cyrilzakka/clinical-trials huggingface dataset:
Intravenous Lidocaine Infusion During Video-assisted Thoracic Procedures for Improved Pain Control

The purpose of this study is to determine whether intravenous lidocaine infusion during a video-assisted chest surgery is effective in reducing the pain involved after the surgery. The hypothesis is that continuous lidocaine infusion during video-assisted thoracoscopic surgery (VATS) reduces morphine consumption and postoperative pain.

Despite newer surgical techniques, many patients still experience moderate to severe postoperative pain after minimally invasive surgeries. Thoracoscopic surgeries are often associated with severe postoperative pain. To relieve the pain, potent narcotics have to be used, which have many side effects. Surgical patients would therefore benefit from an intra-operative analgesic regimen that is safe and effective, has minimal side effects and can reduce their postoperative narcotic requirements. Intravenous lidocaine has been shown previously to relieve cancer pain, chronic pain, and pain after other types of surgery.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Age 18-75
* Scheduled for VATS procedure

Exclusion Criteria:

* Patients receiving antiarrhythmic therapy (Class Ia, Ib, Ic) within one week of surgery
* Patients on preoperative analgesic therapy within one week of surgery
* Patients with history of drug or alcohol abuse
* Patients who are allergic to lidocaine
* Contraindication to self administered morphine (unable to understand the PCA)
* Progression of the procedure to thoracotomy
* Patients who need postoperative mechanical ventilation
* Necessary major deviation from the intraoperative study protocol as per the discretion of the anesthesiologist in charge of the case
* Patients who are breastfeeding or pregnant
* Patient refusal
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of ADHD
* Males and females aged 6-12

Exclusion Criteria:

* Inability of understand or follow instructions
* Is pregnant
* Diagnosis of tic disorder
* History of seizure disorder
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects

This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).

Based upon the significant number of subjects with UA/NSTEMI ACS who are managed medically and their high risk for future cardiovascular events, further exploration of novel treatment strategies for this population, who are under-represented in large clinical trials, is warranted. Potential subjects will be those with a recent UA/NSTEMI event who are to be medically managed. Eligibility for this study will be determined by both the timing of the medical management decision and by prior commercial clopidogrel treatment at the time of randomization. The TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) Study will assess the efficacy and safety of prasugrel and aspirin compared to the current standard of care, clopidogrel and aspirin, for long-term treatment of medically managed UA/NSTEMI ACS subjects.

Eligibility Criteria:
Key Inclusion Criteria:

* Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index event within 10 days prior to randomization
* Had a medical management strategy decision made with reasonable certainty that neither percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is planned for treatment of the index event
* Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event

Key Exclusion Criteria:

* Decision for medical management greater than 72 hours after onset of index event without commercial clopidogrel treatment within 72 hours following onset of the index event.
* Insignificant coronary artery disease (CAD) on coronary angiography if performed for Index Event (absence of greater than or equal to 30% stenosis in at least one native vessel)
* Previous or planned PCI or CABG as treatment for the index event
* PCI/CABG within previous 30 days
* ST-segment elevation myocardial infarction (STEMI) as the index event
* Cardiogenic shock, Refractory ventricular arrhythmias, New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours
* History of ischemic or hemorrhagic stroke, transient ischemic attack (TIA), Intracranial neoplasm, arteriovenous malformation, or aneurysm
* History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring hospitalization for treatment, unless definitive treatment has occurred and there is low likelihood of recurrence
* Hemodialysis or peritoneal dialysis
Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale

The purpose of this study is to establish reliability and validity of the Norwegian version of the Comfort behavioral scale.

Structured pain assessment is the foundation for the management of pain. Several different pain measurement tools exists, among them the Comfort behavioral scale (van Dijk, 2005), developed from the original Comfort scale (Ambuel, 1992). The psychometric properties of the Comfort scale have been tested in several studies, but so far no Norwegian version of the scale has been developed and tested. Neither has the scale been tested in spontaneously breathing children undergoing minor surgery. The aim of this study is to establish incipient psychometric properties of the Norwegian version of the scale among children aged 0-3 years admitted for elective minor surgery.

Eligibility Criteria:
Inclusion Criteria:

* Younger than 3 years old at the time of surgery
* Day care patients admitted for minor elective surgery

Exclusion Criteria:

* Pre-entry use of sedation and/or analgesics
* Neurological or other diseases or drugs (neuromuscular blockers) thet significantly influence motor activity, facial expression, cognition, or emotional state, ex. cerebral palsy, myopathy, severe mental retardation, severe hypotonia, neuromuscular disease
Prospective Cohort Study of the Ability of MRI/DTI to Diagnose Prostate Cancer

The purpose of this study is to examine if investigators can improve diagnosis of prostate cancer by using MRI/DTI?

This is a prospective cohort study of the ability of MRI/DTI to diagnose prostate cancer in men undergoing prostate MRI.

Study design: Male adults who are scheduled to undergo MRI of the prostate, for clinical reasons, will be subjected to additional 10 minutes of image acquisition inside the MRI machine. The added MRI/DTI acquisition does not involve injection of additional contrast material. Investigators will compare between ability of the full mp-MRI images to diagnose prostate cancer to that of the MRI/DTI images

Eligibility Criteria:
Inclusion Criteria:

1. Men who are scheduled to undergo MRI of the prostate at the Department of Imaging, in Beilinson Hospital, Rabin Medical Center
2. Age 18-90.
3. Men who are willing and able to sign an informed consent form.

Exclusion Criteria:

1) Men who cannot complete the full acquisition of the MRI and the MRI/DTI image sequences for any reason.
Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection

A single-centre, industry sponsored, pilot study to assess the feasibility of Single Exposure Dual Energy Subtraction with a Multi-Energy digital radiography detector as an imaging platform for lung lesion detection.

A feasibility study is proposed to investigate the imaging characteristics captured by a Single Exposure Dual-Energy Subtraction digital radiography with KA Imaging's Multi-energy detector.

The acquisition of Dual-Energy Subtraction radiography will consist of using the Multi-Energy detector integrated into the X-ray system in Grand River Hospital. Patient will receive a Multi-Energy Chest radiography exam on the same day as their routine chest CT exam. Each Multi-Energy radiography exam will consist of one Chest PA image and one Chest LAT image. Duration of each procedure is 60 minutes. The Multi-Energy Detector will generate a General Radiography Image and Dual-Energy Subtracted Images.

Visualization of lung lesions by Multi-Energy detector will be compared to corresponding CT exam and general radiography results. Imaging data will be evaluated qualitatively by radiologists on data collection form to describe the findings on the images. Further comparison between general radiography, Dual-Energy Subtraction radiography and CT will be analyzed to determine the differences of imaging characteristics such as description of image quality and visibility of relevant anatomical structures and anomalies.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older.
* Patients with previously diagnosed carcinoma with lung metastases, or patients with previously detected lung nodule
* Subject is able to provide informed consent
* Study participant is scheduled to have a chest CT exam as part of their routine care.
* Study participant is able to stand and be still during the exams.

Exclusion Criteria:

* Not able or willing to provide Informed Consent, or consent is withdrawn.
* Study participant is pregnant
* Study participant is unable to perform standard radiography exam and CT exam
MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).

The HTLV Blot 2.4 Post-Market Clinical Study is an open-label, multi-center, single-blind clinical study of neurological disorders (n=100) and HTLV known-positive (KP) specimens (n=50). This study is being conducted to support additional labeling claims and to further assess the sensitivity and specificity of the HTLV Blot 2.4 in specimens with neurological disorders and HTLV known positive specimens.

Eligibility Criteria:
Inclusion Criteria:

All Specimens:

* Male or female
* Biorepository specimen de-identified of PHI
* Specimen meets HTLV Blot 2.4 labeling collection/handling criteria

HTLV Positive Specimens:

Specimens with a known positive infection of HTLV I, HTLV II or HTLV I/II

Neurological Disorders:

Specimens with a diagnosis or symptoms consistent with any of the following neurological disorders:

* Acute Disseminated Encephalitis
* Amyotrophic Lateral Sclerosis (ALS)
* Autonomic Dysfunction
* Conus Medularis Syndrome
* Chronic Inflammatory Demyelinating Polyneuropathy
* Dermatomyositis
* HTLV associated myelopathy-tropical spastic paraparesis (HAM-TSP)
* Meningitis
* Mild Cognitive Impairment
* Multiple Sclerosis (MS)
* Polymyositis
* Spastic Paraparesis
* Sciatica

Exclusion Criteria:

HTLV Infected:

* specimens with a known infection or history of HIV, HCV or HBV
* specimens not meeting specimen labeling collection / handling criteria

Neurological Disorders

* specimens not meeting specimen labeling collection / handling criteria
Marathon Runners Compared to Sedentary Matched Control Subjects

The investigators wish to compare very active runners in healthy untrained control subjects on a number of parameters.

The project aims to understand the underlying mechanisms by which physical inactivity causes diseases. This the investigators will study the full spectrum of physical activity, from the most inert of the most active people. The investigators have already collected muscle biopsies and established stem cells from people with Type 2 diabetes, obese healthy and normal weight healthy. In this study, the investigators will establish a cohort of highly physically active marathon runners. In a case-control design, the investigators compare muscle stem cell function across the entire spectrum of physical activity / inactivity.

There has never been as much focus on running as in these days. With the knowledge the investigators have today, there is reason to believe that it is healthy to run both in a physical sense, but perhaps also in terms of brain function. However, there has not previously carried out extensive comparative studies of very active runners and healthy untrained control subjects. In this project the investigators will characterize the degree of training in subjects as the investigators will carry out various forms of physiological studies on the subjects' fitness level. The investigators will examine whether there is a linkage between training level and brain function.

The investigators will also examine muscle function at the molecular level. The investigators will isolate stem cells (satellite cells) from muscles biopsy and establish primary muscle cell cultures. By electrical stimulation of these cells in vitro, the investigators can emulate a muscle contraction as during physical activity. The investigators will test the overall hypothesis that physical activity affects stem cell function.

The investigators will further study whether epigenetic phenomena (methylation) of selected DNA sequences are sensitive to training level.

Eligibility Criteria:
Inclusion Criteria:

* 10 marathons, 2 within the last year or 50 km/week the last 5 years

Exclusion Criteria:

* smokers, any medication, chronic diseases, digestion of performance enhancing drugs, pregnancy, alcohol abuse
A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up.
2. Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.
3. At least one measurable lesion conforming to RECIST v1.1.
4. ECOG PS score: 0-1.
5. Expected survival ≥ 12 weeks.
6. Female subjects with fertility must agree to comply with the contraceptive requirements from signing the informed consent form to 7 months after the last administration of the trial drug.

Exclusion Criteria:

1. With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.
2. Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled.
3. Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment.
4. With hypertension and cannot be well controlled by antihypertensive drug treatment.
5. Accompanied by poorly controlled or serious cardiovascular diseases.
6. Subjects with serious infection within 1 month before the first medication.
7. Have a history of immune deficiency, including HIV test positive, other acquired or congenital immune deficiency diseases, or a history of organ transplantation.
8. There are any other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, criminal detention, and other serious diseases (including mental illness) that need combined treatment.
Impact of Liraglutide on Sensory Perception, Sensory Specific Satiety, Liking and Wanting in Type 2 Diabetic Patients

Besides their potential action in the treatment of type 2 diabetes mellitus (T2DM), GLP-1 analogues decrease satiety and food intake leading to a significant weight loss in patients. However, little is known about their effects on food hedonic sensations and taste perception.

The aim of this study is to investigate the impact of Liraglutide on the liking and wanting components of the food reward system, taste sensitivity and sensory specific satiety in type 2 diabetes mellitus (T2DM) patients. According to the review of literature in animal models, it is expected that Liraglutide will modify food preference and gustative perception in humans.

Thirty T2DM patients will be studied before and after 3 months of treatment with Liraglutide (1.2 mg/day). Same tests will be carried out on two consecutive days before and after the treatment administration. Olfactory liking, recalled liking and wanting for several food items will be assessed. Sensory specific satiety will be measured as well as detection thresholds for salty, sweet and bitter tastes. Subjects will also answer questionnaires on hunger, pleasure in eating, and food intake.


Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetic patients

1. with glycemic unbalance despite anti-diabetic treatments and
2. overweight (BMI \> 25 kg/m²)

Exclusion Criteria:

* Impaired renal function (creatinine clearance \< 50 ml/min),
* Pregnancy,
* Congestive heart failure,
* Acute and chronic infection,
* Evolutive cancer,
* Cirrhosis,
* Ongoing antibiotic treatment,
* Smoking (more than 5 cig/day),
* Alcohol consumption (more than 20 g/day),
* Aversion for the foods eaten or smelt during the study,
* Impaired comprehension for cognitive tasks,
* Treatments known to interfere with olfactory and gustative performances
Registry of Local Recurrences After Breast-conserving Surgery

The ReLoCC project is a prospective, multicenter, clinical study to register cases of local recurrence after breast-conserving surgery, in centers dedicated to the treatment of breast cancer, in Portugal and Spain.

The comparison of the results obtained will allow the optimization of the treatment, making it increasingly personalized.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients
2. Age \> 18 years
3. Patients who have previously undergone breast-conserving surgery as part of the treatment of invasive or non-invasive (in situ) breast cancer

   1. and adjuvant breast RT: total (WBI) or partial (PBI)
   2. without adjuvant radiotherapy to the breast
4. Recent histological diagnosis of homolateral, invasive or non-invasive (in situ) breast carcinoma

Exclusion Criteria:

1. Male
2. Age \< 18 years
3. Stage 4 at diagnosis
4. Patients operated outside the participating Centers and for whom it is not possible to obtain complete information regarding the primary treatment
5. History of other primary invasive malignant tumor (except non-melanoma skin carcinomas)
6. Patients already treated for another local recurrence of breast carcinoma
7. Absence of clinical follow-up and records in clinical process
Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns

Antibiotic resistance is a major public health issue as multiresistant bacteria (MRB) are increasing. Among the actions to control resistance, one is an interesting lead: to prevent the emergence of resistant bacteria by limiting possibilities for bacteria to acquire resistance. Mechanisms of resistance genes acquisition are deeply studied but there are few data on the dynamic of acquisition over time. Among the genetic components that disseminate resistance genes, resistance integrons (RI) play a major role in the acquisition and dissemination of antibiotic resistance in gram-negative bacteria. The digestive tract of the newborn (NB), which is initially sterile, is colonized by a bacterial microbiota during the first days of life. It thus appears to be an appropriate model to study the dynamic of resistance acquisition. This project intends to follow the NB of neonatology over time in order to study the dynamic of the digestive acquisition of RI and MRB


Eligibility Criteria:
Inclusion Criteria:

* Mother-child pairs that will be included in the study will be the pairs of all the NB, born in the center (in born) and hospitalized in the neonatology units of each center:

with a predictable stay ≥ 3 weeks in the unit

Exclusion Criteria:

NB will not be included if:

* They exhibit a birth defect, especially on the digestive tract
* They are secondarily hospitalized after a postnatal transfer (out born).
* The parents express their objection for the child to take part in the study
* The stool sample of the mother has not been received
Radiofrequency of Breast Cancers in Non Surgical Patients

To treat breast tumors in non surgical patients with percutaneous technique (radiofrequency). Prospective evaluation of treatment efficiency and tolerance based on clinical and radiological evaluation


Eligibility Criteria:
Inclusion criteria:

* Patients more than 70 years old
* Breast tumors with estrogen receptors
* Non surgical patients
* Life expectancy more than 6 months

Exclusion criteria:

* Presence of a pace maker
* Tumors measuring more than 30 mm on ultrasound evaluation, located less than 10 mm from skin, nipple, or pectoral muscle
* Coagulation disorders
* Contra indications to magnetic resonance imaging or computed tomography with contrast medium injection
* Non visible lesions on magnetic resonance imaging or computed tomography with contrast medium injection