Kornimate/medical-research-clean huggingface dataset:
effects of the use of occlusal splint on the postural balance of individuals with temporomandibular disorder

Conditions: Temporomandibular Disorders

Summary: to investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder. the research group consists of 49 patients (36 getting occlusal splints and 13 as control group) between 18 and 75 years old, both genders, diagnosed as temporomandibular disorder (tmd) by rdc/tmd questionnaire and magnetic resonance imaging of the temporomandibular joints. the research is a randomized, controlled, prospective clinical study with intervention. postural equilibrium will be evaluated by means of a force plate. in the randomization, the splinted group was under an occlusal-stability criterion as well as advised under therapeutic exercises while the control group got only orientation about therapeutic exercises. after 12 weeks, the groups were re-evaluated. the results will be analyzed by categorical data using absolute and relative frequencies as well as continuous data using average, median, standard deviation, 25 and 75 percentiles, besides minimum and maximum values; comparison between the times by non-parametric wilcoxon, mann-whitney and anova tests with a threshold of significance of 0.05.

approved 06/29/2011

Eligibility criteria:
inclusion criteria: * diagnostic criteria temporomandibular disorders and dentate subjects exclusion criteria: * without diagnostic criteria temporomandibular disorders and edentulous subjects

Keywords: postural balance temporomandibular disorders splints
elevated lipoprotein(a) in hospital staff

Conditions: Hypercholesterolemia; Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia; Cardiovascular Diseases

Summary: the objective of this study is to investigate the prevalence of elevated lp(a) in the working general population.

the objective of this study is to investigate the prevalence of elevated lipoprotein(a) concentrations and distribution of lipoprotein(a) in a working general population. this is a prospective study investigating the association of lipoprotein(a) with cardiovascular markers and outcomes.

Eligibility criteria:
inclusion criteria: 1. any healthcare workers working in healthcare settings (regardless of phi and/or private setting) aged 21 and above or family member such as father, mother, siblings, grandparents, spouse and children aged 12 and above of recruited staff with high lpa ≥120nmol/l 2. study team members can also be recruited because we are trying to find the prevalence of elevated lp(a) exclusion criteria: 1. inability to provide informed consent. 2. pregnant women. 3. prisoner
daxibotulinumtoxina for injection for the treatment of plantar fasciitis

Conditions: Plantar Fasciitis

Summary: this is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of a single administration of daxibotulinumtoxina (daxi) (high-dose; low-dose) for injection versus placebo for the management of plantar fasciitis.

approximately 150 subjects, recruited from approximately 20 study centers in the united states (us) will be randomized to daxi (high-dose; low-dose) or placebo group, respectively.

Eligibility criteria:
inclusion criteria: * written informed consent, including authorization to release health information. * male or female subjects 18 to 65 years of age with diagnosis of unilateral plantar fasciitis. * persistent heel pain. * women of child bearing potential must have a negative pregnancy test at screening and injection visits and must use an effective method of contraception during the course of the study. exclusion criteria: * previous injection of botulinum toxin in the lower extremities or feet. * previously suffered a partial or full thickness tear or surgery of the plantar fascia within the 5 years preceding participation in the investigation. * pregnant, nursing, or planning a pregnancy during the study. * current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit. * any condition or situation which, in the investigator's opinion, puts the subject at significant risk, could confound the trial results, or may interfere significantly with the subject's participation in the trial.

Keywords: daxi for injection, plantar fasciitis, heel pain, botulinumtoxina
assessment of disease burden in hairy cell leukemia

Conditions: Hairy Cell Leukemia

Summary: drug-free, single-center, prospective observational pilot study in hairy cell leukemia patients

the v600e gene lesion of b-raf, specific and almost always present in patients with hairy cell leukemia, correlates with the presence of neoplastic cells, therefore of active disease. the measurement of the fractional abundance of the mutated gene, by ddpcr, could therefore constitute a method of molecular assessment of the minimal residual disease. in addition, the values of fractional abundance (fa) of the mutated allele obtained can be integrated coherently in patients' clinical context, along with their pb counts and bm findings. primary objective verify whether the absence of mutation at the end of treatment, indicative of a state of complete molecular response to therapy, can represent a predictor of long treatment-free survival. secondary objectives verify the association between the absence of mutation and the duration of response in patients who do not need treatment for at least 5 years after only one treatment with purine analogues (cladribine and pentostatin) and judged in cr according to current criteria.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of hcl patients: 1. newly diagnosed and candidates for first-line cytoreductive treatment with analogues purines or 2. in relapse after a previous line of treatment, with indication for rescue therapy (repetition of a purine analogue; use of targeted or innovative drugs), except splenectomy or 3. in cr for at least 5 years after a first line of treatment, in the absence of clinical alterations indicative of a state of hematological relapse, or in any case in the absence of an indication for a new line of cytoreductive therapy (time-to-next treatment exceeding 5 years). 2. age ≥ 18 years at enrollment 3. signature of written informed consent exclusion criteria: 1. concomitant second malignancy.
exalt single-use duodenoscope vs reusable scope, a randomized controlled trial

Conditions: Biliary Diseases; Pancreatic Duct Disorder

Summary: this randomized controlled trial (rct) is designed to evaluate the new generation exalt model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.

to ensure a safe and high-quality endoscopy, there are multiple disinfection protocols for endoscopes. side-viewing duodenoscopes with an adjustable accessory device (elevator) contain potential blind spots for debris and bacteria that require specialized cleaning and disinfection methods beyond standard protocols for other endoscopes. it is thought that the duodenoscope's design, persistent postprocedural microbial contamination and biofilm formation make it more prone to cross-contamination5. gromski et al, found there are documented pathogenic transmissions, which led to harm in multiple patients and centers3. infection control was likely related to two major components, reusable duodenoscopes and procedural factors related to how the reusable duodenoscopes were reprocessed3. multidrug-resistant organisms, such as carbapenem-resistant enterobacteriaceae, that were associated with reusable duodenoscopes lead the fda to mandate the transition to improved cleaning and disinfection methods or single-use platforms to eliminate infection transmission. one such single-use platform is the exalt model d (boston scientific, marlboro, ma), which received fda approval in 2020 for use of single-use duodenoscopes. early iterations of the exalt were used on a case-by-case basis per institution-specific protocols, mainly due to the learning curve involved with using the scope. a new version of exalt has been released to market in 2023 with modifications that may make it more feasible to use in all settings requiring a duodenoscope. this randomized controlled trial (rct) is designed to evaluate the new generation exalt model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.

Eligibility criteria:
inclusion criteria: * all patients \> 18 years old who have biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at ct or magnetic resonance cholangiopancreatography * native papilla exclusion criteria: * patients with altered pancreaticobiliary anatomy * pregnancy * patients with percutaneous transhepatic biliary drainage * prior history of ercp * inability to provide informed consent

Keywords: endoscopic retrograde cholangiopancreatography (ercp) duodenoscope single-use reusable biliary disorder pancreatic duct disorder
a study to observe the safety, tolerability, and efficacy of remodulin

Conditions: Pulmonary Arterial Hypertension

Summary: this is a multi-center, single-arm, prospective study to enroll patients diagnosed as pulmonary arterial hypertension. the objective in this study is to observe the efficacy and safety of treprostinil in subjects with pulmonary arterial hypertension.

this is a multi-center, single-arm, prospective study to enroll patients diagnosed as pulmonary arterial hypertension. the expected study period will be 2 years. pah patients, who met nhi criteria, to receive treprostinil subcutaneously/ intravenously, will be invited to join this study for observation. the dosage and administration schedule of study medication will be judged by investigators. if the eligibility criteria have been met and the subject have signed the informed consent, the subjects will be enrolled into this study. there will be 10 visits: visit 1 (screening visit, week -2 \~ -1), visit 2 (week 1, initial of use treprostinil), visit 3 to 9 (week 13 to 85), visit 10 (week 97). the day 1 in week 1 should be the start day of treprostinil treatment. subjects will be returned to the clinics every 3 months (i.e. 12 weeks) after visit 2. the nt-probnp level, who functional class, 6-minute walk distance, echocardiography, pulse oximetry, modified borg dyspnea scale, sf-36 questionnaire, and dosage regimens of treprostinil (including dose adjustment) will be collected. for time to clinical worsening and death, it will be followed up during study period. all intercurrent events within 24 months will be recorded. safety information, including vital signs, and physical exams will be checked. adverse events of special interest (aesis) will be reviewed every visit by using a predesignated aesi checklist.

Eligibility criteria:
inclusion criteria: * diagnosed with symptomatic idiopathic or heritable pah classified as who functional class iii and iv symptoms. * pah patient, who met nhi criteria, will be scheduled to receive subcutaneous/intravenous treprostinil treatment. * ability to adhere to the study visit schedule and understand and comply with all protocol requirements. * will provide completed and signed written informed consents exclusion criteria: * active treatment with injectable prostanoids different from subcutaneous/intravenous treprostinil
bedside evaluation of edema

Conditions: Edema

Summary: edema, commonly called swelling, is a common medical condition, with many causes. clinicians generally find edema by pressing against a patient's skin, usually on the feet or shins, and observing how much dimpling there is in the skin. most clinicians estimate the amount on a scale of mild to severe, or perhaps state the amount as 1 to 4. there is little agreement between observers, and it is hard to judge different clinicians' use of these scales. the first part of this experiment will demonstrate this inconsistency. after clinicians are shown a new technique for measuring edema, the second part of the study will show more accurate and consistent measurements. this will help clinicians to measure edema better, and to communicate their findings to other clinicians more effectively.

the research team will recruit as many clinicians who are conveniently available for the study. clinicians will include attending physicians from any specialty, residents, medical students, physician assistants, physician assistant students, nurses, certified nurse practitioners, and certified nurse practitioner students. once patients and clinicians have been recruited, the research team will maintain a list of the patients and a grid of which clinicians are to examine which patients. each clinician will be given a data collection sheet, listing the patients' room numbers, and a grid for recording results for each of the patient's affected limb(s). the first data collection sheet (before instruction on the quantitative method) will just show a blank free text field so that clinicians can record their results as they normally do. after instruction in the novel quantitative technique, the clinicians will receive another data collection sheet now indicating the intent to have the clinicians record their findings in millimeters. the expectation is that a minimum of 6 examiners will determine the extent of edema on at least 38 limbs. if possible, the research will continue until approximately 100 limbs have been examined by a total of at least 10 to 20 clinicians.

Eligibility criteria:
inclusion criteria: * currently admitted patients * patient who can understand the purpose of the study and sign a consent form * patient has a measurable amount of edema * patient will likely be available during the time the clinicians can examine the patient exclusion criteria: * unable or unwilling to sign the consent form * no measurable edema * currently in isolation for infection control purposes * patients in the behavioral health section of the hospital * maternity patients (due to availability of infant rooming-in) * prisoners * age below 18 years * patients with bilateral lower extremity amputation
istent inject trabecular micro-bypass system continuation post-approval study

Conditions: Glaucoma, Open-Angle

Summary: long term follow up of subjects in the ide study for istent inject to monitor safety

to evaluate the long -term rate of clinically relevant complications associated with istent inject® placement and stability in subjects who have completed participation of the ide clinical trial (gc-008).

Eligibility criteria:
inclusion criteria: * randomized subject followed for 24 months in the gc-008 study * able to understand study requirements * willing to attend scheduled follow-up exams for 5 years post-operatively * able and willing to provide written informed consent on the irb approved informed consent form exclusion criteria: * none
psychiatric assessment of parents of children with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the aim of this study is to carry out a psychological evaluation for the parents of children diagnosed with attention deficit hyperactivity disorder (adhd) and parents of children without adhd as control to detect any psychological problems in those of children with adhd . these problems may be a precipitating factor to cause adhd in their child or have a genetic predisposition to be passed to their children. on the other hand these psychological problems may be caused by the difficulties they encounter in raising their adhd child. the exact relation needs more researches and to be more investigated.


Eligibility criteria:
inclusion criteria: * parents of children diagnosed with adhd according to the american psychiatric association's diagnostic and statistical manual (dsm-v). * children are between 4 and 16 years of age for both sexes. * children with normal iq \> 70%. * parents are able to give informed consent and able to complete the research assessments. exclusion criteria: * parents having chronic debilitating diseases e.g. chronic liver cirrhosis. * parents were participating in other clinical research. * refusal to participate.
alberta project promoting active living and healthy eating in schools

Conditions: Childhood Obesity

Summary: the objectives were to 1) make students eat healthier and be more active; and 2) prevent overweight and obesity. children will therefore be less likely overweight or obese. beginning in january 2008, the alberta project promoting active living and healthy eating in schools (apple schools) was implemented in 10 schools throughout the canadian province, alberta. full-time school health facilitators were placed in each of the schools to implement what is know in canada as comprehensive school health (csh). in the united states, csh is more commonly referred to as "coordinated school health", while the synonymous term "health promoting schools" is often used in australia and europe. the project was evaluated annually in the spring from 2008 to 2011 and as of 2009 evaluations included the use of time-stamped pedometers. the comparison group included approximately 150 schools that were randomly selected to reflect the population of alberta, canada. twenty of these randomly selected schools also participated in data collection which involved the use of time-stamped pedometers.

the alberta project promoting active living and healthy eating in schools (apple schools) is a quasi-experimental pre-post trial with a non-equivalent parallel control group. the intervention began in january 2008 and lasted through june 2011 and was implemented school-wide. as out primary interest is to reduce the prevalence of overweight and obesity in schools, the essential comparisons were across grade five students in differing calendar years. at each survey all grade five students were invited to participate. the current design allowed intervention effects to be assessed over time at the school-level. surveys were administered in the spring of 2008, 2009, 2010, and 2011 in intervention schools. and in the spring of 2008 and 2011 in control schools.

Eligibility criteria:
inclusion criteria: intervention schools: * school located in a socioeconomically disadvantaged neighbourhood and a demonstrated need for health promotion * grade five students with parent consent, who also assented to participate were included in annual evaluations control schools: * grade five students with parent consent, who also assented to participate were included in annual evaluations exclusion criteria: intervention \& control schools: * schools that did not receive jurisdictional approval to participate * grade five students who did not receive parent consent or did not provide their assent were not included in annual evaluations

Keywords: childhood physical activity nutrition health promotion
99mtc-p137 spect/ct in prostate cancer

Conditions: Prostate Cancer

Summary: purpose: this study will take prostate specific membrane antigen (psma) as the targeting of radionuclide labeled molecular probe to explore the diagnostic efficacy of 99mtc-p137 radioactive probe in prostate cancer. combining with spect/ct to optimize the imaging, image analysis and clinical diagnosis process of 99mtc-p137 probe, the aim of the study is to provide new methods and new means for the early detection, early diagnosis, accurate tumor staging, treatment decision and prognosis judgment of malignant tumor, and will provide scientific and clinical basis for the precise diagnosis and treatment of prostate cancer. research objectives: to investigate the clinical translational application value of 99mtc-p137 molecular probe in accurate detection of prostate cancer lesions. research design: a prospective study design will be used in this study. patients meeting the inclusion criteria of this study will be analyzed with 99mtc-p137 spect/ct imaging. to evaluate the diagnostic and prognostic value of 99mtc-p137 nuclear medicine imaging in accurate detection of prostate cancer lesions, clinical surgical specimens and pathological diagnosis will be used as the gold standard. study the population indications: for patients with suspected prostate cancer who plan to undergo surgical resection or puncture biopsy after various examinations, the final pathological results can be obtained.


Eligibility criteria:
inclusion criteria: * patients age 18 or above; * highly suspicious for prostate cancer patients: 1) serum psa is significantly changed compared with before (psa\ 0.35ng/ml; or psa \> 4.0ng/ml with annual change \> 0.75ng/ml); 2) first or second degree relatives have a history of prostate cancer; 3) nuclear magnetic pi-rads score ≥3 points; * the prostate biopsy or surgical pathology is diagnosed with prostate cancer; * available to provide clinical laboratory results (blood routine, biochemical and serum psa) within one month before this study; at least two imaging examinations including ct, mri, nuclear medicine (pet/ct or spect/ct), ultrasound and other imaging techniques; * can complete the inspection autonomously; * voluntary and signed informed consent. exclusion criteria: * there are other malignant tumor history; * severe damage of liver and kidney function; * may not be able to obtain pathology or long-term follow-up results; * don't have access to relevant reference image data and clinical data; * difficult to cooperate.
effect of walking on sand with dietary intervention in overweight type 2 diabetes mellitus patients.

Conditions: Walking, Difficulty; Diabetes Mellitus, Type 2; Hemoglobin; Hb-SC

Summary: type 2 diabetes meletus(t2dm) is a global health concern. the incidence of t2dm globally is increasing exponentially partly due to unhealthy food habits and sedentary life style.exercise and nutritional intervention is long being reported to improve glycemic control and improve quality of life among individuals with t2dm. moderate intensity of walking for 30 minutes is proven to regulate good metabolic control. however, in over weight elderly individuals, joint pain or arthritis walking be a challenging task. therefore, walking on sand which is reported to be easy on joints would be a alternative for those patients.

uncontrolled t2dm has shown to cause multiple complications and alter the normal physiological process of the body. prompt dietary management and regular exercises are reported to improve blood glucose homeostasis and eventually improve the quality of life. physical activity such as regular walking is associated with multiple physical and psychological benefits. walking and a healthy diet is a cornerstone in the treatment of t2dm. several studies have shown positive short-term effects of walking in t2dm. combination of walking and weight training is reported to cause cardiovascular adaptations, muscle hypertrophy, increased capillary density in the muscles of patients with t2dm as well as in healthy people. furthermore, 30 minutes of brisk walking has shown to improve blood glycemic metabolism and reduces cardiovascular risk factors, such as high blood pressure, lipid disorders, and fat mass buildup. however, the elderly with mild to moderate arthritic changes especially in knee joints make walking a bit more challenging. sand walking would be the best alternative than firm surface walking with less joint reaction forces. to the best of our knowledge, scientific literature lacks evidence about the effect of sand walking combined with individualized dietary intervention in t2dm. therefore, the purpose of this study was to compare the effect of sand walking as compared to normal walking on glycemic metabolism, weight, and quality of life in t2dm. the investigators hypothesize that sw would result in better health benefits than nw in t2dm.

Eligibility criteria:
inclusion criteria: 1. diagnosed with type 2 diabetes for past 1 year. 2. hba1c between 7-10%. 3. bmi between 25-29.9 4. age between 45-75 5. sedentary exclusion criteria: 1. diabetic neuropathy 2. active smoker 3. musculoskeletal conditions 4. cardiovascular conditions