cyrilzakka/clinical-trials huggingface dataset:
The Effect of the 3/7 vs 3X9 Method in Resistance Training on Metabolic Stress in Cardiac Rehabilitation

The study proposes to measure the effect of resitance training (RT) (3/7 method) on biological markers of muscle hypertrophy in a cardiac population.

3/7 method consisting of five sets of an increasing number of repetitions (3 to 7) during successive sets and brief inter-set intervals (15 s). This method is compare to 3X9 method, 3 series of 9 repetitions with inter-set (1min).The training exercise consisted of contraction on machine (leg press, triceps press, leg curl, traction, leg extension) with load of \~ 70% of one repetition maximal (1RM).

Before these trainings all subject perform HIIT on bicycles (2 min high intensity (80% Wmax) and 2 min low intensity (50% Wmax) during 30 minutes.

The investigators collect blood sample before exercice, after HIIT and after RT.

It is randomized cross-over study.

The subjects come on two different days minimum 2 days and maximum 10 days between the two tests. They were instructed to avoid exercise the day before they participated in the study.

The investigators collect blood 2 minutes after endurance training (HIIT) and 2 min after RT training.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Coronary artery diseases
* Heart failure with reduced ejection fraction

Exclusion Criteria:

* angina
* acutely decompensated heart failure
* electrocardiographic evidence of ischemia
* significant valvular disease
* orthopedic/neurologic disorders that limited exercise
Effects of a Pulmonary and Cardiovascular Rehabilitation Program

Non-communicable chronic diseases (NCDs) affect approximately 30% of the adult global population, significantly impacting respiratory function and quality of life. Pulmonary and cardiovascular rehabilitation has proven to be an effective therapeutic intervention for managing respiratory symptoms and cardiovascular and improving functional capacity in patients with chronic respiratory conditions. The objective of this study is to evaluate the effects of the pulmonary and cardiovascular rehabilitation program on users of the physical therapy service of CECOM of UNICAMP related to functional capacity, quality of life and respiratory variables after 3 months of the program. Candidates for the pulmonary rehabilitation program are users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease. Candidates for the cardiovascular rehabilitation program are users diagnosed with: infarction (AMI), myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation. They should be referred to physical therapy by the cardiologist with complementary exams and exercise test. The program's assessment will consist of: anamnesis, analysis and recording of complementary exams, physical assessment (weight, height, BMI, cardiac and pulmonary auscultation, blood pressure, heart rate, peripheral oxygen saturation, respiratory muscle strength), functional capacity (six-minute walk test) and quality of life (questionnaire). The program will include aerobic exercises on a treadmill or stationary bike with an intensity between 50-70% of the reserve HR, below the ischemic thresholds. It will also include peripheral muscle strength exercises for the upper and lower limbs, in addition to respiratory muscle training for lung disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Candidates for the pulmonary rehabilitation program: users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease.
* Candidates for the cardiovascular rehabilitation program: users diagnosed with acute myocardial infarction, myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation.
* Referral with medical clearance for rehabilitation

Exclusion Criteria:

* Patients with any contraindication to aerobic or muscle-strengthening physical exercise, such as significant arrhythmias, untreated heart disease, myocarditis, recent or untreated pulmonary embolism, and uncontrolled systemic arterial hypertension, among other conditions.
Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing

10 years of follow-up after surgery for hiatal hernia by tension-free mesh closure or simple suturing.

One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of \> 2 cm axial length, were previously randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia 3 years after the surgery and secondary outcomes were dysphagia score, reflux control and quality of life. The study showed no differences between the groups regarding hiatal hernia recurrence but higher dysphagia scores for solid food at 3 years in mesh group.

This study is a long-term follow-up (\>10 years) after surgery for hiatal hernia by tension-free mesh closure or simple suturing.

Eligibility Criteria:
Inclusion Criteria:

-Patients available at the time of follow-up

Exclusion Criteria:

* Deceased
* Declined participation
Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder

The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury.

The purpose of this study is to see how well TTNS works at preventing incontinence in people with paraplegia from SCI that perform intermittent catheterization to empty their bladder. This study will compare the effectiveness of TTNS at 2 doses, fixed-dose and variable-dose. It will also evaluate the frequency of use, 2 days weekly compared to 5 days weekly.

Based on our pilot trials, tibial nerve stimulation protocols use submotor current intensity with a duration of 200 µs and a frequency of 20Hz. The experimental group will use a submotor "variable dose." The fixed-dose group will use submotor at current intensity at 1mA and designated as "fixed-dose."

TTNS will be used 5 days weekly, per our pilot trial. At 4-months post-SCI, the subject will be instructed to switch to 2x daily if he or she was randomized into the variable dose group of 2 days weekly and thus continue to doing so for the remainder of study participation. Because there is support in the literature for reduced doses of tibial nerve stimulation required for maintenance (1-3x weekly), the RCT includes this frequency comparison arm. All subjects will continue for 1-year post-SCI.

Additionally, we are collecting surveys to help identify characteristics of people (resilience and confidence) and adherence to medication and TTNS use throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* Traumatic or non-traumatic SCI
* Admitted to inpatient rehabilitation within 6 weeks
* T9 level of injury and above who are at greatest risk of morbid NGB
* Regionally located to allow follow-up
* English or Spanish speaking

Exclusion Criteria:

* History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.)
* History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.)
* History of peripheral neuropathy
* pre-SCI symptoms of peripheral neuropathy (numbness and/or tingling in feet, sharp/jabbing/burning pain in feet, sensitivity to touch, lack of coordination, muscle weakness, etc.)
* Pregnancy
* Known injury to the lumbosacral spinal cord or plexus, or pelvis with associated neuropathy
* concern for tibial nerve pathway injury
* absence of toe flexion or autonomic dysreflexia during electric stimulation test
* Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis
Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
* Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.
* FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to \<18 years.
* Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days of the placebo run- in period.
* Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in period.
* Demonstrated reversible airway obstruction.
* Asthma control questionnaire (ACQ) score ≥ 1.5.

Exclusion Criteria:

* Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
* A resting QTcF (Fridericia) ≥450 msec (male) or

  ≥460 msec (female).
* Pregnant or nursing (lactating) women.
* Serious co-morbidities.
* Patients on \>20 mg of simvastatin, \> 40 mg of atorvastatin, \>40 mg of pravastatin, or \>2 mg of pitavastatin.

Other protocol-defined inclusion/exclusion criteria may apply.
Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Operable Breast Cancer

This early phase I trial evaluates the impact of chemotherapy before surgery (neoadjuvant) on the peripheral blood immune phenotype in patients with operable breast cancer. Collecting blood and information from patients with breast cancer may help to understand how the immune system influences response to treatment, and how the immune system reacts to breast cancer treatment.

PRIMARY OBJECTIVES:

I. To evaluate whether pre-neoadjuvant chemotherapy (NAC) peripheral blood immune phenotypes (defined by mass cytometry) are associated with pathologic complete response (pCR) after neoadjuvant chemotherapy in patients with operable breast cancer.

II. To evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls.

SECONDARY OBJECTIVES:

I. To characterize changes in the baseline peripheral blood immune phenotype that arise as a consequence of neoadjuvant chemotherapy.

II. To create a biorepository of peripheral blood samples for future research in breast cancer, including circulating tumor deoxyribonucleic acid (ctDNA), epigenetic and functional studies.

EXPLORATORY OBJECTIVE:

I. To evaluate differences in peripheral blood immune phenotype of patients with oligometastatic breast cancer compared to patients with stage I-III breast cancer.

OUTLINE:

Patients undergo blood sample collection at baseline (prior to first NAC treatment), after taxane and prior to first dose of anthracycline/cyclophosphamide (A/C) (for patients receiving a taxane), end of NAC, 1-4 weeks and 6 months post-surgery. Patients also undergo tissue collection at 1-4 weeks and 6 months post-surgery.

After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Histologically confirmed, operable, invasive breast cancer. Note: Patients with oligometastatic breast cancer (up to 3 isolated distant metastases) will be eligible after review and approval by principal investigator (PI)
* Recommended to receive neoadjuvant systemic treatment by their primary medical oncologist and planning to receive one of the regimens
* Provide written informed consent
* Willing to return to Mayo Clinic for breast cancer surgery
* Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic

Exclusion Criteria:

* Patients who have already initiated neoadjuvant chemotherapy for the current malignancy
* Inability to provide blood samples based on the judgement of the treating physician
* Inability to comply with the protocol
* Patient is pregnant or plans to become pregnant
Meal Timing and Blood Pressure

Brain blood flow, blood pressure, and neurovascular control mechanisms will be measured in middle-aged adults before and after a brief intervention period. The intervention will consist of changing the time in which the participant consumes food each day.

Healthy adults experience a 10-20% decrease in night-time blood pressure, compared with day-time blood pressure. However, 20-40% of middle-aged adults do not demonstrate a decrease in blood pressure. Abnormal blood pressure patterns are linked to sleep disturbances, hypertension, and associated with elevated cardiovascular risk and mortality. Additionally, abnormal diurnal blood pressure patterns are associated with impaired neurovascular control of the circulation, contributing to an increased risk of hypertension, stroke, and cardiovascular disease. Importantly, midlife is the critical period for implementing interventions to prevent or delay future cardiovascular disease. Recent data demonstrates that time-restricted feeding may normalize blood pressure patterns. The overall goal of this study is to determine if time-restricted feeding normalizes blood pressure patterns and improves neurovascular control.

The research aims are:

1. To determine the effect of meal timing on blood pressure patterns in middle-aged adults.
2. To determine the effect of meal timing on neurovascular control in middle-aged adults.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≤ 34 kg/m2
* Non-smoking
* Sedentary or recreationally active
* ≤ 2 Alcoholic drinks per day
* Female subjects: Perimenopausal/Postmenopausal

Exclusion Criteria:

* History or evidence of hepatic, renal, hematological, peripheral vascular disease, or stroke/neurovascular disease, diabetes, uncontrolled hypertension, sleep apnea
* On medications used to treat/manage diseases listed above
* Work overnight shifts
* Clinically diagnosed anxiety or depression
* Pregnant or trying to become pregnant
* Significant surgical history
* Other significant medical conditions at investigator's discretion
Efficacy and Safety of Risperidone and Trazodone Monotherapy and Combination Therapy in Critically Ill Patients With Delirium

The purpose of this randomized clinical trial is to determine whether risperidone alone, trazodone alone, or a combination of risperidone and trazodone is superior for the treatment of ICU acquired delirium. The hypothesis is that combination therapy is superior to either agent alone in treating ICU acquired delirium and sustaining delirium free time.

Delirium is defined as a disturbance of consciousness characterized by an acute onset of impaired cognitive function. Although delirium is thought to be common in the Intensive Care Unit (ICU) there are few studies that have evaluated its incidences, risks and outcomes. It has been associated with increased morbidity, and mortality and increased cost to the healthcare system. In addition to the uncertainty of the incidence of ICU delirium, there is a lack of information about the effects that certain pharmacological treatments have on delirious patients.

The rationale for this study is to evaluate the efficacy and safety of risperidone alone, trazodone alone, and risperidone plus trazodone for the treatment of delirium in critically ill patients when compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years old who are admitted for more than 24 hours in the MICU or SICU
* Patients diagnosed with delirium by primary team (screened positive for delirium using the CAM-ICU or with clinical manifestations of delirium)
* Patients have an order for as-needed haloperidol or have received a one-time dose of haloperidol within 24 hours of randomization
* Patients must be tolerating enteral feeding (greater than 20 mL/hour for more than 12 hours)

Exclusion Criteria:

* Patients who are unlikely to survive 24 hours after admission to the ICU
* Patients who are admitted with a primary neurological condition or injury (i.e. stroke, active seizures, prolonged coma, overdose)
* Patients who can not actively participate in delirium assessment
* Patients actively withdrawing from alcohol or narcotics
* Patients who were treated with any antipsychotic or trazodone within 30 days prior to ICU admission
* Patients with a marked baseline prolongation of the QTc interval (repeated demonstration of QTc interval greater 500 milliseconds (msec))
* Patients with a history of Torsades de Pointes
* Patients with current treatment with an agent having either the potential to affect or increase the risk of QTc prolongation (e.g. erythromycin, any class Ia, Ic, or III antiarrhythmics)
* Patients being treated with a neuromuscular blocker
* Patients in whom haloperidol, risperidone, or trazodone is contraindicated
* Pregnant patients or patients who are breast-feeding
* Patients with a modified Blessed dementia rating scale score ≥4 or an Informant Questionnaire of Cognitive Dysfunction in the Elderly Score ≥4
* Patients in which informed consent can not be obtained from the legally authorized representative
Reducing and Removing Hyaluronic Acid Filler with Hyaluronidase

The purpose of this study is to find how much hyaluronidase should be used when receiving injections of fillers.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* The subjects are in good health
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or Lactation
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness
* Recent Accutane use in the past 6 months
* Subjects prone to hypertrophic and keloidal scarring
* Subjects with tattoos and/or scars on upper medial arms (the treatment area)
* Subjects with known hypersensitivity to hyaluronic acid
Music's Effects on Premature Babies.

This project is being done in order to determine if the music of Mozart will have a soothing effect on premature infants while in the neonatal intensive care unit (NICU). The primary effect to be anticipated will be a reduction in heart rate from baseline, decreased motor activity from baseline, as well as an increase of time in which the babies are in quiet sleep states while the music is being played.

Upon admission, all infants in the NICU are placed on monitors that continuously track their heart rate, respiratory rate, and oxygen saturation. During our study, data will be collected from the monitors already in use. Total time of observation will be approximately 3 hours. In addition, a monitoring device called an Actiwatch will also be used. This device looks similar to a traditional wristwatch and will be loosely strapped to the ankle or wrist of each infant using a foam and velcro strap. This device continuously monitors the baby's movements allowing us to determine if there is a change in the baby's activity level while the music is being played. It will record the baby's activity prior to the start of the music and will continue until 30 minutes after the music has stopped.

The music of Mozart will be played using a small speaker in the baby's isolette. The volume of the music will be set at 10 decibels over background noise, which on previous measurement has been found to be approximately 55 decibels (about the same as a running refrigerator or as the sound of rainfall; 60 decibels is the volume of normal conversation). The volume in the crib will be continuously monitored throughout the hour. As a final recording device, we will also intermittently be using video to capture the reactions of these infants to the music. The study will be done once a week per infant on the same day and at the same time every week


Eligibility Criteria:
Inclusion Criteria:

* All infants born at 28 weeks gestation or who are at least 28 weeks corrected age are eligible to participate. Only those in isolettes (incubators) will be included. Once a baby has been transitioned to a bassinet or crib, the baby will be pulled from the study. In order to be included, these infants must be in stable condition (without serious active medical issues) as decided by their doctor and must be breathing without the use of a ventilator.

Exclusion Criteria:

* Exclusion criteria will include a history of intraventricular hemorrhage involving the white matter (as diagnosed by head ultrasound), as well as those infants born with severe congenital deformities.
Comparison of Outcome Between (ERACS) Versus Traditional Methods in Elective CS

The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient's outcome measures.

The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient outcome measures. The primary outcome is the evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery 11 score (ObsQoR-11) at the time of discharge.

Secondary outcomes are the evaluation of peak numeric postoperative pain rating score within the postoperative hospital stay, total amount of postoperative opioid consumption, postoperative nausea, and vomiting impact score after 6 hours postoperatively and at time of discharge, patient satisfaction using Leiden perioperative care patient satisfaction questionnaire (LPPSq) at time of discharge, presence of post-cesarean ileus and Hospital length to achieve criteria for discharge.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ASA I to ASA II aged from 18 up to 40 years. With non-complicated pregnancy undergoing elective CS.

Exclusion Criteria:

* -Age less than 18 years
* Complications (wound infection, re-exploration, caesarean hysterectomies)
* Recent documented use of opioids Allergy to any drug used during the study.-
* Patients with severe heart diseases, cardiac arrhythmia and myocardial injury.
* uncontrolled diabetic patient
* Severe liver and kidney diseases
* Coagulation defect
Effects of EGCG-Enhanced Extra Virgin Olive Oil on Endothelial Function

This study is being done to determine if the use of EGCG-Enhanced Extra Virgin Olive Oil in a daily diet will improve endothelial function.

Patients will be randomized to receive either placebo ROO (refined olive oil) or study solution EGCG-EVOO (EGCG enhanced extra-virgin olive oil) over the four month study period.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be included in the study if they have an abnormal endothelial function study. This is defined at our institution as an RH-PAT index of less than 2. Patients will undergo two RH-PAT analyses and included abnormal values are obtained on either one or both tests. Only patients who provide written informed consent will be included.

Exclusion Criteria:

* Patients with normal baseline endothelial function studies defined as RH-PAT index \>2 will be excluded. Patients with uncontrolled hypertension \>180/100 while on medication on initial evaluation will also be excluded.