cyrilzakka/clinical-trials huggingface dataset:
Comparative Evaluation of the Evolution of Arterial and Microcirculatory Endothelial Function in Obese Patients With Type-2 Diabetes Versus Non-diabetic Obese Patients After a First Bariatric Surgery

The weight reduction obtained after a first bariatric surgery would improve the vascular (correction of endothelial dysfunction, improvement of arterial wall compliance and evolution of the atherothrombotic process) and microcirculatory function in obese patients with type-2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* The patient is at least 18 years old and under 70 years old
* The patient is available for a follow-up of 12 months
* The patient signed the consent form
* The patient must be affiliated or beneficiary to an health care plan
* The patient is followed in hospital day care in the endocrine and metabolic disorders department at Nimes University Hospital for a first bariatric surgery

Exclusion Criteria:

* The subject participates in another interventional study.
* The subject is in an exclusion period determined by a previous study.
* The subject is under the protection of justice, guardianship or curatorship.
* The subject refuses to sign the consent.
* It is not possible to give the subject informed information.
* The patient is pregnant or breastfeeding.
* Subject with known advanced atherothrombotic disease (arterial disease of the lower limbs, significant carotid plaque (generating stenosis\> 50%), history of myocardial infarction, stroke)
* The subject is type 1 diabetic.
* The subject has already had a bariatric surgery.
Self-myofascial Release With Foam Roller in Patients With Hemophilic Knee Arthropathy

Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscular strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain, and reduce tissue sensitivity.

Design. A randomized clinical trial. Directed: To evaluate the safety and effectiveness of a myofascial self-release protocol with Foam Roller applied in patients with hemophilic knee arthropathy.

Patients: 58 patients with knee arthropathy will be recruited for inclusion in the study. The patients will be recruited in 5 centers, from different regions of Spain.

Intervention: Each session will last approximately 15 minutes, with five physical therapy sessions per week over a period of 8 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 2 months. The treatment program includes 11 exercises to be administered bilaterally. A mobile application will be developed where each patient can observe the exercises to be performed.

Measurement instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Hemophilia Joint Health Score (Joint Condition); dynamometer evaluation (muscle strength); 6-minute walk test (lower extremity functionality); Mobile device (activity log); Finger floor test (muscle flexibility). At the same time, the study will make it possible to determine the joint bleeding caused by the applied physiotherapy treatment.

Expected results: demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, function and joint movement is expected.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a medical diagnosis of hemophilia A or B.
* Patients with a severe phenotype of hemophilia (\<1% FVIII/FIX).
* Patients with a medical diagnosis of hemophilic knee arthropathy and more than 3 points on the Hemophilia Joint Health Score.
* Being over 18 years old.
* No scheduled orthopedic surgeries during the study phase

Exclusion Criteria:

* Patients with hemarthrosis in the month before the beginning of the study.
* Patients unable to walk.
* Severe functional alterations of the upper limb that prevented the exercises.
* Failure to sign the informed consent document
Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer

It is estimated that around 20% of breast cancers (BC) in the UK are preventable through adherence to appropriate health behaviours, i.e., healthy diet, physical activity, limited alcohol, not smoking, and that women at increased risk of BC could benefit from greater decreases in risk than the general population via health behaviour changes. Young women (age \<35 years) who are at increased risk of developing BC currently receive little or no information regarding health behaviours and BC risk, or support for behaviour change. This feasibility study aims to explore whether a novel app is acceptable to women at increased risk and could potentially engage them with improved health behaviours which could reduce their future risk of BC.

Aims

1. To assess the acceptability and usability of the app to young women at increased risk of BC
2. To assess the feasibility of study procedures before running a future efficacy study using the app as an intervention

Objectives

1. Explore views of users of the experiences during and after using the app
2. Explore views of users on their experience of the two different recruitment procedures (targeted mailshot, or social media, newsletters and websites), and the online consent procedure.
3. Interpret user data from the app including frequency and patterns of use of the different functions
4. Analyse recruitment data to explore how the two different recruitment procedures could be improved for the next study
5. Assemble a list of suggested changes to recruitment and consent procedures, and to the app, to be considered before the next study.
6. Quantify health care professional (HCP) time required for administering the private Facebook chat group, and through e-mail/private message support.
7. Quantify researcher time required for cleaning and analysis of app data.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-35 years
* Live in the UK
* Moderate or high risk of BC (see 6.5 for definition)
* Ability to communicate in English
* Ability to download and use an app (available on both ioS and Android)

Exclusion Criteria:

* Previous BC (other cancers will not be excluded)
* Previous preventative mastectomy
* Currently trying to gain weight
* Previous weight loss surgery
* Currently taking weight loss medication, prescribed (for example orlistat, liraglutide, Naltrexone/Bupropion \[Mysimba\]) or other
* Have a medical condition that influences diet and weight, for example, diabetes, inflammatory bowel disease or cystic fibrosis
* Current diagnosis of a psychiatric disorder, for example bipolar psychotic disorder or current self-harm
* Current alcohol or drug dependency
* Current or previous diagnosis of an eating disorder
Difference in Pain Perception by Patients With Prostate Biopsy Using Instillagel Compared With Guided Ultrasound Gel

This is a randomized controlled trial. One group (intervention group) will get in advance to the prostate biopsy rectal approximately 5 cc Instillagel. And one group (control group) will get in advance to the ultrasound -guided prostate biopsy rectal gel. Pain is measured using the Numerical Rating Scale (NRS). The NRS is an imaginary line from 0 until 10. The 0 is no pain and 10 is most worst imaginable pain.

Urologist within Rijnstate use both Instillagel and ultrasound gel during prostate biopsy. According to the protocol, the ultrasound-guided prostate biopsy must be performed using ultrasound gel. Some urologists departed from the protocols because they think that Instillagel will give a pain reduction. With this research we investigate whether Instillagel will have an effect on the pain perception bij the patients.

There will be three moments of pain measurements; Prior to het prostate biopsy. Immediately after the prostate biopsy. And five to thirty minutes after the prostate biopsy, when the patient is dressed and before the patient goes home.

Primary endpoint Pain measured by the Numeric Rating Scale

Secondary endpoints

* Age of patient
* Previous prostate biopsy
* The number of biopsies taken
* Presence of prostate cancer
* Other complications as after prostate biopsy

The prostate biopsy will be performed by a urologist working at the outpatient clinic of Rijnstate. The ultrasound equipment that will be used during prostate biopsy is Aloka ProSound SSD-3500 or Aloka ProSound SSD or SV-3500 SX.

Eligibility Criteria:
Inclusion Criteria:

* outpatient ultrasound guide prostate biopsy
* \> 40 years old.
* Good knowledge of dutch language

Exclusion Criteria:

* coagulation disorders
* disorders of the rectum like hemorrhoids, anal fistula, proctitis, rectal polyps and rectal cancer.
* treated for active urinary tract infection
* known of allergy to lidocaine
* taking antidepressants
* using anaesthetic agents
* neurological disorders such as Parkinsons disease, hernias and spinal cord injury
* treated with radiotherapy for prostate cancer
A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.

The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced homogeneous or heterogeneous emphysema.

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of completion of Aeris' post market follow-up Continuation Study, 03-C10-001PLV.
Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation

The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure. Only patients without an indication for anticoagulants will be included in this trial. Currently, lifelong single antiplatelet therapy (mostly aspirin) is considered the standard of care for these patients. However, this approach poses a bleeding risk with only a minimal reduction in thromboembolic events.

After 3 months, a CT scan will be conducted to assess the presence of thrombosis on the newly implanted TAVI valve. Based on the results of a 4D CT scan, the decision will be made whether the patient should receive no anticoagulant or antithrombotic therapy with apixaban. CT-guided antithrombotic therapy holds the potential for a greater reduction in thromboembolic events without increasing the bleeding risk.


Eligibility Criteria:
Inclusion Criteria:

* Successful TAVI (according to the VARC-3 criteria)10 with any approved device
* Ability to understand and to comply with the study protocol
* Written informed consent

Exclusion Criteria:

* Existing indication for oral anticoagulation (e.g. atrial fibrillation, obstructive valve thrombosis detected by echocardiography prior to inclusion)
* Existing indication for dual antiplatelet therapy at three months after TAVI (rare at this time point)
* Creatinine clearance \<15 mL/min (based on the CKD-EPI formula) or on renal replacement therapy
Ultrasonographic Subcutaneous Scar Scoring System for Traumatic Hand Injured Patients

This study aims to develop an objective scar scoring system via ultrasonography and try to apply it to clinical using.

This study was divided into two parts. The first part of the study is an observational study design. The scar scoring system will be developed, and its test-retest reliability and criterion-related validity will be tested in this part.

The second part is also an observational study design. The clinical application of the system on traumatic injured patients is conducted in the second part. The results from this scar scoring system are correlated with hand function measurements. Moreover, every scar will be recorded three times within one month during routine rehabilitation to investigate the change.


Eligibility Criteria:
Inclusion Criteria:

* Above 20 years old
* Traumatic hand injury (distal from wrist joint above 8 weeks and within one year)
* Able to do active motion and resistive activities
* Understand and cooperate the experiment

Exclusion Criteria:

* Injured by burn
* Have impairment in peripheral nerve and affect the movement
* Combined with other central nerve deficits
BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis

The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective of the study is to assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function.


Eligibility Criteria:
Key Inclusion Criteria:

* Onset of SPMS at least 1 to 2 years prior to randomization. SPMS is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by relapses.
* Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to randomization.
* Have an Expanded Disability Status Scale score of 3.0 to 6.5, inclusive.
* Have a Multiple Sclerosis (MS) Severity Score of 4 or higher.

Key Exclusion Criteria:

* Have a diagnosis of relapsing remitting multiple sclerosis or primary progressive MS as defined by the revised McDonald criteria.
* Had a recent clinical relapse (within 3 months) prior to randomization.
* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply
Hydroxychloroquine or Diltiazem-Niclosamide for the Treatment of COVID-19

No optimal antiviral intervention has been yet validated to treat COVID-19 disease. Comorbidities, such as older age, obesity, diabetes, history of cardiovascular diseases are associated with poor prognosis.

This study aims to evaluate the efficacy of two experimental antiviral treatments, compared to standard of care (SOC), to prevent clinical worsening, hospitalization or death at day 14 in adults with documented SARS-CoV-2 infection, asymptomatic or with symptoms lasting less than 8 days, and associated comorbidities without any severity criteria of the disease at inclusion.

Participants will be randomized to receive SOC alone or SOC + hydroxychloroquine 200 mg three times a day during 10 days or SOC + association of niclosamide 2 g at J1 then 500 mg two times a day with diltiazem 60 mg three times a day during 10 days. Efficacy and tolerance of each treatments will be compared across the three treatment groups during the 28 days of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Positive SARS-CoV-2 test on nasopharyngeal swab
* Onset of symptoms \<8 days prior to randomization
* NEWS score\<4 AND no item ≥2
* At least one comorbidity among: age ≥ 70 years old, history of cardiac disease, diabetes, obesity, chronic kidney disease, chronic respiratory failure, immunosuppression, neoplasia, liver failure (stage ≥ Child-Pugh B)
* Fully able to understand the challenges of the trial
* Signed informed consent
* Covered by Health Insurance

Exclusion Criteria:

For all patients:

* Inability to decide to participate
* Pregnancy or breath feeding
* Hypersensitivity to any of the test drugs
* stage 4 or 5 chronic kidney disease (DFG \<30 mL/min/1.73 m²)

For hydroxychloroquine arm:

* Long QT syndrome or QTc space \>500 ms
* Treatment with piperazine, halofantrine, dasatinib, nilotinib, citalopram, escitalopram, hydroxyzine, domperidone
* Hepatic porphyria, retinopathy, known glucose-6-phosphate dehydrogenase deficiency,
* Heart rate \<50/min
* hypokaliemia \< 3.5 mmol/L

For diltiazem arm:

* Heart rate\<40/min
* Sinus bradycardia, second- or third-degree atrioventricular block
* Left heart insufficiency with pulmonary stasis
* Treatment with dantrolene, pimozide, dihydroergotamine, ergotamine, nifedipine, ivabradine, esmolol, bêta-blockers (bisoprolol, carvedilol, metoprolol, nebivolol), fingolimod
Looking at Cognitive and Brain Changes in People With Lymphoma Receiving CAR-T Therapy

The purpose of this study is to learn about possible changes in cognitive (mental) abilities, such as memory skills and concentration, and in brain anatomy (structure) and function, in people with lymphoma receiving CAR-T therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older
* Planned treatment with commercial CD19-specific CAR T cells (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, or brexacabtagene autoleucel) for lymphoma.
* Patients must have adequate end organ function for CAR T cell therapy

