cyrilzakka/clinical-trials huggingface dataset:
PRAME Immunohistochemistry as an Adjunct for Evaluating Ambiguous Melanocytic Proliferation

Skin melanoma is a common form of skin cancer. Its diagnosis is usually clinically suspected and then affirmed by histopathological examination.

In some cases, the histopathological analysis of these lesions is equivocal, and the malignant or benign nature of the proliferation is difficult to determine with certainty. In these cases, the use of expensive ancillary tests, which are hardly accessible and take a long time to set up (FISH - CGH-array), is usually required.

Anti-PRAME immunostaining, an inexpensive and readily available technic, has recently been described as highly sensitive and specific for diagnosing malignant melanocytic proliferations. Knowledge on its utility for evaluating ambiguous melanocytic neoplasms remains limited.

Our study aims to improve the current body of knowledge on the utility of PRAME immunohistochemistry for evaluating challenging samples of melanocytic proliferation. The secondary objective is to determine the PRAME immunoreactivity profile for each histological subtype of melanocytic proliferations (spitzoid tumors, cellular blue nevi, dysplastic nevi ...)


Eligibility Criteria:
Inclusion Criteria:

* Adult patient at the time of diagnosis (\> = 18 years).
* histopathological diagnosis of "ambiguous melanocytic proliferation" or "atypical melanocytic proliferation" made between January 2016 and December 2020.
* Histological slides archived in the "CRB" biobank available
* Formalin-fixed paraffin-embedded tissue block archived in the "CRB" biobank available
* Informed patient

Exclusion Criteria:

* Patient who has expressed opposition to participating in the study.
Prescription Opioid Effects in Abusers Versus Non-Abusers

The purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.

Prescription opioid abuse is becoming an increasingly widespread and serious public health concern. The 2001 National Household Survey on Drug Abuse report revealed that the number of first-time users of prescription opioid medications for non-medical reasons reached 2 million in the year 2000, a number that has quintupled since 1984. Despite this trend, little experimental research has been directed towards understanding who may be abusing these medications, and under what conditions. The study will examine the reinforcing, subjective, performance, and physiological effects of oxycodone. Because it is not clear who is abusing prescription opioids, the medication effects will be compared in drug abusers and non-drug abusers.

Eligibility Criteria:
Inclusion Criteria:

* In good physical health
* Women reporting regular menstrual cycles lasting between 24 to 35 days
* Able to perform study procedures
* Normal body weight
* Use of opioids for medical purposes (cough, pain, or diarrhea) or recreational purposes at least twice in lifetime with no serious adverse effects
* Current opioid abuse, but not opioid dependence (drug abusers only)

Exclusion Criteria:

* On parole or probation
* Recently convicted of a crime of violence
* History of significant violent behavior
* Current Axis I psychopathology
* Significant Axis II disorder
* Pregnancy
* Women who have irregular menstrual cycles, or who are dysmenorrheic, amenorrheic, or menopausal
* Women who have been pregnant or breastfeeding within the past 6 months
* Women who have had a miscarriage or abortion within the past 6 months
* Women who meet DSM-IV criteria for premenstrual dysphoric disorder
* Women who report suffering from moderate to severe premenstrual symptoms
* Women seeking treatment for premenstrual problems
* Taking prescription or over-the-counter psychotropic medication
* History of chronic pain, or routinely uses over-the-counter analgesics (more than 4 days per month)
* Blood pressure greater than 150/90 mm Hg
* Reports of sensitivity, allergy, or contraindication to opioids
* Non-drug abusers:

  1. Current or lifetime history of substance abuse or dependence according to DSM-IV criteria (those requiring detoxification)
  2. Consumes more than 500 mg caffeine daily
  3. Seeking treatment for substance use
Pediatric Epilepsy Database

The purpose of this database is to collect information for clinical purposes on all children being treated for seizure disorders.

At some point this information may be used to retrospectively review trends in seizure types, diagnostic evaluation and treatment (medical or surgical). The potential data recorded will be that of standard of care provided to these patients, including age, gender, seizure type/classification, diagnostic procedures (eg. EEG, MRI Magnetoencephalography {MEG}, Single Photon Emission Computed Tomography {SPECT}, Positron Emission Tomography {PET}, invasive electrocorticography) and various treatments (medications, diet, or neurosurgical interventions for the treatment of epilepsy). Records in the database will have identifiable information (name, date of birth, date of procedure, medical record number), but these identifying data will be removed, and only nonidentifying data will be used in the event of research completed using information from this clinical database.

Eligibility Criteria:
Inclusion Criteria:

* NONE

Exclusion Criteria:

* NONE
ANNE Diagnostic Agreement With Home Sleep Testing

The main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of ANNE to a Home Sleep Test (HST).

The main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of ANNE to a Home Sleep Test (HST) for the diagnosis of moderate to severe OSA.

Other study objectives include:

* Determining diagnostic yield from multiple nights and better usability compared to current HST in the intended population. This will include all subjects and a focus on olders 65 and older.
* Gathering participant feedback on the use of the sensors and use of the application elicited through focus groups

Eligibility Criteria:
Inclusion Criteria:

* 22 years old.

  * Subjects with suspected OSA based on history and physical. Subjects with self-reported symptoms of OSA based on the STOP-Bang questionnaire indicating affirmative answers to any of the following: snoring, daytime fatigue/sleepiness/tiredness, partners who have observed the subject stopping breathing or choking/gasping during sleep. Persons with a previous diagnosis of OSA are also eligible.
  * Willingness to give written consent and comply with study procedures

Exclusion Criteria:

-An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related to this trial or interferes with the clinical trial and data collection based on the opinion of the investigator, this includes but is not limited to: A. Significant cardiorespiratory disease: patients that are oxygen dependent, previous hospitalization for cardiorespiratory issues, or left ventricular ejection fraction ≤ to 40% B. Respiratory muscle weakness due to a neuromuscular condition C. Awake hypoventilation or suspicion of sleep related hypoventilation D. Chronic opioid medication use E. History of stroke F. History of severe insomnia

* Inability to understand instructions
* Has a skin abnormality that precludes assessment
* Has a history of dementia
* Patients with implanted pacemakers or defibrillators
Spinocerebellar Ataxia Type 27B Natural History Study (SCA27B-NHS)

This international, multi-center, multi-modal, and prospective observational cohort study aims to validate trial outcomes for capturing disease progression in Spinocerebellar Ataxia Type 27B (SCA27B), with combined multi-modal capture of clinical outcome assessments, digital-motor assessments, and molecular biomarkers.

The investigators will perform an international, multi-center, multi-modal, and registry-based standardized prospective Natural History Study (NHS) in Spinocerebellar Ataxia Type 27B (SCA27B), including the presymptomatic phase of the disease (i.e. presymptomatic subjects at risk for SCA27B). Participants will be assessed annually. Clinical data, including clinician-reported outcomes and patient-focused outcomes, will be entered into a clinical database customized to the requirements of this specific study (SCA27B Registry; www.ataxia-registries.org). Digital-motor outcomes comprise digital gait assessment by wearable sensors, and digital assessment of upper limb movements by Q-Motor. At all study visits, participants will be asked to donate biosamples; and participants can elect to participate in sampling of blood, urine, CSF, and/or a skin biopsy. Based on this multimodal protocol, the study aims to determine the most sensitive, comprehensive, and reliable outcome measures for future therapeutic trials in SCA27B.

Eligibility Criteria:
Inclusion Criteria:

* SCA27B: genetic diagnosis of ≥250 uninterrupted GAA repeat expansions in FGF14
* SCA27B risk subject: asymptomatic first-degree relative of SCA27B participant with known or unknown carrier status
* Unrelated healthy controls: no signs or history of neurological or psychiatric disease AND
* Written informed consent AND
* Participants are willing and able to comply with study procedures

Exclusion Criteria:

* SCA27B: Missing informed consent
* SCA27B risk subjects: Missing informed consent
* Unrelated healthy controls: Missing informed consent, or concurrent neurological, orthopedic, or other diseases interfering with the motor assessments
Behavioral and Immunological Factors in Coronary Disease

To explore the immune/inflammatory processes as pathways between depression/exhaustion and coronary artery disease (CAD) progression.

BACKGROUND:

Recent studies demonstrate that the immune system plays an important role in coronary artery disease (CAD). Research also shows that psychological factors such as major depression and acute mental stress are involved in the clinical progression of CAD. Depression is associated with higher levels of immune parameters that play a role in CAD (cytokines, markers of low grade inflammation, infectious pathogen burden, and adhesion molecules), and most of these measures also increase in response to acute physical and mental stress. The pathophysiological mechanisms linking depression and mental stress with adverse cardiovascular outcomes may therefore be mediated by immunological factors.

DESIGN NARRATIVE:

The study examines clinical outcomes in patients who undergo percutaneous coronary revascularization, because a major problem remains the frequent (20 percent-40 percent) occurrence of coronary restenosis and new cardiac events in the six months after the intervention. These adverse outcomes have substantial impact on the costs of medical care and patients' quality of life. Since previous research has not examined the role of behaviorally-induced changes in immune parameters in the prediction of CAD progression, the following immunological measures will be examined: cytokines (IL-1B, IL-4, IL-6, IFNy, TNFa), acute phase proteins (CRP, fibrinogen), lymphocyte counts and differential, adhesion molecules (ICAM-1, LFA, L-selectin), and a composite measure of pathogen burden (CMV, H. pylori, C. pneumoniae). Using a longitudinal design, this project will determine the time course of changes in depression and changes in immune parameters. Moreover, the present study will determine the contribution of behavioral and immunological factors in the clinical progression of coronary disease following coronary angioplasty. These data may therefore improve the identification of patients at risk for recurrent cardiac events and restenosis after coronary angioplasty, and provide further understanding of the pathophysiological mechanisms involved in coronary disease progression.

Eligibility Criteria:
No eligibility criteria
Cancer Care Coordination for Chemotherapy Patients

The purpose of this study is to compare nurse-led care coordination for persons receiving cancer chemotherapy treatment incorporating mobile health technology to nurse-led care coordination without any mobile health enhancements.

This study will randomize sixty (60) participants receiving cancer chemotherapy treatment to receive nurse-led care coordination using a HIPAA-compliant mobile health platform compared to no technology-enhanced care coordination.

All participants receive nurse-led care coordination throughout chemotherapy treatment.

RESEARCH AIMS:

* Demonstration of a HIPAA-compliant social networking platform;
* Facilitate communication and collaboration among patients with cancer and their care team;
* Assess patient health outcomes (chemotherapy-related physical and psychological side effects; pain, quality of life and patient satisfaction)
* Assessment of healthcare utilization including emergency department visits, unplanned clinic visits and hospitalization;
* For patients assigned to the mobile health care coordination, understanding their experience of use of the technology

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Newly diagnosed cancer - any site or stage
* Initiating chemotherapy
* Ability to read and write English
* Manual dexterity sufficient to use a tablet technology
* Cognitive capacity to participate
* Preferential recruitment of publicly insured and/or living in rural communities

Exclusion Criteria:

* Oral chemotherapy
EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging

Aim of the study will be to investigate if Endoscopic Ultrasound (EUS) with elastography can be purposed between the routine staging examinations in patients with pancreatic adenocarcinoma without distant metastasis for the staging of lymph nodes status ("N" in TNM classification)

* in RESECTABLE pancreatic cancer the investigators will evaluate the concordance with EUS elastography and histological findings of lymph nodes obtained during surgery, in order to assess the sensibility, specificity and the positive and negative predictive value of EUS with elastography, the disease-free survival, the percentage of metastatic patients and the overall survival (in patients with or without metastatic lymph nodes).
* in "BORDERLINE resectable" and UNRESECTABLE non-metastatic ("advanced" locally") disease, the investigators will evaluate if the malignant lymph nodes samples during EUS with elastography and fine needle aspiration (FNA) will be related to a decreased survival.

Secondary aim will be to register the prognosis (in terms of survival) of the patients with para-aortic and mediastinal pathological lymph nodes (related to a decreases survival in some series in literature)

Pathological lymph nodes will be assessed by EUS with elastography as lymph nodes: hypoechoic, rounded, rigid (blue) and big (bigger than 1 centimeter)

Eligibility Criteria:
Inclusion Criteria: pancreatic adenocarcinoma without distant metastasis; patients \> 18 years

Exclusion Criteria: distant metastasis and pancreatic adenocarcinoma
Micro-movements in Patients With Prolonged Disorders of Consciousness

The goal of this observational study is to learn about the micro-movements in patients with prolonged disorders of consciousness. The main questions it aims to answer are:

Use the neuropsychological paradigm model to monitor micro-movements, assess the patient's remaining level of consciousness and accurately classify it; screen out patients with cognitive-motor dissociation to improve the prognosis of cognitive function; explore the remaining brain function of patients with chronic disorders of consciousness and promote relevant study of neural mechanisms.

Participants will be subjected to consciousness assessment by CRS-r scale, and their micro-movement changes in response to various emotional stimuli will be captured, along with the collection of EEG and MRI data. Follow-up evaluations will be conducted using the CRS-R scale and GOS scale, with a follow-up period of 6 months.

In accordance with the inclusion and exclusion criteria, a total of about 178 participants will be recruited, including about 89 confirmed cases of prolonged disorders of consciousness and 89 healthy control subjects (HCs). Utilizing the random split algorithm from the machine learning library sklearn, the dataset will be randomly divided into a training set (70%) and a testing set (30%). General information about the participants such as age, gender, time and location of injury, as well as medical history, family history, medication history, and surgical history will be collected.

Participants will undergo dual-person, multiple assessments using the CRS-R scale to evaluate auditory, visual, motor, speech responsiveness, communication, and arousal levels. Micro-movement changes in response to various emotional stimuli will be collected, along with EEG and MRI data.

Follow-up evaluations will be conducted on all enrolled patients using the CRS-R scale and the GOS scale, with a follow-up period of 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with consciousness disorders for more than 28 days following severe brain injury, assessed by the CRS-R scale to meet the criteria for VS or MCS;
2. Aged between 18 and 80 years;
3. Stable vital signs;
4. Voluntary participation of family members with signed informed consent;
5. Good cooperation, minimal facial and spontaneous activities, no use of antiepileptic or sedative drugs.

Exclusion Criteria:

1. Locked-in syndrome;
2. Contraindications for EEG examination;
3. Contraindications for MRI scanning, such as the presence of internal metallic implants;
4. Diseases and factors that may affect brain function assessment, such as metabolic disorders, poisoning, shock, etc.
Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)

Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.

Fase III, multicenter randomised trial comparing up to six cycles of carboplatin and etoposide with up to six cycles of topotecan and cisplatin in patients with extensive stage small cell lung cancer and PS 0-3

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed SCLC
* Extensive stage
* No prior chemotherapy
* WHO PS 0-3
* Adequate organ function (liver, kidney)
* Adequate hematology (bone marrow)
* Informed consent

Exclusion Criteria:

* PS 4
* Inadequate organ function
* Uncontrolled infection
* Concomitant major medical contraindications
Evaluate the Prognostic Significance of Changes in the Systemic Immune-Inflammation Index in Patients with AGC Treated with ICI Therapy.

The SIIR during neoadjuvant therapy can serve as a specific biomarker for predicting the efficacy of immunotherapy in patients with advanced gastric cancer.

A total of 410 patients with advanced gastric cancer treated with neoadjuvant chemotherapy (NAC group, 178) or immunotherapy (ICIs group, 232) were enrolled in two tertiary referral centers. The SIIR (\[SIIpost-treatment - SIIpre-treatment\] / SIIpre-treatment) was calculated. The diagnostic threshold for SIIR was set at the median value (-0.3) A joint model based on longitudinal trajectory and time-to-event analysis was used to assess the correlation between SIIR and the risk of death in patients with advanced gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

(1) preoperative clinical staging of cT2-4NxM0; (2) primary gastric adenocarcinoma confirmed via pathology; (3) no distant metastasis to the liver, lungs, or abdominal cavity as confirmed through preoperative chest X-ray or chest CT, abdominal ultrasound, and abdominal CT; (4) All patients received neoadjuvant therapy, followed by gastrectomy.

Exclusion Criteria:

We excluded patients under 18 or over 80, those with distant metastasis, remnant gastric cancer, prior radiotherapy, other malignancies, abdominal surgery history (except laparoscopic cholecystectomy), recent unstable angina, myocardial infarction, cerebrovascular accidents, or those requiring emergency surgery due to disease progression
Diabetes Complications and the Risk of Cardiovascular and Cerebrovascular Diseases

This study is intended to include 3000 diabetic patients in our hospital to collect complete medical history data, comprehensively improve the screening of diabetic complications and cardiovascular and cerebrovascular risk assessment.

With the economic development and lifestyle change, the incidence and prevalence of diabetes are increasing year by year in both China and the world. Diabetics are associated with a significantly increased risk of cardiovascular and cerebrovascular disease.

It is a cross-sectional study. This study intended to include about 3000 adult patients with previously diagnosed diabetes mellitus, then collect their anthropometric data (age, gender, weight, height, waist circumference, hip circumference and etc.), life history (diet, exercise, smoking, drinking and etc.), medical history, familial medical history, clinical testing results about their diabetes complication, and make a comprehensive assessment of their cardiovascular and cerebrovascular risks. These data will be used to make further research about the diabetes complication and cardiovascular and cerebrovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic symptoms with: plasma glucose level at any time ≥11.1mmol/ L (200mg/ dL), or Fasting plasma glucose level ≥7.0mmol/ L (126mg/ dL), or plasma glucose level ≥11.1mmol/ L (200ng/ dL) for 2 h in OGTT test, or HbA1c ≥6.5%; Or those without typical symptoms should repeated the tests in another day.
* Han Chinese.
* Willingness to participate.

Exclusion Criteria:

* Secondary diabetes.
* Participants in other clinical trials.
FGF-23 Suppressibility by Calcitonin

Introduction:

Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important regulator of FGF-23 production and secretion in healthy humans.

Aim:

In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.

Study Design:

placebo-controlled, cross-over study

Method:

* All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml NaCl 0.9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously
* On both occasions frequent bloodsampling will take place, out an indwelling catheter in de forearm vein.
* Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes
* Mealtimes: Calcium and Phosphate intake standardized on both occasions
* All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics, San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that measures only intact FGF-23
* Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca, albumin, PO4, PTH, 25-OHD and 1,25-OHD

Endpoint:

A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.


Eligibility Criteria:
Inclusion Criteria:

* Healthy man, who are between 20-55 years old, and have a BMI 20-27 kg/m2.

Exclusion Criteria:

* Serum creatinin \>100 mmol/L, or glomerular filtration rate \<80 ml/min.
* Abnormal serum Ca, PO4, albumin, 25-OH vitamin D, or PTH levels.
* Any medication.