cyrilzakka/clinical-trials huggingface dataset:
The Discrepancy in Radiologists' Practice of Intravenous Contrast Imaging Studies Among Chronic Kidney Disease Patients

* There is a discrepancy between protocols used for intravenous imaging for chronic kidney disease including hemodialysis patients among different hospitals and even, among radiologists same selves.
* This questionnaire based study aims to quantify that discrepancy and describe the variables associated with the discrepancy.

* There is a discrepancy between protocols used for intravenous imaging for chronic kidney disease including hemodialysis patients among different hospitals and even, among radiologists same selves.
* This questionnaire-based study aims to quantify that discrepancy and describe the variables associated with the discrepancy.

Eligibility Criteria:
Inclusion Criteria:

* Practicing radiologist

Exclusion Criteria:

* retired radiologist
Pregnolia System Intra-observer Variability

The Pregnolia System is a CE-marked medical device assessing the mechanical stiffness of cervical tissue in women. The Pregnolia Probe has been engineered to minimize the influence of differences in handling and technique by the user.

This project aims to study intra-observer variability of the Pregnolia System in pregnant women in the clinical setting.

Furthermore, a same day repeated measurement serves to investigate the time period needed to recover the pre-measurement stiffness state due to viscoelasticity of the cervical tissue.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject
* Pregnant woman
* Singleton pregnancy
* 18 years or older
* Nulliparous cohort: nulliparous pregnant woman
* Multiparous cohort: multiparous pregnant woman

Exclusion Criteria:

* Lack of informed consent
* Placenta praevia totalis with haemorrhage (irrespective of severity)
* Severe vaginal bleeding
* Rupture of membranes before 34 weeks (to be excluded with pH test)
* Visible tissue scarring at 12 o'clock position on cervix
* Light bleeding (if the bleeding can be stopped, it is no longer an exclusion criterion)
* Cervical dilation ≥ 3 cm
* Cerclage or pessary in place
Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy

The purpose of this study is to evaluate the feasibility and the effectiveness of a patient education program on patients' adherence to adjuvant hormone therapy (anti-estrogen or aromatase inhibitors) for breast cancer, in collaboration with teams of sociologists, patient education and medical oncologists.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18
* History of breast cancer
* Medical prescription for an adjuvant hormonal treatment (anti-estrogens and / or aromatase inhibitors) as monotherapy or in combination with other treatments
* Affiliated to a social security scheme

Exclusion Criteria:

* Refusal to participate, patient protected by guardianship.
* Patient unable to understand the study or unable to follow the education sessions.
* Patient with documented cognitive or psychiatric history.
* Geographical remotness (more than 100 Kms).
Effects of an Adapted Physical Activity With an Interactive Gaming Platform on Fear of Falling and Risk of Falling

This study evaluates the effects of an adapted physical activity with an interactive gaming platform on fall apprehension and risks. Half of the participants will receive a rehabilitation program using the Medimoov gaming program, the other half will receive the standard rehabilitation program.

Medimoov is an innovative interactive gaming platform offering adapted physical activity. Like most serious games, it targets both physical and cognitive components. Studies that evaluate serious games lack an appropriate control group, thus this study aims to evaluate the efficacy of serious games played with the Medimoov platform on fear of falling and fall risks. This pilot study is an open randomized controlled trial in parallel groups with blind data collection for the primary outcome.

The intervention group will follow bi-weekly sessions with Medimoov. The control group will follow the usual rehabilitation program: the standard psychomotor therapy program.

Both interventions will be consistent with rehabilitation programs prescribed by participants' physicians. Each intervention, guided by a psychomotor therapist, will last eight weeks with bi-weekly sessions of 35 minutes.

Participants will be randomly assigned to one of the two groups. Three assessments will be conducted focusing on physical and cognitive capacities. The first assessment will be conducted five or fewer days before the beginning of the rehabilitation program, the second will occur during week 4 and the third one during week 8, at the end of the rehabilitation program. Assessments will be blinded: assessors will not know the assigned group of each participant.

Eligibility Criteria:
Inclusion Criteria:

* To be at least 65 years old,
* To be able to give consent,
* French-speaking,
* To be able to stand upright in a bipedal position, feet together for a time greater than 10 seconds with/without an assistive device,
* To have a score ≥13 on the Short Fall Efficacy Scale (FES-I) (moderate fear of falling).

Exclusion Criteria:

* Not being able to answer the questionnaires,
* Not being able to correctly distinguish the elements on the screen,
* To be in palliative care,
* To be under a legal protection measure,
* To score under 16 at the Mini Mental State Examination,
* To have an acute pathology,
* To have had recent hip surgery (\<2 months).
In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy

The objective of the study is to assess the effect of in-hospital intensive counseling and NRT (nicotine replacement therapy) vs. usual care, on smoking cessation or enrollment to smoking cessation behavioral intervention.

This is prospective randomized clinical trial. The study population will include smokers subjects admitted to internal medicine departments at Soroka University Medical Center.

The study population will be divided randomly into three arms according to intervention intensity (ratio 1:1:1).

Prospective randomized clinical trial. The study population will include smokers subjects admitted to internal medicine departments at Soroka University Medical Center.

The study population will be divided randomly into three arms according to intervention intensity (ratio 1:1:1):

Group 1 - Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant.

Group 2 - Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, and follow up for at least 5 weeks after discharge (will be done weekly by phone for five consecutive weeks).

Group 3 - Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, offering and providing nicotine replacement therapy (NRT) and follow up (will be done weekly by phone for five consecutive weeks).

All participants will be given a smoking cessation leaflet.

Eligibility Criteria:
Inclusion Criteria:

1. Admitted to Internal Medicine at Soroka University Medical Center.
2. Current cigarette smokers (≥ 10 cigarettes per day)
3. Provided written informed consent.

Exclusion Criteria:

1. Substance abuse (except for tobacco).
2. Handicapped or bed ridden patients.
3. Patients who don't speak Hebrew, English, Russian or Arabic.
4. Medically not suitable for NRT-decided by physician on the basis of the patient's medical file.
Physical Activity and Vascular Health During Pregnancy

The aim of this study is to determine the effect of aerobic exercise on maternal and offspring vascular health.

The study will comprise of a randomised pilot trial to assess the effect of a moderate intensity exercise intervention on maternal and offspring vascular health. Participants will be recruited in the first trimester (T1, 10-12 weeks' gestation), and will be randomized to either a 24-week, structured and partially supervised, gym-based exercise intervention beginning in trimester 2 (T2) through to trimester 3 (T3), or a non-exercise control group who receive normal clinical care. The inclusion of this non-exercise control group is critical in allowing us to create an understanding of the adaptation of the vascular system during a normal (non-exercising) pregnancy, and also determining the physical activity and sedentary behaviour engaged in during normal healthy pregnancy. All participants will be asked to attend the laboratory at Liverpool John Moores University on 4 separate occasions synchronised with the end point of each trimester and then within four weeks of delivery. Maternal vascular health, physical activity, sedentary behaviour and fitness will be assessed during each time point throughout pregnancy while the fourth visit will comprise of an offspring vascular assessment. The investigators will also gain information on delivery outcomes including pre-term delivery, complications during labour, induction of labour, caesarean sections and post-partum haemorrhage via medical notes at the Liverpool Women's NHS Foundation Trust.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant female
* No history of cardiovascular disease, gestational diabetes or pre-eclampsia
* Single gestation
* Not on medication affecting cardiovascular health
* A non-smoker for at least 6 months
* Participating in structured exercise \<twice/week
* BMI \<30kg/m\^2 -

Exclusion Criteria:

* Royal College of Obstetricians and Gynaecologists (RCOG) contraindications for pregnancy
* Pregnant by in-vitro fertilisation (IVF)exercise
* BMI \>30kg/m\^2
* \>45 years old
* Structured exercise \>twice/week
* Multiple gestation
* Disability preventing ambulation
* Currently smoking or smoking within past 6 months prior to pregnancy
* Non-English speaking women
Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients

Nociception in intensive care unit is frequently evaluated with some tools such as BPS (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in intubated and brain injured ICU patients. The investigators propose to validate the NCS adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).

Nociception in intensive care unit is frequently evaluated with some tools such as BPS (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in intubated and brain injured ICU patients. The investigators propose to validate the NCS adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).

Eligibility Criteria:
Inclusion criteria:

* Adult, \> or equal to 18-yr
* Admission to intensive care unit
* Brain injured and intubated patient
* Signs of awakening after the interruption of sedation
* Impossibility to self-report pain intensity

Exclusion criteria:

* Eye injuries (glaucoma, keratitis, conjunctivis, cataract)
* Neurodegenerative attack
* Brainstem damage
* Pregnancy
Ventriculo-arterial Coupling in Cirrhotics

Cirrhotic in intensive care unit have a very specific haemodynamic status. Cardiovascular abnormalities in advanced liver cirrhosis are characterized by a hyperdynamic circulation featuring increased heart rate and high cardiac output, concomitant with decreased systemic vascular resistance. As liver cirrhosis progresses, cardiac dysfunction, known as cirrhotic cardiomyopathy, is associated with prognosis of these patients.

