louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00164541: An Arts-Based Initiative for the Prevention of Violence Against Women and Girls
Official title: An Arts-Based Initiative for the Prevention of Violence Against Women and Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Violence
Keywords: dating violence
violence against women
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-14
Enrollment: 1440
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: this project will evaluate a community and school based program to promote healthy relationships and prevent violence (physical, emotional and sexual dating violence) among predominately African American middle school adolescents in an urban setting (Baltimore, MD).

Detailed description: This initiative includes 4 major components: 1) A variety of arts based student activities related to violence prevention (during and after school theatre projects, during and/or after school visual arts project, and the web page design project. (All students will either directly participate in these activities or at least see them), 2) Curricular components for all 7th graders, 3) Violence prevention and early intervention student support/discussion groups, and 4) Faculty and staff training on the subject. The evaluation is a quasi-experimental pre/post test comparison group design (2 schools in each group), where our comparison schools convert to intervention schools one year after serving as comparison schools. We are using both group (student and teacher surveys) and school wide (climate of the school) measures pre and post intervention.

Eligibility criteria: Inclusion Criteria:

* Students in four middle schools in urban Baltimore, MD (Dunbar, Lombard, Calverton and Lemmel Middle Schools)

Exclusion Criteria:

-

Primary outcomes:
measure: Dating violence perpetration
timeFrame: past 12 months
Secondary outcomes:
measure: Dating violence victimization
timeFrame: past 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Dunbar Middle School
state: Maryland
city: Baltimore
country: United States
facility: Calverton
state: Maryland
city: Baltimore
country: United States
facility: Lemmel Middle School
state: Maryland
city: Baltimore
country: United States
facility: Lombard School
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jaqueline Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01177241: Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids
Official title: Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Keywords: retrospective chronic low back pain
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic low back pain on opioids

Brief summary: Using a retrospective analysis of a large commercial claims database and a Medicare database, the investigators evaluated DDEs that have the potential to cause DDIs among chronic low back pain (cLBP) patients on long-term opioid analgesia, which metabolizes through the CYP450 enzyme system, concomitant with other CYP450-metabolized drug(s)


Eligibility criteria: Inclusion Criteria:

* chronic low back pain

Exclusion Criteria:

* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00840541: Phenotyping Diabetic Retinopathy
Official title: Observational Study of Type-2 Diabetic Subjects to Validate Diabetic Retinopathy Phenotypes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type-2 diabetic subjects diagnosed with DR, followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center, with a previous follow-up in which systemic data and ophthalmological examinations were performed regularly.

Brief summary: The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (DR) progression based on available clinical data (demographic, systemic and ophthalmic data).

Detailed description: This study aims to validate and characterize phenotypes of diabetic retinopathy (DR) progression using ophthalmic and systemic data from type-2 diabetic subjects followed at the AIBILI Clinical Trial Center in the last 10 years.

Macular Edema (ME) development during the study period, mainly Clinically Significant ME (CSME) needing treatment, will be the primary indicator for DR progression. CSME will be considered as the primary end-point and will be used to identify phenotypes (and risk markers) of DR progression.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of DR.
* Females or Males;
* Age over 18 years;
* Signed Informed Consent;
* Previous follow-up with regular systemic and ophthalmic assessments.

Exclusion Criteria:

* Cataract or other eye disease that may interfere with fundus examinations;
* Vitreous syneresis or posterior vitreous detachment;
* Dilatation of the pupil \< 5 mm.

Primary outcomes:
measure: CSME
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: AIBILI - Clinical Trial Center
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: José Cunha-Vaz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cunha-Vaz J. Characterization and relevance of different diabetic retinopathy phenotypes. Dev Ophthalmol. 2007;39:13-30. doi: 10.1159/000098497.
Clinical trial NCT02967341: Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients
Official title: Validation of Central Venous (Port A Cath®) Blood Draws for Ciprofloxacin Pharmacokinetic Research in Patients Under Treatment for Childhood Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Childhood Cancer
Neutropenia
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic studies of ciprofloxacin in patients under treatment for childhood cancer.

Detailed description: The concentration of cipro will be determined using a validated high-performance liquid chromatographic (HPLC) method with fluorescence detection. Unbound concentration will be determined by adjusting the pH of the plasma samples to physiological pH (7.4) in a CO2 incubator, followed by ultrafiltration and extraction of ciprofloxacin from the ultrafiltrate (as described above) prior to injection onto the HPLC system.

Eligibility criteria: Inclusion Criteria:

Children who

* are between 1 month and 18 years of age
* are under treatment for any type of childhood cancer
* use ciprofloxacin for prophylaxis of febrile neutropenia as part of regular treatment
* have a PAC for intravenous medication and blood draws.

Exclusion Criteria:

Children will be excluded from this study if we are unable to

* obtain informed consent of both parents and assent of the child (if he/she is over 12 years of age)
* aspire blood from the PAC.

Primary outcomes:
measure: Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Jutte van der Werff ten Bosch, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03853941: Adherence to Activity Limitations in Diabetes
Official title: Adherence to Activity Limitation Recommendations in Patients With Diabetic Foot Ulcers: a 'Proof of Concept' Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Foot Ulcer
Keywords: Motivation
Communication
Healthcare Professional
Training
Adherence
Diabetes
Foot Ulcer
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This study aims to develop and test a theory-based motivation communication training programme for healthcare professionals working with diabetic foot ulcer patients. The investigators will explore the acceptability of the training programme and examine whether the training leads to changes in healthcare professionals' communication style, and results in greater adherence to treatment recommendations (i.e., reduced weight-bearing) in patients.

Detailed description: This is a proof of concept, two-arm non-randomised, controlled before-and-after study. Patient outcomes (perceptions of healthcare professional communication style, treatment self-regulation and adherence to activity reduction) will be collected first during a control/usual care period. Healthcare professionals will then receive the theory-based motivation communication training programme. Subsequently a new group of patients will be recruited as the intervention group and the same outcome measures collected. Control group outcomes will be compared to intervention group outcomes. Interviews will be conducted with healthcare professionals and patients to assess acceptability of the intervention.

Eligibility criteria: Inclusion Criteria:

* Be aged 18 years and over
* Have diabetes according to WHO criteria
* Have a diabetic foot ulcer being treated at the foot clinic at Royal Derby Hospital
* Be able to communicate and complete questionnaire measures in English
* Have capacity to consent and agree to participate.

Exclusion Criteria:

- Patients who are not currently engaging in walking behaviour (e.g., wheelchair-bound patients) or have other physical limitations that restrict ability to use an accelerometer will be excluded.

Primary outcomes:
measure: Change in healthcare professionals' communication style
timeFrame: Baseline
Secondary outcomes:
measure: Change in patients' adherence to activity reduction recommendations
timeFrame: 1 month
measure: Change in patient treatment self-regulation
timeFrame: Baseline
measure: Acceptability of the intervention
timeFrame: Healthcare professional interviews 4-6 weeks following training; Patient interviews 4-6 weeks following baseline
measure: Fidelity of delivery
timeFrame: Baseline
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
Study officials:
affiliation: University of Nottingham
name: Jennie Hancox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05393141: The Effects of Weight Loss on Psoriatic Arthritis
Official title: The Effect of Body Weight Management and Cognitive Exercise Therapy Approach on Psoriatic Arthritis Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriatic Arthritis
Obesity
Keywords: psoriatic arthritis
diet
biopsychosocial exercise
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis. Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. This study aims to determine the effects of dietary and Cognitive Exercise Therapy Approach (BETY-Bilişsel Egzersiz Terapi Yöntemi) interventions on symptoms. Accordingly, 45 overweight/obese subjects with PSA aged 20-65 years will divide into "diet", "diet+bety", and "control" groups. Dietary, laboratory and anthropometric records, Short Form Health Survey, DAPSA (Disease Activity in Psoriatic Arthritis), HAQ (Health Assesment Questionnaire) of all subjects will compare at the baseline and at the end of the study.

Detailed description: Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. The present study aims to determine the effects of dietary and Cognitive Exercise Therapy Approach interventions on symptoms.

* Fourt-five overweight/obese subjects with PSA aged 20-65 years will divide into diet (n=15), diet+bety (n=15), and control (n=15) groups.
* Individually diet programs will be applied according to the metabolic, biochemical, and physical activity status of the subjects prepared by a registered dietitian.
* BETY exercise training will be given by a registered physiotherapist.
* The subjects will be followed for 12 weeks.
* Dietary, laboratory and anthropometric records, Short Form Health Survey, DAPSA (Disease Activity in Psoriatic Arthritis), HAQ (Health Assesment Questionnaire) of all subjects will compare at the baseline and at study completion.

Eligibility criteria: Inclusion Criteria:

* overweight/obese
* diagnosed with PSA

Exclusion Criteria

* pregnancy or lactation

Primary outcomes:
measure: Weight Loss
timeFrame: At the end of 3 months
measure: DAPSA score
timeFrame: At the end of 3 months
Secondary outcomes:
measure: Quality of Life Score
timeFrame: At the end of 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sümeyra Öteleş
Study officials:
References:
Clinical trial NCT05119517: Can the Osteopathic Pedal Pump Reduce Lymphedema in the Lower Extremities in the Elderly? A Mentorship Project.
Official title: Can the Osteopathic Pedal Pump Reduce Lymphedema in the Lower Extremities in the Elderly? A Mentorship Project.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema, Lower Limb
Lead sponsor: Rowan University
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic lymphedema is defined as swelling or edema (excess fluid in the interstitial space) that does not fully resolve overnight by elevating the limb or body part to the level of the heart. Chronic lymphedema is a major clinical problem that is difficult to treat. Osteopathic Pedal Pump is a simple manipulation technique anecdotally thought to reduce leg edema and chronic lymphedema. However, the clinical evidence is only anecdotal and no clinical trials have ever been conducted to test this observation. The purpose of the research is to measure the effectiveness of the Osteopathic Pedal Pump technique for treating lymphedema by measuring before and after treatment limb volumes. The second purpose of this project is to mentor osteopathic medical students in clinical research. There is also a great need to mentor Osteopathic Medical Students because relatively few pursue careers involving clinical research and the benefits osteopathic manipulative treatment remain under investigated.


Eligibility criteria: Inclusion Criteria:

* For phase one subjects must be age 18 or older, be a medical students at Rowan University School of Osteopathic Medicine and not have leg edema which does not resolve with overnight limb elevation. For phase two subjects must be patients at the NJISA in Stratford, NJ age 55 and over and have lower limb lymphedema. Lymphedema is defined as edema that does not resolve with overnight elevation of the lower limb.

Exclusion Criteria:

* Exclusion criteria is the same for both phases. Because the measurements involve placing the lower limb into water subjects with an open wound, sore or cellulitis in the lower limbs will be excluded to ensure good hygiene. Because lymphatic pumping can cause a redistribution of volume in the body, subjects with decompensated heart failure, acute asthma, COPD exacerbation, or active cancer will be excluded. For obvious reasons, those with a non-healed or healing bone fractures will be excluded. Due to potential problems with informed consent those with a diagnosis of dementia on the chart problem list will be excluded.

Primary outcomes:
measure: Change in lower limb volume
timeFrame: Baseline and 1-minute after receiving pedal pump protocol
Secondary outcomes:
Other outcomes:
Locations:
city: Stratford
country: United States
facility: Rowan University School of Osteopathic Medicine
state: New Jersey
Study officials:
affiliation: Rowan University School of Osteopathic Medicine
name: Donald Noll, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01075217: Isovue in Peripheral Digital Subtraction Angiography (DSA)
Official title: A Phase IV Multi-Center Study to Compare ISOVUE -250 and VISIPAQUE 270 for Motion Artifact and Pain in Peripheral Digital Subtraction Angiography (DSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Occlusive Disease
Keywords: Peripheral arterial occlusive disease (PAOD)
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: No significant differences is expected in observed motion artifacts, heat or pain reported during peripheral DSA performed for diagnostic and/or endovascular therapeutic purposes.


Eligibility criteria: Inclusion Criteria:

* provides written informed consent;
* at least 18 years of age;
* scheduled to undergo peripheral DSA for the diagnosis and/or treatment of PAOD

Exclusion Criteria:

* pregnant or lactating female;
* known allergies to one more more ingredients in wither product;
* history of severe congestive heart failure (Class IV);
* previously enrolled or received an investigational compound within 30 days;
* history of hypersensitivity to iodinated contrast agents;
* renal impairment eGFR \<60 mL/min/1.73m2, calculated using the MDRD study equation
* any other medical condition decreasing chances of obtaining reliable data

Primary outcomes:
measure: Level of Pain/Heat in the Lower Extremities Scored by the Participants on the Visual Analog Scale (VAS) Following Intra-arterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA
timeFrame: immediately after administration of agent using a power injector for the administration
Secondary outcomes:
measure: Level of Heat in the Lower Extremities Scored by Group 2 as Assessed on the Heat VAS Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA
timeFrame: Immediately after administration of agent using a power injector for the administration
measure: The Number of Participants With Significant Motion Artifacts (Scores of 3 or 4) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
timeFrame: Immediately postdose
measure: The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
timeFrame: Immediately postdose
measure: The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA
timeFrame: Immediately postdose
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bracco Diagnostics
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Martin Krix, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04925817: 3D Ultrasound Microvessel Imaging for Breast Masses
Official title: 3D Ultrasound Microvessel Imaging for Breast Masses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-06-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.

Detailed description: PRIMARY OBJECTIVES:

I. Optimization of imaging protocol for this new ultrasound technology. II. Investigate the diagnostic performance of the new ultrasound technology using clinically indicated biopsy as the reference standard.

OUTLINE:

Patients undergo 3 dimensional (D) ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.

Eligibility criteria: Inclusion Criteria:

* Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.
* Lesion size of 3 mm or larger.
* Age 18 or greater.

Exclusion Criteria:

* Women with previous breast surgery or breast implant.
* Lacking the capacity to consent.
* Women who are pregnant or lactating.
* Women who are receiving cancer therapy such as chemotherapy or radiation therapy.

Primary outcomes:
measure: Ultrasound diagnostic accuracy using McNemar's test
timeFrame: Up to 1 year
measure: Ultrasound parameters sensitivity using McNemar's test
timeFrame: Up to 1 year
measure: Ultrasound parameters specificity using McNemar's test
timeFrame: Up to 1 year
measure: Ultrasound parameters positive predictive value using McNemar's test
timeFrame: Up to 1 year
measure: Ultrasound parameters negative predictive value using McNemar's test
timeFrame: Up to 1 year
measure: Ultrasound parameters accuracy using McNemar's test
timeFrame: Up to 1 year
measure: Ultrasound parameters calculated by McNemar's test
timeFrame: Up to 1 year
measure: Ultrasound parameters vs. Breast Image Reporting using McNemar's test
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Shigao Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: