cyrilzakka/clinical-trials huggingface dataset:
Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds

The purpose of the study is to determine the effects of both an anthocyanin-rich polyphenol blend and an anthocyanin-rich polyphenol blend combined with a prebiotic blend on fecal microbiota metabolism (assessed by gas chromatograph - mass spectrometry (GC-MS) headspace analysis) and fecal microbiota composition (assessed by next generation sequencing).


Eligibility Criteria:
Inclusion Criteria:

* Male or female of any race or ethnicity between 18 to 70 years of age, inclusive;
* Body mass index (BMI) between 20 - 32 inclusive;
* Non-smoking status;
* Willing to consume assigned dietary supplements for a total of 6 weeks;
* Have access to email and a digital camera or camera phone.

Exclusion Criteria:

* Age \<18 or \>70 years;
* BMI \<20 or \>32;
* Uncontrolled hypertension defined as diastolic blood pressure ≥95 mm Hg or systolic blood pressure ≥160 mm Hg;
* Self-reported presence of atherosclerotic disease and/or cardiopulmonary disease;
* Renal, hepatic, endocrine, gastrointestinal or other systemic disease;
* For women, pregnancy, breast feeding or postpartum less than 6 months;
* Current participation in another research study;
* Allergy to the components in the dietary supplement (inulin, fructooligosaccharide, blueberries, black currant, rice);
* History of drug or alcohol abuse;
* Use of antibiotics within the last 6 months;
* Use of prebiotics or flavonoid-containing dietary supplements within the last 30 days;
* Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence;
* Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids;
* Participating in or planning to begin a weight loss diet during the study period;
* Lifestyle or schedule incompatible with the study protocol;
* Other medical, psychiatric, or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol;
* Use of tobacco products.
The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures

TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation. Optimizing transcatheter valve performance by intra-procedural hemodynamic evaluation of AR and residual transvalvular gradient remains of high clinical importance.

Continuous technological development and procedural refinements are important to further reduce TAVR peri-procedural complications, facilitate the minimalist strategy and improve clinical outcomes following TAVR. Residual aortic regurgitation (AR) has been one of the main drawbacks of TAVR. TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation.

Various actions could be undertaken to minimize AR and its consequences, either intraprocedural (balloon post-dilation, implantation of a second valve) or during follow-up (diuretic treatment, closest clinical follow-up or percutaneous leakage closure). Thus, an accurate diagnosis of the presence and severity of residual AR post-TAVR is key to implement the proper measures and optimize clinical outcomes.

The use of cardiac imaging remains the gold standard for evaluating AR post-TAVR, limitations of contrast amount along with the subjectivity of AR evaluation by aortic angiography, and the challenges of echocardiography at the time of the TAVR procedure represent a significant drawback. Thus, alternative tools for evaluating the presence and severity of AR would be very helpful in this setting.

Current data supports the implementation of hemodynamic measurements during TAVR procedures in order to improve the clinical decision-making process following valve implantation. However, these actions entail an inherent risk associated with the exchange of catheter-wires. The use of a support guidewire with pressure measurement capabilities would facilitate the hemodynamic evaluation of transcatheter valve performance in a safer and more rapid manner.

The new SAVVY guidewire, with both dedicated pacing properties and allowing a continuous hemodynamic pressure monitoring during the procedure, is a unique system in the field and may represent an important step forward in the process of optimizing the TAVR procedure while facilitating procedural steps.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe symptomatic AS undergoing a TAVR procedure.

Exclusion Criteria:

* Failure to provide signed informed consent.
* Extremely calcified aortic valve (Agatston score \>3000 AU)
* Extremely horizontal aorta.
* Severe septal hypertrophy (interventricular septum \>15 mm as measured by TTE).
* Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta.
* Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life threatening complication.
* Young patients (\<18 Years) and pregnant women
Persistent Pain After Laparoscopic Inguinal Hernia Repair

Describe and characterizes laparoscopic postherniotomy patients with persistent moderate/severe pain affecting every day activities - including detailed quantitative sensory assessment


Eligibility Criteria:
Inclusion Criteria:

* Male patients \> 18 yrs
* No sign of hernia recurrence
* Chronic groin pain lasting more than 3 months
* Moderate/severe pain related impairment of everyday activities

Exclusion Criteria:

* Other causes of persistent pain in groin region (hip, other surgical procedures)
* Drug or alcohol abuse
* Conflicting neurological disorders
Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

A study of the safety and pharmacokinetics of solithromycin capsules in adolescents


Eligibility Criteria:
Inclusion Criteria:

* 12 to 17 yo male or female with suspected or confirmed bacterial infection

Exclusion Criteria:

* Bacterial meningitis
* Clinical significant concomitant medical condition
Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn

Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late preterm and term babies caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid.

The investigators hypothesize that ENAC expression will be up-regulated as a result of administration of corticosteroids. This effect will lead to enhanced absorption of fetal lung fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates presenting with TTN.

The primary outcome measure will be the assessment of respiratory distress reflected by TTN clinical score in neonates presenting with TTN and treated with inhaled corticosteroids compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by cesarean section or vaginal delivery
* Diagnosis of TTN
* Parents signed informed consent

Exclusion Criteria:

* Meconium aspiration syndrome
* Respiratory distress syndrome
* Congenital heart disease
* Non respiratory disorders causing tachypnea
ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

To evaluate the fusion status of the hindfoot bones after receiving the ViviGen graft, an FDA approved cellular bone matrix. This is used in a population indicated for hindfoot arthrodesis as an alternative to an autograft.


Eligibility Criteria:
Inclusion Criteria:

* Patient with prescribed standard of care unilateral hindfoot ankle arthrodesis procedure
* Age 18-80
* Willing to complete all follow up evaluations

Exclusion Criteria:

* Prior infection at site of planned arthrodesis
* Prior arthrodesis procedure
* Inability to maintain non-weight bearing status
* Bone defect requiring more than 10 cc of bone graft material
* Known Vitamin D deficiency with a Vitamin D level of \<30ng/ml 1 week prior to surgery
* Inadequate bone stock to allow for rigid internal fixation
* Hemoglobin A1C greater than 8.0%
* Tobacco or Nicotine use 6 weeks prior to surgery
* BMI greater than 40
Comparison of C-Mac D Blade and Fastrach Laryngeal Mask Airway on Cervical Spine Motion Conditions

In patients with cervical spine disorders or hernia, in-line stabilization and immobilization during tracheal intubation is used to avoid neck injury. With direct laryngoscopy cranio-cervical motion can result injury. The aim of the study is to compare two different device (C-Mac D blade versus fastrach LMA ) regarding cervical motions during intubation.

In simulated or clinical settings of restricted neck mobility, videolaryngoscopes and fastrach LMA have performed well but neck motion can be occured. Endotracheal intubation will be performed under fluoroscopy. In this study the neck motion angles will be investigated during intubation . The angles will be assessed on fluoroscopy images. A Angle: Angle of the line between occipital protuberance and anterior process of the foramen magnum with the line between central point of spinous process C1 vertebrae and the anterior process of foramen magnum. The reference line for the occiput is defined as a line between the base of the sella and the opisthion (lineA), and the C1 reference line as a line between the lower cortical margin of the spinous process (line B). The C2 reference line is defined as a line between the anterior , inferior margin of the C2 body and the lower cortical margin of the C2 spinous process (lineC). The C5 reference line is a tangent along the superior endplate of the C5 vertebral body (line D). The groups will be compared statistically.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of cervical disc herniation ( scheduled cervical discectomy)
2. American Society of Anesthesiology (ASA) physical status I-III patients

Exclusion Criteria:

1. ASA IV patients
2. Age under 18 years, over 70 years
3. Hepatic disease
4. Renal disease
5. Cardiac disease
6. Pregnancy
7. Anticipated difficult airway
RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques

Rationale for conducting the study:

The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events.

Study design:

Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques.

Study population:

Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study.

Number of patients:

400

Inclusion criteria:

Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study.

Exclusion criteria:

Patients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons.

Primary outcome variables:

The Forgotten Joint Score (FJS) at 2 years after surgery


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older.
* Eligible for TKR according to local guidelines and routines.
* Willingness to participate in the study.

Exclusion Criteria:

* Patients with extreme malalignment necessitating special implants or techniques.
* Patients unfit for surgery due to other medical reasons.
* Patients who, for other reason such as alcohol or substance abuse, is deemed unsuitable to participate in the study.
* Patients who, for other reasons can't fulfill the required patient recorded outcome measures
Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)

The study will be conducted in crossover trial, with two 12-weeks periods separated by a Wash-out period of at least one month. According to randomization ,patients will be provided with either Diabeloop system or the usual system.

Patients will be trained for the use of blood glucose meter, of external Insulin Pump and Diabeloop system.

In both treatment periods, the same blood glucose meter will be used throughout the duration of the study.

In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be performed during four weeks to improve the efficacy of Diabeloop system with data collection, to test the manual settings by health care providers and patients and to check the good-working of the follow-up platform.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetic patient for at least two years
* Patient treated by external insulin pump for at least 6 months
* Patient with HbA1c ≤ 10%; dosage of less than 4 months done in analysis laboratory medical or equivalent.
* Patient requiring a daily dose of insulin ≤ 50 units
* Patient domiciled in an area with Global System for Mobile Communication (GSM)
* Not isolated patient, not living alone, or having a person "resource" living nearby and having a phone and the key of its place of residence
* Patient not envisaging a journey outside France during the "closed-loop" period
* Patient aged over 18 years
* Patient affiliated to Social Security
* Patient who agreed to participate in the study and who signed an informed consent

Exclusion Criteria:

* Patient with any serious illness that may impair study participation
* Patient having a treatment known to have a significant interference on the glycemia.
* Patient enjoying a measure of legal protection
* Pregnant woman or likely to be
Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation

This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.

This study seeks to address the disparities in the maternal smoking cessation outcomes of previous research by developing an innovative maternal tobacco cessation program that expands the outreach by integrating home visits by community health workers (CHW) into the prenatal healthcare model. The overall aim is to conduct a pilot randomized control trial to test the feasibility, acceptability, and efficacy of a Healthcare Provider-Community Health Worker (HCP-CHW) intervention model that expands outreach by adding eight home visits by CHWs to provide tobacco cessation support services before and after the quit date.

Eligibility Criteria:
Inclusion Criteria:

* \< 24 weeks pregnant
* age \> 18 years,
* current smokers (100 cigarettes in their lifetime and \>3 cigarettes per day in the last 7 days; including poly-tobacco use, combining cigarettes with non-combustible products) confirmed by expired carbon monoxide (CO)
* willing to quit smoking and set a quit date in the next 2 weeks upon enrolling
* enrolled in prenatal care at Loma Linda University Health (LLUH) or Riverside University Health System (RUHS)

Exclusion Criteria:

* severe mental health problems that prevent informed consent and/or CHW intervention
* women who were on Nicotine Replacement Therapy (NRT) or enrolled in a cessation program within 30 days
* unwillingness to participate in audio-recorded key informant interviews or focus groups
Neuromuscular and Cognitive Fatigue During a 24 Hour Treadmill Running Exercise

The main purpose of the present study is to determine the relative contributions of central and peripheral fatigue during an ultra-endurance exercise.

For that purpose, 14 subjects running 24 hours on a treadmill will be compared with a control group being awake during the same period. Subjects who running will have electrically evoked forces on the muscles associated EMG activity, blood samples and muscle biopsy.

Eligibility Criteria:
Inclusion Criteria:

* The subjects of the experimental group will be recruited among experienced ultra-runners . They all have run at least a 12 hour race or longer.
* The control group will be recruited among experienced ultra-runners . Age of control group will be age experimental group more or less 2 years.

Exclusion Criteria:

* The subjects will not be selected if:

  * they were injured in the 3 months before the experiment
  * they had a tendon or joint pathology that could impair strength measurements.
  * they participate to an other experiment at the same time
A Pilot Study of PET-CT in the Assessment of Pulmonary Nodules in Children With Malignant Solid Tumors

Because the management of children with solid tumors hinges on the extent of disease, it is crucial to identify metastatic sites. Helical chest computed tomography (CT) is the standard method of excluding pulmonary metastases. However, CT lacks molecular information regarding nodule histology and often biopsy is required to exclude malignancy. Biopsy procedures carry known risks including those associated with anesthesia and sedation, infection, pneumothorax, hemorrhage, pain and other post-procedure and post-operative complications and may also add unnecessary cost to the management of the patient. We found that the ability of three experienced pediatric radiologists to correctly predict nodule histology based on CT imaging features was limited (57% to 67% rate of correct classification). Also, there was only slight to moderate agreement in nodule classification between these reviewers.

Furthermore, of 50 children who have undergone pulmonary nodule biopsy at St. Jude in the last five years, 44% (22/50) had only benign nodules.

Adult studies have shown that a nuclear medicine scan called fluoro-deoxyglucose (FDG) positron emission tomography (PET) and the fusion modality PET-CT are superior to diagnostic CT in distinguishing benign from malignant pulmonary nodules because FDG PET gives information about the metabolic activity of the nodule. Nodules that are malignant have more metabolic activity, hence more FDG uptake/intensity, than those that are benign. There has been little work done in children to determine the value of PET or PET-CT in the evaluation of pulmonary nodules.

In this study, we seek to assess the feasibility of performing PET-CT for the evaluation of pulmonary nodules in children to obtain preliminary data for sample size determination for a larger multi-institutional trial. The primary objective of the multi-institutional trial will be to compare the accuracy of diagnostic CT alone to PET-CT in distinguishing benign from malignant nodules in children with solid malignancies. We are hopeful that PET-CT will allow us to better direct the clinical management of these patients and to reduce the number of invasive procedures performed to confirm the presence of benign disease.

Eligibility Criteria:
Inclusion Criteria:

* Participant has a known or clinically suspected solid malignancy (excluding brain tumor)
* Nodule must be discovered at the time of diagnosis of the primary malignancy or after the completion of therapy

Exclusion Criteria:

* Participant has not been off therapy for at least 3 weeks before undergoing PET-CT
Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease

Obstructive sleep apnea (OSA) and nonalcoholic fatty liver disease (NAFLD) are frequently encountered in patients with metabolic syndrome (MS). Several data suggest that OSA per se could be a risk factor of liver injury. Most previous studies evaluating the association between OSA severity and the severity of NAFLD used indirect markers of NAFLD including liver imaging or liver injury blood markers or have been performed in morbidly obese patients undergoing intraoperative needle liver biopsy during bariatric surgery.

The current study propose to investigate with a full night polysomnography consecutive patients undergoing percutaneous liver biopsy for suspected NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* Suspected NAFLD requiring per-cutaneous liver biopsy

Exclusion Criteria:

* Other than NAFLD liver disease
* Previously diagnosed or treated OSA
* Excessive alcohol consumption (\>220 gr/week for men, \>140 gr/week for women)
* Pregnancy
* Surgical treatment for obesity past history
Hop Botanical Dietary Supplements - Metabolism and Safety in Women

Human safety studies were carried out to test whether hop botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs. To test this, a hop dietary supplement (previously tested in women at the University of Illinois at Chicago without any harmful effects) was given with four selected FDA-approved drugs to determine if the hop supplement can increase or decrease how these medications are absorbed, metabolized and excreted by the human body. Preclinical studies had predicted that the hop supplement might affect the metabolism or break down of these probe drugs.

At the start of a study, subjects were administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples were drawn and analyzed for the concentration of each drug over time. Afterwards, participants consumed the hop dietary supplement twice daily for 14 days to allow for potential inhibition or induction of drug metabolizing enzymes and transporters. Thereafter, the same drugs were taken again to obtain a second measure of drug concentrations in blood over time. Changes in the concentration-time curve values for each probe drug obtained before and after ingestion of the supplement would indicate that metabolism of the probe drugs is impacted by the hop dietary supplement.

Eligibility Criteria:
Inclusion Criteria:

* healthy peri- and post-menopausal women ages 40 - 79
* non-smokers
* no-significant medical conditions as assessed by subject-reported medical history, physical examination and blood and urine chemistry screens
* no medical condition that requires chronic use of medication

Exclusion Criteria:

* known allergies or hypersensitivity to caffeine, dextromethorphan, sulfonylureas (tolbutamide), benzodiazepines, red clover, licorice, or hops
* positive pregnancy test
* use of hormone therapy within 8 weeks of study initiation for oral agents, 4 weeks for transdermal or other topical agents
* use of caffeine products 7 days before study participation or during the study
* use of citrus products 7 days before study participation or during the study
* use of other prescription (with the exception of the Mirena® IUD) or non-prescription medicines within the 2 weeks prior to study initiation or during the study
* chronic diseases, such as inflammatory bowel disease, that could alter the absorption or metabolism of the probe substrates
* unwillingness to comply with study requirements
* current participation in another clinical trial
* CYP2D6 deficiency based on phenotyping at screening
* smoker
* hops intake (whether as a botanical dietary supplement or beer) within the previous two weeks and during the study
* use of any dietary supplements within the last 2 weeks prior to study initiation and during the study
* obesity (defined as \>33 BMI)
* alcohol or drug abuse
* chronic diseases such as inflammatory bowel disease or diabetes