cyrilzakka/clinical-trials huggingface dataset:
Effects of Seaweed Extract on Blood Glucose Response to Sucrose

This study will examine the impact of the seaweed (Ascophyllum nodosum) extract on blood glucose levels after a sugary drink in healthy subjects.

The aim of this study is to investigate if the seaweed extract, when consumed with the sucrose, can lower blood glucose levels, compared to the raise after sucrose only, in healthy volunteers.

The study is designed as an acute, double-blind, randomised, controlled crossover trial in 16 healthy subjects. Participants will be asked to consume sucrose solution or sucrose solution with added seaweed extract.The effects on blood glucose levels will be determined over 2 hours after the consumption.

Blood glucose levels after a meal rich in sugars depend, among other factors, on the activity of enzymes that digest sugar molecules to glucose. Epidemiological studies suggest that glucose levels after a meal higher than normal, present a great risk for the onset of cardiovascular diseases. Slowing the digestion of sugar through the inhibition of digestion enzymes have been demonstrated as a successful approach in preventing postprandial hyperglycaemia either with pharmacological agents (acarbose, miglitol) or natural dietary compounds.

We demonstrated, in preclinical in vitro experiments, the unique potential of tested seaweed extract to inhibit rat sucrase.

This study will examine the potential of the seaweed extract to modulate blood glucose levels after a sucrose drink in healthy subjects .

The aim of this study is to investigate if the seaweed extract, when consumed with sucrose, can lower blood glucose levels, compared to the raise after sucrose only.

The study is designed as an acute, double-blind, randomised, controlled crossover trial in 16 healthy subjects. Participants will be asked to consume sucrose solution or sucrose solution with added seaweed extract.The effects on blood glucose levels (in capillary blood) will be determined over 2 hours after the consumption. All participants will be characterized for the activity of salivary a-amylase

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years
* Healthy

Exclusion Criteria:

* Smoking
* Diagnosis of any chronic illness (including diabetes, hypertension, gastrointestinal diseases etc.)
* On long term prescribed medication (except contraceptives)
* Pregnant or lactating
* On a special diet or dietary regimen (for weight management or if regularly consuming fruit extract supplements)
* Allergy to fruits vegetables, pollen or seaweed.
* Unwillingness to follow dietary recommendations or record the diet during recommended period
* Donated blood 4 weeks before or intend to donate blood during the study or 4 weeks after the last study samples
* Participation in another research project in parallel which also involves dietary intervention (e.g. taking vitamin supplements) or requires sampling of blood
Low Energy Availability and Pituitary Function (LEAP Study)

The purpose of this study is to learn more about reproductive hormones and if they change in response to 5-days eating an individualized, standardized diet at two levels: energy balance and low energy intake.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-30
* Body mass index between 18.5-24.9 OR 30-45
* Have regular menstrual cycles between 18-40 days over the past 6 months
* Weight stable (not gained or lost 5kg) in the past 3 months

Exclusion Criteria:

* Using hormonal birth control currently or within the past three months
* Polycystic ovary syndrome (current or past diagnosis)
* Pregnant, lactating, planning to become pregnant in next 6 months
* Engaging in regular intentional aerobic exercise
* Significant medical issues (e.g.,cardiovascular disease or diabetes)
Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects

A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of \[14C\]EDP-938 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Males of any ethnic origin, between 18 and 55 years of age, inclusive.
* Able to comprehend and willing to sign an Informed Consent Form
* In good health, determined by no clinically significant findings from medical history, physical examination (check-in only), 12-lead ECG, vital signs measurements, and clinical laboratory evaluations

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
* History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).

  a. Subjects with a history of cholecystitis, cholelithiasis, and/or choledocholithiasis will also be excluded.
* Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
* A body surface area-adjusted estimated glomerular filtration rate (eGFR) ≤ 90 mL/min per 1.73 m2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, at screening
Long-term Efficacy and Safety Evaluation of Growth Hormone in Children in China(CGLS)

Short stature is a relatively common pediatric condition, referring to individuals whose height is more than 2 (-2 SD) standard deviations below the average height of a similar age, gender, and ethnicity population in similar living conditions, or those below the third percentile (-1.88 SD). This study is an open-label, multicenter, prospective and retrospective, observational, cohort study aimed at assessing the long-term safety and efficacy of PEG-rhGH or rhGH treatment for Chinese children with short stature. The study is divided into retrospective cohorts, retrospective prospective cohorts, and prospective cohorts. It is expected to include approximately 10000 patients (including around 3000 in the retrospective cohorts and around 7000 in the retrospective prospective and prospective cohorts). The total duration is expected to be 16 years, including 2 years for study center initiation and patient recruitment and follow-up of patients in the retrospective prospective and prospective cohorts until near-adult height (NAH). The primary objective is to evaluate the long-term safety of PEG-rhGH or rhGH for the treatment of children with short stature (including GHD, ISS, SGA, TS, PWS, NS, SHOX gene deletion, and other etiologies); the secondary objective is to assess the effectiveness of PEG-rhGH or rhGH treatment for children with short stature (including GHD, ISS, SGA, TS, PWS, NS, SHOX gene deletion, and other etiologies).


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 2 years and older with various causes of short stature.
2. Height below the 3rd percentile (-1.88 SD) compared to the height of normal, healthy children of the same age and gender.
3. Belonging to one of the following indications: GHD, ISS, SGA, TS, PWS, NS, SHOX gene deletion, or other causes of short stature.

Note: In this study, the inclusion criteria for the PWS cohort do not impose restrictions on height and age at the start of treatment.

Exclusion Criteria:

1. Patients with fully closed growth plates.
2. Patients with signs of potential tumor progression or those already diagnosed with tumors.
3. Allergic reactions to growth hormone or its adjuvants.
4. Patients who have received any growth hormone treatment other than the investigational drug in the six months prior to screening.
5. Any other circumstances deemed unsuitable for study inclusion by the investigator.
Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation

The purpose of this study is to determine if there is equivalence between two different methods of treating patients with severe bloodstream infection called sepsis. We will randomly assign patients to one of two treatment methods. One of the treatment methods is the current standard of care and uses an infrared sensor on the end of a catheter to determine the adequacy of treatment. The second treatment method is identical to the first but instead of the infrared sensor a blood test that is performed as a part of standard care (with blood drawn from the catheter) will be used to determine the adequacy of treatment. This study will attempt to determine an easier method of guiding treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Suspected infection
2. Any two of four criteria of systemic inflammatory response
3. SBP \< 90 mm Hg after 20cc/kg crystalloid (septic shock) or either a whole blood lactate \> 4 mmol/L (severe sepsis).

Exclusion Criteria:

1. Age \< 18 years
2. Pregnancy
3. Established "Do Not Resuscitate" orders prior to enrollment
4. Primary diagnosis other than sepsis
5. Requirement for immediate surgery in \< 6 hours from admission
6. Any absolute contraindication to central venous catheterization
Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules - 1

The purpose of this protocol is to to compare the clinical utility of two dosage tapering regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification.


Eligibility Criteria:
Inclusion Criteria:

* Females are not pregnant or lactating
* Subjects meet DSM-IV criteria for opiate dependence, are medically and psychiatrically stable, and do not have a current history of benzodiazepine dependence abuse, dependence, or treatment
Patient Satisfaction Survey of Non-surgical Urinary Incontinence Treatment

The purpose of this study is to identify self-reported wellness following nonsurgical treatment of stress urinary incontinence. This will be done by correlating the response of "yes" on the patient acceptable symptom state (PASS) question to responses from other questionnaires regarding urinary symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Adult women (\> 18 years) seeking care for stress urinary incontinence at the URMC in Rochester, NY, DUMC in Durham, NC, Western New York (WNY) Urology Associates in Cheektowaga, NY, or at the UTMB in Galveston, TX.
* English-speaking
* Possess the ability to complete electronic patient reported outcome questionnaires and voiding diaries

Exclusion Criteria:

* Women who decline to participate in the study
* Women were unable to complete electronic patient reported outcome questionnaires
* Women with greater than stage II uterovaginal prolapse or post-hysterectomy prolapse.
* Women considered citizens of the European Union (EU), including EU citizens living in the United States.
Use of Platelet Rich Plasma After Arthroscopic Debridement for Triangular Fibrocartilage Complex Tears

The objective of this study is to compare outcomes and functionality measures of subjects treated with platelet rich plasma (PRP) after arthroscopic debridement of triangular fibrocartilage complex (TFCC) tears to subjects treated with arthroscopic debridement alone.

Patients with triangular fibrocartilage complex (TFCC) tears will undergo treatment with arthroscopic debridement, as is standard of care, followed by treatment with platelet rich plasma (PRP) (24 subjects) versus no treatment with PRP (24 subjects). Outcome measures will include Modified Mayo Wrist scores (pain scale scores, grip strength, wrist range of motion, functional status) and Patient-rated Wrist Evaluation (PRWE) scores.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female \>18 years of age
* triangular fibrocartilage complex (TFCC) tear requiring surgical intervention
* Be willing to undergo arthroscopic debridement and injection with platelet-rich plasma (PRP)
* Be in good health other than the TFCC tear
* Have realistic expectations of surgical results
* Understand and be willing to follow all aspects of the study protocol and have signed and dated the IRB-approved Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed

Exclusion Criteria:

* Have collagen-vascular, connective tissue, or bleeding disorders
* Be a smoker or have smoked in last 2 months
* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
* Have regional sympathetic dystrophy
* Be pregnant, lactating or expecting to be within the next 24 months
* Currently have an alcohol/substance abuse problem or have had a relapse within one year to screening visit
* Have an abscess or infection at the time of surgery
* Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring MRD Based on ctDNA

This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.

The recurrence rate of hepatocellular carcinoma after curative treatment is high, and the minimal residual disease(MRD) in patients is the major cause of liver cancer recurrence, and the MRD is an important basis for the decision of adjuvant therapy after curative treatment. Previous studies have confirmed that circulating tumor DNA(ctDNA)-MRD monitoring model can accurately predict the recurrence of hepatocellular carcinoma patients. It was also found in retrospective analysis that tumor free survival was significantly prolonged after ctDNA-positive treatment for hepatocellular carcinoma after resection. This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.This study is to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 18-75 years;
2. Preoperative imaging examination diagnosed hepatocellular carcinoma (BCLC) stage 0 / stage A/stage B, eligible for radical surgery;
3. ECOG physical status score is 0-1;
4. Child-Pugh score is 5-6 points (Level A);
5. Not received any anti-tumor therapy;
6. Laboratory tests were at normal levels within 7 days before enrollment.

Exclusion Criteria:

1. Patient can't provide blood samples for ctDNA testing;
2. Patient with two or more types of tumors at the same time;
3. Non-primary liver lesions;
4. Pregnant or lactating women;
5. Patient with a history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma;
6. Patient with serious heart disease;
7. Other conditions deemed unsuitable for inclusion by the researcher.
Identification of Psychoactive Substance Users in Young Adults (16 to 25 Years Old) Visiting the Emergency Department

Adolescence is a time for great physical and psychological change and it's often at that period of life that first use of psychoactive substances occurs. Although addiction is rare in teenagers, psychoactive substances abuse can have serious long-term health consequences on them. This is therefore a priority for all healthcare providers to identify early use and abuse of drugs in the youth's population.

The addictive process underlies environmental, genetic and individual causes. That is why it is somehow possible to identify individuals at risk based on some common sociological, cultural and environmental risk factors.

Due to the acute consequences of psychoactive substances abuses, Emergency Departments are main checkpoints for the screening of young drug users. Indeed, one patient out of five admitted in an Emergency Department shows a positive blood alcohol concentration regardless of the reason for their admission. This rate is twice as high as in the overall population. Hence, Emergency Departments are at the front-line for screening, caring, referral and transfer of psychoactive substances users. That is why the Emergency Department is the best place for this study.

In 2004, the special consultations of young consumers were founded in order to deal with these special cases where dependence is not yet established or installed and care has to be adapted to the age. Offering help to this age range represents a real challenge since only 20% of the teenagers come to visit this special consultations on their own initiative. The rest of teenagers are either obliged by their parents or sentenced by a court. The investigators assume that the repetition of care offered to the teenagers by repeated emergency admissions could trigger their own desire to overcome their drug use disorders and visit the Addictionology Department.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 16 to 25 admitted at the Medical and Psychiatric Emergency Department.
* For adults: those who will agree to participate in this study
* For Minors from the age of 16: those who will agree to participate and want to exercise their rights by themselves or for whom one parent or legal guardian agrees for their participation.

Exclusion Criteria:

* patient who doesn't understand French
* patient under legal protection measures or guardianship
* confused person (GSC \< 15)
Imaging of Injury Mechanism and Interaction of Intestinal Bacteria in Children With Mild Traumatic Brain Injury

Traumatic brain injury (TBI) is the leading cause of disability in children and young adults. Children with moderate to severe TBI are typically at risk of poor functional outcome in terms of neurocognitive impairment and behavior problems. Neurocognitive impairments include deficits in attention and working memory, learning and memory, and executive functioning, whereas behavior problems include anxiety, depression and aggression. Neuroimaging techniques based on multi-modal magnetic resonance image (MRI) can detect the structural and functional brain abnormalities objectively and sensitively. Recent evidence indicates that even after mild TBI, children with risk factors for intracranial pathology are at risk of poor neurocognitive and behavioral outcome.Meanwhile, recently, the concept of "gut-brain axis" has been proposed and hint gut microbiota could shape the brain. Some studies have emphasized that human gut microbiota plays an important role in the pathogenesis and development of TBI. However, how the gut affects the brain in patients with TBI is unclear. Thus, combining analysis of neuroimaging and "gut-brain axis" will provide more information for finding the risk factors and imaging diagnostic markers of brain impairment in TBI. It will also helpful for explaining the underlying mechanisms of brain impairment in TBI, providing an objective basis for clinical diagnosis and prediction of the prognosis.


Eligibility Criteria:
Inclusion Criteria:

* age 6-14 years at time of recruitment.
* hospital admission with a clinical diagnosis of TBI for inclusion in the TBI group
* GCS = 15-13.
* loss of consciousness duration≤30 min.
* post-traumatic amnesia duration ≤1 h.

Exclusion Criteria:

* previous TBI.
* visual or auditory disorder interfering with neurocognitive testing.
* current neurological condition affecting the central nervous system with known effects on neurocognitive functioning, other than TBI.
Non-invasive Blood Pressure and Cardiac Output Measurement by Using Applanation Tonometry

To evaluate and to validate accuracy, precision and trending ability of blood pressure and cardiac output measurement by applanation tonometry in cardiological patients having:

* atrial fibrillation
* severe impaired leftventricular function
* severe aortic valve stenosis
* patients having left ventricular assist device

Experimental measurement: continuous blood pressure measurement and cardiac output measurement is performed by the T-Line 200 pro device (Tensys Medical Inc., San Diego, USA) Control measurement: gold-standard continuous blood pressure measurement is performed by invasive blood pressure measurement by arterial cannulation and cardiac output reference is assessed by transcardiopulmonary thermodilution

Increasing complexity of medical interventions and critical care treatment in an elderly getting population requires precise and accurate hemodynamic monitoring.(1) However, advanced invasive hemodynamic monitoring is often combined with complications by arterial or central venous catheterization. Complications such as vessel harming, infection, cardiac arrhythmias and nervous lesions are likely to occur.(2-4) Therefore, in the past various techniques of minimal- or non-invasive hemodynamic monitoring devices have been evaluated.(5, 6) One of the very promising technique is continuous non-invasive blood pressure monitoring by applanation tonometry. Published data revealed efficacy of this technique. (7) However, ability of this technique remains unclear in patients suffering from cardiological pathologies leading to changing stroke volumes as in arterial fibrillation, to highly reduces stroke volume as in severe impaired left-ventricular function or in severe aortic valve stenosis. Further, ability of applanation tonometry in patients without having pulsatile blood flow such as in patients with left-ventricular assist device remains unclear. Therefore, validation of this technique should be performed in the presented study.

Further development of applanation tonometry including pulse contour analysis now enables assessment of cardiac output. However, till now there is limited data assessing validation cardiac output measurement by this method. Cardiac output validation should also be performed in the planed clinical study.

Eligibility Criteria:
Inclusion Criteria:

* atrial fibrillation
* severe impaired leftventricular function
* severe aortic stenosis
* LVAD Patients

Exclusion Criteria:

* Age \<18 years
* pregnancy
* patients having blood pressure difference of more than 10 mmHg on both arms (measurement by "Riva-Rocci" before study enrolment)
* pre-existing on arterial vessels of the arms
* patients who are not able to give informed consent