cyrilzakka/clinical-trials huggingface dataset:
Optimization of Spleen VCTE Examinations with FibroScan

This is an European, prospective, interventional, and multicenter clinical investigation which main objective is to develop a spleen examination dedicated to overweight or obese patients and assess its applicability. It will take place in 4 sites (1 site in the Netherlands, 2 sites in Spain and 1 site in Romania) to include a total of 500 patients (adults and children).


Eligibility Criteria:
Inclusion Criteria:

1. Adult or pediatric patient able to give written informed consent (parents/legal tutors in case of minor patients),
2. Patient affiliated to the healthcare system
3. Adult or children patient followed for a liver disease a suspicion of liver disease or for a consequence of a liver disease, with or without splenomegaly and having a spleen to skin distance (SSD) measurement performed during the screening ultrasound exam.

Exclusion Criteria:

1. Vulnerable patient- other than pediatric patients
2. Patients with ascites
Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion

Randomised controlled trial to contribute to the evidence base for the optimal initial insulin profile for adults with type 1 diabetes commencing insulin pump therapy.

Initiation of insulin pump therapy in people with type 1 diabetes requires conversion of a basal insulin dose, given as once or twice daily long-acting insulin, to a continuous basal infusion regimen. This conversion may be based on basal insulin dose only, or total daily insulin dose, and may result in a flat basal insulin profile or an initial variable basal rate.

Initial variable basal rates aim to replicate circadian changes in insulin requirements and are derived from total basal insulin in adults over 24 years old, and from weight in adults aged 18 to 24 years. Initial rates were developed from 63 well-controlled people with type 1 diabetes over 14 years of age and have been assessed against a flat basal rate in a small randomised controlled trial with 12 participants. Mean glucose was lower in the circadian basal rate group with particular differences noted in the early morning when glucose rises were more pronounced in the flat basal rate group1.

In 50 people with type 1 diabetes treated with insulin pump therapy, HbA1c was lower in those with lower basal rates at midnight, and in those with higher basal rates in the afternoon, suggesting a benefit of circadian patterns2. In 33 people with type 1 diabetes over 16 years of age basal rate distribution established at commencement of pump therapy did not alter over 6 months3. However, a 6 month cross-over study of circadian rates and oligophasic basal rates showed no difference in HbA1c4.

Following initiation on insulin pump therapy basal rates are personalised to capillary blood and continuous interstitial fluid glucose monitoring.

In adults with type 1 diabetes starting insulin pump therapy there are limited data to guide the optimal insulin profile to rapidly achieve target glucose and minimise healthcare professional input.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* Diagnosis of T1DM for \> 1 year
* On MDI with decision made to commence CSII
* Structured education in previous 3 years
* HbA1c ≤ 75mmol/mol (9%)
* Stimulated c-peptide \<200pmol/L
* No severe hypoglycaemia (defined as needing 3rd party assistance) in previous year

Exclusion Criteria:

* Previous CSII
* Night or shift worker
* Recurrent severe hypoglycaemia
* Pregnant or planning pregnancy
* Breastfeeding
* Enrolled in other clinical trials
* Have active malignancy or under investigation for malignancy
* Addison's Disease
* Gastroparesis
* Autonomic neuropathy
* Concomitant use of GLP-1 analogues and gliptins
* Visual impairment
* Reduced manual dexterity
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for coronary angiography
* Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
* Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -\< 80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors

Subjects must meet the following criteria at the qualifying coronary catheterization procedure:

* Evidence of coronary heart disease (at least one lesion in a native coronary artery that has \> 20% reduction in lumen diameter) or prior percutaneous intervention (PCI)
* Left main coronary artery \< 50% reduction in lumen diameter by visual estimation
* Target coronary artery for IVUS must be accessible to the IVUS catheter, must not have a \> 50% reduction in lumen diameter within the target segment (and at least 40 mm in length); cannot have undergone prior PCI or coronary artery bypass graft (CABG) and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous myocardial infarction (MI).

Exclusion Criteria:

* Coronary artery bypass graft surgery \< 6 weeks prior to the qualifying IVUS
* New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction less than 30%
* Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization
* Known hemorrhagic stroke
* Uncontrolled hypertension at randomization
* Fasting Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening
* Type 1 diabetes or poorly controlled type 2 diabetes (hemoglobin A1c \[HbA1c\] \> 9%) at screening.
* Moderate to severe renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73m²) at screening.
Dermal Suturing Only Versus Layered Cutaneous Closure

The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure.

The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure. Our aims are to compare outcomes using a split wound model, where half the wound is sutured with one technique and the other half is sutured with the other. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wounds with a single layer closure will result in cosmetically superior wound outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure with predicted linear closure
* Willing to return for follow up visits

Exclusion Criteria:

* Mentally handicapped
* Incarceration
* Pregnant Women
* Wounds with predicted closure length less than 3 cm
* Wounds unable to be fully closed via primary closure
Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer.

Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated in the second stage.

Participants were treated for at least one 8-week cycle, with additional cycles as long as they had stable or responding disease (per RECIST criteria) and wished to remain on study.

Participants had a final follow-up visit within 4 weeks following the last dose of iniparib, after which time they were contacted by study staff every 3 months for the first year and every 6 months thereafter to assess disease status and survival.

Eligibility Criteria:
Inclusion Criteria:

* Female, age 18 or older;
* Histologically or cytologically confirmed advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (stage III or IV);
* At least one previous regimen with platinum/taxane combination therapy and no curative options as determined by their physician (no limit on the number of prior therapies);
* Confirmed BRCA1 or BRCA2 status;
* One or more measurable lesions, at least 10mm in longest diameter by spiral computed tomography (CT) scan or 20mm in longest diameter when measured with conventional techniques (palpation, plain x-ray, CT or magnetic resonance imaging (MRI));
* Karnofsky performance status ≥70%;
* Estimated life expectancy of at least 16 weeks.

Exclusion Criteria:

* Normal clinical laboratory values;
* Any anti-cancer therapy within 21 days prior to study start;
* Any other malignancy within 3 years of study start, except adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, or basal or squamous cell skin cancer;
* Active viral infection including HIV/AIDS, Hepatitis B or Hepatitis C infection;
* Active central nervous system or brain metastases;
* History of seizures or current treatment with anti-epileptic medication;
* Persistent grade 2 or greater toxicities from prior therapy, excluding alopecia.
Adaptation to Ozone in Individuals With Asthma/Exercise-induced Bronchoconstriction

Researchers found that impairments in the cardiopulmonary system caused by acute exposure to ozone were outweighed by repeated exposures to ozone. The goal of this study is to confirm there will be an adaptation similar to what was previously proved but in individuals with asthma and exercise-induced bronchoconstriction (EIB). The purpose is to examine adaptive responses in a randomized cross-over trial in which physically active individuals will perform submaximal exercise on five days in ozone and filtered air exposures separated by a washout period.


Eligibility Criteria:
Inclusion Criteria:

* Recreationally active individuals
* Diagnosed asthma and/or mild exercise-induced bronchoconstriction: defined by an FEV1 fall equal to or greater than 10% but lower than 25% in the eucapnic hyperventilatory test.
* Able to securely perform a maximal exercise test (responded 'no' to all questions on the PAR-Q+ questionnaire)
* Able to communicate in English

Exclusion Criteria:

* Diagnosed with any cardiorespiratory or vascular diseases
* Pregnant or potentially pregnant
* Non-smoking
* Lower limb musculoskeletal injury or lower limb limitation to cycle on a bicycle ergometer
* Recent respiratory symptoms or upper tract infection within 4 weeks
* On vitamin (e.g., C or E) supplementation
The Role of the Muscle-nervous System Interface in Cancer Cachexia

Sarcopenia is an important component of cachexia associated with cancer, and their high incidence in cancer patients emphasizes the need for a better understanding of its mechanisms, which can result in better therapeutic interventions to reverse this situation and improve the prognosis. Our hypothesis is that the plasma concentration of IL-6 and c-terminal agrin is directly correlated with the loss of muscle mass and development of cachexia.

The agrin is a protein that acts on neuromuscular junctions (NMJs) promoting stabilization of same, which results in the maintenance and growth of muscle fibers, but the cleavage of agrin, a process by which is formed the agrin fragment C-terminus (CAF), has been linked to the development of sarcopenia, because its presence is directly linked to the reduction in the number of muscle fibers, increasing the heterogeneity of fiber size, presence of Central cores and increasing the proportion of type I fibers and consequently a greater degradation of lean body mass. Studies in mice show that the greatest cleavage of agrin carries on development of sarcopenia and human studies report that individuals with higher serum levels of sarcopenia CAF compared to individuals without sarcopenia.

Therefore, aiming at the complexity of cancer associated with the cachexia and the great importance of the maintenance of lean body mass to a better prognosis in disease, is of fundamental importance to elucidate the role of CAF and the factors associated with sarcopenia, the possible use of these proteins for diagnosis and the contribution that this clarification could bring in clinical therapy.

Eligibility Criteria:
Inclusion Criteria:

* cancer diagnosis

Exclusion Criteria:

* continuously use of anti-inflammatory medications;
* present renal and/or liver failure,
* AIDS,
* inflammatory bowel disease or chronic inflammatory processes not related to cachexia.
Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer

This phase II study will evaluate the efficacy of the combination of two monoclonal antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.

Treating patients with primary resistance to the most active multi-agent combination remains a challenging clinical problem. The reported data demonstrated that addition of ERBITUX may reverse IRINOTECAN resistance. Further data support the feasibility of the combination of two monoclonal antibodies (AVASTIN+ERBITUX) with IRINOTECAN with better responses compared to historical controls (ERBITUX±IRINOTECAN). As such, a phase II study was designed to evaluate the efficacy of the combination of AVASTIN plus ERBITUX plus IRINOTECAN as second line treatment in patients progressing while on treatment with FOLFIRI AVASTIN or XELIRI AVASTIN

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic colorectal cancer.
* Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
* ECOG performance status ≤ 2
* Age 18 - 72 years
* Patients with de novo refractory disease (progression of disease as best response at 1st line therapy with FOLFOX/Avastin)
* Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL),renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
* Patients must be able to understand the nature of this study
* Written informed consent

Exclusion Criteria:

* History of serious cardiac disease (unstable angina, congestive heart failure, uncontrolled cardiac arrhythmias).
* History of myocardial infarction or stroke within 6 months.
* Clinically significant peripheral vascular disease.
* History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0.
* Presence of central nervous system or brain mets.
* Evidence of bleeding diathesis or coagulopathy.
* Patients with known hypersensitive reaction to cetuximab
* Blood pressure \> 150/100 mmHg.
* Pregnant or lactating woman.
* Life expectancy \< 3 months.
* Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow.
* Metastatic infiltration of the liver \>50%.
* Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy.
* Active infection requiring antibiotics on Day 1.
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
* Psychiatric illness or social situation that would preclude study compliance.
Case Management for Frequent Users of the Emergency Department

The purpose of this study is to evaluate a specific case management intervention for frequent users (FU) of Emergency Department (ED).

Compared to infrequent or non-users, most of the ED-FU visitors are identified as vulnerable patients because they are more likely to be of low social and economical status, be more isolated and live alone. They report more chronic medical conditions, have a higher mortality rate and consume more healthcare resources.

In the literature, interventions aimed at improving the management of ED-FU have demonstrated several positive outcomes, but there are still some knowledge gaps.

The proposed project tests the hypotheses that case management intervention as compared with standard emergency care

* is a more efficient use of healthcare resources and reduces ED attendance,
* is cost-saving and
* improves quality of life,
* altogether leading to favorable cost-utility ratio.


Eligibility Criteria:
Inclusion Criteria:

* 5 or more attendances during the previous 12 months at the Emergency Department of the University Hospital of Lausanne
* Be capable of communicating in any of the languages spoken by the team (i.e. French, English, German, Italian and Spanish) or through a community interpreter

Exclusion Criteria:

* Patients who cannot give informed consent or are ineligible to receive Case Managers services (e.g. acutely confused, acutely psychotic, intoxicated)
* Patients who are in prison
* Patients with a diagnose of cognitive disorders (delirium, dementia, and other cognitive disorders)
* Patients who are not expected to survive at least 18 months after enrollment
* Patients who will not remain in Switzerland for 12 to 18 months after enrollment
* Family members of a participant already included
Eltrombopag and High-dose Dexamethasone as First Line Treatment for IT

The purpose of this study is to determine the response rate and response duration with the combination of eltrombopag and high-dose dexamethasone

Immune Thrombocytopenia is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading platelet destruction.

Corticosteroids increase the platelet count in about 80 percent of patients.However, many patients have a relapse when the dose of corticosteroid is reduced. Debilitating side effects are common in patients who require long-term corticosteroid therapy to maintain the platelet count. Eltrombopag, it is a small molecule agonist of the c-mpl (TpoR) receptor, which is the physiological target of the hormone thrombopoietin, has been shown to be effectively raise the platelet count in adult patients (aged 18 years and over) who have had their spleen removed or where splenectomy is not an option and have received prior treatment with corticosteroids or immunoglobulins, and these medicines did not work (refractary ITP). There are a few case reports where eltrombopag was an option as first line treatment for IT.

The purpose of this study is to determine the response rate and response duration with the combination of eltrombopag (50mg PO once a day for 4 weeks) and high-dose dexamethasone (40mg PO days 1,2,3,4) in untreated adult patients immune thrombocytopenic or in patients with less than 7 days of treatment with corticosteroids.

A complete platelet response is defined as an increase in platelet counts to \>150×109/L on two consecutive occasions. A partial response is defined as an increase in the platelet count to between 50 and 150×109/L on two consecutive occasions, 1 week apart. Duration of response is considered from the day of the initial administration to the first time of relapse (platelet count \<30×109/L)or to time of analysis.

At the end of the first 5 weeks, the patients will followed by 6 months every month.

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed immune thrombocytopenic (IT) Platelet count less than 30,000/mm3 on two occasions. Platelets \>30000/mm3 with bleeding.
* Less than seven days taking corticosteroids
* Normal to increased numbers of megakaryocytes on bone marrow examination in patients ≥ 60 years
* Subject is ≥ 18 years
* Subject has signed and dated written informed consent.
* No sepsis or fever
* No active infection requiring therapy
* No active chronic viral infection
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

Exclusion Criteria:

* Performance status above or equal to 2.
* Previous treatment with eltrombopag
* Immunosuppressive treatment within the last month
* Previous splenectomy
* Presence of malignant haematological disease
* Connective tissue disease
* Autoimmune hemolytic anemia
* Pregnancy and lactation
* Not willing to participate in the study.
The Influence of Cessation of Pomegranate Juice Intake on Inflammation and Oxidative Stress Markers and Glucose Control in Diabetic and Non Diabetic Chronic Hemodialysis Patients

The current study will investigate chronic hemodialysis patients who were treated in our unit with pomegranate juice intake for 1 year - compared to a control group.

Markers will be taken 3 months after cessation of pomegranate juice intake, for inflammation and oxidative stress and Hb A1c.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Hemodialysis patients three months after termination of study which is currently carried out at our unit; which compared patients taking pomegranate juice three times a week for 1 year to a group that received placebo juice.

Exclusion Criteria:

* Patients who do not currently participate in above mentioned trial
RCT Computer-tailored Intervention on Workplace Sitting

A theory-driven, web-based, computer-tailored advice to influence sitting at work was developed. The study investigated the effects of this computer-tailored intervention to influence workplace sitting on behavioural measures.

The study investigated the effects of the theory-driven, web-based, computer-tailored intervention to influence workplace sitting on objectively measured sitting time, standing time and breaks from sitting, as well as self-reported context-specific sitting. The computer-tailored advice was compared to a generic advice and a 'no-advice' control at 1-month and 3-months follow-up. The 'tailored' group received a web-based computer-tailored intervention including personalized feedback and tips on how to reduce and/or interrupt workplace sitting. The 'generic' group received a web-based intervention containing generic information and tips to reduce and/or interrupt workplace sitting. The control group was a waitlist control condition and received the generic intervention after completing all measurements. Participants were recruited from a convenience sample of two companies (university and environmental agency) in Flanders (i.e. northern Dutch-speaking part of Belgium), mainly employing desk-based workers, having more than 100 staff members and each having at least three different worksite locations.

Eligibility Criteria:
Inclusion Criteria:

* being employed

Exclusion Criteria:

* not being able to stand