louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05221853: Real-time MRI for Evaluating Cardiac Volumetry
Official title: Comparison of Standard Breath-hold Cardiac MRI With a Faster, Free-breathing Scan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Left Ventricle Abnormality
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients referred for routine cardiac MRI at Glenfield Hospital.

Brief summary: This study will compare the accuracy of a real-time Cine sequence in assessing cardiac volumetry.

Detailed description: This is a single-centre prospective study involving up to 570 patients with known or suspected cardiac disease referred for routine clinical cardiovascular magnetic resonance (CMR) assessment at Glenfield General Hospital, Leicester. In addition to standard multi-breath-hold steady-state free precession (SSFP) imaging (undertaken as part of the routine scan), each patient will also undergo additional imaging with a non-breath-hold multi-slice real-time cine sequence.

The primary outcome is the assessment of cardiac volumetry and function (end-diastolic volume, end-systolic volume, stroke volume, ejection fraction and myocardial mass) as measured by (1) the standard multi-breath-hold SSFP technique and (2) the non-breath-hold multi-slice real-time cine sequence. Secondary outcome measures will be (1) the time required for each scan, and (2) image quality for each scan. An additional secondary outcome will be to compare indexed cardiac volumes with those indexed according to measured body-surface area.

Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥ 18 years
2. Referred for routine CMR imaging
3. Willing and able to give informed consent
4. Willing and able to comply with the requirements of the study
5. Able to understand written English

Exclusion Criteria:

1. Severe claustrophobia
2. Absolute contraindications to CMR (those with CMR conditional or safe devices will be eligible for inclusion)
3. Unable to provide informed consent
4. Participants unable to understand written English

Primary outcomes:
measure: Cardiac volumetric assessment 1
timeFrame: 1 day
measure: Cardiac volumetric assessment 2
timeFrame: 1 day
measure: Cardiac volumetric assessment 3
timeFrame: 1 day
measure: Cardiac volumetric assessment 4
timeFrame: 1 day
measure: Cardiac volumetric assessment 5
timeFrame: 1 day
measure: Cardiac strain assessment 1
timeFrame: 1 day
measure: Cardiac strain assessment 2
timeFrame: 1 day
Secondary outcomes:
measure: Time
timeFrame: 1 day
measure: Image quality assessment
timeFrame: 1 day
measure: Body-surface area
timeFrame: 1 day
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: Leics
Study officials:
affiliation: University of Leicester
name: Jayanth Arnold
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04597853: Assessment of Lung Mechanics in COVID-19 Acute Respiratory Distress Syndrome
Official title: Assessment of Lung Mechanics in SARS-CoV-2/ COVID-19 Acute Respiratory Distress Syndrome: A Holistic, Longitudinal Analysis of the Lung-heart-ventilator Interaction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
ARDS
Keywords: lung mechanics
heart-lung interaction
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The project population targeted with this research, consists of a critically ill COVID-19 diagnosed population being admitted to the Institute of Intensive Care of the University Hospital Zurich and treated with mechanical ventilation.

Brief summary: This study is meant to assess the lung mechanics in SARS-CoV-2 induced acute respiratory failure. A precise characterisation of lung mechanics and heart-lung-interactions might allow a better understanding of SARS-CoV-2 induced acute respiratory failure and thus lead to better mechanical ventilation strategies.

This monocentric, observational study of critically ill COVID-19 patients in the ICU, will employ impedance tomography, right-heart catheterization, oesophageal pressure measurements, indirect calorimetry as well as classic mechanical ventilation parameters to characterise the mechanical characteristics of the lung as well as the heart-lung interactions in SARS-CoV-2 induced acute respiratory failure.


Eligibility criteria: Inclusion Criteria:

* SARS-CoV-2 infection
* Moderate to Severe ARDS after Berlin Classification at PEEP 5
* Admission to the Institute of Intensive Care of the University Hospital Zurich
* Invasive Mechanical Ventilation
* Signed Study Informed Consent or emergency procedure according to article 30 HFG

Exclusion Criteria:

* Pregnant or breast feeding patients
* Age \<18 years
* Presumed rejection of the study intervention

Primary outcomes:
measure: Time dependent compliance change
timeFrame: Mixed Model Assessment of compliance over time until extubation (measurements every 2 days up to 90 days)
measure: PEEP and time dependent change in dead space
timeFrame: Mixed Model Assessment of Dead Space over time until extubation (measurements every 2 days up to 90 days)
measure: PEEP and time dependent change in shunt fraction
timeFrame: Mixed Model Assessment of shunt fraction over time until extubation (measurements every 2 days up to 90 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Institute of Intensive Care Medicine, University Hospital Zurich
Study officials:
affiliation: Institute of Intensive Care Medicine, University Hospital Zurich
name: Philipp K Buehler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03543553: From Brain Currents to Interpersonal Flow: Investigating the Social Processing Stream of Schizophrenia
Official title: From Brain Currents to Interpersonal Flow: Investigating the Social Processing Stream of Schizophrenia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Schizophrenia
Cognitive Impairment
Social Competence
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with a diagnosis of schizophrenia will be compared to healthy control participants

Brief summary: The overall objective of this project is to identify the neural signature of the impaired ability to relate socially seen in individuals with schizophrenia. A hypothesized path from the neural processes of social cognition, to social cognition assessed behaviorally, to real-life social interactions is examined. Secondary aims are to compare electrophysiological measures of high vs low level social cognition; to develop assessment methods of real-life behavior; and to increase the ecological validity of schizophrenia research. Much research within the field is devoid of personal meaning and interpersonal context. This project's use of personalized assessment allows for an ecologically valid approach to the social deficits of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* schizophrenia
* schizoaffective disorder

Exclusion Criteria

* diabetes
* Hyperthyroidism
* severe head trauma
* neurological disease

Primary outcomes:
measure: Neurophysiology: EEG
timeFrame: 1 day (when assessed)
measure: Neurophysiology: ERP
timeFrame: 1 day (when assessed)
measure: Cognition
timeFrame: 1 day (when assessed)
measure: Negative symptoms: clinician-rated
timeFrame: 1 day (when assessed)
measure: Negative symptoms: objective 1
timeFrame: 1 day (when assessed)
measure: Negative symptoms: objective 2
timeFrame: 1 day (when assessed)
measure: Social cognition: complex ToM
timeFrame: 1 day (when assessed)
measure: Social cognition: low level ToM
timeFrame: 1 day (when assessed)
measure: Social cognition: facial emotion perception
timeFrame: 1 day (when assessed)
measure: Social cognition: body language reading
timeFrame: 1 day (when assessed)
measure: Functioning
timeFrame: 1 day (when assessed)
measure: Real-world behaviour
timeFrame: 1 day (when assessed)
measure: Real-world social interactions
timeFrame: 1 day (when assessed)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02978053: Light Treatment to Shift-working Nurses
Official title: The Effects of Bright Light on Adaptation to Night Work Among Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shift-Work Sleep Disorder
Keywords: Bright light
Sleepiness
Sleep
Psychomotor vigilance
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This project examines 1) the effects of appropriately timed bright light on adaptation (in terms of sleep and sleepiness) to three consecutive night shifts; and 2) the effects of such bright light on re-adaptation (in terms of sleep and sleepiness) to a day-oriented schedule after the night shift period.

Detailed description: Shift workers frequently experience sleepiness during night shifts, which may have consequences for performance. Sleep duration is often shortened after a night shift. Properly timed bright light treatment is efficient in delaying the circadian rhythm and can enhance alertness, increase performance and prolong sleep after night shifts. There is a lack of studies on light treatment to rotating shift workers. This study is a randomized controlled crossover trial evaluating the effect of bright light treatment on sleep and sleepiness in rotating shift workers with three consecutive night shifts. The aim is to evaluate whether bright light treatment improves adaptation to three consecutive night shifts (reduces sleepiness during night shifts and improves sleep after night shifts), as well as whether such treatment affects re-adaptation to a day-oriented schedule after the night shift period.

Eligibility criteria: Inclusion Criteria:

* A rotating shift work schedule involving three days without night shifts, followed by three consecutive night shifts, followed by three days without night shifts
* Problems with sleepiness during night shifts

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Sleepiness during the night shifts
timeFrame: 3 days
Secondary outcomes:
measure: Psychomotor vigilance during night shifts
timeFrame: 3 days
measure: Sleep after the night shifts
timeFrame: 3 days
measure: Sleepiness during the days after the night shift period
timeFrame: 3 days
measure: Sleep during the days after the night shift period
timeFrame: 3 days
measure: Functioning on each shift, and shift period in total, compared to under normal conditions
timeFrame: 6 days
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
state: Hordaland
Study officials:
affiliation: University of Bergen
name: Bjørn Bjorvatn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615653: EUS Guided Celiac Neurolysis
Official title: Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer Pain
Keywords: Pancreatic cancer
Pancreas cancer
Pain
Celiac Plexus
Neurolysis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: American College of Gastroenterology
First posted: 2012-06-08
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Hypothesis:

  - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
* Rationale:

  * Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.


Eligibility criteria: Inclusion Criteria:

* 1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
* 2. Cytologic or histologic confirmation of pancreatic carcinoma
* 3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
* 4. EUS clinically indicated (for non-study purposes)

Exclusion Criteria:

* 1. Uncorrectable coagulopathy: (INR) \> 1.5 and/or platelets \< 50,000
* 2. Abdominal surgery within 1 month
* 3. Prior celiac plexus or ganglia neurolysis.
* 4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
* 5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.

Primary outcomes:
measure: Pain assessed using a numerical rating scale (NRS) from 0 to 10.
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
citation: Levy MJ, Gleeson FC, Topazian MD, Fujii-Lau LL, Enders FT, Larson JJ, Mara K, Abu Dayyeh BK, Alberts SR, Hallemeier CL, Iyer PG, Kendrick ML, Mauck WD, Pearson RK, Petersen BT, Rajan E, Takahashi N, Vege SS, Wang KK, Chari ST. Combined Celiac Ganglia and Plexus Neurolysis Shortens Survival, Without Benefit, vs Plexus Neurolysis Alone. Clin Gastroenterol Hepatol. 2019 Mar;17(4):728-738.e9. doi: 10.1016/j.cgh.2018.08.040. Epub 2018 Sep 12.
Clinical trial NCT00974753: Prophylactic Ketorolac Post Epiretinal Membrane Surgery
Official title: A Placebo-controlled, Randomized, Clinical Trial of Prophylactic Ketorolac 0.5% in Patients Undergoing Pars Plana Vitrectomy and Phacovitrectomy Epiretinal Membrane Peel Surgery: Assessing Macular Volume With Spectral-domain OCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Edema
Keywords: epiretinal membrane
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the efficacy of ketorolac 0.5%, a topical non-steroidal anti-inflammatory drug (NSAID), to prevent macular edema after epiretinal membrane surgery. Patients undergoing epiretinal membrane surgery have increased risk of macular swelling which can adversely affect vision. Since post-intraocular surgery inflammation is a contributing factor to macular swelling and loss of vision, NSAID drops may be able to prevent or minimize the deleterious effects of macular swelling after epiretinal membrane surgery.


Eligibility criteria: Inclusion Criteria:

* idiopathic epiretinal membrane diagnosis requiring membrane peel surgery

Exclusion Criteria:

* proliferative diabetic retinopathy
* sickle cell retinopathy
* radiation retinopathy
* choroidal folds
* hypersensitivity or allergy to NSAIDs
* wet macular degeneration
* branch retinal vein occlusion (BRVO)
* central retinal vein occlusion (CRVO)
* complicated membrane peel surgery

Primary outcomes:
measure: Change in macular volume from baseline.
timeFrame: Before surgery, at 1 week, 1 month, and 1 year after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Department of Ophthalmology, Hotel Dieu Hospital, Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Jeff Gale, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05464953: Suprachoroidal Triamcinolone Versus Posterior Subtenon Triamcinolone Alone or Formulated in the Management of Diabetic Macular Edema.
Official title: Alazher University Dean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema of Left Eye
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background Retinal vascular disorders, such as diabetic retinopathy, hypertensive retinopathy, retinal hemorrhage, and retinal vein occlusion are significant causes of vision impairment and blindness worldwide. Diabetic retinopathy (DR) is the most common retinal vascular disorder and is the leading cause of vision loss among patients aged 25 to 74 years.

Aim to compare formulated Posterior Subtenon Triamcinolone acetonide (PSTA) injection versus Posterior Subtenon Triamcinolone acetonide alone versus suprachoroidal triamcinolone in the management of diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

* Diminution of vision due to diabetic macular edema.
* CMT ≥ 250 µ.
* Willing to participate in the study.

Exclusion Criteria:

* Unwilling to participate in the study, 2)
* Ischemic RVO,
* previous laser treatment
* Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris,
* patients with previous anti VEGFs or steroid injections or any eye surgery three months before the inclusion,
* Cardiac co-morbidities result in significant hemodynamic changes, 7)Respiratory diseases need treatment with antibiotics,
* Suffering from other chronic diseases as diabetes,
* Patient with allergy from triamcinolone acetonide.

Primary outcomes:
measure: BCVA
timeFrame: Base line
measure: BCVA
timeFrame: at 1st month
measure: BCVA
timeFrame: at 3rd month
measure: BCVA
timeFrame: at 6th month
measure: CMT
timeFrame: at baseline
measure: CMT
timeFrame: at 1st month
measure: CMT
timeFrame: at 3rd month
measure: CMT
timeFrame: at 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Damieta
country: Egypt
facility: Ehab tharwat
state: New Damietta
Study officials:
References:
Clinical trial NCT05563753: Early Antibiotic Therapy and Vaccinations in Preterm Infants
Official title: Impact of Early Antibiotic Therapy on Vaccination Response in Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaccination Reaction
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 82
Sex: ALL
Minimum age (years): 24
Maximum age (years): 32
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants with a gestational age between 24+0 and 31+6 weeks of gestation

Brief summary: Since the neonatal sepsis is still one of the most common causes of death in preterm infants up to 80% receive an perinatal antibiotic treatment. It is also known that an antibiotic treatment is one of the most important influences for the establishment of the intestinal microbiome. This again is important for the development of an healthy neonatal immunosystem. A pilot study showed that an antibiotic therapy in the first week of life had a negative influence on the vaccine titers of preterm infants.

In this study it will be further investigated if an early antibiotic treatment influences the development of the adaptive immunosystem in preterm infants and if this antibiotic treatment effects the development of the intestinal microbiome.

Detailed description: The study wants to investigate the impact of the antibiotic treatment in the first week of live on the adaptive immunosystem. For this the antibody titers against Hepatitis B, Poliomyelitis, Pertussis, Haemophilus influenzae B, Tetanus, Diphtheria and Pneumococcus of very low birth weight infants (VLBWI) who receive an early antibiotic therapy will be compared with the antibody titers of infants who did not receive antibiotic treatment. Further the development of b- and t-cells will be tested.

To show the modulation of the intestinal microbiome through antibiotics stool samples of VLBWI with and without antibiotic therapy in first week of life will be tested for their composition and diversity as well as for the production of short-chained fatty acids (SCFA) In this study 82 VLBWI (42 per group) will be included. Infants will be matched by age and gender.

Eligibility criteria: Inclusion Criteria:

* born at University Hospital Tübingen
* received at least one dose of antibiotics during the first week of life

Exclusion Criteria:

* genetic disorders
* chronic infections
* hematological disorders
* treatment with immunoglobulins during the first 60 days of life
* immunological disorders
* infants with Hepatitis B positive mothers

Primary outcomes:
measure: Vaccination response
timeFrame: 7 Month
measure: Analyses of b- and t-cells development
timeFrame: 7 Month
Secondary outcomes:
measure: Microbiome analyses
timeFrame: 7 Month
measure: Analyses of SCFA production of the intestinal microbiome
timeFrame: 7 month
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospial Tübingen
state: Baden-Württemberg
Study officials:
References: