cyrilzakka/clinical-trials huggingface dataset:
Immuno-positron Emission Tomography Study of 89Zr-S095012 in Patients With Advanced Solid Tumours

The purpose of this study is to assess the whole-body biodistribution and tumour uptake of 89Zr-S095012 in participants with solid tumours treated with S095012 (PD-L1x4-1BB bispecific antibody)


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumour, for which standard treatment options are not available, no longer effective, or not tolerated
* At least one measurable target lesion as per RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Royal Marsden Prognosis score of 0 to 1 (score based on lactate dehydrogenase (LDH) value, albumin value and number of sites of metastasis)
* Adequate organ function as assessed by laboratory tests (especially adequate hepatic function)
* Negative test results for cytomegalovirus (CMV), Epstein-Barr virus (EBV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV) infection, according to local standards.

Exclusion Criteria:

* Participants with no available archived material and no tumour lesions amenable to biopsy
* Participants with primary central nervous system malignancies, with Child-Pugh Class B8 or higher, or C liver cirrhosis
* Participants with active auto-immune disease or immune-related adverse event currently requiring systemic anti-inflammatory agent (more than 10mg/day prednisone or equivalent)
* Participants with a history of an opportunistic infection within a year before the administration of first study drug dose are excluded.
* Participants who received either systemic corticosteroids (\> 10 mg per day of prednisone or equivalent) or other immunosuppressive medication during the 2 months prior to the first dose of the study drug are excluded.
* Participants with prior history of Grade ≥ 3 immune-related pneumonitis, colitis, hepatitis, or myocarditis
* Participants with a history of progressive multifocal leukoencephalopathy
* Participants must not have a history of active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.
Sleep in Critically Ill Patients on Mechanical Ventilation in ICU

15 patients with sepsis, 15 patients with COPD and 15 surgical patients will undergo polysomnographic sleep monitoring up to 24 hours in order to define if there are common sleep features within the groups

It is an observational study in order to define if there are common polysomnographic sleep features within the following three groups of wake critically ill patients on mechanical ventilation in ICU: the group of septical patients, the group of patients with chronic obstructive pulmonary disease in exacerbation and the group of surgical patients without sepsis.

15 patients will be included in each group. They will undergo polysomnographic sleep monitoring during up to 24 hours.

Polysomnograms will be studies then in order to find out if there are common sleep characteristics within the homogeneous patient groups of critically ill.

Eligibility Criteria:
Inclusion Criteria:

* wake non-sedated patients
* mechanical ventilation

Exclusion Criteria:

* age \< 18 years
* pregnant
* Glasgow Coma Scale \< 11
* sedated patients
Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia

Dysfunctional chronic diffuse pain syndrome, concerning 2% of the French population, Fibromyalgia (FM) is classified either as a psychological disease or as a somatic disease. This dichotomous reasoning does not lead to a better understanding and does not allow the use or development of new psychological tools of care.

The issue of the proximity between FM and depression highlighted by some authors and the presence of anxious comorbidities may arise at a different level, that of the transdiagnostic approach. Rumination is one of these transdiagnostic processes that are the subject of recent studies and one of the dimensions of which (abstract analytical rumination) is at work in depression and a number of psychopathologies. The investigator therefore wishes to explore the process of rumination and its abstract analytical dimension in FM and to explore its link with the depressive and anxious manifestations frequently associated with this disorder.


Eligibility Criteria:
Inclusion Criteria:

* FM Criteria of the American College of Rheumatology ACR 1990.
* Major Patients
* free and informed consent signed
* stable treatment for at least one month
* Native French speaker
* Patient covered by health insurance.

Exclusion Criteria:

* Patient deprived of liberty or protected major (under guardianship or curatorship)
Drug Eluting Balloon Venoplasty in AV Fistula Stenosis

DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV fistula stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Arteriovenous (AV) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis.
* Fistula has been in use for at least 1 month and is \> 6 weeks old
* Brachiocephalic AV fistula
* Brachiobasilic AV fistula
* Radiocephalic AV fistula (both proximal and distal)
* Participant \>/=18 yrs old
* Index lesion is less then the length of the DEB, and the reference vessel diameter is appropriate for treatment with the size range of DEB (4mm - 8mm diameter)
* Participant is able to give valid informed consent

Exclusion Criteria:

* Allergy to iodinated Intravenous contrast
* Allergy to Paclitaxel
* Prosthetic grafts
* Long or tandem lesions that cannot be treated with a single DEB
* Thrombosed Arterio-Venous fistulas
* Women who are breastfeeding, pregnant or intending to become pregnant
* Participants of child-bearing age who are unwilling to use a reliable form of contraception for the duration of the study.
Comparison of MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) in Cognitive Assessment in Geriatric Oncology

Compare neurocognitive testing MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) to candidates aged patients with 1st line treatment of their cancer will be received an examination oncogériatric


Eligibility Criteria:
Inclusion Criteria:

* Patient old over 70 years
* Patient with cancer (solid tumor or hematological) for which a 1st line treatment is planned
* Patient candidate an oncogeriatric assessment
* Patient agreeing to participate in the study
* French language
* Lack of subsequent neurological sequelae with cognitive impact stroke, dementia or progressive psychiatric disorder
* Patient having a life expectancy ≥ 6 months

Exclusion Criteria:

* Primitive cancer of the central nervous system or brain metastasis
* Patients unable to meet the cognitive tests
* Refusal to participate
* Realization of a MMSE or MoCA test in the last 6 months
The Study of CM326 in Adult Subjects With Atopic Dermatitis

This is a open-label, multi-center study to evaluate the safety and efficacy of CM326 in atopic adrmatitis subjects.

The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.

Eligibility Criteria:
Inclusion Criteria:

* With confirmed Atopic Dermatitis (AD) at the screening.
* Have the ability to understand the nature of the study and voluntarily sign the informed consent.
* Be able to communicate well with investigators and follow up protocol requirements.
* The subjects agreed to use highly effective contraceptive measures during the study.

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.
* Major surgery is planned during the study period.
* Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView

This study is designed as a prospective observational, non-controlled, non-interventional study.

The aim of this study is to obtain a broad user perspective of the aScope™ 4 Broncho, focusing on the device functionalities within regular clinical practice and therapeutic use of flexible bronchoscopes in the OR and ICU.

The study will include a minimum of 100 adult patients admitted to the operating room (OR) or Intensive Care Unit (ICU) undergoing at least one bronchoscopy procedure. The inclusion will stop when 100 fully evaluable patients or a maximum of 150 patients have been enrolled.

The involved sites will include patients during a five months' period, from September 2017 to January 2018.

Refer to brief description

Eligibility Criteria:
Inclusion Criteria:

* Patient's ≥18 years
* Clinical indication and eligible for an airway procedure involving a bronchoscopy procedure, as judged by the Investigator
* Patients being admitted in the OR or ICU at the investigational site

Exclusion Criteria:

- None
Efficacy of CompuFlo® Technology in Thoracic Epidural Space Identification

The aim of this non inferiority trial is to assess the efficacy of CompuFlo® technology to identify the thoracic epidural space in relation to the gold standard loss of resistance technique.

This non inferiority trial shouts to adress whether the CompuFlo® technology to identify the thoracic epidural space is less efficacious to the gold standard loss of resistance technique (LOR). After informed signed consent patients that will be subjected to gynecological operations and meet the inclusion criteria will be eligible to participate. All operations will be performed under general anesthesia and thoracic epidural analgesia regardless of study arm. Patients will be randomly allocated into two study groups. In the first study group (Group LOR) the thoracic epidural space will be identified by the LOR technique and in the second study group (Group C) by the CompuFlo® technology. The primary outcome is the percentage of thoracic epidural space identification success in either study group.

Eligibility Criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) Physical Status Classification System I-III Body mass index: 18 -35 kg/m2 Gynecological laparotomy with midline incision under general anesthesia and thoracic epidural analgesia

Exclusion Criteria:

Patients' denial to participate in the study ASA Physical Status Classification System \>IV Contraindications to epidural analgesia Patients with sepsis Patients with pre-existing neurologic deficits Pre-existing operations in the thoracic spinal cord Emergency operations Patients with end-stage cancer
Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg

The purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein level goals.


Eligibility Criteria:
Inclusion Criteria:

* A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
* Fasting LDL-C concentrations at Visit 1 as defined in the protocol.
* Discontinuation of all lipid lowering therapy at Visit 1.

Exclusion Criteria:

* History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
* Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
* Severe congestive cardiac failure (as defined by the protocol - Appendix I).
* Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1)..
Dynamic Arterial Elastance During General Anesthesia Induction

This study evaluates if dynamic arterial elastance measured before general anesthesia induction can predict the occurrence of hypotension due to general anesthesia induction.

As general anesthetics may be responsible for vasodilation and cardiac depression, arterial hypotension after induction of general anesthesia is a common event and may contribute to an adverse outcome. Dynamic arterial elastance has been proposed as a functional parameter of arterial tone and studies showed that it was able to predict pressure response to fluid administration in fluid-responsive patients and the amount of mean arterial pressure riduction as a conseguence of noradrenaline dose reduction in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients that will be undergone to general anesthesia for surgery
* Patients that need mini-invasive cardiac output monitoring during surgery

Exclusion Criteria:

* Age \<18 yo
* Pregnancy
* Arrhythmia
* Severe valvular diseases
* Uncorrectable alterations of arterial signal
Prevent Inability To Control Urination

The purpose of this study is to determine the capacity of self-efficacy to predict maintaining a behavior change at four years post urinary control intervention.

This is a study that will monitor and compare attitudes and strategies that women use to maintain behavior changes that prevent urination problems. Women will complete questionnaires, do muscle strength exercises, and bladder training at 3 months, one year, and 4 years post intervention.

Eligibility Criteria:
Inclusion and exclusion criteria

1. Female 55 through 80 years old
2. Post-menopausal-no menstrual cycle for the past 12 months except for women who are on hormone replacement therapy.
3. Continent of urine (using the MESA definition of continence) defined as:

   1. No previous incontinence episode except during pregnancy and/or postpartum period.
   2. Urine loss less than 6 days during the last 365 days
   3. No previous or present incontinence treatment with pharmacological agents, behavioral programs or surgical therapy.
4. No history of bladder cancer, stroke, multiple sclerosis, parkinsonism, epilepsy, spinal cord tumor or trauma.
5. No reported difficulty with activities of daily living, i.e. walking about the house, dressing, getting in/out of bed, getting to/using the toilet, bathing/showering, or eating.

Additional criteria are applied at a physical examination:

1. Mini Mental Status of at least 24
2. Negative for objective urine loss during coughing.
Proximal Humerus Fracture Dislocation Direction and Avascular Necrosis

The purpose of the study is to see if there is a connection between a proximal humerus fracture dislocation direction and the likelihood of developing avascular necrosis. Utilizing a retrospective cohort from the last ten years we hope to bring consenting patients back for a single visit to have x-rays and complete patient reported outcome measures to assess for evidence of avascular necrosis.

The incidence of proximal humerus fractures continues to increase and is among one of the more common fractures seen in the adult population. Proximal humerus fracture dislocations, however, are less common. Despite the decreased prevalence, fracture dislocations have unique challenges with respect to obtaining an anatomical reduction and more frequently involve an open surgical reduction. In addition, depending on other fracture characteristics, there are various treatment options for the fracture itself. While fracture dislocations ultimately lead to increased AVN and revision surgery, further discussion surrounding the direction of dislocation and how it may influence overall outcomes has not been addressed in the previous literature. The study design utilizes a retrospective cohort from the last ten years, by asking patients who have had a previously surgically treated proximal humerus fracture dislocations to come back to the surgeon's private clinic to complete a single visit assessment. During this assessment the consenting participant will receive x-rays and complete patient reported outcome measures. In conjunction, these will be utilized to assess overall function and the existence of avascular necrosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients who underwent operative fixation of proximal humerus fracture dislocation at Royal Columbian Hospital between January 2011 and July 2021
* Willing and able to consent and complete patient reported outcome measures
* Willing and able to follow the protocol and attend a follow-up visit
* Able to read and understand English or have an interpreter available

Exclusion Criteria:

* Skeletally immature patients
* Patient with pathological fractures
* Patients who have had previous operative fixation of proximal humerus
* Patients treated non-operatively
* patients presenting outside of the study duration window
* Patients treated by a non-participating surgeon
* Deceased patients
* Patients unable to complete patient reported outcome measures
* Patients declining to come back to the clinic for updated x-rays
* Dementia
* Incarceration
Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty

To evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR

Total Knee Arthroplasty (TKA) remains the surgical gold standard treatment for patients suffering from end stage osteoarthritis (OA) of the knee. However, due to the high demand and scarce medical resources, the waiting time for surgery is astoundingly lengthy. Controversies are shown on numerous studies on whether physical functionality and mental status decline or remain stable over the waiting period. This study aims to evaluate the progression on patients suffering from end stage OA whilst being on the waiting list for TKR.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with symptomatic osteoarthritis
2. Enlisted on the TKA surgical waiting list
3. Ethnic Chinese
4. Fluent in Cantonese

Exclusion Criteria:

1. Evidence of cognitive dysfunction like dementia
2. Surgery scheduled within 30 days
3. Severe co-morbidity preluding participation
Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device

A retrospective review of demographics and adverse events from cases completed with the RibFix Advantage System. Evaluation of device integrity, and performance by a prospective CT scan with a minimum of 3 months post-implantation.

The RibFix Advantage System is a novel intrathoracic titanium plating system that is FDA-cleared for the treatment of rib fractures. The RibFix Advantage System is designed to be implanted in a less invasive procedure where plates are introduced and placed on the pleural cortex of the rib during video-assisted thoracoscopic surgery. Intrathoracic plate placement allows for smaller cutaneous incisions and less muscle disruption, which may aid in patient recovery compared to traditional open reduction internal fixation systems that are currently available.

The purpose of this study is to gather the first clinical data on this novel device in the context of a case series of patients with radiologic and quality-of-life follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* ≥ 18 years old (no upper limit)
* Underwent surgical repair of rib fracture(s) with the RibFix Advantage System alone or in combination with other systems for fracture repair
* Signed Informed Consent Form for participation in a clinical trial
* Willing and able to return for a follow-up visit (includes a computed tomography (CT) scan of the chest)

Exclusion Criteria:

* Off label use of RibFix Advantage (e.g., active or latent infection at the time of implantation, sepsis, metal sensitivity)
Clinical Stories and Psychological Experiences of Cancer Patients

The purpose of the study is to collect and analyze information from the multidimensional assessment of cancer patients (medical, psychological, psychometric, biological, etc.) treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The collection of information will allow to investigate the possible presence of correlations between psychological aspects and clinical medical conditions of the person during the course/treatment of cancer.

In the course of the study, the possible presence of previous stressful and/or traumatic events, and the presence of psychological, post-traumatic and/or dissociative symptoms during treatment will be explored. Any correlations between medical conditions and psychological, emotional and behavioral characteristics will also be explored. Finally, it will be possible to investigate the effectiveness of psychological interventions that are carried out according to clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between 18 and 99 years old;
* Individuals with a diagnosis of current oncologic disease and in active oncologic treatment at the hospital where the study is conducted;
* Individuals with a history of oncologic disease who have completed oncologic treatment or in follow-up at the hospital where the study is conducted;

Exclusion Criteria:

* Non-signing of informed consent;
* Non-signing of consent/assent by patient/legal guardian;
* Patients with cognitive impairment or legal disqualification;
* Clinical/medical or psychological condition that does not allow completion of self-report questionnaires;
Study to Assess Treatment Patterns and Outcomes With Upadacitinib in Adult Participants With Inflammatory Bowel Disease in Belgium

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. This study will assess the (long-term) effectiveness and safety of upadacitinib in real-world clinical practice in adult participants with moderate to severe ulcerative colitis (UC) and crohn's disease (CD).

Upadacitinib is an approved drug for treating ulcerative colitis (UC) and Crohn's disease (CD). Approximately 280 participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 8 sites across Belgium.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of moderate to severe Crohn's disease or Ulcerative colitis, initiated with upadacitinib at least 12 months prior to inclusion, including participants that were initiated on upadacitinib, but later (i.e. at the moment of data collection) discontinued, or switched to another treatment.
* Participants initiating commercially available upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study
* Participants prescribed upadacitinib in accordance with the approved local label and treatment recommendations

Exclusion Criteria:

* Participants previously exposed to upadacitinib in a clinical trial or early access program
* Participants participating in interventional research (not including non-interventional
* Participants with stoma