cyrilzakka/clinical-trials huggingface dataset:
What is the Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity?

Weight loss maintenance is the biggest challenge in obesity management, with the majority of weight-reduced individuals experiencing weight regain. The intake of probiotics has been shown to help in weight loss, but its potential in maximizing weight loss maintenance remains unknown. Therefore, the main aim of this study is to investigate the impact of probiotic consumption on weight loss maintenance. Secondary aims are to investigate if the intake of probiotics influences gut microbiota, cardio-metabolic profile, appetite and inflammatory markers.


Eligibility Criteria:
Inclusion Criteria:

* class I or II obesity (30 kg/m2 \< BMI \> 40 kg/m2)
* weight stable (\<2 kg variation in weight within the last 3 months)
* not currently dieting to lose weight
* dietary intervention of 1000 kcal energy restriction for 8 weeks using a powder based low energy diet product, followed by 4 week weight stabilization phase (re-introduction of food)
* women who are either post-menopausal, taking oral contraceptives or with a normal cycle (28 ± 2 days)

Exclusion Criteria:

* consumption of probiotics 6 months before taking part in the study
* pregnant
* breast-feeding
* drug or alcohol abuse within the last two years
* currently taking medication known to affect appetite or induce weight loss
* enrolled in another obesity treatment program
* history of psychological disorders
* having had bariatric surgery
* metabolic diseases (such as hypo/hyperthyroidism and diabetes type 1 or 2)
* eating disorders
* lactose intolerance
* gastrointestinal (particularly cholelithiasis), kidney, liver, lung, cardiovascular disease
* malignancies
Enriched QUARTET® Hen Eggs and Cardiovascular Function

Role of oxidative stress in the development of cardiovascular diseases is well known and extensively investigated, because of its direct effects on vascular function, but also on the activation of the immune response. Thus, food products that could increase the antioxidant capacity of the vascular system would also act protective against cardiovascular diseases. However, we lack systematic clinical and pre-clinical research with food products instead of food supplements, which would result in consistent and repeatable results. Many studies have proven the effectiveness of n-3 polyunsaturated fatty acids (n-3 PUFA) in improvement of endothelial function, improvement of elasticity of the vascular wall and the anti-inflammatory effects in patients with chronic diseases, such as metabolic syndrome, if they are taken as an pharmacological preparation. Our research group recently reported that favorable anti-inflammatory properties of n-3 PUFA enriched hen eggs potentially contribute to the improvement of microvascular endothelium-dependent vasodilation in healthy individuals. In addition, this study aimed to determine the effect of QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein; QUARTET No. 012743696, 2014.) consumption on cardiovascular function in both healthy individuals and cardiovascular patients.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers (sedentary)
* healthy volunteers (athletes)
* cardiac patients (patients with acute myocardial infarction, hypertensive patients with/without hypertensive heart disease, heart failure patients)

Exclusion Criteria for Healthy Volunteers:

* oral contraceptives
* drugs that could affect endothelium
* hypertension
* coronary artery disease
* diabetes
* hyperlipidaemia
* renal impairment
* cerebrovascular and peripheral artery disease

Exclusion Criteria for Cardiac Patients:

* known malignant disease
* hereditary metabolic diseases and other hereditary systemic diseases
* autoimmune diseases or systemic diseases with immunopathology
* unregulated hypertension
* recent surgery (3 months)
* recent significant trauma (6 months)
* renal insufficiency (except in diabetic patients unless Endogenous Creatinine Clearance \> 60ml / min)
* active bleeding (hematuria, GI tract, menorrhagia)
* fresh ICV (6 weeks)
* neurodegenerative diseases and epilepsy
* significant anemia (Hg \<110 (men), \<100 (women))
* condition after resuscitation (3 months)
* therapy that significantly affects vascular or immune function (monoclonal antibodies, immunosuppressants, systemic corticosteroids ...)
* chronic respiratory failure and conditions of chronic hypoxemia
* sepsis and chronic active infections with systemic inflammatory response (active tuberculosis, etc.)
* untreated thyroid disease
* active abuse of alcohol and drugs
* liver failure (advanced liver disease with impaired synthetic and metabolic function)
Sex-related Differences in the Response to the Muscle Relaxant Drug Mivacurium

Muscle relaxants are drugs providing muscle relaxation during surgical treatment. Previous studies have shown that males and females respond differently to this kind of drug. Our hypothesis is that males are more sensitive to the effect of Mivacurium (a muscle relaxant) than females, meaning that males need a lower blood concentration of the drug than females in order to obtain a given effect.

Muscle relaxants are a type of drug used to provide muscle relaxation during induction of anesthesia and surgical treatment. Residual drug effect postoperatively (i.e. residual muscle relaxation) occurs frequently and studies have shown that this may be harmful in certain groups of patients. Of special concern is residual effect on upper airway and breathing muscles. A previous study has shown that males and females respond differently to the effect of this kind of drug. It appears that some muscle groups which are important for airway protection and breathing are more sensitive to the effect of muscle relaxants in males than females. Males may therefore be more susceptible to postoperative lung complications than females. In this study we try to determine what causes the observed sex-related difference in response to the muscle relaxant Mivacurium. We have previously shown that this sex-related difference cannot be explained by different pharmacokinetics (what the body does to the drug) in males and females. Our hypothesis is that a pharmacodynamic (what the drug does to the body) difference between sexes exists, i.e. that a lower blood concentration of Mivacurium is needed in males than females in order to obtain a predefined degree of muscle relaxation in certain muscle groups.

Eligibility Criteria:
Inclusion Criteria: Healthy individuals with no current medication -

Exclusion Criteria: Previous complications during anesthesia, pregnancy, allergy to muscle relaxants, smoking, gastrointestinal reflux.

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Beta-Blocker Evaluation in Survival Trial (BEST)

To determine if addition of a beta-blocker to standard therapy in Class III and Class IV heart failure patients reduced total mortality.

BACKGROUND:

Controlled and uncontrolled studies suggested that beta-blockade improves ventricular function in congestive heart failure. Several trials suggested that beta-blockers may also reduce mortality. In the Beta-Blocker Heart Attack Trial, patients with a history of heart failure had less cardiac and sudden-death mortality than those who did not. Patients with a low ejection fraction in the Cardiac Arrhythmia Suppression Trial who were treated with beta-blockade also had a reduction in mortality. The Metoprolol in Dilated Cardiomyopathy trial randomized patients with dilated cardiomyopathies to treatment with metoprolol or placebo. There was a trend toward reduction in a morbidity and mortality endpoint in patients treated with metoprolol, but this was due entirely to a reduction in the need for cardiac transplantation. Thus, despite a reasonable theoretical basis and suggestive clinical studies, the concept that beta-blockers reduced mortality in congestive heart failure patients was unproved.

DESIGN NARRATIVE:

Randomized, double-blind, multicenter. Patients were assigned to standard therapy plus the addition of a beta-blocker (bucindolol) versus a placebo. The primary endpoint was total mortality. A radionuclide ventriculogram was performed within 60 days of randomization. History, physical examination, clinical laboratory studies, chest x-ray, electrocardiogram, and plasma norepinephrine levels were obtained within 14 days of randomization. Patients were stratified by hospital, congestive heart failure etiology, ejection fraction, and gender, and were assigned to a treatment group by an adaptive balancing scheme ("biased coin" randomization). Patients were randomized to either placebo plus standard congestive heart failure treatment or to the beta-blocker plus standard congestive heart failure treatment and followed for a minimum of 18 months. The over three year recruitment period began in May 1995 at the first 35 sites. An additional 55 sites began recruitment on August 14, 1995. Recruitment ended in December, 1998 with the enrollment of 2,708 patients.

Eligibility Criteria:
Men and women, ages 18 and over. Patients had compensated congestive heart failure due to idiopathic dilated cardiomyopathy or coronary disease with ejection fraction less than or equal to 0.35, were in the New York Heart Association functional class III or IV, and were taking an angiotensin-converting enzyme inhibitor, digitalis, and if needed, a diuretic. Patients with a specific indication for, or contraindication to, beta-blockade were excluded.
Effects and Mechanisms of Melatonin on Blood Pressure, Insulin Resistance, and Platelets

The investigators will be studying the effect of melatonin on blood pressure, insulin resistance, and platelets, along with possible reasons for how melatonin cases these effects.

The investigators will be studying the effect of melatonin on blood pressure and insulin resistance, and possible reasons for how melatonin works on blood pressure and IR. Along with blood testing to measure adipokines, insulin resistance (IR), and platelet function (how well your blood clots), 24-hour ambulatory blood pressure monitoring (ABPM) will be used to measure blood pressure, since ABPM is the gold standard (best method) for accurate assessment of blood pressure status and associated cardiovascular risk. Vascular (blood vessel) function, IR, adipokine levels and sleep quality will also be measured. All study endpoints will be measured at baseline and following 6 weeks of daily melatonin 9 mg dosing.

Eligibility Criteria:
Inclusion Criteria:

* Normotensive (SBP \<120) or prehypertensive (SBP = 120-139 mm Hg)
* Age: Young/middle-aged (ages 18-45) and (2) 10 elderly subjects ages 65 and older

Exclusion Criteria:

* Patients with a diagnosis of

  * clinical hypertension and/or diabetes mellitus
  * pregnancy
  * coronary or cerebrovascular disease
  * collagen vascular disease,
  * organ failure (heart, kidney, liver).
* Patients taking anti-inflammatory medications: NSAIDs, corticosteroids, thiazolidinediones, and statins,
* Patients who have taken melatonin previously in the past year.
Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients by Trainees

The primary objective of the study is to evaluate the effect of smart glasses (Head-mounted display Moverio BT-300 (Epson Inc., USA)) on the first-attempt success rate of radial artery cannulation in pediatric patients by less experienced trainees. This study hypothesizes that the use of smart glasses improves the hand-eye coordination and the first-attempt success rate of radial artery cannulation. This is a single-center, randomized, placebo-controlled study comparing the real-time ultrasound image through smart glasses (intervention group) or the ultrasound machine's monitor (control group) during the radial arterial cannulation in pediatric patients undergoing general anesthesia by less experienced trainees.


Eligibility Criteria:
Inclusion Criteria:

* General anesthesia
* Arterial cannulation for hemodynamic monitoring, multiple blood sample

Exclusion Criteria:

* Unstable vital signs, significant arrhythmia or hypotension, Shock
* High risk of peripheral ischemia
* Skin disease, infection, hematoma, recent cannulation at theradial artery
Prospective Surveillance For Respiratory Virus Infections In Children Undergoing Hematopoietic Stem Cell Transplantation

The Study aims to prospectively survey the incidence of respiratory virus infections using molecular methodologies, in children undergoing hematopoietic stem cell transplantation

Samples will be collected with a nasopharyngeal wash and processed for direct fluorescent antibody, culture and Polymerase chain reaction (PCR)

Eligibility Criteria:
Inclusion Criteria:

* Age: Birth to 18 years.
* Patients undergoing an allogeneic HSCT for any disease.
* Parent or guardian willing to sign informed consent.

Exclusion Criteria:

* Intra nasal lesion which precludes the performance of the nasopharyngeal wash.
* Patients on Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP).
Telehealth for Discharge Outcomes in Children

This study will test the feasibility of a telehealth follow-up visit for patients and their caregivers who were recently discharged from a general pediatric inpatient unit.

Patient transitions from hospital to home have increasingly become recognized as a critical opportunity to promote patient safety and high quality care, both at University of California Davis Medical Center and nationwide. With over 16,000 children discharged from U.S. hospitals each day and a rate of 1 in 5 experiencing adverse events related to this process, it is estimated that hospital-to-home transition-related adverse events affect over 1.1 million children annually. The quality of hospital discharge also affects hospital readmission rates, length of hospital stay, and parental satisfaction.

Discharge transition difficulties stem largely from care coordination failures throughout the hospital-to-home transition. The investigators recently conducted a qualitative study analyzing perspectives from parents and physicians of 20 children readmitted within 30 days of hospital discharge. The study identified a theme of caregivers having difficulty re-connecting to the child's medical team for ongoing care after discharge. When problems arose, caregivers reported challenges in knowing who to contact, when to reach out for help, and how to navigate the health system to prevent readmission.

The advent of telehealth presents a unique opportunity to provide seamless follow-up for families following hospital discharge. Although telehealth has not previously been studied as a means of providing pediatric follow-up care after hospital discharge, similar methods of providing post-discharge hospital follow-up, including nurse- or physician-led phone calls and nurse home visits, were highly regarded by families, but failed to impact readmission rates. Telehealth provides a unique advantage over these alternate interventions by allowing face-to-face interaction via videoconference between the patient, caregiver, and hospital physician, who is already familiar with the patient's disease course and overall trajectory. At the investigators' site, although telehealth is readily available for use in most any clinical setting, it is not commonly used for hospital discharge follow-up. Therefore, this study proposes to test the feasibility of a telehealth follow-up visit for patients and their caregivers who were recently discharged from a general pediatric inpatient unit.

Eligibility Criteria:
Inclusion Criteria:

* Parents/legal guardians of patients recently discharged from the University of California Davis Children's Hospital pediatric hospitalist service, who were offered a telehealth follow-up visit following their child's discharge
* Pediatric hospitalists who discharged the above patients and offered a telehealth follow-up visit following discharge

Exclusion Criteria:

• Parents/legal guardians of children discharged from an intensive care or subspecialty service
Monitoring and Mapping of Erectile Nerve During RALP (MMEN Study)

To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during robot assisted laparoscopic radical prostatectomy for preservation of erectile function.

Using NIM-Eclipse monitoring instrument (Medtronic), we will check action potential of cavernous nerve, bulbocavernosus reflex and pudendal nerve somatosensory evoked potential in real time during robot assisted laparoscopic radical prostatectomy for preservation of erectile function. In this feasibility and protocol setting phase I/II study, we will evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping using NIM-Eclipse monitoring instrument.

Eligibility Criteria:
Inclusion Criteria:

* pathologically proven localized prostate cancer (≤cT3a)
* patients to undergo robot-assisted laparoscopic prostatectomy at our center

Exclusion Criteria:

* prior hormone therapy
* prior radiation treatment on prostate or pelvis
* refused to participate
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients

Glaucoma represents a group of conditions that cause damage to the optic nerve and can lead to irreversible vision loss. Current treatments are aimed at lowering intraocular pressure while minimizing medication side effects. Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) is an FDA-approved medication for alleviating eye redness, a common side effect of glaucoma medications. The purpose of this study is to evaluate the effect of Lumify™ on eye redness, intraocular pressure, and eyelid position in patients with glaucoma who are already using the Brimonidine 0.1%, 0.15% or 0.2% eye drops.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Diagnosis of primary open angle glaucoma
* Willing and able to give informed consent
* Current and greater than 6 weeks of brimonidine 0.2%, 0.15% or 0.1% use

Exclusion Criteria:

* Pregnancy
* Prisoners
* Known allergy or sensitivities to brimonidine
* No surgery within the past 6 months
* No history of lid surgery or botox
* Any other significant ophthalmologic disorder or condition with relevant effect on ocular redness, IOP, or eyelid position as evaluated by principal investigator
* Inability to sit comfortably for 30 minutes
* Prior use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines, or phenylephrine dilating drops within 1 week of study
Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants

RATIONALE: Telephone-based cancer education and counseling may help participants learn about ways of preventing cancer and choose a lifestyle that will help them stay healthy as they grow older.

PURPOSE: This randomized clinical trial is studying telephone-based cancer education and telephone-based counseling to see how well they work compared with telephone-based cancer education alone in young participants.

OBJECTIVES:

Primary

* Compare the efficacy of telephone-based cancer education with vs without counseling in younger participants.

Secondary

* Determine the mechanisms by which education with counseling may impact cancer-relevant cognitive and behavioral outcomes.
* Identify teens who may be most and least likely to benefit from education with counseling.

OUTLINE: This is a pilot, controlled, randomized study. Participants are stratified according to age (13-14 years vs 15 years vs 16 years vs 17 years vs 18-21 years), gender, race (white vs black vs other), and health status (chronic disease vs no chronic disease). Participants are randomized to 1 of 2 education arms.

* Arm I: Participants undergo cancer education sessions via telephone over 45 minutes once a week for 8 weeks.
* Arm II: Participants under cancer education sessions as in arm I and counseling techniques during the same telephone sessions.

In both arms, participants receive an intervention kit by mail before the first telephone call. The intervention kit includes age-appropriate self-help materials.

PROJECTED ACCRUAL: A total of 300 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* No life-threatening illness (e.g., cancer)

  * Chronic illnesses (e.g., asthma, diabetes) allowed with permission by physician

PATIENT CHARACTERISTICS:

* No serious restrictions on physical activity, diet, or nutrition, including any of the following:

  * Untreated exercise-induced asthma
  * Orthopedic or neurological problems
  * Medical conditions affecting nutritional status, intestinal absorption, or response to nutritional intervention (e.g., inflammatory bowel disease)
* No serious mental illness or developmental disability that would preclude study compliance, including eating disorders
* Must adequately understand, speak, and read English

PRIOR CONCURRENT THERAPY:

* Not specified
Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes

Our project aims to assess and validate an innovative prognostic and diagnostic test in order to i) define a severity index of the β-thalassemia according to the free α-Hb pool for a better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and iii) follow the evolution of this pool in response to treatment of patients. In the future, this prognostic test based on the measurement of free α-Hb pool may be suitable for routine laboratory practice. To carry out this project, cohort of 85 thalassemic patients and a group of 50 healthy volunteers have been recruited.


Eligibility Criteria:
Inclusion Criteria Patient

* Age ≥ 18 years
* Written informed consent
* Affiliation to social security
* Known Hb Phenotypes
* Biological phenotype corresponding to a classical picture of thalassemia

Healthy volunteers

* Age ≥ 18 years
* Written informed consent
* Affiliation to social security

Exclusion Criteria Patient

* Transfusion for less than 3 months
* Chronic active viral disease: hepatitis B, C, HIV
* Ongoing infections or known inflammatory diseases
* Hyper or Hypothyroidism known or subject treated by Levothyrox
* Active pathology or tumor remission for less than 5 years
* Oral corticosteroid
* Hemoglobinopathy other than thalassemia for patients
* Treatment by Hydroxyurea for more than 3 months
* Treatment by stimulating agent erythropoiesis for longer than 3 months

Healthy volunteers

* Transfusion for less than 3 months
* Chronic active viral disease: hepatitis B, C, HIV
* Ongoing infections or known inflammatory diseases
* Hyper or Hypothyroidism known or subject treated by Levothyrox
* Active pathology or tumor remission for less than 5 years
* Oral corticosteroid
* Genetically related to person with hemoglobinopathy