cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia

The main aim of the investigation is to clarify, whether vitamin D supplementation in coronary artery disease patients with vitamin D deficiency and postchallenge hyperglycemia has an impact on endothelial dysfunction and parameters of insulin sensitivity and beta-cell function.

An improvement of endothelial dysfunction as a cardiovascular surrogate parameter could be translated in a reduced risk for future cardiovascular events, which is of major interest, since patients with postchallenge hyperglycemia face a significantly higher cardiovascular risk than patients with normal glucose tolerance. Furthermore an improvement in insulin sensitivity and/or beta-cell function would identify vitamin D as an important strategy for the prevention of type 2 diabetes. In consideration of the rapidly increasing prevalence of diabetes and the failure of current prevention strategies this could be an important, safe and cheap way to support ongoing lifestyle modifying programs. Our study of course investigates surrogate cardiovascular and insulin sensitivity parameters. Assuming a beneficial effect of vitamin D in our study, this concept would have to be proven in further large outcome as well as diabetes prevention trials.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-75
* Postchallenge hyperglycemia (2h-whole blood glucose value in oral glucose tolerance test above 119 mg/dl, normal fasting glucose)
* Angiographically verified coronary artery disease (\>50% stenosis)
* Serum 25-OH- vitamin D \< 20 ng/ml in winter/spring/autumn and \<25 ng/ml during june-september
* Stable antihypertensive therapy in the last 3 month

Exclusion Criteria:

* Acute coronary syndrome or cerebrovascular event within the previous 1 month
* BMI \> 40 kg/m²
* Serum creatinine \>2.5 times the upper limit of normal
* GOT or GPT \> 3 times the upper limit of normal
* Heart failure \> NYHA class II
* Uncontrolled hypertension (\>160/100 mmHg)
* New onset of statins, ACE-inhibitors or ARBs within the previous 4 weeks
* History of urolithiasis
* Hypercalcaemia
* Major psychiatric disorders
* Ongoing treatment with spironolactone, canrenoate, eplerenone, amiloride, triamterene and aliskiren.
* Treatment with antipsychotic drugs
* Regular significant antioxidants, vitamins or protein supplementation
* Immunosuppressive therapy
* Glucocorticoid therapy
* Ongoing chemotherapy
* Pregnancy
* Any other disease with an estimated life expectancy below 1 year.
Secretory Otitis Media in Adenoids Hypertrophy Patients

This study aims to compare the fate of Secretory Otitis Media in patients with adenoids hypertrophy undergoing Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application

Otitis media with effusion (OME) is one of the most common diseases during childhood . It is defined as collection of non-purulent effusion (mucoid or serous) in the middle ear space without signs of acute infection. It's synomus are serous otitis media, secretory otitis media or glue ear. Adenoid hypertrophy can cause mechanical obstruction of the Eustachian tube which plays an important role in the pathogenesis of OME.

Management of OME consisted of many varieties; 1- Auto inflation, 2- Medical treatment and 3- Surgical. Surgical treatment indicated in cases where the effusion does not resolve spontaneously or failed medical treatment for 3 months and the main purpose of surgery is to restore middle ear aeration. Treatment options are Adenoidectomy with or without Myringotomy or Myringotomy and Tympanostomy tube application.

The aim of this study is to compare the efficacy of each surgical option in management of otitis media with effusion. This study will be carried out in ENT department of Assiut university hospital on 150 child diagnosed as persistent otitis media with effusion due to adenoid enlargement and they will be categorized randomly into three groups (50 cases per each). Group I will undergo Adenoidectomy alone, group II will undergo Adenoidectomy and Myringotomy and group III will undergo Adenoidectomy and Myringotomy and Tympanostomy tube application. All patients will be subjected to full ENT examination and audiological evaluation. Postoperative evaluation will be done for all patients for 3 months through clinical and audiological evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Any case presented with Secretory Otitis Media with adenoids hypertrophy with the following criteria
* Age is between 3 to 17 years old
* With or without chronic tonsillitis
* conductive hearing loss
* Recurrent upper respiratory tract infection
* Dull tympanic membrane on otoscopy (absent cone of light), decreased mobility of tympanic membrane
* Type B tympanogram on tympanometry
* OME not responding to medical treatment for three months

Exclusion Criteria:

* Patients with the following criteria will be excluded from the study
* Previous Myringotomy with or without Tympanostomy Tube application
* Previous adenoidectomy or tonsillectomy
* Previous ear surgery, cleft palate, Down's syndrome, congenital malformation of the ear and cholesteatoma.
Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients

The purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol with or without statin intolerance.

Hypercholesterolemic patients either with or without a history of statin intolerance (1:1 ratio) will be randomized to receive once daily by mouth capsules containing either ETC-1002, ezetimibe, or ETC-1002 + ezetimibe. This study will explore the safety and efficacy of concomitant administration of ETC-1002 and ezetimibe, while also exploring the effect of ezetimibe on ETC-1002 systemic exposure.

Eligibility Criteria:
Key Inclusion Criteria:

* Statin intolerant and statin tolerant
* Fasting LDL-C between 130 mg/dL and 220 mg/dL
* Fasting triglyceride less than or equal to 400 mg/dL
* Body mass index (BMI) between 18 and 45 kg/m2

Key Exclusion Criteria:

* History or current clinically significant cardiovascular disease
* History or current type 1 diabetes or uncontrolled type 2 diabetes
* Use of metformin or thiazolidinediones (TZD) within 3 months of screening
* History of joint symptoms difficult to differentiate from myalgia
* Uncontrolled hypothyroidism
* Liver disease or dysfunction
* Renal dysfunction or nephritic syndrome
* Gastrointestinal (GI) conditions or prior GI procedures
* HIV or AIDS
* History or malignancy
* History or drug or alcohol abuse within last 2 years
* Use of experimental or investigational drugs within 30 days of screening
* Use of ETC-1002 in a previous clinical study
Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation

This study will evaluate heparin as compared to bivalirudin for systemic anticoagulation in adult patients that require extracorporeal membrane oxygenation (ECMO). Half of the participants will receive heparin and half will receive bivalirudin.

The investigators will randomly assign 34 adult patients requiring ECMO to receive bivalirudin or unfractionated heparin in a 1:1 fashion. There will be 17 patients in each group for a total of 34 patients.

Unfractionated heparin binds to antithrombin thereby causing an anticoagulant effect while bivalirudin binds directly to thrombin. Use of unfractionated heparin in this population is problematic due to reliance on adequate levels of circulating antithrombin, complex pharmacokinetics, and variable clearance. Bivalirudin avoids many of these difficulties.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Require ECMO and systemic anticoagulation as determined by the primary treating physician
3. Require anticoagulation to target an activated partial thromboplastin time (aPTT) of 40-60 seconds or 60-80 seconds

Exclusion Criteria:

1. Prior inclusion in this study
2. Patients with known or suspected heparin induced thrombocytopenia
3. Systemic anticoagulation at Legacy for ≥ 24 hours during ECMO immediately prior to study enrollment
4. Allergy to heparin or related products or bivalirudin
5. Known anti-thrombin deficiency
6. Selection of a non-standard aPTT target range
An Evaluation of the Families Addressing Cancer Together (FACT) Intervention

This is a pilot feasibility and acceptability study to inform the development and testing of a novel communication intervention to support parents in their communication with children about cancer. The research questions to be answered by this study are whether the intervention being tested can be feasible and acceptable, and provide preliminary estimates of improvement in parental psychological distress.

This is a single-arm, single center pilot study using a pretest-posttest design to evaluate the feasibility and acceptability of a psychosocial intervention, Families Addressing Cancer Together (FACT). The purpose of the intervention is to decrease parental anxiety by facilitating parental communication about cancer with their children. The primary hypothesis being tested is that an intervention that assists parents with their communication needs with their children can be feasible, acceptable, and reduce parental psychological distress. Findings from this study will inform a future grant application to further test this intervention in a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent reviewed and signed;
* Age equal to or above 18 years;
* Ability to understand and comply with study procedures;
* Be a parent, primary caregiver, or guardian of at least one child between the ages of 3-19 years old with whom the subject has regular contact. The child must have cognitive ability to understand verbal communication;
* Have a new or recurrent diagnosis of invasive solid tumor malignancy within the past 6 months or have a solid tumor cancer diagnosis with disease that is either stage IV or equivalent;
* Have a cancer diagnosis that is likely to require systemic anti-neoplastic therapy, non-office based surgical intervention, radiation therapy, or palliative care/hospice within the next three months.

Exclusion Criteria:

* Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes.
Postural Control, Ankle and Trunk Proprioception in Type 2 Diabetes

The investigators aim to assess the postural control, ankle, and trunk proprioception, plantar sensation, and general cognitive status in patients with Type 2 diabetes.

The investigators aim to assess the postural control on different floors with eyes open, eyes closed, and cognitive dual-task, ankle, and trunk proprioception, plantar sensation, and general cognitive status of patients diagnosed with Type 2 diabetes between the ages of 18-65, and to compare them with healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18-65
* Volunteering to participate in researc
* Being diagnosed with Type 2 diabetes according to the criteria of the American Diabetes Association (ADA)

Exclusion Criteria:

* Insufficient cognitive level
* Traumatic nerve injury
* Presence of congenital anomaly in the upper extremity
* Presence of systematic disease (eg: rheumatological)
* Having a problem involving the neurological system
* Surgery involving the upper extremity in the last 6 months
Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair

To explore whether administering tirofiban in stent-assisted coiling/flow diverting treatments for participants with unruptured intracranial aneurysms can reduce new ischemic lesions on postoperative DWI sequences compared to conventional dual antiplatelet therapy.

This is a single-center, open-label, assessor-blinded randomized controlled trial. Participants with stent-assisted coiling/flow diverting for unruptured intracranial aneurysms will be enrolled and randomized into two groups: Tirofiban group-after femoral artery puncture, initial infusion of 0.4μg/kg body weight/minute over 30 minutes, followed by a continuous infusion of 0.1μg/kg body weight/minute for 24 hours. Meanwhile, routine dual antiplatelet therapy (aspirin 100 mg/day, clopidogrel 75 mg/day) will be administered. Placebo group-100 mg/day aspirin and 75 mg/day clopidogrel. The primary effectiveness endpoint is the numbers and volumes of ischemic lesions on diffusion weighted imaging (DWI) within 48 hours after procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-80.
2. Participants with unruptured cerebral aneurysms eligible for stent-assisted coiling or flow diversion devices.
3. Completement of preoperative antiplatelet preparation.
4. Signed informed consent.

Exclusion Criteria:

1. Abnormal platelet count (normal reference is 100-300×10\^9/L).
2. Allergy to study drugs and anesthetics.
3. Contradictory to MRI examination.
4. Known history of intracranial tumor, arteriovenous malformation, arteriovenous fistula, venous sinus thrombosis, hereditary cerebral small vessel disease, peripheral hemangioma (e.g., aortic aneurysm, limb vascular aneurysm).
5. Known history of cerebral parenchymal hemorrhage, subarachnoid hemorrhage, cerebral infarction, transient ischemic attack, or gastrointestinal bleeding within 6 months.
6. Clear indications for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis).
7. Antiplatelet drug (exclude aspirin and clopidogrel) being taken within 72 hours; anticoagulant drug (including heparin or oral anticoagulants) being taken within 10 days;
8. Participants with recurrent aneurysms who have received neurointerventional treatment.
9. Inability to follow endovascular procedures due to anatomical difficulties.
10. Severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (ALT or AST \> twice the upper limit of normal range) insufficiency.
11. Severe heart failure (NYHA classes III and IV) or severe arrhythmias, including sick sinus syndrome, severe atrioventricular block, and bradycardia-related syncope.
12. Pregnant.
Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease surrogate markers of bone metabolism and early cardiovascular disease in individuals with moderate to severe airflow obstruction and a chronic bronchitis phenotype.

Study participants will be given Roflumilast 500 micrograms daily for 30 days. At baseline, prior to drug administration, blood samples will be collected for analysis of markers of bone metabolism (C-terminal telopeptide of Type I Collagen (CTx), Amino-terminal Propeptide of Type-1 Procollagen (P1NP) and participants will undergo measurement of endothelial function with measurement of brachial flow mediated dilation. After completion of one month of Roflumilast therapy, participants will have a repeat blood collection for measurement of CTx and P1NP and repeat measurement of brachial flow mediated dilation testing.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 50 and 70 with a minimum of ten-pack years of tobacco exposure, airflow obstruction (FEV1/FVC \< 0.70) with an FEV1 \< 70%
* baseline sputum production at least some of the time as reported on the Saint George's Respiratory Questionnaire, and at least one exacerbation within the past year

Exclusion Criteria:

* Subjects with chronic prednisone use, antiresorptive therapy use (bisphosphonates, calcitonin, parathyroid hormone)
* Subjects with a body mass index less than 18 or greater than 34
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.

This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and fenofibrate on liver fat measured with magnetic resonance imaging (MRI) in patients with over-weight and hypertriglyceridemia.


Eligibility Criteria:
Inclusion Criteria: - Provision of informed consent

* Men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated venepuncture
* Have serum triglycerides ≥1.7 mM
* Have liver fat content as assessed by MRI \>5.5%
* Have a body mass index (BMI) \>25 and ≤40 kg/m2

  , Exclusion Criteria: - History of or presence of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* Creatinine clearance \<60 mL/min at screening (Cockcroft-Gault formula).
* Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN
* Total bilirubin \>2.0 mg/dL (34.2 µmol/L)
* Type 2 diabetes, as defined by WHO criteria e.g. fasting plasma Glucose \>7.0 mM or use of antidiabetic therapy
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator. This includes signs of liver disease other than NAFLD that motivates further investigations of treatment based on clinical judgement
* Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse was to be defined as \>14 drinks per week (1 drink = 35 cl beer, 14 cl wine, or 4 cl hard liquor) or as judged by the investigator
Presence of the Arcade of Struthers on Preoperative Ultrasound

To determine the correlation between the presence of the arcade of Struthers on preoperative ultrasound and during endoscopic surgery for cubital tunnel syndrome, and to determine the reliability of a portable ultrasound probe to detect the arcade of Struthers in the arm.

The ulnar nerve comes from the medical cord of the brachial plexus (C8-T1). It travels out of the axilla along the medial border of the arm to pass into the forearm via the cubital tunnel at the elbow. Cubital tunnel syndrome is the result of compression and traction on the ulnar nerve about the elbow, which can occur at multiple sites. The most proximal possible site of compression causing is the arcade of Struthers. This entity has been described as an aponeurotic band, as a fibrous canal or as thickened connective tissue. Regardless of the nomenclature, ulnar nerve compression has been documented at the location of the arcade of Struthers, which is 6 to 10 cm proximal to the medial epicondyle. Simple open in situ decompression typically results in decompression of the ulnar nerve 6 cm proximal and 6 cm distal to the medial epicondyle while endoscopic ulnar nerve decompression decompresses on average 17 cm of the ulnar nerve (range 25-23 cm), thus consistently reaching the area of the arcade of Struthers. Recurrent cubital tunnel syndrome after simple decompression can be due failure to the release of the arcade of Struthers, and the revision surgery involved extending the incision and length of ulnar nerve release. With the advances in ultrasound imaging, the identification of the arcade of Struthers in mid arm is feasible. hence, it would be beneficial to identify the presence and the location of the arcade of Struthers pre-operatively, to direct the surgical procedure to decompress the ulnar nerve more proximally in cases of a simple decompression in situ.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cubital tunnel syndrome
* Planned for endoscopic cubital tunnel release primary surgery
* \>=18 years of age
* no previous arm or elbow surgeries

Exclusion Criteria:

* Revision surgery
* Planned for open cubital tunnel release
* Prior surgical intervention around the arm or the elbow
* \<18 years of age
The Study of Bacteriology and Pathogen Drug Sensitivity of Chronic Dacryocystitis

An observational study was designed to research the bacteriology and pathogen drug sensitivity of chronic dacryocystitis in China and optimize antibiotic therapy.

For patients diagnosed with chronic dacryocystitis，we will collect the secretions after lacrimal passage irrigation, note the characters of the secretions and send the secretions for bacteria culture, analysis and pathogen drug sensitivity.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with chronic dacryocystitis
2. No involvement in other drug experiment in the past 1 week

Exclusion Criteria:

1. Can not cooperate the specimen collection
2. With any other eye disease
Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo

BACKGROUND Vitiligo is a common, often distressing condition. Many of the patients do not achieve sufficient effect from what is regarded as the treatment of choice at present, narrow band(NB)UVB(Tl01). There are reports on some patients partly successfully treated with Tacrolimus ointment.

AIM OF THE STUDY We want to study whether Tacrolimus ointment may give an additive effect on symmetric vitiligo in combination with NB-UVB.

METHODS This is a double blind left/right comparative study with 6 months treatment time. Patients are treated with whole body NB-UVB x 2 or x 3 weekly, in addition to Tacrolimus ointment versus placebo every night on affected half body sites. To measure effects we use photodocumentation in addition to morphometric registration of symmetric target lesions every 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged at least 18 years with a stable, symmetric vitiligo

Exclusion Criteria:

* Patients with segmental vitiligo, aged \< 18 years, known hypersensitivity to Tacrolimus, pregnant or breastfeeding women
Quantitative Imaging Metrics From CECT in Measuring Disease Response or Progression in Patients With Kidney Cancer

This pilot research trial studies quantitative imaging metrics derived from contrast enhanced computed tomography (CECT) in enhancing assessment of disease status in patients with kidney cancer. Quantitative imaging is the extraction of quantifiable features from radiological images for the assessment of disease status. Collecting quantitative imaging metrics from CECT imaging may help doctors predict tumor aggressiveness and nuclear grade (tumor stage) and assess treatment response and prognosis in cancer imaging.

PRIMARY OBJECTIVES:

I. To investigate the role of quantitative imaging metrics (QIM) as a potential DIAGNOSTIC biomarker.

II. To investigate if QIM parameters can differentiate clear cell renal cell carcinoma (RCC) from papillary RCC.

III. To evaluate the tumor grade of the target lesion as assessed by QIM from CECT for agreement with the pathological (Fuhrman) grade.

IV. To investigate the role of QIM as a potential PROGNOSTIC biomarker. V. To develop a novel method of calculating renal tumor contact surface area (CSA) using advanced image-processing technology (MATLAB®, 3 dimension \[D\] Synapse) and predict peri-operative variables such as blood loss, operative time and post-operative estimated glomerular filtration rate (eGFR) in patients undergoing partial nephrectomy (PN).

VI. To develop QIM that would help in predicting postoperative functional outcomes such as predicted surgically resected volume and postoperative glomerular filtration rate (GFR).

OUTLINE:

Patients' clinical and imaging data are collected from routine multiphase CECT imaging and used to establish and validate the classification/prediction rule for QIM.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a renal mass who are scheduled for surgery for presumed RCC
* Subjects scheduled for standard of care contrast enhanced CT examination at USC Norris Comprehensive Cancer Center
* Subjects competent to sign study specific written informed consent

Exclusion Criteria:

* Subjects who are pregnant
* Subjects who cannot consent for themselves