louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04555148: COVIDIG (COVID-19 Hyper-ImmunoGlobulin)
Official title: A Prospective, Open-label, Randomized, Multi-center, Phase 2a Study to Evaluation the Dose Response, Efficacy and Safety of Hyper-Ig (Hyper-immunoglobulin) GC5131 in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2020-09-18
Enrollment: 63
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.


Eligibility criteria: Inclusion Criteria:

* The COVID-19 patient who diagnosed by PCR within 3 days prior to randomized And who is hospitalized with COVID-19 related symptoms
* The subject who has symptoms of COVID-19 within 7 days
* The subject with pneumonia confirmed by imaging diagnosis related to COVID-19 OR a 70-year-old or older OR 60-year-old or older with underlying disease (diabetes or hypertension or obesity or smoker)
* Willing and able to provide written informed consent prior to performing study procedures

Exclusion Criteria:

* asymptomatic patient
* The subject who requiring mechanical ventilation or ECMO
* The subject who are underlying oxygen therapy before affected by COVID-19
* The subject who have received antiviral drugs for other disease within 4 weeks
* History of allergy to IVIG or plasma products
* The subject who received IVIG or convalescent plasma from a person who recovered from COVID-19
* IgA deficiency
* Cretinine \> 2 X ULN
* The subject with a history of thrombosis or high risk of thromboembolism
* The subject with reduced heart function \[NYHA (New York Heart Association) Functional Class III or IV\]; or cerebral cardiovascular disorder or a patient with the medical history (ischemic disease, cardiovascular disease, cerebrovascular disorder, blood vessel disorder, etc.)

Primary outcomes:
measure: Ordinal scale outcome
timeFrame: 7, 14, 21, 28 days
Secondary outcomes:
measure: Viral negative
timeFrame: 1, 3, 5, 7, 10 days
measure: Change in NEWS2 (National Early Warning Score 2)
timeFrame: 7, 14, 21, 28 days
measure: mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00584948: Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome
Official title: Characterization and Treatment of CNS Abnormalities in Premutation Carriers: A Double-Blind Placebo-Controlled Trial of Memantine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fragile X-Associated Tremor/Ataxia Syndrome
Fragile X Premutation Carriers
Keywords: FXTAS, Fragile X Premutation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Forest Laboratories
First posted: 2008-01-02
Enrollment: 94
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if memantine is effective in treating symptoms of Fragile X-associated Tremor Ataxia Syndrome.


Eligibility criteria: Inclusion Criteria:

* Fragile X premutation carrier (CGG repeat 55-200)with neurological symptoms; Clinical FXTAS Stage 1-5

Exclusion Criteria:

* Previous reaction to memantine

Primary outcomes:
measure: Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)
timeFrame: One Year
measure: Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis MIND Institute
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of California, Davis
name: Randi J Hagerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seritan AL, Nguyen DV, Mu Y, Tassone F, Bourgeois JA, Schneider A, Cogswell JB, Cook KR, Leehey MA, Grigsby J, Olichney JM, Adams PE, Legg W, Zhang L, Hagerman PJ, Hagerman RJ. Memantine for fragile X-associated tremor/ataxia syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2014 Mar;75(3):264-71. doi: 10.4088/JCP.13m08546.
Clinical trial NCT05972148: Precision of Complete-arch Digital Implant Impressions With Intraoral Scanning Versus Photogrammetry
Official title: The Accuracy of Intraoral Scanning and Photogrammetry on the Clinical Fit of Long-span Frameworks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Jaw
Keywords: edentulous/edentulism
CAD-CAM
implantology
prosthetic dentistry
clinical studies/trial
clinical outcomes
Lead sponsor: Harvard School of Dental Medicine
Sponsor class: OTHER
Collaborators: name: ITI International Team for Implantology, Switzerland
First posted: 2023-08-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this cross-over clinical trial is to investigate the precision of digital implant impressions using an intraoral scanner and photogrammetry in obtaining complete-arch implant-supported scans.

The main question\[s\] it aims to answer are:

* Is there a difference in precision between intraoral scans and photogrammetry in obtaining digital implant scans?
* Will arch perimeter and jaw type (maxilla vs. mandible) affect the precision results?

Procedures: At each appointment, participants existing permanent/temporary prosthesis or healing caps were unscrewed and temporarily removed for the period of the consultation appointment.

Scanbodies were screwed into their implants for the duration of the appointment.

They underwent two types of digital implant impression procedures (five times each), including intraoral scan and photogrammetry.

Intraoral and extraoral photography were taken.

At the end of each appointment, the scanbodies were removed, and existing bridge/healing caps were reinserted.

The procedures were not painful or required any form of local anesthetic

Comparison group: Researchers compared the precision of intraoral scanning vs. photogrammetry to see which device provided the best precision outcomes.


Eligibility criteria: Inclusion Criteria:

* Present with a completely edentulous arch with at least four implants
* Have bone-level implants
* Intended for restoration with a screw-retained abutment-level fixed implant-supported prosthesis.

Exclusion Criteria:

* Patients unable to tolerate the digital scans impressions
* Presented with implants other than bone-level platforms
* Not intended for restorations with screw-retained abutment-level fixed implant-supported prosthesis
* Not completely edentulous.

Primary outcomes:
measure: To investigate the precision of intraoral scanner compared with photogrammetry in performing complete-arch digital implant impressions
timeFrame: During procedure [two hours]
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Harvard School of Dental Medicine
name: German O Gallucci, DMD
role: STUDY_CHAIR
References:
Clinical trial NCT01791348: The Test-retest Effect of the "d2 Test of Attention".
Official title: The Test-retest Effect of the "d2 Test of Attention" - a Test for Concentration and Performance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition and Attention in Surgeons and Nurses
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The "d2 test of attention" has been used in studies regarding sleep deprivation due to night shifts in hospital staff, in order to determine whether sleep deprivation has an impact on performance. However, by repeating the test there appears to be a test-retest effect, as the participants improve when performing the test more than once. The aim of this study is to determine, whether the "d2 test of attention" has a test-retest effect.

Detailed description: 20 surgeons and 20 surgical nurses will be included in this study. They will be asked, after thorough instruction, to perform the d2 test of attention after a designed schedule. The participants will on day 1 and 2 perform the test 3 times consecutively at intervals of 5 minutes. On day 3, 4 and 5 the test will be repeated only once. After the 5th day follows a 7-day-break. On day 13 the test will again be performed once.

Eligibility criteria: Inclusion Criteria:

- Nurses and surgeons at the department of Surgery, Herlev hospital. Age 22-55 years.

Exclusion Criteria:

* Known sleep disturbances and attentional deficits, previous use of the d2 test of attention, use of central stimulating drugs

Primary outcomes:
measure: Test score for the d2 test of attention
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital, department of surgery
Study officials:
affiliation: Herlev Hospital, department of surgery, Herlev, Denmark
name: Jacon Rosenberg, MD, professor, chief surgeon,
role: STUDY_CHAIR
References:
citation: Niu SF, Chu H, Chen CH, Chung MH, Chang YS, Liao YM, Chou KR. A comparison of the effects of fixed- and rotating-shift schedules on nursing staff attention levels: a randomized trial. Biol Res Nurs. 2013 Oct;15(4):443-50. doi: 10.1177/1099800412445907. Epub 2012 May 15.
citation: Bates ME, Lemay EP Jr. The d2 Test of attention: construct validity and extensions in scoring techniques. J Int Neuropsychol Soc. 2004 May;10(3):392-400. doi: 10.1017/S135561770410307X.
citation: Schlosser K, Maschuw K, Kupietz E, Weyers P, Schneider R, Rothmund M, Hassan I, Bartsch DK. Call-associated acute fatigue in surgical residents--subjective perception or objective fact? A cross-sectional observational study to examine the influence of fatigue on surgical performance. World J Surg. 2012 Oct;36(10):2276-87. doi: 10.1007/s00268-012-1699-5.
Clinical trial NCT01812148: Survival of Peritoneal Mesothelioma After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC)
Official title: Survival of Peritoneal Mesothelioma After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (HIPEC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Mesotheliomas
Keywords: Peritoneal Mesotheliomas
hyperthermic intra-peritoneal chemotherapy (HIPEC)
Oxaliplatin
Cytoreductive surgery
Oxaliplatin HIPEC
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering of peritoneal mesotheliomas undergoing cytoreductive surgery and HIPEC

Brief summary: Review of the investigators hospital experience in cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) for peritoneal mesotheliomas, using Oxaliplatin as intraperitoneal chemotherapeutic agent.

Detailed description: Observation of primary outcome:

* Overall Survival
* Disease-free survival

Influencing factors that will be observe:

* Sex
* Blood loss
* Time of surgery
* Number of resection and anastomosis
* Peritoneal Index (PI score)
* Cytoreductibility (CCR score)

Eligibility criteria: Inclusion Criteria:

* Peritoneal mesothelioma

Exclusion Criteria:

* Non resectable disease

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Disease-Free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Maisonneuve Rosemont Hospital
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Lucas Sideris, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02835248: A Novel System to Detect Falls in Real-life Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Falls
Lead sponsor: BioSensics
Sponsor class: INDUSTRY
Collaborators: name: Brigham and Women's Hospital
name: Spaulding Rehabilitation Hospital
First posted: 2016-07-18
Enrollment: 200
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adult study participants will be recruited from the cohort of participants in the STRIDE Study at the Boston trial site (http://www.stride-study.org/).

Brief summary: Medical alert devices with automatic fall detection functionality use accelerometry to detect a fall and can signal for help if the wearer forgets to, or is incapable of, pressing the alert button. This can save lives and prevent complications associated with long periods of time spent on the floor after a fall. In this project, the sensitivity and false alarm rate of a commercially available medical alert device will be tested in a population of 200 community-dwelling older adults.


Eligibility criteria: Inclusion Criteria:

* Enrolled in the STRIDE Study at the Boston trial site (http://www.stride-study.org/).

Exclusion Criteria:

* Uses a medical alert device

Primary outcomes:
measure: The sensitivity and specificity of ActivePERS fall detection algorithms will be measured by comparing the occurence of falls detected by the wearable device to study participant self reported falls
timeFrame: 2 years
Secondary outcomes:
measure: Near falls as measured by patient self report
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Shalendar Bhasin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BioSensics
name: Joseph T Gwin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01442948: CD16+ Monocytes in Coronary Heart Disease (CHD)
Official title: CD16+ Monocytes in Patients With Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: -CD16+ monocytes
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 1000
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: Patients with angiographically proven coronary heart disease, admitted to the Department of Medicine or Department of Cardiothoracic Surgery of the Martin Luther-University Halle-Wittenberg

Brief summary: Monocytes may be separated into phenotypically and functionally distinct cell types by the presence or absence of the lipopolysaccharide receptor CD14 and the Fcγ-receptor CD16. The investigators hypothesize that the total numbers of CD16+ monocytes are significantly related to cardiovascular outcome in patients with angiographically proven coronary heart disease.


Eligibility criteria: Inclusion Criteria:

* angiographically proven coronary heart disease
* Age \> 18 years

Exclusion Criteria:

* life expectancy \< 12 months
* inability to participate in the trial (to give written informed consent)

Primary outcomes:
measure: Absolute numbers of CD16+ monocytes stratified by tertiles related to the incidence of the combined endpoint
timeFrame: 12 months
Secondary outcomes:
measure: Absolute numbers of CD16+ monocytes stratified by tertiles related to the incidence of each part of the combined endpoint + total death
timeFrame: 12 months
measure: Subgroup analysis for absolute numbers of CD16+ monocytes stratified by tertiles in relation to the combined endpoint
timeFrame: 12 months
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: University Clinic of the Martin Luther-University Halle-Wittenberg
state: Please Select
Study officials:
References:
Clinical trial NCT01506648: Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food
Official title: Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food, Consumed by Young Children Immediately After the Addition of the Enzyme Phytase. A Randomized Single Blind Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bioavailability
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2012-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Study not related to a disease. Nutrition study without drug drug administration. Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young children immediately after the addition of the enzyme phytase. A randomized single blind study

Brief summary: Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young children immediately after the addition of the enzyme phytase. A randomized single blind study


Eligibility criteria: Inclusion Criteria:

1. 12-24 month old
2. Male of female
3. Height and weight between -2.0 SD and +2.0 SD with respect to WHO child growth standards.
4. No mineral and vitamin supplements 2 weeks prior to the study and during the whole duration of the study

Exclusion Criteria:

1. Body temperature ≥ 37.5°C
2. Hemoglobin ≤ 7g/dL
3. Positive RDT test
4. Any metabolic, gastrointestinal or chronic disease (according to the statement of the subject's parent) known chronic diseases at the gastrointestinal tract)
5. Long term mediation (that may affect zinc metabolism) during the whole study to interact with zinc metabolism (such as kidney diseases or

Primary outcomes:
measure: Fractional absorption of zinc
timeFrame: 33 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: CHU-Yalgado Ouédraogo, Service Pédiatrie
Study officials:
References:
Clinical trial NCT00513448: Promoting Physical Activity for Persons With Multiple Sclerosis
Official title: Comparing Individualized Rehabilitation to a Group Wellness Intervention for Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Chronic Disabling Condition
Comparative Evaluation
Physical Activity
Physical Therapy
Rehabilitation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2007-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to determine whether a group wellness intervention or individualized physical rehabilitation was more effective in improving health and physical activity in persons with multiple sclerosis.

Detailed description: Evidence from this study shows that both interventions were effective in improving health and physical activity in persons with multiple sclerosis. The results also show that participants may benefit more physically from individualized physical rehabilitation and more mentally from group wellness interventions. Interventions that combine individualized therapeutic exercise with group health education might be most effective for persons with multiple sclerosis.

Eligibility criteria: Inclusion Criteria:

* A physician-confirmed diagnosis of MS
* Between the ages of 18 to 75 years
* Ability to ambulate 25 meters with or without the use of an adaptive aide

Exclusion Criteria:

* Pregnant
* Cardiovascular disease
* Had fallen more than twice in the past month
* Significant cognitive deficits

Primary outcomes:
measure: Modified Fatigue Impact Scale SF-36 Mental Health Inventory
timeFrame: 16 weeks
Secondary outcomes:
measure: Physical assessments
timeFrame: 16-weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Brown University
name: Matthew A Plow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04572048: Longitudinal One Year Vs Single Day NRP Training.
Official title: Longitudinal One Year Vs Single Day NRP Training: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nurse Training in Neonatal Resuscitation
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The Neonatal Resuscitation Program (NRP) recommends providers renew their certification every 2 years. However, many Neonatal Intensive Care Units (NICUs) in Canada face challenges of significant budget cuts in training and a large number of caregivers to train with a high turnover rate. This situation makes it difficult for managers and nurse educators to ensure up-to-date certification and competence for all clinical staff. In addition, considering that only 0.1% of newborns will require cardiac massage and/or epinephrine, health care professionals' exposure to critical events is low to insure maintenance of expertise. Furthermore, it is shown that there is a significant decrease in knowledge among learners who have undergone specific training after only 3 months. This is worrisome considering that some nurses will not renew their certification if the course is not paid for by the employer, or if they are not released from clinical duties to attend. While keeping in mind the various required components of NRP training: book reading, online exam, performance stations, Integrated Skills Station Assessment (ISSA) and simulations, we would like to assess the educational and financial impact of a new educational strategy developed as to allow more nurses to be retrained thus ensuring maintenance of their neonatal resuscitation expertise.


Eligibility criteria: Inclusion Criteria:

* Newly recruited ( in the last 3 months) neonatal and delivery room registered nurses from level 2 and 3 perinatal centers

Exclusion Criteria:

* Registered nurses that have already completed a NRP training in the past.

Primary outcomes:
measure: Knowledge
timeFrame: 1 year
Secondary outcomes:
measure: Confidence and behavior
timeFrame: 1 year
measure: Cost-efficiency
timeFrame: 1 year
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Cité de la santé de Laval
state: Quebec
city: Montreal
country: Canada
facility: University of Montreal Health Center
state: Quebec
city: Montréal
country: Canada
facility: CHU Sainte-Justine, Dept Neonatology
state: Quebec
city: Québec
country: Canada
facility: CHUL
state: Quebec
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
city: Repentigny
country: Canada
facility: Pierre-Legardeur
Study officials:
References: