Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of compound methyl salicylate liniment for topical pain: a multicenter real-world study in china

Conditions: Pain

Summary: the purpose of this phase ⅳ clinical trial was to evaluate the safety and efficacy of compound methyl salicylate liniment (ammeltz) in a real-life environment in china. this multicenter clinical trial was conducted at 22 hospitals/centers in china between may 2014 and march 2015. the primary aim of the trial was to evaluate the safety of ammeltz in a real-life environment. the secondary monitoring objective was to evaluate the efficacy of ammeltz in the treatment of soft tissue injury pain in a real-life environment. in principle, according to the guide for drug monitoring in production enterprises in china, the number of patients included in the statistical analysis of key drug monitoring should not be less than 3000 in order to provide ample information about the trial drug. therefore, the sample size of this study was chosen to be 3600 cases, considering the dropout rate of the subjects.

the investigators collected demographic data, vital signs, current medical history (type of soft tissue damage), and allergy history of the eligible patients on the day of ammeltz prescription. at the same time, a doctor conducted the physical examination and evaluated the visual analog scale (vas) score of each patient. on the seventh day of the drug administration (one course of the treatment lasts seven days), the investigator asked each patient by telephone about the actual use of the study drug, whether adverse events occurred, and about the self-assessment pain vas score. on the 37th day of the treatment, the patients were interviewed again by telephone to inquire about the occurrence of adverse events . the inclusion criteria for the patients were as follows: 1) age 3-75 years, male or female sex; 2) soft tissue pain caused by shoulder and neck pain, back pain, muscle pain, sprain, strain, contusion, muscle swelling and pain, and arthritis; local symptoms included pain, swelling, bruising, or tenderness; 3) signed informed consent and willing to participate in the study. patients were excluded if they met the following criteria: 1) allergy to any of the ingredients in this drug; 2) pregnant women, lactating women, and infants aged 0-3 years; 3) the affected area in the eye or mucous membranes, eczema, macules, wounds, and damaged skin; 4) patients without indications for the use of this drug.

Eligibility criteria:
the inclusion criteria for the patients were as follows: 1) age 3-75 years, male or female sex; 2) soft tissue pain caused by shoulder and neck pain, back pain, muscle pain, sprain, strain, contusion, muscle swelling and pain, and arthritis; local symptoms included pain, swelling, bruising, or tenderness; 3) signed informed consent and willing to participate in the study. patients were excluded if they met the following criteria: 1) allergy to any of the ingredients in this drug; 2) pregnant women, lactating women, and infants aged 0-3 years; 3) the affected area in the eye or mucous membranes, eczema, macules, wounds, and damaged skin; 4) patients without indications for the use of this drug.
contrast-enhanced 3d t1-weighted gradient-echo versus spin-echo 3 tesla mr sequences in the detection of active multiple sclerosis lesions

Conditions: Magnetic Resonance Imaging; Central Nervous System; Brain; Multiple Sclerosis; Demyelinating Diseases

Summary: gadolinium-enhanced magnetic resonance imaging (mri) is currently the imaging gold standard to detect active inflammatory lesions in multiple sclerosis (ms) patients. the sensitivity of enhanced mri to detect active lesions may vary according to the acquisition strategy used (e.g., delay between injection and image acquisition, contrast dose, field strength, and frequency of mri sampling). selection of the most appropriate t1-weighted sequence after contrast injection may also influence sensitivity. several clinical studies performed at 1.5 tesla have shown that conventional 2d spin-echo (se) sequences perform better than gradient recalled-echo (gre) sequences for depicting active ms lesions after gadolinium injection. as relates to ms, 3.0 tesla systems offer some advantages over lower field strengths, such as higher detection rates for t2 and gadolinium-enhancing brain lesions, an important capability for diagnosing and monitoring ms patients. recent studies have shown that at 3 tesla, 3d gre or 3d fast se sequences provide higher detection rates for gadolinium-enhancing ms lesions, especially smaller ones, than standard 2d se, and better suppress artefacts related to vascular pulsation. however, the comparison of the performance of 3d gre versus 3d se sequences has not been investigated yet. objectives to compare the sensitivity of enhancing multiple sclerosis (ms) lesions in gadolinium-enhanced 3d t1-weighted gradient-echo (gre) and turbo-spin-echo (tse) sequences.


Eligibility criteria:
inclusion criteria: * equal or more than 18 years of age * able to provide written informed consent. * known central nervous system inflammatory disease * magnetic resonance exam needed for evaluation after a clinical event in the last 3 weeks exclusion criteria: * current treatment with dimethylfumarate (tecfidera®), natalizumab (tysabri®) or fingolimod (gilenya®) * contraindications either to 3 tesla magnetic resonance imaging (e.g. certain metallic and electronic implants, claustrophobia) or iv gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency).
the effect of mycophenolate mofetil and cyclophosphamide on the lymphocyte subsets in patients with proliferative lupus nephritis

Conditions: Lupus Nephritis

Summary: this study investigated the effect of mycophenolate mofetil and cyclosphosphamide on lymphocyte subsets in patients with proliferative lupus nephritis. patients with biopsy-proven class iii/iv+/-v ln were randomized to received: 1) prednisolone (0.8mg/kg/day) plus ctx (1.5-2mg/kg/d) for 6 months) followed by azathioprine (aza) (1-1.5mg/kg/d) maintenance; or 2) prednisolone (0.8mg/kg/d) plus mmf (1g bd) for 6 months, followed by mmf (tapered according to clinical status) as maintenance. the lymphocyte subsets and serum cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction treatment. the lymphocyte subsets and serum cytokine profiles will be compared between the two treatment regimens, and also correlated with subsequent risk of relapse.

this study investigated the effect of mycophenolate mofetil and cyclosphosphamide on lymphocyte subsets in patients with proliferative lupus nephritis. patients with biopsy-proven class iii/iv+/-v ln were randomized to received: 1) prednisolone (0.8mg/kg/day) plus ctx (1.5-2mg/kg/d) for 6 months) followed by azathioprine (aza) (1-1.5mg/kg/d) maintenance; or 2) prednisolone (0.8mg/kg/d) plus mmf (1g bd) for 6 months, followed by mmf (tapered according to clinical status) as maintenance. the lymphocyte subsets and serum cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction treatment. the lymphocyte subsets and serum cytokine profiles will be compared between the two treatment regimens, and also correlated with subsequent risk of relapse.

Eligibility criteria:
inclusion criteria: - 1. patients with biopsy proven class iii/iv+/-v ln (isn/rps classification) and active nephritis as indicated by an increase of proteinuria \>1g/day and/or rise in serum creatinine by \>15% compared with baseline, with or without serological reactivation. 2. willing to give informed consent exclusion criteria: 1. patients who have received calcineurin inhibitors or proliferation signal inhibitors as maintenance immunosuppression in the preceding 3 months 2. patients have received biologics therapy (e.g. rituximab, abatacept) in the preceding 12 months 3. patients who are pregnant or lactating

Keywords: lupus nephritis lymphocyte subsets cytokines mycophenolate mofetil cyclophosphamide
lamotrigine extended-release in elderly patients with epilepsy

Conditions: Epilepsy

Summary: this study is being conducted to determine the safety and tolerability of lamotrigine (ltg) in elderly patients with epilepsy. this study will be carried out using an extended-release formulation of lamotrigine (ltg-xr) that will allow once-a-day dosing.


Eligibility criteria:
inclusion criteria: * confident diagnosis of epilepsy * currently treated with one or two antiepileptic medications * able to complete a seizure diary exclusion criteria: * history of hypersensitivity to lamotrigine * progressive diseases that would interfere with the study objectives

Keywords: epilepsy elderly seizure
drug discrimination in methadone-maintained humans study 2

Conditions: Opioid Dependence

Summary: this study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. each subject will receive 2-4 of the listed interventions.


Eligibility criteria:
inclusion criteria: 1. must be between the ages of 18-65. 2. participation in the uams substance abuse treatment clinic methadone maintenance program or the catar clinic little rock with maintenance on a stable dose of methadone (+ or - 10 mg) for at least 1 month prior to study entry. 3. subjects would have to be in "good standing" in the methadone maintenance program in order to participate; i.e., compliance with scheduled medication and group therapy session hours. this would be defined as \< 3 missed methadone medications and missed \< 3 group or \<3 individual therapy sessions in the month prior to study participation 4. subjects must submit a urine sample negative for illicit drugs prior to study entry. 5. subjects must be able to read and understand english. exclusion criteria: 1. unstable medical condition or stable medical condition that would interact with study medications or participation. 2. current diagnosis of other drug or alcohol physical dependence (other than tobacco). 3. history of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression) 4. pregnancy, plans to become pregnant or inadequate birth control. 5. present or recent (\< 1 week) use of over-the-counter psychoactive drug, prescription psychoactive drug or drug that would have major interaction with drugs to be tested. recent use will be defined based upon the pharmacokinetics of the drug and dosing schedule. thus, a short-acting antihistamine taken as needed (e.g., once the night before) will not necessarily rule out a participant; however, 6. history of severe reaction to narcan challenge, which may have been given as part of admission into the methadone maintenance program or to reverse overdose. 7. liver function tests (alt, ast) greater than 3 times normal, bun and creatinine outside normal range, or thyroid function tests outside normal range. 8. ecg abnormalities including but not limited to: bradycardia (\<60 bpm); wolff-parkinson white syndrome; wide complex tachycardia; 2nd degree, mobitz type ii heart block; 3rd degree heart block; left or right bundle branch block.

Keywords: methadone opioid dependence opioid
impact of employee wellness programme

Conditions: Obesity

Summary: the introduction of a wellness programme for workers employed in a clothing factory will improve quality of life, pain, attendance at work and levels of physical activity.

introduction: the prevalence of health risk behaviours is growing amongst south african employees. health risk behaviours have been identified as a major contributor to reduced health related quality of life (hrqol) and the increase prevalence of non-communicable diseases. worksite wellness programmes promise to promote behaviour changes amongst employees and to improve their hrqol. aims: the aim of this study was to evaluate the short-term efficacy of an employee wellness programme on hrqol, health behaviour change, levels of self efficacy, pain intensity, body mass index (bmi) and absenteeism amongst clothing and textile manufacturing employees. methods: the study was a randomised control trial consisting of 80 participants from three clothing manufacturing companies in south africa. the experimental group was subjected to a wellness programme based on the principles of cognitive behaviour therapy (cbt) as well as weekly supervised exercise classes over six weeks. the control group received a once-off health promotion talk and various educational pamphlets, with no further intervention. measurements were recorded at baseline and at six weeks post-intervention. outcome measures used included the eq-5d, brief pain inventory-sf, stanford exercise behaviours scale, stanford self-efficacy scale, stanford self-rated health scale, bmi and absenteeism. data analysis: all the data were analysed with the statistica-8 software program. although t-tests are the most commonly used statistical method for evaluating the differences in the means between two groups (e.g. control and experimental), it assumes that the variable is normally distributed. thus, because the ordinal data were not normally distributed, non-parametric tests were used to evaluate the differences in the medians between the two groups and to determine the level of significance. the sign test was used in place of the paired t-test to determine the within group changes. the mann-whitney u test was used in place of the independent t-test to determine the difference between the two groups.

Eligibility criteria:
inclusion criteria: * all factory workers who volunteered to take part in the study exclusion criteria: * subjects were excluded from the study if they reported uncontrolled diabetes and hypertension, coronary heart disease or any other illness that rendered participation in the exercise component unsafe.

Keywords: occupational health cognitive behavioural therapy physiotherapy physical activity
a non-significant risk clinical study of therapeutic ultrasound for patients with diabetic foot ulcers.

Conditions: Diabetic Foot Ulcer; Peripheral Arterial Disease; Wound; Foot

Summary: this study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (dfu).

the vibratosleeve tus will be used on to assess its acute vasodilatory and perfusion effects in diabetic subjects with pad and dfu. each subject will receive one 90-minute tus treatment in each of 3 treatment sessions. all post-treatment acute assessments will take place immediately following each day's treatment and no follow-up assessments will be required in this study.

Eligibility criteria:
inclusion criteria: 1. presence of at least one dfu (grade 0 or 1 by university of texas classification) 2. diagnosis of diabetes mellitus 3. diagnosis of pad that meets at least one of the following conditions: 1. ankle-brachial index (abi) of \< 0.9 in the same limb as the dfu 2. toe brachial index (tbi) ≤ 0.6 or toe blood pressure ≤ 50 mmhg 3. documented history of pad for a minimum of 3 calendar months prior to time of enrollment 4. aged ≥ 22 years exclusion criteria: 1. rutherford 6 stage pad 2. active dfu infection 3. end-stage renal disease on dialysis 4. hba1c \> 13%. 5. planned pad revascularization. 6. prior stenting in posterior tibial artery. 7. re-vascularization procedure within 25 days prior to enrollment in the study. (note: patients who had re-vascularization procedure earlier than 25 days prior to enrollment are eligible for enrollment if they meet all other criteria). 8. history or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease. 9. acute limb ischemia within 30 days prior to treatment. 10. history or diagnosis of deep venous thrombosis below the knee in treatment leg. 11. any conditions that, in the opinion of the investigator, may render the patient unable to complete the study or lead to difficulties for patient compliance with study requirements, or could confound study data. 12. patient's enrollment in another investigational study that has not completed the required primary endpoint follow-up period (note: patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study).
injections of flograft therapy, autologous stem cells, or platelet rich plasma for the treatment of degenerative joint pain

Conditions: Osteoarthritis; Rheumatoid Arthritis

Summary: this study will assess the outcomes of three currently available regenerative treatments (flograft, autologous stem cell therapy, platelet rich plasma therapy) for painful degenerative conditions of the joints. patients receiving one these treatments will be assessed before the treatment procedure and followed up at four points over the six months after their procedure. patients' pain, quality of life, and pain medication use at follow up will be compared to baseline levels. the investigators hypothesize that all three treatments will be effective in reducing pain, improving quality of life, and reducing pain medication usage.

this is an open-label, non-randomized study assessing the efficacy of three potentially regenerative treatments for degenerative conditions of the joints of the lower back (facet, sacroiliac), upper extremities (e.g., shoulder), and lower extremities (e.g., hip, knee). these treatments are: 1. a single injection of applied biologics' flografttm. 2. a single injection of autologous bone marrow derived stem cells. 3. a single injection of platelet rich plasma. subjects will be assessed prior to treatment for their level of pain, quality of life, and pain medication usage. subjects will be followed up at 4 weeks, 8 weeks, 12 weeks, and 24 weeks after treatment. at each of these follow up visits, pain, quality of life, and pain medication usage will be assessed. the investigators hypothesize that all three treatment groups will experience reduced pain, improved quality of life, and reduced pain medication usage at follow up.

Eligibility criteria:
inclusion criteria: * age 18 or older, * ability to complete follow-up visits, * able to understand the study protocol and provide consent, * significant pain (average pain in the past month greater than or equal to 5, from 0-10), * pain lasting at least 3 months, * pain associated with one of the following conditions: lumbar facet degeneration, - or -degenerative condition causing upper extremity joint pain, - or - degenerative condition causing lower extremity joint pain. exclusion criteria: * current litigation or worker's compensation claim, * unstable pain medication dosage, * previous surgery at the affected site, * injections at the affected site within the past 6 months, * uncontrolled psychiatric condition, * pregnancy or lactating in women, * history of adverse reactions to local anesthetic
aspirin desensitization registry in patients with aspirin hypersensitivity

Conditions: Aspirin Hypersensitivity

Summary: data about aspirin desensitization for patients with coronary artery disease undergoing percutaneous coronary intervention are sparse. this is a prospective, multicenter, observational study including 7 italian centers, to assess safety and feasibility of a standard desensitization protocol in patients with aspirin sensitivity undergoing coronary angiography. patients with history of aspirin sensitivity undergoing coronary angiography are prospectively enrolled.all patients underwent the desensitization procedure with six sequential doses of aspirin (1, 5, 10, 20, 40, and 100 mg) administered orally at predefined intervals, with the procedure lasting 5.5 hours.all patients are followed for desensitization procedure success, description of reactions due to the desensitization procedure, and in hospital major adverse cardiac events (mace). all patients are also followed-up for 12 months in order to assess their long-term risk of mace, compliance with asa therapy, and late occurrence of side reactions due to asa sensitivity.


Eligibility criteria:
inclusion criteria: * history of aspirin hypersensitivity * acute coronary syndrome or known/suspected stable coronary artery disease * intent to undergo percutaneous coronary intervention exclusion criteria: * withdrawal of consent
her2(human epidermal growth factor receptor 2) -positive metastatic breast cancer in russia

Conditions: Breast Cancer

Summary: planned study population consists of approximately 1,000 adult patients with her2-positive mbc receiving anti-her2 therapy in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. patients will be included consecutively from the least recent diagnosis (within defined time period). planned retrospective follow-up period for 1 patient is a period starting from the date of mbc diagnosis until end study or until patient's death, whichever occurs first. end of study will be at least 12 months after the latest date of mbc diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data.

planned study population consists of approximately 1,000 adult patients with her2-positive mbc receiving anti-her2 therapy in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. patients will be included consecutively from the least recent diagnosis (within defined time period). planned retrospective follow-up period for 1 patient is a period starting from the date of mbc diagnosis until end study or until patient's death, whichever occurs first. end of study will be at least 12 months after the latest date of mbc diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data. only patients who were diagnosed between the 1st july 2021 and 1st july 2022 will be included. patients should have at least 12 months of follow-up data. in case patient died within the first 12 months of diagnosis, these data from date of mbc diagnosis until patient's death should also be included. it will be multicenter study

Eligibility criteria:
inclusion criteria: * patients with her2-positive mbc who are receiving or have started any anti-her2 therapy (except for trastuzumab deruxtecan) at the time of inclusion; * the diagnosis of mbc was established between the 1st july 2021 and the 1st july 2022; * patients with the availability of at least 12 months of follow-up data (from the index data) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis; * age ≥ 18 years at the time of inclusion. exclusion criteria: * presence of other malignancies within period since diagnosis until the timepoint of data collection; * patients receiving trastuzumab deruxtecan currently or in the anamnesis; * the participation in any randomized controlled trial within period since diagnosis until end of study.