cyrilzakka/clinical-trials huggingface dataset:
Using Cotyledon Perfusion to Study Drugs Transfer Across the Placenta

Drug prescriptions are usual during pregnancy however women and their fetuses still remain an orphan population with regard to drugs efficacy and safety clinical studies. Most xenobiotics diffuse through the placenta and some of them can alter fetus development resulting in structural abnormalities, growth or functional deficiencies. The aim of the study is to study the drug transfer using human placenta after delivery.

For ethical reasons, pregnant woman are not included in clinical trials so that data regarding safety and efficacy of many drugs are scarce. It is known that xenobiotics across the placental barrier but studies regarding quantity and mechanisms of this transfer remain insuffisant. Among the different methodologies to evaluate drug transfer, perfusion of human cotyledon is one of the most relevant ones. The two sides of the cotyledon, fetal and maternal ones, are perfused within the hour after delivery with EARLE medium in a double closed circuit. The studied drug (it can be any drug given to pregnant mothers) and antipyrine (the control molecule) are added at the beginning of the three hours perfusion realized at 37°C, with maternal flow rate of 12ml/min and fetal one of 6ml/min. Samples are collected along the perfusion and the drugs dosage will be done in the pharmacology department of Cochin Hospital. Tissues of the cotyledon will be also collected to study the proteins, and ARNs expressed. The drug concentrations will be analyzed by calculating fetal to maternal concentrations ratios and a fetal transfer rate (fetal drug quantity on total drug quantity at the end of the perfusion). Then modelling on Monolix software will be done to estimate the transfer constants across the two compartments. Modelling will allow to estimate the interindividual variability and to test covariables like sex, gestation duration, genetics, or protein expression. Proteins will be studied by an appropriated method (western blot, or proteomic analysis). The genetics study will consist in candidate gene approach. Polymorphisms will be chosen in genes coding for transporters or enzymes or their regulators.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women older than 18 years,
* patient with social security or health insurance,
* from the 24th week of amenorrhea,
* patient who has given her consent,

Exclusion Criteria:

* Maternal pathologies pre-existing pregnancy :

  * diabetes-like vascular disease,
  * arterial hypertension,
  * known prothrombotic pathology, history of venous thrombosis or pulmonary embolism,
  * maternal serology HIV+, BHV+, CHV+ and syphilis,
* Pregnancy and fetal pathologies :

  * pre-eclampsia,
  * delayed growth in utero (can affect placental circulation),
  * gestational diabetes without insulin,
  * fetal malformation,
  * known genetic pathology,
* Patient under tutorship or curatorship, or not speaking french,
* Patient who has not given her consent
Pilot Clinical Trial to Evaluate the UNI-DEB for Unresectable Hepatocellular Carcinoma

Pilot Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Over 19 years
* Diagnosis of HCC
* Unresectable asymtomatic uninodular or multinodular tumor.
* Subject who maintain clinically normal hepatopetal flow without main portal vein closure
* At least one measurable target lesion by CT or MRI which 10 mm or more.
* ECOG Performance Status of 0 or 1.
* Child-Pugh class A or B
* Life expectancy of at least 6 months.

Exclusion Criteria:

* Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
* Hepatic resection, liver transplantation or Percutaneous local treatment
* Previously received HCC related medical procedure
* Previously treated with anthracyclines
* Only measurable disease is within an area of the liver previously subjected to radiotherapy.
* Child Pugh C
* Active gastrointestinal bleeding within 6 months from screening.
* Total bilirubin \> 3mg/dL
* WBC \< 3,000cells/mm3
* ANC \< 1,500cells/mm3
* Platelet \< 50,000mm3
* Serum creatinine \> 2mg/dL
* INR \> 1.4
* ALT and AST \> 5 times UNL
* Diffuse HCC defined as \>50% tumor involvement of the whole liver.
The Effect of Heart Rate Variability Biofeedback Training on Health of Intrapartum Women

In this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women.

In this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women. The following validated self-report measures were administered before and at five days after the intervention, Perceived stress scale-10, Beck Anxiety Inventory, and Edinburgh Postnatal Depression Scale.

Eligibility Criteria:
Inclusion Criteria:

* woman
* aged 20 years or more
* able to understand and write Chinese
* singleton birth
* having a full-term and healthy newborn

Exclusion Criteria:

* suicidal ideations
* psychosis
* medical or obstetric complications
Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy

The purpose of this study is to determine whether treating women, who are diagnosed with a mild imbalance of thyroid hormones during pregnancy, with thyroid hormone replacement affects their children's intellectual development at 5 years of age.

