louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05017389: Long Term Health Cohort of Premature Infants
Official title: A Cohort Study on the Long-term Health Outcomes of Premature Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterm
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 1200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: premature infants with gestational age ≤ 36 + 6 weeks.

Brief summary: Establish a clinical diagnosis and treatment and long-term follow-up database of preterm infants, and analyze the effects of prenatal factors (including genetic characteristics, maternal diseases, etc.), postnatal diagnosis and treatment measures and family maintenance environment after discharge on preterm infant mortality and major diseases in the near and long term.

Detailed description: As an increasing large group, the long-term quality of life and health status of preterm infants have become a very important public health problem in China. This cohort study is a single center clinical cohort study. By collecting the clinical diagnosis, treatment and follow-up data of preterm infants admitted to the neonatal department of our hospital for 3 consecutive years (about 1200 cases), and following them for 18 years, a relatively complete resource database for the long-term health and development of preterm infants is established. The effects of perinatal factors, diagnosis and treatment methods and family rearing environment on the survival rate, neurointelligence development, chronic metabolic diseases and respiratory diseases of preterm infants were analyzed. It provides a basis for further improving the diagnosis and treatment plan, exploring potential therapeutic targets and establishing prediction models.

Eligibility criteria: Inclusion Criteria:

1. Live born newborns with gestational age ≤ 36 + 6 weeks
2. Transfer to the neonatal ward of Shanghai Children's medical center within 24 hours after birth
3. Those who have lived in Shanghai for more than 1 year and plan to live in Shanghai for a long time. Parents voluntarily participated in the study and signed informed consent

Exclusion Criteria:

1. Premature infants: termination of treatment due to family factors (non-disease reasons) and hospitalization time ≤ 2 weeks
2. Major congenital malformations
3. Parents refuse to participate in the study

Primary outcomes:
measure: neural development at 1 year old
timeFrame: 1 year
measure: neural development at 2 years old
timeFrame: 2 years
measure: neural development at 6 years old
timeFrame: 6 years
measure: Growth and neural development at 12 years old
timeFrame: 12 years
measure: Growth and neural development at 18 years old
timeFrame: 18 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai children's medical center
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Fei Bei, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT02196389: Comparison Between 4 Different Nasal Dilators
Official title: Comparison Between 4 Different Nasal Dilators: Objective vs Subjective Parameters
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Incompetence of Nasal Valve
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Several nasal dilators are currently commercially available, and can be applied endonasally (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison between these dilators has not been made so far, and would help the clinicians to advise the use of any of these dilators. From clinical experience, endonasal dilators are well supported and improve breathing better than the external dilators

Detailed description: Several nasal dilators are currently commercially available, and can be applied endonasally (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison between these dilators has not been made so far,

Eligibility criteria: Inclusion Criteria:

Patients with nasal obstruction due to external nasal valve problems and with positive Cottle sign.

Age \> 18 and \< 60 years. Ability to give reliable information and written informed consent.

Exclusion Criteria:

Patients with nasal obstruction due to other endonasal anatomic deformities besides external nasal valve dysfunction.

Patients with rhinosinusitis and/or nasal polyps evaluated by nasal endoscopy. Patients with chronic lower airway disease like severe asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis and/or other conditions that interfere with the generation of a reliable Peak Nasal Inspiratory Flow (PNIF) result.

Primary outcomes:
measure: Peak Nasal Inflammatory Flow
timeFrame: 4 weeks
Secondary outcomes:
measure: preference
timeFrame: 4 weeks
Other outcomes:
measure: surgery
timeFrame: 4 weeks
measure: reasons of choice
timeFrame: 4 weeks
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Peter Hellings, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06327789: Trunk Control and Disability in Persons With Multiple Sclerosis
Official title: The Relationship Between Trunk Control and Disability in Persons With Early Relapsing Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: diagnosed with relapsing-remitting multiple sclerosis by an experienced neurologist

Brief summary: This study aims to investigate the relationship between physical disability and trunk control, balance, and pedobarographic parameters in persons with Relapsing Remitting Multiple Sclerosis (RRMS) who have a low Expanded Disability Status Scale (EDSS) score. Twenty-three RRMS patients with an age range of 18-50 years, EDSS score ≤ 3 were included in this study. The patients' level of disability (EDSS), trunk control )Trunk Impairment Scale - TIS), lower extremity functionality (Timed 25-Foot Walk Test - T25FW), upper extremity functionality (Nine Hole Peg Test- 9HPT), balance (Biodex Balance System) and gait (Zebris® FDM 2) were evaluated.


Eligibility criteria: Inclusion Criteria:

* 18-50 years old,
* diagnosed with RRMS by an experienced neurologist
* EDSS score ≤ 3

Exclusion Criteria:

* orthopedic or sensory additional problems in the lower extremity
* who had an interventional procedure in the last six months, and had an attack in the last three months

Primary outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: up to 8 weeks
measure: Trunk Impairment Scale (TIS)
timeFrame: up to 8 weeks
measure: Biodex Balance System (BBS) (MedicalSystems, Shirley, NY, USA)
timeFrame: up to 8 weeks
measure: Step Length (cm)
timeFrame: up to 8 weeks
measure: Stride Length (cm)
timeFrame: up to 8 weeks
measure: Step Width (cm)
timeFrame: up to 8 weeks
measure: Cadence (steps/min)
timeFrame: up to 8 weeks
measure: Velocity (m/s)
timeFrame: up to 8 weeks
measure: Step time (s)
timeFrame: up to 8 weeks
measure: Stride time (s)
timeFrame: up to 8 weeks
measure: Timed 25-Foot Walk Test (T25FW)
timeFrame: up to 8 weeks
measure: Nine-Hole Peg Test (9HPT)
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
Study officials:
affiliation: Samsun University
name: Bilge Piri Çınar
role: PRINCIPAL_INVESTIGATOR
affiliation: Yüksek İhtisas University
name: Güngör Beyza Özvar Şenöz
role: PRINCIPAL_INVESTIGATOR
affiliation: Zonguldak Bulent Ecevit University
name: Hasret Uçar
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Serkan Özakbaş
role: PRINCIPAL_INVESTIGATOR
affiliation: Zonguldak Bulent Ecevit University
name: Mustafa Açıkgöz
role: PRINCIPAL_INVESTIGATOR
affiliation: Zonguldak Bulent Ecevit University
name: Nursena Ceylan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05823389: Flapless Emdogain in the Treatment of Periodontal Residual Pockets
Official title: The Use of Flapless Enamel Matrix Derivative in Treating Periodontal Residual Pockets: A Single-centre Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis, Generalized
Lead sponsor: Arab American University (Palestine)
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 48 adult patients participated in a single-centre randomized clinical trial with split- mouth design. They had presented at re-evaluation after initial non-surgical periodontal therapy (steps 1 and 2 of periodontal therapy) for generalized periodontitis with at least 2 teeth with residual probing pocket depths (PPD) ≥5 and ≤8 mm, with bleeding on probing (BOP). Two teeth with similar PPD were randomized to receive re-instrumentation either with (test) or without (control) adjunctive flapless administration of EMD. Differences in the changes of PPD and BOP from baseline to 6 and 12 months will be analysed, and the frequencies of pocket closure (PPD ≤4 mm and no BOP) will be compared


Eligibility criteria: Inclusion Criteria:

* at least two residual pockets with probing pocket depth (PPD) ≥5 and ≤8 mm,
* bleeding on probing (BOP),
* mobility ≤degree 1 and
* no furcation involvement.

Exclusion Criteria:

* full mouth plaque score \>20%,
* uncontrolled systemic disease,
* history of malignant disease in the oral cavity or previous radiotherapy in the head or neck area,
* pregnant or lactating females,
* drug and alcohol abuse,
* smoking \>10 cigarettes per day and
* inadequate restorative therapy or malocclusion.

Primary outcomes:
measure: Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months
timeFrame: 12 months
measure: Differences in changes of bleeding on probing (BOP) from baseline to 6 and 12 months
timeFrame: 12 months
Secondary outcomes:
measure: frequencies of pocket closure
timeFrame: 12 months
Other outcomes:
Locations:
city: Ramallah
country: Palestinian Territory, occupied
facility: Arab American University
Study officials:
References:
Clinical trial NCT06646289: A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP)
Official title: An Open-label, Multicenter, Phase 2 Follow-on Study for Second Eye Treatment of Patients Previously Treated With a Recombinant Adeno-associated Virus Vector (AAV5 hRKp.RPGR) for Gene Therapy of Adults and Children With X-linked Retinitis Pigmentosa Owing to Defects in Retinitis Pigmentosa GTPase Regulator (RPGR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: X-Linked Retinitis Pigmentosa
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 39
Sex: MALE
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of subretinal delivery of Adeno-associated Virus Vector (AAV5 hRKp.RPGR) gene therapy in adults and children with X-linked retinitis pigmentosa.


Eligibility criteria: Inclusion Criteria:

* Have been treated with AAV5-hRKp.RPGR in study MGT009 and have completed or is currently enrolled in Study MGT010
* Must sign an informed consent form indicating that they understand the purpose and procedures of the study and is willing to participate in the study
* Willing to adhere to the protocol and long-term follow-up

Exclusion Criteria:

- There are no specific exclusion criteria to enroll in this study

Primary outcomes:
measure: Number of Participants With Adverse Events (AE)
timeFrame: From baseline up to 5.5 years
Secondary outcomes:
measure: Change from Baseline in Mean Retinal Sensitivity Within the Central 10 Degrees (MRS10)
timeFrame: Baseline, Months 12, 24, 36, 48 and 60
measure: Change in Retinal Function as Assessed by Pointwise Response in Static Perimetry
timeFrame: From Month 12 up to Month 60
measure: Change in Retinal Function as Assessed by Pointwise Response in Static Perimetry Within Central 30 Degrees Visual Field
timeFrame: From Month 12 up to Month 60
measure: Change from Baseline in Mean Retinal Sensitivity Within the Full Visual Field (MRS90)
timeFrame: Baseline, Months 12, 24, 36, 48 and 60
measure: Change from Baseline in the Low Luminance Questionnaire (LLQ) Domain Scores
timeFrame: Baseline, Month 12
measure: Change from Baseline in Low Luminance Visual Acuity (LLVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart Letter Score
timeFrame: Baseline, Months 12, 24, 36, 48 and 60
measure: Change from Baseline in Best Corrected Visual Acuity (BCVA) by ETDRS Chart Letter Scores
timeFrame: Baseline, Months 12, 24, 36, 48 and 60
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Kellogg Eye Center
state: Michigan
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT04567589: A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Official title: A Cross-sectional Study Among Healthcare Professionals in Canada to Assess Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Uterine Fibroids
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The survey will endeavor to collect 150 completed HCP surveys.

Brief summary: This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Healthcare Professionals (HCPs).

Detailed description: Data will be collected via web-based data capture by HCPs submitting surveys. The survey will be conducted in a single wave over 6 months. All data will be maintained in compliance with local regulations.

Eligibility criteria: Inclusion Criteria:

* HCPs have prescribed Fibristal for the indication of uterine fibroids within the past 6 months.
* HCPs have provided permission to share their responses in aggregate to Health Canada.

Exclusion Criteria:

* HCPs who participated in the cognitive pre-testing of the survey questionnaire to be used for the study.
* HCPs who have been direct employees of Allergan, ICON, Health Canada, or Professional Targeted Marketing (PTM) within the past 5 years.

Primary outcomes:
measure: Percentage of HCPs with correct responses to the knowledge level questions.
timeFrame: 18 - 24 months
Secondary outcomes:
measure: Percentage of HCPs that recall receiving and reading the HCP Letter and HCP Brochure .
timeFrame: 18 - 24 months
measure: Percenatage of HCPs that recall distributing the Fibristal Patient Alert Card
timeFrame: 18 - 24 months
measure: Percentage of patients who recall counselling patients on information included in the Patient Alert Card
timeFrame: 18 - 24 months
measure: Overall score for each HCP will be calculated that totals the correct responses to all of the knowledge-related questions
timeFrame: 18 - 24 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Clinical Trials Registry Team
state: California
Study officials:
affiliation: Allergan
name: Ahunna Ukah
role: STUDY_DIRECTOR
References:
Clinical trial NCT00330889: Effects Of Prednisolone On Rheumatoid Arthritis Patients
Official title: A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-29
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients and pharmacodynamic effects on whole blood gene and protein expression.

Brief summary: This study will assess the Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of Prednisolone on Rheumatoid Arthritis (RA) patients.


Eligibility criteria: Inclusion criteria:

* Meet the ACR criteria for diagnosis of rheumatoid arthritis.
* Required treatment with Prednisolone.
* Currently on a non-steroidal anti-inflammatory agent (NSAID).
* Willing to stay on current dose of NSAID for two weeks during study.

Exclusion criteria:

* Major health issues such as osteoporosis, diabetes, heart failure, heart attack, kidney failure, or acute infection.

Primary outcomes:
measure: Modified Disease Activity Score (DAS28), which was composed of swollen and tender joint counts at 28 sites, a patient's global assessment of disease activity using a visual analogue scale (VAS), and ESR.
timeFrame: 14 days
measure: The levels of selected markers of inflammation, which could include (but were not limited to) ESR, C-reactive protein (CRP), interleukin-6 (IL-6), Rheumatoid factor (RF), and soluble tumor necrosis factor-receptor (TNF-R)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Sheffield
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04535089: Opioid Sparing Analgesia: Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children
Official title: Opioid Sparing Analgesia: Intraoperative Infusion Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Analgesia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-09-01
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perioperative pain control is necessary in children as inadequate treatment may lead to progression of perception of pain and development of chronic pain in the future.

Anesthetists tend to adopt approach to perioperative control of pain by non-opioid drugs that mediate pain modulation. Its use as opioid sparing analgesia in different surgeries leading to mixed results.

Detailed description: Site of study:

This study will be carried out in neurosurgical operating rooms of Zagazig University Hospitals.

b. Sample size: A pilot study was done to estimate percent of children need intraoperative fentanyl was (10%) for dexmedetomidine group, and ( 40%) for lidocaine group, at 0.05 α error and 0.2 β error . Sample size was calculated using Open Epi software, is 32 children in each group.

Eligibility criteria: Inclusion Criteria:

* Age: 6-18 years old.
* Sex: both sexes.
* Physical status: American Society Of Anesthesiologist 1\& II.
* Body Mass Index \>5 th and \< the 85th percentile for age.
* Type of operations: elective intracranial surgeries under general anesthesia.
* Duration of operation \< 3 hours.
* Written informed consent from the parent of child

Exclusion Criteria:

* Altered mental state
* Unsuitability for extubation.
* Patients on beta blocker, alpha 2 agonist.
* Patients on pain killer or with known history of allergy to study drugs.
* Hepatic, renal, Cardiovascular and respiratory disease.
* The patient has the right to withdraw from the study at any time without any negative consequence on their medical or surgical treatment plan.

Primary outcomes:
measure: Intraoperative total fentanyl consumption.
timeFrame: from induction till end of surgery up to 3 hours intraoperative.
Secondary outcomes:
measure: pain intensity
timeFrame: immediately on arrival to PACU, and at 5, 10, 15 minutes till the child will be discharge from PACU postoperative.
measure: level of sedation
timeFrame: up to one hour postoperative
measure: Time to first call for rescue analgesic (fentanyl)
timeFrame: up to one hour postoperative
measure: Total amount of nalbuphine consumption
timeFrame: up to twelve hours postoperative
measure: The duration of Post Anesthesia Care Unite stay
timeFrame: up to 2 hour postoperative
measure: side-effects
timeFrame: up to 12 hour postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University, Faculty of medicine
Study officials:
affiliation: Zagazig University
name: Alshaimaa Kamel, M.D
role: PRINCIPAL_INVESTIGATOR
References: