louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01313481: Effect of the Otago Programme Delivered as Home Exercise or Group Exercise
Official title: A Randomized Controlled Trial of the Effect of Otago Exercise Delivered as Home Exercise or Group Exercise in Fall-prone Older Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Distorted Balance
Keywords: Older persons
Exercise
Balance
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2011-03-11
Enrollment: 125
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to assess the effect on functional balance of Otago exercise performed as home exercise versus group exercise. The investigators hypothesize that Otago exercise is more effective performed as group exercise than home exercise.

Detailed description: The study sample is drawn from persons referred to a falls outpatient clinic. Group exercise and home exercise are delivered by trained physiotherapists. Home exercise follows the original Otago exercise protocol. Group exercise is performed twice a week. The length of the intervention period is 3 months. The main outcome measure is the Berg Balance Scale.

Eligibility criteria: Inclusion Criteria:

* referred to an outpatient falls clinic
* have fallen previous year or have gait or balance problems

Exclusion Criteria:

* Mini Mental Status Examination (MMSE) \< 22
* Not able to walk 10 m without support from another person

Primary outcomes:
measure: Functional Balance by use of the Berg Balance Scale
timeFrame: 3 months
Secondary outcomes:
measure: Fear of falling by the Fall Efficacy Scale International (FES-I), 7 item version
timeFrame: 3 and 6 months
measure: Mobility by the Timed Get up-and-go
timeFrame: 3 and 6 months
measure: Functional leg muscle strength by a Sit-to-stand test
timeFrame: 3 and 6 months
measure: Health related quality of life by the Short Formular 36 (SF-36)
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Tonsberg
country: Norway
facility: Vestfold hospital
state: Vestfold
Study officials:
affiliation: Norwegian University of Science and Technology
name: Jorunn L Helbostad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kyrdalen IL, Moen K, Roysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11.
Clinical trial NCT03228381: The BOSS Study: An Acute Evaluation of Anatomical and Geometric Changes Using the Bladder on a Stick System (BOSS)
Official title: An Acute Evaluation of Anatomical and Geometric Changes Using the Bladder on a Stick System (BOSS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Mitral Regurgitation
Heart Failure
Keywords: Functional Mitral Regurgitation
Heart Failure
Lead sponsor: Mardil Medical
Sponsor class: INDUSTRY
First posted: 2017-07-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of the BOSS Study is to assess acute anatomical and geometric annular and ventricular changes that occur when strategically positioned an external inflatable chambers are applied to the outside of the heart.

Detailed description: Mardil Medical is developing an investigational device for functional mitral regurgitation intended to provide ventricular support with adjustable inflatable chambers to reduce annular dilation, correct papillary muscle displacement, and restore mitral valve leaflet coaptation. In doing so, Mardil Medical is interested in exploring the anatomical and geometric annular and ventricular changes that occur when strategically positioned external inflatable chambers are applied to the outside of the heart. Favorable benefits of circumferential reduction in ventricular wall stress favoring left ventricular (LV) remodeling and acute reshaping of LV segments subtending the deformed mitral valve apparatus needs to be better understood. Mardil Medical is pursuing this study as an initial phase in the Acute Evaluation of Anatomical and Geometric Changes using the Bladder on a Stick System (BOSS).

Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years of age
* Patient undergoing open chest cardiac surgery via sternotomy
* Signed informed consent by patient or legally authorized representative

Exclusion Criteria:

* Any procedure, condition or cardiac anatomy that may impact or compromise the pericardial space (e.g. prior valve surgery, CABG, epicardial pacing leads, pericarditis, history of mantle radiation, or other procedure involving pericardial access)

Primary outcomes:
measure: Acute anatomical changes assessed by echocardiography
timeFrame: At Procedure
measure: Acute geometric changes measured by echocardiography
timeFrame: At Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute at Abbott Northwestern Hospital
state: Minnesota
city: Asuncion
country: Paraguay
facility: Sanatorio Italiano
Study officials:
affiliation: Mardil Medical
name: Sarah Hase
role: STUDY_DIRECTOR
References:
Clinical trial NCT05258981: The Relationship Between Brain MRI Phenotypes, Genes and Cognitive Outcome in CHD Adults
Official title: Exploring the Relationship Between Advanced Multimodal Brain MRI Phenotypes, Genes and Cognitive Outcome in Adults With CHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 225
Sex: ALL
Minimum age (years): 24
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main purpose of this proposal is to perform novel MRI analyses to determine the brain organizational changes associated with altered executive function and the modulating role of variants in neuroresilience and hypoxia response genes in adults with d-transposition of the great arteries (d-TGA).

Detailed description: Aim 1 is structured to determine the relationship between sulcal patterns(measured by MRI) and executive function in adults with d-TGA and if this relationship is modified by (a) presence of neuroresilience gene ApoE ε2 or ε4 alleles, or (b) damaging variants in hypoxia response genes.

Aim 2 is designed to determine the relationship between structural connectivity using rich club (measured by MRI) and executive function in adults with d-TGA and if this relationship is modified by (a) presence of neuroresilience gene ApoE ε2 or ε4 alleles or (b) damaging variants in hypoxia response genes.

In Aim 3, the investigators will determine the relationship between functional connectivity using rich club (measured by MRI) and executive function in adults with d-TGA and if this relationship is modified by (a) presence of neuroresilience gene ApoE ε2or ε4 alleles or (b) damaging variants in hypoxia response genes.

Eligibility criteria: Inclusion Criteria:

* Persons who participated in the Boston circulatory arrest, pH and Hematocrit studies at Boston Childrens Hospital as children (n\~300).
* Normally-developed age- and sex-matched young adults who are able to provide informed consent to undergo the MRI portion of the study and limited neuropsychological evaluation (IQ assessment as well as neuropsychological tests for which normative references are not available).

Exclusion Criteria:

* For controls - inability to complete the MRI (implanted metal, claustrophobia, personal history of mental illness, brain injury, prior brain intervention).
* Intellectual impairment precluding completion of the study questionnaires independently
* Unable to speak and read English fluently

Primary outcomes:
measure: Delis-Kaplan Executive Function Scale (D-KEFS) composite score;
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT04133181: Guided Versus Conventional Periapical Endodontic Surgery
Official title: Clinical and Radiographic Success of Guided Versus Conventional Periapical Endodontic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endodontic Disease
Endodontic Re-treatment Failure
Keywords: Endodontic surgery
Guided surgery
3D guide
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery.

Detailed description: The aim of this study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery. Patients having mandibular posterior teeth indicated for endodontic surgery will be selected. Full medical and dental history will be obtained from all patients. Patients will be randomly assigned to either guided endodontic surgery or conventional endodontic surgery. Surgical procedures will be done under magnification. Root-end cavities will be filled using MTA.Post surgical instrucions will be given to patients. Surgical time will be recorded. Clinical and radiographic success will be asses at 6 and 12 month.

Eligibility criteria: Inclusion Criteria:

1. Patients in good general health.
2. Patients with age ranging between 18-50 years with no sex predilection.
3. Posterior teeth with an indication for endodontic surgery.
4. Patients' acceptance to participate in the study.

Exclusion Criteria:

1. Patients with allergy to materials or medications used in the trial.
2. Pregnant female patients.
3. Teeth with pathoses associated with vertical root fracture.
4. Severe periodontal bone loss detected with a periodontal probe (5 mm probing depth).

Primary outcomes:
measure: Clinical success
timeFrame: 1 year
measure: Radio graphic Success
timeFrame: 1 year
Secondary outcomes:
measure: Time of surgery
timeFrame: During surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Anderson J, Wealleans J, Ray J. Endodontic applications of 3D printing. Int Endod J. 2018 Sep;51(9):1005-1018. doi: 10.1111/iej.12917. Epub 2018 Mar 23.
citation: Strbac GD, Schnappauf A, Giannis K, Moritz A, Ulm C. Guided Modern Endodontic Surgery: A Novel Approach for Guided Osteotomy and Root Resection. J Endod. 2017 Mar;43(3):496-501. doi: 10.1016/j.joen.2016.11.001. Epub 2017 Jan 28.
citation: Ahn SY, Kim NH, Kim S, Karabucak B, Kim E. Computer-aided Design/Computer-aided Manufacturing-guided Endodontic Surgery: Guided Osteotomy and Apex Localization in a Mandibular Molar with a Thick Buccal Bone Plate. J Endod. 2018 Apr;44(4):665-670. doi: 10.1016/j.joen.2017.12.009. Epub 2018 Jan 19.
Clinical trial NCT00226681: Nurses Helping Sudden Cardiac Arrest Survivors Recover After Getting An Implantable Cardioverter Defibrillator (ICD)
Official title: Nursing Interventions Following Sudden Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sudden Cardiac Arrest
Lead sponsor: National Institute of Nursing Research (NINR)
Sponsor class: NIH
First posted: 2005-09-27
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD

Detailed description: This study is one of the first large randomized clinical trials of nursing interventions aimed at improving health outcomes after receiving an ICD. Written informed consent was used in the study.

Eligibility criteria: Inclusion Criteria:

* First time sudden cardiac arrest with ICD implantation during hospitalization, over age 21 years, working telephone in the home, deliverable address for 1 year

Exclusion Criteria:

* Receiving an ICD for primary prevention of sudden cardiac arrest, inability to read, speak, or understand English, no telephone at home or no current address, cognitive or physical impairments that prohibited ability to give informed consent.

Primary outcomes:
measure: To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD
timeFrame: Baseline, 1- and 3-months from implantation
Secondary outcomes:
measure: Improved physical functioning
timeFrame: Baseline, 1- and 3-months from implantation
measure: Improved psychological adjustment
timeFrame: Baseline, 1- and 3-months from implantation
measure: Improved self-efficacy
timeFrame: Baseline, 1- and 3-months from implantation
measure: Lower health care use
timeFrame: Baseline, 1- and 3-months from implantation
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Cynthia Dougherty, ARNP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dougherty CM, Lewis FM, Thompson EA, Baer JD, Kim W. Short-term efficacy of a telephone intervention by expert nurses after an implantable cardioverter defibrillator. Pacing Clin Electrophysiol. 2004 Dec;27(12):1594-602. doi: 10.1111/j.1540-8159.2004.00691.x.
Clinical trial NCT01249781: The Related Factors With Resilience in Caregivers Whose Child With Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Condition 1. Children With ALL Are Still Alive and the Age of 18 Years of Age.
Condition 2. Has Been Completed to Guide the Treatment Regimen Were in Remission.
Condition 3. Caregiver Can or Taiwanese Language Communicator.
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families of children was diagnosed acute lymphoblastic leukemia

Brief summary: The purpose of this study was to explore caregivers stress, family functioning, social support and family resilience of families whose children had acute lymphoblastic leukemia. The significantly correlation among caregivers stress, family functioning, social support and family resilience was also explored.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed as acute lymphoblastic leukemia children, children with cancer are still alive and the age of 18 years of age.
2. Has been completed to guide the treatment regimen were in remission.
3. Caregiver can or Taiwanese language communicator.

Exclusion Criteria:

- Children with metastatic cancer who end chemical treatment of more than one year

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: No.2 Yuh Der Road
Study officials:
References:
Clinical trial NCT04642781: Measurement of Eye Movements While Reading a German Text
Official title: Measurement of Eye Movements While Reading a German Text
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Children
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 127
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children recruited from 4 primary schools in German speaking Switzerland

Brief summary: To establish normative value for reading parameters in healthy children of primary school age and in grades 2-5.

Detailed description: Following initial assessment of feasibility, recruitment is expanded to children attending grades 2-5 recruited from 4 different primary schools in German speaking Switzerland. Two texts of The New International Reading Speed Test (IReST) of similar difficulty are presented on a laptop in randomized order. Children are asked to read the text aloud while eye movements are recorded with an eye tracking bar. The following parameters are analysed: reading speed (words/minute), number of saccades, number of fixations.

