cyrilzakka/clinical-trials huggingface dataset:
Myocardial Injury in Treatment of AAA

Comparison of elective infrarenal aneurysm surgery with open and endovascular technique, respectively, for subclinical ischemic myocardial injury detectable with troponin T and/or 3-channel Holter ECG with ST analysis

Background: Traditional open surgery for abdominal aortic aneurysm (AAA) is burdened with complication risk from several organ systems, and also mortality figures of 3.5 - 5.5%. Over 50% of early mortality can be attributed to cardiovascular complications. Myocardial infarction is the dominant organ-specific cause of both early and late mortality in patients operated on for AAA. Endovascular surgery (EndoVascular Aortic Repair, EVAR) was developed during the 90's as an alternative method that is considered less invasive and more well-tolerated from a cardiovascular perspective.

Troponin T is a very sensitive and specific marker that predicts mortality in patients with acute symptoms of unstable angina and/or heart attack. Previous studies have also shown a high incidence of elevated troponin levels in patients who underwent major surgical procedures, especially vascular surgery, even in the absence of corresponding clinical or ECG-related symptoms of cardiac muscle injury. Several studies have also demonstrated that elevated troponin levels after surgery predict increased morbidity and mortality both short-term and long-term.

Objective: To prospectively compare elective open and endovascular surgery of AAA with respect to myocardial injury detectable with troponin T. Furthermore, to compare open and endovascular AAA surgery for the total number of periods of oxygen deficiency in cardiac muscle during and at early stages after surgery using a special ECG method (48-hour 3-channel Holter ECG with ST analysis).

Main aim of the study: To assess whether EVAR induce less myocardial injury compared with open repair for AAA.

Significance: Myocardial infarction is the predominant cause of mortality in open surgical procedure for AAA. In several previous studies, troponin T rise has been associated with impaired both short-term and long-term prognosis in elderly patients undergoing major elective surgery. This study may provide information on whether the endovascular technique provides a reduction in myocardial injury, measured as elevated troponin T or myocardial ischemia with 3-channel Holter ECG. In this way, our study can provide improved decision support in the choice of the most appropriate treatment method in the individual case.

Eligibility Criteria:
Inclusion Criteria:

* Accepted for AAA surgery of either one of the operative techniques

Exclusion Criteria:

* High anesthesiological risk
* Preoperative cardiac condition with EF \< 25 or ischemic signs on preoperative evaluation
* Severe renal insufficiency with s-creatinine \>200
Visual Outcome After Transsphenoidal Surgery for Pituitary Macroadenoma

Endoscopic endonasal transsphenoidal surgery is a procedure for the treatment of pituitary macroadenomas that cause visual impairment through optic chiasm compression. The aim of this retrospective study is to describe visual outcome after this procedure.


Eligibility Criteria:
Inclusion Criteria:

* Pituitary tumor causing optic chiasm compression (documented on MRI or CT-scan)
* Visual impairment caused by chiasm compression
* Treatment by transsphenoidal endonasal surgery
* Treatment in the Rothschild Foundation (Paris) between 2009 and 2013

Exclusion Criteria:

* Ophtalmologic condition other than optic chiasm compression
A Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276

The purpose of this study is to evaluate the safety and pharmacokinetic characteristics of combination of rosuvastatin and CS-866 and DWJ1276 alone.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male volunteers aged 20 to 50 years
2. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

Exclusion Criteria:

1. A subject who had any allergic history to any drug.
2. A subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, genitourinary, psychology, ophthalmic, dermatology and gastrointestinal function or other significant diseases
3. History or suspicion of current drug abuse
4. A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication

   * Within 1 month: drug known CYP inducer or inhibitor
   * Within 2 weeks: Prescribed or herbal medicine
   * Within 1 weeks: OTC medicine
   * Within 2 days: Consumption of caffeine
5. A subject who had participated in any other clinical study within the last 2 weeks
6. A subject from whom over 400mL of blood was sampled(whole blood donation) within last 2 weeks or plasma/platelet donation within 1 month.
Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders

To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in subjects with autism spectrum disorders


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorders (ASD)
* Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.
* Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics.
* If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening

Exclusion Criteria:

* Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
* Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
* Subjects who have taken another investigational drug within the last 30 days.
* Subjects who are not able to take oral medications
Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis

Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis :

A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least 2 years history of PAR prior to the study
* Positive results of skin prick test
* Patients who provided a signed written informed consent form
* Patients who are able and willing to complete subject diaries
* Patients who agree to maintain consistency in their surroundings throughout the study period

Exclusion Criteria:

* Patients also with non-allergic rhinitis with different causes.
* Patients with severe asthma.
* History of acute • chronic sinusitis within 1 month of Visit 1
* History of intranasal surgeries within 3 months of Visit 1
* Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
* Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1.
* Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug.
High and Low Level Laser Therapy in De Quervain's Tenosynovitis

The aim in this study was to compare the effects of high and low power laser treatments in the treatment of de Quervein tenosynovitis clinically and ultrasonographically.

De Quervain's tenosynovitis is tenosynovitis of the abductor pollicis longus (APL) and extensor pollicis brevis (EPB) tendons. Conservative management includes nonsteroidal anti-inflammatory drugs, wrist and thumb immobilization, ultrasound, and low-level laser therapy (LLLT). According to early literature, low-level laser therapy and ultrasound therapy appear to produce similar biological effects in reducing inflammation and promoting tissue healing.

In a study low-power laser therapy was found to be effective compared to placebo in de Quervain's tenosynovitis.

In a study of 35 female patients, low-power laser therapy (LLLT) combined with a thumb-supported splint was not superior to splint alone in patients with de Quervain's tenosynovitis.

In a more recent study low-power laser therapy was found to be similarly effective to ultrasound therapy.

The investigators found no studies in the literature on the effect of high-power laser therapy. The aim in this study was to compare the effects of high and low power laser treatments in the treatment of de Quervein tenosynovitis clinically and ultrasonographically.

Eligibility Criteria:
Inclusion Criteria:

* Between18-65 years of age
* Wrist pain for more than 3 weeks
* Finkelstein test positive
* Ability to understand commands

Exclusion Criteria:

* Physical therapy, injections, or surgery in the upper extremity in the last 3 months
* Fracture or trauma in the upper extremity in the last 6 months
* Radiating pain due to cervical discopathy
* Infection, loss of sensation, metal implant in the treatment area
* Inflammatory rheumatic diseases
* NSAID use
* Pregnancy or planning pregnancy during treatment
* Malignancy
* Pathology in the wrist on radiograph
Angioplasty and Heart Stents to Treat Individuals With an Occluded Artery Following a Heart Attack

The purpose of this study is to evaluate arterial patency and left ventricular ejection fraction by examining angiographic data one year following a heart attack and treatment with late revascularization.

BACKGROUND:

The Occluded Artery Trial (OAT) is an international study with 3200 participants. Its goal is to determine if delayed mechanical reperfusion by means of percutaneous transluminal coronary angioplasty (PTCA) and stenting reduces death, heart attacks, and hospitalization in individuals with New York Heart Association (NYHA) Class IV heart failure and a persistently occluded infarct-related artery (IRA) 3 to 28 days following a heart attack. While left ventricular (LV) function improvement has been suggested as a benefit of late reperfusion, solid evidence to support this claim is lacking. Furthermore, while stenting has reduced reocclusion rates after total occlusion PTCA, the reocclusion rate after a recent heart attack is unknown.

DESIGN NARRATIVE:

This study is a substudy of OAT and will enroll 380 participants. The primary aims of the study include the following: 1) to compare long-term patency rates between the two treatment groups (conventional medical therapy or PTCA and stenting) by means of follow-up coronary angiography one year after enrollment; and 2) to compare the change in global LV ejection fraction between the two treatment groups utilizing baseline and follow-up contrast LV angiograms. Secondary aims include the following: 1) comparison of regional wall motion and LV volumes; 2) study of the effect of reocclusion and spontaneous recanalization on LV function; and 3) study of the effect of duration of occlusion on changes in LV function after Percutaneous Coronary Intervention (PCI). The substudy will be conducted at 21 OAT study sites. The Substudy Coordinating Center (SCC) is at the University of Alberta in Edmonton, Canada. The Data Coordinating Center (DCC) is at the Maryland Medical Research Institute, which is the DCC for the OAT study. The Angiographic Core Laboratory is at the University of British Columbia.

Eligibility Criteria:
Inclusion Criteria:

* Has experienced a heart attack 3 to 28 days prior to study entry
* Has a persistently occluded IRA
Efficiency of Coupling Targeted Temperature Management to Brain Temperature in Severe Brain Injury

In severe brain-injured patients, it is recommended to strictly control the fever in order to limit brain damage (objective of neuroprotection) via the targeted temperature management (TTM). In the guidelines, the target temperature is the systemic temperature, just for practical reasons (brain temperature not being monitored in most polyvalent ICU). However, in NICU, the brain temperature is monitored routinely via the Intra-Cerebral Pressure (ICP) sensor. Since in the febrile brain-injured patients the objective of the TTM is neuroprotection, it would be more appropriate to target temperature control over the cerebral temperature.

The objective of this study is to evaluate the efficacy of TTM directly coupled to the brain temperature.

Adult patients with brain injury requiring ICP monitoring (Pressio 2, Sophysa France) and fever requiring TTM (cerebral greater than or equal to 38.5 °C) will be enrolled. The TTM will be carried out according to the usual methods of the investigator's service: external cooling devices coupled with cerebral temperature (Artic Sun, Bard France), including two phases: the cooling phase (H0 to H3) and the maintenance phase (from H3 to the end of the cooling).

Two groups will be formed. In the interventional group, coupling of the TTM will be carried out to the cerebral temperature. In the control group, coupling of the TTM will be carried out to the systemic temperature measured at the bladder site.

The primary outcome will be the percentage of time during which the cerebral temperature will be measured within recommended target temperature range (i.e. 36 to 37 °C) during the maintenance phase (H3 to H12): comparison of averages. Cerebral hemodynamic parameters (ICP, transcranial doppler, and brain tissue oxygen partial pressure if available) will also be collected, in order to be correlated with the delta temperature (cerebral temperature minor systemic temperature).

No medical device will be put in place specifically for the need of the study.


Eligibility Criteria:
Inclusion Criteria:

* patients 18 years of age or older
* hospitalized patient in neuro-resuscitation with peak monitoring with cerebral temperature measurement by an intra-parenchymal sensor (Sophysa®)
* patient in hyperthermia (TC ≥ 38.5 °c) and in a situation of brain pain

Exclusion Criteria:

* patient benefiting from a legal protection measure
* pregnant or breastfeeding woman
* previous participation in this study
Comparison of Pre-operative EUS Guided and Intra-operative Direct Portal Vein Pressure Measurement in Pretransplant Cirrhotics

Direct portal pressure measurement under EUS-guidance (EUS-PPM) is a promising alternative to conventional indirect Hepatic Venous Pressure Gradient (HVPG). In patients undergoing liver transplantation for cirrhosis, high pre-operative portal vein (PV) pressure requires intra-operative portal vein inflow modulation (PIM). This pilot study aims to assess correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM).


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis patients scheduled for liver transplant for the standard indications within next 24- 48 hours will be included.

Exclusion Criteria:

* Severe ascites not amenable for tapping
* History of blood thinner consumption within last 5 days
* Active duodenal ulcerations
A Swiss Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children

Plain Language Summary:

Background Glucocorticoids are stress hormones produced by the human body to control inflammation and regulate the immune system. Cortisol is the most well-known example of a glucocorticoid. These stress hormones are essential for the bodys healthy functioning.

To treat certain types of cancer, such as leukemia (blood cancer) in children, glucocorticoids are administered as medications in large quantities. This helps rapidly reduce the number of cancer cells in the body but also leads to the suppression of the body's natural glucocorticoid production, causing a deficiency.

This deficiency can be particularly dangerous for children with leukemia, as their immune defenses are already weakened by chemotherapy, leading to an increased risk of infections. Moreover, the signs of glucocorticoid deficiency in children with leukemia are often indistinguishable from the side effects of chemotherapy, making the deficiency harder to detect.

Objectives The aim of the study is to understand how frequently and for how long the body's natural glucocorticoid production is impaired in children treated for lymphoblastic leukemia and lymphoblastic lymphoma. Additionally, the goal is to identify which children are at particularly high risk.

By gaining a better understanding, this study may help to improve the detection and treatment of glucocorticoid deficiency in children with blood cancer.

Methods Regular low-dose ACTH tests will be conducted to assess the bodys natural glucocorticoid production during and after treatment. To avoid placing additional burden on children who are already heavily affected by the disease, we will only perform these tests when there is already a venous access established and the children are in the hospital for treatment reasons.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with ALL or LBL
* treated for at least 21 sequential days with glucocorticoids between the 01.07.2024 and the 30.06.2027 at the Childrens University Hospital of Basel or at the Childrens Hospital of Aarau
* lnformed consent can be obtained from the patient\&#39;s legal representatives (and the patient if at least 14 years of age) within week 2 of treatment with glucocorticoids

Exclusion Criteria:

- Contraindication to the administration of intravenous synthetical ACTH (Synacthen®): extremely rare cases of known or suspected hypersensitivity to Synacthen®.
Can Structured Education Promote Physical Activity in Those Identified With an Increased Risk of Developing Diabetes

This study is a three-armed randomised controlled trial that aims to determine the effect of a structured educational programme on physical activity levels and glucose tolerance in individuals with impaired glucose tolerance (IGT). The educational programme is designed to promote physical activity by targeting perceptions and knowledge of IGT, exercise self-efficacy, and self-regulatory skills. The study will also investigate whether the effectiveness of the educational programme at promoting self-regulatory skills and physical activity is enhanced by the inclusion of a pedometer and personalised step/day goals.


Eligibility Criteria:
Inclusion Criteria:

* 2-h blood glucose ≥ 7.8 mmol/l and \< 11.1 mmol/l
* Fasting plasma glucose \< 7 mmol/l
* BMI ≥ 25 kg/m2 (or 23 kg/m2 for those from a South Asian ethnic origin)
* Aged 18 or over

Exclusion Criteria:

* Taking medication known to significantly interfere with glucose tolerance
* Participating in regular vigorous physical activity
* Unable to participate in moderate intensity physical activity
* Pregnant
Pain in Diagnostic Hysteroscopy

The objective of this study is to assess which factors influence the pain perceived during diagnostic anesthesia-free hysteroscopy.


Eligibility Criteria:
Inclusion Criteria:

* female gender
* diagnostic hysteroscopy indication
* italian-speaking patients

Exclusion Criteria:

* patients who had previously undergone a diagnostic hysteroscopy
* patients who had been previously undergone to cervical surgery
* ongoing pregnancy
* cervical carcinoma
* pelvic inflammatory disease
* excessive uterine bleeding
* performance of an endometrial biopsy during the procedure
Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction

The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed in-situ or invasive breast carcinoma.
* Tis, T1, T2 invasive or non-invasive carcinoma of the breast; lesion less than 4 cm.
* Unifocal, multifocal or multicentric breast cancers that can be removed by nipple sparing mastectomy with negative surgical margins.
* No extensive intraductal component or patient with distant metastases.
* Patients must be \> 18 years of age.
* No concomitant or history of nipple discharge or skin involvement.
* No prior history of malignancy (less than 5 years prior to study entry), except non-melanomatous skin cancer.
* No prior history of radiation to the chest.
* No collagenous disease (systemic lupus erythematosis, scleroderma, dermatomyositis)No previous non-hormonal therapy including radiation or chemotherapy for current breast cancer.
* No patients with Paget's disease of the nipple.
* No patients with co-existing medical conditions with life expectancy \< 2 years.
* No pregnant or lactating women.
* Eastern Cooperative Oncology Group (ECOG) 0 - 2.
* Signed study-specific informed consent form prior to the study entry.

Exclusion Criteria:

* Retroareolar breast cancer lesions within one cm, depth from the skin surface.
* Concomitant or history of nipple discharge or skin involvement.
* Patient with distant metastases.
* Patient with extensive intraductal carcinoma.
* Any previously irradiated ipsilateral breast cancer.
* Patients with Paget's disease of the nipple.
* Patients with collagenous diseases, as systemic lupus erythematosis, scleroderma or dermatomyositis.
* Other malignancy, except nonmelanomatous skin cancer, less than 5 years prior to participation in this study.
* Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.
* Positive surgical margins following nipple sparing mastectomy.
TEsting for Arterial Disease in Diabetes (TrEAD) Study

This study will focus on determining;

* How accurate the test is in detecting poor circulation
* How it's accuracy compares to other commonly used tests, and
* Whether test results are linked to the chance of ulcer healing or amputation. Across 2 hospitals, 305 diabetic patients will be scanned using the focused ultrasound test as well as other commonly used tests to detect poor circulation. Their results will be compared to a full version of the ultrasound test to identify the most accurate.

In the UK, over 7,000 amputations are performed each year because of diabetes. Most of these (80%) occur when a foot wound, also known as an ulcer, does not heal. The most important cause of this is poor circulation to the feet. Currently, there are no accurate tests that foot specialists can use to detect poor circulation when they see patients. Because of this, poor circulation can be missed and its treatment delayed.

A focused ultrasound test at the ankle, using a sensor and gel on the skin, can detect poor circulation. It is safe, painless and I have previously proven that it can be learned and performed quickly. It may help avoid amputations by detecting poor circulation so that it can be treated quickly.

Eligibility Criteria:
Inclusion Criteria:

* All diabetic patients presenting to the diabetic foot clinics will be eligible for the study.

Exclusion Criteria:

* Patients unable to provide informed consent will also be excluded.