cyrilzakka/clinical-trials huggingface dataset:
Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

The objective of this trial is to study REGN4659 and cemiplimab in treatment-experienced, non-small cell lung cancer (NSCLC) patients. There are 2 phases of this study: a dose escalation phase and a dose expansion phase.


Eligibility Criteria:
KEY Inclusion Criteria:

1. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with unresectable stage IIIB or stage IV disease
2. Combination dose escalation cohorts: Treatment-experienced patients who have received no more than 3 lines of systemic therapy including no more than 2 lines of cytotoxic chemotherapy, and for whom no available therapy has a high probability to convey clinical benefit.
3. Dose escalation cohort C: Anti-PD-1/PD-L1 naïve patients who have received 1 to 2 prior lines of cytotoxic chemotherapy including a platinum doublet-containing regimen
4. Expansion cohort(s): Anti-PD-1/PD-L1 experienced patients who have progressed while receiving therapy or within 6 months of stopping therapy for stage III or IV disease. Patients must not have permanently discontinued anti-PD-1/PD-L1 therapy due to treatment related AE. Patients must have received one line of anti-PD--1/PD-L1 immunotherapy. Patients may also have received one line of chemotherapy

KEY Exclusion Criteria:

1. Expansion cohort(s) only: Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
2. Active or untreated brain metastases or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. Patients must be off (immunosuppressive doses of) corticosteroid therapy
3. Expansion cohort(s) only: Patients with tumors tested positive for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) gene mutations or ROS1 fusions.
4. Radiation therapy within 2 weeks prior to enrollment and not recovered to baseline from any AE due to radiation
5. Patients who received prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody
6. Previous treatment with idelalisib (ZYDELIG®) at any time

Note: Other protocol defined inclusion/ exclusion criteria apply
Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation

Tracheostomy is performed for prolonged mechanical ventilation. Ineffective bandaging following decannulation leaves the tracheostomy wound unsealed, reducing pulmonary function, coughing ability, and voice quality, ultimately leading to decannulation failure. Recently, a new concept enabling intratracheal sealing of the tracheotomy was introduced, potentially solving the issues of air leakage and tracheal wound infection. This study aims to investigate the feasibility of intratracheal tracheostomy sealing in relation to an immediate normalization of physiological airway flow and an improved voice quality.

See protocol document.

Eligibility Criteria:
Inclusion Criteria:

* Tracheostomy for minimum 7 days
* Age \> 18 years
* Capped uncuffed tube size 7 or 8 for at least 24 hours

Exclusion Criteria:

* Cognitive dysfunction (patients who are not able to cooperate with investigation)
Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT

The need to promote research in active aging trough multidisciplinary and innovative approaches is strongly indicated by the European Union. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI)

The European Union emphasizes the need to promote research in active aging trough multidisciplinary and innovative approaches, addressing challenges related to neurodegenerative diseases in old adults. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI).

Methods: A feasibility randomized controlled clinical trial will involve 30 individuals who are over 65 years old, both sex, who have received the diagnosis of MCI, randomly assigned to experimental condition or control group. Both groups will continue to receive standard pharmacological therapy (TAU). The experimental group will undergo a 3-months cognitive remediation program with fully immersive VR with two sessions per week (each session of sixty minutes). The control group will continue with TAU.

Feasibility will be assessed based on tolerability, including dropout rates and acceptability, (proportion of recruited participants among those considered eligible) and side effects. The preliminary measures of effectiveness will be evaluated on cognitive functions, quality of life, biological and social rhythms, anxiety and depressive.

Eligibility Criteria:
Inclusion Criteria:

* age 65 and above, a diagnosis of MCI based on DSM-IV criteria \[American Psychiatric Association, 2000\]

Exclusion Criteria:

* failure to meet inclusion criteria, a diagnosis of epilepsy or severe visual impairments due to potential risks associated with extensive virtual reality stimulation, and severe illnesses impeding bi-weekly intervention attendance
A Morbidity-Mortality and Remodeling Study With Valsartan

The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment, will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.

Several recent clinical trials have demonstrated that angiotensin II receptor blockers (ARBs) have cardiovascular as well as renal protective effects. However, it is a problem that the number of Asian patients is very little in these trials. The researchers examine the treatment meaning by ARB about the prognosis of the patient who amalgamates either among high blood pressure, the ischemic heart disease, and congestive heart failures.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure

Exclusion Criteria:

* Pregnancy
* Severe renal damage
* Severe liver damage
* Acute myocardial infarction
Assessment of Emotional Memory During Transient Global Amnesia

There are few studies on the role played by emotions in transient global amnesia (TGA), in particular with regard to their impact on the functioning of memory. The study investigators wish to better understand the link between episodic memory, emotional state and psychogenic factors during TGA. It would be interesting to see if the patients suffering from TGA triggered by a psychological shock process emotional information differently from those whose TGA was triggered by an "organic" shock (physical effort, trauma, etc.). Finally, amnesic stroke is a good model for better understanding the function of the hippocampus, in particular of the CA1 region, in episodic memory.


Eligibility Criteria:
Inclusion Criteria:

* Subject with no history of transient global amnesia or neurological or psychiatric pathology.
* Patients with a transient global amnesia according to the criteria of Hodges and Warlow (1990) in the acute phase (i.e. within 24 hours after the onset of the stroke), accompanied by a trusted person
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is participating in another study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breastfeeding
* Presence of a focal neurological pathology that may explain the symptoms, history of epilepsy or psychiatric disorders.
* Hypersensitivity to iodinated contrast media.
* Known allergy to 18-FDG.

Non-inclusion criteria concerning control subjects:

* Presence of disorders on neurological assessment
* Presence of cognitive disorders on the neuropsychological assessment (z-score \<-1.65 on the RBANS or on the Stroop test).

Exclusion criteria for the target population:

• Patients will be excluded after the 1st neuropsychological assessment if episodic memory tests show complete recovery from anterograde amnesia.
Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly

The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients \>/= 65 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.


Eligibility Criteria:
Inclusion Criteria:

* All new type II odontoid fractures including \< those in which the fracture line crosses into the body of C2 \< as long as it doesn't enter the superior articular process of C2
* Age 65+
* Stable and unstable fractures
* \< 3 months postinjury
* No previous treatment for an odontoid fracture

Exclusion Criteria:

* Pathologic fractures unrelated to osteoporosis
* Severe dementia or other severe mental health problem if there is no consentable surrogate available
* Participating in other trials or unlikely to attend follow-ups
The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants

The investigators are trying to compare the ultrasound-guided technique vs. palpation method for radial arterial cannulation in infants.

In infants (\<12mo), radial arterial catheterization is sometimes difficult to perform. Moreover, repeated attempts itself would cause the arterial spasm or hematoma. The use of ultrasound as an adjunct to radial arterial cannulation has considered to be the best practice in adults and pediatrics. However, its usefulness or superiority for neonates and infants is not known. Therefore, we would compare ultrasound guided radial arterial cannulation with the usual palpation methods in infants undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Infants under 12 months age undergoing cardiac surgery with radial arterial cannulation

Exclusion Criteria:

* Sign of a skin infection
* Wound near the puncture site
* abnormal circulation of the hand
* any vascular problem at radial or ulnar artery
Study of Pain Control in Hemorrhoidectomy

Patients will get an injection of either SKY0402 or placebo during hemorrhoid surgery, and their pain and pain medicine use will be monitored.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of age at the Screening visit
* American Society of Anesthesiologists (ASA) class 1-3
* Scheduled to have a two or three column excisional hemorrhoidectomy under general anesthesia using the Milligan-Morgan technique
* For female subjects, surgically sterile or at least two years menopausal, or using an acceptable method of birth control; must have a documented negative blood or urine pregnancy test within 24 hours before surgery
* Clinical lab values less than or equal to twice the upper limit of normal or, if abnormal, deemed not clinically significant per the Investigator.
* Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
* Able to speak, read, and understand the language of all subject-facing documents, including the ICF and study questionnaires
* Able and willing to comply with all study visits and procedures

Exclusion Criteria:

* Single-column hemorrhoidectomy or hemorrhoidectomy without an internal component
* Body weight less than 50 kilograms (110 pounds)
* History of hypersensitivity or idiosyncratic reactions or amide-type local anesthetics, opioids, or propofol
* Current painful physical condition or concurrent surgery other than hemorrhoids that may require analgesic treatment (such as non-steroidal anti-inflammatory drug \[NSAID\], opioid, selective serotonin reuptake inhibitor \[SSRI\], tricyclic antidepressant, gabapentin, pregabalin) in the postoperative period for pain that is not strictly related to the hemorrhoidectomy procedure and may confound the postoperative assessments
* Concurrent fissurectomy
* Use of any NSAID including selective COX-2 inhibitor, opioid, SSRI, tricyclic antidepressant, gabapentin, or pregabalin within three days of surgery
* Use of acetaminophen within 24 hours of surgery
* Chronic users of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week
* History of, suspected, or known addiction to or abuse of drugs or alcohol within the past two years
* Current use of glucocorticosteroids or use of glucocorticoids within one month of enrollment into this study
* HIV infection or hepatitis
* Currently pregnant, nursing, or planning to become pregnant during the course of the study or within one month of study drug administration
* Any psychiatric, psychological, medical, or laboratory condition that the investigator feels makes the subject an inappropriate candidate for this clinical trial
* Subjects who have received another investigational drug within the longer of the last 30 days or 10 elimination half-lives
* Previous participation in a SKY0402 study
* Failure to pass drug and alcohol screen
Elucid Labs AIDA™ - Labelled Image Acquisition Protocol

Diagnosis of melanoma involves physical examination of the lesion with many dermatologists adjunctively employing dermoscopes. The rate of misdiagnosis of melanoma remains significant, along with a high rate of referral to biopsy. Elucid Labs (Waterloo, Ontario) has developed a novel handheld, digital dermoscope with accompanying visualization and analysis software - the Artificial Intelligence Dermatology Assistant (AIDA™). Apart from collecting conventional demoscopic images, AIDA also collects images at various spectral bands. The aim of this study is to understand and quantify the value of this novel adjunctive information for dermatologists diagnosing atypical skin lesions.

Patients presenting with atypical skin lesions will undergo assessment by an investigator as per their standard clinical practice (not utilizing AIDA™). If a lesion meeting the inclusion-exclusion criteria is referred for biopsy, informed consent will be obtained and the subject will be enrolled. Subjects will then have images acquired by the AIDA™ system. All lesions scheduled for biopsy (Subgroup A) will be imaged along with at most 2 additional lesions meeting inclusion/exclusion criteria but not referred for biopsy (Subgroup B). For each lesion imaged using AIDA™, the investigator will manually segment the lesion image and list any lesion features which contributed to their recommendation to biopsy or not biopsy. The investigator will first score the lesion according to the ABCD rule using the standard dermoscopy image displayed. They will then state their diagnosis (malignant, dyplastic, or benign) and their diagnostic confidence using a visual analog scale. Once standard demoscopy diagnosis has been collected, the process will be repeated with the use of AIDA™ software outputs. Investigators will also provide an estimate of lesion depth based on AIDA™ depth images. All biopsy results will be recorded by the pathologist. Histopathology determination will be used as the definitive diagnosis of either positive (malignant/dysplastic) or negative (benign). Complete de-identified pathology reports may also be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Is 18 years of age or older
2. Has provided informed consent to participate in the study
3. Is being evaluated by a dermatologist for at least one pigmented skin lesionscheduled for biopsy and meeting the following:

   1. Has a diameter of at least 1 mm and at most 10 mm
   2. Is accessible to the study device (allows for complete seal of device with skin-ie. no ambient light leakage)
   3. Is not within 1 cm of the eyes, on mucosal surfaces, palmar hands, plantarfeet, or under nails
   4. Is intact (eg. no open sores, ulcers, bleeding)
   5. Has not previously been biopsied, excised or traumatized
   6. Does not contain visible scarring or foreign material (eg. tattoos, etc.)

Exclusion Criteria:

1. Any allergy to isopropyl alcohol
Fixed Combination of Dipirone and Codeine Compared to the Isolated Use of Dipyrone and Codeine in Controlling Pain After Pelvic-abdominal Surgery.

Phase III clinical trial, multicentre of superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication).

The main objective is to evaluate the effectiveness and safety of the association in relation to the isolated use of medicines.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years;
* Patients in the 1st postoperative period of open abdominal or pelvic surgery (last 24 hours) and receiving short duration analgesics or opioids in any route of administration on the previous day, being able to receive oral medication and scheduled home discharge in hours or days, with pain moderate to intense intensity (defined as VAS pain ≥ 4);
* Have signed the informed consent form.

Exclusion Criteria:

* Surgical complications to the inclusion of the participant in the research;
* Other serious comorbidities at the discretion of the investigators (such as a history of renal, hepatic, cardiac or other peptic ulcer);
* History of chronic and current use of opioids or other analgesics;
* Users of alcohol or illicit drugs;
* Use of drugs with the potential to interact with study drugs;
* Allergy, hypersensitivity or known contraindication to the use of components of the study drug;
* Psychiatric or social disorders that prevent adequate follow-up to the protocol;
* Show inability to understand and perform current pain assessments in the study;
* Women of childbearing potential, defined as all physiologically capable women of childbearing, unless they are using effective contraceptive methods while administering study medication;
* Any clinical condition that the investigator considers to generate risk to the patient or interfere with the conduct of the study;
* Participation in another clinical study in less than a year (unless participation by the principal investigator is justified).
Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock in Angers University Hospital

the purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

An interventional study compared, in septic shock, the effect of resuscitation strategy targeting normalization of capillary refill time versus strategy targeting serum lactate level. This last highlight a decrease of organ dysfunction at 72 hours with capillary refill time strategy and non-significant trend towards lower 28-day mortality in the capillary refill time strategy group.

The strategy guided by the decreasing of capillary refill time allowed the administration of less fluid than that guided by lactate. This is an important advantage when the intensive care doctor know that the mortality of patient in septic shock increases with the amount of fluid administered.

However, the variations of capillary refill time induced by the principal treatment in septic shock (norepinephrine and fluid resuscitation) during circulatory failure are actually insufficiently described. The purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock
* Presence of a cardiac output monitoring
* Decision by the physician in charge to perform vascular filling or modification the norepinephrine dose

Exclusion Criteria:

* Patient under a tutelage measure or placed under judicial protection
Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients

This prospective nonrandomized multicenter phase II study, will evaluate the possibility of performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years
* performance status WHO \< 2
* Epithelial ovarian, fallopian tubes or primary peritoneal carcinoma (histologically confirmed)
* Unresectable disease because of FIGO stage IV disease proven by imaging (CT Scan or PET CT) and/or diffuse extensive carcinosis considered unresectable for advanced FIGO stage IIIc; or patients unable to support a radical primary surgery because of age, comorbidities or altered general condition.
* No previous debulking surgery before neoadjuvant chemotherapy.
* Patients treated with a minimum of 3 cycles of platinum-based neoadjuvant chemotherapy.
* Response to chemotherapy was radiologically confirmed (Scan-TAP) prior to interval surgery:

No evidence of peritoneal supra-mesocolic carcinomatosis ; Residual pelvic masses smaller than 10 cm ; Absence of suspect supra-centimeter retroperitoneal lymphadenopathy

* able to read, write and understand French.
* Member of a Social Security scheme.
* written informed consent.

Exclusion Criteria:

* Patient unable to support laparoscopy
* psychiatric condition or social or geographic situation that would impede appropriate study participation
* Concomitant participation in another clinical trial evaluating surgical treatment (interfering with the evaluation of the main endpoint)
Understanding COVID-19 Testing Knowledge and Practices Among 2-1-1 Helpline Callers

The purpose of this study is to identify promising health education strategies and culturally appropriate messages for use by 2-1-1 practitioners to promote coronavirus disease of 2019 (COVID) testing behaviors. Previous study findings and evidence-based health communication and education tactics were integrated to create an interactive learning module that includes four narrative scenarios, illustrations, and accompanying questions and responses that inform the audience about COVID testing guidelines. The study will test the effectiveness of the interactive learning module with 2-1-1 callers (n=300) in Connecticut, North Carolina, and Nebraska. Participants' contact information will be shared with us by 2-1-1 with the participants' given consent. The study team will send the potential participant via text message a link to a survey that includes a screen where they will provide informed consent. Those who provide consent will be randomly assigned to receive one of two surveys. The inclusion of the interactive learning module is what varies across the surveys. An experimental group will receive the learning module with a study team-developed pre- and post-survey, and the control group will receive only the study team-developed pre- and post-survey. The post-survey contains questions regarding information covered in the interactive learning module. It is hypothesized that those who complete the interactive learning module in the experimental group will score better on the post-survey questions when compared to the control group. All participants, regardless of experimental or control condition, will receive an information sheet with the most up-to-date scientific guidelines for COVID testing.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who called 211 in Connecticut, Nebraska, or North Carolina on behalf of themselves or their families
* Must be 18 or older
* Must have English language proficiency
* Must be willing to be contacted via text messages or email

Exclusion Criteria:

* N/A