cyrilzakka/clinical-trials huggingface dataset:
Single Ascending Dose, Multiple Ascending Dose, Food Effect Study

This is a 2-part study. Parts 1 and 2 will be a randomized, double-blind, placebo-controlled investigations of SAD (Part 1) and MAD (Part 2) of orally administered INV-101 in healthy adult subjects. Food effect will also be assessed in one cohort in Part 1.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects must follow protocol specified contraception guidance as described in Section 7.4.5 and agree to refrain from sperm donation until 90 days after the last dosing.
* Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee at the screening visit, including the following:

Exclusion Criteria:

1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
4. History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
5. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the study drug or study drug excipients.
Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?

Simulation-based training is essential in learning or maintaining skills in high risk industry such as aviation and railway and in the medical field like anaesthesia. Debriefing following simulation is fundamental in order to reduce the emotional impact of the session and to asses the technical and non-technical skills (behavior). Even if the ideal debriefing method is still to be found, individual debriefing is considered as the gold standard but time consuming. The DEBRIEF-SIM study is a prospective, single blinded, multicentric and randomized study that will compare the individual (defined by learning couple resident and nurse) approach to a grouped (several couples) debriefing. The primary end point is to define the noninferiority of this approach compared to the individual one on the educational impact.

The learners will be debriefed according to their randomization after the first session, but will all undergo individual debriefing following the second session.

Individual debriefing consists in a individual meeting between each subject of the study and the investigator to analyze the management of the anaesthesia crisis simulated.

Grouped debriefing consists in the analysis by the investigator of the management of the anaesthesia crisis simulated in the presence of all the subjects included in the Grouped Debriefing group.

Eligibility Criteria:
Inclusion Criteria:

* Doctor:

  * resident in anesthesia and intensive care CHU Besançon and Dijon

Student nurse anesthetist:

* Student nurse anesthesist 1st or 2nd year of school Besançon and Dijon

Exclusion Criteria:

* Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (\< 18 years)
* Refusal to participate in the study
* Refusal to sign the confidentiality clause
Bipolar Transcranial Alternating Current Stimulation (tACS)

The purpose of this clinical trial is to measure the safety and effectiveness of a non-invasive brain stimulation device called Transcranial Alternating Current Stimulation (tACS) in participants with bipolar disorder (BD).

Participants will be asked to come in for 3 sessions. If participants qualify at the screening visit (session 1) then enrolled participants will complete sessions 2 and 3 as well as have a 30-day follow-up phone call.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of BD based on Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria being met from previous enrollment in the Prechter Bipolar Longitudinal Study
* This study will select BD patients that scored above published norms (upper 50th percentile) on the NEO-PI impulsivity facet to ensure that the recruited patients exhibit the network dysfunction targeted by the tACS paradigm and therefore have the potential to benefit from this neuromodulation technique.
* Patients must be on a stable dose of medication for two weeks prior to Sessions 2 and 3.

Exclusion Criteria:

* Significant neurological abnormalities, such as seizure disorder, mass lesions, etc.
* Known Mendelian disorder
* Active problematic substance use in the past 30 days (as determined by the Substance Use Disorder module of SCID)
* Evidence of suicidal intentions or behaviors in the past month, as judged by affirmative responses to question number 4 or number 5 on the Columbia Suicide Severity Rating Scale (CSSRS) or report of suicidal behaviors in the last 6 months
* Pregnant or trying to become pregnant, or currently lactating.
Post Market Study Using The Elite IQ Device

This is a prospective, open label, single-center clinical study to collect safety and efficacy data on the Elite iQ workstation. The intended use of the Elite iQ device used in this study is for the treatment of hair removal, pseudo folliculitis barbae, and benign vascular and pigmented lesions.

Up to 20 subjects will be enrolled at up to 1 study center. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments on multiple areas of the body such as, but not limited to, the face, legs, and arms. All subjects will be required to return a follow-up visit at 30 - 90 days after the final treatment in each treatment area.

Eligibility Criteria:
Inclusion Criteria:

* A healthy male or female 18 years of age or older.
* Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
* Understands and accepts the obligation and is logistically able to be present for all visits.
* Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion Criteria:

* The subject is hypersensitive to light in the near infrared wavelength region
* The subject has sun-damaged skin (treatment contraindicated with Alex laser only)
* The subject had recent unprotected sun exposure (for Alex laser within four weeks of treatment; for Nd:YAG laser within one week of treatment), including the use of tanning beds or tanning products, such as creams, lotions and sprays
* The subject is taking medication which is known to increase sensitivity to sunlight
* The subject has seizure disorders triggered by light
* The subject is taking anticoagulants
* The subject is taking or have taken oral isotretinoin, such as Accutane®, within the last six months
* The subject is taking medication that alters the wound-healing response
* The subject has a history of healing problems or history of keloid formation
* The subject has an active localized or systemic infection, or an open wound in area being treated
* The subject has a significant systemic illness or an illness localized in area being treated
* The subject has a history of skin cancer or suspicious lesions
* The subject has an autoimmune disease
* The subject is receiving or have received gold therapy
* The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months to entering this study.
* The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
Knowledge, Beliefs and Attitudes of Greek Physiotherapist About Pain Neuroscience Education

An e-survey study will be carried out based on Checklist for Reporting Results of 52 Internet E-Surveys (CHERRIES)". The purpose of this study is to investigate the knowledge, beliefs and behaviour of Greek physiotherapists regarding the pain neuroscience education program (PNE) as an intervention in patients with chronic musculoskeletal pain.

The main questions it aims to answer are:

What physiotherapists know about a PNE program; What physiotherapists believe about the using of a PNE program in patients with chronic musculoskeletal pain? Whether and how often they use a PNE program in patients with chronic musculoskeletal pain? What are the barriers of using PNE in patients with chronic musculoskeletal pain?

Eligibility Criteria:
Inclusion Criteria:

* Physiotherapists who are member of Panhellenic Association of Physiotherapist in Greece, with active clinical practice in Greece and clinical experience in musculoskeletal disorders (\>12 months).

Exclusion Criteria:

* None
Study on Changes of Pulse Oximeter Plethysmographic Amplitude Induced by Respiration in Pediatric Patients

The purpose of this study is to evaluate the variations of respiratory changes in pulse oximeter plethysmographic amplitude (delta POP) according to different contact forces between finger and sensor of pulse oximeter. During general anesthesia without surgical stimuli, pulse oximeter sensor is applied with serial contact force, from 0 to maximal 1.5N (increased by 0.2N) and POP waveform is obtained for 60 seconds. Delta POP will be calculated and compared.


Eligibility Criteria:
Inclusion Criteria:

* children who are aged between 2 and 5 years
* no cardiopulmonary and vascular diseases
* obtained written informed consent from their guardians
* no hemodynamic instability from massive bleeding

Exclusion Criteria:

* significant cardiopulmonary or vascular disease
* significant hemodynamic instability due to massive bleeding etc.
* cyanotic patients
A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for prolonged sedation(≥72h) during mechanical ventilation in the ICU.


Eligibility Criteria:
Inclusion Criteria:

1. Patients or their guardians are able to provide a written informed consent
2. Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria
3. Age ≥ 18 and ≤ 80 years, male or female
4. Body mass index (BMI) \> 18 and \< 30 kg/m2

Exclusion Criteria:

1. participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation；
2. Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction;
3. Organ failure during screening period；
4. Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period;
5. History of epilepsy or status epilepticus;
6. Subjects with a history of drug abuse；
7. Myasthenia gravis or a history of myasthenia gravis;
8. severe arrhythmias or heart disease;
9. Subjects after neurosurgery operation；
10. participants who did not require continuous sedation during mechanical ventilation for endotracheal intubation;
11. Abnormal values of the laboratory examination
12. Subjects who required vasopressor medication to maintain normotensive blood pressure during the screening period (excluding subjects who used vasopressor medication only during surgery);
13. Allergic to relevant drugs ingredient or component;
14. Pregnant or nursing women;
15. Subjects who has participated in clinical trials of other interventions recently;
16. Other conditions deemed unsuitable to be included.
The Role of Ischaemia-reperfusion Injury in the Pathogenesis of Muscle Wasting After Thoracic Aortic Surgery

Single-centre observational study over one year investigating the mechanisms of muscle homeostasis in patients with acute skeletal muscle atrophy following major aortic surgery

Some patients who are critically ill develop a syndrome of muscle weakness called Intensive Care Unit Acquired Paresis. This syndrome involves the development of severe muscle wasting and weakness and affects all skeletal muscles including the muscles which help one breathe. Muscle wasting and weakness whilst critically ill cause prolongation of mechanical ventilation, longer stays on the ICU, reduced mobility and prolonged rehabilitation in survivors. It has also been shown to increase the risk of death on ICU, due to an inability to wean patients from mechanical ventilation. Most patients recover; however in some, the effects last for many years and patients may not recover fully.

Although there is some understanding of why this syndrome develops, the molecular processes underlying the muscle wasting are not well understood. From the current scientific evidence, the investigators have identified a group or family of proteins believed to be important in the development of this condition, the activity of which are regulated by disease processes thought to lead to Intensive Care Unit Acquired Paresis (e.g. infection, inflammation, oxidative stress, immobility).

This research aims to investigate the role of these proteins in human tissue from patients who are at risk of Intensive Care Unit Acquired paresis. Even patients who do not go on to develop the full syndrome, in the early stages of ICU care, show some signs of muscle changes and loss of strength.

Eligibility Criteria:
Inclusion Criteria:

* All adult (\>18) patients undergoing major aortic or aortic valve surgery

Exclusion Criteria:

* Pre-existing cause for neuromuscular weakness or severe wasting (such as previous stroke, neuromuscular disease or malignancy)
High Dose Vitamin D Study

The purpose of this study is to investigate the therapeutic effect and the safety of high-dose vitamin D supplementation in metastatic colorectal cancer patients. We propose to supplement metastatic (stage 4) colorectal cancer patients with oral doses of vitamin D to raise serum 25-hydroxy-vitamin D \[25(OH)D\] levels to the high normal range of 200-250 nmol/L. The primary objective of this study is to evaluate the metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer. The secondary objective is to evaluate patient survival with regards to high-dose vitamin D supplementation.

Hypothesis:

Whereas low doses of vitamin D reportedly play a significant role in prevention of colorectal cancers, do much larger (pharmacological) doses of vitamin D have a significant therapeutic effect against the same kind of cancer?

Metastatic (stage 4) colorectal cancer patients who were randomly assigned to the treatment arm of this study will be orally supplemented with high doses of vitamin D to achieve serum 25(OH)D concentrations of 200-250 nmol/L (80-100 ng/ml). Therefore, the supplementation dosage is not pre-set but will be determined on an individual basis. Vitamin D supplementation will be continued for 16 months, followed by a 12 month follow up period. Monthly monitoring of serum 25(OH)D and calcium levels will assure the safety of our treatment protocol. Subjects in the control arm of the study will be receiving standard cancer care at InspireHealth that includes supplementation with at least 2,000 International Units of vitamin D.

Eligibility Criteria:
Inclusion Criteria (We will recruit stage 4 (metastatic) colorectal cancer patients who are clients at InspireHealth):

* Age \> 18
* Histologically confirmed colon or rectal cancer
* Known metastatic disease (stage-4) confirmed histologically or radiologically
* Life expectancy of \>8 months
* May receive anti-neoplastic therapy at the discretion of their physician
* Stable metastatic disease defined as no change in systemic for the month before and the month after commencing study
* Signed informed consent

Exclusion Criteria(Stage 4 colorectal cancer patients):

* Pregnant / lactating women
* Known hypersensitivity to vitamin D
* Pre-existing renal stone disease based on history
* Pre-existing hypercalcemia
* Severe renal or hepatic dysfunction (≥ 2x of the upper normal range)
* granulomatous disease (TB and sarcoid)
* unable to give informed consent in English (translations of study documents in languages other than English will not be provided)
68Ga-Citrate PET of Healthy Volunteers

This study investigates whole-body distribution kinetics of intravenously administered Gallium-69 (68Ga) citrate by positron emission tomography (PET)/computed tomography (CT). Thereafter, radiation dosimetry of 68Ga-citrate PET/CT will be determined.

Six healthy male volunteers are recruited in this study. Gallium-68 citrate radiopharmaceutical is intravenously injected as a bolus and whole-body distribution kinetics are studied by dynamic whole-body positron emission tomography/computed tomography. During imaging, serial venous blood samples are drawn, plasma is separated and radioactivity is measured by gamma counter. Immediately after imaging session, urine is voided and radioactivity is measured by gamma counting. As a final point, radiation dosimetry due to single Gallium-68 citrate injection is determined.

Eligibility Criteria:
Inclusion Criteria:

* healthy 18-100 year-old men

Exclusion Criteria:

* ongoing infection/inflammation proven by blood or other tests
ARGONAUT: Stool and Blood Sample Bank for Cancer Patients

ARGONAUT is a longitudinal, prospective, observational study that will enroll up to 5,000 advanced-stage cancer patients of diverse racial backgrounds to collect data used to develop precision microbiome medicines and for the identification of clinically actionable cancer-specific biomarkers to guide therapeutic decisions. Four types of solid tumor cancers will be profiled including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) and pancreatic cancer. Healthy control subjects without a cancer diagnosis will also be studied, comprised of individuals at high risk for CRC and healthy individuals at low risk for CRC. Risk assessment will be based on family history or past neoplastic findings during CRC screening. Data collected from this study will be used to develop the most effective new therapies, via microbiome optimization, all to the benefit of patients and the physicians treating them. Stool and blood samples will be collected longitudinally and analyzed to determine the impact of gut microbiome composition and function on the immune system and efficacy of the treatment.

Currently enrolling the CRC, high risk, and low risk cohorts.

Subjects who meet the entry criteria will provide up to 5 samples each of blood and stool over a 2-year period. Approximately 10%-20% of the subjects will provide colon tissue samples, either from research biopsies during Standard of Care (SOC) screening colonoscopy or retained surgical tissue from colectomy. Electronic health records will be obtained at various times for up to 8 years, to collect tumor imaging results and any other updated medical data, with no additional samples collected. In select cases, stool and blood samples will be collected beyond 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Men or women who are ≥ 18 years old with stage III or stage IV non-small cell lung cancer (NSCLC), colorectal cancer, triple-negative breast cancer, or pancreatic cancer treated by a particular cancer treatment for the first time, OR healthy subjects undergoing a standard of care colonoscopy
* Subjects able to provide written informed consent

Exclusion Criteria:

* Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV2
* Subjects without the mental capacity to complete either a written or online questionnaire, alone or with assistance, or make sound decisions
* Women who are pregnant or who plan on becoming pregnant
* Women who are nursing
Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer

This is a two arm, 2-center, Phase II, study of 5-FU, irinotecan, bevacizumab (FOLFIRI-beva) and hydroxychloroquine (HCQ) in patients with previously untreated metastatic colorectal cancer (mCRC).

Up to 155 patients will be screened for DTP-signature and up to 31 evaluable patients who are determined to be DTP-signature high will be treated with FOLFIRI-beva and HCQ.

Patients will continue to receive treatments until evidence of disease progression, intolerable side effects, withdrawal of consent or death.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal cancer, not amenable to curative resection.
* Microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer.
* No prior systemic therapy for metastatic disease.
* Evaluable disease based on RECIST 1.1 criteria.
* Adequate hematological, hepatic and renal functions
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.
* Estimated life expectancy of \> 6 months.
* Negative pregnancy test for female patients with child-bearing potential.
* No history of retinal disorder.
* No history of glucose-6-phosphate dehydrogenase deficiency (G6PD) .
* Considered to be DTP-signature high to receive HCQ treatment

Exclusion Criteria:

* Women who are pregnant or nursing.
* Have received radiotherapy, chemotherapy, biological therapy, or investigational treatment less than four weeks (six weeks for nitrosoureas or mitomycin C) prior to first dose of FOLFIRI-beva or have not recovered from all acute toxicities from prior treatments to grade 1 or less, with the exception of alopecia and those deemed not to affect safety assessment.
* Have concurrent malignancy with exception of malignancy that was treated curatively and without evidence of recurrence within 3 years of study enrollment, or fully resected basal or squamous cell skin cancer and any carcinoma in situ which are considered to be of low risk of recurrence.
* Have had major surgery within 28 days of study enrollment. Placement of a venous access device within 28 days of starting therapy is allowed.
* Have any medical condition that would impair the administration of oral agents including significant bowel resection, inflammatory bowel disease or uncontrolled nausea or vomiting.
* Known central nervous system metastasis. Patients with history of central nervous system metastases are eligible if they are clinically and radiographically stable for at least 3 months and not taking steroids or anticonvulsants.