louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00863278: Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser
Official title: Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser; a Comparative Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Melanosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2009-03-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on the face. Treatment is difficult and to date the best treatment option is the combination of hydroquinone, retinoic acid and steroids combined in topical daily application (called Kligman's trio). Q-switched pigmentary lasers are usually ineffective and can induce post inflammatory hyperpigmentation (PIH). Intense pulsed light can sometimes improve melasma but also induce PIH which limit their use. Recently, pulsed dye laser were demonstrated to be effective in treating some pigmentary defects. Associating blanching cream with hydroquinone to prevent PIH after laser or intense pulsed light has been already reported with success.

The objective of the study is to compare in a prospective intra individual comparative trial the association of pulsed dye laser plus stabilized Kligman's trio to Kligman's trio alone. The secondary objective was to study the frequency and the intensity of the potential side effects including PIH.


Eligibility criteria: Inclusion Criteria:

* Pregnant women or breastfeeding.
* Skin type 5 or 6.

Exclusion Criteria:

* Known allergy to the compounds of the Kligman preparation.
* Refusal to put very high protection sunscreen during the study.
* Concomitant use of topical products that might have an effect on melasma (topical steroids, retinoids, etc...)

Primary outcomes:
measure: MASI score, standardized photos in direct, crossed polarized and UV light, relating to the security: 0 yes 1 N0
timeFrame: visit of screening (V0), 15 days after V0 during the follow visit 1(V1), 3 weeks after V1 during the following visit 2(V2), 3 weeks after V2 during the following visit 3(V3), 10 weeks after V3 during the following visit 4
Secondary outcomes:
measure: Clinical evaluation of potential side-effects (including post inflammatory pigmentation)
timeFrame: visit of screening (V0), 15 days after V0 during the follow visit 1(V1), 3 weeks after V1 during the following visit 2(V2), 3 weeks after V2 during the following visit 3(V3), 10 weeks after V3 during the following visit 4
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
name: PASSERON Ph Thierry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01816178: Using a Voice Output Communication Aid to Facilitate Language Development in Young Children With ASD
Official title: Using a Voice Output Communication Aid to Facilitate Language Development in Young Children With Autism Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Keywords: Autism spectrum Disorders
Voice Output Communication
Lead sponsor: University of South Alabama
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 5
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It was proposed that in order to teach these children to use a Voice Output Communication Aid (VOCA), it should be introduced through a play-based situation using parents as the primary interventionist.

Detailed description: The research will test the effectiveness of using the communication board to improve the frequency of communication and social engagement for these children, and the level or sophistication of that engagement. The study will test the effectiveness of using the communication board in a variety of settings and a variety of practitioners. The study will have sites in and near Jonesboro, Arkansas.

Eligibility criteria: Inclusion Criteria:

Criteria for inclusion included a diagnosis of autism and agreement of the parents to participate and use the VOCA at home.

Exclusion Criteria:

Not diagnosed with Autism Spectrum disorder

Primary outcomes:
measure: Improved Communication
timeFrame: 1 year
Secondary outcomes:
measure: Review of text output from the VOCA
timeFrame: 1 year
Other outcomes:
measure: Improved parent interaction
timeFrame: 1 year
Locations:
city: State University
country: United States
facility: Arkansas State University
state: Arkansas
Study officials:
References:
Clinical trial NCT03263078: Difference Between Inhalation Anesthesia and Total Intravenous Anesthesia in Free Flap Surgery
Official title: Difference Between Inhalation Anesthesia and Total Intravenous Anesthesia in Free Flap Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: inhalation,intravenous anesthesia
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the difference between total intravenous anesthesia to inhaled anesthesia in free flap surgery.

Detailed description: The aim of this study is to perform a randomized controlled trial to examine the effects of different anesthetics on intraoperative hemodynamic stability during free flap surgery and postoperative complications

Eligibility criteria: Inclusion criteria:

Patients who need head and neck cancer excision and free flap reconstruction surgery

Exclusion criteria:

1. preoperative cognitive dysfunction, NYHA CHF \> III or LVEF \< 30%
2. preoperative documented obstructive or restrictive lung disease
3. liver cirrhosis; severe chronic renal insufficiency (GFR \< 30 ml·min-1·1.73 m-2.)
4. peripheral arterial occlusive disease expected to be a contraindication for PiCCO catheter insertion
5. Active cardiac arrhythmias that were assumed to preclude valid assessment using arterial pulse contour analysis
6. anticipated bilateral femoral arterial and central venous catheterization when the jugular and subclavian veins were not available due to surgical extent

Primary outcomes:
measure: Number of patients with postoperative pulmonary complication
timeFrame: 1 day
Secondary outcomes:
measure: Mean arterial blood pressure, MAP (mmHg)
timeFrame: 1 day
measure: Cardiac index , CI (L·min-1·m-2))
timeFrame: 1 day
measure: Systemic vascular resistance index, SVRI (dynes · sec · cm-5)
timeFrame: 1 day
measure: Stroke Volume Variation , SVV (%)
timeFrame: 1 day
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
state: Taiwain
Study officials:
affiliation: Anesthesiology Department, Taichung Veterans General Hospital
name: Yi-Ting Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang YT, Lai CS, Lu CT, Wu CY, Shen CH. Effect of Total Intravenous Anesthesia on Postoperative Pulmonary Complications in Patients Undergoing Microvascular Reconstruction for Head and Neck Cancer: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Sep 15;148(11):1013-21. doi: 10.1001/jamaoto.2022.2552. Online ahead of print.
Clinical trial NCT02263378: A New Supplement for the Immune Response to HPV Infection
Official title: Ellagic Acid and Annona Muricata May Modulate the Immune Response to High Risk HPV Infection. A Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Infection
Keywords: HPV, L-SIL
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether a supplement in which ellagic acid plus annona muricata are combined, may modulate the immune response to high risk HPV infection. Sixty women will be enrolled in a randomized, controlled study, having a histological diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is the activation of onco suppressor protein by the supplement and secondary outcome is the clearance of HPV infection in the treated group.


Eligibility criteria: Inclusion Criteria:

* women with high risk HPV infection
* histological diagnosis of L-SIL

Exclusion Criteria:

* women with no high risk HPV infection
* women without histological diagnosis of L-SIL

Primary outcomes:
measure: variation of onco suppressor protein expression from basal values. The expression variations are represented by the different percentage of positive cells
timeFrame: 6 months
Secondary outcomes:
measure: clearance of the HPV infection
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03014271: Primary Prevention Youth Suicide Trial in Colorado High Schools Prevention Among Colorado High School Students
Official title: The Impact of Sources of Strength, a Primary Prevention Youth Suicide Program, on Sexual Violence Prevention Among Colorado High School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Sexual Violence
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: University of Rochester
name: Texas Tech University
name: Colorado Department of Public Health and Environment
name: Centers for Disease Control and Prevention
First posted: 2017-01-09
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sources of Strength is an evidence based program for youth suicide that trains student key leaders to strengthen social connectedness and healthy norms school-wide and is listed on the National Registry of Evidence Based Programs and Practices (NREPP). This project will expand the existing evidence base by evaluating Sources of Strength for sexual violence outcomes in a randomized controlled trial (RCT) in twenty-four high schools.

Detailed description: At present few programs systematically address broader social-ecological factors such as school-wide norms and youth-adult connectedness that research identifies as major drivers of sexual violence. To address this gap, this application proposes a large-scale RCT evaluation of Sources of Strength to evaluate for sexual violence perpetration outcomes. Sources of Strength is an evidence based program for youth suicide that trains student key leaders to strengthen social connectedness and healthy norms school-wide and is listed on the National Registry of Evidence Based Programs and Practices (NREPP). This project will expand the existing evidence base by evaluating Sources of Strength for sexual violence outcomes, which has never been done before. Twenty-four high schools will be recruited and stratified (rural or urban) and randomly assigned to one of two conditions: (a) immediate Sources of Strength intervention, (b) wait-list for Sources of Strength Implementation after 16 months.

