louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02325765: Study of the Corelation Between Circulating Nuclearsome and SIRS Happened After Congential Cardiac Surgery
Official title: Corelation Between Circulating Nuclearsome and SIRS Happened After Congential Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congential Cardiac Surgery
Keywords: congential cardiac surgery
nuclearsome
systemic inflammation response syndrome
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1-36 months 2.5-15 kilogram accepted congential cardiac surgery

Brief summary: In this study，the investigators want to determine the corelation between circulating nuclearsome and the development of SIRS occured after congenital cardiac surgery, including the serverity of organ damage and inflamation.

Detailed description: Blood was collected from study participants at 6 time points; 1) post-anesthesia induction, 2) post-op hour 0, 3) post-op hour 4, 4) post-op hour 24, 5) post-op hour 48, and 6) post-op hour 72. At each of the 6 time points blood was analyzed for levels of the following:histone,blood routine test , c-reaction protein, procalcitonin, N-terminal pro-brain natriuretic,the hepatorenal function，cardiac function and pulmonary function

Eligibility criteria: Inclusion Criteria:

* children with congenial heart disease

Exclusion Criteria:

* Less than 2.5kg
* Prematurity less than 37 weeks estimated gestational age
* Renal failure as described by the pediatric RIFLE criteria

Primary outcomes:
measure: the perioperation change of histone level
timeFrame: preoperation to 72 hours after congential cardiac surgery
Secondary outcomes:
measure: the perioperation change of c-reaction protein level
timeFrame: preoperation to 72 hours after congential cardiac surgery
measure: the perioperation change of cardiac function
timeFrame: preoperation to 72 hours after congential cardiac surgery
measure: the perioperation change of blood routine test
timeFrame: preoperation to 72 hours after congential cardiac surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Wei Wang, MD
role: STUDY_DIRECTOR
References:
citation: Gao H, Zhang N, Lu F, Yu X, Zhu L, Mo X, Wang W. Circulating histones for predicting prognosis after cardiac surgery: a prospective study. Interact Cardiovasc Thorac Surg. 2016 Nov;23(5):681-687. doi: 10.1093/icvts/ivw198. Epub 2016 Jun 29.
Clinical trial NCT04894565: Physiotherapy Program for Breast Cancer Women Following Surgery: A Pilot Clinical Trial
Official title: Effectiveness of Home-based and Early Institutional Physiotherapy Program for Breast Cancer Women Following Surgery: A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2021-05-20
Enrollment: 23
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Consecutive women with breast cancer who underwent breast cancer surgery
Primary purpose: PREVENTION

Brief summary: pilot study on physical therapy in women with breast cancer immediately following surgery

Detailed description: A pilot, single-arm non-randomized clinical trial was conducted between the period September 2018 and June 2019 on a convenient sample of BC women. Primary study outcomes were pain, disabilities of the Arm, Shoulder, and Hand (DASH), handgrip strength, and quality of life (QoL). The secondary outcome was to assess the feasibility of this pilot study. All outcomes were recorded at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90) under standardized conditions. The interventions were delivered by the physiotherapist early within 24 hours post-operatively, T1, and T2. In addition, home-based exercise was provided with written instructions during hospitalization with rehearsal sessions to ensure the patient's understanding and compliance

Eligibility criteria: Inclusion Criteria:

* women with breast cancer who require surgical resection

Exclusion Criteria:

* in ability to undergo 3 months of physical therapy program

Primary outcomes:
measure: Shoulder/Arm Pain
timeFrame: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
measure: Shoulder mobility
timeFrame: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
measure: Disabilities in daily life
timeFrame: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
measure: Handgrip strength
timeFrame: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
measure: Quality of Life (QoL)
timeFrame: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Secondary outcomes:
measure: Establishing firmly study feasibility
timeFrame: 3 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: KFMC
Study officials:
affiliation: Consultant
name: Noura Binsaad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02004665: Incidence and Prognostic Value of DELIRIUM in Patients With Acute CORonary synDrome: an observatIonal Study
Official title: Incidence and Prognostic Value of DELIRIUM in Patients With Acute CORonary synDrome: an observatIonal Study by the DELIRIUM-CORDIS Investigators.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Acute Coronary Syndrome
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 400
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with acute coronary syndrome and delirium

Brief summary: to evaluate the incidence of delirium in patients with acute coronary syndrome and its correlation with adverse events


Eligibility criteria: Inclusion Criteria:

* acute coronary syndrome patients undergone coronary revascularization or referred to conservative strategy
* age ≥ 70 years
* diagnosis of delirium by the Confusion Assessment Method in the ICU (CAM-ICU) scale

Exclusion Criteria:

* none

Primary outcomes:
measure: in-hospital adverse events incidence
timeFrame: until discharge (4-7 days from admission)
Secondary outcomes:
measure: 12-month adverse events incidence
timeFrame: 12 months
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Cardiovascular Department, Ospedale S.Donato
state: AR
Study officials:
References:
citation: Falsini G, Grotti S, Porto I, Toccafondi G, Fraticelli A, Angioli P, Ducci K, Liistro F, Pieroni M, Taddei T, Romanelli S, Rossi R, Bolognese L. Long-term prognostic value of delirium in elderly patients with acute cardiac diseases admitted to two cardiac intensive care units: a prospective study (DELIRIUM CORDIS). Eur Heart J Acute Cardiovasc Care. 2018 Oct;7(7):661-670. doi: 10.1177/2048872617695235. Epub 2017 Mar 16.
Clinical trial NCT03389165: The Effect of a Wearable Hip Assist Robot on Cardiopulmonary Metabolic Efficiency During Stair Ascent in Elderly Adults
Official title: The Effect of a Wearable Hip Assist Robot on Cardiopulmonary Metabolic Efficiency During Stair Ascent in Elderly Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Unsteady
Health Behavior
Keywords: Wearable hip assist robot
Elderly adult
Metabolic energy expenditure
Stair ascent
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study was to identify the assistance effect of the new wearable hip assist robot, gait enhancing mechatronic system (GEMS) developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) during stair ascent by comparing the energy expenditure of elderly adults with and without the GEMS.

Detailed description: Primary objective of this study is to demonstrate the effect of a wearable hip assist robot on cardiopulmonary metabolic efficiency during stair ascent in elderly adults.

Fifteen elderly adults participated in this study. The stair ascent trials were designed to climb stairs from the first basement level to the fourth floor of the Proton Therapy Center, Samsung Medical Center, Korea. The metabolic energy expenditure was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy) while participants performed randomly assigned two different conditions consecutively:, free ascent without the GEMS (NoGEMS) or robot-assisted ascent with the GEMS (GEMS). Participants rested for 10 minutes between the two trial conditions.

Eligibility criteria: Inclusion Criteria:

* Elderly adults who absence of a history of musculoskeletal or central nervous system diseases
* High levels of physical performance (SPPB \> 8)

Exclusion Criteria:

* Elderly adults who absence of the ability to walk independently due to visual field defects, fractures, or severe muscle weakness
* Severe dizziness that might lead to falls
* Cognitive disorders that might be difficult to understand accurately in this study

Primary outcomes:
measure: Change on metabolic energy expenditure in GEMS condition compared with NoGEMS condition
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD, PhD
role: STUDY_CHAIR
References:
citation: Kim DS, Lee HJ, Lee SH, Chang WH, Jang J, Choi BO, Ryu GH, Kim YH. A wearable hip-assist robot reduces the cardiopulmonary metabolic energy expenditure during stair ascent in elderly adults: a pilot cross-sectional study. BMC Geriatr. 2018 Sep 29;18(1):230. doi: 10.1186/s12877-018-0921-1.
Clinical trial NCT00514865: Placebo-Controlled Study of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: ONO-2333Ms
Major Depressive Disorder
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2007-08-10
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder


Eligibility criteria: Inclusion Criteria:

* Diagnosed with recurrent major depressive disorder

Exclusion Criteria:

* Patients with treatment resistance for depression
* History of alcohol abuse/dependence, substance abuse/dependence within 6 months
* Has clinically significant unstable medical condition
* Has significant risk of suicide

Primary outcomes:
measure: Change from baseline to treatment endpoint in the MADRS total score
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Ono Pharma Investigtional Site
state: Georgia
Study officials:
affiliation: Ono Pharma USA Inc
name: Katsutoshi Hatakeyama, M.S.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01710865: Effectiveness of Two Sealant Materials Over 5 Years
Official title: Evidence Based Effectiveness of Pit and Fissure Sealants Applied By Students and Paediatric Dentists After (Three) Five Years.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Caries
Keywords: Caries prevention
pit and fissure sealants
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effectiveness of a new hydrophilic sealant (Ultraseal XT Hydro) compared to the previously existing hydrophobic sealant materials (Ultraseal XT Plus) which requires prime and dry to dry the tooth surface.

Detailed description: The new hydrophobic sealant material eliminates the step of prime and drying the tooth which prevents from over drying the tooth surface and decreases chair time, which is important when working with children. The null hypothesis is that there is no difference between the materials. The alternate hypothesis is that the Ultraseal XT Hydro is a better material.

Eligibility criteria: Inclusion Criteria:

* Children that are at a high risk of developing caries.

Exclusion Criteria:

* Children that already have sealants or do not need them.

Primary outcomes:
measure: Changes in retention of sealants from baseline to five years
timeFrame: Baseline and every year (baseline to five years)
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Children's Clinic at Western University
state: Ontario
Study officials:
affiliation: Division of Orthodontics and Paediatric Dentistry
name: Dr. Sahza Hatibov-Kofman, D.D.S.FRCD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04091165: Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery
Official title: Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GI Cancer
Nutritional Deficiency
Keywords: food diary
malnutrition
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 23
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: Patients scheduled for surgery in the Moffitt GI Clinic

Brief summary: This study is to assess the usability and acceptability of a digital food consumption diary as part of the perioperative management of gastrointestinal oncology patients and to evaluate the impact of a digital food diary on adherence to dietician-recommended plan and on quality recovery, using a commercially available smart phone application.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of gastrointestinal (GI) cancers confirmed by tissue diagnosis and/or clinical presentation as judged by the treating physician
* Candidate for curative-intent surgery
* Participants will be eligible for participation regardless of degree of malnutrition (as determined at pre-operative dietary consultation)
* Own a smartphone with iOS or Android operating systems with WiFi or 3G/4G connection
* Willingness to download the Livestrong.com MyPlate Calorie Tracker onto a personal smart phone with assumption and responsibility for individual data usage, and creation of login for website data extraction
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Sufficient English language proficiency to execute study tasks

Exclusion Criteria:

* Participants with tube feeds and/or need for parenteral/enteral nutrition
* Participants not willing to download or utilize the commercially available weight monitoring application

Primary outcomes:
measure: Usability of Smart Phone Application
timeFrame: Up to 3 months
measure: Acceptability of Smart Phone Application
timeFrame: Up to 3 months
Secondary outcomes:
measure: Adherence to Recommended Nutritional Plan
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H Lee Moffitt Cancer & Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Pamela Hodul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allenson K, Turner K, Gonzalez BD, Gurd E, Zhu S, Misner N, Chin A, Adams M, Cooper L, Nguyen D, Naffouje S, Castillo DL, Kocab M, James B, Denbo J, Pimiento JM, Malafa M, Powers BD, Fleming JB, Anaya DA, Hodul PJ. Pilot trial of remote monitoring to prevent malnutrition after hepatopancreatobiliary surgery. BMC Nutr. 2021 Dec 9;7(1):82. doi: 10.1186/s40795-021-00487-3.
Clinical trial NCT01987765: Safety and Efficacy of Relestat Ophthalmic Solution 0.05% for Allergic Conjunctivitis in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conjunctivitis, Allergic
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-11-19
Enrollment: 847
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice.

Brief summary: This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Relestat Ophthalmic Solution 0.05% in patients with allergic conjunctivitis who are treated with Relestat as standard of care in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Percentage of Patients Reporting Adverse Events
timeFrame: Up to 10 Months
measure: Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale
timeFrame: Baseline, 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gangwon-do
country: Korea, Republic of
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05159765: Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial
Official title: Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Myopia
Refractive Error
Lead sponsor: Visioneering Technologies, Inc
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 144
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-masked clinical trial. All study devices are market approved/cleared in the localities where the study is conducted. Subjects will be randomly assigned to wear NaturalVue Sphere single vision contact lenses (SVCL) or NaturalVue Multifocal (NVMF) soft contact lenses for a total of three years.


Eligibility criteria: Inclusion Criteria:

1. Male or female, aged 7 to \<13 (inclusive) at the Screening/Baseline examination.
2. Meet the following refractive criteria determined by cycloplegic autorefraction at Screening/Baseline:

   * Spherical Equivalent Refractive Error (SERE): between -0.75 and -5.00 D inclusive.
   * Astigmatism: ≤ -0.75 D
   * Anisometropia: \< 1.000

Exclusion Criteria:

1. Has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses,
2. Appears to exhibit poor personal hygiene, that, in the Investigator's opinion, might prevent safe contact lens wear.
3. Is currently, or within 30 days prior to this study has been, an active participant in another clinical study.
4. Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, multifocal or specialized contact lenses, or ANY other myopia control treatment.
5. The Investigator for any reason considers that it is not in the best interest of the subject to participate in the study, including if the child is not mature enough to independently handle and care for soft contact lenses.

Primary outcomes:
measure: Change in Refractive Error relative to Baseline
timeFrame: Baseline, 12, 24, 36 months
Secondary outcomes:
measure: Change in Axial Length
timeFrame: Baseline,12, 24, 36 months
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Fig Garden Optometry
state: California
city: Deerfield
country: United States
facility: North Suburban Vision Consultants
state: Illinois
city: New York
country: United States
facility: Cooper Eye Care
state: New York
city: Bellaire
country: United States
facility: Bellaire Family Eye Care
state: Texas
city: Toronto
country: Canada
facility: Toronto Eye Care
state: Ontario
city: Waterloo
country: Canada
facility: University of Waterloo School of Optometry
state: Ontario
city: Tsim Sha Tsui
country: Hong Kong
facility: Hong Kong Polytechnic University
city: Singapore
country: Singapore
facility: Myopia Specialist Centre
Study officials:
affiliation: VTI
name: Ashley Tuan, OD, PhD
role: STUDY_CHAIR
References: