louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00317551: Cambridge Anti-Myopia Trial: Accommodation Training and Aberration Control in Myopia Development
Official title: Accommodation Training and Aberration Control in Myopia Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myopia
Keywords: Aberration control
Accommodative facility
Accommodative response
Peripheral refraction
Accommodative convergence to accommodation ratio
Lead sponsor: Anglia Ruskin University
Sponsor class: OTHER
Collaborators: name: Vision CRC
First posted: 2006-04-25
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: We have identified focussing problems related to myopia getting worse. Our trial uses optical and orthoptic interventions that correct the focussing problems to see if this retards myopia progression.

Detailed description: Myopia is a burgeoning health and social problem. Currently there is no acceptable clinical treatment that prevents progression. This study is a double masked placebo controlled block randomized clinical trial of two interventions, to treat accommodative factors we have identified as being significantly correlated to myopia progression (rather than to the presence of myopia). We have shown that the interventions normalise the accommodative factors, and this trial examines the effect of these interventions on myopia progression.

Eligibility criteria: Inclusion Criteria:

* Best corrected visual acuity of 6/5 in each eye
* Myopia in each meridian of at least 0.50 D
* Willingness to give consent
* Willingness to undertake any treatment option

Exclusion Criteria:

* History of systemic/ocular pathology
* History of any ocular surgery
* More than 10D of myopia
* Astigmatism more than 1.00 D

Primary outcomes:
measure: Change in refractive error in myopia in 6 monthly intervals for 2 years
measure: Change in axial length in 6 monthly intervals for 2 years
measure: Age effects on refractive changes over 2 years
Secondary outcomes:
measure: Change in accommodative response in 6 monthly intervals for 2 years
measure: Change in accommodative facility in 6 monthly intervals for 2 years
measure: Change in peripheral refraction in 6 monthly intervals for 2 years
measure: Change in AC/A ratio in 6 monthly intervals for 2 years
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Anglia Ruskin University
state: Cambridgeshire
Study officials:
affiliation: University of Wales Institute Cardiff
name: Daniel J O'Leary, PhD
role: STUDY_DIRECTOR
affiliation: Anglia Ruskin University
name: Peter M Allen, PhD
role: STUDY_CHAIR
affiliation: University of Manchester
name: Hema Radhakrishnan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anglia Ruskin University
name: Richard I Calver, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anglia Ruskin University
name: Ebi P Osuobeni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04515251: Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population
Official title: A Prospective, Observational, Multicenter Study on Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Superior Mesenteric Artery Syndrome
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
Collaborators: name: Imaging Institute of Southern Switzerland
First posted: 2020-08-17
Enrollment: 289
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged from 10 to 15 years

Brief summary: Multicenter, prospective, observational research project on children aged from 10 to 15 years old undergoing abdominal ultrasound examinations during routine clinical practice.

Detailed description: Demographics data, clinical indications, ultrasound diagnosis, and ultrasound measurements will be recorded and stored on an database. Ultrasound measurements will be analyzed to define the normal range of values of Superior Mesenteric Artery (SMA) angle and Superior Mesenteric Artery - Aorta (SMA-A) distance in the pediatric population according to age, Body Mass Index (BMI), and fat parameters.

Eligibility criteria: Inclusion Criteria:

* Male and female children
* Age ranging from10 to 15 years, included
* Abdominal ultrasound examination to be performed for indications other than gastrointestinal evaluation
* Signed Informed Consent

Exclusion Criteria:

* Presence of a disease that could distort the anatomy around the SMA (e.g., abdominal mass, lymphadenopathy, severe scoliosis, free abdominal fluid)
* Oncologic patients at risk of neoplastic cachexia.

Primary outcomes:
measure: Define the normal range of values of the SMA angle
timeFrame: 1 day
Secondary outcomes:
measure: Define the normal range of values of the SMA-A distance LV
timeFrame: 1 day
measure: Define the normal range of values of the SMA-A distance D
timeFrame: 1 day
measure: Define the normal range of values of the SMA angle (degree), SMA-A distance LV
timeFrame: 1 day
measure: Assess the association between the SMA angle and BMI categories
timeFrame: 1 day
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Imaging Institute of Southern Switzerland
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires Genève
Study officials:
affiliation: Imaging Institute of Southern Switzerland
name: Marirosa Cristallo Lacalamita, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01637454: TYPE 2 HEPATORENAL SYNDROME
Official title: NORADRENALINE VERSUS TERLIPRESSIN IN THE TREATMENT OF TYPE 2 HEPATORENAL SYNDROME:A RANDOMIZED STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Safety and Efficacy of Terlipressin and Noradrenaline and Predictive Factors of Response in Type 2 HRS
Keywords: noradrenaline terlipressin type 2 HRS
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2012-07-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not available in some countries. In the present study, the investigators evaluated safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS


Eligibility criteria: Inclusion Criteria:

1. Cirrhosis with ascites with serum creatinine more than 1.5 mg/dl and less than 2.5 mg/dl
2. Absence of shock, fluid losses and treatment with nephrotoxic drug
3. No improvement in renal function following diuretic withdrawal and plasma volume expansion
4. No ultrasound evidence of renal parenchymal disease or obstructive uropathy 5.Absence of proteinuria more than 500 mg/24 hour

Exclusion Criteria:

1. Patients with history of coronary artery disease
2. Cardiomyopathy
3. Ventricular arrhythmia
4. Obstructive arterial disease of limbs -

Primary outcomes:
measure: The primary end point of the study was serum creatinine less than 1.5 mg
timeFrame: 15 days
Secondary outcomes:
measure: Secondary end points include death of patients
timeFrame: 15 days
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research Chandigarh
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Virendra Singh, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alessandria C, Ottobrelli A, Debernardi-Venon W, Todros L, Cerenzia MT, Martini S, Balzola F, Morgando A, Rizzetto M, Marzano A. Noradrenalin vs terlipressin in patients with hepatorenal syndrome: a prospective, randomized, unblinded, pilot study. J Hepatol. 2007 Oct;47(4):499-505. doi: 10.1016/j.jhep.2007.04.010. Epub 2007 May 24.
citation: Ghosh S, Choudhary NS, Sharma AK, Singh B, Kumar P, Agarwal R, Sharma N, Bhalla A, Chawla YK, Singh V. Noradrenaline vs terlipressin in the treatment of type 2 hepatorenal syndrome: a randomized pilot study. Liver Int. 2013 Sep;33(8):1187-93. doi: 10.1111/liv.12179. Epub 2013 Apr 21.
Clinical trial NCT04099654: The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery
Official title: The Effect of Structured Core Stabilization Exercise Program on Functional Capacity, Physical Fitness and Quality of Life in Obese Subjects Awaiting Bariatric Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Exercise
Bariatric Surgery Candidate
Keywords: obese
core stabilization
bariatric surgery
exercise
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, our primary aim is to investigate the effects of structured core stabilization exercise program on functional capacity, body composition, muscle strength, endurance, balance, quality of life in adult obese individuals expecting bariatric surgery. Our secondary aim is to provide the individual with exercise habits and increase the level of physical activity in daily life with the exercise program planned according to the needs of the individual.


Eligibility criteria: Inclusion Criteria:

* Individuals aged between 18-65
* BMI ≥30 kg/m2, individuals waiting bariatric surgery
* No surgical operation in the last 6 months

Exclusion Criteria:

* Musculoskeletal disorders or systemic diseases that may prevent exercise
* The presence of psychiatric or neurological disease affecting cooperation and cognitive functions
* Presence of acute pain
* Heart pain
* Presence of previous myocardial infarction, subjective heart failure, uncontrolled diabetes and hypertension
* Regular exercise for 6 months

Primary outcomes:
measure: Six Minute Walk Test
timeFrame: Change from baseline to 8 weeks, follow up at two months
measure: Assessment of Core Stabilization
timeFrame: Change from baseline to 8 weeks, follow up at two months
Secondary outcomes:
measure: Bioelectrical Impedance Analysis-obesity score
timeFrame: Change from baseline to 8 weeks, follow up at two months
measure: Biodex Balance System-Fall Risk Test
timeFrame: Change from baseline to 8 weeks, follow up at two months
measure: Obesity Specific Quality of Life Scale
timeFrame: Change from baseline to 8 weeks, follow up at two months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References:
Clinical trial NCT05186454: Postoperative Pain Control by Use of Many Drugs in Small Doses Intrathecally
Official title: Multimodal Intrathecal Analgesia for Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Post Operative Pain
Keywords: Intrathecal morphine, midazolam, dexamethasone, cesarean section
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cesarean section is one of the painful operations that require adequate postoperative analgesia. Patients are divided into two groups: Multimodal (DMM) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam.

Morphine (M) group (30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 200 µg morphine


Eligibility criteria: Inclusion criteria:

* ASA I-II
* Age 20-40 years.
* Pregnant women with living fetus.
* Body mass index 20- 35 kg/m2.

Exclusion criteria:

* Patient refusal.
* Age \< 20 or \> 40 years
* Body mass index \< 20 or \> 35.
* Contraindication to spinal anesthesia (severe mitral or aortic stenosis, coagulopathy, Systemic or local infection, increased intracranial pressure and hypovolemia).
* Placental abnormalities: placental abruption, placenta previa or accrete.
* Allergy to drugs used in the study.

Primary outcomes:
measure: 1st analgesic requirement
timeFrame: 24 hours
Secondary outcomes:
measure: Analgesic consumption
timeFrame: 24 hours
measure: Post operative pain
timeFrame: 24 hours
measure: Side effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Fouad Soliman
Study officials:
References:
Clinical trial NCT02755454: Perfusion CT Imaging in Lung Cancer With SBRT
Official title: Perfusion CT Imaging in Patients With Lung Malignancies Receiving Stereotactic Body Radiation Therapy (SBRT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to determine specific perfusion patterns for radiation induced lung changes and residual/recurrent lung malignancies in patients treated with stereotactic body radiotherapy SBRT and thus improve to distinguish radiation changes from residual/recurrent lung cancers. Currently CT is often unable to make a clear differentiation between benign and malignant changes in the lung after SBRT treatment necessitating additional wait time to perform follow up CTs or biopsies. Optimal treatment may be delayed. The investigators want to apply a CT perfusion sequence in addition to the routine follow up CTs with the goal to obtain perfusion values of post treatment lung changes and lung tumours. The investigators' hypothesis is that CT perfusion values will help differentiate benign post radiation changes from residual/recurrent tumour in the lung with higher confidence and may help avoid unnecessary delays in cancer treatment.


Eligibility criteria: Inclusion Criteria:

* Gender: male or female
* CT ordered for baseline and follow up in patients with lung cancer and lung metastases treated with
* Patient will sign a consent form prior to study entry
* Lung cancer and lung metastases are biopsy proven

Exclusion Criteria:

* Patients who are unable to give valid informed consent
* Patients who are unwilling or unable to undergo a CT exam, including subjects with contra-indications to CT exams or intravenous contrast material administration.

Primary outcomes:
measure: Imaging of during and after SBRT treatment for lung malignancies with a combined perfusion and routine CT to assess therapy response of lung cancer and metastases.
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Patrik Rogalla
state: Ontario
Study officials:
affiliation: UHN
name: Patrik Rogalla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00775554: Comparison Study of Using Ultrasound Guidance for Hematoma Blocks vs. Traditional Approach
Official title: "Are Ultrasound-guided Hematoma Blocks for Distal Forearm Fractures Superior to the Landmark-guided Method for Hematoma Blocks?"
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Forearm Fracture
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Will use visual analog scales to compare effectiveness of traditional hematoma block vs ultrasound guided hematoma block with regards to pain. This will be done for closed forearm fractures.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Closed forearm fracture

Exclusion Criteria:

* Mentally impaired, visually impaired or deaf
* Age \< 18
* Alcohol on board

Primary outcomes:
measure: Visual analog scale movement
Secondary outcomes:
Other outcomes:
Locations:
city: New York City
country: United States
facility: St. Luke's Roosevelt Hospital
state: New York
Study officials:
References:
Clinical trial NCT04284254: MT2018-18: Sleeping Beauty Transposon-Engineered Plasmablasts for Hurler Syndrome Post Allo HSCT
Official title: Sleeping Beauty Transposon-Engineered Plasmablasts for Expression and Delivery of Alpha-L-iduronidase in Patients With Hurler Syndrome That Have Previously Undergone Allogeneic Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Mucopolysaccharidosis Type IH (MPS IH, Hurler Syndrome)
Mucopolysaccharidosis Type IH
MPS IH, Hurler Syndrome
Keywords: MPS IH
Hurler syndrome
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a single center, Phase 1/2 study in which patients with Hurler syndrome who have previously undergone allogeneic hematopoietic stem cell transplantation are treated with autologous plasmablasts engineered to express α-L-iduronidase (IDUA) using the Sleeping Beauty transposon system.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Mucopolysaccharidosis type IH (MPS IH, Hurler syndrome)
* Underwent a previous hematopoietic stem cell transplant \>1 year prior to study enrollment
* Age ≥3 years and ≤8 years at time of study registration
* ≥ 10 kilograms body weight
* Creatinine \<1.5 normal for gender and age.
* Ejection fraction ≥ 40% by echocardiogram
* Must commit to traveling to the University of Minnesota for the necessary followup evaluations
* Must agree to stay in the Twin Cities area (\<45-minute drive from the Masonic Children's Hospital) for a minimum of 5 days after each cell infusion
* Voluntary written parental consent prior to the performance of any study related procedures

Exclusion Criteria:

* Prior enzyme replacement therapy within 4 months prior to enrolling on study
* History of B cell related cancer, EBV lymphoproliferative disease or autoimmune disorders
* Evidence of active graft vs. host disease
* Requirement for systemic immune suppression
* Requirement for continuous supplemental oxygen
* Any medical condition likely to interfere with assessment of safety or efficacy of the study treatment.
* In the investigator's judgement, the subject is unlikely to complete all protocol required study visits or procedures, including follow up visits, or comply with the study requirements for participation.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: 1 Year
measure: Growth Velocity (cm/year)
timeFrame: 1 Year
measure: Safety and Tolerability after Infusion: Incidence of Adverse Events
timeFrame: 1 Year
Secondary outcomes:
measure: Z-score Growth Rate
timeFrame: 1 Year
measure: Donor Engraftment
timeFrame: Baseline, 6 months and 1 Year
measure: Levels of circulating antibodies (IgG, IgM, IgA and IgE)
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota, Department of Pediatrics
name: Paul Orchard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03379454: The Impact of Melanoma and Drug Treatment in the Real World
Official title: The Impact of Melanoma and Drug Treatment in the Real World
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Vitaccess Ltd
Sponsor class: INDUSTRY
Collaborators: name: Melanoma UK
name: Royal Marsden NHS Foundation Trust
First posted: 2017-12-20
Enrollment: 819
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (age ≥18 years) with melanoma of any stage, who are resident in the UK, with NHS or CHI number, current or previous diagnosis of melanoma, willing to use their own smartphone or tablet.

Brief summary: An observational, non-interventional registry study to collect real-world data from people living with melanoma and its treatment, which will be available to researchers to further the knowledge of melanoma and improve patient care.

Detailed description: The registry uses Vitaccess' digital real-world evidence platform, and has been developed in collaboration with the patient advocacy group Melanoma UK.

Eligible participants install a study app on their smartphone or tablet. Researchers access aggregated, anonymised data via a cloud-based research portal. The platform provides benefits to participants, which it is hoped will encourage persistence with data submission; these include options to upload electronic documents such as scans, and access an online melanoma community.

The aggregated data are available in close to real time via "dashboards" and can be analysed according to a number of pre-set criteria (e.g. disease stage, age, geographic location).

State-of-the-art technologies and security policies are used in the platform to ensure industry-standard data storage and privacy for all users. Participants' personally identifiable information will remain confidential at all times, and researchers will not be able to identify individuals.

Eligibility criteria: Inclusion Criteria:

* adults with melanoma of any stage, resident in the UK with National Health Service (NHS) or Community Health Index (CHI) number, aged 18 and over, current or previous diagnosis of melanoma, willing to use their own smartphone or tablet.

Exclusion Criteria:

* no specific exclusion criteria

Primary outcomes:
measure: Health-Related Quality of Life (HRQL), general
timeFrame: Monthly throughout 4 year study duration
Secondary outcomes:
measure: Health-Related Quality of Life (HRQL), oncology
timeFrame: Monthly throughout 4 year study duration
measure: Health-Related Quality of Life (HRQL), symptoms
timeFrame: Monthly throughout 4 year study duration
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Vitaccess Ltd
Study officials:
affiliation: Vitaccess Ltd
name: Mark JW Larkin, PhD
role: PRINCIPAL_INVESTIGATOR
References: