louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03023969: Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain
Official title: Implication of Two Different Doses of Intradiscal O2-O3 Injection Upon the Pain Alleviation in Patients With Low Back Pain: A Randomized, Single-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 60
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: Low back pain is very common problem, variable modalities have been introduced to control such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that could reduce the herniation disk size and inflammation.

Detailed description: Intervertebral disc herniation is the most common problem which induces low back pain LBP. The number of patients seek surgical and or alternative therapy increases. The rate of re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years postoperative.

Epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on this medications effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular.

Ozone in mixture with oxygen has been justified in multiple studies have been done, this study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation over 12 month follow up period .

Eligibility criteria: Inclusion Criteria:

* All patients Suffered radicular leg pain and some reported additional back pain.
* All patients are non-responsive to conservative treatment modalities with VAS more than 7.

Exclusion criteria

* presence of bleeding disorder
* local infection
* uncontrolled or degenerative spine disease
* pregnancy
* multilevel disk involvement
* patient refusal.

Primary outcomes:
measure: Pain alleviation by visual analogue scale (VAS)
timeFrame: 12 months
Secondary outcomes:
measure: Reduction of disk herniation by MRI
timeFrame: 6 months
measure: Pain alleviation using Oswestry Low Back Pain Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
citation: Elawamy A, Kamel EZ, Hassanien M, Wahba OM, Amin SE. Implication of Two Different Doses of Intradiscal Ozone-Oxygen Injection upon the Pain Alleviation in Patients with Low Back Pain: A Randomized, Single-Blind Study. Pain Physician. 2018 Jan;21(1):E25-E31.
Clinical trial NCT02961569: Comparison Between Two Strategies for the Diagnosis of TB
Official title: Comparative Study Between the Classical Strategy and a Faster, Daily Collection for the Diagnosis of Contagious Pulmonary Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary TB
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Tuberculosis (TB) is a major cause of death among the "communicable" diseases in the world. Pulmonary TB, the main localization, leads to the dissemination of cases. An earlier diagnosis of contagious pulmonary TB is a cornerstone to stop the air transmission. The aim of the study will be to compare two strategies, in patients with a chest-X-ray in favour of contagious pulmonary TB: the classical strategy of sputa collection during three consecutive early mornings, versus the studied strategy of sputa collection at hour h, hour h+1, hour h+2 during the first early morning.

Detailed description: Tuberculosis (TB) is a major cause of death among the "communicable" diseases in the world. Pulmonary TB, the main localization, leads to the dissemination of cases. An earlier diagnosis of contagious pulmonary TB is a cornerstone to stop the air transmission by starting earlier treatment. The aim of the study will be to compare two strategies, in patients with a chest-X-ray in favour of pulmonary TB: the classical strategy of sputa collection during three consecutive early mornings, versus the studied strategy of sputa collection at hour h, hour h+1, hour h+2 during the first early morning.

Eligibility criteria: Inclusion Criteria:

* All adult patients suspected of pulmonary TB (symptoms: lost weight, hemoptysis, chronic cough or fever, or a Chest-X-Ray (CXR) evocative of pulmonary TB)

Exclusion Criteria:

