cyrilzakka/clinical-trials huggingface dataset:
Prospective Study of Classification and Activity Assessment of Psoriatic Arthritis Based on Power Doppler (PD) Ultrasonography (PDUS)

Psoriatic arthritis (PsA) is a complex inflammatory disease with heterogeneous clinical features, which complicates psoriasis in 30% of patients. PsA involves multiple tissues and clinical domains including skins and nails as well as arthritis, spondylitis, enthesitis, and dactylitis. Power Doppler (PD) ultrasonography (PDUS) is a sensitive non-invasive imaging technology used to assess disease activity and treatment response in PsA. This is a prospective, observational, open-label study to investigate disease activity, therapeutic response and bone destruction based on ultrasonography findings in patients with PsA.


Eligibility Criteria:
Inclusion Criteria:

* PsA patients as defined by CASPAR criteria
* Patients must be able to comply with the visit schedule, treatment plan, laboratory tests and other study procedures
* Patients must be given informed consent

Exclusion Criteria:

* History of other arthritis within the last 12 months
* Concomitant disease with acute or chronic infectious diseases
* Pregnancy or laction
* Poorly tolerated with venipuncture required for blood sampling during the study
Back Pain and Arthroplasty in Orthopedists

The relationship between arthroplasty and low back pain in orthopedists will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Those who have received specialization of orthopaedics and work as a orthopaedics surgery.
* Those who want to participate in the study

Exclusion Criteria:

* Patients with discomfort and operation due to the low back pain
* Physicians in other branches
Survival Study for Participants Treated With Ipilimumab-Nivolumab Combination Therapy

This study will review published trial literature and documents for Overall Survival (OS) to evaluate the association between the hazard of death and each baseline variable.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of melanoma

Exclusion Criteria:

* Age less than 18 years old
Preemptive Strike With Bortezomib in Multiple Myeloma Patients

To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.

Although advances in the treatment of multiple myeloma have led to improved remission rates, the risk for serious relapse is very high. The drug Bortezomib has been highly effective for treatment of the disease in an advanced stage such as post-transplant relapse. Due to the need of maintenance therapies, it is necessary to look to certain drugs that may prolong remission and increase the quality of life. Bortezomib, when taken at the beginning of remission, may prove to be a beneficial maintenance drug for the management of multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with multiple myeloma currently or previously enrolled on UARK 98-026 and currently event-free at the time of the evaluation.
* Performance status of 0-2 based of Southwest Oncology Group (SWOG) criteria
* Previously documented platelet count \> 75,000/ul within a 35 days prior to enrollment
* Previously documented peripheral absolute neutrophil count \>1,000/ul within 35 days prior to enrollment.
* Adequate renal function
* Signed informed consent
* Female subject is post-menopausal or willing to use acceptable birth control
* Male subjects agree to use acceptable method of contraceptive

Exclusion Criteria:

* Hypersensitivity to Bortezomib, boron, or mannitol
* Female subject is pregnant or breastfeeding
* Experienced myocardial infraction within 6 months prior to enrollment
* Received other investigational new drugs within 14 days before enrollment
* Received any anti-myeloma therapy within 14 days
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
* Diagnosed or treated for another malignancy within 3 years of enrollment
Performance Evaluation (Sensitivity/Specificity) of HelioLiver Test for Detection of HCC

De-identified whole blood and serum samples are collected for the purpose of evaluating the performance (sensitivity/specificity) of the HelioLiver Test for the detection of hepatocellular carcinoma (HCC).

The purpose of this study is to define the performance characteristics (sensitivity and specificity) of the Helio Liver Test within a study population of subjects that have been diagnosed with liver cancer at various stages (I to IV) and for control subjects who have been confirmed to not have liver cancer by at least one imaging technique, such as ultrasound, MRI or CT. Control subjects will include patients who are at high-risk for liver cancer and have been recommended to undergo liver cancer surveillance, as well as patients who have non-HCC cancers to determine analytical specificity.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years and Older (Adult, Older Adult)

Exclusion Criteria:

* None
Evaluation of the Gastro-intestinal Tolerance of an Upgraded Composition of an Enteral Tube Feed for Adults

This study evaluates the gastro-intestinal tolerance, nutritional intake, and acceptability of an upgraded composition of an enteral tube feed for adults in need of long term nutritional support.

Four current tube feed products are upgraded with the same product composition and will be investigated in this study. Subjects will be asked to continue with their current tube feeding for 7 days (baseline period) and asked to complete a daily gastro-intestinal tolerance questionnaire. On Day 8, the subjects will switch to one of four upgraded tube feeding products for 14 days (intervention period). The subjects are asked to complete the same gastro-intestinal tolerance questionnaire for again 7 days. On Day 21 (end of intervention), the subjects will return to their original tube feed product and the investigator will follow up on how they are feeling to evaluate tolerability and product acceptability.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Using either an enteral tube feed with approximately 1.0 or 1.5 kcal/mL with or without fibers via a nasogastric tube (NGT), nasojejunal (NJT) or Percutaneous Endoscopic Gastrostomy (PEG) for at least 4 weeks prior to screening
3. Actual and expected average daily intake of enteral nutrition at least 1000 kcal for at least 21 days after the start of baseline period
4. Written informed consent from subject (or impartial witness after verbal consent of subject)

Exclusion Criteria:

1. Subjects receiving total parental feeding (TPN) 2. Gastro-intestinal surgery or any other surgery involving general anaesthesia within 2 weeks prior to screening 3. Subjects with major hepatic or renal dysfunction in the opinion of the Investigator 4. Subjects currently in the intensive care unit 5. Active/flare up condition of chronic illnesses in small or large intestines in the opinion of the Investigator (e.g., active inflammation/flare up of Crohn's disease or ulcerative colitis) within 2 weeks prior to screening, 6. Subjects experiencing cancer treatment-related diarrhea within 2 weeks prior to screening 7. Presence of colostomy or other faecal diversion 8. Known intolerance or allergy to ingredients of study product (e.g. galactosemia, allergy to soy) 9. Inability of the subject to answer the study diary or questionnaires due to e.g., being unconscious, cognitive impairment, or dementia, in the opinion of the Investigator 10. Known pregnancy or lactation 11. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements 12. Active participation in any other clinical study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study in the opinion of the Investigator

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Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients With Medically Refractory Partial Epilepsy

To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and safe minimally invasive technique for control of seizures in such patients.

In this study, we propose to evaluate a novel, thermal therapy and feedback system (Visualase® Thermal Therapy System) as an alternative to surgical resection for the treatment of focal lesional epilepsy in patients that are considered high risk surgical candidates. This system includes the FDA-cleared Visualase Cooled Laser Applicator System (VCLAS), which allows delivery of laser energy while the patient is being imaged by an MRI unit. The Visualase® System works via real-time MR thermal imaging (MRTI) to provide information on the thermal dose delivered to the target, resulting in a more precise and controlled delivery which has heretofore not been possible with previous non-image guided laser technology. We hypothesize that the Visualase system can be used in patients refractory to medication therapy in a minimally invasive procedure to destroy epileptogenic focal lesions in the brain.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older at entry to protocol.
* History of MRI lesional-related epilepsy for at least one year.
* Failure to respond to more than 2 anti-epileptic drugs at adequate dose and duration.
* Candidate for resective epilepsy surgery.
* Considered healthy enough to undergo surgery with general anesthesia.
* The patient has given written informed consent after the nature of the study and alternative treatment options have been explained.
* Must have 3 months of seizure frequency recorded prior to procedure.

Exclusion Criteria:

* Presence of any non-MRI compatible implanted electronic device.
* Presence of a metallic prosthetic or implant including artificial hips, knees, joints, or rods and screws.
* Active Major depression
* History of Suicide attempts
* History of Non-Epileptic Behavioral Spells
Effect of Aerobic Exercise in Patients With Essential Hypertension

The goal of this observational study is to evaluate the effects of a supervised aerobic exercise training program on weight loss, functional capacity, quality of life (QoL), and depression levels in patients with essential hypertension.

Patients who chose the treatment type according to personal preferences were divided into two groups: Group 1(n:91) exercised for six weeks, five sessions per week under the supervision of a medical doctor in the aerobic exercise laboratory, and group 2(n:47) was advised to maintain dietary habits and physical activity levels. Body weight, serum lipid levels, functional capacity, QoL, and depression level of all the participants were evaluated at baseline and 6 weeks later.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age,
* Absence of concomitant other metabolic and cardiovascular diseases.

Exclusion Criteria:

* Having suffered an event of ischaemic heart disease (\<6 months),
* Secondary hypertension,
* Hypertrophic obstructive cardiomyopathy,
* Congestive heart failure,
* Uncontrolled cardiac arrhythmia,
* Thyroid dysfunction,
* Diabetes mellitus,
* Symptomatic peripheral arterial occlusive disease,
* Aortic insufficiency or stenosis,
* Pulmonary or heart disease with dyspnoea at small or moderate effort,
* An outbreak of orthopedic problems on hip, knee or ankles, such as arthroplasty, contracture or severe osteoarthritis,
* Using of antidepressant or anxiolytic drugs,
* Pregnancy,
* Cognitive disfunction.
Antibiotic Use in Facial Fracture Post Injury

Facial fractures make up a significant proportion of injuries in trauma patients (1, 2). Approximately 3 million individuals suffer craniofacial trauma in the United States on a yearly basis, and approximately 50% of all wounds presenting to emergency rooms involve the head and neck (1, 2). Treatment of these fractures often results in standard surgical interventions. While up to the early 1980's perioperative antibiotic prophylaxis in maxillofacial surgery was controversial, its efficacy is well accepted today (3). Previous research work showed that the administration of antibiotics one hour preoperatively and eight hours after the intervention reduces the incidence of infectious complications in facial fractures from 42.2% to 8.9% (4). However there is still no consensus about the duration of the postoperative administration. In literature postoperative prophylaxis in facial fractures varies from single-shot up to duration of 7 and even ten days postoperatively. The use of antibiotics can be associated with allergic or toxic reactions, adverse effects, drug interactions and increasing bacterial resistance (5). In addition some authors assume that a prolonged administration of antibiotics might increase the risk of infectious complications via superinfection. On the other hand a short term or single shot administration might not be enough to prevent the onset of a postoperative infection. Up to date there is no standard to support the duration of antibiotic administration after surgical repair of a facial fracture. In this proposal, Investigators are aiming to investigate if either the utility of antibiotics administered for 3 days or 5 days make a difference in the clinical outcomes after facial fractures.

This proposed research is a retrospective chart review to examine if either the utility of antibiotics administered for 3 days or 5 days make a difference in the clinical outcomes after facial fractures.

Records of trauma patients who were admitted to Methodist Health System (MHS) between January1st 2010 and December 31st 2015 will be retrieved to review the clinical charts according to our inclusion and exclusion criteria.

Patients will be segregated in to two groups according to the duration of antibiotic use, group 1 (less than 3days) and group 2 (5 days).

Basic demographics and clinical outcomes parameters as noted above will be attained from the patient's medical records.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patient's ≥ 18 years of age.
* Blunt and penetration injury.

Exclusion Criteria:

* Pregnant and breast feeding women.
Evaluation of Pain Levels by Quantitative Pupillometry During the Placement of Deep Venous Catheters in Sedated Patients in Intensive Care Unit (PUPICAT)

Pain is common in intensive care and gives rise to multiple consequences that can impact the future of patients. The placement of deep venous catheters are painful gestures of common practice in intensive care. However, some patients are ventilated and sedated and their level of pain is difficult to judge. Quantitative pupillometry seems to be a reliable tool for assessing pain in these patients unable to communicate. The method is already common practice in the operating room for this indication and recent studies increasingly validate its use in intensive care.

The aim of the study is to validate the different levels of pain that can be assessed by pupillometry within this population during catheterization and to identify any non-responding subgroups (in order to conduct future clinical trials evaluating pain therapies).

Three groups of patients will be studied : with aminergic drugs / with curare / without aminergic drugs nor curare.

The measurement of pain levels by quantitative pupillometry (NPi®-200 pupillometer, NeurOptics® USA) will be made in intubated, sedated patients, unable to communicate on their level of pain during the placement of a deep venous catheter.

Pain will be evaluated before starting the placement of the catheter, at puncture(s), at dilation(s), and during the suture of the catheter.

Simultaneously, RASS and BPS scores as well as the patient's vital parameters and the cumulative doses of sedation-analgesia, curare and aminergic drugs will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18 hospitalized in Intensive Care Unit
* Requiring the placement of a deep venous catheter (central venous catheter or dialysis catheter)
* Sedated, intubated, unable to communicate about pain
* No opposition to participation in the study

Exclusion Criteria:

* Any ophthalmological pathology (lesion of the orbital cavity, edematous soft tissue or with an open lesion)
* Any intracranial pathology (stroke, subarachnoid hemorrhage, tumour, etc.)
* Patient post-cardio-respiratory arrest within the first 48 hours
* Medicines interfering with the pupillary reflex: clonidine dexmedetomidine, droperidol, metoclopramide, nitric oxide, scopolamine, atropine
* Patient protected within the law
* Previous participation in the study
Biomarkers for Predicting the Response to Inhaled Corticosteroid in Patients With Chronic Cough.

To investigate the value of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.

Chronic cough is a frequent complaint in respiratory specialists clinic. CVA, UACS, EB, GERC and AC are common causes of chronic cough, among whom, CVA, EB and AC can be classified as corticosteroid responsive cough.

To recognize the eosinophilic airway inflammation and assess the response of inhaled corticosteroid, induced sputum analysis is the most widely used examination but not all the subjects can provide an suitable sample of sputum for measurements and it's time-consuming.

Recently, blood eosinophils, FeNO and total IgE were detected to be biomarkers of eosinophilic airway inflammation for asthmatics. However, whether can they predict the response to corticosteroid in chronic cough remains uncertain.

The present prospective, multi-center, randomized placebo-controlled study aims to explore the value of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-70 years;
2. Coughing lasting ≥ 8 weeks；
3. No abnormality in chest imaging in the past 3 months (or there is abnormality but the investigator judges it not the cause of chronic cough)；
4. FEV1% pred\>70%；FEV1/FVC\>70%；
5. VAS≥30 in the past 48 hours;
6. Non-smokers or patients smoked less than 10 pack-years;
7. Candidates voluntarily participate in and abide by the relevant regulations of the study, can cooperate with corresponding inspections, follow the follow-up plan, and voluntarily sign written informed consent.

Exclusion Criteria:

1. Patients received inhaled or oral corticosteroids or leukotriene receptor antagonist in previous 4 weeks;
2. Patients with history of upper respiratory tract infection in the past 8 weeks;
3. Patients taking angiotensin-converting enzyme inhibitors in previous 8 weeks;
4. Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study;
5. Combined with a definite history of pulmonary diseases such as bronchiectasis, pulmonary interstitial disease, and pulmonary hypertension. Combined with other serious diseases (such as cardiovascular system diseases, metabolic system diseases, immune system diseases, nervous system diseases, etc.) that may affect the normal process of this study;
6. Participating in other drug clinical trial projects.
Are the Continuous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients?

The "Capteur Evadiac" study group, composed of French and Belgian diabetologists, has designed a 1 year randomized controlled multicenter study in order to define what should be the best clinical way of using continuous glucose monitoring in the long term to improve metabolic control in uncontrolled type 1 diabetes patients.

The primary objective of the study is to determine whether patients with chronically poor glycaemic control as evidenced by HbA1c \>= 8% twice can achieve improved metabolic control using during one year CGM together with educative program about insulin adaptation doses compared to conventional self monitoring finger sticks with educative program about insulin adaptation doses alone.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes for ≥ 12 months or more (including Cpeptide negative secondary diabetes)
* Children between 8 and 18 years old
* Adults between 18 and 60 years old
* Patients treated with basal-bolus insulin regimens, pump or multiple daily injection, only with analogs, for at least 6 months
* Performing at least 2 finger sticks glucose controls per day
* Able and motivated to use the device
* HbA1c ≥ 8% twice with HPLC method(DCA 2000 excluded)
* Written informed consent obtained prior to enrollment in the study

Exclusion Criteria:

* Blindness or impaired vision so the screen cannot be recognized
* Allergy to sensor
* Active proliferative retinopathy not stabilized by laser or vitrectomy occurence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during study
* Treatment with systemic corticosteroid or medication known to influence insulin sensitivity in the 3 months prioir to visit 1
* Pregnancy
* Manifest psychiatric disturbance
* Presence of any conditions (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actuel or anticipated that the investigators feels would compromise the patient safety or limit his/her successful participation in the study.
* Hemoglobinopathy that interfers with HbA1c measurement
Healthier At-home Meals for Expectant Mothers

This study is being done to test the feasibility, acceptability, and preliminary efficacy of a meal delivery intervention for managing gestational weight gain among pregnant women with overweight or obesity.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Gestational age ≤ 15 weeks as assessed by ultrasound
* Body mass index (BMI) ≥ 25 kg/m2
* Singleton viable pregnancy
* Receiving care and planning to deliver at UAB
* Residing within the delivery radius of the meal delivery company
* Wi-Fi or Bluetooth Internet connection in home (for digital Wi-Fi enabled study scale)

Exclusion Criteria:

* Self-reported major health conditions (e.g., heart disease, cancer, renal disease, and Type 1 or Type 2 diabetes)
* Current substance abuse
* Current treatment for serious psychiatric disorder (schizophrenia, bipolar disorder)
* Known fetal anomaly
* Planned termination of pregnancy
* Past history or current diagnosis of anorexia or bulimia
* Current use of one or more of the following medications:
* Metformin
* Systemic steroids
* Antipsychotic agents
* Anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight
* Medications for ADHD including amphetamines and methylphenidate
* Any teratogenic agent Class D
* Participation in another dietary and/or weight management intervention during pregnancy
* Unwilling or unable to consume prepared meals delivered weekly
* Unable to understand and communicate in verbal and written English
Vienna Near-Infrared Spectroscopy in Cardiac Arrest Study (VINIRSCA)

Measurement of Near-Infrared Spectroscopy (NIRS) during and after out-of-hospital cardiac arrest (OHCA) in the city of Vienna and the tertiary university hospital of the Medical University of Vienna, Austria.

NIRS will be evaluated as a tool for resuscitation quality assessment as well as a prognosticator for cardiac arrest outcomes. Already-existing literature will be taken into account, and already-existing cutoffs and prognosticating values will be assessed and - if eligible - validated in a real-life setting.

Patients suffering from out-of-hospital cardiac arrest (OHCA) and receiving cardiopulmonary resuscitation (CPR) in terms of advanced life support (ALS) in the city of Vienna, Austria, will be included. A special study team will be dispatched to the event sites by the ambulance service. Trained study fellows will include patients by placing NIRS optodes on the patients' forehead as soon as possible during and/or after CPR. Measurements will continue until 72h post return of spontaneous circulation (ROSC) or the patient's death.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* out-of-hospital cardiac arrest

Exclusion Criteria:

* \<18 years of age