louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01789775: Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema of Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-02-12
Enrollment: 114
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: Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea


Eligibility criteria: Key Inclusion Criteria:

1. Male or female who is at least 18 years of age or older.
2. A clinical diagnosis of facial rosacea.
3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).

Key Exclusion Criteria:

1. More than 20 facial inflammatory lesions of rosacea
2. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.
4. Less than 3 months stable dose treatment with tricyclic anti depressants, cardiac glycosides, beta blockers or other antihypertensive agents.
5. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.

Primary outcomes:
measure: Composite Success Assessment (CEA) and Patient Self Assessment(PSA).
timeFrame: Day 29
Secondary outcomes:
measure: Composite Success Assessment (CEA) and Patient Self Assessment(PSA).
timeFrame: D1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Galderma Investigational Site
city: Nice
country: France
facility: Galderma Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: Galderma Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: Galderma Investigational Site
city: Moscow
country: Russian Federation
facility: Galderma Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Galderma Investigational Site
city: Eskilstuna
country: Sweden
facility: Galderma Investigational Site
Study officials:
References:
Clinical trial NCT01680575: Study on Neutropenia Induced by Adjuvant Paclitaxel/Carboplatin Chemotherapy in Patients With Epithelial Ovarian Cancer
Official title: Development of a Risk Model Predicting Chemotherapy-induced Grade 3-4 Neutropenia by Paclitaxel/Carboplatin in Epithelial Ovarian Cancer: Prospective Observational Study for Model Development and Retrospective Study for Validation of Developed Model
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epithelial Ovarian Cancer
Keywords: Neutropenia
Paclitaxel
Carboplatin
Epithelial ovarian cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 750
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Training cohort (prospective cohort): Patients with epithelial ovarian cancer who underwent staging operation or debulking surgery at university hospital and who are planned to receive adjuvant chemotherapy with paclitaxel and carboplatin.

Validation cohort (retrospective cohort): Patients with epithelial ovarian cancer who received adjuvant chemotherapy with paclitaxel and carboplatin after staging operation or debulking operation.

Brief summary: To develop a robust prediction model to predict the occurrence of grade 3-4 neutropenia induced by adjuvant paclitaxel/carboplatin chemotherapy in patients with epithelial ovarian cancer and to validate this model.


Eligibility criteria: Inclusion Criteria:

* Patients with FIGO stage I-IV epithelial ovarian cancer after staging or debulking surgery
* Patients who is planned to receive (prospective cohort) ro who received (retrospective cohort) adjuvant chemotherapy with paclitaxel and carboplatin
* Patients who have signed approved informed consent

Exclusion Criteria:

* Uncontrolled medical disease
* Active infectious disease
* Previous pelvic radiation therapy
* Previous chemotherapy (prospective cohort)
* Patients with disease which can cause neutropenia
* Patients who will receive other targeted therapy or immunotherapy during adjuvant therapy (prospective cohort).
* Pregnant or lactating woman

Primary outcomes:
measure: Risk prediction model for grade 3-4 chemotherapy induced neutropenia
timeFrame: 1 year
Secondary outcomes:
measure: The association between mannose-binding lectin 2 gene SNP and neutropenia
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Jeong-Yeol Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02123875: ATTEND-Family-led Rehabilitation After Stroke in India
Official title: Family-led Rehabilitation After Stroke in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Christian Medical College and Hospital, Ludhiana, India
Sponsor class: OTHER
Collaborators: name: The George Institute for Global Health, Australia
First posted: 2014-04-28
Enrollment: 104
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: ATTEND Trial is based on early supported discharge- home based stroke rehabilitation model which proves to offer several advantages in low and mid income countries. The objectives of the pilot stude were to determine that with a randomized blinded outcome assessor, controlled trial, family- led caregiver- delivered home based rehabilitation is better than usual care for those with disabling stroke in India and the feasibility of this model.


Eligibility criteria: Inclusion Criteria:

* Adults (\>18 years)
* Recent (\<1 month) acute ischaemic/haemorrhagic/ undifferentiated stroke
* Residual disability (requiring help from another person for everyday activities)
* Expected to survive to discharge from hospital with a reasonable expectation of six month survival
* Able (or by proxy) to provide informed consent

Exclusion Criteria:

* Unable to identify a suitable family - nominated caregiver for training and subsequent delivery of care
* Those unwilling/unable to adhere to follow up.

Primary outcomes:
measure: Change in modified Rankin Score
timeFrame: 3rd and 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Ludhiana
country: India
facility: Christian Medical College and Hospital
state: Punjab
Study officials:
affiliation: Christian Medical College and Hospital
name: Jeyaraj D Pandian, MD DM FRACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
citation: Wang X, Moullaali TJ, Li Q, Berge E, Robinson TG, Lindley R, Zheng D, Delcourt C, Arima H, Song L, Chen X, Yang J, Chalmers J, Anderson CS, Sandset EC. Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients. Stroke. 2020 Aug;51(8):2411-2417. doi: 10.1161/STROKEAHA.119.028523. Epub 2020 Jul 9.
Clinical trial NCT00680875: Intranet-based Tobacco Prevention Program for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Promotion
Tobacco Smoking
Keywords: School Based Services
Prevention
Children
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2008-05-20
Enrollment: 3225
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to create an effective, disseminable, and exciting computer-based tobacco prevention program for 5th and 6th grade students. The goal of this school-based program is to decrease children's behavioral intentions and willingness to use tobacco, and to prevent or delay their initiation of tobacco use.

We will augment the 5th grade program with a booster program in 6th grade, and evaluate the long-term efficacy of the entire tobacco prevention program by conducting a randomized controlled trial in elementary and middle schools.

Detailed description: The aims of this randomized trail are as follows:

* Conduct a randomized trial to assess the effectiveness of the Tobacco Free Town (TFT) program at preventing or delaying initiation of tobacco by 7th grade, and decreasing behavioral intentions and willingness to use tobacco, as compared to the usual tobacco-prevention curriculum implemented in schools. The TFT program consists of 17 effective components delivered in eight sessions over a four-week period in 5th grade with two booster sessions delivered within a one-week period in 6th grade.
* Develop and test the effectiveness of 7 components to include in the booster sessions in 6th grade using an iterative development process including qualitative evaluation using focus and user groups, and culminating in a quantitative evaluation assessing the effectiveness of individual program components.
* Develop a program guide for teachers to accompany the program and develop parent newsletters for teachers to send home with students after each session.
* Examine change from 5th to 7th grade in the mechanisms that the TFT program is designed to target, and assess if these cognitive mechanisms serve to mediate the effects of the program on smoking outcomes.

Eligibility criteria: Inclusion Criteria:

* 5th and 6th grade students attending participating public schools in six counties within a one hour drive of Eugene

Exclusion Criteria:

* Children must be able to read and understand English.

Primary outcomes:
measure: Self reported cigarette and smokeless tobacco use
timeFrame: 2 years
Secondary outcomes:
measure: Intention and willingness to smoke cigarettes or chew smokeless tobacco in the future.
timeFrame: 2 years
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Judy A Andrews, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01302275: Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain
Official title: Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain: Predictors of Response - a Randomised, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polyneuropathy
Peripheral Nerve Injury
Postherpetic Neuralgia
Keywords: neuropathic pain
oxcarbazepine
pain mechanism
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Pain Research Center
name: Innovative Medicines Initiative
First posted: 2011-02-24
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine if the effect of oxcarbazepine on chronic peripheral nerve pain depends on the supposed mechanism of the pain, ie. if oxcarbazepine mainly relieve pain in patients with irritable nerves.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* definite or probable neuropathic pain
* diagnosis of polyneuropathy, postherpetic neuralgia or peripheral nerve inju
* pain duration \> 3 months
* pain rating at baseline \>= 4 point NRS
* Informed consent

Exclusion Criteria:

* other non-neuropathic pain condition
* allergy to oxcarbazepine
* renal or hepatic impairment
* epilepsy
* depression and other serious psychiatric disorders
* serious medical condition
* previous treatment for neuropathic that cannot be stopped
* pregnancy
* patients expected not to be able to comply with study protocol
* treatment with anticonvulsants, antidepressant or opioids

Primary outcomes:
measure: Total pain rated on numeric rating scale
timeFrame: Measurements from week 6 of treatment period
Secondary outcomes:
measure: Response defined as at least 50% reduction in pain score
timeFrame: Week 6 of each treatment period vs. baseline
measure: Neuropathic Pain Symptom Inventory
timeFrame: Week 6 of each treatment period
measure: Patient Global Impression of Change
timeFrame: Week 6 of each treatment period
measure: Rating of evoked pain
timeFrame: Week 6 of each treatment period
measure: Sleep disturbance
timeFrame: Week 6 of each treatment period
measure: Quality of life
timeFrame: Week 6 of each treatment period
measure: Use of escape medication
timeFrame: Week 6 of each treatment period
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
city: Odense
country: Denmark
facility: Department of Neurology, Odense University Hospital
Study officials:
affiliation: Department of Neurology, Odense University Hospital
name: Søren H Sindrup, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03861975: Exploring the Efficacy and Feasibility of the LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening
Official title: Exploring the Efficacy and Feasibility of the LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Heinz Family Foundation
First posted: 2019-03-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an interventional, non-therapeutic screening trial comparing two measurement devices cross-sectionally.
Primary purpose: SCREENING

Brief summary: This research will compare the absolute volumes of the upper extremity using both the LymphaTech Scanner and Perometer in a cohort of patients with a history of invasive or in-situ carcinoma of the breast.

Detailed description: Our trial seeks to assess the efficacy of the LymphaTech Scanner as compared to the Perometer, which is currently used to screen for breast cancer-related lymphedema. The focus of the study is to compare the absolute volumes of the upper-extremity as measured by each device and to compare the time it takes to measure both arms of a patient using each device to assess clinical feasibility.

Eligibility criteria: Inclusion Criteria:

* Participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast and will undergo unilateral breast cancer surgery
* Age \>18 years.
* Ability to understand and the willingness to verbally consent to the trial

Exclusion Criteria:

* History of primary lymphedema.
* Any patient with a current case of cellulitis.
* Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Participants unable to abduct upper-extremity perpendicular to body or to stand comfortably without aid for several minutes, both of which are necessary to perform a LymphaTech Scan

Primary outcomes:
measure: Precision and reliability
timeFrame: 3 years
Secondary outcomes:
measure: Measurement Time
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Alphonse G. Taghian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02092675: Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease
Official title: Endothelial Dysfunction and Frequent Exacerbator Phenotype in Patient With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Endothelial Dysfunction
Keywords: Chronic obstructive pulmonary disease
frequent exacerbator
endothelial dysfunction
Flow mediated dilatation
Systemic inflammation
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 117
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with COPD, smokers and former smokers recruited in an ambulatory basis.

Brief summary: The purpose of this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease.

Detailed description: Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death in developed countries. Acute exacerbations and cardiovascular diseases are the major causes of morbidity and mortality in COPD patients. According to the frequency of exacerbations, phenotype "frequent exacerbator" is defined and characterised with severe clinical course and was recognised as an increased risk for cardiovascular mortality. Recent studies considered that systemic inflammation plays a key role in the pathogenesis of COPD and endothelial dysfunction is a suspected link between increased cardiovascular mortality and systemic inflammation in COPD patients. Endothelial dysfunction is assessed by determining flow mediated dilatation index (FMD index) or plasma markers. Previous studies have suggested the presence of endothelial dysfunction in COPD patients, as well as the deterioration of endothelial function during exacerbations of COPD. This study will, for the first time, systematically explore endothelial dysfunction in two phenotypically distinct groups of COPD patients with simultaneous assessment of endothelial function flow mediated dilatation index (FMD index) and plasma markers.

Eligibility criteria: Inclusion Criteria:

* COPD patients in stable condition ( without exacerbation min 1 months ago)
* Over 40 years
* History of at least 10 py

Exclusion Criteria:

* acute exacerbation of COPD
* active malignancy
* autoimmune disease
* acute myocardial infarction
* diabetes mellitus with late complications
* congestive heart failure
* women of childbearing potential

Primary outcomes:
measure: difference in endothelial dysfunction
timeFrame: 6 months
Secondary outcomes:
measure: difference in pulmonary functional tests
timeFrame: 6 months
Other outcomes:
measure: difference in systemic inflammation
timeFrame: 6 months
Locations:
city: Zagreb
country: Croatia
facility: Univerity Hospital Centre Zagreb
Study officials:
affiliation: University Hospital Zagreb
name: Andrea Vukic Dugac
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03585075: Characterization of the Autofluorescence of Healthy and Pathological Tissues of Vocal Cords
Official title: Caractérisation de l'Autofluorescence Des Tissus Sains et Pathologiques Des Cordes Vocales
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngeal Neoplasms
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples of vocal folds from ENT surgery department, University Hospital of Besançon

Brief summary: The aim of this clinical trial is to provide information about autofluorescence of pathological versus healthy vocal folds tissues.

Experimentations are performed on vocal folds biopsies obtained from patients, surgered at ENT department, university hospital of Besançon. After being extracted, samples of vocal folds are submitted to excitations at 365 nm, 405 nm and 450 nm; light spectral absorptions are measured, and results are compared to reference anatomopathology.


Eligibility criteria: Inclusion Criteria:

* patient view in ENT department, presenting vocal fold lesion that necessitate biopsy
* patient informed and with non opposition

Exclusion Criteria:

* small (\<1mm) and/or brittle sample
* Patients in emergency situations, pregnant or nursing mothers, persons deprived of their liberty, minors or protected adults.

Primary outcomes:
measure: hyperspectral fluorescence of vocal folds
timeFrame: 30 minutes after biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHRU de Besancon
Study officials:
References:
Clinical trial NCT00000275: Cocaine Abuse and ADHD - 10
Official title: Cocaine Abuse and ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: New York State Psychiatric Institute
First posted: 1999-09-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of buproprion in treating individuals with adult attention-deficit hyperactivity disorder (ADHD) and cocaine dependence.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Side effects
measure: Drug use
measure: Cocaine craving
measure: ADHD symptoms
measure: Improvement in functioning
measure: Tolerability
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Herbert Kleber, M.D.
role: PRINCIPAL_INVESTIGATOR
References: