louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01414543: Psychologists' Lived Experience of Client Violence
Official title: Counselling and Clinical Psychologists Lived Experience of Client Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Life Experiences
Keywords: violence
Lead sponsor: University of East London
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 10
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of the proposed research is to gain a detailed understanding and account of psychologists' experience of client violence in clinical practice. The emphasis is upon a detailed understanding of how psychologists perceive and understand their experience of client violence and its impact upon their identity as clinicians and as individuals.

Detailed description: This research is interested in Counselling and Clinical Psychologists who have experienced client violence at their work place. The main research question being asked is how do psychologists' understand their personal experiences of client violence. This is an important and interesting subject for Counselling and Clinical Psychologists as it provides a detailed personal account of the implications of violence upon their personal and professional identity, psychological well being and how they define violence. Furthermore, this research may help facilitate in designing a specific policy and help future research to issue guidelines for counselling and clinical psychologists in order to keep themselves safe within their professional practice. Psychologists working for the National Health Service will be recruited and provided with information regarding the research aims and objectives. There will be interviews held at their place of work for approximately one hour.

Eligibility criteria: Inclusion Criteria:

* Psychologist's who have experienced client violence

Exclusion Criteria:

-

Primary outcomes:
measure: experience of violence
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: National Health Service
Study officials:
affiliation: University of East London
name: Helen Murphy, BA, MSc, DPhil
role: STUDY_CHAIR
References:
Clinical trial NCT02290743: Effect of Kinesio Taping on Muscle Strength in Quadriceps Femoris
Official title: The Effect of One Application of Kinesio Tape on Muscle Strength in Quadriceps Femoris on Patients With Knee Problems or Pain and Weak Quadriceps Femoris - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Knee Pain
Muscle Weakness
Knee Symptoms
Lead sponsor: Norwegian School of Sport Sciences
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to investigate the effect of Kinesio tape on muscle strength of the quadriceps femoris in people with knee pain or symptoms and decreased muscle strength in the quadriceps femoris - a randomized controlled trial.

Detailed description: The aim of the study is to investigate the effect of recoil tape with 0-30% tension, by using one application of Kinesio tape over the muscle fibers of the quadriceps femoris from its origin to its insertion. The participants will be divided into intervention group (taping) and control group (no intervention). Muscle strength test will be performed before and immediately after taping (20-30 minutes) for both groups using hand-held dynamometer measurements (MicroFET 3).

Work is based on the following hypothesis: "Kinesio taping using recoil taping provides increased isometric muscle strength in quadriceps femoris immediately after application".

Eligibility criteria: Inclusion Criteria:

* Shoulder problems
* Low muscle strength in quadriceps femoris
* Positive manual recoil-test for the quadriceps femoris

Exclusion Criteria:

* Knee surgery \<3 month
* Pathology in the knee related to tumors, fractures, neurology, rupture of tendons

Primary outcomes:
measure: Muscle strength
timeFrame: 30 minutes
Secondary outcomes:
measure: Time of break force
timeFrame: 30 minutes
measure: Self-reported strength - effort scale
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian School of Sport Sciences
Study officials:
affiliation: Department of Sports Medicine
name: Grethe Myklebust, Phd, PT
role: STUDY_DIRECTOR
References:
Clinical trial NCT03085043: Magnetic Resonance Whole Body Diffusion-Weighted Imaging in Finding Bone or Lymph Node Metastasis in Participants With High-Risk Prostate Cancer
Official title: Magnetic Resonance Imaging as a Comprehensive Staging Tool for the Evaluation of High-Risk Prostate Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-03-21
Enrollment: 98
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This trial studies how well magnetic resonance whole body diffusion-weighted imaging works in finding cancer that has spread to the bone or lymph nodes (metastasis) in participants with high-risk prostate cancer. Diagnostic procedures, such as magnetic resonance whole body diffusion-weighted imaging (a method to show how water moves in a certain area) may help find bone or lymph nodes metastasis.

Detailed description: PRIMARY OBJECTIVES:

I. To compare accuracies of whole body magnetic resonance imaging (MRI) versus bone scan plus computed tomography (CT) scan in detecting bone or lymph node metastasis in high risk prostate cancer patients.

OUTLINE:

Participants undergo standard of care bone scan, CT of the abdomen and pelvis, and pelvic MRI. Participants also undergo magnetic resonance whole body (WB)-diffusion-weighted imaging (DWI) over 20-30 minutes.

Eligibility criteria: Inclusion Criteria:

* Prostate carcinoma patients at high risk for metastasis with prostate-specific antigen (PSA) more than 20 ng/ml and/or Gleason score = 8/ \> 8.
* Ability to understand and sign informed consent.

Exclusion Criteria:

* Patient is at low risk for metastasis with Gleason score at diagnosis \< 8.
* Currently receiving or history of systemic therapy with testosterone suppressing medication (i.e., lupron, degarelix, abiraterone, enzalutamide) or local radiation therapy.
* Contraindication to magnetic resonance imaging (MRI).

Primary outcomes:
measure: Accuracy of whole body magnetic resonance imaging (MRI)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Sensitivity of MRI, bone scan, and CT scan
timeFrame: Up to 9 years
measure: Specificity of MRI, bone scan, and CT scan
timeFrame: Up to 9 years
measure: Positive predictive value (PPV) of MRI, bone scan, and CT scan
timeFrame: Up to 9 years
measure: Negative predictive value (NPV) of MRI, bone scan, and CT scan
timeFrame: Up to 9 years
measure: Detection of other types of metastases
timeFrame: Up to 9 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Tharakeswara K Bathala
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01266343: Comparison of Anterior Chamber Paracentesis and Conventional Mannitol Infusion in Patients With Primary Acute Angle-closure Glaucoma
Official title: Comparison of Anterior Chamber Paracentesis and Conventional Mannitol Infusion in Patients With Primary Acute Angle-closure Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Acute Primary Angle-closure Glaucoma
Keywords: Glaucoma
anterior chamber paracentesis
conventional Mannitol infusion
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Glaucoma patients

Brief summary: The investigators wanted to reported the results of immediate anterior chamber paracentesis (ACP), compared to Mannitol infusion, in patients with acute primary angle-closure glaucoma (PACG). In this study, the investigators first divided patients into three sub-groups according to their initial intraocular pressure (IOP) for analyzing the differences of IOP control, severity of corneal edema, waiting time for laser peripheral iridotomy (LPI), and visual outcome between ACP and Mannitol infusion.

Detailed description: The investigators demonstrated that ACP could be first considered in patients with initial IOP between 45 to 60 mmHg because it provided better visual outcome than Mannitol infusion through the rapid stabilization of the anterior segment, which was achieved by rapid IOP control, better corneal edema regression, shortening waiting time for LPI. However, ACP should be considered in patients with the initial IOP of 60mmHg and higher only when Mannitol was contraindicated.

Eligibility criteria: Inclusion Criteria:

* first attack of acute PACG;
* initial presenting IOP was higher than 45 mmHg;
* diagnosis confirmed by gonioscopic examination;
* patients within 48 hours of symptom onset.

Exclusion Criteria:

* been incompletely followed up within 2 weeks;
* been using anti-glaucomatous medication before ACP or Mannitol infusion;
* previous intraocular surgeries on the same eye;
* contraindication for Mannitol;
* history of other vision-threatening ocular diseases.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Hui-Chun Ho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00750243: Comparator Study of LT-NS001 in Healthy Subjects With Endoscopic Evaluation
Official title: A Double-Blind, Randomized, Active Comparator Study of LT-NS001 Versus Naprosyn for Seven Days in Healthy Subjects With Endoscopic Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Logical Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare naproxen plasma levels and gastroduodenal mucosal injury after administration of LT-NS001 as compared to Naprosyn in subjects age 45-70.


Eligibility criteria: Inclusion Criteria:

* BMI 18-30 kg/m2
* No NSAID's for 14 days prior to baseline endoscopy

Exclusion Criteria:

* Pregnant/Nursing women
* History of documented gastroduodenal ulcer

Primary outcomes:
measure: Assessment of GI mucosal injury by endoscopy
timeFrame: 7 days
Secondary outcomes:
measure: Comparison of naproxen PK at steady state
timeFrame: 7.5 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
References:
citation: Goldstein JL, Jungwirthova A, David J, Spindel E, Bouchner L, Pesek F, Searle S, Skopek J, Grim J, Ulc I, Sewell KL. Clinical trial: endoscopic evaluation of naproxen etemesil, a naproxen prodrug, vs. naproxen - a proof-of-concept, randomized, double-blind, active-comparator study. Aliment Pharmacol Ther. 2010 Nov;32(9):1091-101. doi: 10.1111/j.1365-2036.2010.04442.x. Epub 2010 Aug 23.
Clinical trial NCT04255043: Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon
Official title: Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for Denovo Lesions in High Bleeding Risk Patients: a Prospective, Multi-center, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects will undergo 1:1 randomization to either IVUS or Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.
Primary purpose: TREATMENT

Brief summary: Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk. Intravascular ultrasound (IVUS) can provide more details of coronary anatomy and stent implantation, overcoming a number of limitations of coronary angiography. However, the benefit of IVUS-guided DCB treatment has not been investigated. This study is designed to compare IVUS-guided and Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.

Detailed description: This is a prospective, multicenter, randomized controlled trial that aims to enroll 260 patients with high bleeding risk.

All patients with coronary denovo lesions suitable for DCB treatment will undergo 1:1 randomization to either IVUS guidance or Angiography guidance using the Central Randomization System.

All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol. Data and images will be collected during the index procedure, and at the predefined 7-month coronary angiography follow-up visit.

Eligibility criteria: Inclusion Criteria:

1. De novo lesions, suitable for DCB treatment.
2. Patients with high bleeding risk.

Exclusion Criteria:

1. Target lesion length \> 15mm.
2. Severe calcified lesions.
3. Left main disease.
4. Ostial lesions.
5. Three-vessel disease.
6. Acute myocardial infarction within 48 hours.
7. Target vessel received stent implantation.
8. Hemodynamic instability.

Primary outcomes:
measure: late lumen loss (LLL) at 7 months after procedure
timeFrame: 7 months
Secondary outcomes:
measure: Target vessel failure (TVF) at 6 months
timeFrame: 6 months
measure: bleeding at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shao-Liang Chen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06033638: Video Documented PBS-Score in Children With Clubfoot
Official title: Agreement and Inter-rater Reliability of Video Documented PBS-Score - An International Cross-sectional Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clubfoot
PBS
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2023-09-13
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born with clubfoot

Brief summary: Evaluate agreement and inter-rater reliability of PBS-score assessments based on video documented material.

Detailed description: 120 children with idiopathic clubfoot will be included from four different countries 30 patients from each participating center. Inclusion criteria include: age 4-14 years, diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto. All items of the PBS-score will be documented using video recordings. Six to eight senior orthopedic surgeons will score a total of 90 children each, not the children from their center of employment, according to the PBS-score based on videos. Collaborating centers include Karolinska University Hospital, Sweden, Hospital Pequeno Príncipe, Brazil, and Hayatabad Medical Complex, Orthopaedic Unit, Peshawar, Pakistan.

Eligibility criteria: Inclusion Criteria:

* Clubfoot

Exclusion Criteria:

-

Primary outcomes:
measure: PBS Score agreement and inter-rater reliability
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Astrid Lindgren Children´s Hospital
state: Region Stockholm
Study officials:
affiliation: Astrid Lindgren Children´s Hospital
name: Eva W Broström, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02318238: Comparison Between 6 Minute Walk Test, 6 Minute Step Test and 4 Metre Gait Speed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Children
Keywords: evaluation
exercise tolerance
healthy children
6MWT
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 74
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to find an alternative to the six minute walk test by validating six minute step test and four metre gait speed in healthy children. Both tests were previously validated in adults and are easier to achieve in non-hospital settings.


Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* a lung disease
* an overweight
* an orthopedic disability which can slow down the subject during tests execution

Primary outcomes:
measure: Walked distance
timeFrame: At 6 minutes
measure: Steps count
timeFrame: At 6 minutes
measure: Time
timeFrame: at 1 minute
measure: 6MWT speed
timeFrame: at 6 minutes
measure: 6MST speed
timeFrame: at 6 minutes
measure: 4MGS speed
timeFrame: at 1 minute
Secondary outcomes:
measure: Dyspnea
timeFrame: at 6 minutes
measure: Perceived exertion
timeFrame: at 6 minutes
measure: Heart rate
timeFrame: at 6 minutes
measure: Oxygen saturation
timeFrame: at 6 minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique universitaire Saint-Luc
Study officials:
affiliation: UCL
name: Sophie De Wulf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02900638: Health Effects of Mentoring
Official title: Pilot Study of Physical Health Effects of Cities Mentor Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Health
Keywords: mentoring
children
cardiovascular health
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 55
Sex: ALL
Minimum age (years): 9
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether mentoring is associated with beneficial cardiovascular health effects in both mentors and mentees.

Detailed description: Participants are randomly assigned to either being a mentor or a wait list control. These participants are drawn from a population of undergraduate students. Participants are also randomly assigned to either being a mentee or a wait list control. These participants are drawn from a population of Chicago Public School children. In total, there will be 30 mentors, 30 control mentors, 30 mentees, and 30 control mentees. Participants will come for a laboratory visit in which cardiovascular health measures will be taken (details below). Visits will occur once at baseline (before the intervention starts), and once post-intervention. The protocol will be the same at the two study visits. Participants in the intervention group will engage in one-on-one mentoring sessions (between mentors and mentees) once a week after school for the school year

Eligibility criteria: Inclusion Criteria:

* Undergraduate student for mentors.
* Chicago Public School student for mentees.

Exclusion Criteria:

* Younger than 9 or older than 14 for mentee conditions.

Primary outcomes:
measure: Obesity [body mass index]
timeFrame: Change in body mass index from baseline to 8 months
measure: Blood Pressure
timeFrame: Change in blood pressure from baseline to 8 months
measure: Pro-inflammatory cytokines [standardized and averaged value of pro-inflammatory cytokines and CRP]
timeFrame: Change in cytokine composite score from baseline to 8 months
measure: Cholesterol
timeFrame: Change in cholesterol from baseline to 8 months
measure: HbA1c
timeFrame: Change in HbA1c from baseline to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT05062538: Cancer Patient Perspectives During COVID-19
Official title: Patient Perspectives in Breast Cancer Care During COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: COVID-19
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult females with diagnosis of invasive breast cancer or ductal carcinoma in situ, seen as surgical consultation between 06/01/19-06/01/20

Brief summary: A web-based survey will be emailed to all adult women diagnosed with invasive breast cancer or ductal carcinoma in situ who have been seen as surgical consultations within the last year (06/01/19-06/01/20).

Detailed description: A web-based survey will be emailed to all adult women diagnosed with invasive breast cancer or ductal carcinoma in situ who have been seen as surgical consultations within the last year (06/01/19-06/01/20). This will ensure that patients at various stages of treatment are included, from initial diagnosis into survivorship. This will allow the investigators to assess changes to initial consultations, surgeries, chemotherapy, and radiation, as well as patient perspectives as it relates to these changes.

The web-based surveys will be given via Redcap. The study team will use a validated questionnaire developed at the University of Miami (Penedo, 2020), which includes a combination of multiple-choice questions, Likert scale ratings, and yes/no questions. A list of potential questions is listed below.

A group of patients will be contacted for semi-structured interviews via telephone as well if (1) patients indicate willingness to participate on a separate RedCap survey or (2) if the patient does not respond to this survey. Phone interviews will be recorded and transcribed verbatim. Multiple members of the research team will separately code the information and evaluate for themes.

Eligibility criteria: Inclusion Criteria:

* Adult females with diagnosis of invasive breast cancer or ductal carcinoma in situ, seen as surgical consultation between 06/01/19-06/01/20

Exclusion Criteria:

* Males
* Patients with non-cancer diagnoses
* Patients with no history of breast cancer

Primary outcomes:
measure: Number of participants with changes implemented to breast cancer treatment
timeFrame: 12 months
measure: Number of participants with treatment concerns during COVID-19 pandemic
timeFrame: 12 months
measure: Number of participants with effects of COVID-19 on psychological, social, and physical well-being of breast cancer patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Colorado Research Center
state: Colorado
Study officials:
affiliation: University of Colorado Health
name: Sarah Tevis
role: PRINCIPAL_INVESTIGATOR
References: