louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02475343: A Novel Method to Assess the Cornea Biomechanical Properties With Schiotz Tonometer
Official title: A Novel Method to Assess the Cornea Biomechanical Properties With Schiotz
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keratoconus
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2015-06-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to use Schiotz tonometer to evaluate the corneal biomechanical properties. The administration of Schiotz tonometer is according to the routine protocol which is use to measure intra-ocular pressure. The results obtained from Schiotz tonometer will be compared with results obtained from ORA and/or Corvis.

Detailed description: Schiotz tonometer, since it firstly be developed more than 100 years ago by Hjalmar Schiotz, has been regarded as a classical method to evaluate intraocular pressure (IOP). In present study, we aims to measure the corneal biomechanical properties with schiotz tonometer and elucidate the clinical significance of this novel measurement. The corneal biomechanical property was calculated with subtracting the value displayed under loaded weight 5.5g from that under loaded weight 7.5g. We named the corneal biomechanical properties obtained with schiotz tonometer as Mulee factor, and the formulation is Mulee factor=value under loaded weight 7.5g (Value 7.5G)-value under loaded weight 5.5g (Value 5.5G).

Eligibility criteria: Inclusion Criteria:

* People without the disease mentioned in exclusion criteria part.

Exclusion Criteria:

* Patients with ocular diseases including keratitis, conjunctivitis, history of chronic eye/systemic diseases except myopia and keratoconus, history of ocular surgery except LASIK, pregnant or lactating females.

Primary outcomes:
measure: The Mulee factor obtained with Schiotz tonometer as a measure of cornea biomechanical property
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Guoying Mu, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01337843: Online Cognitive Behavioral Therapy (CBT) Workbook
Official title: Wellness Workbook: Efficacy of an Online CBT Workbook for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Keywords: Chronic low back pain
cognitive behavioral pain management
coping
mindfulness
physical activity
Back Pain Lower Back Chronic
Lead sponsor: Talaria, Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2011-04-19
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). Participants will be randomly assigned to use the Wellness Workbook or alternative self-help materials and assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome measures include pain-related disability and pain severity.

Detailed description: This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). The Wellness Workbook is an interactive online intervention that uses evidence-based cognitive behavioral therapy (CBT) strategies, behavioral activation and mindfulness training to increase chronic pain patients' quality of life. 198 patients with chronic low back pain will be randomly assigned to use the Wellness Workbook or alternative self-help materials for 10 weeks. Participants will be assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome measures include pain-related disability, pain severity, physical activity, mindfulness and pain-related attitudes and beliefs.

Eligibility criteria: Inclusion Criteria:

* currently experiencing chronic non-cancer pain in the lower back

Exclusion Criteria:

* has a health diagnosis that would prevent him/her from participating fully in the program (e.g., is receiving treatment for cancer)
* does not have regular Internet access

Primary outcomes:
measure: Lower pain related disability and interference scores.
timeFrame: Baseline, 10 weeks, 18 weeks
Secondary outcomes:
measure: Fewer pain-related disabling beliefs and attitudes.
timeFrame: Baseline, 10 weeks, 18 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Talaria Inc
state: Washington
Study officials:
affiliation: Talaria, Inc
name: Susan Stoner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05256043: Investigation of Critically Ill Patients With Newly Diagnosed Diabetes
Official title: Case-control Investigation of Critically Ill Patients With Newly Diagnosed Diabetes: Clinical Characteristics, Glucose Metrics and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Glucose Metrics
Outcome Evaluation
Intensive Care Unit
Lead sponsor: Stamford Hospital
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 1777
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU where they were subsequently diagnosed for the first time with diabetes.

Brief summary: The purpose of this study is to investigate the clinical outcomes and glucose control metrics of critically ill patients with previously undiagnosed diabetes compared to those with known diabetes at the time of admission to the intensive care unit (ICU).

Detailed description: This case control study compares previously undiagnosed diabetic patients (defined as HbA1c \> 6.5% and no history of diabetes), to those with known diabetes, using 1:1 matching. Patients met inclusion criteria by having HbA1c available on ICU admission and at least four blood glucose tests during their ICU stay. Primary outcomes included ICU length of stay and inpatient mortality. Secondary outcomes included glucose metrics: mean blood glucose, coefficient of variation and percentage of patients who developed hypoglycemia.

Eligibility criteria: Inclusion Criteria:20

* Patients admitted between 9/14/2011 and 11/30/19 with HbA1c available on admission and at least four documented blood glucose tests during their ICU stay.

Exclusion Criteria:

* Patients admitted for diabetic ketoacidosis.
* Patients admitted to the ICU following cardiovascular surgery.

Primary outcomes:
measure: Inpatient mortality
timeFrame: 2011-2019
measure: Length of hospital Stay
timeFrame: 2011-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Stamford Health
state: Connecticut
Study officials:
References:
Clinical trial NCT05269043: Advanced Telemonitoring of Patients With COPD in Home Environment
Official title: SHAPES Advanced Telemonitoring of Patients With COPD in Home Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive pulmonary disease.

Brief summary: Chronic obstructive pulmonary disease (COPD) is one of the leading and rising causes of morbidity and mortality worldwide. The most important etiopathogenetic agent is smoking. However, air-pollution probably also plays a crucial role in the disease development, progression and exacerbations. The multimodal-telemedicine approach may provide a useful tool in the patient follow-up with the aim to reduce disease exacerbation rate and improve the health-related quality of life. The study aims to investigate the effects and utility of advanced telemonitoring in elderly COPD patients. All data will be integrated in a single web-based platform in order to analyse the mutual effects of different conditions and variables.


Eligibility criteria: Inclusion Criteria:

* COPD
* ≥ 60 years of age
* Informed written and verbal consent
* Ability to participate in study activities

Exclusion Criteria:

* Active smoking
* Respiratory failure requiring oxygenotherapy or ventilation support
* Severe psychological disturbances
* Absence of collaboration (informed consent)
* Other comorbid pulmonary disease
* Symptomatic heart failure
* Motor neuron diseases (e.g. amyotrophic lateral sclerosis etc.)

Primary outcomes:
measure: Telemetric spirometry - FVC
timeFrame: 3 month
measure: Telemetric spirometry - PEF
timeFrame: 3 month
measure: Telemetric spirometry - FEV1%
timeFrame: 3 month
measure: Telemetric spirometry - FEV1%/FVC ratio
timeFrame: 3 month
measure: Blood oxygen saturation monitoring
timeFrame: 3 month
measure: Particulate matter concentration monitoring
timeFrame: 3 month
measure: Environmental monitoring
timeFrame: 3 month
measure: Adherence monitoring - rate of inhalations per day
timeFrame: 3 month
measure: Adherence monitoring - time of inhalation deviation
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Department of Respiratory Medicine, University Hospital Olomouc, Czech Republic
Study officials:
References:
Clinical trial NCT00290043: Glulisine Pre- and Postmeal
Official title: Glucodynamic Response to Pre- and Postmeal Subcutaneous Injection of 0.15 IU/kg HMR1964 Insulin and RHI in Type 1 Diabetic Subjects in an Open, Randomized, Four-way Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 1
Keywords: Insulin glulisine
Diabetes mellitus Type 1
Postprandial Period
Pharmacokinetics
Glucodynamics
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate in type 1 diabetic patients the glucodynamic response to HMR1964 insulin and RHI (HOE31HPR100) injected subcutaneously before and after a standard meal


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus

Exclusion Criteria:

Primary outcomes:
measure: Outcome measures: Post-prandial glucose and insulin concentrations. Outcome: In T1DM, insulin glulisine provides a better mimic of the physiological postprandial glucose disposal than RHI.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
name: Klaus Rave, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04749043: Virtual Reality Compared to Nitrous Oxide for Labor Analgesia
Official title: Virtual Reality Compared to Nitrous Oxide for Labor Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Virtual Reality
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Comparing VR to an "active control" of nitrous oxide as a current standard of care for non-epidural analgesic in a crossover design
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headsets) are non-inferior to conventional therapy (nitrous oxide) for addressing maternal needs during labor who desire non-epidural pain relief.

Detailed description: The investigators will use a commercially available consumer-grade virtual reality (VR) device and nitrous oxide, a standard of care therapy for laboring women desiring non-epidural analgesic, to determine satisfaction with pain relief with each therapy.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy at \>34 weeks
* Regular uterine contractions
* Pain \> 2/10
* English speaking

Exclusion Criteria:

* BMI \> 40
* Preeclampsia with severe features
* Use of IV analgesics during labor
* Diabetes requiring insulin therapy
* Claustrophobia
* History of epilepsy

Primary outcomes:
measure: Patient satisfaction
timeFrame: 70 minutes
Secondary outcomes:
measure: Pain score
timeFrame: 70 minutes
measure: Anxiety
timeFrame: 70 minutes
measure: Nausea
timeFrame: 70 minutes
measure: Dizzy
timeFrame: 70 minutes
measure: Effectiveness
timeFrame: 70 minutes
measure: Cope with Pain
timeFrame: 70 minutes
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
Clinical trial NCT04658043: Early Socioemotional Intervention for Children With Autism Spectrum Disorder in Hong Kong and Mainland China
Official title: Early Socioemotional Intervention for Children With Autism Spectrum Disorder in Hong Kong and Mainland China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
ASD
socioemotional functioning
Intervention study
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Shenzhen University
name: Guangdong Province, Department of Science and Technology
First posted: 2020-12-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to develop a culturally-sensitive parent-training intervention to enhance socioemotional functioning of young children (aged 3-6) with Autism Spectrum Disorder (ASD) in Mainland China. The investigators will conduct randomized controlled trials to evaluate the effectiveness and feasibility of this program in a pilot study and then a large-scale community-based study in Shenzhen, China, to examine the generalizability of the treatment outcomes of this intervention for Chinese children with ASD.


Eligibility criteria: Inclusion Criteria:

* Children aged 3-6
* Living in Shenzhen, Mainland China
* Diagnosed with ASD or suspected of having ASD

Primary outcomes:
measure: Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
timeFrame: pre-intervention and 4-month post-intervention
measure: Change in the Autism Spectrum Quotient (AQ)
timeFrame: pre-intervention, immediately after the intervention, and 4-month post-intervention
measure: Change in Dyadic Parent-Child Interaction Coding System (DPICS system)
timeFrame: pre-intervention, immediately after the intervention, and 4-month post-intervention
Secondary outcomes:
measure: Change in Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF)
timeFrame: pre-intervention, immediately after the intervention, and 4-month post-intervention
measure: Change in Self-Efficacy in Nurturing Role Questionnaire
timeFrame: pre-intervention, immediately after the intervention, and 4-month post-intervention
measure: Change in Classroom Observation Scale (COS)
timeFrame: pre-intervention, immediately after the intervention, and 4-month post-intervention
measure: Change in Social Responsiveness Scale, Second Edition (SRS-2)
timeFrame: pre-intervention, immediately after the intervention, and 4-month post-intervention
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen University
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Terry Kit-fong Au
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00366743: Evaluation of Visual Outcomes After Myopic LASIK
Official title: Analysis of Visual Outcomes, Contrast Sensitivity, Glare, Induction of High Order Aberrations and Wavefront Technology, Following LASIK Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Myopic Astigmatism
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2006-08-21
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare testing and high order aberrations induced by different laser technologies and to evaluate differences in aberrometer technology. We hypothesized that there will not be differences among conventional or wavefront guided treatments.

Detailed description: The aim of the study was to evaluate and compare visual outcomes, contrast sensitivity, glare testing and induction of high order aberrations by different laser technologies and to evaluate differences in aberrometer technology.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Candidates for bilateral LASIK
* Myopic range: 0.00 to -7.00 D
* Astigmatism: 0.00 to -5.00 D

Exclusion Criteria:

* Pupil size greater than 8mm diameter, infrared measurement
* thin corneas (preoperatively calculated minimal residual bed \< 250 um)
* irregular astigmatism
* asymmetric astigmatism
* unstable refraction
* other criteria that preclude the patient to undergo LASIK

Primary outcomes:
measure: Visual acuity
measure: Contrast sensitivity
measure: Induction of high order aberrations
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Kerry D. Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05809843: OCT and OCT-A Deep Learning in Diabetic Patients Wiht Artificial Pancreas Device
Official title: Deep Learning in Vascular and Structural Retinal Changes in Diabetic Patients Undergoing Artificial Pancreas Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus With Artificial Pancreas Device
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 18 years with diagnosis of type 1 diabetes treated with artificial pancreas device. They did not present other ophthalmological disease

Brief summary: This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in diabetic patients undergoing artificial pancreas device, using optical coherence tomography angiography.

Detailed description: hybrid artificial pancreas systems (CSII) are able to adjust the type 1 diabetic patient's glycemic levels with insulin doses appropriate to the patient's blood glucose.

The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.

The study evaluates the changes in optical coherence tomography angiography features in diabetic patients undergoing artificial pancreas device, elaborating these data with artificial intelligence.

Eligibility criteria: Inclusion Criteria:

* • age older than 18 years

  * diagnosis of type 1 diabetes
  * treatment with artificial pancreas device
  * absence of previous ocular surgery and congenital eye diseases.
  * absence of errors of refraction
  * absence of lens opacities
  * absence of low-quality OCT and OCTA images

Exclusion Criteria:

* age younger than 18 years
* previous ocular surgery and congenital eye diseases
* errors of refraction
* lens opacities
* low-quality OCT and OCTA images

Primary outcomes:
measure: The measurements of retinal and choriocapillary vessel density in type 1 diabetic patients undergoing artificial pancreas device
timeFrame: up to 3months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
References:
Clinical trial NCT00730743: Study on Clinical Outcome of Vascular Inflow Occlusion in Open Liver Resection
Official title: Open Liver Resection With or Without Vascular Inflow Occlusion: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatectomy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate whether applying inflow vascular occlusion in modern liver resection is associated with better clinical outcome.

Eligible patients are randomly assigned to the two surgical techniques: with or without the application of inflow vascular occlusion.

Patients outcome including liver function recovery, operative time and blood loss are compared.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Child-Pugh Class A or B

Exclusion Criteria:

* Informed consent not available
* Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal vein embolisation
* Presence of hepatic artery thrombosis, previous transarterial therapy like TACE, or transarterial internal radiation
* When portal vein resection is anticipated
* Emergency hepatectomy
* Ruptured hepatocellular carcinoma
* Rehepatectomy (repeated liver resection)
* Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver
* When concomitant bowel or bile duct resection is anticipated

Primary outcomes:
measure: Operative blood loss
timeFrame: From skin incision to completion of operation
measure: Operative time
timeFrame: From skin incision to completion of operation
Secondary outcomes:
measure: Operative morbidity and mortality
timeFrame: From date of operation to 30-day after operation
measure: Recovery of liver function
timeFrame: From date of operation to date of discharge
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Departement of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong
name: Kit-fai Lee, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee KF, Chong CCN, Cheung SYS, Wong J, Fung AKY, Lok HT, Lai PBS. Impact of Intermittent Pringle Maneuver on Long-Term Survival After Hepatectomy for Hepatocellular Carcinoma: Result from Two Combined Randomized Controlled Trials. World J Surg. 2019 Dec;43(12):3101-3109. doi: 10.1007/s00268-019-05130-8.
citation: Lee KF, Cheung YS, Wong J, Chong CC, Wong JS, Lai PB. Randomized clinical trial of open hepatectomy with or without intermittent Pringle manoeuvre. Br J Surg. 2012 Sep;99(9):1203-9. doi: 10.1002/bjs.8863. Epub 2012 Jul 24.