cyrilzakka/clinical-trials huggingface dataset:
Transcatheter Arterial Infusion to Patients With Advanced Pancreatic Cancer

The purpose of this study is to evaluate the efficacy of gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion to Patients with Advanced Pancreatic Cancer.

Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. The MPACT trial has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the side-effects related to gemcitabine combined with nab-paclitaxel including anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.

Regional intra-arterial infusion chemotherapy helps to deliver anticancer drugs into the carcinoma tissue more selectively and is considered to be a potential alternative treatment for advanced pancreatic adenocarcinoma with less systemic adverse effects. Ohigashi et al first reported that intraarterial chemotherapy using 5-fluorouracil improved the prognosis and quality of life in patients with advanced pancreatic carcinoma.

The purpose of this study is to evaluate the efficacy of gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion to patients with advanced pancreatic cancer. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every three weeks.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document.
* Age ≥ 18 years and ≤ 80 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
* Primary pancreatic cancer without major anti-cancer treatments.
* Locally advanced, or metastatic pancreatic cancer.
* Presence of at least of one measurable lesion in agreement to RECIST criteria.
* The expected survival ≥ 3 months.
* Adequate organ performance based on laboratory blood tests.
* Patients who are willing or able to comply with study procedures.

Exclusion Criteria:

* Pregnant or nursing women.
* Patients who have received anti-tumor chemotherapy, radiotherapy, or other treatments.
* The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
* Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
* Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
* Cardiovascular and cerebrovascular accidents.
* Allergic to study drugs.
* Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Healthy Oils for Women (HOW Study)

The purpose of this study is to understand the role of a dietary oil to alter chronic disease risk factors in women who are at risk for heart disease and/or diabetes. The investigator's previous study showed that safflower oil reduced trunk fat mass in women with diabetes. The investigators believe safflower oil can also attenuate criteria of metabolic syndrome through reduction in trunk fat mass.

The long-term goal is to develop effective and novel dietary and lifestyle strategies to reduce the progression of metabolic syndrome to chronic diseases such as coronary heart disease. The rationale for conducting this research study is that there are few effective strategies that target changes in body composition and metabolism as a means to attenuate metabolic syndrome. The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims.

Specific Aim 1: Quantify the extent that linoleic acid reduces trunk adipose mass in women with metabolic syndrome.

Specific Aim 2: Measure changes in visceral adipose tissue

Specific Aim 3: Determine the time-dependent effect of linoleic acid to increase adiponectin levels.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Post-menopausal (cessation of menses ≥12 months)
* Age ≥ 50 and ≤ 69 years
* At Least one of the following metabolic syndrome criteria

  * Elevated triglycerides (\>150mg/dl)
  * Reduced HDL-C (\<50mg/dl)
  * Elevated blood pressure (\>130mm Hg systolic or \> 85 mm Hg diastolic)
  * Elevated blood glucose (\>100mg/dl and \<126mg/dl)
* Obese (BMI ≥ 30 kg/m² and ≤ 55 kg/m²)

  * Stable medical therapy for past 3 months
* Stable body weight (within ± 2 kg) for past 3 months
* Waist circumference \>88cm (35 inches)

Exclusion Criteria:

* Substance abuse
* Current/previous diagnosis of type 2 diabetes or fasting blood glucose ≥126 mg/dL
* Current use of medications or supplements known to affect body composition
* Current or previous use of oral hypoglycemic agents or exogenous insulin.
* Impaired cognitive function
* Current or previous diagnosis of renal, heart, or circulatory disease
* Gastrointestinal diseases or disorders
Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia

This study aims to monitor the incidence rates and duration of hospitalisations for rotavirus gastroenteritis (RV GE) and all cause GE, compared to bronchiolitis from 1998 to 2009, in children \< 5 years of age after the introduction of Rotarix in 2006 by year, both inside and outside rotavirus season in Australia. It further aims to compare the two dose regimen of Rotarix with the three dose regimen of RotaTeq from 2007 to 2009.


Eligibility Criteria:
Inclusion Criteria:

* Children \<5 years of age;
* Children with a diagnosis of all-cause gastroenteritis, rotavirus gastroenteritis or bronchiolitis in the Australian Institute of Health and Welfare (AIHW) database in New South Wales, Australian Capital Territory, Tasmania and Northern Territory, from 1998 to 2009;
* Children who were vaccinated with Rotarix or RotaTeq in New South Wales and Queensland, registered in the Australian Childhood Immunisation Register (ACIR) database in Queensland and New South Wales, from 2007 to 2009.

Exclusion Criteria:

No exclusion criteria will be applied.
Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child

In children requiring botulinum toxin injections, improving supervisory procedures of injection sessions to reduce pain and improve the experience of this invasive procedure is needed. The intervention of medical clowns seems very interesting in this goal, but its effectiveness has not been proven within the botulinum toxin injections. The objective of the study is to evaluate in terms of profit the presence or absence of clowns during a session of botulinum toxins by determining their impact on pain and anxiety felt among children and their carers

In the literature, the presence of clowns allows a major reduction of pain and anxiety in children and their accompanying in various medical and hospital surgical settings. A previous study on a population of 60 children was conducted to assess the impact of the presence of clowns during the production of botulinum toxin injection in children but not confirming the benefit of their participation in carrying this medical procedure. The results of this study are opposed to current scientific data. Their impact clown assessment criteria seem however insufficient to actually support the conclusion as to the ineffectiveness of distractibility clowns in this specific medical procedure iterative injection of botulinum toxin.

The objective of the study is to evaluate the pain and anxiety before and after the botulinum toxin injection session in children and hetero-assessment of pain and anxiety by accompanying depending on the presence or not of clown. The second objectives are the evaluation of the course of the session by the injector doctor, the accompanying of the child and to evaluated the effect of distraction during the toxin of the clown or the usual distraction (music, movie...)

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 to 18 years
* Children with a neurogenic spasticity (cerebral palsy, spastic paraplegia, head trauma ...)
* Children with muscular pains orthopedic disorders (POPB, equino varus, ..)
* Botulinum Toxin Injection functional target, improvement in pain or amplitudes
* First injection or repeated injections of toxins
* No opposition formalized

Exclusion Criteria:

* Children between 0 and 1 year
* Opposition formalized to the data use
A Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants with Type 1 Diabetes

This study will be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Female or male adults with Type 1 diabetes
* Ages 18-65 years
* Type 1 DM for at least 3 years
* Using an insulin pump or multiple daily injections (MDI) for at least 3 months
* BMI 25.0 - 35.0

Exclusion Criteria:

* Significant medical history
* Uncontrolled diabetes
* History of surgical treatment for weight loss
* History of malignancy
Serum Prolidase Activity and the Role of Leptin in Osteomalacia

Evaluation of the change of serum Prolidase and Leptin values in the diagnosis and follow-up of osteomalacia and its clinical usability

Osteomalacia describes a bone disorder in adults that is usually caused by long-term vitamin D deficiency. Osteomalacia, a metabolic bone disease characterized by impaired mineralization of the bone matrix.Not a single laboratory finding is specific to osteomalacia.The relationship between collagen and prolidase activity has been observed during fibrotic processes, where an increase in prolidase activity is accompanied by an increase in tissue collagen deposition. It has also been suggested that serum activity is increased in metabolic bone diseases.Leptin is a 16 kDa peptide hormone. It is a member of the long chain helical cytokine family, which is mainly produced by fat cells and proportional to the size of the stored fat. Leptin affects bone remodeling by reducing the activity of osteoclasts and thus participates in the pathogenesis of osteoporosis. In the light of these studies, the investigators planned our study according to the clinical significance of serum prolidase activity in osteomalacia and the place of leptin in osteomalacia.

Eligibility Criteria:
Inclusion Criteria:

* Among the patients who applied to the outpatient clinic, those with clinical complaints of osteomalacia (diffuse pain, fatigue, rapid fatigue, proximal extremity weakness, etc.)
* 25 0H vit. D level of 10ng/ml and below

Exclusion Criteria:

* Other metabolic and endocrine bone diseases (secondary osteoporosis, paget hast, osteogenesis imperfecta, osteomyelitis etc.)
* Patients who have previously received treatment for low vitamin d
* Those with low vitamin D levels due to liver or kidney failure
* Those who receive treatment for tumor
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.

The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Non small cell lung cancer, Stage IIIB or Stage IV
* One and only 1 prior platinum-based chemotherapy
* No other uncontrolled concurrent illness
* Use of highly effective birth control methods in males or females with reproductive potential

Exclusion Criteria:

* Previous participation in another trial within the last 4 weeks
* Surgery within 10 days prior to the start of study treatment
* Brain metastases
* Confirmed diagnosis of infection with the human immunodeficiency virus (HIV)
* Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication
* Breast feeding
Management of Joint Pain Associated With Osteoarthritis of the Knee With Association of Plant Extracts.

The aim of the study is to evaluate at 3 months the effect of a supplementation with extracts of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability of pain for patients suffering from gonarthritic pain.

For this study, 126 patients are going to be included. They will have a supplementation of Cartimotil Fort®, from 1 to 4 capsules per day during 90 days.

on the one hand, during the two visits (inclusion and follow-up), the investigator completes the questionnaire about neuropathic pain (DN4).

on the other hand, patients complete the Osteoarthritis Symptom Inventory Scale (OASIS) 4 times : just after the inclusion visit, at day 30, at day 60 and just before the follow-up visit (day 90). He completes the Patient Global Impression of Improvement (PGII), the Minimal Clinically Important Improvement (MCII) and the Acceptable Symptomatic Statement (PASS) 6 times : just after the inclusion visit, at day 10, at day 20, at day 30, at day 60 and just before the follow-up visit (day 90).

Eligibility Criteria:
Inclusion Criteria:

* VAS of pain : minimum 5/10 on walking or 4/10 at rest
* Patients with a negative PASS (patient considering that the symptomatic state is not acceptable)
* Suffering from mono or bilateral femoro-tibial knee osteoarthrosis with painful seizures (confirmed by a radio of less than two years: stage 2 or 3 on the Kellgreen scale - clinical examination)
* Having agreed to participate in the investigation after receiving information from the investigator

Exclusion Criteria:

* Patients with rheumatological disorders other than osteoarthritis
* Patients for whom knee surgery is planned within 3 months
* Patients who started treatment with chondroitin sulphate (or all treatments of osteoarthritis other than anti-inflammatories and analgesics) for less than one month
* Patients with a BMI greater than 35
* Patients with chronic pain that can interfere with knee osteoarthritis pain
* Patients with reduced mobility or bedridden
* Patients with cognitive impairments not able to participate in the study
* Patients with known allergies to any of the ingredients of Cartimotil Fort®
* Pregnant or breastfeeding patients
* Patients who do not wish to participate in the study.
Comparison of Skinlink With Suture for ED Patients

The purpose of this study is to determine whether suture using the Device of "Leukosan Skinlink" is more faster and safer than that of "nylon" in the treatment of simple wound for ED patients.


Eligibility Criteria:
The inclusion criteria were age 18-75 years,presence of a partial thickness laceration, generally good health without systemic abnormalities,agreement to return for a 14-day follow-up, and written informed consent. The exclusion criteria were previous diagnosis of diabetes mellitus, peripheral vascular disease, or bleeding disorders; history of keloid formation or scar hypertrophy; and allergy to cyanoacrylate compounds or formaldehyde
Breast Localization: RFID Tags vs Wire Localization

The RFID trial focuses on breast localization in patients with non-palpable breast cancers. It aims to demonstrate the improvement in patient comfort when using the Radio Frequency Identification (RFID) tag and LOCalizer™ device compared to the gold standard device.

It is an observational, prospective, single-center, 2-arm (RFID group vs. standard gold), non-randomized and category 3 comparative study. The RFID trial focuses on breast localization in patients with non-palpable breast cancers. These patients will benefit from a mastology consultation: consent will then be acquired. The RFID tag or the gold standard localization will be put in place during this consultation (one day before surgery).

Patients will fill in their questionnaire in two steps:

* during the installation of the device (RFID tag or wire localization) to evaluate the patient's pain,
* then at the 1-month post-operative consultation to assess pain in the interval until surgery Radiologists and surgeons will fill out the questionnaire dedicated to them after each procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older,
* Requiring conservative surgical management for a breast lesion -infra-clinical (fibroadenomas, papillomas, atypical lesions, neoplasia), whose histology will have been proven beforehand by anatomopathology.
* Patients referred to mastology for preoperative identification by the surgeons
* Able to give informed consent to participate in the research.
* Affiliation to a Social Security regime

Exclusion Criteria:

* Multiple breast lesions
* Patients with breast neoplasia during pregnancy.
* Person deprived of liberty or under guardianship or incapable of giving consent
* Refusal to participate
Non-interventional Study (NIS) to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors

This is a multi-centre non-interventional study of patients who are treated with any HMGCoA reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and fluvastatin) for at least 6 months. All HMG-CoA reductase inhibitors must be prescribed in accordance with SmPCs approved in Croatia. Data collection for each patient will take place at a single visit. The investigator will complete a Case Report Form with the patient's demographics, the presence of the factors for high cardiovascular risk, current treatment, cholesterol values as well as with further treatment decision.


Eligibility Criteria:
Inclusion Criteria:

* patients who have been treated with one HMG-CoA reductase inhibitor for at least 6 months without changing the dose for the last 4 weeks at least.
* All patients must sign Informed consent form.

Exclusion Criteria:

* Patients who have not signed the Informed consent form.
* Patients with contraindication for the treatment with HMG-CoA reductase inhibitors as per SmPC approved in Croatia.
The Role of PKC Activation in the Immune-inflammatory Mechanism of Major Depressive Depression

Major Depressive disorder (MDD) is a heterogeneous mental illness. Treated with antidepressants that act on the neurotransmitter and/or their receptors just remitted only one third of patients with MDD, Thus, to improve the efficacy is a major unmet need for depression. Based on the scientific reports, inflammation plays a definite role in the development and treatment of depression, which may be an important way to understand and finally solve the problem. Our team found that there were significant changes in tumor necrosis factor (TNF)-α and other inflammatory factors in depressed patients, which caused neuronal apoptosis and depressive symptoms; PRKCB1(gene of protein kinase C-β) plays an anti-inflammatory role by regulating protein kinase C(PKC) activation in specific brain region, improving neuroplasticity and playing an antidepressant role. In this study, we assumes that the treatment-resistant depression patients maybe due to the immune inflammation and PKC activation inconsistency or unsynchronized, which couldn't reversible microglia polarization and neuronal apoptosis in specific brain regions, then, caused the significant changes at emotional and cognitive neural circuits, so as to exhibit such as emotional, cognitive symptoms of depression. Therefore, activating PKC and regulating immune/inflammatory process will be another way to improve the treatment outcome of depression. Take consideration, we focus on treatment-resistant depression patients, to validate the relationship between PKC activation and the immune inflammatory mechanism of depression, evaluate the antidepressant effect of golimumab or calcium tablet (a PKC activator) plus escitalopram, and initially proposes idividualized treatment strategies for MDD.

This is a randomized, double blind, placebo-controlled antidepressant augmentation trial. All participants are randomly divided into 3 groups treated orally with "escitalopram + golimumab" (N = 60), "escitalopram + calcium tablet" (N = 60) or "escitalopram +placebo" (N = 60).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy men or women of matched age, gender and education with that of treatment-resistant depression (TRD) group;
2. A willingness to adhere to all prohibitions and restrictions necessary for the study;
3. Signed informed consent.

Exclusion Criteria:

1. Participant who have severe mental diseases, physical diseases, cerebrovascular disease, or a history of traumatic brain injury;
2. Participant who had a serious allergic reaction disease or those who have suffered from diseases of the immune system;
3. Participant who used anti-inflammatory drugs, or immunomodulatory drugs no more than 1 month prior randomization;
4. Pregnant or lactating female.
Chuvashia Inappropriate Prescribing Study

This is a cross-sectional study based on an outpatient registry. All medical therapy will be registered in order to assess inappropriate prescribing's, in accordance with the criteria PROMPT and BEERS, also in accordance with the officially approved instructions for the use of this medicinal product.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years old, multimorbidity, signed Patients' Informed Consent

Exclusion Criteria:

* Age \< 50 years, presence of mental illnesses, oncological diseases detected less than 5 years ago, acute cardiovascular pathology within 6 months prior to inclusion.
Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset

The purposes of this research are to investigate (1) if schizophrenia patients and at-risk individuals present bradykinesia and dyskinesia and (2) if tDCS improves motor performance in schizophrenia patients and at-risk individuals. The first hypothesis is that both schizophrenia patients and at-risk individuals show bradykinesia and dyskinesia, and the motor symptoms are more severe in the former than the latter. The second hypothesis is that tDCS improves motor performance in schizophrenia patients and at-risk cases.


Eligibility Criteria:
Inclusion Criteria for schizophrenia patients:

* a diagnosis of schizophrenia without other psychiatric diseases
* having stable psychotic symptoms
* a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
* having no neurological diseases and no medical conditions that affect motor performance

No Exclusion Criteria.

Inclusion Criteria for at-risk individuals:

* a score of nine or above in the Chinese version of the 16-item Prodromal Questionnaire (CPQ-16)
* a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
* having no diagnosis of psychiatric diseases
* having no neurological diseases and no medical conditions that affect motor performance

No Exclusion Criteria.

Inclusion Criteria for healthy controls:

* a score less than nine in CPQ-16
* a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
* having no diagnosis of psychiatric diseases
* having no neurological diseases and no medical conditions that affect motor performance.

No Exclusion Criteria.