Eligibility criteria: Inclusion Criteria:

* high school student in participating school, parents did not withdraw from study

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in sexual violence perpetration measured by method of survey
timeFrame: Baseline; Month 24
measure: Change in suicidal behaviors measured by method of survey
timeFrame: Baseline; Month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Department of Public Health and Environment
state: Colorado
Study officials:
affiliation: Colorado Department of Public Health
name: Tomei Kuehl, MPA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00234871: Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)
Official title: A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Lotrel® on Albuminuria in Hypertensive, Type 2 Diabetic Subjects With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Diabetes
Proteinuria
Keywords: Hypertension
Diabetes
Proteinuria
Tarka
Lotrel
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy


Eligibility criteria: Inclusion Criteria:

* Diabetes
* Hypertension
* Albuminuria

Exclusion Criteria:

* Type 1 DM.
* Subject has severe hepatic dysfunction at Screening as determined by liver function tests:

  * Bilirubin \> 2.0 mg/dL.
  * ALT and/or AST \> 3 times the upper limit of normal.
  * Subject has poorly controlled diabetes, based on HbA1c \> 10% at Screening.
* Subject has non-diabetic renal disease.
* Subject has a hypersensitivity to ACE inhibitor, CCB, torsemide or sulfonylureas.

Primary outcomes:
measure: Changes in urinary albumin:creatinine ratio
timeFrame: 36 weeks
Secondary outcomes:
measure: Changes in blood pressure (BP), BP control, ABPM, proteinuria, GFR lipid parameters, glycemic control, quality of life, CRP, oxidative stress markers, clinical safety labs and adverse events.
timeFrame: 36 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Global Medical Information
role: STUDY_DIRECTOR
References:
Clinical trial NCT02486471: Hemostatic Procedure After Biopsy of the Cervix
Official title: Is a Hemostatic Procedure Required After Biopsy of the Cervix Uteri in Women Undergoing Colposcopy for Cervical Dysplasia? A Multicenter Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Dysplasia
Keywords: cervical dysplasia
colposcopy
haemostatic procedure
biopsy of the cervix uteri
Lead sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Cytological abnormalities of the Cervix uteri need to be clarified by colposcopy biopsy. To avoid bleeding after biopsy, monsel´s paste is a common used Agent. In a randomized clinical Trial the use of monsel´s paste after biopsy will be compared to no Intervention. The Primary outcome of the study is blood loss, secondary outcomes are pain, satisfaction of the patient and influence of Independent factors such as Age and Body mass index.


Eligibility criteria: Inclusion Criteria:

* abnormal pap smear
* first colposcopy ever

Exclusion Criteria:

* pregnancy
* bleeding disorder
* the use of blood thinner
* language barrier
* unwillingness to participate

Primary outcomes:
measure: Blood loss after 15 minutes (5-step visual analogue scale)
timeFrame: 15 minutes
Secondary outcomes:
measure: Blood loss after 3 hours (5-step visual analogue scale)
timeFrame: 3 hours
measure: Blood loss after 6 hours (5-step visual analogue scale)
timeFrame: 6 hours
measure: Blood loss after 24 hours (5-step visual analogue scale)
timeFrame: 24 hours
measure: Sensation of pain after 15 minutes (10-step visual analogue scale)
timeFrame: 15 minutes
measure: Overall Sensation of pain after 24 hours (10-step visual analogue scale)
timeFrame: 24 hours
measure: Overall Satisfaction of the Patient after 24 hours (10-step visual analogue scale)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Zydolab - Institute of Cytology and Immune Cytochemistry
state: NRW
city: Herne
country: Germany
facility: Department of Obstetrics and Gynecology of the Ruhr University Bochum
state: NRW
Study officials:
affiliation: Zydolab - Institute of Cytology and Immune Cytochemistry
name: Ziad Hilal, M. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01099371: Resistance Training in Knee Osteoarthritis
Official title: Progressive Resistance Training in Women With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Knee Osteoarthritis
Keywords: Knee
Osteoarthritis
Exercise
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2010-04-07
Enrollment: 70
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether:

1. Progressive resistance training improves pain and disability
2. Progressive Resistance training improves muscular strength, ability to walk and quality of life

Detailed description: Patients in experimental group participated in a 12-week progressive resistance training using a repetition maximum (RM) exercise in which patients performed 1RM with the maximum bearable weight. Once the 1RM was determined, training was divided into the following regimen: 2 series of 8 repetitions, the first with 50% and the second with 70% of 1RM.

The exercises were knee extension and flexion and hip abduction and adduction, all performed in machines. The 1RM load was reevaluated every 2 weeks.

The control group remained on a three-month waiting list for physiotherapy. Patients were assessed for pain, function, quality of life, muscle strength and six-minute walk test.

Eligibility criteria: Inclusion Criteria:

* Woman
* Age between 40-70 years old
* Pain between 3 and 8 on a 10-point numeric pain scale
* Radiographically confirmed knee OA

Exclusion Criteria:

* Inflammatory diseases or any comorbidity that prohibit exercises, regular physical activity
* Trip plans for the next 12 months

Primary outcomes:
measure: Pain assessed on a 10-point numeric pain scale
timeFrame: week 0
Secondary outcomes:
measure: Disability assessed on WOMAC
timeFrame: week 6
measure: Quality of life assessed on the SF-36
timeFrame: week 6
measure: Six-minute walk test
timeFrame: week 12
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Jamil Natour, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01779271: Phase 3 Study of Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Upper Respiratory Infection
Fever
Keywords: Pelubi
Pelubiprofen
Loxoprofen
Anti-pyretic
Fever
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-01-30
Enrollment: 183
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3 Clinical trial to assess the efficacy and safety of Pelubiprofen Compared to Loxoprofen in patients with Acute upper respiratory infection.


Eligibility criteria: Inclusion Criteria:

1. Over 15 years old
2. Male and Female
3. Patients with fever over 38.0°C due to cold (acute upper respiratory tract infection)
4. Patients with upper respiratory tract infection outbreak within 2 days and who did not received drug administration
5. Subjects who voluntarily or legal guardian agreed with written consent

Exclusion Criteria:

1. Fever reducer administration Within 4 hours from the screening point
2. Any incidence of febrile crisis from the past six months
3. Patients with Ulcers, gastrointestinal disorders which are confirmed by endoscopy
4. Patients with continuously administrating gastrointestinal disorder related drug
5. Patients with severe blood damage
6. Severe hepatic impairment (ALT, AST value more than 2 times the upper limit of the normal range)
7. With severe renal impairment (serum creatinine value is more than 2 times the upper limit of the normal range)
8. Patients with severe left ventricular dysfunction

Primary outcomes:
measure: Changes in Body temperature from baseline
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital, South Korea
Study officials:
References:
Clinical trial NCT00931671: Task-Oriented Aerobic Exercise Training in Chronic Stroke Patients
Official title: Effects of Task-Oriented Aerobic Exercise Training on Cardiorespiratory Fitness and Cerebral Blood Flow in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Physical fitness
Cerebral circulation
Walking
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to investigate (1) the effects of task-oriented aerobic exercise training on cardiorespiratory fitness, cerebral blood flow, oxygenation, functional performance, and physical activity in patients with chronic stroke. (2) the association between outcomes


Eligibility criteria: Inclusion Criteria:

* poststroke duration \> 6 months
* MMSE \> 22

Exclusion Criteria:

* severe cardiovascular disease
* depression
* dementia
* other disease affect the testing of the study

Primary outcomes:
measure: symptom-limited exercise test
timeFrame: 12 wks
Secondary outcomes:
measure: transcranial Doppler measurement
timeFrame: 12 wks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: