cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).

This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of knee (confirmed by American College of Rheumatology \[ACR\] criteria).
* Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.

Exclusion Criteria:

* Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
* Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).

Other protocol-defined inclusion/exclusion criteria may apply.
Distance Learning and Neck Problems During Pandemic Period

For people who use computers a lot, Work-related musculoskeletal disorders of the neck are a common problem . It is generally agreed that the etiology of work-related neck disorders is multidimensional which is associated with, and influenced by, a complex array of individual, physical and psychosocial factors.

Academic staff work involves diverse activities, both in and out of lecture-rooms, designing course curricula, developing lecture and tutorial plans and materials, providing students with information in an interesting and understandable manner, setting questions, and marking examinations .These activities usually involve long periods of sitting and standing, placing a physical demand on the lower back, cervical spine and the vertebral column in general, thus contributing to neck and shoulder discomfort .Lecturers use computers extensively and are thus exposed to many of the same risk factors to which 'office workers' are exposed. Using a computer is associated with poor neck posture most often in a forward head position, which is thought to be one of the most common causes of neck, head and shoulder tension and pain .

Neck pain is costly in terms of treatment, individual suffering, and time lost due to work absenteeism . Effective performance of academic staff of the university is very important as the key factors to a successful day to day running of any university system .

Eligibility Criteria:
Inclusion Criteria:

* At least one year of work experience in the current position as academic stuff.

Exclusion Criteria:

* Spinal deformities or specific medical condition affecting the cervical spine (e.g., ankylosing spondylitis, radiculopathy, tumors, infection and disc prolapse)
* History of spinal surgery
* Previous head or neck trauma
Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases

This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.

This study included an active control group who received the licensed Priorix (measles, mumps, rubella \[MMR\] vaccine).

Eligibility Criteria:
Inclusion Criteria:

* A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination.

Exclusion Criteria:

* History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial
* Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination
Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma ≤ 5 cm

The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic resection or liver transplantation, but less than 20% of HCC patients are suitable for surgery. In the remaining patients with inoperable and advanced HCC, trans-arterial chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete response and commonly develops recurrence. Recently several small studies reported high tumor response and local control rate after stereotactic ablative radiotherapy (SABR) alone or with TACE for inoperable HCC. This study will evaluate SABR effect with 60 Gy in 3 fractionations for HCC with size of ≤ 5 cm and 3 cm apart from gastrointestinal tract.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 20 years of age
* Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
* Unresectable HCC
* Cirrhotic status of Child Pugh class A or B7
* Eastern Cooperative Oncology Group performance status 0 or 1
* single or sum of multiple tumor ≤ 5 cm
* HCC with 3 cm apart from gastrointestinal tract
* The volume of uninvolved must be at least 700 ml
* Incomplete response after trans-arterial chemo-embolization of 1-5
* A single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sessions of stereotactic body radiation therapy (SBRT)
* No evidence of an uncontrolled lesion at any other site
* No evidence of complications of liver cirrhosis
* No evidence of uncontrolled inter-current illness
* Patient or guardian must be able to provide verbal and written informed consent

Exclusion Criteria:

* Patient with previous history of abdominal radiation
* Direct invasion to esophagus, stomach or colon by HCC
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO

The goal of this study is to determine the effectiveness of a direct-to-provider virtual education program ("AF and EKG Interpretation Project ECHO") for primary care providers who manage patients with atrial fibrillation (AF). The main questions this study aims to answer are:

1. Will participants have improvement in knowledge and confidence in managing patients with atrial fibrillation after program completion?
2. Will quality and performance metrics improve at the patient level for program participants?

Participants will be asked to:

* Participate in 12 hours of virtual education sessions over twelve weeks via Zoom.
* Complete a knowledge and confidence assessment online before the program starts and after its completion.


Eligibility Criteria:
Inclusion Criteria:

* Primary care provider (Physician, Nurse Practitioner, Physician Assistant) with primary practice in the state of North Carolina
* Care for adult population

Exclusion Criteria:

* None
Correlating Brain Tissue Oxygen and Regional Cerebral Oximetry

Controversy surrounds the use of regional cerebral oximetry (rSO2) as a measure of true cerebral oxygenation because of extracranial signal contamination and unmeasured confounding of cerebral a:v ratio. The measurement of brain tissue oxygen (PbrO2) has been used in routine neurosurgery and has been shown to reliably demonstrate cerebral hypoxia following severe head injury. It is the most direct measure of cerebral oxygenation. Here, we test the hypothesis that there is a correlation between PbrO2 and rSO2 under conditions of varying inspired oxygen fraction and the varying partial pressure of carbon dioxide in arterial blood in uninjured, normal human brain.

Patients who are scheduled for elective removal of secondary cerebral metastases under general anesthesia will be recruited following written informed consent obtained by a study team member during their preoperative evaluation. BIS and rSO2 optodes will be applied, before induction of anesthesia, by a single researcher on both sides of the patient's forehead, as recommended by the manufacturer. General anesthesia will be maintained by total intravenous anesthesia (TIVA) with a combination of propofol (80-150 mcg/kg/min) and remifentanil (0.05-0.1 mcg/kg/min) targeted to a Bispectral Index range 40-60 (BIS; Covidien, Boulder, CO). Following craniotomy, the LICOX probe will be placed under direct vision into an area of normal brain within the tumor excision canal by the attending neurosurgeon. During a pause in surgery FIO2 and minute ventilation will be sequentially adjusted to achieve the following pairs of ventilation set points: 1) FIO2 0.3 and paCO2 30mmHg, 2) FIO2 1.0 and paCO2 40mmHg. After ≥5 minutes at each set point FIO2, PaCO2, rSO2 and PbrO2 will be recorded as a "snap-shot".

A sample size of 15 achieves an 80% power with a one-sided type I error of 5% to detect a positive correlation of 0.6 (from the null hypothesis of no correlation) between changes in PbrO2 and changes in rSO2 subsequent on alterations made in ventilation strategy. Correlation will be measured using Pearson's Correlation. P values \< 0.05 will be considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for elective removal of secondary cerebral metastases under general anesthesia.

Exclusion Criteria:

* Patients will be excluded if they refuse to give consent, have evidence of elevated intracranial pressure on preoperative CT scan, have coagulopathy, are taking therapeutic agents known to increase bleeding risk, have a history of cardiovascular disease, cerebrovascular disease, suffer from respiratory failure, or are not fluent English speakers.
Oropharyngeal Vs Intravenous Lidocaine Effects on Optic Nerve Sheath Diameter After Intubation

This study aims to evaluate the effects of pre-intubation oropharyngeal topical lidocaine on optic nerve sheath diameter (ONSD) post-endotracheal intubation. The study will measure the ONSD using ultrasonography before intubation, and at 1, 5, and 10 minutes post-intubation. The results will be compared between patients receiving %10 lidocaine topically and %2 intravenous lidocaine.

Increased intracranial pressure (ICP) is a critical condition that requires early and accurate assessment. Traditional invasive ICP monitoring techniques, such as lumbar puncture and intracranial pressure monitoring devices, carry significant risks. Optic nerve sheath diameter (ONSD) measurement via ultrasonography is a non-invasive method that reflects increased ICP.

Patients will be divided into two groups: Group A will receive %10 topical oropharyngeal lidocaine, and Group B will receive %2 intravenous lidocaine. The primary aim of the study is to evaluate the impact of lidocaine on ONSD at 1, 5, and 10 minutes post-intubation and to compare the effects on the two groups.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I or II
* Age 18-65 years
* BMI 18-30
* No history or expected difficult intubation
* No glaucoma or ocular pathology
* No intracranial pressure increase

Exclusion Criteria:

* ASA class III and above
* Obesity (BMI \> 30)
* Difficult intubation history or risk
* Glaucoma or other ophthalmic pathology
* History of intracranial pressure increase or prior ophthalmic/intracranial surgery
* Preoperative sedation
* Active malignancy or ongoing radiotherapy/chemotherapy
Induced Pluripotent Stem Cells for the Development of Novel Drug Therapies for Inborn Errors of Metabolism (iPSC-IEM)

Human induced pluripotent stem cells (iPSCs), are reprogrammed from somatic cells that can self-renew indefinitely and produce different types of cells. They provide human model cell lines for orphan drug development. It is the goal of this study to define new cellular disease models for Inborn Erors of Metabolism, as enabling tools for both drug discovery and development.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent is obtained from the participant or from the parent/ legal guardian
* The participant is aged between 2 months and 50 years
* The diagnosis of an Inborn Error of Metabolism (IEM) is genetically confirmed by Centogene
* The participant is a first-degree or a second-degree relative of an individual with Inborn Error of Metabolism (IEM) genetically confirmed by Centogene

Exclusion Criteria:

* Inability to provide informed consent
* The participant is younger than 2 months or older than 50 years
* The diagnosis of an Inborn Error of Metabolism (IEM) is not genetically confirmed by Centogene and
* The participant is not a first-degree or a seconddegree relative of an individual with Inborn Error of Metabolism (IEM) genetically confirmed by Centogene
* Previously enrolled in the study
Detection of Circulating Therapeutic Monoclonal Antibodies in Biological Samples of Gynecological Cancer Patients.

Quantification of anti PD-1 mAbs in cancer patients is extremely important to monitor pharmacokinetics and effectiveness of immunotherapy. To detect the ICI mAbs in patients' blood plasma samples, we select three anti PD-1 mAbs (cemiplimab, dostarlimab and pembrolizumab) as prognostic biomarkers which will be quantified using different biochemical/analytical assays.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of gynecological malignancy;
* Patients currently undergoing or scheduled to undergo immunotherapy as part of their treatment regimen;
* Age \> 18 years;
* Patients who are able and willing to provide written informed consent to participate in the study.
* Availability of biological samples.

Exclusion Criteria:

* Patients receiving concurrent treatment with other investigational drugs or therapies that may interfere with immunotherapy.
* Presence of significant comorbidities or other medical conditions that, in the opinion of the investigator, would interfere with study participation or interpretation of results (e.g., severe autoimmune diseases, uncontrolled infections);
* Pregnant or breastfeeding women;
* Patients who have received prior monoclonal antibody therapy that could affect the study results;
* Patients who are unable or unwilling to comply with the study procedures and follow-up requirements;
* Brain metastases;
* History of other malignancies within the last 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Preventive Home Visits for Healthy Pensioners- a Randomized Controlled Trial

To investigate whether preventive home visits for healthy persons 75+, made by professional health workers, can change the pattern of care utilization and if the quality of life can improve. The hypothesis is that care utilisation will reduce, mortality decrease and quality of life improve.

To investigate whether preventive home visits for healthy pensioners aged 75 years and over , can change the pattern of care utilization and if the quality of life can improve. To investigate if the results will last after the intervention has come to an end.

The concept of care utilization can in this trial be clarified as:

* use of primary health care
* use of elderly care including elderly houses
* mortality
* use of hospital care

The concept of quality of life will in this trial be measured with a number of self judgements.

The trial is performed as a randomized controlled trial in a small rural community in the north of Sweden. The staff is professional health workers and the visits is performed in the pensioners own homes.

Eligibility Criteria:
Inclusion Criteria:

* older than 75 year
* living in their own home
* living in Nordmaling, Sweeden

Exclusion Criteria:

* any need of elderly care, long term care or frequent health care
A Trial to De-prescribe Inappropriate Medications in the Community Dwelling Elderly

The objective of this trial is to test the beneficial effect of a pharmacist-initiated knowledge transfer intervention to both patients and prescribers on the discontinuation of inappropriate prescriptions, compared to usual care. The investigators hypothesize that the pharmacist-led intervention will reduce inappropriate prescriptions by at least 20% over 6-months compared to usual care. The intervention consists of simultaneously educating consumers and providing physicians with an evidence-based pharmaceutical opinion on inappropriate prescriptions.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 65 years of age and older (no upper age limit)
* Individuals for whom prescription claims derive from only one pharmacy identifier
* Chronic consumption (\> 3 month claims) of one of the target inappropriate prescriptions. (benzodiazepine/non benzodiazepine hypnotic, long-acting sulfonylurea oral hypoglycemic agents, anticholinergic agents (in the form of first-generation antihistamines) or Nonsteroidal anti-inflammatory drugs \[NSAIDs\] )
* Patients who are willing to participate in the study.

Exclusion Criteria:

* A probable diagnosis of dementia (persons without the capacity to provide informed consent), as determined by a) a prescription for memantine or a cholinesterase inhibitor; b) report from a caregiver or family-member; or c) a baseline screening score on the Folstein Mini-Mental State Exam \< 24
* Inability to understand and or communicate in English and/or French
* Patients living in a long-term care facility
* Concomitant use of any antipsychotic medication
Proteomic Study of Chuanhong Zhongfeng Capsule in the Treatment of ACI

Acute cerebral infarction is characterized by high disability rate and high recurrence rate, which poses a great threat to the life and health of the nation. Proteomics technology is a holistic and comprehensive understanding of disease mechanism, cell metabolism and other processes at the protein level. The correlation between acute cerebral infarction and proteomics has become a hot spot of clinical and basic research in recent years. Chuanhong Zhongfeng capsule was developed by Ren Jixue, a master of national medicine, and clinical studies have confirmed that it not only promotes the recovery of neurological function in patients with cerebral infarction, reduces the disability rate, but also improves the long-term prognosis, but its mechanism of action and its target are still unclear. In the present study, we applied 4D Label-free proteomics technology and PRM technology to study for the first time the mechanism of action and potential targets of Chuanhong Zhongfeng Capsule in the treatment of acute cerebral infarction, which will provide a direction for the study of traditional Chinese medicine compounding for the prevention and treatment of cerebral infarction.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for ischemic stroke in the Chinese Guidelines for Diagnosis and Treatment of Ischemic Stroke in the Acute Phase 2018.
2. Meet the diagnostic criteria for ischemic stroke in Chinese medicine.
3. Within 2 weeks of acute onset of ischemic stroke.
4. 4 ≤ NIHSS score \<15.
5. Age 40-80 years old. -

Exclusion Criteria:

1. Diagnosis of hemorrhage or other pathological brain disorders based on head CT or MRI;
2. Allergic individuals, those who are allergic to the test medication or the associated medicinal flavors or components thereof;
3. Age \<40 years or \>80 years;
4. Those with severe liver or kidney function impairment. -
Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students

In Spain, depression, anxiety, and stress are highly prevalent in the general population as well as in college students. In college students, Ramón Arbués et al. found a moderate prevalence of depression (18.4%), anxiety (23.6%) and stress (34.5%). It is essential to take responsibility for promoting health education, disease prevention, protection and care for young people.

Academic performance can be altered due to the stressful nature of exam situations, which can lead to increased anxiety and decrease expected performance, mainly due to effects such as decreased attention span, concentration and retention of information.

Modulation of vagal tone is a therapeutical strategy to heightened parasympathetic activity and withdrawal sympathetic activity. Auricular transcutaneous VNS (ATVNS) by which parasympathetic nerve system is modulated by means of the stimulation of the auricular branch of the vagus nerve that provides somatosensory innervation to the external ear.

It has been shown that there are different effective interventions to reduce the symptoms of stress, depression, anxiety and insomnia in university students, but they are based on psychological interventions or face-to-face and cognitive-behavioral therapeutic approach, so this study proposal incorporates noninvasive atrial stimulation as an alternative to traditional treatments, which apart from being cost-effective, is easy to apply, well tolerated and presumably can have beneficial effects in the short term.

In the present pilot study, authors propose to investigate the degree of depression, anxiety and stress on crucial dates of final exams of 1st year students of the Double Degree Physiotherapy - Physical Activity and Sport Sciences of the Health Department of the TecnoCampus.

Investigators will also evaluate the feasibility of a study to assess the efficacy of a non-pharmacological intervention, through a neuroreflex stimulation of vagal tone, with a non-invasive atrial stimulation protocol.

Personal pronouns have been removed

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Tecnocampus undergraduate students from Physical Therapy and Sports Science Double Degree of 1rst course.
* To sign the informed consent
* Understand Catalan or Spanish language
* With the intention to attend to the first call exams of the 2nd trimester.

Exclusion Criteria:

* Receiving pharmacological medication for anxiety or mental disorders
* Receiving psychological treatment
* Pregnancy or breastfeeding
* Participants with part-time enrolment
* With skin lesions in both auricula,
* Participating in another study
HEALEY ALS Platform Trial - Regimen C CNM-Au8

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Regimen C will evaluate the safety and efficacy of a single study drug, CNM-Au8, in participants with ALS.

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The HEALEY ALS Platform Trial Master Protocol is registered as NCT04297683.

Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen.

If a participant is randomized to Regimen C - CNM-Au8, the participant will complete a screening visit to assess additional Regimen C eligibility criteria. Once Regimen C eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active CNM-Au8 or matching placebo.

Regimen C will enroll by invitation, as participants may not choose to enroll in Regimen C. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen C.

For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683.

Eligibility Criteria:
Inclusion Criteria:

* No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).

Exclusion Criteria:

* The following exclusion criterion is in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).

  1. History of allergy to gold, gold salts, or colloidal gold preparations.