louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05373641: Effect of Repeated Feedback to Registered Nurses Pain Nursing Documentation
Official title: Effect of Repeated Feedback to RNs' Pain Nursing Documentation: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Nurse's Role
Pain
Keywords: RN
Pain nursing
Pain assessment
Pain management
Pain documentation
Audit and feedback
Education
Randomized Controlled Trial
Nursing sensitive quality
Nursing sensitive outcomes
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2022-05-13
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Units serve as a statistical units. Number of units 30, number of individual participants 800-1000.
Primary purpose: OTHER

Brief summary: The aim of the study is to find out how pain nursing documentation audit and educational feedback effect to RN's pain nursing documentation, the average level of pain nursing documentation knowledge of unit RN's, patient satisfaction of pain management and number of pain nursing incident reports. In addition, how background variables are related to the pain nursing documentation.

Research hypothesis:

Pain nursing documentation audit and educational feedback increased RNs' pain nursing documentation and knowledge, patient satisfaction to pain management and effect to number of pain nursing incident reports.


Eligibility criteria: Inclusion Criteria:

* Registered nurses (RN) who work at the Kuopio University Hospital in units of which patients potentially require pain management.

Exclusion Criteria:

* Professionals other than RN
* RN who do not use pain management strategies in their work

Primary outcomes:
measure: Change in RNs' pain documentation
timeFrame: Baseline (T0), month 1 (T1), month 2 (T2), month 3 (T3), month 4 (T4), month 5 (T5) month 6 (T6), month 7 (T7), month 8 (T8)
measure: Change in RNs' pain knowledge
timeFrame: Baseline (T0), month 3 (T3), month (T7)
Secondary outcomes:
measure: Change in patient satisfaction of pain management
timeFrame: Before intervention (T0), month 3 (T3), month 6 (T6), month 8 (T8)
measure: Change in number of pain nursing incident reports
timeFrame: Before intervention (T0), month 8 (T8)
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
References:
Clinical trial NCT00311441: Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children
Official title: A Phase IV, Randomized, Controlled, Single-Blind, Multi-Center Study in Children to Evaluate the Safety, Tolerability and Immunogenicity of Two TBE Vaccines Administered According to Two Different Schedules.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Encephalitis, Tick-Borne
Keywords: TBE, children, vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2006-04-06
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female children, 1 to 10 years of age.

Exclusion Criteria:

* Subjects with documented evidence of TBE
* Subjects, who have been previously vaccinated against TBE

Primary outcomes:
measure: Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.
Secondary outcomes:
measure: Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever
Other outcomes:
Locations:
city: Weilheim
country: Germany
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Drug Information Services
role: STUDY_DIRECTOR
References:
Clinical trial NCT03743441: Physiotherapy Treatment for Chronic Achilles Tendinopathy
Official title: A Double-blind Randomized Controlled Trial of Physiotherapy Treatment for Chronic Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendinopathy
Keywords: Chronic tendinopathy
Low-level Laser Therapy
LLLT
Photobiomodulation
Cryotherapy
Exercise therapy
Randomized Clinical Trial
RCT
Placebo-controlled
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Universidade do Vale do Paraíba
name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2018-11-16
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laser treatment with the proper dosage has been found effective in the treatment of chronic Achilles tendinopathy, and animal research indicate that a combination of cryotherapy followed by LLLT could yield an even better result.

Thus, the main purpose of this project is to test if the addition of low level laser therapy can enhance the treatment result of exercise and cryotherapy in patients with chronic Achilles tendinopathy, yielding less pain and higher function.


Eligibility criteria: Inclusion Criteria:

* Achilles tendinopathy with a minimum duration of three months, pathological appearance of the Achilles tendon with thickened tendon and structural changes of the tendons matrix.

Exclusion Criteria:

* Cortisone injection within the last 6 months, systemic inflammatory disease, previous suture/surgery of the Achilles tendon, pregnancy or familial hypercholesterolemia.

Primary outcomes:
measure: The VISA-A questionnaire: An index of the severity of Achilles tendinopathy
timeFrame: Change from baseline to week 4 and 12
measure: Pain (Numerical Rating Scale)
timeFrame: Change from baseline to week 4 and 12
Secondary outcomes:
measure: Pain pressure threshold algometry
timeFrame: Change from baseline to week 4 and 12
measure: Palpation tenderness
timeFrame: Change from baseline to week 4 and 12
measure: Single legged heel raise
timeFrame: Change from baseline to week 4 and 12
measure: Jump for distance
timeFrame: Change from baseline to week 4 and 12
measure: Thickness of the Achilles tendon
timeFrame: Change from baseline to week 4 and 12
measure: Neovascularization in the Achilles tendon
timeFrame: Change from baseline to week 4 and 12
measure: Qualitative assessment of structural changes of the Achilles tendon
timeFrame: Change from baseline to week 4 and 12
measure: Qualitative assessment of effusion within of the Achilles tendon
timeFrame: Change from baseline to week 4 and 12
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
state: Hordaland
Study officials:
affiliation: University of Bergen
name: Ingvill F Naterstad, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04540341: Effectiveness of Mulligan Mobilization Technique and Core Stabilization Exercise With Knee Osteoarthritis
Official title: Investigation of the Effectiveness of Mulligan Mobilization Technique and Core Stabilization Exercises in Female Patients With Knee Osteoarthritis: A Randomized Controlled Single-Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Keywords: Pain, Joint
Mulligan
Core stabilization
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 42
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is a chronic disease process characterized by degeneration and inflammation in the joint cartilage and subchondral bone, synovial fluid and joint capsule. One of the most affected joints in OA is the knee joint, and the incidence of OA increases with age.

Different treatment approaches are used in the treatment of osteoarthritis. The aim of the study is to examine the effectiveness of Mulligan technique and core exercises applied to female patients with knee osteoarthritis. In addition, the investigators did not find any study examining the effect of Mulligan technique on static balance in the treatment of OA. This is the secondary aim of the study.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with knee osteoarthritis
* To be in the age range of 40-70
* No lower extremity surgery in the last 6 months.
* Agree to participate in the study

Exclusion Criteria:

* Having had hip-knee replacement surgery
* Surgery planned in the last 6 months
* Having received physical therapy in the last 6 months
* Having uncontrollable hypertension and cardiac problems
* Having been diagnosed with rheumatoid arthritis

Primary outcomes:
measure: Pain assessment
timeFrame: 10 minutes
measure: Range of motion assessment
timeFrame: 10 minutes
measure: muscle strength assessment
timeFrame: 10 minutes
measure: functional level assessment
timeFrame: 5 minutes
measure: aerobic endurance assessment
timeFrame: 6 minutes
measure: balance assessment
timeFrame: 5 minutes
measure: Timed Up& Go Test
timeFrame: 5 minutes
measure: assessment of quality of life survey
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Meryem Buke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04524741: Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device
Official title: Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Left Atrial Appendage Occlusion
Lead sponsor: The Second Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 40 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and left atrial appendage radiography, respectively (allocation ratio 1:1).
Primary purpose: TREATMENT

Brief summary: A total of 40 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and left atrial appendage radiography, respectively (allocation ratio 1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. The diameter and depth of the left atrial appendage opening were measured by angiography in group A(ICE group), and measured by ICE in group B(radiography group). The size of the occluder device was selected according to the measurement size of the two groups, the occluder device success rate of the two groups was compared, and the relationship between measurement size and the size of the occluder device was obtained.


Eligibility criteria: Inclusion Criteria:

patients taking class I and class III antiarrhythmic drugs could not prevent atrial fibrillation, patients younger than 80 years old Cha2ds2-vasc score ≥2 and Has-bled score ≥3, not suitable for long-term oral anticoagulant drugs.

Exclusion Criteria:

Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.

Primary outcomes:
measure: record contrast media as well as fluoroscopy time were recorded
timeFrame: in the procedure
measure: measure left atrial appendage opening and depth in different angles by intracardiac echocardiography
timeFrame: in the procedure
measure: measure left atrial appendage opening and depth in different angles by radiography
timeFrame: in the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
Study officials:
References:
Clinical trial NCT04900441: Tele-assessment in Individuals With COVID-19
Official title: Determination of Long Term Rehabilitation Needs and Assessment of Functional Capacity in Individuals With COVID-19 With Tele-assessment Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID-19
tele-assessment
C19-YRS
rehabilitation needs
functional capacity
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have had COVID-19 and whose treatment was completed and the PCR test was negative for 2 times or who passed the positive PCR test for 28 days

Brief summary: In most countries, after the measures taken to reduce the effects of the epidemic and quarantine practices, a remote screening tool has emerged in order to screen the needs developing after COVID-19 and to make the necessary rehabilitation applications in time. Sivan et al. A comprehensive multi-system phone scan of the COVID-19 Yorkshire Rehabilitation Screening Tool (C19-YRS) has been developed by a multidisciplinary rehabilitation team.

This study, which will be carried out using the C19-YRS tool and the 30-second sit-and-go test that evaluates functional capacity and mobility conditions, is expected to contribute to the clinical and literature since most of the studies on COVID-19 focused only on the acute and subacute periods. In addition, considering the pandemic conditions all over the world, it will be possible to benefit from the advantages of the tele-assessment application and by reaching more people, possible clinical problems/needs and whether there is a change functional capacities in individuals after COVID-19 will be identified.


Eligibility criteria: Inclusion Criteria

* being 18 years of age or older,
* Patients who have had COVID-19 and whose treatment was completed and the PCR test was negative for 2 times or who passed the positive PCR test for 28 days,
* Individuals who can take and execute verbal orders,
* giving consent on a voluntary basis

Exclusion Criteria:

* individuals who have not had covid 19 or Acute-stage patients with COVID-19
* individuals who refuse to participate in the tele-assessment
* individuals with dementia, cognitive problems or communication problems

Primary outcomes:
measure: Covid-19 Yorkshire Rehab Screen (C19YRS)
timeFrame: Baseline
measure: 30-sec sit and go test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Bandırma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
References:
Clinical trial NCT04097041: Surgery Compared to Masking Device for Venous Pulsatile Tinnitus
Official title: Surgery Compared to Masking Device for Venous Pulsatile Tinnitus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tinnitus
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Surgery arm - patient undergoes tympanomastoidectomy (approx 2 hour operation on ear and mastoid) where a local soft tissue flap is transferred to cover the sigmoid sinus, a cartilage and perichondrial graft is taken from the tragus to cover the jugular bulb). Patient has routine follow up - H\&P, 2 weeks after surgery and then H\&P, Audiometry and Tympanometry over 12 months post surgery (3rd month, 6th month and 12th month). Non surgery arm - patient has audiological consult and fitting of masking device.

The Patient has a routine follow up - H\&P, 2 weeks after masking fitting and then H\&P, Audiometry, Tympanometry over 12 months (3rd month, 6th month and 12th month). Patient cross over to change arms, at 6 months, if they have no resolution of symptoms.
Primary purpose: TREATMENT

Brief summary: The investigators aim to study whether surgical resurfacing of the sigmoid sinus and jugular bulb will result in elimination of venous pulsatile tinnitus.

Detailed description: Currently there is no known treatments with efficacy for venous pulsatile tinnitus without any pathology. The investigators hope to learn that in surgery, resurfacing of the sigmoid sinus and jugular bulb (acoustic dampening) will eliminate symptoms such as pulsatile tinnitus in patients. The knowledge learned will significantly help treat and alleviate future patients that have pulsatile tinnitus.

The purpose of the study is to examine whether surgical resurfacing of the sigmoid sinus and jugular bulb will result in elimination of pulsatile tinnitus in human subjects.

Eligibility criteria: Inclusion Criteria:

* Unilateral venous pulsatile tinnitus
* Visual Analogue score of severity \>5

Exclusion Criteria:

* Surgery exclusion criteria
* Only hearing ear
* Unfit for surgery / anesthesia
* Visual Analogue score of severity 5 or less

Primary outcomes:
measure: Change from baseline in patient-reported tinnitus score
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Peter Santa Maria, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santa Maria PL. Sigmoid sinus dehiscence resurfacing as treatment for pulsatile tinnitus. J Laryngol Otol. 2013 Jul;127 Suppl 2:S57-9. doi: 10.1017/S0022215113000649. Epub 2013 Apr 18.
Clinical trial NCT03218241: Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote
Official title: A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445, a Factor Xa (fXa) Inhibitor Antidote
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose study of PRT064445 or its matching placebo, in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy men or women between the ages of 18 and 50 years old, inclusive
* BMI 19-32 and weighs at least 60kgs

Exclusion Criteria:

* History or symptoms of bleeding problems or thrombotic conditions
* Clinically significant medical history
* Major surgery, severe trauma, or bone fracture within 3 months

Primary outcomes:
measure: Pharmacodynamics assessments
timeFrame: Up to 28 days
Secondary outcomes:
measure: Pharmacokinetics: Plasma levels of PRT064445
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
Study officials:
References:
Clinical trial NCT01043341: Knowledge and Attitude About HPV Vaccines
Official title: Knowledge and Attitude About HPV Vaccines Among Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knowledge
Attitude
Behavior
Keywords: HPV
vaccines
knowledge
attitude
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2010-01-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to analyze the knowledge and attitude about HPV vaccines among Brazilian women after an educative intervention. The knowledge was measured on sexual behavior and HPV infection. The attitude was measured on acceptance of vaccines.

Detailed description: Two hundred Brazilian women were selected ranged 18 to 30 years old. They were randomized on two groups: 1) One hundred received a brief educative intervention about HPV infection and vaccines and answered a questionaire about sexual behavior, HPV infection and vaccines and 2)one hundred not received anything and answered the same questionaire.

Eligibility criteria: Inclusion Criteria:

* healthy women

Exclusion Criteria:

* previous CIN or cervical cancer treatment

Primary outcomes:
measure: Incorrect knowledge about HPV vaccines was detected on more than 50% women, however the attitude to accept the HPV vaccine was improved after educative intervention.
timeFrame: 2 years
Secondary outcomes:
measure: The acceptance of HPV vaccines by the women was depended on the sponsor by the public heath services
timeFrame: 2 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Cidade de São Paulo
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Sylvia MF Brenna, MD, PHD
role: STUDY_DIRECTOR
affiliation: University of Turku
name: Kari J Sirjanen, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00519441: Do Patients Who Have Had Surgery for Achalasia Suffer From Reflux
Official title: Gastroesophageal Reflux in Patients With Achalasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reflux
Keywords: laparoscopic Heller myotomy, achalasia, reflux
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2007-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients who have had laparoscopic surgery for the treatment of achalasia will be asked to have pH studies done in order to determine is these patients suffer from reflux after surgery.

Detailed description: The purpose of this study is to determine if patients who have laparoscopic Heller myotomies for the treatment of achalasia suffer from reflux after the surgery. Patients at our institution who have had surgery for achalasia will be asked to have pH studies done to determine whether or not these patients have reflux.

Eligibility criteria: Inclusion Criteria:

* Patients who have had laparoscopic Heller myotomies for the treatment of achalasia

Exclusion Criteria:

* Patients under the age of 18 will not be included
* Patients who are receiving anti-reflux therapy will not be included

Primary outcomes:
measure: The objective of this study is to determine the degree of post-operative reflux in patients who have had laparoscopic Heller myotomies for the treatment of achalasia.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Harbourside Medical Tower
state: Florida
Study officials:
affiliation: University of South Florida
name: Sarah M Cowgill, MD
role: PRINCIPAL_INVESTIGATOR
References: