louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01298440: Bevacizumab Effect on Blood Velocity
Official title: The Effect of Intravitreal Bevacizumab (Avastin) Injection on Retinal Blood-Flow Velocity in Patients With Choroidal Neovascularization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choroidal Neovascularization
Lead sponsor: Optical Imaging, Ltd.
Sponsor class: INDUSTRY
First posted: 2011-02-17
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with choroidal neovascularization (CNV)

Brief summary: Retinal blood flow velocity is affected by Bevacizump intravitreal injection. This effect is correlated to treatment success.

Detailed description: The purpose of the study was to carry out a pilot study on the short-term effect of intravitreal Bevacizumab (Avastin) injection on retinal blood-flow velocity and test whether the short-term haemodynamic changes could predict the longer term clinical result of the treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with CNV receiving Bevacizumab intravitreal injection

Exclusion Criteria:

* Candidates in whom the retina could not be seen clearly because of media opacity or a poorly dilating pupil

Primary outcomes:
measure: Blood flow velocity change
timeFrame: 1 day following injection
Secondary outcomes:
Other outcomes:
Locations:
city: Tel aviv
country: Israel
facility: Tel aviv sourasky medical center
Study officials:
affiliation: Tel aviv university Sackler school of medicine
name: Adiel Barak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burgansky-Eliash Z, Lowenstein A, Neuderfer M, Kesler A, Barash H, Nelson DA, Grinvald A, Barak A. The correlation between retinal blood flow velocity measured by the retinal function imager and various physiological parameters. Ophthalmic Surg Lasers Imaging Retina. 2013 Jan-Feb;44(1):51-8. doi: 10.3928/23258160-20121221-13.
Clinical trial NCT00089440: Assessment of Interactions Between Methamphetamine and Aripiprazole - 1
Official title: Assessment of Interactions Between IV Methamphetamine and Aripiprazole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Amphetamine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-08-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the interactions between intravenous methamphetamine and aripiprazole.

Detailed description: This is a double-blind, placebo-controlled human laboratory clinical pharmacology study to assess potential interactions between intravenous d-methamphetamine infusion and treatment with oral aripiprazole.

Eligibility criteria: Inclusion Criteria:

* Must meet DSM-4 criteria for methamphetamine abuse or dependence and are non-treatment seeking.
* Ability to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.

Exclusion Criteria:

* Please contact the site for more information.

Primary outcomes:
measure: Adverse effect measures
measure: pharmacokinetic assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Integrated Substance Abuse Program
state: California
city: New York
country: United States
facility: New York University, School of Medicine
state: New York
Study officials:
affiliation: University of California, Los Angeles
name: Thomas Newton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02220140: Resilience for Young People With ADHD - a Randomized Controlled Trial of a Brief Intervention Program.
Official title: Resilience for Young People With Attention Deficit Hyperactivity Disorder (ADHD) - a Randomized Controlled Trial of a Brief Intervention Program.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: TRYG Foundation
First posted: 2014-08-19
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this project we invite 8.000 young persons (age 18-27) in Denmark and to participate in a randomized controlled intervention study where we aim to test the effectiveness of a web based knowledge and inspiration program about resilience for children, adolescents and adults (called myresilience.org). The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.

Detailed description: The complete CONSORT trial protocol is available at http://myresilience.org/ at the subsite 'about us'.

Eligibility criteria: Inclusion Criteria:

A random sample with 8.000 patients registered in the Danish National Patient Register:

* Age 18-27
* ADHD diagnosis

Exclusion Criteria:

• Request for legal protection against contacts from researchers.

Primary outcomes:
measure: Adult ADHD Self-Report Scale (ASRS-v1.1)
timeFrame: Follow-up will be on the average 1 year after intervention
Secondary outcomes:
measure: The 12-item General Health Questionnaire (GHQ-12)
timeFrame: Follow-up will be on the average 1 year after intervention
Other outcomes:
measure: Youth education attrition
timeFrame: December 2016
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Poul L Bak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05354440: Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System
Official title: Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: BioProtect
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who previously participated in the BP-007 clinical study

Brief summary: Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant™ System

Detailed description: Multi-center, long-term, prospective, observational study for assessment of late rectal toxicity and quality of life in prostate cancer subjects undergoing radiotherapy by means of IMRT following implantation of the BioProtect Balloon Implant System.

Eligibility criteria: Inclusion Criteria:

1. Subject has previously participated in the BP-007 clinical study and completed their IMRT treatment.
2. Subject agrees to complete all required follow-up visits.
3. Subject provides written Informed Consent prior to any study related procedure

Exclusion Criteria:

1. Subject who completed 48 months of follow-up in the BP-007 study.
2. Subjects who are receiving at the time of the study, any other investigational agents/ devices.
3. Subjects unwilling and/or unable to comply with the provisions of the study protocol.

Primary outcomes:
measure: Long Term Rectal And Urinary Toxicity and Quality of Life
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St Luke's Radiation Oncology
city: Ashdod
country: Israel
facility: Assuta Ashdod medical center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht radiation oncology
city: Warsaw
country: Poland
facility: Institute of Maria Skłodowska - Curie
city: Porto
country: Portugal
facility: Cuf Porto institution
Study officials:
References:
Clinical trial NCT05629468: Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris
Official title: Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Pak Emirates Military Hospital
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 75
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the goal of this clinical trial is to measure the efficacy of probiotics for treatment of acne vulgaris, to compare it with azithromycin and to measure the synergistic effect of azithromycin and probiotics for treatment of acne vulgaris

Detailed description: this study aims to answer this research question: in patients of acne vulgaris, is use of probiotics as efficacious as azithromycin in treating acne lesions \& improving quality of life? total 75 patients were divided into 3 groups. group A received azithromycin, group B received probiotics and group C received both drugs. a topical cream was also advised to all groups. outcome was measured as reduction in total lesion count and improvement in patients' quality of life via reduction in Dermatology Life Quality Index score.

Eligibility criteria: Inclusion Criteria:

* Diagnosed Patients of Mild and Moderate acne
* Aged between 15 and 35 years

Exclusion Criteria:

* Severe acne or any systemic inflammatory disease
* Other oral treatment for acne
* Allergic to any drug being used in the study
* Pregnancy
* PCOs
* Any drug which can interact with azithromycin

Primary outcomes:
measure: change or reduction in the Total Lesion Count
timeFrame: at start of the study (baseline), 2 weeks (1st follow up visit), 4 weeks (2nd follow up visit), 8 weeks (3rd follow up visit) and 12 weeks (4th follow up visit).
Secondary outcomes:
measure: change or reduction in the Dermatology Life Quality Index score
timeFrame: at start of the study (baseline) and 12 weeks (last follow up visit).
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: PEMH
state: Punjab
Study officials:
affiliation: Riphah International University, Islamabad
name: Akbar W Syed, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05612568: 5 Years of Eye Screening for ARF in Children Aged <3 Years in Flanders
Official title: Five Years of Eye Screening for Amblyopia Risk Factors in Children Aged <3 Years in Flanders: Epidemiological Retrospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Amblyopia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 250000
Sex: ALL
Minimum age (years): 13
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We include all children with a PlusOptix screening between 2013 and 2018 with the age of 12±1 months or 30±1 months.

Brief summary: Researchers will investigate the distribution and evolution of amblyopia risk factors and other refractive errors in children younger than 3 years of age. The significance and magnitude of current global evolutions in ARF and refractive errors will be verified to update current guidelines and practices. Better insight in associated factors of amblyopia risk factors will contribute to current understanding of amblyopia.

Detailed description: The eye screening program of the Flemish governmental agency 'Kind en Gezin' is a well-implemented screening program for detection of ARF in children under the age of 3 years. This screening covers almost 85% of all children born in the Flemish community. Valuable information about distribution and determinants of refractive errors and ARF are collected at 'Kind en Gezin', but remain unstudied until today.

The aim is to analyze the distribution and evolution of refractive errors in children under the age of 3 years in Flanders. One supposes that identification of patterns in this distribution, and identification of determinants that influence ARF, will lead to improved knowledge about amblyopia (risk factors) and on their turn help optimize the ARF screening program. Evaluation of the distribution and evolution of refractive errors over time, and comparison with global results, will also give researchers insight in the significance of the myopia epidemic in Flanders.

Eligibility criteria: Inclusion Criteria:

* We include all children with a PlusOptix screening between 2013 and 2018 with the age of 12±1 months or 30±1 months. Children who were screened twice, can be included twice with both screening results.

Exclusion Criteria:

* none

Primary outcomes:
measure: Refractive error per eye
timeFrame: Day 1
measure: Difference in refractive error between both eyes
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT06916468: Efficacy of Cotton as a Dampener for Vibration Anesthetic Device
Official title: Improving Patient Comfort of Vibratory Anesthetic Devices With a Cotton Dampener
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Care
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to determine the effectiveness of cotton as a dampener for vibratory anesthetic devices (VADs) for dermatologic patients. It will compare patient preferences for VAD use with and without cotton across different anatomical sites and identify factors, such as chronic pain or neuropathy status, that may influence these preferences. Finally, the study seeks to generate preliminary data to inform potential modifications to VAD use, optimizing patient comfort in dermatologic procedures


Eligibility criteria: Inclusion Criteria:

1. Age range: from 18+
2. Dermatologic patients at Westlake Clinic
3. Consent: Must provide informed consent to participate in the study.
4. Availability: Able to complete the entire study session, which includes testing all sites in a single session

Exclusion Criteria:

1. Broken skin or known peripheral neuropathy on anatomical site of vibration.
2. Allergies: Known allergy or sensitivity to nitrile gloves or cotton

Primary outcomes:
measure: Percentage of participants who preferred the VAD with Cotton as measured patient report.
timeFrame: Up to 45 mins
measure: Percentage of participants who preferred the VAD without Cotton as measured patient report.
timeFrame: Up to 45 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Bryan Carroll, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilkowski CM, Maytin AK, Klatzky RL, Carroll BT. A pilot study comparing the user preference of different forms of mechanical vibration. Arch Dermatol Res. 2024 Jan 10;316(2):69. doi: 10.1007/s00403-023-02797-x. No abstract available.
citation: Sharma P, Czyz CN, Wulc AE. Investigating the efficacy of vibration anesthesia to reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J. 2011 Nov;31(8):966-71. doi: 10.1177/1090820X11422809. Epub 2011 Oct 14.
citation: Gresham KA, Carroll BT. A Simple Elastomer-Pad Vibratory Dampener to Maximize Pain Control of Injections in Patient's Undergoing Dermatological Surgery. Dermatol Surg. 2016 Jun;42(6):788-90. doi: 10.1097/DSS.0000000000000718. No abstract available.
citation: Govas P, Kazi R, Slaugenhaupt RM, Carroll BT. Effect of a Vibratory Anesthetic Device on Pain Anticipation and Subsequent Pain Perception Among Patients Undergoing Cutaneous Cancer Removal Surgery: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2019 Dec 1;21(6):480-486. doi: 10.1001/jamafacial.2019.0733.
Clinical trial NCT06817668: Evaluating Tolerability of ePUHRT With Brachytherapy Boost
Official title: Evaluating Tolerability of Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT) With High Dose Rate Brachytherapy Boost for Unfavorable and Higher Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Brachytherapy boost
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).

Detailed description: Progression free survival from irradiation dose escalation has been demonstrated across multiple prospective randomized studies. Irradiation dose escalation delivered by dual therapy (consisting of external beam irradiation treatment with brachytherapy boost, a type of internal radiation) offers improved survival. Brachytherapy boost makes it possible to safely deliver higher irradiation dose to the prostate gland than can be achieved with dose escalation by standard fractionated external beam treatment.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years old at the time of informed consent
2. Capable of providing informed consent and HIPAA authorization
3. Karnofsky performance score ≥ 70
4. Pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician
5. Candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure
6. Up to date colon cancer screen per per American Cancer Society guidelines

Exclusion Criteria:

1. Prior pelvic irradiation treatment
2. Prior rectal surgery which precludes instrumentation with rectal ultrasound probe.
3. Evidence of nodal or distant disease on screening diagnostic work up.
4. Prior prostatectomy, Holmium laser enucleation of the prostate or transurethral resection of the prostate procedure
5. International Prostate Symptom Score (IPSS) score \> 16 despite medical therapy

Primary outcomes:
measure: Percentage of participants with acute grade ≥ 2 GU toxicity
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of participants with acute grade ≥ 2 GI toxicity
timeFrame: 3 months
measure: Percentage of participants with acute grade ≥ 2 GU toxicity
timeFrame: 3 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University Simon Comprehensive Cancer Center
name: Omar Ishaq, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02778568: Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients
Official title: Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Intermittent Claudication
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Ciência e Tecnologia de Pernambuco
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to analyze the effects of resistance exercise and training on cardiovascular function of peripheral artery disease patients.

Detailed description: Several studies have shown that strength training can promote important benefits for the cardiovascular system in healthy subjects and patients with chronic diseases. However, the effects of resistance exercise on cardiovascular function in intermittent claudication patients are unclear. In addition, it also do not know the chronic effects on cardiovascular function in these patients.

Eligibility criteria: Inclusion Criteria:

* Had a graded treadmill test that was limited by claudication (2 minutes)
* Had an ankle brachial index \<0.90
* Had systolic blood pressure ,160 mmHg and/or diastolic blood pressure,105 mmHg
* Were not performing any regular exercise program
* Were not using antihypertensive medications affecting the heart rate (e.g., b-blockers and nondihydropyridine calcium channel blockers)
* Were nonobese
* Individuals who have not undergone bypass surgery or angioplasty least one year ago

Exclusion Criteria:

* Had no symptoms related to myocardial ischemia during the treadmill test
* Amputation

Primary outcomes:
measure: Change in blood pressure
timeFrame: Change from baseline to 12 and 24 weeks
Secondary outcomes:
measure: Change in Walking distance
timeFrame: Change from baseline to 12 and 24 weeks
measure: Change in Health related Quality of life
timeFrame: Change from baseline to 12 and 24 weeksBaseline, 12 wks and 24 wks
measure: Change in Muscle blood flow of limbs
timeFrame: Change from baseline to 12 and 24 weeks
measure: Change in body fat
timeFrame: Change from baseline to 12 and 24 weeks
measure: Change Serum Cholesterol
timeFrame: Change from baseline to 12 and 24 weeks
measure: Change in serum glucose
timeFrame: Change from baseline to 12 and 24 weeks
measure: Change in TNFalpha
timeFrame: Change from baseline to 12 and 24 weeks
measure: Change in Score Short-physical performance battery
timeFrame: Change from baseline to 12 and 24 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Emergency Hospital of Pernambuco - PROCAPE
state: PE
Study officials:
affiliation: University of Pernambuco
name: Marilia A Correia, MS
role: STUDY_CHAIR
References: