cyrilzakka/clinical-trials huggingface dataset:
Effects of Sleep Privation on Sensorimotor Integration of the Upper Limb During a Manual Endurance Test in Healthy Volunteers-Physiological Study

The investigator showed that a night of sleep deprivation halved the duration of an inspiratory endurance test and that this loss of endurance could be secondary to a lack of activation of the pre-motor cortex. However, the inspiratory endurance test is associated with a feeling of dyspnea that could lead to premature arrest, and the inspiratory drive is complex, both automatic and voluntary. The investigator can reproduce this results on a simpler drive.

During the execution of an exercise involving repeated contractions of the hand it is possible to record the activation of the pre-motor cortex corresponding to the phase of preparation of the movement. The amplitude of these premotor potentials is proportional to the developed motive force.

The purpose of this study is to assess the impact of sleep deprivation on the muscular endurance of non-dominant in healthy subjects.

Hypothesis: Sleep deprivation causes a decrease in manual motor endurance by decreasing cortical pre-motor control.

Main objective: To compare the motor endurance of healthy subjects after a night's sleep and after a sleepless night.

Secondary objective: To compare the amplitude of premature cortical control at the beginning of the endurance test after a night's sleep and after a sleepless night.


Eligibility Criteria:
Inclusion Criteria:

* adult male volunteers;
* 25 to 45 years old
* regularly sleeping more than 6 hours per night;
* no excessive consumers of coffee (\<3 espressos / day);
* absence of muscular or neurological pathology ;
* with a BMI\> 18 and \<25 kg / m²;
* Horne and Ostberg score\> 31 and \<69 ;

Exclusion Criteria:

* female sex
* history of neuromuscular disease ;
* implanted metallic or electronic equipment (vascular stent, ocular implant, pacemaker ...)
* history of epilepsy, or discomfort after sleep deprivation ;
* poor sleepers (PSQI\> 5);
* exercising an activity in staggered hours;
* regularly performing more than 2 nights without sleep per month;
* taking drugs interfering with sleep (antidepressants, benzodiazepines ...);
* having crossed 4 time zones in the previous 4 weeks.
* current participation in another clinical research study;
Role of Exosomes in Pancreatic Cancer Progression

The present pilot study is set up with the objective of identifying circulating markers in the biological fluids (blood and urine) of subjects with pancreatic carcinoma and their association with disease stage, to evaluate their potential use as predictive and diagnostic markers for this tumor of difficult early diagnosis and often inauspicious prognosis.

The study is cross-sectional, single-center, spontaneous, in human tissues. It is a pilot study to gather evidence on the content of extracellular vesicles/exosomes in patients with pancreatic cancer.

The study will be performed on tumor tissue, blood and urine samples. Tissue will be obtained by needle biopsy (fine needle biopsy - FNB) during echoendoscopic examination.

The study aims to characterize the content of extracellular vesicles/exosomes in the biological fluids of subjects with pancreatic cancer with the goal of identifying new markers for this disease. To this end, the following will be carried out:

* an ex vivo and in vitro characterization study of the secretion of these extracellular vesicles/exosomes with analysis of their contents in terms of proteins and nucleic acids;
* a study of the mechanisms of epithelial-mesenchymal transition (EMT), invasion and aggressiveness to highlight a possible association between the secretion of these vesicles and the oncological stage of pancreatic carcinoma;

Eligibility Criteria:
Inclusion criteria:

* People with pancreatic cancer
* 18 years old
* Obtaining informed consent.

Exclusion criteria:

* Patients who do not need or cannot perform endoscopy with biopsy sampling;
* patients with a previous or active neoplastic pathology, different from pancreatic neoplasia.
The Role of Ophthalmologic Tests and EEG Imaging in Alzheimer's Disease

Alzheimer's disease (AD) is a prevalent, long-term progressive degenerative disorder with great social impact. It is currently thought that, in addition to neurodegeneration, vascular changes also play a role in the pathophysiology of the disease. Meantime, EEG resting state has also demonstrated significant change in patients with AD in neuroscience research area. Thus, the combination of these sensitive biomarkers would lead to a potential new biomarker for detection of AD, which has higher specificity and sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease

Exclusion Criteria:

* neurologic disorders
* psychiatric disorders
Safety Study of PLX108-01 in Patients With Solid Tumors

PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophysiology. The secondary objective is to measure the pharmacodynamic activity of PLX3397 via blood, plasma and urine biomarkers of Fms activity.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Solid tumors refractory to standard therapy
* For the Extension cohorts, patients must have measurable disease by RECIST criteria and meet the following disease-specific criteria:

  * For advanced or recurrent mucoepidermal carcinoma (MEC) of the salivary gland, patients must not be candidates for curative surgery or radiotherapy.
  * For pigmented villo-nodular synovitis (PVNS), patients must have a histologically confirmed diagnosis of inoperable progressive or relapsing PVNS, or resectable tumor requesting mutilating surgery, as well as demonstrated progressive disease in the last 12 months.
  * For gastrointestinal stromal tumors (GIST), patients must have failed previous therapy with imatinib and sunitinib. Patients with known PDGFR mutations are excluded, but mutation testing is not required for study entry.
  * For anaplastic thyroid cancer (ATC), patients must have histologically or cytologically diagnosed advanced ATC.
  * For metastatic solid tumors with documented malignant pleural and/or peritoneal effusions, patients must not be receiving specific therapy for the effusion or have an indwelling drain.
* Eastern Cooperative Oncology Group performance status 0 or 1
* Life expectancy \>= 3 months
* Adequate hepatic, renal, and bone marrow function

Exclusion Criteria:

* Specific anti-cancer therapy within 3 weeks of study start
* Uncontrolled intercurrent illness
* Refractory nausea or vomiting, or malabsorption
* Mean corrected QT interval (QTc) \>= 450 msec (for males) or QTc \>= 470 msec (for females)
A Trial on Ultrasound-assisted Spinal Anaesthesia

A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with manual palpation to identify landmarks for performance of spinal anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA I to III
* undergoing surgery amenable to spinal anaesthesia

Exclusion Criteria:

* Patient refusal
* contraindications to regional anaesthesia
* known allergy to local anaesthetics
* bleeding diathesis
* inability to provide informed consent
Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®

A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®

This study is a Phase 1, double-blind, randomized, single dose, parallel-group, 3-arm, Pharmacokinetic (PK) study designed to assess the biosimilarity, including the PK, Pharmacodynamics (PD), safety, tolerability, and immunogenicity of MAB-22 compared with reference Prolia® sourced from the European Union (EU) and United States (US) after single subcutaneous (SC) injection in healthy male participants.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male participants between 25 and 55 years of age (inclusive) on the day of signing the informed consent.
2. Have a body weight between 50.0 and 110.0 kg (inclusive) and a body mass index (BMI) between 18.0 and 32.9 kg/m2 (inclusive).
3. Have 12-lead electrocardiogram (ECG) results without clinically significant abnormal findings confirmed by the investigator.
4. Have vital sign results without clinically significant abnormal findings confirmed by the investigator, including but not limited to:

   1. Resting supine systolic blood pressure \<145 mmHg and diastolic blood pressure of \<90 mmHg.
   2. Heart rate 40 to 100 beats per minute (bpm).
   3. Respiration rate 8 to 20 resp/min.
   4. Temporal or ear temperature 35.5 to 37.6°C.
   5. Oxygen saturation 95 to 100%.
5. Have physical examination results without clinically significant abnormal findings confirmed by the investigator.

Exclusion Criteria:

1. Prior diagnosis of bone disease, or any condition that will affect bone metabolism such as, but not limited to: osteoporosis, osteogenesis imperfecta, hyperparathyroidism, hyperthyroidism, hypothyroidism, osteomalacia, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, current flare-up of osteoarthritis and/or gout, active malignancy, moderate to severe renal disease (defined as glomerular filtration rate \<60 mL/min), Paget's disease of the bone, recent bone fracture (within 6 months), or malabsorption syndrome.
2. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ, such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal, and/or preexisting dental disease at the determination of the investigator.
3. Recent tooth extraction (within 6 months of the screening visit). Edentulous participants are permitted to enroll in the study, as long as the most recent tooth extraction occurred \>6 months prior to the screening visit.
4. Evidence of hypocalcemia (total calcium below the normal range \[8.5 to 10.5 mg/dL or 2.21 to 2.65 mmol/L\]) at screening.
5. Known vitamin D deficiency (defined as vitamin D \<12 ng/mL or \<30.0 nmol/L); or known intolerance to calcium or vitamin D supplements. Retest of vitamin D is allowed once. Vitamin D repletion is permitted (e.g., vitamin D supplements) with a tolerable upper intake level of 100 mcg (4000 IU) daily, at the discretion of the investigator.
Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3)

Nutritional interventions such as ketogenic diet (KD) or fasting are currently under evaluation as anti-cancer treatment. In glioma patient cohorts, the feasibility and safety of fasting in addition to antitumor treatment has been shown. However, it is still unclear whether fasting exerts effects on the glioma tumor tissue at all, and whether fasting causes metabolic or immunological changes in the glioma microenvironment that could be exploited therapeutically. Therefore, the central contribution of this study is to characterize metabolic and immunological changes in the glioma tumor tissue induced by a fasting cycle of 72 hours prior to biopsy or resection.


Eligibility Criteria:
Inclusion Criteria:

* suspicion of glioma World Health Organization (WHO) grade II, III or IV as assessed by cerebral imaging (MRI)
* MRI-suspected relapse of previously diagnosed glioma
* interdisciplinary recommendation for resection or biopsy
* karnofsky performance status \>= 60, Eastern Cooperative Oncology Group Performance Status (ECOG) \<= 2
* creatinine \<= 2,0 mg/dl, urea \<= 100 mg/dl
* alanine aminotransferase (ALAT), alanine aminotransferase aspartate transaminase (ASAT) \<= 7x upper normal limit
* international normalized ratio (INR) ≤ 1,5, thrombocytes \> 100000/µl, leukocytes \> 3000/µl

Exclusion Criteria:

* bowel obstruction, subileus
* insulin-dependent diabetes
* dexamethasone \>4mg/day
* decompensated heart failure (NYHA \> 2)
* myocardial infarction within the last 6 months, symptomatic atrial fibrillation
* severe acute infection or clinically relevant immunosuppression (HIV infection, granulocytopenia \<1000/ µl, lymphocytopenia \<500/ µl
* malnutrition, cachexia (BMI \<18)
* other medical conditions that might increase the risk of the dietary intervention
* pregnancy
* uncontrolled thyroid function
* pancreatic insufficiency
* dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study
* major contraindications to MRI scanning (e.g. presence of implanted MRI-incompatible cardiac devices)
Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort Study

This study was a single-center, prospective, 2-year observational cohort study. The study subjects were ICU patients requiring vasopressor drugs and requiring sedation. According to the use of ciprofol or propofol in the treatment plan (determined by the doctor in charge according to the condition of the subjects), they were divided into groups: ciprofol group and propofol group. A total of 456 subjects were planned to be enrolled, including 304 subjects in the cyclopofol group and 152 subjects in the propofol group. The data of this study were obtained by extracting the routine clinical diagnosis and treatment records of the enrolled subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18;
* It needs to be treated with vasopressors to maintain mean arterial pressure ≥65 mmHg;
* Sedative medication required for comfort, safety, and to facilitate life support measures;
* Obtain the informed consent of the human subjects or their legal representatives.

Exclusion Criteria:

* Pregnant patient;
* Patients with proven acute severe intracranial or spinal neurological disease due to vascular, intracranial dilatation, or injury;
* History of allergy to cyclopofol, propofol, eggs, or soy products;
* History of long-term use of benzodiazepines or opioids;
* Sedative drugs other than propofol or cyclopofol were used at enrollment, or propofol and cyclopofol were used alternately within 24 hours;
* The researchers judged that they are not suitable to participate in this study.
Emotional Intelligence Intervention to Improve Mental Well-Being of Adolescents With Emotional Distress (BEAM)

The goal of this clinical trial is to assess the effectiveness of a multicomponent intervention in adolescents with emotional distress. The main question it aims to answer is:

Does the intervention increase mental well-being, emotional resilience, and emocional intelligence in adolescents with emotional distress?

Participants will:

• Participate in a multi-component intervention for 9 weeks at school.

Background:Adolescence involves biological, psychological and social transformations that increase vulnerability to mental health problems. Emotional intelligence is a protective factor that improves mental well-being. Given the sensitivity of adolescence to mental health disorders, emotional intelligence emerges as a valuable tool for promoting mental well-being.The investigators hypothesize that adolescents aged 14-16 with emotional distress who receive the multicomponent intervention based on emotional intelligence will obtain better scores on the Warwick-Edinburgh Mental Well-being Scale compared to the control group, after the intervention and at 24 weeks post-intervention.

Method :The study is a Randomized Controlled Trial (RCT). The participants and their parents will sign an agreement to participate in the study and will be randomly allocated in control and intervention groups by external researcher using a computer-generated random number. The intervention will be conducted in a school setting between April and November 2025. It will comprise a multicomponent program consisting of nine sessions, each lasting 55 minutes, addressing various topics related to emotional intelligence. Data will be collected from April 2025 to April 2026."Three psychometric scales will be used: Warwick-Edinburgh Mental Wellbeing Scale (WEMWB), Trait Meta-Mood Scale (TMMS-24) and Child Youth Resilience Measure (CYRM-32), with measurements before the intervention (T0), 9 (T1) and 24 weeks follow-up (T2).The group receiving the intervention is expected to show improvements in emotional well-being, emotional intelligence and resilience compared to the control group.

Accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 52 subjects in the first group and 52 in the second group are required to detect a difference equal to or greater than 5 units on the WEMWBS scale. A common standard deviation of 6.8 is assumed. A loss to follow-up rate of 0.1 (10%) and a correlation between observations of 0.4 was estimated.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents with emotional distress scores on the Warwick-Edinburgh Mental Well- being Scale.
* Adolescents aged 14-16 ( in 9th Grade).
* Informed consent form signed (by adolescents and their parent or legal guardian)

Exclusion Criteria:

* Physical illnesses that prevent attendance at scheduled sessions, severe mental disorders (such as Autism Spectrum Disorder, major depression, schizophrenia).
* No comprehension of the language
* Lack of consent from the adolescents or their parents or legal guardians
PortionSize Study 3: Assessment in Free-living Conditions

The objective is to test the accuracy of the PortionSize™ app and the MyFitnessPal© app at measuring energy intake in free-living conditions, tested against the gold-standard, doubly labeled water. Participants will use PortionSize™ and MyFitnessPal apps in separate periods to test the accuracy of the respective apps.

We will recruit adults to use the PortionSize app and the MyFitnessPal free-living conditions. In a within subjects and randomized, counterbalanced design, the accuracy of the PortionSize and MyFitnessPal apps at estimating energy intake in free-living conditions will be tested against the gold-standard, doubly labeled water (DLW), over two non-consecutive four-day periods that should include at least one weekend day and encompass the same days of the week during each period. Participants will be trained in our clinic to use the apps prior to their use in free-living conditions. We will integrate customizable notifications and reminders to remotely prompt participants to record data, resolve data collection problems, etc. These notifications and reminders utilize Ecological Momentary Assessment (EMA) methodology to maximize data collection protocol adherence by reminding participants to capture and send food information at relevant times.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18-62 years
* Body mass index (BMI) 18.5-50 kg/m2
* Ownership of an iPhone model 9 or later, which the participant is willing to use for the study
* Access to Apple ID, password, and email address and willing to use them during the study
* Willing to use data and any accompanying charges as part of study participation
* Willing to complete all study procedures and adhere to study visit timelines
* Willing to be re-contacted for future research and/or follow-up

Exclusion Criteria:

oHave been 6-month weight unstable (gain/loss \>5% last 6 months) and/or active weight loss program

* Any cardiometabolic disorder that significantly affects what or how much people eat
* Active cancer diagnosis or treatment that significantly affects what or how much people eat, excluding some melanomas and other cancers
* PBRC employee, as previous reviewers argued that they are not representative of the community (
* 3rd member of the same household to participate (i.e. the 1st and 2nd members of the household cannot participate simultaneously)
* Women who are currently pregnant or breastfeeding (self-reported)
* Diagnosed with an uncontrolled thyroid disorder (controlled ≥ 3 months of medication)
* Have had or plan to have weight loss surgery (gastric band removal may be allowed at PI discretion)
* Consume \>28 alcoholic beverages per week
* Anyone severely immunocompromised
* Serious digestive disorders that significantly affect what or how much people eat Fluid imbalance and/or on diuretic
* Follows a diet mainly consisting of foods that study staff deems unquantifiable for this study (i.e., liquid supplements, gluten-free specialty items) or consumes a high quantity of specialty foods
* Any condition or circumstance that, in the judgement of the PIs, couldimpede study completion
A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in participants with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have documented diagnosis of untreated de novo MDS with:

  * International Prognostic Scoring System (IPSS) risk categories Int-2 or High (minimum IPSS overall score of 1.5) OR Revised IPSS (IPSS-R) categories intermediate, high or very high (score of \> 3) and
  * Presence of less than 20% bone marrow blasts per bone marrow biopsy/aspirate.
* Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.

Exclusion Criteria:

* Participant has received prior therapy for MDS. (Prior supportive care in form of transfusions or growth factors, etc., is not considered prior therapy).
* Participant has received prior therapy with a BCL-2 Homology 3 (BH3) mimetic.
* Participant has a diagnosis other than previously untreated de novo MDS (as defined in the protocol) including:

  * MDS with IPSS risk categories Low or Int-1 (overall IPSS score \< 1.5)
  * Therapy-related MDS (t-MDS).
  * MDS evolving from a pre-existing myeloproliferative neoplasm (MPN).
  * MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
* Participant has received allogeneic Hematopoietic Stem Cell Transplantation (HSCT) or solid organ transplantation.
* Participant has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.
Effects of Bortezomib-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro

The purpose of this study is to better understand what effects Bortezomib, a drug used for multiple myeloma therapy, has on the immune system.

Subjects on this study will be receiving treatment for multiple myeloma according to the standard of care with a regimen containing Bortezomib.

If a bone marrow sample is clinically indicated to guide treatment, an additional 1 tablespoon of the specimen will be obtained for further laboratory studies.

Approximately 3 tablespoons of blood will be taken for research purposes before therapy with Bortezomib starts. When subjects return for follow-up after cycle 1, 2, and 3 and additional 3 tablespoons of blood will be taken for research purposes.

Optional samples of blood may be taken at follow-up visits after cycles 4, 5 and 6 and 1, 3 and 6 months after completing therapy.

This study also includes a medical record review.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed multiple myeloma
* Therapy with bortezomib alone or bortezomib/dexamethasone being initiated as the standard of care therapy for myeloma by their treating physician

Exclusion Criteria:

* Hypersensitivity to bortezomib, boron or mannitol
* Treatment with other investigational drugs within 28 days before enrollment
* Diagnosed or treated for another malignancy within 6 months of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
* Use of other myeloma directed therapy (except for dexamethasone) in combination with bortezomib