cyrilzakka/clinical-trials huggingface dataset:
A Study of AT-02 in Subjects With Systemic Amyloidosis.

This is a Phase 2 open-label extension study to evaluate the long-term safety, tolerability, and clinical activity of AT-02.

AT-02 is an investigational medicinal product being developed to treat systemic amyloidosis.

The study will enroll subjects with systemic amyloidosis who have participated in AT02-001 study.

The study includes screening period (56 days), treatment period (week 104), follow up (week 112).

The total duration of participant in study is up to 120 weeks.

A Safety Review Committee (SRC) will periodically convene and review all available clinical and laboratory data during the study. A single SRC will monitor safety across all AT-02 studies to ensure that safety signals are assessed in aggregate.

Eligibility Criteria:
Inclusion Criteria:

1. Subject understands the study procedures and can give signed informed consent.
2. Subject is willing and able to comply with this protocol and will be available for the entire duration of the study.
3. Subject must have a confirmed diagnosis of SA per the diagnostic criteria specified in the parent study protocol.
4. Subject must have participated in the study AT01-001 and wishes to receive open-label AT-02.
5. AT02-001 Part 2:

   a. Subjects must have completed the last follow-up visit in AT02-001 Part 2 without significant adverse events, as determined by the Investigator.
6. AT02-001 Part 3:

   a. Subjects must have completed the post-treatment imaging studies in AT02-001Part 3 (e.g., CMR, echocardiogram) without significant AEs in the parent study as determined by the Investigator.
7. Must continue to satisfy the eligibility criteria in the parent study protocol for WOCBP, WONCBP, or male participants

Exclusion Criteria:

1. Is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during this study and follow-up period.
2. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
3. Has acquired any new, clinically significant underlying illness since enrollment in the parent study.
4. Has any clinically significant worsening of organ function associated with underlying SA or clinically significant change in concomitant medications for the treatment of SA since enrollment in the parent study.
5. Estimated glomerular filtration (eGFR) ≤30 mL/min/1.73 m2.
6. Currently using any prohibited concomitant medications.
7. Any contraindication to MRI or MRI contrast.
8. Is currently participating in an interventional clinical study or has participated in another clinical study (other than AT02-001) within the last four (4) weeks or within five (5) half-lives of the prior study treatment, whichever is longer.
Therapy Management in Patients Treated With Anakinra Due to Recurrent Pericarditis

To determine the utility of serial cardiac magnetic resonance (CMR) imaging for guidance of therapy management in patients treated with anakinra due to recurrent pericarditis (RP), compared with c-reactive protein (CRP) assay alone.

Recurrent pericarditis (RP) is a specific pathology of the pericardium included within the pericardial syndromes by the guidelines of the European Society of Cardiology (ESC). The latter defines RP as pericarditis occurring after a symptom-free interval of 4-6 weeks from a documented first episode of acute pericarditis; the recurrences rate may range from 15 to 30%, with a significant increment of 50% in patients treated with corticosteroids or not treated with colchicine. The diagnosis of recurrences follows the same criteria utilized for acute pericarditis, and a viral etiology can often be demonstrated.

The pathogenesis of RP is still debated, but they are self-sustained by an autoinflammatory/ autoimmune amplified response following an exogenous or endogenous trigger. In this context, the cytokine interleukin 1 (IL-1) has been implicated as a key mediator of RP. Anakinra, an IL-1 antagonist, is of particular interest because it limits the self-sustained pathway of RP and may reduce the recurrences. The current 2015 ESC guidelines for the diagnosis and management of pericardial diseases recommend anakinra in cases of proven infection-negative, corticosteroid-dependent RP not responsive to colchicine, but it remains debated the duration of the therapy and when to start its tapering. In this context, cardiac magnetic resonance (CMR) imaging has recently emerged as an interesting imaging biomarker capable of detecting pericardial inflammation, proving pericardial edema and late gadolinium enhancement (LGE), and distinguishing three defined pericardial inflammation phases: acute (edema and LGE), subacute (only LGE) and burned-out (no edema nor LGE).

To overcome the 2015 ESC guidelines limitations, the investigators sought to determine the utility of serial CMR imaging for guidance of therapy management in patients treated with anakinra due to RP, compared with the c-reactive protein (CRP) assay alone, as currently recommended.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients treated with anakinra 100 mg/die if ≥ 18 years old, and
* Pediatric patients treated with anakinra 2 mg/kg/die if \< 18 years old
* Pediatric and adult patients treated with anakinra due to corticosteroid-dependent or not responsive to colchicine or non-steroidal anti-inflammatory drugs (NSAIDs) recurrent pericarditis

Exclusion Criteria:

* Ongoing infection (proved within serology)
* Refuse to participate in the trial
Dermoscopy in Primary Raynaud's Phenomenon

Raynaud's phenomenon (RP) is very frequent in general population (up to 10%). Nailfold capillaroscopy (NFC) is recommended for patients presenting RP, to eliminate systemic disease such as systemic sclerosis. NFC is not easily available in clinical practice. Dermoscopy, used for pigmentary skin lesion screening, may help to detect giant loops, hemorrhages or other capillaries anomalies. However, no study has evaluated the performance of dermoscopy in primary RP. The objective is to determinate which items in dermoscopy are correlated with a normal NFC and predict with a good negative predictive value, a normal NFC in RP patients. The secondary objective is to assess inter-observer reproducibility of dermoscopy in patients with RP.

Raynaud's phenomenon (RP) is very frequent in general population (up to 10%). Nailfold capillaroscopy (NFC) is recommended for patients presenting RP, to eliminate systemic disease such as systemic sclerosis. NFC is not easily available in clinical practice. Dermoscopy, used for pigmentary skin lesion screening, may help to detect giant loops, hemorrhages or other capillaries anomalies. However, no study evaluated the performance of dermoscopy in primary RP. A preliminary study (Tenon Hospital) showed an interest of dermoscopy in primary and secondary RP, with a negative predictive value of dermoscopy of 100% for capillaroscopy.

This is a prospective, multicentric French study comparing dermoscopy and capillaroscopy in patients attending dermatology or vascular medicine departments for the first evaluation of a RP.

The objective is to determinate which items in dermoscopy are correlated with a normal NFC and predict with a good negative predictive value, a normal NFC in RP patients. The secondary objective is to assess inter-observer reproducibility of dermoscopy in patients with RP.

The main hypothesis is that a normal dermocopy on five items is highly predictive of a normal NFC.

During a first consultation for RP, NFC will be realized with a clinical exam and a biological test (antinuclear antibodies), as official recommendations. Dermoscopy of peri-ungueal area will be realized by another investigator, if possible during the same consultation. Photographs of all fingers, except thumbs, will be made and will be reviewed by another investigator of another center. There will be no follow-up.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* first consultation for bilateral Raynaud's phenomenon (RP)
* Bilateral Raynaud's phenomenon affecting at least one finger of each hand defined by a paroxysmal syncopal phase on exposure to cold,
* Affiliated to the French health care systeme

Exclusion Criteria:

* age \< 18 years
* Presence of unilateral RP where the capillaroscopy is normal regardless of the cause
Effect of a New BI-specifiC Antibody Towards Dendritic Cells on Inflammation in Rheumatoid Arthritis

First, this study will evaluate, in vitro, the cellular composition of the synovial fluid from patient with rheumatoid arthritis, gout or osteoarthritis.

Then samples will be test with a new format of bispecific antibody targeting dendritic cells. The production of IL-10 will be the principal criteria of judgment. Production of others cytokines like IL-1B, IL-6, IL-12 and IFN will be checked as well.

Rheumatoid arthritis (RA) is one of the most common autoimmune disease in adult. It exists several drugs but none target dendritic cells even if it seems they play a major role in the physiopathology.

One of the unit of research of Tours recently develop a new format of bispecific antibody which target dendritic cells. The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with RA and patients with gout (for the comparison, because the inflammatory mechanisms are different) and with osteoarthritis (comparison with a non inflammatory disease) Then, we will use this new antibody and evaluate the response by dosing Il-10, IL-6, IL-12, IL1B and IFNy The aim is to verify in vitro if, with this new drug, it is possible to reverse the inflammation and induce a tolerance.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years old
* Proven and possible RA or Gout or osteoarthritis
* Arthritis accessible to a puncture
* Necessary puncture for diagnosis or therapeutic

Exclusion Criteria:

* Microcrystalline rheumatism other than Gout
* Known SpA
* Septic arthritis
* Biomedicament treatment
* Patient having objected to the processing of his data
The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease

The aim of this study is to evaluate prospectively a possible effect of an oral polymeric diet enriched with TGF-beta 2 (Modulen) as compared to Budesonide (one of the commonly accepted treatments for Crohn's disease) on clinical response, mucosal healing and intestinal microbiota in adult patients with newly diagnosed Crohn's disease using a capsule endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed Crohn's Disease
* Mild to moderate severity

Exclusion Criteria:

* Patients who received systemic steroid or Budesonide or biological treatment
* Recent bowel surgery
* Colostomy, ileostomy
* Short bowel syndrome
* Obstructive symptoms
* Pregnancy, lactation
* Cardiac pacemaker or defibrillator
* Swallowing problems
* Uncontrolled metabolic diseases or any other condition that can be exacerbated by steroids
Point-of-care Ultrasound for Acute Kidney Injury

It is aimed to determine prerenal, renal and postrenal diagnoses of patients with acute kidney injury with POCUS performed in the emergency department. Patients who presented to the emergency department and who have acute kidney injury (AKI) according to the KDIGO criteria will be evaluated and patients diagnosed with AKI will be included in the study. The diagnostic accuracy of POCUS with the AKI etiologies of the patients will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

• AKI diagnosis according to KDIGO criteria

Exclusion Criteria:

* Patients with end stage renal failure,
* Failure to perform POCUS in the first two hours of presentation of patient,
* Those with renal malignancy,
* Pregnant women,
* Renal transplantation patients,
* Patients with a single kidney,
* Those with polycystic kidney disease,
* Patients with nephrostomy,
* Patients who are referred from another center,
* Unable to perform adequate imaging,
* Patients who do not give consent for the study will be excluded.
Invasive Coronary Angiography Early in Ischemic Heart Failure

To compare the outcomes of patients with acute heart failure who undergo early coronary angiography vs. usual care


Eligibility Criteria:
Inclusion Criteria: Adult patients with acute heart failure, hospitalized in Ontario, Canada, with evidence of possible ischemic heart disease, defined as at least one of: a) prior myocardial infarction, b) troponin elevation, or c) angina.

Exclusion Criteria:

* Recent myocardial infarction
* Coronary angiogram or revascularization within previous 3 months before admission
* Nonresidents of Ontario, invalid health card number
* HF diagnosed after admission
* Admission BNP or NT-proBNP not diagnostic of HF
* Died within 14 days of admission
* Palliative within 6 months prior to hospital admission
* Elevated creatinine concentration
* Documented anaphylactic contrast allergy
* Ischemic or hemorrhagic stroke within 3 months prior to admission
* Highest category of Hospital Frailty Risk Score
* Active severe bleeding at time of hospital admission
* Absolute platelet count \< 20
* Metastatic cancer
Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and functional outcomes following two standard care procedures for radical cystectomy. The participants will have one of the standard care procedures as part of their care. The two procedures that will be followed are open radical cystectomy and robotic assisted radical cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While newer, RARC is considered to be equivalent to open surgery when it is performed by a trained robotics surgeon. The reported complication rates of RARC appear comparable to open surgery. This means there is no significant difference in the risk between the two standard procedures. However, despite these potential advantages, true comparison between the open and robotic technique with regards to long term cancer related and functional outcomes has not been accomplished because previous studies did not compare patients of equal health status. The researchers hope to learn whether or not patients undergoing RARC recover more quickly than or at the same rate as patients undergoing an open radical cystectomy while having non inferior cancer related outcomes. This study is funded by the National Institutes of Health (NIH).


Eligibility Criteria:
Inclusion Criteria:

1. Patient must have biopsy proven bladder cancer. Official pathology report reviewed at the participating institution is required.
2. Bladder cancer must be clinical stage T1-T4, N0-1, M0. (AJCC 7th edition) or refractory cis (carcinoma in situ).

Exclusion Criteria:

1. Inability to give informed consent.
2. Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
3. At the discretion of the treating surgeon, any pre-existing condition such as severe chronic obstructive pulmonary disease that precludes a safe initiation or maintenance of pneumoperitoneum over a prolonged period of time and during surgery.
4. Age \<18 or \>99 years.
5. Pregnancy.
Vitamin D Supplementation in CKD - Vascular Function, Structure and Immune Regulation

A pilot study to assess feasibility of methods of an observer-blinded randomised controlled trial of the effect of vitamin D supplementation in Chronic Kidney Disease and low vitamin D levels on markers of vascular function (Flow Mediated Dilatation of Brachial Artery), vascular structure (Carotid Intima Media Thickness) and Immune Regulation (frequencies of CD4+CD28null T lymphocytes ad Regulatory T lymphocytes).

The study is a single (observer) blinded feasibility pilot randomised study. Study subjects will be recruited from clinics run by St George's Hospital Renal Department and randomised to treatment arm or no treatment arm.

In treatment arm, six doses of vitamin D tablets (cholecalciferol 100,000 IU, five capsules total) will be administered on weeks 0, 4, 8, 12, 16 and 20. In the no-treatment arm the participants receive no cholecalciferol. Participants will have serum calcium levels measured at week 12.

All participants will undergo estimation of endothelial function, carotid intima-media thickness, CD4+CD28null and regulatory T cell frequency in week 0 and week 26. The observer will be blinded to whether the patient is in the treatment or no-treatment arm whilst the following tests are performed:

1. Measurement of Brachial Artery Flow Mediated Dilatation
2. Measurement of Carotid Intima Media Thickness
3. Quantification of CD4+CD28null and regulatory T cell frequency

The pilot study will assess feasibility of the study methods.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years
2. Calcium \< 2.58mmol/l
3. On an ACE inhibitor/ARB
4. Vitamin D \<75nmol/l
5. eGFR 15- 60ml/min/1.73m2 and stable
6. Informed consent to participate

Exclusion Criteria:

1. Patients already on Vitamin D or calcium supplementation
2. Patients with known malignancies
3. Patients with autoimmune conditions
4. Patients with heart failure (ejection fraction \<40%, Plasma NT pro-BNP\>500pg/ml)
5. Patients with active infection
6. Rapidly deteriorating renal function
7. Recent Acute coronary syndrome or cerebro-vascular event (within the last 6 months)
8. Uncontrolled hypertension (BP\>160 systolic)
Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin

The aim of this study is to assess whether the application of a selective serotonin reuptake inhibitor (SSRI) enhances and prolongs the learning enhancement achieved by anodal transcranial direct current stimulation (atDCS). For this, young and older healthy subjects will be tested with a well established learning paradigm. Results of this study may help to support the application of atDCS also in patients, e.g. with dementia or mild cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* right handedness
* unobtrusive neuropsychological screening
* ability to provide written informed consent
* no pathological findings in head MRI
* age: 18 to 35 years (young adults) or 50-80 years (older adults)
* Highly effective contraception (Pearl Index \< 1) or reliable abstinence from any heterosexual relationships in women of childbearing potential

Exclusion Criteria:

* severe internal or psychiatric disease (especially depression or suicidal thoughts)
* epilepsy
* cognitive impairment (\< SD under age adjusted norm in neuropsychological testing)
* concurrent taking of serotonin precursors (tryptophan, 5-HTP) or MAO inhibitors
* concurrent taking of tramadol or triptans
* concurrent taking of pimozide or linezolid
* concurrent taking of other drugs prolonging the QT-interval
* long-QT-syndrome
* hypokalemia or hypomagnesemia
* known intolerance of the study medication
* claustrophobia or metallic implants, tattoos (MRI exclusion criteria)
* pregnancy or lactation
* participation in another drug-interventional clinical trial within the last month or during the entire study
* probands that are placed in an institution due to official or judicial order
* non-agreement to save and transmit pseudonymised study data within the clinical trial
Fully Automated Pipeline for the Detection and Segmentation of Non-Small Cell Lung Cancer (NSCLC) on CT Images

Accurate segmentation of lung tumor is essential for treatment planning, as well as for monitoring response to therapy. It is well-known that segmentation of the lung tumour by different radiologists gives different results (inter-observer variance). Moreover, if the same radiologist is asked to repeat the segmentation after several weeks, these two segmentations are not identical (intra-observer variance). In this study we aim to develop an automated pipeline that can produce swift, accurate and reproducible lung tumor segmentations.

In this study, we aim to develop and test an automated deep learning detection and segmentation software for non-small cell lung cancer (NSCLC) that can automatically detect and segment tumors on CT scans and thus reduce the human variation. We will assess the level of agreement between a group of radiologists, performing manual versus semi-automatic tumour segmentation. To do so, we will provide radiologists with two sets of CT scans. The first set will be segmented manually; the second one will be segmented using the automated software program.

Subsequently, we will use the inter- and intra-observer variance from the clinical study in a simulation or modeling study. We also compare the time needed and the consistency in segmentations by the software to medical doctors performance.

Reliability and Agreement study:

Primary tumours of 25 lung cancer patients will be delineated by 6 segmentation experts.

1. Assess agreement between automatic segmentation and radiologists' segmentation The primary tumours of 25 patients will be manually segmented by the radiologists and automatically by the the tool. The time needed to perform this task and the reproducibility of the segmentation will be recorded. The degree of overlap between the ROs and the automatic contour will be assessed pairwise using the Dice coefficient.
2. Delination of tumours by the experts, assisted by the software tool For another 25 patients, the experts will be provided with an automatic delineation, performed by the tool. They have the possibility to adjust and validate it. The time needed will be recorded. The difference between the mean overlap fraction in the first situation (manual delineation of experts) and the second situation (delineation of experts+ software tool) will be assessed, using a multi-observer Dice coefficient.
3. Assessment of intra-observer variance The experts will repeat the segmentation of the lung tumours after 2 weeks. They will repeat the manual segmentation (n=25) and the semi-automatic segmentation (n=25). This will make it possible to assess the intra-observer variance in both situations.
4. Qualitative assessment of the experts' preferences using an in-house developed visualization toolbox.

Eligibility Criteria:
Inclusion Criteria:

* Availability of CT scans
* Availability of definite diagnosis

Exclusion Criteria:

* Lack of segmentations
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring

Bloomlife has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional.

Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy.

The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for routine non-stress test (NST) performed at the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman ≥ 18 years old
* Gestational age ≥ 32 weeks and 0 days
* Singleton pregnancy
* Ability to read and understand Dutch or English
* Willingness to participate in the study

Exclusion Criteria:

* Implanted pacemaker or any other implanted electrical device
* Plurality higher than 1
* History of allergies to skin adhesives
* Contraindication to the use of the CTG