Published research reports have stimulated national and international controversy regarding the value of maternal thyroxine therapy given to improve neurodevelopment of the fetus in women with variously defined hypothyroidism. These reports have led to conflicting and confusing recommendations as to whether or not all pregnant women in the U.S. should be screened for subclinical hypothyroidism or hypothyroxinemia.

Pregnant women less than 20 weeks gestation will have a blood test to screen for subclinical hypothyroidism or hypothyroxinemia. If eligible for the trial, patients will receive levothyroxine or placebo until delivery. Blood draws will be done at monthly study visits and the dosage will be adjusted based on test results. The children of these patients will have developmental testing done annually until they are 5 years of age.

Comparison(s): thyroxine supplementation versus placebo given during pregnancy to determine whether therapy is effective in improving intellectual ability at 5 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Subclinical Hypothyroidism as defined by an elevated TSH (≥ 3.00 mU/L) and a free-T4 in the normal range (i.e. 0.86 to 1.90 ng/dL) or Hypothyroxinemia as defined by a TSH in the normal range (0.08 to 2.99 micrometers (mU)/L) and a low free-T4 (\<0.86 ng/dL)
* Singleton Pregnancy
* Gestational age at randomization between 8 weeks 0 days and 20 weeks 6 days

Exclusion Criteria:

1. Major fetal anomaly or demise
2. Planned termination of the pregnancy
3. History of thyroid cancer or current thyroid disease requiring medication
4. Diabetes, on medication (insulin, glyburide)
5. Collagen vascular disease (autoimmune disease), such as lupus, scleroderma and polymyalgia rheumatica, on medication
6. Receiving anticoagulant therapy
7. Depression, currently on treatment with tricyclics or selective serotonin reuptake inhibitors (SSRIs)
8. Other known serious maternal medical complications including:

   1. Chronic hypertension requiring antihypertensive medication (including diuretics)
   2. Epilepsy or other seizure disorder, on medication
   3. Active or chronic liver disease (acute hepatitis, chronic active hepatitis) with persistently abnormal liver enzymes
   4. Cancer (including melanoma but excluding other skin cancers)
   5. Heart disease (tachyrhythmia, class II or greater heart disease or on heart medication). Mitral valve prolapse without arrhythmia is not an exclusion.
   6. Asthma, on oral corticosteroids
9. Known illicit drug or alcohol abuse during current pregnancy
10. Delivery at a non-network hospital
11. Participation in another intervention study that influences maternal and fetal morbidity and mortality, or participation in this trial in a previous pregnancy
12. Unwilling or unable to commit to 5 year follow-up of the infant
IL8 Monitoring and Its Correlation With 251-gene Polymorphism

One hundred eighty critically ill African adult intensive care patients divided into two groups, eighty septic critically ill patients (sepsis group) while, eighty non-septic critically ill patients (SIRS) group. Admission serum IL-8 was measured in both sepsis and SIRS groups. IL-8 (-251A/T) polymorphism was detected in sepsis and SIRS groups.

A total of one hundred eighty African patients (97men and 83 women) were included in the study. Eighty patients developed septic complication during ICU stay (sepsis group). Eighty patients were critically ill without evidence of infectious organism (SIRS group). Patients received anti-inflammatory drugs or corticosteroids before admission, who had immunosuppressive illness, who had chronic organ failure; who had received massive blood transfusion; those with radiation therapy, previous organ transplantation were excluded from the study. At admission, the patient's age, sex, height and weight were recorded. These data include the following: clinical status; sequential organ failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure; central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis. Routine cultures of blood, urine and suspected sites were obtained to determine the presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o. If needed, blood products, intravascular fluid replacement and inotropic and/or vasopressor agents were administered. Each day the attending physician in the ICU evaluated all the study patients for sepsis, severe sepsis, or septic shock.

Eligibility Criteria:
Inclusion Criteria:

Adults patients with clinical diagnosis of sepsis or systemic inflammatory response syndrome.

Exclusion Criteria:

Patients received anti-inflammatory drugs or corticosteroids before admission, patients who had immunosuppressive illness ie. AIDS, patients with chronic liver failure, patients with renal failure, patients with respiratory failure ; patients received massive blood transfusion; patients with radiation therapy, patients with organ transplantation .
Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter

The investigators hypothesize that the white matter of patients with obstetric antiphospholipid syndrome deteriorates over time


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old
* For the target population: only women included in the publication by Pereira et al (2016) will be included, with no obsteric history (fetal death \>10 weeks or 3 unexplained consecutive losses \<10 weeks)
* For the test group: Patients must be positive for antiphospholipid antibodies based on results from Pereira et al (2016)
* For the control group. Patients must be negative for antiphospholipid antibodies according to results from Pereira et al (2016)

Exclusion Criteria:

* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant, parturient or breast feeding
* The patient is claustrophobic
* The patient has a metallic foreign body (e.g. pacemaker)
* The patient has experienced pregnancy loss linked to infectious, metabolic, anatomic or hormonal factors
A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension

This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

Open-label extension

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.
* Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.

Exclusion Criteria:

* Has portal hypertension or chronic liver disease.
* Has history of left sided heart disease or significant cardiac disease.
Using Navigation to Improve Accuracy of Maxillary Balloon Sinusotomy

The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis.

The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis. Adult patients (18 and over) with a confirmed diagnosis of chronic maxillary rhinosinusitis without nasal polyposis (CRSwNP) will undergo maxillary balloon sinusotomy. Block randomization will be performed to determine which side will receive balloon sinusotomy with navigation and which will have balloon sinusotomy using traditional anatomic landmarks. Participants will be followed for approximately 1 month post-procedure for a total study participation time of approximately 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* Candidate for primary endoscopic sinus surgery (ESS) for chronic maxillary rhinosinusitis without nasal polyposis (CRSwNP)
* Failed medical (non-surgical) therapy

Exclusion Criteria:

* History of previous sinus surgery
* Presence of nasal polyps
* Extensive sinonasal osteogeneis
* Cystic fibrosis
* Presence of sinonasal tumors
* Any records flagged "break the glass" or "research opt out."
* Any additional finding which in the opinion of the investigator precludes patient from participating in the study
Cardiometabolic Effects of Sweet Cherry Juice

This study aims to determine the effects of consuming sweet cherry juice on cardiovascular function, glucose regulation, and lipid status in overweight human subjects. The investigators hypothesize that sweet cherry juice consumption will improve metabolic and physiological status in overweight persons compared to a placebo.

The investigators will conduct a randomized, cross-over study lasting 14 weeks and including 1 week for screening/enrollment, 1 week baseline assessment, and two intervention periods of 6 weeks each for the cherry juice and placebo interventions. Two test visits, 3 to 7 days apart, will occur before the start of intervention (baseline, or week 0) and then at weeks 6 and 12. Participants will be randomized to consume either the cherry juice or placebo beverage first, and will cross over to the alternate intervention immediately following the end of the first 6 weeks. Test Visit 1 will include measures of blood pressure, vascular tone, liver fat and stiffness, post-prandial metabolic response to the study beverage, cardiovascular activity and function, and nervous system control of cardiovascular activity and tone. Acute effects of study beverages will be measured, as will the chronic effects of study beverage consumption after 6 weeks. At Test Visit 2, participants will take a standard 75 gram oral glucose tolerance test (OGTT). Participants will be equipped with physiological monitoring devices, which will monitor cardiovascular activity and function and nervous system control of cardiovascular activity and tone, and continuously measure blood pressure. A series of cognitive function tasks will be administered, and a mental stress test will be conducted. The Test Visit 1 and 2 will be repeated at week 6 and week 12 following each intervention with cherry juice or the placebo beverage.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 20 - 65 years
* Post-menopausal women aged 45 - 65 years
* Body Mass Index ≥25 and \<40 kg/m2
* Systolic blood pressure \>120 and \<140 mmHg or diastolic blood pressure \>80 and \<90 mmHg

Exclusion Criteria:

* Diagnosed metabolic disorder
* Diabetes mellitus
* Thyroid disease
* Cardiovascular disease
* Poly-cystic ovary syndrome
* Vasoconstrictive diseases (e.g. Raynaud's phenomenon or Raynaud's disease)
* Digestive disorder (e.g. Crohn's, irritable bowel syndrome, colitis)
* History of gastrointestinal surgery affecting digestion and/or absorption
* Use of medications for hypertension, hyperlipidemia, glycemic control, or weight loss
* Use of medications such as steroids, statins, or non-steroidal anti-inflammatory agents
* Routine use of over-the-counter medications
* Weight change \>5% in the past 6 months
* Performing exercise greater than 60 minutes/day
* Presence of a pacemaker or other internal electronic device controlling rhythm or pacing of heart excludes participant from MindWare procedure
* Presence of atrial fibrillation or other arrhythmia excludes participant from MindWare procedure
A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience

To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.

This study consisted of two phases. In the Induction phase patients were randomized at Baseline 1 (BL1) in a 1:2 ratio to receive:

* I1: HAART or
* I2: Enfuvirtide (90 mg twice a day) + HAART.

Participants who achieved viral suppression \< 50 copies/mL by week 24, confirmed by week 28 or earlier, qualified to enter the Maintenance Phase which started at Baseline 2 (BL2), four weeks after confirmation of response. The Maintenance Phase consisted of three treatment groups:

* M1: HAART continued (patients from I1)

Patients on ENF+HAART (I2) were re-randomized (at a 1:1 ratio) at BL2 to:

* M2: Enfuvirtide stopped and HAART continued
* M3: Enfuvirtide + HAART continued.

The duration of the Maintenance Phase was from BL2 up to 48 weeks after BL1. BL2 could start at the earliest at Week 12 and at the latest Week 32.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected adults \>=18 years of age;
* currently on antiretroviral (ARV) therapy;
* previously treated with 2 or 3 different antiretroviral classes;
* HIV-1 Ribonucleic acid (RNA) \>=1,000 copies/mL;
* Cluster differentiation antigen four (CD4) lymphocyte count \>=200 cells/mm\^3;
* females of childbearing potential must be willing to use a reliable form of effective barrier contraception for the duration of the study and for 30 days after the last dose of study drug.

Exclusion Criteria:

* history of prior use of enfuvirtide or T-1249;
* women who are pregnant, breastfeeding or planning to become pregnant during the study;
* active, untreated opportunistic infection;
* patients on treatment interruption, or patients interrupting ARV therapy within 4 weeks of screening or during the screening period for reasons either than toxicity management.
Optimal Head and Neck Position During Videolaryngoscopy

Optimal patient head and neck position when performing videolaryngoscopy for endotracheal intubation has not yet been established.The investigators aim to assess the effect of two different positions on the laryngeal view obtained and success of tracheal intubation during videolaryngoscopy with two commercially available and well established videolaryngoscopes.

The optimum patient head and neck position for direct laryngoscopy (when the anaesthetist views the larynx with a curved metallic blade before passing a tube for ventilation of the lungs) is traditionally considered to be the "sniffing the morning air" (neck flexion and head extension) position. This has been questioned previously as there is no randomized controlled study to date to explore this statement. The patient should be optimally positioned prior to induction of anaesthesia, especially because in the event of an unexpected difficult intubation, the Difficult Airway Society guidelines suggest the use of an alternative laryngoscope. In current clinical practice a videolaryngoscope (a curved blade with a camera attached to it that allows the anaesthetist to see around corners) has been used as an alternative laryngoscope. To the best of our knowledge, the ideal patient position for videolaryngoscopy has not yet been described. The intubation time and rate of success at intubation using a C-Mac D-Blade videolaryngoscope was previously assessed by Serocki et al, but only in the sniffing position. It is possible that adopting a different position when using the C-Mac D- Blade might result in a superior view of the larynx. Furthermore, the optimal patient position has not yet been assessed for intubation with the King Vision videolaryngoscope.

This key information could gain precious seconds in a difficult airway scenario (when securing the airway with a tube for ventilation proves difficult) and has obvious implications for patient management. The answer to this question could also help the anaesthetists take informed decisions when using videolaryngoscopy to intubate the trachea in elective settings. The investigators aim to assess the effect of two different positions on the laryngeal view obtained during videolaryngoscopy with two commercially available and well established videolaryngoscopes to try and answer this question.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 and above, presenting for elective surgical procedure and requiring tracheal intubation will be invited to take part in the study.

Exclusion Criteria:

* Patients who are refusing to take part, below 18 years of age, pregnant women, American society of anaesthesiologists' class 4 and above, those requiring rapid sequence indication, super morbidly obese (BMI \>50) and those patients requiring awake fibreoptic intubation will be excluded.