Kornimate/medical-research-clean huggingface dataset:
validity and reliability of the turkish version of the functional shoulder score

Conditions: Subacromial Impingement Syndrome

Summary: the aim of this study is to determine the validity and reliability of the turkish version of the functional shoulder score in turkish patients with subacromial impingement syndrome (sis).

the original form of the functional shoulder score will be translated into turkish by two turkish mother tongue translators who also speak english in advanced level. then these translations will be combined into one translation and translated back to english. the pre-final version will be composed and tested on a group of patients with sis. if necessary, readjustments will be made, and the validity of the final version will be investigated in 116 patients with sis. additionally, for the test-retest reliability, 59 patients will fill out the questionnaire again after 3-7 days.

Eligibility criteria:
inclusion criteria: * diagnosis of subacromial impingement syndrome (michener et al, 2009) * to read and understand turkish exclusion criteria: * 50% limitation of passive shoulder range of motion in ≥ 2 planes of motion * glenohumeral instability * fracture or surgery history in the shoulder * another diagnosis that may affect shoulder function (frozen shoulder, primary shoulder arthritis, inflammatory/ neoplastic/neurological conditions, cervical spine induced pain) * systemic musculoskeletal disease

Keywords: functional shoulder score questionnaire subacromial impingement syndrome
safety and efficacy of combination saxagliptin & dapagliflozin added to metformin to treat subjects with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to learn if a combination of bms-477118 (saxagliptin) and bms -512148 (dapagliflozin) added to metformin can improve (decrease) glycosylated hemoglobin (hemoglobin a1c) in patients with type 2 diabetes after 24 weeks of treatment. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus (t2dm) with hba1c ≥ 8.0% and ≤ 12.0% * stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening * body mass index (bmi) ≤ 45.0kg/m2 exclusion criteria: * estimated glomerular filtration rate (egfr) \< 60ml/min/1,73m2 and serum creatinine (scr) ≥ 1.5 mg/dl in males or ≥ 1.4 mg/dl in females * uncontrolled hypertension systolic blood pressure (sbp) ≥ 160mmhg and/or diastolic blood pressure (dbp) ≥ 100mmhg * hepatic disease * cardiovascular disease within 3 months
effect of h. pylori eradication on alleviating symptoms in functional dyspepsia patients

Conditions: Helicobacter Pylori-positive With Functional Dyspepsia

Summary: in patients with helicobacter pylori-positive functional dyspepsia, long-term follow-up for 6 months after standard triple therapy first-line eradication treatment, the rate of symptom disappearance and degree of improvement of functional dyspepsia were confirmed through changes in symptom scores and changes in drug usage, and eradication treatment the purpose of this study is to confirm the rate of symptom disappearance according to the results.


Eligibility criteria:
inclusion criteria: * male and female outpatients between the ages of 19 and 75 * who have symptoms of functional dyspepsia (early fullness, postprandial discomfort, epigastric pain, epigastric soreness) that correspond to rome criteria 4 (diagnostic criteria questionnaire) exclusion criteria: * small intestine and large intestine disease within 6 months of the screening visit (visit 1) * liver, pancreatobiliary disease within 6 months of the screening visit (visit 1) * peptic ulcer within 6 months of the screening visit (visit 1)
pharmacokinetics of benapenem in subjects with renal impairment

Conditions: Complicated Urinary Tract Infection; Cuti

Summary: this is an open-label, multiple center, parallel-group study to compare the pharmacokinetics and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate renal impairment(ri) and healthy subjects. subjects were enrolled with defined degrees of ri based on egfr(estimated glomerular filtration rate) calculated by mdrd (modification of diet in renal disease)formular as follows: nomal renal function(≥90ml/min/1.73m2 ; n=6); mild ri (60-89ml/min/1.73 m2 ; n=6), moderate ri (30-59 ml/min/1.73m2 ; n=6)


Eligibility criteria:
inclusion criteria: * 1.18\~75 years old * 2. bmi 17 to 30 kg/m2 * 3. no known diseases or significant abnormalities on physical exam (subjects with normal renal function only) * 4. egfr ≥ 90 ml/min/1.73m2 (subjects with normal renal function only) * 5. egfr 30 to 59 ml/min/1.73m2 (subjects with mild renal impairment only); egfr 60 to 89 ml/min/1.73m2 (subjects with moderate renal impairment only) exclusion criteria: * 1. hypersensitivity to any of the beta-lactam antibiotics * 2.conditions or disease that may interfere with the evaluation of study drug * 3. acute disease requiring antibiotics within 30 days prior to administration, or a fever within 7 days prior to administration; * 4. drug abuse in 2 years * 5. a blood donation or more than 400 ml of blood loss within 3 months
a multi-center rct to evaluate subsegmental btva treatment for severe emphysema

Conditions: Severe Emphysema

Summary: to compare the efficacy and safety of subsegmental treatment and segmental treatment with intervapor in patients with severe emphysema


Eligibility criteria:
inclusion criteria: 1. age≥18 years old; 2. patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by qct; 3. non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study; 4. 15%predicted≤fev1≤50%predicted, tlc≥100% predicted, rv≥150% predicted (and rv/ tlc≥55%); 5. 6mwd \>140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test) 6. mmrc score≥2; 7. arterial blood gas levels of: paco2≤55 mmhg; pao2\>50 mmhg on room air; 8. mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment. exclusion criteria: 1. contraindications to bronchoscopy, such as: prior myocardial infarction within 1 month, unstable myocardial ischaemia, ejection fraction (ef) ≤ 40%; active haemoptysis; coagulation disorders; malignant cardiac arrhythmia, severe pulmonary hypertension, extreme systemic failure, etc; 2. concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with intervapor. examples of particular relevance include: immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency; 3. use of morphine derivatives within 4 weeks prior to screening; 4. taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit; 5. recent copd exacerbation in preceding 6 weeks; 6. severe emphysema in both the upper and lower lobes of the contralateral lungs, defined as %laa-950 assessed by hrct as a percentage of whole lung lobe volume \> 40%; 7. presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe; 8. presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated wbc, etc.); 9. history of heart and/or lung transplant, lung volume reduction surgery (lvrs), median sternotomy, bullectomy, thoracic surgery with removal of lung tissue and endobronchial lung volume reduction (via valves, coils, stents, etc.); 10. highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist; 11. pregnant or breastfeeding; 12. current enrollment in any other investigational study which has not completed requisite follow-up; 13. any conditions assessed by investigator that make patients inappropriate for enrolment.

Keywords: bronchoscopic thermal vapor ablation (btva) chronic obstructive pulmonary disease (copd) severe emphysema bronchoscopic lung volume reduction (blvr)
a study evaluating bilastine ophthalmic solution 0.6% in the conjunctival allergen challenge (ora-cac®) model.

Conditions: Allergic Conjunctivitis

Summary: to evaluate the efficacy of bilastine ophthalmic solution 0.6% compared to vehicle and zaditen (ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * be at least 18 years old * be willing and able to avoid all disallowed medications and contact lenses * must have a pregnancy test if of childbearing potential * must be able to read an eye chart from 10 feet away exclusion criteria: * must not have any allergies to the study medications * must not have any ocular or non ocular condition that investigator feels will interfere with study parameters * must not have used immunotherapy in the last 2 years * must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
a phase 2b study of istradefylline (kw-6002) for the treatment of parkinson's disease in patients taking levodopa

Conditions: Parkinson's Disease

Summary: the purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the off state in patients with advanced parkinson's disease (pd) treated with levodopa.

to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the off state in patients with advanced parkinson's disease (pd) treated with levodopa. patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/day istradefylline or matching placebo. patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Eligibility criteria:
inclusion criteria: 1. uk parkinson's disease society (ukpds) brain bank criteria (step 1 and 2) for pd. 2. pd stages 2-4 in the off state for modified hoehn and yahr scale. 3. on levodopa/dopa-decarboxylase inhibitor for at least one year. 4. taking at least three doses and \>=300mg of levodopa per day for at least four weeks before randomization. 5. predictable end of dose wearing off. 6. able to satisfactorily complete hauser based 24-hour patient parkinson's diary. 7. have an average of two hours of off time on 24-hour diaries. 8. on a stable regimen of any other anti-parkinson's drugs for at least four weeks before randomization. 9. be at least 20 years of age. 10. be willing and able to give written informed consent. exclusion criteria: 1. taking any excluded medications. 2. neurosurgical treatment or transcranial magnetic stimulation for pd. 3. diagnosis of cancer within 5 years. 4. diagnosis of clinically significant illness of any organ system. 5. diagnosis of dementia or mini-mental status examination score of 25 or less. 6. history of drug or alcohol abuse or dependence within the past two years. 7. history of psychosis. 8. significant drug allergies. 9. taking anticonvulsants for seizures. 10. history of neurological malignant syndrome. 11. pregnant or lactating females.

Keywords: parkinson's disease levodopa end of dose wearing off off time
effect of music on patients' anxiety during lower limb arthroplasty procedures under spinal anaesthesia

Conditions: Anxiety

Summary: the aim of this study is to compare the effect of listening to music, to a control group (no music), on peri-operative anxiety using the validated vas-a, in patients undergoing lower limb arthroplasty procedures under spinal anaesthesia.

music is becoming an increasingly popular adjunct to traditional medical therapies. international studies have shown the numerous benefits of music in a medical setting. music has been used effectively to decrease patients' anxiety under neuraxial anaesthesia for caesarean section. there is currently a lack of evidence supporting the use of music to reduce patients' anxiety under neuraxial anaesthesia for lower limb arthroplasty procedures. the worldwide growth of the ageing population has led to an increased demand for arthroplasty. it is imperative that the anaesthetic technique used for this procedure is both safe and is associated with high levels of patient satisfaction. the purpose of this study is to compare the effect of music, to a control, on peri-operative anxiety in patients undergoing lower limb arthroplasty procedures under spinal anaesthesia.

Eligibility criteria:
inclusion criteria: * all patients, aged 18 years and older, * american society of anaesthesiologists (asa) class i, ii or iii, * patients undergoing primary hip or knee arthroplasty surgery under spinal anaesthesia, * patients with the mental capacity to consent to the study. exclusion criteria: * patients with significant visual or hearing loss, * patients with any contra-indications to spinal anaesthesia, * patients with any contra-indications to moderate sedation including moderate to severe obstructive sleep apnoea (indicated by a "stopbang" score of 5-8) (46), * patients with pre-existing diagnosed anxiety disorders or other serious mental disturbances, * revision arthroplasty (this may require deviation from the standardised anaesthetic technique used for this trial), * anxious patients who cannot be reassured and require additional anxiolytic agents.

Keywords: music perioperative anxiety spinal anaesthesia lower limb arthroplasty
turkish adaptation, validity and reliability of exercise sensitivity questionnaire

Conditions: Heart Diseases; Exercise Addiction; Sensitivity

Summary: interoceptive complex sensations and fear beliefs resulting from cardiac risk factors or cardiovascular disease can further increase one's awareness and attention to bodily situations and cause differences in the interpretation of somatic sensations. these intraceptive somatic sensations may be the underlying factors for participation in exercise and compliance with exercise programs no turkish questionnaire evaluating unpleasant sensations (exercise sensitivity) was found. exercise sensitivity questionnaire, which we planned to validate in our study, is a questionnaire developed by samantha farris et al. in 2020 to measure anxiety, exercise avoidance behavior and exercise sensitivity, which are frequently observed in individuals with heart disease.

the reliability and validity of the scale will begin with language equivalence and cultural adaptation. the scale will be translated from english to turkish by two people who are fluent in turkish and english. a single turkish translation will be obtained from these two turkish translations with a common opinion. the scale, which has been translated into turkish, will be translated into english by two other people who are fluent in turkish and english. the scale translated into english will be compared with the original. if the developer of the scale, miguel blacutt and stults-kolehmainen approves the translation of the scale, participants will be recruited for the study. in the pre-trial phase, a pre- assessment will be conducted with 15 participants to test the intelligibility of the scale. based on the results of the pre-test phase, the final version of exercise sensitivity questionnaire will be able to be modified. exercise sensitivity questionnaire scale questions and questions in the data collection form face to face 450 participants will be included in the study. in order to evaluate the validity of the exercise sensitivity questionnaire.tampa kinesiophobia- heart and tampa kinesiophobia has been validated in turkish, will be used. scales will be repeated after 15 days to assess test-retest reliability.

Eligibility criteria:
inclusion criteria: * being older than 35 years, * having a self-reported heart disease (heart failure, acute myocardial infarction, coronary artery disease, coronary by-pass surgery, heart valve surgery, history of stable angina, cardiac have battery) * to have agreed to participate in the study, * have internet access, * being a mother tongue turkish. * carrying at least two of the cardiac risk factors (hypertension, type 2 diabetes, hyperlipidemia/dyslipidemia, overweight or obesity (bmi\>25), physical inactivity (less than 150 minutes of moderate-intensity exercise per week, smoking) exclusion criteria: * not answering all questions * cognitive defect or cooperation disorder
clinical response of impulsivity after brain stimulation in parkinson's disease

Conditions: Impulsive Behavior; Impulse Disorders; Gambling, Pathological; Eating, Binge; Hoarding Disorder; Hypersexuality; Compulsive Shopping; Dopamine Dysregulation Syndrome; Caregiver Burnout; Parkinson Disease

Summary: the objective of this prospective observational cohort study is to answer the following clinically important questions: 1. in patients with a pre-operative history of icbs, what is the likelihood of improvement or deterioration in icbs post-operatively? 2. what is the risk of developing post-operative de novo icbs after subthalamic nucleus dbs (stn dbs)? 3. which factors are important in predicting changes in icbs after stn dbs? 4. what is the impact of icbs on carer's quality of life qol and burden?

the study will record outcomes related to icbs for pd patients who have already been selected for dbs therapy as a routine clinical treatment in participating in dbs operating centre it is routine practice to assess icbs before dbs decisions are made, but the manner varies across dbs operating centres. the only additional factor to the routine dbs clinical pathway in this study is that the centres involved will perform assessments in a uniform manner to allow data to be combined. a unified set of clinical assessment scales for impulsive control disorders icds and icbs, as well as other relevant neuropsychiatric symptom assessment, will be added to routine pre- and post-operational clinical assessments for participants. the primary endpoint of the study is the change in severity of icbs. if subjects score above 1 in any of given questions on quip-rs, or if subjects had disagreement with carers regarding scores, the parkinson's impulse-control scale, pics will be triggered. pics then will be administered by our trained research fellow (aa), over phone or in the clinic. other scales to be administered are listed below: 1. neuropsychiatric inventory (npi) 2. general anxiety disorder-7 (gad-7) 3. patient health questionnaire-9 (phq9) 4. parkinson's disease questionnaire-39 (pdq-39) 5. euroqol 5 dimension (eq-5d) 6. clinical global impression - severity scale (cgi-s) at baseline and clinician's global impression - improvement scale (ggi-i) post-operatively. 7. zarit caregiver burden scale 8. work and social adjustment scale 9. upps-p impulsive behaviour scale assessments will be performed at baseline, 3, 6 and 12 months post-operatively. results will be analysed to ascertain potential predictive measures for icbs development/change.

Eligibility criteria:
inclusion criteria: * selected for dbs to treat motor symptoms of parkinson's disease * english language fluency exclusion criteria: * nil

Keywords: deep brain stimulation parkinson's disease impulse control disorders impulse control behaviours compulsive shopping hypersexuality binge eating gambling walkabouts hobbyism hoarding punding
digitized grip strength

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is the most common chronic inflammatory arthritis in adults. monitoring of disease activity is based on disease activity score 28 (das 28). there are also validated questionnaires for self-assessment of the disease by the patient. grip strength measured using a digitized sensor used by the patient could be an additional tool to the remote monitoring of patients with ra. main objective : to evaluate the correlation between the measurement of grip strength in the dominant hand measured by a digital sensor and activity of ra assessed by das 28 secondary objective : evaluate the correlation between grip strength of the dominant hand and : * scores of fatigue and pain (vas and facit) * the self-assessment scores known in ra : functional index health assessment questionnaire (haq) and scores of activity rapid3 and radai5. it is a cross-sectional study involving 150 patients followed in our department for ra. grip strength of the dominant hand will be measured by a digitalized sensor during a single visit integrating into the routine monitoring of patients.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis whatever its activity * above 18 years old patients exclusion criteria: * other condition that may affect the level of fatigue and / or grip strength * insufficient level of understanding to perform the measurement and self-report questionnaires
intraarticular injections of platelet-rich plasma in pain's treatment of the osteoarthritic knee

Conditions: Knee Osteoarthritis

Summary: platelet-rich plasma (prp), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. it was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic knees this study therefore seeks to assess the analgesic power of prp in osteoarthritic knees intraarticularly infiltrated, and which patients would benefit most from treatment, eliminating false expectations in the rest.

this is the first clinical trial developed following the report of the spanish competent authority on may 23, 2013, considering the prp as a medicinal product for human use and establishing minimum guarantees required of the product and the process of manufacturing. it has been conducted from the perspective of both the trauma and the specialized treatment of chronic pain anesthesiologist, and manufacturing the prp on the premises of a regional centre for transfusions, all belonging to the public health system and therefore without commercial interests.

Eligibility criteria:
inclusion criteria: * arthritis in the knee rated i, ii, or iii (kellgren-lawrence grading scale) * vas greater than 5 * between 40and 80 years of age exclusion criteria: * level iv arthritis of the knee * either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months * frontal deformity greater than 10 degrees * ipsilateral pathology of the knee or ankle * range of motion or flexibility of the knee less than 90 degrees * deficit of knee extension greater than 15 degrees * anticoagulation treatment, antiplatelet treatment * hepatopathy * hematological neoplastic pathology * active infection * fibromyalgia * chronic fatigue syndrome

Keywords: knee osteoarthritis platelet-rich plasma pain's treatment
brava and fat transfer for breast reconstruction

Conditions: Fat Necrosis of Breast

Summary: breast reconstruction is one of the most challenging aspects in plastic surgery. one of the most sophisticated methods of breast reconstruction is using of autologous fat grafting. brava is a device that invented by dr roger khouri, and is intended to improve the final results of fat grafting.

the purpose of the study is to examine the efficacy of brava with fat grafting in woman undergoing mastectomy in the institution. woman who will agree to participate in the study will be instructed how to wear the brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it.

Eligibility criteria:
inclusion criteria: * woman after mastectomy exclusion criteria: * smokers * collagen disease * low compliance