Kornimate/medical-research-clean huggingface dataset:
a 104 week clinical trial comparing long term glycaemic control of insulin degludec/liraglutide (ideglira) versus insulin glargine therapy in subjects with type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa, asia, europe, north america and south america. the purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (ideglira) versus insulin glargine (iglar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.


Eligibility criteria:
inclusion criteria: * male or female, age greater than or equal to 18 years at the time of signing informed consent * subjects diagnosed with type 2 diabetes mellitus * hba1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis * body mass index greater than or equal to 20 kg/m\^2 * insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes * stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) other oad(s) allowed: sulphonylurea, glinides, pioglitazone, and dpp4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record) exclusion criteria: * screening calcitonin greater than or equal to 50 ng/l * renal impairment estimated glomerular filtration rate (egfr) less than 60 ml/min/1.73 m2 as per ckd-epi value to be defined as listed in the classification ckd-epi using idms for serum creatinine measurement on the day of screening * impaired liver function, defined as alat or asat greater than or equal to 2.5 times upper limit of normal * family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma * history of pancreatitis (acute or chronic) * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening * anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
oto-201 for the treatment of otitis externa

Conditions: Otitis Externa

Summary: this is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. eligible subjects will receive a single dose of 6 mg oto-201 to the affected ear. the study is designed to characterize safety, procedural factors and clinical effect of oto-201 administered in subjects with otitis externa.


Eligibility criteria:
inclusion criteria includes, but is not limited to: * subject is a male or female aged 6 months to 80 years, inclusive * subject has a clinical diagnosis of unilateral otitis externa * subject or subject's caregiver is willing to comply with the protocol and attend all study visits exclusion criteria includes, but is not limited to: * subject has tympanic membrane perforation * subject has a history of known immunodeficiency disease * subject has fungal otitis externa, based on clinical signs

Keywords: otitis externa swimmer's ear ear infection
a pilot multi-institutional study to evaluate the accuracy of a breast cancer locator in patients with palpable cancers

Conditions: Palpable Breast Cancer

Summary: the project objective is to determine whether the breast cancer locator (bcl) can safely and effectively localize breast cancers in patients treated at locations distant from the site of bcl manufacture. this information will be transmitted to cairnsurgical, inc. where the bcl will be fabricated, tested for quality assurance, sterilized and shipped to the patient's surgeon. the surgeon will then utilize the bcl at the time of resection of the palpable breast cancer.

the primary purpose of the study is to determine whether a device called the breast cancer locator (bcl) accurately identifies the location of cancer in the breast. the breast cancer locator is a plastic bra-like form that gives the surgeon information about the location of the cancer in the breast. the location information is derived from an mri which is obtained with the patient lying flat on their back (just as they are on an operating room table). the bcl is then custom-made for the patient using 3d printing technology. the surgeon can feel the cancer, and the surgeon will remove the cancer by feeling the edges of it as the surgeon would normally. since the cancer can be felt, the surgeon does not need an image guidance system such as the bcl to locate the cancer in the breast. other women may have breast cancers that cannot be felt, but are only identified by mammography or mri. if the bcl proves to accurately localize breast cancer, it may be a useful guide for the surgeon for these other women. additionally, the investigators want to determine whether this technology can be successfully employed at multiple sites and what, if any, complications occur during surgery as a result of using this device. the bcl has been used in 19 patients at dartmouth with no complications.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years. 2. histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ. 3. patient desire to undergo breast surgery (lumpectomy or non-skin sparing mastectomy). 4. ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted. 5. the cancer enhances on prone breast mri imaging 6. the cancer is visible on mammography. exclusion criteria: 1. absolute contraindication to mri, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes. 2. severe claustrophobia. 3. contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (creatinine \> 2.0). 4. history of median sternotomy. 5. pregnancy. patient attestation that they are not pregnant will be acceptable. 6. patients receiving neoadjuvant chemotherapy.

Keywords: breast conserving surgery breast imaging breast cancer locator supine mri
telmisartan compared with enalapril in elderly patients with blood hypertension

Conditions: Hypertension

Summary: study to assess the efficacy and tolerability of telmisartan 40-80 mg once daily compared with enalapril 10-20 mg once daily in elderly patients with arterial hypertension.


Eligibility criteria:
inclusion criteria: * age ≥ 65 years * sitting systolic blood pressure (sbp) ≥ 160 mmhg and any diastolic blood pressure (dbp) (safety maximum of sitting dbp 110 mmhg), measured by manual cuff sphygmomanometer at the end of the wash-out period * written informed consent exclusion criteria: * secondary hypertension * malignant hypertension (retinal haemorrhage, exudates or papillary oedema) * clinically significant sodium depletion as defined by serum sodium level \ 5.5 meq/l, clinically significant hypokaliemia as defined by serum potassium level \< 3.0 meq/l * atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which could interfere with the cardiac rhythm * heart rate \< 50 bpm * congestive heart failure (chf) (nyha (new york heart association) functional class chf iii-iv) * angina pectoris or myocardial infarction * cardiac surgery within the past 3 months prior to start the wash-out period * stroke within the past 6 months prior to start the wash-out period * renal insufficiency defined as creatininaemia \> 2mg/dl * bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post renal transplant * liver insufficiency, defined as bilirubinaemia \> 2mg/dl and ast (aspartate aminotransferase) or alt (alanine-aminotransferase) \> twice the upper normal range * clinically significant metabolic and endocrine disease * autoimmune disease * previous history of angioedema * body mass index \> 30kg/m2 * arm circumference \> 32 cm * any condition that may be likely to compromise the trial (alcohol or drug abuse, disability illness, etc.) * concomitant therapy with antihypertensive drugs non-permitted by protocol, or present use of tricyclic antidepressant, corticosteroids or drugs known to affect blood pressure * investigational drug treatment within the past 30 days before the enrolment or concurrent participation to any other trial * sensitivity, significant adverse reaction or contraindications to the study drugs (telmisartan, enalapril, clonidine tts) * predictable lack of patient co-operation
a flexible wound dressing for the management of genital skin conditions

Conditions: Vaginitis; Atrophic Vaginitis; Lichen Planus; Lichen Sclerosus; Menopause Related Conditions

Summary: the objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients


Eligibility criteria:
inclusion criteria: * able to provide informed consent * diagnosed genital skin condition exclusion criteria: * unable to give informed consent * patient unable to apply topical device * allergy or intolerance to ingredients or excipients of the formulation of studied products
evaluating the outcome of cardio selective beta1- blockers use in patients with copd

Conditions: Copd

Summary: to evaluate the outcome of cardio selective beta1 (β1-) blockers use in patients with chronic obstructive pulmonary disease. patient education about the copd and their medications.

chronic obstructive pulmonary disease (copd) is a common preventable and treatable airway disorder characterized by symptoms such as dyspnea, chronic cough, and sputum production along with persistent airflow limitation that is not fully reversible. evidence provided by post hoc analysis of clinical trials and large observational studies suggests a beneficial effect of beta-blockers on mortality and exacerbation in mild to moderate copd patients. evidence concerning cardio selective b blockers. over the past 20 years' non selective b blockers have largely been replaced with cardio selective blockers. cardio selective beta blockers such as atenolol and metoprolol are at least 20 times more potent at blocking b-1 receptors than b-2 receptors. at therapeutic doses the b-1 blocking effect, and therefore the risk of bronco constriction, is negligible. in addition there is strong evidence that b-blocked cause up-regulation and sensitization of b-receptors.

Eligibility criteria:
inclusion criteria: 1. male or female. 2. informed consent. 3. age \>40years. 4. fevl/fvc\<70%. 5. diagnosed 3 month before enrollment (mild-moderate) 6. reversability test pre-post bronchodilators fevl predicted\<200ml/hr and less than 12%. exclusion criteria: 1. asthmatic patient. 2. patient already use b blockers. 3. acute exacerbation. 4. pregnency -lactation. 5. advanced cardiac, renal or liver disease according to investigator opinion.

Keywords: beta blockers -nebivolol
use of hydroxychloroquine alone or associated for inpatients with sars-cov2 virus (covid-19)

Conditions: Coronavirus Infections; SARS-CoV 2; SARS (Severe Acute Respiratory Syndrome); Pulmonary Disease

Summary: the severe acute respiratory syndrome coronavirus 2 (sars-cov2) has been identified in wuhan, china, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. the diagnosis is made by the molecular polymerase chain reaction test. however, diagnostic tests are limited. the clinical care of the patient with covid-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral rna transcription, although a recently published study has shown no benefit. china recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for covid-19. hydroxychloroquine is a drug with great potential treatment, as it can inhibit the ph-dependent steps of replication of various viruses, with a potent effect on sars-cov infection and spread. in this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic sars-cov2.


Eligibility criteria:
inclusion criteria: * males and females aged \> 18 years; * patients with flu syndrome (fever greater than 37.8c or feverish feeling referred by the patient associated with at least 1 respiratory symptom: cough, difficulty breathing, sputum production, nasal or conjunctival congestion, difficulty swallowing, sore throat, runny nose, signs cyanosis, flapping of the nose and dyspnoea); * diagnosis confirmed by real-time pcr or suspected covid-19; * hospitalized patients with: * moderate disease: hypoxemia with o2 saturation \<93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute and / or radiological evidence of pneumonia with pulmonary impairment less than 50%; or * serious illness: hospitalized patients with hypoxemia with o2 saturation \<93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute with radiological evidence of pneumonia with pulmonary involvement above 50% and / or the presence of sepsis ( organ failure) or need for invasive mechanical ventilation. exclusion criteria: * mild cases of flu-like syndrome that do not require hospitalization or o2 saturation greater than or equal to 93% and without radiological evidence of pneumonia; * liver failure or elevation of transaminases greater than 5 times; * cardiac patients with electrocardiogram with extended qt interval; * pregnant women; * use in the last 30 days of hydroxychloroquine or azithromycin; * allergy to hydroxychloroquine or azithromycin.
first-in-man trial of the magnetic-controlled balloon inflation mechanism of a novel ingestible weightloss microcapsule

Conditions: Obesity

Summary: the objective of this study is to demonstrate the ease of deployment of a novel magnetically-controlled ingestible weight loss microcapsule\* and the functionality of the magnetically controlled inflation of the balloon within the stomach.

the objective of this study is to demonstrate the ease of deployment of a novel magnetically-controlled ingestible weight loss microcapsule and the functionality of the magnetically controlled inflation of the balloon within the stomach. device comes in the form of a gelatine coated pill (ø9.6mm x 27mm) . once in the stomach, the device may be driven by external magnetic controllers which can control both its position and orientation. it allows flexible approach of the external magnetic fields in any axial directions of the device, and it also controls the inflation valve which controls the inflation of an attached balloon. the inflated balloon will partially fill up the stomach, giving the subject the feel of satiety to reduce his/her desire to eat more food.

Eligibility criteria:
inclusion criteria * healthy subject, as evidenced by medical history * male or female aged 21-50 years of age * willing to undergo endoscopy to retrieve the balloon and to comply with all study procedures * ability to provide a signed and dated informed consent form exclusion criteria: * individuals with anatomical abnormalities or functional disorders that may inhibit swallowing or passage through to the stomach * individuals with history or symptoms of clinically significant esophageal or gastric disorders, peptic ulcerations, hiatal hernia, patulous pyloric channel, erosive esophagitis, varices, angiectasia, barrett's esophagus * individuals with bowel obstruction, congenital or acquired gi anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease * individuals with bleeding disorders * individuals already having other bioenteric devices placed * individuals who have pace makers, metal implants or other devices on them * pregnant women * individuals unable to make/sign informed consent
caffeine and resistance training in older adults

Conditions: Caffeine and Resistance Training

Summary: introduction: several studies have evaluated and confirmed the ergogenic effect of acute caffeine intake on sports performance, specifically on strength and power performance. however, little is known about the prolonged effects of this supplement on neuromuscular adaptations to strength training. objectives: the present study aims to analyze the effects of acute and chronic caffeine intake on neuromuscular adaptations to strength training, according to sex (men vs. women) and type of exercise (bench press vs. squat), as well as fatigue perception, mood state, and potential side effects in older adults.


Eligibility criteria:
inclusion criteria: * age between ≥ 55 * body mass index (bmi) ≥ 30 kg/m². * physically active subjects (\&gt;150 min/week of moderate exercise). * healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from performing physical exercise. * participants capable of performing the tests. exclusion criteria: * history of neuromuscular, cardiac, or diseases that could affect liver or muscle metabolism. * use of drugs or other stimulants that interfere with caffeine intake and intestinal absorption during the tests and study. * having undergone prolonged periods of forced physical inactivity during the 6 months prior to the study. * performing strenuous exercise within 48 hours prior to the tests. * failing to replicate the same food intake on the two experimental days. * consuming caffeine after 6 pm on the day prior to training or testing.
analysis of t cell metabolism in relapsed aml patients with dlis and bicanorm treatment

Conditions: Acute Myeloid Leukemia, in Relapse

Summary: in this study, the outcomes of relapsed aml patients receiving dlis and bicanorm (sodium bicarbonate) were analyzed including t cell metabolism and immune phenotype.

acute myeloid leukemia (aml) patients suffering from relapse after allogeneic hematopoietic cell transplantation (allo-hct) have a poor survival outcome. donor lymphocyte infusions (dlis) to induce graft-versus-leukemia (gvl) effects have a limited survival benefit. extensive preclinical studies have shown a beneficial effect of sodium bicarbonate on metabolic fitness of leukemia-reactive t cells in gvl aml models. therefore, the investigators aimed to investigate a potential benefit of bicanorm (sodium bicarbonate) treatment accompanying dlis in relapsed aml patients. the investigators determined the metabolic and immune phenotype of t cells isolated from patients receiving dlis before and after bicanorm (sodium bicarbonate) treatment.

Eligibility criteria:
inclusion criteria: * confirmed aml relapse after allo-hct * patients receiving dlis * age ≥ 18 years * written informed consent * ability to understand the nature of the study and the study related procedures and to comply with them exclusion criteria: * age \< 18 years * lack of informed consent
interest of procore needle® for diagnosis of lung cancer

Conditions: Endobronchial Transbronchial Needle Aspiration Lung Cancer Procore

Summary: the procore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna). in this study the investigators are going to evaluate the utility of the procore needle for sampling mediastinal or hilar lymph nodes during ebus-tbna versus standard 22 gauge needle for diagnosis of lung cancer.


Eligibility criteria:
inclusion criteria: * mediastinal lymphadenopathy \>10 millimeters * lung cancer suspected exclusion criteria: * coagulopathy contraindication for midazolam contraindication for bronchoscopy

Keywords: endobronchial transbronchial needle aspiration lung cancer procore
low-energy linear extracorporal shock wave therapy for erectile dysfunction.

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to determine whether extracorporeal shock wave therapy (eswt) is an effective treatment for erectile dysfunction.

erectile dysfunction has a negative impact on quality of life and relationships. thirty to sixty- five percent of men over 40 years of age have erection disorders. current challenges of medical treatment are met with high costs and risks of side effects. emerging new therapy with low-energy shock waves stimulate production of endothelial growth factor and nitrogen oxide which results in angiogenesis. it is our aim to assess efficaciousness of this method on potential to improve erectile dysfunction. we propose a prospective double-blind, randomised, cross-over, sham-controlled trial, to assess how effective shock waves therapy is for erectile dysfunction. patients will receive one treatment per week for ten weeks. subjects will be followed for up to one year after treatment. standardized questionnaires will assess study endpoints for erectile dysfunction. we hypothesize that shock wave therapy could represent a low cost, low risk treatment for erectile dysfunction in men.

Eligibility criteria:
inclusion criteria: * erectile dysfunction for at least 6 months * in relationships * patient accept not to use any other therapy against erectile dysfunction exclusion criteria: * prostatectomy * radiotherapy in pelvis * hormonal therapy against prostate cancer * anatomical penis disorder * penile prosthesis * treatment with anticoagulants (except acetylsalicylic acid 75 mg) * psychiatric disorder * hypogonadism * iief score higher than 25 * pregnant partner og delivered within last 12 months * critical health disease * neurological disorders

Keywords: extracorporeal shock wave therapy eswt erectile dysfunction
preventing antibiotic-associated diarrhea using erceflora

Conditions: Diarrhea, Infantile

Summary: to determine the effectiveness of the pre-biotic bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent filipino children.


Eligibility criteria:
inclusion criteria: * clinically stable children with mild to moderate illness admitted for treatment of bacterial infection. exclusion criteria: * children with unstable medical condition * in any form of immunocompromized state * with contraindication to take medication * has taken antibiotics for 3 weeks before start of trial. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.