cyrilzakka/clinical-trials huggingface dataset:
Does Meal Timing Affect Energy Expenditure

The purpose of this study is to find out if meal timing affects calories burned and blood sugar levels.

10 overweight adult men and women will eat according to two different eating schedules: grazing and time-restricting feeding ("early eating"). While on each eating schedule, metabolism (calories burned) will be measured during a 24-hour stay in a respiratory chamber. Glucose levels-as well as key diurnal rhythms such in heart rate-will also be measured continuously. This study requires two 1-week periods of participation.

Eligibility Criteria:
Inclusion Criteria:

* Are 20-45 years of age
* Have a weight between 150 and 220 lbs
* Have a body mass index between 25 and 35 kg/m2 inclusive (a number calculated from your height and weight)
* If you are a female, have a regular menstrual cycle that is between 25 and 35 days long
* If you are female, had your period within the last 35 days
* Regularly go to sleep between 9:30 pm and 12:00 am
* Regularly eat dinner 9 or more hours after eating breakfast
* Are willing to have about 2/3 cup of your blood stored for future research related to this study

Exclusion Criteria:

* Have diabetes or are on anti-diabetes medication
* Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease
* Have stomach or intestinal problems
* Regularly use medications such as steroids, beta blockers, adrenergic-stimulating agents, and laxatives
* Take any medications or supplements known to affect sleep, circadian rhythms, or metabolism (with the exception that certain forms of birth control are allowed)
* Have abnormal lab work that is clinically significant in the opinion of the study physician
* Are pregnant or lactating
* Take the Depo Provera shot, or use an Interuterine Device (IUD) or hormone patch for birth control
* If you are on hormonal birth control, have been on a stable dose for less than 3 months
* Have smoked or used nicotine/tobacco products within the last 3 months
* Regularly do competitive sport training
* Perform overnight shift work an average of one or more times per week
* Have an irregular sleep schedule
* Have an irregular eating schedule
* Regularly drink 3 or more drinks of alcohol per day
* Are not able or are unwilling to eat only the food and drink served to you by Pennington Biomedical, while in the study
* Are not able or are unwilling to refrain from strenuous exercise while participating in the study
* Are not able to spend 2 separate full days (for about 25 hours each) at Pennington Biomedical
* Are not able to maintain a consistent sleep schedule while participating in the study
* Are not able to maintain a consistent eating schedule while participating in the study
* Are not able to stop drinking coffee and other caffeine-containing drinks on the day of and day prior to testing
Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection

The aim of this trial is to verify, under controlled conditions, the reported efficacy of human cytomegalovirus (HCMV)-specific hyperimmune globulin administration to pregnant women suffering from primary HCMV infection for the prevention of intrauterine HCMV transmission.

HCMV is the leading infectious cause of mental retardation and deafness in infants with congenital HCMV infection. Primary HCMV infections during pregnancy carry the highest risk of fetal infection and disease. No intervention of proven efficacy is available in case of primary HCMV infection in pregnancy. However, a study published in 2005 (Nigro et al., NEJM 353:1350-62, 2005) reported that in pregnant women with primary HCMV infection treated with HCMV-specific hyperimmune globulin (Cytotect®, Biotest) the risk of transmitting the infection to the fetus was reduced from 40% to 16%. Unfortunately, since the study was conducted with inadequate controls, the actual efficacy of hyperimmune globulin could not be properly assessed.

In the present randomized, double-blind, placebo-controlled, multicenter trial pregnant women with ascertained primary HCMV infection at 4-26 weeks of gestation will be randomized to receive Cytotect® or placebo intravenously within 6 weeks after the presumed onset of infection.

Primary efficacy parameter will be the number of HCMV-infected newborns or fetuses.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women (in vitro fertilization permitted)
* \>= 18 years of age
* primary HCMV infection at 5-26 weeks' gestation
* \<= 6 weeks from presumed onset of infection
* gestational age between 5-32 weeks' gestation
* written informed consent

Exclusion Criteria:

* multiple pregnancy
* history of HIV or HBV or HCV infection
* known immunodeficiency or immunosuppression
* congenital or acquired autoimmune disease
* known intolerance to protein of human origin
* known intolerance to immune globulin
* history of adverse effects to vaccination
* hypersensitivity to human immune globulin (pathological IgG or IgA deficiences)
* renal failure
* serious organic or psychiatric disease
* lack of motivation to participate in the study
* women unable to satisfy study requirements
* women not willing or unable to provide written informed consent
* women not willing to give consent to transmission of anonymised data
Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients

Evaluate the potential of ART combined with interferon therapy to achieve functional cure of hepatitis B in HIV/HBV co-infected patients

This is a prospective, non-randomized, clinical observational cohort study. The subjects are the advantageous population for functional cure of hepatitis B in HIV/HBV co-infected patients . Depending on whether interferon therapy is used in the real world , the patients are divided into two groups: the ART combined with interferon group and the ART alone group, with 30 cases in each group. Hepatitis B surface antigen seroclearance rate and seroconversion rate will be observed during the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old, gender unrestricted.
2. Meeting the People's Republic of China Health Industry Standard (WS293-2008) - "AIDS and HIV Infection Diagnostic Criteria", confirmed as HIV-1 infected.
3. HBsAg positive for more than 6 months.
4. At least 1 year of ART treatment prior to screening, and currently undergoing ART treatment with HBsAg \<1000IU/mL, HBeAg negative, HBV DNA \<100IU/ml, CD4+T lymphocyte count \>200 cells/μL and HIV-RNA\<20 copies/ml.

Exclusion Criteria:

1. Pregnant, nursing, planning pregnancy, or with severe mental disorders or uncontrolled epilepsy.
2. Co-infected with Hepatitis A, C, D, or E viruses.
3. With other chronic liver diseases like autoimmune hepatitis, drug-induced hepatitis, alcoholic hepatitis, genetic metabolic liver diseases, or moderate to severe fatty liver.
4. With autoimmune diseases like rheumatoid arthritis, psoriasis, or lupus.
5. Post organ transplant, planning organ transplant, diagnosed or suspected of liver cancer or other malignant tumors, or undergoing immunosuppressive treatment.
6. With severe diseases of heart, lungs, kidneys, brain, retinal disorders, or uncontrolled hypertension or diabetes.
7. Excessive alcohol (average daily alcohol intake \>40g for men, \>20g for women) or drug users.
8. Participated in other interventional trials within the last three months, or other situations deemed inappropriate for inclusion by researchers.
Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control : Retrospective Study

Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension.

Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises.

The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance.

The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.

Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension.

Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises.

The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance.

The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.

This study will be a retrospective quasi-experimental study, conducted at the Diagnosis and Therapeutic Center of the Hôtel-Dieu University Hospital, Assistance Publique - Hôpitaux de Paris, France. The timeframe of the study should is from September 2020 to July 2023.

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* being diagnosed with essential hypertension,
* being followed by a MD of the structure for hypertension management,
* having received a proposition to meet an APN for hypertension management between the day hospitalization and the next MD consultation,
* having received a loaned tensiometer with instructions during the day hospitalization and explanations for HBPM protocol.

Exclusion Criteria:

* being diagnosed with secondary hypertension,
* having APN follow-up before the day hospitalization,
* being lost to follow-up in the twelve months after the MD consultation
* not having the BP measurement by OBPM for the day hospitalization (baseline) and/or the endline (endline),
* pregnancy
* under guardianship or tutorship
* State Medical Help
Cardiorespiratory and Muscular Rehabilitation of Children and Young Adults With Marfan Syndrome.

Marfan syndrome (MFS) is a rare genetic disease (1/5000) characterized by the association of ocular impairment, cardiovascular disease and musculoskeletal disease.

In some chronic conditions, physical activity and training have been shown to be effective in improving muscle strength and functional abilities but also fatigue and quality of life. We hypothesize that the implementation of a personalized exercise rehabilitation program (Personalized Training Program) in children and young adults with MFS, by improving muscle mass, physical endurance, muscle strength, bone mass and quality of life of these patients. In order to test this hypothesis, investigators wish to carry out an interventional, prospective, monocentric study for the first time in children and young adults (\<25 years old) presenting an MFS.

Marfan syndrome (MFS) is a rare genetic disease (1/5000) characterized by the association of ocular impairment, cardiovascular disease and musculoskeletal disease. Chronic fatigue and decreased physical endurance are almost constant complaints of patients with MFS (90% according to some studies), and have an impact on activities of daily living and quality of life. The fragility of the connective tissues and the muscle deficit, responsible for increased stress on the musculoskeletal system, may be involved in this symptomatology. This deficiency in muscle mass is already present in young children and worsens in adolescents and young adults, as researchers have shown in a clinical study carried out in the Toulouse MFS competence center. This muscle deficit may also explain, at least in part, the deficit in bone mass observed in children and adults.

In some chronic conditions, physical activity and training have been shown to be effective in improving muscle strength and functional abilities but also fatigue and quality of life. Investigators hypothesize that the implementation of a personalized exercise rehabilitation program (Personalized Training Program) in children and young adults with MFS, by improving muscle mass, physical endurance, muscle strength, bone mass and quality of life of these patients. In order to test this hypothesis, investigators wish to carry out an interventional, prospective, monocentric study for the first time in children and young adults (\<25 years old) presenting an MFS.

Eligibility Criteria:
Inclusion Criteria:

* Marfan syndrome according to Ghent criteria.
* For minors, signed informed consent of at least one of the holders of the parental authority. For majors, signed informed consent.
* Patient affiliated to a social security scheme or equivalent.

Exclusion Criteria:

- Cardiac contraindications to Personal Training Program: O Severe aorta dilatation (aortic diameter\> 45 mm) O and / or left ventricular failure (left ventricular ejection fraction \<45%) O and / or severe mitral leakage ≥ grade 3

- Pregnancy
Aseptic Techniques During Epidural Analgesia in the Labor Floor

There is an increasing trend in the incidence of infection related to epidural anesthesia. This could be related to methods of aseptic technique as adopted by the anesthesiologist during the performance of the procedure.

The purpose of this study is to compare two methods of aseptic technique for labor epidural insertion; a "conventional" method without wearing a sterile gown (free from living germs or microorganisms) versus strict aseptic method with wearing of sterile gowns.

It is our belief that there will be an increased contamination of epidural equipment and colonization of epidural catheter, secondary to bacterial fallout from the operators' bare hands in the group not wearing the sterile gowns.

At the present time there is no accepted standard for aseptic technique during insertion of an epidural catheter on the labor floor and what is considered to be essential is controversial. Recognizing this, the American Society of Regional Anesthesia (ASRA), the leading authority on regional anesthesia, established a task force to examine and establish guidelines for aseptic practice. Their findings highlighted the lack of good quality studies to support specific recommendations. This is especially true in regards to the use of sterile gowns during the performance of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women requesting epidural analgesia

Exclusion Criteria:

* Patients who have fever requiring antibiotics
* Patients who have received antibiotics in or within the previous 48 hours of labor
* Immuno-compromised patients.
The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma

This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome.

It has been reported that HBV replication can be reacted after chemotherapy or immunotherapy, which will lead to exacerbation of chronic hepatitis B (ECHB). It is still unknown that if percutaneous radiofrequency ablation or liver resection for hepatocellular carcinoma (HCC) will react the replication of HBV or not. This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 75 years
* HBV carrier with HCC
* After percutaneous radiofrequency ablation;
* No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
* No HCV or HIV co-infection
* No previous treatment of HCC
* No previous treatment of HBV except Lamivudine

Exclusion Criteria:

* Patient compliance is poor
* Active clinically serious infections ( \> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0)
* Known history of human immunodeficiency virus (HIV) infection
* Known Central Nervous System tumors including metastatic brain disease
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
* Distantly extrahepatic metastasis
* History of organ allograft
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Excluded therapies and medications, previous and concomitant
* Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization
* Prior use of systemic investigational agents for HCC
* Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
Serum Vitamin D Level and Its Association With Ovarian Reserve and IVF Outcome

Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Recent data from retrospective and prospective trials have demonstrated contradictive results concerning the role of vitamin D in female reproduction and IVF outcome. Some studies have found that women deficient in vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age. It may also have a role to play in endocrine dysfunction and abnormal folliculogenesis in polycystic ovaries .

The aim of this prospective cohort study including infertile women undergoing IVF treatment is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and miscarriage rates .

Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Recent data from retrospective and prospective trials have demonstrated contradictive results concerning the role of vitamin D in female reproduction and IVF outcome. Some studies have found that women deficient in vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age. It may also have a role to play in endocrine dysfunction and abnormal folliculogenesis in polycystic ovaries .

The aim of this prospective cohort study including infertile women undergoing IVF treatment is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and miscarriage rates .

Eligibility Criteria:
Inclusion Criteria:

* Subfertile women,
* Indication for IVF,
* 20-42 yrs of age.

Exclusion Criteria:

* Women on therapeutic supplementation for Vitamin D Deficiency,
* Recurrent high order implantation failure
A Phase 1 Study of LJPC-501 in Patients With Hepatorenal Syndrome

Hepatorenal syndrome (HRS) is a life-threatening condition marked by rapid decline in kidney function in patients with liver cirrhosis or fulminant liver failure. Vasodilation in the gastrointestinal region is largely thought to contribute to the disease. LJPC-501 is a vasoconstrictor that may restore proper circulation and kidney function in patients with HRS.

Vasoconstrictors are considered a promising approach to treat HRS due to the significant vasodilation of the splanchnic circulation that contributes to systemic arterial underfilling and leads to functional decline of the kidney in these patients. Vasoconstrictors currently in use are associated with reduced organ perfusion and have marginal effect on sodium excretion. The vasoconstrictor angiotensin II has been shown to produce significant sodium excretion and urine output in patients with cirrhosis and ascites, supporting its potential utility in the treatment of HRS.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with HRS, as defined by the International Ascites Club \[1\]:

   * Cirrhosis with ascites
   * Serum creatinine \> 1.5 mg/dL
   * No improvement of serum creatinine (decrease to a level of ≤ 1.5 mg/dL) after at least 2 days with diuretic withdrawal and volume expansion with albumin
   * Absence of shock
   * No current or recent treatment with nephrotoxic drugs
   * Absence of parenchymal kidney disease, as indicated by proteinuria \> 500 mg/day, microhematuria (\> 50 red blood cells per high power field) and/or abnormal renal ultrasonography

   Or patients with HRS due to acute alcoholic hepatitis
2. Patient is able to undergo a reliable neurologic exam, as determined by the investigator
3. Patient or legal surrogate is willing and able to provide written informed consent
4. Patient is willing and able to comply with all protocol requirements

Exclusion Criteria:

1. Evidence of shock
2. Current or recent treatment with nephrotoxic drugs
3. Use of midodrine, octreotide, or other vasopressors within 48 hours of screening
4. Current treatment with dialysis
5. Serum creatinine \> 7 mg/dL
6. Active cardiovascular disease within 3 months of screening
7. History of transient ischemic attacks or prior stroke
8. History of organ transplant
9. Ongoing infection requiring intravenous administration of antibiotics (patients with documented infections considered by the Investigator to be controlled within 48 hours of screening may be permitted in the study upon consultation with the Sponsor's Medical Monitor)
10. Participation in a clinical trial within 30 days of screening
11. Patient unlikely to survive more than 72 hours in the opinion of the investigator
12. Patient is pregnant or planning to become pregnant during study