cyrilzakka/clinical-trials huggingface dataset:
TriVascular Post-Market Registry

This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.


Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years or minimum age as required by local regulations.
* Indication for elective repair of AAA with an endovascular stent graft in accordance with the Instructions for Use of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System.
* Subject has signed an Ethics Committee (EC) approved Informed Consent Form. The subject or legal representative has been informed of the nature of the study, has consented to participate, and has authorized the collection and release of his/her medical information.
* Subject intends to electively receive the Ovation™ or Ovation Prime™ Abdominal Stent Graft System.
* Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan.

Exclusion Criteria:

* Subject demonstrates high probability of non-adherence to physician's follow-up requirements.
* Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results.
* Life expectancy less than 1 year
* Pregnancy
* Subjects with poor renal function as indicated by a serum creatinine \> 2.5mg/dl.
Efficacy Study of Iguratimod Combined With Tofacitab in Patients With RF Positive/Negative Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic progressive autoimmune disease with predominantly joint involvement. To compare the efficacy and difference between elamod and tofacitib in the treatment of rheumatoid factor-positive and negative rheumatoid arthritis in RA patients with poor outcome after csDMARDs dosing, in order to better inform the clinical management.

This is an open, controlled, interventional clinical study enrolling patients with active RA who meet the following entry row criteria, and treating patients with IGU 25 mg bid + tofacitinib 5 mg bid for the intervention. The screening period was defined as the screening visit was conducted within 1 month prior to the baseline visit, and efficacy and safety assessments were performed at time points 0, 4, 12, 18, and 24 weeks from the time the subject was treated with the study protocol (see efficacy and safety endpoints for details), and study subjects were asked to come to the hospital for follow-up within ±3 days of the corresponding follow-up point.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18-65 years old
2. Body weight not less than 40kg
3. Patients with a clear diagnosis of rheumatoid arthritis (RA) who meet the diagnostic criteria for RA introduced by the ACR in 1987 or ACR\\EULAR in 2010
4. Joint function grade II-III
5. Active rheumatoid arthritis (defined as active rheumatoid arthritis if the following three conditions are met: ① ≥ 6 joints swollen \[66 joints count\]

   ② ≥ 6 joints tenderness \[68 joints count\]

   ③Erythrocyte sedimentation rate (ESR) \> 28 mm/h or C-reactive protein (CRP) \> 1.0 mg/dL)
6. The Patients have been treated with csDMARDs for ≥ 3 months and have been treated with stable doses of csDMARDs for 4 consecutive weeks prior to study entry, with poor therapeutic outcomes and are being considered for treatment with a combination of biologics (bDMARDs) (according to the 2018 China Rheumatoid Arthritis Treatment Guidelines, poor outcomes, i.e., no significant improvement in RA disease activity within 3 months or failure to achieve treatment goals within 6 months)
7. Subjects must be able and willing to perform subcutaneous (SC) injections on their own, or a qualified person must be available to perform SC injections
8. If taking glucocorticosteroids, prednisone should be ≤10mg or other hormone at a dose equivalent to prednisone and the dose should be kept constant for at least 28d
9. Understand the purpose of the trial and the test procedures and sign a written informed consent form voluntarily

Exclusion Criteria:

1. Patients who have used potent immunosuppressants (such as cyclophosphamide, cyclosporine, azathioprine, etc.), tripterygiam glycosides and so on that affect the evaluation of efficacy in previous rheumatoid arthritis treatment , and who have stopped taking them for less than 4 weeks
2. History of allergy to relevant test drugs
3. Previously treated with bDMARDs
4. Subject has recently received a live vaccine, or plans to use any live vaccine during the study
A Machine Learning Algorithm to Predict Health Clinical Situations in Primary Healthcare for Frail Older Adults.

Introduction: We developed a machine learning algorithm to predict the risk of emergency hospitalization within the new 7 to 14 days with a good predictive performance (AUC=0.85). Data recorded by home aides were send in real time to a secure server to be analyzed by our machine learning algorithm, which predicted risk level and displayed it on a secure web-based medical device. This study aims to implement and to evaluate the sensitivity and specificity's predictions of Presage system for four clinical situations with a high impact on unscheduled hospitalization of older adults living at home: falls, risk of depression (is sadder), risk of undernutrition (eat less well) and risk of heart failure (swollen leg).

Methods This is a retrospective observational multicenter study. To gain insight on both short-and middle-term predictions and how the risk factors evolve through different periods of observation, we developed a series of models which predict the risk of future clinical symptoms.

This is a retrospective observational multicenter study. This study was conducted on two distinct cohorts.

Data between January 2020 - February 2023 from 50 home care facilities using PRESAEGE CARE medical device on a daily basis were analyzed. 740 853 data from 27 439 visits by home aides for 1 478 patients. The patients' mean age was 84,89 years (SD = 8.9 years) with a moderate dependency level and the sample included 1 038 women (70%).

PRESAGE CARE is a medical device CE marked to predict emergency hospitalizations. This e-health system is based on a questionnaire focused on functional and clinical autonomy (ie, activities of daily life), possible medical symptoms (eg, fatigue, falls, and pain), changes in behavior (eg, recognition and aggressiveness), and communication with the HA or their surroundings.

Based on these data, some others risks are evaluated and predict by the artificial intelligence algorithm.

This study aims to evaluate the sensitivity and specificity's predictions of PRESAGE CARE system for four clinical situations with a high impact on unscheduled hospitalization of olders adults living at home: falls, risk of depression (is sadder), risk if (eat less well) and risk of heart failure (swollen leg).

The principal objective was the sensitivity and specificity of four events' prediction: falls, "is sadder", "eat less well" and "swollen leg" for non-tautological events (when events no appear in the observation window).

Secondary objective was the sensitivity and specificity of four events' prediction: falls, "is sadder", "eat less well" and "swollen leg" for tautological events (when events appear in the observation window).

Eligibility Criteria:
Inclusion Criteria:

* frail older adults aged 65 years old and over
* Receive the help of a home care aide using PRESAGE CARE
* All eligible persons were invited to participate and were included if they provided consent
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease

The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age above or equal to 18 years at the time of signing informed consent. Japan: Male or female, age above or equal to 20 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus
* HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol)
* Renal impairment defined either by:

  1. serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m\^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or
  2. serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m\^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g
* Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening

Exclusion Criteria:

* Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
* Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening
* Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening
* Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
* Planned coronary, carotid or peripheral artery revascularisation
* Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Effect of RAS/MAPK Pathway Hyperactivation on Growth' and Bone' Profile of the RASopathies

Costello syndrome (CS) and cardio-facio cutaneous syndrome (CFCS) belongs to RASopathies, a group of multisystemic disorders caused by unregulated signalling through the RAS/MAPK pathway, an intracellular signalling pathway regulating multiple processes such as cellular proliferation, differentiation, survival, apoptosis and also contributing to oncogenesis. They share a recognizable facial appearance, aged appearance, growth delay, muscle-skeletal anomalies, heart defects, neuropsychological features, skin and ocular abnormalities, and cancer predisposition.

Even though life expectancy of individuals with CS and CFCS has increased in the last years due to the improvement of patients' care and a more effective prevention of comorbidities, some of the most challenging aspects impacting on everyday living such as growth failure, accelerate senescence and skeletal-muscle defects, still need to be fully understood. This statement underlies the need to improve clinical research protocols with more innovative techniques (multi-omics profiling) in order to better understand the effect of RAS/MAPK pathway hyperactivations on different systems and to define possible personalized treatments.

Multiomics profiling of the RASopathies

Eligibility Criteria:
Inclusion Criteria:

* Clinical and molecularly confirmed diagnosis of a RASopathy

Exclusion Criteria:

* Only clinical diagnosis of a RASoapthy
Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test

The purpose of this study is to increase the knowledge of the possible diagnostic effect of exercise induced bronchoconstriction performing a repeated exercise challenge test.

Prior studies have shown that the intensity influences the sensitivity of exercise challenge tests (ECT) and that a heart rate-based protocol does not ensure sufficient exercise intensity to induce bronchoconstriction. It is not common clinical practice to perform a pre ECT to establish maximal heart rate or maximal oxygen uptake. The heart rate formula recommended by ATS (HRmax= 220-age) is usually applied to determine recommended intensity of the ECT. Conducting a second ECT, based on the knowledge of the first test, introduce the possibility to adjust the intensity on an individual basis. In addition, based on clinical experience, patients may seem reluctant to perform maximal the first time they undergo an ECT on a treadmill. The hypothesis is that patients are less reluctant to perform maximal the second time they undergo the test when they are more accustomed to the procedure and the treadmill by itself.

Eligibility Criteria:
Inclusion Criteria:

* Referred to Klinikk for allergi og luftveissykdommer
* Meet at least 3 out of 5 criteria (symptoms related to exercise):

  1. Cough during exercise or within 5 minutes after exercise
  2. Wheeze during exercise or within 5 minutes after exercise
  3. Heavy breathing, expiratory in particular, during exercise or within 5 minutes after exercise (duration 5 minutes or more)
  4. Improvement of physical fitness/breath is lacking despite of exercise intensification
  5. Chest tightness during or after exercise
* Patients former diagnosed with-and treated for asthma who have symptoms of EIB are included in the study.

Exclusion Criteria:

* Ongoing respiratory infection or recent respiratory infection, judged by the responsible doctor to be of importance of the result
* The inability to perform an Exercise challenge test with maximum effort
Stress Free Now, a Mind-body Reduction Program for Nurses

Mindful meditation sessions have been associated with an improvement in mindfulness, perceived stress, psychological well-being, anxiety, hostility, and depression. Meditation has been associated with a decrease in autonomic sympathetic activity, heart rate, oxygen consumption and energy expenditure. Randomized controlled trials of online mindfulness and relaxation programs have been studied in patients with conditions such as irritable bowel syndrome, headache, depression, fibromyalgia, and insomnia. Nurses may benefit from such programs given levels of job stress. This study will determine whether an online stress reduction program that incorporates meditation with and without concomitant group support reduces burnout among nurses, including emotional exhaustion and depersonalization. The proposed research study will utilize Stress Free Now, an online stress reduction program developed by Cleveland Clinic Wellness Institute.

This is a randomized, controlled, single-center research study of an online intervention with peer group support to reduce stress in nurses. All participants will be assigned to the intervention or control groups by random number allocation. The duration of the intervention is 6 weeks; follow-up is at 6 and 24 weeks; the duration of the study is 6 months (24 weeks). Total individual participant time commitment will depend on particular intervention or control group assignment. Both intervention and control groups will be requested to complete a set of questionnaires at weeks 0, 6, and 24. The questionnaires will take an estimated 45 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* work as a full-time or part-time nurse at Cleveland Clinic
* have regular internet and email access and be willing and able to attend group support sessions
* work at least one weekday during the week in order to attend orientation and/or group support sessions

Exclusion Criteria:

* participating in another stress reduction research study
* pregnant, lactating, or planning to be pregnant in the next 6 months
* hospitalized for depression in past 12 months
* vacation time away from work for more than 1 week during the first 2 months of the study
* current diagnosis of schizophrenia, other psychotic or bipolar disorder
* other medial, psychiatric, or behavioral limitations that may interfere with study participation or the ability to follow the intervention protocol
* unwilling or uninterested in participating in group sessions
A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress.

The goal of this clinical trial is to compare the effect and time consumption of the Swedish translation of the protocol for RNT-ACT with the internet administrated self-help treatment with therapist support (iCBT) for patients seeking medical care for depression, anxiety or stress at their primary care unit. The trial consists of a feasibility study and a randomized controlled trial with 3- and 12-month follow ups.

The main question it aims to answer are: Is the Swedish translation of a psychological treatment protocol targeting Repetitive Negative Thinking (RNT) based on Acceptance and Commitment therapy (ACT), RNT-ACT, an effective treatment in Swedish primary care for the treatment of people with a high proportion of negative repetitive thoughts, who meet diagnostic criteria for depression and/or anxiety? The question is planned to be elaborated into the following parts:

A feasibility study in which the material and the system are tested at a single care center.

A randomized controlled trial conducted at several health centers where the comparison group is patients who are actualized for traditional psychological treatment in the form of iCBT for either anxiety or depression programs and where they are offered the second treatment arm after 3- and 12-month follow-ups.

A follow-up study where time consumption and patient satisfaction are evaluated in both branches.

Participants will be given either RNT-ACT or iCBT as treatment. The group who are given RNT-ACT will receive 2\*60 minutes of therapy along with mindfulness files to listen to daily between sessions. The group who are given iCBT will receive internet-based Cognitive Behavioral Therapy, one of the forms of delivering Cognitive behavioral therapy that is implemented in Region Skåne and can thus be seen as treatment as usual. Patients will access the treatment through a secure website and communicate with their therapist by text when needed. Researchers will compare the RNT-ACT and iCBT groups to see if there are differences in depressive, anxiety- and stress- related symptoms, rumination, psychological flexibility, client satisfaction and therapist-rated time consumption. In the feasibility study researchers will also evaluate drop-out and recruitment rate.

Eligibility Criteria:
Inclusion Criteria:

* DASS-21 \>25
* Ability to communicate in Swedish orally and in writing

Exclusion Criteria:

* Routine blood tests are carried out including blood count, thyroid hormone, liver status and fluid balance in order to be able to differentially diagnose any physical illness.

In addition to physical illness are exclusion criteria

* Other psychological or psychiatric treatment,
* Suicidality, substance abuse, Anorexia Nervosa, psychosis, bipolar disorder, attention deficit hyperactivity disorder (ADHD) and antisocial personality disorder (as verified based on M.I.N.I 7.0).
Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy

Anastomotic leakage is the major postoperative complication in right colectomy. Evaluation of calcification on coeliac trunk and mesenteric arteries on the preoperative CT scan could allow the identification of patient at-risk of postoperative complications.

A monocentric retrospective study performed at CHD Vendée concluded than a calcification score over or equal to 3 was associated with a higher risk of developping an anastomotic leakage.

The aim of this prospective multicentric study is to validate a calcification score based on preoperative CT scan analysis and focussing at coeliac trunk and mesenteric arteries.This study will involve patients operated on with a scheduled right colectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Scheduled right colectomy with restoration of digestive continuity
* Patient who has had or will have a preoperative abdominal-pelvic CT scan with or without contrast injection
* Patient with the ability to understand the protocol and agree to participate in the study.
* Affiliated with a social security system

Exclusion Criteria:

* Patient requiring a right colectomy or ileocaecal resection for chronic inflammatory bowel disease or on long-term corticosteroid therapy
* Patient with a history of colic resection
* Patient under guardianship, curatorship, or deprived of liberty
* Pregnant, postpartum or breastfeeding women
* Minor patients
Platelet Rich Plasma and Perineural Injection Therapy for Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. Since 2014, two small clinical trials showed the positive effect of PRP in peripheral neuropathy. One study shown the PRP has therapeutic effect for peripheral neuropathy in patients with leprosy. In addition, PRP having protective effect against neurological deficit of facial nerve during superficial parotidectomy. However, these studies have not entirely proved the effects of PRP on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. In addition, the PRP was not used for treating CTS so far. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP injection in patients with CTS.

After obtaining written informed consent, patients of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided PRP injection and control group received one-dose ultrasound-guided 5% dextrose injection. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd, 4th, 8th, 12th, 16th and 24th week after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 year-old.
* Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

* Cancer
* Coagulopathy
* Pregnancy
* Inflammation status
* Cervical radiculopathy
* Polyneuropathy, brachial plexopathy
* Thoracic outlet syndrome
* Previously undergone wrist surgery or steroid injection for CTS