cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Ketamine in Children With Severe Brain Injury for Brain Cell Protection

The purpose of this study is to determine the possible effects of an anesthetic agent called Ketamine on the injured brain in children.

The researchers think that it will effect the outcomes of children with these injuries.


Eligibility Criteria:
Inclusion Criteria:

* are 1 month to 16 years of age; AND
* are admitted to the PICU following severe TBI (any GCS 3-8 inclusive) within 8 hours after the injury; AND
* are intubated and ventilated for the management of TBI; AND
* are anticipated to have an indwelling arterial or venous catheter for blood sampling during the first three days of study enrollment; AND
* have an intra-cranial pressure (ICP) monitoring device for management of TBI.

Exclusion Criteria:

* are less than 4 kilograms in weight upon admission
* are less than 1 month of age;
* are greater than 16 years of age;
* have a clinical diagnosis of non-accidental TBI;
* have suffered immersion injury or prolonged hypoxic injury (lasting greater than 10 minutes);
* have a known allergy to ketamine;
* have a planned removal of endotracheal tube or the removal of central venous catheter AND arterial catheter within 72 hours of study enrollment;
* have a current history of neuromuscular disease;
* have a current history of hepatic failure;
* have a current history of glaucoma
* require chronic treatment with anti-epileptic drugs (AEDs) or devices;
* more than 8 hours have elapsed from the time of injury to PICU admission;
* have documentation of a positive pregnancy test at the time of enrollment;
* if there is a lack of commitment to aggressive intensive care therapies (the subject is either on a DNR status due to pre-existing medical condition, or the family decides to withdraw support prior to participation in the study due to other multiple severe injuries and organ failures resulting from the trauma).
The University of Hong Kong Neurocognitive Disorder Cohort

The HKU Neurocognitive Disorder (NCD) Cohort is a hospital-based, prospective, observational study of older HK Chinese adults with cognitive impairment, with a special focus on studying patients with subjective cognitive decline and mild cognitive impairment.

The HKU Neurocognitive Disorder (NCD) Cohort is a hospital-based, prospective, observational study of older HK Chinese adults with cognitive impairment, with a special focus on studying patients with subjective cognitive decline and mild cognitive impairment, and in particular the biomarkers that predict cognitive and functional decline.

Comprehensive profiling of each subject is performed through a multi-domain assessment protocol including detailed demographics, lifestyle factors, neuropsychological battery, mood, MRI, genetics, blood biomarkers, and other patient-centred parameters including level of disability, quality of life and societal engagement. Ongoing annual follow up captures the essential clinical events and changes in neurocognitive function (conversion to MCI or dementia), mood, level of disability and quality of life; as well as repeat blood tests.

The HKU NCD Cohort is the first-ever Asian dementia cohort to be formally included into the Dementia Platforms UK, achieving an international collaborative status with other UK-based cohorts. The study neuropsychological battery is aligned with the NACC UDS3 battery.

Eligibility Criteria:
Inclusion Criteria:

* Older adults with or without neurocognitive disoder. HKU NCD Cohort focuses primarily on people with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI).

Exclusion Criteria:

* Severe Parkinson's disease, major depressive disorder or severe psychiatric conditions, significant communication difficulties (e.g. aphasia, deafness), terminal cancer or likely end-of-life in the next 12 months.
Effects of Aerobe Interval Training and Moderate Continuous Training in Chronic Obstructive Pulmonary Disease Patients

Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. So far it is poorly understood which form of exercise is the most effective in training this condition. The investigators want to study the physiological response to two different training programs (High intensity aerobe interval training and moderate continuous aerobe training)with special focus on cardiac and skeletal muscle adaptions

Reduced exercise tolerance is one of the hallmarks of COPD and The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. However the weak correlation between exercise capacity and FEV1 implies that other factors than reduced pulmonary function contributes to this impairment . Several studies have found changes in skeletal muscle, with fibre shift, increased oxidative stress, increased inflammatory cytokines and impaired mitochondrial function, suggesting a lower limb dysfunction

Numerous exercise studies in COPD patients have shown physiological and physiological benefits of training and endurance training is now regarded as an important part in pulmonary rehabilitation. It is still uncertain what type of endurance training that is most favourable for COPD patients.

In patients with heart failure and metabolic syndrome aerobe interval exercise have be shown to be superior in improving aerobic capacity and cardiac function

We therefore want conduct a study comparing training effects in patients with moderate to severe COPD, that participated in an identical training program that in HF and metabolic syndrome patients gave significant improvement in aerobic capacity, cardiac function and skeletal muscle function.

Patients will therefore be assigned to either 4x4 minutes high intensity interval treadmill exercise or continuous moderate intensity treadmill exercise 3 times pr week for 12 weeks. Aerobic capacity and work economy, pulmonary,cardiac and skeletal muscle function before and after the exercise training will be measured.

Eligibility Criteria:
Inclusion Criteria:

* COPD with FEV1 25-60 % of exp , FEV1%FVC\<70 %. Age 45-80 years

Exclusion Criteria:

* Heart failure
* symptomatic coronary artery disease
* cancer
* alcohol and drug abuse
* severe mental illness
* Lower respiratory infection last 4 weeks
* participation in exercise- or lung rehabilitation program last 3 months.
* oral steroid use
R(+)PPX High Dose Treatment of ALS

R(+)pramipexole is administered in escalating doses to patients with early ALS. Plasma and spinal fluid levels of R(+)PPX are monitored, in addition to biochemical markers of oxidative stress.


Eligibility Criteria:
Inclusion Criteria:

* definite ALS no prior exposure to R(+)PPX

Exclusion Criteria:

* ALSFRS at baseline \<40 FVC at baseline \<70%
Interlaboratory Reliability of 3D Gait Analysis

The purpose of this study is to determine the interlaboratory reliability of 3D gait analysis performed on healthy subjects on an instrumented treadmill in three different laboratories. This will allow us to evaluate whether the pooling of control data is feasible in future studies. This will support our ambitions to enter into future collaborations to conduct studies with larger samples. Moreover, this way we will know if we can share patient data in the future so that patients can be specifically referred to a lab with expertise on a particular evaluation, e.g. the lab in Maastricht has expertise on perturbations, UZ Gent has expertise on full-body measurements and UHasselt has expertise on balance.

During this study approximately 30 healthy subjects will be recruited (10 from each center) from the staff and students at each center. These subjects are own staff and students of the 3 centers. Each subject will undergo a 3D gait analysis at each center (at UZGent, UHasselt and UMaastricht). Therefore, each subject will be evaluated 3 times. The time between each evaluations will be a maximum of one week.

The evaluations will be performed as per standard procedure in each lab. However, a standardized model (HBM2 lower limb), an agreed walking velocity (0.9 m/s, 1.0 m/s, 1.1 m/s) and an agreed duration per recording (3 min) will be used. The same software will be used to process the collected data. 3D kinematics and kinetic time-series data of the lower limbs will be extracted as outcome data. Absolute reliability indices will be calculated in the following way: First, the standard deviation (SD) of time-series data across different gait cycles will be calculated per participant per center. The SD values across different centers per participant will then be averaged. Finally, the SD values across different participants will form the inter-laboratory reliability indices. In addition, we will use statistical parametric mapping (Anova repeated measures) to compare the full time-series data of each outcome parameter.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects aged 18-65 years old

Exclusion Criteria:

Individuals cannot participate if:

* They suffer from a neurological disorder.
* They experience balance problems.
* They have had surgical procedures on the legs in the past.
* They are taking medication that may affect gait and balance. They experience leg or back pain at the time of test taking.
Open Label Phase II Study of BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec

The purpose of this study is to evaluate the anti-cancer activity and safety of Bay 43-006, in patients who have Chronic Myelogenous Leukemia that resisted to Gleevec treatment, one of the standard medication administered for these patients.


Eligibility Criteria:
Inclusion Criteria:- Have Philadelphia chromosome positive chronic myelogenous leukemia (CML) in chronic phase, as per IBMTR criteria- Have documented hematologic resistance to Gleevec (Imatinib) following a prior hematologic response to Gleevec administered at doses of at least 400 mg/d for at least 3 months.- Have WBC \>20 x 109/L at study entry- Have an ECOG performance status. Status of 0, 1 or 2- Have an anticipated survival of at least 16 weeks.- Be able to comply with study procedures and follow-up examinations.- Signed informed consent must be obtained prior to any study specific procedures. Exclusion Criteria:- Congestive heart failure \> class II as defined by the New York Heart Association Functional Classification (NYHA)- Cardiac arrhythmias requiring antiarrythmics (excluding beta blockers or digoxin)- Active coronary artery disease or ischemia- History of HIV infection or chronic hepatitis B or C - Active clinically serious infections (\> grade 2 NCI-CTC)- Patients with seizure disorder requiring anti-epileptic drugs- History of solid organ allograft
In-Human CXCR4 Imaging of Hematologic and Solid Tumors Using [68Ga]-Pentixafor-PET

The purpose of this study is to determine the uptake of the imaging agent \[68Ga\]-pentixafor with PET/CT scans in people with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), and non-Hodgkin lymphoma (NHL), or you have histiocytic neoplasms (Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD) and/or Rosai-Dorfman disease (RDD).


Eligibility Criteria:
Inclusion Criteria:

Twenty patients with histologically proven treatment-naïve, therapy-refractory or relapsed blood cancers meeting the below criteria will be included:

* Indolent B- or T-cell Non-Hodgkin lymphoma (including cutaneous lymphomas) or Non-Hodgkin lymphoma with variable FDG uptake and clinical course, such as mantle cell lymphoma; and measurable disease according to Lugano criteria

or

* Histiocytic neoplasms (Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD) and/or Rosai-Dorfman disease (RDD)
* MGUS/SMM or MM according to IMWG definitions
* Solid tumors, such as lung cancers, meningioma, adrenocortical neoplasms including cortisol-producing adenomas or high suspicion for tumor, such as in patients with Cushing's disease.
* Age ≥18
* Negative serum pregnancy test for female volunteers of childbearing age and potential (as defined by MSKCC Standards \& Guidelines) from assays obtained \<2 weeks prior to study enrollment/intervention; or negative urine pregnancy test performed on the day of intervention
* MSKCC patients

Exclusion Criteria:

* Breast-feeding
* History of renal functional disorders (chronic kidney disease with eGFR\<30)
* Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
Texting to Promote Breastfeeding (TOPS)

The purpose of the study is to see if a program of text messages that support and promote breastfeeding for expecting and delivered African-American/Black women (called TEAM2BF), as compared to a national maternal health texting program (called Bright By Text), can result in more women being able to breastfeed their infant. Because breastfeeding is healthy for mothers and babies, and because fewer African-American/Black women decide to breastfeed and continue breastfeeding than many other racial and ethnic groups, researchers like us are trying to figure out ways to be supportive to African-American/Black mothers who might be interested in breastfeeding. The investigators will enroll up to 80 mothers and their infants at UHCMC.


Eligibility Criteria:
Inclusion Criteria:

* Expectant women initiating obstetrical care \<34 weeks or at any prenatal visit up to 34 weeks gestation
* Daily access to a mobile phone with text message capabilities,
* Self-identify as African-American/Black,
* English speaking, and
* Infant feeding plan of "might or will breastfeed"
* Receive care at Ahuja Midtown or MAC1200

Exclusion Criteria:

* Committed to feeding formula only to their infant
* No mobile phone with text capability
Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management

Increased indications for transplantation continue to worsen the shortage of organs and need the extension of graft sampling criteria and the search for new potential sources of organs. Despite undeniable success in the short term, due to major advances in surgery, medicine and research, transplant recipients continue to face the risk of chronic rejection and long-term complications.

The University Hospital Federation "FHU SUPORT" was created to optimize the chances of success of the organ transplant and improve the quality of life of the transplanted patient. FHU SUPORT 's ambition is based on a translational strategy that presents two priority areas:

Axis 1: Optimization, evaluation, conditioning of the donor, graft, recipient Axis 2: Personalized follow-up of the transplanted patient in the short and long term Identifying factors for long-term graft and patient survival through translational research from a common cohort and biological collection will predict transplant rejection, prolong graft function, or improve the patient's care.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 (no age limit)
* affiliated to a social security organization
* Recipient (s) of a kidney, liver or heart transplant
* followed by at least one of the FHU SUPORT centers (Tours, Poitiers, Limoges, Rennes)
* having given informed consent to participate in the cohort.

Exclusion Criteria:

* Patient unable to understand the information given by the investigator
* People under the protection of justice
Characterization of the Autofluorescence of Healthy and Pathological Tissues of Vocal Cords

The aim of this clinical trial is to provide information about autofluorescence of pathological versus healthy vocal folds tissues.

Experimentations are performed on vocal folds biopsies obtained from patients, surgered at ENT department, university hospital of Besançon. After being extracted, samples of vocal folds are submitted to excitations at 365 nm, 405 nm and 450 nm; light spectral absorptions are measured, and results are compared to reference anatomopathology.


Eligibility Criteria:
Inclusion Criteria:

* patient view in ENT department, presenting vocal fold lesion that necessitate biopsy
* patient informed and with non opposition

Exclusion Criteria:

* small (\<1mm) and/or brittle sample
* Patients in emergency situations, pregnant or nursing mothers, persons deprived of their liberty, minors or protected adults.
Comparison Between Right and Left Ventricular Systolic Dysfunction as a Risk Factors for Aki in Critical Care Patients

The cardio renal syndrome generally focuses on left ventricular function, and the importance of the right ventricle as a determinant of renal function is described less frequently. Although the risk of AKI is similar for patients with isolated LVD and isolated RVD, the severity of AKI and the associated risk of hospital mortality is highest among those with isolated RVD.

The right ventricle seems to affect renal function through different mechanisms, including Venous Congestion, tricuspid regurgitation, And potential inhibitory effect on left ventricular function The most important mechanism is venous congestion, a manifestation of sodium avidity and fluid expansion, as Directly increasing renal venous pressure causes sodium retention, lowers urinary output, and decreases glomerular filtration and widely thought to explain AKI Venous pressure is directly associated with renal dysfunction, independently of ventricular function, and admission peripheral edema is associated with greater risk of AKI. Such awareness of a primary role of renal venous congestion reshapes our understanding of renal function as not simply a reflection of arterial perfusion, but rather a balance between arterial supply and venous drainage.

.

Eligibility Criteria:
Inclusion Criteria:

* cardiac patient

Exclusion Criteria:

* ESRD pt CKD Cirrhotic patients AKI due to post renal cause
Measles Vaccination Cash Incentives Experimental Evidence From Nigeria

IDinsight is conducting a randomized controlled trial to assess the impact of various sized cash incentives for caretakers of infants that require a 9-month measles vaccination on the completion rate for the vaccine in Nigeria. The purpose of the experiment is to help New Incentives (NI) determine the optimal size of the incentive as they scale to the North West region of Nigeria.


Eligibility Criteria:
Inclusion Criteria:

* Caregiver and infant registered with the New Incentives program
* The infant was nine months or older at the start of the study (note there was no upper age limit as New Incentives only began enrolling infants in October 2016)
* Infant had received at least one previous conditional cash transfer for immunization at an All Babies are Equal Initiative clinic,
* Infant had received their Penta-3 vaccine.
* The caregiver had provided a phone number (either a personal number or a number of someone who can reach them) during registration.

Exclusion Criteria:

* Infant had already received a measles vaccine
Histamine Pharmacogenetics in Children With Atopic Dermatitis

The primary goal of the study is to investigate the impact of a common genetic polymorphism in a histamine detoxification enzyme that may well have a common role in regulating the expression of atopic dermatitis (AD) and other related atopic diseases in children.

Atopic dermatitis (AD) is a common condition in the pediatric population, affecting an estimated 15% of all children greater than 18 months of age in the United States. It is now recognized that AD is a disease of significant heterogeneity with respect to both disease severity and response to conventional pharmacologic therapies. With the recognition of this variability comes the understanding that, as with many other allergic disease, there exist many specific disease phenotypes that ultimately govern response to pharmacologic intervention. The characterization of these unique phenotypes and their associated biologic mediators is therefore of critical therapeutic importance in the development of disease and patient-specific treatment strategies.

The long term objective of this research is to explore the effects of genetic, environmental and developmental influences on the primary determinants of histamine action in atopic children and to identify potential histamine "haplotypes" that may be predictive of disease severity, progression and/or response to therapy.

The primary hypothesis is the presence of HNMT T314 allele and /or slow acetylation genotype is associated with childhood atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian, Hispanic and African American children ages 6 months to 5 years with a diagnosis of atopic dermatitis within the last 12 months will constitute the candidate pool for enrollment into the study group. The diagnosis of atopic dermatitis will be determined by the presence of at least 3 major diagnostic features (i.e., pruritis, rash,relapsing-remitting presentation, family history or atopy) in addition to at least 3 minor features (including but not limited to xerosis, elevated serum IgE, ocular involvement, food allergy). Healthy Caucasian, Hispanic and African American children within the same age range will comprise the pool for enrollment into the control group.

Exclusion Criteria:

* Any child with atopic dermatitis who has a documented history of asthma or bronchospasm or who is currently receiving treatment for either of these conditions will be excluded. Any control subject who has asthma or positive family history of allergy or atopic disease in a first-degree relative (biological mother, father or siblings) will also be ineligible for enrollment.
Analysis of Ocular Surface Microbiota in Dry Eye Patients After Femtosecond Laser-assisted In-situ Keratomileusis (FS-LASIK)

By using 16S rRNA sequencing technology to analyze the changes in ocular surface microbiota before and after surgery, as well as the impact of changes in ocular surface microbiota on FS-LASIK induced DES, new treatment ideas are provided for corneal FS-LASIK induced DES patients, and the incidence of FS-LASIK related DES is reduced.

This study aims to include 160 postoperative patients, who will be divided into a dry eye group and a normal group based on postoperative dry eye examination. Microbial samples of the patient's conjunctival sac will be collected, and changes in the ocular surface microbiota before and after surgery will be analyzed using 16S rRNA sequencing technology. The impact of changes in the ocular surface microbiota on FS-LASIK induced DES will also be analyzed, providing new treatment ideas for FS-LASIK induced DES patients and reducing the incidence of FS-LASIK related DES.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old;
2. Stable refractive index (refractive index change less than 0.5D in the past 2 years);
3. The best corrected far vision (CDVA) is 1.0 or better;
4. Postoperative dry eye patients need to meet the following criteria: Patient's Eye Surface Disease Index (OSDI) ≥ 13 and two of the following three criteria are met: Tear film rupture time (BUT) ≤ 10S Schirmer I test (mm/5min) ≤ 10mm, corneal fluorescein sodium staining exceeding 5 spots;

Exclusion Criteria:

1. History of eye trauma or surgery;
2. Suspected keratoconus;
3. Previously suffering from other eye diseases such as keratitis or edema, glaucoma, uveitis, retinal detachment, macular degeneration, cataracts, amblyopia, etc.;
4. Preoperative history of severe dry eye disease;
5. Patients with systemic diseases, such as hyperthyroidism or autoimmune diseases; Or severe mental disorders, such as anxiety and depression;