louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06197035: The Coping With and Caring for Infants With Special Needs Intervention in Down Syndrome Infants
Official title: Coping and Caring for Families With Babies With Down Syndrome. A Family-centered Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Family
Physical Disability
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two intervention groups, a group with COPCA intervention and a group with standard physiotherapy
Primary purpose: TREATMENT

Brief summary: The objective is to compare the impact of standard infant physical therapy and the family-centered program, Coping with and Caring for Infants with Special Needs (COPCA), on infants born with Down syndrome. This is a randomized controlled trial that will be carried out in the patients' homes and outpatient settings in Spain between January 2024 and March 2024. An evaluation battery will be used that includes child and family outcomes and video analysis of therapy sessions.

The Infant Motor profile will be the primary outcome instrument.


Eligibility criteria: Inclusion Criteria:

* Babies with Down syndrome
* Families involved in Pediatric Physical Therapy

Exclusion Criteria:

* Other associated developmental disorders
* To not speak Spanish
* Do not sign informed consent

Primary outcomes:
measure: Motor Development
timeFrame: 3-6-18 months.
Secondary outcomes:
measure: Family empowerment
timeFrame: 3-6-18 months
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: University of Seville
Study officials:
affiliation: University of Seville
name: Elena Pinero-Pinto, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00382135: A Study of Semen Characteristics After 9 Months of Daily Tadalafil 20 mg
Official title: An Evaluation of Semen Characteristics After 40 Weeks Daily Dosing With 20 mg Tadalafil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Impotence
erectile dysfunction
semen
sperm
Healthy male volunteers
men with mild erectile dysfunction
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2006-09-28
Enrollment: 282
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with 20 mg tadalafil.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects or men with mild erectile dysfunction
* At least 45 years of age
* With specified semen characteristics.

Exclusion Criteria:

* Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
* A history of certain endocrine or hormonal abnormalities
* A history of significant testicular/genital abnormalities
* Any significant reproductive abnormality identified at the start of the study.

Primary outcomes:
measure: Change in sperm production measured at baseline and after 9 months of treatment.
timeFrame: 40 weeks
Secondary outcomes:
measure: Changes in other semen characteristics and reproductive hormones.
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Bothell
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03214835: CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions
Official title: CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Laryngeal Disease
Laryngeal Tumor
Laryngopharyngeal Reflux
Keywords: Larynx
reflux
LPR
tumor
lesion
Lead sponsor: CDx Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Rambam Health Care Campus
First posted: 2017-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The study will take place at Rambam medical center, department of Otolaryngology Head and Neck Surgery, for two years. Patients suspected of LPR or laryngeal l tumor and are candidate for laryngeal or hypopharyngeal biopsies will be recruited.

Detailed description: First- all patients visiting our clinic with laryngeal complaints suspicious for either LPR or laryngeal tumor will fill the RSI questionnaire. Then fiberoptic examination will be performed by a laryngologist that will complete the RFS score.

Patients with suspicious lesions will be referred for TFL standard biopsy and CDx brush biopsy in order to determine whether the lesions are malignant or benign. The pathologic diagnosis of invasive carcinoma from a TFL biopsy is considered equivalent to the pathology results from a direct laryngoscopy biopsy. All patients with benign pathology or carcinoma in-situ (CIS) on TFL biopsy will be referred for subsequent direct laryngoscopy (DL) for definitive diagnosis. At the time of the DL biopsy will include also another CDx brush smear. Patients with benign-appearing lesions will be taken for lesion removal and biopsy.Before removal of the lesion a CDx brush smear will be collected.

All the participants suspected of LPR will have: PHmetry with Manometry andCDx brush biopsy.All relevant demographic and clinical data will be retrieved for analysis.

CDx biopsies will be an addition to the routine management of the patients in the diagnosis and follow-up of laryngeal lesions and LPR and will not replace the standard regimen.

Eligibility criteria: Inclusion Criteria:

* Age 18 or over
* patients suspected to suffer from LPR
* Patients with laryngeal/hypopharyngeal lesions.

Exclusion Criteria:

* Patient refusal
* Patients with anatomical variants which precludes biopsy taking.
* Patients with allergy to lidocain-based local anesthesia agents.

Primary outcomes:
measure: Efficacy of EndoCDx brush
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of pain
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Jacob Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06879535: Long-term Symptomatic Follow-up of Patients with Long COVID Syndrome
Official title: ESTUDIO DE APLICACIÓN DE ESCALAS PARA VALORACIÓN SINTOMÁTICA DEL SÍNDROME DE COVID PERSISTENTE
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Long COVID
Keywords: Long COVID
Long-term follow-up
Symptoms
Scales
Lead sponsor: Hospital del Rio Hortega
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with long COVID who have been attended at the Internal Medicine Department at the Hospital Universitario Río Hortega from Valladolid

Brief summary: The goal of this observational study is to learn about the long-term evolution of long COVID.

The main question it aims to answer is:

Does the main symptoms of the patients diagnosed with long COVID aproximate to those of patients who have had COVID acute infection without devoloping long COVID? Participants will answer mailed survey questions about their main symptons.

Detailed description: Scales, indexes and questionnaires were mailed to 40 patients with long COVID to evaluate their main symptoms. Fatigue, emotional disorders, sleep disorders, cognitive impairments, dyspnea, physical activity, quality of life and pain were analyzed. The patients were reassessed after three years. The same scales, indexes and questionnaires were also sent to a control group of 40 volunteers of the same age and sex as the cases.

Eligibility criteria: Inclusion Criteria:

* patients older than 18 years old and younger than 75 years old
* patients who accepted to participate in the study
* patients who have had COVID acute infection
* patients who have long COVID (cases)

Exclusion Criteria:

* patients who refused to participate in the study at any time of the study
* patients whose diagnosis of long COVID was revoked during the study (cases)

Primary outcomes:
measure: Fatigue
timeFrame: From enrollment to three years later
measure: Emotional disorders
timeFrame: From enrollment to three years later
measure: Sleep disorders
timeFrame: From enrollment to three years later
measure: Cognitive impairments
timeFrame: From enrollment to three years later
measure: Dyspnea
timeFrame: From enrollment to three years later
measure: Physical activity
timeFrame: From enrollment to three years later
measure: Quality of life (healthcare)
timeFrame: From enrollment to three years later
measure: Pain (healthcare)
timeFrame: From enrollment to three years later
Secondary outcomes:
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
Study officials:
References:
Clinical trial NCT05579535: Effect of Weight on Hip Excursion During Gait
Official title: Effect of Weight on Hip Excursion During Gait in Children With Diplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Spastic
Keywords: Ankle;
diplegia
gait
hip excursion
weight
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Children with diplegia had considerably larger hip and knee excursion during gait cycle than did normal developing children.

Objective: To investigate the effect of using weight around the ankle on hip excursion in children with diplegia.

Detailed description: Fifty children with spastic diplegic cerebral palsy were assigned into two groups at random (A, B). Both groups had received the same prescribed exercise program with classical gait training for group A and gait training while using weight around ankle for group B. Treatment was conducted for one hour three sessions per week for successive 3 months. Two-dimensional (2D) gait analysis was used to evaluate hip excursion throughout the gait cycle before and after three months of therapy.

Eligibility criteria: Inclusion Criteria:

* able to follow simple basic commands,
* identified with gait abnormalities described as level II on Gross Motor Function Classification System (GMFCS).
* diagnosed as spastic diplegia.

Exclusion Criteria:

* severe visual or auditory problems,
* lower limb surgical orthopaedic surgery or
* BOTOX injection in the six months preceding the start of the study,
* and uncontrolled seizures.

Primary outcomes:
measure: hip excursion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Nahla
Study officials:
affiliation: Cairo University
name: Nahla mohamed, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodda J, Graham HK. Classification of gait patterns in spastic hemiplegia and spastic diplegia: a basis for a management algorithm. Eur J Neurol. 2001 Nov;8 Suppl 5:98-108. doi: 10.1046/j.1468-1331.2001.00042.x.
Clinical trial NCT05636735: Self-confidence in Midwife Students
Official title: Self-confidence in Midwife Students
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Midwife Students
Keywords: midwife students
self-confidence
stress
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: midwife students

Brief summary: Self-confidence is essential during the training of students but in professional practice. Therefore, the training of students must allow its acquisition.

However, the university environment is particularly stressful for students. This stress can lead to depression. Perceived stress refers to the feeling of inability to pass an exam even if the person has the abilities to do so.

Detailed description: aim of the study is to describe the level of self-confidence of midwife students.

Eligibility criteria: Inclusion Criteria:

* midwife students
* with or without repeating a grade
* in France
* agreeing to participate in the study

Exclusion Criteria:

-

Primary outcomes:
measure: self-confidence
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Ufr Medecine Urca
Study officials:
References:
Clinical trial NCT02901535: Tele-spirometry in Primary Care-Randomized Clinical Trial Cluster:Telemedicine in Chronic Obstructive Pulmonary Disease
Official title: Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Multifaceted Intervention in Symptoms Patients With Respiratory Illness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: telemedicine
chronic obstructive pulmonary disease
Primary Health care
spirometry
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Ministry of Health, Brazil
First posted: 2016-09-15
Enrollment: 240
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
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 the effectiveness of telemedicine multifaceted intervention in symptoms patients with chronic obstructive pulmonary disease.

Detailed description: This study is a randomized clinical trial for patients with chronic obstructive pulmonary disease from a primary care. The purpose is to determine the effectiveness of telemedicine (teleconsultation and telemonitoring) in control of chronic obstructive pulmonary disease symptoms.

Eligibility criteria: Inclusion Criteria:

* spirometry from TelessaudeRS-Universidade Federal do Rio Grande do Sul (from randomization cluster), Modified Medical Research Council Dyspnea \> 0

Exclusion Criteria:

* normal or restrictive spirometry, low quality spirometries (inadequate)

Primary outcomes:
measure: Symptoms
timeFrame: 20 a 22 weeks
Secondary outcomes:
measure: Spirometry - FEV1
timeFrame: 20 a 22 weeks
measure: Spirometry - FVC
timeFrame: 20 a 22 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: TelessaudeRS-Universidade Federal do Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Erno Harzheim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00695435: Tobramycin Tear Concentrations
Official title: Evaluation of Tobramycin Tear Concentrations of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension Versus TOBREX® Ophthalmic Solution in Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye
Keywords: normal volunteers
anti-infective
tobramycin
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-06-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers.


Eligibility criteria: Inclusion:

* Visual Acuity (VA) of 0.6 logMAR or better
* Tear meniscus height of ≥ 0.3mm at Visit 1.
* No concomitant topical ocular medications, including artificial tears, during the study period

Exclusion

* ocular hypertension, iritis or uveitis, glaucoma
* ocular surgery, intraocular surgery or ocular laser procedures in either eye within the past six months
* epithelial herpes simplex (dendritic keratitis); Vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular Rosacea; Mycobacterial infection of the eye; and / or fungal disease of the eye
* lacrimal duct obstruction, dry eye, ocular allergies.
* contact lens within 7 days of Visit 1.
* ocular medications within 14 days of Visit 1.

Primary outcomes:
measure: Tobramycin Tear Concentration Cmax (Maximum Concentration)
timeFrame: 2, 4, 6, 12, and 18 minutes
Secondary outcomes:
measure: Tobramycin Tear Concentration Area Under the Curve (AUC)
timeFrame: 2 to 18 minutes post administration
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT03060135: Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption
Official title: Comparing the Efficacy of Several Popular Online Interventions to Reduce Hazardous Alcohol Consumption: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 878
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: There are a number of popular, freely available online interventions targeting hazardous alcohol consumption. Unfortunately, most have limited or no published evidence regarding their efficacy. Of particular interest is the intervention, 'Hello Sunday Morning.' The current project proposes to evaluate its' efficacy employing a RCT, using The Check Your Drinking intervention as an active comparator in the trial.

Participants will be recruited through Amazon's MTurk crowdsourcing platform. Potential participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 6 months time. Those who agree to be followed-up will be assigned by chance to be asked versus not asked to access one of the interventions and then recontacted 6 months later to ask about their drinking and their impressions of the online intervention. The primary hypothesis to be tested is that participants receiving access to any of the online interventions will report a greater level of reduction in number of drinks in a typical week between the baseline survey and six-month follow-up as compared to participants in the control condition.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or over
* A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
* Typically consumes 15 or more drinks per week,
* Willingness to complete a 6-month follow-up survey

Exclusion Criteria: None

Primary outcomes:
measure: Change in the variable, number of drinks in a typical week, from baseline measurement to 6-month follow-up
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: John A Cunningham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schell C, Godinho A, Cunningham JA. To thine own self, be true: Examining change in self-reported alcohol measures over time as related to socially desirable responding bias among people with unhealthy alcohol use. Subst Abus. 2021;42(1):87-93. doi: 10.1080/08897077.2019.1697998. Epub 2020 Feb 10.
citation: Cunningham JA, Godinho A, Bertholet N. Outcomes of two randomized controlled trials, employing participants recruited through Mechanical Turk, of Internet interventions targeting unhealthy alcohol use. BMC Med Res Methodol. 2019 Jun 14;19(1):124. doi: 10.1186/s12874-019-0770-4.
Clinical trial NCT01939535: Preoperative Staging of Endometriosis With MRI
Official title: Prospective Evaluation of the Value of Magnetic Resonance Imaging as a One-stop-shop for Preoperative Stratification of Patients With Complexe Endometriosis - Imaging Deep Endometriosis Assessment Versus Laparoscopy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Endometriosis
Magnetic resonance imaging
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with endometriosis in a tertiary referral centre

Brief summary: The purpose of the study is to evaluate the value of MRI in preoperative stratification of endometriosis patients needing surgical approach by gynaecologists only or multidisciplinary approach by gynaecologists, urologists or/and abdominal surgeons.

Detailed description: The purpose of the study is to evaluate the value of MRI in preoperative stratification of endometriosis patients needing either a surgical approach by gynaecologists only or multidisciplinary approach by gynaecologists, urologists or/and abdominal surgeons.

Eligibility criteria: Inclusion Criteria:

* Women with strong suspicion of deep infiltrating endometriosis, with already planned surgery

Exclusion Criteria:

* Contra-indications for MRI; claustrophobic patients; patients in bad condition; pregnancy

Primary outcomes:
measure: Odds of changed surgical approach in deep endometriosis based on preoperative MRI findings.
timeFrame: All the imaging findings will be checked during a laparoscopy the latest 80 weeks after the imaging examinations.
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals KULeuven
Study officials:
affiliation: University Hospitals KULeuven
name: Didier Bielen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals KULeuven
name: Elvier Mussen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals KULeuven
name: Carla Tomassetti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals KULeuven
name: Christel Meuleman, PhD
role: PRINCIPAL_INVESTIGATOR
References: