cyrilzakka/clinical-trials huggingface dataset:
Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide

An excess suicide-related morbidity is observed among young people in the Picardie region, as reflected by the \> 100% occupation rate of the Amiens University Hospital Adolescent Medicine Unit

An excess suicide-related morbidity is observed among young people in the Picardie region, as reflected by the \> 100% occupation rate of the Amiens University Hospital Adolescent Medicine Unit. New approaches have been proposed to these problems that have led us to reorganize our diagnostic practices: 1) more precise characterization of suicidal behaviour by using standardized instruments such as the French version of the Columbia-Suicide Severity Rating Scale developed by Posner (C-SSRS); 2) new clinical entities, such as disruptive mood dysregulation disorder, are now proposed in international classifications (DSM 5 field trial); 3) investigations such as recording of the circadian rhythm of motor activity by actigraphy are being studied as a laboratory complement to psychiatric diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* children/adolescents admitted after a suicide attempt

Exclusion Criteria:

* severe depression
* mental retardation
* pervasive developmental disorder
* active psychotic episode,
* drug and alcohol abuse at the time of admission
* organic sleep-wake disorders (sleep-related respiratory and motor disorders, narcolepsy)
* any contraindication formulated by the clinical team
* patients not covered by French national health insurance, patients deprived of their freedom as stipulated in Article L.1121-6 of the French Public Health Code
Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy

This study examines the role of this simple technique on postoperative metastasis and long term survival.

The only hope of long-term survival for patients with primary hepatocellular carcinoma (HCC) is surgical resection or liver transplantation, the former of which is more feasible at present. However, postoperative recurrence or metastasis is an ominous feature for this disease. Innovation of the surgical procedure for improving prognosis is under emergency request. This study examines the role of this simple technique on postoperative metastasis and long term survival.

During the past 20 years, more 600 patients with primary HCC were performed hepatectomy with the new hemorrhage control technique, and prospective randomized controlled trial (RCT) was applied. We further applied a mice model ligating the pedicle of the lesion-located hepatic lobe before hepatectomy to imitate the clinic practice, and evaluated the role of the new technique on postoperative metastasis and survival.

Eligibility Criteria:
Inclusion Criteria:

* HCC patients who will perform left- or right- hemihepatectomy.

Exclusion Criteria:

1. contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C,indocyanine green retention rate at 15min (ICGR15)\>30%,serum hepatitis B virus (HBV)-DNA\>106 copies/ml and serum alanine aminotransferase (ALT)\>2×ULN, serum triglycerides\>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause;
2. pregnancy;
3. age of\<18y or\>65y
Pharmacokinetic Analysis of High Dose Methotrexate in Pediatric Lymphoblastic Malignancies

\* The pharmacokinetics of MTX were assessed with regards to the relevance of several different patient specific factors in 291 pediatric patients, who were administered with high dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear mixed effects modeling.

* Methotrexate (MTX) is one of the critical components for treating all forms of acute lymphoblastic leukemia (ALL), which is the most common pediatric cancer. Unfortunately, high dose MTX has several undesirable side effects and MTX toxicity vastly differs from patient to patient.
* The pharmacokinetics of MTX were assessed with regards to the relevance of several different patient specific factors in 291 pediatric patients, who were administered with high dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear mixed effects modeling.
* The final model was validated using nonparametric bootstrap analysis. Body surface area (BSA), pre-hydration, baseline serum creatinine and 24 h creatinine clearance rate were statistically significant covariates for distributional volume (V) and renal clearance (CL). Herein, is the first report of analysis of the importance of a series of patient factors on pharmacokinetics of MTX by one-compartment model. Using these data, we have established an efficient population pharmacokinetic model for MTX, which can be used to predict safe clinical application of MTX especially in children with ALL.

Eligibility Criteria:
Inclusion Criteria:

* Acute lymphoblastic leukemia and non-hodgkin's lymphoma younger than 18 years old

Exclusion Criteria:

* Non lymphoblastic malignancies or older than 18 years
Motor Learning Approaches From Working on a Vertical Surface in Hemiplegic Children's Upper Limb Motor Skills

Working on a vertical surface is one of the best activities children can do to make themselves more successful in many areas as an infant which builds all those foundational skills required for the all-important task of handwriting.

Motor-learning approaches such as - constraint-induced movement therapy (CIMT) offer an array of sensorimotor experiences in a playful yet repetitive and intense fashion.

A stable shoulder girdle is the co-contraction of muscles around the scapula and shoulder joint.

Depending on the activity, vertical surfaces will have kids moving their arms frequently; reaching up, down, out and around. This supports extension of the arm and an opportunity to strengthen those muscles.

Vertical surfaces facilitate wrist extension. When the wrist is extended, the ring and pinky finger tend to naturally find their way into the palm creating a more optimal grasp pattern. A child is going to be able to execute more precise and legible work when using a functional tripod or quadrupod grasp.

Eligibility Criteria:
Inclusion Criteria:

1. Children diagnosed with spastic hemiplegic cerebral palsy
2. Age 5 to 9 years
3. Manual Ability Classification System (MACS)19 scores I, II.
4. Children who can understand and cooperate with researcher's instructions
5. Children with no visual or hearing impairment

Exclusion Criteria:

1. Children with any surgical interference in the upper limb.
2. Intellectual disability such that simple tasks could not be understood or executed.
3. Inability to combine the study protocol with the regular school program
Nutritional Status and Pharmacological Treatment: Impact on the Toxicity and Quality of Life of Patients With Colorectal and Breast Cancer

Cancer patients undergo many different modalities of treatments. Pharmacological treatment should be well understood. The nutritional status is not taken into account when calculating drug's doses and this may have an impact in toxicity and quality of life. The present study proposes to evaluate the relationship between the calculation of pharmacological treatment's doses, the toxicity and the impact on quality of life among colorectal and breast cancer's patients.

Cancer patients undergo various treatment modalities depending on tumor type, location, disease staging, and overall clinical conditions. Pharmacological treatments and surgeries are fundamental therapeutic strategies in many cases and are part of the daily routine of integrated cancer treatment services. The calculation of pharmacological doses often takes into account the patient's body surface area (BSA) or only weight, without however assessing their nutritional status as such. The surgical procedure, on the other hand, may expose the patient to an inflammatory response secondary to the operative trauma that requires immediate reaction of the diseased organism for an adequate recovery. In this sense, the objective of the present study is to evaluate the relationship between the calculated medication's doses and the nutritional status of patients submitted topharmacological treatment with neoadjuvant or adjuvant intention: patients candidates for surgery. Different instruments will be used for nutritional assessment, as well as a questionnaire on quality of life, a specific criterion for evaluation of toxicities, laboratory tests and imaging. Patients will be observed for 1 year and the data collected will allow the analysis of possible side effects and the impact on quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of Colorectal Cancer or Breast Cancer
* Must have Performance Status to undergo surgery and pharmacological treatment (Adjuvant or Neoadjuvant treatment)

Exclusion Criteria:

* Non-operable patients
* Pacientes with poor Performance Status Eastern Cooperative Oncology Group (PS ECOG) \>2
JessieHug Feasibility and Usability Assessment

The goal of this clinical trial is to evaluates the usability, tolerability, and clinical accuracy of the JessieHug device, a wearable medical device for newborns and infants that collects physiological data. The main questions it aims to answer are:

* Is the device easily usable for parents of newborns and infants?
* Is the device tolerable when worn by infants and are there any safety concerns?
* Is the device able to collect clinically accurate physiologic data compared to a FDA-cleared reference device?

Participants will:

* Place the JessieHug device on their infant two times a week and complete surveys to assess usability, tolerability and safety.
* Have one session where the JessieHug device will be worn at the same time as reference device to determine accuracy.

This study evaluates the usability, tolerability, and clinical accuracy of the JessieHug device, a wearable medical device for newborns and infants that continuously collects physiological data. Three cohorts of infants will be enrolled: newborn, 2-month, and 4-month groups, with each cohort undergoing data collection over a total of eight (8) weeks. The JessieHug device will be assessed for usability and tolerability through parental surveys while the baby wears the device in home and hospital settings. Clinical accuracy of the device will be evaluated through comparison to an FDA cleared reference device in a single outpatient clinic-based data collection event.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy neonates and infants, with cohorts defined by the following age ranges:

   1. newborn (0 weeks and 0/7 days to 0 weeks and 5/7 days),
   2. 2-month (6 weeks and 0/7 days to 11 weeks and 6/7 days),
   3. 4-month (14 weeks and 0/7 days to 19 weeks and 6/7 days)
2. Born after 37 0/7 weeks of pregnancy
3. Parent or legal guardian at time of discharge is able to understand and provide consent for participation
4. Parent or legal guardian at time of discharge is willing and able to participate in study procedures for the duration of the study
5. Parent or legal guardian is fluent in English
6. Parent or legal guardian has access to the internet

Exclusion Criteria:

1. Low birth weight (\< 2500g)
2. Any transfer out of the well baby nursery for increased level of care, including admission to the NICU or transitional nursery.
3. Clinical indication for prolonged postnatal hospitalization (\>4 days)
Effects of Pioglitazone Treatment on Sympathetic Nervous System Function in Metabolic Syndrome Obesity

An abdominal distribution of fat is associated with the greatest heart disease risk, because commonly, several risk factors of metabolic origin cluster in these individuals. When this occurs the condition is called the 'metabolic syndrome'.

Increased activity of the sympathetic nervous system resulting in enhanced release of the stress hormone 'noradrenaline', may be one mechanism by which adverse cardiovascular and metabolic sequela of the metabolic syndrome might be mediated. Impaired insulin action may be one factor contributing to increased noradrenaline release.

The aim of this Study is to determine whether treatment with a drug called pioglitazone which is known to improve insulin action, results in reduced sympathetic nervous system activity and stress hormone release when compared to treatment with a dummy drug (placebo).

The rapidly growing burden of obesity together with a population that is becoming older raises the importance of effective strategies for the primary prevention and treatment of the metabolic syndrome in order to combat the epidemic of type 2 diabetes and to reduce the increased risk of cardiovascular mortality.

Increased sympathetic nervous system activity may participate in the pathogenesis and complications of the metabolic syndrome. This Study will use a randomised controlled design to evaluate the effects of pioglitazone treatment on sympathetic activity in middle-aged subjects with the metabolic syndrome.The results will generate new information on the neuroadrenergic effects of thiazolidinediones in this clinical setting. This is relevant to the understanding of the pathophysiology of the metabolic syndrome and to its clinical management.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 45-65 years,
* non-smokers,
* HOMA index \> 2.5 and
* who meet ATP III criteria for the metabolic syndrome

Exclusion Criteria:

* History of diabetes,
* previous MI, stroke, heart failure, impaired hepatic or renal function.
* Inability to cease medications which may affect study parameters.
Multimodel Magnetic Resonance Imaging (MRI)of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders

To investigate multimodel MRI exploring the pathophysiology of multiple sclerosis and neuromyelitis optica spectrum disorders.

The investigators use multimodel MRI to evaluate the extent of blood-brain barrier and white matter fiber tracts destruction , iron deposition and cerebral blood flow of associated regions in multiple sclerosis and neuromyelitis optica spectrum disorders using contrast-enhanced magnetic resonance imaging , quantitative susceptibility mapping, diffusion tension imaging, and arterial spin labeling with post labeling delay of 2.0 seconds. Transfer constant volume , magnetic susceptibility, cerebral blood flow and fractional anisotropy(FA) value were measured in lesion and normal appearing white matter.

Patients:

Patients with multiple sclerosis and neuromyelitis optica spectrum disorders were included. clinical characteristics such as disease duration, expanded disability status scale(EDSS) score, age, associated laboratory examination(autoantibodies directed to aquaporin-4 and oligoclonal bands in serum as well as cerebrospinal fluid)were recorded.

Imaging scan were conducted at admission, six months and one year after admission

Imaging protocols:

MRI scan protocols: T2 weighted image, T1 weighted image, Diffusion weighted image(DWI), fluid-attenuated inversion recovery(FLAIR), dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI) , diffusion tension imaging(DTI) ,quantitative susceptibility mapping(QSM) , arterial spin labeling(ASL) with post labeling delay(PLD) of seconds, sagittal CUBE Fluid Attenuation Inversion Recovery (FLAIR) images, sagittal 3-dimensional Fast Spoiled Gradient Echo(3D-FSPGR).

Contrast agent:

Omniscan 0.1mmol/kg, Inject rate：2ml/s

Imaging evaluation:

Transfer constant volume value measured by DCE-MRI indicates the extent of blood-brain barrier destruction.

Magnetic susceptibility manifests iron deposition in lesions and normal appearing white matter.

Diffusion tension imaging demonstrates the extent of white matter fiber tracts destruction.

Arterial spin labeling(ASL) with post labeling delay(PLD)of seconds shows cerebral blood flow in associated regions.

Eligibility Criteria:
Inclusion Criteria:

1. a diagnosis of neuromyelitis optica spectrum disorders(according to the 2015 revised diagnostic criteria) or relapsing remitting multiple sclerosis(according to the 2010 revised Mcdonald criteria)
2. age between 18 years old and 60 years old(concluding 18 years old and 60 years old)

Exclusion Criteria:

1. common exclusion for MRI such as patients with claustrophobia
2. patients with poor imaging quality（Poor imaging quality mainly defined as the image cannot be applied to future analysis on account of severe motion artifacts appeared in conventional MRI and mistakes in the MRI process by accident factors which cannot to be applied to future analysis）
3. patients with taking amount of antidepressant recently and with alcoholism and other nervous system diseases
Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery

The primary aim of this project is to standardize the method for lipofilling by identifying the best technique. In this context, the study will investigate the impact of adipose tissue composition and ideal quantity of the injected fat particularly in view of resorption rate. Correlations between adipose tissue composition, amount of transferred fat, already existing subcutaneous fat layer at the grafting site and resorption rate will be made.

The punch biopsy and the non-invasive Lipometer measurements to determine the subcutaneous fat layer thickness in the harvesting and grafting region will be performed in 10 female subjects that undergo elective lipofilling.

The study was registered on Clinicaltrials.gov after start of recruitment.


Eligibility Criteria:
Inclusion Criteria:

* Women, age 18-70 years (limited upwards due to the indication for lipofilling and the amount of possible secondary diseases)
* History of BRCA1 and BRCA2 - positive breast cancer with following subcutaneous mastectomy
* Planned, elective breast-lipofilling
* Thickness of the skin and subcutaneous fat layer of min. 1 cm (detected via sonography)
* Currently healthy individual, willing to participate in this study

Exclusion Criteria:

* Previous surgery at the harvesting site (e.g. caesarian section)
* Pregnancy or planned pregnancy
* Current or preceded chemotherapy
* Preceded radiatio
* Unable to fully understand study procedures and to provide informed consent
Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS

Cesarean section is surging worldwide. For an extended period of surgical practice, the scalpel has been well-known as a gold-standard tool for making surgical incisions. The diathermy, electrocautery, is a substitute.


Eligibility Criteria:
Inclusion Criteria:

* Women with BMI 30- 40 Kg/m2.
* Women pregnant with singletons and planned to have a repeat elective lower-segment CS at 38-39 weeks' gestation due to having had one previous CS.
* Women pregnant with singletons and planned to deliver by lower-segment CS at 38-39 weeks' gestation for the first time (primi-section) due to obstetric indication.

Exclusion Criteria:

* Cases with coagulopathies eg. Hemophilia, von Willebrand disease
* Cases on anti-coagulant therapy eg. Heparin, warfarin
* Cases with chronic diseases expected to affect wound healing, such as diabetes, hypertension, liver diseases, chronic anemia, and renal impairment.
The Effects of Hamstring Stretching With and Without Neural Load on Flexibility, Maximum Isometric Strength and Tibial Nerve Pressure Pain Threshold

The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcala. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. Healthy subjects will be recruited and divided into two groups randomly to perform a hamstring stretching program for two months.

One group will perform a stretch with neural load and the other without neural load, although both groups will stretch for the same amount of time, repetitions and subjective sensation.

Participants will be measured before and after performing their assigned stretch. Then, a new post-stretch measurement will be taken after two months, period during which the subjects will perform the stretching program on their own. Finally, subjects will be asked to quit the stretching program to take a final evaluation measurement after one month of follow-up.

The objective will be to evaluate the effects of stretching with and without neural load on hamstring flexibility (main variable), maximum isometric strength and tibial nerve pressure pain threshold.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects who do not perform hamstring stretches with neural load in their daily training routine

Exclusion Criteria:

* Elite athletes competing or preparing for competition
* Lower limb surgery
* Hamstring injury in the last year
* Neurological, rheumatologic and/or orthopedic pathological history of lower limbs.
* Other comorbidities
Optimized Health-Related Social Needs Screening and Community Linkages

The objective of this study is to to understand the most effective method for health-related social need (HRSN) screening in the challenging environment of an emergency department by randomizing patients to oral or written HRSN screening in the ED.

Bilingual research assistants (RA) will screen patients for eligibility based on the predetermined criteria and approach eligible patients with a brief description of the study and opportunity for participation. Interested participants will complete a verbal consent process to reduce the barriers to participation, a brief demographic questionnaire, and an assessment of health literacy (Newest Vital Sign) followed by the Partners Healthcare HRSN screener randomized to an oral v. iPad screening strategy.

After completion of the screening tool, participants will complete a secondary questionnaire asking about satisfaction with the process, the presence of additional HRSN not recorded by the Partners HealthCare screener, and their perspectives on screening. At the conclusion, all participants will be provided with standardized, bilingual list of community resources to address each of the screening domains.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years patients and either a parent/guardian of a pediatric/cognitively disabled patient in the MGH ED,
2. triaged to the Acute, CDU, Fast Track, Urgent, and Pediatrics areas,
3. English- or Spanish-speaking, and
4. capable of informed consent.

Exclusion Criteria:

1. patients unwilling to have the interview audio-recorded,
2. medically unstable patients, and
3. Section 12, lack of capacity medical hold, sexual assault, child abuse, and emotionally distressed patients.