Eligibility criteria: Inclusion Criteria:

* 8-13 years
* child consent
* parental consent

Exclusion Criteria:

* unability to read

Primary outcomes:
measure: Reading speed
timeFrame: 21 months
measure: number of saccades and fixations
timeFrame: 21 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Basel, University Eye Hospital Basel
Study officials:
affiliation: University Basel, University Eye Hospital Basel
name: Anja M Palmowski-Wolfe, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wertli J, Schotzau A, Trauzettel-Klosinski S, Palmowski-Wolfe A. Feasibility of Eye Movement Recordings with the SMI Tracking Bar in 10- to 11-Year-Old Children Performing a Reading Task. Klin Monbl Augenheilkd. 2020 Apr;237(4):510-516. doi: 10.1055/a-1101-9204. Epub 2020 Apr 24.
citation: Wertli J, Schotzau A, Palmowski-Wolfe A. The Influence of Age on Eye Movements during Reading in Early Elementary School Children. Klin Monbl Augenheilkd. 2023 Apr;240(4):591-598. doi: 10.1055/a-2045-7271. Epub 2023 Apr 25.
Clinical trial NCT06032481: System to Evaluate the Risk of Lymph Node Metastasis Preoperatively in Cervical Cancer
Official title: Preoperative Scoring System to Predict the Risk of Lymph Node Metastasis in Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Lead sponsor: Fujian Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 426
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 426 patients with cervical cancer who underwent radical resection in China were recruited

Brief summary: The lymph node status is difficult to be assessed preoperatively, this study aimed to develop a scoring system for predicting the risk of LNM in cervical cancer patients before operation.

Detailed description: Lymph nodes metastasis (LNM) was proved to be a critical risk factor related to the survival to cervical cancer survival. However, preoperative pelvic magnetic resonance imaging (MR) or computed tomography (CT) tests are less sensitive to assess the risk of lymph node metastasis. PET-CT is too expensive and radiative to be widely used in clinical practice. A model was constructed based on clinical indicators to predict lymph node metastasis preoperatively, providing a reference for clinical treatment.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cervical cancer
* FIGO stage IB1-IIA1
* Undergone radical hysterectomy with pelvic lymphadenectomy
* Peformed pelvic MRI examination preoperatively

Exclusion Criteria:

* Had distant metastases diagnosed before or during the surgery
* Underwent neoadjuvant radiotherapy preoperatively
* Underwent neoadjuvant chemotherapy preoperatively
* Incomplete or inaccuratemedical records

Primary outcomes:
measure: Overall survival
timeFrame: 60 months
Secondary outcomes:
measure: Risk factors influenced LNM
timeFrame: 60 months
measure: The accuracy of the model
timeFrame: 60 months
Other outcomes:
Locations:
Study officials:
affiliation: Fujian Maternity and Child Health Hospital
name: Pengming Sun, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03319381: Geriatric Polytrauma SOP
Official title: Implementation of New Standard Operating Procedures for Geriatric Trauma Patients With Multiple Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geriatrics
Keywords: Algorithm
In-hospital mortality
Multiple trauma
Standard of care
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 311
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma patients admitted via the resuscitation room with need for intensive care treatment after the resuscitation room phase were included in the internal trauma database

Brief summary: This study investigated whether there were improvements in the in-hospital mortality, infection rate, and rate of palliative care among geriatric trauma patients after the implementation of new standard operating procedures (SOPs) for the resuscitation room. These new SOPs, comprising early whole-body computed tomography (CT), damage control surgery, and the use of goal-directed coagulation management, were designed for severely injured adult trauma patients

Detailed description: This study involved the analysis of a prospective single-centre database. Patients admitted via the resuscitation room with need for intensive care treatment after the resuscitation room phase were included and compared before the implementation of the new SOPs (between 1 January, 2000 and 31 December, 2006) and after their implementation in 2009 (between 1 January, 2010 and 31 December, 2012) of our level-I trauma centre.

Eligibility criteria: Inclusion Criteria:

Inclusion in internal trauma database

Exclusion Criteria:

Comprised age \< 65 years, ISS \< 9, and transfers from other hospitals.

Primary outcomes:
measure: In-hospital mortality
timeFrame: 30 days
Secondary outcomes:
measure: Infections
timeFrame: 30 days
measure: Rate of palliative care
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
citation: Peterer L, Ossendorf C, Jensen KO, Osterhoff G, Mica L, Seifert B, Werner CML, Simmen HP, Pape HC, Sprengel K. Implementation of new standard operating procedures for geriatric trauma patients with multiple injuries: a single level I trauma centre study. BMC Geriatr. 2019 Dec 19;19(1):359. doi: 10.1186/s12877-019-1380-z.