cyrilzakka/clinical-trials huggingface dataset:
Exercise Capacity Study of LCZ696 vs. Enalapril in Patients With Chronic Heart Failure and Reduced Ejection Fraction.

The purpose of the study was to determine the effect of LCZ696 vs. enalapril on improvement of exercise capacity in patients with chronic heart failure with reduced ejection fraction.

This study was a randomized, double-blind, double-dummy, parallel-group, active-controlled, two-arm trial to compare LCZ696 200 mg twice daily (bid) to enalapril 10 mg bid in improving exercise capacity, daily physical activity and quality of life in patients with stable chronic heart failure (New York Heart Association III) and reduced left ventricular ejection fraction (LVEF ≤ 40%).

The study consisted of a screening period of 2 weeks during which the subject's eligibility for the study was assessed followed by a double blind treatment period of 12 weeks. Eligible subjects were randomized 1:1 to receive either LCZ696 or enalapril during the double-blind period. Treatment was initiated with LCZ696 100 mg bid or enalapril 5 mg bid (enalapril 10 mg bid for patients at a stable daily dose of enalapril above 10 mg per day or corresponding doses of other angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) prior first screening visit), respectively. Dose was up-titrated after 2 weeks to the final dose of LCZ696 200 mg bid or enalapril 10 mg bid.

Patients continued to take their background medications for chronic heart failure during the study, with the exception of ACEI or ARBs which were replaced by investigational treatment and had to be discontinued before first dose of study drug.

The primary objective was to demonstrate the superiority of LCZ696 200 mg bid compared to enalapril 10 mg bid in improving exercise tolerance (peak respiratory oxygen uptake (VO2peak), adjusted to body weight) as assessed by cardio-pulmonary-exercise testing (CPET) in patients with stable chronic heart failure (NYHA III) and reduced ejection fraction (LVEF ≤ 40%) after 3 months treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of chronic heart failure (NYHA class III) and reduced ejection fraction (LVEF ≤ 40%)
* Reduced ability to exercise, evidenced by VO2peak ≤ 18 ml/min per kg
* Patients had to be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks prior to the screening visit and until randomization visit.

Exclusion Criteria:

* History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs
* Previous history of intolerance to recommended target doses of ACEIs or ARBs
* Known history of angioedema
* Requirement of treatment with both ACEIs and ARBs
* Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
* Symptomatic hypotension
* Impaired renal function
* Pregnant or nursing (lactating) women
Patients Who Die Within Emergency Department

Emergency services are a crowded and chaotic environment.

Emergency services are a crowded and chaotic environment. Aim of this study is to investigate the clinic features of emergency patients who die after brought to emergency service.

This retrospective study will be conducted on patients who die within Emergency Department a tertiary hospital over between 01 January 2013 and 31 December 2015.

Eligibility Criteria:
Inclusion Criteria:

* patients who die within emergency department

Exclusion Criteria:

* patients who die outside emergency department patients who die before they were admitted to emergency department
Blood Glucose and Insulin Responses to Snack Food Products

The purpose of this study is to assess the effects of added food ingredients, when baked into a snack food product, on glycaemic index of the product and glycaemic and insulinemic responses to the product in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (not less than 40% males or females
* Non-smoker
* Aged 18 to 55 years
* Have a body mass index between 18.5 to 29.99 kg/m2
* Fasting blood glucose (finger-stick) \>3.3 and \<5.6 mmol/L (Visit 2)
* Two-hour OGTT glucose (finger-stick) \<7.8 mmol/L (Visit 2)
* Willing and able to provide written informed consent

Exclusion Criteria:

* Females who are lactating or may be pregnant or if of childbearing potential, are not taking adequate contraceptive precautions
* Any significant concurrent illness
* History of allergy likely to interfere with the study or known sensitivity to the test food or its ingredients
* Have assessed an investigational product for GI in the last 72 hours.
* Concurrent participation in any other safety study
* History of diabetes, hepatitis, AIDS, anaemia or a heart condition
* The use of any medication or dietary supplement which might, in the opinion of the principal investigator 1) make participation in the study dangerous to the subject, or 2) may affect the results.
* Had any type of gastrointestinal surgery, including gastric bypass
* Having consumed anything apart from plain water in the 12 hours prior to each test
* Have been medically diagnosed as having high blood pressure or heart disease
Way to Be Active V (Framing vs. Forgiveness)

Employers are increasingly looking for opportunities to motivate sedentary employees to become more physically active. Workplace walking programs have had mixed success and typically show most improvement among participants that are already fairly active at a baseline. The goal of this study is to determine whether a financial incentive program can motivate sedentary employees to increase the number of steps they walk per day to meet a minimum threshold.

The primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives. Secondary outcomes will include the average steps walked per day.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18.
* Participant will need an iPhone or Android smartphone to be able to use the Moves App for tracking steps

Exclusion Criteria:

* Pregnant or lactating
* Participating in another physical activity study
Reducing Health Disparities in Childhood Obesity

In this study, we will address cost barriers to participating in summer programs and hypothesize this will lead to marked improvements in children's obesogenic behaviors and a reduction in excessive, unhealthy weight gain over summer.

For this study, we will rigorously test the impact of providing access to existing community-operated summer programs on weight status (i.e., BMI z-score) and obesogenic behaviors of 1st-3rd grade children from low-income households. Using a pragmatic, Type II hybrid effectiveness-implementation randomized design, we will compare changes in weight status and obesogenic behaviors of children from low-income households randomized to one of two conditions: free summer programming or comparison/control.

Eligibility Criteria:
Inclusion Criteria:

1st through 3rd grade students in the participating schools.

Exclusion Criteria:

The only exclusion criteria will be the diagnosis of an intellectual disability, such as:

Autism Spectrum Disorder Down Syndrome Fragile X Fetal Alcohol and/or a physical disability, such as wheelchair use

This decision was made because of the added resources required to evaluate these children, as well as the inability to sample enough of these children to adequately draw conclusions.

No other exclusion criteria will be used.
Efficacy of Ivabradine in Patient With Both Persistent Atrial Fibrillation and Heart Failure With Reduce Ejection Fraction

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. Previous studies have shown that rate control strategy in AF is non-inferior to rhythm control strategy, in terms of stroke and mortality risk. In addition, rate control strategy is associated with lower risk of hospitalization and non-cardiovascular mortality. Therefore, rate control is an essential strategy to improve quality of life, decrease morbidity and prevent tachycardia-induced cardiomyopathy in AF patients. The recommended rate control agents include beta-blocker, nondihydropyridine calcium-channel blocker (CCB), digoxin and amiodarone. However, in heart failure with reduced ejection fraction patient, the medication of rate control were beta-blocker than digoxin. But several clinical observation study show excess mortality in AF patients. Ivabradine, a If inhibitor, it is well-established that a pacemaker current, If current, is functionally expressed in the sinus node . Previous studies have shown that Ivabradine, If inhibitor, significantly reduces sinus rate and improves prognosis in patients with systolic heart failure. Interestingly, several investigators found that hyperpolarization- activated cyclic nucleotidylated channel 4 current (HCN4), the main isoform of the channel responsible for If current, is also functionally expressed in the Atrioventricular node(AV node). Recent data have shown that inhibition of If current slows AV node conduction in animals and humans. Thus, we want to compare the effect of Ivabradine on ventricular rate with digoxin in this study.


Eligibility Criteria:
Inclusion Criteria:

1. The patient with persistent or permanent atrial fibrillation(24hr ECG) with HFrEF and HFmrEF.
2. After maximal tolerance dose beta-blocker(Bisoprolol 20mg/day，Carvedilol 50mg/day) or intolerant to beta-blocker the resting heart rate from ECG is still faster than 100 or resting heart rate from ECG is greater than 80 but still with symptoms of short of breath and palpitation.
3. Stable heart rhythm medication.(no change of medication in recently one week)
4. Age 20 to 90 years old.
5. The subject must be an adult who can read himself/herself and walk independently.

Exclusion Criteria:

1. Used medication with interaction with digoxin : Clarithromycin, Erythromycin, Azithromycin, ritonavir, lopinavir/ritonavir, Doxycycline, Minocycline, tetracycline。
2. Used medication with interaction with ivabradine: voriconazole, posaconazole, fluconazole, Ombitasvir, Dasabuvir, Carbamazepine, Enzalutamide, Fosphenytoin, Mitotane, Phenobarbital, Phenytoin, Rifampicin
3. Cardiogenic shock.
4. History of symptomatic bradycardia.
5. Renal insufficiency:eGFR\<30 ml/min/1.73m2
6. Pregnancy
7. Heart failure due to congenital heart
8. Severe hypotension(\<90/50mmHg)
Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures

Ethyl chloride vapocoolant sprays provide transient skin anesthesia within seconds of application. The current investigation aim is to compare the effect of ethyl chloride based vapocoolant spray to placebo in reducing pain associated with arterial puncture for gasometry determinations.

The investigators will conduce a double-blind randomized placebo-controlled trial at Emergency Department.

We will enroll patients who come to Emergency Department who need an arterial gasometry determination. Patients will be randomized to intervention-group (ethyl chloride vapocoolant sprays will be usad before arterial puncture) or to placebo-group (alcohol spray as placebo will be used before arterial puncture.) and after the puncture they will rate their pain using a 10 points visual analogue scale.

Single-blind, randomized placebo-controlled trial in an emergency department of Hospital de Basurto in Bilbao, Spain. Patients for whom arterial blood gas analysis had been ordered will be included. They will be randomly assigned to receive application of the experimental ethyl chloride spray or a placebo aerosol spray of a solution of alcohol in water. The assigned spray will be applied just before arterial puncture. The main outcome variable is pain intensity reported on an 11-point numeric rating scale.

Eligibility Criteria:
Inclusion Criteria:

* age: 18-85 years old.
* arterial gasometry determination needed
* III, IV or V level classification on Manchester triage.

Exclusion criteria:

* refusal to participate,
* inability to provide informed consent (non-Spanish speaking, dementia or altered mental state),
* skin disease associated with cold intolerance (Raynaud's phenomenon),
* known allergy to spray contents,
* Glasgow Coma Scale \<15,
* pregnancy,
* under effects of alcohol or drugs,
* Allen test +.
Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability and Platelet Aggregation

Our objective is to determine whether or not the presence of hemoperitoneum in trauma patients is associated with increased Carbon Monoxide (CO) formation, and to determine if elevated Carbon Monoxide levels are associated with cardiovascular depression, impaired platelet aggregation, and/or multiple organ failure.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized males 18 years of age or older,
2. Diagnosis of isolated blunt OR blunt and penetrating trauma,
3. Admitted or expecting to be admitted to the Intensive Care Unit,
4. On mechanical ventilation, and
5. Written informed consent obtained

Exclusion Criteria:

1. Female gender, (Females will be excluded from this study as the menstrual cycle and other estrogen variations are known to be associated with cyclic changes in CO production adding a potential confounder to the interpretations of our findings.)
2. Diagnosis of isolated penetrating trauma,
3. Acute hemothorax or pneumothorax,
4. Treatment with antiaggregants (ASA, clopidogrel, aggrenox or ticlopidine),
5. Enrollment in another research study,
6. Prisoners,
7. Inability to perform CO measurement within 96 hours after hospital admission.
Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture

Late sequelae of a cesarean section related to a uterine scar defects include gynecological symptoms and obstetric complications. The aim of this study was to evaluate the incidence and characteristics of cesarean scar defects after uterine closure by double-layer barbed suture.


Eligibility Criteria:
Inclusion Criteria:

- Patients who underwent elective cesarean section at ≥ 37 weeks of gestation

Exclusion Criteria:

* Patients who underwent concomitant surgical procedures during the cesarean section (i.e., tubal sterilization);
* Patients who underwent a previous abdominal surgery (with exception of appendectomy) including a cesarean section or other laparotomic/laparoscopic uterine surgical procedure (i.e., myomectomy);
* Patients who had a previous diagnosis of Mullerian uterine anomalies elective cesarean for the second time or after uterine surgery;
* Patients who had evidence of PAS disorders or placenta previa.
Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region

Despite the implementation of a national strategy to prevent the transmission of the human immunodeficiency virus (HIV) combining prevention campaigns, condom use, early detection of HIV infections and recommendations for treatment as soon as possible, the number of new HIV-infected patients per year in France does not decrease.

New HIV prevention strategies are therefore clearly needed. Since 2009, several studies have shown that tenofovir disoproxil fumarate and emtricitabine (TDF/FTC), an antiretroviral therapy combining two nucleoside reverse transcriptase inhibitors used for the treatment of patients seropositive for HIV, has preventive activity on HIV transmission. These results enabled the TDF/FTC to obtain in France an extension of the marketing authorization in March 2017 for preexposure prophylaxis (PrEP) of HIV transmission among patients at high risk of contamination.

Since the approval, many studies around the world investigate the use of PrEP in routine practice, highlighting its effectiveness in real life. These studies describe the population of patients who benefit from PrEP in order to adapt their multidisciplinary care but also track the transmission of other sexually transmitted infections to prevent their emergence, given the observed decline in condom use. However, these studies are limited to big cities while PrEP is accessible in all territories.

The Rhône-Alpes region is one of the three French regions that has been the most involved in the implementation of PrEP, one year after the FTC/TDF approval in France. Given the geographical position of the investigators, both in province and close to Switzerland, where the FTC/TDF is not authorized for PrEP, and the non-university nature of five of the six involved hospitals, the investigators would like to determine the profile of patients consulting in this region to benefit from PrEP. This analysis will also determine if the population at risk of the "Alpine Arc" region is similar to that observed in the other cohorts in order to adapt patient care.


Eligibility Criteria:
Inclusion Criteria:

* Patient having initiated or wishing to initiate PrEP according to the recommendations of the French High Authority of Health in the centers involved in the collection of data
* Patient informed of the study and having indicated his non opposition for the collection of his health data

Exclusion Criteria:

* Wardship patient
* Patient under curatorship
* Patient unable to give his non-opposition to the use of his health data
Cognitive Function After Radiation Therapy for Brain Tumours

This study will assess cognitive function in adult patients with a primary brain tumour treated with surgical resection with or without radiation therapy (RT). All types of brain tumours apart from glioblastoma will be included

RT to brain tumours causes cognitive dysfunction. The extent of RT induced changes in cognitive function and radio-sensitivity of the brain is unknown. RT with protons instead of photons spares the healthy brain tissue more and is believed to reduce the risk of cognitive dysfunction. There is modest knowledge on which parts of the brain the investigators need to spare, to prevent cognitive dysfunction.

The study is a cross sectional study assessing cognitive function in patients with brain tumours previously treated with RT compared to a similar non irradiated group. 104 patients with specified brain tumours from Aarhus University Hospital treated in the period 2006-2016 will be included. The patients will do patient reported outcome (PRO) and undergo neuropsychological assessment with standardized tests: They will do this prior to RT treatment and ½, 1, 3 and 5 years afterwards. The PRO's included measures on quality of life, fatigue, sleep, depression, anxiety, and socio demografica. The standardized tests are: Trail making Test (TMT); Hopkins Verbal Learning Test (HVLT); Controlled Oral Word Association Test (COWAT) - Animals and S; Coding and Digit Span from WAIS-IV; Paced Auditory Serial Addition Test (PASAT). The correlation between cognitive scores and RT dose-volume parameters to specific areas in the brain will be tested.

Eligibility Criteria:
Inclusion Criteria:

* The participant must be 18 years or older and Danish speaking.
* Performance status 0-2
* Capable of cooperating on testing
* Diagnosed with one of the following diagnoses according to WHO 2016 classification 16 and been treated between 2006 and 2016

  1. ZM93803 glioma (exclusive glioblastoma)
  2. ZM9401/3 anaplastic astrocytoma, IDH mutant
  3. ZM9400/3 diffuse astrocytoma, IDH-mutant
  4. ZM9411/3 gemistocytisk astrocytoma, IDH mutant
  5. ZM9400/3 diffuse astrocytoma, NOS
  6. ZM9451/3 anaplastic oligodendroglioma, IDH mutant and 1p/19q-co deleted
  7. ZM9450/3 oligodendroglioma, IDH mutant and 1p/19q-co deleted
  8. ZM9450/3 oligodendroglioma, NOS
  9. ZM9451/3 anaplastic oligodendroglioma, NOS
  10. ZM9530/0 meningioma
  11. ZM9470/3 medulloblastoma, NOS
  12. DD352A pituitary adenoma
  13. Other rare brain tumours including skull base sarcomas

      -

      Exclusion Criteria:

      Performance status 3-4 Progression after radiation therapy

      -
A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.

This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* metastatic renal cell cancer of predominantly clear cell type;
* \>=1 measurable lesion.

Exclusion Criteria:

* prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for metastatic renal cell cancer;
* ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily treatment with aspirin (\>325mg/day);
* clinically significant cardiovascular disease.
Natural History Study of and Genetic Modifiers in Spinocerebellar Ataxias

Spinocerebellar ataxias (SCA) are genetic neurological diseases that cause imbalance, poor coordination, and speech difficulties. There are different kinds of SCA and this study will focus on types 1, 2,3, and 6 (SCA 1, SCA 2, SCA 3 , also known as Machado-Joseph disease and SCA 6). The diseases are rare, slowly progressive, cause increasingly severe neurological difficulties and are variable across and within genotypes. The purpose of this research study is to bring together a group of experts in the field of SCA for the purpose of learning more about the disease.

The research questions are:

1. How does your disease progress over time?
2. What are the best ways to measure the progression?
3. Do some genes, other than the gene that is abnormal in your disease, have any effect on the way the disease behaves?

This is a nationwide study and we expect that 800 patients will participate all over the USA. The participants will be in the study for an indeterminate period of time. Study visits will be done every 6 or 12 months depending on the participating site.

If you decide to participate in this study, we will collect 1 tablespoon (15 milliliters) of blood during the first/screening visit in order to extract your DNA. The sample will be sent to the research laboratory of Dr Stefan Pulst at the University of Utah for the study of genetic factors that modify the course of your disease.

As part of this study, we would like to put some of your blood in a tissue repository. Submission of your sample to the repository may give scientists valuable research material that can help them to develop new diagnostic tests, new treatments, and new ways to prevent diseases. Scientists will not use your sample, or material isolated from it, for commercial products or services. Your blood will be kept by Dr. Stefan Pulst.

Your sample will not have your name or other personal information linked to it. Your sample may be shared with researchers at the University of Utah and at other institutions. The only information we will keep with the sample is your age, what disease you have, the age at onset of your disease and the duration of the disease. The principal investigator at your site will be the only person who can link the sample to you. You can have your sample removed from the bank later by written request to your PI.

You do not have to participate in the genetic modifier study or the tissue repository to be in the remaining part of this study.

You will also be asked to complete several assessments that include questionnaires, motor function test, a neurological exam and a physical exam.

Eligibility Criteria:
Inclusion Criteria:

* Presence of symptomatic ataxic disease
* Definite molecular diagnosis of SCA 1, 2,3,or 6 either in the subject or another affected family member
* Willingness to participate in the study and ability to give informed consent.
* Age 6 years and above

Exclusion Criteria:

* Known recessive, X-linked and mitochondrial ataxias
* Exclusion of SCA 1, 2, 3 and 6 by previous DNA testing,
* A lack of willingness to participate in the study