Kornimate/medical-research-clean huggingface dataset:
a pilot study to assess nominal versus controlled stimuli on dentinal hypersensitivity

Conditions: Dentin Sensitivity

Summary: this pilot study will evaluate the use of nominal stimuli to assess dentinal hypersensitivity response relative to a clinically-controlled stimulus.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * sign an informed consent form and be given a copy * be in good general health as determined by the investigator/designee * agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study * agree to not participate in any other oral care study for the duration of this study * agree to return for scheduled visits and follow all study procedures * have dentinal hypersensitivity with at least one tooth with a schiff sensitivity score of at least 1 in response to the examiner applied cold water challenge exclusion criteria: * severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession * active treatment for periodontitis * any diseases or conditions that might interfere with the subject safely completing the study * inability to undergo study procedures * fixed facial orthodontic appliances * a history of kidney stones * self-reported pregnancy or nursing * known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate

Keywords: sensitivity
lipofilling for healing of chronic wounds

Conditions: Wound Healing Disorder

Summary: chronic wounds remain a therapeutic and financial challenge for physicians and the health care systems. innovative, cheap and effective treatment methods would be of immense value. the sublesional fat grafting could be such treatment, although the effectiveness and safety have not been assessed in large randomized clinical trials. the aim of this trial was to analyse the effect of adipose tissue on the healing of chronic lower leg wounds. for this purpose, the wounds were surgically cleaned (wound debridement) and then fat was suctioned out from the stomach or thighs and then injected into the edges of the wound and under the wounds. the wounds are covered with a foam dressing that is changed every 3-4 days. there are controls on days 3, 7, 14 and 21 after the intervention and a follow-up examination 2 months after the intervention. the primary objective is the reduction of the wound area 14 days and 2 month after intervention. secondary objectives are pain level of the wound, bacterial colonialisation of the wound and analysis of the grafted fat tissue (ammount of mesenchymal stem cells)


Eligibility criteria:
inclusion criteria: * patients with leg ulcers of any origin (venous, arterial, mixed arterial-venous, diabetogenic, compressive) * age of ulcer \> 6 weeks * ulcer size \>= 1 cm (minimum diameter) * ulcer / wound with complete destruction of the epidermis (including basement membrane) * patient age \> 18 years * patient consent exclusion criteria: * pregnancy * exposed tendons, ligaments, or bone if maximum diameter \> 2 mm * ulcer size \> 10 cm * immediately preceding vacuum bandage therapy (\< 2 weeks) * possibilities for correcting the cause of the ulcer
polidocanol endovenous microfoam (pem) versus vehicle for the treatment of saphenofemoral junction (sfj) incompetence

Conditions: Varicose Veins

Summary: varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. in this study, patients with varicose veins in the legs will be participating. the purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, polidocanol endovenous microfoam (pem) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.


Eligibility criteria:
inclusion criteria: * incompetence of sfj associated with incompetence of the gsv or other major accessory vein * ability to comprehend and sign an informed consent document and complete study questionnaires in english * ability to record symptoms in accordance with the protocol * symptomatic varicose veins * visible varicose veins exclusion criteria: * patients who only have telangiectatic or reticular veins (clinical finding c1, as assessed by ceap classification of venous disorders). * leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure compression bandaging and stockings * ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion * deep vein reflux unless clinically insignificant in comparison to superficial reflux * peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings * reduced mobility * major surgery, prolonged hospitalization or pregnancy within 3 months of screening * major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.) * known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions * current alcohol or drug abuse * pregnant or lactating women * women of childbearing potential not using effective contraception * history of dvt, pulmonary embolism, or stroke

Keywords: varicose veins
heat shock protein 47 in thrombosis

Conditions: Venous Thromboembolism (VTE); Acute Myocardial Infarction With ST Segment Elevation; Stroke (in Patients With Atrial Fibrillation)

Summary: the goal of this observational study is to learn if the novel biomarker heat shock protein 47 (hsp47) can be used as a prognostic marker for vascular disease in people with acute venous thromboembolism (vte), myocardial infarction (ami) or ischaemic stroke compared to healthy volunteers. the main questions it aims to answer are: 1. are platelet levels of hsp47 higher in patients with acute vte, ami or stroke, compared to healthy volunteers. 2. does platelet levels of hsp47 remain elevated in patients with acute thrombotic events compared to healthy volunteers at 3 and 12-months of follow-up. 3. are platelet levels of hsp47 postively associated with platelet function and negatively associated with fibrinolytic capacity in patients with an acute thrombotic event. participants with vte, ami or stroke will be giving a blood sample at diagnosis and again after 3 and 12 months of follow-up. healthy volunteers will be giving a blood sample once.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * informed consent vte group: * deep vein thrombosis confirmed on ultrasonography or * pulmonary embolism confirmed on computed tomography angiography (cta) ami group: * st-segment elevation on electrocardiogram (ecg) and * culprit lesion(s) on coronary angiography stroke group: * stroke confirmed on magnetic resonance imaging and * atrial fibrillation (detected on ecg, telemtry or holter monitoring) and * stroke localisation classic for afib: cortical, cerebellar, brainstem or subcortical \>1.5 cm in diameter healthy group: - healthy exclusion criteria: * \<18 years of age * no informed consent * known haematological disorders * active haematological malignancy * severe renal insufficiency defined as egfr \<15 or dialysis vte - pulmonary embolism incidentally detected by cta conducted for purposes unrelated to pulmonary embolism assessment without concomitant dvt ami * coronary dissection * takotsubo cardiomyopathy stroke - stroke from other causes, e.g. findings pointing towards large vessel disease healthy * known acute or chronic disease * prior vte, ami, stroke or other thromboembolic event

Keywords: hsp47 heat shock protein 47 biomarker novel biomarker trombosis vte ami stroke
duloxetine versus placebo for fibromyalgia

Conditions: Fibromyalgia

Summary: the primary purpose of this study is to determine if duloxetine reduces pain severity in patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * you are male or female outpatient at least 18 years of age with fibromyalgia. females of child-bearing potential must test negative on a pregnancy test at visit 1. exclusion criteria: * serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition (including unstable hypertension and not clinically euthyroid) or psychological conditions that in the opinion of the investigator would compromise participation or be likely to lead to hospitalization during the course of the study. * abnormal thyroid-stimulating hormone concentrations.
my body is fit and fabulous at school

Conditions: Overweight; Obese

Summary: in order to address and curb the high prevalence of childhood obesity in malaysia, a school-based intervention program, mybff@school is developed for implementation in all schools in the country. the program is specific for overweight and obese students and it is hypothesized that by participating in this program, students will be able to control their body mass index.

a nationwide nutrition survey of malaysian children carried out between 2008-2009 among 3542 children aged from 6 months to 12 years showed a prevalence of 9.8% overweight and 11.8% obesity while in a more recent 2011 global school-based student heath survey showed that the percentage of overweight and obese malaysian school children age 13-15 years old was 25.4% and 10.9% respectively . if left unchecked, these children will grow up to be obese adults, developed various obesity-related complications such as cardiovascular diseases, diabetes etc. realising the urgent needs to address the problems, the ministry of health malaysia with the cooperation of the ministry of education, proposed to implement mybff@school in all schools in malaysia. students participating in mybff@school will take part in a structured physical activity in the form of small sided football game (ssg), and are to attend intensified and interactive nutrition and psychology classes aimed at improving their knowledge, self-esteem and self-empowerment.

Eligibility criteria:
inclusion criteria: classified as overweight and obese based on bmi of 85th percentile and above, according to who growth chart. no medical conditions that could endanger their health when participating in mybff@school. obtained parental and assent consents. exclusion criteria: with either physical or mental disability. with medical condition that prevents him/her to participate in moderate-to-vigorous intensity physical activity. with comorbidities that may interfere with the study such as diagnosed type 2 diabetes mellitus, hypertension, nephritic syndrome, epilepsy, congenital heart disease and skeletal anomalies. on steroids, on anti-epileptics and on methylphenidate.

Keywords: school based intervention overweight obese bmi z score fat mass
the distribution of immunoglobulin isotype in polyclonal hypergammaglobulinemia in systemic and autoimmune diseases

Conditions: Polyclonal Hypergammaglobulinemia; Autoimmune Diseases

Summary: polyclonal hypergammaglobulinaemia is characterized by increased levels of immunoglobulins and is a common feature observed in various diseases such as autoimmune diseases, chronic infectious diseases or lymphoid hemopathy. some autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis or sjögren's syndrome are frequently associated with polyclonal hypergammaglobulinaemia. recent data have suggested that the distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia may be disease-specific. however, isotype repartition in polyclonal hypergammaglobulinaemia remains poorly understood. the investigators will investigate the distribution of immunoglobulin isotype in patients with autoimmune disease and polyclonal hypergammaglobulinaemia. moreover, the investigators will evaluate the isotype repartition as predictor of lymphoma or monoclonal gammopathy among patients with autoimmune diseases.


Eligibility criteria:
inclusion criteria: * all adult patients \> 18 years old * patients with one of the following diseases: systemic lupus erythematosus, rheumatoid arthritis, sjögren's syndrome, autoimmune hepatitis, sarcoidosis or lymphoma. exclusion criteria: * age \< 18 years; * chronic viral hepatitis; * hiv infection, syphilis, * tuberculosis

Keywords: polyclonal hypergammaglobulinemia autoimmune diseases immunoglobulin isotypes
a study of soticlestat in adults and children with rare epilepsies

Conditions: Epilepsy; Dravet Syndrome (DS); Lennox-Gastaut Syndrome (LGS)

Summary: the main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment. participants will receive soticlestat twice a day. participants will visit the study clinic every 2-6 months throughout the study. study treatments may continue as long as the participant is receiving benefit from it.

the drug being tested in this study is called soticlestat (tak-935). this global, open-label extension (ole) study will assess the long-term safety and tolerability of soticlestat in participants with developmental and epileptic encephalopathy (dee) who participated in previous short-term efficacy/safety studies of soticlestat. all participants will receive soticlestat treatment. participants who rollover from previous blinded study will undergo up to 2 weeks of dose optimization period (depending on the previous study) followed by maintenance period. participants who rollover from an open-label study will continue on their current dose until development is stopped by the sponsor, or the product is approved for marketing, or at any time at the discretion of the sponsor. there will be a 4-week safety follow-up period after the last dose in maintenance period, including a 2-week dose tapering period.

Eligibility criteria:
inclusion criteria: 1. participants must have participated in a previous soticlestat study and meet one of the following conditions: * successfully completed a soticlestat clinical study. * received at least 10 weeks of treatment with the study drug in an antecedent placebo-controlled blinded soticlestat clinical study and the participant did not have a serious or severe ae that, in the investigator's or sponsor's opinion, was related to the study drug and would make it unsafe for the participant to continue receiving the study drug. 2. in the opinion of the investigator, the participant has the potential to benefit from the administration of soticlestat exclusion criteria: 1. clinically significant disease, that, in the investigator's opinion, precludes study participation. 2. enrollment in any other clinical trial involving an investigational drug, device, or treatment in the past 90 days (with the exception of an antecedent study involving soticlestat). 3. participant is currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration. 4. suicide attempt within the last year, at significant risk of suicide (either in the opinion of the investigator or defined as 'yes' to suicidal ideation question 4 or 5 on the c-ssrs at screening) or appearing suicidal per investigator judgment.

Keywords: soticlestat drug therapy
clinical and laboratory parameters of myelodysplastic syndromes at upper egypt

Conditions: Myelodysplastic Syndromes

Summary: the aim of our study is to assess clinical \& laboratory parameters of adult egyptian myelodysplastic syndrome patients in upper egypt, its correlation with disease-free survival, overall survival (os) and acute leukemia transformation.

the aim of this study is to assess clinical \& laboratory parameters of adult egyptian myelodysplastic syndrome patients in upper egypt, its correlation with disease-free survival, overall survival (os) and acute leukemia transformation. materials and methods: this study will be conducted in sohag university hospital and assuit university hospitals on available number of newly diagnosed patients with mds according to the diagnostic criteria proposed by the who in 2016 . full history taking, clinical assessment and certain laboratory investigations are conducted to every patient enrolled in this study.

Eligibility criteria:
inclusion criteria: * de novo mds according to who criteria diagnosis 2016 exclusion criteria: * mds on top of aml
preventing osteoporosis in adolescent girls

Conditions: Osteoporosis

Summary: physical activity in adolescents is an important part of bone health. good bone health in adolescents can decrease the risk of osteoporosis. this study will evaluate a program designed to increase the level of physical activity in adolescent girls.

despite the documented health benefits of increased physical activity, there is limited research on behavioral programs designed to increase exercise in adolescents. psychosocial characteristics, such as self-efficacy for exercise, social support for exercise from family and peers, and perceived benefits of and barriers to exercise, may predispose adolescents toward the adoption and maintenance of physical activity. this study will implement a multifaceted behavioral program specifically designed to increase bone strengthening physical activity by addressing many of the psychosocial factors relating to exercise. girls in this study will be enrolled in project fitness and bone (fab). the project fab intervention is delivered during a regular school class period 5 days per week for 10 months. one day per week is devoted to didactic presentations and/or discussion about reasons for being active, ways of overcoming barriers to being active, and strategies for maintaining an active lifestyle. the remaining four days are structured activity sessions, including a range of activities such as modified basketball, aerobic dance, and walking around a track. primary outcome measures will include bone mass (measured via dual-energy x-ray absorptiometer \[dexa\]) and serum and urinary measures of bone formation and resorption. participants will be contacted by telephone 12 months after their final clinic visit to ascertain their activity level at that time.

Eligibility criteria:
inclusion criteria * entering the 10th or 11th grade * participating in fewer then three vigorous activity sessions per week lasting 20 minutes or more or fewer than five moderate activity sessions per week lasting 30 minutes or more * at or below the 75 percentile for age- and gender-specific cardiovascular fitness * past the age of first menstrual cycle exclusion criteria * health problems that would preclude participation in regular exercise

Keywords: females sedentary school-based
ezetimibe added to statin therapy (easy) study (0653-087)(completed)

Conditions: Hypercholesterolemia

Summary: in the context of australian general practice, to determine the efficacy and safety of ezetimibe 10mg/statin 40mg coadministration in patients with uncontrolled cholesterol receiving statin 40mg or more.


Eligibility criteria:
inclusion criteria: * patients who will remain on a stable statin dose of 40mg or more, for the duration of the study * patients with coronary heart disease or diabetes mellitus whose cholesterol levels remain above the initial threshold for government subsidy after at least 3 months of treatment at a daily dose of 40mg or greater of a statin exclusion criteria: * illnesses such as congestive heart failure nyha class iii or iv * uncontrolled hypertension * myocardial infarction * coronary bypass surgery or angioplasty with or without stent within 3 months of the enrolment visit * unstable angina pectoris or unstable or severe peripheral vascular disease * uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, ex: type i or type ii diabetes mellitus that is poorly controlled * serum creatinine \>0.18mmol/l at enrolment or active renal disease with significant proteinuria * disorders of the haematologic, digestive (including malabsorptive disorders) * central nervous system including cerebrovascular disease and degenerative diseases that would limit study evaluation or participation * active acute or chronic hepatobiliary disease * patients taking the following medication: medications known to interact with statin medication including antifungal azoles, macrolide antibiotics, telithromycin; nefazodone; protease inhibitors; amiodarone; danazol and verapamil; fibrates; cyclosporin * tg \>4.0mmol/l while using a statin
mr-hifu for non-invasive thermal therapy of facet-joint syndrome:

Conditions: Facet Joint Syndrome

Summary: patients suffering from facet-joint-syndrome associated with lower-back pain will be treated with mri-guided high intensity focused ultrasound thermal therapy for pain relief.

patients with diagnosed facet-joint-syndrome are suffering from severe pain in the respective regions, mainly lower-back pain. eligible patients will be treated with high intensity focused ultrasound (hifu) under mri control. the control by mri assures on the one hand the correct selection of area to be sonicated and monitors in parallel the temperature, reached in the target area. the aim is to thermally ablate facet joint and/or medial branch nerves at lumbar spine. ablation is deemed to be feasible and successful if temperatures of at least 57°c are reached at the target. the entire procedure will be done under anaesthesia.

Eligibility criteria:
inclusion criteria: * chronic low back pain * clinical diagnosis of lumbar facet joint syndrome * eligible for mri and mr-hifu session * eligible for general anaesthesia * intact skin and soft tissue over treatment zone * facet joint anatomy clearly identifiable * patients must be able to discontinue all pain relief medication for a minimum of 48 hours prior to baseline assessment * patients able to provide consent for the study exclusion criteria: * spinal implants * treatment target zone \< 10 mm from the skin * pregnant female patients * breastfeeding female patients * body weight \> 140 kg * systemic and/or local infections * moderate to high grade of spinal instability * mri contrast agent contraindication * any mri-unsafe implant or pacemaker * facet joint anatomy which is not targetable or reachable due to scars, surgical clips, implants, or prosthesis in the planned beam path of the ultrasound beam