louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05501639: Exacerbation Risk in Asthma
Official title: Exacerbation Risk in Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-08-15
Enrollment: 1899
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: Patients with least two asthma diagnosis will be included. Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use.

Brief summary: The purpose of this study is to conduct a comparative analysis of patients using Tiotropium in combination with Inhaled Corticosteroids (ICS) versus those that use long-acting β2-agonists (LABA) medication in combination with ICS.


Eligibility criteria: Inclusion Criteria:

* Patients with least two asthma diagnosis
* Patients will be required to be concurrently on inhaled corticosteroids (ICS)+Tiotropium (tio) (specifically Tiotropium Respimat® 1.25 mcg) or ICS/LABA
* Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use

Exclusion Criteria:

* Patients with least two diagnosis of chronic obstructive pulmonary disease (COPD) at any time during the study period
* Patients less than 12 years of age
* Patients on biologics within 6 months prior to ICS+Tio or ICS/LABA use
* Patients with prior Tio or ICS/LABA use during the 6-month baseline period
* Patients with urinary bladder obstruction, urinary retention, and glaucoma
* After the propensity score matching (PSM) process, unmatched patients

Primary outcomes:
measure: Time to First Severe Exacerbation
timeFrame: From index date to first severe exacerbation, up to 1 year.
Secondary outcomes:
measure: Time to First Moderate-or-severe Exacerbation
timeFrame: From index date to first moderate-or-severe exacerbation, up to 1 year.
measure: Percentage of Patients With Exacerbation
timeFrame: From index date through first report of exacerbation, up to 1 year.
measure: Rate of Exacerbation at 6 Months and One Year
timeFrame: at 6 months and one year
measure: Percentage of Patients With Health Care Resource Utilization (HCRU)
timeFrame: From index date to end of follow-up, up to 1 year.
measure: Health Care Resource Utilization (HCRU)
timeFrame: From index date to end of follow-up, up to 1 year.
measure: Percentage of Patients With Use of Rescue Medications
timeFrame: From index date to end of follow-up, up to 1 year.
Other outcomes:
Locations:
city: White Plains
country: United States
facility: eMax Health
state: New York
Study officials:
References:
Clinical trial NCT03205839: Acceptance-based Self-help for Individuals With Visible Difference and Social Anxiety
Official title: Effectiveness of Acceptance-based Self-help for Individuals With Visible Difference and Social Anxiety: a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visible Difference
Acceptance and Commitment Therapy
ACT
Skin Condition
Hair Condition
Craniofacial
Burns
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The acceptance and commitment therapy (ACT) model theoretically fits with treating appearance-related anxiety in individuals with a visible difference. This study examines the effectiveness of an acceptance-based self-help manual for this population.

Detailed description: Individuals with visible difference commonly experience social anxiety due to appearance-related concerns. There are limited resources to help people with appearance-related distress, so internet-provided self-help interventions may be beneficial. A pilot randomised controlled trial will compare the effectiveness of an acceptance-based self-help intervention to a waitlist control group.

We hypothesise (1) the acceptance-based self-help intervention will significantly increase participants' "psychological flexibility", (2) significantly decrease fear of negative evaluation from others and (3) significantly increase their quality of life, compared to the waitlist control group. Data will be collected at two time points only.

General distress (CORE-10) will be collected pre-intervention only to ensure randomisation has been successful. Should the two groups significantly differ in distress, this will be accounted for in subsequent analyses.

Eligibility criteria: Inclusion Criteria:

* Individuals who self-identify as having a visible difference to their appearance (such as, but not restricted to: hair and skin conditions, burns, craniofacial conditions, birthmarks, surgical scarring)
* Must self-define as experiencing concerns about social interaction or a loss of social confidence in relation to their visible difference.
* Must be aged 18 years or over
* Must be fluent in English language
* Must have access to a computer and the internet

Exclusion Criteria:

* Currently receiving any form of psychotherapy

Primary outcomes:
measure: Comprehensive assessment of Acceptance and Commitment Therapy processes
timeFrame: Four weeks
Secondary outcomes:
measure: Brief Fear of Negative Evaluation Scale II (BFNE-II)
timeFrame: Four weeks
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Four weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: University of Sheffield
Study officials:
References:
Clinical trial NCT04279639: Observational Trial of Qigong for Patients in Pain
Official title: Observational Trial of Chaoyi Fanhuan Qigong as a Complementary Practice in Patients Receiving Treatment at a Tertiary-care Pain Management Unit: Part II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the Pain Management Unit for management of chronic pain.

Brief summary: This observational study documented outcomes resulting from qigong practice as a complementary self-care practice. All subjects continued with their usual medical care. Recruitment was passive, and participants consisted of those who encountered the practice as part of an earlier clinical trial, or entered the program prior to the observational period (posted information, word-of-mouth), or entered during the observational period (posted information).


Eligibility criteria: Inclusion Criteria:

* Those undertaking qigong practice as a complementary self-care practice at the Pain Management Unit

Exclusion Criteria:

* None

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: 8 week intervals
Secondary outcomes:
measure: Profile of Mood States
timeFrame: 8 week intervals
measure: health-related quality of life
timeFrame: 8 week intervals
measure: Sleep
timeFrame: 8 week intervals
measure: Fatigue
timeFrame: 8 week intervals
measure: Practice log
timeFrame: 8 week intervals
Other outcomes:
Locations:
Study officials:
References:
citation: Curry L, Pike M, Lynch M, Marcon D, Sawynok J. Observational Study of Qigong as a Complementary Self-Care Practice at a Tertiary-Care Pain Management Unit. Evid Based Complement Alternat Med. 2021 Jun 17;2021:6621069. doi: 10.1155/2021/6621069. eCollection 2021.
Clinical trial NCT02502539: Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases
Official title: Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Keywords: Juvenile idiopathic arthritis
Physical exercise
Pro-anti-inflammatory balance
Interleukins
miRNA
Calgranulins
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Juvenile idiopathic arthritis (JIA) is a chronic disease characterized by persistent joint inflammation. The immune system disruption that leads to overproduction of pro-inflammatory cytokines (TNF-α, IL-1, IL-6) is a cascade of events on different levels-some molecular, some cellular, and some systemic. Our objective is to identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients.

Detailed description: Feasibility study

Eligibility criteria: Inclusion Criteria:

* Children between 8 and 12 years
* Tanner stage \< T2
* polyarthritis, oligoarthritis and ERA sub-type of JIA
* Stable disease during 3 months before starting study

Exclusion Criteria:

* Infection
* Fever
* Anti-IL6 treatment
* More than 6h per week of physical activity
* Systemic corticosteroid treatment during the 3 months before starting study
* Systemic JIA
* JIA not mastered by treatments
* Other autoimmunity or auto-inflammatory diseases
* Participation in another clinical research protocol

Primary outcomes:
measure: Percent change
timeFrame: AT DAY 1
Secondary outcomes:
measure: pain (VAS)
timeFrame: at day 1
measure: locomotors function (CHAQ)
timeFrame: at day 1
measure: swelling of knee
timeFrame: at day 1
measure: rate of miRNA
timeFrame: at day 1
measure: plasma level of melatonin
timeFrame: at day 1
measure: sitfness of knee
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: CHU ESTAING
name: Etienne MERLIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01183039: Effects of Training in Healthy Sedentary Subjects
Official title: Cellular Effects of Training in Healthy Sedentary Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Subjects
Keywords: Sedentary
Lead sponsor: 5 Santé
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Régional Universitaire Montpellier
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2010-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to understand underlying mechanisms of improved exercise tolerance in Healthy Sedentary Subjects after training program.

Detailed description: Training protocol used is based on recommendations. A minimum of 20 sessions in 4-6 weeks were proposed. The exercise intensity of exercise corresponds to target heart rate at ventilatory threshold measured during incremental exercise test. Training at this intensity allowed us to individualize effort for each patient.

Eligibility criteria: Inclusion Criteria:

* healthy Sedentary Subjects

Exclusion Criteria:

* neuromuscular disease
* chronic heart failure
* diabetes
* renal diseases
* liver diseases

Primary outcomes:
measure: Effects of training program on mitochondrial function and oxidative stress
timeFrame: 6 to 8 weeks
Secondary outcomes:
measure: Relationship between mitochondrial function, oxidative stress and exercise tolerance in COPD patients
timeFrame: 6 to 8 weeks
Other outcomes:
Locations:
city: Lodeve
country: France
facility: Clinique du souffle La valonie
city: Montpellier
country: France
facility: hopital Arnaud de Vilneuve
city: Osseja
country: France
facility: Clinique du souffle La solane
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Maurice MH Hayot, MCU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05157139: Clinical Trial for Oral Formula of Vanillin and Wheat Germ Oil for Treatment of Mild and Moderate COVID-19 Viral Disease
Official title: Clinical Trial for Oral Formula of Vanillin and Wheat Germ Oil for Treatment of Mild and Moderate COVID-19 Viral Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Mild-to-moderate COVID-19
Keywords: mild-to-moderate COVID-19 vanillin, wheat germ oil
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Assoc. Prof. Ayman Ibrahim Baess
name: Dr. Noha Alaa Eldine Hassan Hamdy
name: Ph. Hanya Hesham Sweilam
First posted: 2021-12-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * The study is a randomized clinical trial to assess a natural formula of vanillin \& wheat germ oil to treat and stop the clinical progression of COVID-19.
* The study aims to treat people with mild-to-moderate COVID-19 before their cases become severe.
* The study duration is a 5-day experimental intervention and an extended 4 weeks follow up.


Eligibility criteria: Inclusion Criteria:

1. PCR confirmed diagnosis for COVID-19.
2. Age ≥18 years.
3. Both genders
4. The disease started within 7 days (ideally 72 hours) of diagnosis or clinical deterioration.
5. Patients diagnosed as mild or moderate

Exclusion Criteria:

1. Patients diagnosed with severe Illness: Individuals who have SpO2 \<92% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<300 mm Hg, respiratory frequency \>30 breaths/min, or lung infiltrates \>50%.
2. General: advanced kidney disease; advanced liver disease; pregnancy (known or potential) or lactation, and advanced cardiovascular diseases.
3. Allergy to Vanilla flavor, vanillin, or wheat germ oil
4. Active cancer

Primary outcomes:
measure: 1. Mean change in the disease severity (clinical assessment).
timeFrame: 3-5 days
measure: 2. Rate of disease remission.
timeFrame: 3-5 days
measure: 3. Hospitaization & Survival rate
timeFrame: up to 4 weeks
Secondary outcomes:
measure: 4. Mean change in complete blood picture
timeFrame: 3-5 days
measure: 5. Mean change in C reactive protein (CRP)
timeFrame: 3-5 days
measure: 9. The mean change in serum interleukin-6 (IL-6)
timeFrame: 3-5 days
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
References:
Clinical trial NCT00503139: Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan
Official title: Enbrel Special Use Result Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 684
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital and Rheumatology clinic

Brief summary: The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives: 1. To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in the long-term use.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria Patients with rheumatoid arthritis (RA) who fulfill all of the following

1. Patients who are refractory to the treatment.
2. Patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted.
3. Patients without a history of or concurrent malignant tumors.

Exclusion Criteria:

Primary outcomes:
measure: Number of Participants in Safety Analysis Population of Etanercept
timeFrame: 3 years
measure: Number of Participants With Treatment Related Adverse Events of Etanercept
timeFrame: 3 years
measure: Number of Participants With Serious Treatment Related Adverse Events of Etanercept
timeFrame: 3 years
measure: Number of Participants With Unlisted Treatment Related Adverse Events of Etanercept
timeFrame: 3 years
measure: European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)
timeFrame: 2 years
Secondary outcomes:
measure: Modified Health Assessment Questionnaire (mHAQ) Score
timeFrame: 2 years
measure: Visual Analog Fatigue Scale (VAFS)
timeFrame: 2 years
measure: European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR)
timeFrame: 2 years
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01679639: A Study to Investigate the Effects of Rifampicin on the Pharmacokinetics of Aleglitazar in Healthy Volunteers
Official title: An Open-label, Fixed-sequence, Three-period, Single Group Study to Investigate the Effects of Rifampicin as an OATP1B1 Inhibitor and a CYP2C8 Inducer on the Pharmacokinetics of Aleglitazar in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-09-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This open-label, fixed-sequence, three-period, single group study will evaluate the effects of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will receive single doses of aleglitazar in all three periods and single doses of rifampicin in periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is up to 14 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, aged 18 to 55 years inclusive at the time of screening
* Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
* Females must be surgically sterile or use two acceptable methods of contraception
* Non-smoker or currently smoking less than five cigarettes/day and willing to abstain from smoking during the study

Exclusion Criteria:

* Any clinically relevant abnormal laboratory test results at screening or on Day -1 of all periods, as judged by the Investigator
* A history of clinically significant disorders (e.g., gastro-intestinal, cardiovascular, hepatic)
* Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* An average alcohol intake of more than 14 units per week
* Volunteers diagnosed, or suspected of having porphyria, and subjects with first degree relatives diagnosed, or suspected of having porphyria
* Diagnosis of Gilberts Syndrome
* A positive screen for drugs of abuse at screening or on admission to the clinical unit

Primary outcomes:
measure: Pharmacokinetics: Area under the plasma concentration time curve
timeFrame: Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12
Secondary outcomes:
measure: Safety: incidence of adverse events
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04144439: Effect of GABA on ADHD and Seizures in Children With Epilepsy.
Official title: Effect of Gamma Aminobutyric Acid on ADHD and Seizures in Children With Epilepsy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Epilepsy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Effect of GABA on ADHD and seizures in Children with epilepsy.

Detailed description: Effect of Gamma aminobutyric acid on ADHD and seizures in Children with epilepsy.

Eligibility criteria: Inclusion Criteria:

* Epilepsy
* ADHD

Exclusion Criteria:

* Epilepsy without ADHD

Primary outcomes:
measure: Number of seizures
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Lecturer of Pediatrics - Kafr Elsheikh University
name: Abeer Salamah, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02475239: Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo
Official title: Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo
Keywords: Benign Paroxysmal Positional Vertigo, Postural Restriction
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2015-06-18
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The standard treatment of posterior semicircular canal benign paroxysmal positional vertigo is the canalith repositioning procedure or the Epley maneuver. Based on the present literature, there is controversy on the efficacy of post-maneuver postural restrictions.The aim of this study was to conduct a randomized controlled trial to compare the treatment efficacy of post-maneuver postural restriction with CRP alone in patients with posterior semicircular canal benign paroxysmal positional vertigo.

Detailed description: Benign paroxysmal positional vertigo is the most common cause of vertigo. Based on the present literature, there is controversy on the efficacy of post-maneuver postural restrictions.Some study designs were not randomized controlled trials. The present study offers an alternative way of postural restriction to maintain postural restriction as much as possible.

Eligibility criteria: Inclusion Criteria:

* Patients with unilateral posterior semicircular canal benign paroxysmal positional vertigo and
* A negative neurologic examination

Exclusion Criteria:

* Secondary benign paroxysmal positional vertigo caused by trauma head injury, inner ear surgery, viral labyrinthitis or Meniere's disease
* Patients with central vertigo, cervical spine, neurologic, otologic, psychiatric diseases
* Patients who used medications that affected the neurologic and otologic systems for less than 48 hours

Primary outcomes:
measure: The Dix-Hallpike test
timeFrame: 2 weeks
Secondary outcomes:
measure: Resolution time
timeFrame: 24 weeks
measure: Medication needed
timeFrame: 24 weeks
measure: the Dizziness Handicap Inventory (DHI)
timeFrame: 24 weeks
measure: Recurrent rate
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Yuvatiya Plodpoai
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Yuvatiya Plodpai, MD
role: PRINCIPAL_INVESTIGATOR
References: