cyrilzakka/clinical-trials huggingface dataset:
Application of "Heidelberg Triangle" Dissection in Pancreatoduodenectomy and Distal Pancreatectomy

Aim of the study :

To evaluate the effect and safety of "Heidelberg Triangle" dissection (TRIANGLE operation) combined with Pancreatoduodenectomy or Distal Pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer .

Methods :

Patients who underwent pancreatoduodenectomy or Distal Pancreatectomy between 01 September 2016 and 30 December 2022 will be included in this retrospective analysis. 3D reconstruction is performed with preoperative enhanced CT, then the region of "Heidelberg Triangle" is categorized . The operation is completed by the same operation team. According to the operation mode, patients were divided into TRIANGLE group and non-TRIANGLE group and And followed up until recurrence, death or missed.

The "Heidelberg Triangle" is an anatomical area composed of Common hepatic artery (CHA), superior mesenteric artery (SMA) and superior mesenteric vein (SMV).

This area is considered to be the common site of recurrence after pancreatic surgery.

Recent studies have shown that TRIANGLE operation can improve the state of the cutting edge and has potential value in improving the prognosis. However, the data on recurrence and survival rate of pancreatic cancer and periampullary cancer after TRIANGLE operation are insufficient.

The aim of the present study is to evaluate the effect and safety of "Heidelberg Triangle" dissection combined with Pancreatoduodenectomy or Distal Pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer .

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed by preoperative imaging and auxiliary examination as resectable or borderline resectable pancreatic malignant tumor or periampullary carcinoma who underwent pancreatoduodenectomy or distal pancreatectomy, with or without TRIANGLE operation.
2. Patients who have no serious abnormalities of blood system, heart and lung function and immune deficiency and can tolerate surgery.
3. Be able to comply with the research visit plan and other program requirements

Exclusion Criteria:

1. Patients accompanied by other systemic malignancies.
2. Central nervous system disease, mental disease, unstable angina pectoris, congestive heart failure, serious arrhythmia and other uncontrollable serious diseases, unable to tolerate surgery.
3. Pregnant and lactating women.
4. Any condition that may impair the safety of patients or the integrity of research data, including serious medical risk factors, medical conditions, and laboratory abnormalities.
Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome

The purpose of this research is to obtain data or information on the safety and effectiveness of low dose naltrexone (LDN) for treating the symptoms of juvenile primary fibromyalgia syndrome. This is a dose finding study to find whether LDN helps the symptoms of juvenile fibromyalgia, and at what dose it does so.

In this pilot dosage-finding and efficacy study, we will experimentally test whether LDN reduces the symptoms of JPFS. We will recruit 40 children with JPFS. Participants will be screened via the JPFS criteria of Yunus and Masi. The study will be an open-label test of various doses of LDN to determine whether LDN reduces JPFS symptoms, and the appropriate dose at which it does so. Primary endpoints will be daily pain, fatigue, and sleep.

The protocol is designed to take 18 weeks. There are a total of 10 study visits, taking place approximately every 2 weeks.

Eligibility Criteria:
Inclusion Criteria:1. Generalized musculoskeletal aching for over 3 months duration 2. Moderate-severe pain in 5 of 11 tender points 3. Age 7 - 17 4. Male or female Exclusion Criteria:1. Diagnosed rheumatic or autoimmune condition contributing to pain 2. Abnormal laboratory results (Rf, ANA, ESR) 3. Use of opioid analgesics in the last 6 months 4. Severe depression and/or anxiety as evidenced by a diagnosis of either disorder, or by evidence based on a clinical interview with the patient and parent at the time of screening. 5. Current or previous psychiatric disorder requiring hospitalization 6. Inability to operate Palm OS® handheld device for self-reports 7. Inability to understand English 8. Inability to attend sessions at Stanford lab every 3 weeks 9. Pregnancy or planned pregnancy, or breastfeeding 10. Abnormal liver functioning tests
A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease

This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Have used artificial tears for dry eye

Exclusion Criteria:

* Start date of over the counter, herbal, prescription or nutritional supplements that may affect dry eye or vision within 3 months prior to study start or an anticipated change in dosage during the study
* History of eye surgery or trauma in the 6 months prior to study start
* Current use or use within 2 weeks of study start, of topical eye medications.
Transcutaneous Spinal Cord Neuromodulation to Normalize Autonomic Phenotypes

This study looks to characterize autonomic nervous system dysfunction after spinal cord injury and identify the potential role that transcutaneous spinal cord stimulation may play at altering neuroregulation. The autonomic nervous system plays key parts in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury typically encounter complications. For both individuals with spinal cord injury and uninjured controls, experiments will utilize multiple parallel recordings to identify how the autonomic nervous system is able to inhibit and activate sympathetic signals. The investigators anticipate that those with autonomic dysfunction after spinal cord injury will exhibit abnormalities in these precise metrics. In both study populations, transcutaneous spinal cord stimulation will be added, testing previously advocated parameters to alter autonomic neuroregulation. In accomplishing this, the investigators hope to give important insights to how the autonomic nervous system works after spinal cord injury and if it's function can be improved utilizing neuromodulation.


Eligibility Criteria:
Inclusion Criteria:

All participants

- age 18-30 years old.

Participants with spinal cord injury

* Adult onset, traumatic spinal cord injury.
* Time since injury 1 year, in an effort to limit baroreflex desensitization.
* American Spinal Injury Association Impairment Scale, A, to limit potential confounders.
* Neurological level of injury, T1-T6, as defined by the International Standards for Neurological Classification of Spinal Cord Injury.

Exclusion Criteria:

* History of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes.
* Women who are pregnant or lactating.
* Currently taking blood thinners.
* Taking anti-hypertensive or other medication that could influence any of the dependent autonomic variables.
Safety and Accuracy of Alveoscopy in Interstitial Lung Diseases

Fibered confocal fluorescence microscopy (FCFM), also referred to as Cell-Vizio® (MaunaKea Technologies, France) is a new technique that produces microscopic imaging in a living tissue, through a 1 mm fiberoptic miniprobe that can be introduced into the working channel of the bronchoscope. The system produces real-time imaging of endogenous fluorophores with a 5 µm lateral resolution and a field of view of 600 x 600 µm. FCFM is able to produce dynamic, high-resolution microimaging of the respiratory bronchiolar walls, alveolar ducts and sacs in vivo during endoscopy (a procedure termed as alveoscopy).

The hypothesis of this study is that an alveoscopy makes it possible to analyze the microstructure of the distal airways in vivo and to collect specific morphologic information in patients with interstitial lung diseases.

The goals of this French Phase II trial are:

* to evaluate the tolerance of the alveoscopy
* to describe the normal appearance of the bronchoalveolar system in spontaneous ventilation in normal subjects
* to describe specific alterations of the bronchoalveolar microstructure in focal or diffuse interstitial lung diseases

The study will include 40 healthy smoker or non-smoker volunteers, 20 patients with normal Chest CT scan and normal respiratory function tests, and 90 patients with focal or diffuse peripheral lung diseases.

The Alveoscopy will be performed under local anesthesia, in awake patients during a standard bronchoscopy. The Alveoscopy will be performed on one side of the bronchial tree (left or right lung). Two to ten separate bronchial areas will be explored in each patient, depending on the pathology, focal or diffuse, and the underlying respiratory function.

A continuous monitoring of the Oxygen saturation, blood pressure, EKG will be performed during the procedure. A chest X-ray will be performed after the procedure to eliminate a pneumothorax.

The morphometric parameters of the alveolar microstructure and their variability will be studied according to the age, gender, lung area explored, smoking status in healthy volunteers and "normal CT scan" subjects, as well as in patients with peripheral lung diseases.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers: normal chest X-rays and normal lung function tests
* Patients without parenchymal lung diseases: normal chest computed tomography (CT) scan, normal lung function tests, indication for a bronchoscopy
* Patients with parenchymal lung disease: indication for a bronchoscopy
* Written informed consent for the alveoscopy

Exclusion Criteria:

* Bleeding disorders
* Pulmonary hypertension
* Contraindication for a bronchoscopy
* known hypersensitivity to the fluorescent contrast agent (if required)
Ethnic/Racial Differences in Metabolism and DNA Adduct Formation

The study will investigate the role of 1,3-butadiene metabolic activation and deactivation in lung cancer risk among various ethnic/racial groups. This project will require urine samples from smokers and nonsmokers from the three ethnic/racial groups recruited by the Clinical and Biomarker Core for the analysis of 1,3-butadiene DNA adducts. Data on nicotine intake (urinary TNE) in these subjects as well as in 400 lung cancer cases and 400 controls from Project 1 will be also required for this project.


Eligibility Criteria:
Inclusion Criteria:

* One of the three targeted ethnic groups:

  * Japanese American - two parents of Japanese descent
  * Non-Hispanic Whites - two parents of non-Hispanic white descent
  * Native Hawaiians will include individuals with at least one parent of Hawaiian descent;
* Smoke 5 cigarettes per day over the past three months;
* \>21 years of age;
* Consumes 14 or fewer drinks of alcohol per week;
* Generally stable and good health (determined by review of medical history);
* Able to provide written voluntary consent before performance of any study related procedure.

Exclusion Criteria:

* Current use of other nicotine containing products for \> 4 times per month (and no use of any nicotine-containing products except cigarettes for 2 weeks prior to their study visits);
* Acute or uncontrolled medical or psychiatric conditions;
* Currently taking any medications that affect relevant metabolic enzymes or anti- inflammatory medications such as ibuprofen (this will be reviewed by study investigators on a case-by-case basis);
* Active infection (e.g., influenza, cold, respiratory infection, sinus infection) at the time of the visit;
* Pregnant or nursing or planning on becoming pregnant during the study;
* Unable to read and understand English.
Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course

A single- center prospective observational study. This study evaluates different aspects of endothelial function. It investigates the endothelial leakage with the venous occlusion plethysmography and the flow-mediated vasodilatation by ischaemia reperfusion testing.


Eligibility Criteria:
Inclusion Criteria:

* Offered patient information and written informed consent
* Female patients aged greater than or equal to 18 years:

  1. for reduction of a primary ovarian tumour or recidive of an ovarian tumour
  2. pregnant patients with:

     * clinical normal pregnancy
     * pregnancy with weight gain of more than 10 kg
     * pregnancy and gestosis
  3. healthy volunteers

Exclusion Criteria:

* Persons without the capacity to consent
* Unability of German language use
* Lacking willingness to save and hand out data within the study
* Accommodation in an institution due to an official or judicial order
* (Unclear) history of alcohol or substances disabuse
* Coworker of the Charité
* Advanced disease of the oesophagus or upper respiratory tract
* Operation in the area of the oesophagus or nasopharynx within the last two months
* Neurological or psychiatric disease
* CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospital stay
* American Society of Anaesthesiologists (ASA) classification greater than IV
* Renal insufficiency (dependency of haemodialysis)
* Pulmonal oedema in thorax x-ray
* History of intracranial hemorrhage within one year of participation in the study
* Conditions following venous thrombosis within the last three years before study inclusion
* Inflammatory or reflective disease of blood vessels (Raynaud-Syndrome, Vasculitis)
* Inherent connective tissue disease(e.g. Marfan Syndrome)
Comparison of the Clinical Examination and the Joint Ultrasonography in Lupus Patients

Arthritis is a current manifestation of systemic lupus erythematosus (SLE) and participates to the SLEDAI composite score calculation (0 to 105). Ultrasonography (US) is a validated and sensitive tool for joint assessment. Published studies showed US joint abnormalities in systemic lupus erythematosus patients with or without joint pain. Nevertheless, ultrasonography evaluations were not standardized and no study compared clinical and ultrasonography assessments. The objectives were 1) to describe ultrasonography joint abnormalities in systemic lupus erythematosus population, 2) to compare clinical and ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical swollen joint count (C-SJC) and SLEDAI (C-SLEDAI) score versus ultrasonography-SJC and ultrasonography-SLEDAI.


Eligibility Criteria:
Inclusion Criteria:

* Systemic Lupus Erythematosus patients (with or without joint involvement).
* subjects will have to sign the inform consent before the beginning of the study

Exclusion Criteria:

* Current pregnancy or no effective contraception
Risk Model of Cognitive Impairment in Diabetes

Development and validation of a risk model for predicting the risk of mild cognitive impairment among individuals of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus ;
* Aged:40 -80 years ;
* Montreal Cognitive Assessment Scale (MoCA) scores 19 - 30;

Exclusion Criteria:

* Mini-mental State Examination(MMSE) scores \< 24;
* Other dementia related neurological diseases or depression, schizophrenia in the past 2 years;
* Central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction;
* Severe sinusitis, nasal cavity and sinus polyps, skull base or nasopharyngeal tumors and other space occupying lesions, congenital diseases and traumatic history of nose, maxillofacial and skull base affecting olfaction;
* Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or severe hypoglycemic coma.
Potential Prognostic Markers of Recovery in Post-stroke Rehabilitation

Despite increasingly effective early treatment strategies for ischemic stroke, post-stroke recovery is often incomplete and depend on spontaneous and therapeutic-induced processes related to neuroplasticity, angiogenesis and reperfusion. These processes are regulated by growth factors, neurotrophines, neurotransmitters, hormones and other factors. This study aims to search biomarkers that prognose brain repair ability and consequently estimate an outcome of stroke patients. The prognostic value of proteins VEGF, IGF-1 and MMP-9 and expression of genes VEGF, IGF-1, MMP-9 is evaluated in association with clinical scales including cognitive assessment scales and depression scales. Blood sample collection as well as scales recording are taken at baseline and 3 weeks later after rehabilitation.

Despite increasingly effective early treatment strategies for ischemic stroke, post-stroke recovery is often incomplete and depend on spontaneous and therapeutic-induced processes related to neuroplasticity, angiogenesis and reperfusion. These processes are regulated by growth factors, neurotrophines, neurotransmitters, hormones and other factors. Recovery activity can be reflected both in the clinical assessment of the patient (based on the NIHSS or MRS scale for example) as well as on the biochemical and molecular level. This study aims to search biomarkers that prognose brain repair ability and consequently estimate an outcome of stroke patients. The prognostic value of proteins VEGF, IGF-1 and MMP-9 and expression of genes VEGF, IGF-1, MMP-9 is evaluated in association with clinical scales including cognitive assessment scales and depression scales. Furthermore, the collected data will be analyzed in relation to demographics and vascular risk factors. Blood sample collection as well as scales recording are taken at baseline and 3 weeks later after rehabilitation. The study group patients will undergo standard post-stroke rehabilitation programme provided by physiotherapist, every day for a period of 3 weeks with weekend gaps.

Eligibility Criteria:
Inclusion Criteria:

* subacute ischeamic stroke,
* age over 18,
* informed consent obtained

Exclusion Criteria:

* intracerebral haemorrhage,
* chronic or significant acute inflammatory factors,
* neurological illness other than ischeamic stroke,
* severe cardio-vascular disease like myocardial infarction less than 30 days, unstable angina pectoris,
* decompensated metabolic or endocrine diseases
Stress and Personality Profiles in IBD

Main aim is to evaluate the role of stress in the evolution of inflammatory bowel disease (IBD) and the quality of life of these patients. A second aim is to establish the existence of any psicopathological profile in these patients. We designed a prospective experimental study were patients are randomized to receive or not a cognitive-behavior program. Patients will be evaluated at 3 and 12 months after the program and study variables will be measured: stress level, coping strategies, quality of life, activity of disease and biological variables related to IBD.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years
* Informed consent
* Crohn's disease or ulcerative colitis diagnosis
* Active disease in the last 18 months

Exclusion Criteria:

* Severe mental disease
* Other severe concomitant disease
A Study to Assess the Safety of ASP7374 in Adult Subjects Aged 20 or Older

The purpose of this study is to confirm the safety until Day 29 after injection of a single dose of quadrivalent vaccine ASP7374 in adult subjects aged 20 or older


Eligibility Criteria:
Inclusion Criteria:

* Medically stable, as judged on the basis of history and concurrent diseases
* Subject understands procedure of the protocol and is willing to comply with the protocol.

Exclusion Criteria:

* Scheduled to receive another vaccine during the study.
* Received influenza HA vaccine within 180 days prior to screening.
* Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine.
* Diagnosis of immune deficit in the past has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome.
* Received one of the following medications or treatment prior to vaccination with the study vaccine:

  * 1. Within 28 days prior to vaccination with the study vaccine

    1. Interferon formulation
    2. Drugs which affect the immune system (e.g., immunosuppressants)
    3. Systemic corticosteroids and inhaled corticosteroids
    4. G-CSF and M-CSF
  * 2. Within 84 days prior to vaccination with the study vaccine

    1. Human immunoglobulin products
    2. Blood products
    3. Blood transfusion
  * 3. Within 180 days prior to vaccination with the study vaccine

    1. High-dose human immunoglobulin products (≥200 mg/kg)
* History of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
* History of seizures (exclude a pyrexial attack in childhood)
* History of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM)
* Body temperature of ≥37.5°C on Day 1 (before vaccination)
* Moderate to severe acute or febrile illness (≥37.5°C) within 7 days prior to vaccination
* Concurrent hepatic disease (exclude fatty liver, hepatic cyst, biliary stone and gallbladder poly, which have laboratory findings only, no clinical symptoms, and not necessary to treat), or AST (GOT) and/or ALT (GPT) of \>100 IU/L at screening on Day 1
* Concurrent renal disease (exclude rental cyst and calculus kidney which have laboratory findings only, no clinical symptoms, and not necessary to treat), or creatinine of \> 1.5 mg/dL at screening
* Concurrent respiratory disease, hematologic disease, or developmental disorders
* Concurrent or previous heart disease
* Concurrent or previous cerebrovascular disorder
* Concurrent malignancy or diagnosis or treatment of malignancy within 5 years before screening
* Diagnosis of mental disorder including schizophrenia, bipolar disorder, or major depressive disorder or cognitive impairment, or received medications for cognitive impairment
* Concurrent disease interfering with the evaluation of local and systemic reactions