Kornimate/medical-research-clean huggingface dataset:
comparison of the effects of electric current with needles and surface electrodes on the abdominal contour of women

Conditions: Abdominal Fat

Summary: the goal of this clinical trial is to compare the acute effects of percutaneous and transcutaneous eletroclipolysis on abdominal contour in women. the main question it aims to answer are: • is there superiority in percutaneous and transcutaneous electrolipolysis techniques? participants will undergo 12 sessions of 50 minutes each performed twice a week, totaling 6 weeks, after randomizing the hemibody for each technique. researchers will compare the hemibody with the percutaneous technique with the hemibody with the transcutaneous technique to see if there is a reduction of the adipose tissue.

abdominal adiposity consists of an increase in adipose tissue in the abdomen region, which may be associated as a risk factor for cardiovascular pathologies, metabolic disorders and dyslipidemias, in addition to affecting self-esteem and social life due to aesthetics body provided by the volume increase of the contour. electrolipolysis proves to be one of the accessible and low-cost resources, capable of promoting good therapeutic results through the passage of electric current to the adipose tissue, either with its percutaneous or transcutaneous technique. the study aims to compare the acute effects of percutaneous and transcutaneous electrolipolysis, considering comfort during execution.

Eligibility criteria:
inclusion criteria: * women between with localized abdominal fat * body mass index (bmi) between 18.5 and 29.9 kg/m2 (adequate weight and overweight) * who have not undergone any treatment for the condition experienced in the last 6 months * sedentary * not on a supervised diet exclusion criteria: * smokers * alcoholics * pregnant women * metabolic and circulatory system disorders * pacemaker * metallic implants * tumors/metastasis * dermatitis * in treatment with corticosteroids and/or prolonged progesterone * skin ulcers/lesions * needle phobia (aichmophobia) * sensitivity alteration in the region to be treated * unable to understand the form and/or procedure * not completing the suggested protocol * dietary changes during the research

Keywords: adipose tissue subcutaneous fat
dental implants with a slactive® vs. sla® surface

Conditions: Partially Edentulous Patients

Summary: this post-market study is to show that dental implants with a slactive® surface (slactive® implants) show non-inferior clinical performance compared to dental implants with a sla® surface (sla® implants). the primary hypothesis is that 12 months after implant loading, the bone loss around the slactive® implants will not be appreciably greater than around the sla® implants. the occurrence of adverse events and device deficiencies will also be recorded to confirm once more the safety of the straumann® bone level tapered (blt), roxolid® implant. osseointegration and anti-inflammatory potential of slactive® implants will be evaluated in the study as secondary endpoints.

this is a prospective, single-blinded, randomized, paired sample, multi-center clinical study. eight visits per patient are scheduled in this study. the final analysis will be conducted after all patients completed the 12-month visit. the study devices are ce- (conformité européenne, meaning european conformity) marked products and used within their intended use. two centers in spain will participate.

Eligibility criteria:
inclusion criteria: * males and females, at least 18 years old * partially edentulous patients in need of two or more dental implants (canine to molars) placed in two different quadrants in healed sites (3 months post extraction) * subject must have voluntarily signed the informed consent, is willing and able to attend scheduled follow-up visits, and agrees that the encoded data will be collected and analyzed exclusion criteria: * any contraindications for oral surgical procedures * dental implant placement contraindicated according to instructions for use (ifu) * subjects with inadequate oral hygiene (fmps ≥ 20%) * subjects who are currently heavy smokers (defined \>10 cigarettes per day or \>1 cigar per day) or who use chewing tobacco * subjects with drug or alcohol abuse * patients requiring soft tissue and bone grafting procedures * inadequate bone volume * severe bruxism or clenching habits * women who are pregnant or planning to become pregnant at any point during the study duration. * patients who have systemic factors that could interfere with the healing process of either bone or soft tissue or the osseointegration process (e.g. bone metabolism disturbances, uncontrolled diabetes mellitus, anticoagulation drugs/ hemorrhagic diatheses) * patients with local factors that could interfere with the healing process, such as untreated periodontal diseases, acute infection of implant site, temporomandibular joint disorders, treatable pathologic diseases of the jaw and changes in the oral mucosa) * conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.

Keywords: dental implants slactive® surface biomarkers blt implant
is kinesio taping able to influence the electrical activity of muscles in patients with low back pain?

Conditions: Chronic Low Back Pain

Summary: objectives: to test if the kinesio tex gold ® is able to change the electromyographic signal of iliocostalis and longissimus muscles in patients with chronic nonspecific low back pain. study design: three-arm, randomized controlled trial with a blinded assessor. location of study: physical therapy clinic of the universidade cidade de são paulo (unicid) patients: sixty-three patients with chronic nonspecific low back pain. intervention: patients allocated to the kinesio taping® group will receive the tape as described by the manufacturer's manual. the patients assigned to the placebo group will receive a micropore tape and the control group will not receive any intervention. all groups will be assessed before and 30 minutes after intervention measures: the following outcomes will be measured: 1) muscle activity and 2) pain intensity. limitations: therapists will not be blinded.

patients who are seeking care for low back pain at the physiotherapy clinic from universidade são paulo will be invited to participate in the study and informed about the objectives of the study and evaluation procedures. patients who agree to participate will sign a consent form. patients will be assessed at baseline and immediately after the interventions. investigators will collect data with regards to personal and anthropometric data, as well as pain intensity (measured by a 0-10 numerical rating scale in all follow up points) and disability (measured by the 0-24 point roland morris disability questionnaire at baseline only). finally, muscle activation will be evaluated by surface electromyography and the maximum voluntary contraction of the trunk at 30 degrees position for a lumbar dynamometer that will be adjusted to the anthropometric profile of patients. the average and maximum values of muscular strength will be obtained by maximum voluntary contraction. the electromyography will capture the muscle activity in an integrated manner to electrogoniometers and will transmit the data via bluetooth to a desktop with a mwx8 software (biometrics) that will analyze the data. before instrumentation patients will be instructed to perform the trunk extension movement the therapist's commands to become familiar with the equipment. soon after will be held instrumentation (placement of electromyography electrodes and electrogoniometers and lumbar dynamometer) maximal voluntary contraction will be collected in trunk extension without kinesio taping

Eligibility criteria:
inclusion criteria: * patients with chronic low back pain (with a duration of at least 3 months), with or without leg pain. exclusion criteria: * patients who have used the kinesio taping previously * any contraindications to the use of kinesio tex gold®, such as allergy or severe skin problems. * patients with nerve root compromise * patients with fracture, tumor, inflammatory and/or infectious diseases * patients with severe cardiorespiratory and/or metabolic diseases * previous spinal surgery

Keywords: kinesio taping low back pain electromyographic emg
acupuncture for post covid-19 fatigue

Conditions: Acupuncture; Post COVID-19 Condition; Fatigue

Summary: the aim of the study is to access the efficacy and safety of acupuncture for post covid-19 fatigue.


Eligibility criteria:
inclusion criteria: * patients aged between 18 and 75. * confirmed covid-19 infection in the past four weeks to six months, and a negative rt pcr and/or antigen-based rapid test at present. * a main complaint of fatigue emerged newly following covid-19 infection. * a score of ≥15 on chalder fatigue scale (cfs, score range 0-33). * participating the trial volunteerly and providing written informed consent. exclusion criteria: * severe anxiety and depression: a score of ≥25 on 17-item hamilton rating scale for depression (hamd-17) and/or a score scores \>29 on 14-item hamilton rating scale for anxiety (hama-14). * significant cognitive dysfunction or suicidal tendency. * usage of anti-anxiety and/or anti-depression treatments over the last three months. * previously diagnosed hypothyroidism or chronic fatigue syndrome. * a complication of serious and poorly controlled underlying diseases. * having symptoms indicating emergency or severe conditions. * concurrent use of other anti-fatigue agents or treatments at present. * impaired walking ability. * pregnant and/or lactating or planning to get pregnant in the next 4 months.
assessing the determinants of 6-minute walk test and its correlation with quality of life

Conditions: Aged

Summary: this study evaluates the determinants of mobility, measured by the 6-minute walk test, and its correlation with quality of life in near elderly patients.

to evaluate the determinants of mobility an its correlation with quality of life, we conducted a study that evaluated patients ability to perform the 6-minute walk test and their corresponding quality of life measured by the eq-5d. cognition was evaluated used the callahan six-item screener, and additional measures of physical performance were assessed using the short physical performance battery. participants disclosed self reported physical function and physical activity. additionally, other participant characteristics including vital signs, medication history and healthcare utilization were determined as well as social, economic and health related information was collected.

Eligibility criteria:
inclusion criteria: * willing to provide informed consent * willing to perform the 6-minute walk without the use of a walker, or the assistance of another person. * ability to speak and understand english exclusion criteria: * medical condition that precludes safe participation in the 6 minute walk test
safety study of increasing doses of combretasatin a1 diphosphate (oxi4503) as monotherapy in subjects with hepatic tumor burden

