Kornimate/medical-research-clean huggingface dataset:
assessment of comfort level following an intravitreal injection by 30 or 32 gauge needles

Conditions: Pain

Summary: the purpose of this study is to determine if a smaller needle size reduces discomfort suffered by patients both during and following intravitreal injections. it is the investigators belief that using a smaller size needle will help patients to be less fearful of intravitreal injections and more amenable to treatment. this study will also evaluate the effect of needle size on post injection intraocular pressure, to see if smaller needles may reduce wound leak and increase the intraocular pressure following injection. the investigators hypothesize that subject eyes injected with the smaller size needle will result in greater patient comfort both during and after their injection as compared to the eye injected with the larger needle. the investigators objective is to reduce any discomfort felt by patients who receive intravitreal injections. the investigators also hypothesize that the smaller needle will result in higher post injection pressures, and another objective is to determine if this can affect patient comfort and increase the risk of glaucomatous optic nerve damage.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \> 18 years * subject's normal therapeutic regimen calls for them to receive two sessions of bilateral injections of the same volume of ranibizumab within the next year. * disease related considerations: none. * other considerations: subjects who must be able to report pain scores during and up to 48 hours following an intravitreal injection. also, subjects must consent to at least 5 intraocular pressure checks per eye for each injection procedure. exclusion criteria: * pregnancy (positive pregnancy test) or lactation * premenopausal women not using adequate contraception. the following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch. * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * special classes of subjects (vulnerable subjects), such as fetuses, pregnant women, children, institutionalized mentally disabled, or others, especially those whose ability to give voluntary informed consent may be in question.

Keywords: intravitreal injection needle size pain intraocular pressure pain following an intravitreal injection
demineralized dentin graft with hydrochloric acid versus nitric acid in alveolar ridge preservation

Conditions: Alveolar Bone Loss

Summary: the reduction in alveolar bone dimensions is an inevitable outcome after tooth extraction due to the healing events that results in bone modeling/remodeling. alveolar ridge preservation is a successful approach that aids in reducing these changes greatly. various techniques have been employed to achieve that outcome utilizing bone grafts and/or membrane. dentin graft is a promising type that can overcome many of the limitations facing mainstream grafts. autogenous source serve the advantage of providing graft with no cross-infection risk or immunogenicity. moreover, the unique structure of dentin makes it suitable for osteoinduction and osteoconduction that yields favorite bone regeneration outcomes. demineralization of dentin is essential to release trapped growth factors, expose collagen fibrils and enhance the grafts degradability and replacement by native tissues. many acids have been investigated for the use in chairside preparation of the dentin graft and hence, clinicians are faced with different choices but little evidence regarding the acid which yield s better outcomes.


Eligibility criteria:
inclusion criteria: * non-restorable teeth * medically healthy * able to provide informed consent and attend follow-up period exclusion criteria: * pregnant * smokers or alcoholic * severe bone loss
ezetimibe plus simvastatin versus simvastatin in patients with hypercholesterolemia and coronary risk factors (p03405)

Conditions: Hypercholesterolemia; Atherosclerosis

Summary: the study was designed to assess whether 6 weeks of co-administration of ezetimibe and simvastatin is more effective than simvastatin monotherapy in allowing patients in the chd risk strata of the ncep iii guidelines to achieve their ldl-c target goal of \ 30 years old with no chd, was \<2.5 mmol/l.


Eligibility criteria:
inclusion criteria: * \>=18 years of age and treated with simvastatin 10 mg or 20 mg for at least 6 weeks and ldl-c levels of \> 2.5 mmol/l to \<=4.20 mmol/l (97 mg/dl to 160 mg/dl) at visit 1. * history of coronary heart disease (type ii diabetic patients \> 30 years old with no chd) * triglycerides \<= 4.00 mmol/l drawn, and liver transaminases (alt, ast) \<=50% above the upper limit of normal at visit 2, with no active liver disease, and/or creatine kinase (ck) \<=50% above the upper limit of normal exclusion criteria: * subjects with body mass index \>=35 kg/sqm at visit 1 * alcohol consumption \> 14 drinks per week * pregnant or lactating * treated with any other investigational drug within 30 days prior visit 1 * previously treated with ezetimibe or participated in a clinical study with ezetimibe * any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study
investigation of the effects of pilates exercises on menopause symptoms and sexual dysfunction in postmenopausal women

Conditions: Menopausal Syndrome; Sexual Dysfunctions; Quality of Life and Menopause

Summary: menopause represents a major transition in a woman's life as estrogen and progesterone levels decline, and this hormonal shift is associated with a range of symptoms that can significantly impact a woman's quality of life, including vasomotor symptoms such as hot flushes and night sweats, and urogenital symptoms such as vaginal dryness and sexual dysfunction.

this study aimed to investigate the effects of pilates exercises on menopausal symptoms and sexual dysfunction in postmenopausal women. the research seeks to understand how an 8-week pilates program, conducted twice a week, influences the quality of life and sexual function during the postmenopausal period. a total of 30 postmenopausal women were included in this study, divided into a pilates group and a control group. the pilates group participated in an 8-week pilates exercise program, while the control group received no exercise intervention but attended menopause information sessions. data were collected using the menopause rating scale (mrs), the menopausal-specific quality of life scale (menqol), and the female sexual function index (fsfi) before and after the intervention. body mass index (bmi) was recorded, but not used in the primary analysis.

Eligibility criteria:
inclusion criteria: * women who have reached menopause * being physically or cognitively competent to exercise * those who agreed to participate in the study exclusion criteria: * those with serious heart disease, dm, kidney, liver, thyroid disease and cancer patients * those receiving hormone therapy * people using antipsychotic medication * those using steroids and derivative drugs * people using insulin sensitizing drugs those with musculoskeletal system diseases that would prevent them from exercising cognitive problems that affect cooperation

Keywords: postmenopause pilates menopausal syndrome sexual dysfunctions quality of life
characterizing rheumatoid arthritis with 68ga-fapi pet/ct

Conditions: Arthritis

Summary: 68ga-fapi has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation, such as igg4-related disease and inflammatory bowel disease. some researches identified fap expression in synovial samples taken from both rheumatoid arthritis and osteoarthritis patients.thus this prospective study is going to investigate whether 68ga-fapi pet/ct may be superior for diagnosis, therapy response assessment and follow-up of arthritis than 18f-fdg pet/ct.

arthritis is a term used to mean any disorder that affects the joints. the two most common forms of arthritis are osteoarthritis and rheumatoid arthritis.rheumatoid arthritis is an autoimmune chronic inflammatory disease of unknown etiology and is characterized by chronic inflammation of the joint capsule's synovial membrane. this chronic inflammation ultimately destroys the underlying cartilage and bone. activated fibroblast-like synoviocytes (fls) line the synovial membrane and are a prominent cell type responsible for inflammation and joint destruction. osteoarthritis is characterized by degradation of joint cartilage. studies demonstrate chondrocytes expressed fap and that chondrocyte fap expression was elevated in patients with osteoarthritis. other researches identified fap expression in synovial samples taken from both rheumatoid arthritis and osteoarthritis patients. however, fap expression was greater in samples taken from refractory rheumatoid arthritis patients in comparison to end-stage osteoarthritis patients.68ga-fapi has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation, such as igg4-related disease and inflammatory bowel disease. recently the investigators have published an article of the application of 68ga-fapi in igg4-related disease which showed it was more sensitive than fdg in detecting a certain type of inflammations. thus this prospective study is going to investigate whether 68ga-fapi pet/ct may be superior for diagnosis, therapy response assessment and follow-up of arthritis than 18f-fdg pet/ct.

Eligibility criteria:
inclusion criteria: * suspected or confirmed untreated arthritis patients; * 18f-fdg pet/ct within two weeks; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * known allergy against fapi * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
the association of endothelial dysfunction and cardiac allograft vasculopathy

Conditions: Heart Transplantation

Summary: progressive cardiac allograft vasculopathy (cav) is a serious complication in long-term survivors after heart transplantation. therefore, we hypothesize that cav is a diffuse and progressive process, and endothelial function may play an important role in predicting clinical outcome after heart transplantation. therefore, this single-blinded study is designed to evaluate endothelial function, microvascular flow response and morphology of coronary artery in cardiac allografts, 1. the simultaneous use of ivus and doppler wire instrumentation in different pharmacological stress; 2. tl-201 spect (dipyridamole stress/rest); to evaluate the correlation of endothelial function, coronary morphology change and tl-201 dipyridamole stress myocardial perfusion image.


Eligibility criteria:
inclusion criteria: 1. heart transplant receipients who undergoing the coronary angiographic follow-up as standard protocols. exclusion criteria: 1. acute illness conditions including infection, congestive heart failure (nyha fc iii, iv), etc. 2. coronary angiographic finding: coronary stenosis\>30% (as grade iii, iv by klauss v et al, am j cardiol 1995; 76:463-6). 3. creatinine \>3.0 mg/dl

Keywords: 1. transplant vasculopathy 2. endothelial dysfunction 3. myocardial perfusion imaging 4. intravascular vascular ultrasound
evolution® duodenal stent for duodenal or gastric outlet obstruction caused by malignant neoplasms

Conditions: Duodenal Obstruction; Gastric Outlet Obstruction

Summary: the objective of this investigation is to compile clinical experience on the use of the evolution® duodenal stent (cook ireland), a ce marked device intended for the palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms. it is not the goal to change the usual treatment practice of the investigator or the center, nor to collect information on uses outside the product's indications. patients will be treated as per usual medical practices.


