cyrilzakka/clinical-trials huggingface dataset:
Cerebral MRI During Sleep

Recent studies in animal models have suggested a critical role for cerebrospinal fluid and Interstitial fluid flux through cerebral parenchyma for removal of byproducts of cellular metabolism and hence in maintaining the health of the brain. This effect is modulated during sleep, suggesting a potentially important mechanism for sleep to maintain both acute homeostasis and long-term cerebral health.

The central goal of these studies is to develop a sensitive MRI biomarker of cerebral conformational changes during sleep. This exploratory work aims to establish the sensitivity and reproducibility of MRI as a non-invasive neuroimaging assessment of cerebral changes during natural sleep and sedation.

Recent studies in animal models have suggested a critical role for cerebrospinal fluid (CSF) / Interstitial fluid (ISF) flux through cerebral parenchyma for removal of byproducts of cellular metabolism and hence in maintaining the health of the brain. It remains unknown to what extent these phenomena exist in the human brain. A key challenge in this work is to make non-invasive and reproducible measurements of the cerebral microenvironment in humans. For these studies, the investigators have implemented a suite of MRI measurements to track physiological changes in the brain during sleep. This exploratory work aims to establish the sensitivity and reproducibility of MRI as a non-invasive neuroimaging assessment of cerebral changes during natural sleep and sedation. The long term goal of this work is to use MRI as an imaging biomarker to assess the cerebral response to normal versus disordered sleep in patients.

Our specific aims will address the following questions:

Aim 1: How sensitive are MRI metrics for determining changes in the brain during sleep?

Aim 2: How reproducible are MRI metrics during sleep and during sedation?

The investigators will recruit 12 normal adult subjects for this study (consecutive respondees to recruitment adverts). The investigators will make regional MRI measurements during onset, maintenance and waking from stage N2 sleep. From these the investigators will characterize which MRI metrics are most sensitive to changes in the cerebral environment, and how these vary for different cerebral regions.

Measurements will be repeated during \~90 minutes of natural sleep, and following oral sedation with 10 mg zaleplon (Sonata).

Eligibility Criteria:
Inclusion Criteria:

* Healthy Adults

Exclusion Criteria:

1. age not in range 18-59
2. smoking / recreational drug use
3. pregnant women / breast feeding
4. contraindication to MRI
5. contraindications to Zaleplon
6. history of cardiovascular pulmonary or cerebral disease (hypertension (diastolic \>90 mmHg, systolic \> 150 mmHg), unstable cerebrovascular syndromes, prior history of cardiac arrhythmias, unstable angina, chronic obstructive pulmonary disease).
7. Current SSRI antidepressant medication
8. History of sleep disorder or currently taking sedative / stimulant medication
Oracea Soolantra Association in Participants With Severe Rosacea

The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical cream associated with Placebo in the treatment of severe Rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject age ≥ 18 years or older;
* Subject with a minimum of 20 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face at Baseline visit;
* Subject with severe rosacea with papulopustular lesions (according to the Investigator's Global Assessment (IGA) score rated 4);
* Female subjects of childbearing potential with a negative urine pregnancy test (UPT);
* Female subjects of childbearing potential must practice a highly effective method of contraception during the study.

Exclusion Criteria:

* Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;
* Subjects with more than 2 nodules of rosacea on the face;
* Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject;
* Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients doxycycline and ivermectin.
Evaluation of the Tyto Thermometer When Used in Clinical Care Setting

Patients who present to the Emergency Department will be evaluated for eligibility to the study. Those meeting all the inclusion criteria and none of the exclusion criteria will undergo an informed consent process and will sign a written consent. Within each age group both afebrile and febrile patients will be represented.

The patients will be divided into 3 study groups by age:

Group 1: up to 1 year Group 2: 1 to 5 years Group 3: older than 5 years

The following temperature measurements will be taken:

1. Three temperature measurements using the Tyto thermometer
2. Temperature measurement using the standard of care
3. Three temperature measurements using the predicate device


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, of any age
2. Subject or Parent/Guardian: able to communicate with study personnel;
3. Subject or Parent/Guardian: able to understand the nature of the study and provide written informed consent
4. Subject or Parent/Guardian willing to comply with study procedures

Exclusion Criteria:

1. Cognitive impairment, history of dementia, psychiatric disorders, mental disorders or PDD.
2. Subject or legal guardian unwilling to sign informed consent form
3. Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site (site of temperature measurement in any one of the devices used).
4. Subjects currently using cooling blankets, ice on their forehead or fans.
5. Subjects receiving treatment with antipyretics, barbiturates, antipsychotics for the past 3 hours.
6. Subjects receiving current systemic treatment with thyroid preparations, corticosteroids or underwent immunizations during the past 7 days.
7. Subjects with documented illicit drug use or alcoholic intoxication
8. Those participating in a clinical trial of an investigational medicinal product
9. Carriers of multi drug resistant bacteria
10. Pregnancy
11. CTAS score of 1-2
Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.

Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails, often due to bone metastases that increase risk for future fractures. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use.

Recent literature has demonstrated the efficacy of multi-modal pain management in treating post-op pain \[1\]. Currently, patients that undergo prophylactic intramedullary femur nail placement at SLU are often treated with both narcotics and toradol, as long as they can tolerate NSAIDs. However, the effect of toradol in addition to narcotics has not been determined. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.

Eligibility Criteria:
Inclusion Criteria:

1. Femoral Shaft or Neck bone lesion
2. 18 years old or greater
3. Plan to undergo prophylactic intramedullary nailing of one femur

Exclusion Criteria:

1. Concurrent pathologic fracture
2. History of advanced renal impairment (eGFR\<30mL/min)
3. History of Peptic Ulcer Disease with bleeding or requiring hospitalization
4. History of NSAID or aspirin allergy
5. Concurrent chemotherapy regimen that prevents NSAID use
6. History of liver disease that precludes use of toradol
7. History of heart failure or cardiovascular disease that precludes toradol usage
8. Pregnancy
9. History of narcotic allergy resulting in anaphylaxis
10. Patients with coagulation disorders or those who require concomitant use of anticoagulant or anti- platelet therapy during the treatment phase of the study.
11. Patients with acetaminophen allergies resulting in anaphylaxis
12. Current use of the medication probenecid
13. Current use of the medication Pentoxifylline
14. History of aspirin induced asthma.
15. Known history of opioid dependence, abuse, or addiction.
16. Bilateral IMN of the femurs
The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men

The purpose of this study is to test a flexible lifestyle program designed to help Latino men make healthy lifestyle changes to lower their risk of developing diabetes and heart disease. The program is called HOMBRE (Hombres con Opciones para Mejorar el Bienestar y bajar el Riesgo de Enfermedades crónicas; English translation: Men with choices to improve well being and decrease chronic disease risk).

This study is a comparative effectiveness trial where obese Latino men will receive, by random assignment, the HOMBRE intervention or a minimal intensity intervention.

The study is designed to test whether a flexible lifestyle program with choices for program engagement will lead to better health outcomes, compared to a minimal intensity self-directed lifestyle program. If proven successful, this study has the potential to significantly impact health outcomes that matter to Latino men through the innovative design of lifestyle interventions to prevent chronic disease.

Eligibility Criteria:
Inclusion Criteria:

* Latino of any race
* BMI \>27 kg/m2
* One or more metabolic syndrome component (high triglycerides, blood pressure, fasting glucose, central obesity, or low HDL cholesterol)
* Primary Care Physician approval of patient study contact
* Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of tow study arms, participate in follow-up for 18 months, and authorize the extraction of relevant information form the Electronic Health Record.

Exclusion Criteria:

Medical exclusions:

* Previous diagnosis of diabetes or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening;
* Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years;
* Inability to walk without the assistance of another person;
* Severe medical co-morbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure;
* Diagnosis of a terminal illness and/or in hospice care;
* Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication
* Initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (The patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.)
* Have had or plan to undergo bariatric surgery during the study period

Other exclusions:

* Having no reliable telephone service
* Plan to move out of the area during the study period
* Family/household member of another study participant or of a study staff member
* Investigator discretion for clinical safety or protocol adherence reasons
Adaptated Physical Activity in Cancerology

This trial will measure the fatigue in breast cancer patients.

Two groups of patients will be realised:

* Arm A: Physical activity during treatment
* Arm B: No physical activity during treatment but after

The aim of the study is to decrease fatigue, with adequate physical activity, in primary breast cancer patients who receive a treatment for their pathology.

This is an open monocentric study, randomized in two parallel arms with a waiting list.

The duration of the physical activty will vary according to the duration of the treatment: from 2 to 6 months.

Several questionnaries (fatigue, quality of life, ...) will be given to patients at the inclusion, at the end of the period of treatment and 3 to 6 months after the end of treatment.

One hundred patients are necessary in this study (fifty in each arm). We expect to a stability of the fatigue in Arm A compared to an increase of the fatigue in arm B.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 75 years (included)
* Patient with a breast tumor, regardless of the stage and size (except metastatic patients)
* Patient with a local recurrence of breast cancer
* Patient with a second non-metastatic breast cancer
* Breast cancer treated, regardless of the surgery, at least by radiotherapy, chemotherapy (neoadjuvant or adjuvant) +/- targeted therapy
* A mandatory social security affiliation.
* Obtaining informed consent in writing, signed and dated.
* Medical certificate of fitness to practice physical (issued by the medical oncologist)

Exclusion Criteria:

* Cancer other than breast cancer and / or associated with breast cancer
* Metastatic Cancer
* in case of surgery before treatment, delay before beginning treatment inferior to 1 month post-surgery
* Men
* Woman pregnant
* Patient with cognitive or psychiatric disorders
* Patients suffering from disability
* Significant alterations in nutritional status (malnutrition with BMI \<19, obese with BMI\> 40, BMI)
* Cardiac contraindication to physical activity
* Knowledge and understanding of the French language enough not to learn the correct way of self-administered questionnaires or respond to questioning
* Participation in another clinical study with a similar objective
* Inability to reach the centers where physical activity takes place
An Exploratory Clinical Study to Evaluate the Safety, Tolerability, Immune Response and Preliminary Efficacy of LM103 Injection in Combination With PD-1 in Patients With Advanced Solid Tumours

This is an exploratory clinical study evaluating the safety, tolerability, immune response and preliminary efficacy of LM103 Injection in combination with PD-1 in patients with advanced solid tumours. The research treatment includes LM103 injection, IL-2 therapy, PD-1 therapy,fludarabine and cyclophosphamide.


Eligibility Criteria:
Inclusion Criteria:

1. The expected survival time is not less than 3 months.
2. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
3. Patients with advanced solid tumors confirmed by histology or cytology: advanced Melanoma, cervical cancer/ovarian cancer, head and neck squamous cell cancer, non-small cell lung cancer, esophageal cancer and other solid tumors that have failed standard treatment regimens, cannot tolerate standard treatment, refuse or do not have standard treatment regimens available.
4. The patient has lesions that can be used for surgical resection (\>1.5 cm3) or biopsy puncture (no less than 6 lesions) for LM103 manufacturing.
5. At least one measurable lesion as the target lesion after collecting tumor tissue from the patient (RECIST v1.1 criteria).
6. Laboratory tests results during the screening period indicate that the subjects have sufficient organ function.

Exclusion Criteria:

1. Have a medical history of other malignant tumors other than the disease under study in the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to thyroid cancer, cervical Carcinoma in situ, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast treated by radical surgery).
2. LM103 received systematic therapy of antineoplastic drugs (including chemotherapy, small molecule targeted drug therapy, Hormone replacement therapy, etc.), or local antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone metastases\>2 weeks before the start of the study and intracranial stereotactic radiotherapy or resection of a single brain metastasis\>3 weeks before the start of the study were acceptable) within 4 weeks before LM103 infusion; Or received clinical investigational drugs or equipment treatment.
3. Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been determined by the researchers to be irreparable and level 2 hypothyroidism for a long time).
4. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
Can Peripheral NIRS Predict the Response to a Fluid Challenge in Pediatric Patients: An Interventional Study

This study will be conducted on pediatric patients up to 14 years of age. The effect of two fluid challenge regimes on cerebral and peripheral NIRS will be assessed, in a randomized double blinded controlled trial. The findings will be correlated with two ultrasound measures, previously validated as markers of fluid responsiveness.

The patients will be recruited during the preoperative consultation. After inhalational induction and placement of all monitors, an intravenous access is established. After induction and securing of the airway via endotracheal tube or laryngeal mask, we note the reference values of all parameters. A pre-fluid challenge ultrasound is done, to assess the inferior vena cava distensibillity index, and the Vmax aortic peak flow velocity. After this the fluid challenge is performed. The second ultrasound measures are done after the fluid challenge. Finally an ultrasound is performed at the end of the operation, before emergence, to assess wether the standard peroperative fluid therapy has affecter these measures. NIBP, SpO2, HR, RR, NIRS values will be noted throughout the whole perioperative period. THe end-goald is to correlate the ultrasound findings to the NIRS-values, and see wether the NIRS can be used as a monitor of fluid therapy in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* all operations excepting cardiac surgery
* BMI \< 30
* ages 1-14 years

Exclusion Criteria:

* any cardiac affection (congenital unoperated heart disease, arrythmias)
* icterus
* refusal
AI Guidance for Biopsy in Suspected Cholangiocarcinoma

Digital single-operator cholangioscopy (DSOC) has emerged as a medical advance with an important role in the evaluation of indeterminate biliary lesions. This technique has demonstrated higher sensitivity in the guidance for tissue acquisition when compared with standard endoscopic retrograde cholangiopancreatography (ERCP). DSOC-guided biopsy is considered technically safe and successful for tissue collection.

Hand in hand with the development of more precise diagnostic techniques, comes the implementation of artificial intelligence (AI) for diagnostic assessment. For the past decade, the role of artificial intelligence (AI) has been increasing at a rapid pace. In the biliary tract, different models have been proposed for the characterization of malignant features. Nevertheless, to date, the discrepancy between the visual impression of the operator and the histological results obtained by cholangioscopy still present, affecting the accuracy the diagnosis.

Based on the above, the investigators aim to assess the diagnostic accuracy of AI for the guidance of tissue acquisition with DSOC compared to DSOC without AI for suspected cholangiocarcinoma. As a secondary aim, the investigators pursue to compare quality of AI-guided biopsies samples vs. DSOC biopsies without AI.

The diagnosis and management of biliary malignancy currently represents a medical challenge. To date, DSOC has demonstrated high sensitivity in the detection of malignant biliary lesions, nevertheless there is not a universal expert consensus for the characterization of this lesions. Also, DSOC has shown to be safe and successful for specimen collection with higher sensitivity when compared with standard ERCP.

Moreover, most of the AI models proposed for characterization of neoplastic features in biliary lesions have demonstrated high reliability during DSOC performance. A model was the proposed by investigators in Ecuador, focused on the identification of features of malignancy. The detection is performed by surrounding the suspected lesion in a bounding box. The detected area is displayed in the right side of the screen. Also, the box/image of the presumptive lesion can also be recorded and reviewed afterwards. After the AI model detects the "malignant area", a tissue sample is collected and taken for histopathological studies.

In addition, due to a variation of the endoscopists´ intra and interobserver agreement and the discrepancy between the visual impression and histopathological findings, the investigators intend to take advantage of our AI model as a diagnostic tool for a more precise acquisition of tissue in lesions suggestive of malignancy during real-time DSOC.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to our center with an indication of DSOC due to suspicion of CBD tumor or indeterminate CBD stenosis.
* Patients who authorized for DSOC-guided biopsy.

Exclusion Criteria:

* Any clinical condition which makes DSOC inviable.
* Patients with more than one DSOC.
* Lost on a six-month follow-up after DSOC.