* Patients who refused or were unable to give written consent

Primary outcomes:
measure: Comparison between the sensitivities of the two strategies for detection of Acid fast bacilli (AFB) on direct stain
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
state: Ile-de-France
Study officials:
affiliation: Unité de Recherches Thérapeutiques, Hôpital Lariboisière
name: Célia Lloret-Linares, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopes A, Mougari F, Chopin D, Pogliaghi M, Munier AL, Delcey V, Simoneau G, Raskine L, Evans J, Mouly S, Cambau E, Bergmann JF, Sellier P. Prospective study comparing the conventional and same-day strategies to diagnose pulmonary tuberculosis. Med Mal Infect. 2020 Feb;50(1):36-42. doi: 10.1016/j.medmal.2019.03.010. Epub 2019 Apr 11.
Clinical trial NCT04608669: Paracetamol Hypothermia Children
Official title: Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Safety Issues
Lead sponsor: Saint George Hospital
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: Temperature variation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint Georges hospital
Study officials:
References:
Clinical trial NCT06197269: Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
Official title: Efficacy And Safety Of Short Course Antibiotic Therapy (72hrs) As Compared To Standard Duration (5-7 Days) Of Therapy In Preterm Neonates With Culture Negative Early Onset Sepsis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early-Onset Neonatal Sepsis
Antibiotic Stewardship
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2024-01-09
Enrollment: 75
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( \>28weeks and \>1000grams ) with culture negative early onset sepsis.

Detailed description: Enrolled participants will be randomly allocated to one of two study groups: 1) Short duration antibiotic' (72hrs), 2) Standard duration antibiotic'(5 - 7days)

Short duration antibiotic group: Antibiotic therapy stopped at the time of randomization i.e. 72 hours after starting antibiotics

Standard duration antibiotic group: antibiotics therapy continued for 5-7 days further after 72 hrs of starting antibiotics.

Eligibility criteria: Inclusion Criteria (All must be present)

* All Preterm neonates (Gestational age \>28weeks and \>1000grams)
* age less than 72hours of life
* Started on antibiotic therapy based on presence of symptoms attributable to sepsis and /or positive sepsis screen but sterile blood culture
* Symptoms resolved at time of randomization

Exclusion Criteria:

* Antibiotics started based on risk factors
* Infants with major congenital anomalies or syndromes.
* Presence of site specific infections including meningitis, pneumonia
* Neonates suspected to have inborn errors of metabolism
* Neonates with Severe birth asphyxia, (Apgar score at 5min \<4 and cord Ph\< 7.0,base excess \<-16)
* Neonates underwent major surgery in 1st week of life
* Deemed by Doctor in charge to be sick enough to be continued on antibiotics

Primary outcomes:
measure: Incidence of 'Treatment Failure'
timeFrame: 15 days of stopping antibiotics
Secondary outcomes:
measure: Mortality
timeFrame: Till 1 month of life
measure: Need for additional courses of antibiotic therapy
timeFrame: Till 1 month of life
measure: Length of hospital stay
timeFrame: From date of birth until date of death or discharge whichever come assessed till 1 month of life
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Lady Hardinge Medical college
state: Delhi
Study officials:
References:
Clinical trial NCT00005769: Hormone Replacement Therapy and Insulin Action: A Double-Blind, Parallel, Placebo-Controlled Hormone Intervention Study in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Menopause
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-06-02
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Considerable controversy exists regarding the effect of estrogen and progesterone on insulin sensitivity in postmenopausal women. Thus, the goal is to examine the effect of estradiol and progestin on in vivo insulin sensitivity and pathways of intracellular glucose metabolism in postmenopausal women. This will be accomplished by examining the effects of unopposed estrogen (CEE) or combination estrogen and progestin (CEE/MPA) versus placebo therapy in 30 early menopausal women (defined from 6 months to 3 years post-cessation of menses). Women will be treated for 16 weeks and the outcome measures will be: 1) insulin sensitivity and glucose oxidation as determined by euglycemic clamp, 2) assessments of insulin sensitivity on muscle biopsy cultures with the primary endpoints being glucose uptake and glycogen accumulation/synthesis, 3) protein levels of insulin action cascade steps based on muscle biopsy Western blots.


Eligibility criteria: Inclusion Criteria:

* 6 months to 3 years since cessation of menses
* BMD 24-33
* no surgically induced menopause

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
Clinical trial NCT05799768: Ketogenic Diet in Rheumatoid Arthritis (RA)
Official title: Ketogenic Diet Intervention in Patients With Rheumatoid Arthritis (RA): a Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Rheumatoid Arthritis
Inflammation
Obesity
Ketogenic Dieting
Metabolic Syndrome
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Rheumatology Research Foundation
First posted: 2023-04-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a 6-week ketogenic diet (KD) intervention where participants with rheumatoid arthritis (RA) will follow a KD plan, supervised and monitored by a dietician. Participants will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home blood ketone/glucose monitors, along with diet records. Participants will fill out health related questionnaires and undergo assessments of body composition, RA disease activity. This study also includes blood draws and fat biopsy of the abdominal region.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of RA according to the ACR/EULAR 2010 criteria for RA.
* On stable doses of DMARDs and/ or biological agents (≥ 2 months prior to study enrollment)

Exclusion Criteria:

* Chronic inflammatory/ autoimmune disease other than RA (e.g. gout, inflammatory bowel disease such as Crohn's disease or ulcerative colitis, lupus, myositis, etc.)
* Prednisone or other glucocorticoid use in the last 4 weeks (exception: intra-articular glucocorticoid injections)
* Insulin use
* Hospitalization in the 30 days prior to study enrollment
* Acute or uncontrolled disease (e.g. cirrhosis, COPD, CKD)
* Malignancy
* Chronic infection (HIV, hep B/C, etc.)
* Heavy drinking
* On a ketogenic diet or exogenous ketone supplement (lses than 3 months prior to study enrollment)
* Recent weight loss (\>5% in the last 2 months)

Primary outcomes:
measure: hsCRP
timeFrame: 6 weeks
Secondary outcomes:
measure: DAS28-CRP
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma University Health Sciences Center
state: Oklahoma
Study officials:
References:
Clinical trial NCT06622668: NTLA-3001 in Adults with Alpha-1 Antitrypsin Deficiency-Associated Lung Disease
Official title: Phase 1/2 Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NTLA-3001 in Participants with Alpha-1 Antitrypsin Deficiency (AATD)-Associated Lung Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Lung Disease
Pulmonary Disease
AATD
Alpha-1 Antitrypsin Deficiency
Alpha-1 Antitrypsin Deficiency-associated Lung Disease
Keywords: AATD
Lead sponsor: Intellia Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will be conducted to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of NTLA-3001 in adults with alpha-1 antitrypsin deficiency (AATD) -associated lung disease

Detailed description: This study consists of 2 parts: Phase 1 is an open-label, single-arm ascending dose study to characterize the safety and activity of NTLA3001 and identify the dose for evaluation in Phase 2. Phase 2 will follow as an open-label, dose expansion study to further characterize the safety and clinical activity of NTLA-3001 and provide an initial assessment of the effect of NTLA-3001 on clinical measures of pulmonary function.

Eligibility criteria: Inclusion:

1. Age 18 years to 75 years
2. Diagnosis of AATD ZZ/ZNull genotypes
3. FEV1 ≥35% and ≤65%
4. No evidence of liver cirrhosis
5. Adequate chemistry and hematology measures at screening
6. Participants must agree not to participate in another interventional study for the duration of this trial.
7. Participants must be capable of providing signed informed consent

Exclusion Criteria:

1. AATD genotypes outside of ZZ or ZNull
2. Participants with total antibodies to adeno-associated virus (AAV) serotype above laboratory assay cut off
3. Participants who have known negative reaction or hypersensitivity to any lipid nanoparticles (LNP) component.
4. Any condition that, in the Investigator's opinion, could adversely affect the safety of the participant.
5. Unwilling to comply with study procedures.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: From NTLA-3001 infusion up to week156 post infusion
Secondary outcomes:
measure: Pharmacodynamics
timeFrame: From NTLA-3001 infusion up to week 156 post infusion
measure: Immune Response
timeFrame: From NTLA-3001 infusion up to week 156 post infusion
measure: Vector Shedding
timeFrame: From NTLA-3001 infusion up to week 156 post infusion, only during phase 2.
Other outcomes:
Locations:
city: Aukland
country: New Zealand
facility: New Zealand Clinical Research
Study officials:
References:
Clinical trial NCT04156568: A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
Official title: A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Children LTBI
Keywords: Children
LTBI
Intervention
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The management of latent Mycobacterium tuberculosis infection is a new priority action for the WHO End Tuberculosis (TB) Strategy. However, national guidelines on latent tuberculosis infection testing and treatment have not yet been developed in children of China. Here, we present the results from the 3-year follow-up of a study that aimed to track the development of active disease in individuals with latent tuberculosis infection, identify priority populations for latent infection management, and explore the most suitable latent infection diagnostic approach.

Detailed description: 1. Baseline analysis of a population-based, multicentre, prospective cohort study

1. A baseline survey of a population-based, multicentre, prospective cohort study were took in children (≤18).
2. Eligible participants were identifi ed by door-to-door survey with a household sampling design.
3. Participants were screened for active tuberculosis and history of tuberculosis then used a tuberculin skin test and an interferon-γ release assay (QuantiFERON \[QFT\]) to test for latent infection.

2. Incidence of active tuberculosis in individuals with latent tuberculosis infection in children of China under different treatment regimens

1. Individuals who had tuberculosis infection at baseline (QFT-positivity or TST tuberculin reaction size \[induration\] of ≥10 mm) were divided and treatment with different therapeutic schedule.
2. Follow-up study were conducted to assess the proportion of latent TB infection converted to active TB

Eligibility criteria: Inclusion Criteria:

* Children (0-18 years old).
* Children with QFT-positive or TST induration ≥10 mm).

Exclusion Criteria:

* Patients are allergic to anti-tuberculsis drugs.
* Parents and/or guardians do not agree to participate in this study.
* Participants with active tuberculosis.

Primary outcomes:
measure: Morbidity
timeFrame: During the 2 year follow-up study
measure: Proportion of adverse reactions
timeFrame: During the 2 year follow-up study
measure: Proportion of lost to follow-up
timeFrame: During the 2 year follow-up study
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital of Capital Medical University
Study officials:
affiliation: Beijing Children's Hospital of Capital Medical University
name: A-Dong Shen, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04647968: Primary vs Secondary Closure of Tracheo-cutaneous Fistulas
Official title: Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tracheostomy Complication
Post Tracheostomy Complications
Tracheostomy
Keywords: tracheostomy
tracheostomy closure
tracheocutaneous fistula
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: The mean of this study is to compare primary and secondary closure of tracheo-cutaneous fistulas and evaluate the differences in outcomes between both techniques.

Detailed description: In this study the investigators wish to recruit patients with a tracheotomy that has been installed for various reasons and that is ready for closure. The investigators intend to randomly allocate them a mean of closure, either primary or secondary. Once the fistula is closed, the investigators will follow them over a substantial period of time to compare outcomes of each mean of closing. Different questionnaires will be used to best evaluate a range of variables.

Eligibility criteria: Inclusion Criteria:

* Being covered by the RAMQ
* Having a tracheostomy either percutaneous or surgical
* Being ready for canula removal and closure of the fistula

Exclusion Criteria:

* Presenting a contraindication to primary tracheotomy closure (granuloma)
* Unable to consent
* Refusal to participate

Primary outcomes:
measure: Patient satisfaction in regards to the scar (change)
timeFrame: 1 week, 1 month, 3 months, 6 months
Secondary outcomes:
measure: Healing time
timeFrame: 6 months
measure: Respiratory complications
timeFrame: 6 months
measure: Self reported quality of life related to dysphonia (change)
timeFrame: 1 week, 1 month, 3 months, 6 months
measure: Persisting fistula
timeFrame: 6 months
measure: Self reported quality of life related to dysphagia (change)
timeFrame: 1 week, 1 month, 3 months, 6 months
measure: Self reported quality of life related to dyspnea (change)
timeFrame: 1 week, 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Simon Brisebois, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References: