cyrilzakka/clinical-trials huggingface dataset:
Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.

This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits will include lung function tests and scans of your bones. The purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion criteria:

* Established clinical history of COPD.
* Baseline FEV1 \<70% predicted normal, and FEV1/FVC ratio of less than 70%.
* Smoking history of at least 10 pack-years, where both current and former smokers will be eligible.
* Must have at least one native, evaluable hip.

Exclusion criteria:

* History of or evidence for metabolic bone diseases other than osteoporosis or osteopenia.
The Correlation Between MAGE-A3, PRAME Polymorphism and Expression Levels of MAGE-A3 and PRAME in NSCLC Patients

Considering the low expression rate of Melanoma-associated antigen 3 (MAGE-A3) in Asian especially Southeast Asian, it would be great interests to investigate the potential polymorphism of MAGE-A3 in Non-Small-Cell Lung Cancer (NSCLC) patients in Taiwan. Meanwhile, it is also interesting to study the expression of Preferentially Expressed Antigen In Melanoma(PRAME) and Epidermal growth factor receptor (EGFR) mutation status as well as to find out significant factors which may affect their expression such as smoking status, histological types, tumour size and stages in Taiwan.

Considering the low expression rate of MAGE-A3 in Asian especially Southeast Asian, it would be great interests to investigate the potential polymorphism of MAGE-A3 in NSCLC patients in Taiwan. Meanwhile, it is also interesting to study the expression of PRAME and EGFR mutation status as well as to find out significant factors which may affect their expression such as smoking status, histological types, tumour size and stages in Taiwan

Eligibility Criteria:
Inclusion Criteria:

- Tissues samples up to 200 cases of NSCLS patients with informed consent, consisting of about 100 cases of adenocarcinoma (AC) and 100 cases of squamous cell carcinoma (SCC), with stage of IB, IIA, IIB and IIIA

Exclusion Criteria:

- No
The Relationship Between Ambulation Capacity and Piriformis Muscle in Patients With Chronic Spinal Cord Injury

Spinal cord injury (SCI) is a neurological condition causing paralysis, sensory abolishmentS and deficits including circulatory, respiratory, otonomic nervous systems, bowel and bladder functions. For patients with SCI, reducing disability, limitations of the impairment and regaining the walking ability are the main rehabilitation goals. There many prognostic factors effecting the recovery and ambulation capacity of patients.

The piriformis muscle (PM) is placed posterior to the hip joint, originates on the anterior surface of the sacrum and the sacrotuberous ligament and passes out of the pelvis through the greater sciatic foramen and separates the foramen into two spaces. The PM is the solely muscle coursing transversely throughout the greater sciatic notch, and it is the main landmark to all the important neurovasculer structures that pass from the pelvis to the gluteal region. PM serves as a hip abductor when the hip is flexed and as a hip external rotator when the hip is extended. It is innervated by branches of the posterior division of the ventral rami of S1, S2 and is the largest muscle among the deep, short external rotators of the hip and provides postural stability while standing and walking. PM has also a functional importance as it connects the sacroiliac joint and hip joint. For these reasons morphology of PM may have a clinical importance for SCI patients whom can walk.

Ultrasonography is radiation-free, noninvasive, available technique that can be used to measure muscle thickness in the monitoring and management of muscle changes during rehabilitation.

The aim of our study is to evaluate the relationship between the PM and the ambulation pattern of motor incomplete patients with chronic SCI. To the best of our knowledge, this is the first study evaluating PM in patients with SCI.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Diagnosis of motor incomplete paraplegia at C or D level according to the spinal cord injury classification of the American Spinal Injury Association (ASIA) Impairment Scale with a neurological injury level between T2-S1

Exclusion Criteria:

* Being under the age of 18 and over the age of 65
* Having joint contracture in the legs
* Unstable medical conditions
* Severe osteoporosis and high fracture risk
* Sacral or coccygeal grade 2 and higher pressure ulcers
* Peripheral neuropathy,
* Psychiatric disorder or cognitive problems
Preparing for the Final Phase of Hepatitis C Elimination. Cairns Final 30%

The study aims to assess the impact of models of HCV care on HCV testing, treatment uptake and cure within Cairns. Point of care testing for HCV , with test and treat strategies will be offered within a primary care service.

Available testing and treatment data will be explored pre and post the intervention period of the project within Cairns Hinterland health services that provide hepatitis C care.

Test and treat strategies of the project will include:

Part A: Same day test and treat clinical trial. The study will explore a 'same day test and treat' model to determine the impact on HCV treatment initiation and cure within a primary care service that recognises that they see people at risk of hepatitis C that are transient, and struggle to return to a care provider to engage in hepatitis C testing and care.

1. HCV RNA point of care (POC) testing
2. Epclusa (Sofosbuvir/Velpatasvir 400mg/100mg) course initiated at same day of visit following a +ve HCV RNA result from the POC test.

Part B: Refresher and clinic in reach support work Primary care service/ General practitioner education and training \~1 hour in-person training for all clinic staff on hepatitis C testing, treatment, retention in HCV care cascade.

Part C: Services evaluation with incentive and peer intervention in HCV care cascade.

Eligibility Criteria:
Inclusion Criteria:

* attending primary health care service of CHHS aged 18 years or over

Exclusion Criteria: only for intervention arm test and treat

* Known to have hepatitis B or HIV infection
* Known to have cirrhosis
* Previous treatment with direct acting antivirals
* Previously received interferon-based hepatitis C treatment that did not work
* Women that are pregnant or breastfeeding
* Already receiving hepatitis C treatment.
Effect of COVID-19 on Platelet Aggregation

This is a mechanistic, observational, prospective, case and control study, to compare platelet aggregation, analyzed by Multiplate-ADP, in hospitalized patients diagnosed with COVID-19 versus healthy controls. Thus will be included 60 patients who present with respiratory symptoms within 72 hours of hospitalization and confirmation of the diagnosis of COVID-19 by laboratory method (RT -PCR and / or positive serology for SARS-CoV-2 - COVID group); this group will be compared to 60 healthy individuals (asymptomatic and with negative SARS-CoV-2 serology), matched by sex and age to the previous group.

There is strong evidence that SARS-CoV-2 infection is associated with atherothrombotic phenomena. However, platelet activity in COVID-19 has not yet been studied.

Thus, the main objective of this project is to evaluate platelet aggregation by the Multiplate-ADP method in hospitalized patients diagnosed with COVID-19, in comparison with the platelet aggregation evaluated by the same method in healthy controls.

Secondary objectives include the assessment of parameters related to coagulation, inflammation, and clinical outcome variables.

This is a mechanistic, observational, prospective, case and control study, which will include 60 patients who present with respiratory symptoms within 72 hours of hospitalization and confirmation of the diagnosis of COVID-19 by laboratory method (RT -PCR and / or positive serology for SARS-CoV-2 - COVID group); this group will be compared to 60 healthy individuals (asymptomatic and with negative SARS-CoV-2 serology), matched by sex and age to the previous group.

Eligibility Criteria:
Inclusion Criteria:

* Agreement to sign the Free and Informed Consent Form (ICF).
* Case group: patients with up to 72 hours of hospitalization for respiratory symptoms.
* Control group: healthy volunteers, defined as having no history (confirmed or suspected) of COVID-19 or chronic diseases (except hypertension, obesity, dyslipidemia)

Exclusion Criteria:

* Known platelet dysfunction or platelet count \<100,000 / µL or\> 450,000 / µL;
* Terminal illness;
* Known liver disease or clotting disorder;
* Hematocrit less than 34% or greater than 55%;
* Previous use of antiplatelet agents and / or anticoagulants (except acetylsalicylic acid and prophylactic heparin);
* Patients on invasive mechanical ventilation or receiving high oxygen flow.
Clinical Data Collection for Obstetric Ultrasound Algorithms

The goal of this clinical trial is to

* Collect ultrasound data from pregnant and non-pregnant individuals presenting to multiple study sites.
* Use the collected data and ultrasound images to train and validate Artificial intelligence algorithms developed by the Sponsor

Consented participants will be asked to take part in a research ultrasound scan

In this study pregnant and no pregnant subjects will be recruited from Obstetrics and Gynecology clinics/hospitals or from Maternal and Fetal Medicine centers. The pregnant subjects will be in Group 1 and non pregnant subjects will be in Group 2. Pregnant subjects are only recruited if they are scheduled for an obstetric standard of care scan . Both the group will undergo research scan, which is a sweep protocol using handheld FDA approved ultrasound device like Vscan. Patient chart history (no PHI), standard of care scan ultrasound images (no PHI), and research scan ultrasound images (no PHI) would be obtained from Group 1 subjects. Patient history (no PHI), research ultrasound images (no PHI) would be obtained from Group 2 subjects The data collected from this study will be used by the sponsor to develop algorithms for screening various fetal health parameters such as gestational age, placenta location, fetal heart rate, number of fetuses, fetal positions etc

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Eligibility Criteria:
Inclusion Criteria:

Pregnant group (Group 1)

1. Participants aged 18 years or older at time of consent.
2. Participants with confirmed pregnancy (positive HCG urine test strip and/or a documented obstetric ultrasound scan.
3. Participants who are scheduled for or referred for a standard-of-care clinical obstetric ultrasound examination.
4. Participants who provide written consent.

Non-pregnant group (Group 2)

1. Participants aged 18 years or older at time of consent.
2. Participants who are not actively pregnant (confirmed using an HCG urine test strip).
3. Participants who provide written informed consent.

Exclusion Criteria:

- 1. Participants for whom participating in this study would delay or compromise care in any way.

2. Participants who are not able to understand or provide written consent.
Effect of Virtual Reality-Based Visual Training for Myopia Control in Children

To assess the efficacy and safety of virtual reality-based visual training (VRVT) in myopia control among children.


Eligibility Criteria:
Inclusion Criteria:

1. Age 8-13 years old (inclusive), regardless of gender;
2. The spherical equivalent of both eyes after cycloplegia was -3.00D to -0.50D (including);
3. Binocular astigmatism ≤3.00D during screening;
4. Anisometropia (according to spherical equivalent) ≤1.50D during screening;
5. The intraocular pressure of any eye during screening was ≤21mmHg;
6. At the time of screening, the best corrected distance visual acuity of any eye was ≥1.0 or LogMAR≤0;
7. Good binocular stereopsis and stereopsis acuity ≤60 ";
8. The subjects and their legal guardians were willing to participate in the study and signed written informed consent.

Exclusion Criteria:

1. Existing or previous history of ophthalmic organic diseases, ophthalmic surgery, and obvious strabismus after wearing glasses;
2. Using orthokeratology lenses, feeding instrument and other myopia prevention and control methods that may affect the study in the past 6 months;
3. Subjects with poor vestibular function such as motion sickness and seasickness;
4. Any history of diseases or syndromes that may cause severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.); 5, any eye refractive media abnormalities (such as cornea, lens abnormalities, etc.);

6. Long-term use (i.e., more than 7 consecutive days in 1 month or more than 30 days in total in 1 year) of any local or systemic use of anticholinergic/anticholinergic drugs (e.g., atropine, scopolamine, tolacamide, etc.) within 21 days before screening and during the expected period of the study, allowing the use of cycloplegic drops for optometry and other examinations; 7. Severe systemic disease considered by the investigator as not suitable for the study; 8. Participation in other clinical trials within 30 days before screening; 9. Only one eye met the inclusion criteria; 10. Poor compliance, unable to go to medical institutions for treatment on a timely and regular basis as required; 11. Any other circumstances deemed inappropriate by the investigator to participate in the study.
Evolution of the Health Status of Caregivers After the Admission of Their Elderly Relative to the Emergency Department

The main objective of this non-interventional, propective and multipercentric study is to Assess the evolution of caregiver burden 1 month after their elderly relative's Emergency Department (ED) admission

The aim purpose of this non-interventional, prospertive study is to compare the evolution of caregiver burden between inclusion and 1month after their elderly relative's ED admission.

Inclusion of caregivers - patients dyads, meeting inclusion criteria and agreeing to participate, is carried out by geriatric mobile teams (EMG) working within Emergengy Department.

At inclusion the following data will be collected:

For the patient :

* Presence of neurocognitive disorders
* Sociodemographic data (age, gender, lifestyle)
* Patient comorbidities
* Autonomy and independence
* Risk of early readmission and loss of autonomy

For the caregiver:

* Socio-demographic data
* The caregiver's burden
* Quality of life
* Resilience capacity will be measured

The follow-up of the caregiver is carried out 1 month after the passage of his elderly relative to Emergency Department (at inclusion). The levels of burden and quality of life as well as the aids set up at home will be collected

Eligibility Criteria:
Inclusion Criteria:

* Adult caregivers - patients aged 75 and over dyads consulting in Emergency Department and living at home
* Patients admitted to the emergency department for less than 48 hours for which a return home is decided
* Non-verbal opposition of the patient and caregiver to the collection of their data.

Exclusion Criteria:

* Hospitalized patient after emergency
* Patient admitted to emergency for life-saving emergency
* Patient living Nursing Home (EHPAD)
* Language barrier
* Absence of identified caregivers
* Severe cognitive impairment as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and absence relative at time of inclusion
* Patients under guardianship
* Oral opposition from the patient and caregiver to their data collection.
Ibuprofen vs. Continuous Indomethacin in the Treatment of PDA

The purpose of this study is to determine whether closure of the PDA in premature neonates using IV ibuprofen vs continuous IV indomethacin has different side effects, eg. effects on renal function, on blood flow velocity in the superior mesenteric artery, the anterior cerebral artery, and the renal artery.

Despite the fact that ibuprofen appears to minimize the renal side effects seen following bolus indomethacin, other concerns regarding both short and long-term safety remain. Indomethacin, on the other hand, has been used to treat premature neonates for many years. Other than transient vasoconstrictive effects, no significant toxicity has been noted. Thus, if we were to be able to eliminate the differential renal effects, indomethacin would remain, for many, the therapy of choice for the premature neonate with a persistent PDA. We hypothesized that continuous administration of indomethacin would provide this option. Ibuprofen therapy has not, to date, been compared with indomethacin administered by continuous infusion. Hence, in the current study we attempted to determine whether continuous indomethacin administration could potentially offer the same advantages as ibuprofen in treating PDA, specifically in terms of mitigation of renal side effects. Specifically, our primary objective was to show no differences in urine output and/or in serum creatinine between the treatment groups. As a secondary objective, we aimed to show no other potentially vascular-mediated clinical differences, eg. Necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP) and on bilirubin albumin binding between the groups.

B-type natriuretic peptide (BNP) is released by ventricular myocytes in response to ventricular volume load. It, in turn, mediates vasodilation, natriuresis and diuresis. Serum BNP levels have been shown to be clinically useful in differentiating between respiratory and cardiac disease, in monitoring heart failure therapies and in serving as early diagnostic biomarkers of ductal patency in premature neonates. As secondary objectives we intend to determine whether a decrease in BNP levels would be an equally reliable indicator of therapeutic efficacy in infants treated with ibuprofen as with indomethacin.In addition we will look at comparative effects on other vascular beds which might mediate long term side effects described above.

Eligibility Criteria:
Inclusion Criteria:

* \< 1500 gm birth weight with PDA confirmed by echocardiography

Exclusion Criteria:

* Additional congenital heart lesions
* Significant congenital malformations
* Documented infection
* Thrombocytopenia (\<60,000)
* IVH grade 4
Cefazolin Pharmacokinetics: Elimination Clearance in Neonates

To document cefazolin disposition (concentration/time profile, protein binding, metabolism, renal elimination characteristics) and its covariates in neonates following intravenous administration of the drug at induction of anesthesia, prior to an invasive procedure

To evaluate if optimalisation of cefazolin dose regimen during neonatal life is needed

Prospective, single-center, open label study on the pharmacokinetics of iv cefazolin administration in neonates admitted in the neonatal intensive care unit, University Hospitals Leuven, Belgium.

Patients will be included after signed informed consent of the parents.

Our aim is to include 40 neonates. Cefazolin has been selected for this study as it is routinely administered in neonates undergoing invasive procedures in our unit. At this stage, we only have the intention to document pharmacokinetics and covariates based on the current clinical practice and therefore will not interfere with either clinical indication, or with dosing as prescribed by the attending physician.

Drug administration and collection of samples will be obtained to the current clinical and nursing standard procedures.

Routine clinical care for scheduled invasive procedures in neonates in our unit is intravenous administration of cefazolin as follows:

* 50 mg/kg, 3 times a day
* an extra dose of 50mg/kg is given after 3 hours for operations longer than 3 h
* each time one dose/day is excluded for neonates with body weight \<2000 g and postnatal age (PNA) \<7 days,
* for invasive operations (e.g. open-heart surgery, laparotomy) the prophylactic administration of cefazolin may be continued for 3-5 days following the completion of surgery.

The antibiotic agent should be administered 30 minutes to 1 hour prior to the start of surgery so that adequate antibiotic levels. Cefazolin is administered to the neonate, through a peripherally inserted venous catheter, during 30 minutes.

Blood will be collected in heparinised tubes through an indwelling arterial line, or deep venous access, always when other routine blood samples are collected for clinical purposes (pO2, pCO2, pH).

Urine samples will be collected through a bladder catheter in patients in whom a bladder catheter is available for clinical indications.

Pharmacokinetic analysis A population pharmacokinetics approach will be used, hereby comparing the data on PK already reported in adults or older children and the newly collected data during neonatal life.

Eligibility Criteria:
Inclusion Criteria:

* signed parental informed written consent
* neonates to whom cefazolin is administered by intravenous route for clinical indications (invasive procedure)

Exclusion Criteria:

* known cefazolin intolerance
Masimo CO-Oximeter Study

This is a study to evaluate the accuracy of the Masimo Rainbow SET Pulse CO-Oximeter in monitoring the hemoglobin levels of patients undergoing isovolemic hemodilution.


Eligibility Criteria:
Inclusion Criteria:

* Any subject that is scheduled to have isovolemic hemodilution

Exclusion Criteria:

* Anything that prevents a subject from having isovolemic hemodilution
Efficacy of High-flow Nasal Oxygen in Preventing Hypoxia During Gastrointestinal Endoscopy: a Retrospective Cohort Study

During painless gastroscopy, the occurrence of hypoxia is a critical concern, especially under intravenous anesthesia using propofol. This study aimed to investigate the incidence of hypoxia during painless gastroscopy and evaluate preventive measures.

From June 15 th 2023 to August 15th 2023, 900 patients who underwent elective gastroscopy in the Renji Hospital, Shanghai Jiao Tong University School of Medicine were selected. They were divided into the high flow nasal cannula oxygen group and the conventional nasal cannula oxygen group by oxygen inhalation. Patient demographics, Mallampati class, and other relevant factors were compared between the two groups. Primary outcomes included the incidence hypoxia (SpO2 \< 90%), while secondary outcomes included subclinical respiratory depression, and adverse events related to nasal oxygen cannula.

Eligibility Criteria:
Inclusion Criteria：

* Patients aged 18 to 70
* Undergoing painless gastroscopy under intravenous anesthesia

Exclusion Criteria：

* Severe respiratory disease
* History of nasal bleeding or mucosal injury
* Emergency cases
* Pregnant or lactating female
Virtual Reality Relaxation for Addiction Inpatients

This trial examines the immediate session effect of Virtual Reality (VR) relaxation, when used at an addiction inpatient ward for adolescents.

Past research has revealed that Virtual Reality nature environments can be used to induce relaxation, yet this type of intervention has not yet been evaluated in a clinical setting. This trial examines whether VR relaxation can be used as a digital equivalent of a (physical) comfort room at an an addiction inpatient ward for adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Patient at Maria Ungdom inpatient ward.
* Sufficient grasp of Swedish to understand terms of study participation and intervention instructions.

Exclusion Criteria:

* Self-reported stereoscopic vision or balance problems hindering VR experience.
* Self-reported history of repeated violent outbursts when using technology.