louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00561158: Eat Well Live Well Nutrition Program
Official title: Dietary Changes in African American Women By Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes or Diabetes Prevention
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: St. Louis University
name: Grace Hill Health Centers, Inc.
First posted: 2007-11-20
Enrollment: 398
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to develop and evaluate a dietary change program specifically for low-income, African-American women who are at risk for developing diabetes due to obesity. The program uses an innovative approach that emphasizes risk awareness, self-efficacy, and skills training through active learning exercises related to healthy eating. The program is delivered by peer educators in the community and addresses economic and cultural factors that are very important to program participants.


Eligibility criteria: Inclusion Criteria:

* African-American Women
* Aged 25-55 years
* No current diabetes, obese (20% over ideal body weight)
* In community neighborhoods

Primary outcomes:
measure: Weight & Body Mass Index (BMI)
timeFrame: pre-, post and three month follow-up
measure: Fat intake (measured by Food Frequency Questionnaire) including: percent calories from fat, percent calories from saturated fat.
Secondary outcomes:
measure: Depressive symptoms (C-ESD)
timeFrame: pre-, post and three month follow-up
measure: Dietary Knowledge: ten items that test knowledge of: i) fat in foods that are specific to target population; ii) Label Reading; iii) modifying recipes to lower fat content; and iv) saturated versus unsaturated fats
timeFrame: pre-, post and three month follow-up
measure: Eating Habits: assessed using Eating Patterns Questionnaire, a 1993 revised version of Food Habits Questionnaire developed by Kristal, Shattuck & Henry
timeFrame: pre-, post and three month follow-up
measure: Attitudes about fat in diet
measure: Cultural relevancy
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Wendy F Auslander, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02875158: Cyclophotocoagulation in Glaucoma
Official title: Modified Settings for Transscleral Cyclophotocoagulation of the Ciliary Body in Glaucoma : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transscleral cyclophotocoagulation of the ciliary body is an effective technique to reduce intraocular pressure in case of glaucoma. Due to concerns over complications, the main indications for this second-line treatment are refractory glaucoma medication / surgery and low visual prognosis. The 2000 milliwatts (mW) for 2 seconds settings are used by the majority of researchers and clinicians according to the published literature. Some have proposed using 1250 mW for 4 seconds to improve the use of this medical procedure.

The aim of this study is to determine how different parameters affect the efficacy of the treatment. This is a prospective double-blinded randomized controlled trial comparing two groups, the experimental group using 1250 mW for 4 seconds and the control group using 2000 mW for 2 seconds.


Eligibility criteria: Inclusion Criteria:

* Patients with poorly controlled high pressure glaucoma
* Cyclophotocoagulation necessary to prevent visual loss
* Cyclophotocoagulation necessary to prevent or to reduce ocular discomfort

Exclusion Criteria:

* Patient has already undergone a cyclophotocoagulation or cryotherapy treatment in the same eye for glaucoma
* Patients receiving concomitant treatment the same day as the intervention
* Patient not able to follow the prescribed post-operative treatment

Primary outcomes:
measure: Intraocular pressure (IOP) evolution
timeFrame: 1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op
Secondary outcomes:
measure: Presence of complications
timeFrame: During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op
measure: Use of medication
timeFrame: 1 month, 6 months, 12 months, 18 months and 24 months post-op
measure: Retreatment
timeFrame: From the initial treatment up to the last visit (24 months)
measure: Visual acuity
timeFrame: 1 month, 6 months, 12 months, 18 months and 24 months post-op
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec
Study officials:
affiliation: Centre de recherche du CHU de Québec : Université Laval
name: Andrew Toren, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06188858: Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity Lymphedema
Official title: Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lymphedema patients

Brief summary: Our aim was to identify optimal incision sites for LVA in extremity lymphedema that would result in the most effective drainage effect for reducing limb edema and enhancing patients' quality of life.

Detailed description: designing the optimal incision sites and identifying functional lymphatic vessels imaging is crucial for success, primarily due to its efficacy in draining edematous lymphatic fluid and reducing swelling in patients with lymphedema. In this study, we conducted patients with LVA lymphedema to investigate the correlation between LVA incision design, intraoperative functional lymphatic vessel assessment, postoperative limb reduction, and patient satisfaction.

question 1：Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity lymphedema

Eligibility criteria: Inclusion Criteria: Aged 18-80 years; Lymphedema and swelling of the limbs for more than 3 months

-

Exclusion Criteria:

* lipedema；myoedema

Primary outcomes:
measure: Number of Participants with lymphedema stage
timeFrame: through study completion, an average of 4 year
measure: Number of Optimal Incision Site Design
timeFrame: through study completion, an average of 4 year
measure: Rate of lymphatic vessel Functional Parameters
timeFrame: through study completion, an average of 4 year
measure: Circumferential Reduction rate
timeFrame: through study completion, an average of 4 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: Chong Liu
Study officials:
affiliation: employee
name: yomao zheng
role: STUDY_DIRECTOR
affiliation: employee
name: chong liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02200458: Near-infrared Software Performance Study
Official title: Near-Infrared Software Performance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Complication
Lead sponsor: Christie Medical Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will look at the performance capabilities of software for VeinViewer.

Detailed description: This study will look at the performance capabilities of future software for VeinViewer.

Eligibility criteria: Inclusion Criteria:

1. Must be 18 years of age or older
2. Must be considered to be in overall good health by investigator
3. Must pass all prescreening questions
4. Must be able to read and understand English

Exclusion Criteria:

1. Presence of tattoos, scarring, and/or extensive hair in the areas to be assessed for cannulation.
2. IV cannulation in the arms or hands in the previous 4 weeks.

Primary outcomes:
measure: Number of Participants for Whom Successful Visualization of Vasculature Was Achieved
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Christie Medical Holdings, Inc.
state: Tennessee
Study officials:
affiliation: Christie Medical Holdings, Inc.
name: Gregory Schears, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01556958: WheezoMeter® Correlation Study
Official title: Prospective Comparative Study of WheezeRATE™ (Wz%) Readings With Spirometry, Symptoms, and Auscultatory Findings in Children With Wheezing.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
Bronchiolitis
Lead sponsor: iSonea
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 19
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric Specialty Clinic

Brief summary: The primary goal of the study is to more firmly establish correlations between WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including spirometry, provider's auscultation, and symptoms at the time of Wz% measurement.


Eligibility criteria: Inclusion Criteria:

* Patients \<= 12 years of age who have wheezing at the time of study as confirmed by the physicians' auscultation.

Control:

* Patients \<= 12 years of age without history of asthma or other pulmonary conditions, and who are without wheezing on physical exam.

Exclusion Criteria:

* Medical problems that would contraindicate Wz% measurement.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Folsom
country: United States
facility: Site 1
state: California
Study officials:
References:
Clinical trial NCT02546258: Evaluation of the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis
Official title: A Prospective, Open Label, Non-comparative Clinical Investigation to Evaluate the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis of Toenails
Keywords: Fungal Nail
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
Collaborators: name: Intertek
First posted: 2015-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, open label, non-comparative clinical investigation to evaluate the performance of a Fungal Nail Treatment on the visual signs of onychomycosis.

The Fungal Nail Treatment is a CE Marked Class I Medical Device and is commercially available as an over-the-counter product.

The ability of the Fungal Nail Treatment to treat the visual signs of mild fungal toenail infections will be determined by a reduction in the surface area of the infection over time. This will be assessed through visual quantification of the infected area from baseline, as measured by image analysis, throughout the treatment period, where subjects will follow instructions for use on the product pack and self-treat for the duration of the investigation or until their condition has resolved. Both subject and podiatrist will assess the improvement of signs and symptoms of the target nail.


Eligibility criteria: Inclusion Criteria:

* Informed consent has been obtained.
* Age between 18 years to 65 years inclusive.
* Gender: male and female subjects.
* Subjects with visual signs of MILD fungal nail infection present on at least one big toenail or with fungal nail infection on one other toenail on the same foot, in addition to the target big toenail (condition of other foot not relevant) as per podiatrist visual assessment.
* Subjects with no more than 50% surface area of the target big toenail visually affected, from the leading distal edge, as assessed by the podiatrist.

Exclusion Criteria:

* Subjects with moderate to severe fungal toenail infection, on either big toenail, as determined by podiatrist assessment.
* Subjects with fungal nail infection on more than two toenails on their target foot.
* Subjects reporting presence of visual symptoms of fungal toenail infection for more than five years.

Primary outcomes:
measure: Percentage reduction of the surface area of infection over time using image analysis
timeFrame: 40 weeks
Secondary outcomes:
measure: Percentage reduction of the surface area of infection over time from baseline to week 4 using image analysis
timeFrame: 4 weeks
measure: The proportion of subjects whose fungal nail infection has resolved
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Intertek CRS
Study officials:
affiliation: Intertek CRS
name: Rashid Haye, MBBS MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01079858: Evaluation of FID 114657 in Dry Eye Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Keywords: Meibomian Gland Dysfunction
Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-03-03
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the overall Meibomian Gland Dysfunction Subject's preference for a particular product. Dry eye symptom relief will also be evaluated based on clinical evaluation and a set of subject questionnaires.


Eligibility criteria: Inclusion Criteria:

* Patients must be at least 18 years of age
* must read and sign the informed consent forms (ICF)
* must agree to comply with the study requirements.
* Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye
* must report having an ocular examination in the last two years
* must be using topical ocular dry eye therapy (artificial tears or Restasis® at least 2 times per day.
* must have been diagnosed with Meibomian Gland Dysfunction / Posterior Blepharitis based on the following criteria: must have dry eye symptoms and Meibomian gland expression grade greater than 1.

Exclusion Criteria:

* Patients cannot wear contact lenses during the study and cannot have a history of hypersensitivity to any component of FID 114657.
* Patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have a history and/or current evidence of active intraocular inflammation in either eye.
* Patients cannot have punctal plugs that were placed less than or equal to 30 days prior to Visit 1, and they cannot have ocular conditions that, in the opinion of the investigator, preclude the safe administration of the test article.
* They cannot have started or changed the dose of chronic systemic medication within 7 days prior to visit 1, and must remain on a stable dosing regimen for the duration of the study.
* Patients cannot have participated in another investigational clinical or research study within 30 days of visit 1.
* Subjects cannot have a history and/or current evidence of the following: epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; active ocular rosacea (excluding subjects enrolled with MGD (posterior blepharitis)); acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal diseases of the eye.

Primary outcomes:
measure: Preference based on subject's relief of dry eye
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04766658: A Study to Evaluate Effects of Gargle Phonation in Voice
Official title: Gargle Phonation in Individuals With Muscle Tension Dysphonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Voice Disorders
Muscle Tension Dysphonia
Speech Therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess subjects with muscle tension dysphonia for perceived effort and acoustic effects of gargle phonation compared to baseline and a sham water swallow.

Detailed description: This study assesses perceived effort following baseline talking, water swallows and gargle phonation. In addition to perceived effort, acoustic and perceptual analyses will be conducted on the recorded voice samples using vowel sounds, the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) and Hearing in Noise Sentences (HINT).

Eligibility criteria: Inclusion Criteria:

* Patients must have a primary or secondary muscle tension dysphonia based clinical assessment with a Mayo clinic speech language pathologist or other Mayo Clinic otolaryngology care provider in Rochester or Phoenix/Scottsdale locations.
* Age 18 through 89.
* Able to provide informed consent.

Exclusion Criteria:

* Anyone not meeting inclusion criteria.
* Anyone unable or unwilling to provide informed consent.
* Anyone unable to complete questionnaires or participate in voice recording.
* Anyone with severe neurological voice or speech disorders.
* Moderate or severe dysphagia for thin liquids.
* Non-English speakers (English as a second language may be included).
* Extensive laryngeal surgery or other surgery or medical condition that may significantly alter the motor or sensory aspects of the larynx.

Primary outcomes:
measure: Rating of Effort Baseline
timeFrame: Baseline
measure: Rating of Effort Post Swallow
timeFrame: After water swallow intervention, approximately 5 minutes
measure: Rating of Effort Post Gargle
timeFrame: After gargle phonation intervention, approximately 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Diana M Orbelo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01169558: A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.
Official title: First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum First BEAT (Bevacizumab Expanded Access Trial)- Brazilian Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-07-26
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.


Eligibility criteria: Inclusion Criteria:

* Previously untreated metastatic colon or rectal cancer;
* Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.

Exclusion Criteria:

* Prior chemotherapy for metastatic colon or rectal cancer;
* Planned radiotherapy for underlying disease;
* central nervous system metastases;
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before study start.

Primary outcomes:
measure: Safety: Number of Participants With Serious and Specific Adverse Events
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Efficacy: Overall Survival
timeFrame: Up to approximately 3 years
measure: Efficacy: Time to Disease Progression
timeFrame: Up to approximately 3 years
measure: Efficacy: Progression-free Survival
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
city: Belo Horizonte
country: Brazil
city: Belo Horizonte
country: Brazil
city: Brasilia
country: Brazil
city: Brasilia
country: Brazil
city: Campinas
country: Brazil
city: Campinas
country: Brazil
city: Caxias Do Sul
country: Brazil
city: Curitiba
country: Brazil
city: Curitiba
country: Brazil
city: Fortaleza
country: Brazil
city: Ijui
country: Brazil
city: Joao Pessoa
country: Brazil
city: Porto Alegre
country: Brazil
city: Porto Alegre
country: Brazil
city: Recife
country: Brazil
city: Ribeirao Preto
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Salvador
country: Brazil
city: Salvador
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: