cyrilzakka/clinical-trials huggingface dataset:
Effect of Acid Reflux on Respiratory Physiology During Exercise in Athletes With GER-Response to Acid Suppression

We propose that acid reflux affects respiratory dynamics (breathing) in patients who are exercising and that athletes improve their exercise capacity with acid suppression therapy. It is our intent to determine whether treatment of GER with strong acid suppression may alleviate symptoms, improve exercise capacity, and improve quality of life.

This is a randomized, blinded, cross-over trial. We plan to take athletes with classical GER, cough, shortness of breath, chest tightness during exercise and subject them to complete pulmonary function testing in conjunction with exercise and pH testing. We will assess whether such athletes experience an increase in reflux duration and episodes during exercise. The athletes will be randomized (in a cross over fashion) to acid suppression (BID Nexium 40 mg) or placebo for 10-12 weeks. Both the athletes and investigators will be blinded. After 10-12 weeks, exercise testing (ramp protocol with VO2 and anaerobic threshold) with concurrent respiratory function testing will be repeated along with symptom assessment. After a brief washout period of 1-2 weeks, the athletes will then cross-over to the other study medication for 10-12 weeks. Again, at the end of the study period, symptomatic relief as well as respiratory function improvement will be assessed by repeating the initial exercise regimen. The exercise regimens during these medication regimens will not be held stable as indirectly, as a results of "feeling better or worse" from the medication/placebo, these patients may increase/ decrease their exercise routine, resulting in changes in their overall endurance, anaerobic threshold, etc (our endpoints). By keeping the regimen stable, we do not allow for the changes to occur which are large enough to detect.

Eligibility Criteria:
Inclusion Criteria:

* We plan to take athletes (cyclists) with GER (heartburn symptoms on a daily-weekly basis which are either improved by a trial of acid suppression or objectively documented via pH/endoscopic testing- this may include during exercise) who experience one or more of the following symptoms during exercise, limiting their perceived ability to exercise to full capacity:

  * choking
  * cough
  * wheezing
  * shortness of breath
  * chest tightness during exercise
* Athletes will be defined as persons who exercise on a routine basis (at least 3 times a week on average) for at least the past 6 months.
* Subjects must be at least 18 years old.

Exclusion Criteria:

* Pregnancy
* Age less than 18 years or greater than 65 years
* Abnormal methacholine challenge tests will not exclude one from enrollment as (has been documented in a prior study) often patients with GER will have heightened bronchial reactivity.
Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens With Plate Haptics in Hyperopic Eyes (HIPER-AT-TORBI)

Observational post-marketing study with prospective follow-up of CE marked medical devices aimed at the treatment of hyperopia and astigmatism in patients with cataract. The objective is to evaluate the clinical results of the implantation of the monofocal aspheric bitoric intraocular lens (IOL) with AT-TORBI 709 plate haptics in cataract surgery of hyperopic eyes with astigmatism.

All patients participating in the study will have the intraocular lens (IOL) AT TORBI 709 implanted from Carl Zeiss Meditec AG, Jena, Germany, with CE marking. All patients will be treated according to standard clinical practice. A preoperative and postoperative evaluation will be carried out one month, six and twelve months after the intervention where the following tests will be performed: refraction, corneal topography, measurement of visual acuity with and without correction, slit lamp examination, eye biometry using the IOLMaster 700 Carl Zeiss Meditec AG, Jena, Germany, CE marked optical non-contact biometer, contrast sensitivity with the CC-100 screen (Topcon Europe, The Netherlands), and the Catquest-9SF (European Registry of Quality Outcomes for Cataract and Refractive Surgery, founded by the European Society of Cataract and Refractive Surgeons). The sponsor has received an unrestricted research grant by Zeiss.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of 50 years of age or older to undergo cataract surgery with phacoemulsification
2. Patient who signs the informed consent.
3. Regular corneal astigmatism between 1.0D and 4.0D.
4. IOL power between 21D and 26D
5. Target-target distance measured with the IOLMaster 700 biometer (Carl Zeiss Meditec AG) greater than 11.6 mm.
6. Patients with hyperopia between 1.0D and 4.0D.

Exclusion Criteria:

1. Patients who do not provide informed consent
2. Patients who do not understand the study procedure
3. Previous corneal surgery.
4. Irregular cornea (eg keratoconus)
5. myopic patients
6. Eye abnormalities or pathologies that could reduce the visual function or stability of the IOL (eg severe amblyopia or macular degeneration)
Together in Recovery With Veterans Through Employment

The purpose of this study is to help Veterans who have opioid use problems with gaining and maintaining meaningful employment. The investigators also want to know employment helps with other aspects of the Veteran's life including starting and staying on necessary medications, mental health needs, and feeling a part of society.

The primary aim of this study is to evaluate the employment outcomes of Individual Placement and Support (IPS) compared to Treatment-as-Usual Vocational Rehabilitation (TAU-VR) in 120 Veterans who are recovering from opioid use disorder (OUD) over 15 months. Specifically, the investigators will see which treatment yields more weeks worked in a competitive job with the hypothesis that IPS will result in better outcomes than TAU-VR. The investigators will interview Veterans in both IPS and TAU-VR groups to investigate the contextual barriers and facilitators of implementing vocational services among Veterans with OUD with the aim to provide solutions and leverage facilitators of success as the VHA expands supported employment services to a new priority population. Investigators will evaluate the impact of vocational services on adherence to prescribed treatment and OUD relapse rates. This study is especially timely given the societal impact of the COVID-19 pandemic on employment and occupational functioning.

Eligibility Criteria:
Inclusion Criteria:

* age 19\* (\<19 year of age in the state of AL is defined minor)
* DSM-5 Axis I diagnosis of OUD
* currently unemployed or underemployed, defined as working \<20hrs/week in a meaningful competitive job for a wage, salary, or commission
* expression of interest in competitive employment; and willing and able to give informed consent

Exclusion Criteria:

* current diagnosis of psychotic disorders since these Veterans already can receive IPS in usual care at TVAMC and BVAMC
* diagnosis of dementia (evidenced in the medical record)
* presence of current severe and unstable medical condition or terminal illness, that would contraindicate study participation or expose them to an undue risk
* unlikely that participant can complete the study

  * e.g., expected deployment, incarceration, long-term hospitalization, or relocation from the vicinity
* active suicidal or homicidal ideation making it unsafe for Veteran to be included
* current participation in another vocational interventional trial
Directional Spread in Geographic Atrophy

Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrial countries. In the late stages of the disease, neovascular changes or the development of geographic atrophy (GA) may induce severe visual loss. GA is characterized by the development of areas of outer retinal atrophy with continuous spread over time that is corresponded to an visual field defect for the patient. The pathogenesis is still incompletely understood. Despite the break-through in the treatment of neovascular AMD by intravitreally administrated vascular endothelial growths factor (VEGF) inhibitors, there is yet no treatment available to slow down or halt the disease process in GA. We and others have demonstrated that the total GA area progression shows large differences between patients. Potential factors influencing differential progression have been intensely studied: While neither systemic nor genetic factors have been shown to influence GA progression, ocular characteristics such as GA baseline size or phenotypic features of fundus autofluorescence (FAF) abnormalities have been identified as risk characteristics for increased GA progression. While these previous studies have mainly focused on the characterization of total GA area progression, topographic directional spread has not been analyzed and relevant predictive markers are yet unknown. There may be large differences in the local GA progression. The primary objective of this study is to identify specific characteristics, for the local GA progression. The knowledge of such risk factors may help to better understand the pathogenesis of GA. The identification of predictive markers will allow for better prognostic assessment of the individual disease process. The DSGA study is the extension trial of the FAM (Fundus Autofluorescence in Age-related Macular Degeneration) study (NCT00393692).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Men and women, any race, aged 55 years or older at the baseline visit
* If both eyes meet the criteria to be study eye either eye will be included into the analysis.
* Patient is willing to undergo ocular examinations once every 6 for up to 24 months

Exclusion Criteria:

* The presence or history of CNV (choroidal neovascular membrane) in the study eye
* Ocular disease in the study eye that may confound assessment of the retina, other than non-exudative AMD (e.g., diabetic retinopathy, uveitis)
* Any systemic disease with a limited survival prognosis (e.g., cancer, severe/unstable cardiovascular disease).
* Any condition that would make adherence to the examination schedule of once every 6 months for up to 24 months difficult or unlikely, e.g., personality disorder, chronic alcoholism, Alzheimer's Disease or drug abuse
* Known medical history of allergy or sensitivity to tropicamide or fluorescein dye that is clinically relevant in the investigator's opinion
White Matter Connections and Memory: the STRATEGIC Study

In patients who have had a stroke, memory problems are common. Some patients with memory problems improve over the first year after stroke, but recovery is unpredictable. The STRATEGIC study assesses patients with recent stroke and follows them up after one year. The study uses cognitive testing and advanced MRI to understand the brain's mechanism for recovery from memory problems and to identify factors that may predict later recovery.

Memory breakdown in older age is a major challenge for medical research, with an increasing burden in personal, societal and fiscal terms. Stroke is an important cause. Memory depends on widespread networks in the brain which are bound together by white matter connections, which essentially act as the wiring of brain networks. This project uses a technique called diffusion tensor MRI to investigate these connections and their relationship to brain function and patterns of memory impairment after stroke.

Previous research showed that a tract called the fornix was most important in the healthy brain and in ageing. However, in individuals at an early stage of memory decline alternative pathways became disproportionately more important. This led to the idea that individuals with early memory decline might be especially vulnerable to injury to these alternative tracts from stroke. The purpose of this project is to test this idea.

The project focuses on patients with recent stroke. Participants undergo MRI, including diffusion tensor MRI, and in-depth testing of memory and other cognitive functions. The pattern of damage to temporal lobe connections in the brain will be assessed and related to the impact of brain infarction on memory. Analysis will determine how undamaged tracts contribute to recovery over one year. Finally, cutting edge computational image analysis techniques will be applied to try and predict memory profile in more detail and extract maximum information about prognosis from brain images.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 50 years
* Recent ischaemic stroke
* English is first language

Exclusion Criteria:

* Previous large artery infarct
* Major neurological or psychiatric condition
* Moderate to severe head injury (Mayo classification)
* Dementia
* Severe cardiac failure
* Active malignancy
Diet, Exercise and/or Rosiglitazone for HIV-Associated Insulin Resistance

The purpose of this study is to determine if, in men and women with excess abdominal fat and insulin resistance, people with HIV infection respond differently than people without HIV to interventions that typically improve body fat distribution and insulin resistance. The specific interventions are:

1. Diet + exercise program.
2. Rosiglitazone treatment.
3. A combination treatment of diet + exercise program and rosiglitazone.

A constellation of nutritional alterations in HIV-infected patients receiving highly active antiretroviral therapies (HAART), including body fat redistribution with subcutaneous adipose tissue (SAT) wasting and visceral adipose tissue (VAT) accumulation, hyperlipidemia, and insulin resistance (IR) has been described. There is a major concern that these developments will be associated with adverse clinical outcomes related to atherosclerosis, as suggested by several case reports (Henry 1998, Behrens 1998, Gallet 1998, Vittecoq 1998). Although there are well documented associations among body fat distribution, insulin resistance, and adverse health outcomes, especially accelerated atherosclerosis, in non-HIV infected individuals, it is unclear if the relationships are affected by HIV infection, or if they reflect the same outcomes. This information is important, since understanding the interrelationships between body fat distribution and metabolism may guide the development of treatment strategies.

The specific hypotheses to be tested are:

1. HIV infection does not affect the relative reductions in visceral (VAT) and subcutaneous adipose tissue (SAT) resulting from diet + exercise, but decreases the effect of this therapy on insulin resistance.
2. HIV infection decreases the changes in insulin resistance and body composition (increase in SAT and decrease in VAT) expected with rosiglitazone.
3. The combination treatment of diet+exercise and rosiglitazone will reduce VAT to a greater extent than rosiglitazone alone, and will improve insulin resistance to greater extent than diet and exercise alone, however these effects will be blunted in HIV-infected subjects.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected or uninfected.
* Body mass index (BMI) at least 25.
* Excess visceral adipose tissue. Excess VAT will be determined in HIV+ and HIV- groups of men by a waist hip ratio \> 0.95 and a waist circumference \>88.2 cm, and in women by a waist:hip \>0.9 and waist circumference \>75.3 cm.
* Insulin resistance (fasting serum insulin level \>16 μU/ml).

Exclusion Criteria:

* Unable to tolerate magnetic resonance imaging (MRI)
* Clinical evidence of active liver disease or a significantly abnormal liver function test (ALT \>2.5x the upper limit of normal).
* Severe hyperlipidemia (fasting plasma triglycerides \>500 mg/dL or fasting total cholesterol \>300mg/dL)
* Current coronary artery disease including angina
* Peripheral vascular disease
* Uncontrolled hypertension
* Participation in a regular exercise program
Micro-Technique Sampling

This is a single-center, exploratory comparative pilot study to identify the most appropriate method for microbial consortia sampling from the skin.

Ten subjects are expected to complete the study at one investigative site in the United States.

The study will consist of 2 visits, Visit 1 (Screening), Visit 2 (Sampling). At Visit 1, subjects will be consented and have their eligibility reviewed. Visit 1 and Visit 2 may be combined into one visit. Visit 1 will involve the informed consent process, screening, and enrollment. Visit 2 will involve sampling of eight (8) test sites on the back with three (3) different sampling methods: swabbing (2 sites/method), cup scrub (2 sites/method), and tape stripping (4 sites/method). All samples will be returned to Kimberly Clark then sent to a laboratory for analysis.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in English, willing and able to read, understand, and sign the informed consent form (ICF);
* Ability to complete the course of the study and comply with instructions;
* Females aged 18 to 40 years, in good general health as deemed by the investigator (no physical required);
* Individuals free of any systemic or dermatological disorder, tatoos in the testing area or recent tanning bed exposure
* Anticipated ability to complete the course of the study and to comply with instructions;
* Females practicing an acceptable method of birth control
* Caucasian individuals with Fitzpatrick skin type I, II, or III
Valsartan in Cardiovascular Disease With Renal Dysfunction (The V-CARD) Study

The purpose of this study is to investigate if an angiotensin II receptor blocker, valsartan 160 mg/day is more effective to reduce the incidence of cardiovascular events as compared to 40 mg/day in patients with moderate renal dysfunction.

It is well known that patients with renal dysfunction have a poor prognosis concerning cardiovascular diseases. That is called "cardiorenal syndrome". It was reported that valsartan was effective in reducing the urine albumin extraction rate in patients with hyper- or normotension. We hypothesized that valsartan was more effective to prevent cardiovascular events by the intermediary of improving renal function.

The primary endpoints are:

* cardiovascular events (cardiac death, non-fatal myocardial infarction, unstable angina requiring rehospitalization, congestive heart failure requiring rehospitalization, revascularization procedures including coronary angioplasty or coronary artery bypass grafting;Stroke or transient ischaemic attack, dissociation aneurysm of the aorta needing hospitalisation;Lower limbs artery obstruction needing hospitalisation .
* end-stage renal dysfunction (introduction of hemodialysis or kidney transplantation)
* 50% reduction of creatinine clearance

The secondary endpoints are:

* systolic and diastolic function of the left ventricle estimated by echocardiography (% FS and E/A ratio)
* specific biochemical markers for cardiac or renal function (urine microalbumin, plasma B-type natriuretic peptide, plasma type 1 plasminogen activator inhibitor, plasma cystatin C)
* % changes of creatinine clearance between start and end of the study period
* transition of 1/(serum Cr) in patients whose u-prot/u-Cr is equal to or more than 1.0
* transition of serum K
* HbA1c
* New onset Atrial Fibrillation
* New onset Diabetes

Eligibility Criteria:
Inclusion Criteria (all required):

* Systolic blood pressure (SBP) \>/= 140 and/or diastolic blood pressure (DBP) \>/= 90 (untreated hypertension cases); or SBP\>/=130 and/or DBP\>/=80 (treated hypertension cases)
* Patients with coronary artery disease (more than 50% stenosis on coronary angiography \[CAG\], coronary computed tomography \[CT\] or coronary magnetic resonance angiography \[MRA\]; coronary spasm; or history of percutaneous coronary intervention \[PCI\]);Unstable angina patient
* Creatinine clearance between 30.0 and 89.9 ml/min

Exclusion Criteria (at least one of following):

* Reduced left ventricular (LV) function (ejection fraction \[EF\] equal to or less than 40%)
* Hyperpotassemia (serum potassium equal to or more than 5.5 mEq/l)
* Rapid progressive glomerular nephritis
* Nephrotic syndrome
* Renal artery stenosis
* Uncontrolled diabetes (HbA1c equal to or more than 9.0%)
* History of allergy to valsartan
* Pregnant women
The Effect of Testosterone Replacement on Bone Mineral Density in Boys and Men With Anorexia Nervosa

Decreased bone strength is a common and serious medical problem present in many people with anorexia nervosa. Men with anorexia nervosa have lower levels of gonadal steroids such as testosterone. Low testosterone levels have been shown to result in low bone density.

We are investigating whether bone mineral density and bone microarchitecture are abnormal in males with anorexia nervosa and whether supplementation with testosterone would improve both bone mineral density and bone microarchitecture.

Low bone mineral density is a co-morbidity associated with anorexia nervosa that has been shown to persist even after weight gain. Peak bone mass accrual occurs during the adolescent years, and a disruption in this critical process increases the risk for developing persistent deficits in bone density, and possibly increased fracture risk. Multiple variables contribute to the bone mass accrual process in puberty including adequate levels of sex hormones and puberty specific changes in levels of these hormones. Teenage boys with anorexia nervosa have lower bone density than normal weight boys of comparable maturity, and also have decreased levels of testosterone, as well as estradiol, when compared with healthy controls. Although testosterone is an important predictor of bone density in males with anorexia nervosa, the effect of testosterone replacement on bone mass accrual and bone microarchitecture in hypogonadal teenage boys and young adult men with anorexia nervosa is unknown. We hypothesize both bone mass and bone microarchitecture are abnormal in anorexia nervosa and that testosterone replacement in adolescent males with anorexia nervosa will improve both bone mass and microarchitecture.

Eligibility Criteria:
Inclusion Criteria:

* Anorexia Nervosa
* Teenage boys and young adult men, age 14-30 years
* Hypogonadism indicated by a testosterone level within the lower 25th percentile for pubertal stage or below normal for pubertal stage

Exclusion Criteria:

* Disease or illness known to affect bone metabolism
* Use of medications known to affect bone metabolism, such as corticosteroids or androgenic steroids, within 3 months of study initiation
* Subjects with a z-score less than -2.5 on DXA secondary to concerns of severely low bone mineral density which may require aggressive monitoring