louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00692874: Quality of Life Analysis of Treatment in Patients With Prostate Cancer on Adjuvant Zoladex Therapy
Official title: Quality of Life Analysis of Prostate Cancer Patient's Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Quality of Life
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 1646
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early or locally-advanced prostate cancer patients on androgen deprivation therapy

Brief summary: This is an open label, non-interventional quality of life analysis for Zoladex treated prostate cancer patients by investigator's questionnaire


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Early or locally-advanced prostate cancer patients on androgen deprivation therapy
* Investigators are requested to recruit patients only with at least 1 month prior Zoladex treatment.

Exclusion Criteria:

* Allergy to substance of medication
* Prostate cancer patients with advanced disease

Primary outcomes:
measure: Elements of a general and three disease-specific investigator questionnaire
timeFrame: Quarterly (plus or minus 3 days )
Secondary outcomes:
measure: Investigator Assessment Report
timeFrame: Yearly (plus or minus 1 week )
Other outcomes:
Locations:
city: Baja
country: Hungary
facility: Research Site
city: Bekescsaba
country: Hungary
facility: Research Site
city: Bekes
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Cegled
country: Hungary
facility: Research Site
city: Dunaujvaros
country: Hungary
facility: Research Site
city: Erd
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Kiskunhalas
country: Hungary
facility: Research Site
city: Nagykoros
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Sopron
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Szentendre
country: Hungary
facility: Research Site
city: Tatabanya
country: Hungary
facility: Research Site
city: Vac
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
Study officials:
affiliation: "Jahn Ferenc" City Hospital Budapest
name: Péter Tenke, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Hungary
name: Csaba Csongvai
role: STUDY_DIRECTOR
affiliation: AstraZeneca Hungary
name: Éva Gulyás
role: STUDY_CHAIR
References:
Clinical trial NCT02893774: Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer
Official title: Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Melanoma
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 314
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: OTHER

Brief summary: Generally, French studies concerned with the quality of life of cancer patients focus on the period of treatment (up to 2 years post diagnosis). However, studies about quality of life "after" cancer are relatively rare (= long-term quality of life, or from 5 years post diagnosis). These studies mainly concern the most common cancers (breast and prostate).

Or changes in quality of life after treatment could be different depending on the type of cancer. In addition, there is a significant influence of sociodemographic variables on the quality of life in remission.

Similarly using remote diagnostics, quality of life questionnaires related to health, must be reassessed because too often developed for situations in process.

Based on these findings, "ELCCA II" study proposes to study for five years, the evolution of the impacts of two types of cancer (breast and melanoma) on quality of life (overall and related to the subjective health), socioeconomic status, and behavioral and emotional dimensions (post-traumatic development, coping, anxiety-depression) of those treated.


Eligibility criteria: Inclusion Criteria:

* diagnosis of cancer (breast or melanoma) since less than 1 month
* no metastasis
* Inform Consent Form signed

Exclusion Criteria:

* severe psychiatric disorder (depression, psychosis, etc.)
* addictive pathology
* longtime antidepressant treatment (\> 3 months)
* Patient pregnant or breastfeeding

Primary outcomes:
measure: long term evolution of quality of life for patient with breast cancer or melanoma
timeFrame: 5 years after initial cancer diagnostics
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: ICO René Gauducheau
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: CAMPONE Mario, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00800774: Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old
Official title: Ten-year Follow-up of Laser in Situ Keratomileusis in Patients 8 to 15 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anisometropia
Keywords: LASIK
safety
efficacy
stability
high anisometropia
patients 8 to 15 years old
conventional treatments have failed
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2008-12-02
Enrollment: 9
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, efficacy, predictability, and stability of laser in situ keratomileusis (LASIK) to correct high anisometropia in patients 8 to 15 years old in whom conventional treatments have failed.

Detailed description: Nine eyes of nine patients (3 male and 6 female) with high anisometropia (\>3.50 D), were included in this study. Minimum follow-up was 10 years. All patients were treated with the Chiron Technolas 217 excimer laser.

Eligibility criteria: Inclusion Criteria:

* High anisometropia (\>3.50 D)
* Patients 8 to 15 years old
* Conventional treatments have failed

Exclusion Criteria:

* Diabetes
* Autoimmune diseases
* Topographic abnormalities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: IOG
state: GO
Study officials:
affiliation: Instituto de Olhos de Goiania
name: Belquiz A Nassaralla, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00627874: Trial of Myopia Prevention Using +3D Lenses
Official title: A Randomised, Controlled Trial of Prevention of Juvenile-Onset Myopia in Chinese Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Australian National University
First posted: 2008-03-04
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess whether a short-term imposed myopic defocus is effective in preventing the development and progression of juvenile-onset myopia in Chinese children.

Detailed description: 1. To determine if +3D lenses wearing for half an hour everyday prevents the development and progression of myopia in school children.
2. To identify ocular parameters and risk factors at baseline associated with development and progression of myopia.

Eligibility criteria: Inclusion Criteria:

* All children in the selected class are enrolled

Exclusion Criteria:

* Hyperopia \> +2.0 D
* High myopia \> -6.0 D
* Astigmatism\> 1.5 D
* Anisometropia \> 1.5 D
* Strabismus and amblyopia
* Any ocular, systemic, or neurodevelopmental conditions that could influence refractive development
* Chronic medication use that might affect myopia progression or visual acuity
* Already receiving other treatment for progressing myopia

Primary outcomes:
measure: Axial Length of eyes
timeFrame: Annual
Secondary outcomes:
measure: Autorefraction
timeFrame: Annual
Other outcomes:
Locations:
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Mingguang He, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06845774: The PROTECT (PrEP Optimization Through Telehealth Care and Treatment) Trial
Official title: Optimizing Low Threshold TelePrEP Care in Syringe Service Programs for People Who Inject Drugs in Appalachia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Prevention
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-02-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The expansion of HIV pre-exposure prophylaxis (PrEP) care has been endorsed as a key strategy for reducing new HIV infections, however, PrEP trials among people who inject drugs (PWID) are rare and uptake of PrEP has been minimal, most notably in rural areas. Structural barriers to healthcare access, lack of providers, and inadequate infrastructure to deliver PrEP are challenges in many rural areas. In addition, PWID often have social determinant barriers to PrEP care. This study will integrate telehealth PrEP care within syringe services programs (SSPs), a venue already routinely accessed by PWID, to reduce structural barriers to evidence-based HIV prevention through co-located comprehensive PrEP services, and test this against a standard of care approach in a pilot randomized clinical trial. The primary objective is to examine preliminary efficacy and effect sizes of novel integrated telehealth care versus standard education and active referral on the primary outcome of PrEP initiation in HIV-negative participants who inject drugs.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age
* report at least one occasion of injection drug use in the past month
* report an indication for PrEP in the past six months consistent with CDC guidelines for PrEP care
* be a documented client of the county SSP at the time of study entry
* express willingness to participate in a multi-session intervention and follow-up

Exclusion Criteria:

* HIV-positive status
* current PrEP care.

Primary outcomes:
measure: PrEP Initiation
timeFrame: 3 months post-baseline
measure: PrEP Initiation
timeFrame: 6 months post-baseline
Secondary outcomes:
measure: PrEP Persistence
timeFrame: 3 months post-baseline
measure: PrEP Persistence
timeFrame: 6 months post-baseline
measure: PrEP adherence
timeFrame: 3 months post-baseline
measure: PrEP adherence
timeFrame: 6 months post-baseline
Other outcomes:
measure: Intervention Acceptability
timeFrame: 2 weeks post-baseline
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Hilary L Surratt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02871674: Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial
Official title: Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorders
Neurodevelopmental Disorders
Attention Deficit Disorder With Hyperactivity
Keywords: Behavioural interventions
Sleep difficulties
Children
Attention Deficit Hyperactivity Disorder
Randomised controlled trial
Saudi Arabia
Behavioural Insomnia
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Shaqra University
First posted: 2016-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to implement and evaluate an RCT of behavioural sleep interventions for children aged 5-12 years with ADHD, and their primary caregivers, (women) in Saudi Arabia to address the following questions:

1. To what extent can a behavioural intervention improve sleep difficulties and increase sleep duration in children with ADHD?
2. To what extent do intervention-induced changes in sleep for children or primary caregivers (women) account for any changes in ADHD symptoms?


Eligibility criteria: Inclusion Criteria:

* The participants will be primary caregivers (women) of children aged 5-12 years who have been diagnosed with ADHD by a psychiatrist, using the criteria taken from Diagnostic and Statistical Manual of Mental Disorders-5 in Saudi Arabia.
* Children with comorbidities will be also included.
* Sleep difficulties are defined as a total score of over 41 in the Children's Sleep Habits Questionnaire (CSHQ).

Exclusion Criteria:

Children will be excluded from the study if they meet any of the following criteria:

* They receive non-pharmacological interventions for their sleep difficulties.
* They have been previously diagnosed as having an intellectual disability (IQ \< 70).
* They have obstructive sleep apnoea, according to the three items in the CSHQ.

Primary outcomes:
measure: The Children's Sleep Habits Questionnaire CSHQ
timeFrame: 2 months
measure: Conners' Parent Rating Scale-48 (CPRS-48)
timeFrame: 2 months
Secondary outcomes:
measure: The Sleep Disorders Scale for primary caregivers
timeFrame: 2 months
measure: The Depression Anxiety Stress Scales DASS
timeFrame: 2 months
measure: Conners' Teachers Rating Scale-28 (CTRS-28)
timeFrame: 1 month
Other outcomes:
measure: Activity monitor (ActiGraph)
timeFrame: 1 month
measure: Activity monitor diary
timeFrame: 1 month
measure: Demographic form
timeFrame: Baseline
Locations:
Study officials:
affiliation: University of Leeds
name: Hetaf A Alammar, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03317574: MEDITOXIN® in Treatment of Crow's Feet Line
Official title: A Randomized, Double-blind, Active Drug Controlled, Multi-center, Phase Ⅰ/Ⅲ Study to Determine the Efficacy and Safety of Meditoxin® in Treatment of Crow's Feet Line
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crow's Feet Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2017-10-23
Enrollment: 250
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: TREATMENT

Brief summary: to determine the efficacy and safety of Meditoxin® in treatment of crow's feet line


Eligibility criteria: Inclusion Criteria:

* Male or female of at least 20 to 65 years old
* Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator

Exclusion Criteria:

* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* Patients with allergy or hypersensitivity to the investigational drugs or their components
* Patients who have bleeding tendency or taking anti-coagulant
* Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
* Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
* Patients who are unable to communicate or follow the instructions
* Patients who are not eligible for this study based on the judgment of an investigator

Primary outcomes:
measure: Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale(FWS)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
Clinical trial NCT04815174: Observational Study of the Clinico-biological Evolution and Standard of Care Offered to Patients With Ebola Virus Disease
Official title: Observational Study of the Clinico-biological Evolution and Standard of Care Offered to Patients With Ebola Virus Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ebola Virus Disease
Lead sponsor: Alliance for International Medical Action
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 711
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with positive RT-PCR admitted in ETC's during the inclusion period were included in the study

Brief summary: This study highlighted the possibility, even in epidemic settings, of providing advanced supportive care for patients with VMEs. Indeed, while the prospect of offering any invasive medical care was widely discussed in 2014 in West Africa with the aim of limiting the exposure of caregivers, the epidemic of 2018-2019 has on the contrary seen the development of a number of medical care strategies, in parallel with the deployment of specific treatments. This study aims to describe a cohort of patients receiving this upgraded supportive care during the tenth epidemic in the DRC.


Eligibility criteria: Inclusion Criteria:

* Laboratory confirmed Ebola Virus Disease

Exclusion Criteria:

-

Primary outcomes:
measure: Mortality
timeFrame: Through the end of the hospitalization, with an average of 11 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beni
country: Congo, The Democratic Republic of the
facility: BENI ETC
state: Nord Kivu
Study officials:
References:
Clinical trial NCT00662974: Searching for the Perfect Oil to Protect the Perineum: A Randomized-Controlled, Double-Blind Trial
Official title: A Randomised Double Blind Clinical Trial to Verify if Perineal Massage Increases the Chances of Delivering With an Intact Perineum Comparing the Two Oils. As Secondary Objective, we Will Evaluate the Effects of Perineal Massage on Specific Tear Location, the Severity of Perineal Tears and the Amount of Suture Material Required for Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Second Stage of Labor
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study we intend to randomly assign each parturient one of two commonly used oils to be applied during the second stage of labor, one of them containing vitamin E. We will verify if perineal massage increases the chances of delivering with an intact perineum comparing the two oils. As secondary objectives, we will evaluate the effects of perineal massage on specific tear location, the severity of perineal tears and the amount of suture material required for repair.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Term pregnancy

Exclusion Criteria:

* Non-vertex pregnancies
* Multiple pregnancies
* Placenta previa
* Placental abruption
* Intra-uterine infection
* Non progressive labor first stage
* Former operations or surgical procedures in the vagina
* Perineal massage during the weeks before labor

Primary outcomes:
measure: perineal tears vs intact perineum
timeFrame: after delivery
Secondary outcomes:
measure: severity of perineal tears amount of suture material required for repair suturing length
timeFrame: after delivery
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Delivery Room, Soroka University Medical Center
Study officials:
References:
Clinical trial NCT06905574: Surgeon-Guided Serratus Block in Breast Reduction Surgery
Official title: Postoperative Analgesic Efficacy of Intraoperative Surgeon-Guided Serratus Block: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain Control
Breast Reduction
Keywords: breast reduction
postoperative pain control
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Surgeon guided serratus block, which can be performed by the surgeon in participants undergoing breast reduction surgery, may reduce the sensation of pain from the surgical field in the postoperative period. Thus, participants experience less pain in the postoperative period, consume less analgesics, and there is a decrease in related complications. The aim of this study was to evaluate the effects of the intraoperative surgeon guided serratus block applied on the analgesic consumption of the participants in the first 24 hours after surgery in participants undergoing breast reduction surgery.


Eligibility criteria: Inclusion Criteria:

* Patient's willingness to be included in the study
* 18-65 years
* Woman
* Operated with inferior pedicled breast reduction technique
* The distance from the sternal notch to the nipple complex is between 25-40cm
* ASA I-II
* Breast Usg result BIRADS 1-2
* Patients who have not previously received RT to the breast and have no history of malignancy

Exclusion Criteria:

* Patient's request/refusal not to be included in the study
* Previous history of malignancy
* RT story,
* ASA 3-4-5-patient group
* Severe organ failure
* Alcohol, drug addiction
* Bupivacaine allergy
* Diagnosis of psychiatric illness and psychiatric drug use
* Surgery lasting longer than 3 hours
* Bleeding diathesis

Primary outcomes:
measure: 24 hours postoperatively opioid consumption
timeFrame: 24 hours
Secondary outcomes:
measure: post-operative acute pain status, post-operative nausea-vomiting status, post-operative NRS determination of pain at rest and in motion determination of complications such as nausea, vomiting, itching, determination of the first PCA analgesic request.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun training and research hospital
Study officials:
affiliation: SAMSUN UNİVERSİTY
name: Ayhan Sönmez
role: STUDY_DIRECTOR
References: