cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Epiduo and Treatment Adherence of Adolescent Patients With Inflammatory Acne

The purpose of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy.

The objective of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy. This non-interventional trial will include a larger population of teenaged acne patients in order to establish the practical contribution of a new mini-questionnaire to the evaluation of adherence for the physician in the daily clinical practice in general and in young adults topically treated with Epiduo in particular. In addition safety and local tolerability profile of Epiduo are to be assessed under marketed conditions.

Eligibility Criteria:
Inclusion Criteria:

* The patient has been diagnosed with moderate inflammatory acne
* Topical monotherapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study
* The patient is aged between 12 and 20 years

Exclusion Criteria:

* Pregnancy or breastfeeding
* Hypersensitivity to the medication or any of the ingredients
* Other contraindications mentioned in the Epiduo SPC
E-Based Technology to Provide Decision Aid on Breast Reconstruction for Women With Breast Cance

Using decision aids has been demonstrated to support women to make treatment decision effectively. However, these studies focused on the decision of receiving breast conservative surgery or mastectomy, had short term follow-ups on decision satisfaction.The aims of this study were: Evaluate the effect of E-based \& personalized breast reconstruction surgery decision aid on women's decision satisfaction and mental health.

Randomized controlled trial will be used to examine the effect of E-based \& personalized breast reconstruction surgery decision aid on decision satisfaction, body image, anxiety and depression. Participants will be randomly assigned into either experimental or control groups with 88 women in each group. After completing the questionnaires at baseline, participants in the experimental group will be asked to receive a E-based \& personalized breast reconstruction surgery decision aid at clinic. Control group will only receive pamphlet and usual care. All participants will be followed up 1 week after consultation, and 1 month, 8 month and 12 month after surgery.

Eligibility Criteria:
Inclusion Criteria:

* age of at least 20 years or under 20 years but married
* females newly diagnosed with breast cancer who are candidates for mastectomy
* ability to read and speak Taiwanese or Mandarin

Exclusion Criteria:

* Women with cancer recurrence
* poor cognitive function
* diagnosed with psychiatric disease
Exploratory Study of Coronary Flow Reserve Measurements, a Non-Invasive Method for Coronary Function Measurements

The aim of this study is to investigate whether the non-invasive ultrasound method for assessment of coronary blood flow, transthoracic Doppler echocardiography-coronary flow reserve (TTDE-CFR), can be used to measure drug effects.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 45-75 years or females aged 60-75 years inclusive
* Carotid and/or femoral atherosclerotic plaque, as assessed by carotid ultrasound examination within the last 5 years
* Abnormal concentrations of lipids or lipoproteins in the blood
* Provision of signed informed consent

Exclusion Criteria:

* Treatment with statins or other lipid-lowering drugs, e.g. fibrates, nicotinic acid, cholesterol absorption inhibitor, within the last 6 months before randomisation
* Current smoking or snuff tobacco use
* Major CV event (myocardial infarction (MI), stroke/ transitory ischemic attack (TIA), Acute Coronary Syndrome (ACS), revascularisation) within the last 6 months before randomisation
* Symptomatic carotid stenosis, atrioventricular (AV) block, QT-prolongation, atrial fibrillation, sinus node disease (such as sick sinus syndrome or symptomatic bradycardia), chronic obstructive pulmonary disease (COPD) or asthma
Comparative Effects of Sciatic Nerve Flossing and Active Release Technique in Cyclists With Sciatica

Thus the aim of my study is to determine the comparative effects of sciatic nerve flossing and active release technique on pain, flexibility, and functionality in lower limbs of cyclists with sciatica.

This study investigates the comparative effects of Sciatic Nerve Flossing and Active Release Technique on pain, flexibility, and functionality in cyclists with sciatica. To compare the efficacy of Sciatic Nerve Flossing and Active Release Technique in reducing pain and improving functional performance in cyclists diagnosed with sciatica over a six-week period. A randomized clinical trial was conducted with 32 participants, aged 18 to 35, diagnosed with sciatica persisting for more than six weeks. Participants were randomly assigned to two groups: Group A received Sciatic Nerve Flossing, while Group B underwent Active Release Technique. Pain levels were measured using the Numeric Pain Rating Scale (NPRS), functional performance was assessed using the Lower Extremity Functional Score (LEFS), and flexibility was evaluated via the Sit and Reach Test.

Eligibility Criteria:
Inclusion Criteria

* Age between 18 to 30 years (16)
* Only male participants were included (15)
* Participates with Positive Passive Straight Leg Raise (PSLR) Test (13)
* Athletes with positive slump test (15)
* Symptoms more than 6 weeks (16)

Exclusion Criteria:

* Lower limb fracture(13)
* Musculoskeletal problems (radiculopathy, myopathy) (13, 14)
* Sciatica along with vascular disorders and diabetic neuropathy, sciatica due to tumor and fractures (15)
* Inflammatory arthritis (16)
* Previous surgical interventions on the lower limbs or spine (15)
* Neurological conditions affecting lower limb function (e.g., multiple sclerosis, spinal cord injuries) (13, 14)
* Patients currently undergoing physical therapy or other interventions for sciatica (15)
* Individuals with contraindications to physical activity or exercise due to health conditions (13, 14)
Trial to Evaluate Safety, Tolerability, and Parmacokinetics of ALN-TTR02 in Healthy Volunteer Subjects

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-TTR02 in healthy volunteer subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index must be between 18.0 kg/m2 and ≤ 31.5 kg/m2;
* Non-smokers for at least 3 months preceding screening;
* Females subjects must be of non-childbearing potential e.g., post-menopausal or pre-menopausal with surgical sterilization;
* Males agree to use appropriate contraception;
* Medical history must be verified by either a personal physician or medical practitioner as appropriate;
* Willing to give written informed consent and are willing to comply with the study requirements.

Exclusion Criteria:

* Known hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection
* Multiple drug allergies or know sensitivity to oligonucleotide
* History of drug abuse and/or alcohol abuse
* Receiving an investigational agent within 3 months prior to study drug administration
* Subjects with safety laboratory test results deemed clinical significant by the Investigator;
* Received prescription drugs within 4 weeks of first dosing
* Subjects who have donated more than 500 mL of blood within the 3 months prior to ALN-PCS02 or placebo administration;
* Subjects who have used prescription drugs within 4 weeks of first dosing
* Considered unfit for the study by the Principal Investigator
* Employee or family member of the sponsor or the clinical study site personnel
Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures

This cohort study investigates radiological and clinical outcome after screw osteosynthesis of radial head fractures with associated injuries (such as rupture of the interosseous membrane and collateral ligaments). Interpretation of radiographs 3 and 9 months post- surgery and patient surveys will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* screw osteosynthesis of radial head fractures

Exclusion Criteria:

* unable to give consent
* dementia
A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)

This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food on the bioavailability of oral aprepitant.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health
* Subject is a nonsmoker
* Subject is willing to comply with the study restrictions

Exclusion Criteria:

* Subject has a history of any illness that might confound the results of the study or might make participation in the study unsafe
* Subject has a history of stroke, seizures, or major neurological disorder
* Subject has a history of cancer
* Subject consumes more than two alcoholic drinks per day
* Subject consumes more than three caffeinated beverages daily
Utility Analysis of an Endoscopy Follow-up System

Although systems are in place to ensure results of tests are communicated to patients, there is currently no generalized accepted strategy to ensure that patients undergo recommended follow-up testing. When follow-up tests are recommended months to years into the future, there is a high likelihood that the test will either be delayed or not performed resulting in the potential for poor outcomes and litigation. For this reason, there is a clear need for systems to be developed which automatically trigger patient communication when the date of a recommended follow-up test is approaching. The investigators propose to design a protocol for ensuring that patients are reminded to schedule follow-up tests and that this communication is documented in the online medical record. This work will provide the foundation for the creation of systems that significantly improve patient care, and can be easily adapted for use in many clinical departments and institutions.

Aim 1. To use patient focus groups to help design a system for improving adherence to endoscopy follow up recommendations

Aim 2. To develop a prototype endoscopy follow up system and test the effectiveness of the system on a cohort of patients due for a surveillance colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* due for a repeat surveillance colonoscopy for follow up of polyps during the study time period

Exclusion Criteria:

* not due for a repeat surveillance colonoscopy for follow up of polyps during the study time period
Cognitive Training and Dual-task Ability

The first goal of this study is to examine the extent to which the inclusion of dual-task practice to standard balance rehabilitation results in greater benefits to dual-task ability. The second goal of this study is to examine the extent to which the addition of cognitive training following balance rehabilitation results in greater benefits to dual-task ability.

Historically, degradation of balance control in older adults has been attributed to impairments of the motor and/or sensory systems. As a result, therapy has focused on motor and sensory impairments. However, evidence suggests that an impaired ability to allocate attentional resources to balance during dual-task situations is a powerful predictor of falls. Despite this fact, few studies have examined whether interventions can improve older adults' dual-task ability. The goal of this study is to develop effective interventions to improve ability to allocate attention to balance and gait under dual-task conditions.

Older adults (n = 44) who have been referred to physical therapy (PT) for gait or balance impairments who have dual-task impairment will be randomized to receive either standard balance rehabilitation or balance rehabilitation with dual-task practice. Following PT, subjects will receive cognitive training (CT), either speed of processing or generalized cognitive training. Primary outcomes are ability to walk while performing four different cognitive tasks of varying difficulty. Assessment will occur at baseline, post-PT, post-CT.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include:
* \> 60 years of age
* documented balance or mobility problems
* dual-task impairment (timed up and go with subtraction task \> 15 s)

Exclusion Criteria:

* Exclusion criteria include:
* cognitive impairment (\> 2 errors on Short Portable Mental Status Questionnaire41)
* progressive medical issues that would impact mobility (e.g., Parkinson's disease).
Comparison of Blood Cardioplegia and Custodiol

Thru the last 20 years it has been a discussion witch solution that gives the best myocardial protection during cardiac arrest by heart operations.

* It has been a tendency that a blood based cardioplegia gives a better protection bye long ischemic times but it has not been possible too conclude in this matter.
* The investigators have two groups of cardioplegia, the blood based and, the crystalloid based cardioplegia.
* It has been done a lot of studies to see what kind of cardioplegia that gives the best myocardial protection. Different temperature, different amount and content, retrograde or antegrade or both, contentiously and further on have been tested without a clear conclusion.
* The investigators decided to make a study with a cohort of patients as homogenous as possible with a cross clamp time around 70 min.
* Adult patients' with a severe aortic stenoses without any other significant heart disease was included in our prospective randomised study.
* Patients with additional significant coronary artery disease (≥ 50% stenoses) were excluded from the study.
* The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the myocardial damage.

Objective: Myocardial protection during a cardiac arrest is mostly managed with cardioplegia. To day we normally used a blood or crystalloid based solutions. It has been published a lot of papers comparing the too groups with different results. To our knowledge no prospective, randomized study has compared modified St Thomas based Blood and Crystalloid cardioplegia on the acknowledged markers (CK-MB, troponin-T) of myocardial damage during aortic valve replacement on patients without additional significant coronary artery disease.

Methods: 100 patients with aorta stenoses undergoing aortic valve replacement without significant coronary artery stenoses or other significant concomitant heart valve disease were included in the study. They were given antegrade cold blood or cold crystalloid cardioplegia delivered through the coronary Ostia every 20 min throughout the period of aortic cross-clamp. CK-MB and troponin-T were compared between the two groups.

Published 2010 in the journal of thoracic and cardiovascular surgery.

Eligibility Criteria:
The study protocol was approved by the local ethical committees. Eligible for operation were:

Inclution Criteria

* patients with mitral regurgitation equal to or larger than grade 3 out of 4.
* Ablation for atrial fibrillation was the only concomitant procedure that was allowed in addition to mitral valve surgery and these patients were block-randomized to ensure equally many patients with ablation in the two groups of cardioplegia.

Exclusion Criteria

* Patients with any other concomitant heart valve disease or coronary artery stenoses (≥ 50%) were excluded from the study.
* Age below 18
* Pregnant
Adaptive Radiotherapy in Non-small Cell Lung Cancer (NSCLC)

The investigators group uses an individualised radiation dose approach in which the dose is escalated up to pre-defined tissue constraints (see below). The target dose to the tumor is 69Gy. However, this dose cannot be reached in approximately 30% of the patients, even with an IMRT (Intensity Modulated Radiotherapy) technique, because the MLD (Mean Lung Dose) constraint of 20Gy is reached at a TTD (Total Treatment Dose) below 69Gy. In this study, the investigators will adapt the treatment by performing a new (PET)-CT at day 12 during radiotherapy and in case of a decreased Planning Target Volume (PTV), the dose mey be increased.

Eligible patients will receive concurrent chemo-radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/- 1Gy, irrespective of lung function.

Other dose constraints: spinal cord max: 54Gy, brachial plexus (Dmax):66Gy.

In concurrent with chemotherapy, radiotherapy will be delivered as follows:

1. First three weeks /30 fractions:twice-daily fractions of 1.5Gy, with 8h to 10h as interfraction interval, 5 days per week. Total dose: 45Gy/30 fractions.
2. Thereafter: once-daily fractions of 2.0Gy, 5 days per week until the target dose has been reached.

In sequential or radiotherapy alone schedules, twice-daily 1.8Gy with an interfraction interval of at least 8h will be delivered.

The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.

Chemotherapy schedules allowed:

1. 1-2 cycles induction chemotherapy: any third generation schedule is allowed. The type will be registered.
2. Concurrent part: (day 1=first day of radiotherapy)

   1. cisplatin-vinorelbine
   2. cisplatin-docetaxel
   3. cisplatin-etoposide
   4. cisplatin-pemetrexed in non-squamous histologies

Q3 week; 3 cycles

When the calculated creatinin clearance is less than 60 ml/min, cisplatin may be substituted for carboplatin.

In case the TTD(Total Treatment Dose)=69Gy cannot be reached because of a limiting MLD, a FDG-PET-CT will be performed at day 12 during radiotherapy. GTV's (Gross Tmor Volume), CTV's (Clinical Target Volume) and PTV's (Planning Target Volume) will be delineated and a new plan calculated. The endpoint will be the proportion of patients that will receive 69Gy.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proven NSCLC
* UICC stage I-III, or solitary metastases (\<6), which are amendable for radical local treatment
* Performance status 0-2
* IMRT technique

Exclusion Criteria:

* Not NSCLC of mixed NSCLC and other histologies (e.g. small cell carcinoma)
* Stage IV, except for solitary (\<6) metastases
* Performance status 3 or more
iPACK for Post-op Pain Following ACL Reconstruction

This study will consist of patients 12 years and older undergoing ACL reconstruction using a quadriceps or bone-patella tendon bone (BTB) graft. The patients will be randomized to adductor canal block alone, or adductor canal block + iPACK block. The primary goal will be to determine the differences in postoperative pain during the first 72 hours when comparing the two groups. Secondary outcomes will include opioid utilization during the first 72 hours postoperatively and range of motion including terminal knee extension at postoperative follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

* Age 12 years and older
* Patients who are scheduled to undergo an ACL reconstruction with quadriceps or BTB graft.

Exclusion Criteria:

* Any contraindication to receiving regional anesthesia. This may include infection at the site of injection, allergy to local anesthetic, or pre-existing nerve injury.
* Patients undergoing hamstring graft or allograft for ACL
* Pre-existing infection at the site of injury
* Patients on chronic opioid treatments
* Pre-existing sensory or motor deficit in operative extremity
* Patients having a revision of previous ACL reconstruction
* Pregnant and/or lactating women
* Weighs less than 40kg
Contrast-Free Magnetic Resonance Imaging for Breast Disease

Prospective, observational cohort study looking at patients either at risk of breast cancer or have clinically suspected breast to assess the diagnostic performance of quantitative, non-contrast MRI.

It is widely recognised that mammography is highly sensitive for detecting breast lesions and a valuable tool for early detection of breast cancer, especially in post-menopausal women with non-dense breast tissue. On post-menopausal non-dense breast tissue, mammography is 90% effective at identifying breast tumours. However, for dense breast tissue, the sensitivity falls to 67%. This means that for women with dense breast tissue, which includes almost all pre-menopausal women and many post- menopausal women, mammography misses one third of tumours.

MRI is the imaging method of choice for detecting breast cancer in women with dense breast tissue however the standard MRI for breast cancer investigation typically uses gadolinium contrast agent. This method is called dynamic contrast enhanced (DCE) MRI and identifies localised regions of (neo)vascularity, which indicates a cancerous lesion. Although DCE can provide valuable information about the tissue, it is often not performed well, is poorly tolerated by patients, and adds additional time to the scan protocol.

Perspectum conducted a recent study demonstrating that liver cancer lesions can be identified using quantitative T1 maps calculated form multiparametric MRI data. Applying this MRI method to breast imaging, would potentially provide a method of identifying breast cancer lesions without using a contrast agent, reducing the scan time and eliminating the need for an intravenous contrast.

The aim of this study is to apply quantitative multiparametric MRI techniques to the area of breast imaging with the aim of developing a contrast-free MR scan which can diagnose the spectrum of breast disease referred to a secondary care breast clinic, including in women with dense breasts.

Eligibility Criteria:
Inclusion Criteria:

* Female 30 years of age and over
* Participant has been referred to a secondary care breast screening clinic.
* Participant is willing and able to give informed consent for participation in the investigation.

Exclusion Criteria

* The participant may not enter the study with any known contraindication to magnetic resonance imaging (including but not limited to a pacemaker or other metallic unfixed implanted device, metallic fragments, extensive tattoos, severe claustrophobia).
* Any other cause, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.