cyrilzakka/clinical-trials huggingface dataset:
A Rehabilitation Education Care Program on Return to Work Among Head and Neck Cancer Survivors

The purpose of this study will to identify factors (performance ability, physical function, psychosocial function, fear of cancer progression, social support, demographic characteristics, and disease-related characteristics) that impact the Return to work and work status in survivors of HNC within one year after completion treatment. Head and neck cancer survivors who have attended a rehabilitation education care program (RECP) intervention will have better performance ability, physical function, psychosocial function, fear of cancer progress, social support, and lower return to work to patients who not attended with the intervention.

The purpose of this 2-year project will involve a randomized controlled clinical trial to evaluate the 3-months RECP. Eligible participants will be recruited from initial completion treatment to 6 months after completion treatment and randomized into a control group and an experimental group, with the control group patients receiving routine hospital care and the experimental group patients receiving the 3-months RECP. Outcomes will be assessed using Return to Work Barrier Scale (RTWBS), Fear of Progression Questionnaire (FoP-Q-SF), Social Support Scale (SSS), University of Washington Quality of Life Scale (UW-QOL), Karnofsky's Performance Score (KPS), Katz Activities of Daily Living Scale (ADL), and Instrument Activities of Daily Living Scale (IADL). Subjective data will be collected at four time points: baseline (6 months after completion of treatment)(T0) and then 9, 12, and 18months after completion of treatment (T1, T2, and T3, respectively). Objective data will be assessed at the same time points. The mixed-model repeated measure ANOVA will be used to analyze the data. The investigators plan to recruit 30 subjects for each group.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of head and neck cancer.
2. Must be age were greater than 18 years and less than 64.5 years
3. Must be able to better performance status and KPS score more than 60
4. Must be had completion of treatment more than 3 months

Exclusion Criteria:

1. Unemployment or retire at the time of cancer diagnosis
2. unstable systemic disease
3. Poor performance status and KPS score less than 60
Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis

This is an observational prospective study to develop predictive biomarkers for pain response in participants with chronic pancreatitis scheduled for endoscopic therapy. Participants will undergo baseline assessments including electroencephalography (EEG), quantitative sensory testing (QST), and psychosocial questionnaires. Response to endoscopic therapy will be assessed at approximately 3, 6, 12 and 18 months post-procedure using questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* adults older than 18 years;
* Cambridge III or IV criteria for Chronic Pancreatitis (CP); or M-ANNHEIM criteria for definitive chronic pancreatitis;
* scheduled for endoscopic therapy for ductal obstruction (may include lithotripsy, pancreatic duct dilation, or stone extraction to facilitate successful stenting) as part of routine clinical care based on multidisciplinary review;
* pain present for ≥ 3 days per week for ≥ 3 months;
* average pain over the last week ≥ 4 on a 11-point numeric rating scale (NRS).

Exclusion Criteria:

* chronic pain syndrome other than CP;
* episode of acute pancreatitis within 2 months of enrollment;
* endoscopic therapy including Endoscopic retrograde cholangiopancreatography (ERCP), Endoscopic ultrasound (EUS) Guided Celiac Plexus Block or pancreatic surgery \< 6 months prior to enrollment;
* active illicit drug use (excludes marijuana use);
* American Society of Anesthesiologists classification \> 3;
* immune-mediated pancreatitis or associated pancreatic neoplasms
* Major neurological disease such as stroke, uncontrolled epilepsy, dementia
* Diagnosis of schizophrenia
* Chronic benzodiazepine use. Use of short acting benzodiazepine on as needed basis is acceptable if participant is able to hold benzodiazepine prior to EEG recording.
* Pregnancy
Effect of Blue Light Filtration on Visual Performance

The purpose of this study is to evaluate photostress recovery with blue light filter clip-on glasses among pseudophakes \[ie, subjects in which the natural lens of the eye has been replaced with an artificial lens (intraocular lens) during cataract surgery\]. This study will enroll subjects previously implanted with no blue light filter intraocular lenses (IOLs) for at least 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Cataract surgery in both eyes with no blue light filtering intraocular lenses for at least 3 months;
* Good ocular health;
* 20/40 or better vision with best correction in both eyes;
* Willing to provide voluntary consent and sign informed consent form;
* Able to competently perform testing;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Ocular pathology, degeneration, or media opacity (cloudiness) that could impact study measurements;
* Other protocol-defined exclusion criteria may apply.
Objective Choroidal Thickness Measurements in Uveitis

Optical Coherence Tomography (OCT) machines are non-contact instruments that can provide micrometer scale imaging of biological tissue. Applying the image processing allows us to automatically measure the choroidal thickness with good interclass correlation coefficient to the manual measurements.


