Kornimate/medical-research-clean huggingface dataset:
achillestendinopathy treated with proximal medial gastrocnemius recession

Conditions: Achilles Tendinopathy; Chronic Pain

Summary: this is a prospective cohort study that will follow 60 patients treated with proximal medial gastrocnemius recession for chronic mid-portion achilles tendinopathy for 5 years postoperatively.

mid portion achilles tendinopathy is a condition that usually resolves by itself without any kind of intervention. if the condition becomes chronic, eccentric training guided by a physical therapist seems to be the best non-surgical intervention. surgical treatment has shown varying results and no gold-standard exists. tightness in the gastrocnemius muscle seems to be a contributing factor for many conditions in the foot and ankle region. retrospective material suggest that proximal medial gastrocnemius recession (pmgr) can be an effective treatment for this condition. no prospective material exists. this study aims at including 60 patients with chronic mid-portion achilles tendinopathy (cmpat) that is non-responsive to eccentric training. patients will be pmgr-surgery and followed for 5 years with proms, muscle function test and mri scans.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years. 2. diagnosis cmpat verified clinically by orthopedic surgeon. symptoms must include mid-portion pain in the achilles, swelling and reduced tolerance for weightbearing. 3. verified diagnosis with mri findings representing pathologic processes of tendon degeneration and repair (13). mri no older than 12 months. 4. duration of symptoms must be at least 12 months. 5. isolated gastrocnemius tightness must be verified with the silfverskiölds test before inclusion. the silfverskiöld test is considered positive if ankle dorsiflexion is restricted to 5 degrees or less with the knee extended, and there is an increase of ankle dorsiflexion of at least 10 degrees when flexing the knee. 6. at least three months of conventional physical therapy with eccentric training must have been tried without providing relief of symptoms. exclusion criteria: 1. previous history of complete achilles tendon rupture. 2. other combined pathologies in the achilles tendon of calf (sequela from trauma, infections, cancer etc.). 3. insertional achilles tendinopathy. 4. previously undergone surgery in affected tendon. 5. patients with severe talocrural pathology or serious malalignment of foot and ankle. 6. severely reduced peripheral circulation. 7. history of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent. 8. patients with a contraindication/non-compliance for mri examination. 9. history of allergic reaction/anaphylactic reaction to local anesthetics. 10. not able to read and/or speak a scandinavian language or english adequately. 11. other serious comorbidity that makes surgery unadvisable.
the impact of the covid-19 pandemic on cardiovascular risk factors in patients with diabetes

Conditions: Diabetes Mellitus; Covid19

Summary: the objective of this study is to compare cardiovascular risk factors in patients with diabetes before the start of the pandemic of the covid 19 (time 1 - t1), after 1 year (time 2 - t2) and 2 years (time 3 - t3) duration. in patients with all types of diabetes, the investigators will compare the value of blood pressure, ldl cholesterol, bmi (body mass index) and glycated haemoglobin in t1, t2 and t3 during outpatient control.

diabetes mellitus (dm) is one of the major risk factors of cardiovascular diseases (cvds), which are the leading cause of death globally. to reduce overall cardiovascular risk in patients with diabetes, it is necessary, in addition to compensation of diabetes, to reduce other risk factors of cardiovascular diseases. the covids 19 (coronavirus disease of 2019) pandemic has in addition to direct influence (fever, pneumonia, olfactory loss, etc.)1,2 also, a lot of indirect effects. these include psychological effects (long term stress, worries, sadness)3,4,5, increased alcohol consumption, changes in eating habits or decreased physical activity due to restrictions to reduce the spread of the virus in population by government. the czech republic (central europe region) is one of the most affected countries in the world by covid 19 pandemic. by 1st of march 2021, the sars-cov2 virus infection was proven in the czech republic in 1 247 051 thousand people, which is 11.7% of the population (11 627 per 100 000, in the usa 8743/100 000, in the uk 6300/100 000, in the germany 2879/100 000, france 5379/100 000)6 due to a long-lasting serious situation, we expect an adverse effect on number of risk factors for cvds. the objective of this study is to compare cardiovascular risk factors in patients with diabetes before the start of the pandemic of the covid 19 (time 1 - t1), after 1 year (time 2 - t2) and 2 years (time 3 - t3) duration. in patients with all types of diabetes, the investigators will compare the value of blood pressure, ldl cholesterol, bmi (body mass index) and glycated haemoglobin in t1, t2 and t3 during outpatient control. the secondary objective is to evaluate behaviour of patients during covid 19 pandemic. the investigators will use a questionnaire. it will be anonymous for a more accurate assessment.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * diabetes mellitus of any type * planned visit to the outpatient diabetic clinic between 1.4. and 31.7.2021 - t2 (creation of the study group) - university hospital ostrava, czech republic * known values of blood pressure, glycated haemoglobin, ldl cholesterol and bmi before the start of the pandemic (1.3.2020), not older than 6 months and no later than 31.3.2020. * signed consent to the use of anonymous data for scientific purposes and publications. exclusion criteria: * failure to meet the criteria for inclusion

Keywords: diabetes mellitus covid 19 ldl hyperlipoproteinemia
impact of maternal xylitol consumption on mutans sterptococci

Conditions: Dental Caries and Streptococcus Mutans Count

Summary: the study was designed to determine whether maternal xylitol consumption through regular chewing of xylitol gums can affect the salivary mutans streptococci (ms), dental caries, and dental plaque levels of their children.

method: study sample included 60 mother and child pairs with high salivary mutans streptococcus (ms) levels. samples were randomly divided into experimental group (30 pairs) and control group (30 pairs). mothers in the experimental group received xylitol chewing gum treatment three times/day for three months, whereas the controls received fluoride varnish. both groups received oral hygiene instructions, dietary counseling and restorative treatment. all children were examined after 6, 12 and 18 months from the initiation of the study to assess caries, plaque and salivary mutans streptococcus (ms) levels.

Eligibility criteria:
inclusion criteria: * mothers with high salivary counts (≥ 105) * mothers having children at least 10 months of age (10-36months) or having a minimal of 8 primary teeth. exclusion criteria: * subjects with systemic disorders or on regular medications

Keywords: xylitol prevention mutans streptococci caries plaque children
school readiness in children with type 1 diabetes

Conditions: Type1diabetes

Summary: it is known that motor and sensory functions are affected in children with type 1 diabetes (t1dm).this may cause children to have restrictions in their daily lives and decrease their participation in activities.motor and sensory factors and participation are important factors affecting children's school readiness.this study was planned to investigate the effects of motor performance, sensory processing, quality of life and participation on school readiness in preschool children with t1dm.


Eligibility criteria:
inclusion criteria: having been diagnosed with type 1 dm in the last 6 months (for type 1 diabetes group) being 60-78 months old exclusion criteria: * - having any neurodevelopmental disorder in addition to diabetes (ex: cerebral palsy, down syndrome, muscular dystrophies..) * starting 1st grade
a safety and tolerability study of bivv020 in adults with cold agglutinin disease

Conditions: Autoimmune Haemolytic Anaemia

Summary: primary objective: to assess the safety and tolerability in participants with cold agglutinin disease (cad), after a single dose of intravenous (iv) bivv020 secondary objectives: to assess, in participants with cold agglutinin disease, after a single dose of intravenous (iv) bivv020: * the effect of bivv020 on complement mediated hemolysis * the pharmacodynamics (pd) of bivv020 relating to complement inhibition * the pharmacokinetics (pk) of bivv020 * the immunogenicity of bivv020

up to 23 weeks (screening period up to 8 weeks, treatment period 15 weeks)

Eligibility criteria:
inclusion criteria : * male and/or female patients, ≥ 18 years of age with cold agglutinin disease as defined by: 1. chronic hemolysis per investigator's judgement, 2. polyspecific direct antiglobulin test (dat) positive, 3. monospecific dat strongly positive for c3d, 4. cold agglutinin (cag) titer ≥ 64 at 4 c; and, 5. igg dat ≤1+. * a hemoglobin level ≤11 mg/dl. * a total bilirubin level above the normal reference range that is thought to be due to hemolysis. * documented vaccinations against encapsulated bacterial pathogens (neisseria meningitidis, including serogroup b meningococcus and streptococcus pneumoniae) within five years of screening or willing to complete protocol specified vaccinations. * having given written informed consent prior to undertaking any study-related procedure. exclusion criteria: * cold agglutinin syndrome secondary to infection, rheumatologic disease, or known high grade hematologic malignancy, or known solid organ tumor. * clinically relevant infection of any kind within one month preceding screening. * treatment with anti-cd20 monotherapy within three months or anti cd20 combination therapies within six months prior to screening. * concurrent treatment with systemic immunosuppressive agents targeting b- or t-cell function and/or cytotoxic agents within 3 months prior to screening. concurrent treatment with other systemic immunosuppressants within 5.5 half-lives of the drug prior to screening. * any specific complement system inhibitor within three months prior to screening. * concurrent treatment with systemic corticosteroids other than a stable daily dose equivalent to ≤10 mg/day prednisone within three months prior to screening. * if female, pregnant or lactating. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
novel triple-dose tuberculosis retreatment regimen

Conditions: Multidrug-resistant Tuberculosis; Pulmonary Tuberculosis; Tuberculosis; Resistance to Tuberculostatic Drugs

Summary: to determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent tuberculosis (tb).

stage 1: this is a pragmatic open-label multi-stage randomized clinical trial. potential participants will be screened and enrolled in damien foundation (df) clinics participating in the trial. first we will perform a two-arm study with 6ehrz as control arm and 6eh³r³z as intervention arm. if at interim analysis the intervention arm is not considered to be non-inferior to the control arm, the intervention stops and enrolment will continue in a an adapted intervention arm and the control arm (6ehrz). otherwise, enrolment continues to 6ehrz and 6eh³r³z. observational study (stage 2): the dsmb members agreed due to safety concerns to continuing the study as a cohort with only the control arm. the control regimen will remain the same (6ehrz). as per routine practice, during treatment patients are in daily contact with the direct observed therapy (dot) supervisor and minimally monthly clinic visits are scheduled for monitoring of safety and treatment response. additionally, liver function tests will be performed at fixed intervals during treatment. six month and one year after treatment completion or cure the patient will be checked for relapse with systematic sputum acid-fast bacilli (afb)-microscopy and tb culture.

Eligibility criteria:
inclusion criteria: * all newly registered patients with smear-positive recurrent pulmonary tb * adults as well as children (no age limit) * able and willing to provide written informed consent * added for stage 2: lives within 5 km of a health facility with a medical doctor exclusion criteria: * all patients with tb initially resistant to rifampicin on xpert mtb/rif testing * patients transferred to a health facility not supported by the damien foundation * patients previously enrolled in the trial, and with another episode of rifampicin-susceptible tb during the study period * those with grade iii elevation of liver function tests at baseline, or with clinically active liver disease at screening * pregnant or breastfeeding woman * hiv co-infected patients requiring treatment with a protease inhibitor

Keywords: rifampicin-susceptible-tb tuberculosis first-line tb relapse tb treatment failure high dose retreatment
effects of the elastic taping on the chronic ankle instability

Conditions: Ankle Sprains; Chronic Ankle Instability; Athletes Foot

Summary: this study will analyze the effects of an elastic taping application protocol in individuals with chronic ankle instability. one group will perform a protocol with increased tape tension for five weeks while the other group will receive the same tape without tension during the same period.

elastic taping is a method widely used in clinical practice for the treatment of ankle instability and shows increasing interest in research to verify its effectiveness. the literature presents several studies with short-term effects, largely in healthy individuals and with several application techniques, with the incremental tensioning of the proposed tape subjectively. the literature presents several studies with short-term effects, largely in healthy individuals and with several application techniques, with the incremental tensioning of the proposed tape subjectively.

Eligibility criteria:
inclusion criteria: * young adults with chronic ankle instability (unilateral or bilateral); * the first sprain episode occurred for at least 1 year pre-study associated with inflammatory symptoms (pain, edema, etc.); * having discontinued for at least 1 day physical activity; * the most recent sprain occurred more than 3 months prior study; * self-reported instability feeling to be confirmed by specific questionnaires. exclusion criteria: * lower limb surgical procedure; * lower limb fracture history; * acute injury (last 3 months) of other lower limb joints resulting in at least 1 day in the interruption of physical activity; * wounds in the ankle region or foot; * own skin disease; * have allergy to bandage; * be in physiotherapeutic treatment.

Keywords: athletic tape ankle sprains chronic ankle instability
comparing efficacy between restricted kinematic alignment vs mechanical alignment in bilateral tka

Conditions: Osteoarthritis, Knee; TKA

Summary: the goal of this rct is to investigate efficacy between restricted kinematic alignment and mechanical alignment tka in simultaneous bilateral tka patients. the main question\[s\] it aims to answer are: * does rka have better functional outcomes than ma in simultaneous bilateral tka patients? * does rka have lower pain score than ma in simultaneous bilateral tka patients? participants will undergo simultaneous bilateral tka and randomized one side will use rka and the other side will use ma.


Eligibility criteria:
inclusion criteria: * age 40-80 years * diagnosis bilateral primary osteoarthritis of knee joint and undergo simultaneous bilateral total knee arthroplasty * asa classification i-ii exclusion criteria: * valgus deformity * bmi \> 40kg/m2 * history of previous knee surgery * active infection of the knee joint

Keywords: restrict kinematic alignment mechanical alignment
bioindicators associated with sarcopenia before and after intensive lifestyle intervention

Conditions: Sarcopenia

Summary: the goal of this clinical trial is to explore whether the bioindicators of body composition, nutrition-related indicators (lymphocytes, albumin), lipids, and thyroid hormones are associated with sarcopenia and the changes in these indicators after an intensive lifestyle intervention. the main questions it aims to answer are: * whether the bioindicators such as lymphocytes, albumin, lipids, thyroid hormones, fat mass, fat-free mass, and basal metabolic mass are associated with the development of sarcopenia. * the changes of these bioindicators that occur in older adults after going through an intensive intervention. participants will receive a 3-month intensive intervention consisting of an intensive nutritional intervention and an individually designed exercise intervention. nutritional and exercise prescriptions are co-designed through a nutritionist and rehabilitation physician. researchers will compare bioindicators in the sarcopenia group before and after intensive lifestyle intervention to determine the association with sarcopenia.


Eligibility criteria:
inclusion criteria: * 1) resident elderly aged 65-90 years old in the district. * 2) voluntary participation in the trial and signing the informed consent form. exclusion criteria: * 1) people with systemic severe diseases, organ failure, malignant tumors, neuromuscular degenerative diseases, or active weight loss. * 2) people with cognitive impairment, incapacitation, or severe mental illnesses who cannot cooperate with the test. * 3) people with cardiac pacemakers and artificial joint implantation or others who cannot undergo the bia test. * 4) people with severe cardiorespiratory dysfunction and physical disabilities who cannot complete the exercise training. * 5) incomplete data, refusal to participate in the survey, body composition analysis, and blood collection.

Keywords: sarcopenia bioindicators intensive lifestyle intervention exercise intervention nutritional intervention
endometrial tissues and mononuclear cells receptivity in pathogenesis of endometrial proliferative processes

Conditions: Endometrial Hyperplasia Without Atypia; Endometrial Hyperplasia With Atypia; Endometrial Cancer; Peripheral Blood Mononuclear Cells; Postmenopause; Estrogen Receptor; Progesterone Receptor

Summary: a prospective observational study of endometrial tissue and peripheral blood mononuclear cells receptivity to sex steroid hormones in postmenopausal patients with endometrial proliferative processes

endometrial cancer is in third place among cancer diseases in female population of russia. the peak morbidity occurs during the postmenopausal period. in this regard, early diagnosis of previous endometrial proliferative processes and effective methods for their treatment are relevant. however, failures with hormonal therapy are often observed. this may be due to the low receptivity of the pathological tissue. it is also known that the functional activity of immunocompetent cells is controlled by the immune system, however, studies of the receptivity of peripheral blood mononuclear cells to sex steroid hormones were carried out in healthy blood donors. changes in mononuclear cells receptivity may be one of the pathogenetic links in the development of endometrial proliferative processes and endometrial cancer. this may also influence the effectiveness of their treatment. in this regard, the purpose of the study is to evaluate the role of the expression of estradiol and progesterone receptor genes in endometrial tissue and peripheral blood mononuclear cells in the occurrence of endometrial proliferative processes in postmenopausal patients with a pathogenetic justification for the choice of treatment method. to achieve this goal, the investigators investigated the expression level of estrogen and progesterone receptors (era, erb, gper, pra, prb, mpr, pgrmc1) by rt-pcr in pathological endometrial tissue and peripheral blood mononuclear cells. gabdh was used as a comparison gene. the data obtained made it possible to determine the significance of mononuclear cell receptivity in the pathogenesis of endometrial proliferative processes.

Eligibility criteria:
inclusion criteria: * endometrial polyps * endometrial hyperplasia * atypical endometrial hyperplasia * endometrial cancer exclusion criteria: * hormonal treatment (estrogen-progestogens, gestagens, gonadotropin-releasing hormone agonists, menopausal hormone therapy and tamoxifen) for 6 months before the study * uterine fibroids, larger than 6-7 pregnancy weeks * pathology of the uterine appendages according to ultrasound pelvis * inflammatory diseases of various localization at the time of taking the material
impacted canine and mixed-reality technology - rct

Conditions: Tooth, Impacted

Summary: the goal of this clinical trial is to determine whether the use of hololens 2 mixed reality goggles for planning alignment of palatally impacted canine reduces: 1) treatment time and 2) the risk of complications compared to planning alignment of palatally impacted canine without hololens 2 goggles. participants will have an impacted canine on palatal side. researchers will use or will not use hololens 2 goggles in planning therapy participants will wear fixed orthodontic appliances for the treatment of impacted canine. during treatment, attachment will fixed to an impacted canine and the direction of traction will be established.


Eligibility criteria:
inclusion criteria: * healthy boys/men and girls/women aged between 10 and 20 years. * palatally impacted canine on one side * axis of the canine \> 10 degrees to the midline as measured on a pantomographic radiograph * during orthodontic treatment, in preparation for alignment of the impacted canine with adequate space for the retained canine exclusion criteria: * dental abnormalities (hyperodontia, hypodontia, etc.) * impacted canines bilaterally * previous trauma to the teeth or face * congenital craniofacial malformations * systemic diseases that would hinder orthodontic treatment/operation * recent radiotherapy
perception of facial expression in subjects with and without crow's feet lines

Conditions: Healthy Volunteers

Summary: this study will examine the perception of facial expressions among individuals with and without crow's feet lines.


Eligibility criteria:
inclusion criteria: * english fluency exclusion criteria: * none