louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04946578: The Effect of Prebiotics on Endurance Performance
Official title: Modulation of the Intestinal Microbiome, and Its Effects on Endurance Exercise Capacity in Moderately Trained Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microtia
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study conforms to a randomized, single-blinded, placebo-controlled parallel study design.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of a six-week period personalised food intervention with prebiotic supplementation on intense exercise performance in healthy, recreationally active adults.

Detailed description: The study conforms to a randomized, single-blinded, placebo-controlled parallel study design.

a prebiotic supplement will be selected based on a participants gut microbiota. 1 sachet of prebiotic or placebo will be given twice a day over a period of 6 weeks.

Before the start of the study, a VO2max test will be performed. Subjects will bring faecal samples which is collected at home. A time to exhaustion of approximately 80% of their VO2max will be performed at baseline and after the 6 weeks intervention period.

Eligibility criteria: Inclusion Criteria:

* Male or female 18 - 40 y
* BMI range 18.5 - 25 kg/m2
* Recreational active (performing non-competitive physical endurance exercise at least two times per week with a minimum duration of 60 minutes per exercise bout)

Exclusion Criteria:

* Smoking
* Performing regular resistance training (3+ times per week, carrying out progressive overload training)
* Subject following an overly imbalanced or restrictive diet as per nutritional advice
* Participants who received antibiotics in the 90 days prior to the start of the study
* Self-admitted lactose intolerance
* Administration of probiotic or prebiotic supplements in the 14 days prior to the study

Primary outcomes:
measure: Time to Exhaustion
timeFrame: From baseline to end of the study (up to max 45 days)
Secondary outcomes:
measure: Gut microbiota composition
timeFrame: From baseline to end of the study (up to max 45 days)
measure: Plasma short chain fatty acids
timeFrame: From baseline to end of the study (up to max 45 days)
measure: Blood glucose
timeFrame: From baseline to end of the study (up to max 45 days)
measure: Insulin
timeFrame: From baseline to end of the study (up to max 45 days)
measure: Intestinal permeability by sugar test
timeFrame: From baseline to end of the study (up to max 45 days)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References:
Clinical trial NCT03474978: Peripherally Inserted Central Catheter Insertion Site and Complication Rate in Neonates
Official title: Peripherally Inserted Central Venous Catheter Insertion Site and Complication Rates in Neonates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Catheterization, Peripheral
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 320
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines whether there is an association between the PICC insertion site and the complications necessitating PICC removal in neonates admitted to neonatal intensive care unit.


Eligibility criteria: Inclusion Criteria:

1. Neonates of all gestational ages admitted to Foothills Medical Centre and Alberta Children's Hospital Neonatal Intensive Care Unit (NICU)
2. Peripherally inserted central venous catheter (PICC) line insertion planned as part of NICU care
3. Venous access available in both upper(above umbilicus) and lower body

Exclusion Criteria:

1. Local infection at potential site of insertion
2. Hemangioma, lymphangioma or malformations in the region of insertion
3. Major chromosomal anomalies

Primary outcomes:
measure: Primary outcome is the presence of any complication which necessitates PICC removal
timeFrame: Through study completion, within 4 weeks
Secondary outcomes:
measure: Secondary outcome will be time to complication post insertion
timeFrame: Through study completion, within 4 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Amuchou Soraisham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02850978: Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease
Official title: Post-marketing Surveillance (PMS) on Long-term Use of Tiotropium+Olodaterol Fixed Dose Combination (Tio+Olo FDC) 5µg/5µg in Patients With Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-08-01
Enrollment: 1335
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000

Brief summary: Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting


Eligibility criteria: Inclusion criteria:

* Patients who have been diagnosed with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) by physician and need relief of various symptoms associated with Long Acting Beta2 Agonist (LABA) or Long Acting Muscarinic Antagonist (LAMA).
* Patients who are prescribed Tio+Olo FDC 5µg/5µg for the first time

Exclusion criteria:

* Patients who have been registered once in this study (i.e., re-entry of patients is not allowed).
* Patients who are participating in a registry or clinical trial.
* Patients who have a contraindication to Tio+Olo FDC 5µg/5µg defined in the package insert for Tio+Olo FDC 5µg/5µg.

Primary outcomes:
measure: Percentage of Participants With Adverse Drug Reactions
timeFrame: From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
Secondary outcomes:
measure: Change of COPD Assessment Test (CAT) Score From Baseline to Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Sato A, Miyazaki A, Nakamura S. Effectiveness of Tiotropium/Olodaterol in the Real World: A Post Hoc Subgroup Analysis After the First Year of Use. Adv Ther. 2022 Oct;39(10):4692-4706. doi: 10.1007/s12325-022-02268-1. Epub 2022 Aug 10.
Clinical trial NCT00388778: The Effect of Doxycycline 100mg and Doxycycline 20mg in Treatment of Mild and Moderate Acne
Official title: The Effect of Doxycycline 100mg and Doxycycline 20mg in Treatment of Mild and Moderate Acne
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Acne
Inflammation
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of twice daily subantimicrobial dose doxycycline 20mg with daily doxycycline 100mg in treatment of mild and moderate Acne.


Eligibility criteria: Inclusion Criteria:

* Acne

Exclusion Criteria:

* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Skin Research Center, Shaheed Beheshti Medical University
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Parviz Toossi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402778: Fixation of Thoracic Epidurals Influencing Catheter-related Infections and Dislocation
Official title: Fixation of Thoracic Epidural Catheters Influencing Catheter-related Infections and Dislocation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dislocation
Infection
Line Colonisation
Line Insertion Site
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: University of Osnabrueck
First posted: 2011-07-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged \> 18 years

Brief summary: Major interest in our investigation is to find out whether distinct fixation techniques influence catheter dislocation and/ or incidence of local inflammation. A systematic comparison of two different fixation techniques with regard to catheter location, analgetic potential and signs of local inflammation will be conducted. To ensure identical patients groups allocation will be strictly randomized. Furthermore, both patient groups will receive identical pain medication via the peridural catheter in situ. All catheter tips will be screened microbiologically after removal.


Eligibility criteria: Inclusion Criteria:

Patients aged \> 18 years and operation with thoracic epidural

Exclusion Criteria:

Refusal of informed consent

Primary outcomes:
measure: Changes in catheter position
timeFrame: 4-6 days
Secondary outcomes:
measure: Secondary variables
timeFrame: 4-6 days
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Heinrich Heine University, University Hospital Duesseldorf, Department of Anaesthesiology
state: NRW
Study officials:
affiliation: Heinrich Heine University, Department of Anaesthesiology, Chairman: Univ-Prof. Dr.med. B. Pannen
name: Peter Kienbaum, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesia, Marienhospital Osnabrueck
name: Martin Beiderlinden, Privatdozent
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02733978: Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic Sclerosis
Official title: Non-invasive Oxygen-Ozone Therapy in the Treatment of Digital Ulcers in Egyptian Patients With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcer
Scleroderma
Keywords: Ozone oxygen
ulcer healing
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Digital ulcers (DUs) in scleroderma result from recurrent Raynaud's phenomenon (RP) and microtrauma with high impact on quality of life, management of DUs is a great challenge for clinicians. Medical use of ozone (triatomic oxygen) was initiated in the 19th century. Ozone has multiple therapeutic effects in wound healing due to the property of releasing nascent oxygen, which has been shown to stimulate antioxidant enzymes.

Detailed description: Digital ulcers (DUs) in scleroderma result from recurrent Raynaud's phenomenon (RP) and microtrauma with high impact on quality of life, management of DUs is a great challenge for clinicians. Medical use of ozone (triatomic oxygen) was initiated in the 19th century. Ozone has multiple therapeutic effects in wound healing due to the property of releasing nascent oxygen, which has been shown to stimulate antioxidant enzymes, we aim to assess the effects of ozone therapy on the healing in Scleroderma DUs and the expressions of vascular endothelial growth factor (VEGF), and endothelin-1 type A receptor (ETAR) and angiotensin II type 1 receptor (AT1R) autoantibodies level in the wounds after treatment.

Eligibility criteria: Inclusion Criteria:

* systemic sclerosis patients with DUs fulfilling ACR/EULAR criteria for diagnosis 2013

Exclusion Criteria:

* calcinosis ulcer traumatic ulcer vasculitis

Primary outcomes:
measure: scleroderma ulcer healing
timeFrame: 4 months
measure: Pain
timeFrame: 4 months
Secondary outcomes:
measure: Ulcer biopsy
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References:
citation: Elvis AM, Ekta JS. Ozone therapy: A clinical review. J Nat Sci Biol Med. 2011 Jan;2(1):66-70. doi: 10.4103/0976-9668.82319.
Clinical trial NCT03043378: Chronic Non-Malignant Pain in Cancer Patients at a Supportive Care Clinic
Official title: Chronic Non-Malignant Pain in Cancer Patients at a Supportive Care Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasms of Independent (Primary) Multiple Sites
Keywords: Malignant Neoplasms of Independent (Primary) Multiple Sites
Non-malignant pain
Supportive care
Questionnaires
Surveys
Chronic non-malignant pain
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants undergoing consultation at the Supportive Care Clinic at MD Anderson Cancer Center.

Brief summary: The goal of this research study is to learn how frequently cancer patients in the Supportive Care Center have chronic, non-malignant pain. Chronic, non-malignant pain is pain that is neither related to cancer nor its treatment and lasts beyond the normal tissue healing time of 3 months.

Detailed description: If participant is found to be eligible and agrees to take part in this study, participant will be asked to complete 3 questionnaires about participant's pain, pain level, and what drugs participant takes to treat participant's pain. Participant will also be asked a few questions about tobacco use. These questionnaires should take about 20 minutes to complete.

Researchers will also collect information from participant's medical record such as participant's date of birth, sex, race, marital status, economic background, and medical history.

Length of Study:

Participation on this study will be over after participant has completed the last questionnaire.

This is an investigational study.

Up to 200 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of cancer with or without active disease
2. Consultation visit at an outpatient supportive care clinic
3. Age 18 or greater
4. Report of having pain within the last 3 months

Exclusion Criteria:

1) Memorial Delirium Assessment Scale \>13

Primary outcomes:
measure: Frequency of Chronic Non-Malignant Pain Among Cancer Patients
timeFrame: 1 day
measure: Frequency of Chronic Non-Malignant Pain Among Cancer Patients
timeFrame: 1 day
measure: Frequency of Chronic Non-Malignant Pain Among Cancer Patients
timeFrame: 1 day
measure: Frequency of Chronic Non-Malignant Pain Among Cancer Patients
timeFrame: 1 days
measure: Frequency of Chronic Non-Malignant Pain Among Cancer Patients
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Hui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06565078: A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants with Primary Immunodeficiency
Official title: Post-marketing Database Survey: a Cohort Study to Evaluate the Safety of Cuvitru in Patients with Primary Immunodeficiency Using the PIDJ2 (Primary Immunodeficiency Database in Japan) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Immunodeficiency Diseases (PID)
Keywords: Primary immunodeficiency disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-08-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.

Brief summary: This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID). This survey will conduct in use of medical database called PIDJ2.


Eligibility criteria: Inclusion Criteria:

1. Patients with primary immunodeficiency (PID) enrolled in the PID patient registry.
2. Participant for whom study drug is entered in the therapeutic drug field on the data set.
3. Participant who is entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
4. Participant for whom the presence or absence of adverse events has been entered in the column of adverse events.

Exclusion Criteria:

1. Participant for whom study drug has not been entered in the drug name in the medical history field during the period from January 24, 2024 to January 23, 2029.
2. Participant who is not entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.
3. Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.

Primary outcomes:
measure: Number of Participants Who Experience Anaphylactic Reaction as an Adverse Event (AE)
timeFrame: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
measure: Number of Participants Who Experience Thromboembolism as an AE
timeFrame: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
measure: Number of Participants Who Experience Aseptic Meningitis as an AE
timeFrame: From initial registration in the database or first dose of study drug, whichever came late, up to end date of data period (up to 5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
References:
Clinical trial NCT01220778: Effects of Physical Activity During Pregnancy on the Newborn's Cognitive Function
Official title: Effects of Physical Activity During Pregnancy on the Newborn's Cognitive Function, the Healthy Mom, Bright Child Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2010-10-14
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Background: It is now generally accepted that an active lifestyle is beneficial for cognition, but can these benefits be transmitted for the active pregnant woman to her unborn child? This has been demonstrated in rats where the pups born of mothers who exercised during pregnancy had increased hippocampal neurogenesis and better memory and learning capabilities. Human studies tend to confirm this by looking at behavioral results, ie. better orientation and state regulation skills in newborns. The aim of the present study is to verify this on the electrophysiological level and to determine the effects of an active lifestyle during pregnancy on the newborn's brain development.

Methods: 60 pregnant women will be included in a randomized controlled trial. The exercise group will be asked to exercise a minimum of 20 minutes, 3 times per week, at a minimal intensity of 55% of their maximal aerobic capacity. The control group will not be given exercise counselling. Newborns' brain activity will be recorded using electroencephalography (EEG) 10 days post partum. The primary outcome measure will be the amplitude and latency of the mismatch negativity (MMN), a component of the auditory event-related potential (ERP) that can be used to investigate the auditory sensory memory.


Eligibility criteria: Inclusion Criteria:

* First trimester of pregnancy
* 20 to 35 years of age
* Pre-pregnancy BMI between 18 and 25
* Primipara
* Without any known health issues
* Use of folic acid

Exclusion Criteria:

* Use of alcohol, cigarettes or illegal drugs
* Pregnancy complications
* Unable or unwilling to breastfeed
* Excessive or insufficient weight gain

Primary outcomes:
measure: Mismatch negativity
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Cepsum
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Elise L.LeMoyne
role: PRINCIPAL_INVESTIGATOR
References:
citation: LeMoyne EL, Curnier D, St-Jacques S, Ellemberg D. The effects of exercise during pregnancy on the newborn's brain: study protocol for a randomized controlled trial. Trials. 2012 May 29;13:68. doi: 10.1186/1745-6215-13-68.
Clinical trial NCT01900678: A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
Official title: VLIC-USA: A Single-Center Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: VytronUS, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this investigation is to evaluate whether pulmonary vein isolation using the VytronUS ablation system is safe and effective acutely and at 3 months.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 70 years old.
* Recurrent symptomatic paroxysmal atrial fibrillation refractory to at least one antiarrhythmic drug.

Exclusion Criteria:

* Prior pulmonary vein isolation
* Presence of intracardiac thrombus
* Indication of inaccessible pulmonary or cardiac anatomy
* Myocardial infarction, PCI, or cardiac surgery in prior three months
* Moderate to severe valvular disease or prior valve replacement
* NYHA Class IV
* LVEF \< 40%
* Previous stroke or TIA
* Serum creatinine \> 2.5mg/dL or allergy to intravenous contrast agents
* Existing bleeding diathesis or history of complications with anticoagulation therapy
* Women who are nursing, pregnant, or trying to become pregnant
* Subjects unwilling or unable to provide consent
* Participation in a drug or device trial that would prevent completion of required study procedures
* Active implantable devices
* Major organ system disease

Primary outcomes:
measure: Device or procedure related adverse events.
timeFrame: Three months post procedure.
Secondary outcomes:
measure: Pulmonary vein isolation.
timeFrame: Three months post procedure.
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Na Homolce Hospital
Study officials:
affiliation: Na Homolce Hospital
name: Petr Neuzil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: