cyrilzakka/clinical-trials huggingface dataset:
Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily

This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* 1-3 oral treatments
* Insulin naive
* BMI (Body Mass Index) less than or equal to 45

Exclusion Criteria:

* Pregnancy
* Retinopathy
* Cardiac disease
* Uncontrolled hypertension
* Recurrent hypoglycaemia
Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease

This study evaluates the effect of ivabradine on endothelial function in patients with coronary artery disease (CAD) after complete revascularization with percutaneous coronary angioplasty (PCI). At least 30 days after PCI, patients will be randomized to receive ivabradine 5 mg twice daily or to continue with standard medical therapy.


Eligibility Criteria:
Inclusion Criteria:

* history of stable coronary disease
* complete coronary revascularization with PCI at least 1 month prior to recruitment
* sinus rhythm
* absence of anginal symptoms

Exclusion Criteria:

* resting heart rate \<60 beats per minute
* severe reduction of left ventricle ejection fraction (\<40%)
* coronary artery by-pass surgery
* myocardial infarction, stroke or cerebral transient ischemic attack within the previous 6 months
* implanted pacemaker, cardioverter, or defibrillator
* sick sinus syndrome
* sinoatrial block
* congenital long QT
* complete atrioventricular block
Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy

The main objective of this study is to determine whether focal-driven therapies for diagnosis and treatment of prostate cancer are preferable over current clinical methods. Different focal procedures will be examined, including magnetic resonance imaging (MRI)-target biopsy, and focal treatment as High Intensity Focused Ultrasound (HIFU), cryoablation and Nano-Knife.

Men who are scheduled to undergo a focal therapy will be given patient information sheet, which explains the study in lay terms. Fully informed consent, written or verbal (by phone) will be sought and documented before collecting any research data.

The following information will be collected for all patients:

* Demographic data: date of birth, age, gender, ethnicity, Height, weight.
* Medical History: number and results of previous biopsies, previous Protein Specific Antigen (PSA) tests.

For patients who have undergone or are scheduled to undergo MRI-US FUSION biopsy, the following information will be collected:

* MRI: MRI protocol, MRI results: suspected lesions, apparent diffusion coefficient (ADC) values.
* Biopsy procedure details and results: duration and success of procedure, number of cores taken, pathological results, following treatment (if applicable).

For patients who have undergone or are scheduled to undergo HIFU or Nano-Knife or Cryotherapy the following data will be collected:

* Procedure details.
* Evaluation of success: results of following PSA test, MRI and/or prostate biopsy.

Patients undergoing HIFU, Nano-Knife or Cryotherapy will also be asked to complete two questionnaires: IPSS, a validated lower urinary tract symptom questionnaire, and IIEF, a validated erectile function questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Men who have underwent, or are scheduled to undergo a focal therapy treatment at Ramat Aviv Medical Center or Rabin Medical Center
2. Age 18-90.

Exclusion Criteria:

None.
Improving the Frequency of Colonoscopy in Patients With a Previous Colorectal Polyp

RATIONALE: Receiving a reminder letter from their doctor may increase the frequency of colonoscopy in patients who have had a colorectal polyp removed.

PURPOSE: This randomized clinical trial is studying how well a reminder letter from their doctor improves the frequency of colonoscopy in patients who have had a colorectal polyp removed.

OBJECTIVES:

* Determine whether rates of surveillance colonoscopy can be substantially increased by linking computerized data on endoscopic screening procedures to computerized pathology data to identify patients with prior adenomatous polyps who are due for repeat colonoscopy.
* Evaluate whether the impact of the intervention varies by patient characteristics, including age, sex, or site of primary care.

OUTLINE: This is a randomized, controlled, crossover study. Patients are stratified according to age (≤ 65 years of age vs \> 65 years of age), gender, time elapsed since last colonoscopy, and primary care physician's (PCP) membership in Harvard Vanguard Medical Associates (yes vs no). Patients are randomized to 1 of 2 arms.

* Arm I: PCPs are mailed response forms (regarding the disposition of their eligible patients \[e.g. patient letter mailed, patient called, scheduled for colonoscopy, colonoscopy completed elsewhere, patient refused procedure, clinical contraindication, patient deceased\]) and letters reminding them that their patients are due for a follow-up colonoscopy. PCPs who do not return response forms within 4 weeks are sent a second set of reminders and patient letters.
* Arm II: Six months after the beginning of the study, PCPs are mailed response forms and patient letters once. A second set of reminders and patient letters are not sent.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Prior diagnosis of adenomatous polyp
* Underwent prior colonoscopy with polypectomy at Brigham and Women's Hospital

  * Due for repeat colonoscopy according to current national guidelines of the American Gastroenterology Association (no colonoscopy within the past 5 years)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Exercise Training in Dystonia

The purpose of this research study is to investigate how the brain and motor behavior changes in individuals with dystonia and other involuntary movement disorders and healthy individuals over time with exercise training.

The study team plan to conduct a randomized prospective, parallel-group, controlled study to examine the effects of exercises in dystonia and other involuntary movement disorders. Patients will be randomized to receive either progressive resistance training or a control treatment following the modified fitness protocol. The study team hypothesize that progressive resistance training will result in better outcomes compared to modified fitness protocol.

Data collect includes 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities (the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, COWA and Animals, and Brief Test of Attention); 4) tests assessing motor abilities including Toronto Western Spasmodic Rating Scale (TWSTRS) and Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS); 5) measures of anxiety and depression (Beck Depression Index, Hamilton Anxiety and Depression Rating Scales); 5) Cervical dystonia related quality of life (CDQ-24); 6) Visual Analog Scales-Quality of Life (VAS QOL) evaluating of health related quality of life.

Eligibility Criteria:
Inclusion Criteria:

Patients with dystonia and other involuntary movement disorders will be recruited whose diagnosis will be confirmed by a Movement Disorders specialist following the criteria recommended by movement disorders society.

* Patients will be eligible if they are ages 30 to 80 years,
* Receive stable doses of regular botulinum toxin injections and are on stable doses of oral pharmacological therapy if applicable, and are able to walk for 6 minutes.
* Age-matched healthy individuals will be recruited for normative data.
* All individuals must be capable of providing informed consent and complying with the study related procedures.

Exclusion Criteria:

Patients will be ineligible if they have a neurological history other than dystonia, have significant arthritis

* Fail the Physical Activity Readiness Questionnaire, have cognitive impairment as indicated by a Mini Mental State Examination score \<23,
* Already exercising.
* As necessitated by the risks of Magnetic Resonance Imaging (MRI) or transcranial magnetic stimulation (TMS), patients who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator), or a certain type of metallic clip in their body (i.e., an aneurysm clip in the brain)
* Active seizure disorder are not eligible for participation in the MRI or TMS portion of the study.
* Individuals who are claustrophobic will also be excluded from participation.
* Women who are or might be pregnant and nursing mothers are not eligible. Pregnancy tests will be carried out for each female subject of child bearing potential prior to the participation in the study and prior to each follow up visit.
Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions

The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC

This prospective phase II randomized study is to determine the impact of thymosin alpha-1 on the concurrent chemoradiotherpay followed by immunotherapy consolidation in patients with locally advanced NSCLC by assessing the survival outcomes, treatment responses and toxicities.

This prospective phase II randomized study is to determine the impact of thymosin alpha-1 on the concurrent chemoradiotherpay followed by immunotherapy consolidation in patients with locally advanced NSCLC by assessing the survival outcomes, treatment responses and toxicities.

Patients with locally advanced NSCLC who will receive concurrent radiochemotherapy followed by immunotherapy consolidation will be randomly divided into two groups (concurrent Tα1 treatment group and control group \[in which Tα1 will not be used\]), and the overall survivals, progression-free survivals (PFS), completion rate of immunotherapy consolidation, toxicities/adverse effects, and peripheral blood immune biomarkers will be compared between these two groups.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥18 years old
* histologically confirmed locally advanced and unresectable NSCLC;
* no prior radiotherapy or surgery;
* with the life expectancy over 12 weeks;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* adequate bone marrow and hepatic and renal functions;
* informed consent

Exclusion Criteria:

* Concurrent enrollment in another clinical trial, unless it is an observational (non-interventional) clinical study;
* With histologically documented combined small-cell lung carcinoma;
* Major surgery (excluding vascular access placement) within 4 weeks prior to enrollment in the study;
* Active or prior documented autoimmune disease within the past 2 years;
* Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis);
* History of innate immunodeficiency;
* History of organ transplant that requires the use of immunosuppressives;
* A mean heart rate-corrected QT interval (QTc) ≥ 470 ms, calculated using Bazett correction from 3 ECG calculation cycles;
* Poorly managed health conditions that include but are not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmia, active peptic ulcer disease or gastritis, active hemorrhagic diseases, hepatitis C or human immunodeficiency virus (HIV) infection, hepatitis B (positive HBsAg and HBV DNA \> 500 IU/ml), and mental disorders/social conditions that may hinder the compliance with the study requirements or the ability to give written informed consent willingly;
* Active tuberculosis;
* Receipt of live or attenuated vaccination within 30 days prior to the first dose of the investigational agents;
* History of another primary malignancy within the past 5 years, excluding adequately treated basal or squamous cell skin cancers or cervical carcinoma in situ;
* Pregnant/breastfeeding women or males/females of reproductive potential who do not use contraception.
Evaluation of Cognitive-Communication Deficits Following Treatment of Primary Brain Tumor Patients

This study is to evaluate which cognitive-linguistic symptoms are most commonly experienced following brain tumor treatment. Cognitive surveys will be administered after treatment of primary brain tumor cancer.


Eligibility Criteria:
Inclusion Criteria:

* be between18 to 89 years old;
* have undergone at least one cycle of a cancer treatment regimen (e.g., chemotherapy, radiotherapy, surgery)
* have completed at least one cycle of a cancer treatment regimen within five years of enrollment in the study;
* be native speakers of American English;
* have obtained a minimum of a high school education;
* self-report at least one cognitive-linguistic or social-emotional deficit as assessed by the FACT-BR; and
* must demonstrate capacity to sign informed consent based on Informed Consent for Research: A Guide to Assessing a Participant's Understanding tool.

Exclusion Criteria:

* are younger than 18 years old or older than 89 years old;
* have not undergone at least one cycle of a cancer treatment regimen following diagnosis (e.g., chemotherapy, radiotherapy, surgery)
* have not undergone at least one cycle of a cancer treatment regimen in the five year period prior to enrollment;
* are not native speakers of American English;
* have not obtained a minimum of a high school education;
* do not self-report at least one cognitive-linguistic or social-emotional deficit as assessed by the FACT-BR; or
* do not demonstrate the capacity to sign informed consent
Telehealth Stretching Exercise Program for Women With Fibromyalgia During the Covid-19 Pandemic

This study is a randomized, single-blinded, parallel, superiority, controlled trial. The main objective is to verify the effects of a telehealth stretching exercise program on pain, depression, sleep parameters and functionality of women with fibromyalgia, during the Covid-19 pandemic. Participants will be women with primary fibromyalgia, seen at public and private health services, in the city of Pelotas (south of Brazil). Participants will be recruited through social networks, newspapers and support from the National Association of Fibromyalgia and Correlated Diseases (Anfibro). Eligible participants will be randomized, stratified by age (30 to 45; 46 to 60), and allocated to one of the two groups, experimental or control. The experimental group will receive a telehealth stretching exercise program twice a week (guided by a professional) and counseling guide to stretching exercises with explanatory video regarding the execution of the protocol proposed by the guide. The total duration of exercise program will be 40 minutes (will be 12 exercise, 3 sets of each stretching for 10 seconds, carried out individually by a video call application - WhatsApp). The control group will receive only counseling guide to stretching exercises with explanatory video regarding the execution of the protocol. Both interventions will last 12 weeks, with outcomes evaluations in three moments: baseline (week 0), midpoint (week 6) and after the intervention (week 13). The following outcomes will be evaluated: generalized index of pain, fatigue and severity of symptoms, depression, level of physical activity, functionality, quality of life and sleep. All outcomes will be evaluated by questionnaires self-completed, that will be answered on Google Docs by video call, with exception of functional test that will be applied by video call. The study's hypothesis consists of improving outcomes for both groups, but with superiority for the experimental group.


Eligibility Criteria:
Inclusion Criteria:

* Women between 30 and 60 years of age;
* Diagnosis of fibromyalgia (according medical confirmation) at least three months before eligibility;
* Inactive for at least three months;
* Inability or unwillingness to give informed consent for participation and to complete the questionnaires;
* Consent to participate in the study regardless of the allocation group.

Exclusion Criteria:

* Presence of another associated rheumatic pathology (secondary fibromyalgia);
* Uncontrolled systemic disease;
* Being under physiotherapeutic treatment;
* Lack of internet access.
Ocular Pressure in Steroid-treated Dermatology Patients

Ocular hypertension and glaucoma are eye conditions associated with abnormally high fluid pressure in the eye (called intraocular pressure or IOP). If left untreated, the elevated IOP may eventually cause damage to the nerve of the eye and potential impairment of vision.

The use of certain drugs has been identified as a risk factor for raised IOP, including various forms of administration of corticosteroids. Corticosteroids can also lead to cataract, which is clouding of the lens in the eye that can affect vision.

In this research study, we would like to find out whether the use of corticosteroids in our dermatology clinic leads to raised IOP, in order to identify patients at risk and to allow them to be more closely monitored than others. It is important to identify those patients who have a corticosteroid-induced pressure rise early enough to prevent them from permanent glaucomatous visual loss.


Eligibility Criteria:
Inclusion Criteria:

* patients on whom corticosteroid treatment is being introduced for a duration of at least 12 weeks

Exclusion Criteria:

* pregnant women
* patients already under glaucoma treatment
* patients unable to give informed written consent or those unable to cooperate fully with the assessments
New Cardiovascular Risk Screening Strategy.

Mortality due to cardiovascular disease (CVD) in Spain accounted for 29% of all deaths (32% in women and 26% in men) in 2017. Out of those, 67% were related to a coronary or a cerebrovascular disease .

A key strategy in primary prevention of CVD is to use risk functions to individualize preventive interventions for each patient. The current CV risk-screening program in some regions of Spain, is based using an adapted Framingham scale, REGICOR's risk function, which is integrated in the primary care electronic health record. This risk function predicts the probability within 10 years of developing a coronary event. However, this function fails to identify patients that fall into low- or intermediate-risk level, and might develop a CV event in the up following 10 years.

Ankle-brachial index (ABI) is a simple, non-invasive and economic technique, which allows detecting peripheral arterial disease (PAD), and gives independent risk function information compared to other coronary risk functions. Even tough, between 13-27% of middle age population have an ABI ≤ 9, around 50-89% of them do not exhibit any symptoms. However, they hold higher mortality risk and CV events. Current clinical guidelines for PAD screening, have a limited level of evidence, and only recommend using ABI on patients aged 50-70, who have diabetes or are smokers, and patients older than 70 years old.

A new risk function, REASON, to assess CVD risk has been designed. This model has proven to improve predictive capacity of holding an ABI ≤ 0.9 on those patients aged 50-74 that are apparently free of CVD. Therefore, a strategy that combines the current CV risk estimation using REGICOR, and the prediction capacity of pathologic ABI with REASON, would allow detecting high-risk patients with a PAD screening program. It is possible that patients, who hold an ABI ≤ 0.9, even if being asymptomatic, will adopt physician's recommendations on healthy life habits and preventive treatment.

The aims of this study are:

* To assess the effectiveness and cost-utility of adding a screening program with ABI to the current strategy of CV risk detection to reduce the incidence of CVD and mortality from all causes in the population aged 50 to 74.
* To assess the effectiveness of adding a screening program with ABI to the current strategy of CV risk detection to improve cardiovascular risk factors in the population aged 50 to 74.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50 to 74, which are free or do not have previous history of CVD. Patients that hold a REGICOR CV risk score ≥7, and REASON risk core ≥7, during a routine primary care visit

Exclusion Criteria:

* Symptomatic PAD
* Coronary disease
* Stroke
* Cardiac revascularization
Acute Effects of Inspiratory Muscle Training at Different Intensities in Healthy People

At least 30 volunteers will be included in the study. After questioning the demographic and clinical information of the participants, dyspnea perception, respiratory functions, respiratory muscle strength, heart rate variability, arterial stiffness, and blood pressure and physical activity levels will be evaluated. Inspiratory muscle training will be done for 15 minutes with an electronic device. Respiratory training will be applied at three different concentrations with 10%, 30% and 60% of maximal inspiratory pressure. Heart rate variability, arterial stiffness, and blood pressure measurements will be repeated after inspiratory muscle training sessions at different intensities.

Cardiovascular diseases are the leading cause of mortality in developed and developing countries and constitute a significant morbidity burden for life. Cardiovascular diseases risk factors include obesity, lipid profile, unhealthy diet, sedentary lifestyle, high blood pressure, increased arteriosclerosis.

Although aerobic exercise is recommended as exercise modality to reduce cardiovascular risk, the effects of resistant exercise on cardiovascular health are not clear. In addition, regular aerobic and resistant exercise regulate cardiac autonomic function.

Inspiratory muscle training is a time-efficient, well-tolerated and safe approach for both healthy people and people with chronic diseases. Long-term inspiratory muscle training has been shown to increase respiratory muscle strength and decrease blood pressure in healthy individuals. One-session inspiratory muscle training has been shown to improve autonomic function in smokers and older individuals. However, the effects of different intensities of inspiratory muscle training on blood pressure, autonomic function, and arterial stiffness in healthy young people are not fully understood. For these reasons, the aim of the study is to investigate the acute effects of inspiratory muscle training at different intensities in healthy people.

At least 30 volunteers will be included in the study. After questioning the demographic and clinical information of the participants, dyspnea perception, respiratory functions, respiratory muscle strength, heart rate variability, arterial stiffness, and blood pressure and physical activity levels will be evaluated. Inspiratory muscle training will be done for 15 minutes with an electronic device. Respiratory training will be applied at three different concentrations with 10%, 30% and 60% of maximal inspiratory pressure. Heart rate variability, arterial stiffness, and blood pressure measurements will be repeated after inspiratory muscle training sessions at different intensities.

Eligibility Criteria:
Inclusion Criteria:

* Healthy People

Exclusion Criteria:

* Body mass index (BMI) \> 30 kg/m²
* Smoking
* The presence of exercise habit
* Medication use
* Neurological, cardiovascular or respiratory disorders