Kornimate/medical-research-clean huggingface dataset:
comparison of bulk-fill composite resins in class ii restorations

Conditions: Class II Dental Caries

Summary: the goal of this clinical trial is to evaluate the clinical performance of class ii restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins . class ii restorations will be performed in patients using three different restorative materials.and restorations will be evaluated using modified us public health service criteria resorations will be photograped and restorations will be evaluated for 6,12 months.

the aim of this clinical study was to evaluate the clinical performance of class ii restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins. methods and materials: class ii restorations will be performed in patients using three different restorative materials: viscalor thermoviscous bulk-fill (vcb; a thermoviscous nanohybrid bulk-fill composite resin) , admira fusion x-tra ( aft: a conventional nanohybrid bulk-fill composite resin) and 3m filtek one bulk-fill restprative (fob: a conventional bulk-fill nanocomposite ) futura bond u adhesive will be used for both conventional bulk-fill composite resin restorations and thermoviscous bulk-fill composite resin restorations. criteria for inclusion of patients in the study : healthy individuals without any systemic disease, patients who is between 18 and 60 years old, patiens who brush their teeth 2 times a day,voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment. criteria for not inclusion of volunteers in research:women who are pregnant or breastfeeding ,patienrs with advanced periodontial disease,patiens using a moving segmental prosthesis,patiens who have maloclusions,patiens who have bruxism,patients with known allergies to resin-based restorative materials and binding agents the restorations will be evaluated using modified us public health service criteria in terms of retention, color match, marginal discoloration, anatomic form, marginal adaptation, secondary caries, postoperative sensitivity, and surface texture. resorations will be photograped and restorations will be evaluated for 6,12 months .

Eligibility criteria:
inclusion criteria: * healthy individuals without any systemic disease * patients who is between 18 and 60 years old, * patiens who brush their teeth 2 times a day * voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment. exclusion criteria: * women who are pregnant or breastfeeding * patients with advanced periodontial disease * patiens using a moving segmental prosthesis * patiens who have maloclusions, * patiens who have bruxism, * patients with known allergies to resin-based restorative materials and binding agents

Keywords: bulk-fill composite thermoviscous bulk-fill composite class ii restorations
imaging of 3d innervation zone distribution in spastic muscles from high-density surface emg recordings

Conditions: Spasticity

Summary: the purpose of this study is to evaluate if it is possible to use a new 3d imaging method to guide botulinum neurotoxin (btx) injection for muscle spasticity management after stroke. this imaging method is called three dimensional innervation zone imaging, or 3dizi.


Eligibility criteria:
inclusion criteria: * a history of not more than one stroke which occurred at least 6 months prior to study enrollment; * elbow flexor spasticity rated at 2 or 3 on modified ashworth scale (mas); * receiving repeated botulinum toxin injection every 3-4 months; * absence of excessive pain in the paretic upper limb; * capacity to provide informed consent, with mini-mental state examination (mmse) must be 25 or higher; the following modified ashworth scale (mas) will be used for spasticity assessment: 0 -no increase in muscle tone; 1 -slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ -slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the rom; 2 -more marked increase in muscle tone through most of the rom, but affected part(s) easily moved; 3 -considerable increase in muscle tone, passive movement difficult; 4 -affected part(s) rigid in flexion or extension. exclusion criteria: * recent botulinum toxin injection \< 4 months; * recent changes in antispastic medications \<3 weeks (i.e., the antispastic medication regime is not stable; * changes in antispastic medications (such as baclofen, tizanidine, dantrolene etc) during the followup research visits. (note: it is clinically rare for patients who receive repeated injections to change their antispastic medications); * history of spinal cord injury or traumatic brain damage; * history of serious medical illness such as cardiovascular or pulmonary complications; * any condition that, in the judgment of a physician, would prevent the person from participating.

Keywords: stroke
pelvic floor muscle function among running women

Conditions: Urinary Stress Incontinence

Summary: this study will examine pelvic floor muscles function amongst women who run on a regular basis compared to controls. women who do not run, will begin running protocol, and second evaluation will be performed following 2 months of training. urinary incontinence will also be assessed.

the study will include women who have been running on a regular basis over two years, at least 3 times a week for half an hour (research group) and women who do not run at all (control group). the participants will answer a personal information questionnaire (including birth and exercise background), and the international consultation on incontinence questionnaire - short form (iciq-sf). outcome measures will include an evaluation of the pfm function using vaginal palpation and abdominal ultrasound examination. women who do not run at all, will begin running training protocol, and second evaluation will be performed following 2 months of training.

Eligibility criteria:
inclusion criteria: * at least six months after giving birth or who have not given birth at all, the running group will recruit healthy women who run at least 3 times a week, 30 minutes, for two consecutive years. the control group will recruit healthy women who do not physical active on a daily basis exclusion criteria: * pregnancy * grade 3 or higher of pelvic organ prolapse.

Keywords: urinary incontinence pelvic diaphragm women's health
pharmacokinetic and pharmacodynamic profiles of aliskiren in japanese patients with mild to moderate essential hypertension

Conditions: Hypertension

Summary: this study will evaluate the pharmacokinetic profile, the effect of rennin inhibition and the relationship among pharmacokinetics, renin-angiotensin system (ras) biomarkers, and blood pressure lowering effects of oral doses of spp100 in japanese patients with mild to moderate essential hypertension. safety will also be evaluated.


Eligibility criteria:
inclusion criteria: * japanese patients with mild to moderate essential hypertension aged 20 to 80 years * blood pressure: mean (based on 3 recordings at 1-2 minute intervals) sitting diastolic blood pressure values on 14 days or 3 days before the treatment should meet the following criteria: * 14 days before treatment: ≥ 90 mmhg and \< 110 mmhg * 3 days before treatment: ≥ 95 mmhg and \< 110 mmhg * the difference in mean sitting diastolic blood pressure between 14 days and 3 days before the treatment is within 10 mmhg * body weight no less than 50 kg exclusion criteria: * patients with mean (based on 3 recordings at 1-2 minute intervals) systolic blood pressure ≥ 180 mmhg and/or mean diastolic blood pressure ≥ 110 mmhg at day -28, day -14 and day -3. * patients with or suspected of having secondary hypertension * patients suspected of having malignant hypertension other protocol-defined inclusion/exclusion criteria may apply

Keywords: pharmacokinetics, pharmacodynamics, safety, ras profile, spp100, aliskiren, japanese, essential hypertension mild to moderate essential hypertension
one more for chronic pain

Conditions: Chronic Pain

Summary: this study will be a single-site, two-arm randomized controlled trial conducted among chronic pain patients. chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either one more or a wait-list control condition (wlc). one more will be delivered individually via a hipaa compliant virtual meeting platform.


Eligibility criteria:
inclusion criteria: * men/women ≥18 years of age * current chronic pain diagnosis * reporting pain ≥3 on 0-10 scale exclusion criteria: * unstable illness judged by clinician to interfere with study participation

Keywords: mindfulness
compassionate same-day evaluation & delivery of xrt for bony metastasis in hospice patients

Conditions: Symptomatic Osseous Bone Lesions From Any Malignancy

Summary: this is a survey study to evaluate the feasibility and effectiveness of an affordable, $400 flat rate, same-day consultation, simulation, and delivery of a single fraction of palliative radiation therapy for patients with symptomatic bony metastatic disease who are currently enrolled in hospice. treatment planning and delivery of palliative radiotherapy will utilize "standard of care" techniques.


Eligibility criteria:
inclusion criteria: * symptomatic osseous bone lesion(s) from any malignancy, whether primary of metastatic, with histological confirmation of malignancy. * currently enrolled in hospice and referred for single fraction palliative radiotherapy. * performance status (to be evaluated by the radiation oncologist), karnofsky performance scale ≥ 20 or ecog performance scale \< 5 . * ability to understand and willingness to sign a written informed consent document exclusion criteria: * pregnancy. * unable to understand english. * unable to complete forms with assistance. * concurrent enrollment in a study of pain management involving medications or devices.

Keywords: urology prostate breast lung chest
effects of cognitive-behavioral therapy on sleep disturbance in peritoneal dialysis patients

Conditions: Sleep Disorders; Kidney Diseases

Summary: sleep disturbance is prevalent in chronic dialysis patients and there is a negative correlation between the quality of life and overall survival and sleep disturbance in them. cognitive-behavioral therapy is an effective behavioral therapy for insomnia clinically. in previous studies, cognitive-behavioral therapy can redress anxiety in chronic hemodialysis patients. this study tries to elucidate its therapeutic effect on the sleep disturbance in chronic peritoneal dialysis patients.

sleep disturbance is prevalent in chronic dialysis patients and there is a negative correlation between the quality of life and overall survival and sleep disturbance in them. so many factors interfering the sleep of these patients, however, there is no effective therapy for them except some drugs, such as hypnotics or anxiolytics. cognitive-behavioral therapy is an effective behavioral therapy for insomnia clinically and it contains three therapeutic domains including stimulus control, sleep restriction therapy, and relaxation training. it has been proven to be beneficial in improving sleep pattern in chronic insomnia and cancer patients and alcoholism. in previous studies, cognitive-behavioral therapy can redress anxiety in chronic hemodialysis patients, however, there is no clinical evidence revealing its effectiveness upon sleep disorders in hemodialysis and peritoneal dialysis patients. our study tries to elucidate the therapeutic effect of cognitive-behavioral therapy on the sleep disturbance in chronic peritoneal dialysis patients. we will perform cognitive-behavioral therapy to eligible peritoneal dialysis patients and evaluate the sleep condition before and after the therapy. moreover, clinical conditions, biochemical and hematological parameters, inflammatory mediators in blood will be measured at baseline, before and after therapy.

Eligibility criteria:
inclusion criteria: * undergoing peritoneal dialysis (pd) for at least 3 months * older than 18 years * have sleep disturbance subjectively exclusion criteria: * unstable clinical conditions or evidence of malignancy * pregnancy * participation in another study that would interfere with the outcome of this study

Keywords: sleep disorder peritoneal dialysis cognitive-behavioral therapy sleep disorder:c23.888.592.796 peritoneal dialysis: f03.870.664
effects of a new antimicrobial dressing on wound healing and incidence of sternal wound infections

Conditions: Surgical Wound Infection

Summary: the primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(ci) of localized, superficial infections at the sternal incisional site as compared to the control group, regular, non-antimicrobial dressing.


Eligibility criteria:
inclusion criteria: * sign an informed consent form that has been approved by the institutional review board. * adults at least 18 years of age. * be undergoing cardiopulmonary bypass surgery with a median sternotomy. * be able to return to the study site, if needed, to have the sternal surgical incision site inspected. exclusion criteria: * be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study. * be in need of a left ventricular assist device. * have an active pre-operative infectious process. * subject is to receive another topical antimicrobial agent (i.e., dermabond® topical skin adhesive) other than the study dressing (as assigned by the randomization schedule).
psilocybin therapy for chronic low back pain

Conditions: Chronic Low-back Pain

Summary: this study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. patients may be recruited at stanford and university of california san francisco (ucsf), study procedures will occur at ucsf. each participant will receive a dose of psilocybin with possibly one or more other drugs. participants will undergo two preparation sessions, a dosing session, three integration sessions to discuss their psilocybin experience, and several follow up sessions.

chronic pain is associated with higher levels of pain-related distress, depression, emotional dysfunction, helplessness, hopelessness, and suicidality. psilocybin is a psychoactive drug that may be well-suited to easing the psychological and emotional symptoms of distress associated with chronic pain. previous studies testing psilocybin therapy have shown improvements on multiple behavioral and psychiatric outcomes, but it is unknown whether psilocybin therapy similarly enables patients to cope with chronic pain more effectively. the investigators will determine whether psilocybin therapy improves patients' ability to cope with chronic low back pain. if psilocybin therapy is an effective treatment in this population, its use could be incorporated into interventions for chronic low back pain and other psychological conditions.

Eligibility criteria:
inclusion criteria: * age 25 to 70 years old * comfortable speaking and writing in english * diagnosed with chronic low back pain * able to attend all in-person visits at ucsf as well as virtual visits * has tried at least two previous medications/ procedures and physical therapy trials for low back pain exclusion criteria: * chronic low back pain that is attributed to malignancy, subacute or acute fracture or infection * low back pain with radiation below the knee * low back pain with neurologic signs present * regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, mao inhibitors, antipsychotics, and stimulants * a health condition that makes study unsafe or unfeasible, determined by study physicians

Keywords: chronic pain psilocybin psilocybin therapy
effects of assistive device on adl function in patients with nerve injury

Conditions: Nerve Injury

Summary: our study is aimed to evaluate the effect of 3d printing assistive device on hand function for patients with neural injury.

background: injury to the central or peripheral nerves can lead to limited hand function and further affect the ability of daily life. the use of assistive devices can assist functional activities and reduce the phenomenon of non-use. 3d printing technology was used to construct personalized, complicated orthosis, and one piece to reduce assembly time. but the evidence most are product development, but few of study investigate the effectiveness and it cannot be widely used for hand injuries. aim: to evaluate the effect of 3d printing assistive device on hand function for patients with neural injury. methods: thirty neural injury patients were recruited and randomized into experimental (3d printing assistive device) or control (universal cuff) groups for 4 weeks of treatment (thirty minutes a time, twice a week). the performance was assessed by a blinded assessor included active range of motion (arom), box and block test, grip dynamometer, upper extremity task, disability of the arm, shoulder and hand questionnaire(dash), general health questionnaire(ghq-12) and quebec user evaluation of satisfaction with assistive technology (quest). the practice performance and adverse effect were recorded. collected data will be analyzed with nonparametric tests by spss version 20.0, and alpha level was set at .05. keywords: neural injury, 3d printing, assistive device, hand function.

Eligibility criteria:
inclusion criteria: * the medical record shows the diagnosis of central or peripheral nerve injury, and the onset is more than three months * able to understand wearing operation instructions and have the ability to give informed consent * able to control shoulder lifting and bending elbows, but difficult to grasp tools exclusion criteria: * older than 75 years old and younger than 20 years old * severe visual or hearing impairment * suffering from other neurological, cardiopulmonary, or musculoskeletal diseases that affect the subject to perform the actions required by this test.
safety study of measles-mumps-rubella-varicella (mmrv) vaccine, priorix-tetra™ in children living in the philippines

Conditions: Mumps; Rubella; Measles; Varicella

Summary: this study will collect data on the safety of the mmrv vaccine (priorix-tetra™) used in routine practice in children aged 12 months to 12 years living in the philippines.

the participating physicians will enroll only those subjects for whom they would prescribe priorix-tetra in the course of their normal clinical practice.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that parent(s)/legally acceptable representative(s) \[lar(s)\] can and will comply with the requirements of the protocol. * written informed consent obtained from the parent(s)/lar(s) of the subject. * male or female subjects living in the philippines between, and including, the ages of 12 months and 12 years at the time of the vaccination. * female subjects of child bearing potential may be enrolled in the study, if the subject: * has agreed to be abstinent or practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 3 months after completion of the vaccination. exclusion criteria: * child in care. * any contraindications to vaccination as stated in the prescribing information. * acute, severe febrile illness at the time of enrollment. the presence of a minor infection, such as a cold, will not exclude the subject from the study. * previous receipt of a measles, mumps, rubella and/or varicella-virus containing vaccine less than 3 months prior to study entry. * previous enrolment in this trial. * subjects with impaired immune function, including primary or secondary immunodeficiencies based on medical history. * history of hypersensitivity to any component of the vaccine. * history of hypersensitivity following previous administration of measles, mumps, rubella and/or varicella-virus containing vaccines. * receipt of human gamma globulins or a blood transfusion within 3 months prior to study entry. * hypersensitivity to latex. * pregnant or lactating female.

Keywords: combined measles-mumps-rubella-varicella vaccine priorix-tetra™ mmrv children post-marketing surveillance philippines
topical intranasal tranexamic acid for epistaxis in the emergency department

Conditions: Epistaxis

Summary: it is estimated that epistaxis results in 4.5 million emergency department visits per year throughout the united states. due to the adverse effects of standard treatment options for epistaxis, tranexamic acid (txa) may be considered an attractive option. in previous studies, when used with nasal packing, txa showed faster time to control of bleeding. the goal of this study is to determine the efficacy and safety of topical intranasal txa applied via atomizer for patients with epistaxis who present to the emergency department.

this is a prospective, randomized, single-center, double-blinded, placebo controlled study comparing efficacy and safety of topical intranasal tranexamic acid for epistaxis. the primary outcome was time to control of bleeding and secondary outcomes were length of stay in the emergency department, re-bleeding within the first 24 hours, and re-bleeding at one week. safety outcomes were the incidence of thromboembolic events and other drug-related adverse events. patients aged 18 years of age or older and diagnosed with anterior epistaxis were included. patients were excluded if they were unable to consent, do not have a valid telephone number, pregnant women, prisoners, cognitively impaired individuals, diagnosis of posterior epistaxis, major trauma, bleeding disorder (such as thrombocytopenia or hemophilia), hemodynamically unstable, or had a known hypersensitivity to study medication. patients were randomly assigned to tranexamic acid treatment group or placebo group. after consenting, patients received txa (100 mg/1ml) or 0.9% sodium chloride (1 ml) in to the affected nostril(s) via intranasal atomization device. if bleeding did not cease, two repeat doses were allowed and after twenty minutes of continued bleeding the study physician could treat with any additional treatment options. patients were contacted via telephone within one week to inquire about incidences of re-bleeding or any complications.

Eligibility criteria:
inclusion criteria: * diagnosed with anterior epistaxis exclusion criteria: * unable to consent, do not have a valid telephone number, pregnant women, prisoners, cognitively impaired individuals, diagnosis of posterior epistaxis, major trauma, bleeding disorder (such as thrombocytopenia or hemophilia), hemodynamically unstable, or had a known hypersensitivity to study medication

Keywords: tranexamic acid epistaxis emergency medicine intranasal txa