cyrilzakka/clinical-trials huggingface dataset:
The Effect of Lifestyle-induced Hepatic Steatosis on Glucagon-stimulated Amino Acid Turnover

Many patients with type 2 diabetes exhibit elevated plasma concentrations of the glucose-mobilising pancreatic hormone glucagon; i.e. hyperglucagonaemia. This contributes to the hyperglycaemic state of the patients and is considered an important component in the pathophysiology of type 2 diabetes; but the mechanisms underlying this phenomenon remain unclear. The liver constitutes the main target organ of glucagon, and studies have shown that hyperglucagonaemia goes hand in hand with hyperaminoacidaemia and that both are associated with non-alcoholic fatty liver disease (NAFLD), independently of the presence of type 2 diabetes. In line with this, several recent studies support the existence of a feedback-cycle between the liver and the pancreatic alpha cells, governed by circulating glucagon and amino acids. The investigators hypothesise that the presence of hepatic steatosis results in hepatic glucagon resistance at the level of amino acid turnover, i.e. impaired glucagon-induced suppression of circulating amino acid concentrations. If this hypothesis proves correct, it would establish build-up of fat in the liver as a core mechanism underlying hyperglucagonaemia and, since the hyperglucagonemia is at least partly responsible for the fasting hyperglycaemia, as an important contributor to the hyperglycaemia of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Normal fasting plasma glucose and glycated haemoglobin (HbA1c) \<42 mmol/mol
* Body mass index (BMI) between 18.5 and 25 kg/m2
* Haemoglobin \>8.3 mmol/l
* Habitual diet in accordance with the Nordic Nutrition Recommendations
* Age between 20 and 65 years
* Oral and written informed consent

Exclusion Criteria:

* Diabetes
* First-degree relatives with diabetes
* Fasting plasma triacylglycerol indicating dyslipidemia (≥2 mmol/l)
* Nephropathy (estimated glomerular filtration rate (eGFR) \<60 ml/min and/or microalbuminuria with an albumin to creatinine ratio of 30-300 μg/mg)
* Known liver disease and/or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2 × normal values
* Signs of liver fibrosis and/or steatosis evaluated by FibroScan (CAP value \>2380 dB/m and/or kPa \>65.0) and/or FIB-4 score (\>1.45)
* \>5% steatosis evaluated by MRI carried out before experimental Day A (see Methods)
* Use of medication
* Use of dietary protein supplementation or any other dietary supplements that cannot be paused during participation
* Excessive training habits, defined as \>2 weekly strength and/or aerobic training sessions
* Pregnancy and/or breastfeeding
* Implanted metal objects incompatible with magnetic resonance imaging (MRI)
* Any condition that the investigator feels would interfere with trial completion
Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)

A multi-centre retrospective review of fistulizing Crohn's disease (CD) patient charts will capture data to measure health care resource utilization associated with the use of Infliximab for treatment of CD. Three health science centres/hospitals from Ontario are targeted to participate in the study, each site is expected to provide 30-40 patient charts with a target of 108 charts total.

This study population was chosen from a non-probability sample.

Eligibility Criteria:
Inclusion Criteria:

* Treatment with infliximab for fistulizing CD.
* Administration of at least one infliximab infusion \>=12 months before the chart review.
* 18 years of age or over (men and women).

Exclusion Criteria:

* Subjects not followed for a full year after their first infusion of infliximab.
* Subjects not followed for a full year prior to their first infusion of infliximab.
* Subjects who had participated in clinical studies during the data collection timeframe.
Transcranial Direct Current Stimulation Associated With Pilates in Low Back Pain

This is a randomized and blind clinical trial, whose objective is to evaluate the effects of transcranial stimulation by direct current associated with exercises based on the pilates method on the performance of patients with chronic low back pain.

Considered a public health problem, low back pain is globally presented as a symptomatology of high prevalence, incidence and recurrence. In addition, it is responsible for a large part of disabilities, reduced functional performance, absences from work and impaired quality of life, which brings biopsychosocial impacts to the affected subjects. Treatments that relieve the symptoms of these patients are of great importance to improve the quality of life of these individuals. Thus, this study aims to evaluate the effects of transcranial direct current stimulation associated with Pilates based exercise on chronic low back pain. This is a randomized clinical trial that will be composed of women between 18 and 65 years of age, with a history of low back pain for more than 12 weeks and a minimum pain intensity equal to 3 cm on the numerical pain scale. The volunteers will be randomized into two distinct groups: stimulation + exercise group (EG - will perform a Pilates based exercise protocol combined with transcranial direct current stimulation) and sham stimulation + exercise group (SG - will perform the same exercise program combined with sham stimulation). The interventions, regardless of the group, will be carried out three times a week for four weeks. Participants will be submitted to three assessments: the first (T0) will be performed before the treatment protocols; the second (T1) will be performed after the four weeks of intervention; and the third (T2) will be a follow-up one month after the end of the treatment protocol. Pain sensation, performance, pressure pain threshold, use will be evaluated. For the statistical analysis, a mixed model ANOVA will be performed for the inter and intragroup comparison, with Tukey's post hoc, considering a significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

Women with chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale

Exclusion Criteria:

* diagnosis of fracture and spine pathologies, fibromyalgia, spine surgery in the last year;
* low cognitive level assessed by the Mini Mental State Examination;
* presence of central neurological diseases (such as Parkinson's and stroke) or psychiatric (such as depression or schizophrenia);
* history of epileptic illness;
* seizure history;
* brain implants;
* pacemaker;
* pregnancy
Mean Platelet Volume and TXA2 Levels in Patients With Polycystic Ovary Syndrome (PCOS)

Polycystic ovary syndrome (PCOS)is closely associated with insulin resistance and hyperinsulinemia as well as with increased incidence in diabetes, hypertension, dyslipidemia and atherosclerosis. Indeed, subjects with PCOS were reported to carry an increased long-term cardiovascular risk, among others. Aiming to correlate the mean platelet volume, the thromboxane A2 level and the PCOS, an observational study was planned. Clinical evaluation of metabolic outcomes in PCOS patients is compared to a placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Women fulfilled two out of three diagnostic criteria for PCOS

Exclusion Criteria:

* Pre-existing secondary endocrine disorders
* History of hypertension, diabetes mellitus or cardiovascular disorders
* Pharmacologic treatment in the last 6 months before entering the study.
Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis

Therapeutic strategies for multiple sclerosis (MS) are essentially based on the use of immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is quite limited, they are not well tolerated and they have a very high cost. Recent works showed an immunomodulatory effects of HMG-CoA reductase inhibitors (the so-called "statins"). In experimental allergic encephalopathy, a murine model of MS, statins inhibit the onset and progression of the disease through a shift from Th1 towards Th2 cytokine production. Other in vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the blood brain barrier. Furthermore, in an open labeled human study in MS, statin regimen was associated with a decreased lesional activity assessed by MRI. Statins are well tolerated drugs, used for many years, with a low cost and with a putative efficacy in MS. The investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a double-blind, placebo-controlled study in 40 patients with a relapsing-remitting MS.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing remitting MS with diagnosis defined by the McDonald criteria (McDonald et al., 2001) with no current disease modifying therapy (interferon, copaxone or immunosuppressant drugs) since at least 3 months and an EDSS score \< 5.
* At least one gadolinium positive lesion on the MRI of the selection phase is needed.
* No current statin therapy.
* Normal renal and hepatic biological tests.
* No current pregnancy
Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.

Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 \& day 14 of each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in the next 4 cycles is the standard clinical practice in Vietnam for breast cancer, this regimen is to facilitate the dose-dense schedule, patients receive every-2-week therapy along with G-CSF support. the accelerated dose-dense schedule improve disease-free and overall survival among women with breast cancer .Primary objective of this study is to compare the efficacy and safety of Nanogen's Pegcyte and Roche's Neulastim for prevention of chemotherapy (Accelerated AC regimen)-induced neutropenia on breast cancer patients. Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be recruited in this trial. All eligible patients receive single subcutaneous injection of study drugs 24 hours after chemotherapy administration in each cycle for 3 consecutive cycles. Efficacy and safety assessments will be assessed based on the incidence of severe neutropenia in combination of temperature \> 38.3℃ or sepsis or life threatening infection and incidence of serious adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 18 - 65 years.
* Patients with histological confirmed primary invasive breast cancer; stage I, II or III.
* Patients had no prior chemotherapy treatments.
* Patients scheduled to undergo myelosuppressive Doxorubicin and Cyclophosphamide chemotherapy for 04 cycles, and Paclitaxel chemotherapy for the next 04 cycles; patients were available for 14 days of each cycle for the first 03 chemotherapy cycles.
* Patients with baseline ANC ≥ 1.5 x 109/L, PLT ≥ 100 x 109/L, HgB ≥ 9 g/dL, WBC ≥ 3,000/mL and albumin ≥ 3.0 g/dL.
* Performance status as per ECOG (Eastern Cooperative Oncology Group) score 0, 1 or 2.
* Willing to give written and signed informed consent.

Exclusion Criteria:

* Patients with prior exposure of G-CSF or GM-CSF or its pegylated products in clinical development less than 6 months prior to randomization.
* Myelotoxic concomitant treatment such as chloramphenicol, methotrexate, immunomodulating agents, interferons during 10 days before randomization.
* Received systemic antibiotic treatment within 72 hours of chemotherapy.
* Chronic use of corticosteroids, prior bone marrow or stem cell transplant.
* Patients who had an immediate/ concurrent exposure to radiotherapy or surgery (within 4 weeks).
* Severe medical disease: cardiovascular, hepatic, renal, pulmonary...
* Known cases of hematological disease (sickle cell anemia, AML...)
* History of HIV positive, active hepatitis.
* Pregnant and lactating women or patients planning to become pregnant.
* Known allergic reactions to study medications.
* Positive to anti-pegfilgrastim antibody test
Erector Spinae Plane Block for Postoperative Pain in Percutaneous Nephrolithotomy Patients: a Retrospective Study

To evaluate the ability of Erector spina Plane block decrease postoperative pain and analgesia requirements in patients undergoing Percutaneous Nephrolithotomy.

Erector spina Plane block was performed with guided ultrasound at T10 Transverse process level would lead to adequate postoperative analgesia ,in Percutaneous Nephrolithotomy surgeries.

Eligibility Criteria:
Inclusion Criteria:

* ASA I- ASA II Patients

Exclusion Criteria:

* history of allergy to the study medication
* refusal to participate
Feasibility Study of the Pilot Post-primary Active School Flag (PPASF) Program

The Feasibility of the post-primary Active School Flag (PPASF) programme. The PPASF is an initative from the Department of Education and Skills in a whole-school program to increase physical activity opportunities involving the students in second level education schools in Ireland. Various actors involved in the process include admin, teachers, and students to create more physical activity opportunities for the students in the school. Process evaluation and fidelity of the program are carried out during the year long process for certificate and two years for achieving the flag. Results of this study will inform the design and implementation of the PPASF in a national roll out across Irish second level education schools.

This is a feasibility study of the post-primary Active School Flag (PPASF) programme. Schools in Ireland that meet the eligibility criteria of; 1) second level education school, 2) has not already achieved the Active School Flag, 3) volunteered to be in the study were selected to take part in this pilot study. Schools not in the programme were matched to provide a comparison data set.

Schools involved in the study are given resources to support the year long program so the school may achieve the PPASF certificate. To achieve the certificate, the schools needed to complete 17 tasks throughout the school year; 1) a staff slideshow, 2) an PPASF team slideshow, 3) class time slideshow 4) PPASF training day, 5) an PPASF awareness week (towards the beginning of the year), 6) website showcase, 7) PPASF whole school questionnaire, 8) PPASF launch event, 9) PPASF action plan, 10) 'Did You Know?' campaign, 11) PA module as part of Social, personal and health education (SPHE) subject for junior cycle students, 12) Active School WALKWAY, 13) Community Mapping of extra curriculum activities, 14) Community Event, 5) Active School Week, 16) PPASF accreditation visit, and 17) school PA space audits.

The PPASF is part of the developing Healthy Ireland Demonstration Project, and the feasibility to collect data in the form of accelerometers, physical health measures and self-perceptions of health are also included in the feasilibility study.

The feasibility study will be monitored quantitatively through a custom design fidelity check list, and in depth process evaluation that includes qualitative methods such as one to one interviews and focus group interviews throughout the academic year.

The secondary outcomes are based on the hypotheses that 1) intervention schools will have more physical activity opportunities and thus 2) more physically active students, especially during the school day. Furthermore, there would be 3) a decrease in sitting time, 4) positive associations between academic related behaviours with physical activity behaviours, 5) and no increase in BMI.

Eligibility Criteria:
Inclusion Criteria:

* students and teachers in the enrolled schools

Exclusion Criteria:

* students and teachers not enrolled in the schools
* students who did not provide consent or assent to take part in the study
An Investigation of Biomarker Candidate Molecules in Laryngeal Carcinoma

The aim of this study was to determine serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin in patients with larynx squamous cell carcinoma; investigate their association with clinical parameters and determine their diagnostic and prognostic value.

Although there has been a significant increase in survival in many other cancer types through the years, no significant increase has been achieved in laryngeal SCC survival rates in the last 50 years. Despite the advancements in surgical techniques, organ preservation protocols and multidisciplinary approach, significant amount of patients have been living with morbidity or dying due to recurrence and metastasis. This lack of significant improvement in mortality rates creates the need for reliable and accurate biomarkers in early diagnosis, treatment and follow-up. Considering that the prognosis of two patients at the same clinical stage and treated with the same treatment protocol may differ, it suggests that there may be some differences at the molecular level apart from clinical stages.

This study was mainly prepared to determine serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin in patients with larynx squamous cell carcinoma; investigate their association with clinical parameters and determine their diagnostic and prognostic value.

To reach these aims, 60 patients who were prospectively and consecutively recruited from those who admitted to Hacettepe University, Department of Otorhinolaryngology, Ankara, Turkey, and were diagnosed with LSCC between May 2018 and February 2020. 20 healthy and age-matched controls were chosen from the hospital staff and relatives of the patients. Serum samples were obtained from all participants at the time of diagnosis, centrifuged and stored at -80 C. ELISA method will be used to analyze the serum levels of VEGF, sVEGFR1, VEGFR2, IGFBP-3, angiogenin and endoglin.

Data analysis will reveal if there are any association between biomarker candidate molecules and clinical parameters.

Eligibility Criteria:
Inclusion Criteria:

* 60 male or female patients with a newly diagnosed laryngeal squamous cell carcinoma
* Patients without any previous history of laryngeal carcinoma
* 20 healthy, age- and sex- matched controls

Exclusion Criteria:

* Previous history of laryngeal squamous cell carcinoma
* Having comorbid systemic diseases like DM, hypertension, cardiologic or rheumatologic diseases
* Having malign tumors elsewhere
* History of chemotherapy/radiotherapy.
Osteoporosis Awareness in Rheumatoid Arthritis Patients

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Rheumatoid arthritis patients are at increased risk for developing osteoporosis. It is crucial to identify whether rheumatoid arthritis patients know and know about this disease. This study investigates awareness and knowledge of osteoporosis in rheumatoid arthritis patients.

Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with rheumatoid arthritis are at high risk of developing osteoporosis due to chronic inflammation and the medications they use. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with rheumatoid arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of rheumatoid arthritis
* Must be between the ages of 18 and 90
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent
Use of CADISS Medical Device to Facilitate Dissection of Epidural Fibrosis in Revision Spine Surgery

The CADISS® System, Chemically Assisted mechanical DISSection, is intended for the selective detachment of pathological tissue layers and/or fibrotic tissues in various surgical procedures without using cutting instruments. It is based on the property of the drug mesna (Sodium 2-mercaptoethane sulfonate) to cleave the disulfide bonds responsible for the adherence of pathological tissues and for the strength of fibrosis. Revision spine surgery is more difficult than primary surgery because of the development of fibrosis and scar tissues since the first operation. Fibrosis may develop in the spinal canal and will adhere strongly to the dura mater and to the nerve roots. This study is a prospective, multi-sites, open label, single cohort clinical trial evaluating the use of CADISS medical devices to facilitate dissection of epidural fibrosis in patients who undergo a revision in spine surgery after at least one year.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old, weight \> 30 Kg
* Eligible for Spine revision surgery, at least one year after primary surgery
* Agree to participate and sign the informed consent

The age and weight of patient are defined according to the instruction for use of the CADISS System currently on the EU market.

Exclusion Criteria:

* \< 18 years old
* Weight ≤ 30 kg
* Primary surgery
* Known hypersensibility to mesna
* Patient is pregnant, breastfeeding or has wish of pregnancy during the study.
* Unable to sign the informed consent
* Participation in any study involving an investigational drug or device within the past 3 Months.
* Individuals under tutorship or trusteeship.
Internal Jugular Venous Distensibility Index and Innominate Venous Flow Patterns As Predictors of Fluid Responsiveness

The measurement of internal jugular vein distensibility index corresponds to the measurement of stroke volume using trans-thoracic Doppler echocardiography in assessing the response to fluid administration in elective surgical patients.


Eligibility Criteria:
Inclusion Criteria:

1. Utilizing intraoperative mechanical ventilation with a tidal volume of 8 ml/kg (PBW).
2. ASA physical status 1-3.
3. Mongoloid ethnicity.
4. Willing to participate in the research and sign the informed consent.

Exclusion Criteria:

1. Patients with symptoms and signs of fluid overload, such as pulmonary edema, pleural effusion, ascites, and peripheral edema.
2. Patients with chronic or acute kidney dysfunction, renal replacement therapy history, and/or oliguria (urine output \<0.5 ml/kg/hour).
3. Patients with cardiovascular diseases, including heart failure, cardiac arrhythmias, moderate-to-severe valvular abnormalities, a history of angina/myocardial infarction, pulmonary hypertension, and peripheral artery disease.
4. Patients with anatomical abnormalities in the neck and chest region that make it impractical to perform jugular vein ultrasound and transthoracic echocardiography.
5. Jugular vein thrombosis.
6. Superior vena cava syndrome.
7. Placement of jugular vein catheter.
8. Body mass index (BMI) greater than 30.0 kg/m2.
9. Patients with contraindications to the use of muscle relaxants.
10. Patients with lung hyperinflation and pleural effusion.

Drop out criteria:

1. Patients who wish to withdraw from the study.
2. Post-anesthesia induction complications and emergencies.
3. Transthoracic echocardiography provides a less representative image due to difficult acoustic window.
An Observational Study of Avastin (Bevacizumab) in Patients With HER2-metastatic or Locally Advanced Breast Cancer

This observational study will evaluate the safety and efficacy of triple negative or HR+ patients with HER2-metastatic or locally advanced breast cancer treated with Avastin (bevacizumab) as first line therapy for at least 12 months and without disease progression for at least 12 months. Data will be collected retrospectively (from the diagnosis to the inclusion in the study) and for 18 months from study start.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* HER2-metastatic breast cancer or locally advanced breast cancer
* Patients with Avastin as first line therapy administered for at least 12 months
* Patients without disease progression after the beginning of Avastin treatment for at least 12 months

Exclusion Criteria:

* Patients not willing to give informed consent