Specifically, diastolic dysfunction has been more emphasized for estimating clinical outcome in cirrhotic patients, whereas systolic dysfunction has limited prognostic implications in hepatorenal syndrome patients.

However, in most cirrhotic patients, cardiac dysfunction is latent and only manifests under stressful conditions because reduced ventricular contractility in these patients is masked by pronounced arterial vasodilation and increased arterial compliance. Therefore, a load-dependent index such as left ventricular ejection fraction is insensitive to detect systolic cardiac impairment in the resting state in cirrhotic patients. Hence, a more appropriate index is required to evaluate the integration of the ventricular and arterial systems in cirrhotic cardiovascular disorders.

Interaction between the left ventricle and the arterial system has been explained on the basis of end-systolic pressure-volume relation. Left ventricular end-systolic elastance (Ees), as quantified by the ratio of end-systolic pressure to end-systolic volume, is an index of the load-independent ventricular contractile state. Given this pressure-volume relationship, effective arterial elastance (Ea) can be calculated by the ratio of end-systolic pressure to stroke volume, indicating a net measure of arterial load. The ratio of these values (Ea/Ees), designated ventriculo-arterial coupling (VAC), represents the integrated interaction of the ventricular and arterial systems.

We can evaluate it with non-invasive echocardiographic method.

We analyse VAC among cirrhotic patients admitted in intensive care unit, with non-invasive echographic method thanks to records made from August 2018 to April 2019.

Hypothesis: VAC decrease from the baseline value when mean arterial pressure is improved.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhotic patients (any cause, any level)
* With acute decompensation
* Admitted in intensive care unit in Croix Rousse Hospital, Lyon, France
* Who receive NOREPINEPHRINE as hemodynamic therapy
* Blood pressure monitoring thanks to an arterial line (radial, humeral or femoral)
* Urinary catheter, suprapubic catheter or any comparable device to monitor urine output.
* The patient did not object to take part of the study.

Exclusion Criteria:

* Acute hemorrhage (Clinical definition or hemoglobin lower than 70g/L at admission)
* Patient requiring kidney replacement therapy
* Patient requiring invasive mechanical ventilation
* Any pathology that makes non-invasive ventriculo arterial coupling assessment impossible (non-sinus rhythm, severe valvular disease)
* Patient who objects to take part of the study
Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease

The purpose of this study is to compare the diagnostic yield with endoscopic mucosal resection (EMR) in hirschsprung's disease versus that of standard rectal suction biopsy. In order to compare EMR versus rectal suction biopsy, patients' diagnostic specimens will be analyzed by tissue size, the presence of submucosal tissue, and positive acteylcholinesterase staining. Additionally, the proportion of patients who would have required subsequent full thickness surgical biopsy with each technique will be compared. Biopsy results will be compared with clinical data including history, Bristol stool scale, anorectal manometry results and SITZ markers studies. Finally, the estimated costs that would have been incurred with each method will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients offered a rectal suction biopsy

Exclusion Criteria:

* any contraindication to general anesthesia or conscious sedation
* contraindication to endoscopy
* untreated or unmanageable coaguloapathy
* thrombocytopenia (\<50)
* inability to provide informed consent.
Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD

The aims of this study are to evaluate auditory sensitivity in teenagers with ADHD using acoustic reflex thresholds (ART) and to examine the effects of ADHD stimulant medication on ART.

Attention-deficit/hyperactivity disorder (ADHD) is the most common neurodevelopmental disorder in children. Besides core ADHD symptoms (inattentiveness, hyperactivity, impulsivity), ADHD also affects the ability to perceive and process sounds. Both hypersensitivity and hyposensitivity to loud sounds are common symptoms in ADHD patients. With stimulant medication, individuals with ADHD become more tolerant of loud noise than when they were non-medicated. It remains unknown exactly how stimulant medication alters the loudness perception. The proposed study will use the acoustic reflex to objectively measure auditory sensitivity to loud sounds. The aims of this study are to evaluate auditory sensitivity in patients with ADHD using acoustic reflex thresholds (ART) and to examine the effects of ADHD stimulant medication on ART. Eligible participants will participate in two sessions (off-med and on-med conditions) conducted on the same day. ADHD patients will be asked to come to the laboratory before taking their ADHD medication. The investigators will repeat three tests before and after taking stimulant medication. The investigators will also conduct screening tests during and between the first and second sessions. The investigators will compare a difference between the two independent groups (ADHD vs. Control) and compare a within subject difference between medication conditions (on-med vs. off-med).

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for all:

* Participant must be aged 13 to 19 years
* Males and females
* All ethnicities
* All socioeconomic statuses
* Normal hearing
* English as a primary language

Additional inclusion criteria for ADHD group:

* Participants must meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD), all subtypes, based on the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
* Stimulant medication with the same drug and dosage for at least 1 year before their enrollment date

Exclusion Criteria:

* History of any major neurological disorders (e.g. seizures excluding febrile seizure under age 6 years, tumors, brain injury, cerebral palsy, tic disorders)
* History of any other major neuropsychiatric disorders (e.g. autism spectrum disorder, mood dysregulation),
* Presence of pressure equalization tubes in either ear
* Documented hearing impairment 20 decibel or higher hearing loss in either ear
* Estimated low cognitive function based on the NIH Toolbox Cognition age-corrected scores (\<70)

Additional exclusion criteria for the ADHD group

* Treatment with any psychotropic medications other than stimulants
* Treatment with any ADHD medication other than stimulants (e.g. alpha-agonists, norepinephrine reuptake inhibitors)

Additional exclusion criteria for the control group

• Treatment with any psychotropic medication
Physiological Effects of Altering Cancer-related Inflammation

This prospective pilot study will examine whether the previously reported effects of NSAIDs on colorectal cancer may be modulated through alterations in tissue gene expression, up regulation of local immune cell infiltrates or down-regulation of the systemic inflammatory response.

Bowel cancer is the second commonest cause of death from cancer in the UK. Of patients who have an apparently curative operation, half unfortunately suffer disease recurrence and die before 5 years. Clearly more research is required to improve outcomes in this condition. Most current research focuses on antitumour strategies, however the reaction of the patient (host) to the tumour is also important. The host inflammatory responses to the cancer are likely to represent part of this host-tumour relationship. Inflammation plays an important role in predicting patients who will die. Currently it is not known whether antiinflammatory drugs have any effect on cancer related inflammation detected in the blood or in/around the tumour.

Aims: We hope to demonstrate that tumour related inflammation in bowel cancer can be altered using anti- inflammatory drugs. This may form the rationale for the use of antiinflammatory drugs to improve prognosis in colorectal cancer patients undergoing surgery.

Methods: This pilot study will investigate whether simple antiinflammatory drugs can alter markers of inflammation both in the blood and in/around the tumour. Patients having bowel cancer surgery will be prescribed one of two anti-inflammatory drugs (aspirin 75mg once daily or ibuprofen 400mg three times daily) for 2 to 3 weeks prior to their operation. Blood and tumour samples before and after the treatment will be analysed.

If the study's aims are met and cancer-related inflammation can be altered prior to surgery, then a larger scale drug trial will be proposed to demonstrate reduced cancer recurrence and improved survival.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 75 years old
* histologically confirmed colon cancer
* evidence of systemic inflammation (C-reactive protein \>10mg/l)
* candidate for elective primary curative resection

Exclusion Criteria:

* Age \<18yrs or \>75yrs
* emergency presentation
* rectal cancer
* distal metastatic disease at presentation
* provision of neo-adjuvant chemo-radiotherapy
* long-term use of aspirin or anti-inflammatory medications (NSAIDS, or steroids
* hypersensitivity to product or excipients or evidence of previous hypersensitivity reactions such as asthma, rhinitis, angioedema or urticaria in response to aspirin, ibuprofen or other NSAID
* intolerance of NSAIDs/ aspirin due to allergy or side effects
* active peptic ulcer disease
* previous history of recurrent gastrointestinal bleeding or bleeding/perforation secondary to previous NSAID use
* previous treatment for gastrointestinal cancer
* alcohol excess (above recommended guidelines)
* chronic renal impairment
* moderate to severe heart failure
* hepatic impairment
Expanded Access 68Gallium-PSMA-11 PET for Prostate Cancer

This expanded access protocol provides eligible participants with investigational 68Ga-PSMA-11 PET imaging to detect and localize prostate cancer for initial and subsequent treatment strategy.


Eligibility Criteria:
Biochemical recurrent and pre-prostatectomy staging participants will be eligible and must meet the following criteria:

Inclusion Criteria:

1. Age ≥ 18 years
2. Histopathologically confirmed or biopsy proven prostate adenocarcinoma.
3. Concern for metastatic disease in one of the following settings:

   1. Initial staging with intermediate to high risk prostate cancer.
   2. Biochemical recurrence after initial therapy.
4. Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation