cyrilzakka/clinical-trials huggingface dataset:
Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium

To observe the effect of preoperative anti-PD-1 monotherapy combined with chemotherapy on patients' perioperative pain and opioid analgesia, and evaluate its effect on the incidence and severity of patients' postoperative delirium.

In this study, the investigators intend to select patients with resectable NSCLC treated with immuno-neoadjuvant therapy in combination with chemotherapy, systematically observe the effect of preoperative anti-PD-1 monotherapy on patients' perioperative pain and opioid analgesia, and evaluate its effect on the incidence and severity of patients' postoperative delirium, in order to provide a clinical basis for the perioperative management of patients treated with immuno-neoadjuvant therapy and promote their postoperative recovery.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage II or stage IIIA non-small cell lung cancer (NSCLC) and meet the requirements for R0 resection;
* American Society of Anesthesiologists (ASA): I-III, age ≥18 years, body mass index (BMI): 18.5-30;
* Normal function of Coagulation and vital organs such as heart, lungs, kidney, and liver;
* Eligible to receive platinum-containing two-drug chemotherapy;
* Sign the informed consent form

Exclusion Criteria

* Prior treatment of any kind for current lung cancer, including chemotherapy, radiation or targeted therapy;
* Preoperative opioid analgesia;
* Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection;
* History of antipsychotic medication in the last 6 months;
* Preoperative Mini-mental state examination (MMSE) score \<23
Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims

Obesity is a public health phenomenon affecting more than 17% of women in France, and more than 20% of men and women in Champagne-Ardenne.

Obese women are more likely to have an unplanned pregnancy, whereas these pregnancies are more at risk than women of normal weight and should be planned or considered after weight loss. These women are also often less well followed in terms of gynecology and especially on contraception.

More and more patients are opting for bariatric surgery. However, bariatric surgery is not trivial. Indeed, the important loss of weight expected is at risk of nutritional deficiencies. In addition, a large number of patients are still obese during the months following surgery. This is why pregnancy is theoretically contraindicated within 12 or 18 months postoperatively.

Women with bariatric surgery must have been properly informed of these risks so that they can choose a contraceptive method, and that can be adapted to both their risk factors and the surgical technique performed.

The purpose of this study is to describe contraception in obese women who have undergone bariatric surgery in Champagne-Ardenne.

Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 50 years old
* Followed at Reims University Hospital after bariatric surgery
* Pre-menopausal status
* Accepting to participate in the study

Exclusion Criteria:

* Women less than 18 or more than 50 years old
* Women with postmenopausal status
* Women refusing to participate
Human Factors Analysis in VR for Burn Treatment

A number of studies have shown that virtual reality (VR) can be used to distract patients from pain and anxiety during painful medical procedures for which medication provides inadequate relief. An inexpensive, commercially available VE could have significant impact in reducing perceived pain involved in a variety of medical procedures. The Virtual Reality Medical Center (VRMC) developed an engaging virtual world that proved to be effective in reducing reported pain ratings of participants experiencing several different forms of painful stimuli. The virtual world called Icy Cool World was found to successfully distract patients from painful stimuli and reduce patients' perceived levels of pain. Phase II looks to expand on these findings and examine the effectiveness as a pain distraction technique for a variety of acute and chronic pain etiologies. The main objective of the clinical investigation will be to expand on the findings from earlier studies and obtain a more comprehensive analysis regarding the clinical versatility of VR pain distraction.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65, male or female, any ethnicity as long as candidates can understand and read English adequately.

Exclusion Criteria:

* We will exclude participants who meet DSM-IV-TR criteria for alcohol or other substance abuse in the past year, or are currently using any recreational drugs, or taking more than 20 alcoholic drinks a week. In addition, the Beck Depression Inventory II (BDI-II) score must be less than 16, with no suicidal ideation.
Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus

The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago.

Exclusion Criteria:

* Tinnitus that is not completely maskable
* Fluctuating tinnitus
* Intermittent tinnitus
* Meniere's Disease
* Ongoing acute or chronic otitis media or otitis externa.
Clinical Study to Evaluate the Safety and Effectiveness of MER® Stents in Carotid Revascularisation.

The aim of the study is to confirm, whether the MER® stent can be used, without limitations, for the endovascular carotid stenosis treatment in daily clinical practice. Eligible patients will undergo the procedure of the common or internal carotid artery stenting using MER® with proximal or distal neuroprotection.

MER® stent will be implanted in eligible patients with common and internal carotid stenosis after an informed consent.

Potential benefit of the MER® stent implantation will be evaluated based on angiography and duplex Doppler ultrasound examination.

Follow ups are scheduled at 30 days, 6 and 12 months after index procedure. Except for clinical follow up patients will undergo carotid vessels ultrasound examination after 6 and 12 months. In case of an emergency visit, caused by the Serious Adverse Event, Patient will undergo: neurological and cardiac evaluation as well as carotid vessels USG examination and extended CT or MRI scans.

In general, all procedures in the study will follow the local standard of care. The type of devices used during the angioplasty (including the MER® stents) will not differ from the devices used in the usual clinical practice in the hospital. DAPT and other medical therapy will be consistent with the rules of the Polish and European Society of Cardiology.

Eligibility Criteria:
Inclusion Criteria:

* De novo lesion located in the internal carotid artery or common carotid artery

  * DS ≥50% (nonsymptomatic patients) and ≤99% based on QCA
  * DS ≥75% (symptomatic patients) and ≤99% based on QCA
* Target lesion available for 20-60mm lenght and 4-10mm diameter scaffold
* Patient eligible for CAS
* Age ≥ 18
* Life expentancy ≥ 12 months
* The patient's written informed consent has been obtained prior to the procedure.

Exclusion Criteria:

* Lack of neurological CAS qualification
* The patient has experienced an acute myocardial infarction within 72 hours of the procedure
* The patient has known paroxysmal, persistent or permanent atrial fibrillation or flutter
* The patient has known gastrointestinal bleeding
* Pregnancy
* DAPT contraindications
* Surgery planned within 1 month after the procedure
* A platelet count \<100,000/mm³ or \>600,000/mm³
* The patient has known nickel, titanium or contrast allergy
* The target vessel is totally occluded
* The patient has stent(s) in the target lesion
* Statin therapy contraindications
* The target lesion has massive calcifications
* Hyperthyroidism
* Post-radiotherapy side effects
* No pulse in femoral artery
* Chronic kidney disease (creatinine level \>2,0 mg/dl or eGFR\<30 mL/min/1.73 m2 or dialysotherapy)
Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department

The investigators test the efficacy of closed reduction in displaced distal radial fractures in the emergency department.

in a multicenter cluster randomized trial the investigators aim to include 134 patients with displaced distal radial fractures awaiting surgery and randomize between closed reduction followed by plaster casting and plaster casting alone. Primairy outcomes are pain in the days leading up to surgery and postoperative hand- and wrist function. Secondary outcomes are length of stay in the emergency department, length of surgey, return to work and complications.

Eligibility Criteria:
Inclusion Criteria:

* displaced distal radial fracture eligible for surgery

Exclusion Criteria:

* ISS traumascore \>16
* open fracture
* multiple fractures in ipsilateral extremety
* neurovascular damage
* previous injury in the same wrist
* inability to complete questionnaires
MMRF Molecular Profiling Protocol

This protocol is now being used as screening for the MyDRUG study

Here we propose an "integrative sequencing approach" utilizing a 1500 gene exome comparative analysis between multiple myeloma or related plasma cell malignancies and normal cells coupled to capture transcriptome sequencing to provide a nearly comprehensive landscape of the genetic alterations for the purpose of identifying informative and/or actionable mutations in patients with multiple myeloma and plasma cell malignancies. The approach will enable the detection of point mutations, insertions/deletions, gene fusions and rearrangements, amplifications/deletions, and outlier expressed genes among other classes of alterations.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a diagnosis of multiple myeloma or related malignancy
2. Patients are undergoing standard of care bone marrow aspirates
3. Patients (male or female) from any race or ethnicity must be at least 18 years of age at the time of registration.
4. Procedure-specific signed informed consent form prior to initiation of any study-related procedures.

Exclusion Criteria:

1. It is the enrolling study physician's discretion to decide if a patient is not fit enough to undergo a bone marrow aspirate.
2. Patients who are incarcerated are not eligible to participate.
3. Women who are pregnant
4. Patients who have had another malignancy within the last five (5) years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix) where there is a possibility to contaminate the bone marrow aspirate.
Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at screening
* Treated with maintenance hemodialysis 3 times a week for ≥ 3 months prior to screening
* Informed consent provided by the study candidate
* For subjects NOT receiving cinacalcet and/or vitamin D therapy for SHPT within 60 days prior to enrollment: Plasma PTH levels ≥ 450 pg/mL (50 pmol/L) during screening, as obtained from the central laboratory and, Serum corrected total calcium ≥ 8.4 mg/dL (2.1 mmol/L) and \< 10.2 mg/dL (2.55 mmol/L) during screening, as obtained from the central laboratory