  * Eastern Cooperative Group (ECOG) performance status of 0 to 2
  * Meet cardiac, pulmonary, hematologic, hepatic, and renal requirements for CART therapy as described in corresponding product package insert
* No evidence of central nervous system disease at study entry
* Fluent and able to communicate well enough in English to complete the study assessments and provide informed consent, in the judgment of the consenting professional. o Patients who report that English is not their primary language will be asked the US Census English proficiency question: "How well do you speak English," and the answer "very well" will be required

Exclusion Criteria:

* Signs and/or symptoms of central nervous system cancer (e.g., metastases, leptomeningeal disease) as determined by their physician, medical records, or by a brain MRI, either at the time of enrollment or during the study period.
* Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report
* History of neurodegenerative disease, or traumatic brain injury with loss of consciousness (\>60 minutes), as per medical records or patient report
* A history of epilepsy as per medical records or patient report
* Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report
* Evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report
* Contraindications to MRI examinations as per standard screening guidelines used in the Department of Radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis

Phase 1 study to assess the safety and biological activity of ATX-MS-1467 in patients with relapsing forms of multiple sclerosis. This will be an open label upward dose titration involving injections on 9 occasions, each two weeks apart. After dosing is complete there will be a 22 week follow up period. Blood samples will be drawn throughout the study to monitor safety and the body's response to the injections and MRI scans will be performed on several occasions to follow the course of the multiple sclerosis during the trial.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients who have definite relapsing multiple sclerosis disease as defined by the McDonald criteria (McDonald et al., 2001 and 2005) and as assessed by a neurologist.

  2. HLA DRB1\*15 positive.

  3. High baseline levels of T-cell proliferation in response to myelin basic protein, defined as \>1000 cpm with a \>3 stimulation index compared to background.

  4. Disease duration equal to or less than 10 years (from the first clinical event).

  5. At least one documented relapse in the previous 12 months or two relapses within the previous 24 months prior to screening.

  6. Must be in a clinically stable or improving neurological state during the 28 days preceding Screening.

  7. EDSS score \< 5.5.

Exclusion Criteria:

* 1. Subjects treated with β-interferon, plasma exchange, intravenous gamma globulin within the 3 months prior to Study Day 1 2. Subjects treated with glatiramer acetate at any time in the past 3. Subjects who have been treated with parenteral steroids or adrenocorticotropic hormone within 3 months days prior to Study Day 1 4. Prior treatment with: cytotoxic agents (including but not limited to cladribine, mitoxantrone, cyclophosphamide, azathioprine, methotrexate), fingolimod, laquinimod, teriflunomide, total lymphoid irradiation, stem cell or bone marrow transplantation, or monoclonal antibody therapy (including natalizumab, daclizumab, alemtuzumab) 5. Prior use of disease related T-cell vaccine or peptide-tolerising agent to treat MS 6. Use of any investigational drug or experimental procedure within 6 months prior to Study Day 1 including cytokine or anti-cytokine therapy
The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice

This is a prospective, non-interventional study of adult patients prescribed topical treatment with ingenol mebutate gel (Picato®) as part of provision of care for the treatment of Non-hyperkeratotic, non-hypertrophic Actinic Keratosis (AK). Patients with complete clearance at 8 weeks will be followed for one year or until retreatment of AK in the area initially treated, whatever comes first. For patients with incomplete clearance in the treated area at 8 weeks the treatment strategy for this area will be recorded but no further follow-up will take place. The effectiveness, tolerability, adherence, patient satisfaction and health-related quality of life (HRQoL) associated with Picato® treatment will be evaluated.

Actinic Keratosis (AK) is caused by exposure to UV radiation and has the potential to regress to normal skin or to progress to squamous cell carcinoma. Ingenol mebutate gel is a relatively new topical treatment option for AK in Greece.

Taking into consideration the limited real-world evidence that is attributed to the recent advent of Picato in the Greek market, this non-interventional observational study aims primarily at assessing the characteristics of patients selected for this treatment, the effectiveness and tolerability of the treatment, patient satisfaction and the impact of the therapy on patients' HRQoL in standard clinical practice.The study will be carried out by approximately 30 physicians practicing in private or public hospitals and clinics in representative geographical regions of Greece.

Eligibility Criteria:
Inclusion Criteria:

* Planned to receive topical ingenol mebutate gel for treatment of Actinic Keratosis according to current labelling in Greece.
* Written informed consent obtained to use the patient's data for the study.

Exclusion Criteria:

* Contraindications according to prescribing information.
* Previous treatment with PICATO in the selected treatment area.