cyrilzakka/clinical-trials huggingface dataset:
Validation of an Ecological Organization and Problem Solving Test (TEM-PRO) in Vocational Rehabilitation

Standard neuropsychological evaluations after severe TBI (traumatic brain injury) often minimizes the executive deficits, these latter are known to seriously impair return to work. Therefore, we developed an ecological organization and problem-solving test in a vocational setting called the TEM-PRO. The test consists of 4 activities of variable complexity, collection and redaction of information and demands to follow well defined rules.

While there may be many reasons for obtaining neuropsychological assessement after TBI, predication of the real world functioning is generally the final goal. Among the cognitive deficits, the dysexecutive syndrome is certainly the most disabling in impeding to return to work. The classical neuropsychological tests often fail to asses theses deficits adequately. Several more ecological tests have been previously developed. Based on the multiple errands test and the six elements test, we built up first an ecological test over 60 minutes for activities of the daily living (test des errances multiples, " TEM, version CRR "). Used regularly in the clinical setting, it was able to evaluate the functional aptitudes of the patients and was useful to complete the classical neuropsychological tests. However test duration is too short and activities are far away from real work scenarios to test working aptitudes. Therefore we developed a new executive-ecological test in a vocational setting (TEM-PRO). The adaptation of the original test in a vocational setting induces the addition of 4 activities of variable complexity, research and redaction of information and demands to follow well defined rules. Skills that are solicited are planning, selective and sustained attention, prospective memory, organization, problems solving and behavior adaption over a long period of time. Based on a pilot study with patients without neurological deficit we assessed that our test displayed good sensitivity without ceiling effect. It allowed a quantitative and differentiated evaluation, a classification of various error types (interpretation and judgment failure, rule breaks, task failures and inefficiencies) and provided a qualitative behavioral analysis.

Eligibility Criteria:
Inclusion Criteria:

French speaking patients, older than 18 years, able to understand and sign the study informed consent, able to answer questionnaires used in the study, suffering from moderate to severe TBI, without invalidate psychiatric comorbidities, without severe memory impairment, capable to participate for 4h in a vocational activity, planning to return to work. Patients still receiving compensation and patients returned to work will be included

Exclusion Criteria:

alcohol or drug abuse, severe physical disability interfering with the test (modified Ranking score \>1), under legal custody.
A Study of Baricitinib in Healthy Japanese Participants

The purpose of this study is to understand the relationship of 3 different dosage forms of baricitinib. This study will also explore the effect of food on how the body absorbs baricitinib. This study will last about 5 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy Japanese male and female (women not of child-bearing potential or after menopause), as determined by medical history and physical examination
* Have a body mass index (BMI) of 18.5 to 29.9 kilogram per square meter (kg/m\^2)
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have an abnormal blood pressure as determined by the investigator
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Are women who are pregnant or lactating
* Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to dosing and during the study.
* Have donated blood of more than 400 milliliter (mL) in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks, or total volume of blood donation within 12 months is 1200 mL (males) or 800 mL (females) at screening.
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions
* Are participants who currently smoke more than 10 cigarettes per day (or equivalent in tobacco or nicotine products) or are unwilling to abide by smoking restrictions
* Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
* Have an absolute neutrophil count (ANC) less than 2000 cells/microliter (µL)
Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries

After severe burn injury, the full-thickness burn areas are excised (in the first week) and then temporarily covered with allograft (cryogenic preserved cadaver skin). This first covering is then replaced with thin skin meshed autograft.

In this study, either the dermal substrates cellularised LG002 or uncellularised LG002 will be grafted, after excision, in symmetrical areas, in replacement of the allografts. Fourteen to twenty one days after this first covering, the dermal substrate will be covered with thin skin meshed autograft.

For lesions that cannot heal spontaneously, the wound is excised until fascia. Four contiguous dermal substrates (uncellularised and cellularised) are randomly grafted on each symmetric area.

A primary siliconized dressing will cover the wound. Secondary dressing: dressing gauze impregnated with physiologic serum and/or sterile dried dressing gauze, the whole is maintained by a (slightly compressive) tubular or elastic bandage.

Thin skin meshed autograft will occur 14 to 21 days after dermal substrate cellularised LG002 or uncellularised LG002 grafting (time frame necessary for the site to vascularize).

Meshed autograft development must be identical in both symmetric areas, for one single patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe burn injuries ≥ 40 % of TBSA (Total Body Surface Area)
* Thermal burn on symmetrical areas allowing grafting of 4 contiguous dermal substrates (cellularised LG002 or uncellularised LG002) on each area
* The patient himself, or his legal representative, must give his informed consent in writing

Exclusion Criteria:

* Anterior progressive serious illness (i.e severe hepatic insufficiency, immunodepression induced by corticotherapy or illness (AIDS))
* Metabolic disease
* Systemic infection or local burn infection
* Known allergy to collagen, streptomycin, Penicillin and/or bovine origine products
Association Between Cerebral Blood Flow Change and Cognitive Function in Hemodialysis Patients

The prevalence of cognitive impairment in maintenance hemodialysis (MHD) patients is 3 to 5 times higher than that in ordinary people, so it is essential to find the associated risk factors in this population. This project intends to evaluate whether changes in cerebral blood flow during dialysis have an impact on cognitive function in middle-aged and elderly MHD patients and clarify their influence on brain imaging characteristics. MHD patients who started hemodialysis at 3 to 6 months were selected to examine the difference in middle cerebral artery flow rate before and after dialysis by transcranial Doppler ultrasound to reflect the changes in cerebral blood flow. Changes in the cognitive function scale assessment (memory, executive function, and other five cognitive domains) and brain magnetic resonance imaging examinations are planned to collect both at baseline and after a one-year follow-up. Then the investigator used the multiple linear regression method to analyze the effects of the difference in middle cerebral artery flow on the changes in cognitive function and the characteristics in brain imaging. The investigators anticipate that the characteristics of the influence of changes in cerebral blood flow on cognitive impairment in Chinese MHD patients will be elucidated in this study, which may provide crucial clinical evidence for finding preventive and intervention measures for cognitive impairment in this group of population.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 50, no gender limitation;
* End-stage renal disease, stable dialysis for 3-6 months;
* Subjects voluntarily participated in the study and signed informed consent, and were able to participate in clinical data collection, neuropsychological assessment, transcranial Doppler ultrasound (TCD), head MRI, and 1-year follow-up.

Exclusion Criteria:

* Congenital mental retardation or disturbance of consciousness, schizophrenia, or history of severe anxiety and depression (Hamilton Depression Scale score more than 17;
* Long-term alcohol or psychotropic drug dependence;
* Those who cannot complete the neuropsychological assessment due to visual impairment, hearing impairment, or limb dysfunction; less than 10 hours of dialysis per week;
* Patients with poor detection of the bilateral temporal window by TCD examination and unable to cooperate with ultrasound examination;
* Those who cannot undergo head MRI examination for various reasons.
Swiss National Registry of Grown up Congenital Heart Disease Patients

Due to successes in the last decades in pediatric heart surgery and cardiology, 90-95% of the children with congenital heart disease reach adult age.This results in an increasing number of adults or "grown-ups" with congenital heart disease (ACHD or GUCH patients) that require special health care organization and training programmes. Long term complications of these GUCH patients and optimum treatment strategies are still poorly known. The aim of this registry is to collect quantitative and qualitative data regarding GUCH patients treated in specialised centres in Switzerland.

The SWISS GUCH registry will capture epidemiologic data, diagnosis, type of earlier treatment / intervention and cardiac complications. Following each visit, the cardiac complications will be captured as well as the mortality.

Every GUCH patient coming for a visit in one of the specialized organisation participating to the registry will be asked to participate. After signing the informed consent form, the patient data will be coded and captured in a web-based data base (secuTrial®).

Pooling the data from the different centres will enable a nation wide register to be established. More robust data on the size and composition of the GUCH population will be obtained. Also long term prognosis of specific patient group will be derived.

Eligibility Criteria:
Inclusion Criteria:

Adult (above 18 years of age) with congenital heart disease, treated in one of the Swiss centre with specialized organisation for GUCH patients.

Signed informed consent. Patients with trisomy 21: the parents or legal guardian will have to give the consent.

Exclusion Criteria:

None
Sugammadex Versus Neostigmine in Pediatric Less Than Two Years Undergoing Cardiac Catheterization

This study hypothesizes that Sugammadex may has more appropriate recovery profile than neostigmine in pediatric cardiac patients undergoing cardiac catheterization. In pediatric cardiac patients, clear and rapid recovery (fast-tracking) is required to maintain hemodynamic within the normal physiological values which may be saved by sugammadex

There are numerous advantages of early tracheal extubation otherwise known as fast-tracking following anesthesia for congenital heart disease (CHD)

Early tracheal extubation not only eliminates the potential morbidity related to an endotracheal tube and mechanical ventilation such as atelectasis, accumulation of secretions, nosocomial infections, and the potential for airway trauma, it also limits the need for sedation and the antecedent adverse effects including respiratory and hemodynamic depression, tolerance, withdrawal, and delirium. Most importantly, the shift from positive pressure to spontaneous ventilation augments cardiovascular function and improves preload. Reversal of neuromuscular blockade is a fundamental aspect of emergence from general anesthesia. Historically, the only option to actively reverse blockade will be to administer anticholinesterase inhibitors, which are unable to reverse deep neuromuscular blockade. They are also associated with a variety of cholinergic side effects, including bradycardia, nausea, and increased secretions, which require concomitant administration of an anticholinergic agent, with its own adverse effects. Sugammadex is a newer, selective relaxant binding agent

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status (ASA) I-III

Exclusion Criteria:

* Legal guardian refusal.
* Any patients with known drug hypersensitivity.
* Kidney failure.
* Liver failure.
* Diseases affecting the neuromuscular junction.
* A history of malignant hyperthermia
Digital Home-Based Prehabilitation Before Surgery

This clinical trial compares two different prehabilitation programs, with no organized prehabilitation, prior to major colorectal cancer surgery. The prehabilitation programs include intensive and coached physical exercise and optimized nutritional intake coupled with smoking cessation, physiological support and correction of poly-pharmacy.

Patients are randomized to either a digital home-based program, a physical hospital-based program or no-organized prehabilitation. The eligible patients are anyone scheduled for colorectal cancer surgery who are fluent in Norwegian able to consent and to understand questionnaires. The main question the study aims to answer is whether a digital home-based program is non-inferior to a hospital-based program in terms of improved physical capacity and maintenance of life-quality. In addition, blood samples will be drawn at three time points, at inclusion, after intervention (prior to surgery) and 6 weeks after surgery to analyze and search for biomarkers reflecting patients' individual surgical risk profile and response to prehabilitation. Participants randomized to intervention, will be given psychological coaching and support, individualized nutritionist counselling, coached, structured and repeated 60 minutes daily exercises for three weeks prior to surgery. The control group will receive no organized prehabilitation in the period of time between diagnose and surgery.

Eligibility Criteria:
Inclusion Criteria:

* Planned for major gastrointestinal cancer surgery
* Fluent in Norwegian and able to consent and to understand questionnaires

Exclusion Criteria:

* Inability to walk for six minutes or to rise independently from a chair
* Inability to comprehend exercise program or to comply with written and oral instructions
* Presence of a cardio-pulmonary condition that precludes exercise
* Living in very remote areas making a hospital-based intervention group impossible to implement
* Being without a permanent address
* Admittance to a hospital facility for \> 50% of the time from diagnosis to surgery
Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures

To compare between ultrasound guided closed reduction and open reduction of zygomatic arch in cases of zygomaticomaxillary fracture.

To evaluate the role of intra-operative ultrasound during zygomatic arch reduction.

To compare between esthetic appearance, orbital movement, wound healing, scaring, and postoperative ocular complications in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with ZMC fractures that require reduction and fixation
* Patients between 20 to 50 years old with no gender predilections

Exclusion Criteria:

* Existence of infection at the fracture line
* Chronic systemic diseases such as metabolic bone disease, immunocompromised status
Molecular and Genomic Profiling of Head and Neck Tumors

The purpose of this study is to study the genetic profile of head and neck tumors and their relationship to treatment response and outcome

Previous research by our group using genetic microarray analysis of HNSCC and normal keratinocytes has identified two distinct groups of genetic expression based on clustering patterns of a subgroup of genes. Clinical data was summarized for each group and overall, patient segregation by gene expression profiling was a better predictor of outcome than clinicopathological variables. Further analysis identified 375 genes that discriminate between the genotypic subtypes of HNSCC. Overall, our preliminary data has shown that the pattern of global gene expression in a HNSCC specimen can be used as a predictor of prognosis. We isolated subsets of genes showing the greatest patterns of divergence in gene expression. We have also identified 366 over-expressed and 246 underexpressed genes when comparing primary tumor to normal surgical margins and have identified a similar number of genes whose expression has changed when comparing primary tumor to lymph node metastasis. Combining these data sets we have identified genes which consistently increase or decrease expression during progression from normal tissue to primary tumor, and subsequently to metastatic node. We have selected several candidate genes for subsequent analysis using HNSCC tissue arrays. Through DNA microarray analysis and other techniques for looking at genetic and molecular characteristics, a more detailed knowledge of the malignant transformation process, and alterations with therapy, in these patients may be obtained. This study will seek to perform comprehensive molecular and genetic profiling to improve biomarker development in HNSCC and correlate this data with patient clinical data. Ultimately it is hoped that tumor specific genetic abnormalities may be identified which could provide targets for treatment strategies such as gene therapy, immunotherapy, or other interventions.

Study Objectives:

To evaluate gene expression patterns in human head and neck squamous cell carcinoma and correlate this with treatment response, both surgical and non-surgical.

To identify a series of diagnostic markers in blood, urine and/or sputum for head and neck squamous cell carcinoma and study the mechanism of action of these proteins.

Eligibility Criteria:
Inclusion Criteria:

* actual or suspected malignant or non-malignant tumors of the head and neck
* planned biopsy and/or resection, or availability of paraffin embedded or stored frozen tumor tissue for non-genetic analysis

Exclusion Criteria:

* insufficient tissue available for both standard diagnostic evaluation and study specimen
Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers

The study purpose is to compare healing rates, cost effectiveness, quality of life and safety of 12 week compression therapy for the treatment of venous leg ulcers with the 3M™ Coban™ 2 Layer Compression System versus short-stretch compression bandage.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, age 18 years or older
* Subjects having a venous leg ulcer (stage C6 according CEAP classification, venous pathology proved by the presence of reflux (Pr)), which is at least 1 cm in any dimension but not larger than 10 cm in any dimension and has at least 5 cm distance to additional ulcers.
* Subjects who are co-operative, willing to give written informed consent prior to study entry, and willing to comply with the study protocol.
* Subjects who are able to understand and answer questionnaire items.
* Subjects who can walk (with or without a walking aid).
* Subjects who have an ABPI (ankle brachial pressure index) of treated leg greater or equal to 0,8 as measured within four weeks prior to enrollment.
* Subjects with venous incompetence as defined by reflux longer than 1,0 second in at least one of the following sites: groin \[femoral vein, junction of GSV\], mid thigh medial \[GSV\], hollow of the knee \[popliteal vein, junction of SSV\], mid calf \[SSV\] in the standing position, measured by Doppler, preferably by duplex within the last 12 month without following active treatment of venous reflux.

Exclusion Criteria:

* Subjects with an ABPI \< 0.8 as measured within four weeks prior to enrollment.
* Subjects whose condition, in the opinion of the investigator, does not require or allow for compression therapy.
* Subjects where the potential study ulcer is infected, i.e. showing signs of clinical infection (not contamination) as evidenced by purulent, malodorous, or recent increase in drainage and/or peri-wound erythema or elevated temperature.
* Subjects receiving any systemic antibiotics.
* Subjects with diagnosed cancerous ulceration.
* Subjects with diabetic foot ulcers (do not exclude diabetics).
* Subjects with circumferential wounds.
* Subjects who started or significantly changed treatment with mood altering substances (e.g. antidepressant drugs) within two weeks prior to enrollment.
* Subjects who are participating in any prospective clinical study that can potentially interfere with this study.
* Subjects who are, in the opinion of the clinical investigator, unsuitable for enrollment in this study, for reasons not specified in the exclusion criteria.
* Subjects with known allergies against the following products: Coban 2 Layer Compression System, Rosidal K, Rosidal soft, Tegaderm Foam, Cavilon NSBF
Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer

The purpose of this study is to collect information about treatment recommendations based on ctDNA testing and whether treatment changes based on ctDNA information result in better outcomes for patients with pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Resectable or borderline resectable pancreatic adenocarcinoma per NCNN guidelines
3. No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer.
4. ECOG performance status ≤ 1
5. Clinically eligible for chemotherapy
6. Able to tolerate collection of up to 20 mL of blood via venipuncture for research blood draw
7. Has residual FFPE specimen available for submission to Natera
8. Able to read, understand and provide written informed consent
9. Willing and able to comply with the study requirements

Exclusion Criteria:

1. Pregnant or breastfeeding
2. Radiologic evidence of distant metastases
3. Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
4. Prior initiation of chemotherapy, radiation therapy, or surgery for pancreatic cancer
5. Neuropathy \> grade 2
6. History of bone marrow or organ transplant
7. Blood transfusion within 1 month of enrollment
8. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
9. Serious medical condition that may adversely affect ability to participate in the study