Exclusion Criteria:

* Parathyroidectomy in the 12 weeks before the date of informed consent
* History of seizure within 12 weeks prior to randomization
* Scheduled for kidney transplant
* Parathyroidectomy anticipated within the next 6 months
* Liver function tests \> than 2 x the Upper Limit of Normal
* Prior use of bisphosphonates, or expected to receive bisphosphonates during the trial
* Subject has previously enrolled in this study
* General
* Other investigational procedures are excluded
* Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
* Subject (male or female) is not willing to use highly effective contraception during treatment and for at least one month (women) and 3 months (men) after the end of treatment
* Subject is pregnant or breast feeding, or planning to become pregnant during study or within 1 month after the end of treatment Male subject with a pregnant partner who is not willing to use a condom during treatment and for at least 1 month after the end of treatment
* Subject has known sensitivity or intolerance to any of the protocol required therapies
* Subject will not be available for protocol-required study visits, to the best of the subject and investigator's knowledge
* Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis

This study looks at the improvements in signs and symptoms in patients with inflammation of the lids, blepharitis, using two different FDA approved topical antibiotic agents, Besifloxocin and Erythromycin. It also evaluates the bacterial cultures in these patients for microbiologic evidence of improvement.

This is a pilot project involving thirty patients with a specific form of inflammtion of the lids called anterior blepharitis. The patients are graded for their signs a symptoms and then randomized to receive either topical Besifloxocin or Erythromycin in addition to standard lid hygiene measures. All patients have cultures of their eyelids performed prior to initiating therapy and are followed for four weeks. The antibiotics are used for two weeks following which repeat cultures of the lids are obtained. The patients are followed for one additional week to ensure that there is no recurrence of their symptoms once the antibiotics are discontinued.

Only adult patients (age 18-100)and women who are not of child bearing potential are included in this study. Then patients have to have symptoms and signs of the disease, blepharitis. Patient who are on unstable antibiotic or steroid regimens and those who cannot discontinue contact lens use are not included in this study.

Eligibility Criteria:
Inclusion Criteria:Acute blepharitis, age 18-100, Signs and symptoms of blepharitis -

Exclusion Criteria: women of child bearing potential, eye surgery within three months of study, contact lens wear, use of topical or antibacterial agents in past two weeks, use of topical or oral steroids in past two weeks unless stable dosage

-
Dislocation Precautions

This study is looking at the impact of giving patients precautions, or restrictions for movement, when undergoing a total hip replacement. Have of the participants will receive precautions, while the other half will not receive any precautions.

Patients undergoing hip replacements are often told by health care providers to avoid specific positions and activities to decrease the risk of their hip dislocating following their surgery. This, however, results in patients becoming more fearful of moving and leads to limitations in their function and decreased quality of life. Previous research has shown that hip dislocations following surgery are most commonly attributed to poor implant position rather than the actions of the patients. Teaching precautions takes up healthcare resources and may use finances that are not necessarily required. This study aims to compare groups with half receiving precautions and half not receiving precautions, to assess the impact of precautions on the patients' quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Receiving a primary total hip arthroplasty (THA) due to osteoarthritis or osteonecrosis
* Over 18
* Willing and able to sign consent

Exclusion Criteria:

* Receiving a lateral approach hip arthroplasty
* Cannot make follow up visits
Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain

This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,

This study is a prospective, blinded, multi-center, multi-reader clinical study that is statistically powered for demonstrating non-inferiority of synthetic 3D MR images compared to conventional MR images with respect to sensitivity and specificity of pathological findings.

The study consists of three parts:

* Clinical MR acquisition,
* Synthetic MR post-processing
* Blinded image evaluation of conventional and synthetic images for each subject.

The study will enroll eligible subjects with an already scheduled brain MRI and also healthy volunteers, that meet applicable site MR safety criteria. The routine MRI scan will include approximately 5-20 minutes extra time for the additional images to be taken. This time will be added to the length of the scheduled scan. It is only the time in the MRI scanner that will differ from standard procedures, no other examinations will be performed.

The study consists of one visit, without additional follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Any gender, aged 0-99 years
* Subject scheduled for MRI of the brain OR Healthy control with passed screening form
* Subject suitable for MRI as judged by investigator
* Subject agrees to 5-20 min extra MRI scan time
* Subject able to understand written and verbal information in English or Spanish
* Provision of informed consent (and assent if applicable)

Exclusion Criteria:

* Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site
* Have severe trauma, disability or pre-existing pathology that is expected to interfere with normal conduct of MRI scanning or complete scanning of the brain
* Have medical condition(s) such as those requiring urgent medical care that, in the opinion of a physician investigator, would prevent safe participation in the study
* Adult subjects (aged 18-99 years) in need of anesthesia during MRI scanning
* Pregnancy at time of enrollment determined according to the clinic's MR Safety Screening policy
* Previous enrollment in this investigation
Effects of Oxytocin on Cognitive and Reactive Fear

The study examines the (sub)regional specificity of anxiolytic oxytocin (OXT) effects on emotional face processing and reactive and cognitive fear. Preliminary data indicate that the Receptor for Advanced Glycation End Products (RAGE) may regulate oxytocin transport into the brain. Thus, the study aims to replicate previous observations of oxytocin effects on the processing of fearful faces in the centro-medial amygdala and to assess whether a RAGE polymorphism (-374 T/A: rs1800624; TT vs. TA/AA), that has been shown to alter transcriptional activity, modulates anxiolytic OXT effects.

So far, no study examined selective oxytocin (OXT) effects on reactive (midbrain periaqueductal gray (PAG), central amygdala (CeA), hypothalamus, and the midcingulate cortex (MCC)) and cognitive fear (ventromedial prefrontal cortex (vmPFC), posterior cingulate cortex (PCC), hippocampus, and basolateral amygdala) and the reward system (striatum) with high spatial resolution. Previous studies showed that 7T functional magnetic resonance imaging (fMRI) results in a higher spatial resolution and specificity than 3T MRI in these brain regions and would thus allow for a more detailed characterization of the neural effects.

To disentangle (sub)region-specific effects of OXT on task-related activations of the cingulate structures, the amygdala, the striatum, PAG and VMPFC, the investigators plan to acquire ultra-high field 7T fMRI data from healthy male participants while they perform (i) an emotional face matching task and (ii) a flight initiation distance (FID) task involving fast- or slow-attacking virtual predators that elicit distinct activations in the reactive and cognitive fear circuits. Furthermore, participants will be pre-stratified depending on RAGE polymorphisms to elucidate possible RAGE-related differential OXT effects.

Eligibility Criteria:
Inclusion Criteria:

* RAGE polymorphism (-374 T/A: rs1800624; TT vs. TA/AA)
* healthy male volunteers
* right handed

Exclusion Criteria:

* current psychiatric illness
* current psychiatric medication or psychotherapy
* MRI contraindication (e.g. metal in body, claustrophobia)
Cancer Associated Thrombosis : What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO

Venous thromboembolism is a common and fatal disease closely related to cancer. The therapeutic challenge is major due to the high risk of recurrent thromboembolism and bleeding in patients with cancer.

Guidelines recommend the use of low molecular-weight heparin for the treatment of Cancer-Associated venous Thromboembolism (CAT) at least for 3 to 6 months of treatment.

However, recent advances through the results of several therapeutic trials such as CARAVAGGIO (NCT03045406) open the door to the use of Direct Oral AntiCoagulants (DOACs) as first-line therapy.

Nevertheless, extrapolation of its results may be limited owing to a large number of inclusion and exclusion criteria, which may have selected a reduced population.

The proportion of patients admitted with acute CAT who may not eligible to a trial as CARAVAGGIO is unknown.

The aim of this study si to assess this proportion in a retrospective multicenter study, of patients admitted for acute Cancer-Associated venous Thromboembolism (CAT).

Eligibility Criteria:
Inclusion Criteria:

Consecutive patients with a newly diagnosed, objectively confirmed:

* symptomatic or unsuspected Deep Vein Thrombosis (DVT) (any location)
* symptomatic or unsuspected Pulmonary Embolism (PE)

Consecutive patients with any type of cancer whose primary brain tumor or known intracerebral metastases and acute leukemia that meets at least one of the following:

* Active cancer defined as diagnosis of cancer within six months or receiving treatment for cancer or any treatment for cancer or recurrent locally advanced or metastatic cancer.
* Cancer diagnosed within 2 years.

Exclusion Criteria:

* pregnant women or breast feeding
A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants

The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with clarithromycin in healthy participants. This study will last up to approximately 85 days for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²)
* Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria:

* Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Participants who regularly use known drugs of abuse
* Women who are lactating and who are of child-bearing potential
* Participants who have known allergies to LY3502970, related compounds, or any components of the formulation