cyrilzakka/clinical-trials huggingface dataset:
An Observational Study to Validate the Cumulative Life Course Impairment (CLCI) Instrument (DermCLCI-p) in Adult Participants With Moderate to Severe Chronic Plaque Psoriasis (PsO)

The IMMagine study aims to validate the newly developed CLCI instrument (DermCLCI-p) in moderate to severe psoriasis (PsO) patients, who will be started on Risankizumb (RZB) treatment and will be enrolled into the validation study up to 28 weeks. The treatment decision for RZB must be made independent of this study enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a dermatologist and presence of moderate to severe psoriasis symptoms according to physician's clinical judgment at the time of recruitment.
* Participants initiating RZB treatment for psoriasis as per local label. Physician's decision for treatment with risankizumab must have been reached prior to and independently of recruitment in the study.
* Participants able to understand and communicate with the investigator and comply with the requirements of the study.
* Willingness and ability to comply with all study requirements.

Exclusion Criteria:

- Current or recent (within the last 30 days) participation in an interventional clinical trial.
Effects of Oral Salmon Calcitonin in Human Osteoarthritis

To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis

Osteoarthritis (OA) is a difficult condition to manage and, thus far, we have no simple, effective interventions for this common cause of pain and disability.

Because parenteral salmon calcitonin (sCT) has positive effects in canine experimental OA, this phase IIa, randomized,placebo-controlled, double-blind trial evaluates the safety, tolerance and clinical efficacy of an oral formulation of sCT in patients with OA.

Patients receive a tablet containing either a placebo, 0.5 mg sCT or 1 mg sCT that they have to take every day in the morning 15 minutes before breakfast for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* radiographic OA according to the criteria of the American College of Rheumatology;
* morning joint stiffness between 15 and 30 minutes;
* pain on weight bearing and motion reported greater than 40 mm on a 0-100 mm visual analogue scale;
* normal liver and kidney function tests;
* serum CRP levels \< 10 mg/l

Exclusion Criteria:

* previous or ongoing treatment with anti-resorptive drugs such as bisphosphonates, estrogen or raloxifene
* crystal deposition diseases
* known hereditary or congenital defects
* clinically significant hepatic, renal, cardiovascular, psychiatric, endocrine and/or hematological diseases
* intra-articular injections of either corticosteroids (previous 3 months) or hyaluronan (previous 6 months)
ALT Routinely Recorded Remotely: A Comparator Study of Liver Function Tests Using the Tasso+ to Venipuncture.

A direct comparison study of blood samples collected using the Tasso+ device and venous blood samples in patients with elevated alanine transaminase (ALT).

This is a prospective, non-blinded, multi-center study to be conducted within the USA. This study will consist of a single arm. Blood will be drawn from each subject, using two different collection methods: the Tasso+ device and the conventional venipuncture method. The results will be compared assess correlation between blood collected at home, by the patient, using the Tasso+ device and blood collected in the office using a Vacutainer (SST, Red Top tube) using venipuncture for alanine transaminase (ALT), aspartate aminotransferase (AST) and total bilirubin.

Participants can complete up to 3 visits and will include self-collected blood samples using the Tasso+ device at home on the day of visit 2 and visit 3.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be willing and able to provide written informed consent prior to study entry
2. Subject is ≥ 18 years of age.
3. Subject must meet the following criterion:

   known recent history of liver function abnormality and requiring follow-up Liver tests (including ALT\>3XULN)
4. Subject must be willing and able to adhere to the assessments, study schedule, prohibitions and restrictions as described in the protocol.
5. Patients may be on any treatment / therapeutic clinical trial as indicated by treating physician

Exclusion Criteria:

1. Pregnant or nursing female by self-report.
2. Presents with abnormal skin integrity or atypical skin health within the areas to be tested (upper shoulders).
3. Subjects who have applied lotion to the skin on the shoulder the day of the visit.
4. Patients with hepatic encephalopathy
5. Vulnerable populations (children, prisoners, pregnant women, participants with diminished decision-making capacity, illiterate populations, educationally disadvantaged populations).
Powered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies

This prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current Standard Of Care stapler (for Pulmonary Artery/Pulmonary Vein transection) and powered vascular stapler.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a confirmed or suspected diagnosis of stage IA to stage IIIA non-small cell lung cancer scheduled for a lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)5;
* Subjects scheduled for VATS lobectomy in accordance with their institution's Standard Of Care;
* Performance status 0-1 (Eastern Cooperative Oncology Group classification);
* American Society of Anesthesiologists (ASA) score \</= 3;
* No prior history of VAT or open lung surgery (on the lung in which the procedure will be performed);
* Willing to give consent and comply with study-related evaluation and treatment schedule; and
* At least 18 years of age.

Exclusion Criteria

* Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment);
* Pregnancy;
* Physical or psychological condition which would impair study participation; or
* The subject is judged unsuitable for study participation by the Investigator for any other reason.
Burnout and Resilience in Hospital-based Nursing and Medical Personnel and Trainees

Aims to look at associations between work stress, burnout and resilience in hospital-based nurses and medical professionals in several EU countries.

Healthcare professionals, in particular, hospital-based nursing and medical staff, especially surgical specialities, are experiencing symptoms of burnout as never before. Within healthcare, job commitment is at stake leading to staff shortages which places further stress on the health care system, creating a vicious cycle of stressful work environment.

This is the context of the present study, and our aim is to explore quantitatively how factors like resilience, work-setting factors like job support, autonomy and leadership contribute to burnout in hospital-based nursing and medical personnel. These factors have been found to be predictive of burnout with few studies looking at synergistic interactions between these predictors. A survey design will be used for quantitative data collection. This study will also include qualitative interview-based study to complement the quantitative study.

Eligibility Criteria:
Inclusion Criteria:

* Hospital-based nurses and doctors

Exclusion Criteria:

* Non-hospital based healthcare professionals, under 18 and over 66, non-medical hospital staff
Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion

In many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision. In patients with suitable anatomy alternatively an endovascular approach can be chosen. Since open surgery is more durable in many countries a laparoscopic procedure using " key hole surgery " has gained wider acceptance. The current study wants to prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with reduced recovery times.

In many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision. In patients with suitable anatomy alternatively an endovascular approach can be chosen. Since open surgery is more durable in many countries a laparoscopic procedure using " key hole surgery " has gained wider acceptance. The current study wants to prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with reduced recovery times.

Study design: Multi center prospective randomized study including patients with infra or juxtarenal aortic aneurysms ( AAA).

In group I the AAA is resected using a conventional long incision and standard procedures for resecting the AAA. A Dacron graft is used in inlay technique to restore blood flow.

In group II a total laparoscopic approach is chosen to exclude the AAA. Identical to open surgery a dacron graft is laparoscopically sawn in to exclude the AAA and to restore blood flow.

In a subgroup II a the laparoscopic anastomosis is performed with a stapling device to simplify and to accelerate the procedure.

Endpoints of the study:

Total operating time, aortic crossclamping time, stay in ICU, return to a regular diet,postoperative ileus, total hospital stay, major and minor complications, blood loss, renal function in cases with juxtarenal AAA.Patients are evaluated for postoperative pain, wound related problems, hernias and time until full mobilisation is achieved.

Hypothesis: The laparoscopic approach though associated with a longer operating time and longer clamping times is associated with a reduced recovery time, les pain and less wound related problems compared to a full length conventional incision.

Eligibility Criteria:
Inclusion Criteria:

* patients with abdominal aortic aneurysms
* fit for open surgery

Exclusion Criteria:

* patients unfit for open surgery
* patients with malignancies
ProbioKid as Prevention Among Kids With Frequent URTI

This study was designed to evaluate the preventive efficacy of a 6-week prophylactic administration of Probiokid® on the incidence of respiratory infections and related complications in frequently sick children.

The microbiota is very important for the development of the immune system in children. Lactic acid bacteria, such as Lactobacillus and Bifidobacterium, are usually administered as probiotics (defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host). Some probiotics were shown to sustain the development of immune competency in newborns, as well as to modulate the adaptive immune response and response to infections. For example, previous research suggests that probiotics decrease the incidence of upper respiratory tract infection (URTI). Probiokid® is a commercially-available formulation that consist of probiotics (Lactobacillus helveticus, Bifidobacterium infantis, Bifidobacterium bifidum) and fructooligosaccharides. This formulation has been shown to decrease the rate of respiratory infection in children supplemented for 3 to 9 months. Therefore the aim of this clinical trial is to assess the efficacy of Probiokid® supplemented for 6 weeks on the prevention of URTI and related complications among children (aged 3 to 10 years-old) that frequently suffer of acute respiratory infections. In addition, the impact of a prophylactic intervention with Probiokid® on the number of physician visits and antibiotic courses prescribed is assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age of children from 3 to 10 years,
* High frequency of acute respiratory tract infections, characterized by a resistance index more than 0.33 (i.e. ARIs more often than once every 3 months).
* Absence of other medications that affect the immune system in the treatment regimen (except for antibiotics, as per the care provider's judgment).

Exclusion Criteria:

• Chronic pathological conditions.
Dysphagia Management During COVID-19 Pandemic

The current study is aimed to determine the procedures applied in the dysphagia clinics during the COVID-19 pandemic period. A questionnaire consisting of 30 questions will be implemented. Each participant will be asked to answer the questions.

The current study is aimed to understand the current clinical conditions and current practice regarding dysphagia management during the pandemic period/normalization period. It is a cross sectional online survey study. The first part is the survey development and testing, the second part is determination of swallowing centers and last part is survey distribution by google forms. A coordinator will be selected for each center to discuss the survey with the entire team and reply the questions.

Eligibility Criteria:
Inclusion Criteria:

* Working on a dysphagia clinic from all over the world

Exclusion Criteria:

* Not willing to participate
* Not working on a dysphagia clinic
Placental Pathology and Inflammatory Factor Analysis of OAPS

This investigation is on placental pathological changes and inflammatory factors associated with obstetric antiphospholipid syndrome.

1. To clarify the correlation between antiphospholipid antibody, ACC1 expression level, Treg cell and placental pathological changes associated with antiphospholipid syndrome. 2. Reveal that antiphospholipid antibodies affect Treg cell differentiation through the key enzyme of lipid metabolism ACC1.

Eligibility Criteria:
Inclusion Criteria:

1. pregnant women with antiphospholipid syndrome (diagnosed by experts with clinical evidence) and healthy pregnant women without antiphospholipid syndrome as a control group
2. consent to join this study and finish the informed consents

Exclusion Criteria:

pregnant women with other autoimmune diseases
Myocardial Inflammation in Systemic Lupus Erythematosus

The goal is to assess for myocardial edema on cardiac MRI during SLE flare to assess for myocardial inflammation.

The over-arching goal of this work is to further the understanding of myocardial damage in systemic lupus erythematosus (SLE) using state of the art CV imaging to investigate a novel potential mechanism of CV injury in SLE, subclinical myocardial inflammation.

Aim 1: Investigate an alternative pathway for CV morbidity in SLE by measuring myocardial edema at time of moderate to severe flare and compare values to post-flare studies and historical healthy controls.

Hypothesis 1: Myocardial edema, measured quantitatively with T2 CMR mapping during moderate to severe SLE flare will be significantly increased compared to 1) historical controls and 2) in SLE patients after resolution of flare.

Aim 2: Perform exploratory analyses investigating relationships between myocardial edema on CMR and markers of SLE disease activity and CV risk factors.

Hypothesis 2: Markers of disease activity including inflammatory makers (ESR and high sensitivity c-reactive protein), complement and autoantibody levels will predict the presence of T2 CMR detected myocardial edema during flare.

Eligibility Criteria:
Inclusion Criteria:

* • Diagnosis of SLE by American College of Rheumatology Classification Criteria \[21\]

  * Active SLE Flare defined by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)\[22\] \> 6 or British Isles Lupus Assessment Group (BILAG) Index A or B.\[23\]

Exclusion Criteria:

* Pregnant
* Allergy to gadolinium
* Severe claustrophobia
* Renal replacement therapy or glomerular filtration rate (GFR) \< 30 mL/min/1.75m²
* Medically unstable for transportation to Ross MRI scanner. Stability will be defined as: not on mechanical ventilation, HR \< 120 BPM, MAP \> 65 mmHg. The treating providers' input on the patient's stability will also be considered in addition to these criteria
* Weight \> 500 pounds
* MR incompatible implanted devices such as neurostimulator pacemakers and implantable defibrillators, presence of intracranial metal or any metal not compatible with CMR
Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.

This is a Phase 3b, open-label, single-group, multisite safety and immunogenicity study of recombinant thrombin (rThrombin) in participants who are at least 18 years of age and undergoing spinal or vascular surgery. Eligible participants will receive topical rThrombin during surgery and complete a 1-month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Currently undergoing cervical, thoracic, or lumbar discectomy; corpectomy, laminectomy, lateral or interbody fusion, including both anterior and posterior approaches (not including minimally invasive procedures; arterial reconstruction; peripheral artery bypass (PAB) grafting; or arteriovenous (AV) vascular access procedures
* History of surgery with high likelihood of exposure to bovine thrombin within the past 3 years. Prior surgery must have been 1 of the following open procedures: open procedures involving the spine or cranium, PAB grafting, AV vascular access procedures, autologous skin grafting, or other surgical procedure accompanied by documented treatment with bovine thrombin
* Age of 18 years or younger at time of informed consent
* If female and of child-bearing potential: Negative pregnancy test result within 14 days prior to treatment
* Use of a medically accepted form of contraception from the time of informed consent to completion of all follow-up study visits, if sexually active male or a sexually active female of childbearing potential
* Signed IRB/independent ethics committee-approved informed consent document

Exclusion Criteria:

* Currently undergoing procedures requiring cardiopulmonary bypass or involving the aortic arch
* Known hypersensitivity to rThrombin or any of its components
* Presence of medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
* Breastfeeding
* Receipt of treatment with any experimental agent within 30 days of study enrollment or treatment
Evaluation of Heart Status in Patients of Beta Thalassemia Using Echocardiogram

Heart failure from myocardial iron deposition is a severe complication for patients with transfusion-dependent beta thalassemia . Increased cardiac iron content impacts the contractility of cardiomyocytes and can also lead to myocarditis, pericarditis, and arrhythmias. The severity of cardiac dysfunction depends on the amount of iron deposited in the myocardium.Echocardiogram is used as noninvasive method to observe heart status. The objective of this study is to evaluate the heart status in patients of Beta Thalassemia from southern China.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with beta-thalassemia

Exclusion Criteria:

* Iron deficiency anemia
Virtual Reality and Autobiographical Recall in Anorexia Nervosa: a Preliminary Study

Clinical trial in patients with Anorexia Nervosa using body-swapping technique e Virtual Reality Body Size estimation tasks and Autobiographic Recall on sympton remission (EDI-3; EDE-Q), body satisfaction and perception


Eligibility Criteria:
Inclusion Criteria:

* Anorexia Nervosa
* Body mass index equal or superior to 15 kg/m2
* Mother tongue Italian
* Semiresidential rehabilitation program

Exclusion Criteria:

* Other eating disorders
* Neurological disorders , clinical history of cerebral damage, presence of psychiatric disorders
Contribution of Stereography (EOS Imaging System) in the Quantification of Femoral Shaft Fractures.

This observational study is a collection of clinical and imaging data of patients with a femoral shaft fracture treated by nails. The aim of this research is the contribution of the EOS imaging system in the quantification of malunions.

The study is based on the collection of clinical and imaging data (using EOS imaging system) necessary for the follow-up of patients who have benefited, most often in the emergency, of a centromedullary nailing of the femoral shaft. The study does not lead to any further examination for the patient since they are followed until the removal of the material, which usually takes place 24 months after the fracture episode. This observational and pilot study is monocentric, prospective on a continuous series of 40 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged at least 16 years (parental agreement signed for minors) or adults at the time of data collection
* Patients with a femoral shaft fractures since january 2014
* Patients with a post-nailing femoral shaft fracture
* Patients with unilateral fracture
* Patients with regional origin allowing a follow-up in Grenoble center

Exclusion Criteria:

* Patients who refuse to sign a non-objective form
* Patients with femoral shaft fracture untreted with nails
Celecoxib as Adjuvant Therapy to Chemotherapy in Patients With Metastatic Colorectal Cancer

The study aimed at evaluation of anticancer effect of celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer

The primary aim of the study is to evaluate the anticancer effect of celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer

Eligibility Criteria:
Inclusion Criteria:

* advanced colorectal cancer

Exclusion Criteria:

* cerebral metastases
* other malignancy
* H pylori infection
* thromboembolism
Cardiac Autonomic Denervation for Cardio-inhibitory Syncope

Background: Autonomic system modification is an established therapeutic approach that has been increasingly used for the treatment of vagal-related symptomatic bradycardia, such as cardio-inhibitory vasovagal syncope1-12.

Although convincing results had been reported from small populations, a large randomized study providing robust evidence on the efficacy of this approach has not yet been performed.

Hypothesis: Cardiac autonomic system modification is effective for the treatment of vagal-related symptomatic bradycardia, and is associated better clinical results as compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 70 years old.
* Cardio-inhibitory response (VASIS 2A or 2B) during tilt test, or after carotid sinus massage.
* Patients with bradycardia mediated by vagal hypertonia documented on 24-hour Holter monitoring and a clear relationship with symptoms.

Exclusion Criteria:

* Ages under 18 and over 70
* Presence of structural heart disease documented by echocardiography.
* Hypothyroidism and hyperthyroidism, drug effects, obstructive sleep apnea and other causes of secondary bradycardia.
* Anatomical disease of the conduction system.
Neuromuscular Electrical Stimulation for Jaw-closing Dystonia

6 patients with jaw-closing dystonia will be treated with neuromuscular electrical stimulation over 8 weeks. The distance the mouth can be opened voluntarily and the oro-mandibular dystonia questionnaire (OMDQ-25) will be employed to determine whether there is any objective change in jaw opening or evidence of functional improvement.


Eligibility Criteria:
Inclusion Criteria:

* Jaw-closing dystonia, which may be primary or secondary to a neurodegenerative disease or medications.
* Unable to voluntarily open jaw fully on examination.
* Evidence of functional impairment resulting from dystonia including inability to completely open the jaw during speaking or eating to such an extent that it interferes with these tasks.
* Patient interested in participating, and willing to attend multiple treatment sessions in the neurology clinic.

Exclusion Criteria:

* Presence of a cardiac pacemaker, implanted defibrillator, or other implanted electronic device.
* Inability to provide consent (either by the patient, spouse, or an identified power of attorney).
* Age under 18 years.
* Pregnancy.