cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Effects of Exercise Training and ARB in DM Patients

The aims of this clinical trial are to assess the impacts on vascular function tests and circulating biomarkers of a short-term (12-week) low-to-median intensity exercise training or ARBs treatment in patients with DM and hypertension.

Inclusion criteria: type II diabetic and hypertensive patients who are aged 30 to 70 year-old with HbA1c ≤ 8.0 % and systolic blood pressure ≥ 140 mmHg. Neither ACEI nor ARB is administrated in recent 6 months. None has significant concomitant systemic diseases such as active infection, malignancy, hepatic or significant renal dysfunction at the time of enrollment (i.e. total bilirubin \> 3 mg/dl，ALT \> 2.5 times the upper limit of normal range and creatinine \> 3 mg/dl in our hospital). Information regarding smoking, hypertension, hyperlipidemia as well as history of cardiovascular disease is obtained from all subjects. No other medication will be modified during the study period. After enrollment, patients are assessed to (1) olmesartan (20 mg per day, with titration), (2) life modification/exercise training for 12 weeks. Vascular function and exercise capacity studies, and peripheral blood testing are performed at baseline and at 12- week follow-up. Data are collected as mean ± SD showing comparison between groups by use of 2-sample t test and chi-square analysis for continuous and categorical variables, respectively. Adjust for the HbA1c level will be adjusted using simple adjustment method (ANCOVA or equivalent regression analysis) while doing the data analysis. Changes between baseline and follow-up measurements are assessed by paired t test. The frequencies of adverse effects between groups will also be comparing by 2-sample t test. A p value \<0.05 is defined as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* patients with diabetes mellitus and hypertension
* age 30-70 years，systolic blood pressure 140-160 mmHg and HbA1c ≤ 8%,
* no history of ACEI or ARB use within 6 months

Exclusion Criteria:

* active cardiovascular diseases
* severe hepatic
* renal dysfunction (CRE ≥ 3 mg/dl，T-Bil ≥ 3 mg/dl)
Zonisamide for Fibromyalgia & Migraine

Patients with fibromyalgia \& migraine are randomized to receive zonisamide or placebo.

Study was not conducted due to logistical problems

Eligibility Criteria:
Inclusion Criteria:

* 18-65 with fibromyalgia \& migraine

Exclusion Criteria:

* allergy sulfa, liver or kidney disease, pregnant or not using contraception
Searching of Apraxia of Speech in Children With Specific Language Impairment

Searching of Apraxia of Speech in Children with Specific Language Impairment


Eligibility Criteria:
Inclusion Criteria:

* Children from 4 to 8 years old diagnosed as specific language impairment

Exclusion Criteria:

* 1. Children with mental retardation or hearing impaired . 2. Children with any neurological or psychiatric disorders.
Clinical Characterization on PDE6A-related Retinitis Pigmentosa in Preparation to a Gene Therapy Trial

Mutations in the PDE6A gene - encoding the -subunit of the rod cGMP-phosphodiesterase - account for 1% of autosomal recessive retinitis pigmentosa (arRP) through impaired regulation of cGMP levels in the rod outer segment. This study aims for a detailed clinical characterization of patients with PDE6A mutations in preparation of a clinical gene replacement study (phase I/II safety trial).

Retinitis pigmentosa (RP) is a clinically and genetically heterogenous group of hereditary retinal disorders, being one of the most common types of retinal degenerations with a prevalence of 1:4000. More than 45 genes have been associated with RP so far, whose defects cause a progressive loss of rod photoreceptor function, followed by cone photoreceptor dysfunction often leading to complete blindness. Mutations in the PDE6A gene - encoding the -subunit of the rod cGMP-phosphodiesterase - account for 1% of autosomal recessive retinitis pigmentosa (arRP) through impaired regulation of cGMP levels in the rod outer segment.

With the help of improved genetic and functional diagnostic tools an early recognition and differentiation has become possible. Still, up to date no established therapy is available, therefore, social and professional consequences are essential tasks to deal with. The modern ophthalmological functional diagnostic tools enable a precise characterisation and early recognition of such retinal diseases. The detailed results and information can help to extend the understanding of the pathological mechanisms involved in these diseases.

In this study the investigators intend to investigate patients with a genetically confirmed diagnosis of Retinitis pigmentosa due to PDE6A mutations hereby assessing the function and structure of the retina with an extensive battery of tests.

Eligibility Criteria:
Inclusion Criteria:

* Retinitis pigmentosa patients with genetically confirmed mutations in the PDE6A-gene
* written informed consent

Exclusion Criteria:

* severe general disease, that would make longer examinations not possible
* patients who cannot give written informed consent independently
BGM and HbA1c POC Device Evaluation

This study aims to assess analytical performance of four BGMs and four HbA1c POC devices in comparison to suitable comparator or reference methods, with the view to evaluate performance in the hands of trained users, as well as intended users who are unfamiliar with the system (lay users, for BGMs only). System usability will also be assessed for all BGMs (including lancing devices) and HbA1c devices.


Eligibility Criteria:
Inclusion Criteria:

Arm 1:

* 13-17 years, diagnosed with diabetes and able to manage condition independently (ideally at least 10% of total Arm 1 population)

  •≥18 years, diagnosed with diabetes
* Able and willing to provide informed consent/assent
* Naïve to the SMBG use of the investigational devices
* 10% naïve to any SMBG (defined as not having performed any SMBG in the last 24 months)
* Haematocrit within 20-60%
* Pre-screen BGM result qualifies for inclusion in any of the five glucose concentration ranges based on % of subjects required to meet the target number per concentration range

Arm 2:

•≥18 years

* Able and willing to provide informed consent
* Diagnosed or not diagnosed with diabetes
* Haemoglobin values ≥ 8g/dL
* Pre-screen HbA1c result qualifies for inclusion in the target HbA1c range and % of subjects required for the mid-range values

Exclusion Criteria:

Arm 1:

* \<13 years
* 13-17 years and not diagnosed with diabetes or unable to manage condition independently
* Previous use of investigational BGM for SMBG
* Haematocrit outside normal range
* Pre-screen BGM result falling in a glucose concentration range that already has sufficient participants.

Arm 2:

* \<18 years
* Haemoglobin value \< 8g/dL
* Pre-screen HbA1c result falling in a concentration range that already has sufficient participants.
Immunologic Aspects of the Pathogenesis of Chronic Sinusitis in Children

Chronic sinusitis is a common pediatric disease; it ranks among the top five infectious diseases of the upper respiratory tract. Its treatment is limited and may be due largely in part to a lack of understanding of its cause. The investigators have preliminary data to support the notion that pediatric chronic sinusitis is a distinct disease, different from acute sinusitis and adult chronic sinusitis. We are proposing to perform pathogenesis studies in children with chronic sinusitis. Specifically, we wish to elucidate the microbiologic features and immunologic factors involved in the formation of this disease. The study plan calls for microbiologic (bacterial, viral, and fungal) and immunologic (inflammatory mediators and leukocyte populations) data to be evaluated through a maxillary sinus washing and mucosal biopsies. Four populations will be studied and they are: 10 children with chronic sinusitis, 5 children with acute sinusitis (positive control), 5 children without sinusitis (negative control) and 5 adults with chronic sinusitis (positive secondary control).


Eligibility Criteria:
Inclusion Criteria:

* chronic sinusitis confirmed by imaging study for greater than 12 weeks subjects have failed medical therapy
Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community

This observational study in a real-world community was designed to perform epidemiological investigation and assess effect of CPAP intervention of obstructive sleep apnea.

Patients with obstructive sleep apnea receiving CPAP or not would be observed in years. Primarily Impact of CPAP on health assessment andx control rate of hypertension would evaluated.

Eligibility Criteria:
Inclusion Criteria:

1) AHI \>= 5 events/h

Exclusion Criteria:

1. Any condition which in the opinion of researched makes the eligible participants unsuitable for this study, such as severe COPD, heart failure in NYHA class III to IV, and others
2. Any condition potentially precluding follow-up visits, such as sereve insomnia, cognitive behavioral disorder, and others
3. Patients receiving CPAP treatment
RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

Treatment of patients with drug-eluting stent restenosis remains a challenge. This study will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent) is superior in the treatment of patients suffering from drug-eluting stent restenosis.

Treatment of patients with drug-eluting stent restenosis remains a major clinical and technical challenge. Currently, drug-eluting stents are widely used in the management of these patients. Recently, the value of the paclitaxel-eluting balloon in this clinical setting has been suggested. However, there is only scarce observational data on the value of this new balloon in patients with drug-eluting stent restenosis.

This prospective, multicenter, randomized clinical trial will compare two different interventional strategies (namely, paclitaxel-eluting balloon vs everolimus-eluting stent) in the treatment of patients with drug-eluting stent restenosis.

Eligibility Criteria:
Inclusion Criteria:

PATIENT:

* Age between 20 and 85 years
* Signed informed consent
* Acceptance of late angiographic control (6-9 months)
* Angina and / or objective evidence of ischemia

LESION:

* In-Stent restenosis (\> 50% visual) any drug-eluting stent
* Knowledge of prior stent location

Exclusion Criteria:

PATIENT:

* Inclusion in another clinical research protocol
* Women of childbearing age
* Severe associated systemic disease (including renal or liver failure)
* Severe depression of left ventricular ejection fraction (LVEF \<25%)
* Disease that affects life expectancy
* Recent myocardial infarction ( \<7 days)
* Time of implantation of the previous DES \<1 month
* Severe difficulties expected for late angiographic study

LESION:

* Angiographic failure during implementation of initial stent(residual stenosis\> 50%)
* Image of large thrombus in-stent (\> vessel diameter)
* Tortuosity or Ca + + with very severe difficulties during prior stent deployment
* Vessel diameter \<2 mm (visual estimate)
* Restenosis only "outside" the stent (The edge of the stent is not affected)
* Completely occlusive restenosis (100%, TIMI 0)
* Very diffuse restenosis (\> 30 mm length)
Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents

The investigators' project will study the effects of optimizing the vit D status of obese adolescents on markers of glucose metabolism and inflammation.

The alarming rise in pediatric obesity over the past few decades has been associated with an increase in the occurrence of impaired glucose tolerance and inflammation in children and adolescents. These conditions are part of the "metabolic syndrome", and children with risk factors such as these are much more likely to develop cardiovascular disease or diabetes as adults compared with their lean peers. Within the last few years there has been a growing body of evidence that optimizing vitamin D (vit D) status may alleviate these obesity-associated complications. Further, there is also research that shows that the better the vit D status of overweight individuals, the more favorably they respond to dieting by losing more body fat. The prevalence of vit D deficiency/insufficiency in the North American population has been classified as an "epidemic" by experts in the field and obese teens are considered at an even greater risk for deficiency because they tend to store vit D in their fat stores which is not readily mobilized for use by the body. The investigators' project will study the effects of optimizing the vit D status of obese adolescents on markers of glucose metabolism and inflammation. Obese teens attending an established adolescent weight loss clinic will be supplemented with high-dose vit D for 6 months (mos) which will be administered concurrently with their standard medical care and treatment. At baseline, 3 mos and 6 mos the investigators will measure vit D status, serum markers of insulin sensitivity and glucose metabolism; serum markers of inflammation; and body weight/height and waist circumference. At baseline and 6 mos only the investigators also measure body composition (percent body fat by dual-energy x-ray absorptiometry) and confounding lifestyle factors known to affect vit D, glucose metabolism or inflammation (e.g., nutrient intake, physical activity, sun exposure, pubertal stage). Results gleaned from this study will help to advance the prevention and treatment of obesity-related complications and have the potential to lead to significant reductions in healthcare costs and co-morbidities.

Eligibility Criteria:
Inclusion Criteria:

* Obese adolescent (BMI \> 85th percentile for age)
* 9-19 years of age
* attending the ADOBE clinic at the University of Missouri

Exclusion Criteria:

* use of vit D supplements other than standard multi-vitamin preparation
* (i.e., should not be receiving vit D \> 1000 IU/d) use of medications that interfere with vit D metabolism (e.g., anti-convulsive)
* history of hepatic or renal disorders;
* undergoing ultraviolet radiation as medical therapy;
* pregnancy;
* cigarette smoking;
* current use of commercial tanning bed;
Lithium for Low-Grade Neuroendocrine Tumors

The purpose of this study is to learn more about the effectiveness and side effects of lithium treatment for subjects with low-grade neuroendocrine tumors.

Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.0; Continue until progressive disease/unacceptable toxicity;Evaluate q 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Must have histologically confirmed metastatic low-grade neuroendocrine neoplasms. Small cell lung cancers, paragangliomas and pheochromocytomas are excluded. Pathologic diagnosis must be confirmed at the University of Wisconsin Carbone Cancer Center (UWCCC). Grading must be confirmed by pathologic review performed at UWCCC.
* Must have measurable disease
* Must have radiographic evidence of disease progression following any prior systemic therapy, chemoembolization, bland embolization, surgery, or observation.
* Must be ≥ 4 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration
* Must be ≥ 3 weeks from the completion of radiation therapy to study registration
* The following laboratory values are to be obtained within 14 days prior to registration: Absolute neutrophils count (ANC) ≥ 1000/mm3; Platelets ≥ 75,000/mm3; Hemoglobin ≥ 8.0 g/dL; Total bilirubin less than or equal 2.0 X the upper limit of normal (ULN); AST less than or equal to 3 X ULN or less than or equal 5 X ULN if liver metastases are present; Creatinine less than or equal ULN; Serum sodium within normal limits
* PS = 0-2
* Capable of understanding the investigational nature, potential risks and benefits fo the study and able to provide valid informed consent.
* Must have available tissue specimens to be analyzed for pathologic confirmation.
* Age ≥ 18 years.
* Women must not be pregnant or lactating.
* Women of childbearing potential and sexually active males are required to use an accepted and effective method of contraception.
* Patients must not have known history of allergic reactions or adverse reactions to Lithium or derivatives.
* Patients are not allowed to be on concurrent chemotherapy or radiation therapy.
* Patients are excluded if they have any of the following:

Gastrointestinal tract disease resulting in an inability to take oral medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, bowel obstruction, or inability to swallow the tablets.

History of hypothyroid disease Significant, active cardiac disease

* Patients must not be taking the following medications: diuretics, ACE inhibitors, NSAIDs (except aspirin or sulindac), neuroleptics, tetracycline, COX2 (cyclooxygenase-2) inhibitors, citalopram, clovoxamine, escitalopram, femoxetine, fluoxetine, fluvoxamine, paroxatine, sertraline, and zimeldine.
* Must be willing to undergo a tumor biopsy pre and post therapy.
* Patients with a concurrent malignancy are allowed on study as long as the patient is not undergoing active treatment for their disease.
* Patients already taking Lithium for any reason are not allowed on study.
QuickVue Influenza A+B Clinical Field Trial

A comparative study of different swab types used for collection of specimens for rapid inluenza testing


Eligibility Criteria:
Inclusion Criteria:

Subjects must have:

* Fever (\>38°C) (at time of visit or within the previous 48 hrs by history) and at least two of the following symptoms:

  * Chills/sweats
  * Cough
  * Dyspnea (labored, difficult breathing)
  * Fatigue
  * Headache
  * Myalgia (deep muscle aches)
  * Nasal congestion
  * Runny nose
  * Sore throat

Exclusion Criteria:

* Patients who are undergoing treatment with antivirals, now or within the last 7 days cannot be included in this study.
Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin

The objective of this study is to compare pharmacokinetics after single oral administration of candesartan and rosuvastatin each separately versus coadministration of candesartan and rosuvastatin in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers af aged between 20 years to 45 years
* Have a weight above 55kg and Ideal body weight (IBW) between -20% and +20% inclusive
* Eligible subjects with acceptable medical history and physical examination

Exclusion Criteria:

- Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with candesartan or rosuvastatin, or other drugs
The Effect Of Face-To-Face and Online-Education Provided To İndividuals With Atrial Fibrillation On Medication Adherence and Satisfaction

This randomized controlled study was conducted to investigate the effects of face-to-face Education and tele-education given to individuals with atrial fibrillation taking oral Anticoagulants on their medication compliance and satisfaction levels.

The study sample comprised 150 individuals. Of them, 50 were assigned to the control Group, 50 in the experimental group 1, and 50 for the experimental group 2.

Data were collected by the Descriptive Information Form, Medication Compliance Notification Scale and Duke Anticoagulant Satisfaction Scale. The Intervention Group 1 Was given face-to-face education. The Intervention Group 2 was given tele-education.

The control group underwent no intervention.

This randomized controlled study was conducted to investigate effects of face-to-face education and tele-education given to individuals with atrial fibrillation taking oral anticoagulants on their medication compliance and satisfaction levels. The study sample comprised 150 individuals. Of them, 50 were assigned to the control group, 50 to the experimental group 1, and 50 to the experimental group 2. Data were collected with the Descriptive Information Form, Medication Compliance Notification Scale and Duke Anticoagulant Satisfaction Scale. The Intervention Group 1 was given face-to-face education. The Intervention Group 2 was given tele-education.

The control group underwent no intervention. The scales were administered to all the groups twice, at the first and last interviews. Frequency, percentage calculation, Chi-square test, significance test between two means, one-way analysis of variance, Wilcoxon sign test, Fisher test, Bonferroni test and dependent groups t test were used in the analysis of data. The intra-group analysis demonstrated that the Medication Compliance Notification Scale score of the intervention group 1 (face-to-face education group) increased significantly in the final measurement compared to those of the control group and intervention group 2 (tele-education group) (p=.000). The inter-group analysis demonstrated that Duke Anticoagulant Satisfaction Scale scores of the three groups statistically significantly different. The difference stemmed from the intervention group 1.

Face-to-face education given to individuals with atrial fibrillation on oral anticoagulants improved their medication compliance and medication satisfaction levels. Nurses should primarily use face-to-face education in the care and education programs of individuals with atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over
* Diagnosed with Atrial fibrillation (AF) for at least a year
* Had been using oral anticoagulant (OACs) for at least 3 months
* Had a smart phone
* Had not previously taken any training on oral anticoagulant medication treatment

Exclusion Criteria:

* The individuals who had disorders that would affect training and experienced complications such as active hemorrhage related to oral anticoagulant use
More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges

This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.


Eligibility Criteria:
Inclusion Criteria:

* Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines
* Patients age is 18 years or greater
* Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form
* Patients must be willing and able to comply with all study requirements

Exclusion Criteria:

* Patients with a life expectancy \<12 months.
* Patients who are or may potentially be pregnant.
* Patient has suffered any of the following in the 4 weeks prior to enrolment:

  * Myocardial Infarction (MI)
  * Coronary Artery Bypass Graft (CABG)
  * Unstable Angina Pectoris
* Patient has primary valvular disease which has not been corrected