cyrilzakka/clinical-trials huggingface dataset:
Study of Hydration Levels in Sports and Non-sports Schoolchildren (EHC)

New knowledge regarding the negative impact of poor hydration on health highlights the need to provide recent epidemiological data on the water intake of the French population, especially among middle school students, a group that has been minimally studied until now. Given the crucial role of adequate hydration in sports performance, it is essential to assess fluid intake and hydration habits among middle school students, who often engage in intense physical activities. The primary outcome of this study is to evaluate whether the proportion of middle school students hydrating adequately according to current recommendations is higher among those engaging in moderate to intense sports compared to those who do little or no sports. The goal is to determine if daily fluid intake is significantly influenced by physical activity among this population. To achieve this, investigators have developed a questionnaire to gather information on the physical activity levels of middle school students, their daily hydration habits, and their liquid intake in relation to their sports activities, using appropriate visuals. This study involves distributing the questionnaire in two middle schools in Brittany between November 2023 and January 2024.


Eligibility Criteria:
Inclusion Criteria:

* Middle school students with little or no sports involvement and middle school students with a moderate to intense level of physical activity

Exclusion Criteria:

* Refusal of the middle school student to participate and parental opposition to their child's participation in this research
Response of Pulse Pressure Variation in PA Catheter Tracing to IV Fluid Bolus in the ICU

The investigators hypothesize that analysis of blood pressure will allow doctors to predict whether or not blood flow from the heart (cardiac output) increases after intravenous fluids are given.

Total to expected enrollment: 70

Eligibility Criteria:
Inclusion Criteria:

* TCV-PO post-operative patients with PA catheters
* Must be 18 years of age and older

Exclusion Criteria:

* History of Pulmonary Hypertension
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 16-week treatment period is complete. Follow-up visits are conducted monthly for three months in order to assess patients for longer term safety.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* ABI \> 0.80
* Three or fewer venous leg ulcers, if multiple must be separated by 2 cm
* Ultrasound demonstrates venous reflux \>0.5 seconds
* Study wound present for 1-24 months
* Study wound 2-15 sq cm surface area
* Clean, granulating wound
* Patient able and willing to sign informed consent and comply with study procedures.
* Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test.

Exclusion Criteria:

* Wound etiology uncertain or not from venous hypertension.
* BMI\>40
* Acute or chronic infectious skin disease
* Allergy or intolerance to Profore(R)
* Wound infection, cellulitis, osteomyelitis
* \>2 weeks' treatment with immunosuppressive agents in recent past
* Investigational drug use within 30 days
* Severe malnutrition, drug and/or alcohol abuse
* Malignant disease unless in remission for 5 years
* History of radiation at the study site
* Other conditions that could impede wound healing
* Known history of HIV or AIDS
* Prior participation in any Dermagraft study
* Treatment with other bioengineered tissue products within 30 days
* Unable to understand the aims and objectives of the trial
* Inability to comply with study protocol
* NYHA Class III or IV CHF
* Uncontrolled diabetes mellitus
* Dorsal foot ulcer
Cortical Modulation of Acute Post-thoracotomy Pain With Transcranial Direct Current Stimulation

The primary objective of this single center, prospective, randomized, double blind clinical trial is to evaluate the effectiveness of anodal transcranial direct current stimulation (tDCS) combined with patient controlled analgesia (PCA) morphine, on intravenous morphine use for postoperative analgesia after thoracotomy. The intervention group will receive treatment with anodal tDCS, whereas the control group will receive sham stimulation.

tDCS has been used for treatment of chronic pain states, but experience with the use of tDCS for treatment of acute postoperative pain is limited. tDCS has been used for postoperative analgesia after lumbar spine surgery, total knee arthroplasty and for post-procedural pain after endoscopic retrograde cholangiopancreatography.

This study investigates the effects of tDCS vs. sham stimulation combined with IV morphine PCA on postoperative morphine consumption for analgesia after thoracotomy for lung cancer.

Patients with malignant lung disease requiring thoracotomy will be randomly assigned to active stimulation or sham stimulation in a double-blind, sham-controlled, parallel design clinical trial. Each group will receive IV morphine PCA and tDCS vs. IV morphine PCA and sham stimulation daily, starting with arrival in the post-anesthesia care unit on the day of surgery and continuing for the first four postoperative days. Anodal tDCS with direct current at intensity 2 mA will be delivered for 20 minutes on five consecutive days, whereas sham stimulation will last for 30 seconds.

Morphine consumption, the number of analgesia demands, and pain intensity at rest, during movement and with cough will be recorded at predetermined time intervals as follows: After surgery, when VAS pain score at rest falls below 30 mm, tDCS will be applied. VAS pain will be measured immediately before the intervention (T0) and immediately after the intervention (T1), and then regularly every one hour for the four hours (Т2-Т5), and then every six hours (Т6-Т9) for five days.

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and able to provide written informed consent,
* Subject is 18-80 years old,
* Subject needs thoracotomy for confirmed malignant lung disease,
* Subject is extubated in the operating room

Exclusion Criteria:

* Subject is pregnant
* Subject is in treatment for psychiatric disease
* Subject is in treatment for neurological disease
* Subject is in treatment for chronic pain
* Subject has history of current or past alcohol or Street Drug abuse
* Subject has received chemotherapy
* Subject has history of previous thoracic or cardiac surgery
* Subject is allergic to medications that will be used in the study
* Subject has pacemaker or automatic implantable cardioverter/defibrillator
* Subject has implants or any other devices in the head, the spinal cord or peripheral nerves
* Subject has confirmed brain lesion, including tumor or metastasis
Orientation Agnosia: Clinical and Anatomical Study

The area of the brain responsible of visuospatial processing data and more specifically the orientation of an object or image is located in parietal lobe, especially on the right side. A dysfunction of this region would result in a disorder of recognition of the orientation of objects and images that the investigators call orientation agnosia. Several isolated cases are reported in the literature but to the investigators knowledge deficit has never been systematically searched, or put into perspective compared to other neuropsychological deficits. Moreover, the precise location of the lesion responsible for such a disorder remains uncertain. The objectives of this study are (1) detect the existence of orientation agnosia in case of right parietal lesion, and (2) to improve the understanding of such a deficit allowing better management of this disorder.

Idem

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years
* french language
* right parietal lesion on cerebral imaging (CT-scan is sufficient), including stroke,arterial malformation, isolated tumoral lesion
* informed consent

Exclusion Criteria:

* previous neurological history except non complicated migraine and stabilized epilepsia without seizure since 5 years
* previous psychiatric history except depression without hospitalization \> one week or anxiety with maximum one anxiolytic treatment
* drug or alcohol abuse
* severe cranial traumatism
* other severe chronic pathology
* psychotropic medication other than a hypnotic or an anxiolytic at low doses without dose modification for at least one month
* visual impairment
* motor or sensory deficit sufficient to render impossible neuropsychological tests
* patient without judicial or administrative liberty
* measure of legal protection or no capable to express their consent
* pregnancy or breastfeeding
MRI/MRSI in Risk Assessment of Prostate Cancer Patients

The purpose of this study is to see if magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) can tell which patients with prostate cancer are at a low risk for their cancer growing and spreading. Magnetic resonance methods use magnets and radio waves to take pictures of body structure (MRI) and to measure amounts of important chemicals within the body (MRSI). This study will look at the structural and chemical properties of prostates before undergoing treatment. Hopefully, doctors will be able to use this method before making treatment decisions for patients with newly diagnosed cancer of the prostate. This study will continue our work to assess the value of MRI/MRSI in addressing what is currently one of the greatest clinical challenges in the management of prostate cancer: the identification of low-risk organ-confined prostate cancer that can be managed expectantly with deferred treatment.

In this study, patients with low-risk, organ-confined prostate cancer identified in clinic or prior to their already scheduled standard of care MRI in the Department of Radiology will be approached for the study. Eligible patients will undergo a baseline eMRI/MRSI exam between 6 and 24 weeks following biopsy. Patients will undergo definitive treatment (radical prostatectomy (RP) or radiation therapy (RT)) or will be placed on deferred therapy. Predictor variables will be recorded for each patient after enrollment, before treatment and during treatment follow-up. Patient outcome-disease progression will be determined by long term clinical follow-up

Eligibility Criteria:
Inclusion Criteria:

1. Gleason ≤6 (grade 3 + 3 or lower) biopsy proven prostate cancer
2. Clinically low-risk localized disease as defined by NCCN guidelines (clinical stage T1-T2a, maximum Gleason score 2-6, peak serum PSA level \< 10 ng/ml)
3. No evidence of disseminated disease (bone or lymph node metastases)
4. Treatment-radical prostatectomy, radiation therapy, or deferred therapy-will be at MSKCC
5. Willingness to undergo serial surveillance TRUS-guided prostate biopsies and eMRI/MRSI examination at MSKCC if placed on deferred therapy protocol
6. In the surgical cohort, RP (radical prostatectomy) is scheduled to occur within six months of eMRI/MRSI study

Exclusion Criteria:

1. Prior treatment (e.g. with hormonal therapy, radical prostatectomy, radiation therapy or cryosurgery)
2. Inability to give informed consent because of age, general medical or psychiatric condition, or physiologic status
3. Presence of known contraindication to eMRI
4. Unwillingness or inability to undergo placement of endorectal MR coil or ultrasound probe. As is the case for a standard MR exam, the presence of a pacemaker or aneurysm clips could pose a risk to patients, making them unable to have an eMRI, and therefore unable to participate in this study.
Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)

This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.

This is a Phase 2 study. During Screening, every patient will receive a run-in injection of aflibercept. On Day 1, patients will be randomized to either the UBX1325 arm or the aflibercept arm. Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28; and sham procedure on Weeks 8, 16, 24, 32, and 40. Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥50 years.
* Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening and Day 1
* BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening.
* Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.

Exclusion Criteria:

* Concurrent disease in the study eye or structural damage, other than wet AMD, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or CFP in the study eye.
* Any ocular/intraocular/periocular infection or inflammation in either eye in the past 12 weeks prior to screening
* Subretinal hemorrhage with bleeding area of 4 or greater disc area in the study eye
* History of vitreous hemorrhage in the study eye within 2 months prior to Screening
* Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study
* Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging
Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease

PRECISION-HD2 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120102 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362331 (SNP2).


Eligibility Criteria:
Key Inclusion Criteria:

* Prescreened with targeted SNP on the same allele as the pathogenic CAG expansion
* Ambulatory, male or female patients aged ≥25 - ≤65 years
* Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4
* Early manifest HD, Stage I or Stage II based on UHDRS Total Functional Capacity Scores ≥7 and ≤13

Key Exclusion Criteria:

* Malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years
* Received investigational drug or implantable device in prior 3 months or investigational oligonucleotide in prior 6 months or 5 halflives of the oligonucleotide, whichever is longer
* Clinically significant medical condition, unstable psychiatric symptoms, substance abuse, or pregnancy
* Inability to undergo brain MRI
* Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture
Ultrasound-guided Treatment in Acute Heart Failure

A randomized non-blinded study comparing ultrasound-guided therapy with conventional therapy in acute heart failure patients.

Study overview:

The purpose of this study is to evaluate whether ultrasound-guided decongestive therapy, guided by a focused thoracic ultrasound protocol combining echocardiography and lung ultrasound, could result in better decongestion and post-discharge prognosis without lengthening hospitalizations in hospitalized Acute Heart Failure patients.

Primary objectives:

To test whether ultrasound-guided therapy could result in reduced 6-month post-discharge mortality rates or re-hospitalization rates

Secondary objectives:

To test whether ultrassound-guided therapy could result in greater decongestion as defined by various congestion parameters, i.e. ultrasound-derived cardiac filling pressures on echocardiography, pulmonary congestion on lung ultrasound, reduction in natriuretic peptides and symptoms, fluid loss etc, and if this can be done without an increase in adverse events or and increase in length of hospitalizations.

Study Design and population:

ECHO-AHF is a non-blinded, randomized trial which will be conducted in 3-5 centers across Europe. Patients entering the ED between 8 am and 5 pm, monday to friady, and who fulfill study criteria will be enrolled and randomized in a 1:1-fashion

Inclusion criteria will consist of: Age 18 years or older and dyspnea at rest or orthophnea, BNP \>400ng/l or a BNP \>100ng/l AND signs of elevated LVEDP on echocardiography and multiple bilateral B-lines on LUS,. Dyspnea on excertion will not be sufficient for enrolment.

Exclusion criteria will consist of: Pulmonary fibrosis, Mental confusion, Chronic dialysis, Pregnancy/breastfeeding, Prisoners, Patient under involuntary treatment, Decision on study participation not made within 6 hours after receiving information regarding the study.

Estimated population size based on power calculation will be approximately 120 patients in total.

Investigational therapy in the treatment group:

Patients randomized to the treatment arm will receive ultrasound-guided therapy based on a focused ultrasound exam done on a daily basis except for saturdays and sundays, and their treatment will be intensified according to a pre-specified, guideline-based treatment protocol, if the daily ultrasound protocol finds them congestive. Patients in the control arm will receive guideline-based conventional decongestive therapy.

Eligibility Criteria:
Inclusion Criteria:

* Multiple bilateral B-lines as a sign of interstitial syndrome on lung ultrasound
* Elevated natriuretic peptide level
* Signs of elevated LVEDP on echocardiography
* Dyspnea at rest or ortophnea

Exclusion Criteria:

* eGFR \<25ml/min/1.73m2 or on dialysis
* Altered mental orientation
* Intubated
* Mitral stenosis or previous mitral valve procedure
* Chronic pulmonary parenchymal disease Pregnancy/breastfeeding
* Prisoners
* Patient under involuntary treatment
* Decision on study participation not made within 6 hours after receiving information regarding the study
A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers

The primary hypothesis of this study is that at 3 months, there will be a higher proportion of intervention participants vs. control participants who report greater risk of harm from misuse of prescription opioids AND heroin.

This study's specific aims are to:

Conduct a randomized controlled trial with 532 high-risk adolescents in 10 School Based Health Centers (SBHCs), to compare PlaySmart to attention/time control games, with assessments post- gameplay (6 weeks), and at 3, 6, and 12 months following enrollment to determine if PlaySmart: 1) increases proportion of participants who report a perception of great risk of harm from misuse of opioids at 3 months; and 2) decreases intentions to misuse opioids; 3) increases self-efficacy for refusing opioids; 4) prevents initiation of opioid misuse, at all time-points.

Eligibility Criteria:
Inclusion Criteria:

* Participants must:
* 1) preferably be enrolled in their high school's School-Based Health Center;
* 2) report NOT having engaged in any prior opioid misuse;
* 3) be at "high-risk" based on their report at baseline of past 30-day use of cigarettes, e-cigarettes, Juul, alcohol, marijuana (including synthetics), amphetamine, cocaine, benzodiazepines, ecstasy, bath salts, or any other misuse of non-opioid prescription drugs or use of non-opioid illicit drugs OR have a score of ≥1 on the PHQ-2 OR a score of ≥1 on the GAD-2 (both screening tools used by SBHA);
* 4) be willing to sit for 60 minutes/session to play the game;
* 5) be able to provide assent/parental/guardian consent (if under age 18).

Exclusion Criteria:

* Failure to meet any of the inclusion criteria.
Development a Method to Extract Antibiotic Concentration From Interstitial Lung and Epithelial Lining Fluid.

Infections are critical factors for the survival of critically ill patients. A serious problem is the high variability of antibiotic concentrations in critically ill patients. This may result in the risk of underdosage with possible ineffective therapeutic levels as well as in the risk of overdosage with possible adverse and toxic effects. Essential for the effectiveness of antibiotic therapy is the antibiotic concentration at target site. The goal of this study is to establish a method to extract Interstitial Lung Fluid (ILF) and Epithelial Lining Fluid (ELF) for antibiotic concentration measurements in patients following lung Transplantation and to calculate a tissue/serum concentration ratio. Improved knowledge regarding tissue penetration of Antibiotics may help to optimize drug dosing and management.

Informed consent will be obtained prior to inclusion. 30 patients following lung Transplantation at the University Hospital of Munich will be included in this study. Intravenous Meropenem will be administered as perioperative antibiotic prophylaxis for lung transplantation. Interstitial Lung Fluid and Epithelial Lining Fluid will be extracted immediately after explantation of the lung from explanted lung tissue. Concentrations of antibiotics will be determined by liquid chromatography-mass spectrometry (LC-MS/MS) in ILF and ELF. Serum samples will be collected according to our in clinical routine established therapeutic drug monitoring. Tissue/Serum concentration ratio will be calculated. ELF will be collected on postoperative day 1-5 when bronchoscopy is performed during clinical routine. Numerous clinical and laboratory parameters will be determined. The investigators expect that correlations between antibiotic target site and blood concentrations and clinical and laboratory parameters will be found.

Eligibility Criteria:
Inclusion Criteria:

1. Lung Transplantation at University Hospital of Munich
2. Administration of Meropenem as perioperative antibiotic prophylaxis
3. Valid informed consent subscribed by the patient prior to inclusion

Exclusion Criteria:

1. missing informed consent
2. subsequent withdrawal of the participation in the study by the patient or the guardian