cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Candesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.


Eligibility Criteria:
Inclusion Criteria:

* Signed Consent of the patient;
* Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who have never been treated and have indication for drug combination treatment.

Obs: The diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmHg, with two months difference between measurements

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can not participate in the study;
* Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;
* Morbid obesity or immunocompromised patients;
* Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;
* Participants who do not have the two upper limbs;
* Participants with important electrocardiographic changes;
* Creatinine clearance - less than 60 mL /min;
* History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;
* Microalbuminuria in urine sample greater than 30 mg/g;
* Patients with history of hypersensitivity to any of the formula compounds;
* Pregnancy or risk of pregnancy and lactating patients;
* Participation in clinical trial in the year prior to this study.
Endometrial Injury and IVF Outcome Parameters in Patients With Failed IVF Cycles

The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients with previous IVF failures.

Endometrial injury was preformed either through hysteroscope during office hysteroscopy through the non touch technique or through pipelle biopsy in the early follicular phase (days 5 to 9) in the preceding cycle of the IVF treatment.

Eligibility Criteria:
Inclusion Criteria:

* Personal history of 2 or more failed IVF/ICSI cycles (RIF)
* Age\</= 42 years
* Good response with good quality embryos in previous attempts (\>2)

Exclusion Criteria:

* Personal history of endometrial tuberculosis/ antituberculous treatment
* Sonographically detected hydrosalpinges
* Intramural fibroids distorting the endometrial cavity, submucous myomas or Asherman's syndrome
* Thrombophilia
Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers

The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).
* Vision correctable to 20/30 or better with contact lenses.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Sensitivity to multi-purpose solutions.
* Use of any topical ocular OTC or prescribed topical ocular medications.
* History (6 months) or current ocular infections or ocular inflammatory events.
* Ocular surgery within the past year.
* Medical condition or use of medications that cause ocular side effects.
* Participation in any investigational study within the past 30 days.
* Other protocol-defined exclusion criteria may apply.
Measuring Mindfulness Application

The purpose of the research study is to learn more about how ROTC cadets may engage with mindfulness training program content that is delivered through a smartphone or website application. Mindfulness training program content includes mindfulness practices that foster attention and awareness.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals who are between 18 and 64 years of age.
2. Individuals who are fluent English speakers.
3. Individuals who have access to either an Apple or Android smart phone and a desktop or laptop computer, are able to adequately and independently use both devices, and have Internet connection.
4. Individuals who are willing and able to consent to participate in the study.
5. Individuals who are in the South Florida ROTC program.

Exclusion Criteria:

1.Individuals with an active and untreated mental condition (e.g., Bipolar disorder, Major Depression) and/or hospitalization for psychological/mental health issues within the last month.
Improving Performance of Combat Soldiers by Utilizing Attentional Training Based on Eye Tracking

Military service in combat units entails exposure to traumatic events that require mental adjustment. To develop and efficiently apply attentional interventions aimed at enhancing soldiers' combat performance, it is essential to extensively investigate the efficiency of these training programs, which has yet to been done. The prupose of the current study is to examine the efficiency of the new attention eye-tracking based training, in comparison to RT-based training and to a control group, in improving performance of combat soldiers. In addition, the influence of the attention training on aspects of psychological resilience will also be examined in questionnaires.

Following the explanation to participants regarding the study process, those who give written consent to participate will be randomly placed into one of three groups: GCFT (N=60), ABMT (N=60), and a neutral control group - task based on eye-tracking (N=60). The study will include 2 measurement points during the military service: before the attention training and after the attention training. In each measurement point, the soldiers will complete computerized tasks to measure threat attention, questionnaires, and performance data from shooting ranges and combat fitness.

Eligibility Criteria:
Inclusion Criteria:

* Each soldier from the cohort that will give his written consent will be able to participate in the study.

Exclusion Criteria:

* Hebrew proficiency is insufficient to complete the study questionnaires.
Music and Perceived Rate of Exertion

The aim of this study was to evaluate the effect of listening to ambient music on the perceived exertion rate during pulmonary rehabilitation for chronic obstructive pulmonary disease patients.


Eligibility Criteria:
Inclusion Criteria:

* participate in the program for at least one month after the initial medical investigation, be free of exacerbations for 1 month and have maintained exactly the same program session for both evaluated sessions

Exclusion Criteria:

* participate to only session of one condition
Anomalous Aortic Origin of Coronary Artery

This project has several objectives ranging from clinical data analysis to computational simulations as listed below:

A) Clinical objectives:

1. Retrospective review of all patients with AAOCA treated surgically and followed medically at the IRCCS Policlinico San Donato aiming to identify risk factors for ischemia or sudden cardiac deaths.
2. Prospective follow-up of all enrolled patients, treated and followed, in adjunct to all the new patients referred aiming to follow across the years any potential rare adverse event (ischemia, angina event, sudden cardiac death).

B) Experimental objectives:

1. Retrieve morphological measurements from CT or MRI (de-identified) of the aortic root and the coronary vessels following the previous work of our group.
2. Construct a parametric model of the aortic root defined by population-based morphologic parameters to describe both healthy/diseased population.
3. Run solid mechanics simulation mimicking the movement of the aortic root in order to test configurations at more risk.
4. Reconstruct 3D surfaces representing the coronary vasculature from imaging for automatically perform the parameter estimation and run computational fluid dynamics simulations.


Eligibility Criteria:
Inclusion Criteria:

* All patients (adults and pediatrics) who have been diagnosed with an anomalous aortic origin of any of the coronary arteries (AAOCA) without any other congenital heart disease and diagnosed/referred or followed at the IRCCS Policlinico San Donato.

Exclusion Criteria:

* Patients with other major congenital heart disease with associated coronary artery origin anomalies will be excluded.

Patients with anomalous origin of the coronary artery from the pulmonary artery (ALCAPA or ARCAPA) will be excluded.

Patients women who are pregnant.
A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib

An Open-label, Randomized, Three-period, Crossover Study of the Effect of Food on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index between 18.0 and 32.0 kg/m2, inclusive.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and/or check-in
* Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at screening and check-in. Females of childbearing potential must agree to use contraception
* Male subjects must agree to use contraception
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions

Key Exclusion Criteria:

* History of drug/chemical abuse within 2 years prior to screening.
* History of alcohol abuse within 12 months prior to screening
* Positive urine drug screen at screening or check-in or positive alcohol test at check-in.
* Use of tobacco- or nicotine-containing products or e-cigarettes (with or without nicotine) within 3 months prior to check-in for Period 1; or positive cotinine at screening or check-in.
* Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to study drug administration on Day 1 of Period 1.
* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to study drug administration on Day 1 of Period 1.
* Use or intend to use any prescription medications/products within 14 days prior to study drug administration on Day 1 of Period 1.
Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

This phase II trial is studying how well cinacalcet hydrochloride works in treating men with recurrent prostate cancer. Cinacalcet hydrochloride may be effective in lowering prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has not responded to previous treatment

PRIMARY OBJECTIVES:

I. To test the hypothesis that once-daily treatment with 30 mg of cinacalcet hydrochloride (Sensipar) will reduce the rate of rise of serum prostate-specific antigen (PSA) compared to pre-treatment PSA values in subjects with biochemically recurrent prostate cancer after failed definitive local therapy.

OUTLINE:

Patients receive cinacalcet hydrochloride orally (PO) once daily (QD) for 20 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate
* For patients who have recurrent disease following surgery as first line therapy ("surgical failures")
* PSA requirement is 0.2 ng/ml or above
* For patients who have recurrent disease following radiation as first line therapy, the eligibility follows the "Phoenix criteria", that is, a rise of 2 ng/mL over the PSA nadir
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Granulocytes \>= 1000/uL
* Serum creatinine =\< 2.0 mg/dl
* Total serum calcium \> 9.0 and \< 10.5 mg/dl
* Total bilirubin =\< 2.0 mg/dl
* Platelet count \>=100,000/uL
* Hemoglobin (Hgb) \>= 9 g/dL
* Total testosterone \>= 50 ng/dL
* Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)

Exclusion Criteria:

* Serious medical illness which would limit survival to less than 3 months
* Active, uncontrolled bacterial, viral or fungal infection
* Hemorrhagic disorder
* Any radiographic evidence of metastatic disease including positive bone scan or computed tomography (CT) abdomen/pelvis
* History of hypocalcemia or seizure disorder
* Patients with known hypersensitivity to any of the components of cinacalcet (cinacalcet hydrochloride)
Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction

The RIP-HIGH trial is a two-arm randomized controlled trial aiming to compare the impact of combined remote ischemic conditioning (RIP) and local ischemic postconditioning (PostC) vs. standard of care on clinical outcome in high-risk ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.

Coronary reperfusion by percutaneous coronary intervention is mandatory to salvage ischemic myocardium and to reduce definite infarct size. However, reperfusion itself also causes irreversible myocardial damage - a phenomenon described as reperfusion injury. Reduction of ischemic and reperfusion injury by ischemic conditioning has been identified as a potential target to reduce myocardial damage.

Remote ischemic conditioning and local ischemic postconditioning might be in particular of clinical benefit in higher risk STEMI patients with Killip class ≥2, where mortality rates are high.

The Remote Ischemic Conditioning with Local Ischemic Postconditioning in High-Risk ST-elevation myocardial infarction patients (RIP-HIGH) trial is a two-arm randomized controlled trial aiming to compare the impact of combined remote ischemic conditioning and local ischemic postconditioning vs. standard of care on clinical outcome in high-risk ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

* Acute chest pain lasting \<12 h
* ST-elevation at the J-point in two contiguous leads of ≥2 mm in men ≥40 years, ≥2.5 mm in men \<40 years and ≥1.5 mm in women (regardless of age) in V2-V3 and/or ≥1 mm in all other leads (52).
* New or presumed new left bundle branch block or right bundle branch block.
* Killip class ≥II on hospital admission or requirement of diuretics because of clinical congestion.
* Written informed consent.

Exclusion Criteria:

* Killip class I on hospital admission.
* Prior fibrinolysis.
* Conditions precluding use of RIC (i.e. paresis of the upper limb, presence of an arteriovenous shunt).
* Pregnancy.
* Age \<18 years.
* Severe co-morbidity with a life expectancy \<6 months.
* Participation in another trial.
Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.


Eligibility Criteria:
Inclusion criteria:

* Group A (Bleeding patients)

  * Overt bleeding judged by the physician to require a reversal agent
  * Currently taking dabigatran etexilate
  * At least 18 years of age
  * Written informed consent
* Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or procedure for a condition other than bleeding

  * Condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
  * Current treatment with dabigatran
  * At least 18 years of age
  * Written Informed consent.

Exclusion criteria:

* Group A (Bleeding Patients)

  * Patients with minor bleeds (epistaxis, hematuria) who can be managed with standard supportive care.
  * Patients with no clinical signs of bleeding
  * Contraindications to study medication including known hypersensitivity to the drug or its excipients.
* Group B (Patients who require emergency surgery or procedure)

  * A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
  * Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial

Chronic heart failure is an important public health problem as it is a leading cause of disability, hospitalization, death, and costs. People who live with advanced chronic heart failure suffer from numerous symptoms that affect their daily lives. The investigators are conducting a randomized clinical trial to evaluate a symptom management and psychosocial care intervention to improve health status (symptom burden, functioning, and quality of life). The results will be directly relevant to patients and families who suffer with this illness, as well as to providers, payers, and other researchers.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or older
* Able to read and understand English
* Consistent access to a telephone
* Patients have a primary care or other provider who is willing to facilitate intervention medical recommendations
* A diagnosis of heart failure with at least one of the following:

\[hospitalization primarily for heart failure in the year prior (including current); taking at least 20 mg oral furosemide (or equivalent) daily in a single or divided dose; Brain natriuretic peptide(BNP) ≥ 100 or N-terminal prohormone of brain natriuretic peptide(NT-proBNP) ≥ 500; EF≤40%\]

* Report a low health status (KCCQ-SF≤70)
* Bothered by at least one target symptom:

\[Pain; Depression; Fatigue; Breathlessness\]

Exclusion Criteria:

* Previous diagnosis of dementia
* Active substance abuse or dependence, defined by either a diagnosis of abuse or dependence or an AUDIT-C ≥ 8, or self-reported substance abuse in the past 3 months
* Comorbid metastatic cancer
* Nursing home resident
* Heart Transplant recipient
* LVAD recipient
Fexofenadine Use in Gastroesophageal Reflux Symptoms

The investigators wish to study the effectiveness of Fexofenadine (an over the counter allergy pill) for the treatment of gastroesophageal reflux symptoms in patients who still have symptoms despite being on a proton pump inhibitor. The investigators will do this by giving participants both Fexofenadine (an H1 blocker) for 2 weeks and placebo (sugar pill) for 2 weeks. The participants will not know which drug they are getting at a particular time. This will help the investigators better assess the true effectiveness of Fexofenadine.

Around 18-28% of North American adults have gastroesophageal reflux symptoms once per week. Of those patients up to 60% may have an inadequate response to proton pump inhibitors and have persistent symptoms. One possible explanation is that this group of patients has nerve related pain. It is thought that H1 receptor activation may sensitize the gastrointestinal tract and esophagus to pain. H1 blockers such as anti-histamines may play a role in treatment of gastroesophageal reflux symptoms that are refractory to proton pump inhibitors by reducing pain perception. The investigators wish to conduct a randomized control trial to test this hypothesis. The investigators will do this by giving participants both Fexofenadine (an H1 blocker) for 2 weeks and placebo (sugar pill) for 2 weeks. The participants will not know which drug they are getting at a particular time. This will help the investigators better assess the true effectiveness of Fexofenadine.

Eligibility Criteria:
Inclusion Criteria:

* A minimum 6-month history of heartburn and regurgitation, as their main symptom
* Experience at least 3-4 days with episodes of heartburn or regurgitation per week
* Female patients who are postmenopausal or using acceptable methods of birth control.

Exclusion Criteria (selected)

* Esophageal stricture
* Primary esophageal motility disorder
* Systemic sclerosis
* Active inflammatory bowel disease
* Zollinger-Ellison syndrome
* Active gastric or duodenal ulcer
* Active infectious or inflammatory conditions of the small or large intestine
* Malabsorption syndromes of the intestine
* History of gastrointestinal cancer
* Current active cancer
* Prior gastric or intestinal surgery
* Pregnant or breast feeding
* Other serious psychiatric or medical disease
Phase 1 Study of Relative Bioavailability of PPI-668 Tablet and Capsule Formulations

This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet.


Eligibility Criteria:
Inclusion Criteria:

1. Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
2. Must be between 18 and 55 years of age, inclusive.
3. Must be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug.
4. Must have a calculated body mass index (BMI) of 18.0 to 29.9 kg/m2.
5. Must be HIV-1 antibody negative.
6. Must be hepatitis B (HBV) surface antigen negative.
7. Must be hepatitis C (HCV) antibody negative.

Exclusion Criteria:

1. Pregnant or lactating subjects.
2. Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematologic, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central or peripheral nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), or immunodeficiency disorders, active infection, or malignancy that is clinically significant or requiring treatment.
3. Have participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing.
4. Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
5. Have poor venous access and unable to donate blood.
6. Have donated blood within 56 days of study dosing.
7. Have donated plasma within 7 days of study dosing.
8. Have taken any prescription medications or over-the-counter medications including herbal products within 28 days of commencing study drug dosing with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or contraceptive medications.
Bispectral Index Guiding Etomidate Used in Children Aged 3 to 10 for Clinical Anesthesia Induction

This research through using bispectral index to guide the induced dose and speed of etomidate lipid emulsion for pediatric total venous anesthesia,and to provide a reference for clinical anesthesia physician.


Eligibility Criteria:
Inclusion Criteria:

1. obtain informed consent;
2. undergoing elective hypospadias repair surgery under general anesthesia;
3. American society of anesthesiologists (ASA) class I-II;
4. aged between 3-10 years old;
5. BMI is 18.5-30 kg/m2;

Exclusion Criteria:

1. systolic blood pressure≥180 mmHg or\<90 mmHg, diastolic blood pressure≥110 mmHg or\<60 mmHg;
2. serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
3. long-term use of hormone or a history of adrenal cortex inhibition;
4. suspected or confirmed difficult airway;
5. suspected or confirmed abuse of narcotic analgesic drugs, psychotropic drugs;
6. neuromuscular disease;
7. mental instability, or have a mental illness;
8. allergic to investigational products or with other contraindication
9. participated in other study within 30 days