cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants

The purpose of this study is to compare how healthy adults process Etrasimod when taken in different forms. One form is Etrasimod taken without food. The other form is Etrasimod mixed with water and 3 different foods. The types of food used are applesauce, chocolate pudding or yogurt.

The study is seeking participants who are:

* Aged 18 or older
* Male or female who are healthy as determined by medical assessment
* Body-mass index (BMI) of 16 to 32, and a total body weight \> 50kg.

The study will take up to 2.5 months, including the screening period. Participants will have to stay at the study clinic for at least 45 days. This includes 5 study periods in total.

Participants will take Etrasimod as a tablet by mouth without food. Participants will also take Etrasimod sprinkled in soft food or water. Blood samples will be taken both before and after participants take Etrasimod. Participants will also answer questions for taste assessment purposes. A follow-up phone call will be made 20 to 27 days after the last study period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* BMI 16 to 32 kg/m2
* body weight more than 50kg

Exclusion Criteria:

* Ongoing or past history of significant medical conditions
* Eye disorders such as macular edema or uveitis
* Ongoing or recent infections
* Use of prescription or non prescription medications within 7 days of first dose
* Smoking or using nicotine products equivalent to more than 5 cigarettes per day
* History of severe allergic or anaphylactic reactions
ANALYSIS OF CLINICAL AND LABORATORY VARIABLES WITH PREDICTION CAPABILITY FOR INDICATION OF INVASIVE MECHANICAL VENTILATION IN PATIENTS WITH COVID-19

This observational and retrospective study will follow the recommendations of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The aim is to verify and analyze the clinical and laboratory variables with prediction capability for indication of invasive ventilatory support in patients with COVID-19. The present study will be carried out in specific care units for patients with suspected or confirmed COVID-19. Individuals with suspected or clinical diagnosis of COVID-19, with a minimum hospital stay of 24 hours and submitted to oxygen therapy or non-invasive ventilation will be selected. Clinical and laboratory variables will be collected from the moment of admission and every 12 hours until the third day of hospitalization. The primary outcome will be rate of endotracheal intubation, while secondary outocomes will be lenght of stay in intensive care unit, and hospital, as well as mortality rate.

Clinical and laboratory data will be collected from medical records from the period of the COVID-19 pandemic (February 2020 to June 2021)

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria will be individuals with confirmed diagnosis of COVID-19 by RT-PCR (reverse- transcriptase polymerase chain reaction), with minimum length of stay of 24 hours in the ICU and, patients who sign the free and clarified consent.

Exclusion Criteria:

* The exclusion criteria for participation in the study will be as follows: (1) patients under the age of 18; (2) patients with a negative laboratory test for COVID-19; (3) patients in need of emergency intubation; (4) patients who underwent previous endotracheal intubation at the same hospitalization.
CIK in Treating Patients With Esophageal Cancer

Chemotherapy is the main treatment method for patients with Esophageal Cancer. However, Relapse remains the major cause of treatment failure.Biological therapies such as CIK stimulate the immune system and stop tumor cells from growing. A series of studies reported that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy may kill more tumor cells. In this study, the patients will be treated with CIK cells after chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Esophageal Cancer.

About 2000 patients with staging I-III of Esophageal Cancer, after accepting chemotherapy, will be randomly divided into group A (receive CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK cells treatment (every 12 weeks). Patients in group B will have no anti-tumor therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients histologically confirmed esophageal carcinoma;
* Patients with staging I-III of esophageal carcinoma;
* Patients who had completed chemotherapy;
* Patients who have a life expectancy of at least 12 weeks;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
* The bone marrow functioned normally (WBC\>4.0×10\^9/L, Hb\>120 g/L, Platelet(PLT)\>100×10\^9/L);
* The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

* Patients who had distant metastases by imaging studies;
* Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
* Patients who were lactating;
* ECOG perform status ≥ 2;
* Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment;
* Patients who are pregnant or nursing;
* Patients with active tuberculosis (highly positive skin tests allowed if no active disease);
* Patients with disease that would preclude general anesthesia;
* Patients with active intractable or uncontrollable infection.
Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers

Octreotide, somatostatin and pentoxyfilline commercially available drugs that are used in various clinical situations. They are safe and known for years. Octreotide and somatostatin have been used in many studies for the prophylaxis and treatment of pancreatitis and post-ERCP pancreatitis, while pentoxyfilline has shown effect on patients with alcoholic hepatitis, obstructive vasculitis etc. The aim of the study is to evaluate the efficacy of any of those treatments for the prophylaxis and treatment of post-ERCP pancreatitis. In addition some molecular markers of acute and chronic inflammation will be measured before and after the endoscopic procedures according to the study protocol.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing endoscopic retrograde cholangiopancreatography

Exclusion Criteria:

* children, pregnant or breastfeeding women
* patients with coagulation disorders
* inability to access the papilla of Vater due to technical difficulties (previous surgery, malignant obstruction)
Trajectories of Psychopathology in Response to NET

Narrative Exposure Therapy (NET) has been proven to be effective in the treatment of Posttraumatic Stress Disorder (PTSD) and trauma-related depression in more than a dozen controlled clinical trials. Symptom reduction was greatest during long-term follow-ups after the completion of the therapy.

In the current study, we will investigate the progression of PTSD symptoms and emotional stress before, during and after therapy. After a semi-structured interview all participants will be asked to report in monthly telephone interviews their core symptoms. Structured interviews after 6 and 12 months are used to validate the outcome. A convenience sample of individuals with a PTSD will be offered participation in the study.

Participants will be recruited through the Center of Excellence for Psychotraumatology, University of Konstanz, with focus on refugees. All of them (approx. 100) will receive a structured interview and a detailed diagnosis. The interview includes questions about sociodemography, traumatic events, PTSD and depression symptomatology. Individuals with a PTSD diagnosis (up to 30) will be offered a Narrative Exposure Therapy (NET).

Irrespective of treatment and diagnosis, respondents are asked to participate in monthly telephone interviews assessing trauma-related and emotional distress and changes in life. Interviews assessing PTSD, depression symptoms and emotional distress will be conducted 6 and 12 months after the initial interview.

In addition, participants receiving NET will rate their PTSD symptoms and functionality prior to each therapy session.

Eligibility Criteria:
Inclusion Criteria:

* For treatment group: PTSD diagnosis (DSM-IV or V)
* For non-treatment group: none

Exclusion Criteria:

* Acute psychosis
* Cerebro-organic disease
* Acute drug or alcohol intoxication
* Already receiving another psychotherapy
* Anti-epileptic drugs at baseline
CCTA to Optimize Diagnostic Yield of Invasive Angiography With AI

Coronary artery disease (CAD) is a leading cause of death. The gold-standard test used to diagnose CAD is invasive coronary angiography (ICA). However, nearly half the patients who receive ICA are found to have no disease or non-significant disease. This means that while they receive a diagnosis, they do not receive any therapeutic benefit. This is concerning because ICA is expensive and it carries a risk to patients. A non-invasive diagnostic test, cardiac computed tomographic angiography (CCTA), has been shown to be as effective as ICA at diagnosing CAD in the right patient population, while being less expensive and less risky for patients. An optimal solution would involve screening to identify which patients are good candidates for CCTA vs. which should receive ICA. This screening tool could be used in a triage pathway to ensure that every patient gets the test that is best for them. The investigators have used Artificial Intelligence (AI) to develop a model for determining which patients should receive ICA vs. which should receive CCTA. The investigators have also developed a triage pathway to direct patients to the most appropriate test. The investigators now plan to evaluate the AI tool combined with the triage pathway through a clinical trial at Hamilton Health Sciences and Niagara Health. This model of care will reduce risk to patients, reduce wait times for ICA and reduce costs to the health care system.


Eligibility Criteria:
Inclusion Criteria

Patients are eligible if they:

1. are ≥18 years of age;
2. are referred for non-urgent (elective) outpatient ICA;
3. have an indication for ICA that includes 'Rule out CAD', 'Cardiomyopathy', or 'Stable CAD'; and
4. are able to provide informed consent in English.

Exclusion Criteria Patients are ineligible if they have:

1. received a prior high-quality coronary computed tomographic angiography (CCTA) within the last 5 years;
2. atrial fibrillation;
3. known severe renal dysfunction (GFR \<35);
4. planned non-coronary cardiac surgery;
5. any prior obstructive CAD, acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass graft; or
6. known severe coronary artery calcification (calcium score \>1000).
A Multicenter, Random Control Study :Early Use of Airway Pressure Release Ventilation (APRVplus) Protocol in ARDS

Animal experimentals have shown that the more physiology-driven airway pressure release ventilation (APRV) methodologies in ARDS may significantly improve alveolar recruitment and gas exchange, increased homogeneity, and attenuate lung injury, without circulatory depression, as compared with conventional low tial volume lung protective ventilation. our previous single centre,random control study showed that clinical benefit for early use of APRV in ARDS. Nonetheless, clinical data on ARDS are still limited, most of them derived from small clinical trials in which variable outdated APRV settings were used, consequently, the findings of these studies were controversial.

Additionally, the previous single-centre,random control study showed that clinical benefit for APRV.Therefore,the investigators are ready to design a multiple centres,random control study to further verify the effect of APRV plus protocol in ARDS.

All the patients included will be randomly assigned to receiving APRV plus protocol or low tidal volume ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Moderate and severe acute respiratory distress syndrome,according to the Berlin definition of ARDS
* receiving tracheal intubation and mechanical ventilation was no longer than 48 hours

Exclusion Criteria:

* Pregnancy
* The expected duration of mechanical ventilation was less than 48 hours
* Intracranial hypertension (suspected or confirmed)
* Neuromuscular disorders that are known to prolong the need for mechanical ventilation
* Known or suspected chronic obstructive pulmonary disease(COPD)
* Terminal stage of disease
* Pneumothorax (drained or not)at enrollment
* Treatment with extracorporeal support (ECMO) at enrollment
* There was a lack of commitment to life support.
Pegylated Liposomal Doxorubicin or Epirubicin in Neoadjuvant or Adjuvant Chemotherapy for Breast Cancer.

Pegylated liposomal doxorubicin or epirubicin in neoadjuvant or adjuvant chemotherapy for breast cancer.

This study is an real-world, multicenter, case control study about comparing pegylated liposomal doxorubicin Efficacy and safety of epirubicin in neoadjuvant and adjuvant chemotherapy for breast cancer. As this trial is a retrospective real-world study, investigator have given patients the dose of trial drugs based on real-world principles of diagnosis and treatment and their clinical experience. This trial only collects and analyzes patients' clinical medications, and does not interfere with patients' real-world diagnosis and treatment. A total of 1050 breast cancer patients are collecting from seven centers. 200 cases in neoadjuvant and 850 cases in adjuvant group. The follow-up examinations and assessment of the subjects were followed by real-world medical treatment routines and the visits were completed according to the routine of treatment. Related check and assessments and collect the following data: follow-up 3years or until the disease recurs (whichever occurs first). Adverse events: remission or stability of adverse events caused by follow-up to treatment in the adjuvant treatment group, follow-up for 3 years or until recurrence of the disease in the neoadjuvant treatment group (whichever first occurred).

Eligibility Criteria:
Inclusion Criteria:

1. Female;
2. Patients with invasive breast cancer diagnosed by menstrual histology in 2014-2018 and receiving neoadjuvant chemotherapy, or patients with invasive breast cancer diagnosed by menstrual histology in 2014-2016 and receiving adjuvant chemotherapy;
3. Chemotherapy regimen recommended by the guidelines for drugs containing anthracycline;
4. Patients whose chemotherapy regimen contains pegylated liposomal doxorubicin or epuroxorubicin;
5. Age :18 -70;
6. Patients with LVEF ≥ 50%.

Exclusion Criteria:

1. Patients with occult breast cancer.
2. Patients receiving two or more anthracyclines during neoadjuvant or adjuvant chemotherapy;
3. Patients who have previously received other chemotherapy regimens;
4. Patients with other malignant tumors in the past 5 years (except for cured cervical carcinoma in situ and basal cell carcinoma of the skin);
5. Patients complicated with severe infection and in need of treatment;
6. Pregnant or lactating women.
Effectiveness of Exercise Through Video Games in Reducing Fatigue Among Children With Leukemia

40 children with cancer who fulfills the inclusion criteria will be included. Participants will be recruited from King Fahad Children's Cancer Center, King Fahad Medical City and King Khaled University Hospital. After obtaining written formal consent, children will be randomly assigned to two groups, control and experimental. Experimental group will play 60 minutes of Wii physical activity games for three weeks, twice each week. while control group will receive conventional therapy. Fatigue will be assessed using pediatric multidimensional fatigue scale- child proxy before, weekly during the study and after. Functional capacity will be measured by six minute walk test before and after study duration, and physical activity will be repeatedly measured by godin-shephard leisure time physical activity questionnaire. All data will be analyzed using appropriate statistical analysis.

The intervention group:

The investigator will:

* handle accompanying each child to the play room, turn on the Wii and ask the child to choose the game he/she prefers to play from the games provided by wii console that requires the movement of the whole body: upper, lower and trunk.
* Monitor the child while playing, helping with the instructions of the game if the child needs assistance as it is only provided in English from the console.
* heart rate and oxygen saturation are planned to be measured every 15 minutes.

The duration is designed to be 60 minutes per session, but the child is allowed to rest for the time needed during the session if he/she feels tired. or if the oxygen saturation of the child reaches 93. or the heart rate reaches the predicted maximum heart rate.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with leukemia, receiving chemotherapy, or off therapy within 6 months.

Exclusion Criteria:

* bone / pulmonary metastasis, having physical or cognitive disability preventing the child from being able to use the controller and board of the console.
The Effect of Brown Adipose Tissue Activation on Insulin Sensitivity in Humans

Recent findings document the presence of active brown adipose tissue (BAT) in humans. Cold exposure via adrenergic stimulation activates BAT, which combusts significant amounts of blood glucose and free fatty acid (FFA) to produce heat. Animal studies suggest that BAT activation improves insulin sensitivity. However, the effect of cold-induced BAT activation on insulin sensitivity and glucose kinetics in humans remains unknown. The investigators' central hypothesis is that cold-induced BAT activation increases whole body insulin sensitivity in humans via augmented plasma glucose and FFA clearance. The specific aims of this study are to define the effects of prolonged (8h) cold exposure BAT activation on: insulin sensitivity (Aim 1); lipolysis and plasma glucose and FFA kinetics (Aim 2); on thermoregulation (Aim 3). Moreover, the investigators plan to investigate for alternative ways, which can activate BAT including cold water ingestion, a single meal ingestion, and a single bout of moderate intensity exercise (Aim 4). For the cold exposure study, subjects will complete 3 trials: a) 8hrs of cold exposure at their individually determined shivering threshold; b) 8hrs of cold exposure at their individually determined shivering threshold plus propranolol; c) 8hrs in thermoneutral conditions (26 - 28°C). For the rest of the arms of subjects will complete two trials: cold or tepid water ingestion, a single meal ingestion or no food ingestion, and a single bout of moderate intensity exercise or no exercise.To study the above aims, the investigators will use positron emission tomography - computed tomography, hyperinsulinemic euglycemic clamp, infusion of stable isotopes, and tissue biopsies. The findings will illuminate the role of BAT on plasma substrate regulation and insulin sensitivity and may aid in the development of lifestyle recommendations and pharmacotherapy for the prevention and treatment of diabetes and insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* men or women
* 18-75 years old
* BMI 20-40 kg/m2

Exclusion Criteria:

* taking diabetes medications
* liver/renal/endocrine/heart disease
* obstructive disease of the gastrointestinal tract
* impaired gag reflex or swallowing disorder
* history of GI surgery or fenilization of esophagus
* GI hypomotility disorder
* cancer
* thyroid or hormone replacement treatment
* beta-blockers
* anabolic or corticosteroids the last 6 mo
* pregnant/lactating women
* individuals that are likely to need PET/CT in the near future for medical reasons
* bleeding disorders/ anemia
* positive hepatitis or HIV screening
* weight less than 36 kg
* pacemaker or other implanted electromedical device
* alcohol and drug abuse
* tobacco use
* impaired cognition
* asthma
* chronic obstructive pulmonary disease (COPD) or other reactive airway diseases
Asthma Attack in the Emergency Department : Reasons Of This Attendance

Objective: Identify modifiable factors that may affect asthma control and the use of emergency room to define customized interventions for the management of asthma prior to emergency room.

Emergency department attendance is always a sign of poor balance or control of asthma. In spite of a decrease in the number of deaths that has been halved in 20 years and hospitalization due to asthmatic disease, the use of emergency center for this disease has not decreased. We now know that the passage through emergencies and hospitalization for aggravation of asthma is in itself a factor of mortality. Acting on the determinants of poor balance or control of asthma is essential to further reduce the mortality and morbidity of asthma.

There is two parts in this study:

Part 1 - Qualitative study by individual interviews until data saturation (although about ten patients should be enough to capture the concepts of interest) on the factors that induce an imbalance of asthma (based on the GINA (Global Initiative for Asthma) report whose criteria are validated).

An interview guide will be written to systematically address all aspects related to asthma control.

In agreement with the patient the interview will be recorded, and the verbatim will be transcribed and coded using a software (Nvivo version 10).

Preparation of a questionnaire

A questionnaire will be developed from:

* analysis of patient verbatim
* other data: GINA criteria, psychological criteria (psychological distress is assessed by the 12-item general health questionnaire (GHQ-12) which is valid psychometric tools in French) and social criteria.

Part 2-Observational cohort qualitative study. The questionnaire thus prepared will be placed in the patient file upon admission. As soon as possible it will be filled by the patient after improvement of his condition and collected by the doctor or nurse who took care of the patient.

To obtain sufficient power to demonstrate significant associations, and assuming that 15 variables are taken into account in a multivariate model and based on the recommendations of 10 subjects per variable, 150 patients are required.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Ambulatory patient, visiting one of these centers
* Diagnosis of asthma already evolving for more than 6 months
* Prescription of treatment for more than 3 months
* Patient who can read and write French
* Agreement for an individual interview (Part 1) or fill up a self-questionnaire (Part 2)
* Health insurance coverage

Exclusion Criteria:

* Patients with other etiology that may explain their dyspnea: heart failure, chronic obstructive pulmonary disease , pneumopathy
* Patients with a social background that is not compatible with the study: a patient who does not speak French, is homeless or does not have a telephone number
* Inpatients