Eligibility criteria:
inclusion criteria: * patients for whom this device would be chosen in standard practice exclusion criteria: * patients for whom this device would not normally be chosen in standard practice
multibranched graft for open repair of thoracoabdominal aneurysms

Conditions: Aneurysm Abdominal; Aneurysm Thoracic

Summary: the objective of the study is the evaluation of the technical success and clinical outcomes of the surgical treatment of thoraco-abdominal aortic aneurysms treated by jotec "taaa spinal loop graft" "custom made "ce equivalent" branched prosthesis, compared with the patient cohort already treated with standard and / or bench-top prostheses gelweave ™ coselli thoracoabdominal grafts.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years; * patients candidates for surgical treatment of thoraco-abdominal aorta of the ii and iii type sec. crawford using "taaa spinal loop graft" "custom made ce equivalent" prosthesis exclusion criteria: • patients aged ≤ 18 years
unidirectional barbed sutures in mucogingival procedures

Conditions: Wound Heal

Summary: the aim of the study is to compare the efficacy of barbed suture with conventional suture in muco-gingival surgeries.

experimental: main treatment group, flap will be approximated using conventional, simple continuous suturing with barbed sutures. comparator: in patients allocated to control group, flap will be approximated using conventional, simple continuous suturing with conventional sutures.

Eligibility criteria:
inclusion criteria: * systemically healthy individuals within an age group of 20-50yrs with presence of attached gingiva, shallow vestibule and frenum interfering with the marginal gingiva. exclusion criteria: * medically compromised patients. * subjects who underwent radiotherapy or chemotherapy in the past 12 months. * smokers
vanderbilt university spasticity management program evaluation plan

Conditions: Spasticity

Summary: people with severe developmental disabilities frequently have comorbidities that make providing care to them more difficult. spasticity is one such comorbidity. it produces increased muscle tone that can cause stiffness in joints and bodily contortions that can interfere with all of the major types of care provided to participants. typically, care areas include splinting, hygiene, dressing, transfers, positioning, ambulation, and engaging in other functional activities. moreover, persons with spasticity often experience pain. typically, spasticity is managed by health care providers using a combination of the following therapies: * physical / occupational therapy (pt / ot) * oral medication * botox injections * intrathecal baclofen administered by the medtronic syncromed pump (itb) * orthopedic / neurological surgery

as individuals are identified as appropriate participants for the program and consent is obtained, the care team for each person, consisting of both medical and caregiver staff, will define up to three specific care area goals and related tasks for treatment. a comprehensive spasticity management program will then be developed for the individual. clinical and outcome assessments at baseline and at follow-up will include measures of range of motion, global spasticity according to a modified ashworth scale, and the time and number of staff required for the task. in addition, video will be obtained of caregivers performing each participant's care area tasks at baseline and follow-up to allow an independent external reviewer to judge task difficulty. treatment will be provided as outlined by the spasticity management plan. follow-up evaluations will be conducted when the participant is at least one year from their initial botulinum injection, or are one year post-implant for itb participants. when the participant is exited from the study, survey physician will be asked to rate the overall impact of the program on each of the individual's care area tasks.

Eligibility criteria:
inclusion criteria: * adult with spasticity residing at clover bottom developmental center in nashville, tennessee. * spasticity must interfere with daily functioning. * care team must be able to identify at least one treatment goal for the potential participant. exclusion criteria: * family or guardian is unwilling to provide written informed consent. * spasticity does not interfere with patient's day-to-day care. * staff who provide daily care are unable to identify a clear treatment goal.

Keywords: spasticity developmental disabilities intrathecal baclofen (itb) botulinum toxin type a (botox)
active play in after school programs

Conditions: Physical Activity; Activity Play; Motor Activity; Quality of Life; Autonomy; Competence; Children; After-School Program

Summary: background: physical activity (pa) is a key component in health promotion and prevention of overweight. interventions delivered in after-school programs (asp) have the potential to become a means of ensuring pa among young schoolchildren. this requires a motivational climate, allowing for self-determination and the intrinsic values of the activity, on the activity's character of play. asp staff could be trained in stimulating all children in physical activities in their everyday life. physiotherapists in primary care possess knowledge of motor development and learning, and are important contributors to an asp-based physical activity intervention. aim: to develop a complex intervention that emphasizes physical activity play, and to examine through a cluster-randomized trial the extent to which the intervention promotes pa and health-related quality of life and prevents overweight in a population of young children. we aim to increase the knowledge and autonomy supportive skills among asp staff members, enabling them to promote physical activity through play among all first graders in asp. in addition to investigate if the children benefit from receiving autonomy support, we aim to study whether the asp staff themselves benefit from giving autonomy support in terms of increased need satisfaction and autonomous motivation for work. the intervention: includes training of asp-staff members in the fundamental principles of self-determination theory and practical applications for motivating young children in pa through play. information will be given on the benefits of a physically active lifestyle and the staff will be encouraged to map opportunities for pa in their local asp and to incorporate strategies to increase pa through play among the children throughout the day. methods/design: a complex intervention using a mixed methods approach will be developed and evaluated. a pilot trial will assess the potential of this approach and provide information necessary to perform a cluster-randomized controlled trial (rct). the cluster-randomized controlled trial (rct) will together with qualitative interviews and observations, evaluate the effectiveness of the intervention. outcomes will be measured at baseline (september /october 2016) at the end of the intervention which lasts for 7 months (may 2017), and 1 year after the end of the intervention (may 2018)


Eligibility criteria:
inclusion criteria: * attends first grade in one of the asps included exclusion criteria: * does not attend first grade in one of the asps included
multicentre real-life follow-up study of rare epileptic syndromes in children and adolescents

Conditions: Epilepsy; West Syndrome; Dravet Syndrome

Summary: rare epilepsies as a whole account for 20-30% of epilepsies, but knowledge about prognostic factors is currently limited. this means that it is difficult to provide adequate information to families at diagnosis and during follow-up. prognostic factors are also important for management as they can have an impact on the patient's outcome (time to intervention, choice of one molecule over another, etc.). finally, few treatments are currently available for these epilepsies. one of the limitations to the development of treatments is the lack of real life data as it is difficult to create reliable primary endpoints such as the rate of patients becoming seizure free naturally compared to a therapeutic intervention. the aim of this real-life study is to evaluate the response to treatment as well as to see the evolution of cognitive and psychiatric comorbidities. as explained above, there are very few randomised trials except for 3 rare epilepsies (infantile spasm syndrome, dravet syndrome, lennox-gastaut syndrome). this has led to the virtual absence of management recommendations, including for the three syndromes mentioned above, where attempts at treatment algorithms have been proposed, although these have not been able to be considered as evidence-based recommendations. as a result, there is some diversity in the management of rare epilepsies from one centre to another. however, this diversity in management can be an asset in a real-life study. this will make it possible to compare different management methods, both in terms of seizure control and medium-term outcome.


Eligibility criteria:
inclusion criteria: * diagnosis for rare epilepsy (based on orpha codes) * holders of parental authority not opposed * be followed in one of the declared centers of the study exclusion criteria: * opposition from the holders of parental authority or the patient
an observational study to learn more about treatment patterns and factors determining the choice of treatment in canadian men with metastatic hormone sensitive prostate cancer in routine medical care

Conditions: Metastatic Hormone-sensitive Prostate Cancer

Summary: this is an observational study in which only data are collected from adult canadian men with metastatic hormone sensitive prostate cancer (mhspc) are studied. participants will not receive any advice on treatment or any changes to the healthcare. metastatic hormone sensitive prostate cancer is a cancer of the prostate gland, a male reproductive gland found below the bladder. metastatic means that cancer has spread to other parts of the body. hormone-sensitive means it can be treated with anti-hormonal therapy such as androgen deprivation therapy (adt). adt lowers the level of testosterone and slows down the growth of cancer cells. however, in some cases, adt alone is not sufficient and doctors recommend combining it with treatments like androgen receptor pathway inhibitors (arpi) and/or docetaxel to stop the growth of cancer cells. arpi slow down the growth of the cancer cells by blocking a sex hormone called the androgens from attaching to the protein found in the cancer cells. arpi includes medicines like apalutamide, darolutamide, and enzalutamide. docetaxel is a medicine used to treat different types of cancer and works by stopping the growth and spread of cancer cells. adt, arpi, and docetaxel are approved treatments for men with mhspc in canada. the participants in this study are already receiving treatment for mhspc as part of their routine medical care from their doctors.


Eligibility criteria:
inclusion criteria: * men aged ≥ 18 years diagnosed with mhspc verified by radiographic evidence of metastasis with conventional imaging (ci) or prostate specific membrane antigen-positron emission tomography (psma-pet), and histologically confirmed carcinoma * at least 6 months follow-up post-diagnosis period, unless the patient died earlier exclusion criteria: * adt use for \>6 months or any use of arpi (adt use in the neoadjuvant or adjuvant setting where the patient has been off treatment for 12 months or more is allowed) * this criterion is to ensure that we are capturing mhspc patients and not metastatic castration-resistant prostate cancer (mcrpc) patients who have progressed from earlier stages * evidence of inclusion in clinical trials during the study period