Conditions: Neoplasm Metastasis

Summary: the purpose of this study is to determine the safety and tolerability of oxi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed carcinoma. tumor must be relapsed or refractory to standard therapies, or have no acceptable standard therapy. 2. measurable disease by recist criteria. 3. subjects must be at least 28 days from other investigational therapy and at least 2 weeks after chemotherapy or radiation therapy. 4. age 18 years or older. 5. eastern cooperative oncology group (ecog) performance score of less than 1. 6. life expectancy of greater than 12 weeks. 7. hemoglobin greater than 10 g/dl. 8. adequate hepatic function. 9. adequate renal function. 10. adequate bone marrow reserve. 11. able to maintain potassium, calcium and magnesium levels within normal ranges. 12. must be able to provide written informed consent. 13. all women of childbearing potential (wocbp) must have a negative serum pregnancy test. 14. wocbp and fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days after the last dose of study medication. exclusion criteria: 1. uncontrolled cns metastases. 2. no other active malignancies. 3. poorly controlled hypertension. 4. recent history of serious cardiovascular conditions. 5. recent history of cva, tia, or intermittent claudication. 6. current anticoagulation therapy. 7. history of cardiac arrhythmias. 8. abnormal ecg findings. 9. subjects who require concomitant medications which cause qtc prolongation. 10. major surgery within 30 days of treatment, or minor surgery within 7 days of treatment. 11. uncontrolled, clinically significant active infection. 12. subjects who are pregnant or lactating. 13. subjects with any other intercurrent medical condition. 14. subjects with a history of solid organ transplant or bone marrow transplant.

Keywords: hepatic tumor burden liver cancer liver carcinoma carcinoma hepatic cancer hepatic carcinoma vda vascular disrupting agent
endothelial function in patients with ectatic compared to normal coronary arteries

Conditions: Coronary Artery Ectasia

Summary: the aim of this study is to show the frequency of endothelial dysfunction in patients suffering from ectatic coronary arteries as compared to those who have normal coronary arteries. should this frequency be significant we would recommend initiating conventional treatment in those patients with ectatic coronary arteries as is the practice in patients with endothelial dysfunction without ectatic arteries


Eligibility criteria:
inclusion criteria: * ectatic coronary arteries defined by cardiac catheterization

Keywords: the function of the endothelium of the arteries in patients suffering from ectatic coronary arteries
clinical evaluation of two toric contact lenses

Conditions: Astigmatism

Summary: the study objective was to compare short-term clinical performance data of two toric contact lenses.

the aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of a monthly toric contact lens when compared to a daily disposable toric contact lens after 15 minutes of daily wear each.

Eligibility criteria:
inclusion criteria: * is between 18 and 40 years of age (inclusive) * has had a self-reported visual exam in the last two years * is an adapted soft contact lens wearer * is not a habitual wearer of either study lens * has a contact lens spherical prescription between +4.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye * have contact lens prescription of no less than -0.75d of astigmatism and no more than -2.25 d in both eyes. * can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logmar) or better in each eye. * can achieve a distance visual acuity of 20/30 (0.18 logmar) or better in each eye with the study contact lenses. * has clear corneas and no active ocular disease * has read, understood and signed the information consent letter. * patient contact lens refraction should fit within the available parameters of the study lenses. * is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so). * is willing to comply with the visit schedule exclusion criteria: * has a cl prescription outside the range of the available parameters of the study lenses. * has a spectacle cylinder less than -0.75d or more than -2.50 d of cylinder in either eye. * has a history of not achieving comfortable cl wear (5 days per week; \> 8 hours/day) * has contact lens best corrected distance vision worse than 20/25 (0.10 logmar) in either eye. * presence of clinically significant (grade 2-4) anterior segment abnormalities * presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. * slit lamp findings that would contraindicate contact lens wear such as: * pathological dry eye or associated findings * pterygium, pinguecula, or corneal scars within the visual axis * neovascularization \> 0.75 mm in from of the limbus * giant papillary conjunctivitis (gcp) worse than grade 1 * anterior uveitis or iritis (past or present) * seborrheic eczema, seborrheic conjunctivitis * history of corneal ulcers or fungal infections * poor personal hygiene * has a known history of corneal hypoesthesia (reduced corneal sensitivity) * has aphakia, keratoconus or a highly irregular cornea. * has presbyopia or has dependence on spectacles for near work over the contact lenses. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.
a study to evaluate safety, engraftment, and efficacy of vc-01 in subjects with t1 diabetes mellitus

Conditions: Type 1 Diabetes

Summary: vc01-103 will evaluate an experimental combination product, cell replacement therapy intended to provide a functional cure to subjects with type 1 diabetes.

this trial will test if vc-01 combination product can be implanted and maintained with safety, tolerability, and efficacy for up to month 12/week 52.

Eligibility criteria:
inclusion criteria: * men and non-pregnant women * diagnosis of t1dm for a minimum of 3 years. * stable, optimized diabetic regimen * acceptable candidate for implant and explant procedures. * willing and able to comply with protocol requirements. * meet insulin dosing requirements per protocol exclusion criteria: • advanced complications associated with diabetes
parents at the center: information management in adhd - clinical trial

Conditions: Health Literacy; Attention Deficit Disorder With Hyperactivity; Computer Literacy; Information Management; Parents

Summary: health literacy is an integral part of the pathway for the successful transfer of information between patients and providers. parents of children with attention deficit/ hyperactivity disorder (adhd) play an essential role in chronic care as they offer critical information to providers that drives appropriate education and disease management. we propose the development and evaluation of an electronic data entry tool that enables parents to communicate data essential to treatment of their children, regardless of their own literacy skills. the research plan addresses a question central to patient-centered information management: how does health literacy influence parents' report of data on adhd and the process-level events that result from parent-provider communication? the following specific aims organize the clinical study: proposal: 1) to assess the effect of health literacy on successful completion of parent-reported adhd health information in both paper-based and pchr formats, and, 2): to determine the association between health literacy and process-level outcomes for adhd that stem from parent-provider exchange of information. the formal evaluation will study a diverse cohort of parents in a randomized trial of data entry (paper versus pchr) for adhd-specific information. primary care records for children of this cohort will be analyzed for the prior 12 month period. both a retrospective examination of documented adhd processes of care and a prospective evaluation of the utility of data from the pchr will occur. literacy level is a primary variable of interest throughout the evaluation.


Eligibility criteria:
inclusion criteria: * primary language of parent/guardian is english or spanish * parent/guardian reports that child has been diagnosed with adhd * current child age is between 5 years and 12 years * child in question resides with the parental subject primarily * parent/guardian reports that they are the primary caretaker of the child * parent/guardian reports that they are the person who communicates with the primary care provider * parent/guardian reports that child is currently taking medication for adhd or has taken it within the last 3 months exclusion criteria: * parent reports that child in question has been diagnosed with mental retardation, autism, pervasive developmental disorder, aspergers, or bipolar disorder
effects of medisinstart for type 2 diabetes

Conditions: Type 2 Diabetes

Summary: medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up appointments with a pharmacist. the aim of the service is to promote correct medication use and increase patient adherence. the effect of medisinstart has previously been studied among patients starting a new cardiovascular drug. the aim of the project is to map the effects of medisinstart among patients starting a new medication for type 2 diabetes. knowledge about the effects of medisinstart is important in order to maximize the benefits of the service for patients and society. the project is being conducted as a randomized controlled trial among adult patients starting a new medication for type 2 diabetes. the intervention group receives medisinstart, while the control group only receives prescription dispensing as normal. data collection includes hba1c analysis in blood samples and responses to questionnaires. hba1c is an established measure of glycemic control.


Eligibility criteria:
inclusion criteria: * extracted a new drug/active substance (a10a/a10b) for type 2 diabetes * age ≥ 18 years * the drugs are administered by the patient/relatives * good command of norwegian, both written and spoken exclusion criteria: * inability to understand and/or complete consent forms, questionnaires and/or other patient-oriented materials * not able to attend physical appointments in the pharmacy * not given written consent to participate in the study * diabetes medication is administered by a healthcare professional * known pregnancy * hba1c is unsuitable as an average measure of blood glucose at baseline * received initiation of medication for type 2 diabetes within the last year * ongoing participation in other studies involving similar interventions to increase adherence and ensure correct medication use

Keywords: medication related problems adherence type 2 diabetes pharmacist-led intervention consultation pharmacy
harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies

Conditions: Heart Failure

Summary: the purpose of this study is to determine whether the harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies is feasible.

heart failure is a devastating condition affecting nearly 6 million patients in the united states alone. ischemic cardiomyopathy, or pump failure secondary to previous heart attack, is considered by many to be the leading cause of heart failure. stem cell therapy, or regeneration of the lost myocardium, is an intervention that has the potential for reversing the detrimental effects of this disease. recently published evidence has shown preliminary results indicating the safety and feasibility of utilizing cardiac stem cells for the treatment of ischemic cardiomyopathy. the ability to use a commonly practiced method, such as endomyocardial biopsy, to isolate and expand stem cell cultures could, potentially, make this therapy widely available. the results of this study will be important for the design of future clinical trials.

Eligibility criteria:
inclusion criteria: 1. any heart failure patient scheduled for rhc without contraindication for biopsy. 2. any patient undergoing biopsy for diagnostic purposes may also be included in the study. exclusion criteria: 1. severe comorbidities (ast, alt, serum creatinine \> 3 times the upper limit of normal). 2. pregnancy or women of childbearing potential. 3. anticoagulation which cannot be stopped for 5-7 days. 4. hepatitis b, c or hiv. 5. inability to give informed consent.

Keywords: stem cell therapy