cyrilzakka/clinical-trials huggingface dataset:
Sedative Premedication: Efficacy On Patient Experience

Seven French university hospitals will participate in this multicentric prospective, blinded and randomized study. The investigators designed 3 study groups: Lorazepam 2.5mg, Placebo (microcrystalline celluloses) and no premedication at all. The third group (no premedication) is necessary in order to evaluate a placebo response, which may be significant on anxiety level and patients perceptions of care. It was calculated that 969 patients had to be included in order to obtain a 5 point difference between groups on the EVAN score with 80 % statistical power, leading to the inclusion of 1200 patients with an estimated maximum dropout rate of 15 %. All adults below 70 years and scheduled for elective surgery under general anesthesia can be included after information by an anesthesiologist in charge of the study and written informed consent. Non inclusion criterions are: a weight below 45 Kg, a counter indication to benzodiazepine, surgeries that could impair cognitive functions (cardiac or neurologic surgery), usual use of neuroleptics or lithium, drug addiction or former cognitive disease. The technique of anesthesia will be decided by the attending anesthesiologist, who will be unaware of the premedication technique, independently of the study protocol.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged 18 to 70 years or more;
* About a weight greater than 45 kg;
* Subject to benefit from a scheduled surgery under general anesthesia;
* Topic respecting the ambivalence clause defined below:

  1. Having no cons-indication to the use of benzodiazepines;
  2. Having no known allergy to benzodiazepines;
  3. May be a candidate for the prescription of premedication;
* Topic able to complete a self-administered questionnaire;
* Subject has signed a written informed consent and agreeing to abide by the instructions of the Protocol

Exclusion Criteria:

* - Topic of over 70 years;
* Topic 45 kg or less;
* Topic demanding to receive anxiolytic premedication;
* Subject severe respiratory insufficiency;
* Topic minor, pregnant or breastfeeding, about not being affiliated to the social security system;
* Topic for which surgery is performed under local anesthesia;
* Subject unable to perform only a self-administered questionnaire (inability to read French, severe cognitive impairment);
* Subject to which the scheduled surgery may cause postoperative cognitive dysfunction (intracranial surgery, extracorporeal circulation);
* Topic scheduled for obstetrical surgery or outpatient;
* Subject treated with antipsychotic (neuroleptic or lithium);
* Subject with cognitive impairment already documented (Alzheimer, dementia, neurological sequelae);
* Subject active consumer of narcotics;
* Subject has not signed informed consent.
Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary Hypertension

MOMENTOUS is a multi-center, randomized study to prospectively evaluate the performance of an ECG-based AI device to predict whether participants with interstitial lung disease (ILD) are at high risk of undiagnosed pulmonary hypertension.

The goal of this study is to evaluate the use of an ECG-based AI device that may help predict if participants with interstitial lung disease (ILD) are at high risk of undiagnosed pulmonary hypertension (PH). The study seeks to determine whether use of the device increases the rate of new PH diagnoses over a period of 6 months as compared to current standard of care.

The study will recruit participants with ILD from lung disease clinics who will each receive a 12-lead ECG (a test that measures the electrical activity of the heart) following consent. The device will analyze the 12-lead ECG results to identify participants that are at high risk of having undiagnosed PH.

Participants will be randomly assigned to either the Device or Control group. For participants in the Device group investigators will receive the results of the device. In the Control group investigators will not receive the results of the device. Additionally, participants in the Device group identified as "high risk" by the device will receive a transthoracic echocardiogram and a right heart catheterization (RHC). Participants in the Device group who are not high risk and all participants in the Control group will not receive these additional tests as part of the study, but will receive standard of care treatment as determined by their physicians, which may include an echocardiogram or RHC if clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at the time of consent
* A known diagnosis of interstitial lung disease
* Willing and able to provide informed consent and undergo all study-specific procedures, including echo and RHC, if required

Exclusion Criteria:

* A known diagnosis of pulmonary hypertension (including patients prescribed a therapy specifically for pulmonary arterial hypertension (PAH))
* A RHC was completed within the previous 1 year or ordered and not yet completed at the time of consent
* LV ejection fraction ≤ 40% on most recent echo or cardiac MRI, if available
* Unclassifiable Tempus PH ECG risk result after up to 2 ECG acquisitions
* A contraindication to RHC exists (for example, mechanical right heart valve)
* Physician decision that if a patient is directed to RHC by the study protocol, the potential risks of RHC outweigh the potential benefits
* There is a severe concomitant illness limiting life expectancy to less than 6 months (at the discretion of the investigator)
* There is a medical or social factor that makes the patient a poor candidate for the study and/or unlikely to be able to comply with the study protocol or complete study procedures (at the discretion of the investigator)
Hypoglycemia and the Mineralocorticoid Receptor

The purpose of this study is to look at whether blockade of the mineralocorticoid receptor will result in changes in the cardiovascular and inflammatory response to hypoglycemia.

The effect of ongoing hypoglycemia on cardiovascular autonomic function is unclear and the focus of this protocol. In our preliminary studies, the investigators demonstrated that baroreflex sensitivity is impaired during hypoglycemia in healthy individuals. Treatment with eplerenone (200mg total administered in two doses in the 15 hours prior to the hypoglycemic clamp) prevented this impairment.

The study is based on the overarching hypothesis that hypoglycemia leads to increases in aldosterone/mineralocorticoid receptor (MR) activity and increased cardiovascular injury.

This study will address the following Specific Aims:

To test the hypothesis that MR blockade will reduce the adverse effects of hypoglycemia on inflammation and on autonomic control of cardiovascular function.

The investigators will determine the effects of hypoglycemia (50 mg/dl for 2.0 hours) on the blood inflammatory factor interleukin-6 levels, and on cardiovascular autonomic function (baroreflex sensitivity) in each subject under two conditions - pretreatment with MR blockade (eplerenone) and pretreatment with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Males and females age 18 to 40 years

Exclusion Criteria:

* Pregnancy
* Lactation
* Menopause
* Any medical condition other than treated hypothyroidism.
* Alcoholism
* Active tobacco use
* In all subjects, any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.
* Use of medications other than physiological thyroxine replacement
* Serum potassium \>5.0 mmol/L
* Estimated glomerular filtration rate \< 60 mL/min
The 4th Month Oral Consultation at Pregnant Women

Epidemiological studies have suggested that maternal periodontitis affects the fetal-placental unit, with an increased risk of adverse pregnancy outcome. Indeed, it has been suggested that the direct or indirect action of parodontopathogenic bacteria induces an inflammatory cascade that leads to spontaneous premature labor. Also, non-treatment of caries and periodontal disease can lead to acute pain and stress. This may promote self-medication and the inappropriate use of analgesic medications, potentially harmful to the health of the fetus. As part of the prevention of complications of pregnancy associated with oral diseases, the National Agency for Accreditation and Evaluation in Health (ANAES) has set up a system that allows any pregnant woman to consult between the 4th and 7th month of pregnancy, an oral health professional to carry out a complete assessment and free care. This study aims at evaluating this device among pregnant women and healthcare professionals 4 years after its implementation. On the other hand, it will make it possible to look for a possible link between the realization of an oral prenatal follow-up and the outcome of the pregnancy.

This study will concern two populations:

* pregnant women attending hospital during pregnancy monitoring and / or being hospitalized in one of the maternity wards associated with the project,
* health professionals in charge of the follow-up of these pregnant women and their childbirth.

The study will include:

* 500 pregnant women: 300 in Nantes and 200 in Brest
* 150 health professionals.

Eligibility Criteria:
Inclusion Criteria for pregnant women:

Any woman who is consulting or hospitalized in a maternity unit participating in the project is eligible for the following criteria:

* a voluntary adult woman who gave oral consent
* pregnant women (2nd and 3rd trimesters) or postpartum women hospitalized at the maternity ward
* women agreeing to participate in the study

For health professionals:

* midwife, maieutician, gynecologist and obstetrician,
* have graduated from a specialty,
* agreeing to participate in the study

Exclusion Criteria for pregnant women:

* child
* person under curatorship, under guardianship, deprived of liberty,
* refuse to fill in the questionnaire,
* no understanding of oral or written French,

For health professionals:

- Not graduated
Monoclonal Antibody Plus Cyclophosphamide in Treating Patients With Metastatic Cancer

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody and cyclophosphamide in treating patients with metastatic cancer.

OBJECTIVES: I. Evaluate the clinical feasibility and toxicity of monoclonal antibody OKT3 given with low-dose cyclophosphamide in patients with advanced malignancies. II. Perform serial immune monitoring on patients treated with this regimen. III. Identify any clinical responses produced by this regimen.

OUTLINE: Biological Response Modifier Therapy with Suppressor Cell Inhibition. Anti-CD3 Murine Monoclonal Antibody OKT3, MOAB OKT3; with Cyclophosphamide, CTX, NSC-26271.

PROJECTED ACCRUAL: At least 9 evaluable patients per diagnostic category will be required initially; if any response is seen during the dose-finding portion of the study, a total of 24 patients with that diagnosis will be entered.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Metastatic cancer considered incurable by standard therapy and for which no higher priority protocol is available Locally progressive primary brain tumors (e.g., astrocytoma, glioma) are also eligible Brain metastases allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-4 (poor performance status brain tumor patients specifically eligible) Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: No history of adult asthma No emphysema No pulmonary insufficiency No pulmonary edema Other: No AIDS or positive HIV serology No pregnant women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Delivery of Polyphenols in Gum as an Anti-Caries Agent

The short-term effects of chewing gum containing xylitol and/or blackberry extract on oral microbiota was studied. Fifty healthy adults participated in a randomized, placebo-controlled, cross-over design study.

The short-term effects of chewing gum containing xylitol and/or blackberry extract on oral microbiota was studied. Fifty healthy adults participated in a randomized, placebo-controlled, cross-over design study. One group chewed 1 piece of xylitol-containing chewing gum 4 times/day and the other chewed 1 piece of BBE+xylitol-containing gum 4 times/day. All wore a custom stent with a sterile enamel chip luted to the facial surface during the 1-day experiment. Unstimulated saliva was collected at 8 am and 4 pm, and enamel chips were harvested at 4 pm. A week later participants chewed gum from the other group. The bacterial composition in saliva and on the enamel chips were assessed using real-time PCR.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy, had 20 or more natural erupted teeth, and had gingivitis (bleeding on probing \[BOP\] in more than 15% of sites, less than 25% sites with \> 4 mm probing pocket depths (PPD), and less than 5% sites with 5 mm depth PPD, who were a non-smoker, willing to participate, and verbally understood and signed an informed consent prior to enrollment

Exclusion Criteria:

* unable or unwilling to provide informed consent or follow study protocol, current smoker, systemic condition including diabetes mellitus, liver disease, kidney disease, autoimmune disease, and any cardiovascular condition that would require premedication prior to dental treatment, use of systemic antibiotics within three months of study entry, use of over the counter or prescription medications known to have anti-inflammatory/immunosuppressant activities (e.g., nonsteroidal anti-inflammatory drugs (\>14 day use in past 3 months), steroids, vitamin supplements, statin drugs, topical chlorhexidine on a daily basis, pregnancy as diagnosed by administered of a pregnancy test, cancer or cancer therapy within the last year, immunosuppression (e.g., organ transplant), orthodontic therapy (current or within the last 6 months), inability to communicate verbally or in writing, clinically detectable oral mucosal inflammatory condition (e.g., aphthous, lichen planus, leukoplakia, oral cancer), or febrile illness, persistent cough or current infectious condition (e.g., influenza, hepatitis), or any PPD of 6 mm or greater at the time of the baseline periodontal examination.
Does Urinary TIMP2 and IGFBP7 Can Identify High Risk Patients of Progression From Mild and Moderate to Severe Acute Kidney Injury During Septic Shock?

Septic shock is one of the leading causes of death in patients admitted to the intensive care unit (ICU). Acute kidney injury (AKI) occurs in almost 50% of septic patients and is associated with significant mortality. Progression to the last stage (KDIGO stage 3) of AKI is an important step in the disease, as it usually requires initiation of RRT. Renal biomarkers are unable to accurately identify those patients who will progress to severe AKI (KDIGO 3). However, identification of patients at risk of progression to severe AKI could help the clinician to initiate optimal therapy including RRT. A new urine test, the Nephrocheck™ corresponding to the product of the urinary concentrations of 2 markers of renal tubule injury (TIMP2 and IGFBP7) has been validated. The Investigator have already performed two previous studies including septic shock patients (AKICHECK and BIOOCHECK). those previous datas will be reanalysed to examine whether the new urinary biomarkers TIMP2 and IGFBP7 can predict progression within 24 hours and 72 hours from mild and moderate (KDIGO 1 or 2) to severe AKI (KDIGO 3) in patients with septic shock.

-All the datas required will be collected from two previous studies (AKICHECK and BIOCHECK) performed in 3 centers: Amiens medical ICU, Melun medico surgical ICU and Montpellier Medical ICU.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Septic shock (according to Bone's criteria) within 4 hours of introduction of catecholamines
* AKI, characterized by a KDIGO score ≥ 1
* Social security coverage

Exclusion Criteria:

* AKI requiring emergency RRT (in the critical care physician's opinion).
* Anuria
* Stage 4-5 chronic kidney failure with a GFR below 30 ml/min.
* Rapidly progressing renal disorders (glomerulonephritis, HUS, blockage, etc.)
* Obstructive AKI
* Probable glomerular damage (nephritic syndrome, nephrotic syndrome, chronic glomerulonephritis)
* Pregnancy or breastfeeding
* Legal guardianship or lack of social security coverage.
* Cardiocirculatory arrest
* Life expectancy \<48 hours.
* Child C cirrhosis
* Prior occurrence of AKI during the current hospital stay
* Transplantation
* Subject participating in another study with an exclusion period ongoing at the time of the pre-inclusion
A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus

The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.


