cyrilzakka/clinical-trials huggingface dataset:
Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

Systemic sclerosis (SSc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. No curative treatment is available. Pre-clinical abnormalities can be found such as specific autoantibodies. The association of Raynaud phenomenon and SSc-specific anti-nuclear antibodies is the hallmark of pre-scleroderma subjects, among who around 47% declare a complete disease after five years. The aim of this study is to assess in this particular population the preventive effect of an anti-platelet treatment.

In this study, platelet activation is targeted as it could play a key role in the pathogenesis of SSc. It has been shown in several publications that platelets are activated in SSc with a correlation between the level of activation and disease activity. Secondary to this activation, soluble and membrane effectors were increased, and induced vascular damages and fibrosis. The results obtained in the laboratory (CNRS UMR-5164) directly involved platelets in this mechanism by inducing the thymic stromal lymphopoietin (TSLP) production by endothelial cells and by showing the pro-fibrotic effect of TSLP. In vivo data in SSc murine model recently obtained, confirmed the preventive role on fibrosis of clopidogrel. The early control of this platelet activation could prevent the course of events leading to SSc.

The therapeutic strategy assessed in this study will be the oral administration of clopidogrel (75 mg per day) during two years to subjects presenting an association of specific dysimmunity and Raynaud phenomenon (RP). The administration of clopidogrel will be double-blinded versus placebo.

Subjects will be included and treated during a 2-year period and will be followed for a period of 36 months after treatment, i.e. a total of 60 months. The follow-up will be every six months mainly comprising clinical examination, patient reported outcomes and blood sampling.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old, and less than 85 years old.
* Patient with positive AAN (AAN ≥ 1/160) with the following specificity: anti-Scl70 or anti-centromere or anti-RNApolIII, or any other auto-antibodies related to systemic sclerosis
* Patient with RP reported by the subject and confirmed by the physician.
* Patient affiliated to a health insurance system.
* Patient who accepts to participate to the study and signs an inform consent form.

Exclusion Criteria:

* Patient with an SSc diagnosis according to ACR/EULAR 2013 criteria.
* Patient with skin fibrosis at screening.
* Patient with antiplatelet treatment at screening.
* Patient with contraindications to clopidogrel.
* Patient treated by immunosuppressive agent at screening.
* Patient treated by anticoagulants at screening
* Pregnant or breastfeeding women.
* Women of childbearing age refusing effective contraception method during the study treatment (24 months).
* Incompetent adults (i.e. Individuals under the protection of a conservator)
Length of Small Bowel. How Can Standardise Measurement and Why?

Measurement of the small bowel length studied by anatomists, surgeons and radiologists. Results were highly different among these series. Technical and mechanical factors have major effects on measures. Investigators decided to reach a standardization for the measurement of small bowel length.

Small bowel length will be measure in patients undergoing intraabdominal surgery. This will be establish by two surgeon from Treitz ligament to ileocecal valve two, consecutively. For measurement, a tape will place to antimesenteric, mesenteric border and the midline between these two sides.

Exclusion criteria include patients with inflammatory bowel disease, peritonitis, prior abdominal surgery.

Demographic data, patients clinical details and small bowel length will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for abdominal surgery

Exclusion Criteria:

* Inflammatory bowel disease
* History of intraabdominal surgery
* peritonitis
Liver Protection of RIPC in Pediatric Living Donor Liver Transplantation

Remote ischemic preconditioning(RIPC) is emerging as an promising therapeutic paradigm to combat the detrimental impact of ischemic and reperfusion injury. In liver transplantation, ischemic and reperfusion injury severely impacts the post-surgery liver function and patient outcome. This prospective, double blind, randomized clinical trial is aimed to test the protective effect of RIPC against hepatic ischemic and reperfusion injury in pediatric liver transplantation.

Pediatric liver transplantation remains the major therapeutic strategy for pediatric biliary atresia patients. With almost 60 years of improvements and refinements in surgical techniques and perioperative management standards, liver transplantation is gaining popularity and gradually turns out to be the only curative treatment option for patients with irrevocable liver failure, such as childhood acute or chronic liver failure, inherited liver diseases and also biliary atresia. In liver transplantation, hepatic ischemic and reperfusion injury (HIRI) remains to be a critical clinical issue. Importantly, it is well known that the severity of HIRI may have fundamental impact on the transplanted organ function and long term graft survival. Furthermore, pediatric patients are more venerable and less tolerated to receive an ischemic donor liver due to their small body weight.Although detrimental impact of HIPI on graft function has long been recognized, little progress has been made to attenuate the severity of the HIPI compared to cardiac ischemic and reperfusion (IR) injury. In experimental animal models, remote ischemic preconditioning has been consistently shown to have beneficial effects. However, this protective paradigm has yet not been tested in liver transplantation patients in clinical scenario. Considering the growing number of pediatric patients undergoing liver transplantation and their possibly underdeveloped organ function, the investigators sought to determine whether remote ischemic preconditioning could ameliorate HIPI and improve long term graft/patient survival in pediatric liver transplantation patients using this double-blind randomized clinical trial.

Eligibility Criteria:
The inclusion criteria were as follows:

1. American society of anesthesiologists score of I-III;
2. age of 3-72 months
3. elective living LT surgery.

The exclusion criteria were as follows:

1. peripheral vascular disease;
2. history of thromboembolism;
3. systemic or local infection before surgery;
4. autoimmune diseases;
5. severe congenital heart disease
6. history of LT.
Skin Incision Skewness at Cesarean Section

Skin incision skewness, incision length on both sides of the midline and patient's perception of the scar after cesarean section will be compared between the following two groups: (1) Drawing of an incision line prior to skin incision and (2) no drawing of an incision line.

Some aspects of the surgical techniques employed during cesarean section have already been evaluated in regards to possible improvements of cosmetic outcome, such as the use of different skin closure materials or whether subcutaneous fat suture closure leads to better results than non-closure. Another point to be considered is the skewness of the scar. Many surgeons make the skin incision based on their experience without prior measurement and drawing of an incision line. However, following a predefined incision line may reduce the rate of skew incisions. Therefore, this study aims to compare these two approaches to the skin incision.

Participating women will be recruited at the Department of Obstetrics and Gynecology of the Medical University of Vienna. They will be included into the study after written informed consent and will be randomized into one of the two groups (drawing of an incision line prior to skin incision versus no drawing of an incision line) on the day of cesarean section.

Skewness of the skin incision in each group will be assessed after cesarean section. Furthermore, it will be determined whether there are any differences in the incision length on both sides of an imaginary line from the umbilicus to the clitoris between these two techniques. Additionally, patient's perception of the scar before discharge from hospital will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* First cesarean section

Exclusion Criteria:

* Performance of an acute cesarean section
* Previous cesarean section
* Body mass index \> 35 kg/m²
Subclassification of the Syndrome of Inappropriate ADH Secretion

The aim of this study is to evaluate the different types of osmotic dysregulation in patients with Syndrome of Inappropriate ADH (SIADH) and, hence, to analyze the pathophysiology of SIADH.

These types will be characterized by measurement of AVP and copeptin while performing an osmotic stimulation with infusion of hypertonic saline.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years,
* hyponatremia \< 132 mmol/L
* SIADH

Exclusion Criteria:

* age \< 18 years
* cerebral metastases
* serum sodium \> 132mmol/L
Influence of Food on the Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Japanese Male Volunteers

Study to investigate the relative bioavailability and pharmacokinetics of the fixed-dose combination tablets (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg) in the fed condition compared with those of the same fixed-dose combination in the fasting condition in healthy Japanese male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteers without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
2. Age: ≥20 and Age ≤35 years
3. Body weight: ≥50 kg
4. Body mass index (BMI): ≥18.0 and ≤25.0 kg/m2
5. Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
2. Diseases of the central nervous system (such as epilepsy) or psychiatric or neurological disorders
3. Chronic or relevant acute infections
4. Any clinical relevant findings in laboratory test results deviating from normal
5. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilitic test, or an human immunodeficiency virus (HIV) test
6. History of surgery of the gastrointestinal tract (except appendectomy)
7. History of relevant orthostatic hypotension, fainting spells, or blackouts
8. Known hypersensitivity to any component of the formulation (telmisartan and amlodipine), to any other angiotensin II receptor blockers, or to any other dihydropyridine compound
9. Intake of drugs with a long half-life (≥24 hours) within at least 1 month or less than 10 half-lives of the respective drug before drug administration
10. Intake of drugs which might reasonably influence the results of the trial on the basis of the knowledge at the time of protocol preparation within 7 days before drug administration
11. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational products before drug administration
12. Smoker (≥20 cigarettes/day)
13. Alcohol abuse (60 g or more ethanol/day: e.g., 3 middle-sized bottles of beer, 3 gous \[equivalent to 540 mL\] of sake)
14. Drug abuse
15. Blood donation (more than 100 mL within 4 weeks before drug administration)
16. Excessive physical activities (within 1 week before drug administration)
17. Intake of alcohol within 2 days before drug administration
18. Inability to comply with dietary regimen of the study centre
19. Inability to refrain from smoking during trial days
20. Subjects judged to be inappropriate by the investigator or a sub-investigator
Mechanisms of Semaglutide Therapy in Heart Failure Patients

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, primarily used for treatment of type-2 diabetes mellitus. GLP-1 receptors are present on pancreatic islet β-cells, δ-cells and α-cells. Their stimulation increases insulin and somatostatin secretion, and decreases glucagon secretion. In addition, GLP-1 receptor agonists appear to have multiple extrapancreatic actions, which remain poorly defined. In large clinical trials, semaglutide improved the outcomes in obese patients, patients with heart failure with preserved ejection fraction, and decreased the heart failure hospitalizations in patients with type 2 diabetes. The aim of the present study is to investigate the underlying mechanisms of the beneficial clinical effects of semaglutide in the setting of chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-80 years
* Presence of heart failure
* Body-mass index 27 kg/m2 or greater
* Stable optimally tolerated dosages of heart failure therapies for 3 months
* N-terminal pro B-type natriuretic peptide levels \>350 pg/mL

Exclusion Criteria:

* Presence of type 1 or type 2 diabetes or glycated haemoglobin higher than 6.5%
* Pregnancy or potential to become pregnant
* Cancer
* Liver dysfunction (aspartate aminotransferase and/or alanine aminotransferase \> 3 times upper limits of normal or total bilirubin greater than 1.5 times upper limits of normal)
* Renal dysfunction (estimated glomerular filtration rate less than 25 mL/min/1.73 m2)
* Hospitalization in the past 3 months for reasons other than heart failure
* New York Heart Association (NYHA) functional class I or functional class IV symptoms.
* Prior or planned bariatric surgery
* Self-reported change in body weight \>11 lbs (5 kg) within 3 months before enrollment
* Acute or chronic infection
A Study of Changes in Hepatic Function During Radiation Therapy Using Hepatobiliary Single Photon Emission Tomography (SPECT)

Radiation-induced liver disease (RILD) is a syndrome characterized by the development of anicteric ascites approximately 2 weeks to 4 months after hepatic irradiation. Previous studies have shown that both the volume of liver irradiated and the dose of radiation delivered are prominent factors for development of RILD. While use of a population-based normal tissue complication probability model allows investigators to limit the risk of RILD to a clinically acceptable level, a test that permits investigators to determine an individual's risk of RILD during the course of treatment may allow for individualized treatment modifications, either to prevent toxicity or increase efficacy.

Early, but subclinical physiologic changes in the liver may be associated with the future development of RILD. There are currently limited data on how a local change in hepatic function associates with regional radiation dose, and how the change of hepatic function during and after radiation therapy (RT) associates with RILD. In the present study, a radiological methodology that is minimally invasive will be used to measure volumetric hepatic functions in patients with intrahepatic malignancies before, during, and after a course of fractioned radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* cancer patients undergoing radiation of the Liver
* women and men who agree to avoid pregnancy
* life expectancy of at least 6 months

Exclusion Criteria:

* pregnant women
* breatsfeeding women
* prisoners
The Effects of Wild Blueberries on Depressive Symptoms in Young Adults

This study aims to investigate the effects of a 6-week dietary intervention of 22 g freeze-dried whole wild blueberry powder. The outcomes include measures of depression, anxiety, anhedonia, cognitive function, and biomarkers of inflammation and oxidative stress.

A randomized, double-blind, placebo-controlled, parallel-design study assessing the effects of a 6-week intervention of wild blueberry powder in young adults with depressive symptoms. A total of 60 participants will be randomly assigned to either 22 g blueberry powder or a matched placebo powder consumed daily with water. The severity of depression, anxiety, anhedonia, perceived stress, and quality of life will be measured at baseline and 6 weeks later. In addition, we will assess changes in cognitive function and transient mood 2 hours after consuming a single dose of blueberries.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 24 years of age
* Patient Health Questionnaire-9 score ≥ 10 and a score ≥ 2 on the sum of items 1 and 2
* Willingness to provide blood samples

Exclusion Criteria:

* Any medically significant condition (e.g. diabetes, endocrine or gastrointestinal disorders)
* Taking medication (excluding hormonal contraception)
* History of mental illness (excluding anxiety and unipolar depressive disorders)
* Allergy to blueberries or any other Vaccinium species
* Receiving psychotherapy or counselling
All Ligaments Left In Knee Arthroplasty Trial

Compare the clinical and patient reported outcomes of the Vanguard XP Knee System to the Vanguard CR Knee System in patients with antero-medial osteoarthritis of the knee with an intact anterior cruciate ligament.

The purpose of the proposed ALLIKAT study (All Ligaments Left in Knee Arthroplasty Trial) is to evaluate the early outcome of a Total Knee Replacement device that retains both cruciate (Vanguard XP) by comparing it with a control group of patients implanted with an established single cruciate retaining device (Vanguard CR). The study also aims to examine short and long term descriptive cohort outcome data. A small preference cohort group of 60 patients receiving the Vanguard XP Knee System will be recruited alongside the RCT group. This data will be used to confirm the external validity of the RCT group and to contribute to the safety data for the British Orthopaedic Association's Beyond Compliance Programme.

Evaluation will include intra-operative and post-operative complications, longer term survivorship and patient reported outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Primary Osteoarthritis of the knee involving one or more compartments of the joint.
* Intact Anterior and Posterior Cruciate Ligaments.
* Intact collateral ligaments.
* Correctable coronal deformity.
* No more than 15 degrees of fixed flexion deformity.

Exclusion Criteria:

* Age under 18 years.
* Revision knee replacement surgery.
* Rheumatoid Arthritis.
* Traumatic aetiology.
* History or clinical signs of ACL rupture.
* Previous arthroscopy related to ACL injury or reconstruction.
* Correction of a flexion contracture that may require extensive resection of distal femur.
* Altered pain perception and / or neurologic affection (for example as a complication arising from diabetes).
* Unable to consent for themselves.
* Patients with language or cognitive issues that may prevent them completing the follow up requirements.
* Contraindications for the device:

  * Cementless application of components.
  * BMI ≥40 kg/m2.
  * Use of Anterior Stabilized Bearings.
  * Patients with severe pre-operative varus or valgus deformity ≥ 15 degrees.
  * Correction or revision of previous joint replacement procedure on index knee.
  * Infection.
  * Sepsis.Osteomyelitis.
  * Osteoporosis (requiring treatment).
* Relative contraindications include:

  * Unco-operative patient or patient with neurologic disorders who is incapable of following directions.
  * Osteoporosis.
  * Metabolic disorders which may impair bone formation.
  * Osteomalacia.
  * Distant foci of infections which may spread to the implant site.
  * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
  * Vascular insufficiency, muscular atrophy, neuromuscular disease.
  * Incomplete or deficient soft tissue surrounding the knee, including the anterior cruciate ligament.
The Carrier Rates of Pseudomonas Aeruginosa in Family Members of Children With Cystic Fibrosis

Pseudomonas aeruginosa (Pa) is the bacterium that causes one of the most consequential lung infections in people with CF. Many young children do not have Pa in their lungs but will become infected as they get older. The investigators want to learn more about how Pa is passed from person to person, especially to someone with Cystic Fibrosis (CF).

People with CF (cystic fibrosis) often have lung infections which occur repeatedly or worsen over time. The lung infections are most often caused by bacteria. Pseudomonas aeruginosa (Pa) is the bacterium that causes one of the most consequential lung infections in people with CF. Many young children do not have Pa in their lungs but will become infected as they get older. The investigators want to learn more about how Pa is passed from person to person, especially to someone with CF. The respiratory secretions of someone colonized with Pa can transmit or pass on the bacterium. The bacterium can be passed through direct contact by two individuals kissing or touching hands. Another way to pass Pa is by indirect contact such as touching an object like an eating utensil or drinking glass that has been used by someone with Pa.

There are many unanswered questions about Pa lung infections in people with CF. For example, it is not known why some people with CF develop Pa lung infections earlier than others. Nor is it known why it is difficult to eradicate Pa in some children and why some children's condition to deteriorate quicker than other after becoming infected with Pa.

Biological parents of children with CF are carriers of one CF causing gene mutation. It is also possible that they are carriers of additional, but milder, CF-related gene mutations. It is possible that the carrier status of the parents of CF children place them at risk of acquiring and carrying Pa in their lungs.

Biological parents of children who have CF will be asked to participate. This study plans to assess the frequency of Pa in biological parents and to correlate the clinical and microbiological status of CF children with PA carrier rates of their parents.

Parents will be asked to complete questionnaires at one routine, clinic visit, have nasal and throat cultures collected during their child's routine scheduled visit and again 3-4 months later (at another routine visit). The investigators are also asking permission to review the medical records of their child with CF.

Eligibility Criteria:
Inclusion Criteria:

* Biological parents of children with CF will be invited to participate and included if their children meet the following criteria:

  * children's age is more than 5 years and less than 20 years of age.

Exclusion Criteria:

* Biological parents of children younger than 5 years of age or older than 20 years of age.
* Step parents.