cyrilzakka/clinical-trials huggingface dataset:
Effect of Genetic Polymorphisms on the Clinical Response to SGLT2 Inhibitors in Heart Failure Patients

Sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown further reductions in heart failure hospitalization, cardiovascular events, and mortality, especially for heart failure patients.

The SGLT2 gene, also known as SLC5A2 (solute carrier family 5 member 2), is located on chromosome 16 and is responsible for encoding SGLT2.

Several SLC5A2 mutations alter SGLT2 expression, membrane location, or transporter function.

Several common genetic variations were found in the SLC5A2 gene that may affect the response to treatment with SGLT2 inhibitors.

Sodium-glucose cotransporter-2 inhibitors (SGLT-2i), which were first investigated and licensed for the treatment of diabetes, are now emerging as a promising class of drugs for the treatment of heart failure (HF), even in people without diabetes.

Significant reductions in worsening heart failure or cardiovascular death were shown under treatment with dapagliflozin and empagliflozin in the trials of patients with heart failure.

Several common genetic variations were found in the SLC5A2 gene that may affect the response to treatment with SGLT2 inhibitors.

The most recent SLC5A2 Single Nucleotide Polymorphisms (SNPs) that reduce the risk of heart failure included two intronic SLC5A2 SNPs, s9934336, and rs3116150, both associated with the expression levels of the transporter.

This study aims to detect the association between SLC5A2 single nucleotide polymorphisms and variability in response to SGLT2 Inhibitors as well as the association between cardiac biomarkers and non-coding RNA in patients with Heart Failure.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients NYHA class II to III.
* Heart failure patients with reduced left ventricular ejection fraction (LVEF) \< 45% or with preserved left ventricular ejection fraction (LVEF) \> 45%
* Patients who will be candidate for add-on treatment with SGLT2.
* Patients who will be able to sign informed consent to participate in the study.

Exclusion Criteria:

* Contraindications to SGLT2.
* Significant coronary artery diseases (CAD), coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or valve surgery within 3 months.
* Pregnant or breastfeeding women.
* Patients with estimated glomerular filtration rates less than 30 mL/min/1.73 m2, as determined using the CKD-EPI equation.
Ultrasound-assisted Bilateral Transversus Abdominis Plane Block for Open Prostatectomy

The purpose of this study is to compare the quality of a transversus abdominis plane blockade with an intravenous pain therapy with opioids. Due to the relatively low side effect profile and comparably few contraindications, this method offers a good option, to be a standard procedure or better alternative in the treatment of pain in surgery of the prostate.


Eligibility Criteria:
Inclusion Criteria:

* patients at the age of 18 and above, who need an open prostatectomy
* written consent exists

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) classification \> III
* Allergy to local anaesthesia
* Contraindications to one of the applied methods
* previous surgery on the abdominal wall
* chronic pain patients
* Myasthenia gravis
* alcohol dependence
* increased intraocular pressure
* lacking willingness to save and hand out data within the study
* Participation in another trial according to the German Drug Law
* accommodation in an institute due to an official or judicial order
Comparison of Two Tests in the Assessment of the Accuracy of Esophageal Pressure Variations Measurement During Mechanical Ventilation

Esophageal pressure measurement, obtained with the use of an esophageal balloon catheter, is fundamental to assess mechanical characteristics of the respiratory system during mechanical ventilation. The correct positioning of the catheter (usually at the medium third of the esophagus) is crucial for an accurate measurement of esophageal pressure. Usually the correct positioning of the catheter is verified with an occlusion test (If the patient is breathing spontaneously) or with thoraco-abdominal compressions (if the patient is sedated and paralyzed). Aim of this study is to compare the accuracy of these two methods at different PEEP and esophageal catheter positions.


Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation for clinical purposes

Exclusion Criteria:

* Hemodynamic instability
* Esophageal diseases
* Refusal of the patient
Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)

The primary hypothesis constitutes that the fish-oil preparation (Omegaven) is superior to the preparation based on Soja-oil (Lipovenös)to reduce signs and symptoms in patients with active rheumatoid arthritis.

The study can be considered a phase III trial (comparison of two licensed preparations in a non-approved indication). This controlled double blind trial aims to compare the effect of parenterally applied fat emulsions on the disease activity of RA patients, as expressed by changes of the DAS28.

To test for the hypothesis patients are randomized and treated with 2ml/kg bodyweight of both preparations for seven consecutive days. These treatment cycles are repeated four times at monthly intervals. For not improving patients (DAS28 decrease \<0.6) escapes before the third and the fourth treatment cycle are foreseen. In case of escape patients are treated with Omegaven in an open manner.

Efficacy parameters comprise the DAS28, the ACR-criteria, the M-HAQ, the SF-36, and the co-medication consumption. To assess safety laboratory parameters, comprising, LFT, KFT, CBC, fasting glucose, cholesterol, HDL, LDL, neutral fat, and urinary analysis are performed. Moreover, blood pressure control and clinically examinations are performed on a regular basis.

Study recruitment started in fall 2004 and was completed in November 2006.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* RA according to the ACR criteria
* active RA (DAS28 \> 4.0) at the screening visit
* insignificant DAS28-change (\<0.6) between screening and the first intervention

Exclusion Criteria:

* age lower than 18 yrs.
* pregnancy and insufficient birth control
* lactation
* army service
* lack of independence
* relevant therapeutic or dietary changes during the last three months
* relevant therapeutic or dietary changes foreseen for the study duration (including surgery)
* application of Omega-3 fatty acids during the last three months
* application of Omega-3 fatty acids intended for the study duration
* prednisolone \> 10 mg/day
* contraindication for Omegaven or Lipovenös (according to the label)
Cerebral, Meningeal Biopsy by Flexible Endoscopy in Patients Without Neurological Diagnosis

The investigators will take cerebral and subarachnoid biopsy by flexible endoscopy in patients without neurological findings. The investigators will use retrospective and prospective patients.

Test the useful of the flexible endoscopy in patients without neurological diagnosis.

Developed a diagnosis method for idiopathic neurological findings.

Compare the cerebral and subarachnoid biopsy each other

Eligibility Criteria:
Inclusion Criteria:

* patients with neurological disease and with out diagnosis

Exclusion Criteria:

* death of the patient
* patients with neurological diagnosis
Effect of Structured Exercise in Patients With Knee Osteoarthritis

The aim of this randomized controlled trial is to evaluate the effect of Nordic walking and inspiratory muscle training (IMT) on cardiopulmonary function in patients with knee osteoarthritis (OA). Mild-to-moderate knee OA patients are randomly allocated into Experimental group (Nordic walking plus routine management) or Control group (Routine management). While End-stage knee OA patients are randomly allocated into Experimental group (IMT plus pre-operative rehabilitation exercise) or Control group (Pre-operative rehabilitation exercise). Participants are invited to undergo two assessments, including baseline assessment, post-intervention assessment. Researchers will compare two groups to see if the cardiopulmonary function can be improved after intervention.

This study recruits patients with different stages and assigns them into different interventions and comparing the effect with those not receiving intervention. It will provide the evidence in terms of the exercise that can promote cardiopulmonary function and at the same time reduce pain and disability for patients with different stages of knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* pain on the most days in one or both knees in the past month;
* difficulty with at least one of daily living activities measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale;
* radiographic evidence of knee OA in the tibial-femoral compartment (Kellgren and Lawrence grade, K/L ≥1, K/L 1-3 regarded as mild-to-moderate knee OA, others waiting for knee arthroplasty regarded as end-stage knee OA);
* with normal or corrected visual and auditory function and walking unaided;
* primary knee OA for more than 6 months, be stable on medication for at least 3 weeks.

Exclusion Criteria:

* knee surgery priorly;
* have steroid injection in previous three weeks;
* have inflammatory arthritis (e.g., rheumatoid); or unstable angina, or myocardial infarction, or cardiac surgery; or stroke; or treatment with steroids, hormones, or cancer chemotherapy; or pulmonary diseases (force vital capacity\<80% of predicted and/or forced expiratory volume at first second\<70% of predicted); or a history of exercise-induced asthma;
* unable to understand the procedure and potential risks of the study;
* medically unstable that indicate unsafe to participate in exercise test
Effects of Spironolactone Combination Therapy on Proteinuria, Kidney Function, and Blood Pressure

The detrimental effects of aldostrone are not adequately arrested by the use of angiotensin converting enzyme (ACE), angiotensin II receptor blocker (ARB) or a combination of both. Recent evidence has provided robust evidence that aldostrone escape plays an important role in this regard. It is believed that aldostrone escape occurs quite commonly with reports indicating prevalence rates as high as 22% with ARBs and 40% with ACE inhibitors. In a trial of patients with diabetes and hypertension it was shown that treatment of aldostrone escape with spironolactone 25 mg daily for three months significantly reduces proteinuria. A number of other trials have similarly observed that addition of spironolactone to an ACE inhibitor based regimen provides additional benefits on proteinuria reduction, blood pressure control, and prevention of glomerular filtration rate (GFR) decline. Most of the available trials in this regard are of short duration (e.g. three months), and have added spironolactone to an ACE or ACE+ARB based regimen (the so-called triple blockade). Currently, evidence evaluating efficacy of a combined ARB+spironolactone regimen compared with conventional double RAS blockade (i.e. ACE+ARB) is lacking. Hence, this randomized open label trial was initiated to determine the effects of addition of spironolactone 25 mg daily to losartan over a period of 18 months.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes patients with diabetic nephropathy in the range of micro- or macroalbuminuria
* treatment with combination of enalapril and losartan for more than one year

Exclusion Criteria:

* history of non-adherence to prescribed medication assessed by the prescribing physician
* baseline potassium \> 5.5 meq/L
* chronic kidney disease stages 4 or 5
* history or evidence of non-diabetic kidney disease
Safety and Efficacy Study of Novel Gene Therapy ZM-01 for X-linked Retinoschisis Patients

This trial is meant to evaluate the safety and efficacy of ZM-01 of X-linked retinoschisis. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye.

X-linked retinoschisis (XLRS) is a rare, inherited retinal disease caused by mutations in the RS1 gene. Individuals affected by XLRS often experience progressive visual impairment from a young age, potentially leading to legal blindness. There is currently no established clinical treatment available. We developed an innovative adeno-associated virus (AAV)-based gene therapy for individuals with XLRS. Six to nine subjects with XLRS received a single unilateral intravitreal injection of ZM-01 at ascending doses.

Eligibility Criteria:
Inclusion Criteria:

Subjects who meet all of the following criteria will be enrolled into the study

1. Diagnosis of X-linked retinoschisis consistent with the presence of RS1 gene mutation
2. Male, aged between 3 and 18 years old, in overall good health except for XLRS condition
3. Capable of undergoing visual and retinal function assessment.
4. The visual acuity of the study eye not better than: 0.4 (68 ETDRS letters equivalent)
5. No carbonic anhydrase inhibitors have been used at present and for 3 months before treatment
6. Laboratory tests meet the following criteria:

   1. Hemoglobin ≥ 11.0 g/dL
   2. White blood cell counts ranged from 3,300 to 12,000 cells /mm³;
   3. Platelet count 125,000-550,000 /mm³;
   4. Alanine aminotransferase (ALT) is not higher than 1.5 times the upper limit of the normal range of laboratory tests;
   5. Serum creatinine was no higher than 1.1 times the upper limit of the normal range for laboratory tests;
   6. Prothrombin time (PT) ≤14.5 seconds and partial thromboplastin time (PTT) ≤ 36.0 seconds.
7. Willing to discontinue aspirin, aspirin-containing products, and any other medications that may alter clotting function at least 7 days before dosing.
8. Be able to understand and sign informed consent.

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria before enrollment were excluded from the study

1. Previously received any AAV gene therapy
2. The following mutations in RS1 gene: R141H, C59S or C223S
3. Pre-existing eye conditions that cause severe vision loss or increase the risk of intravitreal injections (e.g., advanced glaucoma, uveitis, or severe retinal detachment)
4. Ocular diseases in which there is opacity of the lens, cornea, or other media, hindering adequate observation and examination of the retina
5. Use anticoagulant or antiplatelet drugs within 7 days before dosing
6. Use any experimental drug within 3 months prior to registration
7. Presented any situation that causes the investigator to believe the subject might not adhere to the study protocol or that participation might pose an unacceptable risk to the subject
To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma

To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma
* Ann Arbor Stage II, III or IV

Exclusion Criteria:

* Has receive rituximab
* Allergies or hypersensitivity to murine, chimeric, human or humanised proteins
* Previous treatment for NHL
* Any malignancy
* Current or recent treatment with any other investigational medicinal product or device
* pregnant or lactating
Sex Differences in Relative Survival and Excess Mortality Following Acute Myocardial Infarction

The aim of this study was to estimate the impact of sex on relative survival and excess mortality following acute myocardial infarction (AMI) using a population-based cohort within a relative survival framework. Patient-level data concerning demographics, co-morbidity, cardiovascular risk factors and treatments at discharge were extracted from the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART), a population-based registry of outcomes for patients hospitalized with acute coronary syndrome. Patients were followed-up for their vital status after AMI hospitalisation, with censoring at the end of follow-up on the 31st of December, 2013.

Details of SWEDEHEART and data validation have been described previously. Cases of acute myocardial infarction were defined as STEMI and NSTEMI according to the current European Society of Cardiology, American College of Cardiology and American Heart Association guidelines and determined at local level by the attending Consultant.

Eligibility Criteria:
Inclusion Criteria:

* Patients were included if they are aged over 18 years who had been hospitalised following acute myocardial infarction between 1st January, 2003 and 31st December, 2013

Exclusion Criteria:

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MAP for Coaches: Translating Sports Injury Prevention Knowledge to Youth Sport Coaches

The goal of this clinical trial is to test the effectiveness of the MAP for Coaches, a web-based Musculoskeletal Athletic injury Prevention training course, in youth sport coaches. The main question it aims to answer are:

* Is the MAP for Coaches effective in increasing coaches' sport-specific knowledge of musculoskeletal injuries (types, incidence, risk factors, mechanisms, and best prevention practices, with focus on neuromuscular training warm-up exercise programs)?
* Is the MAP for Coaches effective in increasing coaches' motivation (self-efficacy and intention) to use sport-specific neuromuscular training warm-up exercise programs?

The additional questions it aims to answer are:

* Are the effects of the MAP for Coaches sustained in the short- and long-term?
* Is the MAP for Coaches effective in promoting the use of sport-specific neuromuscular training warm-up exercise programs in youth sport coaches?

Regardless of group, participants will receive the MAP for Coaches eLearning training course; however, the participants allocated to the control group will have their post-test survey completed right after they review the sport-specific 2-page injury prevention e-book containing an overview of the MAP for Coaches training course, including an infographic summary (Summarized MAP for Coaches eLearning Training Course). The intervention group will complete the post-test survey after the full training including both the course summary and the detailed course modules (the full training).

The investigators will compare the two groups to see if an exposure to the (Full) MAP for Coaches eLearning Training Course improves study outcomes compared with the control group.


Eligibility Criteria:
Inclusion Criteria:

* Active and ongoing engagement in team youth sport coaching
* Member of a youth sport organization in the United States
* Must be a team sport coach for one of the following: soccer, basketball, football or volleyball

Exclusion Criteria:

* Additional engagement in adult coaching
* No email address contact
Oestrogen Withdrawal in Hypopituitary Women

By exploring hormonal status in hypopituitary women during oestrogen treatment and without estrogen substitution the influence on sexhormones and organ function is estimated.

38 hypopituitary women were examinined twice. During oestrogen treatment and after 1 month estrogen withdrawal. A control group of healthy women were examined once.Antropometric data and hormonal parameters were collected.

Eligibility Criteria:
Inclusion Criteria:

* Hypopituitarism
Leptin Biology in Adipose Tissue

Leptin is a fat hormone which acts in maintaining energy balance. However, leptin levels are high in obese subjects indicating resistance to the actions of leptin. High leptin levels have been associated with increased cardiovascular and metabolic risks, but it is not clear if increased leptin or leptin resistance contributes to the increased cardiovascular risk. Further, even though leptin receptors are present in fat tissue, leptin's role in fat tissue functions are not completely investigated in humans. Based on preliminary data the investigators hypothesize that resistance to leptin action in obese adipose tissue is responsible for altering the expression of adipose tissue proteins which contribute to the development of cardiovascular and metabolic dysfunction. To test this hypothesis the investigators propose a novel study directed at investigating the leptin dependent changes in adipose tissue protein expression using adipose tissue obtained from lean and obese human subjects


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years
2. BMI BMI ≤25 (lean) or \>30 kg/m2 (obese)
3. Going to undergo a surgical procedure where omental and subcutaneous adipose tissue may be biopsied.

Exclusion Criteria:

Inability to provide written informed consent.

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Internet-Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder

Panic Disorder with or without agoraphobia (PD/A) is a common, and unless it is treated, often chronic psychiatric disorder. The are effective pharmacological as well as psychological treatments for PD/A. Because of the lack of availability of the most effective psychological treatment, cognitive behavior therapy (CBT), self-help based CBT treatments have been developed. One of those are Internet-based CBT. The aim of this study is to compare the effectiveness of Internet and group CBT for PD/A in a regular psychiatric setting. 113 patients are consecutively and randomly assigned to either treatment (both lasting 10 weeks). The main outcome measure is the Panic Disorder Severity Scale(PDSS). The study hypothesis is that treatments will show equal effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Primary Panic Disorder with or without Agoraphobia (PD/A)

Exclusion Criteria:

* active substance abuse
* physiological etiology of panic symptoms
* under 18 years of age
* severe depression or suicidal ideation.
* if on drugs for PD, not having had a constant dosage for 2 months
* undergoing other cognitive behavioral treatment
Capsaicin for the Treatment of Cannabinoid Hyperemesis Syndrome

This study aims to determine if capsaicin cream offers symptomatic relief to patients suffering from Cannabinoid Hyperemesis Syndrome (condition that leads to repeated and severe bouts of vomiting).

Objectives:

The purpose of this study is to determine if capsaicin cream offers symptomatic relief to patients suffering from Cannabinoid Hyperemesis Syndrome. We hypothesize that the use of topical capsaicin may provide effective symptomatic relief more quickly than conventional anti-emetic therapy alone thereby decreasing costs for continued drug therapies, repeat laboratory testing, radiographic imaging, and specialist consults.

Primary endpoint:

Time to resolution of symptoms, clinical improvement in pain score as defined by visual analog score.

Approach and methods:

Patients presenting to the UVA Emergency Department with chief complaint of nausea and vomiting who endorse cannabinoid use via inhalation or consumption. Patients 18 years of age and older will be included in the study and patients who have another clear indication for nausea/vomiting or cyclic vomiting (infection, appendicitis, pain, etc.) will be excluded. Patients who are enrolled in the study will be randomized 1:1 to treatment vs. placebo. All patients will be allowed 1L of intravenous fluids and one to two standard anti-emetics. The Investigational Drug Services team at UVA will be involved in compounding the capsaicin treatment versus placebo and drug/placebo shall remain in place for at least 30 minutes. Clinical improvement will be scored based on visual analog score for pain and assessment at hourly increments until discharge or admission.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Diagnosis of cannabinoid hyperemesis syndrome

Exclusion Criteria:

* Patients who receive more than 2 anti-emetic therapies prior to screening for enrollment
* Patients who receive haloperidol as an anti-emetic therapy
* Pregnant women
* Prisoners