cyrilzakka/clinical-trials huggingface dataset:
Medical Office Intervention for Adolescent Drug Use - Attention Study Supplement

This study will use the CCPT II to assess attention in 12-21 year olds enrolled in a randomized controlled trial of a brief behavioral treatment for substance abuse.

This study will describe at baseline levels of attention using a well validated instrument (Connors Continuous Performance Test II) and explore the association between attention levels and substance use. The primary study hypothesis is that lower initial levels of substance use (as measured by percent days abstinent) will be associated with higher attention levels. We envision that this data will inform a better understanding of how attention may modify treatment response.

Research among adolescents with substance use problems presents unique challenges to investigators. Issues with recruitment, confidentiality, and follow-up have been cited as common limitations to research in this area. One likely contributor to decreased treatment persistence and follow-up is the limited ability to sustain attention that many adolescents, especially those with substance problems, may manifest. (Taper, 2002) Thus, assessing attention before beginning substance abuse treatment has the potential not only to inform the science of adolescent addiction medicine, but also to guide the development of therapies to specifically address attention deficits among adolescent substance users. Adolescent outpatients being treated for substance problems have not been systematically studied for clinical or subclinical attention levels.

The primary aims this study are as follows:

1. To test the feasibility of administering the Connors Continuous Performance Test II (CCPT II), a well validated measure of attention, to a sample of 12-21 year old patients receiving treatment for substance abuse.
2. To obtain baseline descriptive statistics on the CCPT II in a previously understudied group of young patients receiving treatment for substance abuse.
3. To estimate the magnitude of the association between substance use and levels of attention at baseline before treatment.
4. To explore the degree to which attention may affect response to substance abuse treatment in general and specifically motivational interviewing.

Eligibility Criteria:
Inclusion Criteria:

* CRAFFT score of 1 or more
* Have used cannabis, alcohol or another drug on at least two occasions during the 30 days preceding their visit
* Can read and understand English

Exclusion Criteria:

* Require immediate hospitalization or referral to residential substance abuse treatment
* Will not be available to complete the study assessments over the next 9 months.
Do Probiotics Reduce The Risk Of Severe Necrotising Enterocolitis (NEC) In Infants Born Before 32 Weeks Gestation?

Necrotising enterocolitis (NEC) is one of the leading causes of mortality and morbidity in very preterm infants. This study aims to determine whether NEC rates are different between infants who receive probiotics versus infants who do not receive probiotics. The study has a retrospective cohort design and will utilise routinely collected data from the UK National Neonatal Research Database (NNRD). The cohort will comprise all infants born before 32 weeks gestation and cared for in neonatal units in England and Wales between 2016 and 2022. A propensity score matched approach will be used to conduct two comparisons: i) the risk of necrotising enterocolitis (NEC) between who do and those who do not receive probiotics in the first 14 days of life ii) the risk of NEC between babies who receive the two most common probiotic products used in UK units, (Labinic and Proprems).


Eligibility Criteria:
Inclusion Criteria:

* Eligible infants must have been born at less than 32 weeks gestation and be cared for in a English or Welsh unit which contributes data to the National Neonatal Research Database (this includes all NHS neonatal units in England and Wales).
* Infants born in the period January 1st, 2016, to December 31st, 2022 (7 years) will be included.

Exclusion Criteria:

* They have missing data for any of: gestational age at birth, birth weight, year of birth and date of death (for those that died).
* Their NNRD record does not include details of their first admission or begins after Day 3 of life.
* The absolute value of their recorded birthweight for gestational age z score exceeds 4 or is missing.
* They die in the first two postnatal days of life.
* They have a major congenital abnormality
Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis

The purpose of this study is to evaluate efficacy, safety and tolerability of secukinumab in Chinese patients with active nr-axSpA. Treatment difference of secukinumab 150mg vs. placebo in Chinese nr-axSpA patients in terms of ASAS 40 response rate as well as safety profile will be provided by the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-nursing female patients at least 18 years of age
* Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria
* Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
* Active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index \>=4 cm
* Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline
* Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline
* Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response
* Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response

Exclusion Criteria:

* Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally
* Inability or unwillingness to undergo MRI
* Chest X-ray or MRI with evidence of ongoing infectious or malignant process
* Patients taking high potency opioid analgesics
* Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.
Analysis of the Fixation of the Proximal Biceps Tendon

Ten randomly selected patients that have undergone an open proximal biceps tendon tenodesis with an EndoButton for bicipital pathology with Christopher Schmidt, MD, will be asked to participate in the study. The study will assess the tendon healing to bone through magnetic resonance imaging (MRI). Individuals will also be asked to fill a visual analog scale (VAS) pain and disability of the arm shoulder and hand (DASH) assessment tools. The variables for our objective will include age, hand dominance, gender and chronicity of symptoms prior to surgery, and other related surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Undergone open subpectoral proximal biceps tenodesis with the EndoButton

Exclusion Criteria:

* No history of surgery or disability in the contra-lateral extremity
* Not a member of a legally restricted group or protected population
* No prior surgery or further surgery on the extremity of interest
* No condition preventing the individual from undergoing a MRI
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)

Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)

A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis: 5-year Results From the K0202 Extension Study

Eligibility Criteria:
Inclusion Criteria:

1. Subject who enrolled K0202 Clinical Trial(parent study) and has been given more than one medication.
2. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. Any other condition which the investigator judges would make patient unsuitable for study participation
A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults

This is a Phase 1, open-label, fixed-sequence, 3-period study to evaluate the effect of multiple doses of itraconazole and a single dose of cyclosporine on the single-dose PK of PF-07081532 in otherwise healthy, overweight or obese, adult female and male participants.

The 3 study periods will be conducted consecutively without a break.


Eligibility Criteria:
Inclusion Criteria:

1. Otherwise healthy female and male participants must be at least 18 years of age at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurement, standard 12-lead ECG and clinical laboratory tests).
2. BMI: ≥25.0 kg/m2 at Screening.
3. Stable body weight, defined as \<5 kg change (per participant report) for 90 days before Screening.

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
2. Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at Screening.
3. Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin)
4. Personal or family history of MTC or MEN2, or study participants with suspected MTC per the investigator's judgment.
5. Acute pancreatitis, a history of repeated episodes of acute pancreatitis, or history of chronic pancreatitis.
6. Symptomatic gallbladder disease.
7. Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders (eg, Cushing Syndrome).
8. History of depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years from screening.
9. Known medical history of active liver disease, including chronic hepatitis B or C, primary biliary cirrhosis, alcoholic liver disease, primary sclerosing cholangitis, autoimmune hepatitis, overlap syndrome, or prior known drug-induced liver injury.
10. History of HIV infection.
11. Any lifetime history of a suicide attempt.
12. Use of prohibited medications
13. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
14. Standard 12-lead ECG that demonstrates clinically relevant abnormalities that mayaffect participant safety or interpretation of study result.
15. Participants with clinical laboratory test abnormalities at Screening. -
Efficiency of Function-oriented Taping Application in Low Back Pain Patients

Purpose of this study is to determine the efficiency of functional tape application to patients with acute or subacute low back pain. 40 patients with acute-subacute low back pain were divided into two groups: control and experimental group. To control group, McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments were applied. To experimental group, functional taping were applied in addition of these treatments. Range of Motion (ROM), Visual Analogue Scale (VAS), Tampa Scale of Kinesiophobia (TSK) and The Oswestry Disability Index (ODI) were evaluated preand post-treatment and datas were analyzed with statistical methods. In analysis; p value was accepted p\<0,05 for t test and Mann Whitney U test process. In the measurements that compared the improvement of both groups, based on pre- and post-treatment evaluations; improvement in the experimental group was significantly higher in all of these parameters of ROM, VAS, TSK and ODI than in the control group (p\<0,05). The use of functional rigid taping in patients with acute and subacute low back pain provided a statistically significant improvement in all measured values of patients and provide better results than the control group. However, there is a need for comparative new studies in order to measure the effectiveness of rigid taping in a more accurate way.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 20 and 65
* Being literate in Turkish
* Having lower back pain for less than 3 months
* Informed Consent Form for taping application to have been signed

Exclusion Criteria:

* Allergic reaction on the skin
* Hypertension, Type 2 diabetes mellitus (DM) and Presence of accompanying systemic disease other than hypercholesterolemia
* Not being able to communicate
* Using corsets and similar supports
* Having a body mass index \> 30
* Use of antidepressant and myorelexan medication
Single and Multiple Dose Study in Japanese Subjects

This study will explore the safety, tolerability, and serum uric acid lowering effect of RDEA3170 in healthy Japanese males to allow comparison with the Western population.

While clinical studies of RDEA3170 to date have been limited to a Western population, it is recognized that both intrinsic and extrinsic factors may impact the PK, PD, safety, and dose response in different ethnic populations. The purpose of this study is to explore the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of single and multiple doses of RDEA3170 in healthy Japanese males, and to allow comparison of these parameters with the Western population.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand the study procedures and the risks involved, and willing to provide written informed consent before the first study related activity.
* Healthy adult male subject born in Japan.
* Subject has parents and grandparents who are Japanese.
* Subject is in possession of a valid Japanese passport.
* All laboratory parameters should be within normal limits or considered not clinically significant by the investigator.
* Screening serum urate level ≥ 4.5 mg/dL.
* Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
* Subject has a normal or clinically acceptable physical examination.
* Subject has no clinically relevant abnormalities in blood pressure, heart rate, and body temperature, per the Investigator's judgment.

Exclusion Criteria:

* Positive serology to human immunodeficiency virus (HIV-1 or HIV-2).
* Positive test for active hepatitis B or hepatitis C infection.
* History or suspicion of kidney stones.
* Undergone major surgery within 3 months prior to Day 1.
* Exposed to an investigational drug (or a medical device) within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to Day 1 or is currently participating in another study of an investigational drug (or medical device).
* Prior exposure to RDEA3170.
Protective Effects of Exercise Training

Rationale. Sleep loss is a risk factor for cardiovascular events mediated through endothelial dysfunction.

Objective. To determine if 7 weeks of exercise training can limit cardiovascular dysfunction induced by total sleep deprivation (TSD) in healthy young men.

Methods: 16 subjects will be examined during 40-h TSD, both before and after 7 weeks of interval exercise training. Vasodilatation induced by ACh, insulin and heat (42°C) as well as pulse wave velocity (PWV), blood pressure and heart rate (HR) will be assessed at baseline, during TSD, and after one night of sleep recovery. Biomarkers of endothelial activation, inflammation, and hormones will bemeasured from morning blood samples at 07:00


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Men
* 18 - 35 yrs

Exclusion Criteria:

* Consumming 400 mg of caffeine per day,
* Body mass index (BMI) greater than 30 kg/m²,
* Taking medication.
* Excessive daytime somnolence (Epworth Sleepiness Scale \>9)
* Sleep complaints (Pittsburgh Sleep Quality Index \>5)
* Inability to be considered as an intermediate chronotype on the Horne and Ostberg questionnaire (score \<31 or \>69)
* Traines subject (Ricci Gagnon questionnaire \>35)
Growth and Tolerance of Young Infants Fed Infant Formulas

This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.


Eligibility Criteria:
Inclusion Criteria:

* healthy infant
* full term
* birth weight \> 2490 g
* 0 to 8 days of age
* parent/physician agree to not use medications affecting tolerance/growth
* parent agrees to sole source feeding of study formula
* parent agrees to not use vitamin/mineral supplements
* parent has signed consent/HIPAA authorization

Exclusion Criteria:

* any maternal, fetal, or infant history affecting growth and tolerance
* participation in any other study not preapproved by Abbott
TEA, ESB and Paravertebral Block During Single-lung Ventilation for Lung Resection

Thoracotomy operations are known to be painful surgical procedures, so providing effective intraoperative and postoperative analgesia is so important for all anaesthesiologists. Ineffective pain management interferes with deep breathing, coughing, and remobilization resulting in atelectasis and pneumonia.

Ultrasound-guided ESP block is a myofascial plane block that provides analgesia for thoracic or abdominal segmental innervation depending on the level of the injection site. Thoracic epidural analgesia (TEA) is considered the gold standard analgesic technique for thoracic surgeries. But the invasiveness of this technique, the rare but serious neurologic complications and the failure rates up to 30% are the disadvantages of epidural analgesia

The aim of this study is to compare the effect of different blocks as TEA, erector spinae block or paravertebral block on improving peri-operative analgesia and post-operative outcome in pulmonary resection in adult patients.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 to 70 years old for elective lung resection. with American Society of Anesthesiology physical status (ASA-PS) I-III

Exclusion Criteria:

* Total pneumonectomy
* Hepatic or renal dysfunction.
* contraindications for epidural anesthesia as Coagulopathy and neurological and spinal deficits.
* emergency cases
Open Label, Extension Study of PRO044 in Duchenne Muscular Dystrophy (DMD)

The purpose of this study is to see whether PRO044 is safe and effective to use as medication for Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 44 in the DNA for the dystrophin protein.

A Phase II, open-label, extesion study. Following a Screening period of up to one month, subjects previously treated with PRO044, and eligible for enrolment in PRO044-CLIN-02, will be allocated to one of three groups to receive either 6 mg/kg or 9 mg/kg PRO044 weekly by IV infusion or 6 mg/kg weekly by SC injection for 48 weeks.

Safety and tolerability, pharmacokinetics (PK), pharmacodynamic (PD) and efficacy assessments will be conducted at regular intervals throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects previously treated with PRO044.
2. Continued use of glucocorticoids for a minimum of 60 days prior to study entry with a reasonable expectation that the subject will remain on steroids for the duration of the study. Changes to the dose regimen or cessation of glucocorticoids will be at the discretion of the Principle Investigator (PI) in consultation with the subject/parent and the Medical Monitor. If the subject is not on steroids, involvement in the study needs to be discussed with the medical monitor

Exclusion Criteria:

1. Current, or history of, liver or renal disease.
2. Acute illness within 4 weeks prior to the first dose of PRO044 (Week 1) which may interfere with the measurements.
3. Severe cardiac myopathy which in the opinion of the Investigator prohibits participation in this study
4. Need for daytime mechanical ventilation.
5. Screening aPTT above the upper limit of normal (ULN).
6. Screening platelet count below the lower limit of normal (LLN).
7. Use of anticoagulants, antithrombotics or antiplatelet agents.
8. Use of any investigational product within 6 months prior to the start of Screening for the study.
9. Current or history of drug and/or alcohol abuse.
Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study

Coronary angiography-derived FFR assessment (AngioQFA) is a novel technique for physiological lesion assessment based on 3-dimensional (3D) quantitative coronary angiography (QCA) and virtual hyperemic flow derived from contrast frame count without drug-induced hyperemia. The goal of this prospective, multicenter trial is to compare the diagnostic performance of AngioQFA with invasive FFR as the reference standard. The secondary purpose is to compare the diagnostic accuracies of the computational fluid dynamics (CFD)-based index of microcirculatory resistance (IMR) using wire-based IMR as the reference standard.


Eligibility Criteria:
Inclusion Criteria

* General Inclusion Criteria:

  1. Age ≥18 years.
  2. Coronary angiography is required for patients with suspected or confirmed coronary artery disease.
  3. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
* Angiographic Inclusion Criteria:

  1. Diameter stenosis of 30%-90% by visual estimate
  2. Reference vessel size ≥2 mm in stenotic segment by visual estimate

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded:

* General Exclusion Criteria:

  1. Subject has undergone CABG of the target vessel.
  2. Evidence of an acute myocardial infarction within one week prior to the intended procedure.
  3. Severe heart failure (NYHA≥III)
  4. Patients with other serious conditions not eligible for clinical trials, such as severe arrhythmia or tachycardia, sinus syndrome, asthma, severe chronic obstructive pulmonary disease.
  5. Serum creatinine level of \>150µmol / L.
  6. Subject has known allergy to iodinated contrast agents, adenosine, or ATP.
  7. Pregnant or breastfeeding.
  8. Repeated enrollment.
  9. Any other factors that the researchers consider not suitable for diagnostic intervention or FFR and IMR detection, such as the target vessel has collateral circulation, coronary spasm, the target vessel plaque rupture resulting in myocardial infarction, or other reasons deemed unsuitable for inclusion.
* Angiographic Exclusion Criteria:

  1. Myocardial bridge or coronary artery fistula on the study lesions.
  2. The target lesion ≥50% diameter stenosis in the left main coronary artery or ostial lesions less than 3 mm to the RCA.
  3. Low-quality angiography with poor contrast agent filling or inability to detect vascular boundaries due to various reasons, vascular overlap or severe distortion of the target vessel to fully expose the lesion location is not expected to be calculated.