louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03910881: Technology-enabled Patient Support System for Self-management of CF
Official title: Technology-enabled Patient Support System for Self-management of Pediatric Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Using a one-group pre-post design, evaluate the effect of the adapted technology-assisted PSS on patient-reported outcomes (PROs).
Primary purpose: OTHER

Brief summary: This project will test a technology-enabled patient support system (PSS) as a self-management tool for children with CF and their family caregivers.

Detailed description: The goal of this study is to refine and test a technology-enabled patient support system (PSS) as a tool for self-management of pediatric CF. The PSS includes two components: 1) patient-facing: an app with customizable dashboards for tracking patient-generated outcome measures and providing personally relevant decision-making support; and 2) clinic-based: clinical patient management and technical support. Using a one-group pretest-posttest design, we will evaluate the effect of the adapted technology-assisted PSS on patient-reported outcomes (PROs). Study hypothesis: Among pediatric CF patients treated at the UAB CF Center, the use of technology-aided PSS over 6 months will improve health-related quality of life (primary outcome) as well as patient satisfaction, patient activation, and shared decision-making (secondary outcomes).

Eligibility criteria: Inclusion Criteria:

Diagnosis of Cystic Fibrosis -

Exclusion Criteria:

None

-

Primary outcomes:
measure: Health-related quality of life (CFQ-R scores)
timeFrame: 3 months
measure: Health-related quality of life (CFQ-R scores)
timeFrame: 6 months
Secondary outcomes:
measure: Shared decision-making (CollaboRate scores)
timeFrame: 3 months
measure: Shared decision-making (CollaboRate scores)
timeFrame: 6 months
measure: Patient/caregiver satisfaction (PACIC scores)
timeFrame: 3 months
measure: Patient/caregiver satisfaction (PACIC scores)
timeFrame: 6 months
measure: Patient/caregiver activation (PAM scores)
timeFrame: 3 months
measure: Patient/caregiver activation (PAM scores)
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT05342181: Static and Dynamic Core Stability Exercises in Potpartum Back Pain
Official title: Comparison of Static and Dynamic Core Stability Exercises on Pain and Disability in Postpartum Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Keywords: Pain and disability in postpartum
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of static exercises with dynamic core stability on pain and disability in postpartum back pain.

Detailed description: The study comprised 28 participants. The individuals were subdivided into binary groups, group A performed static exercises and group B performed dynamic exercises including swiss ball, each containing 14 subjects. Baseline treatment (Hot pack, TENS and posture correction) to both groups was given along with core stability exercises. Core stability exercises were performed on both group for 4 weeks. The pretreatment and post treatment tests are measured using the scale VAS (visual analog scale) and Oswestry disability index questionnaire. Both groups have shown the improvement in postpartum lumber pain and an improved in daily life activities. But swiss ball exercises have more significant improvement on pain and disability in patients having postpartum lumber pain.

Eligibility criteria: Inclusion Criteria:

* Age groups of 18 to 35
* Pain more than 4/10 on VAS
* Without referred pain to lower limbs
* Women with normal delivery

Exclusion Criteria:

* Nulliparous women
* Osteoporosis and OA
* Systemic arterial hypertension
* Hypersensitivity to electrical modalities
* Any fracture (spine, rib) or injury
* Any abdominal surgery
* Any other general ailment
* Vertebral or disc pathologies

Primary outcomes:
measure: Oswestry disability index
timeFrame: 4th week
measure: visual analog scale
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: General Hospital
state: Punjab
Study officials:
affiliation: General hospital lahore
name: Sara Aabroo, pp-dpt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04837781: The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement
Official title: The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement (Conventional and Accelerated): Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Position Anomalies
Keywords: Orthodontic, tooth movement, acceleration
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of vitamin D3 deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic. Assessing both lower anterior teeth alignment and the rate of maxillary canine retraction.

Detailed description: To evaluate the effect of vitamin D deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic, additionally find the effect of vitamin D deficiency on molar anchorage loss, canine rotation, lower incisor crowding alignment time, pain experienced by the patient during OTM and rate of orthodontically induce apical root resorption.

Eligibility criteria: Inclusion Criteria:

1. Age ranged from 18 to 30 years, from both sex.
2. Healthy general medical condition, healthy periodontal condition.
3. Malocclusion that requires extraction of the maxillary first premolars, followed by canine retraction, with moderate lower incisor crowding (Little's irregularity index 3-6mm).
4. Normal shape and structure of maxillary canine, with no history of filling or root canal treatment and normal shape and structure of maxillary first molar.

Exclusion Criteria:

1. Pregnant women.
2. Patient with renal or liver disease.
3. Patient taking corticosteroid or anticonvulsant drugs.
4. Patient with thyroid or parathyroid problems.

Primary outcomes:
measure: Canine retraction rate
timeFrame: 4 weeks
measure: Canine retraction rate
timeFrame: 8 weeks
measure: Canine retraction rate
timeFrame: 12 weeks
measure: Canine retraction rate
timeFrame: 16 weeks
Secondary outcomes:
measure: Alignment efficiency
timeFrame: 4 weeks
measure: Alignment efficiency
timeFrame: 8 weeks
measure: Alignment efficiency
timeFrame: 12 weeks
measure: Root resorption
timeFrame: 12 weeks
measure: pain perception
timeFrame: 7 days
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Dentisry-University of Baghdad
state: Al-Rusafa
Study officials:
affiliation: University of Baghdad
name: Mushriq Abid, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Attar A, Abid M. The Effect of Vitamin D3 on the Alignment of Mandibular Anterior Teeth: A Randomized Controlled Clinical Trial. Int J Dent. 2022 Feb 14;2022:6555883. doi: 10.1155/2022/6555883. eCollection 2022.
Clinical trial NCT02796781: Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases
Official title: Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Interstitial Lung Diseases
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
Collaborators: name: Regend Therapeutics
First posted: 2016-06-13
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Interstitial lung diseases (ILD) are a group of diseases affecting the lung interstitium. The lung scarring that occurs in ILD is often irreversible with only mitigating therapy available so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to investigate whether lung stem cells can regenerate damaged lung tissue. During the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with interstitial lung disease
* Clinically stable
* Written informed consent signed

Exclusion Criteria:

* Allergic to cell therapy;
* Patients with serious significant pulmonary infection need anti-infection treatment;
* Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months;
* Patients with malignant tumor in the past 5 years;
* Participated in other clinical trials in the past 3 months;
* Patients with serious heart disease(NYHA class Ⅲ-Ⅳ)
* Pregnant or lactating women;
* The investigator assessed as inappropriate to participate in this clinical trial.

Primary outcomes:
measure: Increase of diffusing capacity of the lung for carbon monoxide (DLCO)
timeFrame: 24 weeks
Secondary outcomes:
measure: Increase of total lung capacity (TLC)
timeFrame: 24 weeks
measure: Increase in 6 minute walk distance (6MWD)
timeFrame: 24 weeks
measure: Life quality: assessed by St. George respiratory questionnaire (SGRQ)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
References:
citation: Zuo W, Zhang T, Wu DZ, Guan SP, Liew AA, Yamamoto Y, Wang X, Lim SJ, Vincent M, Lessard M, Crum CP, Xian W, McKeon F. p63(+)Krt5(+) distal airway stem cells are essential for lung regeneration. Nature. 2015 Jan 29;517(7536):616-20. doi: 10.1038/nature13903. Epub 2014 Nov 12.
Clinical trial NCT04589481: Effectiveness of Different Candies Against Bad Breath
Official title: Effectiveness of Different Candies Against Bad Breath
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bad Breath
Keywords: halitosis
volatile sulphur compounds
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Ricola Group AG Schweiz
First posted: 2020-10-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Three different variants of a candy are being tested by each participant. The candies are randomly assigned to the subjects, so that each subject has tested each of the three candies once. Randomization creates a different order for each participant. The study will be carried out on three different days.
Primary purpose: DIAGNOSTIC

Brief summary: This study is to analyze whether the candies can relieve or eliminate bad breath, both subjectively and objectively.

Detailed description: This study is to systematically examine an existing candy, which is easily available and is intended to relieve or eliminate bad breath. The main aim of the study is to determine the effectiveness of the candies on the subjective perception of bad breath. The secondary outcome of the study is to investigate whether there is actually a decrease in volatile sulphur compounds (VSC) in the exhaled air and also a decrease in bad breath during organoleptic measurement.

The purpose of the study is to investigate whether the different candies can relieve or eliminate bad breath, both subjectively and objectively.

Eligibility criteria: Inclusion Criteria:

* Non- smoker
* No general medical illness or medication

Exclusion Criteria:

* Allergies/intolerances to ingredients of the products used
* Chronic diseases
* Smoker
* Pregnancy

Primary outcomes:
measure: Organoleptic analysis of breathing air sample
timeFrame: max 60 minutes at 3 different days
measure: Measurement of volatile sulphur compounds (VSC) in ppb (parts per billion).
timeFrame: max 60 minutes at 3 different days
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäres Zentrum für Zahnmedizin UZB
Study officials:
affiliation: Universitäres Zentrum für Zahnmedizin Basel (UZB)
name: Andreas Filippi, Prof. Dr. med. dent.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01732081: "Real-life" Cohort of Patients With Chronic Hepatitis B Virus Infection
Official title: Hepatitis B Cohort: Predictive Factors of the Outcome of Chronic Hepatitis B Virus Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Keywords: Hepatitis B
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 3000
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: Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France

Brief summary: It is estimated that 350-400 million people worldwide are chronically infected with hepatitis B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of chronic HBV infection and are responsible of about 500,000 deaths each year. Although some predictive factors of the outcome of chronic HBV infection were reported, it remains needed to more precisely determine the factors which are associated with the outcome in non-selected patients. Indeed, these factors should help to identify patients who are likely to have a better or worse evolution of their chronic HBV infection over time and thus, to adapt their clinical management and monitoring.Therefore, our purpose is to constitute a "real-life" cohort of non-selected patients to create a database of epidemiological, clinical, biological, virological and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)

Exclusion Criteria:

* Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV)
* Decompensated cirrhosis
* History of liver transplantation
* History of hepatocellular carcinoma (HCC)

Primary outcomes:
measure: to determine factors associated with the outcome of chronic HBV infection
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT01286181: Device-guided Breathing for Shortness of Breath in COPD
Official title: Device-guided Slow Breathing in COPD Patients With Clinically Significant Dyspnea: Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Dyspnea
Hyperinflation
Keywords: COPD
Biofeedback
Dyspnea
Quality of life
Stress
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although drug therapies and pulmonary rehabilitation have greatly improved COPD symptoms, as many as 50% of patients with severe COPD have inadequately controlled dyspnea. Device-guided breathing is a behavioral intervention that guides respiratory rates into a therapeutic range; prolongation of the expiratory phase improves hyperinflation, the most significant driver of dyspnea in this population. Device-guided breathing, has no known side-effects, and may represent a cost effective adjunctive treatment for dyspnea in severe COPD.


Eligibility criteria: Inclusion Criteria:

* Current or former cigarette smokers of at least 10 pack-years
* Clinically significant dyspnea, as determined by a score of at least 2 on the Medical Research Council Dyspnea Score questionnaire (0-4), or through pulmonary function test results of a residual volume (RV) of \> 150% predicted or an FEV1 of \<65% predicted
* Clinical diagnosis of chronic obstructive pulmonary disease

Exclusion Criteria:

* Unable to use the slow-breathing device due to hearing impairment
* Poor motivation or lack of interest in using the device
* Pulmonary Rehabilitation ordered as a new therapy at the time of enrollment

Primary outcomes:
measure: Determine effect of increased device-guided breathing on health-related quality of life measures.
timeFrame: 8 weeks
Secondary outcomes:
measure: Evaluate effect of device-guided slow breathing on daily physical activity.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto Benzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00382681: Evaluation of an Investigational Multi-Purpose Disinfecting Solution for Care of Soft Contact Lenses
Official title: Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Care
Keywords: Contact Lens Care
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-09-29
Enrollment: 252
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses.


Eligibility criteria: Inclusion Criteria:

* Successful daily wear of FDA Group I or IV lenses on a two-week or longer replacement schedule for at least one month.
* Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
* Successful lens wear for at least 8 hours per day.
* Vision correctable to 20/30.
* Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
* No corneal surgery within the past 12 months.
* No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
* No over-the-counter or prescription ocular medication.
* No enrollment in another clinical study within 30 days prior to enrollment.

Exclusion Criteria:

* None

Primary outcomes:
measure: Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses
timeFrame: Day 90
Secondary outcomes:
measure: Average Lens Wearing Time
timeFrame: Day 90
Other outcomes:
Locations:
city: Elkin
country: United States
facility: Elkin
state: North Carolina
Study officials:
affiliation: Alcon Research
name: Leslie Napier
role: STUDY_DIRECTOR
References:
Clinical trial NCT05066581: Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement
Official title: Vitoria Sleep Smart City: Interactive Intervention for Sleep Improvement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Sleep Hygiene
Lead sponsor: Hospital Universitario Araba
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
name: Ayuntamiento de Vitoria
name: Ibermatica
name: Bioaraba
First posted: 2021-10-04
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Currently, the investigators know that there is a high and increasing prevalence of sleep quality and quantity deficits in the general population with the social and health consequences that this entails. There are numerous activity wristbands linked to mobile apps that analyze sleep, but none can generate individualized recommendations for improvement interacting with the person. The main objective of the current project is to develop a virtual and interactive sleep assistant to increase the quantity and quality of sleep. Secondary objectives being the improvement of daytime sleepiness and the quality of life of the persons.

Methodology: 202 participants in active employment who meet the criteria of "poor sleepers" (defined by a Pittsburg test score \>5) are divided into 2 study groups. 1. Intervention group: Sleep data will be collected using validated questionnaires (SATED and the Sleep Hygiene Index) and objectively employing an activity bracelet, in which weekly, through a live chat, the medical staff of the sleep units will offer recommendations for the improvement of the deficits detected. 2. Control group: Same protocol as the intervention group, but the participants will not receive the recommendations via the interactive chat.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 65 years

Exclusion Criteria:

* Patients previously diagnosed and treated for sleep pathology (such as insomnia, Obstructive Sleep Apnea (OSA), Restless Legs Syndrome (RLS), narcolepsy or parasomnia, among others).
* Severe medical or psychiatric comorbidities.
* Subjects who are not capable of using mobile technology such as Smartphone.
* Subjects who are not committed to actively participate, putting into practice the sleep recommendations given by the assistant.

Primary outcomes:
measure: Total sleep time
timeFrame: Eight months
Secondary outcomes:
Other outcomes:
Locations:
city: Vitoria-gasteiz
country: Spain
facility: Hospital Universitario Alava
state: Alava
Study officials:
References: