cyrilzakka/clinical-trials huggingface dataset:
NEOnatal Multiexposure to Medical Devices Plasticizers: Endocrine Disruption MIXture Effects and Neurodevelopmental Disorders

The goal of this observational study is to evaluate the neurodevelopment of children from the ARMED NEO cohort through the ASQ3 score.

Dose the multiexposure to medical devices plasticizers during the neonatal intensive care unit stay increases the risk of developing neurodevelopmental disorders ? Patients (their parents) will complète several questionnaires (ASQ3, environnemental survey, EPICES score) during a planned teleconsultation with the research team


Eligibility Criteria:
Inclusion Criteria:

* Live patient who participated in the ARMED NEO study, included at the Clermont-Ferrand or Lille hospitals
* Patient whose holders of parental authority have expressed their non-opposition to their participation in the study

Exclusion Criteria:

* Patient whose guardians have expressed opposition to their participation in the study
* Patient with no French speaking parent
* patient
Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis

OBJECTIVES: I. Determine the response, disease-free survival, and overall survival of patients with primary light chain amyloidosis treated with high-dose melphalan and autologous stem cell transplantation.

II. Determine the toxicity of this regimen in these patients.

PROTOCOL OUTLINE: Patients may receive induction chemotherapy before study entry. Patients then receive filgrastim (G-CSF) or another growth factor for 4-6 days as peripheral blood stem cell (PBSC) mobilization. PBSC (or bone marrow) is harvested over 2-3 days.

Patients receive high-dose melphalan IV over 30 minutes twice daily on days -2 and -1. PBSC and/or bone marrow is reinfused on day 0. Patients receive G-CSF beginning on day 0 and continuing until blood counts recover. This course may be repeated 4-12 weeks later.

Patients are followed every 3 months for 1 year and then annually for 5 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Disease Characteristics

* Histologically confirmed primary amyloidosis
* Ineligible for other high priority national or international study

Prior/Concurrent Therapy

* Biologic therapy: Concurrent participation in gene therapy trials allowed
* Chemotherapy: Prior chemotherapy allowed No other concurrent chemotherapy
* Endocrine therapy: No concurrent steroids unless given with amphotericin B, for adrenal failure, or for septic shock No concurrent hormones except for non-disease-related conditions (e.g., insulin for diabetes)
* Other: No concurrent barbiturates or acetaminophen Concurrent participation in supportive care trials allowed

Patient Characteristics

* Performance status: ECOG 0-3
* Hepatic: Bilirubin less than 2 times normal
* Renal: Creatinine less than 2.5 mg/dL OR On stable hemodialysis
* Pulmonary: DLCO at least 60% predicted OR Clearance by pulmonologist
* Other: HIV negative
The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis

The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery.

The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery, thereby improving the overall prognosis of cardiac surgery patients, reducing the incidence of complications, and shortening the length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* ASA II/III
* BMI 16.5-31 kg/㎡
* Elective cardiac surgery under CPB
* Volunteer to participate and sign informed consent

Exclusion Criteria:

* Redo cardiac surgery
* Patients who do not cooperate or cannot communicate
* Abusers of alcohol, drugs or narcotics
* Pregnant or Breastfeeding
Verbal and Written Instruction Versus Verbal and Written Plus Simulation in Patients With Breast Cancer and Their Caregivers

The purpose of this study is to compare two different ways of teaching people how to give injections at home. The first is what we do now, which is teaching patients and/or their caregivers verbally and by giving written instructions. The second is what we do now (verbal and written instructions) along with a demonstration and practice using a needle and an injection pad that feels similar to skin and fat. This is being done to find the best method for teaching people to give an injection at home.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Over 18 years of age
* No history of performing injections
* Patient must be receiving pegfilgrastim during adjuvant or neoadjuvant chemotherapy
* Patient will have the pegfilgrastim administered at home either by self administering or by a caregiver.

Exclusion Criteria:

* Patient or caregiver desire to inject (with saline) during or immediately following the injection teaching
* Prior self-injection or injection administration experience of any type
* Patients with history of anaphylaxis or other severe reactions to latex
* Patients that required pegfilgrastim injection be administered in clinic
Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers of Acute Moderate to Severe Traumatic Brain Injuries

After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. Periods of care transitions, such as ICU discharge, are most difficult. The majority (93%) of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information or practical skills to either survivors, or to long-term caregivers (\>6 months post injury), rather than education, support, and skill-building that the new caregiver may use proactively that will benefit the dyad acutely after injury. The Aims of this proposal are to: (1) Determine feasibility, satisfaction, and data trends of CG-Well; and (2) Understand how baseline psychosocial risk factors affect response to CG-Well compared to an Information, Support, and Referral control group. To accomplish this, I will first enroll 6-10 caregivers and tailor CG-well until each finds the intervention acceptable, appropriate, and feasible. I will then enroll 100 (50/group) dyads and determine satisfaction ratings, recruitment, retention, and treatment fidelity of CG-Well. Additionally, I will determine if caregivers report reductions in depressive symptoms and improvements in life changes as a result of improvements in task difficulty and threat appraisal in CG-Well compared to ISR at six months. Information obtained in Aims 1 and 2 will be used to plan a larger Phase III trial of CG-Well. Completing these Aims and the training plan will improve outcomes of caregivers and downstream outcomes of survivors of msTBI, and provide me with the skillset necessary to become an independent researcher who can develop and test high-impact, high-fidelity, sustainable interventions.


Eligibility Criteria:
Inclusion criteria:

* Survivor and caregiver ≥18 years old
* Survivor GCS 3-12 after resuscitation
* Survivor \< 2 weeks post injury
* English Speaking - survivor and caregiver

Exclusion criteria:

* Patient not expected to survive.
* Pregnant - survivor or caregiver
* Prisoner - survivor or caregiver
* History of pre-existing condition that would interfere with follow-up in caregiver or survivor (e.g., substance abuse, alcoholism, end-stage cancers)
* Major prior debilitating neurological or mental health disorder in caregiver or survivor (e.g., schizophrenia, bipolar, stroke, dementia).
Shanghai Children's Health, Education and Lifestyle Evaluation, Preschool (the SCHEDULE-P Study)

Shanghai is one of pilot areas for the early education of 3-6 years old infants in China. Shanghai Municipal Education Commission has been actively exploring more effective early education guidance methods. This survey, in the form of online questionnaire and site test, aims to dynamically evaluate the changes in the early development level of children in Shanghai and provide scientific basis for providing better early education services in the future.


Eligibility Criteria:
Inclusion Criteria:

* All 3-year-old children entered into public kindergartens or private kindergartens in Shanghai since 2016.

Exclusion Criteria:

* Children entered into international kindergartens
The Benefits of a High-intensity Interval Training Intervention Delivered in a School Setting Among Adolescents

A 12-week school-based high-intensity interval training intervention, with 8 classes of year 7 students randomly allocated to either intervention or control group. The interval training sessions will last for 6 to 10 minutes and will be delivered 5 times per week. Outcome variables will be physical activity, body composition, cardiorespiratory fitness, muscular strength, bone health, executive function, mental wellbeing, and academic performance, which will be measured pre- and post-intervention and two months after the intervention has been completed.

The purpose of this study is to: 1) evaluate the effectiveness of a 12-week school-based HIIT intervention on cardiorespiratory fitness (primary outcome), physical activity, body composition, muscular strength, bone health, executive function, wellbeing, enjoyment, affect, self-efficacy and academic performance among 12-13-year-old adolescents; 2) to examine the changes of these outcomes following a two-month unstructured summer holiday after the study has been completed; 3) to conduct a process evaluation for the study.

The study is a 12-week high-intensity interval training intervention, which is 6 to 10-minute in length and will be delivered 5 times per week among year 7 adolescents, at the start of physical education and physical activity lessons. We will examine the effectiveness of this intervention on outcomes, such as body composition, cardiorespiratory fitness, muscular health, bone health, cognitive function, mental wellbeing, and academic performance. In addition, The investigators will evaluate the fitness changes between school days (structured day) and a two-month summer holiday (unstructured days). This will be achieved by collecting data at three timepoints: pre- and post-intervention and after a 2-month (summer holiday) following the completion of the intervention.

The high-intensity interval training includes resistance-based exercises, such as jumping jacks, high knees, burpees, squat jumps, lunge jumps, and mountain climbers.

Eligibility Criteria:
Inclusion Criteria:

• Year 7 students

Exclusion Criteria:

* Unable to perform high-intensity exercises due to existing medical contraindications
* Unable to understand the study procedures and provide consent
Syndactyly Versus Closed Reduction in 5th Metacarpal Neck Fracture

This study aims to compare the functional results of two different therapeutic approaches in patients that present with a 5th metacarpal neck fracture. Patients will be randomly assigned to be treated with either syndactyly or closed reduction plus inmovilization.

Syndactyly, although limiting the activity of the patient, allows a quick mobilization and recovery, as well as a better management in daily activities compared with immobilization with splint. In addition, follow-up of these fractures is difficult due to poor compliance, since patient profile is young people who give little relevance to their pathology in the hand.

The purpose of our study is to carry out a randomized clinical trial of good methodological quality to assess whether immobilization with syndactyly for 3 weeks does not imply loss of functionality or residual symptoms, avoiding rigidity, postinflammation arthritis or loss of grip strength, demonstrating that early mobilization of fractures of the fifth metacarpal provides clinically satisfactory results compared to prolonged immobilization provided that the volar fracture angle does not exceed 70 ° nor does it produce digital movement disruption.

Eligibility Criteria:
* Inclusion Criteria:
* Men and Women ≥ 18 years old.
* Admitted to the Emergency Department with fracture of 5th metacarpal neck, in acute phase (maximum 72 h of evolution) with a possibility of clinical and radiological follow-up of at least 6 months.
* Willing to participate in the study and give their consent in writing.
* Exclusion Criteria:
* Patients younger than 18 years.
* Patients presenting with more than 72 h of evolution
* Patients with comminuted neck fractures.
* Patients with angulation greater than 70 in the lateral-oblique plane
* Patients with clinical-radiological disruption
* Patients with previous fractures in the metacarpal.
* Patients with open fracture grade II-III Gustilo.
* Patients with bifocal fractures or fractures in another metacarpal-phalanx or carpal bones requiring different treatment.
* Polytraumatized patients requiring further care that prevents them from adjusting to the therapeutic regimen specific to the protocol of isolated metacarpal fractures.
* Patients with congenital anomalies on hand affect
* Patients with a psychic disability (dementia-psychiatric illness or mental disorder) that prevents their collaboration in the follow-up
* Patients with medical or surgical pathologies that at the discretion of the investigator do not allow their participation in the study.
* Patients with inability to understand the nature and purpose of the study and / or to accept written participation in the study.
* Unable to attend the pre-established clinical follow-up.
* Do not wish to participate or give their consent in writing.
Family Based Interventions: Preschool Children and Parent

To assess the efficacy of a 2-year family-based weight prevention program in a cohort of overweight preschool children and overweight parent pairs.

BACKGROUND:

The proposal targets a population of individuals of great public health importance who are of high risk for weight gain: pre-school children of overweight parents. Family-based interventions are both theoretically and functionally reasonable approaches for use with these subjects, and the choice to focus on both increased physical activity and healthier food choices in the context of the family's environment is appropriate. The decision to include weight management outcomes on the parent as secondary endpoint is strategically wise and may provide important insights into the process of weight management. A broad array of data is to be collected and strong justification is provided for the inclusion of each.

The study is in response to an initiative issued by the National Institute of Diabetes and Digestive and Kidney Diseases and entitled "Innovative Approaches to the Prevention of Obesity". The resulting grant was later reassigned to the National Heart, Lung, and Blood Institute.

DESIGN NARRATIVE:

Approximately fifty child/parent pairs were recruited and randomized evenly to one of two groups: usual care versus an intervention focused on diet and activity strategies that included weekly group visits (24 weeks), biweekly group visits for parents (12 weeks), monthly group visits for parents (6 months) and quarterly group visits (12 months). Cognitive-behavioral therapy was used to guide interventions, which focussed on empowering a parent as the primary medium by which lifestyle changes were made. Major data collection at baseline, twelve, and 24 months included measures of weight; food and activity records; activity monitor recordings; biopsychosocial profiles; blood lipids, glucose, and insulin; process measures; parenting behavior; and child behavior. The primary study outcome measure was age- and gender-appropriate changes in BMI (expressed as a binomial response). Additional outcomes of particular interest were weight changes in the parent, diet and physical activity levels, parenting skills, and biopsychosocial measures.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Improving Mobility and Reducing Fatigue in People With Multiple Sclerosis by Electrical Stimulation Therapy

The objective of the clinical trial is to quantify the capacity of a translatable protocol of electrical nerve stimulation (TENS) to improve walking performance and self-reported disabilities of persons with MS. The hypothesis is that activation of sensory nerve fibers with augmented TENS promotes recovery of sensorimotor function and improves the disability status of individuals with MS. The rationale for the proposed clinical trial is that the approach provides a low-cost therapeutic strategy for persons with MS to manage walking limitations and fatigue.

The study will involve a randomized, double-blind, controlled trial. Randomization will be accomplished by recruiting two individuals with a similar level of disability at a time and flipping a coin (two persons present) to determine the group assignment (A or B) of the person who contacted the investigators first. The participants and outcome assessors will be blinded to group assignment. Both groups will receive the treatment (real or sham) during the first 4 weeks (3 sessions/week)and then there will be an 8-week follow-up period. Participants will be evaluated at weeks 0, 4, 8, and 12.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, write, and speak English to ensure safe participation in the project
* Clinical diagnosis of multiple sclerosis
* Mild-to-moderate level of disability
* On stable doses of symptom-treating medications
* No MS exacerbations within the last 30 day
* Healthy enough to complete the protocol as indicated by the absence of a medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in tests that involve electrical nerve stimulation (e.g., not implanted devices or internal metal)
* Able to arrange own transportation to Boulder campus

Exclusion Criteria:

* Documented MS-related relapse within the last 30 days
* Medical diagnosis or condition that is considered to be a contraindication to participating in the intervention, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than basal cell cancer), other neurological disorders, or pregnancy.
* Vestibular disorder
* Musculoskeletal disorder
* History of seizure disorders
* \>2 alcoholic drinks/day,or present history (last 6 months) of drug abuse
* Spasticity that requires the individual to change an activity more than once a week
* Skin disease or sensation problems in the legs or hands that influence some activities more than once a week
* Claustrophobia
* Metallic implants
* Inability to attend treatment sessions 3 days per week for 6 weeks
Efficacy Comparison of Two Kinds of Treatment in Treating Dry Eye Caused by Meibomian Gland Dysfunction

This study aims to evaluate the efficacy of intense pulsed light in treating dry eye caused by meibomian gland dysfunction and make a comparison between the traditional treatment.


Eligibility Criteria:
Inclusion Criteria:

* patients with dry eye syndrome and diagnosed as MGD

Exclusion Criteria:

* an infection or inflammatory disease;
* ocular surgical history with in the last 3 months
* SGOGREN SYNDROME
Stroke Volume Variation and Pulse Pressure Variation as Predictors of Fluid Responsiveness During Kidney Transplantation

The aim pf this prospective study is to investigate the ability of stroke volume variation (SVV) and pulse pressure variation (PPV) to predict fluid responsiveness in patients undergoing kidney transplantation.

Optimal intraoperative fluid management guided by central venous pressure (CVP), a traditional intravascular volume status indicator has been established to improve transplanted graft function during renal transplantation. Recently, stroke volume variation (SVV) and pulse pressure variation (PPV), dynamic preload indices derived from the arterial waveform are increasingly advocated as predictors of fluid responsiveness in anesthetized patients and critically ill patients. However, their usefulness in renal failure patients undergoing renal transplantation has not been investigated. Thus, the aims of this study is to investigate accuracy of SVV and PPV for predicting fluid responsiveness in patients undergoing kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

- chronic renal failure patients undergoing renal transplantation

Exclusion Criteria:

* patients with cardiac arrhythmia
* patients with reduced left ventricular function (EF \< 40%)
* patients with valvular heart disease
* patients intracardiac shunt
* patients with pulmonary hypertension
* patients with extensive peripheral vascular disease
* patients with preoperative use of vasopressors or inotropics
Risk Factors for Beta-lactam Target Non Attainment in Critically Ill Patients BETALACTACRIT

Beta-lactams agents are time-dependent antibiotics. Their bactericidal effects are associated with the time spent above the minimal inhibitory concentration (MIC) of the bacteria. In ICU patients, many pathophysiological changes may occur, which significantly alter beta-lactam pharmacokinetics (increasing in distribution volume, hypoalbuminemia or change in glomerular filtration rate...), leading to antibiotic underexposure, which may explain some treatment failures and risk of emergence of a multi-resistant bacteria.

Many guidelines advocate to reach a fixed target for the steady-state free plasma concentration of beta-lactam between 4 and 8 times of the MIC. However, clinical evidences supporting that septic patients in ICU would benefit from such optimization remain low and contradictory, and use of surrogate MICs based on critical breakpoints instead of actual MICs are significant limitations in the description of beta-lactam exposure among ICU patients with sepsis.

In this study, the investigators aim to indentify profiles of intensive care unit patients which are more likely to be associated with pharmacological failure (\< 4 time the MIC of the bacteria). The investigators also aim to identify association between failure and poor clinical outcome.

The duration of patient participation extends from the inclusion visit (D1), to discharge from intensive care; if the participant is still in intensive care at D90, the last visit with data collection will be at D90. The maximum duration of participation in the study will therefore be 3 months.

Taking into account 3 months of set-up, 1 year of recruitment, 3 months of participant follow-up, 3 months of data processing and 3 months of interpretation, 2 years will be sufficient to carry out this project.

Eligibility Criteria:
Inclusion Criteria:

* Participant over 18 years of age.
* Hospitalized in intensive care unit.
* Bacterial infection documented by culture.
* Treatment with beta-lactam for less than 48 hours.
* Person not objecting to participation in the study. If the particpant is unable to receive the information, it will be given to a relative and his or her non-opposition will be collected; the patient's non opposition will be sought and collected as soon as his or her condition permits.

Exclusion Criteria:

* Measurement of MIC of the bacterium in question impossible.
* Patients allergic to beta-lactam antibiotics.
* Patients with an estimated hospital stay of less than 3 days.
* Participants with "complex" infectious sites: central nervous system infection, osteoarticular infection, etc.
* Patients already included in the present study on the occasion of a previous beta-lactam administration.
* Adult patients under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.