cyrilzakka/clinical-trials huggingface dataset:
Prediction of Falls in Older Inpatients Hospitalized at Angers University Hospital

The primary objective of this study is to elaborate a new simple clinical tool for the risk of falls among older inpatients.

Falling is a common event within hospitals, with a rate calculated between 2.9-13 per 1,000 bed-days . Falls lead to prolonged length of hospital stays (LHS). The first step of an efficient and cost-effectiveness strategy of fall prevention is the screening of individuals at higher risk of falls. Recently, a brief geriatric assessment (BGA) composed of a few number of items has demonstrated to successfully predict the risk of prolonged LHS (5). We hypothesized that the use of the BGA items would make it possible to predict the occurrence of falls among older inpatients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* participants who did not issue opposition to participation in the study
* Patients hospitalized at the University Hospital of Angers in acute care units participating in study
* Being affiliated to a social security regime

Exclusion Criteria:

* Opposition to the use of information collected for research purposes.
* Age \< 65 years
Nonlinear Elasticity Mapping of Breast Masses

This proposed technique, called "Nonlinear Elasticity Mapping (NEM)", is an innovative approach to estimate (i.e., linear and nonlinear) elasticity to provide complementary and relevant information for identification and characterization of breast masses.

The proposed technique includes imaging the (nonlinear) elasticity parameter in a quantitative manner and measuring two new and relevant parameters. These parameters, together with linear elasticity, are used to differentiate breast masses. The first parameter is the nonlinearity of the elasticity.

Measuring the nonlinearity of elasticity is obtained by recording ultrasound scans of object under different values of externally applied compression, and processing the resulting data. The central element of the proposed method is the solution of an inverse problem by which the linear and nonlinear parameters are estimated and a map of tissue nonlinearity is produced, in which the malignant masses can be identified. In addition to estimating the elasticity, will also evaluate the heterogeneity of the (linear) elasticity parameter distribution within the mass as an indicator of malignancy. In a previously performed pilot study, tested the proposed method on a small group of patients.

The goal of this project is to take the next logical step, which is to test this method in a clinical study on a larger population of patients to obtain statistically meaningful results. Assuming that the proposed method continues to demonstrate high specificity, this technique can have a significant impact on breast cancer diagnosis and management.

Eligibility Criteria:
Inclusion Criteria:

* Without a history of mastectomy or implants, which are identified to have findings on their clinical breast ultrasound.

Exclusion Criteria:

* Previous mastectomy or implants
* Any condition that does not allow proper use of imaging devices.
AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis

The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD).

Subjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years of age
2. Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
3. Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
4. Signed informed consent obtained by subject or Legally Authorized Representative

Exclusion Criteria:

1. Subject has fixed and dilated pupils
2. Pregnant women
3. Presence of Moyamoya
4. History or presence of clotting disorder.
5. Platelet count less than 100,000, INR greater than 1.4
The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis

Currently, lots of researches aimed at quality of life of patients with peritoneal dialysis and hemodialysis related issues. There is no study related to establish the predictive model of quality of life. This study will investigate the predictive model of quality of life in terms of peritoneal dialysis (PD) or hemodialysis (HD) patients. These results will offer the further evidence to the government to develop the effective interventions for dialysis patients. The optimal goal is to promote the quality care.


Eligibility Criteria:
Inclusion Criteria:

* above 20 years old PD or HD patients
* conscious clear and no psychosis
* literate and can communicate
* willing to participate and sign informed consent

Exclusion Criteria:

* Not volunteer
* subject felt weak or uncomfortable and patients decision to withdraw from the study
Tumor Phenotypes and Correlation to Clinical Outcomes in Cancer

The purpose of this study is to identify the genetic makeup of cancers, the cancer response, and the correlation of the cancer response to standardized regimens of cancer treatment.

To identify the genetic makeup of cancers, the cancer response, and the correlation of the cancer response to standardized regimens of cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer receiving chemotherapy
* Have had or will have tissue and/or blood samples collected
Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients.

The purpose of the study is to compare continuous versus intermittent strategy for enteral nutrition. The study will examine if there is a difference in achieving nutritional delivery goals, tolerance and number of complications of enteral nutrition.

The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our ICU from the 1st of June 2018 to the 31st of May 2019 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Enteral nutrition will be administered via nasogastric of orogastric tube. Patients will be randomised in 2 groups. In the group of patients receiving continuous feeding will be enteral nutrition administered via enteral feeding pump for at least 16 hours par day. In the group of patients receiving intermittent feeding will be enteral nutrition administered as 30-60minutes lasting bolus via enteral feeding pump 6 times per day. Following the administration of the bolus the patient will be placed for 30 minutes in semi-upright sitting position. Enteral nutrition requirement and composition will be standardised with the adoption of international guidelines. In 5 subsequent days from the enteral nutrition commencement will be examined if there is a difference in achieving energy and protein targets, tolerance and number of complications of enteral nutrition in between both groups. As achievement of energy and protein targets will be considered at least 80% of calculated values. The tolerance of enteral nutrition will be evaluated by the clinical examination of the abdomen, presence of diarrhoea, vomiting and the gastric residual volume of at least 0,5 liter. As the complications of enteral nutrition will be regarded the aspiration of gastric contents and ventilator associated pneumonia. Nutritional status parameters will be analysed. the length of hospital stay, ICU length of stay and 28-day mortality will be also monitored.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 - 80 years
* indication of enteral nutrition with nasogastric or orogastric tube
* Nutrition Risk in the Critically Ill (NUTRIC) score ≥5
* Body mass index between 18 - 50
* mechanical ventilation expected for at least 72 hours

Exclusion Criteria:

* upper gastrointestinal tract surgery in previous medical history
* bowel obstruction
* bowel ischemia
* acute pancreatitis
* severe diarrhoea (\>1l/24hours)
* gastrointestinal bleeding
* short bowel syndrome
* malabsorption syndrome in previous medical history
* ongoing enteral nutrition on admission to ICU
Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* 20-40 years old pregnant woman with gestational age of 20-32 week;
* positive serum HBsAg;
* HBV DNA≥1.0x106 copies/ml;

Exclusion Criteria:

* with previous antiviral treatment;
* with clinical sign of threatened miscarriage or related treatment in early pregnancy;
* positive serum HAV, HCV, HDV and HEV tests;
* fetus deformity by 3-D ultrasound examination;
* on other dugs, such as immune modulators, cytotoxic drugs or steroids;
* husbands are infected with HBV.
Feasibility and Efficacy of A Remote Tai Chi Program in Older Adults

This project is designed to explore the feasibility and preliminary efficacy of a remote Tai Chi program on older adults' 24-hour movement behaviors (i.e., physical activity, sedentary behavior and sleep patterns).

This study employed a 26-week cross-over, randomized control trial design in which each participant was assigned to one of two condition (i.e., 10 participants/cohort, 2 cohorts/condition) sequences at baseline: 1) the Tai Chi intervention condition then the usual care condition; or 2) usual care condition then intervention condition. The intervention condition requested participants participate in remote Tai Chi program for 60 minutes/session 2 times/week beyond their usual care. The usual care condition asked participants to maintain regular activities without Tai Chi and not to change their regular activity routine. Each condition lasted 12 weeks, with a 2-week washout separating treatments. The researchers monitored intervention fidelity via monthly follow-up phone calls.

Eligibility Criteria:
Eligible participants met the following inclusion criteria: 1) aged 60 years or older; 2) basic English communication skills; 3) without cognitive impairments or physical/mental dis-abilities that might limit their ability to practice TC, 4) computer/smartphone with internet access; and 5) provided informed consent. Participants who lacked the capacity to consent or had any medical condition that could make it potentially unsafe to be in an unsupervised physical space were excluded from the study.
Randomized Trial for Pharmacogenomics-based Proton Pump Inhibitor Therapy in Children

Proton pump inhibitors are administered to children as off-label use in Japan. The purpose of this study is to evaluate the effects of CYP2C19 genotypes on pharmacokinetic /pharmacodynamic profiles of PPI in children. The results will provide the beneficial information for the individualized medicine of PPI in children.


Eligibility Criteria:
Inclusion Criteria:

* Patients with gastroesophageal reflux
* The patient's parent or guardian gives written informed consent including pharmacogenomic analysis
* The patient is willing and able to give assent to participate.

Exclusion Criteria:

* Serious hepatic disease, pulmonary disease, renal disease and blood disorder
* Inadequate clinical conditions
Thumb Osteoarthritis: A Cross-Sectional Study of Mechanisms

This study examines carpometacarpal osteoarthritis (CMC OA) and aims to elucidate the biomechanical, neuromuscular, and somatosensory mechanisms that contribute to CMC OA symptoms by using orthopaedic biomechanics and quantitative pain testing. Completion of this study will provide a comprehensive dataset describing how movement strategies (muscle activity and joint posture) as well as experimental and clinical pain differ between individuals with CMC OA and age-matched controls.

This study was funded by that National Institutes of Health through KL2 TR001429 and was registered as a clinical trial at the request of the funding agency. The goal of this exploratory, career development project was to conduct an observational, cross-sectional study of individuals with and without carpometacarpal osteoarthritis (CMC OA). Interestingly, even though approximately a third of postmenopausal women have radiographic evidence of CMC OA, less than ten percent of all women visit the doctor with painful symptoms. This disconnect between radiographic evidence of disease and presence of painful, clinical symptoms makes CMC OA challenging to study. Here, participants were recruited into two groups: CMC OA and age-matched controls. Participants with CMC OA were defined as those recruited from orthopaedic clinics with a diagnosis of CMC OA. Age-matched controls were defined as those recruited from the community who reported during screening that they had no pain or clinical symptoms of CMC OA. All participants participated in two sessions, a biomechanics session to evaluate movement (muscle activity, joint posture) and a somatosensory testing session to evaluate pain sensitization. All participants also completed clinical outcome measures and a hand x-ray. Analyses were completed on two groups based on radiographic evidence of CMC OA: early-stage and end-stage. Note, participant assignment to the analysis groups did not necessarily match the recruitment groups, as some control subjects had radiographic evidence of end-stage CMC OA and some individuals with diagnosed CMC OA had radiographic evidence of early-stage disease. The goal of this study was to build a small, comprehensive dataset describing how movement strategies (muscle activity and joint posture) as well as experimental and clinical pain differ across individuals with CMC OA.

Eligibility Criteria:
Inclusion Criteria:

* CMC OA Subjects:

  * female between the age of 40 to 90 years
  * end-stage CMC OA diagnosed by a board-certified clinician
* Age-Matched Control:

  * female between the age of 40 to 90 years
  * no joint or muscle pain in the hand or wrist

Exclusion Criteria:

* All Groups:

  * pregnant women; minors (under age 18); mentally disabled; any persons incarcerated, on parole, on probation, or awaiting trial
  * individuals with concomitant musculoskeletal pathologies (other than osteoarthritis) in the hand or wrist, including distal radius fracture, contracture, trigger finger, and carpal tunnel
  * individuals with history of uncontrolled diabetes, rheumatoid arthritis, muscular dysfunction, or neurological disease
Bevacizumab and Endothelium Dependent Vasodilation

The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most reported side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody against vascular endothelial growth factor, hypertension had an overall incidence up to 32%. The increase in blood pressure occurs early in treatment. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this side effect is essential for optimal treatment with this class of drugs.

The primary objective is to explore the effect of bevacizumab infusion on endothelium-dependent vasodilation of forearm resistance arteries.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-50 years old
2. Male
3. Results of serum glucose, lipids and creatinine should be within the laboratory's reference ranges.
4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion Criteria:

1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
2. History of or current abuse of drugs, alcohol or solvents.
3. History of malignant disease.
4. First degree relatives with a history of cancer before the age of 50
5. First degree relatives with a history of premature cardiovascular disease before the age of 50
6. Current use of medication.
7. Clinical evidence of cardiac or pulmonary disease
8. Hypertension ( systole \>140mmHG, diastole \>90mmHg)
9. Diabetes mellitus
10. Smoking
11. Any clinically relevant abnormality on ECG.
12. A history of thrombosis or first degree family members with a history of recurrent thrombosis
13. Inability to understand the nature and extent of the trial and the procedures required.
14. Previous participation in a study with bevacizumab
Pediatric Difficult Airway Prediction Using Ultrasonography

Recognition of difficult airway is purported to be the most important factor in successful management of difficult airway. The incidence of difficult airway in pediatrics is much less than in adults; however, airway related complications can lead to hypoxic brain damage or even death especially in younger age groups as neonates and infants.The aim of this work is to evaluate the feasibility and accuracy of ultrasound measurements (hyomental distances, tongue measurements, and anterior neck soft tissue thickness at the level of hyoid bone, thyrohyoid membrane, and thyroid cartilage) in predicting difficult laryngoscopy and difficult mask ventilation in pediatric patients undergoing elective surgery under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Gender both males and females
* ASA Class I and II
* Age 1month to 10 years
* Children undergoing elective surgery under general anaesthesia

Exclusion Criteria:

* congenital upper airway malformation,
* head and neck swellings,
* scars,
* radiation to the neck,
* tracheotomy,
* Neurosurgical or cardiac procedures
* ENT surgeries
High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia

This study is a prospective, single center and observational open clinical study.

Biliary atresia (BA) is a significant disease leading to liver failure in infancy, with BA accounting for 50% of infant liver transplantation cases. Many BA children experience complications related to malnutrition, particularly during the first year of life. These complications are primarily characterized by reduced muscle mass and structural protein, impaired bone mineralization, diminished fat reserves, and deficiencies in vitamins and trace elements. Some studies have indicated that oral administration of specialized medium-chain triglycerides (MCT) and branched-chain amino acids FSMP with polysaccharides still result in malnutrition and growth retardation among BA children, necessitating enteral nutrition support treatment through tube feeding. The American Association for the Study of Biliary Atresia conducted a study on the prognosis of 104 children with biliary atresia after Kasai surgery across six clinical centers. They found that the key period for changes in growth rate occurred six months post-surgery, with faster-growing children exhibiting better prognoses compared to those with slower growth rates. Active nutritional therapy can enhance the prognosis of children with biliary atresia, particularly before and after Kasai surgery within the initial six-month period following surgery. Currently, there is no standardized process for using Foods for Special Medical Purpose in China nor any regulations governing the addition and monitoring of trace elements and vitamins. Therefore, this study aims to improve overall outcomes for children with biliary atresia through standardized nutrition assessment procedures as well as education, intervention, and follow-up measures.A total of 300 hospitalized patients were enrolled, all of whom received high MCT formula nutritional support following the Kasai operation, in order to investigate the impact of high MCT formula on the nutritional status and growth of children with biliary atresia after undergoing the Kasai procedure.

Eligibility Criteria:
Inclusion Criteria:

The Kasai procedure for infants with biliary atresia under the age of 3 months.

Exclusion Criteria:

* Complicated with cirrhosis, hepatitis, or other hepatic disorders;
* Complicated with other systemic serious diseases (such as congenital multiple malformations, chromosome abnormalities)
Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Late-onset Neonatal Sepsis

The purpose of the study is to investigate the plasma levels of Soluble Urokinase Plasminogen Activator Receptor (suPAR) at the diagnosis and after treatment of sepsis, and to determine whether it has a diagnostic and prognostic value in late-onset neonatal sepsis.

Infection is a leading cause of neonatal morbidity and mortality worldwide. The clinical presentation of neonatal infection is subtle and nonspecific. Microbiologic cultures of clinical specimens, the gold standard for diagnosis, have low sensitivity and are not available in time to influence initial therapy. Therefore, reliable and rapid in vitro tests are needed for early diagnosis and management of infection in neonates. suPAR, secreted from the cells (neutrophils, lymphocytes, macrophages, endothelial cells) has recently been reported to be a potential biomarker for several infection diseases. The levels of suPAR have not been studied in newborn infants yet.

Eligibility Criteria:
Inclusion Criteria:

* Infants with late-onset neonatal sepsis

Exclusion Criteria:

* Infants without parents' consent