuals on psychotropic medications must be stabilized on it for at least two weeks prior to beginning the study. 7. any other medical or psychiatric conditions that the investigators believe may compromise the individual's ability to safely participate in the study.
essential oil for chronic low back pain

Conditions: Chronic Low-back Pain

Summary: the specific objective of this study is to assess the safety and clinical efficacy of a new individualised spinal rehabilitation programme involving copaiba essential oil (ceo) therapy compared to usual care for people with chronic low back pain. research in complementary and alternative medicine has increased over the last 15 years. as biochemical research shows, these substances carry the ability to relieve pain and to reduce inflammation. in doing so, it aims to: 1. improve the health outcomes for individuals with chronic low back pain (clbp) by positively impacting their pain, disability, work capacity, physical activity and mental health, and 2. reduce the chronic health burden on society associated with treatment, sick leave, rehabilitation, and involuntary retirement, by reducing health-related costs. the primary clinical hypothesis is that patients with clbp receiving individualised spinal care and additional ceo topical treatment will have superior short- and long-term outcome (defined by condition specific quality of life and general well-being) compared to usual care.


Eligibility criteria:
inclusion criteria: * chronic low back pain with or without irradiating pain (pain \> 3 months) * low back pain is the dominant symptom, and visual analog pain scale (low back pain)\>4 * normal cognitive function, voluntary participation * able to read and answer the questionnaires in english or hungarian language exclusion criteria: * previous spinal surgery * untreated metabolic bone disease * active malignant disease * pregnancy * severe osteoporosis, fracture or posttraumatic deformity * spinal infection * neuromuscular disease * autoimmune disease * myelopathy * congenital spinal deformity * mental disorders * severe sciatica * severe spinal instability * refusing the study protocol
oral health in patients hospitalized because of ischemic stroke

Conditions: Oral Disease; Stroke, Ischemic

Summary: maintaining good oral health is essential for general health and quality of life. results of many anal-yses showed that stroke patients had poorer oral condition and worse periodontal status than control population. the aim of the study was to carry out a clinical observation concerning condition of oral health in stroke patients and healthy population. the oral health was assessed in patients with stroke and in (control group). the following elements were assessed: missing teeth, the presence of active caries foci, the presence of existing fillings and prosthetic restorations. to assess oral hygiene api (approximal plaque index) was used. as part of periodontal examina-tion, the following were assessed: the presence of dental deposits, the depth of the existing periodontal pockets, tooth mobility according to hall and sulcus bleeding index during probing (sbi).


Eligibility criteria:
inclusion criteria: * first ischemic stroke, with symptoms from the anterior cerebral artery (basin of the internal carotid artery), with a significant neurological deficit (minimum 3 points according to national institute of health stroke scale (nihss)) exclusion criteria: * aphasia, disturbances of consciousness, mental disorders- making it impossible to express informed consent, * surgery of the salivary glands- disrupting the secretion of saliva, * diseases that disrupt salivary secretion (diabetes mellitus, sjogren's syndrome, condition after radio-therapy in the area of the salivary glands)

Keywords: stroke oral health dentition periodontium
18f-pbr06/total body pet imaging in patients with stemi

Conditions: Myocardial Infarction

Summary: the study will use 18f-pbr06/uexplorer to study the activation of macrophages and systemic perfusion in patients with st-segment elevation myocardial infarction (stemi) or stable angina (sa). participants will receive the total-body pet/ct scan on the seventh day (day 7, d7) and d180 of enrolment.

the aim of our study is to explore the activation of macrophages in patients with st-segment elevation myocardial infarction (stemi) or stable angina (sa) using the 18 kda translocator protein (tspo) radioligand 18f n-fluoroacetyl-n-(2,5-dimethoxybenzyl)-2-phenoxyaniline (18f-pbr06) in combination with the world's first commercially available total-body pet/ct (uexplorer). the investigators expect to enroll 10 patients diagnosed with stemi and 10 patients with sa who receive coronary angiography (cag) and the percutaneous coronary intervention (pci), and 5-10 healthy individuals diagnosed with sa but presenting negative cag at renji hospital, shanghai. the activation of macrophages (tspo uptake) and blood perfusion in different organs will be studied using 18f-pbr06/uexplorer. with written consent from eligible participants, the investigators will review past medical records and document the medical history for each participant. patients will undergo pci on the day of enrolment (12 hours within the symptom onset for stemi patients). screen procedures will be performed at the seventh day of enrolment (day 7, d7) and day 180 (d180). participants will receive one dose of the non-therapeutic administration of the radioactive tspo tracer 18f-pbr06 and receive a whole-body scan by uexplorer. tspo uptake and blood flow in the heart, kidney, liver, brain, and lung will be recorded. all participants will be followed for 1 year after enrolment. blood samples will be collected and echocardiography will be performed at d7 and d180. major adverse cardiovascular events (mace) will be recorded throughout the follow-up.

Eligibility criteria:
inclusion criteria: * aged 18-75 years old * diagnosed with stemi, nstemi or suspected sa (acc/aha guidelines) * half male and half female * undergo cag and pci treatment if necessary (primary pci for stemi patients within12 hours after symptom onset) * written informed consents will be offered and signed by all participants exclusion criteria: * history of myocardial infarction/vascular disease/heart failure/systemic inflammatory diseases before enrolment * patients who are pregnant/breastfeeding, or in a plan to have a baby during the year after cag/pci * people under the age of 18 years old * inability to lie or maintain posture during the scanning procedure
comparison of concentration of vasopressin during robot-assisted laparoscopic myomectomy

Conditions: Uterine Leiomyoma

Summary: the purpose of this study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy.

this study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy. we would like to evaluate the feasibility and validity of this study for future phase iii randomized clinical trials through this preliminary randomized assignment study. uterine fibroids are the most common tumors in women, and uterine myomectomy, which is performed as a treatment for them, is basically a high risk of bleeding and blood transfusion. a common method to reduce intraoperative bleeding is to inject diluted vasopressin into the subserosal areas of the fibroids. however, no proper level of vasopressin dilution has been determined so far, so we want to determine an effective dilution concentration of vasopressin that can minimize side effects through this clinical trial.

Eligibility criteria:
inclusion criteria: * informed consent * age: 19-60 year-old women * plan of myomectomy for uterine leiomyomas * leiomyoma subclassification system 2-7 (robot-assisted laparoscopic myomectomy is possible) * american society of anesthesiologists physical status classification 1 or 2 * a person who understands the contents of the clinical trial, is cooperative with the trial, and is judged to be able to participate until the end of the study exclusion criteria: * pregnancy or breastfeeding * a single diameter of uterine leiomyoma is greater than 12 cm or more or multiple leiomyomas with more than five * suspicious disease of uterine malignancy * patient with has a history of pelvic surgery (cesarean section, myomectomy, etc.) and is expected to have severe pelvic adhesion * a person who is hypersensitive or contraindicated to vasopressin * a person who is hypersensitive or contraindicated to tranexamic acid * considered as inappropriate by the researcher's judgment

Keywords: leiomyoma uterine fibroid uterine myomectomy hemostasis vasopressin dilution
optimizing body composition for function in older adults

Conditions: Obesity; Overweight With Indications for Weight Loss

Summary: the purpose of this pilot study is to compare two strategies intended to improve the health of overweight older adults by improving body composition. one strategy, resistance training, is designed to preserve skeletal muscle mass. the other strategy, the use of a ppar-γ agonist, is designed to enhance the loss of fat from visceral and skeletal depots. these strategies will be used in conjunction with a hypocaloric diet and will be compared to a hypocaloric diet alone to determine if either of these strategies are superior in reducing visceral fat and preserving muscle mass.

