louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06184763: Evolution of the 6-minute Walk Test in Patients Treated With ELEXACAFTOR / TEZACAFTOR / IVACAFTOR
Official title: Evolution of the 6-minute Walk Test in Patients Treated With ELEXACAFTOR / TEZACAFTOR / IVACAFTOR
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
CFTR modulators
6-minutes walk test
physical activity
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 73
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort: cystic fibrosis patients followed in the respiratory diseases department of the Renee Sabran Hospital (approximately 100 patients)

Brief summary: The aim of the study is to identify a link between the new CFTR modulators and physical activity in cystic fibrosis patients.

The triple combination of CFTR modulators (ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR) has recently changed the management of cystic fibrosis.

This treatment has been shown to rapidly improve patients' respiratory function, with a gain in FEV1 at 1 month ranging from 10.4% to 13.6%. It also reduces the number of respiratory exacerbations and improves the nutritional status and quality of life of treated patients.

To date, there is limited data on the impact of these new therapies on physical activity. Few studies have investigated changes in exercise or physical activity parameters under ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR.

The 6-minute walk test is a validated field test used routinely to assess the exercise capacity of patients with chronic respiratory diseases, including cystic fibrosis.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 12 years with cystic fibrosis, heterozygous for the F508del mutation of the CFTR gene, treated with ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR.
* Patients followed in the respiratory diseases department of the Renee Sabran Hospital
* 6-minute walked test performed in the year preceding initiation of ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR
* 6-minute walked test performed after treatment initiation (between the 3rd month and the 14th month)
* No opposition to participation

Exclusion Criteria:

* - Age \< 12 years
* Pregnancy
* Discontinuation or reduction in dosage of ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR
* Patients objecting to the use of their data for research purposes

Primary outcomes:
measure: distance walked in the 6-minute walk test (metres)
timeFrame: between the 3rd month and the 14th month post treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Giens
country: France
facility: Respiratory diseases department, Renee Sabran Hospital (Hospices civils de Lyon)
Study officials:
References:
Clinical trial NCT04571463: Ethyl Glucuronide in Urine Samples of Pregnant Women Within the HUS ja PHHYKY Area
Official title: Etyyliglukuronidin Esiintyminen Virtsassa äitiysneuvola- ja äitiyspoliklinikkakäyntien yhteydessä HUS:n ja PHHYKY:n Alueella
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Finnish Pediatric Neurology Association
name: Finnish Foundation for Alcohol Studies
name: Päijänne Tavastia Central Hospital
name: Helsinki University Central Hospital
name: Seinajoki Central Hospital
First posted: 2020-10-01
Enrollment: 505
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for the ethylglucuronide (EtG) testing consists of the visitors in the HYKS, PHHYKY and the cities of Helsinki and Lahti prenatal care units, as well as the HYKS and PHHKYKY prenatal care units dedicated for the alcohol and drug abusing mothers (HAL- / HALSO-poliklinikka).

Brief summary: In order to find how many women continue using alcohol during their pregnancies the plan is to anonymously test routine urine samples collected during pregnancies for ethylglucuronide (ETG), a metabolite of ethanol that is detectable in urine up to several days after alcohol consumptions. Altogether 600 samples are taken in the prenatal care units and the prenatal care units dedicated for the alcohol and drug abusing mothers both in the Helsinki and Lahti areas. Test results are used to estimate and compare the prevalence of severe maternal drinking in the different populations.


Eligibility criteria: Inclusion Criteria:

* Pregnant

Exclusion Criteria:

-

Primary outcomes:
measure: EtG
timeFrame: Day 1
Secondary outcomes:
measure: Nicotine
timeFrame: Day 1
measure: Cannabis
timeFrame: Day 1
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: HALSO-poliklinikka
state: Päijät-Häme
city: Lahti
country: Finland
facility: Äitiyspoliklinikka/neuvola
state: Päijät-Häme
city: Helsinki
country: Finland
facility: HAL-poliklinikka
state: Uusimaa
city: Helsinki
country: Finland
facility: Äitiyspoliklinikka/neuvola
state: Uusimaa
Study officials:
affiliation: HUCS
name: Hanna Kahila, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02257463: Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
Official title: Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
inspiratory muscle training
dyspnea
Quality of Life
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 60
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim is to study effectiveness of inspiratory muscle training as a part of exercise training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to general exercise training program in regard to respiratory muscle strength, dyspnea, exercise performance and quality of life.


Eligibility criteria: Inclusion Criteria:

* Exsmokers
* Low PImax compared to reference values \[lower limits of normal: 80 cmH2O for patients less than or equal 54 years old; 71 cmH2O for patients' age between 55-64 years; and 65 cmH2O for patients 65 years old \].
* Stable patients without history of exacerbation or hospitalization four weeks before starting the study.

Exclusion Criteria:

* Lack of motivation and compliance.
* Patients with significant reversibility following bronchodilation defined as an increase in FEV1 of more than 12% and 200 ml from the pre-bronchodilator value
* Unstable cardiac disease \[severe heart failure, dangerous dysrhythmias, recent myocardial infarction or unstable angina (within 4 weeks)\].
* Uncontrolled hypertension
* Recent pneumothorax (within 6 weeks)
* Recent abdominal or thoracic surgery (within 6 weeks)
* Known progressive neuromuscular disorders
* Recent gastrointestinal bleeding (within 4 weeks)
* Current smokers
* Active cancer
* Patients with advanced liver diseases, or renal impairment.
* Known connective tissue diseases
* Significant endocrinal abnormalities

Primary outcomes:
measure: changes in respiratory muscle strength
timeFrame: after 4 weeks and after 8 weeks of study
measure: changes in perception of dyspnea
timeFrame: after 4 weeks and after 8 weeks of study
measure: changes in exercise performance
timeFrame: after 4 weeks and after 8 weeks of study
measure: changes in quality of life
timeFrame: after 4 weeks and after 8 weeks of study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mansoura University
name: Ahmed S Elmorsi, MD
role: STUDY_CHAIR
affiliation: Mansoura University
name: Mohamad E Eldesoky, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mona AA Mohsen, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Nesrien M Shalaby, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Dina A Abdallah, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02742363: Long Term Dental Effects in Adolescents Who Were Treated for Cancer in Childhood
Official title: Long Term Oral and Dental Effects in Adolescents Who Were Treated for Cancer in Childhood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 32
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old. The maximum time span of entering the study group-up to 20 years after last session of oncology treatment.

Brief summary: The investigators aim is to explore associations between specific types of cancer therapy, age at treatment and the presence of dental abnormalities in adolescence.

The study will help identify unique dental changes, malformations and or missing teeth that appear in adolescence as a secondary complication due to anticancer treatment (chemotherapy and or radiotherapy) given in childhood.

Materials and methods:

* Study Group: 200 patients, at least 12 years old, who were treated for Cancer at the age of 0-10 years old.
* The following data will be collected: Demographic information, Medical Status, Cancer therapy, Intraoral examination, Oral soft and hard tissue condition and radiographic examination.


Eligibility criteria: Inclusion Criteria:

* were treated for Cancer at the age of 0-10 years old

Exclusion Criteria:

* None

Primary outcomes:
measure: Oral abnormalities associated with cancer therapy.
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT04124263: Use of Short Text Messages to Promote Medication Adherence in Hypertensive Patients
Official title: Use of Short Text Messages to Promote Medication Adherence in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Adherence, Treatment
Keywords: Hypertension
Primary Health Care
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
Collaborators: name: Medtronic Foundation
First posted: 2019-10-11
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: OBJECTIVE: To evaluate the effect of intervention by sending short text messages with a reminder of the time of medication use, compared to sending educational messages, on adherence to drug treatment in patients with hypertension. METHODOLOGY: Prospective, randomized, controlled, double-blind, parallel group study that will be performed in patients with hypertension seen at a community pharmacy in Brazil. The following groups will be compared: a) intervention group 1: 70 hypertensive patients registered for access to medication associated with usual care, in addition to text messages via mobile phone with educational information b) intervention group 2: 70 hypertensive patients registered for access to medications that will additionally receive text messages at the times indicated in the prescription for use of each indicated medication, in addition to educational information. After the washout period, the groups will have the active interventions changed for an additional 90 days. The proportion of adherent and non-adherent patients with and without controlled BP in both groups will be compared after the periods of application of the different interventions.


Eligibility criteria: Inclusion Criteria: hypertension diagnosis, age, availability of mobile phone with short message texts access and ability to read and access short message texts -

Exclusion Criteria: visual, hearing or mental disabilities that disables receiving short message texts , being pregnant, recently delivered or breastfeeding

-

Primary outcomes:
measure: Treatment adherence
timeFrame: Seven months (including one month of washout period)
Secondary outcomes:
measure: Blood pressure
timeFrame: Seven months (including one month of washout period)
Other outcomes:
Locations:
city: Vitória Da Conquista
country: Brazil
facility: Farmácia Escola da UFBA, campus Anísio Teixeira
state: Bahia
Study officials:
References:
Clinical trial NCT05868863: Percutaneous Cementoplasty With or Without Screw Fixation
Official title: Percutaneous Cementoplasty With or Without Screw Fixation for Bony Pelvis Lesions in Elderly Patients : Feasibility, Safety and Clinical Outcomes.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interventional Radiology
Keywords: Cementoplasty
bone pelvic
elderly
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lesion of the bony pelvis treated by percutaneous cementoplasty with or without screw fixation at university hospital center of Saint-Etienne between January 1st 2012 and February 28th 2023 will be included.

Brief summary: Bone pathologies such as fragility fractures and neoplastic bone lesions are frequently encountered in rheumatology. When these lesions affect the pelvis, they are responsible both for pain that is sometimes very disabling, but also for significant functional disorders due to their location.

Different methods may be used to treat these lesions. The current challenge is to use less and less invasive techniques such as radio-guided cementoplasty to be able to treat all types of people, especially the most fragile. Among the elderly, the prevalence of these bone pathologies continues to increase due to the aging of the population and the improvement of diagnostic means.

Detailed description: The aim of this study is to retrospectively evaluate the outcome of cementoplasty of the pelvis in people aged 80 and over suffering from osteoporotic fractures or neoplastic lesions of the bony pelvis AND to assess the feasibility, safety and efficiency of this treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with lesion of the bony pelvis treated by percutaneous cementoplasty with or without screw fixation at university hospital center of Saint-Etienne between January 1st 2012 and February 28th 2023

Exclusion Criteria:

* Other interventional treatment at the same time and at the same location

Primary outcomes:
measure: Feasibility of the technique
timeFrame: Months: 3
Secondary outcomes:
measure: Safety of the technique by number of adverse events
timeFrame: Months: 3
measure: Number of Analgesic intake before and after the procedure
timeFrame: Months: 3
measure: Analysis Functional criteria: walking
timeFrame: Months: 3
measure: Analysis Functional criteria: early rising
timeFrame: Months: 3
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Sylvain GRANGE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03434886: Outcomes in CF Patients Accessing Their Registry Health Records
Official title: Evaluating Outcomes in European Cystic Fibrosis Patients With Access to Their Health Records: a Randomised Control Trial of a Registry Patient Portal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Cystic Fibrosis Registry of Ireland
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 282
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A multifactorial, parallel group, randomised control study in cystic fibrosis (CF) patients aged 13-30 years over an 18 month period. Patients will be offered read-only access to their CF registry electronic health record (CF View), or educational videos on CF (videos), or videos and CF View, or usual standard of care. The study aims are to examine the effect of patient access to C View on a range of clinical outcomes, health service usage, health literacy and patient reported outcomes.


Eligibility criteria: Inclusion Criteria:

* diagnosed with CF
* registered with their national CF patient registry
* FEV1pp ≥40
* aged 13-30 years

Exclusion Criteria:

* organ transplantation
* FEV1pp \<40

Primary outcomes:
measure: FEV1pp
timeFrame: 18 months
Secondary outcomes:
measure: Health literacy
timeFrame: 12 months
measure: Health-related quality of life
timeFrame: 12 months
measure: BMI
timeFrame: 18 months
measure: Pulmonary exacerbations
timeFrame: 18 months
measure: Hospitalisations
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02000986: Dietary and Exercise Interventions in Preventing Cardiovascular Disease in Younger Survivors of Leukemia, Lymphoma, or Brain Tumors
Official title: Effect of Non-Pharmacologic Interventions on Risk Factors of Cardiovascular Disease in Survivors of Childhood Leukemia, Lymphoma and Brain Tumor
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Childhood Brain Tumor
Childhood Hodgkin Lymphoma
Childhood Non-Hodgkin Lymphoma
Malignant Childhood Neoplasm
Keywords: Hodgkin's Lymphoma
Brain and Nervous System
Non-Hodgkin's Lymphoma
Leukemia, not otherwise specified
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial studies dietary and exercise interventions in preventing cardiovascular disease in younger survivors of childhood cancer. Eating a healthy diet and exercising regularly may reduce the risk of cardiovascular disease in younger survivors of childhood cancer.

Detailed description: Participants receive personalized exercise plan and prescription tailored to individual needs and current level of activity and fitness, and they also receive 2 one-hour individual exercise training sessions consisting of 20-30 minutes cardiovascular activity and strength training. Participants receive nutritional education consisting of energy balance, appropriate portion sizes, calorie count, and basic nutrition skills such as label reading every 2 weeks for 12 weeks.

After completion of study treatment, patients are followed for up to 6 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pediatric cancer
* Patients 3 months to 1 year after completion of therapy

Exclusion Criteria:

* Patients who are already on antihypertensive or insulin or cholesterol lowering medication
* Patients who have not been evaluated for exercise tolerance and cleared by their physician for participation
* Inability to understand program instructions due to language barrier or mental disability
* Unable to participate in the outlined exercise program due to a physical disability

Primary outcomes:
measure: Feasibility determined by average attendance and retention
timeFrame: At 3 months
Secondary outcomes:
measure: Feasibility determined by average attendance and retention from the blood pressure at enrollment
timeFrame: At 6 months
measure: Acceptability level at time of enrollment
timeFrame: At 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Massey Cancer Center
name: Marieka A Helou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03404986: Ultrasound Guided Ureteroscopy and Ureteric Stones
Official title: Ultrasound Guided Ureteroscopy for the Treatment of Lower Third Ureteric Stones in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteric Stone
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of urolithiasis is steadily increasing with an estimation of 1 out of 11 people in the United States. The prevalence of calculi in Afro-Asian region including Arab Republic of Egypt ranges from 4% to 20%. Ureteroscopy is one of the first line treatments for definitive management of ureteric stones. Conventional ureteroscopy relies on intraoperative fluoroscopy for visualization and guidance, exposing the patient, surgeon and operating room staff to ionizing radiation. To minimize the hazards of ionizing radiation there has been a trend toward radiation free alternative imaging modalities . Ultrasound provides an excellent alternative for upper urinary tract imaging because it is radiation free, rapid, portable and allows excellent visualization of the renal pelvis and calyces. There is increasing awareness and concern about the clinical use of ionizing radiation and the need to decrease exposure of patients and medical professionals. Ultrasound guided ureteroscopy in pregnant females and children- in whom fluoroscopy is to be minimized or avoided when possible - has been reported.


Eligibility criteria: Inclusion Criteria:

1. Patients with single symptomatic lower third ureteric radio-opaque stones indicated for endoscopic treatment.
2. Age group 18 years old or above.
3. Stone size 15 mm or less.

Exclusion Criteria:

1. Patients with bilateral ureteric stones
2. Ureteric congenital anomalies e.g. double ureter and ectopic ureter.
3. Previously failed ureteroscopy or previous ureteroneocystostomy.

Primary outcomes:
measure: Number of patients treated effectively by the two methods
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References: