Kornimate/medical-research-clean huggingface dataset:
topical sulfasalazine and oral lichen planus

Conditions: Oral Lichen Planus; Topical Sulfasalazine; Corticosteroids

Summary: oral lichen planus (olp) is a chronic inﬂammatory disease that affects the mucosal membrane. t-cell mediated damage against the mucosal epithelial cells is implicated in the pathogenesis of olp, although the exact mechanism is unknown. sulfasalazine is extensively used in inﬂammatory bowel disease and is effective on immune-related inﬂammatory disease such as crohn's disease, rheumatoid arthritis, and behcet's disease. in spite of its effectiveness, the anti-inﬂammatory mechanism is not clearly understood.

* patients will be recruited in a consecutive manner from the outpatient diagnostic center, faculty of dentistry, cairo university. * a total number of 46 patients will be included in this study. the 23 patients categorized as study group (s group) will use topical sulfasalazine prepared by dissolving one tablet of commercially available (colosalazine - ec 500 mg 20 tab, manufactured by: alexandria company for pharmaceuticals \& chemical industries, alexandria) in 100 ml of distilled water 4 times per day as a mouth wash combined with topical corticosteroids 4 times per day as a topical gel in an alternate sequence. there are no expected side effects of this treatment due to its topical application however, the patient will be instructed to stop the treatment if any adverse reactions occur such as allergy and coming to the clinic next day. * the 23 patients categorized as control group (c group) will receive topical corticosteroids gel only 4 times per day. the treatment regimen will be continued for 4 weeks with follow up visits one per week. * medical history will be taken, thorough oral examination will be done, and a full questionnaire will be filled for each patient. * all participants in the study groups will undergo adequate oral hygiene performance measures with complete removal of plaque and calculus as they implement intraoral inflammation and intensify both extension and symptoms of olp lesions. patients will be advised to evade accidental trauma on soft tissues using soft bristles toothbrush. acidic, spicy, hard, hot food and beverages will be avoided.

Eligibility criteria:
inclusion criteria: * - patients with 30-65 years old * patents with atrophic olp exclusion criteria: * - smokers * pregnant or lactating ladies and * patients under topical or systemic steroids during the last two months * patients using lichenoid reaction-inducing drugs, * patients with positive hepatitis c virus (hcv) antibodies, diabetes and hypertension * patients having amalgam filling adjacent lesions will not also be included
effect of androgel on type 2 diabetic males with hypogonadism

Conditions: Diabetes Mellitus Type 2

Summary: this is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.

type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress. hypogonadism( low testosterone) is also associated with increased levels of inflammatory mediators and atherosclerosis. this project is about studying the effect of testosterone replacement on different inflammatory cells in blood and urine. it will also compare the dose dependent effect on inflammatory cells. this also involves comparing level of inflammation in hypogonadic diabetic males treated with testosterone with those not treated with any replacement therapy. this study involves applying androgel for 8 wks and studying effects during this time and thereafter.

Eligibility criteria:
inclusion criteria: * males with age 35-75 years inclusive. * evidence of hypogonadism: low free testosterone. * type 2 diabetes * people on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed. * if currently on testosterone replacement,testosterone treatment will be held for 8 weeks. * bp under control even if on medication. exclusion criteria: * coronary event or procedure in previous past 4 wks. * high psa * h/o prostate cancer * hepatic or renal disease * participation in any other concurrent clinical trial * any other life- threatening , non cardiac disease. * uncontrolled bp * congestive heart failure * high hemoglobin * use of investigational agent or therapeutic regimen within 30 days of study.

Keywords: dm type 2 hypogonadism testosterone androgel
evaluation of specialized water dance intervention

Conditions: Spastic; Pain, Chronic; Stress; Quality of Life

Summary: individuals with profound intellectual and multiple disabilities (pimd) have extensive health problems and need for personal assistance throughout the day. few physical- and health promoting activities are available for them and among the activities, few have been scientifically evaluated. specialized water dance intervention (swan) is a new method developed to relieve discomfort and promote physical wellbeing among people with pimd. the aim of the study is to evaluate the effects of swan on stress, spasticity, pain, alertness, wellbeing and social interaction among individuals with pimd. individuals with profound intellectual and multiple disabilities (pimd) have extensive health problems and need for personal assistance throughout the day. few physical and health promoting activities are available for them. among the activities, few have been scientifically evaluated. specialized water dance intervention (swan) is a new method developed to relieve discomfort and promote physical wellbeing among people with pimd. the aim of the study is to evaluate the effects of swan on stress, spasticity, pain, alertness, wellbeing and social interaction among individuals with pimd. prospective randomized controlled intervention study in which the effects of swan are tested in a two-group cross-over design with pre-, under- and post-measurements. the study is conducted as a multicenter study with four participating county councils/regions i sweden (varmland county council, region orebro county, region ostergotland and region gavleborg). the swan intervention is given once a week for 3 months (12 occasions). each swan session is 45 minutes and is led by two swan leaders.


Eligibility criteria:
inclusion criteria: * have a profound intellectual and multiple disabilities corresponding to level iv-v in the gross motor function classification system. * aged 16-65 years * be accustomed to water and not find discomfort of activities in water. exclusion criteria: * severe hearing impairment/deafness * have wounds/infections that are infectious in the pool
safety and performance of hydrophobic and hydrophilic intraocular lenses after bilateral cataract surgery

Conditions: Senile Cataract

Summary: subjects who had a bilateral age-related cataract surgery with the iols at elana 841p and at lisa tri 839mp will be contacted and invited to attend a postoperative visit more than one year after the surgery

the main objective of this clinical investigation is to collect data on the iols at elana 841p and at lisa tri 839mp in subjects who underwent bilateral cataract surgery with the use of the two different types of iols to confirm the long-term performance and safety of the iols. retro-prospective, comparative, non-interventional, non-randomized, single center study on medical devices with one follow-up visit after more than 12 months of a bilateral cataract surgery.subjects who had a bilateral age-related cataract surgery with the iols at elana 841p and at lisa tri 839mp will be contacted and invited to attend a postoperative visit more than one year after the surgery.

Eligibility criteria:
inclusion criteria: 1. adult patient of any gender; 2. patients who had an uncomplicated (no intra-operative complication) age-related cataract surgery 3. currently implanted with an iol model at elana 841p into the capsular bag in one eye and with the iol model at lisa tri 839mp into the capsular bag of the other eye. 4. the postoperative visit was scheduled to be conducted more than one year after the second eye surgery. 5. given written informed consent by patient. exclusion criteria: 1. patients unable to meet the limitations of the protocol or likely of non-cooperation during the study 2. patient whose freedom is impaired by administrative or legal order 3. concurrent participation in another drug or device investigation that could confound the outcome of this investigation.
intrapulmonary percussive ventilation for children with bronchiolitis on non-invasive ventilation support

Conditions: Bronchiolitis

Summary: prospective randomized study of patients admitted to the pediatric intensive care unit suffering from bronchiolitis and are supported on non invasive positive pressure ventilation. the patient population will be divided into two groups, one group will receive conventional treatment and the other group will receive conventional treatment and three times a day of physiotherapy using intrapulmonary percussive ventilation.


Eligibility criteria:
inclusion criteria: * bronchiolitis * picu patients * non invasive pressure support ventilation * age \< 24 months exclusion criteria: * age \> 24 months * invasive ventilation * no parental consent
intracoronary transplantation of bone marrow derived mononuclear cells in pediatric cardiomyopathy

Conditions: Cardiomyopathy

Summary: according to the high morbidity and mortality of idiopathic dilated cardiomyopathy (idcm) in pediatric, new modality of treatment is emerging. there are some case reports of administration of stem cell therapy. the investigators design the first randomized clinical trial in this setting. the investigators enroll 32 pediatric idcm patients in two groups (16 pts. in each group including cell therapy and control). the investigators assess the safety and efficacy of intracoronary transplantation of autologous bone marrow derived mononuclear cells in this patients compared to control group.

dilated cardiomyopathy as the most common form of cardiomyopathy is a rare but life-threatening disorder in children. the primary cause of nearly 37 % of children with dcm was unknown at diagnosis. despite of the developing in the medical and surgical treatment during the past several decades, standard treatments (including digitalis, diuretics, inhibitors of ace, beta blockers, antiplatelet drugs and treatments antiarrhythmic), may stabilize the condition, but will not restore heart function to its previous condition. therapy remains complex and expensive. for some not all children the heart transplantation is only option and mortality continues to be high, also. stem cell and cell-based therapies offer an innovative approach to reverse cardiac structure and function towards normal, possibly reducing the need for aggressive therapies and cardiac transplantation. according to the inclusion and exclusion criteria of trial, 32 patients with left ventricular ejection fraction less than 45% who resistance to the standard medical therapy were randomly allocated in 2 groups including bm-derived mononuclear (n=16) and control (n=16). only the mnc group underwent the bone marrow aspiration and intracoronary injection. the investigators followed all of patients at 2 weeks, 1, 2, 4 and 6 months after transplantation for cell therapy group or registration for placebo by physical examination, laboratory tests and imaging such as echocardiography, cxr and cmr.

Eligibility criteria:
inclusion criteria: 1. age between 1-16 year(s) 2. lvef \<45% (echocardiography) 3. duration of diagnosis more than 3 months 4. resistance to standard therapy more than 2 months 5. informed consent exclusion criteria: 1. congenital heart disease 2. active infection less than one month 3. dysrhythmia 4. cardiogenic shock 5. renal failure 6. immune deficiency (documentation) 7. terminal illness or malignancy(documentation) 8. torch (documentation) 9. metabolic disorder (documentation) 10. neuromuscular disorder (documentation) 11. autoimmune disease (documentation) 12. developmental delay 13. cytotoxic drugs 14. previous bone marrow transplant 15. contraindications to cmr such as metallic implants

Keywords: dilated cardiomyopathy pediatric heart failure cell therapy
a study of gdc-0810 versus fulvestrant in postmenopausal women with advanced or metastatic breast cancer resistant to aromatase inhibitor (ai) therapy

Conditions: Breast Cancer

Summary: the primary purpose of this study is to evaluate the efficacy, safety, and tolerability of gdc-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (er+)/ human epidermal growth factor receptor 2 negative (her2-) breast cancer resistant to ai therapy. the development of gdc-0810 has been halted by the sponsor and the enrollment in this study has been discontinued. participants currently enrolled in the study who are experiencing clinical benefit may continue receiving gdc-0810 as a single agent or fulvestrant until disease progression (pd), unmanageable toxicity, withdrawal of consent, exhaustion of gdc-0810 drug supply, or termination of the study by the sponsor.


Eligibility criteria:
inclusion criteria: * postmenopausal women with histologically or cytologically confirmed invasive, er+/her- (defined by local guidelines) metastatic or inoperable, locally advance breast cancer * participants for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study * participants must have measurable disease by recist v1.1 or non-measurable, evaluable disease with atleast one evaluable bone lesion by recist v1.1 based on radiologic scans within 28 days of day 1 of cycle 1 * participants with radiologic/objective evidence of breast cancer recurrence or progression while on or within 6 months after the end of adjuvant treatment with an ai, or progression while on or within 1 month after the end of prior ai treatment for locally advanced or metastatic breast cancer exclusion criteria: * her2-positive disease * prior treatment with fulvestrant * prior treatment with greater than (\>) 1 cytotoxic chemotherapy regimen or \>2 endocrine therapies for advanced or metastatic disease
clinical characteristics and outcomes of coronary heart disease

Conditions: Coronary Heart Disease

Summary: this study evaluated and compared the prognostic value of different baseline data and clinical variables to develop predictive model in patients with chd.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with coronary heart disease (chd) admitted to the first affiliated hospital of xinjiang medical university. 2. the diagnosis is based on clinical assessments, including symptomatic evaluation, electrocardiographic findings, and coronary angiography. exclusion criteria: we excluded patients who had serious heart failure, malignant tumor，rheumatic heart disease, valvular heart disease, congenital heart disease, pulmonary heart disease and serious dysfunction of the liver or kidney.
observational study to observe the safety of levemir® treatment in patients with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this observational study is conducted in europe. the study aims to observe the incidence of serious adverse drug reactions in subjects with type 2 diabetes during levemir® treatment.


Eligibility criteria:
inclusion criteria: * any patient with type 2 diabetes * currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin) * selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient exclusion criteria: * known or suspected allergy to study product(s) or related products. * pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months
molecular fluorescence endoscopy of (pre)malignant esophageal lesions

Conditions: Barrett Esophagus; Esophageal Cancer; Dysplasia in Barrett Esophagus

Summary: to improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in barrett's esophagus (be), there is a need for better endoscopic visualization and the ability for targeted biopsies. optical molecular imaging of neoplasia associated biomarkers could form a promising technique to accommodate this need. it is known that the biomarker c-met is overexpressed in dysplastic and neoplastic areas in be segments versus normal tissue and has proven to be a valid target for molecular imaging. edinburgh molecular imaging ltd (emi) has developed a fluorescent tracer specifically targeting c-met by labeling a small peptide to a fluorescent fluorophore: 'emi-137'. the investigators hypothesize that when emi-137 is administered intravenously, it accumulates in c-met expressing high grade dysplasia (hgd) and esophageal adenocarcinoma (eac), enabling (early) cancer visualization using a newly developed fluorescent fiber-bundle. this hypothesis will be tested in the current pilot intervention study.

see brief summary.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, eligible for a diagnostic and/or therapeutic endoscopy; * at least a suspicion of low grade dysplasia (lgd) based on a prior endoscopy; * world health organization (who) performance score of 0-2; * written informed consent; * mentally competent person that is able and willing to comply with study procedures; * for female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal: * a negative serum pregnancy test prior to receiving the tracer; * willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter. exclusion criteria: * pregnancy or breast feeding; * advanced stage eac patient not suitable for endoscopic resection; * medical or psychiatric conditions that compromise the patient's ability to give informed consent; * concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last three months prior to the start of the treatment * the subject has been included previously in this study or has been injected with another investigational medicinal product within the past six months. * history of myocardial infarction (mi), transient ischemic attack (tia), cerebrovascular accident (cva), pulmonary embolism, uncontrolled congestive heart failure (chf), significant liver disease, unstable angina within 6 months prior to enrollment. * the subject had any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to investigational medicinal product (imp) administration. occasional use of analgesics, such as non-steroid anti-inflammatory drugs and/or paracetamol, was permitted at the discretion of the investigator. use of hormonal contraceptives is permitted.

Keywords: be eac hgd esophagus
effect of preemptive low dose norepinephrine infusion on intraoperative hemodynamic stability and postoperative outcomes in patients undergoing brain tumor resection with a craniotomy

Conditions: Brain Tumor

Summary: in the experimental group, norepinephrine at a concentration of 5 mcg/ml is preemptively administered through peripheral venous catheter with a size of 20 g or more from the time of anesthesia induction to the end of anesthetic administration. the norepinephrine is not preemptively administered in the control group. for anesthesia, total intravenous anesthesia using propofol and remifentanil is performed. during anesthesia, the injection rate of the test drug is allowed to be adjusted according to the blood pressure within the permissible range, and anesthesia management such as fluid infusion, blood transfusions, and drug administration is performed according to the judgment of the anesthesiologist, and there are no restrictions. the achievement of hemodynamic stability during anesthesia is judged by the percentage (%) of the time when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure during the total anesthesia duration. the number of hemodynamic unstability occurred, and the number of patients with hemodynamic unstability are also sought. the incidence of postoperative complications between the two groups is also compared.


Eligibility criteria:
inclusion criteria: patients aged 20 to 65 who undergo elective craniotomy for brain tumor resection exclusion criteria: 1. emergency surgery 2. if the subject includes those who cannot read the consent form (e.g. illiterate, foreigners, etc.) 3. cognitive dysfunction 4. pregnant, lactating 5. congestive heart failure (new york heart association scores ≥3) 6. arrhythmia 7. renal dysfunction (estimated glomerular filtration rate less than 30 ml/min/1.73m2) 8. patients with severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, asthma under treatment, etc.) 9. uncontrolled hypertension (baseline blood pressure greater than 140/90)
a first in human study to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of inhaled etd001 in healthy subjects

Conditions: Cystic Fibrosis

Summary: this is a first in human study of etd001 a new drug being developed for the treatment of cystic fibrosis. the study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of inhaled etd001in healthy male and female subjects.


Eligibility criteria:
inclusion criteria: * males and females using suitable methods of contraception, or females of non-childbearing potential * consent to study participation * body weight ≥ 50 kg and body mass index 19 - 30 kg/m2 * vital sign assessments within the normal ranges * healthy as determined following physical and laboratory examinations at screening visit * spirometry readings (fev1 and fvc) to be ≥ 80% of predicted value exclusion criteria: * acute or chronic illness detected at the screening visit * respiratory tract infection within 4 weeks of the screening visit * use of prescribed or otc medication within 14 days of the screening visit * history of regular alcohol use over the recommended limits within 6 months of screening, or history/evidence of alcohol or drug abuse * smoker or use of tobacco products within 6 months of screening * abnormal blood or urine laboratory test results at screening * recent participation (within 3 months) in another clinical trial * current, or history of, allergy that may be contraindicated