cyrilzakka/clinical-trials huggingface dataset:
Orbital Fractures Registry

Approximately 300 patients presenting orbital blow-out fracture will be enrolled prospectively in this registry. All patients, surgically and nonsurgically treated as per standard (routine) of care will be followed-up (FU) within the registry for a period of 6 months.

Approximately 300 patients presenting with a displaced orbital fracture (OFx) in the floor and/or medial wall (blow-out fracture) will be enrolled prospectively in this registry. All patients, surgically and nonsurgical treated will be followed-up (FU) within the registry. FU period for all patients will include assessments post-treatment at 6 weeks, 3 months and 6 months as corresponding with the local standard (routine) visit schedule at each participating clinic.

Data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (ie, complications). Computer Tomography (CT) scans or Cone Beam-CT (CBCT) scans taken as per standard of care will be collected within the registry.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older at the time of the injury
* Patients with a dislocated fracture of the inferior and/or medial orbital wall, either

  * Diagnosed at the study site via CT or CBCT within 2 weeks of the date of the injury, OR
  * Who will undergo secondary reconstruction

Exclusion Criteria:

* Bilateral orbital fracture
* Concomitant displaced fracture(s) of the orbital roof or any other area of the orbit
* Concomitant ruptured globe
* Displaced fracture of the malar bone
* Displaced midface fracture
* Displaced nasoorbitoethmoidal (NOE) fracture or complex zygoma fractures
* Presence at the time of enrollment of any disease with influence on eye motility (eg, strabismus, myasthenia gravis, Graves' ophthalmopathy)
* Previous radiotherapy in the orbital region
* Participation in any other medical device or medicinal product study within the previous month(s) that could influence the results of the present study
Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors

The main purpose of this study is to evaluate the safety and performance of the AutoLITT system for the treatment of recurrent/progressive glioblastoma multiforme tumors (GBM).


Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy
* Clinical/radiographic suspicion of tumor recurrence/progression

Exclusion Criteria:

* Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).
CMV-TCR-T Cells for CMV Infection After Allogenic HSCT

This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after allogenic HSCT.

Cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation (HSCT) is common and can be lethal without prompt treatment. In this prospective study, HLA-A\*02:01/11:01/24:02-restricted CMV-specific T cell receptor (TCR) will be introduced into the T cells of HSCT donors by ex vivo lentiviral transduction to generate CMV-TCR-T cells. An escalated dose ranging from 1×10\^3/kg to 5×10\^5/kg of CMV-TCR-T cells will be infused into patients with CMV infection. The safety, efficacy, pharmacokinetics and cytokine levels of allogenic CMV-TCR-T cell therapy will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Age 1-60 years, gender unlimited.
2. Diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with CMV infection after allo-HSCT.
3. Karnofsky Score ≥ 70 or Lansky Score ≥ 50.
4. TCR-T cell donor inclusion criteria:

1) Age ≥ 8 years; 2) Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3/6 HLA match with TCR-T cell recipients enrolled; 4) Lymphocyte count = (0.8\~4) × 10\^9/L; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation.

Exclusion Criteria:

1. Patients with active aGVHD one day before TCR-T cell infusion.
2. Patients with severe kidney disease (Cr \> 3×normal value), liver damage (TBIL \>2.5×upper limit of normal value, ALT and AST \> 3×upper limit of normal value) or heart failure (NYHA heart function grade IV) one week before TCR-T cell infusion.
3. Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
4. Have other malignancies.
5. Have relapsed and uncontrolled hematologic malignancies.
6. Serologically positive for HIV-Ab or TAP-ab.
7. Pregnant or lactating women.
8. Anticipated to have other cell therapies in 4 week post TCR-T cell infusion.
9. Participated in any other clinical study of drugs and medical devices before 30 days of enrollment.

11. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.

12. TCR-T cell donor exclusion criteria:

1. Positive for any of the following: HbsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA;
2. Other uncontrolled infection;
3. Have taken immunosuppressive drugs 1 week before PBMC collection;
4. Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.
Studying Pain and Symptom Distress in Patients With Advanced Colon Cancer, Rectal Cancer, Pancreatic Cancer, or Liver Cancer

RATIONALE: Studying a patient's understanding of his or her illness, pain, symptoms, and quality-of-life may help the study of advanced cancer and may help patients live more comfortably.

PURPOSE: This clinical trial is studying pain and symptom distress in patients with advanced colon cancer, rectal cancer, pancreatic cancer, or liver cancer.

OBJECTIVES:

* To describe illness perception as indicated in the five domains of the Common Sense Model (i.e., identity, cause, time line, consequences, controllability) and their relationship to symptom distress in patients with colon, rectal, pancreatic, or liver (i.e., hepatocellular carcinoma) cancer.
* To describe pain and other symptoms and their relationship to overall symptom distress in these patients.
* To describe overall quality of life (QOL) and its specific summary scales in these patients.
* To explore the relationship among characteristics (i.e., sociodemographic, disease, health status) associated with illness perceptions, overall symptom distress, and QOL in these patients.

OUTLINE: Patients undergo an empirical examination of illness perceptions as predictors of disease, specifically from the five domains in the Common Sense Model. Patients undergo an assessment of the relationship between influencing characteristics (i.e., sociodemographic), symptoms, and behavioral factors (i.e., illness perceptions, overall symptom distress, and quality of life). Patients complete questionnaires to evaluate demographics by the Sociodemographic, Disease, and Health Status Tool; illness perception by the Illness Perception Questionnaire-Revised (IPQ-R); symptoms and symptom distress by the Memorial Symptom Assessment Scale (MSAS) and Brief Pain Inventory; and quality of life by the SF-12. Patients also undergo a medical chart review and self-report on sociodemographic characteristics.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed colon, rectal, pancreatic, or liver (i.e., hepatocellular carcinoma) cancer

  * Stage III or IV colon, rectal, or pancreatic cancer
  * Child-Pugh class B or C hepatocellular carcinoma

PATIENT CHARACTERISTICS:

* Able to read English
* Able to provide written informed consent and complete questionnaire packet

PRIOR CONCURRENT THERAPY:

* Any treatment modality (e.g., chemotherapy, radiotherapy, surgery) allowed
Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis Patients

This is a prospective, randomized, double-blind, parallel group trial to assess the efficacy and safety of intravenous dextrose 5% solution compare with normal saline (standard care) in wash back procedure during haemodialysis in patients with end stage renal failure (ESRF) with respect to systolic blood pressure control over 3 months period.

The primary objective is to establish efficacy of 5% dextrose solution compared with normal saline (0.9% sodium chloride solution) with respect to systolic blood pressure control in subjects with end stage renal failure (ESRF) on regular hemodialysis. Secondary objectives include monitoring the change in body weight, thirst level and body fluid volume.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory, clinically stable maintenance HD patients on a thrice weekly HD regime.
* Have regular hemodialysisforat least 6 months or more.
* Willing and able to provide written, signed informed consent after the nature of the study has been explained.
* Willing and able to comply with all study procedures.
* Age ≥18 years; Age \< 75 years old

Exclusion Criteria:

* Diabetes mellitus, Malignancy, Pregnancy
* Inability or unwillingness to provide written consent.
* Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
* Simultaneous participation in another clinical study except observational trials
* Any psychological condition which could interfere with the patient's ability to comply with the study protocol
* Inability to perform a blood pressure measurement on the upper limb
* Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period.
* Life expectancy \< 6 months
* Recent acute myocardial infarction, congestive cardiac failure, stroke, angina or ICU admission within last 6 months,
* Planned to migrate/move out of the city
* Alcohol abuse/ drug abuse within last 6 months
* Missed \> 2 hemodialysis sessions over 1 month
* Requiring non- cuff catheter for hemodialysis
* Admitted for major infection within the last one month
Survival Outcomes of Lung Cancer

This is a prospective study to analyze the survival outcomes of different groups about lung cancer patients.

This study aims to analyze the survival outcomes of different groups about lung cancer patients. All the groups were assessed to the treatment decisions guided by molecular profiling and clinical judgment of principal investigators

Eligibility Criteria:
Inclusion Criteria:

1. Understand the requirements and contents of the clinical trial .
2. Age ≥ 18 years.
3. Histopathology or cytology confirmed lung cancer
4. ECOG \<=2.
5. Predicted survival ≥ 12 weeks.
6. Adequate bone marrow hematopoiesis and organ function
7. Presence of measurable lesions according to RECIST 1.1.

Exclusion Criteria:

1. Subjects who have received any of the following treatments must be excluded:

   * Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
   * Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
2. Presence of spinal cord compression or meningeal metastasis.
3. History of other malignant tumors within 2 years.
4. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
5. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
6. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
7. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
8. Heart-related diseases or abnormalities
9. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
10. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb drugs due to previous bowel resection.
11. Live vaccine was given 2 weeks before the first medication.
12. Women who are breastfeeding or pregnant.
13. Hypersensitivity to the test drug and the ingredients.
14. Other conditions assessed by the investigator to be unsuitable for participation in the study.
Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects

Primary Objective:

Injection Site Tolerability

Secondary Objectives:

* To assess the safety profile of alirocumab SAR236553 (REGN727)
* To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)

Total duration for each subject (not including screening) will be approximately 85 days.

Eligibility Criteria:
Inclusion criteria:

* Serum LDL-C levels \>100 mg/dL.

Exclusion criteria:

* Subjects indicated for the use of statins according to criteria in Adult Treatment Program (ATP) III Guidelines, as updated in 2004.
* Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening. Subjects must be willing to maintain a consistent diet for the duration of the study.
* Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, cholesterol absorption inhibitors, fibrates, niacin, bile acid resins, or red yeast rice.
* Fasting serum triglycerides \>200 mg/dL measured after an 8-12 hour fast.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Internet-based Treatment of Stress and Anxiety in Myocardial Infarction With Non-obstructive Coronary Arteries

Patient with myocardial infarction with non-obstructive coronary arteries and takotsubo syndrome often have high levels of stress and anxiety. At present there are no treatment alternatives in this group of patients. Previously, cognitive behavioral therapy (CBT), primarily aiming at relieving stress, has been shown to decrease morbidity in patient with myocardial infarction with obstructive coronary arteries. The present open randomized study aims to decrease stress and anxiety in patients with myocardial infarction with non-obstructive coronary arteries and takotsubo syndrome by an internet-based CBT focusing on stress and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* a suspected diagnosis of MINOCA or takotsubo syndrome with coronary angiography without diameter stenosis ≥50%
* age 35-80 years
* admission-ECG with sinus rhythm
* PSS-14 ≥ 25 and/or HADS-A ≥ 8 during admission
* reading and writing proficiency in Swedish
* computer/Internet access and literacy

Exclusion Criteria:

* strong clinical suspicion of myocarditis
* spontaneous coronary artery dissection
* acute pulmonary embolism
* acute myocardial infarction type 2
* cardiomyopathy other than takotsubo syndrome
* a previous myocardial infarction due to CAD
* expected poor compliance to behavioural therapy
* not likely to survive \> one year due to for example cancer
Deep Inferior Epigastric Artery Flap for Breast Reconstruction

Background: There is no consensus on the duration of prophylactic antibiotics for autologous breast reconstruction after mastectomy. We try to standardize prophylactic antibiotics use during breast reconstruction with deep inferior epigastric perforator flap following mastectomy.

Methods: This retrospective case series involved 108 patients who underwent immediate breast reconstruction with deep inferior epigastric perforator flap in Ditmanson Medical Foundation Chia-Yi Christian Hospital between 2012 and 2019. Patients were divided into three groups based on prophylactic antibiotic duration: 1 day, 3 days and \>7 days for patients with drains Data were analyzed between January and April, 2021.


Eligibility Criteria:
Inclusion Criteria:

* This retrospective study involved 108 patients who underwent immediate DIEP flap breast reconstruction after unilateral or bilateral mastectomy at the Ditmanson Medical Foundation Chia-Yi Christian Hospital between 2012 and 2019.

Exclusion Criteria:

* Age \< 20 years old.
Flipped Learning and Escape Room Method on Nursing Students

The impact of interactive education methods on nursing education will be evaluated.

This study aims to evaluate the effects of reverse learning and escape room methods on nursing students' infection control knowledge and learning skills. The study is an original study in terms of focusing on infection control with relevant interactive methods. The study will contribute to the literature in terms of the development of knowledge-based skills such as providing hand hygiene, opening sterile bundles, opening and placing sterile materials in sterile bundles, wearing and removing personal protective equipment, and disposing of waste materials within the scope of infection control. In addition, the questions to be answered in the study are listed below.

Eligibility Criteria:
Inclusion Criteria:

* Receiving training on infection control for the first time

Exclusion Criteria:

* Having received training on infection control before
* Not attending the final test, follow-up test
* Not attending class
Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction

Triage of acute ischemic stroke (AIS) patients is critical, to decrease time to treatment, and improve functional outcome. The therapeutic standard of care for AIS consecutive to large vessel occlusion (LVO) is the association of intravenous (IV) alteplase administration and mechanical thrombectomy (MT). However, there are limited places where MT can be performed. Therefore, there is a need for innovative tools to identify, in the ambulance, patients with LVO that require MT. Sending the patients at the right, avoiding futile stops (i.e. in places where MT is not available), is definitively a strategy that saves time.

There is currently no biomarker nor Point Of Care (POC) Lab Testing to solve this issue and clinical scoring methods such as the NIHSS have a low accuracy rate to detect LVO. The relevance of blood biomarkers for LVO diagnosis and therapeutic decisions needs to be confirmed for effective triage in the setting of AIS with LVO, which represent 30% of all AIS.

The main objective of our study is to determine diagnostic performances of a panel of selected blood biomarkers to identify patients with AIS consecutive to LVO among those with stroke suspicion, within 24 hours of stroke symptom's onset before brain imaging.

This could facilitate the triage of patients with LVO refractory to thrombolysis treatment, who may benefit most from MT.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms consistent with stroke \<24 hours
* Adult patients ≥ 18 years old
* Non opposition of the patient or his/her relatives to the research (emergency inclusion procedure)

Exclusion Criteria:

* Patient under guardianship or curatorship
InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

Nutritional status is a measurable and modifiable factor that is often not considered during treatment and its clinical impact undervalued due in part to the heavy demands on clinicians in low and middle income countries to deliver therapy to large numbers of patients. The proposed study will create a biobank of clinical data and biological specimens which will foster future studies on cancer progression and prognosis as well as toxicities during treatment which may impact survivorship and late-effects. Eligible patients must be between 3 years and 18 years of age at time of assent/consent, have newly diagnosed B- or T-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia confirmed by pathology report, and must be receiving treatment at one of the participating centers. Patients receiving hematopoietic cell transplant will be excluded. Institutions were selected to ensure representation of several global health indicators related to nutritional status and wealth classification according to the World Bank. Data related to demographic variables (socioeconomic status, food security), lifestyle habits (diet, physical activity), nutritional anthropometrics (height, weight and arm anthropometry), and nutritional biological indices (stool and blood) will be collected at designated timepoints throughout treatment and one year after the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be between 3 years and 18 years of age at time of assent/consent.
* Patients must have newly diagnosed B- or T-cell ALL, or mixed phenotype acute leukemia confirmed by pathology report.
* Patients must be receiving treatment at one of the participating centers.

Exclusion Criteria:

- Patients receiving hematopoietic cell transplant.
Evaluation if Physostigmine Reduces Symptoms in Patients Who Has Developed a Delirium in Intensive Care After a Surgery

Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in Intensive care after a surgery


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders aged \> 18 years, \< 85 years of ICU C1 after elective or emergency heart surgery with or without extracorporeal circulation (heart-lung machine and/or extracorporeal membrane oxygenation), with suspected delirium. (May be suspected if a patient does not show adequate improvement of vigilance 24 h after adequate reduction or stop of sedative medicine)
* Patients (\>18a, \<85a) with CAM-ICU diagnosed delirium
* Patients of legal capacity and patients with appointed representative

Exclusion Criteria:

* Asthma
* hypersensitivity against Physostigmine salicylate, Sodium metabisulfite, Nitrogen
* gangrene mechanical obstipation
* mechanical urinary retention
* Dystrophia myotonica
* Depolarization block after depolarising muscle relaxants
* Intoxications with "irreversibly acting" cholinesterase inhibitors
* closed head trauma
* obstructions at gastro-intestinal tract and at urinary tract
* neurological diseases
* left ventricular ejection fraction \< 40%
* Simultaneous Participation in other clinical trials or participation ind other clinical trials in the last 30 days
* untreated coronary heart disease
* wish to have children, pregnancy or nursing
* patients with addictive disorder in medical history