cyrilzakka/clinical-trials huggingface dataset:
Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

Prospective, open, randomised, parallel, multicentre, two arm trial comparing a new form of luteal support (S.C.) to an approved comparator (vaginal gel).


Eligibility Criteria:
Inclusion Criteria:

* Age 18- 42 (upon starting COH);
* BMI \<30 kg/m2;
* \<3 prior ART cycles (IVF, ICSI and related procedures);
* Baseline (day 2-3 of cycling) FSH \<15 IU/L and E2 \<80 pg/mL;
* Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid);
* At least 3 retrieved oocytes;
* Patient has given written informed consent.

Exclusion Criteria:

* Intramural uterine fibroids that distort the uterine cavity or polyps \>1 cm;
* Stage III or IV endometriosis (endometriomas);
* Hydrosalpinx;
* History of past poor response to COH resulting in canceling ART;
* Use of thawed/donated oocytes;
* Use of thawed/donated embryos;
* Patients affected by pathologies associated with any contraindication of being pregnant;
* Hypersensitivity to study medication;
* Uncontrolled adrenal or thyroid dysfunction;
* Undiagnosed vaginal bleeding;
* History of arterial disease;
* Patients with hepatic impairment;
* Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
* High grade cervical dysplasia;
* Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;
* History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages wherein pregnancy developed to a minimum of a gestational sac on TVUS;
* Participation in a concurrent clinical trial or another trial within the past 2 months;
* Use of concomitant medications that might interfere with the study evaluation;
* Pre-implantation genetic diagnosis/screening.
An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects

To evaluate inter-ethnic similarity in pharmacodynamics between Japanese and Caucasian healthy adult male subjects by comparing electrophysiological reactions after administering E2014 to extensor digitorum brevis muscle (EDB).


Eligibility Criteria:
Inclusion criteria:

1. Participants aged between 20 and 44 years at the time of obtaining informed consent.
2. Participants whose M wave amplitude potential (between baseline and negative peak) in the EDB by stimulating peroneal nerve in the foot joints is 1 mV or more during electrophysiological examinations at the times of screening and immediately before administration.
3. Participants who are judged to be eligible for study entry by an investigator or subinvestigator at screening and at immediately before pre-treatment medical examination.
4. Participants who are given a full explanation about the objective and details of this study before starting screening and give written consent based on their free will.

Exclusion Criteria:

1. Participants who have a complication or history of peripheral neuropathy, nerve root impairment, muscle disease.
2. Participants with a disease that may influence the study drug evaluation, such as disorders of the gastrointestinal tract, liver, respiratory, endocrine, hematological, neurological, psychiatric and cardiovascular system, and congenital abnormality in metabolism.
3. Participants who have accessory deep peroneal nerve.
4. Participants who previously received a treatment with botulinum toxin.
5. Participants with a history of hypersensitivity to any component of E2014 (human serum albumin, succinate buffer solution).
6. Participants who are positive for urine drug screening at the time of screening or immediately before study drug administration.
7. Participants who received prescription drug(s) within 1 month before study drug administration.
8. Participants who have been treated with another investigational drug within 4 months before study drug administration.
9. Participants who have experienced heavy exercise or hard labor within 2 weeks before study drug administration.
10. Participants who underwent blood transfusion within 3 months before, those whose 400 mL of whole blood was collected within 3 months before, or those whose 200 mL of whole blood was collected within 1 month before study drug administration.
11. Participants who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or serologic test for syphilis (STS).
12. Participants who received a diagnosis of acquired immunodeficiency syndrome (AIDS) or those with positive result for human immunodeficiency virus.
13. Participants who are unwilling or unable to abide by the requirements of this study, or those who may violate the prohibitions and restrictions of this study.
14. Participants who are judge to be ineligible for study entry by a principal investigator or subinvestigator.
Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy.

This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy.

Two years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life).

The main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old,
* Patient to be operated in first intention of a sleeve gastrectomy
* Initial BMI between 35Kg/m² and 40 Kg/m² associated with an obesity-related comorbidity (hypertension, obstructive sleep apnea syndrome, type II diabetes, early osteoarthritis authenticated by a rheumatologist or an orthopedist, dyslipidemia, hepatic steatosis) OR initial BMI ≥ 40 Kg/m².
* Multidisciplinary follow-up of at least 6 months before surgery
* Validation of the surgical intervention in a multidisciplinary consultation meeting
* Certificate of no contraindication by a psychiatrist
* Patient who has the capacity to understand the protocol and has given consent to participate in the research,
* Patient with social security coverage.

Exclusion Criteria:

* Eating disorder or mental disorder
* Misunderstanding of the protocol
* Psychiatric contraindication
* Initial BMI \<35Kg/m².
* Initial BMI between 35Kg/m² and 40 Kg/m² without comorbidities.
* Esophagitis of grade B and above on the Oeso-Gastro-Duodenal Fibroscopy
* CARLSSON score (score ≥ 4) preoperatively
* Presence of a Proton-Pump Inhibitors treatment
* Patient to have a 2-stage surgery (first sleeve gastrectomy then gastric bypass or Single Anastomosis Duodeno-Ileal bypass)
* Patient participating in another interventional clinical research protocol involving a drug or medical device
* Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion and up to 24 months after surgery
* Patient under guardianship, curators or legal protection,P
Can the Belgian Coastal Environment Improve Physical and Cognitive Health in Older Adults?

The goal of this interventional study is to learn if exposure to coastal environments improves the physical and cognitive health of older adults over the age of 60. The main questions it aims to answer are:

Does coastal exposure affect physical stress levels in older adults? Does coastal exposure affect self-reported stress levels in older adults? Does coastal exposure affect cognitive measures, such as sustained attention, in older adults? Does coastal exposure affect sleep quality in older adults? Is there a difference between the various components of coastal environments (e.g. dykes, dunes,...) in their effect on older adults' physical stress?

This wil be a within-subject study, in which participants get exposed to both a coastal and an urban environment to compare their response to these environments. The study will occur in two phases: in the first phase the exposure will consist of walks in the environments, in the second phase the exposure will be virtual, through immersive video-fragments.

For the first phase, participants will perform both a coastal and urban walk on different days, equipped with wearable sensors (namely a wrist- and chestband) to measure various parameters such as heart rate and skin conductivity. Before, during and after the walk saliva samples will be collected for cortisol analysis. Before and after the walks they will also answer some questions (on e.g. overall demographics but also self-reported mental health) and perform cognitive tests (to study e.g. sustained attention). For the second phase, the exposure will consist of video fragments and participants will get exposed to both environments on the same day. All the measures above will be collected as well, except for salivary cortisol.


Eligibility Criteria:
Inclusion Criteria:

You are willing to make the time needed to complete the experiment. You understand and can communicate in Dutch. You are 60 years or older and retired. You are familiar with the city of Ostend. This means you visit Ostend multiple times per year and are preferably familiar with the area around the Grote Post and Fort Napoleon.

You smoke no more than 10 cigarettes per day. You are able and comfortable walking for approximately 30 minutes at an average pace without aids such as a cane or walker.

You do not have a pacemaker. You are not blind or deaf. You do not take tricyclic antidepressants or clozapine.

Exclusion Criteria:

People who cannot participate in the entire experiment, do not speak Dutch, are under 60 years old or not yet retired, have a pacemaker, are blind or deaf, take tricyclic antidepressants or clozapine, are not at all familiar with the city of Ostend, smoke more than 10 cigarettes per day, or are unable to walk for 30 minutes continuously without aids are not eligible to participate in the experiment.
Epidemiology of Fluoroquinolone Resistance in Human Commensal Flora in Patients Hospitalised in Medical Wards

Emergence of bacterial resistance to antibiotics, which is a major public health issue, appears to involve predominantly commensal flora. No data exists concerning risk factors for the carriage of fluoroquinolone resistant bacteria in the flora of hospitalised patients. We will conduct a prospective open study including all unselected patients hospitalised in medical wards of one hospital. Nasal, pharyngeal and rectal swabs will be performed upon admission as well as a review of potential risk factors, after patient's information and acceptance. Resistance testing aiming 3 pathogens (Staphylococcus, Streptococcus and E. coli) will be performed on all specimens, and a case control study will compare risk factors from the resistant and non-resistant groups, for each pathogen. A thousand patients should be included in a year's time. This work could help understand risk factors involved in the carriage of fluoroquinolone resistant pathogens, potentially responsible for invasive infections and inter-patient transmission of resistance. Limiting bacterial resistance and transmission is a goal that can be successfully undertaken only if resistance mechanisms, but also risk factors of acquiring resistant bacteria are better understood.


Eligibility Criteria:
Inclusion Criteria:

* all adult patients admitted to the internal medicine, oncology, cardiology and geriatric unit of Beaujon Hospital, Clichy, France.
* patient agreement

Exclusion Criteria:

* Age \< 18
* patient refusal or incapable
Functional Microscale Organotypic Assays to Predict Patient Response to Anti-Angiogenesis Therapies

The primary objective of this research is to evaluate response to systemic therapy, including anti-angiogenesis therapy and/or immune-based therapies via 18F-DCFPyL prostate-specific membrane antigen (PSMA)-based positron emission tomography/computed tomography (PET/CT) in patients with metastatic renal cell carcinoma (RCC) and to compare qualitatively with conventional imaging response criteria - Response Evaluation Criteria In Solid Tumors (RECIST 1.1) and histopathological endpoints including isolation, enumeration and staining of Circulating Tumor Cells (CTC).

Response of systemic therapy, including anti-angiogenesis therapy and/or immune-based therapies will be quantified using PSMA-based PET imaging using a novel agent,18F-DCFPyL, as a non-invasive imaging biomarker of tumor neovasculature to functionally monitor renal cell cancer neovasculature in patients undergoing systemic anti-angiogenesis therapy. PSMA PET will be compared with response to anti-angiogenesis therapy using conventional imaging computed tomography(CT)-based RECIST1.1 criteria as well as histopathological endpoints (tumor vascular density, immunohistochemical staining for PSMA and neovascularization (cluster of differentiation(CD)105, CD31). Whole body PSMA PET/CT scans will be obtained at baseline, following adjuvant anti- angiogenic therapy and when the patient becomes refractory to treatment.

The rationale and time points for obtaining PET scans is planned with respect to the typical natural history of metastatic RCC. This project will obtain information from tumors that are responding to anti-angiogenesis therapy and those resistant to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with locally advanced (\>/=cT3) or metastatic clear cell RCC as proven by biopsy.
* Adults, 18 years of age or older.
* Surgical candidates who have clinical indication for nephrectomy and standard-of-care biopsy of metastatic disease followed by possible standard of care systemic anti-angiogenesis based treatment regimen
* Have consented to participate in the University of Wisconsin Carbone Cancer Center Biobank.

Exclusion Criteria:

* Patients who have received prior RCC systemic therapies
* Prior history of prostate cancer
* Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
* Unable to lie flat during or tolerate PET/CT
* Serum creatinine \> 2 times the upper limit of normal
Interdental Hygiene Methods in Young Adults

Oral health is essential for overall well-being and systemic health. A key factor in preserving this health is maintaining the balance of the interdental microbiota, which involves regulating the quantity of pathogenic bacteria in interdental spaces (IS). These IS represent a unique ecological niche where the body has limited specific defense mechanisms, making them vulnerable to infections.

In adults, the colonization of interdental spaces by pathogenic bacteria increases the risk of periodontal diseases, which are themselves associated with non-communicable diseases such as cardiovascular diseases, diabetes, and certain types of cancer.

Preventing interdental microbiota dysbiosis from a young age is therefore a priority to maintain quality oral health and contribute to good systemic health throughout life. However, conventional brushing techniques cover only accessible tooth surfaces and cannot reach the interdental spaces. Currently, the use of interdental brushes (IDBs) is recognized as the most effective method for interdental hygiene. There are various types of IDBs, differing in several aspects that influence their effectiveness and usability. The main differences relate to their shape, size, and calibration using an interdental probe or not, allowing adaptation to different interdental space sizes. To date, only one study has demonstrated the effectiveness of daily calibrated interdental brush use in reducing dysbiosis and interdental inflammation among young adults. However, no research has yet been conducted to compare the effectiveness of the various types of IDBs available on the market (calibrated versus non-calibrated).


Eligibility Criteria:
Inclusion Criteria:

* Person between 18 and 30 years old
* Person who has given free, informed, express written consent
* Person affiliated to a French social security system
* Person living or working in Lyon or the Lyon conurbation served by public transport (TCL)

Exclusion Criteria:

* Person with a smoking addiction
* Person participating in another study related to oral hygiene
* Patients at high risk of infective endocarditis
* Person with chronic pathologies
* Person having taken antibiotic treatment during the month preceding the start of the study
* Pregnant, parturient or breastfeeding woman
* Persons deprived of liberty by a judicial or administrative decision
* People receiving psychiatric care
* Persons admitted to a health or social establishment for purposes other than research
* Adults subject to a legal protection measure (guardianship, curatorship)
* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
* Person with fewer than 20 natural teeth
* Person performing interdental hygiene and/or daily mouthwashes.
* Person wearing orthodontic appliance
* Person with periodontal disease (stage ≥ II periodontal lesions according to the Chicago 2017 classification (i.e. PD ≥ 4 mm, and/or CAL ≥ 4 mm) and/or generalized (\>30% of sites )), active caries or during dental care
Ceftaroline Diffusion Into Cerebrospinal Fluid of Children

Ceftaroline fosamil is an intravenous (IV) drug that belongs to a group of antibiotics called cephalosporins . Antibiotics are drugs used to treat infections. Clinical studies in adults patient shave shown ceftaroline fosamil to be effective against many bacteria that are resistant to other currently approved antibiotics. Some of these bacteria may be responsible for infections in the central nervous system.The main aim of this study is to gather information to determine how much of a single IV dose of ceftaroline fosamil will enter into a child's CSF so that the benefit of giving ceftaroline fosamil to children with infections can be better determined.

Children 6 months to 17 years of age admitted to the hospital because of infected VPS (ventriculitis) will be eligible for the study. A total of twelve eligible patients will be included in the study. Eligible study subjects would be patients who have undergone VPS removal and placement of EVD tubing and are being treated with standard IV antibiotics for ventriculitis. CSF cultures are obtained before antibiotics treatment is initiated. Standard initial antibiotics regimen is usually IV ceftriaxone and vancomycin. The antibiotics regimen is subsequently adjusted based on the pathogen recovered from the CSF culture. Total IV antibiotic treatment is usually 14 days. Following clearance of the infection the patient undergoes new VPS insertion by neurosurgery service.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 months - 17 years
* Ventriculitis due to VPS infection (abnormal CSF parameters consistent with meningeal inflammation and/or positive CSF culture)
* VPS is externalized and External Ventriculostomy Drain (EVD) is in place
* Patient has IV access and is receiving antibiotic treatment for VPS infection
* Parent/Guardian signed written informed consent
* Negative urine or serum pregnancy test for females of child-bearing potential

Exclusion Criteria:

* Known Allergy to beta-lactam antibiotics
* Moderate to severe renal impairment (Creatinine clearance \< 50mL/minute)
* Parent/Guardian written consent cannot be obtained
* Positive urine or serum pregnancy test
Efficacy and Safety of Micafungin for Injection in Prevention and Treatment of Fungal Infection in Hematological Tumors

This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors.

This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors. Researchers screened suitable subjects according to the admission criteria, and after signing the informed consent form, micafungin sodium for injection was used for preventive or empirical treatment. During the treatment period, subjects who need to change the treatment plan due to uncontrollable infection or other reasons will withdraw from this research and the researchers will decide the follow-up treatment plan.All subjects were monitored for efficacy and safety according to the visit plan during the research.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, male or female
2. Patients with hematological tumors
3. Neutropenia: The absolute neutrophils count (ANC) in peripheral blood was 0.5×109/L or was expected to be ANC\<0.5×109/L 48 hours later.
4. Fever: single measurement of oral temperature ≥ 38.3℃ (axillary temperature ≥ 38.0℃) or oral temperature ≥ 38.0℃ (axillary temperature ≥ 37.7℃) lasts for more than 1h
5. Patients with high risk factors of IFD (Invasive Fungal Disease), such as patients treated with allo-HSCT, patients with acute leukemia (including MDS) undergoing primary induction or rescue chemotherapy, patients with expected granulocytosis lasting more than 10 days, patients with severe granulocytosis or patients with severe aplastic anemia receiving antithymic globulin (ATG) therapy or HSCT therapy, etc.

Exclusion Criteria:

1. The patient is being treated with an antifungal drug
2. People who are known or suspected to be allergic to echinocandins
3. The infection is suspected to be caused by parasites, viruses or Mycobacterium tuberculosis.
4. Existing drug sensitivity results suggest that patients resistant to micafungin
5. Severe chronic liver disease with Child-Pugh grade C
6. Fever caused by tumor
7. Micafungin in the Treatment of Fungal Infections Caused by Cryptococcus, Zygomycetes and Trichospora that Are Ineffective
8. Removal of the central venous catheter can effectively relieve fever, and it is difficult to determine whether micafungin is effective or not.
9. Patients who were not considered suitable for the research
Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality

The main purposes of this study are as follows:

Compare the effect of painful stimuli with and without Hypnosis and Virtual Reality (HVR) on healthy volunteers.

* Use of sensors and captors to monitor physiological and neurophysiological changes by painful stimulus
* Monitor level of pain and anxiety with and without HVR
* Monitor level of unpleasantness of the pain with and without HVR
* Monitor level of Anxiety, Absorption, Dissociation, Satisfaction and Comfort with and without HVR

The control of pain and anxiety in a hospital environment is usually managed by pharmacological means that involve a series of risks and side effects.

For many years, non-drug solutions have been of interest to the public and the care staff. The benefits of hypnosis and of virtual reality are highlighted in many studies and today allow a different approach to medicine. It is important to invest in tools that are less expensive and also effective for the well-being of the patient and the care staff. The use of a blended solution using both clinical hypnosis and virtual reality has been only scarcely documented.

Eligibility Criteria:
Inclusion Criteria:

- 18 years old to 70 years of age

Exclusion Criteria:

* Deaf subject
* Blind
* Non-proficiency in French (research language)
* Psychiatric disorder
* Patient under 18 years old
* Phobia of deep water
* Head or face wounds
* Claustrophobia
* Neurological disease
* Allergy to cutaneous electrodes
* Chronic pain and/or chronic analgesics consumption
* Medication affecting the autonomic nervous system
* Dizziness