cyrilzakka/clinical-trials huggingface dataset:
Low Intraocular Pressure Cataract Surgery With Zeiss Quatera in Glaucoma Patients

You were selected to participate in this observational study because you suffer from glaucoma and cataracts. For the cataract you will have cataract surgery. This study will not affect your treatment, it will only collect data on what is performed before, during and after the procedure.

The aim of this data collection is to demonstrate the safety of a new generation of cataract surgical devices in patients who also suffer from glaucoma. They are glaucoma patients who have an increased sensitivity to eye pressure increases both during and after surgery. The new surgical device makes it possible to safely perform cataract surgery under low pressures. This could, at least theoretically, provide an advantage for patients who also suffer from glaucoma.

Cataract surgery is a highly standardized procedure. However a new phacoemulsification system "Quatera 700" has been developed by Carl Zeiss Meditec. The system has a unique patented QUATTRO Pump that directly controls infusion and aspiration and enables a synchronous change in both. It has four membranes, which directly regulate infusion and aspiration and maintain a pre-set intraocular pressure (IOP), resulting in a stable anterior chamber during the surgery. The membranes are activated by pneumatic pressure regulated by sensors that measure infusion and aspiration flows which allows the system to determine and compensate for incisional leakage as well. This innovative pump system allows surgeons to significantly decrease the intra-ocular pressure during cataract surgery. In respect to competitive devices on the market, the Quatera system is able to operate with pressure four times lower than average. Especially in glaucoma patients (patients suffering from optic nerve head damage due to elevated intraocular pressures), performing surgery with lower intra-ocular pressures would help in avoiding extra nerve fiber layer damage and overall safety of the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with glaucoma that are diagnosed with age-related cataract

Exclusion Criteria:

* Unwilling to sign informed consent
* Functionally monophtalmic patient
* Endothelial dystrophy
* Active uveitis
* Known corticosteroid responder
* Presence of uncontrolled systemic disease
DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease

Purpose: The purpose of this study is to evaluate the Delay Alternating with Nutation for Tailored Excitation (DANTE) SPACE sequence in clinical studies to determine whether it can provide more useful information for clinical diagnosis.

Participants: 100 participants with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI will be recruited.

Procedures (methods): Patients with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI who will have an additional non-FDA approved sequence (DANTE SPACE) added to their clinical scan. The investigational sequence requires less than 15 minutes and will be added following the standard MRI sequence.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and older
* Concern for intracranial vascular disease
* Scheduled to undergo a clinical vessel wall MRI

Exclusion Criteria:

* Claustrophobia
* Implanted metallic devices, parts, vascular clips, or other foreign bodies.
* Known hypersensitivity to gadolinium contrast or to any component of gadolinium contrast refractory to standard medications (antihistamines, steroids)
* Impaired kidney function (serum creatinine level \> 1.8 mg/dL or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
* Any woman who is pregnant or has reason to believe she is pregnant via self report
Evaluating Light-tissue Reaction and Transdermal Drug Delivery by Multiphoton Microscopy

In this study, the investigators will evaluate the potential of multiphoton microscopy as a non-invasive imaging modality for monitoring of the radiofrequency-tissue and light-tissue reaction. The investigators will also investigate drug delivery using multiphoton microscopy.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* younger than 18 years
Remote Exercise Program Delivery Using a Mobile Application for Pulmonary Arterial Hypertension

This study will determine the feasibility of a mobile application-based home exercise rehabilitation program for patients with pulmonary hypertension.

Pulmonary rehabilitation programs that incorporate exercise training are an important component of optimal medical care for pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), which improves exercise performance, quality of life, and may even modify disease progression.

To date, no studies have utilized mobile health (mHealth) technology to provide exercise program interventions in the pulmonary hypertension population. Leveraging mobile technology, such as smartphones or tablets, to administer a home-based exercise rehabilitation program could improve patient access, satisfaction, and participation, while providing sustained physiologic benefits and incurring major cost savings compared to inpatient or outpatient-based supervised programs.

This study hypothesis is that a home-based exercise program delivered by a mobile app will be feasible and safe for PAH/CTEPH patients. The secondary outcomes assessed will explore whether there are changes in exercise capacity, health-related quality of life, and right ventricular function, compared to standard care.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old.

   Either 2 OR 3
2. Diagnosis of PAH by a right heart catheterization with documented mean pulmonary arterial pressure (mPAP) ≥ 20 mmHg, pulmonary arterial wedge pressure ≤ 15 mmHg and a pulmonary vascular resistance (PVR) \> 3 wood units.
3. Diagnosis of CTEPH with mPAP ≥ 20 mmHg, pulmonary arterial wedge pressure ≤ 15 mmHg and a pulmonary vascular resistance (PVR) \> 3 wood units. Evidence of thromboembolic occlusion of the pulmonary arterial system. The patient must be deemed inoperable for, or have persistent pulmonary hypertension after, thromboendarterectomy.
4. Must own a mobile smart phone or tablet and have internet access at home.
5. Stable doses of PAH medications for ≥3 months. Changes to diuretic doses or anticoagulation within 3 months are permitted.

Exclusion Criteria:

1. High-risk PAH, defined as REVEAL 2.0 score ≥9 or high-risk according to the 2015 European Society of Cardiology/European Respiratory Society (ESC/ERS) guidelines table.
2. Syncope in previous 3 months.
3. Unstable coronary artery disease.

   * Canadian Cardiovascular Society Class ≥ II angina.
   * Myocardial infarction in the past 3 months.
   * Symptomatic coronary artery disease with ≥50% stenosis on angiogram.
4. Moderate obstructive lung disease defined as forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio \< 0.7 and FEV1 \< 70% predicted.
5. Active treatment for malignancy other than non-melanoma skin cancer in past 12 months.
6. Life expectancy \< 12 months.
7. Actively listed for lung transplantation.
8. Cognitive, sensory, or musculoskeletal limitation that precludes participation in an exercise program, according to the investigator.
The Effect of Digital Game Use in Teaching Subcutaneous Injection Administration Skills to Nursing Students

The goal of this to determine the effect of a digital game-based application on learning satisfaction and self-confidence in the acquisition of subcutaneous drug administration skills by nursing students.

The research hypotheses it aims to answer are:

* Hypothesis 1: The subcutaneous injection knowledge level of the students who are educated with the digital game method is higher than the students who receive the traditional education.
* Hypothesis 2: The subcutaneous injection skill test scores of the students who were educated with the digital game method were higher than the students who received the traditional education.
* Hypothesis 3: The satisfaction and self-confidence level of the students who are educated with the digital game method towards subcutaneous injection is higher than the students who receive the traditional education.

In studies on the use of digital games in nursing education; Students value instant feedback, visuals and experiential learning, the game developed to improve their decision-making and reasoning skills is extremely useful, useful and enjoyable, from nursing students to those with no previous operating room experience. It has been stated that when the application is made with a game-like simulation, the information is more permanent, they behave more collaboratively, and they experience less fear. The study was planned in a randomized controlled experimental design with pretest-posttest, experimental and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* Being a 1st year nursing student

Exclusion Criteria:

* Previous training in subcutaneous application skills
Perry Virtual - A Prospective and Observational Rural Health Trial

The principal objective of the study is to determine if patient-empowered, real-time and home- based patient monitoring of vital parameters can lead to:

* Reduction in admission rates and improved clinical management of chronically ill patients
* Reduction in use of medications
* Reported quality of life

A minimum of 100 patients will be recruited, monitored and observed over 6 months from home with the Coala Heart Monitor. The study population will be representative of rural, high-risk, Medicare (65+ of age) subjects with chronic conditions and will be recruited by the Perry Community Hospital in Linden, TN.

More than 46 million Americans, or 15% of the US population, live in rural areas. According to the Center of Disease Control (CDC), rural Americans face numerous health disparities and more likely to die from heart disease, cancer, unintentional injury, chronic lower respiratory disease, and stroke than their urban counterparts. A series of studies from CDC have drawn attention to the significant gap in health between rural and urban Americans.

Heart palpitations account for over 70 million US primary care visits every year and is the second most common reason for visiting a cardiologist in the US. With the increased availability of single-lead consumer ECG solutions increasing the demand on providers, home- based solutions are needed enabling cost-effective, prescription-based and diagnostic monitoring solution are needed.

The Coala Heart Monitor was introduced in Scandinavia in 2017 and in the US in 2019. The device is connected to the patient's smartphone and records ECG as well as heart and lung sounds.The complementary cloud-based data analytics platform, Coala Care, analyzes the full disclosed, high resolution data using smart algorithms to detect cardiac rhythm deviations by advanced pattern recognition including real-time AFib detection based on P-waves and R-R dispersion. The heart sounds are further transformed into high-fidelity phonocardiograms (PCG) for murmur detection in real time. Heart and lung sounds can be listened to remotely.

Both health care providers and patients can view the results - the former via the HIPAA- compliant online portal and the latter via the Coala smartphone app - and physicians can send secure private messages immediately if something requires a follow-up.

The COVID-19 Coronavirus pandemic has quickly transformed cardiovascular medicine with shift from traditional hands-on care to remote hands-off telemedicine to keep patients and their medical staff safe.

Eligibility Criteria:
Inclusion Criteria:

* History of frequent admissions, defined as minimum of 2 during the last 6 months
* ICD diagnosis for COPD and/or hypertension and/or diabetes and/or cardiovascular diseases
* Patient has Smartphone or Tablet, as well as Internet connection in their homes (or 3G/4G/5G connection)

Exclusion Criteria:

* Subjects with Pacemaker, ICD or Implanted Loop Recorder
* Subjects with no experience in using Smartphones and Apps
* Vulnerable Subjects (prisoners, elderly with decisional incapacity)
Impact of Folates in the Care of the Male Infertility

Unexplained male infertility is increasing, and, nowadays, the investigators only can propose palliative treatment, as In VITRO Fertilization (IVF). The folate metabolism is a key for the maintenance of genome integrity. A dysfunction in this pathway can be responsible of spermatogenesis defects, and further, of infertility. Few assays have shown that folate treatment can improve sperm parameters and fertility, till 30% in some of theses studies. The purpose of the investigators study is to demonstrate the impact of folates treatment on improvement of sperm parameters and on the rate of success of in VITRO fertilization procedures.

The folate impact in the treatment of male infertility will be reviewed by this large multicentric randomized controlled double-blind study comparing 2 parallel groups of 184 patients. In each group: folic acid 15mg/day versus placebo, orally for at least 3 months (duration of a cycle of spermatogenesis). This assay will evaluate the effectiveness of treatment with folic acid compared to its placebo in infertile men with the outcome of IVF+/-ICSI techniques (pregnancy rate). It will also assess the impact of folate therapy on sperm parameters, and further, the impact on abnormal sperm DNA methylation profiles.

Eligibility Criteria:
Inclusion Criteria:

* Couple whose man is from 18 to 60 years old
* Couple whose man presents an infertility indicating a care in VITRO fertilization with or without intracytoplasmic sperm injection (IVF +/- ICSI)
* Couple whose spouse is from 18 to 38 years old
* Couple whose spouse do not present particular factors of infertility
* Couple Taken care in IVF +/- ICSI
* Couple with social insurance
* 2 members of the couple having signed the consent

Exclusion Criteria:

* Etiology of not genetic known male infertility : infertility of neoplastic origine, infertility of definitive obstructive origin
* Presence of a factor of feminine infertility : A definitive infertility tubal, Turned out ovarian incapacity (FSH \> 9 and/or CFA \<= 8)
* Male infertility requiring the appeal to some sperm testicular or in some frozen sperm- Men or women attend of HIV or hepatitis B or C
* Epileptic men
* Men under anti-folic treatment
* Men presenting a big sensibility to the folic acid or to one of the constituents of the drug
* Couple of which one of the partners refuses to participate in the study
Rifaximin in Patients With Monoclonal Gammopathy

This trial studies how well rifaximin works in treating patients with monoclonal gammopathy. Antibiotics, such as rifaximin, may help to kill bacteria in the intestines and reduce the abnormal protein or cells in patients with monoclonal gammopathy.

PRIMARY OBJECTIVE:

I. To evaluate the effect of a 2-week course of rifaximin on clonal immunoglobulin (Ig) in patients with monoclonal gammopathy.

SECONDARY OBJECTIVES:

I. To evaluate safety and tolerability of a 2-week course of rifaximin.

II. To evaluate changes in stool microbiota by 16S ribosomal ribonucleic acid (rRNA) gene (16S) sequencing.

III. To evaluate changes in gammopathy as assessed by changes in clonal Ig and/or plasma cells.

OUTLINE:

Patients receive rifaximin orally (PO) thrice daily (TID) on days 1-14 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of monoclonal gammopathy of undetermined significance based on International Myeloma Working Group (IMWG) criteria
* Patients will be enrolled into one of 3 cohorts:

  * Cohort A: IgA gammopathy
  * Cohort B: IgG gammopathy / or light chain gammopathy
  * Cohort C: IgM gammopathy / asymptomatic macroglobulinemia
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients who have received antibiotics within last 3 weeks
* Patients who are receiving any other investigational agents for gammopathy. Patients with clinical myeloma requiring anti-myeloma therapy are also excluded
* History of allergic reactions or intolerance attributed to rifaximin or compounds of similar chemical or biologic composition to antibiotic under study
* The effects of rifaximin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of rifaximin administration
Short Term Statin Treatment and Endothelial Dysfunction Due to Ischemia and Reperfusion Injury

Rationale:

Apart from their cholesterol lowering effects, statins have cholesterol-independent pleiotropic actions, such as upregulation of 5'-ectonucleotidase and up-regulation of NO-synthase that may increase tolerance against ischemia-reperfusion injury (IR-injury). Several animal studies have shown reduction of IR-injury as a result of statin treatment in both the heart and the kidney. Recently the investigators have shown, using Annexin A5 targeting after voluntary ischemic exercise to assess IR-injury, a protective effect of a 7 day oral rosuvastatin treatment. A three day treatment with atorvastatin however failed to reduce annexin targeting.

Assessment of the flow mediated dilation of the brachial artery as measure of endothelial (dys)function, is a validated model to research effects of possible protective strategies and perform mechanistic experiments on IR-injury in humans in vivo.

The investigators hypothesize that pretreatment with statins can increase endothelial tolerance against ischemia and reperfusion injury.

Objective:

To study the protective effect of pretreatment (both 3 day and 7 day) with rosuvastatin and atorvastatin on flow mediated dilation after 15 minutes ischemia and 15 minutes reperfusion.

Study design: placebo-controlled randomised double-blind trial

Study population: Healthy volunteers, age 18-50

Intervention: Treatment with either rosuvastatin 20 mg, atorvastatin 80mg or placebo during either 3 or 7 days

Main study parameters: Difference in flow mediated dilation before and after 15 minutes ischemia.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Treatment with rosuvastatin or atorvastatin is not expected to harm the volunteers. Most reported side effects of rosuvastatin and atorvastatin are gastro-intestinal complains and myalgia. The volunteers will not benefit directly from participating in this study.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50
* Written informed consent

Exclusion Criteria:

* Smoking
* History of any cardiovascular disease
* Hypertension (in supine position: systole \>140 mmHg, diastole \>90 mmHg)
* Diabetes Mellitus (fasting glucose \>7.0 mmol/L or random glucose \>11.0 mmol/L)
* Hyperlipidaemia (fasting total cholesterol \>5.5 mmol/L or random cholesterol \>6.5 mmol/L)
* Alanine amino transferase \>90 U/L
* Creatine kinase \>440 U/L
* Raised rhabdomyolysis risk

  * GFR \<60 ml/min
  * Overt clinical signs of hypothyroidism
  * Myopathy in family history
  * Alcohol abuse
* Concomitant chronic use of medication
* Participation to any drug-investigation during the previous 60 days as checked with VIP check.
* Professional athletes
Identifying Targets of Maladaptive Metabolic Responses in Heart Failure

The purpose of the research is to help researchers understand changes in metabolism in patients that develop heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects are capable of giving informed consent.
2. Age 19-89
3. Diagnosis of chronic heart failure
4. Any patients scheduled for at least one of the following procedures:

   1. LVAD implantation or as recipient for cardiac transplantation.
   2. LVAD placement both as bridge to transplant and as destination therapy.
   3. LVAD explantation
   4. Valve replacement or repair
   5. Catheterization and myocardial biopsy for idiopathic cardiomyopathy
   6. Coronary artery bypass graft (CABG)

Exclusion Criteria:

1. Life expectancy less than 2 weeks
2. Diagnosed with following co-morbidities: cancer, chronic kidney disease (GFR≤30 or serum creatinine \>2.1), active infection or treatment with antibiotics or persistent infectious disease (hepatitis, HIV, etc), cirrhosis, active substance abuse and/or alcohol dependence (≥ 14 alcoholic beverages per week).

Control Myocardial Tissue from Donor Hearts Inclusion Criteria

1. Samples collected from non-failing hearts deemed unsuitable for transplantation by TransLife because of either acute recipient issues or post-harvest evidence of pathology or positive but benign serology.
2. Normal cardiac function from medical records

Exclusion Criteria:

1. Pathological remodeling and extensive infarction with limited non-pathological regions of myocardium.
2. Abnormal or impaired cardiac function from medical records, which are self determinants for rejection as a donor organ.