Eligibility Criteria:
Inclusion Criteria:

* To the control group - ability to perform OCT examination
* To the uveitis group - with one or more of the following clinical features (as indicators for active state of the disease):

  1. \>1+ anterior chamber cells;
  2. \>1+ vitreous haze;
  3. presence of vitreous cells;
  4. presence of blood in anterior chamber;
  5. presence of blood in vitreous;
  6. presence of aqueous or vitreous pigment.

Exclusion Criteria:

* To the control group - diagnosed uveitis
* In case of all groups:

  1. inability to give informed consent;
  2. inability to maintain stable fixation for OCT imaging.
Efficacy Study of a Ginger and Cardamom Gelatin for Xerostomy in Terminally Ill Patients

Xerostomia or dry mouth is the subjective feeling that there is not enough saliva in your mouth. It's a frequent symptom in terminally ill patients receiving palliative care, reducing their quality of life and comfort. Usual recommendations in these patients are good oral hygiene and mouthwashes, ad libitum consumption of camomile and lemon juice infusions, and ad libitum sucking of cold (e.g. ice, ice cream) or citric products (e.g. pineapple). Other xerostomia treatments such as artificial saliva and pharmacological drugs (e.g. pilocarpine) are less used in terminally ill patients due to cost and secondary effects.

The purpose of this randomized parallel clinical trial is to determine if a new recipe of gelatin with orange juice, cardamome and ginger is more effective in the control of xerostomia than the usual treatment of camomile infusion with lemon juice against. Treatments will be consumed ad libitum during one week. The main outcome is the subjective assessment of dry mouth at end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Receiving palliative care for terminall illness at MUTUAM PADES
* Complaining of dry mouth and should not have been treated for this problem
* Able to prepare the study supplemental products by himself/herself or having a personal carer willing to do so

Exclusion Criteria:

* Disease of oral mucosa (e.g. oral mycosis, coated oral cavity ).
* Oropharinx neoplasm treated with surgery or radiotherapy.
* Severe cognitive impairment (More than 7 errors in Pfeiffer scale)
* Motor dysphagia causing coordination problems in swallowing.
* Life expectancy less than seven days (Last Days Situation).
Registry for Chronic Obstructive Pulmonary Disease With Pulmonary Hypertension in China

Pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD). It is reported that over half of COPD patients develop pulmonary hypertension. COPD and pulmonary hypertension may have pathological or genetics interactions so that patients having both disorders tend to have poor prognosis. Echocardiography is widely used to detect pulmonary hypertension, but it's not accurate enough. Therefore, high-quality data reflecting the prevalence, disease course and outcome of pulmonary hypertension in COPD is very limited in China. The aim of the study is to detect pulmonary hypertension with right heart catheterization, describe its outcome in Chinese COPD patients and explore the underlying interaction mechanism.


Eligibility Criteria:
Inclusion Criteria:

* Stable chronic obstructive pulmonary disease (COPD) patients

Exclusion Criteria:

* Patients with other serious respiratory diseases
* Patients with pulmonary hypertension other than group 3
* Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases
* Patients with limited life expectancy
* Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months
* Psychopath or addict
Non-interventional Study to Assess the Frequency of Cachexia in Patients With Non-small Cell Lung Cancer.

The purpose of this study is to assess the frequency of cachexia and the management of cachexia and associated symptoms in a patient population with non-small cell lung cancer (NSCLC).

This is a cross-sectional, non-interventional, European (France and Belgium), multicentric prevalence study, conducted on a representative population of 500 patients with NSCLC, to assess the frequency and the management of cachexia and associated symptoms.

The study will be conducted in accordance with the professional code of ethics and the good epidemiological practices guidelines developed by the ADELF (the Association of French-Speaking Epidemiologists) and in accordance with the STROBE recommendations for the drafting of reports and publications related to the study.

The information will be collected during a single visit to the oncologist/lung specialist as part of the usual patient management of his/her lung cancer. The physician will explain the purpose of the study to the patient with an information form specific to the study and will inform him/her of the option to refuse or withdraw from participation. The patient information form in France or a specific consent form in Belgium will be signed by the patient and a copy will be given to him/her (the original will be kept by the physician).

This study does not require any additional specific data. Data will come from the medical file and from the routine disease management. Furthermore, the following self-completion questionnaires will be proposed to patients: Visual analogue scale for dietary intake (dietary intake VAS), assessment of the concerns associated with the anorexia/cachexia (Anorexia-Cachexia module of the Functional Assessment of Anorexia/Cachexia Therapy \[FAACT\] questionnaire), quality of life (EORTC QLQ-C30), and assessment of physical activity (IPAQ, International Physical Activity Questionnaire). Abdominal CT-scan, if available, will be collected for assessment of skeletal muscle mass index at L3.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age and older
* Patient with NSCLC
* Patient who has been informed of the study and who has signed a patient information leaflet for France or an informed consent for Belgium
* Patient able to complete a self-assessment questionnaire

Exclusion Criteria:

* Patient unable to consent and/or unable to sign the patient information form in France or an informed consent in Belgium
* Patient with a complete resection of an early stage NSCLC
* History of head and neck cancer
Resident Observed Burnout After Daily Supplementation With Coffee

Coffee drinking is frequently reported as a negative outcome in studies on burnout, but the effect of an increased coffee intake on resident burnout has not been reported in the literature. This study is a prospective, interventional cohort study enrolling up to 50 residents from the Internal Medicine Residency Program to look at the relationship between coffee and resident burnout.

Resident burnout is increasingly being recognized as detrimental to both physician well being and patient care. It has been linked to an increased rate of medical errors and a reduced quality of patient care. In addition, there have been multiple high-profile physician suicides in the past years. This has resulted in a renewed focus on physician mental health and workload.

Eligibility Criteria:
Inclusion Criteria:

* A resident in the NYU Internal Medicine residency program

Exclusion Criteria:

* Allergy or intolerance to coffee or caffeine
* Pregnancy
A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants

The purpose of this study is to evaluate the effect of co-administration of itraconazole or verapamil on the drug levels of MYK-224 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 and 30 kg/m\^2, inclusive
* Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine laboratory assessments
* Adequate acoustic windows to enable accurate transthoracic echocardiographic assessment
* Left Ventricular Ejection Fraction (LVEF) ≥60% at screening and ≥55% prior to MYK-224 dosing

Exclusion Criteria:

* Any acute or chronic medical illness
* History of dizziness and/or recurrent headaches
* History of heart disease

Other protocol-defined inclusion/exclusion criteria apply
Placebo-Controlled Trial With GlyTI-M Among Children With Attention Deficit Hyperactivity Disorder (ADHD)

Although psychostimulant is the first line of drug to treat Attention Deficit Hyperactivity Disorder, (ADHD), actually there are 10-20% ADHD patient do not response well to current medication. Most of parents of children with ADHD in Taiwan dislike to use psychostimulant. We expect that GlyTI-M will have better efficacy than placebo to reduce ADHD symptoms. This study will also help us to understand the mechanism of ADHD and give a way to develop new drug and also a more possible way to treat ADHD children under 6 years old.

The accumulated neuro-image, hereditary and animal studies showed the correlation between glutamate transport dysfunction and ADHD psychopathology. However, there is limited clinical trial to testify the effect of modulating the NMDA receptor function of glutamate to treat ADHD.

GlyTI-M is an endogenous Glycine transporter I inhibitor, and it acts on the glutamatergic synapse to modulate the neurotransmission of N-Methyl-D-Aspertate (NMDA) receptor. This study aims to explore the effect of GlyTI-M among children with ADHD.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill the criteria of ADHD according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV).
* Subjects and parents agree to participate in the study and provide informed consent.

Exclusion Criteria:

* Autism, Mental retardation.
* inability to follow protocol.
Incidence and Course of Stress Hyperglycemia in Critically Ill Children Admitted to PICU of Assiut University Children Hospital

Detection of the prevelance of stress hyperglycemia in patients admitted to pediatric intensive care unit of Assiut university children hospital , asses its pattern ,course ,risk factors, its relation to the outcome and its management.

Critically ill patients often develop endocrine and metabolic changes, particularly disruptions of glucose homeostasis that result in hyperglycemia and hypoglycemia.Stress hyperglycemia commonly occurs in children with critical illnesses.

Stress hyperglycemia results from increased gluconeogenesis relative to the clearance of glucose as well as from the development of insulin resistance affecting glucose uptake. These mechanisms are mediated through increased production of counteracting hormones (i.e., epinephrine, norepinephrine, cortisol, glucagon, and growth hormone). Furthermore, stress hyperglycemia is associated with pro-inflammatory cytokines, oxidative stress, and therapeutic interventions. Those factors in turn inhibit the secretion of insulin by pancreatic β cells through α-adrenergic receptor stimulation, interfere with insulin receptor signaling and/or insulin-regulated glucose channels, and directly interfere with proper glucose transport and utilization in peripheral cells.

Several studies have demonstrated the association of stress hyperglycemia in critically ill children with mortality. Specifically, peak and duration of stress hyperglycemia appear to be associated with mortality. Peak blood glucose concentrations tend to be much higher in non survivors compared with survivors. Similarly, non survivors tend to have exposure to longer duration of stress hyperglycemia compared with survivors. This association of stress hyperglycemia with mortality appears across different pediatric disease states, including septic shock, burns, traumatic brain injury, post cardiac surgery, and trauma. Additionally, stress hyperglycemia is associated with longer periods of ICU and hospital stay and more frequent nosocomial infections, including surgical site infections in critically ill children. While all these studies demonstrate strong associations between stress hyperglycemia and poor clinical outcomes, they do not necessarily demonstrate a cause and effect relationship.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill children admitted to emergency and intensive care unit with blood glucose level more than or equal 200 mg\\dl.

Exclusion Criteria:

* Documented cases of diabetes mellitus
Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia

The purpose of this clinical research study was to establish a recommended phase 2 once daily (QD) dose of dasatinib and to assess the efficacy of the investigational drug for relapsed or refractory (resistant to previous treatment) leukemia in children and adolescents. The side effects that this oral investigational drug may have in children, and the levels of the drug in the blood, will be studied at different doses.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Ph-positive (Ph+) Chronic Myelogenous Leukemia in chronic, accelerated or blast phase or Ph+ acute lymphoblastic leukemia (ALL) with imatinib-resistant disease or intolerance to imatinib.
* Ph-negative acute leukemia in second or subsequent relapse
* Age \>1 and \<21 years
* Lansky or Karnofsky scale \>60
* Life expectancy \>3 weeks
* Adequate hepatic and renal function
* Written informed consent

Exclusion Criteria:

* Subjects for whom potentially-curative therapy was available, including electing immediate \[ie, planned \<45 days\] stem-cell transplantation. Subjects in Stratum 1 were to have had an ongoing identical HLA donor search, and may have discontinued study if a donor became available.)
* Subjects with symptomatic central nervous system (CNS) disease (eg, convulsions due to their CNS disease).
* Subjects who had not recovered from acute toxicity of previous therapy.
* Clinically-significant disorder of platelet function (eg, von Willebrand's disease) or ongoing gastrointestinal bleeding.
* Serious uncontrolled medical disorder or active infection
* Uncontrolled or significant cardiovascular disease
* Use of any investigational agent or any other anticancer agent within 14 days prior to treatment start.
* Prior therapy with dasatinib
* Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
* Subjects taking certain medications that are accepted to have a risk of causing QTc prolongation.
* Women of Child Bearing Potential with a positive pregnancy test prior to study drug administration.
* Expected noncompliance, or unable to have regular follow-up due to psychologic, social, familial, or geographic reasons.
* Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this study.
Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA

Sofosbuvir plus daclatasvir with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C. The objectives were to identify factors associated with sofosbuvir/daclatasvir plasma concentrations variations and to evaluate their impact on viral kinetics.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatitis C virus infection treated with sofosbuvir/daclatasvir
* Patients with at least one measurement of sofosbuvir or daclatasvir plasma concentration
* Follow-up of at least 3 months after the end of treatment

Exclusion Criteria:

* Patients with severe renal failure (estimated glomerular filtration rate (eGFR)\<30ml/min/1.73m2)
* Patients with liver transplantation during therapy
SterEotactic AbLative Radiotherapy in PatiEnts With HypertrophiC ObstrucTive Cardiomyopathy

Hypertrophic obstructive cardiomyopathy (HOCM) is an inherited myocardial disease which leads to the muscle in the wall of the heart growing and thickening to the point that it blocks blood flow exiting the heart with increasing risk of sudden cardiac death, heart failure, and atrial fibrillation. Surgical septal myectomy and alcohol septal ablation are two invasive therapies for drug-refractory symptomatic patients with HOCM. Unfortunately, some patients may be unsuitable for both the two procedures. Recently, stereotactic ablative radiotherapy, usually used for the treatment of tumours, was confirmed to be feasible, safe and effective in destroying abnormal tissue in heart by targeting high energy heavy ion beams at a specific area of the body precisely. In this study we will determine whether radiation ablation, can be used to destroy the thick heart muscle at the point of obstruction safely and effectively.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years
* Drug-refractory symptomatic patients with HOCM
* Willing and able to give written informed consent

Exclusion Criteria:

* Enrolled in another clinical study.
* Patient unable to tolerate lying flat for one hour
* Pregnant Or Lactating Women
* With other contraindications for receive stereotactic ablative radiotherapy