louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00279838: Computer Assisted Total Knee Replacement
Official title: Computer Assisted Navigation in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Osteoarthritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2006-01-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intraoperative computer-assisted navigation improves prosthetic implant positioning as compared to conventional intraoperatve instrumentation in Total Knee Arthroplasty (TKA).

Detailed description: Primary data to be obtained is to determine whether mechanical axis of the limb malignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation.

Three months after surgery follow-up radiographic data will provide evidence on the initial implant position as determined with a series of x-rays including: full length standing, standard AP weight bearing, lateral, patellar, kneelingfilm views and CT evaluation. In addition, a correlation betweeen the CT measures and the kneeling x-ray can be performed at this time. Clinical (Knee Scale Society, WOMAC, and SF-36) data will also be obtained at the three month interval.

Eligibility criteria: Study participants must:

1. Be over 18 years of age.
2. Require a TKA and is considered by the investigator to be a suitable candidate for the specific knee prosthesis identified in protocol.
3. The subject has given consent to the transfer of his/her information to the sponsor.

Primary outcomes:
measure: To determine whether mechanical axis of the limb malalignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation
Secondary outcomes:
measure: To compare the frontal alignment of the femoral and tibial components from full length standing radiographs
measure: To compare sagittal alignment of the femoral and tibial components from lateral radiographs
measure: To compare the rotation of the femoral and tibial components from CT Scan.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Mary I. O'Connor, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04241055: Values Affirmation to Improve Teachers' Outcomes
Official title: Can a Values Affirmation Improve the Classroom Outcomes and Well-being of K-12 Teachers?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psychological
Lead sponsor: Wake Forest University
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Relay Graduate School of Education
First posted: 2020-01-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this project is to examine whether a values affirmation intervention improves teacher-student relationships, classroom performance, and well-being of first-year teachers.


Eligibility criteria: Inclusion Criteria:

* Must be teachers (current or prospective) affiliated with the Relay Graduate School of Education in the targeted classes/programs
* Must consent to participate and begin the experimental (values affirmation or control) exercise

Exclusion Criteria:

* None

Note: Our primary hypotheses focus on the effects of values affirmation for first-year teachers, particularly White first-year teachers at majority minority schools. Participants who are not White first-year teachers will be permitted in the study, but will not be included in confirmatory analyses.

Primary outcomes:
measure: Student-teacher relationships
timeFrame: Approximately 6 months post-intervention
measure: Teacher well-being
timeFrame: Approximately 6 months post-intervention
measure: Classroom Assessment Scoring System (CLASS) - "Instructional Support" dimension
timeFrame: Approximately 6 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University (via online survey tool)
state: North Carolina
Study officials:
References:
Clinical trial NCT03835455: Acceptability and Feasibility of Finger Foods
Official title: A Mixed Methods Study to Determine the Acceptability and Feasibility of Providing Finger Foods as Nutritional Support for Patients After Stroke in Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Keywords: Finger food
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 31
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: On stroke rehabilitation ward

Brief summary: This study will investigate the feasibility of using a finger food menu on an acute stroke rehabilitation ward. This study has a mixed methods design, with quantitative, qualitative and economic components which will be used to inform a future randomised control trial.


Eligibility criteria: Inclusion Criteria:

* Current patient on stroke rehabilitation ward
* 65 years or older
* Normal textured food

Exclusion Criteria:

* On the end of life pathway
* Partial or full enteral feeding
* Significant food allergies, intolerances or other dietary restrictions that could not be catered for by the finger food menu.
* Unable to give consent or no consultee able to consent on behalf of patient
* In a side room on the ward

Primary outcomes:
measure: Eligibility rate
timeFrame: 6 months
measure: Recruitment rate
timeFrame: 6 months
measure: Attrition rate
timeFrame: 6 months
Secondary outcomes:
measure: Dietary intake of participants over 3 mealtimes
timeFrame: 3 mealtimes
measure: Costs of implementing a finger food menu
timeFrame: 6 months
measure: Fidelity of intervention
timeFrame: 6 months
Other outcomes:
measure: Patient experience
timeFrame: 6 months
measure: Staff experience
timeFrame: 6 months
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS trust
Study officials:
affiliation: University of Southampton
name: Milly Heelan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06292455: Association of Anthropometrics With Grip Strength and Smash Quality Post Six Week Elastic Resistance Training
Official title: Association of Hand and Forearm Anthropometrics With Grip Strength and Forehand Smash Quality Following Six-week Elastic Resistance Training in Collegiate Badminton Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anthropometric Measurements and Elastic Resistance Training
Sports Physical Therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To determine the association of hand and forearm anthropometrics on grip strength and forehand smash quality of badminton players after six-weeks of elastic resistance training.

Detailed description: As literature suggests that anthropometrics such as BMI and height do affect many game outcomes but specific anthropometrics have not been considered before so it is included in this study. Similarly the affects of elastic resistance training for lower limb has been recorded while the literature lacks for upper limb.

Eligibility criteria: Inclusion Criteria:

* collegiate players of Badminton.
* Players attending at least two training sessions per week for the past one month

Exclusion Criteria:

* Players having strain or sprain of upper or lower limb within the last months
* Payers having any cardiovascular, neuromusculoskeletal or other systematic pathology.

Primary outcomes:
measure: Smash quality (Power)
timeFrame: BAseline to six-week
measure: Smash quality (Speed)
timeFrame: BAseline to six-week
measure: Smash quality (Distance)
timeFrame: BAseline to six-week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah international University
state: ICT
Study officials:
affiliation: Riphah International University
name: Waqar Ahmad Awan, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01806155: Prevalence of Post-craniotomy Headache in Siriraj Hospital
Official title: Prevalence of Post-craniotomy Headache in Siriraj Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adult Brain Tumor
Headache
Keywords: craniotomy
headache
postoperative
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-03-07
Enrollment: 200
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: Patient undergoing major craniotomy

Brief summary: Headache after major craniotomy may be a problem in taking care of the patients. The investigators want to identify the incidence of headache after major craniotomy and also the risk factors.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing major craniotomy

Exclusion Criteria:

* emergency surgery or traumatic patients
* may need postoperative ventilatory support more than 2 days
* cannot communicate
* psychiatric patients
* chronic use of benzodiazepine or drug abuse
* cannot follow the treatment

Primary outcomes:
measure: The incidence of headache after major craniotomy
timeFrame: 3 months
Secondary outcomes:
measure: risk factors of headache after major craniotomy such as sex, education
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
References:
Clinical trial NCT05221255: Effect of Spinal Magnetic Stimulation on Management of Functional Constipation in Adults
Official title: Effect of Spinal Magnetic Stimulation on Management of Functional Constipation in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Keywords: spinal magnetic stimulation, constipation
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: interventional prospective trial
Primary purpose: TREATMENT

Brief summary: conservative management of functional constipation is a preferable method including biofeedback and spinal magnetic stimulation sessions

Detailed description: Constipation varies in presentation and severity among patients and affects patients' quality of life of varied degrees depending on how it manifests and how severe it is. The prevalence of constipation in the general population is estimated to affect about 20% of the population

Spinal Magnetic Stimulation (SMS) is a non-invasive, painless neurophysiological treatment that uses extracorporeal magnetic stimulation to direct extracorporeal magnetic stimulation to the spinal nerves and deep muscles to aid bowl evacuation without the use of surgery. This noninvasive approach was created to help with micturition, expiration, and bowel function

The aim of this work is to study the efficacy of SMS and biofeedback versus biofeedback in the management of functional constipation.

Eligibility criteria: Inclusion Criteria:

* adults patients diagnosed by Rome IV criteria as having functional constipation

Exclusion Criteria:

* Patients younger than 18 years old.
* Patients with irritable bowel syndrome.
* Anal hemorrhoids or bleeding.
* Any condition that may complicate bowel problems, such as Parkinson's disease, stroke, or traumatic brain injury.

Primary outcomes:
measure: Number of weekly bowel movement
timeFrame: after 15 days
measure: The Bristol Stool Scale (from 1 to 5)
timeFrame: After 15 days
measure: Numerical rating scale (from 0 to 10)
timeFrame: After 15 days
measure: Patient Assessment of Constipation Quality of Life questionnaire
timeFrame: After 15 days
measure: pressure manometry
timeFrame: After 15 days
Secondary outcomes:
measure: Number of weekly bowel movement
timeFrame: after one month
measure: The Bristol Stool Scale (from 1 to 5)
timeFrame: After one month
measure: Numerical rating scale (from 0 to 10)
timeFrame: After one month
measure: Patient Assessment of Constipation Quality of Life questionnaire
timeFrame: After one month
measure: Pressure manometry
timeFrame: After one month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Nehad ElShatby
Study officials:
affiliation: Alexandria University
name: Nehad ElShatby, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01825655: Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching
Official title: Effect of Long Acting Antihistamine on Opioid- Induced Pruritus: A Double-blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pruritus
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 3
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is determine if long acting antihistamine like cetirizine can help with itching induced by opioid pain medications.


Eligibility criteria: Inclusion Criteria:

* Children age 6-18yrs on opioids who develop pruritus and are willing to participate in the study

Exclusion Criteria:

* Children with history of chronic urticaria
* Children with other chronic pruritic condition like eczema, contact dermatitis, psoriasis
* Children with known hypersensitivity to cetirizine/zyrtec
* Children on H1 antihistamine like diphenhydramine, hydroxyzine, cetirizine, loratadine, fexofenadine, chlorpheniramine within the last 7days prior to randomization
* Children who have received Ondansetron within 24hrs prior to randomization
* Children who are on Tricyclic antidepressants
* Children who are unwilling or unable to swallow the capsule.
* Children with chronic liver or kidney disease

Primary outcomes:
measure: Change in Itch Score
timeFrame: Baseline to 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Children's Hospital of Richmond at VCU
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Santhosh Kumar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03006055: The Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Circulating Tumor Cells.Breast
Lead sponsor: Beijing Viroad Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-30
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE approved. Application data of CellCollector in China is not available now. The purpose of this clinical trial is to confirm the validation and safety of CellCollector in Chinese patients.


Eligibility criteria: Inclusion Criteria:

* Metastasis breast cancer confirmed with imaging examination
* Have agreed to undergo CTC analysis in vivo;
* ECOG：0-2

Exclusion Criteria:

* Non-metastasis breast cancer

Primary outcomes:
measure: Validation of CellCollector
timeFrame: 6 month
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: The 307th Hospital of Chinese People's Liberation Army
state: Beijing
Study officials:
References:
Clinical trial NCT05539755: Outcome Indicators of Non-surgical Therapy of Peri-implantitis
Official title: Outcome Indicators of Non-surgical Therapy of Peri-implantitis: a 6-months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Infections
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives: To identify patient and implant indicators influencing the non-surgical therapeutic outcomes of peri-implantitis at 6-months follow-up.

Material and methods: This prospective cohort study included patients with at least one implant diagnosed with peri-implantitis according to the 2017 World Workshop. Non-surgical therapy consisted in a mechanical debridement of the peri-implant pockets combined with the metronidazole 500 mg every 8 hours during 7 days. At baseline and at 6 months, clinical and radiographic variables were collected to calculate the success of the therapy. The influence of patient and implant/prosthetic variables on disease resolution were assessed trough simple and multiple logistic regression analysis at patient and implant level using generalized estimation equations models.


Eligibility criteria: Inclusion Criteria:

* Subjects over 18 years old
* At least one implant in function for more than 1 year diagnosed with peri-implantitis following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018).

Exclusion Criteria:

* Previous surgical therapy of peri-implantitis
* Allergy to metronidazole
* Clinical implant mobility
* Pregnancy or lactating females
* Previous non-surgical treatment (i.e., submucosal debridement) of the affected implants at least 12 months before
* Use of systemic antibiotics during the previous 3 months as well as use of systemic antibiotics for endocarditis prophylaxis,
* Systemic diseases, medications, or conditions that may compromise wound healing and influence the outcome of the therapy.

Primary outcomes:
measure: Disease resolution
timeFrame: 6 months
Secondary outcomes:
measure: Changes in PPD
timeFrame: From baseline to 6 months
measure: Changes in Bleeding on probing (BoP)
timeFrame: From baseline to 6 months
measure: Changes in Suppuration on probing (BoP)
timeFrame: From baseline to 6 months
measure: Changes in soft tissue margin
timeFrame: From baseline to 6 months
measure: Changes
timeFrame: From baseline to 6 months
measure: Plaque index (PI)
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universitat Internacional de Catalunya
state: Catalonia
Study officials:
References:
Clinical trial NCT01531855: Post-exercise Insulin Reductions in Type 1 Diabetes
Official title: The Metabolic and Glycaemic Responses to Reductions in Rapid-acting Insulin Dose After Running Exercise in People With Type 1 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: T1DM, Exercise
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Diabetes UK
First posted: 2012-02-13
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators hypothesise that reducing rapid-acting insulin dose after exercise will help prevent Type 1 diabetes individuals experiencing hypoglycaemia.


Eligibility criteria: Inclusion Criteria:

* T1DM,
* Male,
* basal-bolus regimen (insulin glargine / detemir with insulin lispro / aspart),
* HbA1c \< 9.9%,
* aged 18-50.

Exclusion Criteria:

* HbA1c \> 10%,
* not treated with basal-bolus (insulin glargine / detemir with insulin lispro / aspart),
* aged \<18 \> 50.

Primary outcomes:
measure: 24 hour blood glucose area under the curve
timeFrame: 24 hours
Secondary outcomes:
measure: Ketogenesis
timeFrame: 60 minutes before and 24 hours post-exercise
Other outcomes:
Locations:
city: Newcaslte upon Tyne
country: United Kingdom
facility: Clinical Research Facility
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Daniel J West
role: PRINCIPAL_INVESTIGATOR
References:
citation: West DJ, Morton RD, Bain SC, Stephens JW, Bracken RM. Blood glucose responses to reductions in pre-exercise rapid-acting insulin for 24 h after running in individuals with type 1 diabetes. J Sports Sci. 2010 May;28(7):781-8. doi: 10.1080/02640411003734093.
citation: Campbell MD, Walker M, Trenell MI, Luzio S, Dunseath G, Tuner D, Bracken RM, Bain SC, Russell M, Stevenson EJ, West DJ. Metabolic implications when employing heavy pre- and post-exercise rapid-acting insulin reductions to prevent hypoglycaemia in type 1 diabetes patients: a randomised clinical trial. PLoS One. 2014 May 23;9(5):e97143. doi: 10.1371/journal.pone.0097143. eCollection 2014.
citation: Campbell MD, Walker M, Trenell MI, Jakovljevic DG, Stevenson EJ, Bracken RM, Bain SC, West DJ. Large pre- and postexercise rapid-acting insulin reductions preserve glycemia and prevent early- but not late-onset hypoglycemia in patients with type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2217-24. doi: 10.2337/dc12-2467. Epub 2013 Mar 20.
Clinical trial NCT06374355: Semibranch Registry - Retrospective
Official title: Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Retrospective, Multicentre Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Aneurysm
Endovascular Aortic Repair
Stent-Graft Endoleak
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pararenal or thoracoabdominal aortic pathology, who are treated with a endovascular semibranch stentgraft

Brief summary: The goal of this registry is to evaluate the semibranch in branched endovascular arotic repair, which is a new tool in endovascular branched aortic repair.

Detailed description: The main question it aims to answer are:

* Patency of the semibranch
* Feasibility of the technique regarding cannulation and stentgrafting

Eligibility criteria: * Patient has been treated with the semibranch stentgraft
* Patient is over 18 years old

Primary outcomes:
measure: Freedom from target vessel instability
timeFrame: 30 days after intervention
measure: Mortality
timeFrame: 30 days after intervention
measure: Technical success
timeFrame: 12 hours after intervention
Secondary outcomes:
measure: Morbidity
timeFrame: During follow up period (up to 3 years)
measure: Freedom of Endoleak type I and III
timeFrame: During follow up period (up to 3 years)
measure: Long term mortality
timeFrame: During follow up period (up to 3 years)
measure: Branch patency
timeFrame: During follow up period (up to 3 years)
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Muenster University Hospital
Study officials:
References: