Kornimate/medical-research-clean huggingface dataset:
flaxseed consumption, alone and in combination with the mediterranean-like diet, on some indicators related to atherosclerosis

Conditions: Coronary Artery Disease

Summary: flaxseed consumption has beneficial effects on cardiovascular risk factors. in addition, the benefit of the mediterranean-like diet in primary and secondary prevention of cardiovascular diseases has been shown.the purpose of this study is to investigate the effects of flaxseed consumption, alone and in combination with the mediterranean-like diet, in adjunct to conventional medical treatment, in improving vascular endothelial function, plasma lipid profile and high sensitivity c-reactive protein of coronary artery disease (cad) patients.

a randomized placebo controlled clinical trial will be conducted in rajaie cardiovascular center in tehran, iran. after review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. the participants are 81 eligible coronary artery disease patients, aged 20-75 years. intervention groups will be received 30 g/d flaxseed, alone, or with weekly mediterranean-like diet menu and control group will be received capsules of wheat fiber as placebo for 3 months. vascular endothelial function will be evaluated through measurement of flow mediated dilatation (fmd) in brachial artery and carotid intima-media thickness (c-imt) via ultrasound sonography and plasma level of asymmetric di-methyl arginine (adma). fasting blood sample will be taken to measure malondialdehyde (mda), lipid profile, high sensitive c-reactive protein and inflammatory cytokines (interleukine-6 \[il-6\] and tumor necrosis factor-a \[tnf-a\]).

Eligibility criteria:
inclusion criteria: 1. coronary artery disease patients (more than 50% blockage in coronary arteries) needed angioplasty with stent 2. willing to participation in the study exclusion criteria: 1. cigarette smoking 2. continuous consumption of any antioxidant supplement such as vitamin e, vitamin c and selenium in last month 3. consumption of flaxseed or any omega-3 supplement at the beginning of the study 4. َadvanced renal disease 5. unwillingness to continuance 6. any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
efficacy and safety of repaglinide and metformin combination therapy in type 2 diabetes failing on oral anti-diabetic drugs

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in chinese subjects with type 2 diabetes inadequately controlled with oad (oral anti-diabetic drugs).


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 12 weeks * hba1c: 8.0-10.0% * current treatment with oad on monotheray or oad on combination therapy * body mass index (bmi): 21.0-35.0 kg/m2 exclusion criteria: * known or suspected allergy to trial product(s) or related products * recurrent major hypoglycaemia as judged by the investigator * uncontrolled hypertension * any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the investigator
multimodal management of neck and back pain in the emergency department (multi-ed)

Conditions: Musculoskeletal Pain

Summary: the purpose of this study is to assess the feasibility and acceptability of psychologically-informed physical therapy (pipt) in the ed in a pilot study of ed patients with neck or back pain. we will conduct a single-site, prospective trial comparing the combined program in one group with a usual care-only group. primary outcomes will focus on feasibility based on recruitment and retention rates, and acceptability based on a 5-point patient satisfaction scale, while secondary outcomes will include pain severity, pain interference, anxiety, physical function, opioid use, repeat ed visits, and hospitalizations at 1 hour and at 24 hours, 1 month and 3 months after ed discharge. we will use pilot study results to develop a protocol for a larger pragmatic randomized clinical trial designed to rigorously evaluate pipt in the ed combined with spine health follow up for ed patients with neck or back pain. we will perform a process evaluation of our proposed clinical trial study design, including characterizing and quantifying the degree of cbt and pt components used by treating pts while in the ed and during spine health follow up, number of spine health visits attended in the first month, and integration into usual ed care. qualitative interviews will be used to identify facilitators, barriers and potential solutions to intervention and research study procedures based on the patients' experience.


Eligibility criteria:
inclusion criteria: * adults (age 18 years or older), * presented to the ed with pain in the neck and/or back, * a diagnosis of musculoskeletal pain as determined by an ed provider, * able to read and understand the consent form in english. exclusion criteria: * suspected to have a non-musculoskeletal cause of pain; * unable to provide informed consent or to comprehend or complete study measures or procedures due to cognitive impairment, including evidence of drug, medication or alcohol intoxication, or due to severe hearing or speech impairment; * unable to safely participate due to critical illness, emergent surgical need, other serious medical condition (including active covid-19 infection), * ed provider judgment.
lymphatic mapping in treating patients with stage i or stage ii cancer of the vulva

Conditions: Vulvar Cancer

Summary: rationale: lymphatic mapping may improve the ability to detect cancer of the vulva. purpose: this phase iii trial is studying how well lymphatic mapping works in treating patients with stage i or stage ii cancer of the vulva.

objectives: * determine the negative predictive value of a negative sentinel lymph node in patients with invasive squamous cell carcinoma of the vulva. * determine the location of the sentinel node in these patients. outline: patients receive injection(s) of isosulfan blue into the dermis at the junction of the tumor and normal vulvar skin. once the afferent lymphatic channel and sentinel node have been identified, patients undergo unilateral or bilateral inguinal-femoral lymphadenectomy followed by resection of the primary tumor with adequate margins. preoperative lymphoscintigraphy is also performed. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or until recurrence. projected accrual: a total of 40-630 patients will be accrued for this study within 2-6 years.

Eligibility criteria:
disease characteristics: * histologically confirmed invasive squamous cell carcinoma of the vulva that is greater than 1 mm in thickness as measured from the nearest rete peg * tumor size must be 2-6 cm * no recurrent disease * prior excision of the primary disease or a history of carcinoma in situ of the vulva allowed * no tumor extending into the urethra, anus, vagina, rectum, or bladder * no grossly suspicious or inflamed groin nodes on physical exam * no grossly infected primary tumors patient characteristics: age: * any age performance status: * gog 0-3 life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no other invasive malignancy within the past 5 years except non-melanomatous skin cancer * no known hypersensitivity to phenylethane compounds prior concurrent therapy: * no prior cancer therapy that contraindicates therapy in this study biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * see disease characteristics * no prior groin dissection

Keywords: stage i vulvar cancer stage ii vulvar cancer squamous cell carcinoma of the vulva
the network study: soldiers connecting for work and health

Conditions: Alcohol Use Disorder; Depression

Summary: this study will examine the efficacy of an internet-based brief intervention designed to reduce risky behavior in soldiers as they transition from active duty into the civilian workforce as a veteran. up to 700 soldiers intending to separate from the army will be recruited, with the intention of drawing a final sample of 450 participants. study participants will be randomly assigned to either the intervention or the control group, stratified by age and gender.

the combination of alcohol use and negative emotional states is a particularly toxic combination for suicide risk. the current study examines changes in alcohol/drug use/misuse and depression as soldiers undergo the transition from active duty to veteran and offers a personalized internet-based brief intervention intended to prevent/reduce alcohol misuse and depression in this population. the study's objectives are to empirically quantify the form of changes that occur with respect to alcohol use and depression over the transition; to identify stable individual risk factors (e.g., personality, military experiences) and dynamic risk factors (e.g., changes in stressors and normative contexts over time) that may be associated with differential temporal patterns of suicide-related behavior (i.e., alcohol use/misuse) and cognition (i.e., depression); and lastly, to determine whether a simple, internet-delivered brief intervention shown can reduce risky behavior in the transitioning veteran population.

Eligibility criteria:
inclusion criteria: * is us solider intending to separate from active duty during the study enrollment period * intends to seek civilian employment * plans to live in us exclusion criteria: * plans to retire and not seek civilian employment * plans to live outside of the us * is separating or retiring from the national guard or reserves

Keywords: negative emotional states anxiety alcohol norms trauma ptsd stress self-medication
study of hs235 for assessing the pharmacokinetics, safety, and pharmacodynamics in overweight/obese healthy subjects

Conditions: Overweight and Obesity

Summary: study of hs235 for assessing the pharmacokinetics, safety, and pharmacodynamics of hs235 in overweight and obese otherwise healthy subjects

a phase 1 study assessing the pharmacokinetics, safety, and pharmacodynamics of hs235 in overweight and obese otherwise healthy subjects: single ascending dose (sad) in males and postmenopausal females and multiple ascending dose (mad) in males and females of non-childbearing potential

Eligibility criteria:
inclusion criteria: 1. male or female above 40 years of age, inclusive. 2. body mass index (bmi) between 28 and 40 kg/m2, inclusive. 3. body weight at or below 140 kg with a stable body weight. 4. in good health or with no clinically significant medical conditions 5. females who are post-menopausal or are of non-child bearing potential. 6. male subjects must be willing not to donate sperm for 90 days after the last dose. 7. able to understand the study procedures and provide signed informed consent to participate in the study. exclusion criteria: 1. females with a positive pregnancy test or who are lactating. 2. subjects with diabetes or have previous history of diabetes. 3. subjects who have recently donated blood, plasma and platelets. 4. subjects with history of alcoholism or drug abuse. 5. subjects who received systemic or topical medications, depot injections or implants, hormone replacement, non-prescribed medication or herbal remedies, or daily glucocorticoids for \> 1 month in previous year. 6. subjects with clinically significant abnormal pulse or blood pressure or temperature. 7. subjects with a history of a clinically significant medical disorder or lab abnormality. 8. subjects with a significant history of multiple drug allergies, including infusion reactions and hypersensitivity to any of the excipients of hs235. 9. subjects who are carriers of the hepatitis b surface antigen (hbsag) and are carriers of the hepatitis c antibody (except if polymerase chain reaction ribonucleic acid (pcr rna) is negative); or have a positive result to the test for human immunodeficiency virus (hiv) antigen or antibody. 10. subjects who have, in the opinion of the investigator, an abnormality in the echocardiogram or 12-lead ecg that put them at increased risk during the study. 11. current or history of treatment with medications that may cause significant weight gain or loss, within 3 months or 5 half-lives of screening. 12. obesity induced by other endocrine disorders. 13. previous surgical treatment for obesity. 14. current or history of treatment with medications that may cause significant weight gain or loss.
prostate resection after microwave ablation (prama)

Conditions: Prostate Carcinoma

Summary: this phase i trial tests the safety of magnetic resonance imaging (mri)/ ultrasound (us) fusion guided transperineal targeted microwave ablation (tma) before a radical prostatectomy (rp) and how well it works in treating patients with prostate cancer. prostate cancer is the second most common cancer in men and most will never become aggressive. despite this, most men choose to undergo treatment which may include surgery. removing the prostate gland and sometimes the lymph nodes (radical prostatectomy) is an invasive treatment for prostate cancer that can have a significant negative on quality of life. tma is a less invasive procedure that uses high temperatures given through the skin between the scrotum and the rectum (transperineal). using focused high energy and heating tumor cells to several degrees above normal body temperature may kill them without affecting the surrounding tissue. using multiparametric (mp)mri/us to create a 3-dimensional picture of the tumor may help in planning and preventing damage to healthy tissue. giving mri/us fusion guided transperineal tma prior to radical prostatectomy may kill tumor cells, and may improve the quality of life in patients with prostate cancer.

primary objective: i. to determine the feasibility of transperineal targeted microwave ablation of an mri-identified index prostate cancer in patients undergoing radical prostatectomy. secondary objectives: i. koelis trinity ability to plan and guide treatment needles and ablations in the prostate index lesion. ii. impact of treatments on functional outcomes and quality of life. iii. predictability of medwaves avecure microwave ablation charts. iv. predictability of post microwave ablation mpmri. outline: patients undergo mri/us fusion guided transperineal targeted tma and then undergo standard of care rp same day or at 30 days post-tma on study. patients undergo planning mpmri of prostate prior to tma. patients also undergo blood sample collection at screening and post rp.

Eligibility criteria:
inclusion criteria: * adult men diagnosed with prostate cancer and undergoing prostatectomy as treatment of choice * index lesion visible on multiparametric mri confirmed by targeted biopsies using koelis trinity (registered trademark) * patient suitable for intravenous (iv) sedation or general anesthesia and tma * free, informed, and written consent, dated and signed before the enrollment and before any exam required by the trial exclusion criteria: * past medical history of prostate surgery * past medical history of radiotherapy or pelvic trauma * past treatment for prostate cancer (pca) (radiation, ablation, androgen deprivation therapy \[adt\], chemotherapy)
effect of lifestyle intervention vs physical therapy treatment in patients with secondary lymphedema after cancer

Conditions: Lymphedema, Secondary

Summary: participants with lymphedema secondary to cancer treatment will participate in a two week rehabilitation programme focusing on physical therapy treatment and a two week programme focusing on physical exercise. the purpose is to assess the effect of the rehabilitation programmes on lymphedema and measures of physical performance.

traditionally, physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging is used for treatment of cancer treatment induced lymphedema. alternatively, lifestyle interventions are used as treatment, with focus on physical exercise. however, the effects of such interventions are scarcely documented. thus, the purpose of this study is to assess the effect of physical therapy treatment and physical exercise on lymphedema and measures of physical performance. the study will be performed in a randomized cross-over design, encompassing 26 participants with secondary lymphedema related to cancer treatment. firstly, half of the participants in the intervention group will be randomized to a two week rehabilitation programme focusing on physical activity while the other half to a rehabilitation programme focusing on physical therapy treatment, and the other way around three months later. in addition. there will be a control group with cancer related lymphedema not participating in any rehabilitation programme. pre and post of each of the two week rehabilitation periods the following measurements will be performed: the magnitude of lymphedema by volume measurements of the limbs (by dxa); measurements of maximal strength, range of movement, flexibility, balance, physical functionality and questionnaires about perceived health and level of physical activity.

Eligibility criteria:
inclusion criteria: * secondary lymphedema in arm or/and leg related to cancer exclusion criteria: -
evaluation of effaclar duo+m on acne lesions in subjects with mild to moderate acne on face and trunk

Conditions: Acne

Summary: this single-center, open, non-randomized study aims the efficacy evaluation of effaclar duo+m and effaclar+m purifying foaming gel on total acne lesion count, pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne.

the study will be conducted in accordance with the principles of resolution 466/2012 of the conselho nacional de saúde do brasil3, ethical principles from the declaration of helsinki (and subsequent modifications) and good clinical practice. statistical methodology: quantitative variables, or those that can reasonably be treated as such, are summarized using the minimum, maximum, measures of central tendency such as the mean and median \& measures of dispersion such as the standard deviation (sd). qualitative variables are summarized in the form of counts and percentages. significance level: the null hypothesis will generally be rejected if a p-value less than 0.05 (5% significance level) is produced by the statistical procedure.

Eligibility criteria:
inclusion criteria: * phototype i to vi * mild to moderate acne on the face and trunk exclusion criteria: * cutaneous pathology on the studied zone other than acne * topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products

Keywords: facial and truncal acne effaclar duo+m acne lesions
physical exercise as a targeted therapy in patients with chronic rheumatic muscle inflammation

Conditions: Myositis

Summary: the objectives of this study are to test if hypoxia in muscle tissue is an important factor contributing to clinical symptoms in chronic rheumatic muscle inflammation and to evaluate if a 12 week endurance exercise program will improve muscle tissue hypoxia and disability in patients with chronic rheumatic muscle inflammation.


Eligibility criteria:
inclusion criteria: * patients with chronic, stable polymyositis or dermatomyositis with diagnosis of definite or probable polymyositis or dermatomyositis (bohan and peter 1975) * age 18-80 years * duration since diagnosis \> 6 months * exercising \< once a week, * stable disease activity and medication for at least one month. ten healthy controls matched for age, gender and physical exercise level will be included. - exclusion criteria: * severe pulmonary fibrosis * heart or lung conditions that contraindicate vigorous exercise * severe osteoporosis * not being able to perform the exercise program.

Keywords: myositis physical exercise disability
resilience coaching for adolescents with chronic musculoskeletal pain

Conditions: Pain, Chronic; Pain Syndrome; Psychological

Summary: the goal of this clinical trial is to learn about resilience coaching in adolescents with chronic musculoskeletal pain. the main questions it aims to answer are to 1) determine how helpful resilience coaching is for teens with chronic musculoskeletal pain, 2) which participants are best suited for resilience coaching, and 3) barriers and facilitators to implementing resilience coaching as part of routine clinical care. participants will complete survey measures and participate in the resilience coaching intervention called promoting resilience in stress management (prism). researchers will compare youth in prism to those receiving usual care to determine whether prism leads to greater improvements in functional disability, psychological distress, and pain intensity than usual care alone.

the purpose of this study is to find out if a resilience coaching program called promoting resilience in stress management (prism) can help youth with chronic musculoskeletal pain better cope with their chronic illness.researchers will recruit a total of 130 youth with chronic musculoskeletal pain and one of their caregivers (total number of participants = 260). teens will be randomly assigned to either a control group (usual care) or a treatment group (prism + usual care). prism consists of 4 study visits with a resilience coach, and one optional coming together session in which caregivers are invited to join. prism will occur over approximately 12 weeks. all participants will complete survey measures at baseline, 3-months and 9 months. selected participants in prism will be invited to participate in interviews to provide feedback on the intervention. we will also interview 10 pediatric rheumatologists at other centers to obtain their feedback on the intervention and whether it would be valuable and feasible in their clinical setting. at the end of the study, researchers will assess whether participants in prism had improved functional disability, psychological distress and pain intensity as compared to the usual care arm.

Eligibility criteria:
inclusion criteria: * patient participants aged 12-17 years, * newly diagnosed with chronic musculoskeletal pain, defined as bone, joint, muscle, or related soft tissue pain lasting ≥ 3 months * willing to provide informed consent/assent * one caregiver willing to consent and participate in dyad * dyad identifies english as primary language * mild or greater impairment due to pain (defined as patient reported outcomes measurement information system pain interference t-score ≥ 60 at time of last clinic visit and/or self- or parent- reported impairment of activities of daily living due to pain at time of screening) exclusion criteria: * unable to provide assent and/or without a legal guardian able to provide consent for the study subject or themselves * isolated/localized head pain or abdominal pain * complex regional pain syndrome (crps) * receiving cognitive behavioral therapy at time of screening

Keywords: resilience coaching chronic musculoskeletal pain