in this pilot we propose to recruit 88 older (65 - 79 yrs) men (n=48) and women (n=40) at risk for disability and with indications for weight loss according to nih guidelines. all will be enrolled in a dietary intervention designed to generate a caloric deficit of 500 kcal/day for a 4 month period. all will receive supplemental vitamin d and calcium. these participants will be randomized into one of 4 groups: group 1 - hypocaloric diet (and placebo) group 2 - hypocaloric diet and resistance training designed to maximize muscular power (and placebo) group 3 - hypocaloric diet and a ppar- γ agonist (pioglitazone/actos™) group 4 - hypocaloric diet and resistance training and pioglitazone/actos™ the specific aims of the pilot are: 1. in both men and women, to determine whether randomization to resistance exercise is associated with an increased retention of appendicular non-bone lean mass compared to those not undergoing power training. 2. in both men and women, to determine whether randomization to the pioglitazone group is associated with an increased loss of visceral adiposity relative to randomization to the non-pioglitazone group. 3. assess the feasibility of the recruitment, assessment and intervention strategies 4. to estimate adherence to the weight loss, exercise training, and drug interventions; 5. in this population, to determine measurement characteristics of the functional outcomes that will be considered as primary end-points of the larger study. 6. to obtain pilot data on a subset of participants to determine the feasibility, acceptability and measurement characteristics of muscle samples (biopsies) to quantify intramyocellular lipid in this study population.

Eligibility criteria:
inclusion criteria: * weight stable, indication for weight loss per nih guidelines, performance on the short physical performance battery score 3-10 exclusion criteria: * diabetes, weight \> 136 kg, medical condition that limits exercise participation, congestive heart failure, abnormal kidney function, higher alt than normal, currently involved in a weight loss or exercise program, current smoking, alcohol or drug abuse, taking anti-inflammatory steroids, taking protein supplements, taking ppar-gamma agonist, edema, anemia

Keywords: body composition sarcopenia weight loss trials intervention studies elderly
positron emission tomography (pet) study with (11c) flumazenil to determine central gabaa receptor occupancy of azd6280

Conditions: Anxiety

Summary: the study is carried out in order to determine the relationship between the dose of azd6280 and the blood concentration of azd6280, and to investigate to which extent azd6280 binds to gabaa receptors


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18-30 kg/m2 and weight of 60-100 kg * clinically normal physical findings, medical history and laboratory values. exclusion criteria: * clinically significant illness or clinical relevant trauma within 2 weeks before the study start. * history of clinically significant heart arrythmias or heart disease/problems. * previous participation in a pet study within the past 12 months. suffer from claustrophobia and would be unable to undergo mri (magnetic resonance imaging) or pet scanning.

Keywords: anxiety gaba receptors positron emission tomography pet phase i
effects of different power training intensities in older adults

Conditions: Investigating the Effects of Power Training in the Elderly

Summary: power (strength × velocity) is a crucial component for maintaining independence during aging. therefore, investigating interventions aimed at improving this physical capacity is essential for this population. the aim of this study is to examine the effects of power training (pt) performed at low to moderate intensity (ptlm; 40-60% of 1-repetition maximum \[1rm\]) and moderate to high intensity (ptmh; 65-80% of 1rm) on muscle power, kinematic gait parameters, strength, muscle thickness, and functional performance in older adults. participants will be randomly assigned to perform ptlm and ptmh. data collection will occur before and after familiarization, as well as at weeks 8 and 16 of the training programs. participants will undergo a series of tests in the following sequence: 1) muscle thickness and 1rm test; 2) muscle power, maximum voluntary contraction, and rate of force development; 3) functional performance. the primary analyses will be conducted on an intention-to-treat basis, comparing the effects of the interventions and groups over time. generalized estimating equations (gee) will be used, considering the factors of group (2 levels) and time (3 levels). paired comparisons will be assessed using the bonferroni post-hoc test to identify significant differences between groups and time points. all tests will be performed using jasp software (version 0.16.4.0), with statistical significance set at p \< 0.05 for all analyses.


Eligibility criteria:
inclusion criteria: * age 60 years or older * no participation in regular and systematic resistance training in the last three months * no absolute or relative contraindications to exercise * no musculoskeletal injuries that could interfere with training and assessments exclusion criteria: * use of steroids, nutritional supplements, or ergogenic substances * failure to complete all study phases * failure to complete more than 80% of the training sessions (32 sessions)

Keywords: aging resistance training functional capacity muscle strength muscle hypertrophy