cyrilzakka/clinical-trials huggingface dataset:
Substudy of Protocol 2019-002498-80 - NCT04223050: Comparing Mortality for Low Vs High Peripheral Oxygen Saturation in COPD-patients with Acute Exacerbation (O2flow-COPD)

As protocol NCT04223050. This substudy furthermore investigates the role of oxidative stress in the administration of oxygen in COPD patients.

Studies have shown that oxidative stress plays a critical role in the pathogenesis of COPD and its comorbidities. Oxidative stress refers to a state in which the activity of oxidants (e.g. reactive oxygen species (ROS)) outweighs that of antioxidants. ROS can be introduced exogenously by for example cigarette smoke and atmospheric pollution, but is also produced endogenously as a byproduct of ATP production in mitochondria or from immune cells during oxidative burst. When high fractions of inspired oxygen are administered, excess O2 can lead to formation of additional ROS, which depletes antioxidants and induces an inflammation with leukocyte-derived inflammatory mediators migrating to the site of injury. In turn, this causes cellular hypertrophy, increased surfactant secretion, and cellular influx of monocytes and mast cells. During the final, fibrotic phase of oxygen toxicity, irreversible, persistent destruction of the pulmonary lining have occurred with collagen disposition, thickening of pulmonary interstitial space, and fibrosis.

This substudy therefore aim to investigate the relation between oxygen therapy in COPD patients admitted with acute exacerbation, oxidative stress, and mortality.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* ability to give informed consent
* previously diagnosed COPD (either confirmed diagnosis at prior hospital - contact or from their general practitioner or confirmed diagnosis by the treating physician in the emergency department (verified by use of relevant medication))
* admitted with acute exacerbation (acute and worsened shortness of breath) of COPD
* requiring oxygen treatment

Exclusion Criteria:

* Instability at arrival requiring immediate lifesaving treatment, e.g. intubation or non-invasive ventilation, within the first 30 minutes
* Expected total length of stay in hospital \< 12 hours
* Planned transfer to another hospital within 12 hours
* Unwilling to have repeated arterial blood gas analyses within the first 12 hours
* Patients judged terminal by treating physician in the emergency department
* Non-residents of the particular country
* Expected impossible follow-up
* Fertile women (\<50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
* Prior participation in the study
Blood Pressure Management in the Care Home Population

The UK care home population is projected to increase significantly over the coming decades. A high proportion of individuals in a care home have multiple long-term conditions and take large amounts of prescribed medication. This means they are routinely excluded from research studies and so there is little evidence on which to base treatment of long-term conditions such as high blood pressure. Furthermore, given that 1 in 4 people admitted into a care home die within 1 year, the benefit of treating high blood pressure to reduce the risk of heart attack or stroke must be balanced with the need to optimise quality of life. The aim of this study is to describe the health and social characteristics of the UK care home population with a particular focus on the management of blood pressure in the population. It is hoped that the findings of this study will help inform future research into the management of chronic conditions in care home residents.

The investigators will use the connected Bradford dataset to examine UK electronic health records to describe the UK care home population and management of hypertension in this population. The sample will include all adults aged 65 and over who have been admitted into a care home between January 2016 and December 2019. The investigators will extract data at the time of care home admission including age, sex, ethnicity, coded diagnosis of hypertension, indices of frailty and risk of falls as well as comorbidities relevant to cardiovascular risk and falls risk. Analysis will include looking at the prevalence of hypertension amongst the care home population, describing treatment patterns (i.e. number and type of prescribed anti-hypertensive medications, frequency of blood pressure monitoring) and the proportion of patients with blood pressure controlled according to National Institute of Health and Care Excellence (NICE) guidelines. The investigators will also look to establish whether there are any changes in the number and type of prescribed antihypertensive medication before and after admission to a care home (i.e. intensification of pharmacological therapy or deprescribing) and whether this differs amongst different subgroups of populations including patients with terminal illness and stroke diagnosis. The investigators will also estimate frequency of falls in the year following care home admission.

Eligibility Criteria:
Inclusion Criteria:

* registered to a GP practice contributing to the Connected Bradford dataset at the point of admission
* a recorded length of stay in a care home of longer than six weeks
* recorded social care entry for nursing or residential care in the Bradford council social care data.

Exclusion Criteria:

* no exclusion criteria applied to keep the sample representative of the real-world care home population.
Population Pharmacokinetic Study Based on Quantitative Pharmacology in Patients With Lenalidomide

This is a non-intervention, prospective, open-label and observational clinical trial. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study was to establish a population pharmacokinetic(PPK) model of lenalidomide and explore factors associated with the adverse events of lenalidomide from a pharmacokinetic(PK) perspective.

Studies have found that there is significant interpatient variability in the plasma concentration of lenalidomide, and the PK parameters of lenalidomide do not affect its efficacy but may be correlated with its toxicity. Therefore, the investigators plan to conduct a PPK study on lenalidomide to identify factors contributing to interpatient PK differences, thus refining regimens to mitigate its adverse reactions, in the hope of optimizing the clinical application of lenalidomide. At least 50 patients are planned to be included. It should be noted that the study does not interfere with the patients' treatment plans. Except for the discomfort during blood sampling, patients will not be exposed to any risks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are above the age of 18
* Patients who receive lenalidomide treatment

Exclusion Criteria:

* Patients have received other investigational systemic drugs
* The clinical data are deemed insufficient
* There appear other factors that rendered them ineligible.
RELAXaHEAD for Headache Patients (Phase I)

The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of headaches. While there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in an earlier epilepsy study and beta tested with headache specialist and migraine patient input. It also is an electric headache diary. This 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAX for use with headache patients. One arm will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual care (MUC) group (this group receives standard of care and uses the electronic daily symptom reporting diary). The goals are to assess the feasibility and adherence of the RELAX intervention in persons with headache (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache related outcome measures (Aim 2).


Eligibility Criteria:
Inclusion Criteria:

* Meets migraine criteria based on International Classification of Headache Disorders (ICHD) 3 beta (based on questions in RedCap
* 4 or more headache days per month

Exclusion Criteria:

* Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy for Migraine in the past year
* Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy
* Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
* Opioid or barbiturate use 10+ days a month
* Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
* Not having a smartphone
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel

The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.


Eligibility Criteria:
Inclusion Criteria:

* Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria
* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)
* Deemed medically fit and stable to receive the product per the investigator's evaluation
* Repeat leukapheresis is not feasible per the investigator's assessment
* Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release
* In the investigator's opinion, there is no satisfactory alternative therapy available to the individual

Exclusion Criteria:

* History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel
* Uncontrolled active infection or inflammation per physician assessment
* Primary central nervous system lymphoma
10-week Yoga Practice Effect on Cognitive and Motor Function in Older Adults

Thirty-three healthy elderly people, who were classified into two age groups, participated in this study. All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing. In the experimental group, participants (n = 18) had to participate in 10 weeks of yoga classes. In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.

Experimental measurements: Brunel, PSS-14 and HAD questionnaires


Eligibility Criteria:
Inclusion Criteria:

* age, from 60 years old
* a statement by a local family physician about general good physical health
* never tired to practice yoga before

Exclusion Criteria:

* cardiovascular diseases
* musculoskeletal system diseases (osteoporosis, osteochondrosis, hernias)
* neurodegenerative diseases
* oncological diseases
* glaucoma
* injuries and surgeries in last 3 years
Efficacy of Seprapack Sinus Dressing Versus No Dressing in the Prevention of Intranasal Adhesions Following Sinus Surgery

The purpose of this study is to investigate if the space occupying effect of Seprapack will lead to a reduction in post operative adhesions and more healing of the sinus cavity when compared to the use of no packing material.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* requiring bilateral endoscopic ethmoidectomy (anterior or posterior)
* intact middle turbinates
* willing to return for all follow-up visits
* signed written informed consent

Exclusion Criteria:

* patients with craniofacial abnormalities (e.g. cleft palate)
* patients without intact middle turbinates
* patients on long-term oral steroids or other chemotherapeutic agents that might delay healing. Short-term pulse steroid therapy and topical steroids are acceptable
* patients with inflammatory conditions, other than chronic sinusitis or nasal polyposis, including but not limited to sarcoidosis, rhinitis, ozena, Wegner's granulomatosis, nasal malignancy, recreational drug abuse
* patients with cystic fibrosis
* women that are pregnant or women of childbearing age potential who are not practicing an acceptable method of birth control
* patients with bleeding disorders or who are receiving anticoagulants
* patients that may require a Lothrop procedure
Drug Interaction Study to Assess the Effect of Co-Administered Miravirsen and Telaprevir in Healthy Subjects

The purpose of this study is to assess the safety, tolerability, and affect on blood levels of miravirsen and telaprevir when administered together.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Weight ≤ 85 kg
* Females of non-childbearing potential (postmenopausal or surgically sterile) or males who are surgically sterile or using an acceptable form of birth control

Exclusion Criteria:

* Current, clinically significant illness or medical condition
Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury

This study investigates the effect of daily mobile app reminders to exercise in conjunction with standard physical therapy on adherence to exercise and recovery after whiplash injury of the neck. Participants will be divided into two groups, the experimental (Arm A) and control group (Arm B). Both groups will complete a standard physical therapy program under the supervision of a physiotherapist. Both groups will get illustrated home exercise programs and will be advised to continue exercising at home. In addition, the experimental group will receive one daily push notification via a mobile app to perform a daily exercise at home.

Whiplash injury of the neck is the most common injury resulting from a traffic accident. Although most people recover completely, 30 to 50% of them develop chronic neck pain and disability. Also, long sick leaves and lower productivity at work create a burden on the healthcare system.

Conservative treatment includes exercise, physical therapy modalities such as transcutaneous electric nerve stimulation (TENS), and ultrasound therapy. Although conservative treatment is recommended, the evidence of its efficacy remains unclear. Education after the injury can be beneficial in lowering anxiety and pain.

Many studies are investigating the usefulness of mobile apps in various medical conditions. In rehabilitation medicine, apps are used to increase knowledge about different conditions, as a measurement tool, and as an intervention to increase adherence to the prescribed therapy.

After the enrollment in the study, participants will complete the two-part physical therapy program (2x10 sessions, 5times/day, 3-week break in between) under the supervision of a physiotherapist at the outpatient clinic. After completing the program, the participants will get a home exercise program, group A via mobile app, and group B via papers, and will be encouraged to continue exercising at home. Also, group A will download a mobile app, "WIapp," that was developed for this purpose and will receive one daily push notification as a reminder to perform a daily exercise at home.

The investigators hypothesize that daily reminding to exercise via mobile app can increase adherence to prescribed therapy and overall increase recovery.

Eligibility Criteria:
Inclusion Criteria:

* patients who sustained whiplash injury of the neck in a car accident as drivers or co-drivers
* diagnosed with a whiplash injury of the neck by physical and rehabilitation medicine specialist within 3 months
* Neck Disability Index (NDI) score higher than 5 (10%)
* possession of and ability to use a smartphone and a mobile app
* age ≥ 18 years
* signed written informed consent

Exclusion Criteria:

* bone fracture sustained in the accident
* spinal cord injury
* accident in any other type of vehicle other than car
* treatment of malignant disease in the last 5 years
* expected non-compliance (not possible to use a smartphone because of severe mental or physical impairment)
Safety and Efficacy Study of Duet TRS

The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be 18-65 years of age.
* The patient has a BMI of 40-60 kg/m2 or 35-40 kg/m2 with comorbidities
* The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.

Exclusion Criteria:

* The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc)
* The patient is pregnant.
* The patient has an active, or history of, infection at the operative site.
* The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent.
* Patient has an abdominal ventral hernia
* The patient has a history of liver disease
* The patient has a history of drug or alcohol abuse
* The patient has a history of venous thrombosis or pulmonary embolism
* The patient has a history of coagulopathy
Biomarker Changes and Anxiolytic Effects-Phase 2

This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava. The investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in adults with generalized anxiety disorder.

This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava, a natural dietary supplement. The investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in adults with generalized anxiety disorder. Clinical measures of anxiety, blood, and urine will be obtained. Biomarkers of interest include PRKACA, cortisol, urinary TCE, and NA5HT. Participants will be assessed pre- and post-treatment. The participants will also be followed for 12 weeks after the end of treatment to identify any potential rare adverse events, particularly liver toxicity, that appear in a delayed fashion.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-50 who meet Diagnostic Statistical Manual (DSM)-5 criteria for GAD as the primary psychiatric diagnosis
* No more than one failed therapeutic trial of an FDA approved medication for the treatment of GAD
* Score of\>14 on the Hamilton Anxiety Rating Scale at both screening and baseline
* At least a 4 (moderate) on the Clinical Global Impressions Severity Scale at both screening and baseline
* Females of potential childbearing status must use adequate contraceptive precautions.

Exclusion Criteria:

* Unwilling/unable/unsafe to stop psychotropic medications (if on any) for the duration of the study
* Inability to refrain from acetaminophen, alcohol or other potentially hepatotoxic substances
* History of liver disease or current liver disease or clinically significant elevation in serum liver chemistries
* Unstable medical or neurological condition
* Positive urine drug screen for substances of abuse
* Active substance abuse/dependence
* Lifetime history of a psychotic disorder, bipolar disorder, PTSD or Obsessive Compulsive Disorder
* Any significant risk for self-harm or suicidality as determined by the principal investigator or suicide attempt within the last 6 months
* Psychotherapy newly instituted during the 6 weeks leading up to enrollment in the study. Subjects established in psychotherapy without change during the course of the study may participate
* Montgomery-Asberg Depression Rating Scale (MADRS) \> 17 (moderate or severe depressive symptoms)
Early Exposure of Medical Students to Night Shifts: Impact on Well-being and Anxiety

This is an interventional study assessing the impact of 'shadowing night shifts' early during medical school, on the wellbeing and level of anxiety of a students during their first official night shifts.


Eligibility Criteria:
Inclusion Criteria:

* Students of the class of 2021 at the Faculty of Medicine of Saint Joseph University in their fifth year (Med 2).

Exclusion Criteria:

* student who has already been on call during internships in Lebanon or abroad, as well as students in other medical years.
Early Diagnosis and Treatment Standardization of Delirium

1. Observe the characteristics of delirium patients, searching for early diagnostic methods or finding risk factors
2. Design a guideline for delirium, diagnosis or treatment

The study is consisted of two parts; First, observational study of gastric cancer patients admitted to hospital, diagnosing the presence of delirium or subsyndromal delirium and collecting patient data, including assessment, self-report surveys, and electronic medical records.

Second, Designing a guideline for treating delirium patients in Korea using the study data and reviewing other studies, guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Curable malignant gastric cancer

Exclusion Criteria:

* Gastrointestinal stromal tumor
* Uncurable cancer
Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects

The purpose of this study is to evaluate the influence of HRS9531 injection on pharmacokinetics of metformin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
2. Male subjects aged 18-45 years on the date of signing informed consent (inclusive);
3. Body weight ≥50 kg, body mass index (BMI) within the range of 20.0-30.0 kg/m2 (inclusive);
4. HbA1c\<6.0%.

Exclusion Criteria:

1. Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study;
2. Obvious gastric emptying abnormalities or gastrointestinal diseases in the past, or had undergone gastrointestinal surgery (except for gastrointestinal polyps, appendix, and haemorrhoidectomy)
3. Past history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2), a history of pancreatitis or symptomatic gallbladder stones;
4. Surgery within 6 months prior to dosing, planned to undergo surgery during the study period;
5. Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;
6. Blood donation history or blood loss ≥400 mL within 3 months or ≥200 mL within 1 month before dosing, or received blood transfusion within 3 months before dosing;
7. Allergic constitution includes severe drug allergy or history of drug allergy;
8. Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
9. Abnormal laboratory test results or abnormal examinations considered unsuitable to participate in this trial;
10. History of hypoglycaemia;
11. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.