cyrilzakka/clinical-trials huggingface dataset:
Cook Balloon Versus Propess After 12 Hours of Rupture of Membranes

The objective is to demonstrate the superiority of the strategy of labor induction by Cook® cervical ripening balloon between recommended strategy by dinoprostone (propess®) on the reduction of the time between cervical ripening and delivery in case of unfavorable cervix after 12 hours of PROM in term pregnant women.

The inclusion begins after 12 hours of PROM for a pregnant woman who has an unfavourable cervix and no B streptococcus. The case is discussed during the obstetric staff every morning.

If the cervix is unfavourable (cervical Bishop's score \<6), the information of the study is given to the patient and the consent collected.

An antibiotic is started at the beginning of the inclusion by amoxicillin (or clindamycin in case of allergy of amoxicillin) to prevent choroamnionitis.

After randomization, the patient is included in one of the two groups: Cook ® balloon or Propess ®.

* In the Cook cervical ripening balloon group: the device is introduced by a resident or a doctor. No traction on the probe was done. It is left in place for maximum 12 hours. Oxytocin is added at the end of the first 6 hours even if device is fallen. An epidural analgesia can be started before or after the installation of oxytocin
* In dinoprostone vaginal group: the device is placed in vaginal fornix by the midwife for maximum 24 hours. If Propess ® is fallen before the first 12 hours, another one could be introduce if the cervix stayed unfavourable.

After 24 hours, it is removed. If they are any contraction, oxytocin is started with or without epidural analgesic.

* The fetal heart rate is monitoring 30 minutes before and after the insertion of the device. After, the patient has a monitoring each 6 hours.
* Since the oxytocin is started, the monitoring is registered in continue until the delivery.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women

  * 18 years old With a singleton live cephalic pregnancy ≥ 37+0 weeks Gestational age estimated from the first trimester ultrasound (realized between 11 and 13+6 weeks of gestation) PROM without spontaneous labour in the 12 hours after the rupture. The diagnostic of PROM is clinic or biologic (ActimProm® test).

Unfavourable cervix (Bishop's score \< 6) Agreement of the patient after clear, loyal and appropriate information Subject covered by or having the rights to the French Social Security system

Exclusion Criteria:

* Vaginal infection by B streptococcus or in urinary sample during actual or anterior pregnancy Meconium fluid amniotic Contraindication of vaginal delivery (placenta praevia, ...) Temperature \> 38,2°C Suspicion of chorio-amnionitis among Newton requirements Intra-uterine growth restriction \< 3rd percentile with Doppler abnormalities History of cesarean and uterine scare Suspected genital herpes infection Known VIH seropositivity (confirmed by blood serology) Fetus with suspected severe congenital abnormalities Pathological fetal heart rate (see appendix 1) Contra-indications to Propess®, Cook® Cervical Ripening Balloon, Oxytocin Women under guardianship or trusteeship
Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer

The purpose of this study is to determine the effect of exemestane on the pharmacokinetics (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast cancer. Additionally, this study will evaluate the safety and tolerability of entinostat in combination with exemestane, and assess the effectiveness of entinostat in combination with exemestane in terms of best overall response and overall survival.

SNDX-275-0130 is a Phase 1, two-cohort, open-label, drug-drug interaction study of entinostat and exemestane. All patients will be enrolled into one of two cohorts to receive either entinostat monotherapy followed by entinostat plus exemestane (Cohort 1), or exemestane monotherapy followed by exemestane plus entinostat (Cohort 2).

The cohorts will enroll sequentially, meaning that Cohort 1 will enroll prior to Cohort 2. Cohort 1 will evaluate exemestane's effect on the PK of entinostat. Cohort 2 will evaluate entinostat's effect on the PK of exemestane. In both Cohorts, each treatment cycle will be 28 days. Patients will participate in only one cohort.

All patients will be assessed at Screening and at specified times during the conduct of the study using standard clinical and laboratory assessment. Patients will also be assessed for tumor response per standard of care after the Screening Period. Response to treatment will be assessed by computerized tomography (CT), magnetic resonance imaging (MRI) and bone scans as appropriate. Patients will continue receiving their appropriate cycles of study treatment until tumor progression or adverse events (AEs) occur which necessitate discontinuing therapy as determined by the Investigator.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female patients
* Histologically or cytologically confirmed ER+ breast cancer at initial diagnosis and have locally recurrent or metastatic disease that has progressed to where the patient is a candidate to receive exemestane as determined by the Investigator
* Patients receiving palliative radiation at the non-target lesions must be clinically stable prior to receiving the first dose of study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patient must have acceptable, applicable laboratory requirements
* Patients may have a history of brain metastasis provided certain protocol criteria are met
* Able to understand and give written informed consent and comply with study procedures

Exclusion Criteria:

* Rapidly progressive or life-threatening metastases
* Inability to swallow oral medications or gastrointestinal (GI) malabsorption syndromes
* History of significant GI surgery as determined by Investigator
* A medical condition that precludes adequate study treatment or increases patient risk
* Currently enrolled in (or completed within 30 days prior to study drug administration) another investigational drug study
Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation

The main objective of the present project is to develop an imaging-based tool to determine the origin and cause of persistent atrial fibrillation (AF). The result of the study is a diagnostic method which aids the medical work-up of patients suffering from this disease.

Atrial fibrillation (AF) is the most common arrhythmia associated with substantial morbidity and mortality in humans. Histopathological studies of persistent AF have reported extracellular matrix remodeling with fibrotic infiltration which may cause atrial dilation. The degree of the fibrosis might have a significant impact on wave propagation during AF. The main objective of the present project is to develop an imaging-based tool to determine the origin and cause of persistent AF. The obtained clinical parameters of patients and controls (electrocardiography, ecocardiography and MR imaging data) will be correlated with known markers in order to identify novel markers for AF diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* age: 20-80 years
* weight: 50-120 kg
* persistent, permanent or paroxysmal atrial fibrillation
* clinically stable patients: outside of an acute cardiac event with constant chronic medication
* optimum echographic window

Exclusion Criteria:

* patients with: rheumatic mitral disease; acute myocardial-pericarditis; chronic rheumatism, under chronic or immunomodulatory treatment; infectious-inflammatory process of any cause
* patients undergoing oncology treatment
* patients under medication in another study
* patients undergoing immunosuppressive therapy
* contraindication for magnetic resonance imaging (MRI)
* patients with valvular prosthesis, pacemaker of any type, metallic elements in the body (including metal particles accidentally in the body or as a result of exercising certain professions); pregnant patients; patients with known poly-allergy; patients with altered renal function (creatinine clearance \<40 mL/min determined by the Cockcroft-Gault formula).
Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma

Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma.

But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice.

Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb) with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities.

But the grade 3 or worse toxicities associated with GCb are not infrequent and need more effective and more tolerable regimens.

GemOx has been reported to be effective and have very favorable toxicity profiles.


Eligibility Criteria:
Inclusion Criteria:

* Cytologically of histologically confirmed urothelial carcinoma
* Locally advanced or metastatic disease
* Measurable disease according to RECIST v.1.1
* ECOG PS 0-2
* Cisplatin-unfit condition (any of the followings: NYHA functional class 3, creatinine clearance 30-60 ml/min, and ECOG PS=2)
* Adequate organ function
* Chemotherapy-naive

Exclusion Criteria:

* Histology other than urothelial carcinoma, but squamous cell carcinoma or adenocarcinoma mixed with urothelial carcinoma are allowed
* CNS metastases
* Peripheral neuropathy grade 2 or worse
* Serious medical or surgical conditions
Muscle Relaxant Effect and Safety of Mivacurium Chloride and Succinylcholine for Bronchoscopy

The goal of this clinical trial is to evaluate whether mivacurium chloride and succinylcholine can provide effective and safe muscle relaxation in adult patients aged 18-60 years undergoing bronchoscopy who require muscle relaxants during anesthesia. The main questions it aims to answer are:

* Is the recovery of spontaneous breathing within 15 minutes after drug discontinuation with mivacurium chloride non-inferior to succinylcholine?
* How do mivacurium chloride and succinylcholine compare in terms of intraoperative hemodynamics and post-operative recovery and comfort? Researchers will compare the mivacurium chloride group and the succinylcholine group to observe if mivacurium chloride can provide similar or better recovery effects compared to succinylcholine.

Participants will:

* Receive either mivacurium chloride (0.14 mg/kg induction bolus + 0.5 mg/kg/h maintenance infusion) or succinylcholine (1 mg/kg induction bolus + 5 mg/kg/h maintenance infusion) as a muscle relaxant during bronchoscopy.
* Have their vital signs, including blood pressure, oxygen saturation, and heart rate, monitored at multiple time points during the procedure.
* Be assessed post-procedure for spontaneous breathing recovery, consciousness recovery, and time to laryngeal mask airway (LMA) removal, as well as overall comfort and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for painless bronchoscopy who require muscle relaxants during anesthesia.
2. Aged between 18 and 60 years.
3. Classified as Grade I-III according to the American Society of Anesthesiologists (ASA) Physical Status Classification.
4. Patients voluntarily participate and sign an informed consent form.

Exclusion Criteria:

1. Patients with known allergies to any of the drugs involved in the study.
2. Patients with severe organic diseases of the brain, heart, lungs, liver, kidneys, or other major organs.
3. Patients with intracranial hypertension, asthma, cataracts, glaucoma, or other eye diseases.
4. Patients with myasthenia gravis, myasthenic syndrome, severe reduction or deficiency of cholinesterase, upper motor neuron injury, or upper motor neuron diseases that may cause abnormal responses to muscle relaxants.
5. Patients who have used medications affecting neuromuscular transmission function before the procedure.
6. Pregnant or breastfeeding patients.
7. Patients who have experienced extensive burns, acid-base imbalance, or electrolyte disturbances within the past six months.
8. Patients known or suspected to be homozygous for the atypical gene for plasma cholinesterase.
Evaluation of the Ketogenic Potential of Different Diet Supplements

Evaluate the capacity of different dietary supplements to increase ketone production in healthy adults.

The aim of this study is to evaluate the capacity of different dietary supplements to increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate, carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which multiple blood samples are taken in order to measure ketone production.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged of 18 years old or older.
* Non-smoking.

Exclusion Criteria:

* Diabetes or prediabetes
* Uncontrolled hypertension
* Uncontrolled thyroid function
* Taking medication that will affect lipid/glucose metabolism
* Severe infection or inflammation
* Pregnancy
Effectiveness of Respiratory Protection During Simulated Resuscitation: a Prospective Cohort Study

The study hypothesizes that EHMRs with P100 filters will provide superior respiratory protection during simulated CPR compared to disposable N95 FFRs as measured by qualitative fit testing.

To this end, the study is a prospective observational cohort to evaluate the effectiveness of disposable FFRs and EHMR during simulated CPR. The primary endpoint will be subject report of detection of the testing agent during a 2 minute session of simulated chest compressions on a mannequin while wearing the respiratory protection that subjects routinely wear during the course of employment.


Eligibility Criteria:
Inclusion Criteria:

* Current use of respirator within last 7 days
* Completed fit test with respirator within last 2 years

Exclusion Criteria:

* Previous adverse reaction to fit testing or testing agent
* Development of any health problem that precludes use of a respirator since last occupational health evaluation
Intravenous Iron in Patients With Anemia of Chronic Kidney Disease

The objective of this study is the evaluation of the efficacy and safety of intravenous iron sucrose in anemic patients with chronic kidney disease not on renal replacement therapy.

This is a randomized, open label, phase IV study in anemic predialysis patients (Hb between 8 and 11.5 g/dl) who require iron supplementation. The duration of the study for each patient will be approximately 6 months. Patients will be randomized to one of two treatment arms and admitted to the anemia correction phase (days 1-43). Treatment will be intravenous iron sucrose alone versus iron sucrose plus rhEPO. The main treatment evaluation will at the end of the correction phase: The primary end-point will be the change of hemoglobin during correction phase. Secondary end-points will be the change of ferritin and transferrin saturation from baseline to day 43. Safety assessments will include recording of adverse events, vital signs, physical examinations and clinical laboratory tests. Incidence and severity of adverse events will be compared between the two different treatment arms.

Eligibility Criteria:
Inclusion Criteria:

Chronic kidney disease Anemia (Hb 8 - 11.5 g/dl) Age above 18 years Signed informed consent

Exclusion Criteria:

Rapid progression of kidney disease Need for dialysis Uncontrolled hypertension
Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)(COMPLETED)

This study is to evaluate the effectiveness of a new drug on congestion in subjects with seasonal allergic rhinitis. This effect will be compared to placebo and to the decongestant, pseudoephedrine.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 to 65 years of age, of either sex, and of any race.
* Subjects must have a history of SAR due to ragweed for the last two consecutive ragweed seasons.
* Subjects must be skin-test positive for the ragweed pollen allergen used in the Environmental Exposure Unit (pollen chamber at the Screening Visit or within 12 months prior to the Screening Visit.
* Subjects must develop a pre-defined severity of allergy symptoms within 90-minute after entering the pollen chamber during the pollen challenge at the Priming visit (Visit 2), and prior to dosing (Visit 3), in order to qualify for the study.
* Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to randomization at the Treatment Visit. Female subjects and female partners of male subjects must be using an acceptable form of birth control during the study.
* Blood pressure and pulse rate must be within normal ranges.

Exclusion Criteria:

* Subjects who have had an upper or lower respiratory tract infection within approximately 28 days (4 weeks) before Priming (Visit 2) and thereafter.
* Subjects who have a dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator.
* Subjects with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
* Subjects who have used any investigational drugs, including placebo, within 30 days of Screening or for the duration of this stud, or who are participating in any other clinical study.
* Subjects with a history of rhinitis medicamentosa.
* Subjects with a history of anaphylaxis or severe or serious reaction to skin testing.
* Subjects who are being medically treated for any of the following conditions: narrow-angle glaucoma, increased intraocular pressure, urinary retention, hypertension, severe coronary artery disease, ischemic heart disease, diabetes mellitus, hyperthyroidism, renal impairment, or prostatic hypertrophy; current treatment with monoamine oxidase (MAO) inhibitors.
* Subjects with a history of a positive test, or are symptomatic, for HIV, TB (not due to vaccination), and hepatitis B (not due to vaccination) or hepatitis C.
* Subjects with asthma that requires medication other than occasional (\<=3 uses per week) use of an inhaled short-acting b-2 agonist.
Serum Retinoic Acid Induced Protein 14 (RAI14) and Metastasis Associated Cancer Colon -1 (MACC-1) in Breast Cancer

1. Measurement of serum levels of Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) as biomarkers for diagnosis of breast cancer.
2. Study their relationship to disease stages and clinicopathological features of BC.
3. Compare the diagnostic performance of serum RAI14 and serum MACC-1 with serum Carcinoembryonic antigen (CEA) and Cancer antigen 15-3 (CA15-3) for diagnosis of BC.

Breast cancer (BC) is one of the most prevalent Neoplasms and the second leading reason of death from cancer in women. Every year approximately 2.3 million new cases of BC are diagnosed worldwide. Due to the high impact of this type of cancer, the early detection, early diagnosis and effective treatment, will improve the diagnosis of patients and lower the associated mortality rates. Carcinoembryonic antigen (CEA) and Cancer antigen 15-3 (CA15-3) are the most commonly used serum markers in the diagnosis and follow up of BC, However their clinical applications still remain controversial.

Retinoic acid induced protein 14 (RAI14) is an actin-binding protein which participates in physiological processes such as the regulation of cell polarity and transport of spermatozoa. Recent studies showed that RAI14 is overexpressed in several malignant tumors with a significant role in the development of tumors . The serum RAI14 is a reliable novel marker in the early diagnosis and chemotherapy monitoring of triple-negative BC.

Metastasis-associated colon cancer-1 (MACC-1) is a newly identified tumor marker, first identified in colon cancer tissue as a prognostic indicator and inducer of metastasis .It is located on human chromosome 7 (7p21.1) and shown to be a key regulator of the hepatocyte growth factor-mesenchymal epithelial transition factor( HGF-MET) pathway in colon cancer. It is shown that serum MACC-1 can be a potential biomarker for diagnosis and progression in patients with BC. There was a strong correlation between MACC-1 expression and the clinical and the primary tumor, regional nodes, metastasis (TNM) stages of BC.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with benign breast lesions.
2. Patients with breast cancer who were confirmed by histopathological studies and did not receive any treatment.

Exclusion Criteria: 1- Patients who received chemotherapy or radiotherapy. 2- Patients with known other organ malignancy.
Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit

Post-traumatic stress disorder (PTSD) is a psychiatric pathology noticed in the DSM-5, in troubles due to a traumatism or a stress factor and appearing at least 1 month after confrontation with trauma. This trouble can become chronic, and be the source of psychiatric and somatic comorbidities, which themselves have personal, professional and economic consequences at the level of the individual and society.

Some studies looked at the psychological effects induced by a stay in intensive care unit (ICU) since few years. The emergence of PTSD in these patients has been described, with an incidence varying from 4% to 60%.

The literature is contradictory about identified risk factors for PTSD. It's not possible to design a screening of these patients actually, only focused on the risk factors. It has been shown that the presence of acute stress trouble (presence of symptoms during the first month after the traumatism) was a risk factor for PTSD. Early detection of acute stress disorder could be a way to screen risk of emergence of a post-intensive care PTSD. Post-intensive care consultations have been done at 6 months, but not systematically. Only few symptoms are looked for and a sizable part of this population were not being followed probably due to a non-diagnosed-PTSD. In case of the emergence of a post-intensive care PTSD, those patients will never be diagnosed and treated, favoring all complications linked to this trouble.

Associated with other factors, IES-R (Impact Event Scale Revisited) at the ICU exit would permit an exhaustive screening of patients at risk for PTSD and could permit to propose them an adapted care and then limit the emergence of PTSD and its consequences..

In this study, the investigators will screen acute stress symptoms within 8 days following the ICU's exit, using the IES-R, in order to evaluate his ability to predict the emergence of a PTSD at three months. IES-R is an auto-questionnaire, easy and fast with good psychometrics capacities for PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old leaving an intensive care unit after a stay of more than 72 hours, in one of the medical and surgical intensive care units of the E Herriot Hospital
* Patient having given his agreement to participate in this study

Exclusion Criteria:

* Patient not understanding French language
* Confused patient (clinical assessment)
* Patient under protection measure or deprived from his rights