Kornimate/medical-research-clean huggingface dataset:
effects of synbiotic supplementation in metabolic syndrome

Conditions: Metabolic Syndrome

Summary: to evaluate the effects of synbiotic supplementation on insulin resistance, and lipid profile in subjects with metabolic syndrome, in a randomized, double-blind, placebo-controlled pilot study, 38 subjects with metabolic syndrome will be supplemented with either synbiotic or placebo capsules twice/day for 28 weeks. both the synbiotic (g1) and the placebo (g2) groups will be advised to follow an energy balanced diet and physical activity recommendations. parameters related to metabolic syndrome and insulin resistance will be measured every 7 weeks during the study course.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * having three of the following five features: increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated tg (≥150 mg/dl), reduced hdl-c (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the national cholesterol education program adult treatment panel iii report * bmi : 25≥ bmi ≥ 40 exclusion criteria: * use antibiotic 2 weeks before recruitment to the study * a history of alcohol consumption * pregnancy \& breast feeding , professional athelets * a history of cardiovascular disease, pulmonary disease, renal disease \& celiac disease
an online system to improve diabetes self-care

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to see if an online program for patients with diabetes helps patients improve their self-care (how they take their medications, what they eat, how much they exercise, and whether they smoke).

patient portals are online programs that can provide a number of functions for patients, among them: * ability to request appointments, referrals, and medication refills; * ability to send secure electronic messages to medical staff, and to receive replies; * access to the medical record; * disease management we are comparing two patient portals with different sets of features to determine if personalized information and guidance can improve self-care and measures of diabetes-related health. self-care measures will be assessed using standardized questionnaires at baseline, 3, and 6 months. chart review will be used to assess measures of diabetes-related health.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes mellitus * has access to internet * has e-mail address * established patient at one of four participating practices at university of colorado hospital exclusion criteria: * non-english speaking

Keywords: disease management patient access to records medical records systems, computerized questionnaires physician-patient relations medical records
hashimoto - a surgical disease. total thyroidectomy makes antibodies disappear and ameliorates symptoms

Conditions: Hashimoto's Disease

Summary: the investigators have already proven that absolute total thyroidectomy gives elimination of anti-tpo antibodies. our hypothesis is that this elimination also eliminates the typical hashimoto symptoms, namely: serious tiredness, increased need of sleep, pain in musculature and joints and dryness in eyes and mouth. the prerequisite for this effect is that the total thyroidectomy is meticulously performed. there exists no other treatment that can eliminate the antibodies. the study is randomized between operation and ordinary conservative medical treatment with thyroxine control and supplementation. the symptoms in both groups are evaluated by 5 different quality of life schemes, internationally approved.

the study hypothesis is that elimination of anti-tpo antibodies ameliorates the typical hashimoto symptoms like tiredness,increased need of sleep, pain in musculature and joints and dryness in eyes and mouth. it is necessary that the total thyroidectomy is meticulously performed. we have proven the effect on the antibodies, and we have also proven that the operation procedure can be performed without more complications like recurrent nerve damage and hypocalcemia. neutrality is secured by randomization done by a neutral institution, laryngoscopy by neutral doctors and instructions filling out the qol-schemes performed by non-biased study nurses. the study runs for at least 18 months with controls every 6 months. blood samples are taken and international approved qol-schemes are filled in. in addition to the randomised main group a side group of patients fulfilling 2 of the 3 inclusion criteria are followed in parallel in order to elucidate the spontaneous development of the disease and showing critical values of antibodies making the symptoms turn up.

Eligibility criteria:
inclusion criteria: 1. patients referred due to typical symptoms, believed to be related to hashimoto´s disease, but not relieved by thyroxin substitution. optimal thyroid substitution treatment is already provided. 2. anti-tpo\>1000 3. hypothyroidism with a need for thyroxin supplementation 4. written informed consent by the patient - information particularly emphasising and quantifying the risk of complications (e.g. recurrent laryngeal nerve palsy). the patient should be informed by a medical endocrinologist as well as a surgeon. exclusion criteria: 1. patients \<18 years of age. 2. pregnancy. 3. unable to comprehend information adequately to give informed consent. 4. general anaesthesiological contraindications. 5. an unexpected finding of cancer in the surgical group is not a reason for exclusion per se, but this group should be analyzed separately. it is expected that any different loading in quality of life would bias the medically treated group.

Keywords: chronic thyroiditis total thyroidectomy anti-tpo proms sf36 fatigue questionnaire fatigue autoimmune symptoms hads fss fvas
effects of smoking on non-surgical periodontal therapy in generalized aggressive periodontitis

Conditions: Generalized Aggressive Periodontitis; Smoking

Summary: smoking is the major preventable risk factor in the initiation and progression of periodontal diseases. periodontitis risk was found to be 3.9 times higher among smokers aged between 19-30 years and 2.8 times higher among smokers aged 31-40 years compared to non-smokers. aggressive periodontitis (agp), is characterized by a rapid attachment loss usually incompatible with the amount of plaque and dental calculus. it is often not possible to predict the prognosis of treatment with various treatment options in cases of aggressive periodontitis. it was hypothesized that non-smoker patients with generalized aggressive periodontitis (gagp) will respond better to conventional mechanical non-surgical periodontal therapy compared to the smokers. therefore, the aim of this study was to evaluate the effects of smoking on the outcomes of non-surgical periodontal treatment in terms of the clinical, biochemical and microbiological parameters.


Eligibility criteria:
inclusion criteria: * having at least six permanent teeth, including incisors and/or first molars with severe periodontal disease * having at least one site with probing depth (pd) and clinical attachment level (cal) ≥5 mm and six teeth other than first molars and incisors with similar pd and cal measurements * familial aggregation exclusion criteria: * medical disorders such as diabetes mellitus, immunological disorders * having an antibiotic or periodontal treatment in the last 6 months * having \<15 teeth

Keywords: generalized aggressive periodontitis non-surgical periodontal therapy periodontopathogens smoking gingival crevicular fluid
clinical surveillance vs. anticoagulation for low-risk patients with isolated subsegmental pulmonary embolism

Conditions: Pulmonary Embolism; Embolism; Embolism and Thrombosis; Lung Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Venous Thromboembolism; Anticoagulant-induced Bleeding; Bleeding

Summary: the clinical significance of pulmonary embolism (pe) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (sspe), remains controversial. whether isolated sspe represents "true" pe, a clinically more benign form of pe, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated sspe benefit from anticoagulant treatment is uncertain. despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated sspe (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated sspe receive anticoagulant treatment, which is associated with an increased risk of bleeding. the overall objective of the randomized controlled safe-sspe trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated sspe.


Eligibility criteria:
inclusion criteria: 1. informed consent as documented by signature 2. age ≥18 years 3. objective diagnosis of symptomatic or asymptomatic isolated sspe exclusion criteria: 1. presence of leg deep vein thrombosis (dvt) or upper extremity dvt (subclavian vein or above) 2. active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months 3. ≥1 prior episode of unprovoked vte (absence of a transient or permanent risk factor) 4. clinical instability (systolic blood pressure \<100 mm hg or arterial oxygen saturation \<92% at ambient air) at the time of presentation 5. active bleeding or at high risk of bleeding 6. severe renal failure (creatinine clearance \<30ml/min) 7. severe liver insufficiency (child-pugh b or c) 8. concomitant use of strong cyp3a4 inhibitors or strong cyp3a4 inducers 9. known hypersensitivity to rivaroxaban 10. need for therapeutic anticoagulation for another reason 11. therapeutic anticoagulation for \>72 hours for any reason at the time of screening 12. hospitalized for \>72 hours prior to the diagnosis of isolated ssp (hospital-acquired vte) 13. known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential) 14. lack of safe contraception in women of childbearing potential 15. refusal or inability to provide informed consent 16. prior enrolment in this trial

Keywords: subsegmental pulmonary embolism
effectiveness of passive and active rom exercises following tka

Conditions: Osteoarthritis; Total Knee Arthroplasty

Summary: the purpose of the study is to determine the effectiveness of new interventional approaches in the early postoperative phase following total knee arthroplasty (tka). it is assumed that active training programs are more effective in improving physical function than the passive standard-of-care therapy.

the major objectives of rehabilitation after tka are the early regain of range of motion (rom) and mobilization of the patient. continuous passive motion (cpm) is frequently used as part of the postoperative care regime following tka with the aim to increase knee joint mobility and improve postoperative recovery despite little conclusive scientific evidence. conflicting research findings have generated an ongoing debate on its usage. as the greatest loss of function occurs in the first month following tka, it is surprising that the rom therapy during hospital stay is still carried out passively. a passive mobilization of the knee joint with cpm does not encourage the patients to actively participate in their rehabilitation. research on the effectiveness of active rom exercises added to standard physiotherapy during the short in-hospital period is lacking so far.the objective of this study is to compare the passive clinical standard therapy (cpm) with different active training programs (controlled active motion, cam). it was hypothesised that the cam therapies are more effective in improving physical function than the cpm therapy.

Eligibility criteria:
inclusion criteria: * patients with knee osteoarthritis and scheduled for primary tka * age: 50-80 exclusion criteria: * bmi \> 40 * musculoskeletal and neurological disorders that limit physical function * any planned further joint surgery within 6 months * substantial pain or functional limitation which make the patients unable to perform study procedures

Keywords: rehabilitation total knee arthroplasty range of motion continuous passive motion controlled active motion postoperative physical therapy
a study to assess the efficacy and safety of asp1941 in asian subjects with type 2 diabetes mellitus

Conditions: Type II Diabetes Mellitus

Summary: the purpose of this study is to assess the efficacy of asp1941 based on the changes in hba1c as well as its safety in asian subjects with type 2 diabetes mellitus.

this is a multi-center, active-controlled, double-blind, double-dummy, parallel-group comparative study. after a screening period followed by a placebo run-in period under the single-blind condition, subjects will be randomized to either the asp1941 or the acarbose group. subjects will take the study drug under the double-blind condition in the treatment period. after completion of the study drug administration, a follow-up period will be provided.

Eligibility criteria:
inclusion criteria: * diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study * stable diet and exercise program for at least 6 weeks before the study * for the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy * bmi of 20.0 to 45.0 kg/m2 * for the hypoglycemic agent non-naïve subject, subject has a hba1c value between 6.8 and 10.0% at screening and has a hba1c value between 7.0 and 10.0%, inclusive, at run-in period * for the hypoglycemic agent naïve subject, subject has a hba1c value between 7.0 and 10.0%, inclusive, at run-in period exclusion criteria: * type 1 diabetes mellitus * proliferative diabetic retinopathy * receiving insulin within 12 weeks prior to the study * history of clinically significant renal disease(s) * significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc. * urinary tract infection or genital infection * continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics * history of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study * severe infection, serious trauma, or perioperative subject * known or suspected hypersensitivity to asp1941, acarbose or other alpha-gi * history of treatment with asp1941 * participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study * serum creatinine value exceeding the upper limit of normal range * urinary microalbumin/urinary creatinine ratio \>300 mg/g

Keywords: urine glucose ipragliflozin plasma glucose asp1941
ultrasound guided knee injections in musculoskeletal medicine

Conditions: Knee Osteoarthritis

Summary: this study will compare the accuracy and patient reported outcomes between four different techniques used to perform a knee injection.

this study will compare the accuracy and patient-oriented outcomes between various techniques for intra-articular knee injections. historically, a joint line (intercondylar) technique of injection at the medial or lateral joint line, reliant solely upon clinical palpation, has been the most popular approach among primary care and orthopedic providers. newer approaches, making use of ultrasound visualization to accomplish access to the intercondylar recess and the anterolateral suprapatellar pouch, have gained in popularity. because of uncertain accuracy with the traditional approach, this study is designed to determine if sonographic visualization combined with either of these two newer techniques improves accuracy and affects patient-oriented outcomes.

Eligibility criteria:
inclusion criteria: * male or female, age 18 to 90 * clinician determined need for intra-articular knee injection * radiograph confirmed grade 1-4 kellgren lawrence osteoarthritis scale exclusion criteria: * allergy to contrast dye, shellfish * allergy to egg product or hyaluronate * allergy to lidocaine * localized skin infection at planned site of injection * inability to complete follow-up phone call three months following the injection * viscosupplementation injection within 6 months of the current evaluation

Keywords: knee osteoarthritis ultrasound sonography injection
comparing minilaparotomy and laparoscopic cholecystectomy as a day surgery procedure

Conditions: Gallstone Disease

Summary: minlaparotomy (mc) and laparoscopic cholecystoctomy (lc) are commonly applied surgical techniques for the management of symptomatic gallstone disease and both techiques have shown to be feasible for day surgery. however, to our knowledge the long-term outcome between these approaches has not been compared in randomised trials as day surgery procedures.


Eligibility criteria:
inclusion criteria: * cholelithiasis confirmed by preoperative ulrasound * no significant co-morbidities * the asa physical status classification 1 or 2 * age 18 to 65 yrs. * bmi less than 35 * less than a one hour journey from hospital to home * patient´s own motivation to daysurgery exclusion criteria: * elevated liver laboratory tests * earlier jaundice * a suspicion or verified stones in the common bile duct * acute cholecystitis * a history of pancreatitis * hepatic cirrhosis * suspicion of cancer * previous open upper abdominal surgery * asthma * peptic ulcer * bleeding disorders

Keywords: 5-year outcome after cholecystectomy
efficacy and safety study of tolamba™ in ragweed-allergic adults

Conditions: Rhinitis, Allergic, Seasonal

Summary: the purpose of this study is to find out if a new investigational vaccine, tolamba™, is safe and effective in reducing the symptoms of ragweed allergy.

ragweed allergy is the most common seasonal allergy in north america. allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoidance of the allergen or medication. it may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance. this study compares the safety and efficacy of two different dosing regimens of tolamba™ with placebo in reducing the symptoms of ragweed-allergic adults over two consecutive ragweed pollen seasons. comparison(s): subject-rated allergy symptoms of subjects treated with tolamba™ dose-intense regimen or tolamba™ lower-dose regimen, compared with subjects treated with placebo.

Eligibility criteria:
inclusion criteria: * has a history of ragweed allergic rhinitis (hayfever) during at least the last 2 consecutive seasons that has required treatment with antihistamines, decongestants and/or nasal steroids, but where symptom relief has been incomplete * is willing to stay in their ragweed area during the historical peak period of the local ragweed season, and willing to travel for no more than 2 weeks (cumulative time) outside of their ragweed area during the entire season exclusion criteria: * has had any hospital admissions for asthma * has smoked within the past year, or has a ≥10-pack per year smoking history * has had any previous immunotherapy with ragweed pollen extract, or was in a previous clinical trial with tolamba™ * has used xolair within the past 12 months * has a history of anaphylaxis

Keywords: ragweed allergy allergic rhinitis hay fever seasonal treatment immunotherapy vaccine
a study to compare the drug levels of atazanavir and cobicistat between the coadministration of age-appropriate mini-tablet formulations and the coadministration of the individual reference products in healthy adults under fed conditions

Conditions: Healthy Participants

Summary: the purpose of this study is to evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in healthy adult participants.


Eligibility criteria:
inclusion criteria: • body mass index (bmi) of 18.0 to 32.0 kg/m\^2, inclusive. bmi = weight (kg)/\[height(m)\]\^2 exclusion criteria: * significant acute or chronic medical illness * history of a clinically significant drug rash, stevens-johnson syndrome or gilbert's syndrome * inability to swallow oral medication * major surgery within 4 weeks of study treatment administration other protocol-defined inclusion/exclusion criteria apply

Keywords: healthy participants atazanavir cobicistat reyataz tybost evotaz
risk and aesthetic assesment in implant patient

Conditions: Implant Assesment

Summary: this study examines the peri-implant risk assessment diagram and the aesthetic, peri-implant health status, and gingival level around the implant in patients with implants by comparing them in smokers and non-smokers. : after completion of the examination, 298 dental implants for at least three months after functional prosthesis loading, except for patients with bruxism and uncontrolled diabetes, were included in the study. patients are primarily divided into smokers and non-smokers. in all implant patients, plaque, gingival index, bleeding on probing, pocket depth, clinical attachment loss, gingival recession, keratinized thickness, keratinized width, vestibule depth, pink aesthetic score, and peri-implant disease risk analysis are evaluated in sequence.


Eligibility criteria:
inclusion criteria: * 18-70 years old patients * patients who are systemically healthy and have a controlled medical condition * patients with fixed prosthesis on the implant at least 6 months after the functional prosthetic loading of the dental implant exclusion criteria: * patients with uncontrolled systemic diseases * those who have the habit of bruxism

Keywords: implant disease risk assesment pink esthetic score implant quality scale periodontal health periodontal disease
first-in-human study to assess safety and tolerability of a single subcutaneous dose of sar441255 in lean to overweight subjects

Conditions: Overweight; Healthy Subjects

Summary: primary objective: to assess the safety and tolerability of sar441255 after ascending single subcutaneous (sc) doses secondary objectives: to assess the pharmacokinetic parameters of sar441255 in plasma after ascending single sc doses to assess the pharmacodynamic effects on glycemic parameters (fasting and postprandial glucose, c-peptide and insulin)

study duration per participant is approximately 8 weeks including a 21-day screening and baseline phase, a 4-day treatment phase and a 28-day follow up period after dosing.

Eligibility criteria:
inclusion criteria : * male and female subjects, between 18 and 55 years of age, inclusive * body mass index ≥20 and ≤30 kg/m2 * body weight between 65 and 90 kg, inclusive * no concomitant medication * fasting plasma glucose \<126 mg/dl * hemoglobin a1c \<6.5% * triglycerides \<300 mg/dl * low-density lipoprotein (ldl) cholesterol \<200 mg/dl * permanent sterile or postmenopausal, if female exclusion criteria: * any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, gynecologic (if female), ocular, or infectious disease, or signs of acute illness. * any medication (including over the counter products and any other herbal/alternative remedies such as st john's wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.