cyrilzakka/clinical-trials huggingface dataset:
Determining Chewing Performance Level in Children

The study will investigate to verify whether pediatric dentists could determine chewing performance level by using Karaduman Chewing Performance Scale in children.

The KCPS was developed by physical therapists who had expertise in pediatric swallowing disorders. This scale could be used as a practical tool to define chewing disorders as a common language for professionals due to its quick and easy to use features. However, its reliability in other professions has not been verified. The study will investigate to verify whether pediatric dentists could determine chewing performance level by using Karaduman Chewing Performance Scale in children.

Eligibility Criteria:
Inclusion Criteria:

* Typical developing children
* Children with cerebral palsy (CP)
* Above the age of 2 years

Exclusion Criteria:

* Children who were under the age of 2 years
* Who used any medicine and/or oral appliances that may affect chewing performance
* Who had a previous evaluation of chewing function and received any chewing training
Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Population

Data collection for better patient characterization in a highly treatment experienced population. Studying the clinical practice for the treatment of HIV multiexperienced patients in the real life.

The research will be divided into two phases:

* The first phase intends to define and understand the clinical practice using a questionnaire about general topics: definitions of multiexperienced patients and VL failure, therapeutic strategies and behaviour in particular cases.
* The second part of the research will collect the clinical data of double PIs failure patients.


Eligibility Criteria:
Inclusion Criteria:

Patients double PIs failure

Exclusion Criteria:

Not Applicable
Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults

This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin monovalent influenza vaccine in immunocompromised children and young adults.

This is a prospective observational study. This study will not dictate vaccine administration, nor the vaccine product to be used. It will collect data in St Jude patients who will receive the vaccine as part of their clinical care per institutional guidelines. Research participants will receive two doses of inactivated H1N1 swine-origin monovalent influenza vaccine administered 28 days apart as part of clinical care. Each dose contains 15 mcg of hemagglutinin antigen (HA).Follow-up visits will be scheduled 28 days after each dose and at day 208+/- 14 days for blood work. The day of administration of the first vaccine dose is counted as day 0. At each of these visits, blood will be collected to assess for immunogenicity. Research participants will be given a diary card to record symptoms for 28 days . They will be asked to bring this diary back at the next visit. Other vaccine-related adverse events will also be collected by retrospective chart review.

Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight who have an underlying diagnosis of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 months through 21 years of age at the time of entry into the study;
* Body weight of 13 kg or greater at the time of entry into the study;
* Participant is immunocompromised due to cancer, HIV, or sickle cell disease or receipt of a stem cell transplant;
* Participant or participant's parent/legal guardian available by telephone during the course of the study;
* Written informed consent (and assent, if applicable) obtained;
* Potential research participant received or will receive H1N1 swine-origin monovalent influenza vaccine within 24 hours of study entry.

Exclusion Criteria:

* Proven history, by RT-PCR, of H1N1 swine-origin influenza infection prior to study entry;
* Receipt of a stem cell transplant within one year prior to study entry;
* Participation in P1088 study.
Safety and Effectiveness of Giving Indinavir and Nelfinavir to HIV-Infected Patients

The purpose of this study is to see if it is safe and effective to treat HIV-infected patients with indinavir (IDV) plus nelfinavir (NFV), 2 anti-HIV medications.

It is thought that IDV plus NFV will be a safe drug combination for treating HIV.

It is hypothesized that the administration of indinavir with nelfinavir will be generally safe and well tolerated.

This is a parallel, time-lagged, 2-stage, multiple-dose, 24-week study in HIV-1 seropositive patients. In the 3-week, randomized, double-blind phase of Stage A, patients receive either indinavir plus nelfinavir (Group A1: 9 patients) or indinavir placebo plus nelfinavir placebo (Group A2: 3 patients) for the first week. In Week 2, patients in Group A1 have the nelfinavir dose increased. This dose escalation for nelfinavir is contingent upon the patient having completed 1 week of the study drugs without experiencing Grade 3 or worse toxicity and/or serious drug-related adverse events. Patients in Group A2 continue to receive placebo until Week 3, at which time they receive indinavir plus nelfinavir (initial dose), while patients in Group A1 continue with indinavir plus nelfinavir (escalated dose). At Week 4 all patients in Stage A (including those originally assigned to receive placebo) receive open-label indinavir plus nelfinavir (escalated dose) for the remainder of the 24 weeks.

After at least 6 patients in Stage A have completed at least 2 weeks of therapy with nelfinavir plus indinavir with acceptable tolerability, Stage B begins. In the 2-week, randomized, double-blind phase of Stage B, patients receive either indinavir plus nelfinavir (Group B1: 9 patients) or indinavir placebo plus nelfinavir placebo (Group B2, 3 patients). After 2 weeks, all patients in Stage B (including those originally assigned to receive placebo) receive open-label indinavir plus nelfinavir for the remainder of the 24 weeks.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have a CD4 count of at least 100 cells/mm3.
* Have a plasma viral load (level of HIV in the blood) of at least 30,000 copies/ml.
* Are at least 18 years old.

Exclusion Criteria

You will not be eligible for this study if you:

* Have ever been treated with any protease inhibitors (PIs).
Attentional Capacity and Working Memory in Coronary Artery Disease Patients: Impact of the Presence of a Sleep Apnea Syndrome and Chronic Effects of Treatment With CPAP

The presence of Obstructive Sleep Apnea Syndrome (OSAS) has a high frequency in patients victims of a coronary artery disease (CAD) (myocardial infarction, revascularization). Unlike patients seen in a sleep Laboratory with an impact on daytime functioning, CAD apneic patients do not complain in their daytime functioning. The objective of this study is to explore whether the objective cognitive assessment measures may be a good marker of the efficacy of CPAP treatment given to non-sleepy apneic CAD patients.

Coronary patients with an AHI between 15 and 40 / h will be treated (or not) after randomization with CPAP treatment. The expected results are: CPAP apneic coronary patients should have a positive impact on cognitive performance, particularly on attention span and working memory measured by improvement in the Paced Auditory Serial Addition Test score (PASAT score).


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to the Clinical Physiology Department of Exercise of the Saint Etienne University Hospital (myocardial infarction, coronary stenting or coronary artery bypass) and referred for care in cardiac rehabilitation
* A native French speaker
* No daytime sleepiness (ESS \<or = 10)
* Signature of informed consent by the patient

Exclusion Criteria:

* Patients with a previous diagnosis of sleep apnea syndrome
* Patients with severe heart failure (stage III and IV of the NYHA)
* Patients with a neurodegenerative disease or other known cognitive disorders
* Presence of progressive disease other than coronary artery disease (cancer for example)
* Patients participating in other research that can change their cognitive function or drowsiness
Effect of Rehabilitation on Ejection Fraction (FE) in Cardiopathic and Non Cardiopathic Patients Undergoing Major Orthopedic Surgery

It is a trial aimed to evaluate the ejection fraction in the preoperative phase and during follow-up in two groups of subjects undergoing major orthopedic surgery: the first consisting of subjects without history of cardiac disease, and the second from subjects with a history of cardiopulmonary disease


Eligibility Criteria:
Inclusion Criteria:

* Age: \< or equal 18 and \> or equal 85 years
* major orthopedic surgery
* rehabilitation at our site
* a positive history for the cardiopathic group

Exclusion Criteria:

* Age: \> 85 and \< 18
* impossibility to participate to the rehabilitative protocol or come to the follow up visit
* lack of consensus
* previous acute cerebrovascular and / or cardiological events within 6 months prior to enrollment
* previous myocardial (percutaneous and / or surgical) revascularization interventions within the 6 months prior to enrollment
* previous (even in pediatric age) interventions of surgical correction of congenital heart disease
* severe heart failure
* reimplantation of prosthesis
Deep Neuromuscular Relaxation in Patients for Thoraco-laparoscopic Esophagectomy

Rationale: Endoscopic (thoraco-laparoscopic) esophageal surgery is a high risk procedure where the use of deep neuromuscular block (NMB) may increase field visibility and anaesthesia conditions. Under these conditions, boluses of muscle relaxants can be given on indication only OR by continuous infusion. We hypothesize that deep NMB by continuous infusion of rocuronium as compared to on demand bolus administration facilitates surgical and anesthesia conditions during thoraco-laparoscopic esophageal resection but higher doses of sugammadex are needed to reverse NMB at the end of surgery.

Objective: Primary objective is to evaluate the use of deep muscle relaxation versus on indication only on surgical and anesthesia conditions in patients for endoscopic esophageal resection. Secondary objectives are to evaluate the (hypothetical) dose of sugammadex needed in both groups in an economical perspective and to compare the intra-operative cardiac and respiratory incidents and post-operative complication rate of both groups.

Study design: a single-center randomized controlled double-blinded intervention study.

Study population: All patients \> 18 years to undergo a thoracolaparoscopic esophageal resection.I Intervention: Patients are randomized to receive either continuous infusion of rocuronium 0.6 mg/kg/hr (group 1) or continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group 2). On demand boluses of Rocuronium 0.3 mg/kg can be given in both groups.

Main study parameters/endpoints: The primary outcome parameter of this study is the SRS during the abdominal phase of thoracolaparoscopic esophageal surgery. Secondary outcomes measured are SRS during the thoracic phase, the number of on demand boluses infused, the dose of Sugammadex needed in both groups to reach a TOF of \> 90%, duration of surgery, a cost-analysis, the incidence of intra-operative cardiac and respiratory incidents and the ability of surgeons to estimate which neuromuscular blocking regime was given to the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients, undergoing elective thoraco-laparoscopic esophageal resection (either Ivor Lewis or McKeown variant)
* Written informed consent

Exclusion Criteria:

* pregnancy
* Known allergies for aminosteroid-type muscle relaxants or sugammadex.
* Severe kidney dysfunction (GFR \< 30), patients on dialysis
* Liver function disorders
* Myasthenia Gravis or other (neuro)muscular diseases
* Patients with carcinomatosis
* Use of anti-epileptics and lithium or drugs containing Kinin
Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer

This phase II trial will study the effectiveness and toxicity of sequential high dose MVAC followed by gemcitabine and cisplatin, as first line treatment in patients with locally advanced or metastatic bladder cancer.

High dose MVAC and Cisplatin/Gemcitabine combination regimens have shown comparable efficacy in the first line treatment of advanced or metastatic bladder cancer, whereas the latter regimen has better tolerability. The efficacy and tolerability of the sequential administration of these two regimens is not known.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed transitional cell carcinoma of the urinary bladder.
* Metastatic or locally advanced disease.
* No prior chemotherapy.
* Performance status (World Health Organization) 0-2.
* Measurable or evaluable disease.
* Measurable disease is defined as at least 1 unidimensional measurable lesion

  ≥20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease.
* Adequate liver (bilirubin ≤ 1.5 Upper Normal Limit, serum glutamate-pyruvate aminotransferase/serum glutamic pyruvic transaminase ≤ 2 Upper Normal Limit, ALP ≤ 2.5 Upper Normal Limit), renal (creatinine ≤ 1.5 Upper Normal Limit) and bone marrow (absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3) function.
* Life expectancy \> 3 months.
* Patients must be able to understand the nature of this study and give written informed consent.

Exclusion Criteria:

* History of serious cardiac disease (unstable angina, severe congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias).
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
* Active infection.
* Uncontrolled inflammation.
* Pregnant or lactating women.
* Psychiatric illness or social situation that would preclude study compliance.
Molecular Assessment of Lymph Nodes in Patients With Resected (Stage I to IIIA) Non-small Cell Lung Cancer

This is a prospective study of surgically resected samples and lymph nodes of lung cancer patients. For histopathologically positive lymph nodes from a complete resection, the investigators would like to analyse tumor tissue by allelotyping and comparing these results with those observed in the primary lung tumor to establish a cartography of molecular alteration in resected lung cancer. For non histopathologically positive lymph nodes, the investigators would like to research the presence (or not) of micrometastasis by allele-specific PCR (polymerase chain reaction).

Genetic: It is a prospective study during two years with three years for follow-up. No control group is recruited.

Eligibility Criteria:
Inclusion Criteria:

* Patients with resectable non-small cell lung cancer (stage I to IIIA), with a complete resection of the tumor and paired lymph nodes.
* Informed consent is required.

Exclusion Criteria:

* Another cancer
* Chemotherapy before surgical treatment
MENIPREP STUDY : EVALUATION OF THE EFFECTIVENESS OF PRP INJECTION IN THE MANAGEMENT OF DEGENERATIVE MENISCAL LESIONS: RANDOMIZED CONTROLLED TRIAL DOUBLE BLIND VERSUS REFERENCE TREATMENT"

Meniscal tissue has very limited intrinsic properties in terms of repair, given the low mitotic activity of chondrocytes and poor vascularization. Nevertheless, its capacity for regeneration, in vivo and in vitro, can be stimulated by the contribution of growth factors, as has been widely described in the medical and scientific literature. Platelet Enhanced Plasma (PRP) is an autologous biological product (that is, derived from the patient's blood) containing a growth factor concentrate. The contribution of these growth factors stimulates cartilage repair by stimulating neovascularization, collagen synthesis and activation of chondrocytes. Intra-articular injection PRP is an autologous biological product, now used in daily practice for the treatment of early osteoarthritic lesions.

The hypothesis of this work is that the injection of PRP in contact with LMD(Degenerative Meniscal Lesions) will improve the clinical symptomatology of our patients compared to reference treatment (intra-auricular injection of corticosteroids).


Eligibility Criteria:
Inclusion Criteria:

Men and women aged 20 to 80

* MDD diagnosis objected to MRI (grade II/III)
* Joint pain for more than 3 month
* Absence of bone lesion or moderate knee osteoarthritis stage \<2 on the Kellgren Laurence scale (objectified on radiography in schuss) in the 6 months prior to inclusion
* Axial deformity of the lower limbs less than or equal to 5 °
* Signed consent signed by the patient
* Ability to perform procedures as part of the follow-up (walk 50 steps on a flat surface and up / down stairs).
* Be affiliated to a health insurance scheme

Exclusion Criteria:

* Axial deformity\> 5 °
* Ligament instability
* Major injuries or surgery of the target knee or lateral contralateral knee in the 12 months preceding the inclusion visit
* Ligament reconstruction in the 12 months prior to the inclusion visit
* Need a cane or assistance to move
* BMI\> 35
* Thrombocytopenia \<150 G / L
* Thrombocytosis\> 450 G / L
(Val)Ganciclovir TDM in Transplant Recipients

The aim of this study is to gain more insight into therapeutic drug monitoring and thus the pharmacodynamics and pharmacokinetics of ganciclovir, in the context of prophylaxis and treatment of CMV infections, in order to provide the patient with an adequate dose.

Patients undergoing solid organ or stem cell transplantation are at risk of developing cytomegalovirus (CMV) infection or reactivation. The risk of CMV infection / reactivation and its severity depends on the CMV serostatus of donor and recipient. Valganciclovir (oral pro-drug of ganciclovir) prophylaxis is used to postpone CMV infection or reactivation to a later point in the post-transplantation.

CMV infection/reactivation does not always lead to clinical disease. Valganciclovir (oral) can be used when CMV DNA is detected in the blood, but patient has no or few complaints. However, in case of severe symptoms such as colitis, nephritis, hepatitis, pneumonitis, uveitis or encephalitis (active CMV disease) then ganciclovir is indicated intravenously. In clinical recovery treatment is often completed with valganciclovir.

It is important that the ganciclovir level is adequate, because too high level can lead to side effects such as cytopenia and a too low level can lead to treatment failure and resistance development. There are different dosing schedules mentioned in different sources. These schemes are based on dated literature.

The aim of (val)ganciclovir therapeutic drug monitoring (TDM) is to gain more insight into the pharmacodynamics and pharmacokinetics of ganciclovir, in the context of prophylaxis and treatment of CMV infections, in order to provide the patient with an adequate dose.

Eligibility Criteria:
Inclusion Criteria:

* Must receive ganciclovir intravenously or valganciclovir orally as routine care
* Must have received a solid organ or stem cell transplant
* Must be be 18 years or older

Exclusion Criteria:

There are no exclusion criteria.
Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation

After corneal transplantation, topical corticosteroids are used to reduce the risk of rejection.

However, the optimal postoperative treatment regimen is unknown. In most cases, a topical steroid is administered for at least 6 months after surgery, but it remains to be determined whether potent steroids offer better protection than weak steroids. Also, the length of the treatment is debated.

Since the use of steroids is not without potential serious ocular side effects, it is of considerable importance to investigate these problems.

The study aims to examine the frequency of rejection episodes after posterior lamellar keratoplasty; specifically comparing a short course of potent steroids versus a long course of weak steroids.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated for primary or secondary corneal endothelial failure at the department of ophthalmology, Aarhus University Hospital

Exclusion Criteria:

* Not fulfilling the above
Non-Invasive Eye Tracking for the Diagnosis of Delirium on ICU

In this trial, the investigators seek to demonstrate the feasibility of a system in continuously detecting 'inattention' as a subset of CAM-ICU in a small representative sample of patients in the Intensive Care Unit (ICU) at Chelsea \& Westminster NHS Foundation Trust.

Delirium is an acute confusional state that affects many patients admitted to the hospital, especially intensive care. The current diagnosis of delirium is through the use of the Confusional Assessment Method in Intensive Care Unit (CAM-ICU) task based questionnaire. The core prinicipal to CAM-ICU is inattention; this is tested through asking the patient to remember a task and execute it on demand, e.g. squeezing the operator's hand everytime the letter A is said and then spelling CASABLANCA.

The aim of this study is to find correlates to inattention. Eye-gaze data is ideally suited for this task as eyes move to pay attention to the environment.

A video camera based eye-tracker has been developed that sits at the end of the bed (head-camera) and another behind the patient (scene-camera). The head-camera uses machine learning to measure the gaze of the patient's eyes while the scene-camera finds what the patient is looking at. Simulations are then run from the scene camera and the patient's gaze is then compared to find whether the patient is paying attention to what is simulated.

Once per day, a member of the local research team will fill in a non-validated questionnaire based on work by MacMurchy et al.

M. MacMurchy, S. Stemler, M. Zander, C. P. Bonafide, Acceptability, Feasibility, and Cost of Using Video to Evaluate Alarm Fatigue, Biomedical Instrumentation \& Technology 51 (2017) 25-33.

Eligibility Criteria:
Inclusion Criteria:

1. Aged \>18
2. Predicted Delirium as defined by the Early PREdiction of DELIRium in ICU patients (E-PREDELIRIC) score ≥ 20%
3. Expected length of stay ≥ 2 days

Exclusion Criteria:

1. Non-concordant eyes
2. Visual Impairment
3. Dementia
4. Inability for facial recognition and eye tracking to be performed reliably
5. Lack of signed consent form / nominated consultee form
6. In-ability to perform CAM-ICU reliably