Eligibility Criteria:
Inclusion Criteria:

a) Must have one of following diagnoses: i) Meet European League Against Rheumatoid (EULAR)/American College of Rheumatology 2019 Classification Criteria for systemic lupus erythematosus (SLE) OR ii) Biopsy-proven acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), or discoid lupus erythematosus (DLE): Participants without a concurrent SLE diagnosis are eligible b) Active cutaneous lupus disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (mCLASI-A) score ≥ 6 c) Active cutaneous lupus skin lesion(s) amenable to biopsy

• Women of childbearing potential (WOCBP) and men must agree to follow instructions for method(s) of contraception, if applicable

Exclusion Criteria:

* Active severe or unstable neuropsychiatric SLE
* Active, severe Lupus Nephritis (LN)
* Any British Isles Lupus Assessment Group (BILAG) A or B, unless within the constitutional, musculoskeletal and/or mucocutaneous domains

Other protocol-defined inclusion/exclusion criteria apply
Evaluation of Neuroinflammation in Children With Infantile Spasms

The purpose of this study was to investigate the presence of neuroinflammation in children with infantile spasms using 11C-PK11195 positron emission tomography (PK PET) scan, and its response to ACTH treatment by repeating the PK PET scan after treatment.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of 'cryptogenic IS'
* Normal MRI
* No other neurological disorder

Exclusion Criteria:

* Abnormal MRI
* No anti-inflammatory medication 48 hrs prior to PK PET scans
* Parent/guardian unable to give written consent
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis

ARCT-032-02 is a Phase 2, open-label, multicenter, multiple-ascending dose study of ARCT-032 in adults with CF who are not eligible for CFTR modulator therapy or are not taking CFTR modulators due to drug intolerance, poor response, or lack of access to modulators.

This is an open-label, multiple-ascending dose study of ARCT-032 in adults with CF who are not on CFTR modulator therapy. After successful screening, eligible participants will receive nebulized ARCT-032 daily for 4 weeks, and then followed for safety for a total of 12 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

1. Confirmed diagnosis of Cystic Fibrosis
2. Not eligible for CFTR modulator therapy, or not taking CFTR modulators for at least 60 days prior to dosing (e.g. due to intolerance, poor response, or lack of access to modulators).
3. FEV1 between 40% and 100% of predicted value

Exclusion Criteria:

1. History of illness or medical condition that might pose an additional risk or may confound study results
2. Recent moderate or severe hemoptysis
3. Recent major surgery
4. Solid organ or hematologic transplant
5. Requirement of supplemental oxygen while awake or \> 2L per minute while sleeping.
6. Chronic maintenance systemic corticosteroids exceeding equivalent of daily 15 mg oral prednisone or 30 mg every other day
7. Adequate liver and kidney function as determined by lab tests
Ob/Gyn Residency Podcast Curriculum

This a randomized trial comparing the use of an organized podcast curriculum using the podcast, CREOGs Over Coffee, to usual teaching for first and second year Ob/Gyn residents on their obstetrics rotations. Residents at HUP and PAH will be included. Post intervention questionnaires will be administered at the end of each block to assess resident satisfaction with their block as well as confidence in their clinical care and skills. CREOG scores will be used to assess knowledge differences.

All PGY-1 and PGY-2 Ob/Gyn residents at the Hospital of University of Pennsylvania (HUP) and Pennsylvania Hospital (PAH) will be eligible and recruited for this randomized trial over the period of January 2021 January 2023 (period chosen as CREOGs are given in January, and trial will start immediately after next CREOG exam). There are currently 7 PGY-1 residents and 8 PGY-2 residents at HUP and 7 PGY-1 residents and 8 PGY-2 residents at PAH. In two academic years, with the addition of 7 PGY-1 residents at HUP and 7 PGY-1 residents at PAH, this will total 43 residents.

Residents will be randomized individually to receive a podcast curriculum vs. usual teaching on the labor floor rotations. Rotations where there will be a podcast curriculum include labor and delivery, night float, and Maternal Fetal Medicine. The details of the curriculum for each rotation will be listed below. At all times, all residents will have access to the podcast content, but those randomized to usual teaching will not be given an organized podcast curriculum for each rotation. Currently, usual teaching includes didactic teaching for the above topics on Thursday mornings (7am-12 pm), clinical teaching while on the rotations, simulation training, and self-learning.

Residents will be protected against undue influence or coercion as those that are administering the surveys and recruiting residents (FC) will not be involved in their residency reviews.

Eligibility Criteria:
Inclusion Criteria:

* Residents that are PGY1-2 at the Hospital of the University of Pennsylvania and Pennsylvania Hospital in OB/Gyn

Exclusion Criteria:

* Those not meeting inclusion criteria