cyrilzakka/clinical-trials huggingface dataset:
CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals

The purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.

As part of the management of COVID-19 related severe ARDS, the World Health Organization (WHO) recommends prone positioned mechanical ventilation. At this time, it is unclear whether there is a role for prone positioning (PP) of non-mechanically ventilated patients.

The objective of this trial is to determine whether PP improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.

Patients randomized to the intervention arm will continue with prone positioning until study inclusion criteria are no longer met, discharge from hospital, day 60 in hospital, or until death or discharge to hospice. Daily assessments will occur until day 60 or until the patient is discharged from hospital or is deceased. The investigators anticipate recruitment to be completed within 12 months of starting the trial.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with probable COVID-19. Probable is defined as Influenza like illness (ILI) symptoms OR confirmed COVID-19 exposure AND COVID-19 testing performed. ILI is defined as any one of the following symptoms including: fever, new or worsening cough, coryza, new or worsening dyspnea, or sore throat.
* Goals of care are do-not-intubate (R3 or M1/M2 in Alberta).
* Need for oxygen ≥2 L to maintain SpO2 ≥92%. If the patient is on long-term oxygen, the O2 requirements must be ≥2 L above their baseline.
* Patient can be positioned to and from prone to supine with minimal assistance (maximum one person assistance).

Exclusion Criteria:

* Decreased level of consciousness (Glasgow Coma Scale \< 10) or precluding ability to self-reposition.
* Hemodynamic instability (Systolic Blood Pressure \< 90 mmHg and or Lactate \>5 mmol/L or HR \>120, not responsive to fluid resuscitation).
* Complete bowel obstruction.
* Active upper gastrointestinal bleeding.
* Poor neck mobility or patient inability to lie prone comfortably.
* Unstable spine, femur, or pelvic fractures.
* Pregnancy - third trimester.
* Full resuscitation status including ICU and willingness to accept invasive mechanical ventilation (i.e. R1/R2 goals of care).
* Imminent palliation or end of life expected on admission (i.e. C1/C2 goals of care).
Oral Sirolimus for In-Stent Restenosis

Despite recent advances in interventional cardiology including the success of drug-eluting stents in de-novo coronary lesions, the treatment of in-stent restenosis remains a challenging clinical issue. Given the efficacy of the systemic sirolimus administration to prevent neointimal hyperplasia in animal models and to halt and even reverse the progression of allograft vasculopathy, the aim of the present double-blind, placebo-controlled study was to evaluate the efficacy of a 10-day oral sirolimus treatment with two different loading regimens for the prevention of recurrent restenosis in patients with in-stent restenosis.

Three-hundred symptomatic patients with in-stent restenotic lesions were randomly assigned to one of three treatment arms: placebo, usual dose or high dose sirolimus. Patients received a cumulative loading dose of 0, 8 or 24 mg of sirolimus two days prior to and the day of repeat intervention followed by maintenance therapy of 2 mg/day for 7 days. Angiographic restenosis at 6-months angiography was the primary end point of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with angina pectoris or exercise-induced ischemia in the presence of angiographically significant in-stent-restenosis in native coronary arteries.

Exclusion Criteria:

* Patients with acute coronary syndromes or with severe infectious diseases the presence of severe kidney failure (serum creatinine \> 2.2 mg/dl) contraindications to sirolimus
Development of Clinical Indicators From the Swiss RAI-HC

The project aims at deriving frailty (FI) and complexity (CI) indices from data collected with the Resident Instrument Assessment - Home Care adapted for Switzerland (RAI-HC). Data were collected in 2015 by trained nurses in clinical routine with the primary purposes of health state assessment and individual home care planning. The study consists in a retrospective secondary analysis of health data from the Minimal Data Set (MDS), used to derive frailty and complexity indices according to published definitions and guidelines for index derivation. The analysis further aims at estimating the predictive power of these indices on undesirable health outcomes (falls, hospitalizations and deaths). The goal is to provide home care institutions and nurses valid algorithms to compute useful clinical indicators without additional assessment that the one routinely done with the RAI-HC.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 or older who were assessed in 2015 with the Swiss RAI-HC in clinical routine for care planning by the Geneva Institution for Home care and Assistance (imad) in Geneva, Switzerland

Exclusion Criteria:

* Men and women aged 17 or younger and/or who did not receive a full RAI-HC assessment in 2015
A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence

To assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.

Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Recurrence of HCC is still a great challenge and threat to the patients after resection surgery. Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. HCC patients who meet the eligibility criteria of this clinical trial will be administrated Anlotinib 12mg QD PO d1-14, 21 days per cycle. The disease free survival (DFS), overall survival (OS) and any adverse effect during the 8 cycles of Anlotinib treatment will be evaluated in order to assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.

Eligibility Criteria:
Inclusion Criteria:

* No allergic history of Anlotinib
* 18-75 years
* No history of severe arrhythmia or heart failure
* No history of severe ventilation dysfunction or severe pulmonary infection
* No acute or chronic renal failure, creatinine clearance \> 40 mL/min
* Liver function is normal: child-pugh grade A or grade B (≤7 points), total bilirubin ≤ 3.0 mg/dL, albumin ≥ 28 g/L, AST, ALT, ALP≤ 5 times of the upper limit of normal value
* Blood test: the absolute neutrophil count ≥ 1.5×10\^9 /L, Hb ≥ 8.5 g/L, PLT ≥ 75×10\^9 /L (without blood transfusions and drug therapy 14 days before the screening)
* Blood coagulation function: INR≤2.3
* ECOG: 0-2
* Pathology: hepatocellular carcinoma
* Satisfy any of the following:

A. portal vein, hepatic vein or bile duct carcinoma thrombus B. microvascular invasion (MVI) grade II (\> 5 MVI, or MVI occurs in the area more than 1 cm from the tumor) C. tumor number ≥ 3 D. preoperative rupture of tumor or tumor invasion adjacent organs

* Patients participate in the study voluntarily and sign informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Patients who have had or are currently complicated with other malignant tumors
* Recurrent hepatocellular carcinoma
* Patients who participated in other clinical trials within 1 month
* Patients with mental illness
* Patients treated with targeted drugs, immunotherapy (such as PD1 antibody), FOLFOX systemic chemotherapy or huaier granules after surgery
* Urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed
Gene Expression Profiling in Normal Tissue and Tumor Tissue From Patients With Colon Cancer That Has Spread to the Liver, Lungs, or Peritoneum

RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This laboratory study is using gene expression profiling to evaluate normal tissue and tumor tissue from patients with colon cancer that has spread to the liver, lungs, or peritoneum.

OBJECTIVES:

* Evaluate gene expression profiles in normal and tumor tissue from patients with colon cancer metastatic to the liver, lungs, or peritoneum.
* Establish cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum.
* Determine the specific gene expression changes that result in the manifestation of the drug-resistant phenotype for each metastatic site.

OUTLINE: This is a pilot study.

Tumor and normal tissue collected during surgery are analyzed for gene expression profiling by cDNA microarray. Tissue is also analyzed for thymidylate synthase (TS) gene expression by quantitative PCR and for protein expression by western blot. Gene expression patterns are correlated with TS levels.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of colon cancer metastatic to the liver, lungs, or peritoneum

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Stroke-induced Myocardial Dysfunction: Role of GDF-15 (SMOG-15) Clinical Work Package

The aim of this study is to analyze the relationship between the blood biomarker GDF-15 and heart damage after stroke.

It is being conducted in France, in the Neurology Department of the Dijon University Hospital (Burgundy). The research is interventional because a biological blood test will be performed, as well as a heart rhythm recording and several cardiac echograms during the hospitalization of the participants and during the follow-up consultation scheduled 4 to 6 months after the stroke.

A total of 130 stroke patients will participate in this study.

Participation includes 4 visits:

* Inclusion visit (within 24 hours of the first stroke symptoms)
* visit 1 (within 24 to 72 hours of stroke)
* visit 2 (within 48 hours of visit 1)
* Visit 3 (approximately 4-6 months post-stroke)


Eligibility Criteria:
Inclusion Criteria:

* Adult with acute symptomatic cerebral infarction documented by brain imaging on admission (cerebral angioscan or cerebral MRI)
* Whose first symptoms appeared within 24 hours before inclusion
* Whose consent to participate in this study was obtained from the patient or a close relative.

Exclusion Criteria:

* Person with a history of symptomatic stroke, either ischemic or hemorrhagic
* Anyone with a history of heart disease including: atrial fibrillation or flutter (known or discovered on admission), chronic heart failure, pacemaker, defibrillator, or other cardiac devices
* Person with acute heart failure, suspected infective endocarditis, STEMI, or concurrent pulmonary embolism
* A person who is not a member or beneficiary of a social security system
* Person deprived of liberty
* Person subject to a legal protection measure (curatorship, guardianship)
* Person subject to a legal protection measure
* Pregnant, parturient or breastfeeding woman
Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation

The purpose of this study is to compare gene expression profiles in endometrial biopsies during the window of implantation after triggers of oocyte maturation using GnRH agonist or hCG and compared with their natural cycles in order to identify genes that may be dysregulated in GnRH agonist-triggered cycles.

The investigators also intend to evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation (COH) which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. The use of a GnRH agonist for induction of final oocyte maturation in ovarian stimulation cycles utilizing GnRH antagonist for pituitary suppression has proven to be an effective method of preventing the risk of OHSS development.

Unfortunately, some studies, but not all, have also reported lower pregnancy rates in these cycles as compared to cycles using hCG trigger and this has been attributed to possible impaired endometrial receptivity.

The investigators intend to obtain endometrial biopsies collected from the same subject in a natural cycle and then a biopsy during either a GnRH agonist or hCG triggered stimulation. Expression profiles of mRNAs will first be screened using microarray technology. Relative levels of specific mRNAs that display altered expression in the GnRH-triggered samples, as assayed by microarray, will then be confirmed by real-time, quantitative reverse transcription/polymerase chain reaction (Q-PCR). The investigators shall also evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

Eligibility Criteria:
Inclusion Criteria:

* Oocyte donors
* Ages between 21 and 33
* Normal baseline serum FSH \< 10mIU/mL

Exclusion Criteria:

* Hypothalamic dysfunction
* Smokers
* Baseline serum FSH ≥ 10mIU/mL
Comparison of Analgesic Efficiency Between IPACK Block and Surgical Infiltration After Total Knee Arthroplasty

The purpose of this retrospective study is to compare the analgesic efficiency of IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) with surgical infiltration after total knee arthroplasty. The main objective is to compare cumulative morphine consumption the first 24 hours after surgery. The secondary objectives are to compare pain scores, types and amounts of other analgesics needed during the first 24 hours after surgery.

After patient agreement, data will be collected on patient records and will be compared into 2 groups.

Data will be :

* cumulative consumption of morphine during the first 24 hours after surgery
* pain scores during the first 24 hours after surgery
* amount of analgesics during the first 24 hours after surgery
* maximal pain score during the first 24 hours after surgery

Eligibility Criteria:
Inclusion criteria:

- All adults patients after a total knee arthroplasty since november 2015

Exclusion criteria:

- Child, non primitive surgery
Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour

Giant cell tumors are mostly benign tomoral processes, most often responsible for areas of osteolysis in the metaphysoepiphyseal area of long bones, representing 5-6% of primary bone tumors. The bone weakening induced by these beaches leads to pain and risk of fracture, and this is what leads the patient to consult.

These tumors are found particularly in the young adult population between 20 and 40 years old, are locally aggressive, but malignant transformations and metastases (pulmonary) are quite rare.

In this study, the investigators wish to retrospectively study the oral care of patients who presented with a giant cell tumor and were treated with Denosumab at the University Hospital of Strasbourg and their associated oral follow-up


Eligibility Criteria:
Inclusion criteria:

* Adult subject, having presented a giant cell tumor treated with adjuvant or neoadjuvant denosumab at the HUS from 01/01/2014 to 08/31/2022.
* Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes.

Exclusion criteria:

* Subject having expressed their opposition to the retrospective reuse of their data for scientific research purposes
* Pathology finally labeled other than giant cell tumour.
* Treatment with denosumab was not initiated because of death, change in treatment protocol, etc.
* Absence of oral follow-up element.
Augmented Reality Navigation Versus Traditional CT Guidance for Preoperative Localization of Pulmonary Nodules

This study aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules.

This study is an open-label prospective single-center non-inferiority randomized controlled clinical trial. Patients in the Pulmonary Hospital Affiliated to Tongji University who are scheduled to undergo percutaneous puncture localization of small pulmonary nodules are used as the research subjects. According to the entry and exit criteria Patients were included in the clinical trial, and the enrolled patients were randomly divided into the AR glasses-assisted puncture localizing group (experimental group) and the CT-guided conventional pulmonary nodule puncture localizing group (control group), aiming to evaluate the puncture of pulmonary nodules guided by Intelligent AR glasses. Non-inferiority of localization compared with conventional CT-guided pulmonary nodule puncture localization.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80, no gender limit;
2. Chest CT shows that the nodule involves the outer third of the lung and can be removed by wedge resection;
3. Chest CT (lung window mode), the maximum diameter of the nodule is ≤2 cm;
4. Physical condition score ECOG 0-2 points;
5. If you plan to undergo percutaneous puncture and localization of small pulmonary nodules, the puncture needle path will be determined by the attending physician;
6. Patients voluntarily participate and sign informed consent.

Exclusion Criteria:

1. The lesion is located in front of the scapula, and the needle path is blocked;
2. The distance between the center of the lesion and the top of the diaphragm is \< 3 cm;
3. The lesion is adjacent to the hilus or large blood vessels;
4. Pleural adhesions caused by a history of thoracotomy or pleural infection;
5. The patient voluntarily withdraws midway.
The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty

The purpose of this study is to determine if music therapy interventions as adjunct to standard surgical care reduces pre- and post-operative pain and anxiety in patients undergoing total shoulder arthroplasty as compared with patients who receive standard of care without music therapy.

This is a prospective, randomized, non-blinded clinical trial. The primary objective is to measure differences in pain and anxiety scores before and after music therapy interventions as compared to patients who do not receive music therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years of age
* Body mass: 50-125 kg (inclusive )
* Elective total or reverse total shoulder arthroplasty surgery by the study investigator
* Gender: male or female (non-pregnant)
* American Society of Anesthesiologists physical classification scale 1-3
* Fluent in written and spoken English
* Patients capable of giving informed consent

Exclusion Criteria:

* Age less than 18 years of age
* Non-elective surgery by the study investigator
* Pregnancy
* American Society of Anesthesiologists physical classification scale 4-5
* Non-English speaking persons
* Diagnosis of cognitive disorder or musicogenic epilepsy
* Pre-existing hearing problems, defined as inability to independently hear speech or music at average volume
* Diagnosis of cognitive disorder including psychosis and dementia and/or musicogenic epilepsy
* Anatomical abnormalities of the shoulder such as cancerous lesions or congenital defects
To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma

This study is designed to compare the safety, tolerability, and pharmacokinetics of QBX258 (sequential administration of a fixed dose of VAK694 and single ascending doses of QAX576) in patients with well-controlled mild to moderate asthma.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects age 18-60 years (inclusive)
* Well controlled mild to moderate atopic asthma
* Female subjects must be post-menopausal or surgically sterile
* Male subjects must be using two methods of contraception
* Subjects must have a positive skin prick test to one or more common airborne allergen

Exclusion Criteria:

* Participation in any clinical investigation or use of other investigational drugs at time of enrollment
* A history of clinically significant ECG abnormalities
* History of malignancy of any organ system
* Smokers (use of tobacco products in the previous 3 months)
* Use of prescription drugs other than those required for control and relief of asthma
* Use of oral steroids within 12 weeks prior to dosing
* FEVI \< 80% predicted at screening or baseline
* Use of albuterol more than twice a week for relief of asthma
* Patients suffering from active hay fever at baseline or likely to require treatment during the study
* History of chronic respiratory disease other than asthma or chronic allergic rhinitis
* Emergency room visit within 6 weeks of screening due to asthma
* Hospitalization for asthma in the last year
* History of intubation/assisted ventilation for asthma in the last 5 years
* Administration of live vaccines within the preceding month

Other protocol-defined inclusion/exclusion criteria may apply.
Effect of Intervention for Colonoscopy Quality is Associated With the Personal Characteristics

This study aims to investigate whether the personal characteristics of the endoscopist is associated with effect of interventions for colonoscopy quality improvement.

This is a prospective, 9-month, multicenter, single-blind study. Baseline quality indicators including adenoma detection rate, polyp detection rate, withdrawal time and adenomas per colonoscopy of each endoscopist were measured in the health promotion centers of academic hospitals for 3 months. Follow-up measurements of quality indicators were repeated every 3 months after each interventions (personal notification of quality indicators, open notification of quality indicators, and colonoscopy quality education by a GI faculty. At the end of the study, personal characteristics of each endoscopist was evaluated using fear of negative evaluation scale, cognitive flexibility inventory, and almost perfect scale.

Suboptimal colonoscopy quality is associated with development of interval colorectal cancer and colorectal cancer-related death. It is uncertain how to improve colonoscopy quality effectively. The quality of screening colonoscopy for colorectal cancer depends on the endoscopist who performed the examination. The aim of this study was to investigate the impact of endoscopists' personal characteristics on the quality of colonoscopy and effectiveness of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Highly experienced board-certified gastroenterologists performed colonoscopies in health screening endoscopy centers.
* Endoscopists who sign the consent
* Patients for quality indicators of endoscopists

  * routinely perform outpatient screening, surveillance and diagnostic colonoscopy (first-time screening colonoscopies performed and had no previous colonoscopy within 3 years).

Exclusion Criteria:

* endoscopists who refuse to sign the consent
* Patients for quality indicators of endoscopists

  * Known hereditary polyposis syndrome, Inflammatory bowel disease, those with surgically altered anatomy, undergone previous colonoscopy within 3 years